example of qualitative research in health care

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Qualitative Methods in Health Care Research

Vishnu renjith.

School of Nursing and Midwifery, Royal College of Surgeons Ireland - Bahrain (RCSI Bahrain), Al Sayh Muharraq Governorate, Bahrain

Renjulal Yesodharan

1 Department of Mental Health Nursing, Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Judith A. Noronha

2 Department of OBG Nursing, Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Elissa Ladd

3 School of Nursing, MGH Institute of Health Professions, Boston, USA

Anice George

4 Department of Child Health Nursing, Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Healthcare research is a systematic inquiry intended to generate robust evidence about important issues in the fields of medicine and healthcare. Qualitative research has ample possibilities within the arena of healthcare research. This article aims to inform healthcare professionals regarding qualitative research, its significance, and applicability in the field of healthcare. A wide variety of phenomena that cannot be explained using the quantitative approach can be explored and conveyed using a qualitative method. The major types of qualitative research designs are narrative research, phenomenological research, grounded theory research, ethnographic research, historical research, and case study research. The greatest strength of the qualitative research approach lies in the richness and depth of the healthcare exploration and description it makes. In health research, these methods are considered as the most humanistic and person-centered way of discovering and uncovering thoughts and actions of human beings.

Introduction

Healthcare research is a systematic inquiry intended to generate trustworthy evidence about issues in the field of medicine and healthcare. The three principal approaches to health research are the quantitative, the qualitative, and the mixed methods approach. The quantitative research method uses data, which are measures of values and counts and are often described using statistical methods which in turn aids the researcher to draw inferences. Qualitative research incorporates the recording, interpreting, and analyzing of non-numeric data with an attempt to uncover the deeper meanings of human experiences and behaviors. Mixed methods research, the third methodological approach, involves collection and analysis of both qualitative and quantitative information with an objective to solve different but related questions, or at times the same questions.[ 1 , 2 ]

In healthcare, qualitative research is widely used to understand patterns of health behaviors, describe lived experiences, develop behavioral theories, explore healthcare needs, and design interventions.[ 1 , 2 , 3 ] Because of its ample applications in healthcare, there has been a tremendous increase in the number of health research studies undertaken using qualitative methodology.[ 4 , 5 ] This article discusses qualitative research methods, their significance, and applicability in the arena of healthcare.

Qualitative Research

Diverse academic and non-academic disciplines utilize qualitative research as a method of inquiry to understand human behavior and experiences.[ 6 , 7 ] According to Munhall, “Qualitative research involves broadly stated questions about human experiences and realities, studied through sustained contact with the individual in their natural environments and producing rich, descriptive data that will help us to understand those individual's experiences.”[ 8 ]

Significance of Qualitative Research

The qualitative method of inquiry examines the 'how' and 'why' of decision making, rather than the 'when,' 'what,' and 'where.'[ 7 ] Unlike quantitative methods, the objective of qualitative inquiry is to explore, narrate, and explain the phenomena and make sense of the complex reality. Health interventions, explanatory health models, and medical-social theories could be developed as an outcome of qualitative research.[ 9 ] Understanding the richness and complexity of human behavior is the crux of qualitative research.

Differences between Quantitative and Qualitative Research

The quantitative and qualitative forms of inquiry vary based on their underlying objectives. They are in no way opposed to each other; instead, these two methods are like two sides of a coin. The critical differences between quantitative and qualitative research are summarized in Table 1 .[ 1 , 10 , 11 ]

Differences between quantitative and qualitative research

Qualitative Research Questions and Purpose Statements

Qualitative questions are exploratory and are open-ended. A well-formulated study question forms the basis for developing a protocol, guides the selection of design, and data collection methods. Qualitative research questions generally involve two parts, a central question and related subquestions. The central question is directed towards the primary phenomenon under study, whereas the subquestions explore the subareas of focus. It is advised not to have more than five to seven subquestions. A commonly used framework for designing a qualitative research question is the 'PCO framework' wherein, P stands for the population under study, C stands for the context of exploration, and O stands for the outcome/s of interest.[ 12 ] The PCO framework guides researchers in crafting a focused study question.

Example: In the question, “What are the experiences of mothers on parenting children with Thalassemia?”, the population is “mothers of children with Thalassemia,” the context is “parenting children with Thalassemia,” and the outcome of interest is “experiences.”

The purpose statement specifies the broad focus of the study, identifies the approach, and provides direction for the overall goal of the study. The major components of a purpose statement include the central phenomenon under investigation, the study design and the population of interest. Qualitative research does not require a-priori hypothesis.[ 13 , 14 , 15 ]

Example: Borimnejad et al . undertook a qualitative research on the lived experiences of women suffering from vitiligo. The purpose of this study was, “to explore lived experiences of women suffering from vitiligo using a hermeneutic phenomenological approach.” [ 16 ]

Review of the Literature

In quantitative research, the researchers do an extensive review of scientific literature prior to the commencement of the study. However, in qualitative research, only a minimal literature search is conducted at the beginning of the study. This is to ensure that the researcher is not influenced by the existing understanding of the phenomenon under the study. The minimal literature review will help the researchers to avoid the conceptual pollution of the phenomenon being studied. Nonetheless, an extensive review of the literature is conducted after data collection and analysis.[ 15 ]

Reflexivity

Reflexivity refers to critical self-appraisal about one's own biases, values, preferences, and preconceptions about the phenomenon under investigation. Maintaining a reflexive diary/journal is a widely recognized way to foster reflexivity. According to Creswell, “Reflexivity increases the credibility of the study by enhancing more neutral interpretations.”[ 7 ]

Types of Qualitative Research Designs

The qualitative research approach encompasses a wide array of research designs. The words such as types, traditions, designs, strategies of inquiry, varieties, and methods are used interchangeably. The major types of qualitative research designs are narrative research, phenomenological research, grounded theory research, ethnographic research, historical research, and case study research.[ 1 , 7 , 10 ]

Narrative research

Narrative research focuses on exploring the life of an individual and is ideally suited to tell the stories of individual experiences.[ 17 ] The purpose of narrative research is to utilize 'story telling' as a method in communicating an individual's experience to a larger audience.[ 18 ] The roots of narrative inquiry extend to humanities including anthropology, literature, psychology, education, history, and sociology. Narrative research encompasses the study of individual experiences and learning the significance of those experiences. The data collection procedures include mainly interviews, field notes, letters, photographs, diaries, and documents collected from one or more individuals. Data analysis involves the analysis of the stories or experiences through “re-storying of stories” and developing themes usually in chronological order of events. Rolls and Payne argued that narrative research is a valuable approach in health care research, to gain deeper insight into patient's experiences.[ 19 ]

Example: Karlsson et al . undertook a narrative inquiry to “explore how people with Alzheimer's disease present their life story.” Data were collected from nine participants. They were asked to describe about their life experiences from childhood to adulthood, then to current life and their views about the future life. [ 20 ]

Phenomenological research

Phenomenology is a philosophical tradition developed by German philosopher Edmond Husserl. His student Martin Heidegger did further developments in this methodology. It defines the 'essence' of individual's experiences regarding a certain phenomenon.[ 1 ] The methodology has its origin from philosophy, psychology, and education. The purpose of qualitative research is to understand the people's everyday life experiences and reduce it into the central meaning or the 'essence of the experience'.[ 21 , 22 ] The unit of analysis of phenomenology is the individuals who have had similar experiences of the phenomenon. Interviews with individuals are mainly considered for the data collection, though, documents and observations are also useful. Data analysis includes identification of significant meaning elements, textural description (what was experienced), structural description (how was it experienced), and description of 'essence' of experience.[ 1 , 7 , 21 ] The phenomenological approach is further divided into descriptive and interpretive phenomenology. Descriptive phenomenology focuses on the understanding of the essence of experiences and is best suited in situations that need to describe the lived phenomenon. Hermeneutic phenomenology or Interpretive phenomenology moves beyond the description to uncover the meanings that are not explicitly evident. The researcher tries to interpret the phenomenon, based on their judgment rather than just describing it.[ 7 , 21 , 22 , 23 , 24 ]

Example: A phenomenological study conducted by Cornelio et al . aimed at describing the lived experiences of mothers in parenting children with leukemia. Data from ten mothers were collected using in-depth semi-structured interviews and were analyzed using Husserl's method of phenomenology. Themes such as “pivotal moment in life”, “the experience of being with a seriously ill child”, “having to keep distance with the relatives”, “overcoming the financial and social commitments”, “responding to challenges”, “experience of faith as being key to survival”, “health concerns of the present and future”, and “optimism” were derived. The researchers reported the essence of the study as “chronic illness such as leukemia in children results in a negative impact on the child and on the mother.” [ 25 ]

Grounded Theory Research

Grounded theory has its base in sociology and propagated by two sociologists, Barney Glaser, and Anselm Strauss.[ 26 ] The primary purpose of grounded theory is to discover or generate theory in the context of the social process being studied. The major difference between grounded theory and other approaches lies in its emphasis on theory generation and development. The name grounded theory comes from its ability to induce a theory grounded in the reality of study participants.[ 7 , 27 ] Data collection in grounded theory research involves recording interviews from many individuals until data saturation. Constant comparative analysis, theoretical sampling, theoretical coding, and theoretical saturation are unique features of grounded theory research.[ 26 , 27 , 28 ] Data analysis includes analyzing data through 'open coding,' 'axial coding,' and 'selective coding.'[ 1 , 7 ] Open coding is the first level of abstraction, and it refers to the creation of a broad initial range of categories, axial coding is the procedure of understanding connections between the open codes, whereas selective coding relates to the process of connecting the axial codes to formulate a theory.[ 1 , 7 ] Results of the grounded theory analysis are supplemented with a visual representation of major constructs usually in the form of flow charts or framework diagrams. Quotations from the participants are used in a supportive capacity to substantiate the findings. Strauss and Corbin highlights that “the value of the grounded theory lies not only in its ability to generate a theory but also to ground that theory in the data.”[ 27 ]

Example: Williams et al . conducted a grounded theory research to explore the nature of relationship between the sense of self and the eating disorders. Data were collected form 11 women with a lifetime history of Anorexia Nervosa and were analyzed using the grounded theory methodology. Analysis led to the development of a theoretical framework on the nature of the relationship between the self and Anorexia Nervosa. [ 29 ]

Ethnographic research

Ethnography has its base in anthropology, where the anthropologists used it for understanding the culture-specific knowledge and behaviors. In health sciences research, ethnography focuses on narrating and interpreting the health behaviors of a culture-sharing group. 'Culture-sharing group' in an ethnography represents any 'group of people who share common meanings, customs or experiences.' In health research, it could be a group of physicians working in rural care, a group of medical students, or it could be a group of patients who receive home-based rehabilitation. To understand the cultural patterns, researchers primarily observe the individuals or group of individuals for a prolonged period of time.[ 1 , 7 , 30 ] The scope of ethnography can be broad or narrow depending on the aim. The study of more general cultural groups is termed as macro-ethnography, whereas micro-ethnography focuses on more narrowly defined cultures. Ethnography is usually conducted in a single setting. Ethnographers collect data using a variety of methods such as observation, interviews, audio-video records, and document reviews. A written report includes a detailed description of the culture sharing group with emic and etic perspectives. When the researcher reports the views of the participants it is called emic perspectives and when the researcher reports his or her views about the culture, the term is called etic.[ 7 ]

Example: The aim of the ethnographic study by LeBaron et al . was to explore the barriers to opioid availability and cancer pain management in India. The researchers collected data from fifty-nine participants using in-depth semi-structured interviews, participant observation, and document review. The researchers identified significant barriers by open coding and thematic analysis of the formal interview. [ 31 ]

Historical research

Historical research is the “systematic collection, critical evaluation, and interpretation of historical evidence”.[ 1 ] The purpose of historical research is to gain insights from the past and involves interpreting past events in the light of the present. The data for historical research are usually collected from primary and secondary sources. The primary source mainly includes diaries, first hand information, and writings. The secondary sources are textbooks, newspapers, second or third-hand accounts of historical events and medical/legal documents. The data gathered from these various sources are synthesized and reported as biographical narratives or developmental perspectives in chronological order. The ideas are interpreted in terms of the historical context and significance. The written report describes 'what happened', 'how it happened', 'why it happened', and its significance and implications to current clinical practice.[ 1 , 10 ]

Example: Lubold (2019) analyzed the breastfeeding trends in three countries (Sweden, Ireland, and the United States) using a historical qualitative method. Through analysis of historical data, the researcher found that strong family policies, adherence to international recommendations and adoption of baby-friendly hospital initiative could greatly enhance the breastfeeding rates. [ 32 ]

Case study research

Case study research focuses on the description and in-depth analysis of the case(s) or issues illustrated by the case(s). The design has its origin from psychology, law, and medicine. Case studies are best suited for the understanding of case(s), thus reducing the unit of analysis into studying an event, a program, an activity or an illness. Observations, one to one interviews, artifacts, and documents are used for collecting the data, and the analysis is done through the description of the case. From this, themes and cross-case themes are derived. A written case study report includes a detailed description of one or more cases.[ 7 , 10 ]

Example: Perceptions of poststroke sexuality in a woman of childbearing age was explored using a qualitative case study approach by Beal and Millenbrunch. Semi structured interview was conducted with a 36- year mother of two children with a history of Acute ischemic stroke. The data were analyzed using an inductive approach. The authors concluded that “stroke during childbearing years may affect a woman's perception of herself as a sexual being and her ability to carry out gender roles”. [ 33 ]

Sampling in Qualitative Research

Qualitative researchers widely use non-probability sampling techniques such as purposive sampling, convenience sampling, quota sampling, snowball sampling, homogeneous sampling, maximum variation sampling, extreme (deviant) case sampling, typical case sampling, and intensity sampling. The selection of a sampling technique depends on the nature and needs of the study.[ 34 , 35 , 36 , 37 , 38 , 39 , 40 ] The four widely used sampling techniques are convenience sampling, purposive sampling, snowball sampling, and intensity sampling.

Convenience sampling

It is otherwise called accidental sampling, where the researchers collect data from the subjects who are selected based on accessibility, geographical proximity, ease, speed, and or low cost.[ 34 ] Convenience sampling offers a significant benefit of convenience but often accompanies the issues of sample representation.

Purposive sampling

Purposive or purposeful sampling is a widely used sampling technique.[ 35 ] It involves identifying a population based on already established sampling criteria and then selecting subjects who fulfill that criteria to increase the credibility. However, choosing information-rich cases is the key to determine the power and logic of purposive sampling in a qualitative study.[ 1 ]

Snowball sampling

The method is also known as 'chain referral sampling' or 'network sampling.' The sampling starts by having a few initial participants, and the researcher relies on these early participants to identify additional study participants. It is best adopted when the researcher wishes to study the stigmatized group, or in cases, where findings of participants are likely to be difficult by ordinary means. Respondent ridden sampling is an improvised version of snowball sampling used to find out the participant from a hard-to-find or hard-to-study population.[ 37 , 38 ]

Intensity sampling

The process of identifying information-rich cases that manifest the phenomenon of interest is referred to as intensity sampling. It requires prior information, and considerable judgment about the phenomenon of interest and the researcher should do some preliminary investigations to determine the nature of the variation. Intensity sampling will be done once the researcher identifies the variation across the cases (extreme, average and intense) and picks the intense cases from them.[ 40 ]

Deciding the Sample Size

A-priori sample size calculation is not undertaken in the case of qualitative research. Researchers collect the data from as many participants as possible until they reach the point of data saturation. Data saturation or the point of redundancy is the stage where the researcher no longer sees or hears any new information. Data saturation gives the idea that the researcher has captured all possible information about the phenomenon of interest. Since no further information is being uncovered as redundancy is achieved, at this point the data collection can be stopped. The objective here is to get an overall picture of the chronicle of the phenomenon under the study rather than generalization.[ 1 , 7 , 41 ]

Data Collection in Qualitative Research

The various strategies used for data collection in qualitative research includes in-depth interviews (individual or group), focus group discussions (FGDs), participant observation, narrative life history, document analysis, audio materials, videos or video footage, text analysis, and simple observation. Among all these, the three popular methods are the FGDs, one to one in-depth interviews and the participant observation.

FGDs are useful in eliciting data from a group of individuals. They are normally built around a specific topic and are considered as the best approach to gather data on an entire range of responses to a topic.[ 42 Group size in an FGD ranges from 6 to 12. Depending upon the nature of participants, FGDs could be homogeneous or heterogeneous.[ 1 , 14 ] One to one in-depth interviews are best suited to obtain individuals' life histories, lived experiences, perceptions, and views, particularly while exporting topics of sensitive nature. In-depth interviews can be structured, unstructured, or semi-structured. However, semi-structured interviews are widely used in qualitative research. Participant observations are suitable for gathering data regarding naturally occurring behaviors.[ 1 ]

Data Analysis in Qualitative Research

Various strategies are employed by researchers to analyze data in qualitative research. Data analytic strategies differ according to the type of inquiry. A general content analysis approach is described herewith. Data analysis begins by transcription of the interview data. The researcher carefully reads data and gets a sense of the whole. Once the researcher is familiarized with the data, the researcher strives to identify small meaning units called the 'codes.' The codes are then grouped based on their shared concepts to form the primary categories. Based on the relationship between the primary categories, they are then clustered into secondary categories. The next step involves the identification of themes and interpretation to make meaning out of data. In the results section of the manuscript, the researcher describes the key findings/themes that emerged. The themes can be supported by participants' quotes. The analytical framework used should be explained in sufficient detail, and the analytic framework must be well referenced. The study findings are usually represented in a schematic form for better conceptualization.[ 1 , 7 ] Even though the overall analytical process remains the same across different qualitative designs, each design such as phenomenology, ethnography, and grounded theory has design specific analytical procedures, the details of which are out of the scope of this article.

Computer-Assisted Qualitative Data Analysis Software (CAQDAS)

Until recently, qualitative analysis was done either manually or with the help of a spreadsheet application. Currently, there are various software programs available which aid researchers to manage qualitative data. CAQDAS is basically data management tools and cannot analyze the qualitative data as it lacks the ability to think, reflect, and conceptualize. Nonetheless, CAQDAS helps researchers to manage, shape, and make sense of unstructured information. Open Code, MAXQDA, NVivo, Atlas.ti, and Hyper Research are some of the widely used qualitative data analysis software.[ 14 , 43 ]

Reporting Guidelines

Consolidated Criteria for Reporting Qualitative Research (COREQ) is the widely used reporting guideline for qualitative research. This 32-item checklist assists researchers in reporting all the major aspects related to the study. The three major domains of COREQ are the 'research team and reflexivity', 'study design', and 'analysis and findings'.[ 44 , 45 ]

Critical Appraisal of Qualitative Research

Various scales are available to critical appraisal of qualitative research. The widely used one is the Critical Appraisal Skills Program (CASP) Qualitative Checklist developed by CASP network, UK. This 10-item checklist evaluates the quality of the study under areas such as aims, methodology, research design, ethical considerations, data collection, data analysis, and findings.[ 46 ]

Ethical Issues in Qualitative Research

A qualitative study must be undertaken by grounding it in the principles of bioethics such as beneficence, non-maleficence, autonomy, and justice. Protecting the participants is of utmost importance, and the greatest care has to be taken while collecting data from a vulnerable research population. The researcher must respect individuals, families, and communities and must make sure that the participants are not identifiable by their quotations that the researchers include when publishing the data. Consent for audio/video recordings must be obtained. Approval to be in FGDs must be obtained from the participants. Researchers must ensure the confidentiality and anonymity of the transcripts/audio-video records/photographs/other data collected as a part of the study. The researchers must confirm their role as advocates and proceed in the best interest of all participants.[ 42 , 47 , 48 ]

Rigor in Qualitative Research

The demonstration of rigor or quality in the conduct of the study is essential for every research method. However, the criteria used to evaluate the rigor of quantitative studies are not be appropriate for qualitative methods. Lincoln and Guba (1985) first outlined the criteria for evaluating the qualitative research often referred to as “standards of trustworthiness of qualitative research”.[ 49 ] The four components of the criteria are credibility, transferability, dependability, and confirmability.

Credibility refers to confidence in the 'truth value' of the data and its interpretation. It is used to establish that the findings are true, credible and believable. Credibility is similar to the internal validity in quantitative research.[ 1 , 50 , 51 ] The second criterion to establish the trustworthiness of the qualitative research is transferability, Transferability refers to the degree to which the qualitative results are applicability to other settings, population or contexts. This is analogous to the external validity in quantitative research.[ 1 , 50 , 51 ] Lincoln and Guba recommend authors provide enough details so that the users will be able to evaluate the applicability of data in other contexts.[ 49 ] The criterion of dependability refers to the assumption of repeatability or replicability of the study findings and is similar to that of reliability in quantitative research. The dependability question is 'Whether the study findings be repeated of the study is replicated with the same (similar) cohort of participants, data coders, and context?'[ 1 , 50 , 51 ] Confirmability, the fourth criteria is analogous to the objectivity of the study and refers the degree to which the study findings could be confirmed or corroborated by others. To ensure confirmability the data should directly reflect the participants' experiences and not the bias, motivations, or imaginations of the inquirer.[ 1 , 50 , 51 ] Qualitative researchers should ensure that the study is conducted with enough rigor and should report the measures undertaken to enhance the trustworthiness of the study.

Conclusions

Qualitative research studies are being widely acknowledged and recognized in health care practice. This overview illustrates various qualitative methods and shows how these methods can be used to generate evidence that informs clinical practice. Qualitative research helps to understand the patterns of health behaviors, describe illness experiences, design health interventions, and develop healthcare theories. The ultimate strength of the qualitative research approach lies in the richness of the data and the descriptions and depth of exploration it makes. Hence, qualitative methods are considered as the most humanistic and person-centered way of discovering and uncovering thoughts and actions of human beings.

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Qualitative Research – a practical guide for health and social care researchers and practitioners

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Darshini Ayton, Monash University

Tess Tsindos, Monash University

Danielle Berkovic, Monash University

Copyright Year: 2023

Last Update: 2024

ISBN 13: 9780645755404

Publisher: Monash University

Language: English

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Table of Contents

• Acknowledgement of Country
• About the authors
• Accessibility statement
• Introduction to research
• Research design
• Data collection
• Data analysis
• Writing qualitative research
• Peer review statement
• Licensing and attribution information
• Version history

Ancillary Material

About the book.

This guide is designed to support health and social care researchers and practitioners to integrate qualitative research into the evidence base of health and social care research. Qualitative research designs are diverse and each design has a different focus that will inform the approach undertaken and the results that are generated. The aim is to move beyond the “what” of qualitative research to the “how”, by (1) outlining key qualitative research designs for health and social care research – descriptive, phenomenology, action research, case study, ethnography, and grounded theory; (2) a decision tool of how to select the appropriate design based on a guiding prompting question, the research question and available resources, time and expertise; (3) an overview of mixed methods research and qualitative research in evaluation studies; (4) a practical guide to data collection and analysis; (5) providing examples of qualitative research to illustrate the scope and opportunities; and (6) tips on communicating qualitative research.

About the Contributors

Associate Professor Darshini Ayton is the Deputy Head of the Health and Social Care Unit at Monash University in Melbourne, Australia. She is a transdisciplinary implementation researcher with a focus on improving health and social care for older Australians and operates at the nexus of implementation science, health and social care policies, public health and consumer engagement. She has led qualitative research studies in hospitals, aged care, not-for-profit organisations and for government and utilises a range of data collection methods.  Associate Professor Ayton established and is the director of the highly successful Qualitative Research Methods for Public Health short course which has been running since 2014.

Dr Tess Tsindos  is a Research Fellow with the Health and Social Care Unit at Monash University in Melbourne, Australia. She is a public health researcher and lecturer with strong qualitative and mixed methods research experience conducting research studies in hospital and community health settings, not-for-profit organisations and for government. Prior to working in academia, Dr Tsindos worked in community care for government and not-for-profit organisations for more than 25 years. Dr Tsindos has a strong evaluation background having conducted numerous evaluations for a range of health and social care organisations. Based on this experience she coordinated the Bachelor of Health Science/Public Health Evaluation unit and the Master of Public Health Evaluation unit and developed the Evaluating Public Health Programs short course in 2022. Dr Tsindos is the Unit Coordinator of the Master of Public Health Qualitative Research Methods Unit which was established in 2022.

Dr Danielle Berkovic  is a Research Fellow in the School of Public Health and Preventive Medicine at Monash University in Melbourne, Australia. She is a public health and consumer-led researcher with strong qualitative and mixed-methods research experience focused on improving health services and clinical guidelines for people with arthritis and other musculoskeletal conditions. She has conducted qualitative research studies in hospitals and community health settings. Dr Berkovic currently provides qualitative input into Australia’s first Living Guideline for the pharmacological management of inflammatory arthritis. Dr Berkovic is passionate about incorporating qualitative research methods into traditionally clinical and quantitative spaces and enjoys teaching clinicians and up-and-coming researchers about the benefits of qualitative research.

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Qualitative Research: Understanding Patients' Needs and Experiences

• The PLoS Medicine Editors

Published: August 28, 2007

• https://doi.org/10.1371/journal.pmed.0040258
• Reader Comments

Citation: The PLoS Medicine Editors (2007) Qualitative Research: Understanding Patients' Needs and Experiences. PLoS Med 4(8): e258. https://doi.org/10.1371/journal.pmed.0040258

Copyright: © 2007 The PLoS Medicine Editors. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Why do up to half of all patients with tuberculosis (TB) fail to adhere to drug treatment [ 1 ]? The answer to this question is a matter of life and death, since nonadherence contributes to disease relapse and mortality [ 2 ]. In last month's PLoS Medicine, Salla Munro and colleagues argue that qualitative studies—in which researchers listen to what patients, care givers, and health care providers have to say—can provide important insights into why nonadherence occurs [ 3 ]. Their paper is a “meta-ethnography” [ 4 ], a systematic review and synthesis of qualitative studies on adherence to TB medication. The review found a wide array of factors to explain nonadherence, such as the belief that if one's symptoms have disappeared there is no need to finish a course of treatment. We published this review because we thought it would play a role in improving the delivery of TB treatment and ultimately in reducing the enormous global burden of the disease.

PLoS Medicine has now published two such meta-ethnographies (the first looked at adherence to HIV medication [ 5 ]). We have also published a small number of individual qualitative studies. For example, in our special issue on social medicine ( http://collections.plos.org/plosmedicine/socialmedicine-2006.php ), we published a qualitative study of migrant workers in the US that found that farm working and housing conditions are organized according to ethnicity and citizenship and that this hierarchy determines health disparities [ 6 ]. We have been very selective in our editorial decisions about which qualitative studies to publish. In our decision-making process, we have been guided by two crucial questions.

The first question is whether a qualitative approach was the right way to answer the research question. Quantitative research strives to be objective: human beings, health, and illness are the objects of investigation. Such investigation has led to extraordinary biomedical advances—yet patients often fail to reap the benefits because health professionals may not understand how best to deliver them in the context of patients' multifaceted lives. The academic editor of Salla Munro and colleagues' study commented that thinking of TB drugs simply as a “biomedical intervention” without factoring in patients' needs and broader social contexts creates circumstances that increase the likelihood of poor adherence to treatment. Qualitative research is the best way to understand these needs and contexts.

Astrid Fletcher and colleagues, for example, used quantitative methods to objectively determine who (in terms of age, sex, and education level) did not use the eye-care services available in India [ 7 ]. But they adopted a qualitative approach to answer the question of why people did not use these services. David Leon and colleagues, during a quantitative study on hazardous alcohol drinking in Russia, learned that much alcohol was consumed in the form of what were described as “surrogates” [ 8 ]. Qualitative research helped to identify what these surrogates were—they included eau de Cologne and over-the-counter medications.

When researchers investigate the experiences of people receiving or failing to receive health care, identify themes in these subjective stories, and integrate these themes into the greater context of human life experience, the results are informative to care providers. The usefulness of these results lies precisely in their subjectivity: the subjects are telling us, or we are finding out through more subtle observation, what matters to them.

The results of qualitative research can also help to inform the very process of research itself. Qualitative approaches can help us to understand, for example, why some patients decline to participate in clinical trials [ 9 ], or how patients experience the trial process itself. They can even be used to refine or improve a clinical trial in “real time.” In a trial of a computerized decision support tool for patients with atrial fibrillation being considered for anticoagulation treatment, Madeleine Murtagh and colleagues used qualitative evidence in deciding to discontinue one arm of the trial (the intervention in that arm was causing confusion amongst the patients and was unlikely to produce valid data) [ 10 ]. When a quantitative study is assessing the effectiveness of a complex multifaceted intervention, qualitative methods can help to tease out why such an intervention works or fails [ 11 ]. Qualitative approaches can also help to identify which of many possible research questions should receive priority for investigation, often by asking the research participants themselves. For example, patients with asthma may value easy-to-use inhalers more highly than a new class of drug.

Once it is clear that qualitative methods constitute the right approach for a study submitted to PLoS Medicine, the second question is whether the study meets our criteria for rigor and relevance. For a study to be suitable, regardless of the methodology, it should address an important topic in clinical medicine or public health and it should have the potential to transform our understanding of the causes or treatment of disease. In assessing any study, quantitative or qualitative, we are always on the lookout for biases, poorly described methods, and limited generalizability or overinterpretation of the data. In specifically assessing qualitative studies, we additionally wish to be reassured that the researchers used some type of “quality control” in analyzing the data—for example, were the data independently analyzed by at least two researchers and did consistent themes emerge from the data each time?

One characteristic of PLoS Medicine is the very broad range of research that we have published to date. We feel that such a range is appropriate for a medical journal, since understanding the complex nature of illness and health care requires a variety of different research approaches. “What is involved is not a crossroads where we have to go left or right,” Martyn Hammersley has argued in a discussion of the false dichotomy between quantitative and qualitative research. “A better analogy is a complex maze where we are repeatedly faced with decisions, and where paths wind back on one another” [ 12 ].

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• 2. Volmink J, Garner P (2006) Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev 2, CD003343.
• 4. Noblit GW, Hare RD (1988) Meta-ethnography: Synthesizing qualitative studies. Newbury Park (CA): Sage. 88 p.
• 12. (1992) Deconstructing the qualitative–quantitative divide. In: Brannen J, editor. Mixing methods: Qualitative and quantitative research. Aldershot (United Kingdom): Avebury. pp. 39–55. editor.

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Qualitative studies are often used to research phenomena that are difficult to quantify numerically. 1,2 These may include concepts, feelings, opinions, interpretations and meanings, or why people behave in a certain way. Although qualitative research is often described in opposition to quantitative research, the approaches are complementary, and many researchers use mixed methods in their projects, combining the strengths of both approaches. 2 Many comprehensive texts exist on qualitative research methodology including those with a focus on healthcare related research. 2-4 Here we give a brief introduction to the rationale, methods and quality assessment of qualitative research.

https://doi.org/10.1136/dtb.2017.2.0457

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Key issues in qualitative research

Qualitative research allows deeper understanding of the richness and complexity of social phenomena. Qualitative methods can provide evidence on health and illness and can be used in various ways: 3

To complement quantitative methods, or when quantitative methods are impractical (e.g. when the topic is sensitive, poses measurement problems or is concerned with process and/or interaction; the research population is very small; or for intensive understanding of an innovation before widespread introduction). 3

In the exploratory stages of an applied health research programme, when they may clarify the research question and generate hypotheses. 3 Study design is often described as flexible or ‘emergent’ and researchers may have to adapt a study through a process of ‘progressive focussing’ in response to important but unanticipated findings. 3

To assess a pre-specified hypothesis, as in quantitative research. 3

To study particular experiences in depth rather than population averages or generalisations, and explore experiences from different perspectives. 3 For example, assessment of patient satisfaction is complex and varies between cultures or settings, which can make it difficult to develop quantitative measurement instruments. 5

To involve potential users in development and implementation of interventions. 6

To interpret the findings of quantitative research. 3

For example, in one study, alongside a quantitative review on the efficacy of telephone counselling for informal carers of people with dementia, qualitative methods were used to explore carers' experiences of receiving telephone counselling and counsellors' experiences of conducting telephone counselling. 7 Analysis of quantitative and qualitative results identified areas for improvement.

While the same ethical principles (autonomy, non-maleficence [doing no harm], beneficence and justice) apply equally to both quantitative and qualitative research, the application of these principles should take into account the nature of the research proposed. 3 The risks of serious physical harm arising from qualitative research are rarely as high as in quantitative medical studies. However, such research may cause psychological harm, damage to self-esteem and have an adverse impact on interpersonal relationships. Qualitative researchers should seek to minimise such risks. A ‘good’ interviewer builds rapport, encouraging trust and disclosure. In addition, the interviewer also needs to allow opportunities for the interviewee to withdraw or cease disclosure. 4

People, settings, processes, events or data are sampled in qualitative research in order to understand a particular problem, rather than to statistically represent a wider population. In contrast to quantitative methods, where many participants are sampled by randomisation, the small number of participants in qualitative research are often deliberately chosen for their ability to illuminate the research question (known as purposive sampling). 2 , 3 Such sampling may include the selection of outlier cases, cases with maximum variation or homogeneous cases.

Data collection

Methods of collecting data include observation, interviews and focus groups. 3  It is usual to write field notes, but methods can also include video or audio recordings.

Observation

Observation allows researchers to notice events and relationships in a ‘natural’ setting, which may produce insights about which the participants may not be aware. Observation (with varying levels of participation by the researcher in the events being observed) may require a prolonged time period but allows the observer to check their record against an informant's description and note discrepancies. 3

One-to-one interviews are used when the researcher wants to find out something that cannot be directly observed (e.g. how consumers evaluate health services, what understanding and attitudes underlie particular kinds of health behaviour). 3

Good questions in qualitative interviews should be open-ended, neutral, sensitive and clear to the interviewee. 8 , 9 It is usually best to start with questions that the interviewee can answer easily and then proceed to more difficult or sensitive topics. 8 Open questions allow the respondent to answer in their own words and interviews where there is a good rapport may be more likely to create a context in which respondents are prepared to discuss sensitive topics and penetrate beyond a superficial level. 2 , 3 Researchers should monitor their interviewing technique, critically appraise recordings of their interviews and ask others for their comments, noting in particular whether leading questions are being asked, whether cues are picked up or ignored, and whether interviewees are given enough time to explain what they mean. 8

Interviews can be tightly structured or more flexible: 3

A structured (standardised) interview is one in which the wording and order of all questions are exactly the same for every respondent. This aims to ensure that any differences between respondents are not attributable to differences in the questionnaire or research procedures.

A semi-structured interview covers topics on the researcher's agenda, but the phrasing and ordering of questions are tailored to the vocabulary and understanding of respondents, rather than imposing a uniform set of questions, which may be interpreted differently by respondents.

A ‘depth’ or ‘long’ interview, involves no specific set of questions. The participant's perspective on the phenomenon of interest should unfold as the participant and not the researcher views it. 3 The flexibility of such interviews may uncover new unanticipated areas or ideas.

Focus groups

Focus groups (or group interviews) are informal discussions in which participants focus collectively on a topic or issue, usually presented to them (either verbally or in written form) as a vignette to discuss. 3 , 10 Focus group participants (usually 6-8 people) may be existing clusters of people (e.g. family members, friends or work colleagues) or assembled specifically for the research. 10

The advantage of a focus group is the interaction of group participants with each other, as well as with the researcher/moderator. Such interaction is helpful to:

gain access to participants' own assumptions, meanings, vocabulary and thinking patterns;

identify concepts and practices central to the respondents, and to design subsequent questionnaires using respondents' own words or phrases, enhancing future participants' understanding of research questions;

observe how people interact to construct meanings attributed to health and illness, how opinions are formed, expressed, defended and sometimes modified in discussion and debate with others;

enable participants to have more control over the research agenda, which may generate unexpected insights into areas important to them; and

identify obstacles or objections that prevent or discourage individuals from healthy behaviours, and explore individuals' understanding of, and responses to, health-related media messages. 10

Data analysis

Whereas quantitative analysis seeks to reduce data, generating a series of statistics, qualitative analysis aims to represent data using detailed knowledge of cases. Qualitative research studies typically produce very large amounts of data, which are reduced and summarised into codes, concepts, categories, themes and theory. 3

There are many different approaches to analysis in qualitative research, including thematic analysis, framework analysis, grounded theory, interpretive phenomenological analysis, conversation analysis and discourse analysis. 2 , 3 , 11 , 12

Grounded theory derives theory from data using a constant comparative method. 2 , 3 , 11 , 12 Items in the raw data (e.g. interviews, field notes) are broken down, so that as many ideas and concepts as possible are identified and systematically coded, while at the same time comparing them with previous incidents. 2 , 3 Standardised rules are used for transcribing data to limit the risk of misinterpretation. Codes and categories can be based on the respondent's own words. 3 The data are simultaneously organised and reassembled, so that the researcher can identify relevant elements and relationships by cataloguing the substantive topics and attaching labels to concepts and themes that they see emerging from the material (rather than reflecting prior theoretical assumptions), developing core categories and ultimately explaining phenomena. 2 , 3 The analysis is iterative with the findings of preliminary analyses of data from the first phases of fieldwork informing subsequent work. 3

There should be careful documentation of all analytic decisions that lead to the creation of categories, forming an audit trail that provides evidence to support the integrity of the coding, categorisation and interpretive choices made throughout the qualitative data analysis process. 2

Researchers should also demonstrate continuous reflection on the fit between data and reality, by regarding all theoretical explanations, categories, hypotheses and questions about the data as being provisional until they are compared with the data. 3 They should give clear explanations of methods and demonstrate that they have considered alternative possible explanations for their data. 3

A study may be adapted through a process of iterative ‘progressive focussing’ in response to important unanticipated findings. 3 ‘Data saturation’ is a point at which no new themes or ideas arise from data analysis, and data collection can stop at that point.

Researchers' pre-existing assumptions are often challenged by qualitative research, as ideas are raised by respondents and new concepts and theories can develop that help to explain nuance and complexity. 13 Qualitative studies are not seeking statistical generalisability, but to provide insights with applicability to other settings and situations. It is helpful to have the qualitative researchers' description of what they have done and how it was done, so that readers can judge how transferable the findings are to other contexts. 14

Quality assessment

Qualitative methodologies are derived from many fields of social research with different philosophies and underlying assumptions. 3 There is, therefore, more than one correct way to conduct qualitative research, and there are debates and disagreements about qualitative methodology that can be confusing. 15

Quality assessment of qualitative research studies remains a contested area. 16–18 In addition, as qualitative researchers may have an impact on the data, they must show the efforts they undertook to prevent this from influencing the data. 7

Just as the quality of quantitative studies may be assessed using checklists, many checklists are available to help assess qualitative studies. 16 , 17 For example, the Critical Skills Appraisal Programme (CASP) has produced a checklist to aid evaluation of qualitative research (see Box). 19

CASP checklist 19

Screening questions:

Was there a clear statement of the aims of the research?

Is a qualitative methodology appropriate? Is it worth continuing? (Only continue if both these questions are answered ‘yes’).

Was the research design appropriate to address the aims of the research?

Was the recruitment strategy appropriate to the aims of the research?

Were the data collected in a way that addressed the research issue?

Has the relationship between researcher and participants been adequately considered?

Have ethical issues been taken into consideration?

Was the data analysis sufficiently rigorous?

Is there a clear statement of findings?

How valuable is the research?

A more detailed checklist (the COREQ) consists of 32 items in three domains: 20

The research team and reflexivity (covering items such as the researchers' sex, credentials, occupation, experience or training; the relationship with the participants; researchers' biases and assumptions).

The study design (e.g. the theoretical framework, sampling, how participants were approached, the setting, description of the sample, data collection and the audit trail)

Data analysis and reporting (e.g. the number of data coders and description of coding method, whether participant quotations were presented to illustrate the themes, whether data were consistent, and whether themes were clearly presented in the findings).

Comparison between qualitative and quantitative research

The table below summarises some key differences between qualitative and quantitative research.

• View inline

Comparison of quantitative and qualitative research 3

How can qualitative and quantitative research complement each other?

Qualitative research can complement quantitative approaches. Two examples are given below:

Survey research

Qualitative field work (e.g. using observations, interviews or focus groups) to achieve a better understanding of health problems; generation of questions and response options to capture the reality of participants' experiences; qualitative interviews to seek feedback on the perceived meanings and wording of proposed survey questions; quantitative analysis of survey responses from a large, randomly selected sample.

Intervention development and evaluation

Qualitative fieldwork to illuminate the complexity of a health problem, explore barriers and facilitators for change and explore suitable types and designs of treatment or intervention; qualitative methods to involve users in intervention design to ensure that it meets recipient needs and that it is engaging, feasible and sustainable; randomised controlled trial to assess the effectiveness of an intervention; qualitative study to explore how interventions work (and why they don't work) in the real world.

Qualitative research is a technical discipline that is important in providing valuable descriptions of complex phenomena. Qualitative studies differ from quantitative studies in that they often generate rather than test hypotheses; focus on processes, thoughts, feelings and experiences rather than outcomes; and assess small numbers of participants in depth rather than large sample sizes. Such research is designed to capture concepts that are hard to enumerate with quantitative research methods. Findings from qualitative research can enhance the design of other types of research and the implementation of health interventions. Data are often collected using observation, interviews or focus groups, usually recorded and transcribed, which allow the exploration of topics in the respondents' own words and understanding. Analysis of the information must be systematic and transparent; checklists exist to help assess the quality of qualitative studies. Qualitative methods can complement quantitative methods to add a further dimension to research, although there may be issues around the generalisability of results from one context to another. Evidence from qualitative studies can lead to a richer understanding of the complex reality of people's lives and their experience of illness and medical care.

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• ↵ Cochrane Qualitative and Implementation Methods Group , 2013 . Qualitative and implementation evidence and Cochrane reviews [online]. Available: http://methods.cochrane.org/sites/methods.cochrane.org.qi/files/public/uploads/Handbook52_QQ_Qualitative_web%20update%20Oct%202015.pdf [Accessed 18 January 2017] .
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• Volume 11, Issue 2
• Qualitative methods in research on healthcare quality
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• P van Royen 2 ,
• 1 Lecturer in Medical Sociology, Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK
• 2 Professor of General Practice, Department of General Practice, University of Antwerp, Universiteitsplein 1, 2610 Antwerp, Belgium
• 3 Professor of Quality in Health Care, Clinical Governance Research & Development Unit, Department of General Practice & Primary Health Care, University of Leicester, Leicester LE5 4PW, UK
• Correspondence to:
 Dr C Pope, Lecturer in Medical Sociology, Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK;
 c.pope{at}bristol.ac.uk

There are no easy solutions to the problem of improving the quality of care. Research has shown how difficult it can be, but has failed to provide reliable and effective ways to change services and professional performance for the better. Much depends on the perspectives of users and the attitudes and behaviours of professionals in the context of their organisations and healthcare teams. Qualitative research offers a variety of methods for identifying what really matters to patients and carers, detecting obstacles to changing performance, and explaining why improvement does or does not occur. The use of such methods in future studies could lead to a better understanding of how to improve quality.

• qualitative methods
• qualitative research
• quality of care

https://doi.org/10.1136/qhc.11.2.148

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“ I went to see Roy Griffiths (architect of the 1984 NHS reforms and supermarket chief executive) in his office at Sainsbury's and while I was talking to him his secretary handed him a piece of paper. He looked at it and said: `OK'. I asked him: `What do you mean OK?' and he said: `My organisation is OK today'. It turned out he had just six measures on that piece of paper and from those he could tell what the state of Sainsbury's health had been the day before; things like the amount of money taken yesterday, the freshness quotient—the amount of stuff on the shelves—the proportion of staff on duty and so on .” NHS regional manager quoted in Strong and Robinson. 1

The above quote illustrates a view of management in the retail sector that was seen in the UK in the 1980s as a role model for health services. The quality of health care could be assured if we could only develop good quantitative measures such as performance indicators, and thus identify problems, make changes, and improve health services. This vision has been tempered with the realisation that the issue of “quality” is more complicated and nebulous than this model of management implies, especially in the case of complex health systems and services. The assessment of quality of services can no longer be confined to simply monitoring such aspects as waiting time, but requires an understanding of the experience of waiting for care—for example, the nature of the clinical environment, the adequacy of communication by and with health professionals, the context and manner in which treatment is delivered, and whether services and care meet expectations. Moreover, it is increasingly recognised that views of quality depend on one's perspective: patients, providers, politicians, and the public may all have contested views of what constitutes high or poor quality care.

The concept of quality in health care is multidimensional and complex and some of the questions we want to ask about the quality of care or services may not be amenable to quantitative measurement. Qualitative research has come to the fore in health and social research by providing ways of answering these sorts of questions, 2, 3 both in the form of “stand alone” or independent research projects and as a complement to quantitative studies.

The use of qualitative methods in qualitative research involves the systematic collection, organisation, and analysis of textual material derived from talk or observation. It is rooted in the interpretive perspectives found in the humanities and social sciences that emphasise the importance of understanding, from the viewpoint of the people involved, how individuals and groups interpret, experience, and make sense of social phenomena. It is not possible here to elaborate on the origins and theoretical underpinnings of this distinctive approach to research, but it is important to be aware that qualitative research is informed by a quite different paradigm to that which governs quantitative clinical and biomedical research. The emphasis in qualitative research on understanding meanings and experiences makes it particularly useful for quality assessment and for unpacking some of the complex issues inherent to quality improvement. This paper explores some of the qualitative methods that can help to gather information about the delivery of good quality health care and explain variations in health care provision.

THE METHODS

Qualitative researchers study phenomena and events in their natural settings, often interpreting them in terms of the subjective meanings attached by the individual. Qualitative methods for collecting data include interviews, observation, and analysis of documents. Different methods may be appropriate to different situations and different research questions. In some cases a single method may be used while in others a combination of methods may be employed. In this paper we focus on interview based and observational methods as these are the most commonly used in quality assessment.

Interview based methods

Individual face to face interviews may be either semi-structured or in-depth. Semi-structured interviews are typically based on a flexible topic guide that provides a loose structure of open ended questions to explore experiences and attitudes. In-depth interviews provide an opportunity to obtain more detail about an issue or experience, and are especially useful for exploring experiences of care. Because this method elicits people's own views and accounts, it can have the additional benefit of uncovering issues or concerns that had not been anticipated or considered by the researchers. In order to ensure that really detailed information is gathered, interview methods require experienced researchers with the necessary sensitivity and ability to establish rapport with respondents, to use topic guides flexibly and follow up questions and responses.

Focus groups are similar in structure to face to face interviews but they use the interaction of a group of, typically, 6–8 people to generate data. This allows group members to talk to one another, argue and ask questions, and is especially useful for finding out about shared experiences. Focus groups have been successfully used with users and staff. One adaptation of this method is the “exploration group” in which different healthcare providers who have direct contact with a particular health problem review and discuss some material such as audio or video taped cases or interviews in order to develop an interpretative explanation. 4

Another variant is the “quality circle”. This convenes a small group of healthcare providers and patients who meet at regular times for a determined period to formulate hypotheses or action points to improve quality in health care. 5

Observation based methods

The systematic observation of organisational settings, team behaviour, and interactions is especially useful in studying quality issues as it allows researchers to uncover everyday behaviour rather than only relying on interview accounts. These methods are increasingly used in the study of organisation and delivery of care 6 and can be especially useful in uncovering what really happens in particular healthcare settings—for example, in the study of everyday work in labour wards 7 —and for formative evaluation of new services.

Narrative based medicine

Narrative based medicine is one of several patient centred approaches that can give the physician access to the lived experience of their patients. This is the context in which the physician interprets symptoms and signs and in which personal healthcare decisions are made. It can therefore be an approach to understanding how healthcare decisions are made.

Qualitative methods are designed to yield detailed and holistic views of the phenomena under study. The aim of qualitative research is not therefore to identify a statistically representative set of respondents or to produce numerical predictions. Qualitative research questions tend to be exploratory and not tied to formal hypothesis testing, so the sampling strategies used in qualitative research are purposive or theoretical rather than representative or probability based. 8 This means that respondents are sampled based on specific predetermined criteria in order to cover a range of constituencies—for example, different age, social class, and cultural backgrounds (see box 1). 9 To locate hard to reach individuals or groups, researchers can use “convenience” venues, informants, or social networks.

Box 1 Focus group study to obtain information directly from adolescent young women on their knowledge and expectations concerning contraceptive use and their attitude to healthcare

To obtain a range of views, a purposive direct sampling strategy was followed to organise the focus groups. Four secondary schools with different educational levels were selected because of the correlation with sexual behaviour of adolescents. In each school all 17 year old young women of one small 5th grade class were asked to participate. Each group comprised six or seven participants, with a total of 26. Differences in sexual experiences and social classes fostered lively interaction within the groups. The discussions were tape recorded, transcribed, and analysed by content analysis. Knowledge of the daily use and side effects of contraceptives was insufficient. The general practitioner was the most frequently consulted healthcare provider for the first pill prescription, but for a gynaecological examination they thought they had to visit a gynaecologist. Mothers and the peer group were important in teenagers' decision making and should be considered when communicating with adolescent young women.

The sample sizes for interview studies tend to be much smaller than those used in survey or more quantitative research; they may include 30–50 respondents, although this can vary with the research question asked. Similarly, observational studies may be based on a single case study, perhaps focusing on one organisational setting such as a clinic or ward.

Qualitative analyses attempt to preserve the textual form of the data gathered and to generate analytical categories and explanations. This may be done inductively—that is, obtained gradually from the data—or deductively—that is, with a theoretical framework as background (box 2), 10 either at the beginning or part way through the analysis as a way of approaching the data.

Box 2 Investigation of barriers to implementing guidelines for the management of depression in general practice 10

Information about how general practitioners (34 in the intervention group) managed patients with depression were obtained from review of records and assessment of outcome with a standard patient completed questionnaire. The guidelines were issued to the general practitioners and they were then interviewed individually to identify their personal barriers to acting on the recommendations. The interviews were semi-structured and were recorded and transcribed. Psychological theories of behaviour change were used as the framework for analysing the interviews. The transcripts were repeatedly studied independently by several researchers. An example of the barriers identified through use of a theoretical framework relates to the theory of self-efficacy. Some general practitioners did not feel able to ask about suicide risk because they lacked confidence in their ability to use an appropriate form of words. After the general practitioners had been given suggestions for phrases to use, the proportion of patients whose suicide risk had been assessed increased.

There are various software packages designed to assist with the organisation and retrieval of qualitative data. Among those most commonly used are QSR NUD*IST 11 and Atlas Ti. 12 Some of these packages enable sophisticated analysis, allowing the researcher to make theoretical links within the data set; others identify co-occurring codes and provide opportunities to annotate codes or portions of text. All of these processes are integral to qualitative data analysis, but whether software is used or not, the key point about the analysis is that it relies on systematic and rigorous searching of text for categories and themes. These categories and themes are collected together, compared, and re-analysed to develop hypotheses or theoretical explanations. When conducting this coding analysis the researcher gives consideration to the actual words used, the context, the internal consistency, the specificity of responses that is more based on own experiences of respondents, and the big ideas beneath all detailed information. 13 It is important in this process not to lose sight of the narrative and textual structure of qualitative data, and to pay attention to the context of items of data (box 3). While software packages can assist with this labour intensive process and offer great potential for managing large data sets, they are not a substitute for thorough knowledge or “immersion” in the data which enables the researcher to identify connections and patterns, to make systematic comparisons, and to develop interpretations.

Box 3 The coding process

As the researcher comes across an idea or phenomenon, a label is attached. A fragment from adolescent girls' focus groups 9 : “ I always talk to my mother because I can tell her everything. You can always get reliable information from your mother .” Considering the actual words used, possible labels for this fragment are: “communication”, “mother”, “reliable”, “information”.

When the idea or phenomenon reappears in the text, the label is once again attached. “ If it is really necessary, I will talk to my mother. But I don't like that, but .. ”

After reading again all codes and fragments, a better formulation of the code can be found; for this fragment, the label “information sources/mother” can be used.

Specificity: responses based on specific experiences are more important. “ I always talk to my mother . . .” is more specific than “ Girls of my class are used to talk to their mother .”

Codebooks consist of a set of codes that capture the key analytical constructs. Step by step you progress in the level of analysing: raw data ← description ← interpretation ← recommendation.

RELIABILITY AND VALIDITY

When it comes to judging the quality of qualitative research, qualitative methods are often seen as scoring highly in terms of internal validity. By documenting how people really behave in “natural” everyday situations and examining in detail what people mean when they describe their experiences, feelings, attitudes and behaviour, these methods are seen as providing an accurate representation of the phenomena studied. Reliability, which is a particular strength of quantitative research, cannot always be judged so easily within a qualitative study. The settings and groups studied within qualitative research may be unique to the particular context or time period, and it is unlikely that a study can be replicated in the way that a controlled experiment can. Sometimes it is possible to involve other researchers in the analytical process to code the data independently or to discuss emerging themes and categories to try to reach consensus about the interpretation of the data. It is important that a clear account of the data collection and analysis is provided to allow readers to judge the evidence and interpretations presented. This clear exposition is also essential for judging the transferability of findings to other settings or groups.

SOME EXAMPLES OF QUALITATIVE RESEARCH ABOUT THE QUALITY OF HEALTH CARE

Qualitative research has been used in a number of ways to look at the quality of health care. To illustrate how these methods can inform quality improvement, we focus on three areas where qualitative methods have made a contribution: (1) in identifying salient features of care to inform service delivery and organisation; (2) in exploring organisational and other obstacles to change, notably within the context of healthcare evaluation; and (3) by complementing other research approaches either in the preliminary development of measures or in explaining or implementing findings.

Identifying what really matters to patients and care providers

Interviews or focus group methods are especially helpful in assessing user views of services and healthcare provision and in revealing why some care is perceived as poor quality. One interview study looked at patients' perceptions of the reassurance provided by rheumatologists and found that the typical methods of imparting reassurance, often by minimising or downplaying the seriousness of the arthritic condition, were frequently misinterpreted by patients. This study showed that clinicians needed to be more aware of patients' own views and experience of health problems and to adapt their explanations and information giving to increase its salience for this group of patients. 14 Similarly, an Australian study 15 found that the quality of information and reassurance given to women receiving abnormal cervical smear test results was poor and recommended different ways of organising the service to meet women's information needs and to improve the quality of care.

Qualitative work can be helpful in identifying cultural and social factors that hinder or encourage service use. This information can be directly fed back to healthcare providers to help them improve service delivery (box 1). 9 In the UK, focus groups with women from ethnic minorities 16 identified administrative and language barriers which prevented these women from using cervical screening services.

Identifying obstacles to change

By establishing the reasons behind certain behaviours, qualitative research can help to identify barriers to practice change. Success will be more likely if the methods used to implement change are chosen to address the prevailing barriers. 17 Interview studies have been used to identify modifiable factors associated with prescribing by general practitioners 18 and to distinguish doctor and patient related factors that explain a high level of prescribing of antibiotics. 19 Sometimes qualitative research is helpful in understanding how organisations and teams within them work on a day to day basis. Observational research by Hughes and Griffiths 20 on rationing in cardiac care conferences and neurorehabilitation meetings showed how decisions differed between these two types of service. Making these decision rules explicit makes it possible to see how this process might be improved or adapted. Elsewhere, interviews with general practitioners were used in a randomised trial of the implementation of guidelines for the management of depression in general practice to tailor intervention strategies to the needs of practitioners. 10 The identified barriers to change included doctors' perceived ability to assess suicide risk and inform patients about taking their medication (box 2). Further research is needed to elucidate the most efficient methods for identifying barriers to change and to investigate theoretical frameworks that can be used to understand barriers.

The complex structures and behaviours of healthcare organisations are increasingly recognised as critical factors in determining the quality of care. 21 Qualitative methods offer a potential approach to assisting leaders of organisations to appreciate some of the local issues to be considered when introducing new ideas or transforming systems of care. However, more research is needed to investigate which qualitative methods could be most useful, and in what circumstances they should be used.

Another strength of qualitative research lies in its role within formative evaluation. Qualitative methods can provide insights to the process of policy implementation, identifying where and why this is successful, uncovering initial “teething problems”, and suggesting solutions. Qualitative methods have also been used to guide the design of a new “one stop” clinic for women with menstrual problems and to evaluate the service from the patient's perspective. 22

Complementing other research

Qualitative methods have long been used to inform more quantitative research approaches, notably assisting with research design and the development of outcome measures. They have been used in preliminary work for surveys to develop and test questionnaires—for example, the development of quantitative measures of patients' views should begin with an exploration of the views of samples of patients using qualitative methods (box 4). 23

Box 4 Development of a measure of patients' views of care across the primary/secondary interface 23

The aim was to develop a standard quantitative measure of the views of patients referred from primary to secondary care. In order to identify the issues of concern to patients, a purposeful sample of patients who had been referred to secondary care was identified. Six focus group meetings were held and five patients who could not travel to a meeting were interviewed individually. Two researchers independently studied the transcripts and developed coding schemes. Differences were resolved through discussion. Five main themes emerged from the data:

getting into care;

fitting in with staff and systems of care;

knowing what's going on (obtaining information);

continuity of care;

limbo (progress through the healthcare system).

Failures in the first four themes led patients to report feeling as though they were not making progress and had been left in a state of limbo.

They can also be used as part of the process of dissemination of research evidence, and may be especially helpful in making findings relevant to patients and care providers. Thus, although it can be difficult to incorporate the views of patients or carers, qualitative methods may sometimes be useful in informing recommendations and guidelines. 24, 25 The choice of method will depend on the topic and the evidence base, but patient or carer focus groups or interviews can be appropriate if the guideline is concerned with the interpersonal aspects of care, with very small subgroups of patients or carers, or if the available evidence is limited.

CONCLUSIONS

This paper has introduced some of the methods of qualitative research and outlined some ways in which they can contribute to research into quality improvement and management of change. Quality improvement is a major goal of the healthcare systems of most developed countries yet, despite almost two decades of research, effective approaches remain elusive. In order to understand better the human and organisational factors that influence the quality and safety of care, researchers should remember the potential role of qualitative methods. Qualitative research encompasses a range of methods that have successfully been used to explore issues of healthcare delivery from patient and provider perspectives. They can help both to illuminate different facets of “quality” and to inform quantitative approaches to researching health care.

Key messages

There are several methods for collecting data in qualitative research, including both interview based methods and observation based methods.

Sampling methods are theoretical or purposive, and analysis may be inductive or deductive.

These methods may be used to identify what really matters to patients and carers, and can also be used to explain the obstacles to improvement and why improvement does or does not occur.

Qualitative methods could make an important contribution to understanding how to improve the quality of health care.

BIBLIOGRAPHY

Suggested introductory books to qualitative research methods:

Denzin NK, Lincoln YS, eds. Handbook of qualitative research . Thousand Oaks: Sage, 1998.

Gantley M, Harding G, Kumar S, Tissier J. An introduction to qualitative methods for health professionals . Master Classes in Primary Care Research No 1 (editors Carter Y, Shaw S, Thomas C). London: Royal College of General Practitioners, 1999.

• ↵ Strong P , Robinson J. The NHS: under new management . Milton Keynes: Open University Press, 1990: 81.
• ↵ Mays N , Pope C. Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ 1995 ; 311 : 42 –5. OpenUrl FREE Full Text
• ↵ Malterud K . Qualitative research: standards, challenges, and guidelines. Lancet 2001 ; 358 : 483 –8. OpenUrl CrossRef PubMed Web of Science
• ↵ Wijnen G , Schillemans L, Hermann I. Introduction of the WVVH prevention card in general practice (in Dutch). Huisarts Nu 1993 ; 22 : 17 –21 OpenUrl
• ↵ Schillemans L , De Grande L, Remmen R. Using quality circles to evaluate the efficacy of primary health care. In: Conner RF, Hendricks M, eds. International innovations in evaluation methodology. New directions in program evaluation 42 . San Francisco: Jossey-Bass, 1989: 19–27.
• ↵ Murphy E . Micro-level qualitative research. In: Fulop N, Allen P, Clarke A, et al , eds. Studying the organisation and delivery of health services research methods . London: Routledge, 2001: 40–55.
• ↵ Hunt S , Symonds A. The social meaning of midwifery. Basingstoke: Macmillan, 1995.
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• ↵ Peremans L , Hermann I, Avonts D, et al . Contraceptive knowledge and expectations by adolescents: an explanation by focus groups. Patient Educat Counsel 2000 ; 40 : 133 –41. OpenUrl CrossRef
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• ↵ Donovan J , Blake D. Qualitative study of interpretations of reassurance among patients attending rheumatology clinics: “just a touch of arthritis, doctor?” BMJ 2000 ; 320 : 541 –4. OpenUrl Abstract / FREE Full Text
• ↵ Kavanagh A , Broom D. Women's understanding of abnormal cervical smear test results: a qualitative interview study. BMJ 1997 ; 314 : 1388 –91. OpenUrl Abstract / FREE Full Text
• ↵ Naish J , Brown J, Denton, B. Intercultural consultations: investigation of factors that deter non-English speaking women from attending their general practitioners for cervical screening. BMJ 1994 ; 309 : 1126 –8.
• ↵ Grol R . Personal paper: beliefs and evidence in changing clinical practice. BMJ 1997 ; 315 : 418 –21. OpenUrl FREE Full Text
• ↵ Carthy P , Harvey I, Brawn R, et al . A study of factors associated with cost and variation in prescribing among GPs. Fam Pract 2000 ; 17 : 36 –41. OpenUrl Abstract / FREE Full Text
• ↵ Coenen S , Van Royen P, Vermeire E, et al . Antibiotics for coughing in general practice: a qualitative decision analysis. Fam Pract 2000 ; 17 : 380 –5. OpenUrl Abstract / FREE Full Text
• ↵ Hughes D , Griffiths L. `Ruling in' and `ruling out': two approaches to the micro rationing of health care. Soc Sci Med 1997 ; 44 : 589 –99.
• ↵ Plsek P . Redesigning health care with insights from the science of complex adaptive systems. In: Institute of Medicine. Crossing the quality chasm. A new health system for the 21st century . Washington DC: National Academy Press, 2001: 309–22.
• ↵ Abu J , Baker R, Habiba M, et al . Qualitative and quantitative assessment of women's views of a one-stop menstrual clinic compared to traditional gynaecology clinics. Br J Obstet Gynaecol 2001 ; 108 : 993 –9. OpenUrl
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Qualitative Health Research

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• Description
• Aims and Scope
• Editorial Board
• Abstracting / Indexing
• Submission Guidelines

Qualitative Health Research provides an international, interdisciplinary forum to enhance health and health care and further the development and understanding of qualitative health research. The journal is an invaluable resource for researchers and academics, administrators and others in the health and social service professions, and graduates, who seek examples of studies in which the authors used qualitative methodologies. Each issue of Qualitative Health Research provides readers with a wealth of information on conceptual, theoretical, methodological, and ethical issues pertaining to qualitative inquiry. A Variety of Perspectives We encourage submissions across all health-related areas and disciplines. Qualitative Health Research understands health in its broadest sense and values contributions from various traditions of qualitative inquiry. As a journal of SAGE Publishing, Qualitative Health Research aspires to disseminate high-quality research and engaged scholarship globally, and we are committed to diversity and inclusion in publishing. We encourage submissions from a diverse range of authors from across all countries and backgrounds. There are no fees payable to submit or publish in Qualitative Health Research .

Original, Timely, and Insightful Scholarship Qualitative Health Research aspires to publish articles addressing significant and contemporary health-related issues. Only manuscripts of sufficient originality and quality that align with the aims and scope of Qualitative Health Research will be reviewed. As part of the submission process authors are required to warrant that they are submitting original work, that they have the rights in the work, that they have obtained, and that can supply all necessary permissions for the reproduction of any copyright works not owned by them, and that they are submitting the work for first publication in the Journal and that it is not being considered for publication elsewhere and has not already been published elsewhere. Please note that Qualitative Health Research does not accept submissions of papers that have been published elsewhere. Sage requires authors to identify preprints upon submission (see https://us.sagepub.com/en-us/nam/preprintsfaq ). This Journal is a member of the Committee on Publication Ethics (COPE) .

This Journal recommends that authors follow the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals formulated by the International Committee of Medical Journal Editors (ICMJE).

Qualitative Health Research is an international, interdisciplinary, refereed journal for the enhancement of health care and to further the development and understanding of qualitative research methods in health care settings. We welcome manuscripts in the following areas: the description and analysis of the illness experience, health and health-seeking behaviors, the experiences of caregivers, the sociocultural organization of health care, health care policy, and related topics. We also seek critical reviews and commentaries addressing conceptual, theoretical, methodological, and ethical issues pertaining to qualitative enquiry.

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Manuscript submission guidelines:

Qualitative Health Research (QHR)  has specific guidelines! While  Sage Publishing has general guidelines , all manuscripts submitted to QHR must follow our specific guidelines (found below). Once you have reviewed these guidelines, please visit QHR ’s  submission site  to upload your manuscript.   Please note that manuscripts not conforming to these guidelines will be returned and/or encounter delays in peer review.   Remember you can log in to the submission site at any time to check on the progress of your manuscript throughout the peer review process.

1. Deciding whether to submit a manuscript to QHR

1.1 Aims & scope

1.2 Article types

2. Review criteria

2.1  Original research studies

2.2 Pearls, Piths, and Provocations

2.3 Common reasons for rejection

3.  Preparing your manuscript

3.1 Title page

3.2 Abstract

3.3 Manuscript

3.4 Tables, Figures, Artwork, and other graphics

3.5 Supplemental material

4. Submitting your manuscript

5. Editorial Policies

5.1 Peer review policy

5.2 Authorship

5.3 Acknowledgments

5.4 Funding

5.5 Declaration of conflicting interests

5.6 Research ethics and participant consent

6. Publishing Policies

6.1 Publication ethics

6.2 Contribtor's publishing agreement

6.3 Open access and author archiving

1. Deciding whether to submit a manuscript to QHR 

QHR  provides an international, interdisciplinary forum to enhance health and health care and further the development and understanding of qualitative health research. The journal is an invaluable resource for researchers and academics, administrators and others in the health and social service professions, and graduates, who seek examples of studies in which the authors used qualitative methodologies.  Each issue of QHR provides readers with a wealth of information on conceptual, theoretical, methodological, and ethical issues pertaining to qualitative inquiry.

Rather than send query letters to the Editor regarding article fit, QHR asks authors to make their own decision regarding the suitability of their manuscript for QHR   by  asking: Does your proposed submission make a meaningful and strong contribution to qualitative health research literature? Is it useful to readers and/or practitioners?

The following manuscript types are considered for publication.

• Original Research Studies : These are fully developed qualitative research studies. This may include mixed method studies in which the major focus/portion of the study is qualitative research. Please read  Maintaining the Integrity of Qualitatively Driven Mixed Methods: Avoiding the “ This Work is Part of a Larger Study”  Syndrome . 
• Pearls, Piths, and Provocations : These manuscripts should foster discussion and debate about significant issues, enhance communication of methodological advances, promote and discuss issues related to the teaching of qualitative approaches in health contexts, and/or encourage the discussion of new and/or provocative ideas. They should also make clear what the manuscript adds to the existing body of knowledge in the area.
• Editorials : These are generally invited articles written by editors/editorial board members associated with QHR.

Please note, QHR does NOT publish pilot studies. We do not normally publish literature reviews unless they focus on qualitative research studies elaborating methodological issues and developments. Review articles should be submitted to the Pearls, Piths, and Provocations section. They are reviewed according to criteria in 2.2.

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2. Review criteria 

2.1 Original research

Reviewers are asked to consider the following areas and questions when making recommendations about research manuscripts:

• Importance of submission : Does the manuscript make a significant contribution to qualitative health research literature?  Is it original? Relevant? In depth? Insightful? Is it useful to the reader and/or practitioner?
• Methodological considerations : Is the overall study design clearly explained including why this design was an appropriate one? Are the methodology/methods/approaches used in keeping with that design? Are they appropriate given the research question and/or aims? Are they logically articulated? Clarity in design and presentation? Data adequacy and appropriateness? Evidence of rigor?
• Ethical Concerns : Are relevant ethical concerns discussed and acknowledged? Is enough detail given to enable the reader to understand how ethical issues were navigated? Has formal IRB approval (when needed) and consent from participants been obtained?
• Data analysis, findings, discussion : Does the analysis of data reflect depth and coherence? In-depth descriptive but also interpretive dimensions? Creative and insightful analysis? Are results linked to existing literature and theory, as appropriate? Is the contribution of the research clear including its relevance to health disciplines and their practice?
• Manuscript style and format : Is the manuscript organized in a clear and concise manner? Has sufficient attention been paid to word choice, spelling, grammar, and so forth? Did the author adhere to APA guidelines? Do diagrams/illustrations comply with guidelines? Is the overall manuscript aligned with QHR guidelines in relation to formatting?
• Scope:  Does the article fit with QHR ’s publication mandate? Has the author cited the major work in the area, including those published in QHR ? 

The purpose of papers in this section is to raise and discuss issues pertinent to the development and advancement of qualitative research in health-related arenas.  As the name Pearls, Piths, and Provocations suggests, we are looking for manuscripts that make a significant contribution to areas of dialogue, development, experience sharing and debate relevant to the scope of QHR in this section of the journal.  Reviewers are asked to consider the following questions when making recommendations about  articles in the Pearls, Piths, and Provocations section.

• Significance :   Does the paper highlight issues that have the potential to advance, develop, and/or challenge thinking in qualitative health related research?
• Clarity :   Are the arguments clearly presented and well supported? 
• Rigor :   Is there the explicit use of/interaction with methodology and/or theory and/or empirical studies (depending on the focus of the paper) that grounds the work and is coherently carried throughout the arguments and/or analysis in the manuscript? Put another way, is there evidence of a rigorously constructed argument?
• Engagement :   Does the paper have the potential to engage the reader to ‘think differently’ by raising questions, suggesting innovative directions for qualitative health research, and/or stimulating critical reflection?   Are the implications of the paper for the practice of either qualitative research and/or health clear? 
• Quality of the writing :   Is the main argument of the paper clearly articulated and presented with few grammatical or typographical issues? Are terms and concepts key to the scholarship communicated clearly and in sufficient detail? 

QHR  most commonly turns away manuscripts that fall outside the journal’s scope, do not make a novel contribution to the literature, lack substantive and/or interpretative depth, require extensive revisions, and/or do not adequately address ethical issues that are fundamental to qualitative inquiry. Submissions of the supplementary component of mixed methods studies often are rejected as the findings are difficult to interpret without the findings of the primary study. For additional information on this policy, please read  Maintaining the Integrity of Qualitatively Driven Mixed Methods: Avoiding the “ This Work is Part of a Larger Study”  Syndrome . 

3. Preparing your manuscript for submission 

We strongly encourage all authors to review previously published articles in QHR for style prior to submission.

QHR  journal practices include double anonymization. All identifying information MUST be removed completely from the Abstract, Manuscript, Acknowledgements, Tables, and Figure files prior to submission. ONLY the Title Page and Cover Letter may contain identifying information. See  Sage’s general submission guidelines  for additional guidance on making an anonymous submission.

Preferred formats for the text and tables of your manuscript are Word DOC or PDF. The text must be double-spaced throughout with standard 1-inch margins (APA formatting). Text should be standard font (i.e., Times New Roman) 12-point. 

3.1 Title page 

• The title page should be uploaded as a separate document containing the following information: Author names; Affiliations; Author contact information; Contribution list; Acknowledgements; Ethical statement; Funding Statement; Conflict of Interest Statements; and, Grant Number. Please know that the Title Page is NOT included in the materials sent out for Peer Review.
• Ethical statement: An ethical statement must include the following: the full name of the ethical board that approved your study; the approval number given by the ethical board; and, confirmation that all your participants gave informed consent. Authors are also required to state in the methods section whether participants provided informed consent, whether the consent was written or verbal, and how it was obtained and by whom. For example: “Our study was approved by The Mercy Health Research Ethics Committee (approval no. XYZ123). All participants provided written informed consent prior to enrollment in the study.” If your study did not need ethical approval (often manuscripts in the Pearls, Piths, and Provocations may not), we still need a statement that states that your study did not need approval and an explanation as to why. For example: “Ethical Statement: Our study did not require an ethical board approval because it did not directly involve humans or animals.” 

3.2 Abstract and Keywords

• The Abstract should be unstructured, written in narrative form. Maximum of 250 words. This should be on its own page, appearing as the first page of the Main Manuscript file.
• The keywords should be included beneath the abstract on the Main Manuscript file. 
• Length: 8,000 words or less excluding the abstract, list of references, and acknowledgements. This applies to both Original Research and Pearls, Piths, and Provocations. Please note that text from Tables and Figures is included in the word count limits. On-line supplementary materials are not included in the word limit. 
• Structure: While many authors will choose to use headings of Background, Methods, Results, and Discussion to organize their manuscript, it is up to authors to choose the most appropriate terms and structure for their submission. It is the expectation that manuscripts contain detailed reflections on methodological considerations.
• Ethics: In studies where data collection or other methods present ethical challenges, the authors should explicate how such issues were navigated including how consent was gained and by whom. An anonymized version of the ethical statement should be included in the manuscript (in addition to appearing on the title page).
• Participant identification: Generally, demographics should be described in narrative form or otherwise reported as a group. Quotations may be linked to particular participants and/or demographic features provided measures are taken to ensure anonymity of participants (e.g., use of pseudonyms).
• Use of checklists: Authors should not include qualitative research checklists, such as COREQ (COnsolidated criteria for REporting Qualitative research).  Generally, authors should use a narrative approach to describe the processes used to enhance the rigor of their study. For additional information on this policy, please read  Why the Qualitative Health Research (QHR) Review Process Does Not Use Checklists
• References: APA format. While there is no limit to the number of references, authors are recommended to use pertinent references only, including literature previously published in QHR . References should be on a separate page.   QHR adheres to the APA 7 reference style. View the APA guidelines to ensure your manuscript conforms to this reference style. Please ensure you check carefully that both your in-text references and list of references are in the correct format.
• Authors are required to disclose the use of generative Artificial Intelligence (such as ChatGPT) and other technologies (such as NVivo, ATLAS. Ti, Quirkos, etc.), whether used to conceive ideas, develop study design, generate data, assist in analysis, present study findings, or other activities formative of qualitative research. We suggest authors provide both a description of the technology, when it was accessed, and how it was used (see  https://uk.sagepub.com/en-gb/eur/chatgpt-and-generative-ai ).
• Manuscripts that receive favorable reviews will not be accepted until any formatting and copy-editing required has been done. 
• Tables, Figures, Artwork, and other graphics should be submitted as separate files rather than incorporated into the main manuscript file. Within the manuscript, indicate where these items should appear (i.e. INSERT TABLE 1 HERE).
• TIFF, JPED, or common picture formats accepted. The preferred format for graphs and line art is EPS.
• Resolution: Rasterized based files (i.e. with .tiff or .jpeg extension) require a resolution of at least 300 dpi (dots per inch). Line art should be supplied with a minimum resolution of 800 dpi.
• Dimension: Check that the artworks supplied match or exceed the dimensions of the journal. Images cannot be scaled up after origination.
• Figures supplied in color will appear in color online regardless of whether or not these illustrations are reproduced in color in the printed version. For specifically requested color reproduction in print, you will receive information regarding the costs from Sage after receipt of your accepted article. 
• Core elements of the manuscript should not be included as supplementary material.
• QHR  is able to host additional materials online (e.g., datasets, podcasts, videos, images etc.) alongside the full-text of the article. For more information please refer to Sage’s general  guidelines on submitting supplemental files .

4. Submitting your manuscript 

QHR  is hosted on Sage Track, a web based online submission and peer review system powered by ScholarOne™ Manuscripts. Visit  https://mc.manuscriptcentral.com/QHR  to login and submit your article online. 

IMPORTANT:  Please check whether you already have an account in the system before trying to create a new one. If you have reviewed or authored for the Journal in the past year it is likely that you will have had an account created.  For further guidance on submitting your manuscript online please visit  ScholarOne Online Help . 

5. Editorial policies 

QHR  adheres to a rigorous double-anonymized reviewing policy in which the identities of both the reviewer and author are always concealed from both parties.

Sage does not permit the use of author-suggested (recommended) reviewers at any stage of the submission process, be that through the web-based submission system or other communication. Reviewers should be experts in their fields and should be able to provide an objective assessment of the manuscript. Our policy is that reviewers should not be assigned to a manuscript if:

•  The reviewer is based at the same institution as any of the co-authors

•  The reviewer is based at the funding body of the manuscript

•  The author has recommended the reviewer

•  The reviewer has provided a personal (e.g. Gmail/Yahoo/Hotmail) email account and an institutional email account cannot be found after performing a basic Google search (name, department and institution). 

Qualitative Health Research  is committed to delivering high quality, fast peer-review for your manuscript, and as such has partnered with Web of Science. Web of Science is a third-party service that seeks to track, verify and give credit for peer review. Reviewers for Qualitative Health Research can opt in to Web of Science in order to claim their reviews or have them automatically verified and added to their reviewer profile. Reviewers claiming credit for their review will be associated with the relevant journal, but the article name, reviewer’s decision, and the content of their review is not published on the site. For more information visit the  Web of Science  website.

The Editor or members of the Editorial Team or Board may occasionally submit their own manuscripts for possible publication in the Journal. In these cases, the peer review process will be managed by alternative members of the Editorial Team or Board and the submitting Editor Team/Board member will have no involvement in the decision-making process. 

Manuscripts should only be submitted for consideration once consent is given by all contributing authors. Those submitting manuscripts should carefully check that all those whose work contributed to the manuscript are acknowledged as contributing authors. The list of authors should include all those who can legitimately claim authorship. This is all those who meet all of the following criteria:

(i)   Made a substantial contribution to the design of the work or acquisition, analysis, interpretation, or presentation of data,  (ii)  Drafted the article or revised it critically for important intellectual content,  (iii) Approved the version to be published,  (iv) Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship, although all contributors who do not meet the criteria for authorship should be listed in the Acknowledgments section. Please refer to the  International Committee of Medical Journal Editors (ICMJE) authorship guidelines   for more information on authorship.

Authors are required to disclose the use of generative Artificial Intelligence (such as ChatGPT) and other technologies (such as NVivo, ATLAS. Ti, Quirkos, etc.), whether used to conceive ideas, develop study design, generate data, assist in analysis, present study findings, or other activities formative of qualitative research. We suggest authors provide both a description of the technology, when it was accessed, and how it was used. This needs to be clearly identified within the text and acknowledged within your Acknowledgements section. Please note that AI bots such as ChatGPT should not be listed as an author. For more details on this policy, please visit  ChatGPT and Generative AI . 

5.3 Acknowledgements

All contributors who do not meet the criteria for authorship should be listed in an Acknowledgements section. Examples of those who might be acknowledged include a person who provided purely technical help, or a department chair who provided only general support.

Please supply any personal acknowledgements separately to the main text to facilitate anonymous peer review. 

Per  ICMJE recommendations , it is best practice to obtain consent from non-author contributors who you are acknowledging in your manuscript.

1.3.1 Writing assistance

Individuals who provided writing assistance, e.g., from a specialist communications company, do not qualify as authors and so should be included in the Acknowledgements section. Authors must disclose any writing assistance – including the individual’s name, company and level of input – and identify the entity that paid for this assistance. It is not necessary to disclose use of language polishing services. 

Qualitative Health Research   requires all authors to acknowledge their funding in a consistent fashion under a separate heading.  Please visit the  Funding Acknowledgements   page on the Sage Journal Author Gateway to confirm the format of the acknowledgment text in the event of funding, or state that: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. 

It is the policy of  Qualitative Health Research to require a declaration of conflicting interests from all authors enabling a statement to be carried within the paginated pages of all published articles.

Please ensure that a ‘Declaration of Conflicting Interests’ statement is included at the end of your manuscript, after any acknowledgements and prior to the references. If no conflict exists, please state that ‘The Author(s) declare(s) that there is no conflict of interest’. For guidance on conflict of interest statements, please see the ICMJE recommendations  here . 

Research involving participants must be conducted according to the  World Medical Association Declaration of Helsinki

Submitted manuscripts should conform to the  ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals :

All manuscripts must state that the relevant Ethics Committee or Institutional Review Board provided (or waived) approval. Please ensure that you blind the name and institution of the review committee until such time as your article has been accepted. The Editor will request authors to replace the name and add the approval number once the article review has been completed. Please note that in itself, simply stating that Ethics Committee or Institutional Review was obtained is not sufficient.  Authors are also required to state in the methods section whether participants provided informed consent, whether the consent was written or verbal, and how it was obtained and by whom.

Please do not submit the participant’s informed consent documents with your article, as this in itself breaches the participant’s confidentiality. The Journal requests that you confirm to us, in writing, that you have obtained informed consent recognizing the documentation of consent itself should be held by the authors/investigators themselves (for example, in a participant’s hospital record or an author’s institution’s archives).

Please also refer to the  ICMJE Recommendations for the Protection of Research Participants . 

6. Publishing Policies 

Sage is committed to upholding the integrity of the academic record. We encourage authors to refer to the Committee on Publication Ethics’  International Standards for Authors  and view the Publication Ethics page on the  Sage Author Gateway .

6.1.1 Plagiarism

Qualitative Health Research  and Sage take issues of copyright infringement, plagiarism or other breaches of best practice in publication very seriously. The Committee on Publication Ethics (COPE) defines plagiarism as: “When somebody presents the work of others (data, words or theories) as if they were his/her own and without proper acknowledgment.” We seek to protect the rights of our authors and we always investigate claims of plagiarism or misuse of published articles. Equally, we seek to protect the reputation of the journal against malpractice. Submitted articles may be checked with duplication-checking software. Where an article, for example, is found to have plagiarised other work or included third-party copyright material without permission or with insufficient acknowledgement, or where the authorship of the article is contested, we reserve the right to take action including, but not limited to: publishing an erratum or corrigendum (correction); retracting the article; taking up the matter with the head of department or dean of the author's institution and/or relevant academic bodies or societies; or taking appropriate legal action.

6.1.2 Prior publication

If material has been previously published it is not generally acceptable for publication in a Sage journal. However, there are certain circumstances where previously published material can be considered for publication. Please refer to the guidance on the  Sage Author Gateway  or if in doubt, contact the Editor at the address given below. 

6.2 Contributor's publishing agreement

Before publication, Sage requires the author as the rights holder to sign a Journal Contributor’s Publishing Agreement. Sage’s Journal Contributor’s Publishing Agreement is an exclusive licence agreement which means that the author retains copyright of the work but grants Sage the sole and exclusive right and licence to publish for the full legal term of copyright. Exceptions may exist where an assignment of copyright is required or preferred by a proprietor other than Sage. In this case copyright in the work will be assigned from the author to the society. For more information please visit the  Sage Author Gateway . 

Qualitative Health Research  offers optional open access publishing via the Sage Choice programme and Open Access agreements, where authors can publish open access either discounted or free of charge depending on the agreement with Sage. Find out if your institution is participating by visiting Open Access Agreements at Sage . For more information on Open Access publishing options at Sage please visit Sage Open Access . For information on funding body compliance, and depositing your article in repositories, please visit Sage’s Author Archiving and Re-Use Guidelines and Publishing Policies .

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• Using qualitative...

Using qualitative methods in health related action research

• Related content
• Peer review
• Julienne Meyer , professor of adult nursing
• City University, St Bartholomew School of Nursing and Midwifery, London E1 2EA

This is the last in a series of three articles

Series editors: Catherine Pope and Nicholas Mays

The barriers to the uptake of the findings of traditional quantitative biomedical research in clinical practice are increasingly being recognised. 1 2 Action research is particularly suited to identifying problems in clinical practice and helping develop potential solutions in order to improve practice. 3 For this reason, action research is increasingly being used in health related settings. Although not synonymous with qualitative research, action research typically draws on qualitative methods such as interviews and observation.

Summary points

Action research is increasingly being used in healthcare settings

It is a style of research rather than a specific method

Three elements are important: the participatory character of action research; its democratic impulse; and its simultaneous contribution to social science and social change

(Credit: LIANE PAYNE)

What is action research?

Action research is not easily defined. It is a style of research rather than a specific method. First used in 1946 by Kurt Lewin, a social scientist concerned with intergroup relations and minority problems in the United States, the term is now identified with research in which the researchers work explicitly with and for people rather than undertake research on them. 4 Its strength lies in its focus on generating solutions to practical problems and its ability to empower practitioners—getting them to engage with research and subsequent “development” or implementation activities. Practitioners can choose to research their own practice, or an outside researcher can be engaged to help them identify problems, seek and implement practical solutions, and systematically monitor and reflect on the process and outcomes of change.

Most definitions of action research incorporate three important elements: its participatory character; its democratic impulse; and its simultaneous contribution to social science and social change. 5

Participation in action research

Participation is fundamental to action research: it is an approach which demands that participants perceive the need to change and are willing to play an active part in the research and the change process. All research requires willing subjects, but the level of commitment required in an action research study goes beyond simply agreeing to answer questions or be observed. The clear cut demarcation between “researcher” and “researched” that is found in other types of research may not be so apparent in action research. The research design must be continually negotiated with participants, and researchers need to agree an ethical code of practice with the participants. 6 This is especially important as participation in the research, and in the process of change, can be threatening. 7 8 Conflicts may arise in the course of the research: outside researchers working with practitioners must obtain their trust and agree rules on the control of data and their use and on how potential conflict will be resolved within the project. The way in which such rules are agreed demonstrates a second important feature of action research—namely, its democratic impulse.

Democracy in action research

“Democracy” in action research usually requires participants to be seen as equals. The researcher works as a facilitator of change, consulting with participants not only on the action process but also on how it will be evaluated. One benefit of this is that it can make the research process and outcomes more meaningful to practitioners, by rooting them in the reality of day to day practice.

Throughout the study, findings are fed back to participants for validation and to inform decisions about the next stage of the study. This formative style of research is thus responsive to events as they naturally occur in the field and frequently entails collaborative spirals of planning, acting, observing, reflecting, and replanning. However, care needs to be taken in this process as it can be threatening: democratic practice is not always a feature of healthcare settings. An action researcher needs to be able to work across traditional boundaries (for example, between health and social care professionals or between hospital and community care settings) and juggle different, sometimes competing, agendas. This requires excellent interpersonal skills as well as research ability.

Action research typology (adapted from Hart and Bond) 3

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Contribution to both social science and social change

There is increasing concern about the “theory-practice” gap in clinical practice; practitioners have to rely on their intuition and experience since traditional scientific knowledge—for example, the results of randomised controlled trials—often does not seem to fit the uniqueness of the situation. Action research is seen as one way of dealing with this because, by drawing on practitioners' intuition and experience, it can generate findings that are meaningful and useful to them.

The level of interest in practitioner led research is increasing in Britain, in part as a response to recent proposals to “modernise” the NHS through developing new forms of clinical governance. 9 This and other national initiatives (the NHS Research and Development Strategy, the National Centre for Clinical Audit, the NHS Centre for Reviews and Dissemination, the Cochrane Collaboration, Centres for Evidence Based Practice) emphasise that research and development should be the business of every clinician. Practitioner led research approaches, such as single case experimental designs, 10 reflective case studies, 11 and reflexive action research, 12 are seen as ideal research methods for clinicians concerned with improving the quality of patient care. 13

In considering the contribution of action research to knowledge, it is important to note that generalisations made from action research studies differ from those made on the basis of more conventional forms of research. To some extent, reports of action research studies rely on readers to underwrite the account of the research by drawing on their own knowledge of human situations. It is therefore important, when reporting action research, to describe the work in its rich contextual detail. The researcher strives to include the participants' perspective on the data by feeding back findings to participants and incorporating their responses as new data in the final report. In addition, the onus is on the researcher to make his or her own values and beliefs explicit in the account of the research so that any biases are evident. This can be facilitated by writing self reflective field notes during the research.

The strength of action research is its ability to influence practice positively while simultaneously gathering data to share with a wider audience. However, change is problematic, and although action research lends itself well to the discovery of solutions, its success should not be judged solely in terms of the size of change achieved or the immediate implementation of solutions. Instead, success can often be viewed in relation to what has been learnt from the experience of undertaking the work. For instance, a study which set out to explore the care of older people in accident and emergency departments did not result in much change in the course of the study. 14 However, the lessons learnt from the research were reviewed in the context of national policy and research and carefully fed back to those working in the trust; as a result, changes have already been made within the organisation to act on the study's recommendations. Some positive changes were achieved in the course of the study (for example, the introduction of specialist discharge posts in accident and emergency departments), but the study also shed light on continuing gaps in care and issues that needed to be improved in future developments. Participants identified that the role of the “action researcher” had enabled greater understanding and communication between two services (the accident and emergency department and the department of medicine for elderly people) and that this had left both better equipped for future joint working. In other words, the solutions emerged from the process of undertaking the research.

Different types of action research

Four basic types of action research have been identified: experimental, organisational, professionalising, and empowering (table). 3 Though this typology is useful in understanding the wide range of action research, its multidimensional nature means that it is not particularly easy to classify individual studies. For instance, a study might be classified as “empowering” because of its “bottom up approach” in relation to the fourth distinguishing criterion of “change intervention,” but the other distinguishing criteria may be used to classify the same study as a different action research type (experimental, organisational, or professionalising). This situation is most likely to occur if the researcher and practitioners hold differing views on the nature of society. It may be more fruitful to use this typology as a framework for critiquing individual studies and, in particular for thinking about how concepts are operationalised, the features of particular settings, and the contribution of the people within those settings to solutions. 15

Action research in health care

At a time when there is increasing concern that research evidence is not sufficiently influencing practice development, 16 action research is gaining credibility in healthcare settings. 17 For example, the Royal College of Physicians in England has become involved in an action research study exploring the roles of clinicians, clinical audit staff, and managers in implementing clinical audit and ways of overcoming organisational barriers to audit. 18 The NHS Research and Development Programme has commissioned a systematic review of the action research. Elsewhere Ong has used “rapid appraisal,” a type of action research, to engage users in the development of health care policy and practice. 19

Lay participation in care in a hospital setting: an action research study

Participation.

Careful negotiation to recruit willing volunteers to examine practice and initiate lay participation in care

“Bottom up” approach to change via weekly team meetings

Researcher as facilitator and multidisciplinary team member

Goal of empowering practitioners and lay people in this setting

Working collaboratively with multidisciplinary team

Participants given “ownership” of the data to determine how it might be shared with wider audience

Contribution to social science and social change

Case study of multidisciplinary team on one general medical ward in London teaching hospital using:

Qualitative methods to highlight key themes emerging in the project

Quantitative methods for comparison of subgroups

Main action-reflection spirals

Reorganising the work of the ward:

Changes in patient care planning

New reporting system, including bedside handover with patient

Introduction of modified form of primary nursing system

Multidisciplinary communication:

Weekly team meetings instituted

Introduction of a handout for new staff and team communication sheet

Closer liaison with community nurses before discharge

Lay participation in care:

Development of resources for patient health education

Introduction of medicine reminder card system

Patient information leaflet inviting patients to participate in care

Insights into health professionals' perceptions of lay participation in care

Some positive changes achieved (for example, improved attitudes to lay participation in care, patient education, improved ward organisation)

Identified barriers to changing healthcare practice

Action research has also been used in hospital settings to facilitate closer partnerships between staff and users, notably in a study which focused on the introduction of lay participation in care within a general medical ward of a London teaching hospital (box). This study used a range of methods, including depth interviews, questionnaires, documentary analysis, and participant observation to generate data about health professionals' perceptions of lay participation in care and the difficulties encountered in changing practice. 20 21

In this study, health professionals expressed extremely positive views about user and carer involvement when completing an attitude scale, confirming the results of previous research on health professionals' attitudes towards user and carer involvement in care. 22 However, the interview data showed that they had some serious doubts and concerns, and observation of practice revealed that these doubts and concerns were inhibiting the implementation of lay participation. This action research was able to explore the relation between attitudes and practices and explain what happened when lay participation was introduced into a practice setting. It showed that although current policy documents advocate lay participation in care (user and carer involvement), some health professionals were merely paying lip service to the concept and were also inadequately prepared to deliver it in practice. By working closely with practitioners to explore issues in a practical context, the researcher gained more insight into how the rhetoric of policy might be better translated into reality.

Further reading

• Susman GI ,

Conclusions

Action research does not focus exclusively on user and carer involvement, though clearly its participatory principles makes it an obvious choice to explore these issues. It can be used more widely—to foster better practice across interprofessional boundaries and between different healthcare settings, for example. 14 23 It can also be used by clinicians to research their own practice. 10 It is an eclectic approach to research and draws on a variety of data collection methods. The focus on the process as well as the outcomes of change helps to explain the frequent use of qualitative methods by action researchers.

Competing interests None declared.

This article is taken from the second edition of Qualitative Research in Health Care , edited by Catherine Pope and Nicholas Mays, published by BMJ Books

• Sackett DL ,
• Richardson WS ,
• Rosenberg W ,
• Hennessy D.
• Titchen A ,
• Secretary of State for Health
• Matyas TA ,
• Robinson J.
• Wilson-Barnett J ,
• Macleod Clark J
• Brooking J.
• Robinson A.

• Open access
• Published: 13 May 2024

Patient medication management, understanding and adherence during the transition from hospital to outpatient care - a qualitative longitudinal study in polymorbid patients with type 2 diabetes

• Léa Solh Dost   ORCID: orcid.org/0000-0001-5767-1305 1 , 2 ,
• Giacomo Gastaldi   ORCID: orcid.org/0000-0001-6327-7451 3 &
• Marie P. Schneider   ORCID: orcid.org/0000-0002-7557-9278 1 , 2  

BMC Health Services Research volume  24 , Article number:  620 ( 2024 ) Cite this article

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Metrics details

Continuity of care is under great pressure during the transition from hospital to outpatient care. Medication changes during hospitalization may be poorly communicated and understood, compromising patient safety during the transition from hospital to home. The main aims of this study were to investigate the perspectives of patients with type 2 diabetes and multimorbidities on their medications from hospital discharge to outpatient care, and their healthcare journey through the outpatient healthcare system. In this article, we present the results focusing on patients’ perspectives of their medications from hospital to two months after discharge.

Patients with type 2 diabetes, with at least two comorbidities and who returned home after discharge, were recruited during their hospitalization. A descriptive qualitative longitudinal research approach was adopted, with four in-depth semi-structured interviews per participant over a period of two months after discharge. Interviews were based on semi-structured guides, transcribed verbatim, and a thematic analysis was conducted.

Twenty-one participants were included from October 2020 to July 2021. Seventy-five interviews were conducted. Three main themes were identified: (A) Medication management, (B) Medication understanding, and (C) Medication adherence, during three periods: (1) Hospitalization, (2) Care transition, and (3) Outpatient care. Participants had varying levels of need for medication information and involvement in medication management during hospitalization and in outpatient care. The transition from hospital to autonomous medication management was difficult for most participants, who quickly returned to their routines with some participants experiencing difficulties in medication adherence.

Conclusions

The transition from hospital to outpatient care is a challenging process during which discharged patients are vulnerable and are willing to take steps to better manage, understand, and adhere to their medications. The resulting tension between patients’ difficulties with their medications and lack of standardized healthcare support calls for interprofessional guidelines to better address patients’ needs, increase their safety, and standardize physicians’, pharmacists’, and nurses’ roles and responsibilities.

Peer Review reports

Introduction

Continuity of patient care is characterized as the collaborative engagement between the patient and their physician-led care team in the ongoing management of healthcare, with the mutual objective of delivering high-quality and cost-effective medical care [ 1 ]. Continuity of care is under great pressure during the transition of care from hospital to outpatient care, with a risk of compromising patients’ safety [ 2 , 3 ]. The early post-discharge period is a high-risk and fragile transition: once discharged, one in five patients experience at least one adverse event during the first three weeks following discharge, and more than half of these adverse events are drug-related [ 4 , 5 ]. A retrospective study examining all discharged patients showed that adverse drug events (ADEs) account for up to 20% of 30-day hospital emergency readmissions [ 6 ]. During hospitalization, patients’ medications are generally modified, with an average of nearly four medication changes per patient [ 7 ]. Information regarding medications such as medication changes, the expected effect, side effects, and instructions for use are frequently poorly communicated to patients during hospitalization and at discharge [ 8 , 9 , 10 , 11 ]. Between 20 and 60% of discharged patients lack knowledge of their medications [ 12 , 13 ]. Consideration of patients’ needs and their active engagement in decision-making during hospitalization regarding their medications are often lacking [ 11 , 14 , 15 ]. This can lead to unsafe discharge and contribute to medication adherence difficulties, such as non-implementation of newly prescribed medications [ 16 , 17 ].

Patients with multiple comorbidities and polypharmacy are at higher risk of ADE [ 18 ]. Type 2 diabetes is one of the chronic health conditions most frequently associated with comorbidities and patients with type 2 diabetes often lack care continuum [ 19 , 20 , 21 ]. The prevalence of patients hospitalized with type 2 diabetes can exceed 40% [ 22 ] and these patients are at higher risk for readmission due to their comorbidities and their medications, such as insulin and oral hypoglycemic agents [ 23 , 24 , 25 ].

Interventions and strategies to improve patient care and safety at transition have shown mixed results worldwide in reducing cost, rehospitalization, ADE, and non-adherence [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 ]. However, interventions that are patient-centered, with a patient follow-up and led by interprofessional healthcare teams showed promising results [ 34 , 35 , 36 ]. Most of these interventions have not been implemented routinely due to the extensive time to translate research into practice and the lack of hybrid implementation studies [ 37 , 38 , 39 , 40 , 41 ]. In addition, patient-reported outcomes and perspectives have rarely been considered, yet patients’ involvement is essential for seamless and integrated care [ 42 , 43 ]. Interprofessional collaboration in which patients are full members of the interprofessional team, is still in its infancy in outpatient care [ 44 ]. Barriers and facilitators regarding medications at the transition of care have been explored in multiple qualitative studies at one given time in a given setting (e.g., at discharge, one-month post-discharge) [ 8 , 45 , 46 , 47 , 48 ]. However, few studies have adopted a holistic methodology from the hospital to the outpatient setting to explore changes in patients’ perspectives over time [ 49 , 50 , 51 ]. Finally, little is known about whether, how, and when patients return to their daily routine following hospitalization and the impact of hospitalization weeks after discharge.

In Switzerland, continuity of care after hospital discharge is still poorly documented, both in terms of contextual analysis and interventional studies, and is mainly conducted in the hospital setting [ 31 , 35 , 52 , 53 , 54 , 55 , 56 ]. The first step of an implementation science approach is to perform a contextual analysis to set up effective interventions adapted to patients’ needs and aligned to healthcare professionals’ activities in a specific context [ 41 , 57 ]. Therefore, the main aims of this study were to investigate the perspectives of patients with type 2 diabetes and multimorbidities on their medications from hospital discharge to outpatient care, and on their healthcare journey through the outpatient healthcare system. In this article, we present the results focusing on patients’ perspectives of their medications from hospital to two months after discharge.

Study design

This qualitative longitudinal study, conducted from October 2020 to July 2021, used a qualitative descriptive methodology through four consecutive in-depth semi-structured interviews per participant at three, 10-, 30- and 60-days post-discharge, as illustrated in Fig.  1 . Longitudinal qualitative research is characterized by qualitative data collection at different points in time and focuses on temporality, such as time and change [ 58 , 59 ]. Qualitative descriptive studies aim to explore and describe the depth and complexity of human experiences or phenomena [ 60 , 61 , 62 ]. We focused our qualitative study on the 60 first days after discharge as this period is considered highly vulnerable and because studies often use 30- or 60-days readmission as an outcome measure [ 5 , 63 ].

This qualitative study follows the Consolidated Criteria for Reporting Qualitative Research (COREQ). Ethics committee approval was sought and granted by the Cantonal Research Ethics Commission, Geneva (CCER) (2020 − 01779).

Recruitment took place during participants’ hospitalization in the general internal medicine divisions at the Geneva University Hospitals in the canton of Geneva (500 000 inhabitants), Switzerland. Interviews took place at participants’ homes, in a private office at the University of Geneva, by telephone or by secure video call, according to participants’ preference. Informal caregivers could also participate alongside the participants.

Study flowchart

Researcher characteristics

All the researchers were trained in qualitative studies. The diabetologist and researcher (GG) who enrolled the patients in the study was involved directly or indirectly (advice asked to the Geneva University Hospital diabetes team of which he was a part) for most participants’ care during hospitalization. LS (Ph.D. student and community pharmacist) was unknown to participants and presented herself during hospitalization as a “researcher” and not as a healthcare professional to avoid any risk of influencing participants’ answers. This study was not interventional, and the interviewer (LS) invited participants to contact a healthcare professional for any questions related to their medication or medical issues.

Population and sampling strategy

Patients with type 2 diabetes were chosen as an example population to describe polypharmacy patients as these patients usually have several health issues and polypharmacy [ 20 , 22 , 25 ]. Inclusions criteria for the study were: adult patients with type 2 diabetes, with at least two other comorbidities, hospitalized for at least three days in a general internal medicine ward, with a minimum of one medication change during hospital stay, and who self-managed their medications once discharged home. Exclusion criteria were patients not reachable by telephone following discharge, unable to give consent (patients with schizophrenia, dementia, brain damage, or drug/alcohol misuse), and who could not communicate in French. A purposive sampling methodology was applied aiming to include participants with different ages, genders, types, and numbers of health conditions by listing participants’ characteristics in a double-entry table, available in Supplementary Material 1 , until thematic saturation was reached. Thematic saturation was considered achieved when no new code or theme emerged and new data repeated previously coded information [ 64 ]. The participants were identified if they were hospitalized in the ward dedicated to diabetes care or when the diabetes team was contacted for advice. The senior ward physician (GG) screened eligible patients and the interviewer (LS) obtained written consent before hospital discharge.

Data collection and instruments

Sociodemographic (age, gender, educational level, living arrangement) and clinical characteristics (reason for hospitalization, date of admission, health conditions, diabetes diagnosis, medications before and during hospitalization) were collected by interviewing participants before their discharge and by extracting participants’ data from electronic hospital files by GG and LS. Participants’ pharmacies were contacted with the participant’s consent to obtain medication records from the last three months if information regarding medications before hospitalization was missing in the hospital files.

Semi-structured interview guides for each interview (at three, 10-, 30- and 60-days post-discharge) were developed based on different theories and components of health behavior and medication adherence: the World Health Organization’s (WHO) five dimensions for adherence, the Information-Motivation-Behavioral skills model and the Social Cognitive Theory [ 65 , 66 , 67 ]. Each interview explored participants’ itinerary in the healthcare system and their perspectives on their medications. Regarding medications, the following themes were mentioned at each interview: changes in medications, patients’ understanding and implication; information on their medications, self-management of their medications, and patients’ medication adherence. Other aspects were mentioned in specific interviews: patients’ hospitalization and experience on their return home (interview 1), motivation (interviews 2 and 4), and patient’s feedback on the past two months (interview 4). Interview guides translated from French are available in Supplementary Material 2 . The participants completed self-reported and self-administrated questionnaires at different interviews to obtain descriptive information on different factors that may affect medication management and adherence: self-report questionnaires on quality of life (EQ-5D-5 L) [ 68 ], literacy (Schooling-Opinion-Support questionnaire) [ 69 ], medication adherence (Adherence Visual Analogue Scale, A-VAS) [ 70 ] and Belief in Medication Questionnaire (BMQ) [ 71 ] were administered to each participant at the end of selected interviews to address the different factors that may affect medication management and adherence as well as to determine a trend of determinants over time. The BMQ contains two subscores: Specific-Necessity and Specific-Concerns, addressing respectively their perceived needs for their medications, and their concerns about adverse consequences associated with taking their medication [ 72 ].

Data management

Informed consent forms, including consent to obtain health data, were securely stored in a private office at the University of Geneva. The participants’ identification key was protected by a password known only by MS and LS. Confidentiality was guaranteed by pseudonymization of participants’ information and audio-recordings were destroyed once analyzed. Sociodemographic and clinical characteristics, medication changes, and answers to questionnaires were securely collected by electronic case report forms (eCRFs) on RedCap®. Interviews were double audio-recorded and field notes were taken during interviews. Recorded interviews were manually transcribed verbatim in MAXQDA® (2018.2) by research assistants and LS and transcripts were validated for accuracy by LS. A random sample of 20% of questionnaires was checked for accuracy for the transcription from the paper questionnaires to the eCRFs. Recorded sequences with no link to the discussed topics were not transcribed and this was noted in the transcripts.

Data analysis

A descriptive statistical analysis of sociodemographic, clinical characteristics and self-reported questionnaire data was carried out. A thematic analysis of transcripts was performed, as described by Braun and Clarke [ 73 ], by following six steps: raw data was read, text segments related to the study objectives were identified, text segments to create new categories were identified, similar or redundant categories were reduced and a model that integrated all significant categories was created. The analysis was conducted in parallel with patient enrolment to ensure data saturation. To ensure the validity of the coding method, transcripts were double coded independently and discussed by the research team until similar themes were obtained. The research group developed and validated an analysis grid, with which LS coded systematically the transcriptions and met regularly with the research team to discuss questions on data analysis and to ensure the quality of coding. The analysis was carried out in French, and the verbatims of interest cited in the manuscript were translated and validated by a native English-speaking researcher to preserve the meaning.

In this analysis, we used the term “healthcare professionals” when more than one profession could be involved in participants’ medication management. Otherwise, when a specific healthcare professional was involved, we used the designated profession (e.g. physicians, pharmacists).

Patient and public involvement

During the development phase of the study, interview guides and questionnaires were reviewed for clarity and validity and adapted by two patient partners, with multiple health conditions and who experienced previously a hospital discharge. They are part of the HUG Patients Partners + 3P platform for research and patient and public involvement.

Interviews and participants’ descriptions

A total of 75 interviews were conducted with 21 participants. In total, 31 patients were contacted, seven refused to participate (four at the project presentation and three at consent), two did not enter the selection criteria at discharge and one was unreachable after discharge. Among the 21 participants, 15 participated in all interviews, four in three interviews, one in two interviews, and one in one interview, due to scheduling constraints. Details regarding interviews and participants characteristics are presented in Tables  1 and 2 .

The median length of time between hospital discharge and interviews 1,2,3 and 4 was 5 (IQR: 4–7), 14 (13-20), 35 (22-38), and 63 days (61-68), respectively. On average, by comparing medications at hospital admission and discharge, a median of 7 medication changes (IQR: 6–9, range:2;17) occurred per participant during hospitalization and a median of 7 changes (5–12) during the two months following discharge. Details regarding participants’ medications are described in Table  3 .

Patient self-reported adherence over the past week for their three most challenging medications are available in Supplementary Material 3 .

Qualitative analysis

We defined care transition as the period from discharge until the first medical appointment post-discharge, and outpatient care as the period starting after the first medical appointment. Data was organized into three key themes (A. Medication management, B. Medication understanding, and C. Medication adherence) divided into subthemes at three time points (1. Hospitalization, 2. Care transition and 3. Outpatient care). Figure  2 summarizes and illustrates the themes and subthemes with their influencing factors as bullet points.

Participants’ medication management, understanding and adherence during hospitalization, care transition and outpatient care

A. Medication management

A.1 medication management during hospitalization: medication management by hospital staff.

Medications during hospitalization were mainly managed by hospital healthcare professionals (i.e. nurses and physicians) with varying degrees of patient involvement: “At the hospital, they prepared the medications for me. […] I didn’t even know what the packages looked like.” Participant 22; interview 1 (P22.1) Some participants reported having therapeutic education sessions with specialized nurses and physicians, such as the explanation and demonstration of insulin injection and glucose monitoring. A patient reported that he was given the choice of several treatments and was involved in shared decision-making. Other participants had an active role in managing and optimizing dosages, such as rapid insulin, due to prior knowledge and use of medications before hospitalization.

A.2 Medication management at transition: obtaining the medication and initiating self-management

Once discharged, some participants had difficulties obtaining their medications at the pharmacy because some medications were not stored and had to be ordered, delaying medication initiation. To counter this problem upstream, a few participants were provided a 24-to-48-hour supply of medications at discharge. It was sometimes requested by the patient or suggested by the healthcare professionals but was not systematic. The transition from medication management by hospital staff to self-management was exhausting for most participants who were faced with a large amount of new information and changes in their medications: “ When I was in the hospital, I didn’t even realize all the changes. When I came back home, I took away the old medication packages and got out the new ones. And then I thought : « my God, all this…I didn’t know I had all these changes » ” P2.1 Written documentation, such as the discharge prescription or dosage labels on medication packages, was helpful in managing their medication at home. Most participants used weekly pill organizers to manage their medications, which were either already used before hospitalization or were introduced post-discharge. The help of a family caregiver in managing and obtaining medications was reported as a facilitator.

A.3 Medication management in outpatient care: daily self-management and medication burden

A couple of days or weeks after discharge, most participants had acquired a routine so that medication management was less demanding, but the medication burden varied depending on the participants. For some, medication management became a simple action well implemented in their routine (“It has become automatic” , P23.4), while for others, the number of medications and the fact that the medications reminded them of the disease was a heavy burden to bear on a daily basis (“ During the first few days after getting out of the hospital, I thought I was going to do everything right. In the end, well [laughs] it’s complicated. I ended up not always taking the medication, not monitoring the blood sugar” P12.2) To support medication self-management, some participants had written documentation such as treatment plans, medication lists, and pictures of their medication packages on their phones. Some participants had difficulties obtaining medications weeks after discharge as discharge prescriptions were not renewable and participants did not see their physician in time. Others had to visit multiple physicians to have their prescriptions updated. A few participants were faced with prescription or dispensing errors, such as prescribing or dispensing the wrong dosage, which affected medication management and decreased trust in healthcare professionals. In most cases, according to participants, the pharmacy staff worked in an interprofessional collaboration with physicians to provide new and updated prescriptions.

B. Medication understanding

B.1 medication understanding during hospitalization: new information and instructions.

The amount of information received during hospitalization varied considerably among participants with some reporting having received too much, while others saying they received too little information regarding medication changes, the reason for changes, or for introducing new medications: “They told me I had to take this medication all my life, but they didn’t tell me what the effects were or why I was taking it.” P5.3

Hospitalization was seen by some participants as a vulnerable and tiring period during which they were less receptive to information. Information and explanations were generally given verbally, making it complicated for most participants to recall it. Some participants reported that hospital staff was attentive to their needs for information and used communication techniques such as teach-back (a way of checking understanding by asking participants to say in their own words what they need to know or do about their health or medications). Some participants were willing to be proactive in the understanding of their medications while others were more passive, had no specific needs for information, and did not see how they could be engaged more.

B.2 Medication understanding at transition: facing medication changes

At hospital discharge, the most challenging difficulty for participants was to understand the changes made regarding their medications. For newly diagnosed participants, the addition of new medications was more difficult to understand, whereas, for experienced participants, changes in known medications such as dosage modification, changes within a therapeutic class, and generic substitutions were the most difficult to understand. Not having been informed about changes caused confusion and misunderstanding. Therefore, medication reconciliation done by the patient was time-consuming, especially for participants with multiple medications: “ They didn’t tell me at all that they had changed my treatment completely. They just told me : « We’ve changed a few things. But it was the whole treatment ». ” P2.3 Written information, such as the discharge prescription, the discharge report (brief letter summarizing information about the hospitalization, given to the patient at discharge), or the label on the medication box (written by the pharmacist with instructions on dosage) helped them find or recall information about their medications and diagnoses. However, technical terms were used in hospital documentations and were not always understandable. For example, this participant said: “ On the prescription of valsartan, they wrote: ‘resume in the morning once profile…’[once hypertension profile allows]… I don’t know what that means.” P8.1 In addition, some documents were incomplete, as mentioned by a patient who did not have the insulin dosage mentioned on the hospital prescription. Some participants sought help from healthcare professionals, such as pharmacists, hospital physicians, or general practitioners a few days after discharge to review medications, answer questions, or obtain additional information.

B.3 Medication understanding in the outpatient care: concerns and knowledge

Weeks after discharge, most participants had concerns about the long-term use of their medications, their usefulness, and the possible risk of interactions or side effects. Some participants also reported having some lack of knowledge regarding indications, names, or how the medication worked: “I don’t even know what Brilique® [ticagrelor, antiplatelet agent] is for. It’s for blood pressure, isn’t it?. I don’t know.” P11.4 According to participants, the main reasons for the lack of understanding were the lack of information at the time of prescribing and the large number of medications, making it difficult to search for information and remember it. Participants sought information from different healthcare professionals or by themselves, on package inserts, through the internet, or from family and friends. Others reported having had all the information needed or were not interested in having more information. In addition, participants with low medication literacy, such as non-native speakers or elderly people, struggled more with medication understanding and sought help from family caregivers or healthcare professionals, even weeks after discharge: “ I don’t understand French very well […] [The doctor] explained it very quickly…[…] I didn’t understand everything he was saying” P16.2

C. Medication adherence

C.2 medication adherence at transition: adopting new behaviors.

Medication adherence was not mentioned as a concern during hospitalization and a few participants reported difficulties in medication initiation once back home: “I have an injection of Lantus® [insulin] in the morning, but obviously, the first day [after discharge], I forgot to do it because I was not used to it.” P23.1 Participants had to quickly adopt new behaviors in the first few days after discharge, especially for participants with few medications pre-hospitalization. The use of weekly pill organizers, alarms and specific storage space were reported as facilitators to support adherence. One patient did not initiate one of his medications because he did not understand the medication indication, and another patient took her old medications because she was used to them. Moreover, most participants experienced their hospitalization as a turning point, a time when they focused on their health, thought about the importance of their medications, and discussed any new lifestyle or dietary measures that might be implemented.

C.3 Medication adherence in outpatient care: ongoing medication adherence

More medication adherence difficulties appeared a few weeks after hospital discharge when most participants reported nonadherence behaviors, such as difficulties implementing the dosage regimen, or intentionally discontinuing the medication and modifying the medication regimen on their initiative. Determinants positively influencing medication adherence were the establishment of a routine; organizing medications in weekly pill-organizers; organizing pocket doses (medications for a short period that participants take with them when away from home); seeking support from family caregivers; using alarm clocks; and using specific storage places. Reasons for nonadherence were changes in daily routine; intake times that were not convenient for the patient; the large number of medications; and poor knowledge of the medication or side effects. Healthcare professionals’ assistance for medication management, such as the help of home nurses or pharmacists for the preparation of weekly pill-organizers, was requested by participants or offered by healthcare professionals to support medication adherence: “ I needed [a home nurse] to put my pills in the pillbox. […] I felt really weak […] and I was making mistakes. So, I’m very happy [the doctor] offered me [home care]. […] I have so many medications.” P22.3 Some participants who experienced prehospitalization non-adherence were more aware of their non-adherence and implemented strategies, such as modifying the timing of intake: “I said to my doctor : « I forget one time out of two […], can I take them in the morning? » We looked it up and yes, I can take it in the morning.” P11.2 In contrast, some participants were still struggling with adherence difficulties that they had before hospitalization. Motivations for taking medications two months after discharge were to improve health, avoid complications, reduce symptoms, reduce the number of medications in the future or out of obligation: “ I force myself to take them because I want to get to the end of my diabetes, I want to reduce the number of pills as much as possible.” P14.2 After a few weeks post-hospitalization, for some participants, health and illness were no longer the priority because of other life imperatives (e.g., family or financial situation).

This longitudinal study provided a multi-faceted representation of how patients manage, understand, and adhere to their medications from hospital discharge to two months after discharge. Our findings highlighted the varying degree of participants’ involvement in managing their medications during their hospitalization, the individualized needs for information during and after hospitalization, the complicated transition from hospital to autonomous medication management, the adaptation of daily routines around medication once back home, and the adherence difficulties that surfaced in the outpatient care, with nonadherence prior to hospitalization being an indicator of the behavior after discharge. Finally, our results confirmed the lack of continuity in care and showed the lack of patient care standardization experienced by the participants during the transition from hospital to outpatient care.

This in-depth analysis of patients’ experiences reinforces common challenges identified in the existing literature such as the lack of personalized information [ 9 , 10 , 11 ], loss of autonomy during hospitalization [ 14 , 74 , 75 ], difficulties in obtaining medication at discharge [ 11 , 45 , 76 ] and challenges in understanding treatment modifications and generics substitution [ 11 , 32 , 77 , 78 ]. Some of these studies were conducted during patients’ hospitalization [ 10 , 75 , 79 ] or up to 12 months after discharge [ 80 , 81 ], but most studies focused on the few days following hospital discharge [ 9 , 11 , 14 , 82 ]. Qualitative studies on medications at transition often focused on a specific topic, such as medication information, or a specific moment in time, and often included healthcare professionals, which muted patients’ voices [ 9 , 10 , 11 , 47 , 49 ]. Our qualitative longitudinal methodology was interested in capturing the temporal dynamics, in-depth narratives, and contextual nuances of patients’ medication experiences during transitions of care [ 59 , 83 ]. This approach provided a comprehensive understanding of how patients’ perspectives and behaviors evolved over time, offering insights into the complex interactions of medication management, understanding and adherence, and turning points within their medication journeys. A qualitative longitudinal design was used by Fylan et al. to underline patients’ resilience in medication management during and after discharge, by Brandberg et al. to show the dynamic process of self-management during the 4 weeks post-discharge and by Lawton et al. to examine how patients with type 2 diabetes perceived their care after discharge over a period of four years [ 49 , 50 , 51 ]. Our study focused on the first two months following hospitalization and future studies should focus on following discharged and at-risk patients over a longer period, as “transitions of care do not comprise linear trajectories of patients’ movements, with a starting and finishing point. Instead, they are endless loops of movements” [ 47 ].

Our results provide a particularly thorough description of how participants move from a state of total dependency during hospitalization regarding their medication management to a sudden and complete autonomy after hospital discharge impacting medication management, understanding, and adherence in the first days after discharge for some participants. Several qualitative studies have described the lack of shared decision-making and the loss of patient autonomy during hospitalization, which had an impact on self-management and created conflicts with healthcare professionals [ 75 , 81 , 84 ]. Our study also highlights nuanced patient experiences, including varying levels of patient needs, involvement, and proactivity during hospitalization and outpatient care, and our results contribute to capturing different perspectives that contrast with some literature that often portrays patients as more passive recipients of care [ 14 , 15 , 74 , 75 ]. Shared decision-making and proactive medication are key elements as they contribute to a smoother transition and better outcomes for patients post-discharge [ 85 , 86 , 87 ].

Consistent with the literature, the study identifies some challenges in medication initiation post-discharge [ 16 , 17 , 88 ] but our results also describe how daily routine rapidly takes over, either solidifying adherence behavior or generating barriers to medication adherence. Participants’ nonadherence prior to hospitalization was a factor influencing participants’ adherence post-hospitalization and this association should be further investigated, as literature showed that hospitalized patients have high scores of non-adherence [ 89 ]. Mortel et al. showed that more than 20% of discharged patients stopped their medications earlier than agreed with the physician and 25% adapted their medication intake [ 90 ]. Furthermore, patients who self-managed their medications had a lower perception of the necessity of their medication than patients who received help, which could negatively impact medication adherence [ 91 ]. Although participants in our study had high BMQ scores for necessity and lower scores for concerns, some participants expressed doubts about the need for their medications and a lack of motivation a few weeks after discharge. Targeted pharmacy interventions for newly prescribed medications have been shown to improve medication adherence, and hospital discharge is an opportune moment to implement this service [ 92 , 93 ].

Many medication changes were made during the transition of care (a median number of 7 changes during hospitalization and 7 changes during the two months after discharge), especially medication additions during hospitalization and interruptions after hospitalization. While medication changes during hospitalization are well described, the many changes following discharge are less discussed [ 7 , 94 ]. A Danish study showed that approximately 65% of changes made during hospitalization were accepted by primary healthcare professionals but only 43% of new medications initiated during hospitalization were continued after discharge [ 95 ]. The numerous changes after discharge may be caused by unnecessary intensification of medications during hospitalization, delayed discharge letters, lack of standardized procedures, miscommunication, patient self-management difficulties, or in response to an acute situation [ 96 , 97 , 98 ]. During the transition of care, in our study, both new and experienced participants were faced with difficulties in managing and understanding medication changes, either for newly prescribed medication or changes in previous medications. Such difficulties corroborate the findings of the literature [ 9 , 10 , 47 ] and our results showed that the lack of understanding during hospitalization led to participants having questions about their medications, even weeks after discharge. Particular attention should be given to patients’ understanding of medication changes jointly by physicians, nurses and pharmacists during the transition of care and in the months that follow as medications are likely to undergo as many changes as during hospitalization.

Implication for practice and future research

The patients’ perspectives in this study showed, at a system level, that there was a lack of standardization in healthcare professional practices regarding medication dispensing and follow-up. For now, in Switzerland, there are no official guidelines on medication prescription and dispensation during the transition of care although some international guidelines have been developed for outpatient healthcare professionals [ 3 , 99 , 100 , 101 , 102 ]. Here are some suggestions for improvement arising from our results. Patients should be included as partners and healthcare professionals should systematically assess (i) previous medication adherence, (ii) patients’ desired level of involvement and (iii) their needs for information during hospitalization. Hospital discharge processes should be routinely implemented to standardize hospital discharge preparation, medication prescribing, and dispensing. Discharge from the hospital should be planned with community pharmacies to ensure that all medications are available and, if necessary, doses of medications should be supplied by the hospital to bridge the gap. A partnership with outpatient healthcare professionals, such as general practitioners, community pharmacists, and homecare nurses, should be set up for effective asynchronous interprofessional collaboration to consolidate patients’ medication management, knowledge, and adherence, as well as to monitor signs of deterioration or adverse drug events.

Future research should consolidate our first attempt to develop a framework to better characterize medication at the transition of care, using Fig. 2   as a starting point. Contextualized interventions, co-designed by health professionals, patients and stakeholders, should be tested in a hybrid implementation study to test the implementation and effectiveness of the intervention for the health system [ 103 ].

Limitations

This study has some limitations. First, the transcripts were validated for accuracy by the interviewer but not by a third party, which could have increased the robustness of the transcription. Nevertheless, the interviewer followed all methodological recommendations for transcription. Second, patient inclusion took place during the COVID-19 pandemic, which may have had an impact on patient care and the availability of healthcare professionals. Third, we cannot guarantee the accuracy of some participants’ medication history before hospitalization, even though we contacted the participants’ main pharmacy, as participants could have gone to different pharmacies to obtain their medications. Fourth, our findings may not be generalizable to other populations and other healthcare systems because some issues may be specific to multimorbid patients with type 2 diabetes or to the Swiss healthcare setting. Nevertheless, issues encountered by our participants regarding their medications correlate with findings in the literature. Fifth, only 15 out of 21 participants took part in all the interviews, but most participants took part in at least three interviews and data saturation was reached. Lastly, by its qualitative and longitudinal design, it is possible that the discussion during interviews and participants’ reflections between interviews influenced participants’ management, knowledge, and adherence, even though this study was observational, and no advice or recommendations were given by the interviewer during interviews.

Discharged patients are willing to take steps to better manage, understand, and adhere to their medications, yet they are also faced with difficulties in the hospital and outpatient care. Furthermore, extensive changes in medications not only occur during hospitalization but also during the two months following hospital discharge, for which healthcare professionals should give particular attention. The different degrees of patients’ involvement, needs and resources should be carefully considered to enable them to better manage, understand and adhere to their medications. At a system level, patients’ experiences revealed a lack of standardization of medication practices during the transition of care. The healthcare system should provide the ecosystem needed for healthcare professionals responsible for or involved in the management of patients’ medications during the hospital stay, discharge, and outpatient care to standardize their practices while considering the patient as an active partner.

Data availability

The anonymized quantitative survey datasets and the qualitative codes are available in French from the corresponding author on reasonable request.

Abbreviations

adverse drug events

Adherence Visual Analogue Scale

Belief in Medication Questionnaire

Consolidated Criteria for Reporting Qualitative Research

case report form

standard deviation

World Health Organization

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Acknowledgements

The authors would like to thank all the patients who took part in this study. We would also like to thank the Geneva University Hospitals Patients Partners + 3P platform as well as Mrs. Tourane Corbière and Mr. Joël Mermoud, patient partners, who reviewed interview guides for clarity and significance. We would like to thank Samuel Fabbi, Vitcoryavarman Koh, and Pierre Repiton for the transcriptions of the audio recordings.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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LS, GG, and MS conceptualized and designed the study. LS and GG screened and recruited participants. LS conducted the interviews. LS, GG, and MS performed data analysis and interpretation. LS drafted the manuscript and LS and MS worked on the different versions. MS and GG approved the final manuscript.

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Solh Dost, L., Gastaldi, G. & Schneider, M. Patient medication management, understanding and adherence during the transition from hospital to outpatient care - a qualitative longitudinal study in polymorbid patients with type 2 diabetes. BMC Health Serv Res 24 , 620 (2024). https://doi.org/10.1186/s12913-024-10784-9

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Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts

• Jeremy Segrott   ORCID: orcid.org/0000-0001-6215-0870 1 ,
• Sue Channon 2 ,
• Amy Lloyd 4 ,
• Eleni Glarou 2 , 3 ,
• Josie Henley 5 ,
• Jacqueline Hughes 2 ,
• Nina Jacob 2 ,
• Sarah Milosevic 2 ,
• Yvonne Moriarty 2 ,
• Bethan Pell 6 ,
• Mike Robling 2 ,
• Heather Strange 2 ,
• Julia Townson 2 ,
• Qualitative Research Group &
• Lucy Brookes-Howell 2  

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Background/aims

The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University’s Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration.

We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper.

Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies.

Conclusions

Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit’s experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations.

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The value of using qualitative methods within randomised control trials (RCTs) is widely recognised [ 1 , 2 , 3 ]. Qualitative research generates important evidence on factors affecting trial recruitment/retention [ 4 ] and implementation, aiding interpretation of quantitative data [ 5 ]. Though RCTs have traditionally been viewed as sitting within a positivist paradigm, recent methodological innovations have developed new trial designs that draw explicitly on both quantitative and qualitative methods. For instance, in the field of complex public health interventions, realist RCTs seek to understand the mechanisms through which interventions generate hypothesised impacts, and how interactions across different implementation contexts form part of these mechanisms. Proponents of realist RCTs—which integrate experimental and realist paradigms—highlight the importance of using quantitative and qualitative methods to fully realise these aims and to generate an understanding of intervention mechanisms and how context shapes them [ 6 ].

A need for guidance on how to conduct good quality qualitative research is being addressed, particularly in relation to feasibility studies for RCTs [ 7 ] and process evaluations embedded within trials of complex interventions [ 5 ]. There is also guidance on the conduct of qualitative research within trials at different points in the research cycle, including development, conduct and reporting [ 8 , 9 ].

A high proportion of trials are based within or involve clinical trials units (CTUs). In the UK the UKCRC Registered CTU Network describes them as:

… specialist units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. They have the capability to provide specialist expert statistical, epidemiological, and other methodological advice and coordination to undertake successful clinical trials. In addition, most CTUs will have expertise in the coordination of trials involving investigational medicinal products which must be conducted in compliance with the UK Regulations governing the conduct of clinical trials resulting from the EU Directive for Clinical Trials.

Thus, CTUs provide the specialist methodological expertise needed for the conduct of trials, and in the case of trials of investigational medicinal products, their involvement may be mandated to ensure compliance with relevant regulations. As the definition above suggests, CTUs also conduct and support other types of study apart from RCTs, providing a range of methodological and subject-based expertise.

However, despite their central role in the conduct and design of trials, (and other evaluation designs) little has been written about how CTUs have integrated qualitative work within their organisation at a time when such methods are, as stated above, now recognised as an important aspect of RCTs and evaluation studies more generally. This is a significant gap, since integration at the organisational level arguably shapes how qualitative research is integrated within individual studies, and thus it is valuable to understand how CTUs have approached the task. There are different ways of involving qualitative work in trials units, such as partnering with other departments (e.g. social science) or employing qualitative researchers directly. Qualitative research can be imagined and configured in different ways—as a method that generates data to inform future trial and intervention design, as an embedded component within an RCT or other evaluation type, or as a parallel strand of research focusing on lived experiences of illness, for instance. Understanding how trials units have integrated qualitative research is valuable, as it can shed light on which strategies show promise, and in which contexts, and how qualitative research is positioned within the field of trials research, foregrounding the value of qualitative research. However, although much has been written about its use within trials, few accounts exist of how trials units have integrated qualitative research within their systems and structures.

This paper discusses the process of embedding qualitative research within the work of one CTU—Cardiff University’s Centre for Trials Research (CTR). It highlights facilitators of this process and identifies challenges to integration. We use the Normalisation Process Theory (NPT) as a framework to structure our experience and approach. The key gap addressed by this paper is the implementation of strategies to integrate qualitative research (a relatively newly adopted set of practices and processes) within CTU systems and structures. We acknowledge from the outset that there are multiple ways of approaching this task. What follows therefore is not a set of recommendations for a preferred or best way to integrate qualitative research, as this will comprise diverse actions according to specific contexts. Rather, we examine the processes through which integration occurred in our own setting and highlight the potential value of these insights for others engaged in the work of promoting qualitative research within trials units.

Background to the integration of qualitative research within CTR

The CTR was formed in 2015 [ 10 ]. It brought together three existing trials units at Cardiff University: the South East Wales Trials Unit, the Wales Cancer Trials Unit, and the Haematology Clinical Trials Unit. From its inception, the CTR had a stated aim of developing a programme of qualitative research and integrating it within trials and other studies. In the sections below, we map these approaches onto the framework offered by Normalisation Process Theory to understand the processes through which they helped achieve embedding and integration of qualitative research.

CTR’s aims (including those relating to the development of qualitative research) were included within its strategy documents and communicated to others through infrastructure funding applications, annual reports and its website. A Qualitative Research Group (QRG), which had previously existed within the South East Wales Trials Unit, with dedicated funding for methodological specialists and group lead academics, was a key mechanism through which the development of a qualitative portfolio was put into action. Integration of qualitative research within Centre systems and processes occurred through the inclusion of qualitative research in study adoption processes and representation on committees. The CTR’s study portfolio provided a basis to track qualitative methods in new and existing studies, identify opportunities to embed qualitative methods within recently adopted studies (at the funding application stage) and to manage staff resources. Capacity building and training were an important focus of the QRG’s work, including training courses, mentoring, creation of an academic network open to university staff and practitioners working in the field of healthcare, presentations at CTR staff meetings and securing of PhD studentships. Standard operating procedures and methodological guidance on the design and conduct of qualitative research (e.g. templates for developing analysis plans) aimed to create a shared understanding of how to undertake high-quality research, and a means to monitor the implementation of rigorous approaches. As the QRG expanded its expertise it sought to develop innovative approaches, including the use of visual [ 11 ] and ethnographic methods [ 12 ].

Understanding implementation—Normalisation Process Theory (NPT)

Normalisation Process Theory (NPT) provides a model with which to understand the implementation of new sets of practices and their normalisation within organisational settings. The term ‘normalisation’ refers to how new practices become routinised (part of the everyday work of an organisation) through embedding and integration [ 13 , 14 ]. NPT defines implementation as ‘the social organisation of work’ and is concerned with the social processes that take place as new practices are introduced. Embedding involves ‘making practices routine elements of everyday life’ within an organisation. Integration takes the form of ‘sustaining embedded practices in social contexts’, and how these processes lead to the practices becoming (or not becoming) ‘normal and routine’ [ 14 ]. NPT is concerned with the factors which promote or ‘inhibit’ attempts to embed and integrate the operationalisation of new practices [ 13 , 14 , 15 ].

Embedding new practices is therefore achieved through implementation—which takes the form of interactions in specific contexts. Implementation is operationalised through four ‘generative mechanisms’— coherence , cognitive participation , collective action and reflexive monitoring [ 14 ]. Each mechanism is characterised by components comprising immediate and organisational work, with actions of individuals and organisations (or groups of individuals) interdependent. The mechanisms operate partly through forms of investment (i.e. meaning, commitment, effort, and comprehension) [ 14 ].

Coherence refers to how individuals/groups make sense of, and give meaning to, new practices. Sense-making concerns the coherence of a practice—whether it ‘holds together’, and its differentiation from existing activities [ 15 ]. Communal and individual specification involve understanding new practices and their potential benefits for oneself or an organisation. Individuals consider what new practices mean for them in terms of tasks and responsibilities ( internalisation ) [ 14 ].

NPT frames the second mechanism, cognitive participation , as the building of a ‘community of practice’. For a new practice to be initiated, individuals and groups within an organisation must commit to it [ 14 , 15 ]. Cognitive participation occurs through enrolment —how people relate to the new practice; legitimation —the belief that it is right for them to be involved; and activation —defining which actions are necessary to sustain the practice and their involvement [ 14 ]. Making the new practices work may require changes to roles (new responsibilities, altered procedures) and reconfiguring how colleagues work together (changed relationships).

Third, Collective Action refers to ‘the operational work that people do to enact a set of practices’ [ 14 ]. Individuals engage with the new practices ( interactional workability ) reshaping how members of an organisation interact with each other, through creation of new roles and expectations ( relational interaction ) [ 15 ]. Skill set workability concerns how the work of implementing a new set of practices is distributed and the necessary roles and skillsets defined [ 14 ]. Contextual integration draws attention to the incorporation of a practice within social contexts, and the potential for aspects of these contexts, such as systems and procedures, to be modified as a result [ 15 ].

Reflexive monitoring is the final implementation mechanism. Collective and individual appraisal evaluate the value of a set of practices, which depends on the collection of information—formally and informally ( systematisation ). Appraisal may lead to reconfiguration in which procedures of the practice are redefined or reshaped [ 14 , 15 ].

We sought to map the following: (1) the strategies used to embed qualitative research within the Centre, (2) key facilitators, and (3) barriers to their implementation. Through focused group discussions during the monthly meetings of the CTR QRG and in discussion with the CTR senior management team throughout 2019–2020 we identified nine types of documents (22 individual documents in total) produced within the CTR which had relevant information about the integration of qualitative research within its work (Table  1 ). The QRG had an ‘open door’ policy to membership and welcomed all staff/students with an interest in qualitative research. It included researchers who were employed specifically to undertake qualitative research and other staff with a range of study roles, including trial managers, statisticians, and data managers. There was also diversity in terms of career stage, including PhD students, mid-career researchers and members of the Centre’s Executive team. Membership was therefore largely self-selected, and comprised of individuals with a role related to, or an interest in, embedding qualitative research within trials. However, the group brought together diverse methodological perspectives and was not solely comprised of methodological ‘champions’ whose job it was to promote the development of qualitative research within the centre. Thus whilst the group (and by extension, the authors of this paper) had a shared appreciation of the value of qualitative research within a trials centre, they also brought varied methodological perspectives and ways of engaging with it.

All members of the QRG ( n  = 26) were invited to take part in a face-to-face, day-long workshop in February 2019 on ‘How to optimise and operationalise qualitative research in trials: reflections on CTR structure’. The workshop was attended by 12 members of staff and PhD students, including members of the QRG and the CTR’s senior management team. Recruitment to the workshop was therefore inclusive, and to some extent opportunistic, but all members of the QRG were able to contribute to discussions during regular monthly group meetings and the drafting of the current paper.

The aim of the workshop was to bring together information from the documents in Table  1 to generate discussion around the key strategies (and their component activities) that had been adopted to integrate qualitative research into CTR, as well as barriers to, and facilitators of, their implementation. The agenda for the workshop involved four key areas: development and history of the CTR model; mapping the current model within CTR; discussing the structure of other CTUs; and exploring the advantages and disadvantages of the CTR model.

During the workshop, we discussed the use of NPT to conceptualise how qualitative research had been embedded within CTR’s systems and practices. The group produced spider diagrams to map strategies and actions on to the four key domains (or ‘generative mechanisms’ of NPT) summarised above, to aid the understanding of how they had functioned, and the utility of NPT as a framework. This is summarised in Table  2 .

Detailed notes were made during the workshop. A core writing group then used these notes and the documents in Table  1 to develop a draft of the current paper. This was circulated to all members of the CTR QRG ( n  = 26) and stored within a central repository accessible to them to allow involvement and incorporate the views of those who were not able to attend the workshop. This draft was again presented for comments in the monthly CTR QRG meeting in February 2021 attended by n  = 10. The Standards for QUality Improvement Reporting Excellence 2.0 (SQUIRE) guidelines were used to inform the structure and content of the paper (see supplementary material) [ 16 ].

In the following sections, we describe the strategies CTR adopted to integrate qualitative research. These are mapped against NPT’s four generative mechanisms to explore the processes through which the strategies promoted integration, and facilitators of and barriers to their implementation. A summary of the strategies and their functioning in terms of the generative mechanisms is provided in Table  2 .

Coherence—making sense of qualitative research

In CTR, many of the actions taken to build a portfolio of qualitative research were aimed at enabling colleagues, and external actors, to make sense of this set of methodologies. Centre-level strategies and grant applications for infrastructure funding highlighted the value of qualitative research, the added benefits it would bring, and positioned it as a legitimate set of practices alongside existing methods. For example, a 2014 application for renewal of trials unit infrastructure funding stated:

We are currently in the process of undertaking […] restructuring for our qualitative research team and are planning similar for trial management next year. The aim of this restructuring is to establish greater hierarchical management and opportunities for staff development and also provide a structure that can accommodate continuing growth.

Within the CTR, various forms of communication on the development of qualitative research were designed to enable staff and students to make sense of it, and to think through its potential value for them, and ways in which they might engage with it. These included presentations at staff meetings, informal meetings between project teams and the qualitative group lead, and the visibility of qualitative research on the public-facing Centre website and Centre committees and systems. For instance, qualitative methods were included (and framed as a distinct set of practices) within study adoption forms and committee agendas. Information for colleagues described how qualitative methods could be incorporated within funding applications for RCTs and other evaluation studies to generate new insights into questions research teams were already keen to answer, such as influences on intervention implementation fidelity. Where externally based chief investigators approached the Centre to be involved in new grant applications, the existence of the qualitative team and group lead enabled the inclusion of qualitative research to be actively promoted at an early stage, and such opportunities were highlighted in the Centre’s brochure for new collaborators. Monthly qualitative research network meetings—advertised across CTR and to external research collaborators, were also designed to create a shared understanding of qualitative research methods and their utility within trials and other study types (e.g. intervention development, feasibility studies, and observational studies). Training events (discussed in more detail below) also aided sense-making.

Several factors facilitated the promotion of qualitative research as a distinctive and valuable entity. Among these was the influence of the broader methodological landscape within trial design which was promoting the value of qualitative research, such as guidance on the evaluation of complex interventions by the Medical Research Council [ 17 ], and the growing emphasis placed on process evaluations within trials (with qualitative methods important in understanding participant experience and influences on implementation) [ 5 ]. The attention given to lived experience (both through process evaluations and the move to embed public involvement in trials) helped to frame qualitative research within the Centre as something that was appropriate, legitimate, and of value. Recognition by research funders of the value of qualitative research within studies was also helpful in normalising and legitimising its adoption within grant applications.

The inclusion of qualitative methods within influential methodological guidance helped CTR researchers to develop a ‘shared language’ around these methods, and a way that a common understanding of the role of qualitative research could be generated. One barrier to such sense-making work was the varying extent to which staff and teams had existing knowledge or experience of qualitative research. This varied across methodological and subject groups within the Centre and reflected the history of the individual trials units which had merged to form the Centre.

Cognitive participation—legitimising qualitative research

Senior CTR leaders promoted the value and legitimacy of qualitative research. Its inclusion in centre strategies, infrastructure funding applications, and in public-facing materials (e.g. website, investigator brochures), signalled that it was appropriate for individuals to conduct qualitative research within their roles, or to support others in doing so. Legitimisation also took place through informal channels, such as senior leadership support for qualitative research methods in staff meetings and participation in QRG seminars. Continued development of the QRG (with dedicated infrastructure funding) provided a visible identity and equivalence with other methodological groups (e.g. trial managers, statisticians).

Staff were asked to engage with qualitative research in two main ways. First, there was an expansion in the number of staff for whom qualitative research formed part of their formal role and responsibilities. One of the three trials units that merged to form CTR brought with it a qualitative team comprising methodological specialists and a group lead. CTR continued the expansion of this group with the creation of new roles and an enlarged nucleus of researchers for whom qualitative research was the sole focus of their work. In part, this was linked to the successful award of projects that included a large qualitative component, and that were coordinated by CTR (see Table  3 which describes the PUMA study).

Members of the QRG were encouraged to develop their own research ideas and to gain experience as principal investigators, and group seminars were used to explore new ideas and provide peer support. This was communicated through line management, appraisal, and informal peer interaction. Boundaries were not strictly demarcated (i.e. staff located outside the qualitative team were already using qualitative methods), but the new team became a central focus for developing a growing programme of work.

Second, individuals and studies were called upon to engage in new ways with qualitative research, and with the qualitative team. A key goal for the Centre was that groups developing new research ideas should give more consideration in general to the potential value and inclusion of qualitative research within their funding applications. Specifically, they were asked to do this by thinking about qualitative research at an early point in their application’s development (rather than ‘bolting it on’ after other elements had been designed) and to draw upon the expertise and input of the qualitative team. An example was the inclusion of questions on qualitative methods within the Centre’s study adoption form and representation from the qualitative team at the committee which reviewed new adoption requests. Where adoption requests indicated the inclusion of qualitative methods, colleagues were encouraged to liaise with the qualitative team, facilitating the integration of its expertise from an early stage. Qualitative seminars offered an informal and supportive space in which researchers could share initial ideas and refine their methodological approach. The benefits of this included the provision of sufficient time for methodological specialists to be involved in the design of the proposed qualitative component and ensuring adequate costings had been drawn up. At study adoption group meetings, scrutiny of new proposals included consideration of whether new research proposals might be strengthened through the use of qualitative methods where these had not initially been included. Meetings of the QRG—which reviewed the Centre’s portfolio of new studies and gathered intelligence on new ideas—also helped to identify, early on, opportunities to integrate qualitative methods. Communication across teams was useful in identifying new research ideas and embedding qualitative researchers within emerging study development groups.

Actions to promote greater use of qualitative methods in funding applications fed through into a growing number of studies with a qualitative component. This helped to increase the visibility and legitimacy of qualitative methods within the Centre. For example, the PUMA study [ 12 ], which brought together a large multidisciplinary team to develop and evaluate a Paediatric early warning system, drew heavily on qualitative methods, with the qualitative research located within the QRG. The project introduced an extensive network of collaborators and clinical colleagues to qualitative methods and how they could be used during intervention development and the generation of case studies. Further information about the PUMA study is provided in Table  3 .

Increasing the legitimacy of qualitative work across an extensive network of staff, students and collaborators was a complex process. Set within the continuing dominance of quantitative methods with clinical trials, there were variations in the extent to which clinicians and other collaborators embraced the value of qualitative methods. Research funding schemes, which often continued to emphasise the quantitative element of randomised controlled trials, inevitably fed through into the focus of new research proposals. Staff and external collaborators were sometimes uncertain about the added value that qualitative methods would bring to their trials. Across the CTR there were variations in the speed at which qualitative research methods gained legitimacy, partly based on disciplinary traditions and their influences. For instance, population health trials, often located within non-health settings such as schools or community settings, frequently involved collaboration with social scientists who brought with them experience in qualitative methods. Methodological guidance in this field, such as MRC guidance on process evaluations, highlighted the value of qualitative methods and alternatives to the positivist paradigm, such as the value of realist RCTs. In other, more clinical areas, positivist paradigms had greater dominance. Established practices and methodological traditions across different funders also influenced the ease of obtaining funding to include qualitative research within studies. For drugs trials (CTIMPs), the influence of regulatory frameworks on study design, data collection and the allocation of staff resources may have played a role. Over time, teams gained repeated experience of embedding qualitative research (and researchers) within their work and took this learning with them to subsequent studies. For example, the senior clinician quoted within the PUMA case study (Table  3 below) described how they had gained an appreciation of the rigour of qualitative research and an understanding of its language. Through these repeated interactions, embedding of qualitative research within studies started to become the norm rather than the exception.

Collective action—operationalising qualitative research

Collective action concerns the operationalisation of new practices within organisations—the allocation and management of the work, how individuals interact with each other, and the work itself. In CTR the formation of a Qualitative Research Group helped to allocate and organise the work of building a portfolio of studies. Researchers across the Centre were called upon to interact with qualitative research in new ways. Presentations at staff meetings and the inclusion of qualitative research methods in portfolio study adoption forms were examples of this ( interactive workability ). It was operationalised by encouraging study teams to liaise with the qualitative research lead. Development of standard operating procedures, templates for costing qualitative research and methodological guidance (e.g. on analysis plans) also helped encourage researchers to interact with these methods in new ways. For some qualitative researchers who had been trained in the social sciences, working within a trials unit meant that they needed to interact in new and sometimes unfamiliar ways with standard operating procedures, risk assessments, and other trial-based systems. Thus, training needs and capacity-building efforts were multidirectional.

Whereas there had been a tendency for qualitative research to be ‘bolted on’ to proposals for RCTs, the systems described above were designed to embed thinking about the value and design of the qualitative component from the outset. They were also intended to integrate members of the qualitative team with trial teams from an early stage to promote effective integration of qualitative methods within larger trials and build relationships over time.

Standard Operating Procedures (SOPs), formal and informal training, and interaction between the qualitative team and other researchers increased the relational workability of qualitative methods within the Centre—the confidence individuals felt in including these methods within their studies, and their accountability for doing so. For instance, study adoption forms prompted researchers to interact routinely with the qualitative team at an early stage, whilst guidance on costing grants provided clear expectations about the resources needed to deliver a proposed set of qualitative data collection.

Formation of the Qualitative Research Group—comprised of methodological specialists, created new roles and skillsets ( skill set workability ). Research teams were encouraged to draw on these when writing funding applications for projects that included a qualitative component. Capacity-building initiatives were used to increase the number of researchers with the skills needed to undertake qualitative research, and for these individuals to develop their expertise over time. This was achieved through formal training courses, academic seminars, mentoring from experienced colleagues, and informal knowledge exchange. Links with external collaborators and centres engaged in building qualitative research supported these efforts. Within the Centre, the co-location of qualitative researchers with other methodological and trial teams facilitated knowledge exchange and building of collaborative relationships, whilst grouping of the qualitative team within a dedicated office space supported a collective identity and opportunities for informal peer support.

Some aspects of the context in which qualitative research was being developed created challenges to operationalisation. Dependence on project grants to fund qualitative methodologists meant that there was a continuing need to write further grant applications whilst limiting the amount of time available to do so. Similarly, researchers within the team whose role was funded largely by specific research projects could sometimes find it hard to create sufficient time to develop their personal methodological interests. However, the cultivation of a methodologically varied portfolio of work enabled members of the team to build significant expertise in different approaches (e.g. ethnography, discourse analysis) that connected individual studies.

Reflexive monitoring—evaluating the impact of qualitative research

Inclusion of questions/fields relating to qualitative research within the Centre’s study portfolio database was a key way in which information was collected ( systematisation ). It captured numbers of funding applications and funded studies, research design, and income generation. Alongside this database, a qualitative resource planner spreadsheet was used to link individual members of the qualitative team with projects and facilitate resource planning, further reinforcing the core responsibilities and roles of qualitative researchers within CTR. As with all staff in the Centre, members of the qualitative team were placed on ongoing rather than fixed-term contracts, reflecting their core role within CTR. Planning and strategy meetings used the database and resource planner to assess the integration of qualitative research within Centre research, identify opportunities for increasing involvement, and manage staff recruitment and sustainability of researcher posts. Academic meetings and day-to-day interaction fulfilled informal appraisal of the development of the group, and its position within the Centre. Individual appraisal was also important, with members of the qualitative team given opportunities to shape their role, reflect on progress, identify training needs, and further develop their skillset, particularly through line management systems.

These forms of systematisation and appraisal were used to reconfigure the development of qualitative research and its integration within the Centre. For example, group strategies considered how to achieve long-term integration of qualitative research from its initial embedding through further promoting the belief that it formed a core part of the Centre’s business. The visibility and legitimacy of qualitative research were promoted through initiatives such as greater prominence on the Centre’s website. Ongoing review of the qualitative portfolio and discussion at academic meetings enabled the identification of areas where increased capacity would be helpful, both for qualitative staff, and more broadly within the Centre. This prompted the qualitative group to develop an introductory course to qualitative methods open to all Centre staff and PhD students, aimed at increasing understanding and awareness. As the qualitative team built its expertise and experience it also sought to develop new and innovative approaches to conducting qualitative research. This included the use of visual and diary-based methods [ 11 ] and the adoption of ethnography to evaluate system-level clinical interventions [ 12 ]. Restrictions on conventional face-to-face qualitative data collection due to the COVID-19 pandemic prompted rapid adoption of virtual/online methods for interviews, observation, and use of new internet platforms such as Padlet—a form of digital note board.

In this paper, we have described the work undertaken by one CTU to integrate qualitative research within its studies and organisational culture. The parallel efforts of many trials units to achieve these goals arguably come at an opportune time. The traditional designs of RCTs have been challenged and re-imagined by the increasing influence of realist evaluation [ 6 , 18 ] and the widespread acceptance that trials need to understand implementation and intervention theory as well as assess outcomes [ 17 ]. Hence the widespread adoption of embedded mixed methods process evaluations within RCTs. These broad shifts in methodological orthodoxies, the production of high-profile methodological guidance, and the expectations of research funders all create fertile ground for the continued expansion of qualitative methods within trials units. However, whilst much has been written about the importance of developing qualitative research and the possible approaches to integrating qualitative and quantitative methods within studies, much less has been published on how to operationalise this within trials units. Filling this lacuna is important. Our paper highlights how the integration of a new set of practices within an organisation can become embedded as part of its ‘normal’ everyday work whilst also shaping the practices being integrated. In the case of CTR, it could be argued that the integration of qualitative research helped shape how this work was done (e.g. systems to assess progress and innovation).

In our trials unit, the presence of a dedicated research group of methodological specialists was a key action that helped realise the development of a portfolio of qualitative research and was perhaps the most visible evidence of a commitment to do so. However, our experience demonstrates that to fully realise the goal of developing qualitative research, much work focuses on the interaction between this ‘new’ set of methods and the organisation into which it is introduced. Whilst the team of methodological specialists was tasked with, and ‘able’ to do the work, the ‘work’ itself needed to be integrated and embedded within the existing system. Thus, alongside the creation of a team and methodological capacity, promoting the legitimacy of qualitative research was important to communicate to others that it was both a distinctive and different entity, yet similar and equivalent to more established groups and practices (e.g. trial management, statistics, data management). The framing of qualitative research within strategies, the messages given out by senior leaders (formally and informally) and the general visibility of qualitative research within the system all helped to achieve this.

Normalisation Process Theory draws our attention to the concepts of embedding (making a new practice routine, normal within an organisation) and integration —the long-term sustaining of these processes. An important process through which embedding took place in our centre concerned the creation of messages and systems that called upon individuals and research teams to interact with qualitative research. Research teams were encouraged to think about qualitative research and consider its potential value for their studies. Critically, they were asked to do so at specific points, and in particular ways. Early consideration of qualitative methods to maximise and optimise their inclusion within studies was emphasised, with timely input from the qualitative team. Study adoption systems, centre-level processes for managing financial and human resources, creation of a qualitative resource planner, and awareness raising among staff, helped to reinforce this. These processes of embedding and integration were complex and they varied in intensity and speed across different areas of the Centre’s work. In part this depended on existing research traditions, the extent of prior experience of working with qualitative researchers and methods, and the priorities of subject areas and funders. Centre-wide systems, sometimes linked to CTR’s operation as a CTU, also helped to legitimise and embed qualitative research, lending it equivalence with other research activity. For example, like all CTUs, CTR was required to conform with the principles of Good Clinical Practice, necessitating the creation of a quality management system, operationalised through standard operating procedures for all areas of its work. Qualitative research was included, and became embedded, within these systems, with SOPs produced to guide activities such as qualitative analysis.

NPT provides a helpful way of understanding how trials units might integrate qualitative research within their work. It highlights how new practices interact with existing organisational systems and the work needed to promote effective interaction. That is, alongside the creation of a team or programme of qualitative research, much of the work concerns how members of an organisation understand it, engage with it, and create systems to sustain it. Embedding a new set of practices may be just as important as the quality or characteristics of the practices themselves. High-quality qualitative research is of little value if it is not recognised and drawn upon within new studies for instance. NPT also offers a helpful lens with which to understand how integration and embedding occur, and the mechanisms through which they operate. For example, promoting the legitimacy of a new set of practices, or creating systems that embed it, can help sustain these practices by creating an organisational ambition and encouraging (or requiring) individuals to interact with them in certain ways, redefining their roles accordingly. NPT highlights the ways in which integration of new practices involves bi-directional exchanges with the organisation’s existing practices, with each having the potential to re-shape the other as interaction takes place. For instance, in CTR, qualitative researchers needed to integrate and apply their methods within the quality management and other systems of a CTU, such as the formalisation of key processes within standard operating procedures, something less likely to occur outside trials units. Equally, project teams (including those led by externally based chief investigators) increased the integration of qualitative methods within their overall study design, providing opportunities for new insights on intervention theory, implementation and the experiences of practitioners and participants.

We note two aspects of the normalisation processes within CTR that are slightly less well conceptualised by NPT. The first concerns the emphasis within coherence on identifying the distinctiveness of new practices, and how they differ from existing activities. Whilst differentiation was an important aspect of the integration of qualitative research in CTR, such integration could be seen as operating partly through processes of de-differentiation, or at least equivalence. That is, part of the integration of qualitative research was to see it as similar in terms of rigour, coherence, and importance to other forms of research within the Centre. To be viewed as similar, or at least comparable to existing practices, was to be legitimised.

Second, whilst NPT focuses mainly on the interaction between a new set of practices and the organisational context into which it is introduced, our own experience of introducing qualitative research into a trials unit was shaped by broader organisational and methodological contexts. For example, the increasing emphasis placed upon understanding implementation processes and the experiences of research participants in the field of clinical trials (e.g. by funders), created an environment conducive to the development of qualitative research methods within our Centre. Attempts to integrate qualitative research within studies were also cross-organisational, given that many of the studies managed within the CTR drew together multi-institutional teams. This provided important opportunities to integrate qualitative research within a portfolio of studies that extended beyond CTR and build a network of collaborators who increasingly included qualitative methods within their funding proposals. The work of growing and integrating qualitative research within a trials unit is an ongoing one in which ever-shifting macro-level influences can help or hinder, and where the organisations within which we work are never static in terms of barriers and facilitators.

The importance of utilising qualitative methods within RCTs is now widely recognised. Increased emphasis on the evaluation of complex interventions, the influence of realist methods directing greater attention to complexity and the widespread adoption of mixed methods process evaluations are key drivers of this shift. The inclusion of qualitative methods within individual trials is important and previous research has explored approaches to their incorporation and some of the challenges encountered. Our paper highlights that the integration of qualitative methods at the organisational level of the CTU can shape how they are taken up by individual trials. Within CTR, it can be argued that qualitative research achieved high levels of integration, as conceptualised by Normalisation Process Theory. Thus, qualitative research became recognised as a coherent and valuable set of practices, secured legitimisation as an appropriate focus of individual and organisational activity and benefitted from forms of collective action which operationalised these organisational processes. Crucially, the routinisation of qualitative research appeared to be sustained, something which NPT suggests helps define integration (as opposed to initial embedding). However, our analysis suggested that the degree of integration varied by trial area. This variation reflected a complex mix of factors including disciplinary traditions, methodological guidance, existing (un)familiarity with qualitative research, and the influence of regulatory frameworks for certain clinical trials.

NPT provides a valuable framework with which to understand how these processes of embedding and integration occur. Our use of NPT draws attention to the importance of sense-making and legitimisation as important steps in introducing a new set of practices within the work of an organisation. Integration also depends, across each mechanism of NPT, on the building of effective relationships, which allow individuals and teams to work together in new ways. By reflecting on our experiences and the decisions taken within CTR we have made explicit one such process for embedding qualitative research within a trials unit, whilst acknowledging that approaches may differ across trials units. Mindful of this fact, and the focus of the current paper on one trials unit’s experience, we do not propose a set of recommendations for others who are working to achieve similar goals. Rather, we offer three overarching reflections (framed by NPT) which may act as a useful starting point for trials units (and other infrastructures) seeking to promote the adoption of qualitative research.

First, whilst research organisations such as trials units are highly heterogenous, processes of embedding and integration, which we have foregrounded in this paper, are likely to be important across different contexts in sustaining the use of qualitative research. Second, developing a plan for the integration of qualitative research will benefit from mapping out the characteristics of the extant system. For example, it is valuable to know how familiar staff are with qualitative research and any variations across teams within an organisation. Thirdly, NPT frames integration as a process of implementation which operates through key generative mechanisms— coherence , cognitive participation , collective action and reflexive monitoring . These mechanisms can help guide understanding of which actions help achieve embedding and integration. Importantly, they span multiple aspects of how organisations, and the individuals within them, work. The ways in which people make sense of a new set of practices ( coherence ), their commitment towards it ( cognitive participation ), how it is operationalised ( collective action ) and the evaluation of its introduction ( reflexive monitoring ) are all important. Thus, for example, qualitative research, even when well organised and operationalised within an organisation, is unlikely to be sustained if appreciation of its value is limited, or people are not committed to it.

We present our experience of engaging with the processes described above to open dialogue with other trials units on ways to operationalise and optimise qualitative research in trials. Understanding how best to integrate qualitative research within these settings may help to fully realise the significant contribution which it makes the design and conduct of trials.

Availability of data and materials

Some documents cited in this paper are either freely available from the Centre for Trials Research website or can be requested from the author for correspondence.

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Acknowledgements

Members of the Centre for Trials Research (CTR) Qualitative Research Group were collaborating authors: C Drew (Senior Research Fellow—Senior Trial Manager, Brain Health and Mental Wellbeing Division), D Gillespie (Director, Infection, Inflammation and Immunity Trials, Principal Research Fellow), R Hale (now Research Associate, School of Social Sciences, Cardiff University), J Latchem-Hastings (now Lecturer and Postdoctoral Fellow, School of Healthcare Sciences, Cardiff University), R Milton (Research Associate—Trial Manager), B Pell (now PhD student, DECIPHer Centre, Cardiff University), H Prout (Research Associate—Qualitative), V Shepherd (Senior Research Fellow), K Smallman (Research Associate), H Stanton (Research Associate—Senior Data Manager). Thanks are due to Kerry Hood and Aimee Grant for their involvement in developing processes and systems for qualitative research within CTR.

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Segrott, J., Channon, S., Lloyd, A. et al. Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts. Trials 25 , 323 (2024). https://doi.org/10.1186/s13063-024-08124-7

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What are the strengths and limitations to utilising creative methods in public and patient involvement in health and social care research? A qualitative systematic review

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There is increasing interest in using patient and public involvement (PPI) in research to improve the quality of healthcare. Ordinarily, traditional methods have been used such as interviews or focus groups. However, these methods tend to engage a similar demographic of people. Thus, creative methods are being developed to involve patients for whom traditional methods are inaccessible or non-engaging.

To determine the strengths and limitations to using creative PPI methods in health and social care research.

Electronic searches were conducted over five databases on 14th April 2023 (Web of Science, PubMed, ASSIA, CINAHL, Cochrane Library). Studies that involved traditional, non-creative PPI methods were excluded. Creative PPI methods were used to engage with people as research advisors, rather than study participants. Only primary data published in English from 2009 were accepted. Title, abstract and full text screening was undertaken by two independent reviewers before inductive thematic analysis was used to generate themes.

Twelve papers met the inclusion criteria. The creative methods used included songs, poems, drawings, photograph elicitation, drama performance, visualisations, social media, photography, prototype development, cultural animation, card sorting and persona development. Analysis identified four limitations and five strengths to the creative approaches. Limitations included the time and resource intensive nature of creative PPI, the lack of generalisation to wider populations and ethical issues. External factors, such as the lack of infrastructure to support creative PPI, also affected their implementation. Strengths included the disruption of power hierarchies and the creation of a safe space for people to express mundane or “taboo” topics. Creative methods are also engaging, inclusive of people who struggle to participate in traditional PPI and can also be cost and time efficient.

‘Creative PPI’ is an umbrella term encapsulating many different methods of engagement and there are strengths and limitations to each. The choice of which should be determined by the aims and requirements of the research, as well as the characteristics of the PPI group and practical limitations. Creative PPI can be advantageous over more traditional methods, however a hybrid approach could be considered to reap the benefits of both. Creative PPI methods are not widely used; however, this could change over time as PPI becomes embedded even more into research.

Plain English Summary

It is important that patients and public are included in the research process from initial brainstorming, through design to delivery. This is known as public and patient involvement (PPI). Their input means that research closely aligns with their wants and needs. Traditionally to get this input, interviews and group discussions are held, but this can exclude people who find these activities non-engaging or inaccessible, for example those with language challenges, learning disabilities or memory issues. Creative methods of PPI can overcome this. This is a broad term describing different (non-traditional) ways of engaging patients and public in research, such as through the use or art, animation or performance. This review investigated the reasons why creative approaches to PPI could be difficult (limitations) or helpful (strengths) in health and social care research. After searching 5 online databases, 12 studies were included in the review. PPI groups included adults, children and people with language and memory impairments. Creative methods included songs, poems, drawings, the use of photos and drama, visualisations, Facebook, creating prototypes, personas and card sorting. Limitations included the time, cost and effort associated with creative methods, the lack of application to other populations, ethical issues and buy-in from the wider research community. Strengths included the feeling of equality between academics and the public, creation of a safe space for people to express themselves, inclusivity, and that creative PPI can be cost and time efficient. Overall, this review suggests that creative PPI is worthwhile, however each method has its own strengths and limitations and the choice of which will depend on the research project, PPI group characteristics and other practical limitations, such as time and financial constraints.

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Introduction

Patient and public involvement (PPI) is the term used to describe the partnership between patients (including caregivers, potential patients, healthcare users etc.) or the public (a community member with no known interest in the topic) with researchers. It describes research that is done “‘with’ or ‘by’ the public, rather than ‘to,’ ‘about’ or ‘for’ them” [ 1 ]. In 2009, it became a legislative requirement for certain health and social care organisations to include patients, families, carers and communities in not only the planning of health and social care services, but the commissioning, delivery and evaluation of them too [ 2 ]. For example, funding applications for the National Institute of Health and Care Research (NIHR), a UK funding body, mandates a demonstration of how researchers plan to include patients/service users, the public and carers at each stage of the project [ 3 ]. However, this should not simply be a tokenistic, tick-box exercise. PPI should help formulate initial ideas and should be an instrumental, continuous part of the research process. Input from PPI can provide unique insights not yet considered and can ensure that research and health services are closely aligned to the needs and requirements of service users PPI also generally makes research more relevant with clearer outcomes and impacts [ 4 ]. Although this review refers to both patients and the public using the umbrella term ‘PPI’, it is important to acknowledge that these are two different groups with different motivations, needs and interests when it comes to health research and service delivery [ 5 ].

Despite continuing recognition of the need of PPI to improve quality of healthcare, researchers have also recognised that there is no ‘one size fits all’ method for involving patients [ 4 ]. Traditionally, PPI methods invite people to take part in interviews or focus groups to facilitate discussion, or surveys and questionnaires. However, these can sometimes be inaccessible or non-engaging for certain populations. For example, someone with communication difficulties may find it difficult to engage in focus groups or interviews. If individuals lack the appropriate skills to interact in these types of scenarios, they cannot take advantage of the participation opportunities it can provide [ 6 ]. Creative methods, however, aim to resolve these issues. These are a relatively new concept whereby researchers use creative methods (e.g., artwork, animations, Lego), to make PPI more accessible and engaging for those whose voices would otherwise go unheard. They ensure that all populations can engage in research, regardless of their background or skills. Seminal work has previously been conducted in this area, which brought to light the use of creative methodologies in research. Leavy (2008) [ 7 ] discussed how traditional interviews had limits on what could be expressed due to their sterile, jargon-filled and formulaic structure, read by only a few specialised academics. It was this that called for more creative approaches, which included narrative enquiry, fiction-based research, poetry, music, dance, art, theatre, film and visual art. These practices, which can be used in any stage of the research cycle, supported greater empathy, self-reflection and longer-lasting learning experiences compared to interviews [ 7 ]. They also pushed traditional academic boundaries, which made the research accessible not only to researchers, but the public too. Leavy explains that there are similarities between arts-based approaches and scientific approaches: both attempts to investigate what it means to be human through exploration, and used together, these complimentary approaches can progress our understanding of the human experience [ 7 ]. Further, it is important to acknowledge the parallels and nuances between creative and inclusive methods of PPI. Although creative methods aim to be inclusive (this should underlie any PPI activity, whether creative or not), they do not incorporate all types of accessible, inclusive methodologies e.g., using sign language for people with hearing impairments or audio recordings for people who cannot read. Given that there was not enough scope to include an evaluation of all possible inclusive methodologies, this review will focus on creative methods of PPI only.

We aimed to conduct a qualitative systematic review to highlight the strengths of creative PPI in health and social care research, as well as the limitations, which might act as a barrier to their implementation. A qualitative systematic review “brings together research on a topic, systematically searching for research evidence from primary qualitative studies and drawing the findings together” [ 8 ]. This review can then advise researchers of the best practices when designing PPI.

Public involvement

The PHIRST-LIGHT Public Advisory Group (PAG) consists of a team of experienced public contributors with a diverse range of characteristics from across the UK. The PAG was involved in the initial question setting and study design for this review.

Search strategy

For the purpose of this review, the JBI approach for conducting qualitative systematic reviews was followed [ 9 ]. The search terms were (“creativ*” OR “innovat*” OR “authentic” OR “original” OR “inclu*”) AND (“public and patient involvement” OR “patient and public involvement” OR “public and patient involvement and engagement” OR “patient and public involvement and engagement” OR “PPI” OR “PPIE” OR “co-produc*” OR “co-creat*” OR “co-design*” OR “cooperat*” OR “co-operat*”). This search string was modified according to the requirements of each database. Papers were filtered by title, abstract and keywords (see Additional file 1 for search strings). The databases searched included Web of Science (WoS), PubMed, ASSIA and CINAHL. The Cochrane Library was also searched to identify relevant reviews which could lead to the identification of primary research. The search was conducted on 14/04/23. As our aim was to report on the use of creative PPI in research, rather than more generic public engagement, we used electronic databases of scholarly peer-reviewed literature, which represent a wide range of recognised databases. These identified studies published in general international journals (WoS, PubMed), those in social sciences journals (ASSIA), those in nursing and allied health journals (CINAHL), and trials of interventions (Cochrane Library).

Inclusion criteria

Only full-text, English language, primary research papers from 2009 to 2023 were included. This was the chosen timeframe as in 2009 the Health and Social Reform Act made it mandatory for certain Health and Social Care organisations to involve the public and patients in planning, delivering, and evaluating services [ 2 ]. Only creative methods of PPI were accepted, rather than traditional methods, such as interviews or focus groups. For the purposes of this paper, creative PPI included creative art or arts-based approaches (e.g., e.g. stories, songs, drama, drawing, painting, poetry, photography) to enhance engagement. Titles were related to health and social care and the creative PPI was used to engage with people as research advisors, not as study participants. Meta-analyses, conference abstracts, book chapters, commentaries and reviews were excluded. There were no limits concerning study location or the demographic characteristics of the PPI groups. Only qualitative data were accepted.

Quality appraisal

Quality appraisal using the Critical Appraisal Skills Programme (CASP) checklist [ 10 ] was conducted by the primary authors (ORP and CH). This was done independently, and discrepancies were discussed and resolved. If a consensus could not be reached, a third independent reviewer was consulted (JRM). The full list of quality appraisal questions can be found in Additional file 2 .

Data extraction

ORP extracted the study characteristics and a subset of these were checked by CH. Discrepancies were discussed and amendments made. Extracted data included author, title, location, year of publication, year study was carried out, research question/aim, creative methods used, number of participants, mean age, gender, ethnicity of participants, setting, limitations and strengths of creative PPI and main findings.

Data analysis

The included studies were analysed using inductive thematic analysis [ 11 ], where themes were determined by the data. The familiarisation stage took place during full-text reading of the included articles. Anything identified as a strength or limitation to creative PPI methods was extracted verbatim as an initial code and inputted into the data extraction Excel sheet. Similar codes were sorted into broader themes, either under ‘strengths’ or ‘limitations’ and reviewed. Themes were then assigned a name according to the codes.

The search yielded 9978 titles across the 5 databases: Web of Science (1480 results), PubMed (94 results), ASSIA (2454 results), CINAHL (5948 results) and Cochrane Library (2 results), resulting in 8553 different studies after deduplication. ORP and CH independently screened their titles and abstracts, excluding those that did not meet the criteria. After assessment, 12 studies were included (see Fig.  1 ).

PRISMA flowchart of the study selection process

Study characteristics

The included studies were published between 2018 and 2022. Seven were conducted in the UK [ 12 , 14 , 15 , 17 , 18 , 19 , 23 ], two in Canada [ 21 , 22 ], one in Australia [ 13 ], one in Norway [ 16 ] and one in Ireland [ 20 ]. The PPI activities occurred across various settings, including a school [ 12 ], social club [ 12 ], hospital [ 17 ], university [ 22 ], theatre [ 19 ], hotel [ 20 ], or online [ 15 , 21 ], however this information was omitted in 5 studies [ 13 , 14 , 16 , 18 , 23 ]. The number of people attending the PPI sessions varied, ranging from 6 to 289, however the majority (ten studies) had less than 70 participants [ 13 , 14 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ]. Seven studies did not provide information on the age or gender of the PPI groups. Of those that did, ages ranged from 8 to 76 and were mostly female. The ethnicities of the PPI group members were also rarely recorded (see Additional file 3 for data extraction table).

Types of creative methods

The type of creative methods used to engage the PPI groups were varied. These included songs, poems, drawings, photograph elicitation, drama performance, visualisations, Facebook, photography, prototype development, cultural animation, card sorting and creating personas (see Table  1 ). These were sometimes accompanied by traditional methods of PPI such as interviews and focus group discussions.

The 12 included studies were all deemed to be of good methodological quality, with scores ranging from 6/10 to 10/10 with the CASP critical appraisal tool [ 10 ] (Table  2 ).

Thematic analysis

Analysis identified four limitations and five strengths to creative PPI (see Fig.  2 ). Limitations included the time and resource intensity of creative PPI methods, its lack of generalisation, ethical issues and external factors. Strengths included the disruption of power hierarchies, the engaging and inclusive nature of the methods and their long-term cost and time efficiency. Creative PPI methods also allowed mundane and “taboo” topics to be discussed within a safe space.

Theme map of strengths and limitations

Limitations of creative PPI

Creative ppi methods are time and resource intensive.

The time and resource intensive nature of creative PPI methods is a limitation, most notably for the persona-scenario methodology. Valaitis et al. [ 22 ] used 14 persona-scenario workshops with 70 participants to co-design a healthcare intervention, which aimed to promote optimal aging in Canada. Using the persona method, pairs composed of patients, healthcare providers, community service providers and volunteers developed a fictional character which they believed represented an ‘end-user’ of the healthcare intervention. Due to the depth and richness of the data produced the authors reported that it was time consuming to analyse. Further, they commented that the amount of information was difficult to disseminate to scientific leads and present at team meetings. Additionally, to ensure the production of high-quality data, to probe for details and lead group discussion there was a need for highly skilled facilitators. The resource intensive nature of the creative co-production was also noted in a study using the persona scenario and creative worksheets to develop a prototype decision support tool for individuals with malignant pleural effusion [ 17 ]. With approximately 50 people, this was also likely to yield a high volume of data to consider.

To prepare materials for populations who cannot engage in traditional methods of PPI was also timely. Kearns et al. [ 18 ] developed a feedback questionnaire for people with aphasia to evaluate ICT-delivered rehabilitation. To ensure people could participate effectively, the resources used during the workshops, such as PowerPoints, online images and photographs, had to be aphasia-accessible, which was labour and time intensive. The author warned that this time commitment should not be underestimated.

There are further practical limitations to implementing creative PPI, such as the costs of materials for activities as well as hiring a space for workshops. For example, the included studies in this review utilised pens, paper, worksheets, laptops, arts and craft supplies and magazines and took place in venues such as universities, a social club, and a hotel. Further, although not limited to creative PPI methods exclusively but rather most studies involving the public, a financial incentive was often offered for participation, as well as food, parking, transport and accommodation [ 21 , 22 ].

Creative PPI lacks generalisation

Another barrier to the use of creative PPI methods in health and social care research was the individual nature of its output. Those who participate, usually small in number, produce unique creative outputs specific to their own experiences, opinions and location. Craven et al. [ 13 ], used arts-based visualisations to develop a toolbox for adults with mental health difficulties. They commented, “such an approach might still not be worthwhile”, as the visualisations were individualised and highly personal. This indicates that the output may fail to meet the needs of its end-users. Further, these creative PPI groups were based in certain geographical regions such as Stoke-on-Trent [ 19 ] Sheffield [ 23 ], South Wales [ 12 ] or Ireland [ 20 ], which limits the extent the findings can be applied to wider populations, even within the same area due to individual nuances. Further, the study by Galler et al. [ 16 ], is specific to the Norwegian context and even then, maybe only a sub-group of the Norwegian population as the sample used was of higher socioeconomic status.

However, Grindell et al. [ 17 ], who used persona scenarios, creative worksheets and prototype development, pointed out that the purpose of this type of research is to improve a certain place, rather than apply findings across other populations and locations. Individualised output may, therefore, only be a limitation to research wanting to conduct PPI on a large scale.

If, however, greater generalisation within PPI is deemed necessary, then social media may offer a resolution. Fedorowicz et al. [ 15 ], used Facebook to gain feedback from the public on the use of video-recording methodology for an upcoming project. This had the benefit of including a more diverse range of people (289 people joined the closed group), who were spread geographically around the UK, as well as seven people from overseas.

Creative PPI has ethical issues

As with other research, ethical issues must be taken into consideration. Due to the nature of creative approaches, as well as the personal effort put into them, people often want to be recognised for their work. However, this compromises principles so heavily instilled in research such as anonymity and confidentiality. With the aim of exploring issues related to health and well-being in a town in South Wales, Byrne et al. [ 12 ], asked year 4/5 and year 10 pupils to create poems, songs, drawings and photographs. Community members also created a performance, mainly of monologues, to explore how poverty and inequalities are dealt with. Byrne noted the risks of these arts-based approaches, that being the possibility of over-disclosure and consequent emotional distress, as well as people’s desire to be named for their work. On one hand, the anonymity reduces the sense of ownership of the output as it does not portray a particular individual’s lived experience anymore. On the other hand, however, it could promote a more honest account of lived experience. Supporting this, Webber et al. [ 23 ], who used the persona method to co-design a back pain educational resource prototype, claimed that the anonymity provided by this creative technique allowed individuals to externalise and anonymise their own personal experience, thus creating a more authentic and genuine resource for future users. This implies that anonymity can be both a limitation and strength here.

The use of creative PPI methods is impeded by external factors

Despite the above limitations influencing the implementation of creative PPI techniques, perhaps the most influential is that creative methodologies are simply not mainstream [ 19 ]. This could be linked to the issues above, like time and resource intensity, generalisation and ethical issues but it is also likely to involve more systemic factors within the research community. Micsinszki et al. [ 21 ], who co-designed a hub for the health and well-being of vulnerable populations, commented that there is insufficient infrastructure to conduct meaningful co-design as well as a dominant medical model. Through a more holistic lens, there are “sociopolitical environments that privilege individualism over collectivism, self-sufficiency over collaboration, and scientific expertise over other ways of knowing based on lived experience” [ 21 ]. This, it could be suggested, renders creative co-design methodologies, which are based on the foundations of collectivism, collaboration and imagination an invalid technique in the research field, which is heavily dominated by more scientific methods offering reproducibility, objectivity and reliability.

Although we acknowledge that creative PPI techniques are not always appropriate, it may be that their main limitation is the lack of awareness of these methods or lack of willingness to use them. Further, there is always the risk that PPI, despite being a mandatory part of research, is used in a tokenistic or tick-box fashion [ 20 ], without considering the contribution that meaningful PPI could make to enhancing the research. It may be that PPI, let alone creative PPI, is not at the forefront of researchers’ minds when planning research.

Strengths of creative PPI

Creative ppi disrupts power hierarchies.

One of the main strengths of creative PPI techniques, cited most frequently in the included literature, was that they disrupt traditional power hierarchies [ 12 , 13 , 17 , 19 , 23 ]. For example, the use of theatre performance blurred the lines between professional and lay roles between the community and policy makers [ 12 ]. Individuals created a monologue to portray how poverty and inequality impact daily life and presented this to representatives of the National Assembly of Wales, Welsh Government, the Local Authority, Arts Council and Westminster. Byrne et al. [ 12 ], states how this medium allowed the community to engage with the people who make decisions about their lives in an environment of respect and understanding, where the hierarchies are not as visible as in other settings, e.g., political surgeries. Creative PPI methods have also removed traditional power hierarchies between researchers and adolescents. Cook et al. [ 13 ], used arts-based approaches to explore adolescents’ ideas about the “perfect” condom. They utilised the “Life Happens” resource, where adolescents drew and then decorated a person with their thoughts about sexual relationships, not too dissimilar from the persona-scenario method. This was then combined with hypothetical scenarios about sexuality. A condom-mapping exercise was then implemented, where groups shared the characteristics that make a condom “perfect” on large pieces of paper. Cook et al. [ 13 ], noted that usually power imbalances make it difficult to elicit information from adolescents, however these power imbalances were reduced due to the use of creative co-design techniques.

The same reduction in power hierarchies was noted by Grindell et al. [ 17 ], who used the person-scenario method and creative worksheets with individuals with malignant pleural effusion. This was with the aim of developing a prototype of a decision support tool for patients to help with treatment options. Although this process involved a variety of stakeholders, such as patients, carers and healthcare professionals, creative co-design was cited as a mechanism that worked to reduce power imbalances – a limitation of more traditional methods of research. Creative co-design blurred boundaries between end-users and clinical staff and enabled the sharing of ideas from multiple, valuable perspectives, meaning the prototype was able to suit user needs whilst addressing clinical problems.

Similarly, a specific creative method named cultural animation was also cited to dissolve hierarchies and encourage equal contributions from participants. Within this arts-based approach, Keleman et al. [ 19 ], explored the concept of “good health” with individuals from Stoke-on Trent. Members of the group created art installations using ribbons, buttons, cardboard and straws to depict their idea of a “healthy community”, which was accompanied by a poem. They also created a 3D Facebook page and produced another poem or song addressing the government to communicate their version of a “picture of health”. Public participants said that they found the process empowering, honest, democratic, valuable and practical.

This dissolving of hierarchies and levelling of power is beneficial as it increases the sense of ownership experienced by the creators/producers of the output [ 12 , 17 , 23 ]. This is advantageous as it has been suggested to improve its quality [ 23 ].

Creative PPI allows the unsayable to be said

Creative PPI fosters a safe space for mundane or taboo topics to be shared, which may be difficult to communicate using traditional methods of PPI. For example, the hypothetical nature of condom mapping and persona-scenarios meant that adolescents could discuss a personal topic without fear of discrimination, judgement or personal disclosure [ 13 ]. The safe space allowed a greater volume of ideas to be generated amongst peers where they might not have otherwise. Similarly, Webber et al. [ 23 ], , who used the persona method to co-design the prototype back pain educational resource, also noted how this method creates anonymity whilst allowing people the opportunity to externalise personal experiences, thoughts and feelings. Other creative methods were also used, such as drawing, collaging, role play and creating mood boards. A cardboard cube (labelled a “magic box”) was used to symbolise a physical representation of their final prototype. These creative methods levelled the playing field and made personal experiences accessible in a safe, open environment that fostered trust, as well as understanding from the researchers.

It is not only sensitive subjects that were made easier to articulate through creative PPI. The communication of mundane everyday experiences were also facilitated, which were deemed typically ‘unsayable’. This was specifically given in the context of describing intangible aspects of everyday health and wellbeing [ 11 ]. Graphic designers can also be used to visually represent the outputs of creative PPI. These captured the movement and fluidity of people and well as the relationships between them - things that cannot be spoken but can be depicted [ 21 ].

Creative PPI methods are inclusive

Another strength of creative PPI was that it is inclusive and accessible [ 17 , 19 , 21 ]. The safe space it fosters, as well as the dismantling of hierarchies, welcomed people from a diverse range of backgrounds and provided equal opportunities [ 21 ], especially for those with communication and memory difficulties who might be otherwise excluded from PPI. Kelemen et al. [ 19 ], who used creative methods to explore health and well-being in Stoke-on-Trent, discussed how people from different backgrounds came together and connected, discussed and reached a consensus over a topic which evoked strong emotions, that they all have in common. Individuals said that the techniques used “sets people to open up as they are not overwhelmed by words”. Similarly, creative activities, such as the persona method, have been stated to allow people to express themselves in an inclusive environment using a common language. Kearns et al. [ 18 ], who used aphasia-accessible material to develop a questionnaire with aphasic individuals, described how they felt comfortable in contributing to workshops (although this material was time-consuming to make, see ‘Limitations of creative PPI’ ).

Despite the general inclusivity of creative PPI, it can also be exclusive, particularly if online mediums are used. Fedorowicz et al. [ 15 ], used Facebook to create a PPI group, and although this may rectify previous drawbacks about lack of generalisation of creative methods (as Facebook can reach a greater number of people, globally), it excluded those who are not digitally active or have limited internet access or knowledge of technology. Online methods have other issues too. Maintaining the online group was cited as challenging and the volume of responses required researchers to interact outside of their working hours. Despite this, online methods like Facebook are very accessible for people who are physically disabled.

Creative PPI methods are engaging

The process of creative PPI is typically more engaging and produces more colourful data than traditional methods [ 13 ]. Individuals are permitted and encouraged to explore a creative self [ 19 ], which can lead to the exploration of new ideas and an overall increased enjoyment of the process. This increased engagement is particularly beneficial for younger PPI groups. For example, to involve children in the development of health food products, Galler et al. [ 16 ] asked 9-12-year-olds to take photos of their food and present it to other children in a “show and tell” fashion. They then created a newspaper article describing a new healthy snack. In this creative focus group, children were given lab coats to further their identity as inventors. Galler et al. [ 16 ], notes that the methods were highly engaging and facilitated teamwork and group learning. This collaborative nature of problem-solving was also observed in adults who used personas and creative worksheets to develop the resource for lower back pain [ 23 ]. Dementia patients too have been reported to enjoy the creative and informal approach to idea generation [ 20 ].

The use of cultural animation allowed people to connect with each other in a way that traditional methods do not [ 19 , 21 ]. These connections were held in place by boundary objects, such as ribbons, buttons, fabric and picture frames, which symbolised a shared meaning between people and an exchange of knowledge and emotion. Asking groups to create an art installation using these objects further fostered teamwork and collaboration, both at an individual and collective level. The exploration of a creative self increased energy levels and encouraged productive discussions and problem-solving [ 19 ]. Objects also encouraged a solution-focused approach and permitted people to think beyond their usual everyday scope [ 17 ]. They also allowed facilitators to probe deeper about the greater meanings carried by the object, which acted as a metaphor [ 21 ].

From the researcher’s point of view, co-creative methods gave rise to ideas they might not have initially considered. Valaitis et al. [ 22 ], found that over 40% of the creative outputs were novel ideas brought to light by patients, healthcare providers/community care providers, community service providers and volunteers. One researcher commented, “It [the creative methods] took me on a journey, in a way that when we do other pieces of research it can feel disconnected” [ 23 ]. Another researcher also stated they could not return to the way they used to do research, as they have learnt so much about their own health and community and how they are perceived [ 19 ]. This demonstrates that creative processes not only benefit the project outcomes and the PPI group, but also facilitators and researchers. However, although engaging, creative methods have been criticised for not demonstrating academic rigour [ 17 ]. Moreover, creative PPI may also be exclusive to people who do not like or enjoy creative activities.

Creative PPI methods are cost and time efficient

Creative PPI workshops can often produce output that is visible and tangible. This can save time and money in the long run as the output is either ready to be implemented in a healthcare setting or a first iteration has already been developed. This may also offset the time and costs it takes to implement creative PPI. For example, the prototype of the decision support tool for people with malignant pleural effusion was developed using personas and creative worksheets. The end result was two tangible prototypes to drive the initial idea forward as something to be used in practice [ 17 ]. The use of creative co-design in this case saved clinician time as well as the time it would take to develop this product without the help of its end-users. In the development of this particular prototype, analysis was iterative and informed the next stage of development, which again saved time. The same applies for the feedback questionnaire for the assessment of ICT delivered aphasia rehabilitation. The co-created questionnaire, designed with people with aphasia, was ready to be used in practice [ 18 ]. This suggests that to overcome time and resource barriers to creative PPI, researchers should aim for it to be engaging whilst also producing output.

That useable products are generated during creative workshops signals to participating patients and public members that they have been listened to and their thoughts and opinions acted upon [ 23 ]. For example, the development of the back pain resource based on patient experiences implies that their suggestions were valid and valuable. Further, those who participated in the cultural animation workshop reported that the process visualises change, and that it already feels as though the process of change has started [ 19 ].

The most cost and time efficient method of creative PPI in this review is most likely the use of Facebook to gather feedback on project methodology [ 15 ]. Although there were drawbacks to this, researchers could involve more people from a range of geographical areas at little to no cost. Feedback was instantaneous and no training was required. From the perspective of the PPI group, they could interact however much or little they wish with no time commitment.

This systematic review identified four limitations and five strengths to the use of creative PPI in health and social care research. Creative PPI is time and resource intensive, can raise ethical issues and lacks generalisability. It is also not accepted by the mainstream. These factors may act as barriers to the implementation of creative PPI. However, creative PPI disrupts traditional power hierarchies and creates a safe space for taboo or mundane topics. It is also engaging, inclusive and can be time and cost efficient in the long term.

Something that became apparent during data analysis was that these are not blanket strengths and limitations of creative PPI as a whole. The umbrella term ‘creative PPI’ is broad and encapsulates a wide range of activities, ranging from music and poems to prototype development and persona-scenarios, to more simplistic things like the use of sticky notes and ordering cards. Many different activities can be deemed ‘creative’ and the strengths and limitations of one does not necessarily apply to another. For example, cultural animation takes greater effort to prepare than the use of sticky notes and sorting cards, and the use of Facebook is cheaper and wider reaching than persona development. Researchers should use their discretion and weigh up the benefits and drawbacks of each method to decide on a technique which suits the project. What might be a limitation to creative PPI in one project may not be in another. In some cases, creative PPI may not be suitable at all.

Furthermore, the choice of creative PPI method also depends on the needs and characteristics of the PPI group. Children, adults and people living with dementia or language difficulties all have different engagement needs and capabilities. This indicates that creative PPI is not one size fits all and that the most appropriate method will change depending on the composition of the group. The choice of method will also be determined by the constraints of the research project, namely time, money and the research aim. For example, if there are time constraints, then a method which yields a lot of data and requires a lot of preparation may not be appropriate. If generalisation is important, then an online method is more suitable. Together this indicates that the choice of creative PPI method is highly individualised and dependent on multiple factors.

Although the limitations discussed in this review apply to creative PPI, they are not exclusive to creative PPI. Ethical issues are a consideration within general PPI research, especially when working with more vulnerable populations, such as children or adults living with a disability. It can also be the case that traditional PPI methods lack generalisability, as people who volunteer to be part of such a group are more likely be older, middle class and retired [ 24 ]. Most research is vulnerable to this type of bias, however, it is worth noting that generalisation is not always a goal and research remains valid and meaningful in its absence. Although online methods may somewhat combat issues related to generalisability, these methods still exclude people who do not have access to the internet/technology or who choose not to use it, implying that online PPI methods may not be wholly representative of the general population. Saying this, however, the accessibility of creative PPI techniques differs from person to person, and for some, online mediums may be more accessible (for example for those with a physical disability), and for others, this might be face-to-face. To combat this, a range of methods should be implemented. Planning multiple focus group and interviews for traditional PPI is also time and resource intensive, however the extra resources required to make this creative may be even greater. Although, the rich data provided may be worth the preparation and analysis time, which is also likely to depend on the number of participants and workshop sessions required. PPI, not just creative PPI, often requires the provision of a financial incentive, refreshments, parking and accommodation, which increase costs. These, however, are imperative and non-negotiable, as they increase the accessibility of research, especially to minority and lower-income groups less likely to participate. Adequate funding is also important for co-design studies where repeated engagement is required. One barrier to implementation, which appears to be exclusive to creative methods, however, is that creative methods are not mainstream. This cannot be said for traditional PPI as this is often a mandatory part of research applications.

Regarding the strengths of creative PPI, it could be argued that most appear to be exclusive to creative methodologies. These are inclusive by nature as multiple approaches can be taken to evoke ideas from different populations - approaches that do not necessarily rely on verbal or written communication like interviews and focus groups do. Given the anonymity provided by some creative methods, such as personas, people may be more likely to discuss their personal experiences under the guise of a general end-user, which might be more difficult to maintain when an interviewer is asking an individual questions directly. Additionally, creative methods are by nature more engaging and interactive than traditional methods, although this is a blanket statement and there may be people who find the question-and-answer/group discussion format more engaging. Creative methods have also been cited to eliminate power imbalances which exist in traditional research [ 12 , 13 , 17 , 19 , 23 ]. These imbalances exist between researchers and policy makers and adolescents, adults and the community. Lastly, although this may occur to a greater extent in creative methods like prototype development, it could be suggested that PPI in general – regardless of whether it is creative - is more time and cost efficient in the long-term than not using any PPI to guide or refine the research process. It must be noted that these are observations based on the literature. To be certain these differences exist between creative and traditional methods of PPI, direct empirical evaluation of both should be conducted.

To the best of our knowledge, this is the first review to identify the strengths and limitations to creative PPI, however, similar literature has identified barriers and facilitators to PPI in general. In the context of clinical trials, recruitment difficulties were cited as a barrier, as well as finding public contributors who were free during work/school hours. Trial managers reported finding group dynamics difficult to manage and the academic environment also made some public contributors feel nervous and lacking confidence to speak. Facilitators, however, included the shared ownership of the research – something that has been identified in the current review too. In addition, planning and the provision of knowledge, information and communication were also identified as facilitators [ 25 ]. Other research on the barriers to meaningful PPI in trial oversight committees included trialist confusion or scepticism over the PPI role and the difficulties in finding PPI members who had a basic understanding of research [ 26 ]. However, it could be argued that this is not representative of the average patient or public member. The formality of oversight meetings and the technical language used also acted as a barrier, which may imply that the informal nature of creative methods and its lack of dependency on literacy skills could overcome this. Further, a review of 42 reviews on PPI in health and social care identified financial compensation, resources, training and general support as necessary to conduct PPI, much like in the current review where the resource intensiveness of creative PPI was identified as a limitation. However, others were identified too, such as recruitment and representativeness of public contributors [ 27 ]. Like in the current review, power imbalances were also noted, however this was included as both a barrier and facilitator. Collaboration seemed to diminish hierarchies but not always, as sometimes these imbalances remained between public contributors and healthcare staff, described as a ‘them and us’ culture [ 27 ]. Although these studies compliment the findings of the current review, a direct comparison cannot be made as they do not concern creative methods. However, it does suggest that some strengths and weaknesses are shared between creative and traditional methods of PPI.

Strengths and limitations of this review

Although a general definition of creative PPI exists, it was up to our discretion to decide exactly which activities were deemed as such for this review. For example, we included sorting cards, the use of interactive whiteboards and sticky notes. Other researchers may have a more or less stringent criteria. However, two reviewers were involved in this decision which aids the reliability of the included articles. Further, it may be that some of the strengths and limitations cannot fully be attributed to the creative nature of the PPI process, but rather their co-created nature, however this is hard to disentangle as the included papers involved both these aspects.

During screening, it was difficult to decide whether the article was utilising creative qualitative methodology or creative PPI , as it was often not explicitly labelled as such. Regardless, both approaches involved the public/patients refining a healthcare product/service. This implies that if this review were to be replicated, others may do it differently. This may call for greater standardisation in the reporting of the public’s involvement in research. For example, the NIHR outlines different approaches to PPI, namely “consultation”, “collaboration”, “co-production” and “user-controlled”, which each signify an increased level of public power and influence [ 28 ]. Papers with elements of PPI could use these labels to clarify the extent of public involvement, or even explicitly state that there was no PPI. Further, given our decision to include only scholarly peer-reviewed literature, it is possible that data were missed within the grey literature. Similarly, the literature search will not have identified all papers relating to different types of accessible inclusion. However, the intent of the review was to focus solely on those within the definition of creative.

This review fills a gap in the literature and helps circulate and promote the concept of creative PPI. Each stage of this review, namely screening and quality appraisal, was conducted by two independent reviewers. However, four full texts could not be accessed during the full text reading stage, meaning there are missing data that could have altered or contributed to the findings of this review.

Research recommendations

Given that creative PPI can require effort to prepare, perform and analyse, sufficient time and funding should be allocated in the research protocol to enable meaningful and continuous PPI. This is worthwhile as PPI can significantly change the research output so that it aligns closely with the needs of the group it is to benefit. Researchers should also consider prototype development as a creative PPI activity as this might reduce future time/resource constraints. Shifting from a top-down approach within research to a bottom-up can be advantageous to all stakeholders and can help move creative PPI towards the mainstream. This, however, is the collective responsibility of funding bodies, universities and researchers, as well as committees who approve research bids.

A few of the included studies used creative techniques alongside traditional methods, such as interviews, which could also be used as a hybrid method of PPI, perhaps by researchers who are unfamiliar with creative techniques or to those who wish to reap the benefits of both. Often the characteristics of the PPI group were not included, including age, gender and ethnicity. It would be useful to include such information to assess how representative the PPI group is of the population of interest.

Creative PPI is a relatively novel approach of engaging the public and patients in research and it has both advantages and disadvantages compared to more traditional methods. There are many approaches to implementing creative PPI and the choice of technique will be unique to each piece of research and is reliant on several factors. These include the age and ability of the PPI group as well as the resource limitations of the project. Each method has benefits and drawbacks, which should be considered at the protocol-writing stage. However, given adequate funding, time and planning, creative PPI is a worthwhile and engaging method of generating ideas with end-users of research – ideas which may not be otherwise generated using traditional methods.

Data availability

No datasets were generated or analysed during the current study.

Abbreviations

Critical Appraisal Skills Programme

The Joanna Briggs Institute

National Institute of Health and Care Research

Public Advisory Group

Public and Patient Involvement

Web of Science

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Acknowledgements

With thanks to the PHIRST-LIGHT public advisory group and consortium for their thoughts and contributions to the design of this work.

The research team is supported by a National Institute for Health and Care Research grant (PHIRST-LIGHT Reference NIHR 135190).

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Olivia R. Phillips and Cerian Harries share joint first authorship.

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Nottingham Centre for Public Health and Epidemiology, Lifespan and Population Health, School of Medicine, University of Nottingham, Clinical Sciences Building, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK

Olivia R. Phillips, Jo Leonardi-Bee, Holly Knight & Joanne R. Morling

National Institute for Health and Care Research (NIHR) PHIRST-LIGHT, Nottingham, UK

Olivia R. Phillips, Cerian Harries, Jo Leonardi-Bee, Holly Knight, Lauren B. Sherar, Veronica Varela-Mato & Joanne R. Morling

School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, Leicestershire, LE11 3TU, UK

Cerian Harries, Lauren B. Sherar & Veronica Varela-Mato

Nottingham Centre for Evidence Based Healthcare, School of Medicine, University of Nottingham, Nottingham, UK

Jo Leonardi-Bee

NIHR Nottingham Biomedical Research Centre (BRC), Nottingham University Hospitals NHS Trust, University of Nottingham, Nottingham, NG7 2UH, UK

Joanne R. Morling

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Author contributions: study design: ORP, CH, JRM, JLB, HK, LBS, VVM, literature searching and screening: ORP, CH, JRM, data curation: ORP, CH, analysis: ORP, CH, JRM, manuscript draft: ORP, CH, JRM, Plain English Summary: ORP, manuscript critical review and editing: ORP, CH, JRM, JLB, HK, LBS, VVM.

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Phillips, O.R., Harries, C., Leonardi-Bee, J. et al. What are the strengths and limitations to utilising creative methods in public and patient involvement in health and social care research? A qualitative systematic review. Res Involv Engagem 10 , 48 (2024). https://doi.org/10.1186/s40900-024-00580-4

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Exploring shared decision-making needs in lung cancer screening among high-risk groups and health care providers in China: a qualitative study

• Xiujing Lin 1 ,
• Fangfang Wang 1 ,
• Yonglin Li 1 ,
• Fang Lei 2 ,
• Weisheng Chen 3 ,
• Rachel H. Arbing 4 ,
• Wei-Ti Chen   ORCID: orcid.org/0000-0002-2342-045X 4 &
• Feifei Huang   ORCID: orcid.org/0000-0003-0197-8687 1  

BMC Cancer volume  24 , Article number:  613 ( 2024 ) Cite this article

32 Accesses

Metrics details

The intricate balance between the advantages and risks of low-dose computed tomography (LDCT) impedes the utilization of lung cancer screening (LCS). Guiding shared decision-making (SDM) for well-informed choices regarding LCS is pivotal. There has been a notable increase in research related to SDM. However, these studies possess limitations. For example, they may ignore the identification of decision support and needs from the perspective of health care providers and high-risk groups. Additionally, these studies have not adequately addressed the complete SDM process, including pre-decisional needs, the decision-making process, and post-decision experiences. Furthermore, the East-West divide of SDM has been largely ignored. This study aimed to explore the decisional needs and support for shared decision-making for LCS among health care providers and high-risk groups in China.

Informed by the Ottawa Decision-Support Framework, we conducted qualitative, face-to-face in-depth interviews to explore shared decision-making among 30 lung cancer high-risk individuals and 9 health care providers. Content analysis was used for data analysis.

We identified 4 decisional needs that impair shared decision-making: (1) LCS knowledge deficit; (2) inadequate supportive resources; (3) shared decision-making conceptual bias; and (4) delicate doctor-patient bonds. We identified 3 decision supports: (1) providing information throughout the LCS process; (2) providing shared decision-making decision coaching; and (3) providing decision tools.

Conclusions

This study offers valuable insights into the decisional needs and support required to undergo LCS among high-risk individuals and perspectives from health care providers. Future studies should aim to design interventions that enhance the quality of shared decision-making by offering LCS information, decision tools for LCS, and decision coaching for shared decision-making (e.g., through community nurses). Simultaneously, it is crucial to assess individuals’ needs for effective deliberation to prevent conflicts and regrets after arriving at a decision.

Peer Review reports

Low-dose computed tomography (LDCT) is an effective tool for early lung cancer detection and has been proven to enhance survival rates in individuals at high-risk for lung cancer [ 1 , 2 ]. However, global LDCT usage is limited, with only 2-35% of eligible individuals undergoing screening [ 3 , 4 , 5 , 6 , 7 ], in contrast to 16-68% of eligible candidates undergoing colorectal cancer screening [ 8 ]. Improvements in LDCT screening rates for high-risk groups have been modest. The intricate balance between the advantages and risks of LDCT impedes the utilization of lung cancer screening (LCS) [ 9 ]. Notably, compared to their non-screened counterparts, high-risk individuals who underwent LDCT had a remarkable 24% decrease in lung cancer mortality [ 2 ]. However, the benefits of LDCT come with potential drawbacks, such as radiation-induced cancer, needless examinations, invasive procedures stemming from false positives, overdiagnosis, incidental discoveries, and psychological burdens [ 10 ]. These complexities render the LDCT screening decision-making process multifaceted and reliant on personal preferences. Hence, guiding high-risk groups toward well-informed choices regarding LCS is pivotal and represents a substantial mechanism for advancing the secondary prevention of lung cancer.

Shared decision-making is defined as “a collaborative approach for health care providers and patients in making informed health decisions”, which involves considering evidence regarding the benefits and risks of medical options, as well as individuals’ preferences and values [ 11 ]. This decision-making process allows both health care providers and individuals as well as their family members to engage in deliberation which leads to identifying the most appropriate decision for the situation [ 12 ]. Multiple guidelines strongly recommend shared decision-making as an essential step before patients undergo LDCT. Shared decision-making is also stipulated as a prerequisite for LDCT reimbursement by the Centers for Medicare and Medicaid Services in the United States [ 13 , 14 , 15 , 16 ]. Regrettably, the utilization of shared decision-making in clinical practice is currently not optimal [ 17 , 18 ]. Patients do not know what LDCT is, and they often report a lack of about the risks and benefits of LDCT. As a result, patients often have concerns about the risks of LDCT, and health care providers frequently fail to inquire about individuals’ preferences [ 19 ]. Consequently, there has been a notable increase in the literature focusing on barriers to shared decision-making from the perspectives of both health care providers and lung cancer high-risk groups. For example, studies have shown that the barriers to shared decision-making include different perceptions about the use of shared decision-making and a lack of time to communicate with providers. However, there are some limitations in terms of methodology and the comparative nature of the studies that focus on LCS shared decision-making. First, previously published studies focused on identifying barriers to shared decision-making and neglected decision support from physicians and patients. For instance, one study found that a lack of professionalism in health care providers is a barrier to shared decision-making, yet no studies have examined specific LCS shared decision-making decision supports for health care providers [ 19 ]. Second, current research centers on short-term decision-making experiences, such as cognitive consequences experienced immediately following shared decision-making. However, studies have not adequately addressed the complete shared decision-making process – pre-decisional needs, the decision-making process itself, and post-decision experiences, such as decision regret. Third, the COVID-19 pandemic has introduced a new risk of LDCT usage (exposure to the health-care environment) [ 20 ]. The added risk alters the benefit-risk ratio of LDCT under pre-COVID-19 guideline recommendations. Fourth, shared decision-making, developed in Western societies, is rarely discussed in China. The national climate and medical systems of China and Western countries differ greatly [ 21 ], and the lack of evidence on LCS shared decision-making in China indicates a need for an assessment of shared decision-making in those who require LDCT.

This study aimed to explore the decisional needs and decision support of shared decision-making for LCS among Chinese high-risk individuals and their health care providers using data collected through in-depth one-on-one interviews.

Theoretical framework

The Ottawa Decision-Support Framework (ODSF) is an evidence-based conceptual framework that is structured around three key components [ 22 ]: (1) assessing decisional needs, such as insufficient knowledge, complex decision types, and limited resources; (2) providing decision support, which encompasses clinical counseling, decision-making tools, and decision coaching; and (3) evaluating decisional outcomes, which includes assessing the quality of the decision-making process and its impact. According to the ODSF, successful decision support should be guided by an assessment of the individual’s knowledge and his/her ability to make his/her own decision to reduce their unmet needs and achieve a final health decision with the support of health care providers and family members. The ODSF has been successfully used within several populations with health needs to guide health decisions and provide decision support [ 23 , 24 ].

This qualitative study emphasizes the “who, what, and where” of events or experiences [ 25 ]. The central research question posed was, “What are the decisional needs and supports of LCS shared decision-making among individuals at high-risk of lung cancer and health care providers?” Consequently, a descriptive qualitative approach was deemed appropriate for exploring the decisional needs and supports for LCS shared decision-making among individuals at high-risk of lung cancer and health care providers [ 26 ]. This descriptive qualitative study adhered to the Consolidated Criteria for Reporting Qualitative Studies (COREQ) checklist [ 27 ]. Ethical approval for this study was obtained from the ethics committee of Fujian Medical University (Approval No. 2,023,098).

Inclusion and exclusion criteria

Aligned with the guidelines for the early detection of lung cancer in China [ 14 ], the inclusion criteria used for the high-risk group for lung cancer were as follows: (a) aged between 50 and 74 years; (b) had at least one of the following risk factors for lung cancer: a smoking history ≥ 30 pack-years, which includes current smokers or individuals who quit smoking within the last 15 years; prolonged exposure to passive smoking (living or working with smokers for 20 years or more); a history of COPD; a history of occupational exposure to asbestos, radon, beryllium, chromium, cadmium, nickel, silicon, soot, or coal soot for a minimum of 1 year; or a family history of lung cancer; (c) verbal confirmation of undergoing LCS shared decision-making; (d) undergone LDCT within the past 5 years; (e) Able to converse in Mandarin; (f) absence of cognitive or psychological disorders; and (g) willingness to share their personal stories. The exclusion criteria used for the high-risk group for lung cancer were as follows: (a) previous history of lung cancer; and (b) cognitive or psychological disorders (such as depression and anxiety). The inclusion criteria used for health care providers were as follows: (a) certified physicians or nurses; (b) expertise in LCS; and (c) willingness to share their experiences. Healthcare providers who were receiving external training were excluded from participation in the study.

Qualitative data collection

The data were collected from March 2023 to May 2023. A purposive sampling method was used to identify and recruit individuals at high-risk for lung cancer, as well as local health care providers from five community healthcare centers and two surgical oncology departments of tertiary hospitals. Study flyers provided information on the purpose of the study and the inclusion and exclusion criteria and were distributed to potential participants on site. After participants expressed their interest in the study, they were screened for eligibility to participate and their informed consent was secured. Next, a one-on-one interview was scheduled and a questionnaire was completed by participants to obtain their demographic data (gender, age, residential area, smoking status, etc.). One-on-one interviews were conducted in Mandarin, digitally recorded, with study data stored on a passworded encrypted laptop. Each interview lasted approximately 20 to 40 min. A private room in the clinic was used for all the in-depth interviews.

The interview questions were formulated based on the ODSF and after a comprehensive literature review [ 28 ], with extensive discussions among researchers of the study (Feifei Huang, PhD, RN, Professor, specializing in lung cancer prevention and psycho-oncology; Weisheng Chen, MD, specializing in lung cancer prevention, diagnosis and treatment; and Wei-Ti Chen PhD, RN, CNM, FAAN, specializing in intervention design and qualitative data collection). To ensure the acceptability and credibility of the interview guide, the interview questions were pilot tested with four participants in total, including two health care providers and two individuals at high-risk of lung cancer. As a result, some misconceptions regarding the interview questions were identified and subsequently modified. For instance, we replaced the term “decision tools” with “patient decision aids” to help participants to better understand the posed questions. The final interview questions are outlined in Table 1 . Tables 2 and 3 summarize key demographic data collected on the high-risk individuals and health care providers, respectively.

The sample size was determined by data saturation, that is, recruitment ended at the point where no new themes emerged from the participants’ experiences [ 29 ]. Data saturation was reached at approximately the twenty-seventh in-depth interview with a high-risk lung cancer individual, with another three high-risk lung cancer individuals being interviewed to ensure that the data reached complete saturation. Data saturation was reached at approximately the seventh in-depth interview with healthcare providers, with another two healthcare providers interviewed to ensure data saturation.

Data analysis

Since the interviews were conducted in Mandarin, a bilingual coding technique was used to keep the data in the original Chinese format, and the coding assignments were in English (e.g., decision negotiation). To ensure accuracy and minimize potential translation errors, two bilingual researchers (Chinese and English) reviewed and confirmed the translations [ 30 ]. The process of data analysis began with data collection. To analyze the data, content analysis was guided by the ODSF and Nvivo software version 12 was used [ 31 ]. The classification of themes was performed both inductively (derived from the quotes of research participants) and deductively (derived from the ODSF theoretical framework) under the principle of complementarity. The detailed steps of the data analysis process are illustrated in Fig. 1 .

Directed content analysis flowchart

Trustworthiness

Credibility, dependability, confirmability and transferability were employed to assure the trustworthiness of this study’s findings [ 32 ]. To enhance credibility, the researcher dedicated ample time to establishing meaningful interactions with the participants, thereby building trust for effective data collection. Regarding dependability, two researchers cross-checked and rectified codes that did not precisely reflect participants’ perspectives. Furthermore, an audit trail and reflexivity techniques were used during the data analysis process, which included tracking the interview and data analysis notes and memos. To ensure confirmability, the supervisor reviewed and selected quotations, codes, and categories, thereby validating the accuracy of the coding process. In terms of transferability, participants were purposefully selected from both urban and rural areas to incorporate a wide range of perspectives. Herein, a comprehensive description of the entire research process is presented to facilitate reproducibility of the study.

Out of a total of 44 participants consented, five participants (4 high-risk individuals and 1 health care provider) dropped out of the study due to their busy schedules and lack of interest in participating. A total of 39 eligible volunteers composed the study sample. Among them, 30 individuals were classified as at high-risk for lung cancer with an average age of 61.27 ± 7.92 years, while nine health care providers had an average age of 36.78 ± 7.45 years. Five health care provider participants specialized in lung cancer prevention, diagnosis, and treatment, and four specialized in general medical education and community cancer screening education. Detailed demographic information on the participants can be found in Tables  2 and 3 .

A total of 546 unique codes related to LCS shared decision-making were identified. Following the framework of the ODSF, participants’ decisional needs and supports for shared decision-making were categorized (refer to Fig.  2 ; Table  4 ).

Participants’ viewpoints on shared decision-making based on ODSF

Decisional needs

We identified four categories related to the theme of decisional needs, including LCS knowledge deficits, inadequate supportive resources, shared decision-making conceptual bias, and delicate doctor-patient bonds.

Theme 1: LCS knowledge deficit

Many high-risk study participants expressed that they did not have access to reliable and authoritative medical information. Many of the high-risk participants shared their inability to access LCS-related information and their limited capacity to distinguish accurate LCS information from misinformation. Furthermore, participants mentioned that a negative personal view of life influenced their active engagement in shared decision-making with health care providers and/or family, which diminished their comprehensive understanding of LCS.

“Some people are negative, they believe God’s will can decide everything, so when they faced a decision, they will ask the gods instead of making a decision according to their actual situation” H13 (high-risk individual, female, 53 years-old).

Theme 2: inadequate supportive resources

Participants emphasized that shared decision-making was hindered by financial, transportation and time-related barriers to hospital visits. Furthermore, unfamiliarity with the process of seeking medical treatment also presented an obstacle to shared decision-making. Notably, participants expressed negative emotions related to the LDCT test which influenced their shared decision-making. In particular, the LDCT process was not well received by individuals who had claustrophobia. Participants described feeling claustrophobic during the process of the imagological examination. The requirement for patients to lie flat during the examination, combined with the confined and dim space, can lead to feelings of depression and suffocation. Additionally, the machine’s noise and concerns about potential risks (such as radiation and false positives) from having LDCT scans may have heightened patients’ negative emotions and fears.

“Since I smoke, I’m always scared of getting bad test results. If the results are bad, it’s just really scary, I don’t think I have the sanity to make shared decisions with my doctors. I need help.” H11 (a high-risk individual, female, 54 years-old).

“I struggle with claustrophobia, and every time I have a test, I feel really trapped. It would be difficult for me to have shared decision-making when I have a claustrophobia. It felt like my mind was blank.” H12 (a high-risk individual, male, 52 years-old).

Several participants mentioned experiencing anxiety regarding the test results. They expressed their apprehension about potential adverse outcomes and indicated that this anxiety affected their ability to engage in shared decision-making with their doctors. Moreover, after experiencing claustrophobia, some participants expressed that they felt an inability to make shared decisions with their doctors in a rational manner.

Theme 3: Shared decision-making conceptual bias

Some participants mentioned that they were not familiar with the specific term ‘shared decision-making’. Health care providers shared the perspective that excessive communication with the high-risk group about their condition might lead to a refusal of subsequent treatment, potentially jeopardizing their health.

“I believe that when it comes to professional matters, it’s best to rely on trained professionals. Most patients don’t have expert medical knowledge, and even if they do, they might be hesitant about certain exams. That, in my opinion, doesn’t do much good for their health.” M8 (a general practitioner, female, 36 years-old).

Additionally, participants had misconceptions about shared decision-making. For example, health care providers had misconceptions about shared decision-making in LDCT screenings – some believed that shared decision-making meant merely providing information about the benefits and risks of LDCT; others confused the concepts of informed consent and shared decision-making all together; and a few providers viewed encouraging high-risk groups to conduct LDCT screening to be a part of shared decision-making. Some participants believed shared decision-making to be merely a procedural step to schedule a test appointment.

“I think shared decision-making means thoroughly informing those in high-risk groups about the pros and cons of a particular exam and ultimately letting them make the call.” M5 (a physician specialist, male, 25 years-old).

“When we suggest undergoing a medical examination, doctors might assume that this visit is a necessary step for patients to get a chance to be examined, not a step for shared decision-making. As a result, they may believe that there’s no necessity for patient education.” H13 (a high-risk individual, female, 53 years-old).

Theme 4: delicate doctor-patient bonds

Both health care providers and high-risk individuals emphasized that time constraints pose a significant barrier to shared decision-making. Some participants noted that doctors, who often express concerns about work-related burnout, were hesitant to provide comprehensive information about LDCT.

“I believe that doctor burnout contributes to their reluctance to discuss lung cancer screening with patients.” H9 (a high-risk individual, male, 57 years-old).

Furthermore, health care providers and participants encountered challenges with communication. Health care providers struggled to simplify complex information for easy understanding, while participants had difficulty clearly expressing their needs.

“Effective communication is essential for both doctors and patients. The doctor’s ability to convey information and the patient’s capacity to express their needs are crucial. Insufficient communication skills represent a challenge for both parties.” M6 (a physician specialist, male, 27 years-old).

Participants also mentioned that they were hesitant to express their thoughts to doctors whom they do not know well.

“Building trust is not a simple task. When patients and I have a strong connection and they trust us enough to share their true thoughts, it significantly reduces barriers to shared decision-making. On the other hand, some doctors who aren’t deeply connected with the community may struggle to gain patients’ trust, leading to communication challenges that hinder shared decision-making.” M2 (a nurse in grade A tertiary hospital, female, 41 years-old).

Others believe that the professional competence of doctors plays a pivotal role in shared decision-making in LCS. People often opt for doctors from tertiary hospitals who were perceived to have a higher level of professionalism, which is conducive to shared decision-making.

“Personally, I believe that the expertise of doctors in county-level hospitals may not be as advanced, which affects my level of trust in them. I tend to find doctors in top-tier tertiary hospitals to be more credible.” H12 (a high-risk individual, male, 52 years-old).

Decision support

Three categories related to the theme of decision support were identified: provide information throughout the LCS process, providing a shared decision-making coach, and provide decision tools.

Theme 1: provide information throughout the LCS process

Participants shared that they would like to know information about LDCT before and after undergoing the screening test. Desired information prior to screening included: eligibility criteria for LCS; benefits and risks of LDCT, the LDCT process itself, primary and secondary prevention of lung cancer, the cost of LDCT, potential emergencies and appropriate responses during LDCT, guidelines for Medicare reimbursement related to LDCT, and the medical visit steps. Most participants wanted information after the screening to include the interpretation and monitoring of LDCT results as well as the recommended frequency of LDCT.

Theme 2: providing a shared decision-making decision coach

Several participants said that it is necessary to enhance shared decision-making beliefs to better support the decision-making process for LCS, which is inherently a preference-sensitive decision.

“In China, shared decision-making isn’t commonly practiced. Many physicians here may not be familiar with the concept, even though it’s something they should consider adopting. Personally, I strongly believe in the importance of implementing shared decision-making.” H6 (a high-risk individual, male, 58 years-old).

High-risk individuals emphasize the importance of establishing a foundation for knowledge before engaging in shared decision-making. Participants advocated for a basic understanding of medical concepts, with decision counselors possessing specialized medical expertise.

“Before participating in shared decision-making, I’d like to gain some basic medical knowledge.” H4 (a high-risk individual, female, 53 years-old).

Due to time and energy constraints, clinicians found it challenging to engage in shared decision-making. However, the community doctors in our study stated that they had more time to communicate and share opinions and that their closer patient-provider relationships could facilitate the shared decision-making process in China.

“We only present the benefit and harm of LDCT briefly. We don’t have enough time to describe these in more detail. You know, lung cancer pathology and knowledge of imaging are too complex for high-risk individuals of lung cancer. For individuals who don’t have professional backgrounds, it is impossible for them to understand totally, what we can do is try to get them to understand as much as possible in a limited time.” M5 (a doctor in grade A tertiary hospital, male, 25 years-old).

“It’s important to involve community health providers in shared decision-making for a couple of reasons. Firstly, we tend to establish a strong rapport with patients, and they often trust us more compared to clinicians. Additionally, we have the advantage of spending more time communicating with patients, which makes us better suited to facilitate shared decision-making.” M9 (a general practitioner, male, 42 years-old).

Theme 3: providing decision tools

Participants expressed the need for decision tools and made several suggestions for decision tools to better cater to diverse groups. Decision tools are instruments that aid users in clarifying the congruence between their decisions and their individual values by presenting relevant options along with their associated benefits and potential drawbacks. Through the use of decision tools, users are assisted in arriving at clear, high-quality decisions.

The participants had several suggestions for providing decision tools. First, various information modalities such as videos, images, and written content should be integrated into tools to accommodate varying education levels and preferences. Second, tailored information that aligns with LCS decision-making is preferred. Third, a three-way interaction model involving patients, decision tools, and health care providers could enhance effectiveness. Fourth, medical knowledge should be presented in a comprehensible manner to improve accessibility. Additionally, access to more detailed information is necessary. Fifth, the time spent using decision tools should be less than 20 min to prevent impatience. Sixth, most participants emphasized addressing credibility concerns, through incorporating medical professionals into the tool’s development team, emphasizing authoritative sources, and involving experts from reputable hospitals. Finally, most participants acknowledged that value clarification exercises should be integrated to help users articulate their personal screening preferences to ensure a comprehensive approach to decision support.

Shared decision-making plays a crucial role in enhancing the understanding of LCS and LDCT in high-risk groups. Shared decision-making can also establish realistic expectations for health outcomes and ultimately improve decision-making for the best treatment or screening option [ 33 ]. This qualitative study provides insights into the decisional needs and necessary support for shared decision-making in LDCT screening, from the perspectives of health care providers and high-risk individuals in China. Specifically, LDCT screening decisions should evaluate the knowledge, availability of supportive resources, health care providers’ understanding of shared decision-making concepts, and quality of doctor-patient relationships. At present, both providers and screeners require decision support surrounding LDCT information and need shared decision-making coaching to effectively arrive at a decision. This study finding is valuable for shaping the design of future interventions that aim to facilitate decision-making and has the potential to increase the use of LDCT screening in Chinese society.

Our findings also contribute to the classification refinement of the ODSF. Regarding LCS knowledge, we have observed that high-risk groups not only lack specific knowledge of LCS, but also face challenges accessing relevant information and struggle with their capacity to distinguish accurate LCS information from misinformation. Previous multimodel public health interventions have focused on education related to specific LCS knowledge and ignored the need to access correct information, insufficiently addressing the needs of populations at high-risk of lung cancer [ 34 ]. Therefore, in addition to limited knowledge, limited access to information and lack of identification undermine the contributions of high-risk groups in shared decision-making.

In terms of support and resources, it is essential to consider not only conventional limitations such as financial and health system resources, but also the psychological well-being of high-risk populations. The proportion of smokers is greater among those at high-risk for lung cancer than among those at high-risk for other types of cancers (such as breast cancer and colorectal cancer) [ 35 ]. Being a smoker can affect the execution of shared decision-making due to perceived stigma, lung cancer fatalism, and heightened levels of worry and fear of contracting lung cancer [ 35 ]. Additionally, concerns about potential risks associated with LDCT serve as a barrier to the shared decision-making process with health care providers [ 9 ].

Our findings provide new insights into the core constructs of decisional needs, including awareness of shared decision-making and doctor-patient bonds. Additionally, shared decision-making awareness studies have demonstrated that bias can lead to differences in individual preferences, which can hinder the initiation of shared decision-making and result in higher levels of decision conflict [ 36 ]. Additionally, studies have shown that poor doctor-patient communication can lead to low-quality shared decision-making. For example, dismissive clinicians who dominate decision-making encounters, use negative verbal or nonverbal cues, or fail to respect patients’ concerns have been shown to act as barriers to shared decision-making for many patients [ 37 ]. Conversely, clinicians who strive to understand individual needs and preferences can foster a sense of partnership and facilitate their involvement in shared decision-making processes [ 38 ]. It has also been found that allocating limited time for consultations as well as poor communication skills results in ineffective shared decision-making [ 39 ]. Limitations in skill and time can impede the ability to be fully informed by health care providers, to process and reflect on the information received, and to engage in meaningful discussions between providers and individuals [ 37 ]. Furthermore, the presence of trust is identified as a facilitator of shared decision-making. Establishing a trusting relationship with health care providers encourages patients to feel more comfortable asking questions, sharing personal information, and discussing their concerns [ 39 ].

Currently, the use of shared decision-making in clinical practice is suboptimal in China [ 11 ]. Fortunately, our study provides potential mitigation strategies. First, the need for comprehensive decision tools that appeal to diverse groups of patients was emphasized by both high-risk groups and health providers. A decision tool can furnish information, facilitate patient-doctor dialog, and enhance therapeutic outcomes [ 33 ]. However, the availability of decision tools for LCS is limited and their applications are less than ideal, partly due to their failure to be tailored to personal needs. For instance, most LCS decision tools are presented as single-page materials or premade videos, which may not fully address participants’ needs. Our findings highlight the demand for personalized decision tools for LCS in China. Second, some participants suggested that decision counselors should not be limited solely to clinicians; community health care providers can also serve as counselors for decision-making. This aligns with the concept that shared decision-making requires multisectoral collaboration [ 40 ]. Community nurses in particular, share similar ethnic, linguistic, and geographic backgrounds with the residents they serve compared to other nurses. Consequently, they are more likely to encounter high-risk populations in the community [ 41 ]. Additionally, due to the nature of their work, they have more time to engage in shared decision-making discussions with high-risk groups. Research has revealed that community nurses, in their roles as coordinators, educators, researchers, navigators, and practitioners, can play multidimensional roles essential for leading successful LCS [ 42 ]. Hence, future research should actively promote the development of community nurses as counsellors for LCS to alleviate the burden on hospital-based physicians. Third, both health care providers and high-risk groups should receive education on shared decision-making. Our findings reveal that both sides still possess a vague understanding of shared decision-making, often conflating it with informed consent (patient-led) and paternalism (physician-led) models. Unlike in Western countries, humanistic medicine education in China is lacking, resulting in an inadequate grasp of patient-centered medical-ethical principles among health providers and patients [ 21 ]. Future interventions in China should emphasize humanistic medicine to establish the foundation of shared decision-making.

Our findings are rooted in Chinese culture, which, along with broader Asian cultural influences, places a significant emphasis on Confucianism and sociocultural values such as family support, care, and respect for familial hierarchy and authority [ 43 ]. Therefore, the insights provided by this paper may be applicable to other Asian countries. Despite the rapid development of SDM research in the West, the actual implementation of SDM in clinical practice is not as favorable [ 44 ]. One contributing factor is that highly developed patient decision aids often overly focus on standardized processes, deviating from a more humanistic approach that can be applied universally [ 44 ]. Moreover, the ongoing wave of globalization has resulted in increasingly multicultural societies, necessitating a broader scope of SDM coverage that includes individuals from diverse cultural backgrounds. Therefore, avoiding cultural stereotypes and actively inquiring about patients’ preferences become especially crucial. The results of our study contribute valuable insights into individual decisional needs and decision support from the perspectives of both individuals at high-risk for lung cancer and health care providers. These perspectives can assist patient decision aids in avoiding excessive standardization. Simultaneously, the perspective embedded in our findings is well-suited to accommodate the multicultural nature of Western countries. Future studies should seek to bridge the gap in SDM between Eastern and Western contexts.

Limitations

There are several limitations in this study. First, since the high-risk lung cancer individuals in our study did not undergo LCS shared decision-making recently, their views on LCS shared decision-making may have been subject to recall bias. Second, all study participants were from Fujian Province, which is a southeastern province in China. It is possible that recruitment from a broader geographical area may have led to a wider range of perspectives and experiences and thus influenced the point at which data saturation was reached. Third, as a qualitative, in-depth interview study, generalizations of findings to a larger population are not possible. Future quantitative studies should explore decision-making experiences among a broad range of high-risk groups and health care providers in China to enhance data triangulation and thus, the credibility and reliability of the study’s findings.

Guiding high-risk groups toward well-informed choices regarding LCS represents a substantial gain toward advancing secondary prevention of lung cancer. This descriptive qualitative study offers valuable insights into decision-making regarding LDCT screening among Chinese high-risk groups and their health care providers. The findings from this study highlight the decisional needs and decision support for shared decision-making for LCS using the ODSF conceptual framework. Future studies should target intervention development to offer decision support by evaluating individuals’ decisional needs, enabling them to make choices confidently, and with minimal conflict and decisional regret. In addition, this study may also serve as a starting point for the development of more effective decision tools for LDCT screening.

Availability of data and materials

The de-identified datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

Abbreviations

Low-dose computed tomography

Lung cancer screening

The Ottawa Decision-Support Framework

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Acknowledgements

The authors are grateful to all the participants in this study.

This work was supported by the National Natural Science Foundation of China [grant number 72304068] and the General Project of Fujian Provincial Nature Science Foundation (grant number 2021J01133126).

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XJL had full access to all of the data and takes responsibility for the integrity of the data and the accuracy of the data analysis. FFW and YLL contributed to the study design, data collection, data analysis and interpretation, and writing of the manuscript. FL. and WSC contributed to the recruitment, data collection and interpretation, and writing of the manuscript. WTC contributed to the study design, coordination, interpretation, and writing of the manuscript. FFH contributed to the overall study design, interpretation, and writing of the manuscript. All authors approved the final version of the manuscript.

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Lin, X., Wang, F., Li, Y. et al. Exploring shared decision-making needs in lung cancer screening among high-risk groups and health care providers in China: a qualitative study. BMC Cancer 24 , 613 (2024). https://doi.org/10.1186/s12885-024-12360-0

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CRO Guide   >  Chapter 3.1

Qualitative Research: Definition, Methodology, Limitation & Examples

Qualitative research is a method focused on understanding human behavior and experiences through non-numerical data. Examples of qualitative research include:

• One-on-one interviews,
• Focus groups, Ethnographic research,
• Case studies,
• Record keeping,
• Qualitative observations

In this article, we’ll provide tips and tricks on how to use qualitative research to better understand your audience through real world examples and improve your ROI. We’ll also learn the difference between qualitative and quantitative data.

Table of Contents

Marketers often seek to understand their customers deeply. Qualitative research methods such as face-to-face interviews, focus groups, and qualitative observations can provide valuable insights into your products, your market, and your customers’ opinions and motivations. Understanding these nuances can significantly enhance marketing strategies and overall customer satisfaction.

What is Qualitative Research

Qualitative research is a market research method that focuses on obtaining data through open-ended and conversational communication. This method focuses on the “why” rather than the “what” people think about you. Thus, qualitative research seeks to uncover the underlying motivations, attitudes, and beliefs that drive people’s actions. 

Let’s say you have an online shop catering to a general audience. You do a demographic analysis and you find out that most of your customers are male. Naturally, you will want to find out why women are not buying from you. And that’s what qualitative research will help you find out.

In the case of your online shop, qualitative research would involve reaching out to female non-customers through methods such as in-depth interviews or focus groups. These interactions provide a platform for women to express their thoughts, feelings, and concerns regarding your products or brand. Through qualitative analysis, you can uncover valuable insights into factors such as product preferences, user experience, brand perception, and barriers to purchase.

Types of Qualitative Research Methods

Qualitative research methods are designed in a manner that helps reveal the behavior and perception of a target audience regarding a particular topic.

The most frequently used qualitative analysis methods are one-on-one interviews, focus groups, ethnographic research, case study research, record keeping, and qualitative observation.

1. One-on-one interviews

Conducting one-on-one interviews is one of the most common qualitative research methods. One of the advantages of this method is that it provides a great opportunity to gather precise data about what people think and their motivations.

Spending time talking to customers not only helps marketers understand who their clients are, but also helps with customer care: clients love hearing from brands. This strengthens the relationship between a brand and its clients and paves the way for customer testimonials.

• A company might conduct interviews to understand why a product failed to meet sales expectations.
• A researcher might use interviews to gather personal stories about experiences with healthcare.

These interviews can be performed face-to-face or on the phone and usually last between half an hour to over two hours. 

When a one-on-one interview is conducted face-to-face, it also gives the marketer the opportunity to read the body language of the respondent and match the responses.

2. Focus groups

Focus groups gather a small number of people to discuss and provide feedback on a particular subject. The ideal size of a focus group is usually between five and eight participants. The size of focus groups should reflect the participants’ familiarity with the topic. For less important topics or when participants have little experience, a group of 10 can be effective. For more critical topics or when participants are more knowledgeable, a smaller group of five to six is preferable for deeper discussions.

The main goal of a focus group is to find answers to the “why”, “what”, and “how” questions. This method is highly effective in exploring people’s feelings and ideas in a social setting, where group dynamics can bring out insights that might not emerge in one-on-one situations.

• A focus group could be used to test reactions to a new product concept.
• Marketers might use focus groups to see how different demographic groups react to an advertising campaign.

One advantage that focus groups have is that the marketer doesn’t necessarily have to interact with the group in person. Nowadays focus groups can be sent as online qualitative surveys on various devices.

Focus groups are an expensive option compared to the other qualitative research methods, which is why they are typically used to explain complex processes.

3. Ethnographic research

Ethnographic research is the most in-depth observational method that studies individuals in their naturally occurring environment.

This method aims at understanding the cultures, challenges, motivations, and settings that occur.

• A study of workplace culture within a tech startup.
• Observational research in a remote village to understand local traditions.

Ethnographic research requires the marketer to adapt to the target audiences’ environments (a different organization, a different city, or even a remote location), which is why geographical constraints can be an issue while collecting data.

This type of research can last from a few days to a few years. It’s challenging and time-consuming and solely depends on the expertise of the marketer to be able to analyze, observe, and infer the data.

4. Case study research

The case study method has grown into a valuable qualitative research method. This type of research method is usually used in education or social sciences. It involves a comprehensive examination of a single instance or event, providing detailed insights into complex issues in real-life contexts.  

• Analyzing a single school’s innovative teaching method.
• A detailed study of a patient’s medical treatment over several years.

Case study research may seem difficult to operate, but it’s actually one of the simplest ways of conducting research as it involves a deep dive and thorough understanding of the data collection methods and inferring the data.

5. Record keeping

Record keeping is similar to going to the library: you go over books or any other reference material to collect relevant data. This method uses already existing reliable documents and similar sources of information as a data source.

• Historical research using old newspapers and letters.
• A study on policy changes over the years by examining government records.

This method is useful for constructing a historical context around a research topic or verifying other findings with documented evidence.

6. Qualitative observation

Qualitative observation is a method that uses subjective methodologies to gather systematic information or data. This method deals with the five major sensory organs and their functioning, sight, smell, touch, taste, and hearing.

• Sight : Observing the way customers visually interact with product displays in a store to understand their browsing behaviors and preferences.
• Smell : Noting reactions of consumers to different scents in a fragrance shop to study the impact of olfactory elements on product preference.
• Touch : Watching how individuals interact with different materials in a clothing store to assess the importance of texture in fabric selection.
• Taste : Evaluating reactions of participants in a taste test to identify flavor profiles that appeal to different demographic groups.
• Hearing : Documenting responses to changes in background music within a retail environment to determine its effect on shopping behavior and mood.

Below we are also providing real-life examples of qualitative research that demonstrate practical applications across various contexts:

Qualitative Research Real World Examples

Let’s explore some examples of how qualitative research can be applied in different contexts.

1. Online grocery shop with a predominantly male audience

Method used: one-on-one interviews.

Let’s go back to one of the previous examples. You have an online grocery shop. By nature, it addresses a general audience, but after you do a demographic analysis you find out that most of your customers are male.

One good method to determine why women are not buying from you is to hold one-on-one interviews with potential customers in the category.

Interviewing a sample of potential female customers should reveal why they don’t find your store appealing. The reasons could range from not stocking enough products for women to perhaps the store’s emphasis on heavy-duty tools and automotive products, for example. These insights can guide adjustments in inventory and marketing strategies.

2. Software company launching a new product

Method used: focus groups.

Focus groups are great for establishing product-market fit.

Let’s assume you are a software company that wants to launch a new product and you hold a focus group with 12 people. Although getting their feedback regarding users’ experience with the product is a good thing, this sample is too small to define how the entire market will react to your product.

So what you can do instead is holding multiple focus groups in 20 different geographic regions. Each region should be hosting a group of 12 for each market segment; you can even segment your audience based on age. This would be a better way to establish credibility in the feedback you receive.

3. Alan Pushkin’s “God’s Choice: The Total World of a Fundamentalist Christian School”

Method used: ethnographic research.

Moving from a fictional example to a real-life one, let’s analyze Alan Peshkin’s 1986 book “God’s Choice: The Total World of a Fundamentalist Christian School”.

Peshkin studied the culture of Bethany Baptist Academy by interviewing the students, parents, teachers, and members of the community alike, and spending eighteen months observing them to provide a comprehensive and in-depth analysis of Christian schooling as an alternative to public education.

The study highlights the school’s unified purpose, rigorous academic environment, and strong community support while also pointing out its lack of cultural diversity and openness to differing viewpoints. These insights are crucial for understanding how such educational settings operate and what they offer to students.

Even after discovering all this, Peshkin still presented the school in a positive light and stated that public schools have much to learn from such schools.

Peshkin’s in-depth research represents a qualitative study that uses observations and unstructured interviews, without any assumptions or hypotheses. He utilizes descriptive or non-quantifiable data on Bethany Baptist Academy specifically, without attempting to generalize the findings to other Christian schools.

4. Understanding buyers’ trends

Method used: record keeping.

Another way marketers can use quality research is to understand buyers’ trends. To do this, marketers need to look at historical data for both their company and their industry and identify where buyers are purchasing items in higher volumes.

For example, electronics distributors know that the holiday season is a peak market for sales while life insurance agents find that spring and summer wedding months are good seasons for targeting new clients.

5. Determining products/services missing from the market

Conducting your own research isn’t always necessary. If there are significant breakthroughs in your industry, you can use industry data and adapt it to your marketing needs.

The influx of hacking and hijacking of cloud-based information has made Internet security a topic of many industry reports lately. A software company could use these reports to better understand the problems its clients are facing.

As a result, the company can provide solutions prospects already know they need.

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Qualitative Research Approaches

Once the marketer has decided that their research questions will provide data that is qualitative in nature, the next step is to choose the appropriate qualitative approach.

The approach chosen will take into account the purpose of the research, the role of the researcher, the data collected, the method of data analysis , and how the results will be presented. The most common approaches include:

• Narrative : This method focuses on individual life stories to understand personal experiences and journeys. It examines how people structure their stories and the themes within them to explore human existence. For example, a narrative study might look at cancer survivors to understand their resilience and coping strategies.
• Phenomenology : attempts to understand or explain life experiences or phenomena; It aims to reveal the depth of human consciousness and perception, such as by studying the daily lives of those with chronic illnesses.
• Grounded theory : investigates the process, action, or interaction with the goal of developing a theory “grounded” in observations and empirical data. 
• Ethnography : describes and interprets an ethnic, cultural, or social group;
• Case study : examines episodic events in a definable framework, develops in-depth analyses of single or multiple cases, and generally explains “how”. An example might be studying a community health program to evaluate its success and impact.

How to Analyze Qualitative Data

Analyzing qualitative data involves interpreting non-numerical data to uncover patterns, themes, and deeper insights. This process is typically more subjective and requires a systematic approach to ensure reliability and validity. 

1. Data Collection

Ensure that your data collection methods (e.g., interviews, focus groups, observations) are well-documented and comprehensive. This step is crucial because the quality and depth of the data collected will significantly influence the analysis.

2. Data Preparation

Once collected, the data needs to be organized. Transcribe audio and video recordings, and gather all notes and documents. Ensure that all data is anonymized to protect participant confidentiality where necessary.

3. Familiarization

Immerse yourself in the data by reading through the materials multiple times. This helps you get a general sense of the information and begin identifying patterns or recurring themes.

Develop a coding system to tag data with labels that summarize and account for each piece of information. Codes can be words, phrases, or acronyms that represent how these segments relate to your research questions.

• Descriptive Coding : Summarize the primary topic of the data.
• In Vivo Coding : Use language and terms used by the participants themselves.
• Process Coding : Use gerunds (“-ing” words) to label the processes at play.
• Emotion Coding : Identify and record the emotions conveyed or experienced.

5. Thematic Development

Group codes into themes that represent larger patterns in the data. These themes should relate directly to the research questions and form a coherent narrative about the findings.

6. Interpreting the Data

Interpret the data by constructing a logical narrative. This involves piecing together the themes to explain larger insights about the data. Link the results back to your research objectives and existing literature to bolster your interpretations.

7. Validation

Check the reliability and validity of your findings by reviewing if the interpretations are supported by the data. This may involve revisiting the data multiple times or discussing the findings with colleagues or participants for validation.

8. Reporting

Finally, present the findings in a clear and organized manner. Use direct quotes and detailed descriptions to illustrate the themes and insights. The report should communicate the narrative you’ve built from your data, clearly linking your findings to your research questions.

Limitations of qualitative research

The disadvantages of qualitative research are quite unique. The techniques of the data collector and their own unique observations can alter the information in subtle ways. That being said, these are the qualitative research’s limitations:

1. It’s a time-consuming process

The main drawback of qualitative study is that the process is time-consuming. Another problem is that the interpretations are limited. Personal experience and knowledge influence observations and conclusions.

Thus, qualitative research might take several weeks or months. Also, since this process delves into personal interaction for data collection, discussions often tend to deviate from the main issue to be studied.

2. You can’t verify the results of qualitative research

Because qualitative research is open-ended, participants have more control over the content of the data collected. So the marketer is not able to verify the results objectively against the scenarios stated by the respondents. For example, in a focus group discussing a new product, participants might express their feelings about the design and functionality. However, these opinions are influenced by individual tastes and experiences, making it difficult to ascertain a universally applicable conclusion from these discussions.

3. It’s a labor-intensive approach

Qualitative research requires a labor-intensive analysis process such as categorization, recording, etc. Similarly, qualitative research requires well-experienced marketers to obtain the needed data from a group of respondents.

4. It’s difficult to investigate causality

Qualitative research requires thoughtful planning to ensure the obtained results are accurate. There is no way to analyze qualitative data mathematically. This type of research is based more on opinion and judgment rather than results. Because all qualitative studies are unique they are difficult to replicate.

5. Qualitative research is not statistically representative

Because qualitative research is a perspective-based method of research, the responses given are not measured.

Comparisons can be made and this can lead toward duplication, but for the most part, quantitative data is required for circumstances that need statistical representation and that is not part of the qualitative research process.

While doing a qualitative study, it’s important to cross-reference the data obtained with the quantitative data. By continuously surveying prospects and customers marketers can build a stronger database of useful information.

Quantitative vs. Qualitative Research

Image source

Quantitative and qualitative research are two distinct methodologies used in the field of market research, each offering unique insights and approaches to understanding consumer behavior and preferences.

As we already defined, qualitative analysis seeks to explore the deeper meanings, perceptions, and motivations behind human behavior through non-numerical data. On the other hand, quantitative research focuses on collecting and analyzing numerical data to identify patterns, trends, and statistical relationships.  

Let’s explore their key differences: 

Nature of Data:

• Quantitative research : Involves numerical data that can be measured and analyzed statistically.
• Qualitative research : Focuses on non-numerical data, such as words, images, and observations, to capture subjective experiences and meanings.

Research Questions:

• Quantitative research : Typically addresses questions related to “how many,” “how much,” or “to what extent,” aiming to quantify relationships and patterns.
• Qualitative research: Explores questions related to “why” and “how,” aiming to understand the underlying motivations, beliefs, and perceptions of individuals.

Data Collection Methods:

• Quantitative research : Relies on structured surveys, experiments, or observations with predefined variables and measures.
• Qualitative research : Utilizes open-ended interviews, focus groups, participant observations, and textual analysis to gather rich, contextually nuanced data.

Analysis Techniques:

• Quantitative research: Involves statistical analysis to identify correlations, associations, or differences between variables.
• Qualitative research: Employs thematic analysis, coding, and interpretation to uncover patterns, themes, and insights within qualitative data.

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• Last modified: January 3, 2023
• Conversion Rate Optimization , User Research

Valentin Radu

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