preliminary study in research methodology

Pilot Study in Research: Definition & Examples

Julia Simkus

Editor at Simply Psychology

BA (Hons) Psychology, Princeton University

Julia Simkus is a graduate of Princeton University with a Bachelor of Arts in Psychology. She is currently studying for a Master's Degree in Counseling for Mental Health and Wellness in September 2023. Julia's research has been published in peer reviewed journals.

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Saul McLeod, PhD

Editor-in-Chief for Simply Psychology

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul McLeod, PhD., is a qualified psychology teacher with over 18 years of experience in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

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A pilot study, also known as a feasibility study, is a small-scale preliminary study conducted before the main research to check the feasibility or improve the research design.

Pilot studies can be very important before conducting a full-scale research project, helping design the research methods and protocol.

How Does it Work?

Pilot studies are a fundamental stage of the research process. They can help identify design issues and evaluate a study’s feasibility, practicality, resources, time, and cost before the main research is conducted.

It involves selecting a few people and trying out the study on them. It is possible to save time and, in some cases, money by identifying any flaws in the procedures designed by the researcher.

A pilot study can help the researcher spot any ambiguities (i.e., unusual things), confusion in the information given to participants, or problems with the task devised.

Sometimes the task is too hard, and the researcher may get a floor effect because none of the participants can score at all or can complete the task – all performances are low.

The opposite effect is a ceiling effect, when the task is so easy that all achieve virtually full marks or top performances and are “hitting the ceiling.”

This enables researchers to predict an appropriate sample size, budget accordingly, and improve the study design before performing a full-scale project.

Pilot studies also provide researchers with preliminary data to gain insight into the potential results of their proposed experiment.

However, pilot studies should not be used to test hypotheses since the appropriate power and sample size are not calculated. Rather, pilot studies should be used to assess the feasibility of participant recruitment or study design.

By conducting a pilot study, researchers will be better prepared to face the challenges that might arise in the larger study. They will be more confident with the instruments they will use for data collection.

Multiple pilot studies may be needed in some studies, and qualitative and/or quantitative methods may be used.

To avoid bias, pilot studies are usually carried out on individuals who are as similar as possible to the target population but not on those who will be a part of the final sample.

Feedback from participants in the pilot study can be used to improve the experience for participants in the main study. This might include reducing the burden on participants, improving instructions, or identifying potential ethical issues.

Experiment Pilot Study

In a pilot study with an experimental design , you would want to ensure that your measures of these variables are reliable and valid.

You would also want to check that you can effectively manipulate your independent variables and that you can control for potential confounding variables.

A pilot study allows the research team to gain experience and training, which can be particularly beneficial if new experimental techniques or procedures are used.

Questionnaire Pilot Study

It is important to conduct a questionnaire pilot study for the following reasons:

• Check that respondents understand the terminology used in the questionnaire.
• Check that emotive questions are not used, as they make people defensive and could invalidate their answers.
• Check that leading questions have not been used as they could bias the respondent’s answer.
• Ensure that the questionnaire can be completed in a reasonable amount of time. If it’s too long, respondents may lose interest or not have enough time to complete it, which could affect the response rate and the data quality.

By identifying and addressing issues in the pilot study, researchers can reduce errors and risks in the main study. This increases the reliability and validity of the main study’s results.

Assessing the practicality and feasibility of the main study

Testing the efficacy of research instruments

Identifying and addressing any weaknesses or logistical problems

Collecting preliminary data

Estimating the time and costs required for the project

Determining what resources are needed for the study

Identifying the necessity to modify procedures that do not elicit useful data

Adding credibility and dependability to the study

Pretesting the interview format

Enabling researchers to develop consistent practices and familiarize themselves with the procedures in the protocol

Addressing safety issues and management problems

Limitations

Require extra costs, time, and resources.

Do not guarantee the success of the main study.

Contamination (ie: if data from the pilot study or pilot participants are included in the main study results).

Funding bodies may be reluctant to fund a further study if the pilot study results are published.

Do not have the power to assess treatment effects due to small sample size.

• Viscocanalostomy: A Pilot Study (Carassa, Bettin, Fiori, & Brancato, 1998)
• WHO International Pilot Study of Schizophrenia (Sartorius, Shapiro, Kimura, & Barrett, 1972)
• Stephen LaBerge of Stanford University ran a series of experiments in the 80s that investigated lucid dreaming. In 1985, he performed a pilot study that demonstrated that time perception is the same as during wakefulness. Specifically, he had participants go into a state of lucid dreaming and count out ten seconds, signaling the start and end with pre-determined eye movements measured with the EOG.
• Negative Word-of-Mouth by Dissatisfied Consumers: A Pilot Study (Richins, 1983)
• A pilot study and randomized controlled trial of the mindful self‐compassion program (Neff & Germer, 2013)
• Pilot study of secondary prevention of posttraumatic stress disorder with propranolol (Pitman et al., 2002)
• In unstructured observations, the researcher records all relevant behavior without a system. There may be too much to record, and the behaviors recorded may not necessarily be the most important, so the approach is usually used as a pilot study to see what type of behaviors would be recorded.
• Perspectives of the use of smartphones in travel behavior studies: Findings from a literature review and a pilot study (Gadziński, 2018)

Further Information

• Lancaster, G. A., Dodd, S., & Williamson, P. R. (2004). Design and analysis of pilot studies: recommendations for good practice. Journal of evaluation in clinical practice, 10 (2), 307-312.
• Thabane, L., Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., … & Goldsmith, C. H. (2010). A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology, 10 (1), 1-10.
• Moore, C. G., Carter, R. E., Nietert, P. J., & Stewart, P. W. (2011). Recommendations for planning pilot studies in clinical and translational research. Clinical and translational science, 4 (5), 332-337.

Carassa, R. G., Bettin, P., Fiori, M., & Brancato, R. (1998). Viscocanalostomy: a pilot study. European journal of ophthalmology, 8 (2), 57-61.

Gadziński, J. (2018). Perspectives of the use of smartphones in travel behaviour studies: Findings from a literature review and a pilot study. Transportation Research Part C: Emerging Technologies, 88 , 74-86.

In J. (2017). Introduction of a pilot study. Korean Journal of Anesthesiology, 70 (6), 601–605. https://doi.org/10.4097/kjae.2017.70.6.601

LaBerge, S., LaMarca, K., & Baird, B. (2018). Pre-sleep treatment with galantamine stimulates lucid dreaming: A double-blind, placebo-controlled, crossover study. PLoS One, 13 (8), e0201246.

Leon, A. C., Davis, L. L., & Kraemer, H. C. (2011). The role and interpretation of pilot studies in clinical research. Journal of psychiatric research, 45 (5), 626–629. https://doi.org/10.1016/j.jpsychires.2010.10.008

Malmqvist, J., Hellberg, K., Möllås, G., Rose, R., & Shevlin, M. (2019). Conducting the Pilot Study: A Neglected Part of the Research Process? Methodological Findings Supporting the Importance of Piloting in Qualitative Research Studies. International Journal of Qualitative Methods. https://doi.org/10.1177/1609406919878341

Neff, K. D., & Germer, C. K. (2013). A pilot study and randomized controlled trial of the mindful self‐compassion program. Journal of Clinical Psychology, 69 (1), 28-44.

Pitman, R. K., Sanders, K. M., Zusman, R. M., Healy, A. R., Cheema, F., Lasko, N. B., … & Orr, S. P. (2002). Pilot study of secondary prevention of posttraumatic stress disorder with propranolol. Biological psychiatry, 51 (2), 189-192.

Richins, M. L. (1983). Negative word-of-mouth by dissatisfied consumers: A pilot study. Journal of Marketing, 47 (1), 68-78.

Sartorius, N., Shapiro, R., Kimura, M., & Barrett, K. (1972). WHO International Pilot Study of Schizophrenia1. Psychological medicine, 2 (4), 422-425.

Teijlingen, E. R; V. Hundley (2001). The importance of pilot studies, Social research UPDATE, (35)

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A Practical Guide to Writing Quantitative and Qualitative Research Questions and Hypotheses in Scholarly Articles

Edward barroga.

1 Department of General Education, Graduate School of Nursing Science, St. Luke’s International University, Tokyo, Japan.

Glafera Janet Matanguihan

2 Department of Biological Sciences, Messiah University, Mechanicsburg, PA, USA.

The development of research questions and the subsequent hypotheses are prerequisites to defining the main research purpose and specific objectives of a study. Consequently, these objectives determine the study design and research outcome. The development of research questions is a process based on knowledge of current trends, cutting-edge studies, and technological advances in the research field. Excellent research questions are focused and require a comprehensive literature search and in-depth understanding of the problem being investigated. Initially, research questions may be written as descriptive questions which could be developed into inferential questions. These questions must be specific and concise to provide a clear foundation for developing hypotheses. Hypotheses are more formal predictions about the research outcomes. These specify the possible results that may or may not be expected regarding the relationship between groups. Thus, research questions and hypotheses clarify the main purpose and specific objectives of the study, which in turn dictate the design of the study, its direction, and outcome. Studies developed from good research questions and hypotheses will have trustworthy outcomes with wide-ranging social and health implications.

INTRODUCTION

Scientific research is usually initiated by posing evidenced-based research questions which are then explicitly restated as hypotheses. 1 , 2 The hypotheses provide directions to guide the study, solutions, explanations, and expected results. 3 , 4 Both research questions and hypotheses are essentially formulated based on conventional theories and real-world processes, which allow the inception of novel studies and the ethical testing of ideas. 5 , 6

It is crucial to have knowledge of both quantitative and qualitative research 2 as both types of research involve writing research questions and hypotheses. 7 However, these crucial elements of research are sometimes overlooked; if not overlooked, then framed without the forethought and meticulous attention it needs. Planning and careful consideration are needed when developing quantitative or qualitative research, particularly when conceptualizing research questions and hypotheses. 4

There is a continuing need to support researchers in the creation of innovative research questions and hypotheses, as well as for journal articles that carefully review these elements. 1 When research questions and hypotheses are not carefully thought of, unethical studies and poor outcomes usually ensue. Carefully formulated research questions and hypotheses define well-founded objectives, which in turn determine the appropriate design, course, and outcome of the study. This article then aims to discuss in detail the various aspects of crafting research questions and hypotheses, with the goal of guiding researchers as they develop their own. Examples from the authors and peer-reviewed scientific articles in the healthcare field are provided to illustrate key points.

DEFINITIONS AND RELATIONSHIP OF RESEARCH QUESTIONS AND HYPOTHESES

A research question is what a study aims to answer after data analysis and interpretation. The answer is written in length in the discussion section of the paper. Thus, the research question gives a preview of the different parts and variables of the study meant to address the problem posed in the research question. 1 An excellent research question clarifies the research writing while facilitating understanding of the research topic, objective, scope, and limitations of the study. 5

On the other hand, a research hypothesis is an educated statement of an expected outcome. This statement is based on background research and current knowledge. 8 , 9 The research hypothesis makes a specific prediction about a new phenomenon 10 or a formal statement on the expected relationship between an independent variable and a dependent variable. 3 , 11 It provides a tentative answer to the research question to be tested or explored. 4

Hypotheses employ reasoning to predict a theory-based outcome. 10 These can also be developed from theories by focusing on components of theories that have not yet been observed. 10 The validity of hypotheses is often based on the testability of the prediction made in a reproducible experiment. 8

Conversely, hypotheses can also be rephrased as research questions. Several hypotheses based on existing theories and knowledge may be needed to answer a research question. Developing ethical research questions and hypotheses creates a research design that has logical relationships among variables. These relationships serve as a solid foundation for the conduct of the study. 4 , 11 Haphazardly constructed research questions can result in poorly formulated hypotheses and improper study designs, leading to unreliable results. Thus, the formulations of relevant research questions and verifiable hypotheses are crucial when beginning research. 12

CHARACTERISTICS OF GOOD RESEARCH QUESTIONS AND HYPOTHESES

Excellent research questions are specific and focused. These integrate collective data and observations to confirm or refute the subsequent hypotheses. Well-constructed hypotheses are based on previous reports and verify the research context. These are realistic, in-depth, sufficiently complex, and reproducible. More importantly, these hypotheses can be addressed and tested. 13

There are several characteristics of well-developed hypotheses. Good hypotheses are 1) empirically testable 7 , 10 , 11 , 13 ; 2) backed by preliminary evidence 9 ; 3) testable by ethical research 7 , 9 ; 4) based on original ideas 9 ; 5) have evidenced-based logical reasoning 10 ; and 6) can be predicted. 11 Good hypotheses can infer ethical and positive implications, indicating the presence of a relationship or effect relevant to the research theme. 7 , 11 These are initially developed from a general theory and branch into specific hypotheses by deductive reasoning. In the absence of a theory to base the hypotheses, inductive reasoning based on specific observations or findings form more general hypotheses. 10

TYPES OF RESEARCH QUESTIONS AND HYPOTHESES

Research questions and hypotheses are developed according to the type of research, which can be broadly classified into quantitative and qualitative research. We provide a summary of the types of research questions and hypotheses under quantitative and qualitative research categories in Table 1 .

Research questions in quantitative research

In quantitative research, research questions inquire about the relationships among variables being investigated and are usually framed at the start of the study. These are precise and typically linked to the subject population, dependent and independent variables, and research design. 1 Research questions may also attempt to describe the behavior of a population in relation to one or more variables, or describe the characteristics of variables to be measured ( descriptive research questions ). 1 , 5 , 14 These questions may also aim to discover differences between groups within the context of an outcome variable ( comparative research questions ), 1 , 5 , 14 or elucidate trends and interactions among variables ( relationship research questions ). 1 , 5 We provide examples of descriptive, comparative, and relationship research questions in quantitative research in Table 2 .

Hypotheses in quantitative research

In quantitative research, hypotheses predict the expected relationships among variables. 15 Relationships among variables that can be predicted include 1) between a single dependent variable and a single independent variable ( simple hypothesis ) or 2) between two or more independent and dependent variables ( complex hypothesis ). 4 , 11 Hypotheses may also specify the expected direction to be followed and imply an intellectual commitment to a particular outcome ( directional hypothesis ) 4 . On the other hand, hypotheses may not predict the exact direction and are used in the absence of a theory, or when findings contradict previous studies ( non-directional hypothesis ). 4 In addition, hypotheses can 1) define interdependency between variables ( associative hypothesis ), 4 2) propose an effect on the dependent variable from manipulation of the independent variable ( causal hypothesis ), 4 3) state a negative relationship between two variables ( null hypothesis ), 4 , 11 , 15 4) replace the working hypothesis if rejected ( alternative hypothesis ), 15 explain the relationship of phenomena to possibly generate a theory ( working hypothesis ), 11 5) involve quantifiable variables that can be tested statistically ( statistical hypothesis ), 11 6) or express a relationship whose interlinks can be verified logically ( logical hypothesis ). 11 We provide examples of simple, complex, directional, non-directional, associative, causal, null, alternative, working, statistical, and logical hypotheses in quantitative research, as well as the definition of quantitative hypothesis-testing research in Table 3 .

Research questions in qualitative research

Unlike research questions in quantitative research, research questions in qualitative research are usually continuously reviewed and reformulated. The central question and associated subquestions are stated more than the hypotheses. 15 The central question broadly explores a complex set of factors surrounding the central phenomenon, aiming to present the varied perspectives of participants. 15

There are varied goals for which qualitative research questions are developed. These questions can function in several ways, such as to 1) identify and describe existing conditions ( contextual research question s); 2) describe a phenomenon ( descriptive research questions ); 3) assess the effectiveness of existing methods, protocols, theories, or procedures ( evaluation research questions ); 4) examine a phenomenon or analyze the reasons or relationships between subjects or phenomena ( explanatory research questions ); or 5) focus on unknown aspects of a particular topic ( exploratory research questions ). 5 In addition, some qualitative research questions provide new ideas for the development of theories and actions ( generative research questions ) or advance specific ideologies of a position ( ideological research questions ). 1 Other qualitative research questions may build on a body of existing literature and become working guidelines ( ethnographic research questions ). Research questions may also be broadly stated without specific reference to the existing literature or a typology of questions ( phenomenological research questions ), may be directed towards generating a theory of some process ( grounded theory questions ), or may address a description of the case and the emerging themes ( qualitative case study questions ). 15 We provide examples of contextual, descriptive, evaluation, explanatory, exploratory, generative, ideological, ethnographic, phenomenological, grounded theory, and qualitative case study research questions in qualitative research in Table 4 , and the definition of qualitative hypothesis-generating research in Table 5 .

Qualitative studies usually pose at least one central research question and several subquestions starting with How or What . These research questions use exploratory verbs such as explore or describe . These also focus on one central phenomenon of interest, and may mention the participants and research site. 15

Hypotheses in qualitative research

Hypotheses in qualitative research are stated in the form of a clear statement concerning the problem to be investigated. Unlike in quantitative research where hypotheses are usually developed to be tested, qualitative research can lead to both hypothesis-testing and hypothesis-generating outcomes. 2 When studies require both quantitative and qualitative research questions, this suggests an integrative process between both research methods wherein a single mixed-methods research question can be developed. 1

FRAMEWORKS FOR DEVELOPING RESEARCH QUESTIONS AND HYPOTHESES

Research questions followed by hypotheses should be developed before the start of the study. 1 , 12 , 14 It is crucial to develop feasible research questions on a topic that is interesting to both the researcher and the scientific community. This can be achieved by a meticulous review of previous and current studies to establish a novel topic. Specific areas are subsequently focused on to generate ethical research questions. The relevance of the research questions is evaluated in terms of clarity of the resulting data, specificity of the methodology, objectivity of the outcome, depth of the research, and impact of the study. 1 , 5 These aspects constitute the FINER criteria (i.e., Feasible, Interesting, Novel, Ethical, and Relevant). 1 Clarity and effectiveness are achieved if research questions meet the FINER criteria. In addition to the FINER criteria, Ratan et al. described focus, complexity, novelty, feasibility, and measurability for evaluating the effectiveness of research questions. 14

The PICOT and PEO frameworks are also used when developing research questions. 1 The following elements are addressed in these frameworks, PICOT: P-population/patients/problem, I-intervention or indicator being studied, C-comparison group, O-outcome of interest, and T-timeframe of the study; PEO: P-population being studied, E-exposure to preexisting conditions, and O-outcome of interest. 1 Research questions are also considered good if these meet the “FINERMAPS” framework: Feasible, Interesting, Novel, Ethical, Relevant, Manageable, Appropriate, Potential value/publishable, and Systematic. 14

As we indicated earlier, research questions and hypotheses that are not carefully formulated result in unethical studies or poor outcomes. To illustrate this, we provide some examples of ambiguous research question and hypotheses that result in unclear and weak research objectives in quantitative research ( Table 6 ) 16 and qualitative research ( Table 7 ) 17 , and how to transform these ambiguous research question(s) and hypothesis(es) into clear and good statements.

a These statements were composed for comparison and illustrative purposes only.

b These statements are direct quotes from Higashihara and Horiuchi. 16

a This statement is a direct quote from Shimoda et al. 17

The other statements were composed for comparison and illustrative purposes only.

CONSTRUCTING RESEARCH QUESTIONS AND HYPOTHESES

To construct effective research questions and hypotheses, it is very important to 1) clarify the background and 2) identify the research problem at the outset of the research, within a specific timeframe. 9 Then, 3) review or conduct preliminary research to collect all available knowledge about the possible research questions by studying theories and previous studies. 18 Afterwards, 4) construct research questions to investigate the research problem. Identify variables to be accessed from the research questions 4 and make operational definitions of constructs from the research problem and questions. Thereafter, 5) construct specific deductive or inductive predictions in the form of hypotheses. 4 Finally, 6) state the study aims . This general flow for constructing effective research questions and hypotheses prior to conducting research is shown in Fig. 1 .

Research questions are used more frequently in qualitative research than objectives or hypotheses. 3 These questions seek to discover, understand, explore or describe experiences by asking “What” or “How.” The questions are open-ended to elicit a description rather than to relate variables or compare groups. The questions are continually reviewed, reformulated, and changed during the qualitative study. 3 Research questions are also used more frequently in survey projects than hypotheses in experiments in quantitative research to compare variables and their relationships.

Hypotheses are constructed based on the variables identified and as an if-then statement, following the template, ‘If a specific action is taken, then a certain outcome is expected.’ At this stage, some ideas regarding expectations from the research to be conducted must be drawn. 18 Then, the variables to be manipulated (independent) and influenced (dependent) are defined. 4 Thereafter, the hypothesis is stated and refined, and reproducible data tailored to the hypothesis are identified, collected, and analyzed. 4 The hypotheses must be testable and specific, 18 and should describe the variables and their relationships, the specific group being studied, and the predicted research outcome. 18 Hypotheses construction involves a testable proposition to be deduced from theory, and independent and dependent variables to be separated and measured separately. 3 Therefore, good hypotheses must be based on good research questions constructed at the start of a study or trial. 12

In summary, research questions are constructed after establishing the background of the study. Hypotheses are then developed based on the research questions. Thus, it is crucial to have excellent research questions to generate superior hypotheses. In turn, these would determine the research objectives and the design of the study, and ultimately, the outcome of the research. 12 Algorithms for building research questions and hypotheses are shown in Fig. 2 for quantitative research and in Fig. 3 for qualitative research.

EXAMPLES OF RESEARCH QUESTIONS FROM PUBLISHED ARTICLES

• EXAMPLE 1. Descriptive research question (quantitative research)
• - Presents research variables to be assessed (distinct phenotypes and subphenotypes)
• “BACKGROUND: Since COVID-19 was identified, its clinical and biological heterogeneity has been recognized. Identifying COVID-19 phenotypes might help guide basic, clinical, and translational research efforts.
• RESEARCH QUESTION: Does the clinical spectrum of patients with COVID-19 contain distinct phenotypes and subphenotypes? ” 19
• EXAMPLE 2. Relationship research question (quantitative research)
• - Shows interactions between dependent variable (static postural control) and independent variable (peripheral visual field loss)
• “Background: Integration of visual, vestibular, and proprioceptive sensations contributes to postural control. People with peripheral visual field loss have serious postural instability. However, the directional specificity of postural stability and sensory reweighting caused by gradual peripheral visual field loss remain unclear.
• Research question: What are the effects of peripheral visual field loss on static postural control ?” 20
• EXAMPLE 3. Comparative research question (quantitative research)
• - Clarifies the difference among groups with an outcome variable (patients enrolled in COMPERA with moderate PH or severe PH in COPD) and another group without the outcome variable (patients with idiopathic pulmonary arterial hypertension (IPAH))
• “BACKGROUND: Pulmonary hypertension (PH) in COPD is a poorly investigated clinical condition.
• RESEARCH QUESTION: Which factors determine the outcome of PH in COPD?
• STUDY DESIGN AND METHODS: We analyzed the characteristics and outcome of patients enrolled in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) with moderate or severe PH in COPD as defined during the 6th PH World Symposium who received medical therapy for PH and compared them with patients with idiopathic pulmonary arterial hypertension (IPAH) .” 21
• EXAMPLE 4. Exploratory research question (qualitative research)
• - Explores areas that have not been fully investigated (perspectives of families and children who receive care in clinic-based child obesity treatment) to have a deeper understanding of the research problem
• “Problem: Interventions for children with obesity lead to only modest improvements in BMI and long-term outcomes, and data are limited on the perspectives of families of children with obesity in clinic-based treatment. This scoping review seeks to answer the question: What is known about the perspectives of families and children who receive care in clinic-based child obesity treatment? This review aims to explore the scope of perspectives reported by families of children with obesity who have received individualized outpatient clinic-based obesity treatment.” 22
• EXAMPLE 5. Relationship research question (quantitative research)
• - Defines interactions between dependent variable (use of ankle strategies) and independent variable (changes in muscle tone)
• “Background: To maintain an upright standing posture against external disturbances, the human body mainly employs two types of postural control strategies: “ankle strategy” and “hip strategy.” While it has been reported that the magnitude of the disturbance alters the use of postural control strategies, it has not been elucidated how the level of muscle tone, one of the crucial parameters of bodily function, determines the use of each strategy. We have previously confirmed using forward dynamics simulations of human musculoskeletal models that an increased muscle tone promotes the use of ankle strategies. The objective of the present study was to experimentally evaluate a hypothesis: an increased muscle tone promotes the use of ankle strategies. Research question: Do changes in the muscle tone affect the use of ankle strategies ?” 23

EXAMPLES OF HYPOTHESES IN PUBLISHED ARTICLES

• EXAMPLE 1. Working hypothesis (quantitative research)
• - A hypothesis that is initially accepted for further research to produce a feasible theory
• “As fever may have benefit in shortening the duration of viral illness, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response when taken during the early stages of COVID-19 illness .” 24
• “In conclusion, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response . The difference in perceived safety of these agents in COVID-19 illness could be related to the more potent efficacy to reduce fever with ibuprofen compared to acetaminophen. Compelling data on the benefit of fever warrant further research and review to determine when to treat or withhold ibuprofen for early stage fever for COVID-19 and other related viral illnesses .” 24
• EXAMPLE 2. Exploratory hypothesis (qualitative research)
• - Explores particular areas deeper to clarify subjective experience and develop a formal hypothesis potentially testable in a future quantitative approach
• “We hypothesized that when thinking about a past experience of help-seeking, a self distancing prompt would cause increased help-seeking intentions and more favorable help-seeking outcome expectations .” 25
• “Conclusion
• Although a priori hypotheses were not supported, further research is warranted as results indicate the potential for using self-distancing approaches to increasing help-seeking among some people with depressive symptomatology.” 25
• EXAMPLE 3. Hypothesis-generating research to establish a framework for hypothesis testing (qualitative research)
• “We hypothesize that compassionate care is beneficial for patients (better outcomes), healthcare systems and payers (lower costs), and healthcare providers (lower burnout). ” 26
• Compassionomics is the branch of knowledge and scientific study of the effects of compassionate healthcare. Our main hypotheses are that compassionate healthcare is beneficial for (1) patients, by improving clinical outcomes, (2) healthcare systems and payers, by supporting financial sustainability, and (3) HCPs, by lowering burnout and promoting resilience and well-being. The purpose of this paper is to establish a scientific framework for testing the hypotheses above . If these hypotheses are confirmed through rigorous research, compassionomics will belong in the science of evidence-based medicine, with major implications for all healthcare domains.” 26
• EXAMPLE 4. Statistical hypothesis (quantitative research)
• - An assumption is made about the relationship among several population characteristics ( gender differences in sociodemographic and clinical characteristics of adults with ADHD ). Validity is tested by statistical experiment or analysis ( chi-square test, Students t-test, and logistic regression analysis)
• “Our research investigated gender differences in sociodemographic and clinical characteristics of adults with ADHD in a Japanese clinical sample. Due to unique Japanese cultural ideals and expectations of women's behavior that are in opposition to ADHD symptoms, we hypothesized that women with ADHD experience more difficulties and present more dysfunctions than men . We tested the following hypotheses: first, women with ADHD have more comorbidities than men with ADHD; second, women with ADHD experience more social hardships than men, such as having less full-time employment and being more likely to be divorced.” 27
• “Statistical Analysis
• ( text omitted ) Between-gender comparisons were made using the chi-squared test for categorical variables and Students t-test for continuous variables…( text omitted ). A logistic regression analysis was performed for employment status, marital status, and comorbidity to evaluate the independent effects of gender on these dependent variables.” 27

EXAMPLES OF HYPOTHESIS AS WRITTEN IN PUBLISHED ARTICLES IN RELATION TO OTHER PARTS

• EXAMPLE 1. Background, hypotheses, and aims are provided
• “Pregnant women need skilled care during pregnancy and childbirth, but that skilled care is often delayed in some countries …( text omitted ). The focused antenatal care (FANC) model of WHO recommends that nurses provide information or counseling to all pregnant women …( text omitted ). Job aids are visual support materials that provide the right kind of information using graphics and words in a simple and yet effective manner. When nurses are not highly trained or have many work details to attend to, these job aids can serve as a content reminder for the nurses and can be used for educating their patients (Jennings, Yebadokpo, Affo, & Agbogbe, 2010) ( text omitted ). Importantly, additional evidence is needed to confirm how job aids can further improve the quality of ANC counseling by health workers in maternal care …( text omitted )” 28
• “ This has led us to hypothesize that the quality of ANC counseling would be better if supported by job aids. Consequently, a better quality of ANC counseling is expected to produce higher levels of awareness concerning the danger signs of pregnancy and a more favorable impression of the caring behavior of nurses .” 28
• “This study aimed to examine the differences in the responses of pregnant women to a job aid-supported intervention during ANC visit in terms of 1) their understanding of the danger signs of pregnancy and 2) their impression of the caring behaviors of nurses to pregnant women in rural Tanzania.” 28
• EXAMPLE 2. Background, hypotheses, and aims are provided
• “We conducted a two-arm randomized controlled trial (RCT) to evaluate and compare changes in salivary cortisol and oxytocin levels of first-time pregnant women between experimental and control groups. The women in the experimental group touched and held an infant for 30 min (experimental intervention protocol), whereas those in the control group watched a DVD movie of an infant (control intervention protocol). The primary outcome was salivary cortisol level and the secondary outcome was salivary oxytocin level.” 29
• “ We hypothesize that at 30 min after touching and holding an infant, the salivary cortisol level will significantly decrease and the salivary oxytocin level will increase in the experimental group compared with the control group .” 29
• EXAMPLE 3. Background, aim, and hypothesis are provided
• “In countries where the maternal mortality ratio remains high, antenatal education to increase Birth Preparedness and Complication Readiness (BPCR) is considered one of the top priorities [1]. BPCR includes birth plans during the antenatal period, such as the birthplace, birth attendant, transportation, health facility for complications, expenses, and birth materials, as well as family coordination to achieve such birth plans. In Tanzania, although increasing, only about half of all pregnant women attend an antenatal clinic more than four times [4]. Moreover, the information provided during antenatal care (ANC) is insufficient. In the resource-poor settings, antenatal group education is a potential approach because of the limited time for individual counseling at antenatal clinics.” 30
• “This study aimed to evaluate an antenatal group education program among pregnant women and their families with respect to birth-preparedness and maternal and infant outcomes in rural villages of Tanzania.” 30
• “ The study hypothesis was if Tanzanian pregnant women and their families received a family-oriented antenatal group education, they would (1) have a higher level of BPCR, (2) attend antenatal clinic four or more times, (3) give birth in a health facility, (4) have less complications of women at birth, and (5) have less complications and deaths of infants than those who did not receive the education .” 30

Research questions and hypotheses are crucial components to any type of research, whether quantitative or qualitative. These questions should be developed at the very beginning of the study. Excellent research questions lead to superior hypotheses, which, like a compass, set the direction of research, and can often determine the successful conduct of the study. Many research studies have floundered because the development of research questions and subsequent hypotheses was not given the thought and meticulous attention needed. The development of research questions and hypotheses is an iterative process based on extensive knowledge of the literature and insightful grasp of the knowledge gap. Focused, concise, and specific research questions provide a strong foundation for constructing hypotheses which serve as formal predictions about the research outcomes. Research questions and hypotheses are crucial elements of research that should not be overlooked. They should be carefully thought of and constructed when planning research. This avoids unethical studies and poor outcomes by defining well-founded objectives that determine the design, course, and outcome of the study.

Disclosure: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Barroga E, Matanguihan GJ.
• Methodology: Barroga E, Matanguihan GJ.
• Writing - original draft: Barroga E, Matanguihan GJ.
• Writing - review & editing: Barroga E, Matanguihan GJ.

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Home » Exploratory Research – Types, Methods and Examples

Exploratory Research – Types, Methods and Examples

Table of Contents

Exploratory Research

Definition:

Exploratory research is a type of research design that is used to investigate a research question when the researcher has limited knowledge or understanding of the topic or phenomenon under study.

The primary objective of exploratory research is to gain insights and gather preliminary information that can help the researcher better define the research problem and develop hypotheses or research questions for further investigation.

Exploratory Research Methods

There are several types of exploratory research, including:

Literature Review

This involves conducting a comprehensive review of existing published research, scholarly articles, and other relevant literature on the research topic or problem. It helps to identify the gaps in the existing knowledge and to develop new research questions or hypotheses.

Pilot Study

A pilot study is a small-scale preliminary study that helps the researcher to test research procedures, instruments, and data collection methods. This type of research can be useful in identifying any potential problems or issues with the research design and refining the research procedures for a larger-scale study.

This involves an in-depth analysis of a particular case or situation to gain insights into the underlying causes, processes, and dynamics of the issue under investigation. It can be used to develop a more comprehensive understanding of a complex problem, and to identify potential research questions or hypotheses.

Focus Groups

Focus groups involve a group discussion that is conducted to gather opinions, attitudes, and perceptions from a small group of individuals about a particular topic. This type of research can be useful in exploring the range of opinions and attitudes towards a topic, identifying common themes or patterns, and generating ideas for further research.

Expert Opinion

This involves consulting with experts or professionals in the field to gain their insights, expertise, and opinions on the research topic. This type of research can be useful in identifying the key issues and concerns related to the topic, and in generating ideas for further research.

Observational Research

Observational research involves gathering data by observing people, events, or phenomena in their natural settings to gain insights into behavior and interactions. This type of research can be useful in identifying patterns of behavior and interactions, and in generating hypotheses or research questions for further investigation.

Open-ended Surveys

Open-ended surveys allow respondents to provide detailed and unrestricted responses to questions, providing valuable insights into their attitudes, opinions, and perceptions. This type of research can be useful in identifying common themes or patterns, and in generating ideas for further research.

Data Analysis Methods

Exploratory Research Data Analysis Methods are as follows:

Content Analysis

This method involves analyzing text or other forms of data to identify common themes, patterns, and trends. It can be useful in identifying patterns in the data and developing hypotheses or research questions. For example, if the researcher is analyzing social media posts related to a particular topic, content analysis can help identify the most frequently used words, hashtags, and topics.

Thematic Analysis

This method involves identifying and analyzing patterns or themes in qualitative data such as interviews or focus groups. The researcher identifies recurring themes or patterns in the data and then categorizes them into different themes. This can be helpful in identifying common patterns or themes in the data and developing hypotheses or research questions. For example, a thematic analysis of interviews with healthcare professionals about patient care may identify themes related to communication, patient satisfaction, and quality of care.

Cluster Analysis

This method involves grouping data points into clusters based on their similarities or differences. It can be useful in identifying patterns in large datasets and grouping similar data points together. For example, if the researcher is analyzing customer data to identify different customer segments, cluster analysis can be used to group similar customers together based on their demographic, purchasing behavior, or preferences.

Network Analysis

This method involves analyzing the relationships and connections between data points. It can be useful in identifying patterns in complex datasets with many interrelated variables. For example, if the researcher is analyzing social network data, network analysis can help identify the most influential users and their connections to other users.

Grounded Theory

This method involves developing a theory or explanation based on the data collected during the exploratory research process. The researcher develops a theory or explanation that is grounded in the data, rather than relying on pre-existing theories or assumptions. This can be helpful in developing new theories or explanations that are supported by the data.

Applications of Exploratory Research

Exploratory research has many practical applications across various fields. Here are a few examples:

• Marketing Research : In marketing research, exploratory research can be used to identify consumer needs, preferences, and behavior. It can also help businesses understand market trends and identify new market opportunities.
• Product Development: In product development, exploratory research can be used to identify customer needs and preferences, as well as potential design flaws or issues. This can help companies improve their product offerings and develop new products that better meet customer needs.
• Social Science Research: In social science research, exploratory research can be used to identify new areas of study, as well as develop new theories and hypotheses. It can also be used to identify potential research methods and approaches.
• Healthcare Research : In healthcare research, exploratory research can be used to identify new treatments, therapies, and interventions. It can also be used to identify potential risk factors or causes of health problems.
• Education Research: In education research, exploratory research can be used to identify new teaching methods and approaches, as well as identify potential areas of study for further research. It can also be used to identify potential barriers to learning or achievement.

Examples of Exploratory Research

Here are some more examples of exploratory research from different fields:

• Social Science : A researcher wants to study the experience of being a refugee, but there is limited existing research on this topic. The researcher conducts exploratory research by conducting in-depth interviews with refugees to better understand their experiences, challenges, and needs.
• Healthcare : A medical researcher wants to identify potential risk factors for a rare disease but there is limited information available. The researcher conducts exploratory research by reviewing medical records and interviewing patients and their families to identify potential risk factors.
• Education : A teacher wants to develop a new teaching method to improve student engagement, but there is limited information on effective teaching methods. The teacher conducts exploratory research by reviewing existing literature and interviewing other teachers to identify potential approaches.
• Technology : A software developer wants to develop a new app, but is unsure about the features that users would find most useful. The developer conducts exploratory research by conducting surveys and focus groups to identify user preferences and needs.
• Environmental Science : An environmental scientist wants to study the impact of a new industrial plant on the surrounding environment, but there is limited existing research. The scientist conducts exploratory research by collecting and analyzing soil and water samples, and conducting interviews with residents to better understand the impact of the plant on the environment and the community.

How to Conduct Exploratory Research

Here are the general steps to conduct exploratory research:

• Define the research problem: Identify the research problem or question that you want to explore. Be clear about the objective and scope of the research.
• Review existing literature: Conduct a review of existing literature and research on the topic to identify what is already known and where gaps in knowledge exist.
• Determine the research design : Decide on the appropriate research design, which will depend on the nature of the research problem and the available resources. Common exploratory research designs include case studies, focus groups, interviews, and surveys.
• Collect data: Collect data using the chosen research design. This may involve conducting interviews, surveys, or observations, or collecting data from existing sources such as archives or databases.
• Analyze data: Analyze the data collected using appropriate qualitative or quantitative techniques. This may include coding and categorizing qualitative data, or running descriptive statistics on quantitative data.
• I nterpret and report findings: Interpret the findings of the analysis and report them in a way that is clear and understandable. The report should summarize the findings, discuss their implications, and make recommendations for further research or action.
• Iterate : If necessary, refine the research question and repeat the process of data collection and analysis to further explore the topic.

When to use Exploratory Research

Exploratory research is appropriate in situations where there is limited existing knowledge or understanding of a topic, and where the goal is to generate insights and ideas that can guide further research. Here are some specific situations where exploratory research may be particularly useful:

• New product development: When developing a new product, exploratory research can be used to identify consumer needs and preferences, as well as potential design flaws or issues.
• Emerging technologies: When exploring emerging technologies, exploratory research can be used to identify potential uses and applications, as well as potential challenges or limitations.
• Developing research hypotheses: When developing research hypotheses, exploratory research can be used to identify potential relationships or patterns that can be further explored through more rigorous research methods.
• Understanding complex phenomena: When trying to understand complex phenomena, such as human behavior or societal trends, exploratory research can be used to identify underlying patterns or factors that may be influencing the phenomenon.
• Developing research methods : When developing new research methods, exploratory research can be used to identify potential issues or limitations with existing methods, and to develop new methods that better capture the phenomena of interest.

Purpose of Exploratory Research

The purpose of exploratory research is to gain insights and understanding of a research problem or question where there is limited existing knowledge or understanding. The objective is to explore and generate ideas that can guide further research, rather than to test specific hypotheses or make definitive conclusions.

Exploratory research can be used to:

• Identify new research questions: Exploratory research can help to identify new research questions and areas of inquiry, by providing initial insights and understanding of a topic.
• Develop hypotheses: Exploratory research can help to develop hypotheses and testable propositions that can be further explored through more rigorous research methods.
• Identify patterns and trends : Exploratory research can help to identify patterns and trends in data, which can be used to guide further research or decision-making.
• Understand complex phenomena: Exploratory research can help to provide a deeper understanding of complex phenomena, such as human behavior or societal trends, by identifying underlying patterns or factors that may be influencing the phenomena.
• Generate ideas: Exploratory research can help to generate new ideas and insights that can be used to guide further research, innovation, or decision-making.

Characteristics of Exploratory Research

The following are the main characteristics of exploratory research:

• Flexible and open-ended : Exploratory research is characterized by its flexible and open-ended nature, which allows researchers to explore a wide range of ideas and perspectives without being constrained by specific research questions or hypotheses.
• Qualitative in nature : Exploratory research typically relies on qualitative methods, such as in-depth interviews, focus groups, or observation, to gather rich and detailed data on the research problem.
• Limited scope: Exploratory research is generally limited in scope, focusing on a specific research problem or question, rather than attempting to provide a comprehensive analysis of a broader phenomenon.
• Preliminary in nature : Exploratory research is preliminary in nature, providing initial insights and understanding of a research problem, rather than testing specific hypotheses or making definitive conclusions.
• I terative process : Exploratory research is often an iterative process, where the research design and methods may be refined and adjusted as new insights and understanding are gained.
• I nductive approach : Exploratory research typically takes an inductive approach to data analysis, seeking to identify patterns and relationships in the data that can guide further research or hypothesis development.

Advantages of Exploratory Research

The following are some advantages of exploratory research:

• Provides initial insights: Exploratory research is useful for providing initial insights and understanding of a research problem or question where there is limited existing knowledge or understanding. It can help to identify patterns, relationships, and potential hypotheses that can guide further research.
• Flexible and adaptable : Exploratory research is flexible and adaptable, allowing researchers to adjust their methods and approach as they gain new insights and understanding of the research problem.
• Qualitative methods : Exploratory research typically relies on qualitative methods, such as in-depth interviews, focus groups, and observation, which can provide rich and detailed data that is useful for gaining insights into complex phenomena.
• Cost-effective : Exploratory research is often less costly than other research methods, such as large-scale surveys or experiments. It is typically conducted on a smaller scale, using fewer resources and participants.
• Useful for hypothesis generation : Exploratory research can be useful for generating hypotheses and testable propositions that can be further explored through more rigorous research methods.
• Provides a foundation for further research: Exploratory research can provide a foundation for further research by identifying potential research questions and areas of inquiry, as well as providing initial insights and understanding of the research problem.

Limitations of Exploratory Research

The following are some limitations of exploratory research:

• Limited generalizability: Exploratory research is typically conducted on a small scale and uses non-random sampling techniques, which limits the generalizability of the findings to a broader population.
• Subjective nature: Exploratory research relies on qualitative methods and is therefore subject to researcher bias and interpretation. The findings may be influenced by the researcher’s own perceptions, beliefs, and assumptions.
• Lack of rigor: Exploratory research is often less rigorous than other research methods, such as experimental research, which can limit the validity and reliability of the findings.
• Limited ability to test hypotheses: Exploratory research is not designed to test specific hypotheses, but rather to generate initial insights and understanding of a research problem. It may not be suitable for testing well-defined research questions or hypotheses.
• Time-consuming : Exploratory research can be time-consuming and resource-intensive, particularly if the researcher needs to gather data from multiple sources or conduct multiple rounds of data collection.
• Difficulty in interpretation: The open-ended nature of exploratory research can make it difficult to interpret the findings, particularly if the researcher is unable to identify clear patterns or relationships in the data.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Research guides, guide to research and writing for the academic study of religion.

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Preliminary Research

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Developing a good research question is impossible without doing some preliminary research.  Preliminary research gives you background information on your topic, answering questions such as who, what, when and where.  This research will also help you determine controversies related to your topic and determine if there are enough sources available to cover the topic effectively.

 You will encounter and learn much more information than you will convey in your final paper. Background information will enrich your research paper but should not bog it down in trivia. For example, if you were doing a paper on Hildegaard of Bingen, you should know that she was born into a noble family in Germany in 1098 and entered a hermitage at the age of eight and became a Benedictine Abbess. This information will help you contextualize her work in your own mind but your research paper should not be a simple recitation of these facts. Your research question should take you beyond the common knowledge found in encyclopedias, but without that  common knowledge your research will lack a solid foundation.

What follows is a list of resources that you may find useful for doing preliminary research in the field of Religious Studies. Keep in mind the type of information that you will need based on your preliminary topic and where your topic falls in the topic pyramid. Remember that the pyramid is a continuum rather than a series of discrete stages, so your topic likely will draw on both columns for some resources.

Resources for Preliminary Research

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Role of Preliminary Research in the Research Process

This article is meant primarily for early researchers and students of humanities especially media to guide them in their qualitative research. Submitting a research report/dissertation/thesis/term paper involves a plethora of interconnected processes which run parallel to each other but at times one process becomes dominant depending on the research stage. The entire research process can be divided into four overlapping stages, which are: preliminary research, data collection, data interpretation and analysis, and data presentation. The article focuses upon the preliminary research i.e. the first and foremost stage, which is often overlooked by early researchers. Up until now, to my knowledge, authors writing about conducting research concentrated on the main processes but ignored seeming integral points, for instance, the idea generation step which precedes what Roger D. Wimmer and Joseph R. Dominick call 'selecting a research topic' (2006:26). The writer of the article has attempted to weave together all the interlinked steps involved, which are otherwise either not elaborated or writers tend to focus on a certain perspective and certain steps more than others. Even when writers offer explanations, these are seen as research procedures rather than as steps involved in preliminary stage.

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A thesis/Dissertation, as one piece of work, should be a text that addresses the issues of the community; all divisions and sub-divisions ought to be interconnected and interrelated to become a process leading to one goal. Thus, the text has threefold dimension. The first is that few people know the underlying principle of a research; that is the wisdom behind the idea, the efforts and the pains of carrying out a research in a particular field of knowledge. The second is a request to students to fall in love and to have passion for the kind of study they want to undertake; this increases the motivation and disposes them to go extra miles for comprehensive and immense discovery where understanding, application and generation of new knowledge take place. The third reason, which is equally important, maybe the most important in writing this text, concerns the organization of the report; in this case the presentation of a thesis/dissertation. Students should be more and more motivated to carry out research in various fields of knowledge, particularly when they have means; and postgraduate students should be increasingly encouraged to take part in research initiatives, for this helps to find new meanings of life.

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Module 6: Research

Preliminary research strategies.

The first step towards writing a research paper is pretty obvious: find sources. Not everything that you find will be good, and those that are good are not always easily found.  Having an idea of what you’re looking for–what will most help you develop your essay and enforce your thesis–will help guide your process.

Example of a Research Process

A good research process should go through these steps:

• Decide on the topic.
• Narrow the topic in order to narrow search parameters.
• Create a question that your research will address.
• Generate sub-questions from your main question.
• Determine what kind of sources are best for your argument.
• Create a bibliography as you gather and reference sources.

Each of these is described in greater detail below.

The research process is messy! Do not start research haphazardly—come up with a plan first.

A research plan should begin after you can clearly identify the focus of your argument. First, inform yourself about the basics of your topic (Wikipedia and general online searches are great starting points). Be sure you’ve read all the assigned texts and carefully read the prompt as you gather preliminary information.  This stage is sometimes called pre-research .

A broad online search will yield thousands of sources, which no one could be expected to read through. To make it easier on yourself, the next step is to narrow your focus. Think about what kind of position or stance you can take on the topic. What about it strikes you as most interesting? Refer back to the prewriting stage of the writing process, which will come in handy here.

Preliminary Search Tips

• It is okay to start with Wikipedia as a reference, but do not use it as an official source. Look at the links and references at the bottom of the page for more ideas.
• Use “Ctrl+F” to find certain words within a webpage in order to jump to the sections of the article that interest you.
• Use quotation marks to narrow your search from just tanks in WWII to “Tanks in WWII” or “Tanks” in “WWII”.
• Find specific types of websites by adding “site:.gov” or “site:.edu” or “site:.org”. You can also search for specific file types like “filetype:.pdf”.
• Click on “Search Tools” under the search bar in Google and select “Any time” to see a list of options for time periods to help limit your search. You can find information just in the past month or year, or even for a custom range.

Use features already available through Google Search like Search Tools and Advanced Search to narrow and refine your results.

As you narrow your focus, create a list of questions that you’ll need to answer in order to write a good essay on the topic.  The research process will help you answer these questions.

Another part of your research plan should include the type of sources you want to gather. Keep track of these sources in a bibliography and jot down notes about the book, article, or document and how it will be useful to your essay. This will save you a lot of time later in the essay process–you’ll thank yourself!

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Organizing Your Social Sciences Research Paper

• 6. The Methodology
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The methods section describes actions taken to investigate a research problem and the rationale for the application of specific procedures or techniques used to identify, select, process, and analyze information applied to understanding the problem, thereby, allowing the reader to critically evaluate a study’s overall validity and reliability. The methodology section of a research paper answers two main questions: How was the data collected or generated? And, how was it analyzed? The writing should be direct and precise and always written in the past tense.

Kallet, Richard H. "How to Write the Methods Section of a Research Paper." Respiratory Care 49 (October 2004): 1229-1232.

Importance of a Good Methodology Section

You must explain how you obtained and analyzed your results for the following reasons:

• Readers need to know how the data was obtained because the method you chose affects the results and, by extension, how you interpreted their significance in the discussion section of your paper.
• Methodology is crucial for any branch of scholarship because an unreliable method produces unreliable results and, as a consequence, undermines the value of your analysis of the findings.
• In most cases, there are a variety of different methods you can choose to investigate a research problem. The methodology section of your paper should clearly articulate the reasons why you have chosen a particular procedure or technique.
• The reader wants to know that the data was collected or generated in a way that is consistent with accepted practice in the field of study. For example, if you are using a multiple choice questionnaire, readers need to know that it offered your respondents a reasonable range of answers to choose from.
• The method must be appropriate to fulfilling the overall aims of the study. For example, you need to ensure that you have a large enough sample size to be able to generalize and make recommendations based upon the findings.
• The methodology should discuss the problems that were anticipated and the steps you took to prevent them from occurring. For any problems that do arise, you must describe the ways in which they were minimized or why these problems do not impact in any meaningful way your interpretation of the findings.
• In the social and behavioral sciences, it is important to always provide sufficient information to allow other researchers to adopt or replicate your methodology. This information is particularly important when a new method has been developed or an innovative use of an existing method is utilized.

Bem, Daryl J. Writing the Empirical Journal Article. Psychology Writing Center. University of Washington; Denscombe, Martyn. The Good Research Guide: For Small-Scale Social Research Projects . 5th edition. Buckingham, UK: Open University Press, 2014; Lunenburg, Frederick C. Writing a Successful Thesis or Dissertation: Tips and Strategies for Students in the Social and Behavioral Sciences . Thousand Oaks, CA: Corwin Press, 2008.

Structure and Writing Style

I.  Groups of Research Methods

There are two main groups of research methods in the social sciences:

• The e mpirical-analytical group approaches the study of social sciences in a similar manner that researchers study the natural sciences . This type of research focuses on objective knowledge, research questions that can be answered yes or no, and operational definitions of variables to be measured. The empirical-analytical group employs deductive reasoning that uses existing theory as a foundation for formulating hypotheses that need to be tested. This approach is focused on explanation.
• The i nterpretative group of methods is focused on understanding phenomenon in a comprehensive, holistic way . Interpretive methods focus on analytically disclosing the meaning-making practices of human subjects [the why, how, or by what means people do what they do], while showing how those practices arrange so that it can be used to generate observable outcomes. Interpretive methods allow you to recognize your connection to the phenomena under investigation. However, the interpretative group requires careful examination of variables because it focuses more on subjective knowledge.

II.  Content

The introduction to your methodology section should begin by restating the research problem and underlying assumptions underpinning your study. This is followed by situating the methods you used to gather, analyze, and process information within the overall “tradition” of your field of study and within the particular research design you have chosen to study the problem. If the method you choose lies outside of the tradition of your field [i.e., your review of the literature demonstrates that the method is not commonly used], provide a justification for how your choice of methods specifically addresses the research problem in ways that have not been utilized in prior studies.

The remainder of your methodology section should describe the following:

• Decisions made in selecting the data you have analyzed or, in the case of qualitative research, the subjects and research setting you have examined,
• Tools and methods used to identify and collect information, and how you identified relevant variables,
• The ways in which you processed the data and the procedures you used to analyze that data, and
• The specific research tools or strategies that you utilized to study the underlying hypothesis and research questions.

In addition, an effectively written methodology section should:

• Introduce the overall methodological approach for investigating your research problem . Is your study qualitative or quantitative or a combination of both (mixed method)? Are you going to take a special approach, such as action research, or a more neutral stance?
• Indicate how the approach fits the overall research design . Your methods for gathering data should have a clear connection to your research problem. In other words, make sure that your methods will actually address the problem. One of the most common deficiencies found in research papers is that the proposed methodology is not suitable to achieving the stated objective of your paper.
• Describe the specific methods of data collection you are going to use , such as, surveys, interviews, questionnaires, observation, archival research. If you are analyzing existing data, such as a data set or archival documents, describe how it was originally created or gathered and by whom. Also be sure to explain how older data is still relevant to investigating the current research problem.
• Explain how you intend to analyze your results . Will you use statistical analysis? Will you use specific theoretical perspectives to help you analyze a text or explain observed behaviors? Describe how you plan to obtain an accurate assessment of relationships, patterns, trends, distributions, and possible contradictions found in the data.
• Provide background and a rationale for methodologies that are unfamiliar for your readers . Very often in the social sciences, research problems and the methods for investigating them require more explanation/rationale than widely accepted rules governing the natural and physical sciences. Be clear and concise in your explanation.
• Provide a justification for subject selection and sampling procedure . For instance, if you propose to conduct interviews, how do you intend to select the sample population? If you are analyzing texts, which texts have you chosen, and why? If you are using statistics, why is this set of data being used? If other data sources exist, explain why the data you chose is most appropriate to addressing the research problem.
• Provide a justification for case study selection . A common method of analyzing research problems in the social sciences is to analyze specific cases. These can be a person, place, event, phenomenon, or other type of subject of analysis that are either examined as a singular topic of in-depth investigation or multiple topics of investigation studied for the purpose of comparing or contrasting findings. In either method, you should explain why a case or cases were chosen and how they specifically relate to the research problem.
• Describe potential limitations . Are there any practical limitations that could affect your data collection? How will you attempt to control for potential confounding variables and errors? If your methodology may lead to problems you can anticipate, state this openly and show why pursuing this methodology outweighs the risk of these problems cropping up.

NOTE:   Once you have written all of the elements of the methods section, subsequent revisions should focus on how to present those elements as clearly and as logically as possibly. The description of how you prepared to study the research problem, how you gathered the data, and the protocol for analyzing the data should be organized chronologically. For clarity, when a large amount of detail must be presented, information should be presented in sub-sections according to topic. If necessary, consider using appendices for raw data.

ANOTHER NOTE: If you are conducting a qualitative analysis of a research problem , the methodology section generally requires a more elaborate description of the methods used as well as an explanation of the processes applied to gathering and analyzing of data than is generally required for studies using quantitative methods. Because you are the primary instrument for generating the data [e.g., through interviews or observations], the process for collecting that data has a significantly greater impact on producing the findings. Therefore, qualitative research requires a more detailed description of the methods used.

YET ANOTHER NOTE:   If your study involves interviews, observations, or other qualitative techniques involving human subjects , you may be required to obtain approval from the university's Office for the Protection of Research Subjects before beginning your research. This is not a common procedure for most undergraduate level student research assignments. However, i f your professor states you need approval, you must include a statement in your methods section that you received official endorsement and adequate informed consent from the office and that there was a clear assessment and minimization of risks to participants and to the university. This statement informs the reader that your study was conducted in an ethical and responsible manner. In some cases, the approval notice is included as an appendix to your paper.

III.  Problems to Avoid

Irrelevant Detail The methodology section of your paper should be thorough but concise. Do not provide any background information that does not directly help the reader understand why a particular method was chosen, how the data was gathered or obtained, and how the data was analyzed in relation to the research problem [note: analyzed, not interpreted! Save how you interpreted the findings for the discussion section]. With this in mind, the page length of your methods section will generally be less than any other section of your paper except the conclusion.

Unnecessary Explanation of Basic Procedures Remember that you are not writing a how-to guide about a particular method. You should make the assumption that readers possess a basic understanding of how to investigate the research problem on their own and, therefore, you do not have to go into great detail about specific methodological procedures. The focus should be on how you applied a method , not on the mechanics of doing a method. An exception to this rule is if you select an unconventional methodological approach; if this is the case, be sure to explain why this approach was chosen and how it enhances the overall process of discovery.

Problem Blindness It is almost a given that you will encounter problems when collecting or generating your data, or, gaps will exist in existing data or archival materials. Do not ignore these problems or pretend they did not occur. Often, documenting how you overcame obstacles can form an interesting part of the methodology. It demonstrates to the reader that you can provide a cogent rationale for the decisions you made to minimize the impact of any problems that arose.

Literature Review Just as the literature review section of your paper provides an overview of sources you have examined while researching a particular topic, the methodology section should cite any sources that informed your choice and application of a particular method [i.e., the choice of a survey should include any citations to the works you used to help construct the survey].

It’s More than Sources of Information! A description of a research study's method should not be confused with a description of the sources of information. Such a list of sources is useful in and of itself, especially if it is accompanied by an explanation about the selection and use of the sources. The description of the project's methodology complements a list of sources in that it sets forth the organization and interpretation of information emanating from those sources.

Azevedo, L.F. et al. "How to Write a Scientific Paper: Writing the Methods Section." Revista Portuguesa de Pneumologia 17 (2011): 232-238; Blair Lorrie. “Choosing a Methodology.” In Writing a Graduate Thesis or Dissertation , Teaching Writing Series. (Rotterdam: Sense Publishers 2016), pp. 49-72; Butin, Dan W. The Education Dissertation A Guide for Practitioner Scholars . Thousand Oaks, CA: Corwin, 2010; Carter, Susan. Structuring Your Research Thesis . New York: Palgrave Macmillan, 2012; Kallet, Richard H. “How to Write the Methods Section of a Research Paper.” Respiratory Care 49 (October 2004):1229-1232; Lunenburg, Frederick C. Writing a Successful Thesis or Dissertation: Tips and Strategies for Students in the Social and Behavioral Sciences . Thousand Oaks, CA: Corwin Press, 2008. Methods Section. The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Rudestam, Kjell Erik and Rae R. Newton. “The Method Chapter: Describing Your Research Plan.” In Surviving Your Dissertation: A Comprehensive Guide to Content and Process . (Thousand Oaks, Sage Publications, 2015), pp. 87-115; What is Interpretive Research. Institute of Public and International Affairs, University of Utah; Writing the Experimental Report: Methods, Results, and Discussion. The Writing Lab and The OWL. Purdue University; Methods and Materials. The Structure, Format, Content, and Style of a Journal-Style Scientific Paper. Department of Biology. Bates College.

Writing Tip

Statistical Designs and Tests? Do Not Fear Them!

Don't avoid using a quantitative approach to analyzing your research problem just because you fear the idea of applying statistical designs and tests. A qualitative approach, such as conducting interviews or content analysis of archival texts, can yield exciting new insights about a research problem, but it should not be undertaken simply because you have a disdain for running a simple regression. A well designed quantitative research study can often be accomplished in very clear and direct ways, whereas, a similar study of a qualitative nature usually requires considerable time to analyze large volumes of data and a tremendous burden to create new paths for analysis where previously no path associated with your research problem had existed.

To locate data and statistics, GO HERE .

Another Writing Tip

Knowing the Relationship Between Theories and Methods

There can be multiple meaning associated with the term "theories" and the term "methods" in social sciences research. A helpful way to delineate between them is to understand "theories" as representing different ways of characterizing the social world when you research it and "methods" as representing different ways of generating and analyzing data about that social world. Framed in this way, all empirical social sciences research involves theories and methods, whether they are stated explicitly or not. However, while theories and methods are often related, it is important that, as a researcher, you deliberately separate them in order to avoid your theories playing a disproportionate role in shaping what outcomes your chosen methods produce.

Introspectively engage in an ongoing dialectic between the application of theories and methods to help enable you to use the outcomes from your methods to interrogate and develop new theories, or ways of framing conceptually the research problem. This is how scholarship grows and branches out into new intellectual territory.

Reynolds, R. Larry. Ways of Knowing. Alternative Microeconomics . Part 1, Chapter 3. Boise State University; The Theory-Method Relationship. S-Cool Revision. United Kingdom.

Yet Another Writing Tip

Methods and the Methodology

Do not confuse the terms "methods" and "methodology." As Schneider notes, a method refers to the technical steps taken to do research . Descriptions of methods usually include defining and stating why you have chosen specific techniques to investigate a research problem, followed by an outline of the procedures you used to systematically select, gather, and process the data [remember to always save the interpretation of data for the discussion section of your paper].

The methodology refers to a discussion of the underlying reasoning why particular methods were used . This discussion includes describing the theoretical concepts that inform the choice of methods to be applied, placing the choice of methods within the more general nature of academic work, and reviewing its relevance to examining the research problem. The methodology section also includes a thorough review of the methods other scholars have used to study the topic.

Bryman, Alan. "Of Methods and Methodology." Qualitative Research in Organizations and Management: An International Journal 3 (2008): 159-168; Schneider, Florian. “What's in a Methodology: The Difference between Method, Methodology, and Theory…and How to Get the Balance Right?” PoliticsEastAsia.com. Chinese Department, University of Leiden, Netherlands.

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13 Preliminary studies and pilot testing

• Published: June 2015
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Preliminary studies are usually needed to develop different aspects of the trial procedures or to collect data to facilitate the planning and conduct of the trial. They may use qualitative or quantitative methods, and can be designed to refine the intervention or the evaluation. They may be small and quick, such as a qualitative study to ask potential trial participants to review a draft information sheet for clarity and acceptability. They may, however, take over a year, such as a study to check the incidence of a seasonal disease that must last at least a year. Pilot studies are tests of the full trial procedures on a small sample of potential participants. They aim to ensure that any problems with the conduct of the trial will be identified so that procedures can be changed before the full trial starts. Every trial should be preceded by at least one pilot study.

Introduction to preliminary studies and pilot testing   216

Preliminary studies   216

Purposes   216

Design of preliminary studies   218

Pilot testing   220

Purpose   220

Design of the pilot test   220

1 Introduction to preliminary studies and pilot testing

The time between the idea for an intervention trial and first entering participants into the trial is usually long, generally at least a year and often several years. Even when funding for a trial has been obtained, which, in itself, may take a year or more, there is often much work to do before the first participant can be enrolled into the trial. This chapter outlines the kinds of investigations and studies that may be carried out before starting the main trial to try to maximize the possibility that the trial will be conducted successfully. We divide these into two kinds of study. First are preliminary studies to develop different aspects of the trial procedures or to collect data to facilitate the planning and conduct of the trial. Second are pilot studies which are tests of the full trial procedures on a small sample of potential participants to make sure, in so far as is possible, that any problems with the conduct of the trial will be identified, so that procedures can be changed before the full trial starts.

Though often very useful, no specific type of preliminary study is invariably essential, whereas a pilot study should always be planned, though such studies can range from a relatively brief testing of the intervention and its evaluation that lasts a week or less through to an extensive period of testing and refinement of the intervention and evaluation methods that spans several months, or even a year or more.

2 Preliminary studies

2.1 purposes.

Preliminary studies are often conducted to refine the intervention and evaluate its acceptability, feasibility, cost, and uptake. For example, prior to a large field trial of a multi-component intervention that aimed to improve adolescent sexual and reproductive health in Tanzania, a preliminary study was carried out to test and refine the intervention. The main cluster randomized trial was planned to involve about 10 000 adolescents in over 120 schools, with an initial follow-up period of 3 years. A preliminary study was conducted to develop and refine the intervention methods that would be used to train and support teachers and class peer educators who would deliver the in-school sexual and reproductive health education intervention to be used in the trial ( Obasi et al., 2006 ).

Preliminary studies may be needed to provide local up-to-date data, in order to calculate or confirm the sample size required for the main trial. For example, before embarking on a field trial of a malaria vaccine that will be evaluated for its effect in reducing the incidence of clinical cases of malaria, a preliminary study may be required to obtain estimates of the incidence of cases of malaria in the study population, probably spanning a complete year, in order to allow for seasonal variation in transmission. The outcome from such preliminary studies provides the data necessary for designing the size of the main trial. It is commonly found in trial design that investigators are over-optimistic about the likely frequency of outcome events in their trial population. Consequently, after a preliminary (baseline) study, the size of the main trial needs to be increased. Sometimes, the reverse happens, but not so commonly! In so far as is possible, the baseline study should be conducted under similar conditions to those that will hold in the main trial. Thus, for example, if insecticide-impregnated bed-nets are to be distributed to all children participating in a trial of a malaria vaccine, as may be required for ethical reasons, this should be done for the baseline studies to avoid over-estimating the likely incidence of malaria in the trial population ( Leach et al., 2011 ).

In some cases, preliminary investigations may even show that the proposed study population will not be suitable. A trial of a vaginal microbicide gel to prevent HIV transmission among women in Ghana was based upon an assumption of an annual transmission rate of HIV in the trial population of 5% a year. Baseline studies were not conducted to verify this assumption, and, once the trial had started, it was discovered that the actual transmission rate was only about 1% a year. Thus, an expensive trial had to be abandoned, because of a lack of statistical power ( Peterson et al., 2007 ). Had it been known, before the trial started, that it should have been five times as large, it perhaps would never have been started.

Preliminary studies may also be needed to estimate how long it will take to enrol the target number of trial participants, the proportion of participants who are likely to be lost to follow-up, the best interval to have between follow-up visits, and the overall duration of the trial.

Other preliminary studies are helpful to refine the design of specific methods for use in the process and/or impact the evaluation within the main trial, and to evaluate their acceptability, feasibility, and cost. For example, will taking blood specimens, skin snips, or self-administered vaginal swabs be feasible and acceptable? Can the cold chain be maintained for vaccines or specimens that need to be kept cold, and for how long, since this will govern how frequently they need to be taken to or from the field research team? How many staff will be required, and how much will it cost, to carry out and collect data and specimens from 60 participants a day, for example?

It will also be necessary to explore the likely community acceptance of the trial (see Chapter 9 ), staff training needs, and other logistic requirements related to field and laboratory activities, data management, and study clinics. Some of these data may have already been collected in studies previously conducted by the trial team or by others, but, in other circumstances, special preliminary studies are required.

Many preliminary studies can be small and quick such as a qualitative study to ask potential trial participants to review a draft information sheet for clarity and acceptability. On the other hand, others may take over a year such as a study to check the incidence of a seasonal disease that must cover at least one 12-month period.

An example of a relatively large preliminary study conducted prior to a trial was the feasibility study for a multicentre trial of the impact of a vaginal microbicide on HIV incidence among women at high risk of acquiring sexually transmitted infections (STIs) that was conducted in four East and Southern African countries ( McCormack et al., 2010 ). The main trial was planned to be conducted over several years at a likely cost of tens of millions of pounds, so it was crucial to ensure, prior to starting the main trial, that the sample size was right and that the methods planned for all aspects of the trial were both feasible and acceptable. Within the Tanzanian site for the trial, for example, a preliminary study was designed ( Vallely et al., 2007 ). This lasted more than a year, to:

identify the population groups to invite to participate in the trial

work out how best to deliver the intervention and related clinical services

evaluate the likely acceptability of the microbicide gel

test and refine the study methods and instruments

estimate the incidence of the primary (HIV) and secondary (STIs, reported use of the microbicide gel) outcomes for the main trial, and

estimate the costs of each of the activities needed for the trial.

2.2 Design of preliminary studies

The design and methods used for preliminary studies should be tailored to address the specific issues and questions to be answered. Often, both qualitative and quantitative methods will be required, drawing upon social and behavioural sciences, and economic, epidemiological, laboratory, statistical, and community development approaches. Usually, a preliminary study will be relatively short term and inexpensive, in comparison to the main trial. Ideally, the main trial should be started soon after the preliminary study to avoid the situation changing between the two. This frequently raises the question of whether preliminary studies should be built into the funding proposal for the main trial, or whether they should be the subject of one or more separate preliminary funding proposals. If the latter approach is adopted, there may be a delay between the preliminary investigations and funding being secured for the main trial. A reasonable approach might be to present the design of the main trial to the funding agency, but acknowledging that preliminary studies will be necessary to confirm some of the assumptions in the proposal such as disease incidence rates. The funding for the main trial might then be made conditional on the results of the preliminary investigations. If the preliminary studies indicate that additional funding will be required for the main trial, for example, because the sample size has been underestimated, then the agency may wish to reconsider the proposal. The best strategy will often depend on the work that has been done in the past and the degree to which the results of the preliminary studies might affect the size, duration, or cost of the trial. Further details on some of the social and behaviour science methods that can be used within preliminary studies can be found in Chapter 15 .

It is usually best to conduct the preliminary studies in the same general population, but in different individuals (or clusters) from those who will be involved in the main trial.

A preliminary study for the in-school intervention component of the Tanzanian adolescent sexual and reproductive health trial mentioned in Section 2.1 was conducted over a period of about 6 months in five schools that would not be included in the subsequent trial but that were conveniently located close to the offices of the research institution coordinating the trial. Teachers and class peer educators were selected and trained to deliver the in-school sessions and were then observed actually teaching the sessions to evaluate the session quality and how long it took to teach each session. The study identified misunderstandings and that there were some topics that the teachers obviously felt uncomfortable teaching, for example. Researchers also interviewed the teachers, peer educators, school headteachers, some of the students, and their parents to get their impressions of each session and the course as a whole and their suggestions for improvements. In the course of this preliminary study, many lessons were also learned about the resources that would be needed, the best ways to select the teachers and peer educators, and how to gain the trust of the local education department, school authorities, local religious leaders, students, and their parents.

The feasibility study in the Tanzania site of the microbicide trial mentioned in Section 2.1 involved conducting a rapid assessment and mapping of bars, guesthouses, restaurants, shops, sellers of local brew, and wayside food sellers, and enumeration of the number of women working in them to identify the potential numbers that could be invited to join the subsequent trial. A group of these women were invited to join a preliminary longitudinal cohort study which would receive all the proposed trial procedures, except being given either the microbicide or placebo gel. The procedures included setting up study clinics that the women were asked to attend on a quarterly basis and the regular monitoring of the outcomes that were proposed for the trial, including tests for HIV and other STIs, pregnancy, and reported sexual behaviours. The opportunity was taken to conduct comparisons of alternative ways of collecting data on self-reported sexual behaviours (including face-to-face interviews and use of pictorial diaries kept by the women) and of testing various alternative methods for interacting and exchanging information with women participants, their representatives, the owners and managers of the institutions in which they worked, community leaders, and relevant local officials. Discussions and negotiations were held with health facilities where women were referred for clinical care beyond the scope of the trial team themselves. The feasibility study also allowed detailed preparations and negotiations with national and international regulatory authorities.

Pre-testing of procedures for data and specimen collection and analysis should always be part of the preliminary studies for a trial. For example, any information sheet or questionnaire should be translated and back-translated if it is to be administered in a different language from the original in which it was designed. If it is going to be administered in several different languages, this can take a considerable amount of organization and time. The document should be pre-tested by administering it to a small number of volunteers. This will usually reveal problems with the order or clarity of information or questions, or with the coding of answers. Clearly, enough time must be left to act on the lessons learned during the pre-testing, and it may be necessary to pre-test several sequential versions of an information sheet or data collection form, before it is considered ready for pilot testing. More details on questionnaire design are given in Chapter 14 .

3 Pilot testing

3.1 purpose.

Every field trial should be preceded by a pilot study (also known as a pilot test) prior to launching the main trial. This should test, on a small scale, all the study procedures, including the selection of eligible potential participants, their enrolment, recording the required data, specimen collection (if applicable), supervision systems, quality control, and data processing. If the trial involves multiple data collection rounds, where either staff or procedures change between rounds, it is a good idea to pilot test the procedures before each round.

3.2 Design of the pilot test

The design of the pilot study should be as similar as possible to the design of the procedures in the main trial, and the population selected to take part should be representative of the trial population (though not part of it). In a drug or vaccine trial, the actual interventional and comparison products (for example, drug or vaccine or placebo) might be administered, and procedures tested for monitoring immediate outcomes and responding to any potential AEs. However, sometimes, only the standard comparison product or placebo is used in the pilot study, as those included in the pilot study might not be included in the long-term safety monitoring that would be present in the main trial. For example, only the placebo gel was used in the pilot test for the microbicide trial described in Sections 2.1 and 2.2 . For other types of intervention, such as the combination of in-school sexual and reproductive health education, training of health workers and youth condom promoters, and community-wide supportive activities that were evaluated within the trial that was also mentioned in Sections 2.1 and 2.2 , the interventions were pilot-tested in separate communities.

Usually, it is best to conduct the pilot study in individuals or a cluster that will not be included in the main trial, in order to avoid having to go back to the same individuals to collect similar data in the main trial. In a multi-round trial, the same specific individuals or clusters might participate in the pilot test that precedes each data collection round. This has logistic advantages. The field teams will get to know the community in which the pilot tests are conducted, facilitating logistics such as where to conduct the survey, where to stay overnight, and who the best local people are to ask to help introduce the study to householders or to help find people who do not come forward for the trial. It also has the technical advantage that the individuals and communities involved in subsequent rounds of the pilot test will have had similar prior exposure to the procedures to those in the main trial population.

The pilot study can often be linked to staff training. For example, in a multi-round field trial of vitamin A supplementation in children, staff received a specific training course that covered all the field data collection methods that would be used in the subsequent trial round. This course lasted a total of 2 weeks and included both classroom and practical training. During the first week, the practical training included ‘mock interviewing’ their colleagues and role plays, in which one interviewer asked questions of the trainer, while all the field interviewers entered the answers into the questionnaire. The pilot test was carried out early in the second week, so that any necessary changes could be made to the procedures, or even to the data collection forms, in time for the interviewers and their supervisors to be brought up to speed on the modifications before the end of the 2-week training period.

Every step in the field trial processes should be tested in the pilot study. Importantly, the pilot test of data and specimen collection procedures must allow enough time for the pilot data to be entered on to computers, ‘cleaned’, and analysed, so that these systems can also be checked for functionality. Similarly, whenever possible, any specimens collected during the pilot test should be processed, so that, at a minimum, it is possible to check that the specimens have been collected and transported correctly and are in good condition. In addition, enough time must be allowed between the completion of the pilot test and all its checks, for revisions to be made to the instruments and procedures if they are needed. All too often, inexperienced trial managers do not allow enough time for this and hope that no changes will be needed or are then under pressure to ignore indications from the pilot test that improvements would be desirable.

Sometimes, investigators are tempted to use the results from a small, time-limited pilot test to predict whether the sample size that was calculated for the main trial will be sufficient. While a small pilot test can give rise to worries about recruitment rates and suggest ways of increasing these, pilot studies will usually not have been designed with sufficient numbers or duration to give a precise enough estimate of trial outcomes to make it sensible to attempt to use it to test sample size calculations. Given very wide CIs around the outcome estimates that are likely in a small pilot test, such projections may be very misleading. If there is a need for checks on the assumptions used in the trial sample size calculation, these should be tested within a preliminary study, as described in Section 2.2 .

Leach, A. , Vekemans, J. , Lievens, M. , et al. 2011 . Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa.   Malaria Journal , 10 , 224. 10.1186/1475-2875-10-224

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McCormack, S. , Ramjee, G. , Kamali, A. , et al. 2010 . PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial.   Lancet , 376 , 1329–37. 10.1016/S0140-6736(10)61086-0

Obasi, A. I. , Cleophas, B. , Ross, D. A. , et al. 2006 . Rationale and design of the MEMA kwa Vijana adolescent sexual and reproductive health intervention in Mwanza Region, Tanzania.   AIDS Care , 18 , 311–22. 10.1080/09540120500161983

Peterson, L. , Nanda, K. , Opoku, B. K. , et al. 2007 . SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana.   PLoS One , 2 , e1312. 10.1371/journal.pone.0001312

Vallely, A. , Shagi, C. , Kasindi, S. , et al.; Microbicides Development Programme. 2007 . The benefits of participatory methodologies to develop effective community dialogue in the context of a microbicide trial feasibility study in Mwanza, Tanzania.   BMC Public Health , 7 , 133. 10.1186/1471-2458-7-133

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What is Research Methodology? Definition, Types, and Examples

Research methodology 1,2 is a structured and scientific approach used to collect, analyze, and interpret quantitative or qualitative data to answer research questions or test hypotheses. A research methodology is like a plan for carrying out research and helps keep researchers on track by limiting the scope of the research. Several aspects must be considered before selecting an appropriate research methodology, such as research limitations and ethical concerns that may affect your research.

The research methodology section in a scientific paper describes the different methodological choices made, such as the data collection and analysis methods, and why these choices were selected. The reasons should explain why the methods chosen are the most appropriate to answer the research question. A good research methodology also helps ensure the reliability and validity of the research findings. There are three types of research methodology—quantitative, qualitative, and mixed-method, which can be chosen based on the research objectives.

What is research methodology ?

A research methodology describes the techniques and procedures used to identify and analyze information regarding a specific research topic. It is a process by which researchers design their study so that they can achieve their objectives using the selected research instruments. It includes all the important aspects of research, including research design, data collection methods, data analysis methods, and the overall framework within which the research is conducted. While these points can help you understand what is research methodology, you also need to know why it is important to pick the right methodology.

Why is research methodology important?

Having a good research methodology in place has the following advantages: 3

• Helps other researchers who may want to replicate your research; the explanations will be of benefit to them.
• You can easily answer any questions about your research if they arise at a later stage.
• A research methodology provides a framework and guidelines for researchers to clearly define research questions, hypotheses, and objectives.
• It helps researchers identify the most appropriate research design, sampling technique, and data collection and analysis methods.
• A sound research methodology helps researchers ensure that their findings are valid and reliable and free from biases and errors.
• It also helps ensure that ethical guidelines are followed while conducting research.
• A good research methodology helps researchers in planning their research efficiently, by ensuring optimum usage of their time and resources.

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Types of research methodology.

There are three types of research methodology based on the type of research and the data required. 1

• Quantitative research methodology focuses on measuring and testing numerical data. This approach is good for reaching a large number of people in a short amount of time. This type of research helps in testing the causal relationships between variables, making predictions, and generalizing results to wider populations.
• Qualitative research methodology examines the opinions, behaviors, and experiences of people. It collects and analyzes words and textual data. This research methodology requires fewer participants but is still more time consuming because the time spent per participant is quite large. This method is used in exploratory research where the research problem being investigated is not clearly defined.
• Mixed-method research methodology uses the characteristics of both quantitative and qualitative research methodologies in the same study. This method allows researchers to validate their findings, verify if the results observed using both methods are complementary, and explain any unexpected results obtained from one method by using the other method.

What are the types of sampling designs in research methodology?

Sampling 4 is an important part of a research methodology and involves selecting a representative sample of the population to conduct the study, making statistical inferences about them, and estimating the characteristics of the whole population based on these inferences. There are two types of sampling designs in research methodology—probability and nonprobability.

• Probability sampling

In this type of sampling design, a sample is chosen from a larger population using some form of random selection, that is, every member of the population has an equal chance of being selected. The different types of probability sampling are:

• Systematic —sample members are chosen at regular intervals. It requires selecting a starting point for the sample and sample size determination that can be repeated at regular intervals. This type of sampling method has a predefined range; hence, it is the least time consuming.
• Stratified —researchers divide the population into smaller groups that don’t overlap but represent the entire population. While sampling, these groups can be organized, and then a sample can be drawn from each group separately.
• Cluster —the population is divided into clusters based on demographic parameters like age, sex, location, etc.
• Convenience —selects participants who are most easily accessible to researchers due to geographical proximity, availability at a particular time, etc.
• Purposive —participants are selected at the researcher’s discretion. Researchers consider the purpose of the study and the understanding of the target audience.
• Snowball —already selected participants use their social networks to refer the researcher to other potential participants.
• Quota —while designing the study, the researchers decide how many people with which characteristics to include as participants. The characteristics help in choosing people most likely to provide insights into the subject.

What are data collection methods?

During research, data are collected using various methods depending on the research methodology being followed and the research methods being undertaken. Both qualitative and quantitative research have different data collection methods, as listed below.

Qualitative research 5

• One-on-one interviews: Helps the interviewers understand a respondent’s subjective opinion and experience pertaining to a specific topic or event
• Document study/literature review/record keeping: Researchers’ review of already existing written materials such as archives, annual reports, research articles, guidelines, policy documents, etc.
• Focus groups: Constructive discussions that usually include a small sample of about 6-10 people and a moderator, to understand the participants’ opinion on a given topic.
• Qualitative observation : Researchers collect data using their five senses (sight, smell, touch, taste, and hearing).

Quantitative research 6

• Sampling: The most common type is probability sampling.
• Interviews: Commonly telephonic or done in-person.
• Observations: Structured observations are most commonly used in quantitative research. In this method, researchers make observations about specific behaviors of individuals in a structured setting.
• Document review: Reviewing existing research or documents to collect evidence for supporting the research.
• Surveys and questionnaires. Surveys can be administered both online and offline depending on the requirement and sample size.

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What are data analysis methods.

The data collected using the various methods for qualitative and quantitative research need to be analyzed to generate meaningful conclusions. These data analysis methods 7 also differ between quantitative and qualitative research.

Quantitative research involves a deductive method for data analysis where hypotheses are developed at the beginning of the research and precise measurement is required. The methods include statistical analysis applications to analyze numerical data and are grouped into two categories—descriptive and inferential.

Descriptive analysis is used to describe the basic features of different types of data to present it in a way that ensures the patterns become meaningful. The different types of descriptive analysis methods are:

• Measures of frequency (count, percent, frequency)
• Measures of central tendency (mean, median, mode)
• Measures of dispersion or variation (range, variance, standard deviation)
• Measure of position (percentile ranks, quartile ranks)

Inferential analysis is used to make predictions about a larger population based on the analysis of the data collected from a smaller population. This analysis is used to study the relationships between different variables. Some commonly used inferential data analysis methods are:

• Correlation: To understand the relationship between two or more variables.
• Cross-tabulation: Analyze the relationship between multiple variables.
• Regression analysis: Study the impact of independent variables on the dependent variable.
• Frequency tables: To understand the frequency of data.
• Analysis of variance: To test the degree to which two or more variables differ in an experiment.

Qualitative research involves an inductive method for data analysis where hypotheses are developed after data collection. The methods include:

• Content analysis: For analyzing documented information from text and images by determining the presence of certain words or concepts in texts.
• Narrative analysis: For analyzing content obtained from sources such as interviews, field observations, and surveys. The stories and opinions shared by people are used to answer research questions.
• Discourse analysis: For analyzing interactions with people considering the social context, that is, the lifestyle and environment, under which the interaction occurs.
• Grounded theory: Involves hypothesis creation by data collection and analysis to explain why a phenomenon occurred.
• Thematic analysis: To identify important themes or patterns in data and use these to address an issue.

How to choose a research methodology?

Here are some important factors to consider when choosing a research methodology: 8

• Research objectives, aims, and questions —these would help structure the research design.
• Review existing literature to identify any gaps in knowledge.
• Check the statistical requirements —if data-driven or statistical results are needed then quantitative research is the best. If the research questions can be answered based on people’s opinions and perceptions, then qualitative research is most suitable.
• Sample size —sample size can often determine the feasibility of a research methodology. For a large sample, less effort- and time-intensive methods are appropriate.
• Constraints —constraints of time, geography, and resources can help define the appropriate methodology.

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How to write a research methodology .

A research methodology should include the following components: 3,9

• Research design —should be selected based on the research question and the data required. Common research designs include experimental, quasi-experimental, correlational, descriptive, and exploratory.
• Research method —this can be quantitative, qualitative, or mixed-method.
• Reason for selecting a specific methodology —explain why this methodology is the most suitable to answer your research problem.
• Research instruments —explain the research instruments you plan to use, mainly referring to the data collection methods such as interviews, surveys, etc. Here as well, a reason should be mentioned for selecting the particular instrument.
• Sampling —this involves selecting a representative subset of the population being studied.
• Data collection —involves gathering data using several data collection methods, such as surveys, interviews, etc.
• Data analysis —describe the data analysis methods you will use once you’ve collected the data.
• Research limitations —mention any limitations you foresee while conducting your research.
• Validity and reliability —validity helps identify the accuracy and truthfulness of the findings; reliability refers to the consistency and stability of the results over time and across different conditions.
• Ethical considerations —research should be conducted ethically. The considerations include obtaining consent from participants, maintaining confidentiality, and addressing conflicts of interest.

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Frequently Asked Questions

Q1. What are the key components of research methodology?

A1. A good research methodology has the following key components:

• Research design
• Data collection procedures
• Data analysis methods
• Ethical considerations

Q2. Why is ethical consideration important in research methodology?

A2. Ethical consideration is important in research methodology to ensure the readers of the reliability and validity of the study. Researchers must clearly mention the ethical norms and standards followed during the conduct of the research and also mention if the research has been cleared by any institutional board. The following 10 points are the important principles related to ethical considerations: 10

• Participants should not be subjected to harm.
• Respect for the dignity of participants should be prioritized.
• Full consent should be obtained from participants before the study.
• Participants’ privacy should be ensured.
• Confidentiality of the research data should be ensured.
• Anonymity of individuals and organizations participating in the research should be maintained.
• The aims and objectives of the research should not be exaggerated.
• Affiliations, sources of funding, and any possible conflicts of interest should be declared.
• Communication in relation to the research should be honest and transparent.
• Misleading information and biased representation of primary data findings should be avoided.

Q3. What is the difference between methodology and method?

A3. Research methodology is different from a research method, although both terms are often confused. Research methods are the tools used to gather data, while the research methodology provides a framework for how research is planned, conducted, and analyzed. The latter guides researchers in making decisions about the most appropriate methods for their research. Research methods refer to the specific techniques, procedures, and tools used by researchers to collect, analyze, and interpret data, for instance surveys, questionnaires, interviews, etc.

Research methodology is, thus, an integral part of a research study. It helps ensure that you stay on track to meet your research objectives and answer your research questions using the most appropriate data collection and analysis tools based on your research design.

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• Research methodologies. Pfeiffer Library website. Accessed August 15, 2023. https://library.tiffin.edu/researchmethodologies/whatareresearchmethodologies
• Types of research methodology. Eduvoice website. Accessed August 16, 2023. https://eduvoice.in/types-research-methodology/
• The basics of research methodology: A key to quality research. Voxco. Accessed August 16, 2023. https://www.voxco.com/blog/what-is-research-methodology/
• Sampling methods: Types with examples. QuestionPro website. Accessed August 16, 2023. https://www.questionpro.com/blog/types-of-sampling-for-social-research/
• What is qualitative research? Methods, types, approaches, examples. Researcher.Life blog. Accessed August 15, 2023. https://researcher.life/blog/article/what-is-qualitative-research-methods-types-examples/
• What is quantitative research? Definition, methods, types, and examples. Researcher.Life blog. Accessed August 15, 2023. https://researcher.life/blog/article/what-is-quantitative-research-types-and-examples/
• Data analysis in research: Types & methods. QuestionPro website. Accessed August 16, 2023. https://www.questionpro.com/blog/data-analysis-in-research/#Data_analysis_in_qualitative_research
• Factors to consider while choosing the right research methodology. PhD Monster website. Accessed August 17, 2023. https://www.phdmonster.com/factors-to-consider-while-choosing-the-right-research-methodology/
• What is research methodology? Research and writing guides. Accessed August 14, 2023. https://paperpile.com/g/what-is-research-methodology/
• Ethical considerations. Business research methodology website. Accessed August 17, 2023. https://research-methodology.net/research-methodology/ethical-considerations/

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Language and Grammar Rules for Academic Writing

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Conducting Preliminary Research

Barry Mauer and John Venecek

We discuss the following topics on this page:

Introduction

Preliminary research strategies, finding scholars.

We also provide the following activities:

Conducting Preliminary Research [Refresher]

• Finding Scholars [Refresher]

Sometimes called “pre-research,” preliminary research is an inventive stage in which you investigate possible topics of interest. For example, once you fully understand your assignment, the next step might be to conduct some background research online, or talk to friends and classmates. However, while it’s a good idea to try out your ideas with non-experts, the real test is to try them out with experts. If your ideas are not fully formed yet, you can ask experts to help guide you in the right direction. Undergraduate students often overlook this strategy, but it can be incredibly effective and it can lead to good research topics and resources. Let’s take a closer look at some more preliminary research strategies.

Consider using some of the ideas below:

• Explore Literary Studies Journals: Scholars share their work through many venues, but the most important is peer-reviewed scholarly journals in their field. Princeton keeps a list of some of the most important literary studies journals . Imagine yourself as a future contributor to one of these journals!
• Work with a Mentor: A mentor is someone who can help and guide you as a scholar during the research process. Mentorship can take many forms; UCF offers many mentorship programs such as the Research And Mentoring Program (RAMP) , McNair Scholars Program , Honors Undergraduate Thesis (HUT) , and the Office of Undergraduate Research (OUR) . Many of these offer financial and logistical support to students.
• Delve into the Invention Stage: This can be a messy process, so keep a notebook to jot down ideas and questions as they occur to you. You’ll need to develop a research question, so those notes may come in handy later. Also, think about what types of sources you’ll need to complete your project. The assignment may specify certain types, such as scholarly monographs and journal articles, but what else might you need? What about media and other primary sources? Where would you find them? Should you explore digital archives or make an appointment with an archivist?
• Manage your Time : Think about time-management and set milestones. Even though pulling all-nighters is a rite of passage for college students, your stress will be greatly reduced (and  the quality of your research enhanced) if you’re not racing to finish everything at the last minute. Be sure to keep those milestones simple and achievable so you don’t get overwhelmed by unrealistic goals. We encourage you to use a planner!
• Investigate Professional Organizations : Many famous authors have organizations dedicated to their legacy. One of these is The William Faulkner Society , which assembles lists of scholarly journals, conferences and conventions, research centers and information sources, and interdisciplinary university institutes. Many such organizations also provide scholarships for students. Look through the contents of author societies’ websites, as well as recent journals and conference proceedings, to help you generate ideas for your own research.
• Talk to Experts : Finally, ask for help! You’re attending a large university where you’re surrounded by highly educated people. Don’t be afraid to schedule appointments and conduct interviews with them. Also, consider meeting with the subject librarian in your major to get an overview of key resources and tools available at the library.

Taking time to work through the preliminary research process will set the foundation for everything that comes after, and it will make your job easier.

A word about mentorship: having a mentor (whether faculty or peer) will vastly improve your experience as a researcher. Even many experienced researchers have their own mentors because they understand the value that comes with being a mentee. If you plan to work with a mentor, keep in mind a few points:

• If you are having difficulty with the research, put in some work on your own to address the problem before going to your mentor, The mentor’s job is to help you, not to do the work for you.
• Ask your mentor about their own research process so you can better understand the tasks and skills involved.
• Keep a positive attitude; even if you feel like you do not yet have the necessary knowledge or skills, tell yourself that you are in the learning stage and that you are doing your best.
• Recognize that a mentor is there to help but may not be able to meet all your needs. Take ownership of your own learning and research.
• It is okay to seek mentorship from more than one person.

Background Research [1 min 20 sec] [1]

For more advice on Conducting Preliminary Research, consider the following from WritingCommons.org: [2]

The goal of Preliminary Research is not necessarily to become an authority on a specific topic so much as to identify conversation chatter: across disciplines, what are experts talking about? And, ultimately, if given a choice, what interests you the most? Preliminary Research could involve

• discussions with friends about ideas.
• interviews with experts, bosses, clients, and teachers.
• scanning a wikipedia page or Google search
• skimming over documents to learn about the genres and research methods of particular discourse communities/community of practice.

Throughout these chapters we have been emphasizing the idea of scholarship as conversation. This notion extends beyond the written paper to the entire research process, and nowhere is it more important than during your literature review! Just to reiterate this point, here are a few ideas to consider:

• Talk To Your Instructor : Don’t be afraid to talk to your instructor at different stages of your research. This is a good way to stay on track, make sure the scope and purpose of your project are on target, and to make sure you’re finding the right types of sources. Your instructor may also know about important books or articles you haven’t discovered yet as well as key researchers or theorists who work in your area:
• Meet with a Librarian:  University and college libraries usually offer a research consultation service. It is recommended to schedule an appointment as early in the process as possible. Consultations generally focus on the same search strategies discussed throughout this course, but they will be tailored to your individual needs/project.
• Interview an Expert : Whether at your university or someone you’ve discovered during your literature review, consider setting up an informational interview. To get started, introduce yourself, briefly describe your research project, explain why you’re contacting them, and request an interview or assistance with a specific research problem. You might not get a response from everyone, but you’ll be surprised how willing established researchers are to talk to student scholars who show initiative.

The best way to find scholars to talk to about your work is to look through the scholarly literature and identify the authors of the work you like. You can also look through the citations in their works to identify other authors. Then you can look up those people online. Most researchers are affiliated with institutions like universities and they have email addresses you can find on their faculty webpage. You can write to them at their institution, share your interest in their work, and ask for a consultation.

  Finding Scholars [Refresher]

• List three things you have researched (they don’t have to be related to school projects). Discuss your experiences with any of the research you listed. Which parts did you enjoy the most? Where did you have the most difficulty? Did you find what you were looking for? How valuable was the information and the experience?

Feel free to use a grid format, as above, or just make a list of these items under each entry.

• Sometimes the  publication date  is tricky – a work might have remained unpublished for a long period of time. If so, note when it was written (approximately) and then published. Sometimes a work may have been revised and republished. If so, indicate the publication date of the version you read (its original publication date, and not the publication date of the anthology).
• Literary genre  refers to whether a work is a novel, short story, drama, poem, parable, allegory, non-fiction, essay, folk or fairy tale, sacred text, children’s literature, or memoir. Additionally,  literary themes  can be part of genres as in comedy, tragedy, lyric, epic, detective or crime stories, science fiction, supernatural, historical, etc. These are not strict categories and a work may combine more than one.
• Nation or region of author  can be tricky as well. For instance, an author may write in a country far from where they were born and/or raised. Or they may be born in a country that is divided by region. Note anything significant about the author’s place(s).
• The  brief description  is just a sentences or a few sentences to indicate what the literature is about. It does not need to include a plot summary or a complete list of characters and themes. For example, we could say that Homer’s  Odyssey  is the story of a hero and the obstacles he faces on his journey home from war.
• Initial thoughts  are just that: thoughts upon a first reading. These could be about things you notice, things you like or dislike, things that intrigue you, things that are confusing, things that are mysteries, things that are easy or difficult, elements of the texts such as style, voice, meter, diction, etc.
• Major theory or type of criticism  refers to the major literary theories (Marxist, feminist, post-colonial, formal, historical, linguistic, audience studies, structuralist, post-structuralist, etc.) or the themes or issues being addressed. These are not strict categories and a work may combine more than one.
• The  brief description  is just a sentences or a few sentences to indicate what the literary criticism or theory is about. It does not need to include a summary of the whole argument, but should include the major claim(s).
• Initial thoughts  are just that: thoughts upon a first reading. These could be about things you notice, things you like or dislike, things that intrigue you, things that are confusing, things that are mysteries, things that are easy or difficult, elements of the texts such as style, voice, diction, etc.
• If there are any elements of your assignment that need clarification, please list them.
• What was the most important lesson you learned from this page? What point was confusing or difficult to understand?
• NKU, Steely Library, director. Background Research . YouTube , YouTube, 13 Dec. 2017, https://www.youtube.com/watch?v=0gXGMJAXSU4&t=74s . Accessed 1 Apr. 2022. ↵
• Writing Commons. “Preliminary Research.” Writing Commons , 11 Aug. 2020, https://writingcommons.org/section/invention/preliminary-research/ . ↵

Students often overlook the importance of managing and organizing their research as part of the literature review. There are many programs available online, such as Zotero. There is no one proper way to manage your research, but it’s important to have a system that works for you.

As you continue down your path to becoming a researcher, one of two things tends to happen.  A) you have a closet full of printed journal articles that you are saving “just in case”, but you have no idea what’s in there, or why it was important; or B) you are constantly trying to remember what that one article was that you read that one time, but it wasn’t relevant at the time, so you threw it away; or C) all of the above.

Luckily there are citation management programs to help you wrangle and organize your research. As a bonus, they will format your bibliography into the appropriate style at the click of a button.

There are many citation management options to choose from. The key is to find the one that works best with your research style.  The most popular freely available options are Mendeley and Zotero.

For more information about each option, check out the UCF library’s guides to citation management .

Looking for an easy way to compare the different citation management system features? See this chart created and maintained by Penn Libraries.

Strategies for Conducting Literary Research, 2e Copyright © 2021 by Barry Mauer and John Venecek is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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Grant Section Analysis: Approach and Preliminary Studies

Part 3 in a section-by-section overview with tips, suggestions, and examples for writing a strong research grant application., lisa goffman.

• April, 2014

DOI: 10.1044/cred-pvd-lfs003

The following is a transcript of the presentation video, edited for clarity.

We’re now moving to the Approach and Preliminary Studies section.

We’ve talked a great deal about this idea that projects have to be high in significance and high in innovation.

But all is lost when an approach is not feasible or does not lead to data that will accomplish the aims of the project. I think we all understand that. The statistical plan is crucial for assessing the likelihood that the project will yield interpretable results. In the Summary Statement, it’s my experience and I expect the experience of others in this room, that the Approach generally receives the most attention.

Take a great deal of care with this section. As with every other section, obviously.

Considerations and Common Weaknesses

Everybody has mentioned that it would benefit you to read what the reviewer is supposed to attend to during the reviews. For every mechanism, this is accessible online. For every mechanism — F-awards, Rs — the reviewer has questions they are supposed to attend to as they fill out the critique.

For all grants, the question is: Does the research plan address scientific significance, originality, and feasibility? The really key issue is that you are evaluating the probability of a sustained and powerful impact of this work.

For training grants — and I think training grants are a little confusing, and there was a question about this earlier today. For training grants which are Fs or even career grants, the Ks, what the reviewers are supposed to think about is whether the research plan will provide the applicant with individualized and supervised experiences that will develop the research skills needed for his or her career.

Even though it seems as if what is being attended to is the skill set that you’re developing for your career, it always boils down to a compelling, feasible, strong research plan. Always, always, always.

It seems as though, in the training grants, reviewers are attending to different things, but in many ways — they attend to the training potential, in addition to the strength of the other components.

A strong research plan is an essential part of considering review of training and review of impact of this work.

What are some considerations? We’ve talked at length about the approach linking clearly to the theoretical and clinical questions. I’m going to do is give you a beautiful example of this in a few minutes.

Impact is actually a combination of all of the components we’re thinking about right now — significance, innovation, approach. Approach can be very heavily weighted in the impact score. In fact, even if this is a highly significant, highly innovative piece of work without difficulties with the experiments, it would completely lower the impact if people don’t believe you could do it.

Very often, difficulties with the conceptual background become really obvious in the development of the experiments. I often get really excited about a grant, and then I read the experiments and I’m like, they’re not really testing this. Avoiding problems with that conceptual framework — this beautiful linkage we’ve talked about — is crucial.

The statistical plan, including power analysis, is often talked about in the summary statement. I’m trying to draw on various components that I think show up a lot.

Preliminary data, even for an F31, are crucial. They might just be used to illustrate feasibility. In our speech group yesterday, we reviewed a grant that had this very cool synchrony analysis, — but including even one figure showing how they collected a feasibility figure from one subject, I think, would have very much clarified the analysis plan and how the data will be analyzed. Even for a very first F31 grant, feasibility data are absolutely critical.

Another consideration in my potpourri of considerations is reliability being included. We are working with humans, we are often working with disordered humans. To have reliable coding procedures, tests, fidelity of administration in an intervention study — you cannot cover everything in your six to twelve pages, but your reviewer has to be convinced that you know how to handle these issues.

In feasibility, these are issues that I find come up. Feasibility of recruiting participants is huge. Shelley mentioned this dynamic between the power problem and funding. If you cannot find 30 people with well-specified Broca’s aphasia, and you can’t convince people that’s believable, you’re in very big trouble, for example.

Ambitiousness of the work. The contingency of aims. I think we’re talked about that quite a bit.

Aims that are overly tied and contingent are a problem. But some other frequently occurring weaknesses are that aims are overly diffuse and unrelated. You’re looking for that happy medium, of the aims being really connected but not overly contingent. You don’t want to find that after six months, if specific aim one doesn’t work, you’re done. But you also don’t want them to be diffuse and unrelated.

We’ve talked about this one as well — and this really needs to be worked into the Approach section. The inclusion and integration of an appropriate scientific team.

I would add a mentor with appropriate experience, in the training grant world. If you have a wonderful mentor who is really equipped to mentor parts of your project, but you’re the first person they’ve ever mentored, for example, you may want a more experienced mentor — this kind of goes into that category.

If you’re applying a new statistic or a new methodology, you must integrate that consultant.

Include authentic pitfalls. It’s very easy to say this very global thing of what might go wrong. But you need pitfalls that demonstrate that you’re thinking this through. I’m going to give you an example of this in just a moment.

Sometimes you realize in your critiques that the reviewer misunderstood what you were doing. This I put on here because it happens to me a lot. I use methodologies that are really tied to a particular theory that happens to not be my theory. I have learned that it is my responsibility to be incredibly explicit about my theoretical perspective — to blame myself when the reviewers miss the boat here.

This is something reviewers do often — I’m a reviewer a lot and I know I misunderstand when somebody resubmits and explains it. But it’s their job to make it so that I don’t have to read it for nine hours to understand what they’re talking about.

I think we’ve talked a lot about the power of pictures, so I’m just going to zoom through this and the next slide.

Power Analysis

I’m going to give you one example — and this is thanks to Elena for this example — of where the power estimate should go. This gives one framework that deals with the issue of being incredibly concise and dealing with the page limits.

The power estimate can go in many sections. This gives you a sense of the flexibility of how you can construct your proposal. It can go with Preliminary Studies, with pilot data for each task, for example.

It can go with the Approach Section. It might be with your participants, where you are describing the number of your participants. If you are using a similar method, if similar effect sizes are predicted across the whole experiment — you can include your power analysis in that subject section.

Or it can go before each individual study, if your different studies really have different methodologies that are being applied. Or you can do a Statistical Plan section.

I think I’ve done all of these, depending on what the grant is. The point of this example is that there is not a rule, except that it be included, and that it be included in a really accessible way, that is the most space efficient.

This is an example from Elena.

Studies involving children will use a minimum of 25 children per group (50 children total). Power calculations based on the most similar studies completed during the last grant cycle indicate that this N size should provide a minimum of 80% power to detect significant effects at p < .05.

So that’s her first power estimate. Then she has another group — but she is being so space efficient here.

Adult samples tend to show larger between-group effects for similar tasks, requiring fewer subjects.

So here’s how many we require for the adults. And then, finally:

Although these estimates are used for planning purposes, we routinely check effect sizes when approximately two thirds of the data have been collected so that data from additional subjects can be included if effect sizes are smaller than anticipated. Our recruitment sources (i.e., available school programs) are sufficiently large to allow this measure of flexibility.

Think of the number of things she’s demonstrated in this section. She is able to alleviate any concerns her reviewer might have about the power analysis and the ability to find participants. A lot of the feasibility issues are addressed in this very readable paragraph.

That’s one example, and on this slides there are some additional resources for thinking about this issue.

Example Approach

For this second example, I asked Larry Leonard and he kindly agreed to share a grant, this is actually an R21 that was recently funded. I think he is a master, and the best way to kick off this session is to look at a pretty masterful arrangement of the theory, the aims, the methods, and the pitfalls. Hopefully this brings it together and sends us off with a nice example as we look at each other’s grants.

I extracted this from his six-page R21 application.

Many common errors in SLI across different languages….can be logically related to an assumption of inappropriate extraction of nonfinite subject-verb sequences.

You’re going to see in a minute what it means, if you don’t know already.

There is now emerging evidence that children with SLI are, in fact, prone to extract nonfinite subject-verb sequences from larger structures in the input. However, the next crucial step for this proposal – demonstrating that this inappropriate extraction is related to a failure to grasp the structural dependencies in larger structures – has not yet been taken.

This gives theoretical depth — why there is a gap, what this proposal is going to do — in very few words.

Translational implications — this is for an NIDCD panel.

This perspective could lead to a wholly new approach to treatment. Specifically, intervention might be directed at comprehension, to help children learn the structural dependency between nonfinite sequences and early appearing finite verb information. A new approach is sorely needed, given that previous intervention attempts have produced only modest results at best.

Here is a big problem in the world of SLI. I might be able to solve it.

Then his Specific Aims.

Will typically developing children make use of early-appearing finite information in questions that serve as cues to information appearing later in the questions, while children with SLI fail to make use of this information?

So when kids when SLI say “dogs running” and omit that critical “are” does it have to do with how they are comprehending the bigger sentence? That’s what he’s trying to understand. He’s made that really clear.

Will children’s sensitivity or insensitivity to this early-appearing finite information serve as a significant predictor of their consistency/inconsistency in using the same tense/agreement forms in their own speech?

This has been a long-standing problem in SLI, and he has a new idea about it. Which is why it’s an R21.

So we’re going from the theory, to the aims, and now the specific analyses.

To address Specific Aim 1, we will compare the three groups of children on the looking-while-listening measures. First, we will examine the children’s mean RT in shifting gaze from distractor to target using an ANOVA with participant group as a between-subjects variable. We expect a significant interaction, with the TD-A and TD-Y groups showing faster RTs in the finite-cue condition than in the no-finite cue condition, whereas the children with SLI will show no RT difference between the two cue conditions.

Incredibly clear, we know how this is going to come out — or how he predicts it will.

For the second analysis, using mean percentage of looking at the target in the pre-noun time window, we expect a similar interaction. Judging from the effect sizes in our pilot work, we have determined that an n of 18 for each group in each experiment will have power greater than .80 at p < .05.

And there is the power analysis — it’s all there.

Now, the last piece is to move to complex findings and caveats. He has a very sophisticated and precise way of saying, “however, I might be wrong.”

To address Specific Aim 2, we will use regression analyses……we ask if the children’s mean percentage of (pre-noun) looking to the target in the finite-cue condition serves as a predictor of the child’s use of copula or auxiliary forms.

So, are they analyzing that first word driving their responses, or might it be something else?

Here’s alternate predictions, pitfalls, and caveats in such a slick way. We will also include the children’s scores on the Sentence Structure subtest of the CELF-P2 as well as the children’s digit span scores. The former serves as a general language comprehension measure that does not focus on the kinds of structural ties hypothesized to be related to the children’s inconsistent use of copula and auxiliary forms.

The latter (digit span) serves as a measure of verbal short-term memory. This measure is included because a failure to grasp the structural ties between an early appearing finite form and a later appearing noun may be due to a failure to retain the finite information.

So he has the core hypothesis, but also allows for alternate possibilities — maybe comprehension, or maybe short-term memory. These are how the data will inform his hypotheses, here are the caveats.

And finally, we’re really looking to see if these looking measures predict unique variance, or if these other measures are really explaining the variability we observe in these kids.

In this analysis we seek to determine if our looking measure predicts unique variance in the children’s copula and auxiliary use scores over and beyond the variance explained by the Sentence Structure and digit span scores.

When I’m getting ready to write, I look at this kind of example and say, “Can I make things hang together like this?” I know it’s weird to just read it, but I wanted to kick this off by looking at this example.

It’s a really standard design, but it includes all of the crucial components.

Final Thought

I have exactly one more slide here. This is approach-related. And we’ve talked a lot about critiques being really important — and critiques being very often focused on approach, in my experience.

This is actually from my current grant that was funded, and this was the round that it was funded on. But I got this beautiful comment. You can tell this is extracted from my critique because you can’t read it, but it says:

The quantitative measures developed by the Principal Investigator have thus far been used only to evaluate group differences. The current proposal provides the opportunity to extend this research to see if these measures also reflect individual differences. This opportunity will be lost without a more complex statistical analysis more appropriate to the multivariate and longitudinal design.

We were just talking about this issue, where I planned my standard ANOVA, and my reviewer said, “You could make this so much better.” And I did. I went and got a stats consultant. This was a funded proposal. This is a last little message about what the reviewers put into the process.

Lisa Goffman Purdue University

Developed by Lisa Goffman with input from Elena Plante.

Presented at Lessons for Success (April 2014). Hosted by the American Speech-Language-Hearing Association Research Mentoring Network.

Lessons for Success is supported by Cooperative Agreement Conference Grant Award U13 DC007835 from the National Institute on Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health (NIH) and is co-sponsored by the American Speech-Language-Hearing Association (ASHA) and the American Speech-Language-Hearing Foundation (ASHFoundation). Copyrighted Material. Reproduced by the American Speech-Language-Hearing Association in the Clinical Research Education Library with permission from the author or presenter.

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• 10 Research Question Examples to Guide Your Research Project

10 Research Question Examples to Guide your Research Project

Published on October 30, 2022 by Shona McCombes . Revised on October 19, 2023.

The research question is one of the most important parts of your research paper , thesis or dissertation . It’s important to spend some time assessing and refining your question before you get started.

The exact form of your question will depend on a few things, such as the length of your project, the type of research you’re conducting, the topic , and the research problem . However, all research questions should be focused, specific, and relevant to a timely social or scholarly issue.

Once you’ve read our guide on how to write a research question , you can use these examples to craft your own.

Note that the design of your research question can depend on what method you are pursuing. Here are a few options for qualitative, quantitative, and statistical research questions.

Other interesting articles

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

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• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

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Natural lime–cork mortar for the seismic and energetic retrofit of infill walls: design, materials, and method.

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2. materials and methods, 2.1. selection of materials, 2.2. specimen preparation, 2.3. mechanical characterization of the composite matrix.

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2.3.1. Three-Point Bending Tests

2.3.2. compressive strength tests, 2.4. thermophysical analysis, 3. conclusions, author contributions, institutional review board statement, informed consent statement, data availability statement, conflicts of interest.

• Verderame, G.M.; Iervolino, I.; Ricci, P. Report on the Damages on Buildings Following the Seismic Event of 6th of April 2009 Time 1.32 (UTC)—L’Aquila M = 5.8, V1. 20. Available online: http://reluis.it (accessed on 21 August 2024).
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Buda, R.; Pucinotti, R. Natural Lime–Cork Mortar for the Seismic and Energetic Retrofit of Infill Walls: Design, Materials, and Method. Appl. Sci. 2024 , 14 , 7503. https://doi.org/10.3390/app14177503

Buda R, Pucinotti R. Natural Lime–Cork Mortar for the Seismic and Energetic Retrofit of Infill Walls: Design, Materials, and Method. Applied Sciences . 2024; 14(17):7503. https://doi.org/10.3390/app14177503

Buda, Rocco, and Raffaele Pucinotti. 2024. "Natural Lime–Cork Mortar for the Seismic and Energetic Retrofit of Infill Walls: Design, Materials, and Method" Applied Sciences 14, no. 17: 7503. https://doi.org/10.3390/app14177503

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• Study Protocol
• Open access
• Published: 22 August 2024

Pilot trial protocol: community intervention to improve depressive symptoms among Peruvian older adults

• Tatiana Cruz-Riquelme 1 ,
• Alejandro Zevallos-Morales 1 ,
• Ivonne Carrión 1 ,
• Diego Otero-Oyague 1 , 2 ,
• Vanessa Patiño 1 , 2 ,
• Dafne Lastra 1 ,
• Rubén Valle 3 ,
• José F. Parodi 1 ,
• Suzanne L. Pollard 4 ,
• Lesley Steinman 5 ,
• Joseph J. Gallo 6 , 7 &
• Oscar Flores-Flores   ORCID: orcid.org/0000-0002-9780-937X 1  

Pilot and Feasibility Studies volume  10 , Article number:  112 ( 2024 ) Cite this article

130 Accesses

Metrics details

Non-pharmacological interventions have proven effective at alleviating depression and anxiety symptoms in older adults. Methodological refinement and testing of these interventions in new contexts are needed on a small scale before their effectiveness and implementation can be evaluated. The purpose of this pilot study is to assess the feasibility of a future large-scale trial comparing an adapted mental health multi-component evidence-based intervention (VIDACTIVA) versus standard care for older adults experiencing depression symptoms in urban, resource-limited settings in Lima, Peru. Furthermore, this study will explore the acceptability, feasibility, and fidelity of implementing the intervention.

We will conduct an open-label, mixed methods pilot feasibility study with two parallel groups. A total of 64 older adults, stratified by sex, will be randomized at a 1:1 ratio to either the “intervention” or “control.” Participants will be followed for 22 weeks after enrollment. Those in the intervention group will receive eight VIDACTIVA sessions administered by community health workers (CHWs) over 14 weeks, with an additional eight weeks of follow-up. Participants in the control group will receive two psychoeducation sessions from a study fieldworker and will be directed to health care centers. Standard care does not involve CHWs. We will evaluate screening rates, recruitment strategies, retention rates, the acceptability of randomization, and assessments. Additionally, we will assess preliminary implementation outcomes—acceptability, feasibility, and fidelity—from the perspectives of CHWs (interventionists), older adults (main participants), older adults’ relatives, and healthcare professionals.

If the findings from this feasibility trial are favorable, a fully powered randomized controlled trial will be conducted to evaluate `both the effectiveness and implementation of the intervention. This research will make a substantial contribution to the field of mental health in older adults, particularly by emphasizing a meticulous examination and documentation of the implementation process. By doing so, this study will offer valuable methodologies and metrics for adapting and assessing mental health interventions tailored to the unique needs of older adults in resource-constrained contexts and diverse cultural settings.

Trial registration

The current trial registration number is NCT06065020, which was registered on 26th September 2023.

Peer Review reports

Depression is highly prevalent among older adults [ 1 ] and affects approximately one in three older adults worldwide [ 2 ]. Depression often coexists with anxiety symptoms [ 3 ] and are linked to adverse outcomes such as falls, disability, cognitive impairment, dementia, suboptimal management of chronic conditions, and an increased risk of suicide [ 4 , 5 , 6 ]. Loneliness frequently accompanies depression [ 7 ] and is independently associated with negative health consequences, including mortality [ 8 ].

Despite the availability of effective non-pharmacological treatments such as behavioral activation and problem-solving therapy for late-life depression and anxiety symptoms [ 6 , 9 , 10 ], these therapies often remain out of reach for those in need. The scarcity of mental health professionals, including psychologists and psychiatrists, is a significant barrier, particularly in low- and middle-income countries (LMICs) [ 11 , 12 ]. To address this challenge, the World Health Organization (WHO) promotes task-shifting and task-sharing interventions that integrate non-specialists into routine healthcare delivery [ 13 ]. Task-shifting involves redistributing tasks from highly trained professionals to individuals with less extensive training, including non-professionals to maximize resource efficiency. Task-sharing underscores the importance of collaborative care within a team of providers, with mental health specialists transitioning from direct service providers to trainers, supervisors, and consultants [ 14 ]. Task-sharing interventions that tap into community resources, such as community health workers (CHWs), not only expand the workforce but also reduce mental health stigma and can provide essential support to older adults [ 15 , 16 ].

In Peru, despite its classification as an upper-middle-income country, a significant gap exists between the demand for and supply of mental health services, with historical limitations in centralized care in psychiatric hospitals. However, in the last 12 years, there has been an increase in political will highlighted by the approval of Law 29889, which guarantees rights and promotes comprehensive mental health reform. This included the creation of community mental health centers (CMHCs) to provide specialized mental health care to communities, strengthening primary care [ 17 , 18 , 19 ]. Typically, CMHCs are staffed with specialized mental health professionals, including psychiatrists and psychologists, while the primary care centers may occasionally have psychologists on their teams. CMHCs offer care for moderate and severe cases while providing technical support to primary care centers [ 18 ].

Among Peruvian older adults with depression, more than 75% do not receive any form of treatment [ 20 ]. Psychiatrist-to-population ratio is 3 per 100,000 people, and the psychologist-to-population ratio is 10 per 100,000 [ 21 ]. Given these limited structural and human resources for mental health, there is an urgent need for innovative approaches to delivering mental health care to older adults.

We present a protocol for a pilot feasibility trial of a community-based mental health multi-component intervention designed to alleviate depressive symptoms among Peruvian older adults living in urban, resource-limited settings. This trial builds upon previous community-level studies that enhanced our understanding of older adults’ perceptions of mental health and their specific needs in the Peruvian context [ 22 , 23 ]. In alignment with the community-based approach endorsed by the Peruvian Ministry of Health and the WHO, we iteratively adapted components of the Program to Encourage Active Rewarding Lives (PEARLS), an evidence-based intervention for underserved older adults with depression developed in the USA [ 24 , 25 ], to create the Vidas Activas y Valiosas ( VIDACTIVA ) program tailored to the Peruvian context. The primary components of VIDACTIVA include problem solving [ 10 ], behavioral activation [ 26 ], and psychoeducation provided by CHWs under the supervision of a clinical team.

The objective of this protocol is to evaluate the feasibility of conducting a larger-scale clinical trial while simultaneously assessing preliminary implementation and clinical outcomes. We will assess the acceptability and feasibility of the intervention from the various perspectives of those involved (CHWs, older adults, family members, and health professionals) and evaluate the fidelity of intervention delivery by CHWs within a resource-constrained urban setting.

Study setting

Our study will be conducted in Villa El Salvador (VES), an urban district situated to the south of Lima. VES is home to a population of 432,170 residents, among whom 7% are aged 60 years and older [ 27 ]. The majority of older adults in this area are Andean migrants who initially settled here during 1970s. As of 2022, the poverty rate among older adults in this district was high, reaching 28%, with an estimated monthly income averaging less than 358.60 Nuevos Soles (approximately 95 US dollars) [ 28 ]. The life expectancy in VES is slightly below the national average, at 72.8 years, compared to the country’s average of 76.9 years. Within the older adult population, 20% of respondents reported experiencing illiteracy, and half lacked access to a pension [ 29 ]. In VES, in 2023, there were three CMHCs and 16 primary health centers serving the community. Both primary health centers and CMHCs have CHWs, who are community members that volunteer to support various health activities. The size of CHW networks and their specific duties and responsibilities can vary significantly depending on the health center.

Study design and sample size

Our study adopts a mixed-method feasibility pilot trial, employing an open-label design with a type 2 implementation-effectiveness focus and featuring two parallel groups. We plan to randomize a total of 64 older adults (60 years and older) stratified by sex and dividing them equally into “control” and “intervention” groups. The decision to include 64 participants was influenced by the availability of pairs of trained CHWs, who will be responsible for delivering the intervention to a group of 32 participants each. The trial is scheduled to run for a duration of 22 weeks from the start of enrollment. For a visual representation of our study design, please refer to Fig.  1 .

Schematic of the protocol study design and assessments

Study participants

Our study encompasses four distinct participant categories:

Older adults

This group will be the focus of our intervention, and they will be randomized into either the intervention or control group. Older adults will have to meet the following inclusion criteria:

Older adults ≥ 60 years old with the capacity to provide consent.

Current residence in VES, Lima, Perú.

Depressive symptoms, determined by a score equal to or greater than 6 on the Patient Health Questionnaire-9 (PHQ-9).

The exclusion criteria for will be:

Previous self-reported diagnosis of bipolar disorder, dissociative disorder, psychosis, or dementia.

Alcohol abuse, using the 4-item CAGE screening questionnaire. Individuals with a score equal or greater than 2 will be excluded [ 30 ].

Cognitive impairment based on six-items screener [ 31 ]. The score ranges from 0 (worst) to 6 (best). If participants score less than 3, they would be excluded.

Relatives or family members

This category comprises family members or relatives of the older adult participants. Preliminary work has revealed that older adults do not live alone and that family members can play significant roles as both facilitators and/or barriers to the acceptance of mental health care [ 22 , 23 ]. Their involvement will be on sharing their perspectives regarding any observed changes in the older adult receiving the intervention and identifying strategies for engaging relatives in potential future family-oriented interventions. To be eligible for participation in this category, individuals must meet the following inclusion criteria:

An adult aged 18 years or older with the capacity to provide informed consent.

Reside in the same household as an older adult who is participating in the intervention group.

Be referred by an older adult who is actively participating in the intervention group.

Health professionals

This category encompasses a diverse group of health professionals, such as nurses, technicians, social workers, psychologists, and psychiatrists, who are actively engaged in providing care or holding managerial roles within the healthcare system. Their pivotal role in this study involves offering valuable insights, perspectives, and opinions concerning the delivery of the intervention. To be eligible for participation in this category, individuals must meet the following inclusion criteria:

Be currently employed at primary health care centers or community mental health centers or within the local Ministry of Health administration in the district of VES.

A minimum of 6 months of work experience in the district of VES.

• Community health workers

CHWs will play a crucial role in delivering the intervention. Fourteen CHWs will actively participate in this pilot trial. These CHWs have undergone comprehensive training totaling 27 h, carefully designed, and conducted by our clinical team. The training curriculum was centered on the nuances of mental health in older adults and on the specific components of the intervention. Additionally, these CHWs were actively engaged in the iterative adaptation phase preceding this pilot trial. We will obtain and register their experiences, opinions, and insights regarding the intervention delivery.

Recruitment

Recruitment and enrollment of older adults.

To ensure effective recruitment and enrollment of older adults, our approach will be led by two fieldworkers. We will employ two primary strategies:

Engagement with community organizations: Initially, we will collaborate with leaders of community organizations in which older adults actively participate, such as Soup Kitchens and Church gatherings. In this collaborative effort, we will provide essential information about our study to these organizations. Subsequently, we will organize group meetings within these community settings to personally acquaint older adults with the study details. We will thoroughly explain the study and leave contact information for our study coordinator, making it convenient for interested individuals to enroll.

Door-to-Door invitations: Recognizing that some older adults may not actively participate in community groups, we will take a more proactive approach. Our team will visit residences on the outskirts of the VES district, extending personal invitations to potential participants. We believe that reaching out to older adults who may not be part of community organizations will allow us to include those who are potentially most in need.

After providing written informed consent, individuals will undergo a screening process based on our eligibility criteria. For those who express interest but do not meet the eligibility requirements, we will provide valuable information about their nearest primary care center. This approach ensures that even those ineligibles for our study receive guidance on accessing healthcare resources.

Recruitment of relatives of older adults

Relatives of older adults will be recruited directly through referrals from older adults participating in the trial. We will initiate contact through phone calls to obtain consent for conducting in-depth interviews.

Recruitment of health professionals

Health professionals, with whom we collaborated during the previous iterative pilot study of adapting the VIDACTIVA, will be invited for in-depth interviews about their perspectives on the intervention. We will reach out to them via phone calls.

CHWs who have previously worked with us in the iterative pilot will continue their involvement in this trial.

Randomization

Upon establishing the eligibility of older adults who consented to join the study, they will undergo randomization administered through an online platform (accessible at https://www.sealedenvelope.com/ ) by the research team. This computer-based randomization system will employ a 1:1 allocation scheme to assign individuals to either the intervention group or the usual care group. The allocation will be stratified based on sex and will utilize random permuted blocks of varying sizes.

Fieldworkers in charge of periodic assessments will be blinded to the treatment allocation. Researchers and study participants will not be blinded to treatment allocation due to the nature of the intervention.

Study groups

Intervention arm.

In the intervention arm, participants will receive the comprehensive VIDACTIVA intervention, which consists of eight in-person sessions led by two CHWs over a 14-week period. There will be an additional eight-week follow-up phase, during which participants will receive monthly phone calls (a total of two calls) to maintain contact and support (see Fig.  2 ).

Timeline of the intervention sessions for VIDACTIVA. Visit 0: This initial visit is an informal introduction by CHWs. Sessions 1–8: These structured sessions share the same format but progressively taper. The first 4 sessions occur weekly, session 5th to 7th occur every 2 weeks and session 8th is 4 weeks after 7th session. Follow-up: Two monthly phone calls also conducted by CHWs

Each pair of CHWs will work closely with one older adult participant throughout the intervention journey. To establish a strong foundation, a “meeting zero” will occur before the first session. During this introductory meeting, CHWs will have the opportunity to introduce themselves, foster mutual understanding, and build trust with the participant.

The core VIDACTIVA intervention consists of eight sessions, each encompassing the following components:

Problem-solving exercises.

Planning of pleasant, social, and physical activities.

Psychoeducation on depression and anxiety in older adults.

For a detailed breakdown of the content covered in each session, please refer to Table  1 .

Throughout the trial, alongside their individual sessions with older adult participants, CHWs will actively engage in weekly group and individual supervision sessions led by a clinical psychologist. These supervision meetings will serve as platforms for discussing challenges and difficulties encountered during the intervention, providing constructive feedback, tracking the progress of each older adult, and offering space for CHWs to share their thoughts and emotions. Importantly, these meetings will also facilitate peer support and emphasize self-care among CHWs.

Control group

Participants will receive psychoeducation sessions addressing depression and anxiety at older age, which will be delivered through two separate visits (week 0 and week 10) by a trained study fieldworker.

During the initial visit at week 0, participants will receive comprehensive information about the community resources available to them. They will also receive guidance on how to access standard care services provided at their local health canter. If a participant is already receiving some form of mental health care, educational sessions will still be offered, enhancing their existing care. Importantly, any changes in mental health treatment status, whether initiation or cessation, will be meticulously recorded during the study assessments.

Measures and evaluation

Research evaluations will include baseline (week 0), middle (week 5), end of intervention (week 14), and at the end of follow-up (week 22); see Fig.  1 . Quantitative data from questionnaires will be electronically collected by a trained fieldworker using REDCap electronic data capture tools and tablets.

Baseline demographics

After providing informed consent, baseline information will be obtained on age, sex, gender, literacy, civil status, working status, household composition, health insurance, and whether participants are caregivers. Additionally, we will ask about the medications used and the presence of chronic conditions, namely, hypertension, diabetes, chronic respiratory disease, osteoporosis, cataracts, glaucoma, chronic kidney disease, cancer, anxiety disorders, and mood disorders. Furthermore, we will obtain information about self-reported hearing status [ 32 ] and self-reported vision status [ 33 ]. Finally, we will measure quality of life with the EuroQoL-5D (EQ-5D-5L) [ 34 ], independence (Katz Index) [ 35 ], food insecurity scale [ 36 ], physical frailty [ 37 ], and perceived social support (Medical Outcomes Study Social Support Survey—mMOS-SS) [ 38 ]. We will obtain information on whether the participant is receiving any type of mental health therapy (pharmacotherapy or psychotherapy).

Feasibility of carrying out a larger trial

We will collect feasibility data from the pilot trial, which will allow us to assess and plan a full-scale randomized controlled trial (RCT). A comprehensive overview of these feasibility domains, encompassing quantitative indicators, qualitative data, and predefined success criteria, can be found in Table  2 . The qualitative data will be sourced from a variety of avenues, including field notes maintained by the study coordinator and interviews with participants. Special attention will be given to those who chose not to participate or who withdrew from the study. These interviews will allow us to elucidate the underlying reasons and barriers contributing to their decisions, thereby enhancing our understanding of the trial’s feasibility and participant perspectives.

Our progression criteria are not solely based on quantitative success thresholds; instead, we will integrate qualitative data from semi-structured interviews with the quantitative criteria for each domain described in Table  2 . For instance, if we do not reach the screening and recruitment targets, we will explore from the fieldworkers' perspectives how we can improve for a future phase. Reasons could include the number of fieldworkers, the way the study is presented, the recruitment strategies, or other factors. In the domain of retention, if a high proportion of participants drop out after being randomized to the control group, we will use the semi-structured interviews to understand their reasons. This feedback may lead us to reconsider the study design, or the type of control used for the future trial.

Implementation outcome measures

Implementation outcomes serve as a vital lens through which we can unravel the intricacies of the implementation process, allowing us to pinpoint and address intermediate factors that may impact the success of an intervention within its specific context [ 39 , 40 ]. These outcomes hold immense significance because they enable us to assess the effectiveness of delivery of VIDACTIVA, paving the way for future research and practice. Without successful implementation, clinical outcomes remain elusive.

To comprehensively evaluate the acceptability, feasibility, and fidelity of the intervention delivery, we will employ mixed methods approaches [ 37 , 38 ]. A concise overview of the domains, methodologies, and schedule for data collection is provided in Table  3 , which offers a clear roadmap for our assessment process.

Acceptability and feasibility

To evaluate the acceptability and feasibility of our intervention, we will employ an explanatory sequential mixed-methods approach. For older adults, we will start by collecting quantitative data through the Acceptability of Intervention Measure (AIM) and Feasibility of Intervention Measure (FIM) Likert scales [ 41 ]. Subsequently, we will conduct in-depth interviews with a subset of 16–20 older adults, including those who were both less and more satisfied with the intervention. These interviews aim to delve into the participants’ experiences with the program. During these interviews, we will explore feelings about the intervention, thoughts on the activities facilitated by the CHWs, aspects older adults’ value and find satisfying, as well as areas they believe could be improved.

We will use a convergent mixed-methods approach with CHWs, older adult relatives, and health professionals, combining quantitative scores from the Feasibility and Acceptability Likert scales with in-depth interviews, all within the same phase [ 42 ]. This comprehensive approach ensures a holistic interpretation of the data.

Interviews with CHWs will focus on various aspects, including challenges faced while providing the intervention to different older adults, time invested, compensation, self-care practices, and overall satisfaction. In addition to these interviews, we will collect valuable insights during weekly supervision sessions, where a designated note-taker will document CHWs’ experiences and interactions with participants and their families, if applicable.

Interviews with family members will explore their perceptions of mental health care, their acceptance of the intervention, positive changes observed in the family member receiving the intervention, and various other related topics.

Interviews with health professionals will seek to understand their perspectives on the long-term feasibility of the intervention and explore potential avenues for support and collaboration, such as funding opportunities and referrals. This multifaceted approach ensures a thorough examination of the intervention's acceptability and feasibility from multiple perspectives.

We will evaluate the fidelity of the delivery of intervention using a convergent mixed methods approach that includes quantitative indicators and in-depth interviews. The details are displayed in Table  3 .

We will analyze various indicators derived from the PEARLS fidelity instrument [ 43 ]. Additionally, we will audio record one session (middle session) to evaluate the interaction and relationships of CHWs with older adults, communication skills, and rapport. We will closely evaluate the execution of problem-solving exercises and the scheduling of activities. To facilitate this assessment, we are developing a concise checklist outlining the essential steps of problem-solving exercises.

This multifaceted approach to assessing fidelity will offer a nuanced perspective on the accuracy and integrity of intervention delivery by CHWs, providing rich data that will help guide how to adapt VIDACTIVA intervention and implementation for future RCTs.

Clinical measures

The preliminary primary clinical outcome will be depressive symptoms. The secondary outcomes will include anxiety symptoms and loneliness.

Depressive symptoms

To assess the severity of depressive symptoms, we will use the self-report Patient Health Questionnaire-9 (PHQ-9). We will utilize the Spanish version validated for use in Peruvian population [ 44 , 45 ]. The PHQ-9 is a 9-item questionnaire. Each item is rated on a 4-point scale. Scores within the range of 5 to 9 indicate mild symptoms, scores between 10 and 14 signify moderate symptoms, a range of 15 to 19 indicates moderately severe symptoms, and scores of > 20 suggest severe depression.

Anxiety symptoms

We will evaluate the severity of anxiety symptoms using the Generalized Anxiety Disorder-7 (GAD-7), a validated Spanish version [ 46 ]. The questionnaire has 7 items, each with a 4-point scale, with scores between 0 and 21 points. Scores are consider as follows: 0–4 (minimal), 5–9 (mild), 10–14 (moderate), and 15–21 (severe) symptoms [ 46 ]. The GAD-7 has demonstrated excellent psychometric properties [ 47 ].

Loneliness will be assessed using the Three-Item Loneliness Scale (TIL-3) in its Spanish version [ 48 , 49 ]. Respondents will indicate how frequently they experience feelings of lacking companionship; being excluded; and experiencing social isolation. Participants will provide responses on a 3-point Likert scale, ranging from 1 “hardly ever” to 3 “often.” Individual responses will be summed, with higher scores indicative of greater loneliness. The TIL-3 yields a score ranging from 3 to 9.

Data analysis

To visualize participant flow, we will employ a CONSORT diagram [ 50 ]. For a comprehensive overview, we will provide summary statistics, including means, standard deviations, medians, interquartile ranges, counts, or percentages, for all baseline characteristics, implementation outcomes, and clinical measures.

To provide a comprehensive view of the intervention’s delivery process, we will adopt a mixed-methods approach [ 42 , 51 ]. This approach will facilitate the creation of a detailed and holistic portrayal of the intervention's implementation. Our plan includes obtaining meta-inferences and creating joint displays for both the implementation and clinical outcomes.

Qualitative data will be organized using MAXQDA software (VERBI GmbH, Berlin, Version 18.2). Qualitative data from in-depth interviews will be analyzed by a multi-disciplinary team. We will examine the initial transcripts and generated preliminary coding categories through an inductive process using the constant comparative method [ 52 ]. Through this analytical process, we will identify patterns and commonalities, as well as particularities, that will enhance our understanding of the acceptability and feasibility of the intervention from the perspective of participants, their relatives, CHWs, and other health professionals involved in providing care to older people.

Clinical outcome measures will be summarized for each trial arm at specific time points. We will estimate effect sizes as between-group mean differences for each outcome using linear mixed models post-trial (week 14) and at the end of the follow-up period (week 22). We will present parameter estimates along with 95% confidence intervals. It is important to note that hypothesis testing will not be conducted because this is a pilot trial. All the statistical analyses will be performed using Stata v.17 software provided by StataCorp (College Station, TX).

Planned interim analysis and stopping rules

No interim analysis has been planned.

Multiple testing

Given that this feasibility study is exploratory and that there is no hypothesis testing, there will be no adjustment made to the analysis for multiple testing.

The following protocol study has been approved by Universidad de San Martín de Porres (USMP) Institutional Ethical Review Board (reference #948–2023) and Asociacion Benefica PRISMA Ethical Committee (reference #CE0453.23): This trial is registered at Clinical Trials.gov with the identifier NCT06065020. We will obtain written informed consent from the study participants.

We present the justification and methods for the pilot feasibility trial “VIDACTIVA,” a multi-component CHW-lead intervention for Peruvian older adults experiencing depressive and anxiety symptoms. The VIDACTIVA intervention has undergone iterative adaptation from the well-established “Program to Encourage Active, Rewarding Lives” (PEARLS), which has been successfully implemented in the USA over the past 15 years [ 24 , 25 , 53 ].

While PEARLS has indeed shown significant positive outcomes in addressing depressive symptoms and improving quality of life [ 54 ], it is essential to recognize the limitations in generalizing its results to low-resource settings and distinct cultural beyond the United States and in the adoption of CHW-led mental health interventions.

The primary objective of this pilot feasibility trial is to bridge these knowledge gaps and prepare for a more extensive and comprehensive trial. The insights gathered throughout this trial will be instrumental in refining our strategies for the main trial. Pilot feasibility testing becomes notably intricate when conducted with populations that have historically been underrepresented in clinical trials, such as older adults [ 55 ], and in low-resource settings characterized by significant organizational, cultural, and infrastructural challenges [ 42 ]. Explicit attention to culture is needed to obtain health equity [ 56 ]. The findings from this study have the potential to inform future adaptations, assessments, and implementations of interventions involving CHWs in urban resource-constrained settings, thereby expanding the mental health workforce to address pressing needs.

While the intervention primarily targets the alleviation of depressive and anxiety symptoms, we recognize that most older adults experience multiple chronic conditions, a phenomenon known as multimorbidity [ 57 ]. We anticipate that case discussions during supervision sessions can provide valuable insights into other potential components of a future or refined CHW-led intervention. Furthermore, a key element of the problem-solving component is that older adults themselves select the problems they wish to address and propose solutions. During these exercises, the identified problem may relate to other chronic conditions that older adults are managing (e.g., improving diabetes control). This user-centered approach has the potential to indirectly impact the management of other health conditions, illustrating the broader positive effects of the intervention. This approach aligns with the efforts to integrate mental health with non-communicable diseases care, centering the experience of the people living with mental illness (PAHO) [ 16 , 58 ].

Trial status

At the time of manuscript submission, recruitment for this study was ongoing. Recruitment started on 23rd October 2023, is not yet complete and is due to completion on 30th July 2024. This is protocol version 1.2. The trial sponsor is the Universidad de San Martin de Porres.

Availability of data and materials

Not applicable.

Abbreviations

Community health worker

Community mental health center

Randomized controlled trial

Low-middle income countries

Universidad de San Martin de Porres

Program to Encourage Active, Rewarding Lives

World Health Organization

Pan-American Health Organization

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Acknowledgements

We wish to extend our sincere gratitude to Mr. Tony and the Oscar Romero Parish Center for their invaluable contribution in generously providing a spacious training facility for our community health workers. Our appreciation also goes out to the University of San Martín de Porres, School of Medicine, and the Center for Aging Research (CIEN) in Lima, Peru, for their unwavering and fundamental support throughout this endeavor. Furthermore, we would like to express our deep thanks to AB PRISMA for their meaningful collaboration, which greatly enriched the development of this project.

The trial is part of an Oscar Flores-Flores Fellowship supported by the Fogarty International Center (FIC) and the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH), United States, under Award Number K43TW011586. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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Facultad de Medicina Humana, Centro de Investigación del Envejecimiento (CIEN), Universidad de San Martin de Porres, Lima, Peru

Tatiana Cruz-Riquelme, Alejandro Zevallos-Morales, Ivonne Carrión, Diego Otero-Oyague, Vanessa Patiño, Dafne Lastra, José F. Parodi & Oscar Flores-Flores

Asociación Benéfica PRISMA, Lima, Peru

Diego Otero-Oyague & Vanessa Patiño

Facultad de Medicina Humana, Centro de Investigación en Epidemiología Clínica y Medicina Basada en Evidencias, Universidad de San Martin de Porres, Lima, Peru

Rubén Valle

Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA

Suzanne L. Pollard

Health Promotion Research Center, Department of Health Systems and Population Health, University of Washington School of Public Health, Seattle, WA, USA

Lesley Steinman

Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

Joseph J. Gallo

Department of General Internal Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA

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Contributions

JFP, SLP, LS, JJG, and OFF conceived the protocol. TCR, IC, DOO, VP, DL, RVR, and OFF are conducting the study trial. OFF secured the study funding. TCR, AZM, and OFF wrote the manuscript. All the authors contributed to the critical review of the manuscript. All the authors approved the final version of the manuscript.

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Correspondence to Oscar Flores-Flores .

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The following protocol study has been approved by Universidad de San Martín de Porres (USMP) Institutional Ethical Review Board (FWA 00015320, reference #948–2023) and Asociacion Benefica PRISMA Ethical Committee (FWA00001219, reference #CE0453.23). Written informed consent will be obtained from all participants before enrollment into the study.

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Cruz-Riquelme, T., Zevallos-Morales, A., Carrión, I. et al. Pilot trial protocol: community intervention to improve depressive symptoms among Peruvian older adults. Pilot Feasibility Stud 10 , 112 (2024). https://doi.org/10.1186/s40814-024-01540-1

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Received : 17 December 2023

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DOI : https://doi.org/10.1186/s40814-024-01540-1

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