Four types: single holistic, single embedded, multiple holistic, multiple embedded
The post-positive paradigm postulates there is one reality that can be objectively described and understood by “bracketing” oneself from the research to remove prejudice or bias. 27 Yin focuses on general explanation and prediction, emphasizing the formulation of propositions, akin to hypothesis testing. This approach is best suited for structured and objective data collection 9 , 11 and is often used for mixed-method studies.
Constructivism assumes that the phenomenon of interest is constructed and influenced by local contexts, including the interaction between researchers, individuals, and their environment. 27 It acknowledges multiple interpretations of reality 24 constructed within the context by the researcher and participants which are unlikely to be replicated, should either change. 5 , 20 Stake and Merriam’s constructivist approaches emphasize a story-like rendering of a problem and an iterative process of constructing the case study. 7 This stance values researcher reflexivity and transparency, 28 acknowledging how researchers’ experiences and disciplinary lenses influence their assumptions and beliefs about the nature of the phenomenon and development of the findings.
A key tenet of case study methodology often underemphasized in literature is the importance of defining the case and phenomenon. Researches should clearly describe the case with sufficient detail to allow readers to fully understand the setting and context and determine applicability. Trying to answer a question that is too broad often leads to an unclear definition of the case and phenomenon. 20 Cases should therefore be bound by time and place to ensure rigor and feasibility. 6
Yin 22 defines a case as “a contemporary phenomenon within its real-life context,” (p13) which may contain a single unit of analysis, including individuals, programs, corporations, or clinics 29 (holistic), or be broken into sub-units of analysis, such as projects, meetings, roles, or locations within the case (embedded). 30 Merriam 24 and Stake 5 similarly define a case as a single unit studied within a bounded system. Stake 5 , 23 suggests bounding cases by contexts and experiences where the phenomenon of interest can be a program, process, or experience. However, the line between the case and phenomenon can become muddy. For guidance, Stake 5 , 23 describes the case as the noun or entity and the phenomenon of interest as the verb, functioning, or activity of the case.
Yin’s approach to a case study is rooted in a formal proposition or theory which guides the case and is used to test the outcome. 1 Stake 5 advocates for a flexible design and explicitly states that data collection and analysis may commence at any point. Merriam’s 24 approach blends both Yin and Stake’s, allowing the necessary flexibility in data collection and analysis to meet the needs.
Yin 30 proposed three types of case study approaches—descriptive, explanatory, and exploratory. Each can be designed around single or multiple cases, creating six basic case study methodologies. Descriptive studies provide a rich description of the phenomenon within its context, which can be helpful in developing theories. To test a theory or determine cause and effect relationships, researchers can use an explanatory design. An exploratory model is typically used in the pilot-test phase to develop propositions (eg, Sibbald et al. 31 used this approach to explore interprofessional network complexity). Despite having distinct characteristics, the boundaries between case study types are flexible with significant overlap. 30 Each has five key components: (1) research question; (2) proposition; (3) unit of analysis; (4) logical linking that connects the theory with proposition; and (5) criteria for analyzing findings.
Contrary to Yin, Stake 5 believes the research process cannot be planned in its entirety because research evolves as it is performed. Consequently, researchers can adjust the design of their methods even after data collection has begun. Stake 5 classifies case studies into three categories: intrinsic, instrumental, and collective/multiple. Intrinsic case studies focus on gaining a better understanding of the case. These are often undertaken when the researcher has an interest in a specific case. Instrumental case study is used when the case itself is not of the utmost importance, and the issue or phenomenon (ie, the research question) being explored becomes the focus instead (eg, Paciocco 32 used an instrumental case study to evaluate the implementation of a chronic disease management program). 5 Collective designs are rooted in an instrumental case study and include multiple cases to gain an in-depth understanding of the complexity and particularity of a phenomenon across diverse contexts. 5 , 23 In collective designs, studying similarities and differences between the cases allows the phenomenon to be understood more intimately (for examples of this in the field, see van Zelm et al. 33 and Burrows et al. 34 In addition, Sibbald et al. 35 present an example where a cross-case analysis method is used to compare instrumental cases).
Merriam’s approach is flexible (similar to Stake) as well as stepwise and linear (similar to Yin). She advocates for conducting a literature review before designing the study to better understand the theoretical underpinnings. 24 , 25 Unlike Stake or Yin, Merriam proposes a step-by-step guide for researchers to design a case study. These steps include performing a literature review, creating a theoretical framework, identifying the problem, creating and refining the research question(s), and selecting a study sample that fits the question(s). 24 , 25 , 36
Using multiple data collection methods is a key characteristic of all case study methodology; it enhances the credibility of the findings by allowing different facets and views of the phenomenon to be explored. 23 Common methods include interviews, focus groups, observation, and document analysis. 5 , 37 By seeking patterns within and across data sources, a thick description of the case can be generated to support a greater understanding and interpretation of the whole phenomenon. 5 , 17 , 20 , 23 This technique is called triangulation and is used to explore cases with greater accuracy. 5 Although Stake 5 maintains case study is most often used in qualitative research, Yin 17 supports a mix of both quantitative and qualitative methods to triangulate data. This deliberate convergence of data sources (or mixed methods) allows researchers to find greater depth in their analysis and develop converging lines of inquiry. For example, case studies evaluating interventions commonly use qualitative interviews to describe the implementation process, barriers, and facilitators paired with a quantitative survey of comparative outcomes and effectiveness. 33 , 38 , 39
Yin 30 describes analysis as dependent on the chosen approach, whether it be (1) deductive and rely on theoretical propositions; (2) inductive and analyze data from the “ground up”; (3) organized to create a case description; or (4) used to examine plausible rival explanations. According to Yin’s 40 approach to descriptive case studies, carefully considering theory development is an important part of study design. “Theory” refers to field-relevant propositions, commonly agreed upon assumptions, or fully developed theories. 40 Stake 5 advocates for using the researcher’s intuition and impression to guide analysis through a categorical aggregation and direct interpretation. Merriam 24 uses six different methods to guide the “process of making meaning” (p178) : (1) ethnographic analysis; (2) narrative analysis; (3) phenomenological analysis; (4) constant comparative method; (5) content analysis; and (6) analytic induction.
Drawing upon a theoretical or conceptual framework to inform analysis improves the quality of case study and avoids the risk of description without meaning. 18 Using Stake’s 5 approach, researchers rely on protocols and previous knowledge to help make sense of new ideas; theory can guide the research and assist researchers in understanding how new information fits into existing knowledge.
Columbia University has recently demonstrated how case studies can help train future health leaders. 41 Case studies encompass components of systems thinking—considering connections and interactions between components of a system, alongside the implications and consequences of those relationships—to equip health leaders with tools to tackle global health issues. 41 Greenwood 42 evaluated Indigenous peoples’ relationship with the healthcare system in British Columbia and used a case study to challenge and educate health leaders across the country to enhance culturally sensitive health service environments.
An important but often omitted step in case study research is an assessment of quality and rigour. We recommend using a framework or set of criteria to assess the rigour of the qualitative research. Suitable resources include Caelli et al., 43 Houghten et al., 44 Ravenek and Rudman, 45 and Tracy. 46
Although “pragmatic” case studies (ie, utilizing practical and applicable methods) have existed within psychotherapy for some time, 47 , 48 only recently has the applicability of pragmatism as an underlying paradigmatic perspective been considered in HSR. 49 This is marked by uptake of pragmatism in Randomized Control Trials, recognizing that “gold standard” testing conditions do not reflect the reality of clinical settings 50 , 51 nor do a handful of epistemologically guided methodologies suit every research inquiry.
Pragmatism positions the research question as the basis for methodological choices, rather than a theory or epistemology, allowing researchers to pursue the most practical approach to understanding a problem or discovering an actionable solution. 52 Mixed methods are commonly used to create a deeper understanding of the case through converging qualitative and quantitative data. 52 Pragmatic case study is suited to HSR because its flexibility throughout the research process accommodates complexity, ever-changing systems, and disruptions to research plans. 49 , 50 Much like case study, pragmatism has been criticized for its flexibility and use when other approaches are seemingly ill-fit. 53 , 54 Similarly, authors argue that this results from a lack of investigation and proper application rather than a reflection of validity, legitimizing the need for more exploration and conversation among researchers and practitioners. 55
Although occasionally misunderstood as a less rigourous research methodology, 8 case study research is highly flexible and allows for contextual nuances. 5 , 6 Its use is valuable when the researcher desires a thorough understanding of a phenomenon or case bound by context. 11 If needed, multiple similar cases can be studied simultaneously, or one case within another. 16 , 17 There are currently three main approaches to case study, 5 , 17 , 24 each with their own definitions of a case, ontological and epistemological paradigms, methodologies, and data collection and analysis procedures. 37
Individuals’ experiences within health systems are influenced heavily by contextual factors, participant experience, and intricate relationships between different organizations and actors. 55 Case study research is well suited for HSR because it can track and examine these complex relationships and systems as they evolve over time. 6 , 7 It is important that researchers and health leaders using this methodology understand its key tenets and how to conduct a proper case study. Although there are many examples of case study in action, they are often under-reported and, when reported, not rigorously conducted. 9 Thus, decision-makers and health leaders should use these examples with caution. The proper reporting of case studies is necessary to bolster their credibility in HSR literature and provide readers sufficient information to critically assess the methodology. We also call on health leaders who frequently use case studies 56 – 58 to report them in the primary research literature.
The purpose of this article is to advocate for the continued and advanced use of case study in HSR and to provide literature-based guidance for decision-makers, policy-makers, and health leaders on how to engage in, read, and interpret findings from case study research. As health systems progress and evolve, the application of case study research will continue to increase as researchers and health leaders aim to capture the inherent complexities, nuances, and contextual factors. 7
Home » Case Study – Methods, Examples and Guide
Table of Contents
A case study is a research method that involves an in-depth examination and analysis of a particular phenomenon or case, such as an individual, organization, community, event, or situation.
It is a qualitative research approach that aims to provide a detailed and comprehensive understanding of the case being studied. Case studies typically involve multiple sources of data, including interviews, observations, documents, and artifacts, which are analyzed using various techniques, such as content analysis, thematic analysis, and grounded theory. The findings of a case study are often used to develop theories, inform policy or practice, or generate new research questions.
Types and Methods of Case Study are as follows:
A single-case study is an in-depth analysis of a single case. This type of case study is useful when the researcher wants to understand a specific phenomenon in detail.
For Example , A researcher might conduct a single-case study on a particular individual to understand their experiences with a particular health condition or a specific organization to explore their management practices. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a single-case study are often used to generate new research questions, develop theories, or inform policy or practice.
A multiple-case study involves the analysis of several cases that are similar in nature. This type of case study is useful when the researcher wants to identify similarities and differences between the cases.
For Example, a researcher might conduct a multiple-case study on several companies to explore the factors that contribute to their success or failure. The researcher collects data from each case, compares and contrasts the findings, and uses various techniques to analyze the data, such as comparative analysis or pattern-matching. The findings of a multiple-case study can be used to develop theories, inform policy or practice, or generate new research questions.
Exploratory Case Study
An exploratory case study is used to explore a new or understudied phenomenon. This type of case study is useful when the researcher wants to generate hypotheses or theories about the phenomenon.
For Example, a researcher might conduct an exploratory case study on a new technology to understand its potential impact on society. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as grounded theory or content analysis. The findings of an exploratory case study can be used to generate new research questions, develop theories, or inform policy or practice.
A descriptive case study is used to describe a particular phenomenon in detail. This type of case study is useful when the researcher wants to provide a comprehensive account of the phenomenon.
For Example, a researcher might conduct a descriptive case study on a particular community to understand its social and economic characteristics. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a descriptive case study can be used to inform policy or practice or generate new research questions.
An instrumental case study is used to understand a particular phenomenon that is instrumental in achieving a particular goal. This type of case study is useful when the researcher wants to understand the role of the phenomenon in achieving the goal.
For Example, a researcher might conduct an instrumental case study on a particular policy to understand its impact on achieving a particular goal, such as reducing poverty. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of an instrumental case study can be used to inform policy or practice or generate new research questions.
Here are some common data collection methods for case studies:
Interviews involve asking questions to individuals who have knowledge or experience relevant to the case study. Interviews can be structured (where the same questions are asked to all participants) or unstructured (where the interviewer follows up on the responses with further questions). Interviews can be conducted in person, over the phone, or through video conferencing.
Observations involve watching and recording the behavior and activities of individuals or groups relevant to the case study. Observations can be participant (where the researcher actively participates in the activities) or non-participant (where the researcher observes from a distance). Observations can be recorded using notes, audio or video recordings, or photographs.
Documents can be used as a source of information for case studies. Documents can include reports, memos, emails, letters, and other written materials related to the case study. Documents can be collected from the case study participants or from public sources.
Surveys involve asking a set of questions to a sample of individuals relevant to the case study. Surveys can be administered in person, over the phone, through mail or email, or online. Surveys can be used to gather information on attitudes, opinions, or behaviors related to the case study.
Artifacts are physical objects relevant to the case study. Artifacts can include tools, equipment, products, or other objects that provide insights into the case study phenomenon.
Conducting a case study research involves several steps that need to be followed to ensure the quality and rigor of the study. Here are the steps to conduct case study research:
Here are some examples of case study research:
Case studies have a wide range of applications across various fields and industries. Here are some examples:
Case studies are widely used in business and management to examine real-life situations and develop problem-solving skills. Case studies can help students and professionals to develop a deep understanding of business concepts, theories, and best practices.
Case studies are used in healthcare to examine patient care, treatment options, and outcomes. Case studies can help healthcare professionals to develop critical thinking skills, diagnose complex medical conditions, and develop effective treatment plans.
Case studies are used in education to examine teaching and learning practices. Case studies can help educators to develop effective teaching strategies, evaluate student progress, and identify areas for improvement.
Case studies are widely used in social sciences to examine human behavior, social phenomena, and cultural practices. Case studies can help researchers to develop theories, test hypotheses, and gain insights into complex social issues.
Case studies are used in law and ethics to examine legal and ethical dilemmas. Case studies can help lawyers, policymakers, and ethical professionals to develop critical thinking skills, analyze complex cases, and make informed decisions.
The purpose of a case study is to provide a detailed analysis of a specific phenomenon, issue, or problem in its real-life context. A case study is a qualitative research method that involves the in-depth exploration and analysis of a particular case, which can be an individual, group, organization, event, or community.
The primary purpose of a case study is to generate a comprehensive and nuanced understanding of the case, including its history, context, and dynamics. Case studies can help researchers to identify and examine the underlying factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and detailed understanding of the case, which can inform future research, practice, or policy.
Case studies can also serve other purposes, including:
There are several advantages of case study research, including:
There are several limitations of case study research, including:
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> > . This involves the researcher immersing him or herself in the daily lives and routines of those being studied. This often requires extensive work in the setting being studied. This is called fieldwork. Observation provides insight into the behavior patterns and social organizations that operate and constitute a particular bounded system or case. . Researchers will learn about the person or persons that are part of the case by speaking with these people. Talking with informants is called interviewing. The types of interviews conducted by researchers vary in degree of formality (informal interview to semi-structured to structured interviews). . Researchers may also learn about a bounded system by collecting and studying artifacts (e.g. written protocols, charts, flowsheets, educational handouts) - materials used by members of the system or case being studied. - aimed at understanding a particular case because the case itself is of interest (e.g. how one person managed a stroke). A case may be of interest because it has particular features or because it is ordinary. - aimed at providing insight into an issue or problem or to refine a theory. In this instance, understanding the complexities of the case is secondary to understanding something else (e.g. case study of 'Sally' provides insights into the problems with healthcare in the US). - a number of cases are studies jointly in order to understand a phenomenon, population or general condition. Often referred to as a multiple-case study (e.g. 15 primary care practices are studied as single but conjoined cases in order to understand how obesity is discussed in this setting). (2nd edition, pp. 293-312). Thousand Oaks, CA. Sage Publications. . PL Munhall (Ed.) pp. 359-384. Boston, MA: Jones and Bartlett Publishers. . San Francisco: Jossey-Bass. (2nd ed.) Newbury Park, CA: Sage Publications. (pp. 236-247). Thousand Oaks, Sage Publications. . Thousand Oaks, CA: Sage Publications. (2nd ed.). Newbury Park, CA: Sage Publications. to return to Common Research Traditions |
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College students with adhd: a selective review of qualitative studies.
1.1. qualitative research methods, 1.2. the present study, 2. materials and methods, 2.1. search strategy, 2.2. study selection, 2.3. variable identification, 3.1. quantitative results, 3.2. qualitative results, 3.2.1. the college experience of students with adhd, 3.2.2. interventions, 3.2.3. cognitive and academic functioning, 3.2.4. self-functioning, 4. discussion, 5. conclusions, author contributions, conflicts of interest, appendix a. summaries of included studies, appendix a.1. the college experience of students with adhd, appendix a.1.1. college transitions, appendix a.1.2. adhd as an identity, appendix a.1.3. race, appendix a.1.4. community college, appendix a.2. interventions, appendix a.2.1. coaching, appendix a.2.2. strategies, appendix a.2.3. medication, appendix a.3. cognitive and academic functioning, appendix a.4. self-functioning.
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Cohen, S.L.; Shavel, K.; Lovett, B.J. College Students with ADHD: A Selective Review of Qualitative Studies. Disabilities 2024 , 4 , 658-677. https://doi.org/10.3390/disabilities4030041
Cohen SL, Shavel K, Lovett BJ. College Students with ADHD: A Selective Review of Qualitative Studies. Disabilities . 2024; 4(3):658-677. https://doi.org/10.3390/disabilities4030041
Cohen, Shira L., Katie Shavel, and Benjamin J. Lovett. 2024. "College Students with ADHD: A Selective Review of Qualitative Studies" Disabilities 4, no. 3: 658-677. https://doi.org/10.3390/disabilities4030041
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Background: Guidelines depend on effect estimates, usually derived from randomised controlled trials, to inform their decisions. Qualitative research evidence may improve decisions made but where in the process and the methods to do this have not been so clearly established. We sought to describe and appraise how qualitative research has been used to inform World Heath Organization guidance since 2020.
Methods: We conducted a document analysis of WHO guidelines from 2020 to 2022. We purposely sampled guidelines on the topics of maternal and newborn health (MANH) and infectious diseases, as most of the qualitative synthesis to date has been conducted on these topics, likely representing the 'best case' scenario. We searched the in-built repository feature of the WHO website and used standardised search terms to identify qualitative reporting. Using deductive frameworks, we described how qualitative evidence was used to inform guidelines and appraised the standards of this use.
Results: Of the 29 guidelines, over half used qualitative research to help guide decisions (18/29). A total of 8 of these used qualitative research to inform the guideline scope, all 18 to inform recommendations, and 1 to inform implementation considerations. All guidelines drew on qualitative evidence syntheses (QES), and five further supplemented this with primary qualitative research. Qualitative findings reported in guidelines were typically descriptive, identifying people's perception of the benefits and harms of interventions or logistical barriers and facilitators to programme success. No guideline provided transparent reporting of how qualitative research was interpreted and weighed used alongside other evidence when informing decisions, and only one guideline reported the inclusion of qualitative methods experts on the panel. Only a few guidelines contextualised their recommendations by indicating which populations and settings qualitative findings could be applied.
Conclusions: Qualitative research frequently informed WHO guideline decisions particularly in the field of MANH. However, the process often lacked transparency. We identified unmet potential in informing implementation considerations and contextualisation of the recommendations. Use in these areas needs further methods development.
Keywords: Guideline development; Qualitative evidence synthesis; Qualitative research.
© 2024. The Author(s).
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Journal of Orthopaedic Surgery and Research volume 19 , Article number: 557 ( 2024 ) Cite this article
Metrics details
Acute ankle sprains represent one of the most common traumatic injuries to the musculoskeletal system. Many individuals with these injuries experience unresolved symptoms such as instability and recurrent sprains, leading to chronic ankle instability (CAI), which affects their ability to maintain an active lifestyle. While rehabilitation programs focusing on sensorimotor, neuromuscular, strength and balance training are primary treatments, some patients require surgery when rehabilitation fails. A critical analysis of the patient-reported outcome tools (PROs) used to assess CAI surgical outcomes raises some concerns about their measurement properties in CAI patients, which may ultimately affect the quality of evidence supporting current surgical practice. The aim of this research is to develop and validate a new PRO for the assessment of ankle instability and CAI treatment outcomes, following recent methodological guidelines, with the implicit aim of contributing to the generation of scientifically meaningful evidence for clinical practice in patients with ankle instability.
Following the COnsensus-based Standards for the selection of Health Measurement Instruments (COSMIN), an Ankle Instability Treatment Index (AITI) will be developed and validated. The process begins with qualitative research based on face‒to‒face interviews with CAI individuals to explore the subjective experience of living with ankle instability. The data from the interviews will be coded following an inductive approach and used to develop the AITI content. The preliminary version of the scale will be refined through an additional round of face‒to‒face interviews with a new set of CAI subjects to define the AITI content coverage, relevance and clarity. Once content validity has been examined, the AITI will be subjected to quantitative analysis of different measurement properties: construct validity, reliability and responsiveness.
The development of AITI aims to address the limitations of existing instruments for evaluating surgical outcomes in patients with CAI. By incorporating patient input and adhering to contemporary standards for validity and reliability, this tool seeks to provide a reliable and meaningful assessment of treatment effects.
Not applicable.
Acute ankle ligament injuries are among the most common musculoskeletal injuries in both the general and sports populations [ 14 ]. A significant number of people who have suffered a first ankle ligament injury have unresolved posttraumatic symptoms lasting more than 1 year, such as feelings of instability (33–55%), recurrent episodes of ‘giving way’ and sprains (3–35%), and, in some cases, pain [ 17 , 39 ]. This condition is referred to as chronic ankle instability (CAI), a multifaceted syndrome that is associated with functional and/or structural deficiencies and impaired quality of life and decreased physical activity [ 2 , 15 ].
CAI patients are primarily treated with a comprehensive rehabilitation program that emphasizes ankle sensorimotor, strength and balance training. Rehabilitation has been reported to improve subjective symptoms and functional limitations and reduce the risk of ankle reinjury in CAI patients [ 1 , 9 ]. However, despite prolonged functional rehabilitation, some patients with CAI continue to experience significant activity restrictions due to ankle problems. When rehabilitation fails, surgery appears to be a viable therapeutic option for restoring joint function by targeting and correcting the mechanical deficiency of the injured ankle–ligament complex [ 5 ]. The current scientific literature supports the use of different surgical strategies for treating ankle instability, ranging from anatomical repair of the native ligamentous complex to the use of different graft reconstruction techniques, performed via open surgery, minimally invasive and arthroscopic techniques [ 13 , 22 , 37 ]. Unfortunately, there is poor agreement on the surgical standard of care for CAI, and guidelines for determining the surgeon’s choice are still lacking [ 23 , 41 ].
To compare and select appropriate surgical options for treating CAI properly, a combination of reliable tools, including both patient-related and clinician-generated parameters, must be considered [ 35 ]. Patient-reported outcome measures (PROs) are recognized modalities for accounting for the patient’s perspective on his/her current condition. This subjective view is of primary importance for the evaluation of any given treatment and should also ideally contribute in a positive manner to the clinical decision-making process. The ability of a PRO to produce clinically meaningful data is embodied in the multifaceted concept of validity, which can generally be defined as the ability of the instrument to measure the construct it purports to measure [ 6 ]. However, a critical analysis of the literature reveals that validity is an issue for current PROs used to assess CAI surgical outcomes [ 7 , 20 ], raising some concerns about the quality of the evidence supporting clinical practice in patients with ankle instability.
The primary aim of this research was to address this knowledge gap by developing a new patient-reported outcome tool, following methodological guidelines, specifically designed to assess ankle instability and changes following therapeutic interventions. This study protocol describes the process of developing and validating a new tool to evaluate ankle instability, the Ankle Instability Treatment Index (AITI).
The best available evidence about the clinimetric properties of PROs in the specific CAI population suggests the use of the Foot and Ankle Ability Measure (FAAM), the Foot and Ankle Outcome Score (FAOS), and the Karlsson score as the most appropriate PROs for evaluating surgical outcomes in CAI patients [ 7 , 12 , 16 ]. The FAAM and the FAOS were originally conceived as region-specific scores to evaluate functional limitations associated with a variety of foot and ankle problems [ 21 , 31 ]. Only retrospective evidence of validation has been obtained for patients suffering from ankle instability [ 3 , 11 , 30 ]. Both PROs thus do not specifically assess symptoms of ankle joint instability, which raises concerns about their ability to tap an essential disease-specific feature representing a primary target of any ankle stabilization procedure [ 40 ].
The Karlsson score was developed in 1991 to assess joint function after treatment for lateral ankle ligament injuries [ 16 ]. Since its inception, the scale has served as a useful tool in research dealing with the treatment of ankle instability, as evidenced by the frequent use of the scale to report the results of CAI surgery [ 34 ]. However, a systematic review published in 2007 on the available PROs in foot and ankle research area highlighted that the scale lacked evidence on important aspects of validity, such as content validity, reliability and responsiveness [ 20 ]. Since this observation, to the best of the authors’ knowledge, there has been no further analysis of the scale’s validity.
On the basis of these observations, the authors believe that the development of a new PRO for the evaluation of CAI surgical outcome, following the most recent guidelines on PRO properties, is justified by the current state of knowledge.
A focus group consisting of all the authors of this publication (Dr. Pietro Spennacchio, Professor Jon Karlsson, Professor Romain Seil, Dr. Caroline Mouton and Dr. Eric Hamrin Senorski) with recognized expertise and previous publications in the field of ankle instability and outcome tools met initially to discuss the purpose and basic concepts of the new scale. The experts agreed that the main purpose of the project would be to develop an evaluative tool capable of assessing, through direct patient feedback, the symptomatic state of the CAI subject as well as its modification with treatment, according to what is most important to the patient.
The described development procedure adheres to the minimum requirements of validity and reliability as set forth by the latest version of the COnsensus based Standards for the selection of Health Status Measurements INstruments [COSMIN] [ 24 ]. The process of developing the new rating scale is shown in Fig. 1 . It is a multistage process that involves iteratively and interactively, experts and patients in various qualitative and quantitative stages of development to produce a clinically meaningful scale [ 4 ]. To ensure the development of an instrument with high content validity, the process begins with a qualitative research phase aimed at exploring the subjective feelings and formulations of CAI subjects through individual face‒to-face interviews. The qualitative part of the research belongs to the “phenomenology” design type and can be related to the following question: “What do people with chronic ankle instability experience? “, with the aim of allowing participants to provide an insightful perspective on their subjective experience of living with ankle instability [ 18 , 33 ]. The subjective feedback from the CAI subjects will then be used to support the definition of the construct to be assessed by the new scale.
Flow diagram showing the multiphase process of AITI development. AITI: Ankle Instability Treatment Scale. CAI: Chronic ankle instability. PROs: patient-reported outcomes
The inclusion criteria for participation in the development and validation of the new score are detailed in Table 1 . The clinical diagnosis of chronic ankle instability reported in this study is consistent with the Position Statement on Selection Criteria for CAI subjects in Research defined by the International Ankle Consortium [ 12 ]. Recruitment will be conducted in a single center by a member of the focus group, who is an experienced foot and ankle surgeon (PS). In line with the stated phenomenological qualitative study design, sampling will be carried out via a criterion sampling strategy, with the most prominent criterion being the participant’s experience of the phenomenon of ankle instability, as supported by the diagnostic criteria outlined in Table 1 [ 18 ].
Written informed consent will be obtained from all participants before the face-to-face interviews begin. A preliminary list of clinical features of ankle instability, derived from the experience of the developers and the content of PROs commonly used in the research dealing with ankle instability, will be defined to provide prior theoretical knowledge that will serve as a testing ground for the information emerging from the interviews. The interviews follow a framework of open-ended questions designed to encourage discussion of the patient’s subjective experience of the different dimensions of the pathology, as well as the change expected from a treatment designed to improve their current disease (Table 2 ). The interviewer will take special care to avoid any specific guidance or influence on the answers, to allow the participant to express his/her own feelings, perceptions and thoughts, using his/her own words as freely as possible.
The qualitative interviews will be conducted, transcribed verbatim and progressively coded by one researcher (PS). The raw data will be analyzed repeatedly from the first interviews onwards via an inductive coding scheme [ 8 ]. The aim is to define data with labels that will allow them to be grouped into preliminary categories that will allow the progressive coding of all the content collected during the interviews. The emerging categories will be analyzed for similarities in content and finally grouped into higher categories to establish a preliminary framework of the phenomenon of ankle instability, which comprises the different dimensions of the condition experienced by CAI patients [ 18 ]. The emerging categories and their content will be reported to the focus group. Any missing points suggested by comparisons with existing knowledge and the developers’ experience in treating ankle instability will be explored further with additional questions in subsequent interviews to iteratively configure the conceptual framework of ankle instability of the new scale.
The interviews will continue until saturation is reached, defined as the point at which no additional codes or insights emerge in three consecutive interviews, confirming clear data redundancy. On the basis of practical guidelines and estimates from previous qualitative phenomenological studies, a minimum of 10 face‒to‒face interviews are expected [ 24 , 32 ].
The conceptual framework developed will be used to design the domains and items of the new scale in its preliminary version. The information from the previous interviews will be used to generate relevant items, paying particular attention to the wording spontaneously evoked by the patient to ensure clarity and the patient-reported nature of the instrument.
The preliminary scale will be tested through a new round of face‒to‒face interviews with a minimum of 30 new participants not involved in the previous qualitative interviews who meet the same inclusion criteria, as described in Table 1 [ 24 ]. The purpose of the interviews will be to confirm the clarity of each instruction, item and response option. In the case of any unclear item or wording, the participant will be asked to explain his uncertainties and to suggest modifications that are able to improve the clarity of the question. Any possible missed aspects of the ankle instability construct will be further investigated through dedicated probing to explore the patient’s perspective on the content coverage of the scale. During the interview, a quantitative assessment of the content relevance of the scale will be carried out to confirm the instrument’s ability to analyze what matters to patients diagnosed with CAI [ 24 , 28 ]. The respondents will be asked to rate the relevance of the items on a 4-point scale to calculate the content validity ratio for the item’s relevance and appropriateness of the scaling options [ 19 ].
The relevance of the items and the comprehensiveness of the instrument will be further investigated from the perspective of professionals (Orthopaedics and Physiotherapists) )with established experience in the treatment of ankle instability outside the development team. The AITI with a dedicated rating form will be emailed to these professionals, and they will be asked to rate the relevance of each item to the construct of ankle instability. The raters will also be asked to comment on whether any aspects of the construct of instability have been omitted.
After content validity has been examined, the AITI will be subjected to an analysis of different measurement properties, as outlined below.
The construct validity of the AITI will be examined by defining its internal consistency, which is the extent to which the scale items are correlated with each other, thus measuring the same construct and supporting the derivation of a composite score from the sum of the items [ 38 ]. The cohort size of the subjects required to adequately determine the construct validity will be further defined when preliminary data will be available on a sample of 20 CAI patients to ensure statistical power for each analysis.
The correlation between items is defined by calculating the Cronbach’s α. Internal consistency between the items between 0.70 and 0.95 is considered acceptable [ 26 ]. To ensure a clear interpretation of the internal consistency statistics, the dimensionality of the scale will be tested with a confirmatory factor analysis [ 25 ]. The number of items making up the scale will also determine the appropriate recruitment size for internal consistency analysis, with a sample size of at least six times the number of items retained [ 24 ].
The construct validity of the AITI will be further explored by testing the hypothesis of an expected relationship with 2 scores commonly selected by researchers to assess CAI surgical outcomes in a minimum of 50 CAI patients [ 24 ]: the Karlsson scale [ 16 ] and the FAAM sports subscale [ 3 ]. The available evidence for the validation of the comparator instruments in CAI population subjects supports an expected relationship in the midrange of 0.4–0.8, as defined by the calculation of Pearson’s product‒moment correlation coefficients (parametric data) or Spearman’s r (rank correlation) coefficients (nonparametric correlation) [ 36 ].
In addition to the definition of internal consistency described above, the reliability of the AITI will be further investigated by determining test reproducibility and measurement error in a sample size of CAI participants, which will be further defined once preliminary data are available with the new instrument. In accordance with the COSMIN guidelines, a minimum of 50 CAI subjects will be included in this analysis [ 24 ]. Reproducibility (test‒retest reliability) is the extent to which repeated measurements in stable individuals yield similar responses [ 38 ]. Patients participating in this step of validation will complete the new outcome scale twice, with a 10–14-day interval between the two administrations. In line with the definition of a PRO as information that comes directly from patients without interpretation by a clinician [ 27 ], the questionnaire will be administered in a strict self-administered mode without external support, which may introduce bias related to caregiver interpretation.
Evaluation of the test–retest reliability of the scale will be performed by calculating the intraclass correlation coefficient (ICC-agreement) with 95% confidence intervals (CI) [ 10 ]. On the basis of the ICC values, the standard error of measurement (SEM) and the minimal detectable change (MDC) will be calculated.
Responsiveness is defined as the ability of a questionnaire to detect clinically important changes over time, even if these changes are small [ 36 ]. This is a fundamental property for any instrument purporting to evaluate the effect of a therapeutic intervention (evaluative instrument). The instrument responsiveness will be the last property to be analyzed, only after all the facets of validity outlined above have finally been proven to be at least as adequate [ 24 ]. A new group of minimum 30 CAI patients [ 24 ] will be analyzed using the instrument before and after an ankle stabilization procedure at a minimum follow-up of 1 year, a time point that is expected to show a modification of the preoperative patient’s health state. The effect size (ES) and the standardized response mean (SRM) will be determined as indicators of the ability of the new instrument to detect real changes [ 36 ].
The most important direct patient perspective on a given treatment, captured through valid and reliable PROs, is considered an essential outcome for generating the data necessary to incorporate effective and meaningful treatment strategies into clinical practice [ 29 ]. The authors noted that the existing evidence on CAI surgical outcomes is mainly based on PROs with limited evidence of validity, which casts doubt on the consistency and reliability of the data supporting current treatment algorithms [ 20 , 34 ].
This study protocol describes the process of developing and validating a new disease-specific patient-reported tool for the evaluation of ankle instability treatment, the AITI. The focus on patient input in defining scale content and adherence to the latest consensus-based standards for PRO validity and reliability represent the strategy for developing an instrument with appropriate measurement properties in CAI patients. The authors believe that this process is a necessary step in the search for scientifically sound data ensuring a reliable, evidence-based standard of care for patients suffering from ankle instability.
No datasets were generated or analysed during the current study.
Ankle Instability Treatment Index
Chronic Ankle Instability
Effect Size
Foot and Ankle Ability Measure
Foot and Ankle Outcome Score
Intraclass Correlation Coefficient
Minimal Detectable Change
Patient-reported Outcome Measures
Standard Error of Measurement
Standardized Response Mean
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Spennacchio, P., Senorski, E.H., Mouton, C. et al. A new patient-reported outcome measure for the evaluation of ankle instability: description of the development process and validation protocol. J Orthop Surg Res 19 , 557 (2024). https://doi.org/10.1186/s13018-024-05057-4
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