case study clinical method

Case Study Research Method in Psychology

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.

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Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

Olivia Guy-Evans is a writer and associate editor for Simply Psychology. She has previously worked in healthcare and educational sectors.

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Case studies are in-depth investigations of a person, group, event, or community. Typically, data is gathered from various sources using several methods (e.g., observations & interviews).

The case study research method originated in clinical medicine (the case history, i.e., the patient’s personal history). In psychology, case studies are often confined to the study of a particular individual.

The information is mainly biographical and relates to events in the individual’s past (i.e., retrospective), as well as to significant events that are currently occurring in his or her everyday life.

The case study is not a research method, but researchers select methods of data collection and analysis that will generate material suitable for case studies.

Freud (1909a, 1909b) conducted very detailed investigations into the private lives of his patients in an attempt to both understand and help them overcome their illnesses.

This makes it clear that the case study is a method that should only be used by a psychologist, therapist, or psychiatrist, i.e., someone with a professional qualification.

There is an ethical issue of competence. Only someone qualified to diagnose and treat a person can conduct a formal case study relating to atypical (i.e., abnormal) behavior or atypical development.

 Famous Case Studies

• Anna O – One of the most famous case studies, documenting psychoanalyst Josef Breuer’s treatment of “Anna O” (real name Bertha Pappenheim) for hysteria in the late 1800s using early psychoanalytic theory.
• Little Hans – A child psychoanalysis case study published by Sigmund Freud in 1909 analyzing his five-year-old patient Herbert Graf’s house phobia as related to the Oedipus complex.
• Bruce/Brenda – Gender identity case of the boy (Bruce) whose botched circumcision led psychologist John Money to advise gender reassignment and raise him as a girl (Brenda) in the 1960s.
• Genie Wiley – Linguistics/psychological development case of the victim of extreme isolation abuse who was studied in 1970s California for effects of early language deprivation on acquiring speech later in life.
• Phineas Gage – One of the most famous neuropsychology case studies analyzes personality changes in railroad worker Phineas Gage after an 1848 brain injury involving a tamping iron piercing his skull.

Clinical Case Studies

• Studying the effectiveness of psychotherapy approaches with an individual patient
• Assessing and treating mental illnesses like depression, anxiety disorders, PTSD
• Neuropsychological cases investigating brain injuries or disorders

Child Psychology Case Studies

• Studying psychological development from birth through adolescence
• Cases of learning disabilities, autism spectrum disorders, ADHD
• Effects of trauma, abuse, deprivation on development

Types of Case Studies

• Explanatory case studies : Used to explore causation in order to find underlying principles. Helpful for doing qualitative analysis to explain presumed causal links.
• Exploratory case studies : Used to explore situations where an intervention being evaluated has no clear set of outcomes. It helps define questions and hypotheses for future research.
• Descriptive case studies : Describe an intervention or phenomenon and the real-life context in which it occurred. It is helpful for illustrating certain topics within an evaluation.
• Multiple-case studies : Used to explore differences between cases and replicate findings across cases. Helpful for comparing and contrasting specific cases.
• Intrinsic : Used to gain a better understanding of a particular case. Helpful for capturing the complexity of a single case.
• Collective : Used to explore a general phenomenon using multiple case studies. Helpful for jointly studying a group of cases in order to inquire into the phenomenon.

Where Do You Find Data for a Case Study?

There are several places to find data for a case study. The key is to gather data from multiple sources to get a complete picture of the case and corroborate facts or findings through triangulation of evidence. Most of this information is likely qualitative (i.e., verbal description rather than measurement), but the psychologist might also collect numerical data.

1. Primary sources

• Interviews – Interviewing key people related to the case to get their perspectives and insights. The interview is an extremely effective procedure for obtaining information about an individual, and it may be used to collect comments from the person’s friends, parents, employer, workmates, and others who have a good knowledge of the person, as well as to obtain facts from the person him or herself.
• Observations – Observing behaviors, interactions, processes, etc., related to the case as they unfold in real-time.
• Documents & Records – Reviewing private documents, diaries, public records, correspondence, meeting minutes, etc., relevant to the case.

2. Secondary sources

• News/Media – News coverage of events related to the case study.
• Academic articles – Journal articles, dissertations etc. that discuss the case.
• Government reports – Official data and records related to the case context.
• Books/films – Books, documentaries or films discussing the case.

3. Archival records

Searching historical archives, museum collections and databases to find relevant documents, visual/audio records related to the case history and context.

Public archives like newspapers, organizational records, photographic collections could all include potentially relevant pieces of information to shed light on attitudes, cultural perspectives, common practices and historical contexts related to psychology.

4. Organizational records

Organizational records offer the advantage of often having large datasets collected over time that can reveal or confirm psychological insights.

Of course, privacy and ethical concerns regarding confidential data must be navigated carefully.

However, with proper protocols, organizational records can provide invaluable context and empirical depth to qualitative case studies exploring the intersection of psychology and organizations.

• Organizational/industrial psychology research : Organizational records like employee surveys, turnover/retention data, policies, incident reports etc. may provide insight into topics like job satisfaction, workplace culture and dynamics, leadership issues, employee behaviors etc.
• Clinical psychology : Therapists/hospitals may grant access to anonymized medical records to study aspects like assessments, diagnoses, treatment plans etc. This could shed light on clinical practices.
• School psychology : Studies could utilize anonymized student records like test scores, grades, disciplinary issues, and counseling referrals to study child development, learning barriers, effectiveness of support programs, and more.

How do I Write a Case Study in Psychology?

Follow specified case study guidelines provided by a journal or your psychology tutor. General components of clinical case studies include: background, symptoms, assessments, diagnosis, treatment, and outcomes. Interpreting the information means the researcher decides what to include or leave out. A good case study should always clarify which information is the factual description and which is an inference or the researcher’s opinion.

1. Introduction

• Provide background on the case context and why it is of interest, presenting background information like demographics, relevant history, and presenting problem.
• Compare briefly to similar published cases if applicable. Clearly state the focus/importance of the case.

2. Case Presentation

• Describe the presenting problem in detail, including symptoms, duration,and impact on daily life.
• Include client demographics like age and gender, information about social relationships, and mental health history.
• Describe all physical, emotional, and/or sensory symptoms reported by the client.
• Use patient quotes to describe the initial complaint verbatim. Follow with full-sentence summaries of relevant history details gathered, including key components that led to a working diagnosis.
• Summarize clinical exam results, namely orthopedic/neurological tests, imaging, lab tests, etc. Note actual results rather than subjective conclusions. Provide images if clearly reproducible/anonymized.
• Clearly state the working diagnosis or clinical impression before transitioning to management.

3. Management and Outcome

• Indicate the total duration of care and number of treatments given over what timeframe. Use specific names/descriptions for any therapies/interventions applied.
• Present the results of the intervention,including any quantitative or qualitative data collected.
• For outcomes, utilize visual analog scales for pain, medication usage logs, etc., if possible. Include patient self-reports of improvement/worsening of symptoms. Note the reason for discharge/end of care.

4. Discussion

• Analyze the case, exploring contributing factors, limitations of the study, and connections to existing research.
• Analyze the effectiveness of the intervention,considering factors like participant adherence, limitations of the study, and potential alternative explanations for the results.
• Identify any questions raised in the case analysis and relate insights to established theories and current research if applicable. Avoid definitive claims about physiological explanations.
• Offer clinical implications, and suggest future research directions.

5. Additional Items

• Thank specific assistants for writing support only. No patient acknowledgments.
• References should directly support any key claims or quotes included.
• Use tables/figures/images only if substantially informative. Include permissions and legends/explanatory notes.
• Provides detailed (rich qualitative) information.
• Provides insight for further research.
• Permitting investigation of otherwise impractical (or unethical) situations.

Case studies allow a researcher to investigate a topic in far more detail than might be possible if they were trying to deal with a large number of research participants (nomothetic approach) with the aim of ‘averaging’.

Because of their in-depth, multi-sided approach, case studies often shed light on aspects of human thinking and behavior that would be unethical or impractical to study in other ways.

Research that only looks into the measurable aspects of human behavior is not likely to give us insights into the subjective dimension of experience, which is important to psychoanalytic and humanistic psychologists.

Case studies are often used in exploratory research. They can help us generate new ideas (that might be tested by other methods). They are an important way of illustrating theories and can help show how different aspects of a person’s life are related to each other.

The method is, therefore, important for psychologists who adopt a holistic point of view (i.e., humanistic psychologists ).

Limitations

• Lacking scientific rigor and providing little basis for generalization of results to the wider population.
• Researchers’ own subjective feelings may influence the case study (researcher bias).
• Difficult to replicate.
• Time-consuming and expensive.
• The volume of data, together with the time restrictions in place, impacted the depth of analysis that was possible within the available resources.

Because a case study deals with only one person/event/group, we can never be sure if the case study investigated is representative of the wider body of “similar” instances. This means the conclusions drawn from a particular case may not be transferable to other settings.

Because case studies are based on the analysis of qualitative (i.e., descriptive) data , a lot depends on the psychologist’s interpretation of the information she has acquired.

This means that there is a lot of scope for Anna O , and it could be that the subjective opinions of the psychologist intrude in the assessment of what the data means.

For example, Freud has been criticized for producing case studies in which the information was sometimes distorted to fit particular behavioral theories (e.g., Little Hans ).

This is also true of Money’s interpretation of the Bruce/Brenda case study (Diamond, 1997) when he ignored evidence that went against his theory.

Breuer, J., & Freud, S. (1895).  Studies on hysteria . Standard Edition 2: London.

Curtiss, S. (1981). Genie: The case of a modern wild child .

Diamond, M., & Sigmundson, K. (1997). Sex Reassignment at Birth: Long-term Review and Clinical Implications. Archives of Pediatrics & Adolescent Medicine , 151(3), 298-304

Freud, S. (1909a). Analysis of a phobia of a five year old boy. In The Pelican Freud Library (1977), Vol 8, Case Histories 1, pages 169-306

Freud, S. (1909b). Bemerkungen über einen Fall von Zwangsneurose (Der “Rattenmann”). Jb. psychoanal. psychopathol. Forsch ., I, p. 357-421; GW, VII, p. 379-463; Notes upon a case of obsessional neurosis, SE , 10: 151-318.

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Money, J., & Ehrhardt, A. A. (1972).  Man & Woman, Boy & Girl : The Differentiation and Dimorphism of Gender Identity from Conception to Maturity. Baltimore, Maryland: Johns Hopkins University Press.

Money, J., & Tucker, P. (1975). Sexual signatures: On being a man or a woman.

Further Information

• Case Study Approach
• Case Study Method
• Enhancing the Quality of Case Studies in Health Services Research
• “We do things together” A case study of “couplehood” in dementia
• Using mixed methods for evaluating an integrative approach to cancer care: a case study

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Methodology

• What Is a Case Study? | Definition, Examples & Methods

What Is a Case Study? | Definition, Examples & Methods

Published on May 8, 2019 by Shona McCombes . Revised on November 20, 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organization, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating and understanding different aspects of a research problem .

Table of contents

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyze the case, other interesting articles.

A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

• Provide new or unexpected insights into the subject
• Challenge or complicate existing assumptions and theories
• Propose practical courses of action to resolve a problem
• Open up new directions for future research

TipIf your research is more practical in nature and aims to simultaneously investigate an issue as you solve it, consider conducting action research instead.

Unlike quantitative or experimental research , a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

Example of an outlying case studyIn the 1960s the town of Roseto, Pennsylvania was discovered to have extremely low rates of heart disease compared to the US average. It became an important case study for understanding previously neglected causes of heart disease.

However, you can also choose a more common or representative case to exemplify a particular category, experience or phenomenon.

Example of a representative case studyIn the 1920s, two sociologists used Muncie, Indiana as a case study of a typical American city that supposedly exemplified the changing culture of the US at the time.

While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:

• Exemplify a theory by showing how it explains the case under investigation
• Expand on a theory by uncovering new concepts and ideas that need to be incorporated
• Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews , observations , and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data.

Example of a mixed methods case studyFor a case study of a wind farm development in a rural area, you could collect quantitative data on employment rates and business revenue, collect qualitative data on local people’s perceptions and experiences, and analyze local and national media coverage of the development.

The aim is to gain as thorough an understanding as possible of the case and its context.

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In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis , with separate sections or chapters for the methods , results and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyze its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

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

• Normal distribution
• Degrees of freedom
• Null hypothesis
• Discourse analysis
• Control groups
• Mixed methods research
• Non-probability sampling
• Quantitative research
• Ecological validity

Research bias

• Rosenthal effect
• Implicit bias
• Cognitive bias
• Selection bias
• Negativity bias
• Status quo bias

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In this special issue we have asked the contributors to make a case for the case study. The guest editors, Jeffrey Longhofer, Jerry Floersch and Eric Hartmann, intergrate ideas from across the disciplines to explore the complexties of case study methods and theory. In education, Gary Thomas explores the importance of ethnographic case studies in understanding the relationships among schools, teachers, and students. Lance Dodes and Josh Dodes use the case study to articulate a psychoanalytic approach to addiction. In policy and generalist practice, Nancy Cartwright and Jeremy Hardie elaborate a model for a case-by-case approach to prediction and the swampy ground prediction serves up to practitioners. Christian Salas and Oliver Turnbull persuasively write about the role of the case study in neuro-psychoanalysis and illustrate it with a case vignette. In political science, Sanford Schram argues for a bottom up and ethnographic approach to studying policy implementation by describing a case of a home ownership program in Philadelphia. Eric Hartman queers the case study by articulating its role in deconstructing normative explanations of sexuality. In applied psychology, Daniel Fishman describes a comprehensive applied psychology perspective on the paradigmatic case study. Richard Miller and Miriam Jaffe offer us important ways of thinking about writing the case study and the use of multi-media. Each contributor brings a unique perspective to the use of the case study in their field, yet they share practical and philosophical assumptions.

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Longhofer, J., Floersch, J. & Hartmann, E. A Case for the Case Study: How and Why They Matter. Clin Soc Work J 45 , 189–200 (2017). https://doi.org/10.1007/s10615-017-0631-8

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Teaching with Case Studies to Develop Clinical Reasoning

By Ann Horigan 

• Owen, M.I. (2017). A case study scavenger hunt for senior nursing students. Journal of Nursing Education, 56(3), 191. doi: 10.3928/01484834-20170222-13.  Describes the use of a case study and simulation used with a group of senior nursing students in a synthesis seminar. The purpose of the exercise in this course was to provide students with a standardized method of analyzing and synthesizing content from previous courses to help prepare them for the RN licensure exam.  Good example of using a case study with low fidelity simulation and demonstrates that students benefit from this type of exercise. However, this was done in a sim lab setting in small groups of students and does not delve into issues of using case studies in a didactic setting to establish and further clinical reasoning.
• Peery, A. (2015). Use of the unfolding case study in teaching nurse educator master of science in nursing students. Journal of Nursing Education, 54(3), 180. doi: 10.3928/01484834-20150217-11 . Course for nurse educator MSN students done in an online format which uses an unfolding case study to work through challenging issues that a nurse educator is likely to encounter. Unfolding cases promote inquiry among students and should be believable and relevant to the class. Four steps to developing an unfolding case study are discussed. Students found the exercise useful and made them aware of situations they otherwise may not have been aware of in education. It is a dynamic and engaging method for teaching and preparing for real-life scenarios. This article is helpful as it notes the steps in devising an unfolding case study and the benefits of using this type of exercise. It would be more helpful if this had been set up as a formal inquiry with specific measures of application and synthesis pre and post. As it is, it describes an experience and innovative method which is helpful.
• Kaylor, S. and Strickland, H. (2015). Unfolding case studies as a formative teaching methodology for novice nursing students.  Journal of Nursing Education, 54(2), 106-110. doi:10.3928/01484834-20150120-06. Describes a way in which unfolding case studies can be used to teach undergraduate nursing, novice students evidence based practice information rather than the case study acting as a summative evaluation of knowledge. Unfolding case studies develop over time and are unpredictable to the learner. If well done, promotes experiential education and imagination. Students picture themselves as part of the scenario. Enables students to practice making decisions and evaluating the effects of those decisions in a non-threatening environment. When this is done in small groups, students are developing decision making, communication, clinical judgment and problem solving. Helps students connect dots between theory and practice. Authors recommend that this is not the only method of active learning used throughout the semester and should be used several times but not exhaustively.  Excellent article that presents a unique active learning method with benefits, barriers, lessons learned. Would be interesting to see what students thought of it as a learning method.
• Dudas, K. (2012). Podcast and unfolding case study to promote active learning. Journal of Nursing Education, 51(8), 476. DOI:10.3928/01484834-20120719-02. Describes the use of a pre-class podcast used to give information for an unfolding case study on a patient with a neuromuscular disorder completed in class. Information from the podcast was reviewed at the beginning of class and then students were given the unfolding case study. Class reconvened and answers to the case study reviewed. Students reported feeling actively involved in learning and that clinical decision making skills improved. Students wanted these more frequently in the course. Authors state that while unfolding case studies are time consuming to prepare, the benefits from active learning outweigh the time needed.
• Utterback, V., Davenport, D. Gallegos, B. & Boyd, E. (2012). The critical difference assignment: An innovative instructional method. Journal of Nursing Education, 51(1), 42-45. DOI:10.3928/01484834-20111116-03. Describes an assignment called the Critical Difference assignment where two case studies are given to students who must use reasoning to differentiate between the 2 cases. The cases have similar patient presentations but have differing and unknown underlying pathophysiologies. Students must compare and contrast symptoms, lab results, diagnostic studies to come to an understanding of the critical difference between the 2 cases and then develop a plan of care for each case based on the similarities and differences in the cases. These studies are called companion case studies and are purposely constructed so that students must discriminate between 2 similarly presenting patient problems. The outcomes from this type of learning are that the learner can learn by themselves, learn with others, share information, and make decisions. This mirrors the ability to work with others in the clinical setting. Excellent example of how to move students thinking to the next level. Again, would be interesting to see what students thought of experience as well as any objective measures of how this has helped initiate clinical judgment or improve abilities in clinical judgment.
• Priddy, K. & Crow, M. (2011). Clinical imagination: Dynamic cast studies using an attribute listing matrix. Journal of Nursing Education, 50(10), 591-594. DOI:10.3928/01484834-20110630-03. Describes how to develop and use a matrix for choosing elements of a case study so that they are randomly generated and students have differing elements with different outcomes. It allows for more opportunities to role model and richer discussion. The number of choices on the matrix can be based on the context and the problem at hand. This can be done based on developmental level of students and where they are in the nursing curriculum. It describes the steps of how to implement this in class in detail which is very helpful. The variety of options possible gives opportunity for great discussion and generation of nursing knowledge. Great example of what can be done in smaller groups as formative or summative evaluation. Would be difficult to do in a large lecture course. Again, no objective measures of how this has pushed students to think and engage.
• Bennett, C., Kennedy, S. & Donato, A. (2011). Preparing NP’s for primary care: Unraveling complexity with unfolding cases. Journal of Nursing Education, 50(6), 328-331. doi:10.3928/01484834-20110228-05. Describes the use of Backward Design (identifying desired results, identifying evidence of learning and developing teaching methods) to design a course for nurse practitioners in a behavioral health therapeutics course. Faculty developed cases that included an initial patient encounter and follow up encounter which were video taped with actors and complications of treatment or new problems were added at follow up visits. In the final step of Backward Design, creating teaching methods, the authors used Zull’s model of learning as brain change, which encourage innovative strategies to teach in context. There is an emphasis on reflection and iterative knowledge development. The authors found that students’ iterative thought processes advanced as they were able to practice as independent clinicians in a safe and collaborative environment. Course evaluations were done based on university requirements and therefore did not evaluate this method specifically, but they state that written feedback was overwhelmingly positive. Would be nice to see objective measures of advancement of clinical thinking, maybe samples of how grades improved over the semester or how pass rates on certification exams improved.
• Beyer, D. (2011). Reverse case study: To think like a nurse. Journal of Nursing Education, 50(1), 48-50.  doi:10.3928/01484834-20101029-06. Describes combining two active learning strategies, case studies and concept mapping into a reverse case study to promote critical thinking and problem solving. The article outlines a process for creating a reverse case study to be used in small groups. They are given a blank concept map with elements of the nursing process and patient history on it, but with no specific information other than a list of medications. Students work backward from that point to devise a list of anticipated medical problems the patient probably experiences and the care for these problems. The complexity of the cases can be manipulated by the number and type of medications. Groups then present their cases and priorities. This is a unique twist on the traditional case study. It could be done at every level of nursing education and development. A lab or discussion course would probably be best, not a class of 100+ students.
• Tanner, C. (2009). The case for cases: A pedagogy for developing habits of thought. Journal of Nursing Education, 48(6), 299-300.  An editorial that argues that the use of case based learning as a method that supports experiential thinking, clinical judgment and encourages students to “think like a nurse”. No information on actual work done in classroom.
• Sandstom, S. (2006). Use of case studies to teach diabetes and other chronic illnesses to nursing students. Journal of Nursing Education, 45(6), 229-232. Case studies increase learning by “placing” them in a situation where they must use or apply knowledge learned in the classroom. They are in a real world situation with decisions to make. The use of the example case study is done in the laboratory setting about diabetes as students are learning to draw up insulin and monitor blood glucose. Discusses 2 other assignments related to diabetes content that students are assigned. The article lacks depth about how the case studies are developed and why. No objective findings of student evaluation or learning other than the author’s recitation of what has been said in lab.
• Schlenker, E. & Kerber, C. (2006). The CARE case study method for teaching community health nursing. Journal of Nursing Education, 45(4), 144. Stands for Case study, Application, Research, Evaluation. Goal of this method is to facilitate understanding of theoretical content, foster interaction between faculty and students and knowledge sharing, give opportunities to apply knowledge in the classroom. Case studies are developed based on current topics in community health nursing and introduced during class time. Students work in small groups to answer clinical questions. The authors state that this has been well received by students who are motivated and excited to come to class and have done the prep work. There is no description of how the case studies are generated other than by choosing current topics in community health nursing, there is also no further discussion of how this method is used but a generic description. More detail would be helpful.
• Loving, G. & Siow, P. (2005). Use of an online case study template in nursing education. Journal of Nursing Education, 44(8), 387-388. The authors created a template to be used in online nursing courses that was based on interactivity and feedback for faculty to use in the design of case studies. It is a set of online forms that allows faculty to enter information. Students also work through this case study and click on multiple choice answers where feedback is given. This isn’t particularly helpful information. It doesn’t inform how the body of the case should be created, the elements, whether they should unfold and how or how the students interface with the case study in detail. 
• Tarcinale, M. (1987). The case study as a vicarious learning technique. Journal of Nursing Education, 26(8), 340-341. Discusses vicarious learning or learning through imagination, which I think now 30 years later would be experiential, or situational learning. The learner will use information from previous experiences to help solve current situational problems. Components of a case study are discussed (very helpful and one of only a few articles that do this). The placement of the case study in class depends on what it would be used for. Helpful information, but I think that the case study method has evolved quite a bit over time to include the reverse and unfolding case studies. However this is a good summary of how a basic case study can be used to bring abstract concepts to more concrete understanding.
• Page, J., Kowlowitz, V. & Alden, K. (2010). Development of a scripted unfolding case study focusing on delirium in older adults. The Journal of Continuing Education in Nursing, 41(5), 225-230. DOI:10.3928/00220124-20100423-05. The article begins by talking about how simulation is an important piece of practice based learning and that continuing education for nurses should incorporate more of it. The article then goes on to describe how to develop an unfolding case study. (might be splitting hairs, but case studies and simulation are not the same, many times simulation will use a case study, but sometimes it doesn’t. And not all uses of case studies are simulation. They don’t do a good job of connecting the two in the article) The steps for developing a case study for use are outlined as well as how to review it before implementing it. The authors present data on evaluation of the case by nurses who were involved in the continuing education. This is good information, detailed in the description of how the case can be developed, presented and evaluated.
• Jones, D. & Sheridan, M., (1999). A case study approach: Developing critical thinking skills in novice pediatric nurses. The Journal of Continuing Education in Nursing, 30(2), 75-78. Key component of nursing is problem solving, but not all nurses are good at it. The use of case studies promotes problem solving and critical thinking. They can be done with real or hypothetical situations. Provides an opportunity to enact in decision making when a real clinical situation isn’t available. In novice pediatric nurses, case studies reinforce what was learned in school but also introduce them to unique situations in family focused nursing. The article goes on to describe that case studies should include certain elements and gives and example. The article does not present data on how case studies have improved novice nurses comfort level or competence in working with families and children or if novice nurses found them useful during an orientation period.
• Smallheer, B. (2016). Reverse case study: A new perspective on an existing teaching strategy. Nurse Educator, 41(1), 7-8. DOI: 10.1097/NNE.0000000000000186. Traditional case studies can be limited to utilizing the lower portion of Blooms taxonomy, remembering, understanding, applying.  The reverse case study can engage students in higher parts of taxonomy: analyzing evaluating and creating. Students actually develop the scenario which means they must analyze and evaluate material in creating the materials and data for the case study. The article gives an example of a graded reverse case study done in a nursing pharmacology class. During the session, faculty observed collaboration, team work, prioritization and critical thinking. This type of case study refocuses students from being task oriented to being thinkers and planners. Would be an excellent process for lab or seminar group, clinical post conference group. May be difficult to do in a large class without splitting into groups. Again, wonder if there are any objective measures regarding student outcomes.
• Porter-Wenzlaff, L. (2013). Unfolding multicourse case study: Developing students administrative competencies. Nurse Educator, 38(6), 241-245. DOI: 10.1097/01.NNE.0000435263.15495.9f. The articles describes an unfolding case study that is done over 2 semesters in 2 courses. This is done in 2 graduate level nurse executive courses that are leveled. Students work in teams as the nurse executive of a fictional facility and must work through administrative complexities such as physician relations, resource allocation etc. Students are to do individual pieces of projects and come together and use the work in the larger objective. The projects progress across semesters and ideally students teams are the same as semesters change. The author recognized that students felt over whelmed and unprepared for this learning (and probably would have no matter the format) but found ways to help them work through by validating their concerns, having help available and that learning is an ongoing process. This paper does a great job of reporting anecdotal feedback from students, although it acknowledges there were no formal pre and post measures of implementation of this case study format.
• Harrison, E., (2012). How to develop well written case studies: The essential elements. Nurse Educator, 37(2), 67-70. DOI: 10.1097/NNE.0b013e3182461ba2. Briefly discusses the history of the use of case studies as educational tool in nursing. Suggests that case studies, much like narratives, should have a setting, characters, plot and elements of style that come together to create a mystery, a puzzle to be solved by the information given and knowing what additional information is needed. Students identify important data from that data that may be superfluous or not essential to the case. This is a unique way to describe a case study and how to create elements that nurses may forget, or not emphasize in their creation of case studies. Would be helpful to know if this paradigm has been used by others and if they found it effective.
• Henning, J.E., Nielsen, L.E. & Hauschildt, J.A. (2006). Implementing case study methodology in critical care nursing: a discourse analysis. Nurse Educator, 31(4):153-8. Describes a change in content delivery technique based on student feedback that lectures were boring and they wanted to experience more patient scenarios. Case study approach was adopted to increase interaction between teacher and students. Used method by Stepien et al. to analyze the case.  A model for discussion was then used with the case method which uses 3 types of discussion, 1. Frame the discussion where interest is generated and background information is given. 2. Conceptual discussion – teacher guides students in grasping concept 3. Application discussions where students discuss newly acquired knowledge is discussed as applied to scenarios. Using this method required that the teacher learn a new way to talk with or to students; had to learn how to elicit information from students and respond to them.  Student participation increased significantly with each addition of the next level of discussion where the teacher adjusted their questioning/cuing of students to elicit more response. They found that students spoke 2x as much as professor and both students and teacher seemed to become more comfortable with their new role as discussions went on. Very helpful in describing a way in which a classroom discussion can take place, one that elicits student participation and lets students guide the learning and morphs into a review discussion where the teacher makes sure that students understand the material accurately and use their discussion to apply newly acquired material.
• Ciesielka, D. (2003). Clues for clinicians: a case study approach to educating the renaissance nurse. Nurse Educator, 28(1), 3-4. Describes a way to integrate the humanities into a rigorous graduate curriculum already packed with science in order to prepare nurses to be able to work with patients of all cultures and social status. Developed Clues for Clinicians and used in the first clinical reasoning/clinical judgment course in nurse practitioner program. Instead of deriving cases from standard everyday clinical practice, cases were developed based on historical accounts. Faculty guided students in problem solving and students found themselves discussing the medical issue while also investigating a part of medical history.. Feedback was unanimously positive. I’m not convinced that this infuses humanities to the extent that the authors think it does, but it does keep interest and encourages student participation and reasoning as well as gives students something memorable to hang the information on. 
• Dowd, S.B. & Davidhizar, R. (1999). Using case studies to teach clinical problem-solving. Nurse Educator, 24(5), 42-6. Discusses advantages of using case studies to as well as preparation for faculty. Lists ways to prepare the case studies and how case studies can be solved.  Case studies connect theory to practice. They require preparation on the part of faculty and flexibility in allowing students to solve the case.
• Summary of findings: Most studies lack any data regarding student performance in clinical reasoning or judgment pre/post implementation of this method. While there is evidence that students find this method useful and engaging, no study presents findings that demonstrate that the case study method does what it’s purported to do. Studies discuss the preparation that must go into the case study development, that there are different ways of using the case study method (traditional, unfolding, reverse) and that students find them beneficial as well as how thinking is transformed to reach higher levels of Blooms Taxonomy. Almost all studies discuss case studies used in small groups or large classes broken into groups. None discuss how to lead a large class through a case and if/how this can engage students as well as improve their clinical reasoning. Only one articles discusses the use of an ongoing case that continues to the next semester, and this is for graduate students who are at a very different level of processing information than undergraduate students.

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Case Study | Definition, Examples & Methods

Published on 5 May 2022 by Shona McCombes . Revised on 30 January 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organisation, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating, and understanding different aspects of a research problem .

Table of contents

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyse the case.

A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

Prevent plagiarism, run a free check.

Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

• Provide new or unexpected insights into the subject
• Challenge or complicate existing assumptions and theories
• Propose practical courses of action to resolve a problem
• Open up new directions for future research

Unlike quantitative or experimental research, a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

If you find yourself aiming to simultaneously investigate and solve an issue, consider conducting action research . As its name suggests, action research conducts research and takes action at the same time, and is highly iterative and flexible. 

However, you can also choose a more common or representative case to exemplify a particular category, experience, or phenomenon.

While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:

• Exemplify a theory by showing how it explains the case under investigation
• Expand on a theory by uncovering new concepts and ideas that need to be incorporated
• Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews, observations, and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data .

The aim is to gain as thorough an understanding as possible of the case and its context.

In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis, with separate sections or chapters for the methods , results , and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyse its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

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What Is a Case Study?

Weighing the pros and cons of this method of research

Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

Cara Lustik is a fact-checker and copywriter.

Verywell / Colleen Tighe

• Pros and Cons

What Types of Case Studies Are Out There?

Where do you find data for a case study, how do i write a psychology case study.

A case study is an in-depth study of one person, group, or event. In a case study, nearly every aspect of the subject's life and history is analyzed to seek patterns and causes of behavior. Case studies can be used in many different fields, including psychology, medicine, education, anthropology, political science, and social work.

The point of a case study is to learn as much as possible about an individual or group so that the information can be generalized to many others. Unfortunately, case studies tend to be highly subjective, and it is sometimes difficult to generalize results to a larger population.

While case studies focus on a single individual or group, they follow a format similar to other types of psychology writing. If you are writing a case study, we got you—here are some rules of APA format to reference.  

At a Glance

A case study, or an in-depth study of a person, group, or event, can be a useful research tool when used wisely. In many cases, case studies are best used in situations where it would be difficult or impossible for you to conduct an experiment. They are helpful for looking at unique situations and allow researchers to gather a lot of˜ information about a specific individual or group of people. However, it's important to be cautious of any bias we draw from them as they are highly subjective.

What Are the Benefits and Limitations of Case Studies?

A case study can have its strengths and weaknesses. Researchers must consider these pros and cons before deciding if this type of study is appropriate for their needs.

One of the greatest advantages of a case study is that it allows researchers to investigate things that are often difficult or impossible to replicate in a lab. Some other benefits of a case study:

• Allows researchers to capture information on the 'how,' 'what,' and 'why,' of something that's implemented
• Gives researchers the chance to collect information on why one strategy might be chosen over another
• Permits researchers to develop hypotheses that can be explored in experimental research

On the other hand, a case study can have some drawbacks:

• It cannot necessarily be generalized to the larger population
• Cannot demonstrate cause and effect
• It may not be scientifically rigorous
• It can lead to bias

Researchers may choose to perform a case study if they want to explore a unique or recently discovered phenomenon. Through their insights, researchers develop additional ideas and study questions that might be explored in future studies.

It's important to remember that the insights from case studies cannot be used to determine cause-and-effect relationships between variables. However, case studies may be used to develop hypotheses that can then be addressed in experimental research.

Case Study Examples

There have been a number of notable case studies in the history of psychology. Much of  Freud's work and theories were developed through individual case studies. Some great examples of case studies in psychology include:

• Anna O : Anna O. was a pseudonym of a woman named Bertha Pappenheim, a patient of a physician named Josef Breuer. While she was never a patient of Freud's, Freud and Breuer discussed her case extensively. The woman was experiencing symptoms of a condition that was then known as hysteria and found that talking about her problems helped relieve her symptoms. Her case played an important part in the development of talk therapy as an approach to mental health treatment.
• Phineas Gage : Phineas Gage was a railroad employee who experienced a terrible accident in which an explosion sent a metal rod through his skull, damaging important portions of his brain. Gage recovered from his accident but was left with serious changes in both personality and behavior.
• Genie : Genie was a young girl subjected to horrific abuse and isolation. The case study of Genie allowed researchers to study whether language learning was possible, even after missing critical periods for language development. Her case also served as an example of how scientific research may interfere with treatment and lead to further abuse of vulnerable individuals.

Such cases demonstrate how case research can be used to study things that researchers could not replicate in experimental settings. In Genie's case, her horrific abuse denied her the opportunity to learn a language at critical points in her development.

This is clearly not something researchers could ethically replicate, but conducting a case study on Genie allowed researchers to study phenomena that are otherwise impossible to reproduce.

There are a few different types of case studies that psychologists and other researchers might use:

• Collective case studies : These involve studying a group of individuals. Researchers might study a group of people in a certain setting or look at an entire community. For example, psychologists might explore how access to resources in a community has affected the collective mental well-being of those who live there.
• Descriptive case studies : These involve starting with a descriptive theory. The subjects are then observed, and the information gathered is compared to the pre-existing theory.
• Explanatory case studies : These   are often used to do causal investigations. In other words, researchers are interested in looking at factors that may have caused certain things to occur.
• Exploratory case studies : These are sometimes used as a prelude to further, more in-depth research. This allows researchers to gather more information before developing their research questions and hypotheses .
• Instrumental case studies : These occur when the individual or group allows researchers to understand more than what is initially obvious to observers.
• Intrinsic case studies : This type of case study is when the researcher has a personal interest in the case. Jean Piaget's observations of his own children are good examples of how an intrinsic case study can contribute to the development of a psychological theory.

The three main case study types often used are intrinsic, instrumental, and collective. Intrinsic case studies are useful for learning about unique cases. Instrumental case studies help look at an individual to learn more about a broader issue. A collective case study can be useful for looking at several cases simultaneously.

The type of case study that psychology researchers use depends on the unique characteristics of the situation and the case itself.

There are a number of different sources and methods that researchers can use to gather information about an individual or group. Six major sources that have been identified by researchers are:

• Archival records : Census records, survey records, and name lists are examples of archival records.
• Direct observation : This strategy involves observing the subject, often in a natural setting . While an individual observer is sometimes used, it is more common to utilize a group of observers.
• Documents : Letters, newspaper articles, administrative records, etc., are the types of documents often used as sources.
• Interviews : Interviews are one of the most important methods for gathering information in case studies. An interview can involve structured survey questions or more open-ended questions.
• Participant observation : When the researcher serves as a participant in events and observes the actions and outcomes, it is called participant observation.
• Physical artifacts : Tools, objects, instruments, and other artifacts are often observed during a direct observation of the subject.

If you have been directed to write a case study for a psychology course, be sure to check with your instructor for any specific guidelines you need to follow. If you are writing your case study for a professional publication, check with the publisher for their specific guidelines for submitting a case study.

Here is a general outline of what should be included in a case study.

Section 1: A Case History

This section will have the following structure and content:

Background information : The first section of your paper will present your client's background. Include factors such as age, gender, work, health status, family mental health history, family and social relationships, drug and alcohol history, life difficulties, goals, and coping skills and weaknesses.

Description of the presenting problem : In the next section of your case study, you will describe the problem or symptoms that the client presented with.

Describe any physical, emotional, or sensory symptoms reported by the client. Thoughts, feelings, and perceptions related to the symptoms should also be noted. Any screening or diagnostic assessments that are used should also be described in detail and all scores reported.

Your diagnosis : Provide your diagnosis and give the appropriate Diagnostic and Statistical Manual code. Explain how you reached your diagnosis, how the client's symptoms fit the diagnostic criteria for the disorder(s), or any possible difficulties in reaching a diagnosis.

Section 2: Treatment Plan

This portion of the paper will address the chosen treatment for the condition. This might also include the theoretical basis for the chosen treatment or any other evidence that might exist to support why this approach was chosen.

• Cognitive behavioral approach : Explain how a cognitive behavioral therapist would approach treatment. Offer background information on cognitive behavioral therapy and describe the treatment sessions, client response, and outcome of this type of treatment. Make note of any difficulties or successes encountered by your client during treatment.
• Humanistic approach : Describe a humanistic approach that could be used to treat your client, such as client-centered therapy . Provide information on the type of treatment you chose, the client's reaction to the treatment, and the end result of this approach. Explain why the treatment was successful or unsuccessful.
• Psychoanalytic approach : Describe how a psychoanalytic therapist would view the client's problem. Provide some background on the psychoanalytic approach and cite relevant references. Explain how psychoanalytic therapy would be used to treat the client, how the client would respond to therapy, and the effectiveness of this treatment approach.
• Pharmacological approach : If treatment primarily involves the use of medications, explain which medications were used and why. Provide background on the effectiveness of these medications and how monotherapy may compare with an approach that combines medications with therapy or other treatments.

This section of a case study should also include information about the treatment goals, process, and outcomes.

When you are writing a case study, you should also include a section where you discuss the case study itself, including the strengths and limitiations of the study. You should note how the findings of your case study might support previous research. 

In your discussion section, you should also describe some of the implications of your case study. What ideas or findings might require further exploration? How might researchers go about exploring some of these questions in additional studies?

Need More Tips?

Here are a few additional pointers to keep in mind when formatting your case study:

• Never refer to the subject of your case study as "the client." Instead, use their name or a pseudonym.
• Read examples of case studies to gain an idea about the style and format.
• Remember to use APA format when citing references .

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach .  BMC Med Res Methodol . 2011;11:100.

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach . BMC Med Res Methodol . 2011 Jun 27;11:100. doi:10.1186/1471-2288-11-100

Gagnon, Yves-Chantal.  The Case Study as Research Method: A Practical Handbook . Canada, Chicago Review Press Incorporated DBA Independent Pub Group, 2010.

Yin, Robert K. Case Study Research and Applications: Design and Methods . United States, SAGE Publications, 2017.

By Kendra Cherry, MSEd Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

• Open access
• Published: 08 April 2024

Methods of determining optimal cut-point of diagnostic biomarkers with application of clinical data in ROC analysis: an update review

• Mojtaba Hassanzad 1 &
• Karimollah Hajian-Tilaki 2 , 3  

BMC Medical Research Methodology volume  24 , Article number:  84 ( 2024 ) Cite this article

Metrics details

Introduction

An important application of ROC analysis is the determination of the optimal cut-point for biomarkers in diagnostic studies. This comprehensive review provides a framework of cut-point election for biomarkers in diagnostic medicine.

Several methods were proposed for the selection of optional cut-points. The validity and precision of the proposed methods were discussed and the clinical application of the methods was illustrated with a practical example of clinical diagnostic data of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and malondialdehyde (MDA) for prediction of inflammatory bowel disease (IBD) patients using the NCSS software.

Our results in the clinical data suggested that for CRP and MDA, the calculated cut-points of the Youden index, Euclidean index, Product and Union index methods were consistent in predicting IBD patients, while for ESR, only the Euclidean and Product methods yielded similar estimates. However, the diagnostic odds ratio (DOR) method provided more extreme values for the optimal cut-point for all biomarkers analyzed.

Overall, the four methods including the Youden index, Euclidean index, Product, and IU can produce quite similar optimal cut-points for binormal pairs with the same variance. The cut-point determined with the Youden index may not agree with the other three methods in the case of skewed distributions while DOR does not produce valid informative cut-points. Therefore, more extensive Monte Carlo simulation studies are needed to investigate the conditions of test result distributions that may lead to inconsistent findings in clinical diagnostics.

Peer Review reports

One of the most important medical challenges is the clinical evaluation of diagnostic tests, which is of interest to clinical experts and statistical researchers. The gold standard methods are likely to be invasive and costly. Therefore, an evaluation of new diagnostic tests is very important. If the result of the diagnostic test is binary, sensitivity (Se) and specificity (Sp) are used as measures of the diagnostic accuracy. Se (true positive rate) refers to the probability of a positive test result for the persons with Target Condition (TC). The Sp (true negative rate) is the probability that the test result is negative, provided the person is without TF [ 1 , 2 , 3 ]. From a clinical perspective, in addition to Se and Sp, two other measures, the positive and negative predictive values, are of interest to clinicians. The negative predictive value (NPV) indicates the probability that a person is without TC if the test result is negative. The positive predictive value (PPV) denotes the probability of having TC if the test result is positive. The PPV and NPV are clinically important but they are influenced by the prevalence of TC in target population. Clinicians are interested in the PPV and NPV and want to assess the likelihood that a person is with TC or without TC based on the test results [ 2 , 3 ]. As a rule, the results of the gold standard status and the test are summarized in Fig.  1 as follows:

A summary of test result and its true condition

However, no longer diagnostic tests are confined to positive/negative results. Many biomarkers in laboratory tests yield results on a continuous scale. The Receiver Operator Characteristic (ROC) curve analysis is a method of choice to determine the diagnostic accuracy (area under the ROC curve-AUC) and partial area [ 3 ]. However, from clinical decision-making, it is interesting to define an optimal cut-point on continuous biomarkers. Several methods for optimal cut-point selection have been proposed [ 4 , 5 , 6 , 7 , 8 , 9 ]. The choice of priority between these methods is a matter of interest in clinical practice. Thus, the objective of this study was to provide an updated extensive review of ROC analysis and the methods of cut-point selection of biomarkers with application using clinical data. In the following sections, first, we provided an overview of ROC analysis for diagnostic biomarkers. In particular, we focused on the different methods of cut-point selection for laboratory diagnostic test. We illustrated the five popular methods of cut-point selection with clinical data. The consistency and inconsistency of findings were discussed depending on the distribution of test results in diseased and healthy populations.

Overview of ROC curve for quantitative biomarker

Many diagnostic markers in modern medicine are quantitative. Various cut-off points can be considered for them, from which the Se and Sp for each of the points are derived [ 1 ]. The trade-off between (1-Sp) and (Se) should be plotted on a coordinate system, and the process of changes in Se versus (1-Sp) is called the receiver operating characteristics (ROC) analysis curve [ 2 , 3 ]. This curve shows the diagnostic accuracy of the test and expresses clinically and statistically the area under the curve (AUC) of the diagnostic power of the test, which corresponds exactly to the Wilcoxon statistic [ 10 ]. Historically, this was used in radars during World War II to identify the point as a target or object (true positive or Se) amidst the clutter (FP or 1-Sp) on the ROC [ 11 , 12 ]. It was later used by Lusted in radiology to characterize pulmonary tuberculosis and to determine the correlation of FP and FN findings in several studies on the interpretation of chest radiographs and more recently in clinical epidemiology to determine the diagnostic accuracy of biomarkers [ 13 ]. This graph therefore clearly determines the presence or absence of the desired result for objects or persons. In the medical and statistical literature, this ROC curve is often used to evaluate the diagnostic significance of quantitative markers. However, the most important thing about the ROC curve is that it can be used to determine the optimal cut-off point for quantitative biomarkers.

The structure of the ROC graph was shown in Fig. 2 . The ROC graph is plotted in a 1 × 1 square, where the vertical axis corresponds to the Se rate, but the horizontal axis of this graph corresponds to the FP rate. Within this square, there is a curve and a diameter [ 3 , 14 ]. The lower left corner is Se = 0 & Sp = 1, i.e. the highest possible cut-off value of the test. As we move from the lower left corner to the upper right corner, the Se increases but the Sp decreases. As a result, the cut-off value gets lower and lower, and at the end of the upper right corner of the square, the Se and Sp are 1 and 0, respectively, i.e. the lowest possible cut-off value for this test [ 11 ]. The stricter the criteria for determining a positive result, the more points on the curve shift downwards and to the left. If, on the other hand, a looser criterion is applied, the point on the curve shifts upwards and to the right [ 15 ].

Empirical and smooth ROC curve

Interpretation of different shapes of ROC curve

If the ROC curve lies above the square diameter, this means that the test correctly determines the difference between the two target populations (healthy people, and sick people). The closer this curve is to the upper left corner, the better the diagnostic significance. Even if this curve is placed in the left-hand corner with the indication (0.1), the test has full diagnostic significance (Se = Sp = 1) [ 11 , 16 ]. If the curve is placed on the diameter, this means that the two identified populations have been randomly classified [ 11 , 16 ]. If the curve is below the diameter, this means that the test results are completely misleading. So the basic idea of this graph is that all points should be near the upper left corner. However, among all these points, we should look for the point with the best cut-off value, as this point is used to determine the threshold value for distinguishing between two healthy and diseased populations.

Area Under the Curve (AUC)

The area under the ROC curve is abbreviated as AUC. The AUC can be calculated either parametrically under binormal distributions (or other pairs of distributions of test results) [ 17 , 18 , 19 ] or nonparametrically (i.e. empirically, without making any distributional assumptions of test results) [ 18 , 19 , 20 ]. Several methods have been suggested to calculate the standard error of AUC either parametrically or nonparametrically. The other index is the partial area that might be interested at clinical relevant range of false positive [ 19 , 20 , 21 , 22 ]. The AUC is one of the indicators of diagnostic accuracy when comparing diagnostic tests in the ROC analysis. The AUC summarizes the entire position of the ROC curve and is not dependent on a specific operating point [ 3 ]. AUC is interpreted in the following two ways: The statistical concept of AUC is the probability that the criterion value of an individual randomly drawn from a population of individuals with a diseased condition is greater than the criterion value of another individual randomly drawn from a population of individuals with a healthy condition [ 18 ], or that it is interpreted as the mean true positive rate (average Se) over all possible FP rates. One of the purposes of the ROC curve is to compare two or more diagnostic tests in the ROC analysis. Of course, the higher the AUC value, the higher the accuracy of the test. The maximum value that the AUC can have is 1, which means that the diagnostic test correctly and completely distinguishes two populations (this is the case when the distribution of the test result for two populations, namely healthy and diseased, does not overlap at all). If the AUC is 0.5, this means that the differentiation is random and the ROC curve lies exactly on the square diameter.

Parametric and nonparametric AUC

The most popular parametric model is the binormal model that assumes the distributions of test results in a healthy and sick population follow a Gaussian distribution with different means and standard deviation. Based on this assumption, a smooth ROC curve can be driven, and the AUC can be calculated with a closed formula as follows:

Where, µ1, µ0 the mean of the diseased and healthy population and σ1, σ0 are the standard deviation of the diseased and healthy population respectively, and ϕ is, the cumulative standard normal distribution function.

The nice property of the ROC curve is that AUC is invariant to any monotonic transformation of the decision scale. However, binormal model is a theoretical model, and it is not observed in real life, in particular when the sample size is small. The alternative nonparametric approach is more practical for non-binormal data. The nonparametric Wilcoxon statistics provide an estimate of the trapezoidal role of AUC. Hajian-Tilaki and Hanley showed practical calculation of non-parametric AUC based on the pseudo-accuracy and its sampling variability [ 10 ]. This latter approach is more convenient for non-Gaussian data with a small sample size. For example, Fig. 2 provides binormal AUC (smooth cure) and nonparametric AUC (empirical AUC). However, as we pointed out already, the AUC is the Se averaged over all possible cutoffs and thus the comparison of two diagnostic tests based on AUC can be misleading when they are crossing each other and results in a wrong conclusion because the AUC is the sensitivity averaged over all possible cutoffs. In this situation, the Se at a given relevant range of FPF and at an optimal cut-point is interesting.

Main issues of performing diagnostic test

The main issues of diagnostic tests are how the test results will be used in real life (is the test for “rule in” or “rule out”, what is the target population? What are the next steps given the positive test results, and so on). Although the Youden index provides beautiful statistical properties and clinical interpretations, it may not be recommended in real life for cut-off selection because it assumes an equal weight for Se and Sp. For example, in a screening test for cancer, the false negative results are much more serious than false positive because the positive results usually should be confirmed by other tests and procedures. Medical diagnostic tests can have different indications for use as a diagnosis, prognosis, monitoring, risk assessment, treatment choice and so on. For example, for the “rule-out” test for cancer, a typical cutoff is a prespecified level of Se (for example, 99%) and a clinical acceptable level of Sp. Another issue of applying a diagnostic test for evaluation of Se and Sp is that a test should be applied from the same source to the target population. For example, for diagnosing Alzheimer's Disease (AD), the target population might be subjects with memory problems and with and without AD. If one calculates the Sp based on the “healthy” subjects, it provides a very biased estimation. We should emphasize that the best methods of cut-point selection with desirable statistical properties and clinically relevant, cannot solve the problems of design in performing diagnostic test. Another bias may arise with further work-up, when primarily the test result is negative. The results of a diagnostic test affect the gold standard test (or reference test) that is used to verify the test results. This type of bias sometimes called “verification bias” or “work-up bias”. The partial verification may occur when only those with a positive test receive the reference standard test and differential verification occurs where a different reference test is used depending on whether the preliminary test was positive or negative. Blinding work-up may reduce such bias.

Rationale of optimal cut-off value for quantitative diagnostic biomarkers

When a quantitative diagnostic test is performed, two groups cannot be completely distinguished due to the overlap of test results in the group of patients and healthy individuals [ 23 ]. An example: Imagine two hypothetical distributions that refer to a situation in which the average test result is 80 in the patient group and 60 in the non-patient group. If the cut-off value is set to 70 in this situation, people with the disease whose test result is below 70 are incorrectly classified as not having the disease (FN). However, if the doctor lowers the cut-off value to 65 in order to increase the Se of the test, the number of people who test positive increases (the Se increases), but the number of FP results also increases. In general, it is important to determine a cut-off value with adequate Se and Sp, as the use of less stringent criteria to increase Se leads to a trade-off in which Sp decreases.

Methods of determining optimal cut-off value

One of the most important applications of the ROC curve is the determination of the optimal cut-off value for quantitative biomarkers. The search for the optimal cut-off value is not only about maximizing Se and Sp but also about finding a suitable compromise between the two based on various criteria [ 11 ]. When a disease is highly contagious or associated with severe complications, Se is more important than Sp. In contrast, Sp is more important than Se when it comes to whether a test is expensive or risky. If there is no trade-off between Se and Sp, or if both are equally important, it makes the most sense to maximize both [ 11 ]. Several methods have been introduced to determine the optimal cut-off point, but some of them are very common and it should be noted that each of them has unique assumptions, and the selection of each one is based on the importance of the Se versus the Sp of the test. The most important of these methods are as follows:

Youden’s J statistic

Euclidean distance.

Index of union (IU)

Cost approach

Positive likelihood ratio (lr +) and negative likelihood ratio (lr–), maximum product of sensitivity and specificity, number needed to misdiagnose (nnm), analytical method.

Diagnosis Odds Ratio

Min P -Value

The Youden index uses the maximum vertical distance of the ROC curve from the point (X, Y) on the diagonal (random line). In fact, the Youden index maximizes the difference between the Se and FP rate, in other words, it maximizes the percentage of Net correct classification:

Therefore, the optimal cut-off point is calculated by maximizing Se + Sp at different cut-off points [ 15 , 23 ].

Another way to determine the optimal cut-off value is to use the Euclidean distance from the coordinates (0, 1) in the left corner of the ROC space. In this method, the optimal cut-off value is determined according to the basic principle that the AUC value should be maximum. Therefore, the distance between the coordinate (0, 1) and the ROC curve should be minimized. The Euclidean distance is defined as follows:

The point at which this value is minimized is considered the optimal cut-off value [ 3 , 23 ].

Index of Union (IU)

The Index of Union (IU) uses the absolute value difference between the diagnostic measure and the AUC value to minimize the misclassification rate, which is calculated using the following formula.

IU is a method to find the point at which Se and Sp are maximized simultaneously. This is similar to the Euclidean distance. The difference, however, is that it minimizes the absolute value differences between the AUC value and the diagnostic measurements (Se and Sp), and this index also minimizes the difference between Se and Sp. The cut-off point at which the IU is minimized is optimal. This method does not require complex calculations, as it only checks whether the Se and Sp at the optimal cut-off value are sufficiently close to the AUC values or not. Furthermore, in most cases, IU has a better diagnostic performance than other methods [ 5 ].

The cost approach is a method for determining the optimal cut-off value that takes into account the benefits of correct classification or the costs of misclassification. This method can be used when the costs of true positive (TP), true negative (TN), FP, and FN in a diagnostic test are known [ 24 ]. There are two ways to determine the cut-off value using the cost approach: to calculate the cost itself or use the cost index (f m ).

where Pr is the prevalence and C TN , C FP , C TP , and C FN refer to the costs of TNs, FPs, TPs, and FNs, respectively. These four costs should be mentioned in a common unit. When the cost index ( f m ) is maximized, the average cost is minimized, and this point is regarded as the optimal cut-off value [ 24 ].

Another method to determine the optimal cut-off value in terms of costs is to use the misclassification cost term (MCT). Considering only the prevalence of the disease, C FN, and C FP , the point at which the MCT is minimized is determined as the optimal cut-off value [ 6 , 23 ].

Positive likelihood ratio ( \(L{R}^{+}\) ) is the ratio of true positives to FPs and negative likelihood ratio ( \(L{R}^{-}\) ) is the ratio of FNs to true negatives. Researchers can choose a cut-off value that either maximizes \(L{R}^{+}\) or minimizes \(L{R}^{-}\) . The larger the \(L{R}^{+}\) is, the more information it has for the diagnostic test, but with the \(L{R}^{-}\) it is exactly the opposite: if it is close to zero, the test performs better [ 23 , 24 ].

In this method, the point at which the product of Se and Sp reaches the maximum is regarded as the optimal cut-off value [ 7 , 15 ].

This method refers to the number of patients in whom a misdiagnosis is estimated when a diagnostic test is performed. In other words: If number needed to misdiagnose (NNM) = 10, this means that ten people would need to be tested to find one misdiagnosed patient. The higher the NNM (maximize), the better the test performance [ 11 ].

This method is related to the NNM, with the difference that the NNM assumes that the costs of FP and FN are equal, but otherwise, there is a new formula where FN equals C equals FP, resulting in a weighted NNM. To find the most appropriate cut-off value, the weighted NNM can be maximized to account for both the proximity of test results to gold standard results and the cost of misdiagnosis (FP and FN) [ 11 ].

Diagnostic odds ratio (DOR)

The diagnostic odds ratio (DOR) is calculated by dividing the \(L{R}^{+}\) by the \(L{R}^{-}\) . By maximizing the LR + and minimizing the LR-, the optimal cut-off point can be determined. Note that the \(L{R}^{+}\) is between 0 and + ∞, but the \(L{R}^{-}\) is between 0 and 1. The DOR is between 0 and + ∞; if DOR = 1, it means that the DOR shows no relationship between the test results and the target conditions. But if both FP and FN are zero, the test has both Se and Sp of 100% [ 8 , 15 ].

The log(DOR) has an approximately normal distribution and with SE(LOG(DOR)) you can obtain a confidence interval for LOG(DOR) and then calculate the limit value of the confidence interval for DOR by subtracting the antilogarithm. Obviously, the lack of FP and FN data at a given cut-off value can lead to low accuracy of LOG(DOR) estimation [ 8 , 15 ]. The DOR has a disadvantage: it produces a very low or very high cut-off point. One of the limitations of the statistical behavior of DOR is that it is associated with a higher mean square error (MSE) in the right tail, resulting in an unstable measurement. Therefore, it is suggested to minimize the MSE instead of maximizing it. Hajian-Tilaki has presented a graphical method based on a study relying on the distribution of data over the population and shown that the DOR is not compatible with Youden and Euclid’s methods in determining the optimal cut-off point and is sometimes noninformative under certain conditions [ 15 ].

Minimum P -value approach (min P)

In this method, all cut-off points resulting from the trade-off between Se and FP are determined, the P -value is calculated for each of them and the point with the smallest P -value is selected as the optimal cut-off point [ 5 , 9 ]. Statistically, this P -value is driven from a chi-square distribution with one degree of freedom.

A review of performance of different methods of optimal cut-point

To compare different methods for determining the optimal cut-off point, various population-based and Monte Carlo simulation studies were conducted, the results of which are summarized in Table 1 . In the study by Hajian-Tilaki, the four methods were compared based on different distributions of data in patients and healthy individuals, including Youden's J-statistic, Euclidean distance, product of Se and Sp, and diagnostic odds ratio (DOR). Of these methods, only the DOR differed from the other methods. However, the cut-off point in other methods was almost similar and consistent under binormal distributions, but when using DOR, the cut-off point is too high or too low, which is not reliable. That is if the model was binormal with similar variances for two groups, the DOR metric curve was U-shaped, and maximizing it gives the optimal cut-off point on the extreme critical values. But when the variances were different, the DOR increased exponentially, so the optimal cut-off point was very high, but when the healthy group had more variance, the optimal cut-off point was very low; in the cases where the bilogistic model was considered to have equal variance, the DOR was fixed at different cut-off points, but in the case where the variance of the patient group was larger, it had a linear relationship (straight line) with a positive slope at different cut-off points, making the optimal cut-off point very high. As an advantage of ROC analysis for quantitative diagnostic tests, it is recommended to use the Youden index, the Euclidean index, or the product of Se and Sp to obtain optimal cut-off values [ 15 ].

In the Ünal simulation study, methods such as Youden's J-statistic, minimum P -value, maximum product of Se and Sp, Euclidean distance and IU were applied to the simulated data. By comparing MSE, relative bias, bootstrap SD, coverage and average length, it was found that IU and Euclidean distance determine the best cut-off point, but the author rather recommends IU due to its clinical significance and easier understanding for clinicians [ 5 ].

In the simulation study by Rota et al., the comparison and calculation of different methods for determining the optimal cut-off value was carried out in the form of a simulation, as in the Ünal study, with the difference that the IU method was not used. In the report on Euclidean distance, almost better performance in terms of MSE, bias, etc. was shown in estimating the optimal cut-off point, although the author did not declare this method as the best method for determining the optimal cut-off point [ 9 ].

Habibzadeh et al. used methods such as Se = Sp (this method determines the point corresponding to the optimal cut-off point resulting from the maximum product of Se by Sp), Bayesian approach, Youden's J-statistic, Euclidean distance, maximum weighted NNM, and an analytical method using Hooper et al.’s population-based distribution data [ 25 ]. They considered MCT and had information such as the cost of FP and FN and pretest probability, a more appropriate optimal cut-off point could be determined by maximum weighted NNM and analytical methods [ 11 ].

Perkins and Schisterman evaluated the Youden and Euclidean distance methods using population-based distribution data. Both methods reached almost the same optimal cut-off point, but in their study, the Youden method was recommended more due to its clinical concept, as it increases the rate of correct classification and decreases the rate of misclassification, although the Euclidean method has more geometric significance, less clinical significance and also maximizes the rate of misclassification [ 26 ].

Liu used simulation data with a normal distribution [ 7 ]. The Youden, Euclidian, and Product methods were used to determine the optimal cut-off point. The comparison criterion for these three methods was the MSE, which was lowest for the Product and Euclidian methods, while the Youden method had the highest MSE, especially when the classification accuracy was low [ 7 ].

Moreover, Gerke et al. utilized simulation data with four different scenarios, including the healthy and sick groups with two normal distributions with different mean and variance, the healthy group with normal distribution and the sick group with gamma distribution, and the last scenario in which the healthy group had an exponential distribution and the sick group had a gamma distribution. The Youden, Euclidean, and Product methods were used to calculate the true optimal cut-off value. The result was that these three methods had the same true optimal cut-off value only in the first scenario, in which the two groups were normally distributed but had different mean values (in the other scenarios, however, there was a difference of one hundredth) [ 27 ].

Statistical software for ROC curve analysis

Statistical programs used to perform ROC curve analysis included various commercial software programs such as IBM SPSS, MedCalc, SAS, Stata, and NCSS as well as open-source software (OSS) such as R and Metz-ROC [ 23 ]. IBM SPSS, the most widely used commercial software, can perform basic statistical analysis for ROC curves, such as plotting ROC curves and calculating AUC and CI with statistical tests, but it lacks the comparison of two correlated ROC curves. This output-based software does not report the optimal cut-off point, but only gives the non-parametric ROC curve, AUC, 95% CI, and test (H0: AUC = 0.5, H1: AUC ≠ 0.5). Stata provides several functions for analyzing ROC curves, including partial AUC (pAUC) [ 28 ], comparing multiple ROC curves, determining the optimal cut-off value using the Youden index, and comparing two or more output AUCs. MedCalc provides a sample size estimate for a single diagnostic test and includes various analysis methods to determine the optimal cut-off value, but does not provide a function to calculate pAUC. In terms of NCSS, this software can: generate empirical and binormal ROC curves, calculate AUC, determine the cut-off value, calculate other ROC curve performance criteria such as the Youden index and misclassification cost, plot the ROC curve and other diagnostic measures. SAS also has a number of functions for ROC analysis, including PROC ROC: This method can be used to generate ROC curves, calculate the AUC, and compare the AUCs of two ROC curves. PROC LOGISTIC: This method can be used to fit logistic regression models and then to create ROC curves. PROC NLMIXED: This method can be used to fit mixed non-linear models, which can then be used to create ROC curves. In contrast to commercial software packages, the program R is a free OSS that contains all functions for the analysis of ROC curves using packages such as ROCR, pROC and optimal cutpoints. Among the R packages, ROCR is one of the most comprehensive packages for ROC curve analysis and contains functions for calculating the AUC with CI. pROC can be used to compare the AUC with the pAUC of different methods and provides CI for Se, Sp, AUC, and pAUC. Similar to ROCR, pROC also offers some functions for determining the optimal cut-off value, which can be determined using the Youden index and the Euclidean index. Optimal cut-points is a sophisticated R package specifically designed to determine the optimal cut-off point value [ 6 ]. Although these R packages have a large number of functions, they require good programming knowledge of the R language. A web tool for R-based ROC curve analysis, which includes easy ROC and plotROC, is a web-based program that uses the R packages such as plyr, pROC, and optimal cut-points to perform ROC curve analysis and extends the functionality of several ROC packages in R so that researchers can perform ROC curve analysis through an easy-to-use interface without having to write R code [ 29 , 30 ].

An illustration of different methods of cut-point selection with clinical data

In a clinical study of diagnostic accuracy of biomarkers, 30 patients of IBD and 30 healthy individuals were recruited based on pathologic examination [ 31 ]. The target population was patients who were referred to the outpatient clinics for their check-up for diagnosis of IBD. It was similar that physicians need to discriminate between IBD and healthy individuals in real life. All suspected patients underwent colonoscopy for pathology examination as gold standard. Then, blood samples were taken for all subjects to measure three biomarkers blindly including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and malondialdehyde (MDA), were collected from 30 patients with inflammatory bowel disease (IBD) and 30 healthy control The equal sample size of IBD patients and healthy subjects were taken in order to achieve a higher statistical power of testing diagnostic accuracy. This 50% prevalence of IBD patients in our dataset does not influence the sensitivity and specificity of diagnostic biomarkers and thus it is not distorted the cut-point selection because the criteria for cut-point selection for all methods based on the sensitivity and specificity not based on PPV and NPV.

In our analysis, we applied the nonparametric ROC analysis to derive the AUC of different biomarkers and their 95% confidence interval (CI) in predicting IBD. The diagnostic accuracy of each biomarker in predicting IBD and the optimal cut-off point were calculated with 5 different methods for each biomarker using NCSS software. In addition, R software was also used to draw the density plot. The Youden index, Product, Euclidian, and IU, and DOR methods were used to determine the optimal cut-off point.

Figure 3 displays the density plot of the pairs of distributions of three biomarkers including CRP, ESR, and MDA in IBD patients and healthy individuals. The distribution of CRP in healthy people was normal, but in IBD patients it had a large tail and extension on the right side and was skewed. ESR was elongated on the right side in both patients and healthy individuals. On description, the degree of elongation and skewness was greater in patients than in healthy individuals. The MDA value suggested a bimodal distribution in both patients and healthy subjects.

The density plot of the pairs of distributions of CRP, ESR, and MDA in the diseased (IBD) and the nondiseased individuals

Table 2 and Fig. 4 demonstrate the nonparametric ROC curves that all three biomarkers have significant predictive power, but CRP has a higher diagnostic accuracy than MDA and ESR. Table 3 indicates that the three Youden, Euclid, and Product methods have the same optimal cut-off point for CRP. As a result, Se and Sp were the same, and the IU estimated the cut-off point to be slightly below 6 mg/L. But the cut-off point of the DOR was at the upper extreme. Table 4 illustrates that the optimal cut-off point for the ESR is completely identical for the three Euclidian, Product, and IU methods, but differs significantly for the Youden method. The Youden method determined higher values (39 mm/h) for the ESR, which had a low Se. In contrast, the DOR method showed a limit value for the cut-off point. This obtained cut-off point had a high DOR, but compared to the Sp (Sp = 0.97), the Se (Se = 0.22) of this point was low. Table 5 represents that the optimal cut-off point for MAD is the same for the Euclidian, Product, and IU methods (1.7 μmol/L), but higher for the Youden method (2.1 μmol/L) with Se = 0.50 and Sp = 0.93. In contrast, the cut-off point of the DOR was higher (2.3 μmol/L), meaning that the DOR was maximal but had a low Se.

Nonparametric ROC curve of three Biomarkers of CRP, ESR and MDA in predicting IBD patients

Defining the optimal cut-points for quantitative biomarkers plays a crucial role in clinical decision-making in diagnostic medicine. ROC analysis is an optional choice for determining the optimal cut-off value. However, there is no single standard method to determine the optional cut-off value of biomarkers. As illustrated in this comprehensive review, several methods have been proposed in the context of ROC analysis. The best known is the Youden index due to its clinical interpretation, which maximizes the proportion of correct classification after correcting for the random level. In some scenarios of the underlying distributions of biomarkers, especially for binormal distributions with equal variance, the Euclidean index, which maximizes the points on the ROC curve from the left corner of the ROC space at (0,1), may be more accurate than the Youden index [ 9 ], but these two methods gave a similar estimate of the cut-point in the ROC space in the above scenario [ 15 ].

Our findings in clinical investigation of biomarkers in IBD patients showed that the density function of ESR and CRP was skewed to the right tail, but not the distribution of CRP in healthy individuals. While the density function of MDA indicated a bimodal shape in both IBD patients and healthy individuals. Despite the presence of bimodal shapes and a right-skewed distribution, the three Euclidean, Product and IU metrics yielded quite similar estimates of the optimal cut-off points, but the Youden index yielded a higher cut-off value. The greatest inconsistency was found in DOR compared to other metrics. It always yielded the optimal cut-point in the critical tail. Our findings are in accordance with the results of other studies [ 15 , 32 ]. The inconsistency of the results of DOR is related to the convex distribution of log(DOR) as a ratio metric. In particular, for a pair of Gaussian distributions, the metric of log(DOR) is U-shaped across different cut-points [ 15 , 32 ].

In several studies, population-based biomarker distributions and Monte Carlo simulation studies with repeated samples have shown that the three Youden, Euclidean and Product methods yield similar estimates of cut-points under certain conditions of Gaussian distributions [ 15 ]. However, log(DOR) results in a higher/extreme value of the cut-point, which has very low validity and reliability. Hajian–Tilaki investigated the population distribution based on test results and suggested in some scenarios of the data from the bilogistic model in diseased and non-diseased individuals that log(DOR) itself is noninformative and its metric is flat across the value of the different cut-points [ 15 ].

For the clinical practice of determining cut-points, sample data were used in the current study to illustrate the practical application of the NCSS software in cut-point selection. Software has been developed for cut-point selection in clinical research as described in this detailed review. The SPSS software does not offer this calculation directly. The R software in the ROC analysis library does offer these optimal cut-points, but may be more specialized and less familiar to clinicians. In our experience, a practitioner can use the NCSS software to create an estimate of the optimal cut-points using at least five methods in the ROC analysis: Youden index, Euclidean index, Product method, IU and DOR.

The present study provided a practical example and indicated how the optimal cut-points can be calculated in clinical research. We have shown that in some scenarios, the four common methods for selecting optional cut-points can lead to identical results. However, the inconsistency of cut-point selection is possible in some other conditions of test results with skew distributions or bimodal form.

The results of the ongoing study on the clinical example of biomarker data for prediction of IBD represented that the four Youden, Euclidean, Product of Se and Sp and IU methods gave a similar cut-point for CRP, but DOR gave a higher value for cut-point selection. Nevertheless, for ESR and MAD, the Youden index gave different results than Euclidean, Product and IU methods. This inconsistency may depend in part on the underlying distributions of test scores in diseased and healthy populations that we have shown the density function of test results with graphical presentation. The higher degree of skewness and heterogeneous variance may lead to greater inconsistency in the results. In our example, the extreme value of the cut-point of DOR can be explained by the convex distribution of log(DOR) as a ratio criterion. This result is consistent with other findings in the selection of cut-points [ 32 ]. Thus, extensive Monte Carlo simulation studies are needed to explore the conditions for the distribution of test results that may lead to inconsistent results by different methods for the cut-point in the evaluation of clinical diagnostic tests. We had a small sample dataset and all data was used for training model. Thus, our study may limit to lack of external dataset for cross-validation of diagnostic performance of calculated optimal cut-points with different methods because the diagnostic performance of selected cut-points was calculated with training dataset only.

Overall, the four methods including Youden index, Euclidean index, Product, and IU can produce quite similar optimal cut-points for binormal pairs with the same variance. The cut-point determined with the Youden index may not agree with the other three methods in the case of skewed distributions while DOR may not produce valid informative cut-points. Therefore, more extensive Monte Carlo simulation studies are needed to investigate the conditions of test result distributions that may lead to inconsistent results in clinical diagnostics.

Availability of data and materials

Data cannot be shared openly but are available on request from corresponding author.

Abbreviations

Receiver operator characteristics

Nondiseased

Sensitivity

Specificity

Negative predictive value

Positive predictive value

True positive fraction

True negative fraction

False negative fraction

False positive fraction

Area under the curve

• Index of union
• Diagnostic odds ratio

Positive likelihood ratio

Negative likelihood ratio

Number needed to mis diagnosed

Partial area

Inflammatory bowel disease

C-reactive protein

Malondialdehyde

Erythrocyte sedimentation

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Hassanzad, M., Hajian-Tilaki, K. Methods of determining optimal cut-point of diagnostic biomarkers with application of clinical data in ROC analysis: an update review. BMC Med Res Methodol 24 , 84 (2024). https://doi.org/10.1186/s12874-024-02198-2

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Application of flipped classroom teaching method based on ADDIE concept in clinical teaching for neurology residents

• Juan Zhang 1 ,
• Hong Chen 2 ,
• Xie Wang 2 ,
• Xiaofeng Huang 1 &
• Daojun Xie 1  

BMC Medical Education volume  24 , Article number:  366 ( 2024 ) Cite this article

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As an important medical personnel training system in China, standardized residency training plays an important role in enriching residents’ clinical experience, improving their ability to communicate with patients and their clinical expertise. The difficulty of teaching neurology lies in the fact that there are many types of diseases, complicated conditions, and strong specialisation, which puts higher requirements on residents’ independent learning ability, the cultivation of critical thinking, and the learning effect. Based on the concept of ADDIE (Analysis-Design-Development-Implementation-Evaluation), this study combines the theory and clinical practice of flipped classroom teaching method to evaluate the teaching effect, so as to provide a basis and reference for the implementation of flipped classroom in the future of neurology residency training teaching.

The participants of the study were 90 neurology residents in standardised training in our hospital in the classes of 2019 and 2020. A total of 90 residents were divided into a control group and an observation group of 45 cases each using the random number table method. The control group used traditional teaching methods, including problem based learning (PBL), case-based learning (CBL), and lecture-based learning (LBL). The observation group adopted the flipped classroom teaching method based on the ADDIE teaching concept. A unified assessment of the learning outcomes of the residents was conducted before they left the department in the fourth week, including the assessment of theoretical and skill knowledge, the assessment of independent learning ability, the assessment of critical thinking ability, and the assessment of clinical practice ability. Finally, the overall quality of teaching was assessed.

The theoretical and clinical skills assessment scores achieved by the observation group were significantly higher than those of the control group, and the results were statistically significant ( P  < 0.001). The scores of independent learning ability and critical thinking ability of the observation group were better than those of the control group, showing statistically significant differences ( P  < 0.001). The observation group was better than the control group in all indicators in terms of Mini-Cex score ( P  < 0.05). In addition, the observation group had better teaching quality compared to the control group ( P  < 0.001).

Based on the concept of ADDIE combined with flipped classroom teaching method can effectively improve the teaching effect of standardized training of neurology residents, and had a positive effect on the improvement of residents’ autonomous learning ability, critical thinking ability, theoretical knowledge and clinical comprehensive ability.

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Introduction

As an important medical education system, the standardized residency training system is of great significance in China’s clinical medical training system [ 1 – 2 ]. In order to continuously improve the clinical medical talent training system and build a talent training system with clinical medical characteristics, China began to implement the resident standardized training system in 2014. Under the standardized clinical teaching plan, residents can achieve the requirements and objectives of multidisciplinary training required by the primary professional title through rotational learning and clinical teaching evaluation among various departments [ 3 ]. The implementation of the system not only greatly improves the professional ability of clinical medical staff, but also effectively saves medical resources and costs. However, neurology diseases are relatively abstruse and complex, with many critical diseases and strong professionalism, which requires physicians to have better autonomous learning ability, richer knowledge reserve and clinical emergency problem-solving ability.

The ADDIE model consists of five components: analysis, design, development, implementation, and evaluation [ 4 ]. The ADDIE teaching theory, as a new type of teaching theory, focuses on the needs and goals of the students. It allows the teacher to be the decision maker for learning [ 5 ], to set and develop the necessary learning steps and to implement them effectively by analysing the main learning objectives of the students and taking into account the students’ own realities. Learning effectiveness is checked through appropriate clinical teaching practice sessions to assess whether the learning requirements have been met, and it helps students to enhance their understanding of the learning content. It not only improves the educator’s ability to teach, but most importantly, the effectiveness of the students’ learning is also improved. Gagne instructional design method is mainly composed of nine learning events, such as training attention, informing learner of objectives, stimulating recall of prior learning, presenting stimulus, and providing learning guidance [ 6 ]. Compared with Gagne teaching design method, ADDIE model teaching method has the advantages of simple steps and easy implementation, and is often used in medical education design. Lucia et al. [ 7 ] used ADDIE model to develop the basic life support course in the process of adult cardiac arrest related surgery. Under the guidance of this theory, it not only realized the technical innovation in cardiopulmonary resuscitation education and systematization, but also had important positive significance for medical education. Maya et al. [ 8 ] developed and implemented the covid-19 elective course for pediatric residents by using the idea of ADDIE teaching. As an effective teaching method, this course provides necessary disaster response and flexible education for pediatric residents. Therefore, the teaching concept plays an important role in medical education.

Flipped classroom [ 9 ] was first popularised in the United States, where people advocated homework to replace the classroom learning format, and has gradually been applied to the medical education business in recent years [ 10 ]. It is different from traditional teaching. As an emerging mode of teaching, it advocates a student-centred approach, whereby the teacher prepares teaching videos or materials through an online platform and sends the materials to the students in a uniform manner before the students arrange their own study plan and time [ 11 – 12 ]. Therefore, this model is not limited by time and place, and students can learn according to their own situation and their own speed. When encountering difficult points, students can also watch the video repeatedly, interact and discuss with other students, or organise the questions and feedback them to the teacher for one-by-one answers.

Therefore, the flipped classroom teaching method based on AddIE teaching concept can formulate and implement the corresponding learning and training plan in combination with the clinical teaching needs of standardized training of neurology residents and the actual situation at this stage, encourage students to independently arrange learning time, and give the initiative of learning to students, so as to overcome the disadvantages of tight classroom time, heavy tasks, and students’ inability to study and think deeply in traditional medical teaching, which has a positive effect on the cultivation of students’ autonomous learning ability, the formation of critical thinking ability, and the improvement of professional knowledge and clinical comprehensive ability. Mini-CEX (Mini clinical exercise assessment) is considered to be an effective method for evaluating the clinical ability and teaching function of residents [ 13 ]. In this study, the theoretical and technical knowledge, autonomous learning ability and critical thinking ability were evaluated and scored, and the clinical comprehensive ability of residents was evaluated by mini CEX method, so as to provide a comprehensive and objective evaluation for clinical teaching results. This study is an exploration of medical clinical education mode, in order to provide reference for clinical teaching mode of standardized training of residents.

Materials and methods

Study design.

A prospective controlled experimental design of research was used in this study.

Participants

The participants of the study were 90 residents of the classes of 2019 and 2020 participating in the standardized residency training in the Department of Neurology of our hospital. Random number table method was used to divide 90 residents into control group and observation group with 45 residents in each group. There were 21 males and 24 females in the control group, aged 23–28 (25.40 ± 2.78) years. The observation group consisted of 23 males and 22 females, aged 22–27 (24.37 ± 2.59) years. All subjects signed an informed consent form. By comparing the general data of the residents in both groups, the results suggested no statistical significance ( p  > 0.05).

Training methods

Both groups of residents underwent a one-month standardized residency training in the Department of Neurology. During the training period, the instructors trained the residents according to the standardized residency training syllabus, which mainly included theoretical learning and skills operation. The two groups of teachers were.

randomly assigned and the quality of teaching was monitored by the department head.

Control group

The group adopted traditional teaching methods, including problem-based learning (PBL), case-based learning (CBL) and lecture based learning (LBL). PBL refers to a problem-oriented teaching method in which students seek solutions around problems [ 14 ]. CBL refers to the case-based teaching method, that is, to design cases according to teaching objectives, take teachers as the leading role, and let students think, analyze and discuss [ 15 ]. LBL refers to the traditional teaching method [ 16 ]. In the first week of enrollment, teachers will conduct unified enrollment assessment, enrollment education and popularization of basic knowledge of Neurology. The second week is mainly based on the traditional LBL teaching method, mainly for common diseases in the Department of Neurology, including ward round, bedside physical examination, auxiliary examination analysis, and putting forward the diagnosis basis and treatment plan. In the third week, CBL teaching method is mainly used to consolidate the knowledge learned through case study. In the fourth week, PBL teaching method is mainly used to promote problem learning and knowledge understanding by asking and answering questions. The learning outcomes were evaluated before leaving the department four weeks later. The detailed process was shown in Fig.  1 .

Flow chart of resident training process for two groups

Observation group

This group adopted the flipped classroom teaching method based on the ADDIE teaching concept. The training content of the first week was the same as that of the control group. From the second to the fourth week, the flipped classroom teaching method based on the ADDIE teaching concept was adopted, with a total of 38 class hours. By analysing the content of the syllabus and the actual situation of the subjects, we designed and developed a characteristic and targeted teaching programme and implemented it, and conducted a unified assessment of the learning outcomes before the residents left the department in the fourth week. The concrete programme is shown in Table  1 .

Step 1: composition of the teaching team

The members of the teaching team included a department head, 10 neurology lead teachers, and two non-neurology ADDIE specialists. The department chair is responsible for overseeing the overall quality of teaching, and the instructors are responsible for the teaching and learning of all students and the assessment of their outcomes. The ADDIE experts integrate the ADDIE concepts into the clinical learning curriculum plan of the standardised residency training according to the specific arrangement and actual situation of the curriculum.

Step 2: setting of teaching objectives

The teaching objectives of standardised training for neurology residents mainly include the following aspects: (1) To understand and master common neurological diseases and their diagnosis and treatment processes, such as migraine, tension headache, benign paroxysmal positional vertigo, peripheral facial palsy, Parkinson’s disease, posterior circulation ischemia, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, epilepsy, etc.; (2) To understand and master systematic physical examination of the neurological system methods; (3) Proficiency in performing skillful operations related to neurological diseases, including lumbar puncture, etc.; (4) Familiarity with the management process of common neurological emergencies, including acute-phase cerebral infarction, acute-phase cerebral haemorrhage, and epileptic status persistent, etc.; and (5) Improvement of the resident’s ability of communicating with the team, collaborating with the team, communicating with the patients and the ability of dealing with the emergency problems on a temporary basis.

Step 3: concrete teaching plan

With the unanimous agreement and unremitting efforts of the teaching team, the curriculum and methodology for the standardised training of residents in the flipped classroom based on the ADDIE teaching concept was finalised. The teaching plan will be carried out in 5 steps, as shown in Table  1 .

Step 4: implementation of flipped classroom teaching method based on ADDIE teaching philosophy

Project analysis.

The final teaching task of this training mainly includes two aspects: (1) To complete all the teaching objectives set above; (2) To improve the residents’ comprehensive clinical ability in the process. Before the start of the training through the questionnaire form of the resident’s knowledge base of neurological specialities for the initial assessment, which helps to understand the current learning situation of the students, in order to facilitate the tailored teaching. At the same time, the main teaching tasks and teaching objectives were combined to analyse the specific form and content of the project, so as to develop a more practical and targeted programme.

Project design

The specific content of the project mainly includes: (1) Admission assessment: after admission to the department, all residents will conduct a unified admission mission and popularise the basic knowledge of neurology; (2) Flipped classroom teaching method: before the class, the leading teacher will analyse and sort out the common neurology diseases and their diagnosis and treatment processes according to the disease types based on the requirements of the syllabus, make a good teaching plan, and study a disease type at a time. Teachers will send teaching resources including PPT, video, cases, literature, etc. to the social platform. At the same time, they put forward the content and requirements to be mastered, and put forward 3–5 questions for students to think about in accordance with the focus of the teaching. Students can arrange their own study time, group themselves and have group discussions to try to solve the problems, and they can also ask questions to the teaching staff through the social platform at any time. Students can choose to go to the library or check the relevant literature on the Internet to expand their knowledge. In this session, knowledge transfer is completed; (3) Bedside practice teaching: the teacher communicates with the patient in advance, so that the students can conduct bedside questioning of medical history, physical examination, auxiliary examination and analysis. The diagnosis and diagnostic basis are proposed, and the teacher observes and assists the whole process.

Project development

After the teacher has finished the theoretical learning and practical teaching, he/she will ask targeted questions, pointing out what the students have done well and what needs to be improved in the process of questioning and treating the patients. At the same time, specific learning tasks are assigned for different students. Students are encouraged to report to the teacher about the patient’s condition and treatment plan, and propose their own treatment ideas. They are also allowed to ask the teacher any questions or problems that they cannot solve during the consultation. This teaching method is of great significance for students to master the theoretical knowledge of diseases and cultivate their clinical thinking.

Project implementation

Through the teaching team’s development of a specific and detailed teaching programme, methods such as entrance examination, flipped classroom teaching method, bedside practical teaching, and special case discussion were adopted. When encountering problems, students take the initiative to consult the literature and information or solve the problems independently through group discussion. If the problem cannot be solved, the students will seek help from the teachers, in order to practice students’ independent learning, teamwork and clinical diagnosis and treatment thinking ability.

Programme assessment

Students are assessed on their theoretical and professional skills knowledge at the end of the programme training. Students’ independent learning ability, critical thinking ability, clinical practice ability are assessed using relevant assessment methods, and finally the overall teaching quality is assessed, after which the teacher comments and summarises the results of the assessment.

Observation indicators

Theory and skill knowledge assessment.

This assessment includes two parts: theory and skill operation. The theoretical assessment mainly consists of the basic knowledge of neurology and the diagnosis and treatment process and medication of common neurology diseases. Skill operation involves lumbar puncture, thoracentesis, abdominal puncture, cardiopulmonary resuscitation, and other necessary items. The theory and skill operation parts were each worth 50 points, totalling 100 points. Unified assessment and grading will be conducted by the teachers.

Self-directed learning ability assessment scale

After the fourth week of training, the self-learning ability assessment form [ 17 ] was used to assess residents’ self-learning ability. The main contents include self motivation belief and objective behavior. Self motivation belief also includes self motivation (5 items) and learning belief (3 items). Objective behavior mainly includes four aspects: making learning goals and plans (4 items), self-monitoring and adjustment (7 items), obtaining and processing information (4 items) and communication and cooperation ability (7 items). The Likert scale [ 18 ] is used for a 5-level response system, which includes 5 levels of “completely non compliant”, “basically non compliant”, “average”, “basically compliant”, and “completely compliant”. The corresponding scores are 1 point, 2 point, 3 point, 4 point, and 5 point, with a total score of 150 points. The level of the score is positively correlated with the strength of autonomous learning ability. The Cronbach’s alpha coefficient was 0.929, the split half reliability was 0.892, and the content validity index was 0.970, indicating that the scale has good internal consistency, reliability and validity.

Critical thinking skills assessment scale

The Critical Thinking Skills Assessment Scale [ 19 ], which consists of seven dimensions, namely, truth-seeking, open-mindedness, analytical ability, and systematisation, with 10 items for each dimension, was used for the assessment at the end of the fourth week of training. A 6-point scale was used, ranging from “Strongly Disagree” to “Strongly Agree”, with scores ranging from 1 to 6, and the opposite for negative responses. The total score of the scale is 70–420, where ≤ 210 indicates negative performance, 211–279 indicates neutral performance, 280–349 indicates positive performance, and ≥ 350 indicates strong critical thinking skills. The Cronbach’s alpha coefficient was 0.90, the content validity index was 0.89, and the reliability was 0.90, indicating that the internal consistency, reliability and validity were good.

Clinical practice competence assessment

Clinical practice competence was assessed at the end of the fourth week of training using the mini-CEX scale [ 20 ], which included the following seven aspects: medical interview, physical examination, humanistic care, clinical diagnosis, communication skills, organisational effectiveness, and overall performance. Each aspect is rated from 1 to 9: 1 to 3 as “unqualified”; 4 to 6 as “qualified”; and 7 to 9 as “excellent”. The Cronbach’s alpha coefficient of the scale was 0.780, and the split-half reliability coefficient was 0.842, indicating that the internal consistency and reliability of the scale were relatively high.

Teaching quality assessment

Teaching quality assessment was conducted at the end of the fourth week of assessment, using the teaching quality assessment scale [ 21 ]. The specific content includes five aspects: teaching attitude, teaching method, teaching content, teaching characteristics, and teaching effect. The Likert 5-point scale was used, and the rating was positively correlated with the quality of teaching. The Cronbach’s alpha coefficient was 0.85 and the reliability was 0.83, which showed good reliability and validity.

Data analysis

SPSS 23.0 statistical software was used to analyse the data. Measurement information was expressed as mean ± standard deviation ( \( \bar x \pm \,S \) ), and t-test was used for comparison between groups. Comparison of the unordered data between the two groups was performed using the χ2 test, or Fisher’s exact method. p -value < 0.05 was considered a statistically significant difference.

The scores and statistical analysis results of theory, skill assessment, self-learning ability assessment, critical thinking ability assessment of the two groups of students were shown in Table  2 . The results of mini CEX assessment and statistical analysis were shown in Table  3 . The results of teaching quality assessment and statistical analysis were shown in Table  4 .

The standardised training of residents is an important medical personnel training system in China. It is a key link in the training of high-quality residents, which requires clinicians to have not only solid clinical expertise, but also noble medical character to better serve patients in outpatient and inpatient medical work. In recent years, due to the continuous development of China’s economic level, people’s demand for health is also increasing. Neurological system diseases are diverse, and certain diseases such as acute cerebrovascular disease, epilepsy, central nervous system infections, acute disseminated encephalomyelitis, Guillain-Barré, etc., have an acute onset and a rapid change in condition, which requires neurology residents to accurately identify and manage certain neurological emergencies and serious illnesses at an early stage. It puts forward higher requirements on the basic quality of neurology residents and brings more challenges to the clinical teaching of standardised neurology residency training. Therefore, the traditional teaching methods can no longer meet the current teaching requirements put forward under the new situation and new policies. Only by continuously improving and innovating the clinical teaching methods and improving the quality of teaching can the professional quality construction and training quality of residents be improved [ 22 ].

This study found that through four weeks’ teaching assessment, the theoretical and clinical skills assessment scores of the observation group were significantly higher than those of the control group, and the results were statistically significant ( P  < 0.001). Meanwhile, the scores of autonomous learning ability and critical thinking ability of the observation group were also better than those of the control group, with statistically significant differences ( P  < 0.001). In terms of Mini-Cex assessment, the observation group had better scores than the control group both in medical interview and physical examination ( P  < 0.01) and in humanistic care, clinical diagnosis, communication skills, organisational effectiveness, and overall performance ( P  < 0.05). In addition, the observation group also had higher scores compared to the control group regarding the quality of teaching in this study ( P  < 0.001). Previous studies have shown that the ADDIE concept can be applied to the design of clinical ethics education programmes and can be an effective tool for healthcare education, providing an established structure for the development of educational programmes [ 23 ]. Saeidnia [ 24 ] et al. used the ADDIE model to develop and design an educational application for COVID-19 self-prevention, self-care educational application to help people learn self-care skills at home during isolation, which can be used as an effective tool against COVID-19 to some extent. For the sake of reducing postoperative complications of breast cancer, Aydin [ 25 ] and others designed and developed a mobile application to support self-care of patients after breast cancer surgery with the support of the ADDIE model concept, which can provide professional medical guidance and advice for postoperative patients and is widely used in both education and clinical settings. Therefore, the ADDIE model concept has not only achieved better outcomes in the design of medical education, but also played a positive role in all aspects of disease prevention guidance and postoperative care.

As a flexible, targeted and effective new teaching method, flipped classroom method has been studied by many scholars in the field of basic medicine and clinical education. Pual [ 26 ] et al. found that the flipped classroom method was more effective for teaching clinical skills by comparing the two methods of course implementation, flipped teaching and online teaching. Du [ 27 ] and others found that a fully online flipped classroom approach increased classroom participation and adequate student-faculty interaction in distance education, and improved overall medical student exam pass rates during the COVID-19 pandemic, with better teaching and learning outcomes. Sierra [ 28 ] and others found that the flipped classroom method achieved better teaching and learning outcomes in a cardiology residency training programme, with higher acceptance among participants and teachers, and improved physicians’ assessment scores compared to traditional and virtual model teaching methods. Meanwhile, the Mini-CEX method was used in this study to assess the overall clinical competence of residents. This method, as a formative assessment, can not only provide a more accurate and comprehensive assessment of physicians’ comprehensive clinical competence, but also effectively promote physicians’ learning and growth [ 29 – 30 ]. Objective structured clinical examination(OSCE), as a method of evaluating students’ clinical comprehensive ability, understanding and application by simulating clinical scenarios, is widely used in the pre internship training of Undergraduates’ professional clinical practice skills [ 31 ]. Compared with OSCE, Mini-CEX is not limited by site and time, and it is time-consuming, simple and comprehensive. It can more systematically and comprehensively evaluate students’ clinical comprehensive ability [ 32 – 33 ]. Therefore, Mini-CEX is selected as the main clinical evaluation method in this study. Khalafi [ 34 ] et al. found that the use of Mini-CEX as a formative assessment method had a significant impact on the improvement of clinical skills of nursing anaesthesia students. Shafqat [ 35 ] et al. assessed the validity and feasibility of Mini-CEX by adopting it as a direct observation to assess its effectiveness and feasibility in an undergraduate medical curriculum. The study found that the altered method was effective in measuring student competence, improving clinical and diagnostic skills of medical students, and enhancing teacher-student interaction.

This study found that using ADDIE concept combined with flipped classroom teaching method, residents’ autonomous learning ability, critical thinking ability, theoretical knowledge and clinical comprehensive ability were improved. Analyze the potential causes: ADDIE, as a comprehensive medical teaching design concept, mainly includes five dimensions: analysis, design, development, implementation and evaluation. First, it systematically analyzes the specific clinical teaching needs and combines them with the current actual situation of students. On this basis, it flexibly sets the teaching plan, especially with the flipped classroom method, and pays attention to student-centered, This is quite different from the teacher centered concept in traditional teaching methods. This method encourages students to use their spare time to study independently through the text and video materials distributed by the teacher platform to meet the personalized needs of each student. At the same time, students actively explore the problems raised and encountered by teachers, which not only stimulate students’ interest in learning, but also greatly improve students’ autonomous learning and independent thinking ability. Furthermore, students’ collaborative discussion of problems and teachers’ in-depth explanation promoted the formation of students’ critical thinking, improved students’ learning effect and classroom efficiency, and improved students’ clinical comprehensive ability.

Limitations and recommendations

Although this study achieved some clinical teaching value, we still have many shortcomings. First, the limited number of residency trainers resulted in an insufficient sample size for this study, which may have an impact on the results. Second, due to the limitations of the residency training syllabus and policy, the training in this study was conducted for only one month, in fact, the training of speciality knowledge and talent development often need more sufficient time. Third, the study only used the Mini-CEX to assess the residents’ comprehensive clinical competence, and the scale selection in this area is relatively homogeneous, which may have an impact on the real assessment results. Therefore, in the future, we will expand the sample size, giving more reasonable and sufficient time for teaching training and knowledge digestion and assimilation, by using multiple scales to conduct in-depth assessment in various aspects, with a view to obtaining more reliable and persuasive results, which will provide reference for the teaching of specialised clinical medicine.

Based on the ADDIE concept combined with flipped classroom teaching method, this study conducted research in the residency training and found that compared with the traditional teaching method, the new teaching concept combined with flipped classroom teaching method can effectively improve the autonomous learning ability, critical thinking ability, theoretical knowledge and clinical comprehensive ability of neurology residents, and had better teaching quality. In clinical medical education, we should actively conform to modern teaching ideas. On the basis of traditional teaching, we should actively integrate new ideas and methods, give full play to the advantages of different teaching methods, so as to continuously improve the teaching efficiency and quality.

Data availability

The datasets used and/or analysed in this study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors would like to thank all the faculty members of the Department of Neurology of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine for their support of the clinical teaching programme for standardized residency training.

This study was funded by the National Natural Foundation of China under the National Science Foundation of China (Grant No. 82274493) and Scientific Research Project of Higher Education Institutions in Anhui Province (Grant No. 2023AH050791).

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JZ wrote the manuscript. JZ and HC collected the data. HC, XW, XH obtained and analysed the data. DX revised the manuscript for intellectual content. JZ confirmed the authenticity of all original data. All authors had read and approved the final manuscript.

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Zhang, J., Chen, H., Wang, X. et al. Application of flipped classroom teaching method based on ADDIE concept in clinical teaching for neurology residents. BMC Med Educ 24 , 366 (2024). https://doi.org/10.1186/s12909-024-05343-z

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DOI : https://doi.org/10.1186/s12909-024-05343-z

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• v.107(1); 2019 Jan

Distinguishing case study as a research method from case reports as a publication type

The purpose of this editorial is to distinguish between case reports and case studies. In health, case reports are familiar ways of sharing events or efforts of intervening with single patients with previously unreported features. As a qualitative methodology, case study research encompasses a great deal more complexity than a typical case report and often incorporates multiple streams of data combined in creative ways. The depth and richness of case study description helps readers understand the case and whether findings might be applicable beyond that setting.

Single-institution descriptive reports of library activities are often labeled by their authors as “case studies.” By contrast, in health care, single patient retrospective descriptions are published as “case reports.” Both case reports and case studies are valuable to readers and provide a publication opportunity for authors. A previous editorial by Akers and Amos about improving case studies addresses issues that are more common to case reports; for example, not having a review of the literature or being anecdotal, not generalizable, and prone to various types of bias such as positive outcome bias [ 1 ]. However, case study research as a qualitative methodology is pursued for different purposes than generalizability. The authors’ purpose in this editorial is to clearly distinguish between case reports and case studies. We believe that this will assist authors in describing and designating the methodological approach of their publications and help readers appreciate the rigor of well-executed case study research.

Case reports often provide a first exploration of a phenomenon or an opportunity for a first publication by a trainee in the health professions. In health care, case reports are familiar ways of sharing events or efforts of intervening with single patients with previously unreported features. Another type of study categorized as a case report is an “N of 1” study or single-subject clinical trial, which considers an individual patient as the sole unit of observation in a study investigating the efficacy or side effect profiles of different interventions. Entire journals have evolved to publish case reports, which often rely on template structures with limited contextualization or discussion of previous cases. Examples that are indexed in MEDLINE include the American Journal of Case Reports , BMJ Case Reports, Journal of Medical Case Reports, and Journal of Radiology Case Reports . Similar publications appear in veterinary medicine and are indexed in CAB Abstracts, such as Case Reports in Veterinary Medicine and Veterinary Record Case Reports .

As a qualitative methodology, however, case study research encompasses a great deal more complexity than a typical case report and often incorporates multiple streams of data combined in creative ways. Distinctions include the investigator’s definitions and delimitations of the case being studied, the clarity of the role of the investigator, the rigor of gathering and combining evidence about the case, and the contextualization of the findings. Delimitation is a term from qualitative research about setting boundaries to scope the research in a useful way rather than describing the narrow scope as a limitation, as often appears in a discussion section. The depth and richness of description helps readers understand the situation and whether findings from the case are applicable to their settings.

CASE STUDY AS A RESEARCH METHODOLOGY

Case study as a qualitative methodology is an exploration of a time- and space-bound phenomenon. As qualitative research, case studies require much more from their authors who are acting as instruments within the inquiry process. In the case study methodology, a variety of methodological approaches may be employed to explain the complexity of the problem being studied [ 2 , 3 ].

Leading authors diverge in their definitions of case study, but a qualitative research text introduces case study as follows:

Case study research is defined as a qualitative approach in which the investigator explores a real-life, contemporary bounded system (a case) or multiple bound systems (cases) over time, through detailed, in-depth data collection involving multiple sources of information, and reports a case description and case themes. The unit of analysis in the case study might be multiple cases (a multisite study) or a single case (a within-site case study). [ 4 ]

Methodologists writing core texts on case study research include Yin [ 5 ], Stake [ 6 ], and Merriam [ 7 ]. The approaches of these three methodologists have been compared by Yazan, who focused on six areas of methodology: epistemology (beliefs about ways of knowing), definition of cases, design of case studies, and gathering, analysis, and validation of data [ 8 ]. For Yin, case study is a method of empirical inquiry appropriate to determining the “how and why” of phenomena and contributes to understanding phenomena in a holistic and real-life context [ 5 ]. Stake defines a case study as a “well-bounded, specific, complex, and functioning thing” [ 6 ], while Merriam views “the case as a thing, a single entity, a unit around which there are boundaries” [ 7 ].

Case studies are ways to explain, describe, or explore phenomena. Comments from a quantitative perspective about case studies lacking rigor and generalizability fail to consider the purpose of the case study and how what is learned from a case study is put into practice. Rigor in case studies comes from the research design and its components, which Yin outlines as (a) the study’s questions, (b) the study’s propositions, (c) the unit of analysis, (d) the logic linking the data to propositions, and (e) the criteria for interpreting the findings [ 5 ]. Case studies should also provide multiple sources of data, a case study database, and a clear chain of evidence among the questions asked, the data collected, and the conclusions drawn [ 5 ].

Sources of evidence for case studies include interviews, documentation, archival records, direct observations, participant-observation, and physical artifacts. One of the most important sources for data in qualitative case study research is the interview [ 2 , 3 ]. In addition to interviews, documents and archival records can be gathered to corroborate and enhance the findings of the study. To understand the phenomenon or the conditions that created it, direct observations can serve as another source of evidence and can be conducted throughout the study. These can include the use of formal and informal protocols as a participant inside the case or an external or passive observer outside of the case [ 5 ]. Lastly, physical artifacts can be observed and collected as a form of evidence. With these multiple potential sources of evidence, the study methodology includes gathering data, sense-making, and triangulating multiple streams of data. Figure 1 shows an example in which data used for the case started with a pilot study to provide additional context to guide more in-depth data collection and analysis with participants.

Key sources of data for a sample case study

VARIATIONS ON CASE STUDY METHODOLOGY

Case study methodology is evolving and regularly reinterpreted. Comparative or multiple case studies are used as a tool for synthesizing information across time and space to research the impact of policy and practice in various fields of social research [ 9 ]. Because case study research is in-depth and intensive, there have been efforts to simplify the method or select useful components of cases for focused analysis. Micro-case study is a term that is occasionally used to describe research on micro-level cases [ 10 ]. These are cases that occur in a brief time frame, occur in a confined setting, and are simple and straightforward in nature. A micro-level case describes a clear problem of interest. Reporting is very brief and about specific points. The lack of complexity in the case description makes obvious the “lesson” that is inherent in the case; although no definitive “solution” is necessarily forthcoming, making the case useful for discussion. A micro-case write-up can be distinguished from a case report by its focus on briefly reporting specific features of a case or cases to analyze or learn from those features.

DATABASE INDEXING OF CASE REPORTS AND CASE STUDIES

Disciplines such as education, psychology, sociology, political science, and social work regularly publish rich case studies that are relevant to particular areas of health librarianship. Case reports and case studies have been defined as publication types or subject terms by several databases that are relevant to librarian authors: MEDLINE, PsycINFO, CINAHL, and ERIC. Library, Information Science & Technology Abstracts (LISTA) does not have a subject term or publication type related to cases, despite many being included in the database. Whereas “Case Reports” are the main term used by MEDLINE’s Medical Subject Headings (MeSH) and PsycINFO’s thesaurus, CINAHL and ERIC use “Case Studies.”

Case reports in MEDLINE and PsycINFO focus on clinical case documentation. In MeSH, “Case Reports” as a publication type is specific to “clinical presentations that may be followed by evaluative studies that eventually lead to a diagnosis” [ 11 ]. “Case Histories,” “Case Studies,” and “Case Study” are all entry terms mapping to “Case Reports”; however, guidance to indexers suggests that “Case Reports” should not be applied to institutional case reports and refers to the heading “Organizational Case Studies,” which is defined as “descriptions and evaluations of specific health care organizations” [ 12 ].

PsycINFO’s subject term “Case Report” is “used in records discussing issues involved in the process of conducting exploratory studies of single or multiple clinical cases.” The Methodology index offers clinical and non-clinical entries. “Clinical Case Study” is defined as “case reports that include disorder, diagnosis, and clinical treatment for individuals with mental or medical illnesses,” whereas “Non-clinical Case Study” is a “document consisting of non-clinical or organizational case examples of the concepts being researched or studied. The setting is always non-clinical and does not include treatment-related environments” [ 13 ].

Both CINAHL and ERIC acknowledge the depth of analysis in case study methodology. The CINAHL scope note for the thesaurus term “Case Studies” distinguishes between the document and the methodology, though both use the same term: “a review of a particular condition, disease, or administrative problem. Also, a research method that involves an in-depth analysis of an individual, group, institution, or other social unit. For material that contains a case study, search for document type: case study.” The ERIC scope note for the thesaurus term “Case Studies” is simple: “detailed analyses, usually focusing on a particular problem of an individual, group, or organization” [ 14 ].

PUBLICATION OF CASE STUDY RESEARCH IN LIBRARIANSHIP

We call your attention to a few examples published as case studies in health sciences librarianship to consider how their characteristics fit with the preceding definitions of case reports or case study research. All present some characteristics of case study research, but their treatment of the research questions, richness of description, and analytic strategies vary in depth and, therefore, diverge at some level from the qualitative case study research approach. This divergence, particularly in richness of description and analysis, may have been constrained by the publication requirements.

As one example, a case study by Janke and Rush documented a time- and context-bound collaboration involving a librarian and a nursing faculty member [ 15 ]. Three objectives were stated: (1) describing their experience of working together on an interprofessional research team, (2) evaluating the value of the librarian role from librarian and faculty member perspectives, and (3) relating findings to existing literature. Elements that signal the qualitative nature of this case study are that the authors were the research participants and their use of the term “evaluation” is reflection on their experience. This reads like a case study that could have been enriched by including other types of data gathered from others engaging with this team to broaden the understanding of the collaboration.

As another example, the description of the academic context is one of the most salient components of the case study written by Clairoux et al., which had the objectives of (1) describing the library instruction offered and learning assessments used at a single health sciences library and (2) discussing the positive outcomes of instruction in that setting [ 16 ]. The authors focus on sharing what the institution has done more than explaining why this institution is an exemplar to explore a focused question or understand the phenomenon of library instruction. However, like a case study, the analysis brings together several streams of data including course attendance, online material page views, and some discussion of results from surveys. This paper reads somewhat in between an institutional case report and a case study.

The final example is a single author reporting on a personal experience of creating and executing the role of research informationist for a National Institutes of Health (NIH)–funded research team [ 17 ]. There is a thoughtful review of the informationist literature and detailed descriptions of the institutional context and the process of gaining access to and participating in the new role. However, the motivating question in the abstract does not seem to be fully addressed through analysis from either the reflective perspective of the author as the research participant or consideration of other streams of data from those involved in the informationist experience. The publication reads more like a case report about this informationist’s experience than a case study that explores the research informationist experience through the selection of this case.

All of these publications are well written and useful for their intended audiences, but in general, they are much shorter and much less rich in depth than case studies published in social sciences research. It may be that the authors have been constrained by word counts or page limits. For example, the submission category for Case Studies in the Journal of the Medical Library Association (JMLA) limited them to 3,000 words and defined them as “articles describing the process of developing, implementing, and evaluating a new service, program, or initiative, typically in a single institution or through a single collaborative effort” [ 18 ]. This definition’s focus on novelty and description sounds much more like the definition of case report than the in-depth, detailed investigation of a time- and space-bound problem that is often examined through case study research.

Problem-focused or question-driven case study research would benefit from the space provided for Original Investigations that employ any type of quantitative or qualitative method of analysis. One of the best examples in the JMLA of an in-depth multiple case study that was authored by a librarian who published the findings from her doctoral dissertation represented all the elements of a case study. In eight pages, she provided a theoretical basis for the research question, a pilot study, and a multiple case design, including integrated data from interviews and focus groups [ 19 ].

We have distinguished between case reports and case studies primarily to assist librarians who are new to research and critical appraisal of case study methodology to recognize the features that authors use to describe and designate the methodological approaches of their publications. For researchers who are new to case research methodology and are interested in learning more, Hancock and Algozzine provide a guide [ 20 ].

We hope that JMLA readers appreciate the rigor of well-executed case study research. We believe that distinguishing between descriptive case reports and analytic case studies in the journal’s submission categories will allow the depth of case study methodology to increase. We also hope that authors feel encouraged to pursue submitting relevant case studies or case reports for future publication.

Editor’s note: In response to this invited editorial, the Journal of the Medical Library Association will consider manuscripts employing rigorous qualitative case study methodology to be Original Investigations (fewer than 5,000 words), whereas manuscripts describing the process of developing, implementing, and assessing a new service, program, or initiative—typically in a single institution or through a single collaborative effort—will be considered to be Case Reports (formerly known as Case Studies; fewer than 3,000 words).