case study methodology in law

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Case study research.

Last update: April 07, 2022

A legal scholar who uses the term ‘case’ will probably first think of a legal case. From a socio-legal perspective, the understanding of this concept is, however, slightly different. Case study research is a methodology that is useful to study ‘how’ or ‘why’ questions in real-life.

Over the last forty years, researchers from sociology, anthropology and various other disciplines have developed the case study research methodology dramatically. This can be confusing for legal researchers. Luckily, both Webley and Argyrou have written an article on case study research specifically for legal researchers. Webley writes, for example, that this methodology allows us to know ‘how laws are understood, and how and why they are applied and misapplied, subverted, complied with or rejected’. Both authors rely upon the realist tradition of case study research as theorised by Yin. Yin defines the scope of a case study as: “An empirical inquiry that investigates a contemporary phenomenon in depth and within its real-life context, when the boundaries between phenomenon and context are not clearly evident”.

Before you start collecting data for your case study, it is important to think about the theory and the concepts that you will want to use, as this will very much determine what your case will be about and will help you in the analysis of your data. You should then decide which methods of data collection and sources you will consult to generate a rich spectrum of data. Observations, legal guidelines, press articles… can be useful. Legal case study researchers usually also rely extensively on interviews. The meaning that interview participants give to their experiences with legal systems can uncover the influence of socio-economic factors on the law, legal processes and legal institutions.

Case studies strive for generalisable theories that go beyond the setting for the specific case that has been studied. The in-depth understanding that we gain from one case, might help to also say something about other cases in other contexts but with similar dynamics at stake. However, you need to be careful to not generalize your findings across populations or universes.

Argyrou, A. (2017) Making the Case for Case Studies in Empirical Legal Research. Utrecht Law Review, Vol.13 (3), pp.95-113

Flyvbjerg, B. (2006.) Five Misunderstandings about Case-Study Research, Qualitative Inquiry 12( 2), 219-245.

Gerring, J. (2004) What Is a Case Study and What Is It Good for? American Political Science Review 98( 2), 341-354.

Simons, H. (2014) Case Study Research: In-Depth Understanding in Context. In P. Leavy (Ed.), The Oxford Handbook of Qualitative Research, Oxford University Press.

Webley, L. (2016) Stumbling Blocks in Empirical Legal Research: Case Study Research. Law and Method, 10.

Yin, R. K. (2009). Case study research: Design and methods (4th Ed.). Thousand Oaks, CA: Sage.

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• October, 2016
• Stumbling Blocks in Empirical Legal Research: Case Study Research
• October 2016
• Artikel Stumbling Blocks in Empirical Legal Research: Case Study Research
• Artikel Statistical Analyses of Court Decisions: An Example of Multilevel Models of Sentencing
• Redactioneel Introduction Special Issue Stumbling Blocks in Empirical Legal Research

Citeerwijze van dit artikel: Lisa Webley, ‘Stumbling Blocks in Empirical Legal Research: Case Study Research’, 2016, oktober-december, DOI: 10.5553/REM/.000020

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• Introduction

Such legal research employs an empirical method to draw inferences from observations of phenomena extrinsic to the researcher. Putting it simply, legal researchers often collect and then analyse material (data) that they have read, heard or watched and subsequently make claims about how what they have learned may apply in similar situations that they have not observed (by inference). 1 x For insight into the extent to which legal researchers undertake empirical research and the lack of clarity around empirical methods in law see Epstein, L. and King, G. (2002) ‘The Rules of Inference’ Vol. 69 No. 1 The University of Chicago Law Review 1-133 at 3-6, Part I. One such form of empirical method is the case study, a methodological term which has been used by some researchers to describe studies that employ a combination of data sources to derive in-depth insight into a particular situation, by others to denote a particular ideological approach to research recognizing that the study is situated within its real-world context. 2 x Yin, R. K. (2014) Case Study Research Design and Methods (5th edn.) Sage Publications, 12-14. It is consequently a flexible definition encompassing approaches to the data and the stance of the researcher, 3 x See Hamel, J. with Dufour, S. and Fortin, D. (1993) Qualitative Research Methods Volume 2 , Sage Publications, ch 1. but its malleability has led some researchers incorrectly to stretch the term to encompass any study that focuses on one or a restricted number of situations. 4 x See Gerring, J. Case Study Research: Principles and Practices , Cambridge, Cambridge University Press, 2007 at 6. For a further discussion see Gerring, J. ‘What is a case study and what is it good for?’ (2004) Vol. 98 No 2 American Political Science Review 341-354. This looseness in definition in a legal context may perhaps be linked to confusion as between teaching and research case studies; some traditions in legal education employ a teaching method known also as ‘case study method’ which operates quite differently from its research counterpart. For a discussion of the differences between teaching and research case studies see Yin, 2014, 20 and for a discussion of teaching case studies see Ellet, W., (2007) The Case Study Handbook: How to Read, Discuss, and Write Persuasively About Cases , Boston MA, Harvard Business Review Press; Garvin, D. A. (2003) ‘Making the Case: Professional Education for the World of Practice.’ (Sept–Oct) Harvard Magazine 56-65. This has resulted in concerns that the definition has been co-opted as a means to explain any small n 5 x ‘n’ (number) is used to denote the number of observations in the study, N is used to describe the total number within the population when n denotes the sample observed. empirical study that has a focus on a particular subject, time-frame or location, and further that this has led to poor quality empirical research in law. 6 x For a discussion of the state of empirical research in law see Epstein and King, 2002. This is perhaps unsurprising, as law programmes tend to be very strong at teaching lawyers how to source, interrogate and then draw valid inferences from legal data sources such as cases and legislation, but less adept in the context of other types of data (for example survey data, interviews, non-legal documents and/or observation). 7 x See Webley, L. (2010) ‘Part III Doing Empirical Legal Studies Research Chapter 38 - Qualitative Approaches to ELS’ in Cane, P. and Kritzer, H. (eds.) Oxford Handbook of Empirical Legal Studies , Oxford, Oxford University Press. Case study method usually involves an array of research methods to generate a spectrum of numerical and non-numerical data that when triangulated provide a means through which to draw robust, reliable, valid inferences about law in the real world. 8 x For a discussion about the differences between numerical (quantitative) and non-numerical (qualitative) data see Webley, id; Epstein and King, 2002, at 2-3; King,G., Keohane, R. O., and Verba, S ., Designing Social Inquiry: Scientific Inference in Qualitative Research , Princeton NJ, Princeton University Press, 1994 at 6. It is relatively underused in empirical legal research. This article aims to make a contribution to those new to the case study method. It will examine the purpose of and why one may wish to undertake a case study, and work through the key elements of case study method including the main assumptions and theoretical underpinnings of this method. It will then turn to the importance of research design, including the crucial roles of the academic literature review, the research question and the use of rival theories to develop hypotheses in case study method. It will touch upon the relevance of identifying the observable implications of those hypotheses, and thus the selection of data sources and modes of analysis to allow for valid analytical inferences to be drawn in respect of them. In doing so it will consider, in brief, the importance of case study selection and variations like single or multi case approaches. Finally, it will conclude with some thoughts about the strengths and weaknesses associated with undertaking research via a case study method. It will address frequent stumbling blocks encountered by researchers, as well as ways so as to militate against common problems that researchers encounter. The discussion is necessarily cursory given the length of this article, but the footnotes provide much more detailed sources of guidance on each of the points raised here. This article is an introduction to a case study method rather than an analytical work on the method.

• 1. Case Study Method: Purpose of a Case Study, Why Undertake One?

Case study method falls within the social science discipline and as such has scientific underpinnings. The case study examines phenomena in context, where context and findings cannot be separated. Case study design is also sometimes used to investigate how actors consider, interpret and understand phenomena (e.g., law, procedure, policy) and therefore allows the researcher to study perceptions of processes and how they influence behaviour, for example to understand judges’ sentencing choices in a Dutch police court. 9 x Mascini, P., van Oorschot, I., Weenink, D. and Schippers, G., (2016) ‘Understanding judges’ choices of sentence types as interpretative work: An explorative study in a Dutch police court’, (37) (1) Recht der Werkelijkheid 32-49. This may help to understand how laws are understood, and how and why they are applied and misapplied, subverted, complied with or rejected. This can flow back into the legal and policy making processes, court procedure, sentencing, punishment, diversion of offenders etc., and may have a high impact as a result. The conditions precedent for case study method have been succinctly explained by Yin as follows:

‘doing a case study would be the preferred method, compared to the others, in situations when (1) the main research questions are “how” or “why” questions; (2) a researcher has little or no control over behavioural events; and (3) the focus of study is a contemporary (as opposed to entirely historical) phenomenon.’ 10 x Yin, 2014: xxxi and further 16-17.

The key points to note here are that a case study is a real-world in-depth investigation of a current complex phenomenon. The research will take place in situ (rather than in the library or moot court room) where the researcher cannot control the behaviour of research participants.

The purpose of the study is to learn how or why something happens or is the way it is, and this is achieved by collecting and triangulating a range of data sources to test or explore hypotheses. 11 x Triangulation is the term used to explain that a research question is considered from as many different standpoints as possible, using as many different data types as possible to permit a holistic examination of the question to see which explanations, if any, remain consistent across all data sources. It caters for a wide range of modes of enquiry: the investigation may be exploratory (explore why or how something is the way it is), descriptive (describe why or how something is the way it is) or explanatory (determine which of a range of rival hypotheses, theories etc. explain why or how X is the way it is). 12 x Yin, 2014: 5-6. Some categorise case studies as those designed to be theory orientated, and those designed to be practice orientated. 13 x See Dul, J. and Hak, T. (2008) Case Study Methodology in Business Research , Oxford: Elsevier 8-11, 30-59. Thereafter the design scope is very broad; the data collected may be qualitative and/or quantitative, collected via a variety of methods, and the case study may be a single case or be made up of a small number of cases. The breadth of data collected may be illustrated by Latour’s ethnography of the Conseil d’Etat in France, which studied the connections between human and non-human actors to explore their relationship with ‘the legal’ and ‘the Law’ is assembled in that court context. 14 x Latour, B. (2010) The Making of Law: An Ethnography of the Conseil D’Etat , Cambridge: Polity Press. Case study method is a way of thinking about research and a process through which one seeks to produce reliable, fair findings. It can provide deep insight into a particular situation, whether particular in time, in location or in subject-matter. 15 x For a discussion of ethnomethodological aims to study practical life as experienced in context as an end in itself, as experience is subjective and situational, see Small, M.L. ‘‘How many cases do I need?’ On science and the logic of case selection in field-based research’ (2009) Vol. 10 (1) Ethnography 5, 18. It may allow for transferable findings in respect of the theoretical propositions/hypotheses being examined if not to a population as would often be the situation in much quantitative research. 16 x For greater insight on this point see Lipset, S. M., Trow, M. and Coleman, J.S. (1956) Union Democracy: The Internal Politics of the International Typographical Union , New York: New York Free Press at 419-420; Yin, 2014, 21. For a discussion of the problems inherent in aping quantitative terminology in qualitative work see, Small, 2009, 10, and at 19 for further reading on the logic of case study selection and further reading on extended case method. It aims to examine rival hypotheses, propositions, potential explanations previously advanced (exploratory study), or to test findings from a previous case study examining similar phenomena in a new instance (a replication or confirmation study). 17 x Gerring, 2007, 346.

As described so far it is a research method that appears to have a lot in common with experiments and tests of statistical significance. But case study method differs markedly from a big data survey or double-blind experiment in that it seeks explicitly a phenomenon in its natural environment and (in most instances) without means to control for variables, including the behaviour of any participants. 18 x Although note that there are some scholars who believe that case study method can include elements of experimental testing, for example, Gerring, J. and McDermott, R. (2007) ‘An Experimental Template for Case Study Research’ Vol. 51 No. 3 American Journal of Political Science 688-701. One such study in law that has been described by some, if not by the researchers themselves, as a case study did include an experimental design within the battery of methods employed see: Moorhead, R., Sherr, A., Webley, L., Rogers, S., Sherr, L., Paterson, A. & Domberger, S. (2001) Quality and Cost: Final Report on the Contracting of Civil Non-Family Advice and Assistance Pilot (Norwich: The Stationery Office). Experiments aim to control some factors so as to test hypotheses under different conditions, quantitative studies attempt to control for environmental factors through sampling techniques and data collection instrument design so as to minimise their biasing effects, but case study method does not involve control of the environment, or control for the environment, instead it aims to harness context and work within it. It examines in great detail one situation (referred to as a case or unit) or a very small number of situations, to use context as a means to particularise the findings. It also seeks to explain which elements of context may mean that some of the findings are applicable to other situations and if so under what conditions. A case study tells the researcher about the case and the extent to which previous explanations are sustained, in some instances it may also allow the researcher to make claims that some of the findings can be applied to another case or cases too, although this is heavily dependent on the research design and its execution. 19 x Campbell, D.T. Foreword in Yin, 2014 xviii. But it is rarely, if ever, a method that can be used by one to want to make universal claims. A case is not a proxy for a sample of a population in a survey, for example, it is a study of a phenomenon in itself rather than a means through which to view the whole world. Having said that, samples can be used to help select cases in a sound manner. 20 x Seawright, J. and Gerring, J. (2008) ‘Case Selection Techniques in Case Study Research: A Menu of Qualitative and Quantitative Options’ Vol. 61 No. 2 Political Research Quarterly 294-308.

Case studies are only one of a number of ways to undertake socio-legal or criminological research and it is important to give proper consideration to the full range of research methods prior to making a final decision to adopt a case study method. 21 x Yin, 2014: chapter 1. It may be better to employ a different one: legal history; doctrinal legal study (legal cases, legislation, regulatory documents); a policy study (policy documents, communiqués etc.); a statistical analysis (an analysis of the number of different types of legal cases that go before the courts, their key features and what role these play in chances of success for the plaintiff); a large-scale survey; stand-alone interviews; or an experiment in a simulated setting (asking lawyers to read through some scenarios and explain what advice they would give to a client in those situations). But a case study could employ a number of these methods in combination, so how then does one determine whether case study method is right for one’s study? It will largely depend on the nature of the research question to be answered and one’s appetite for undertaking in-depth research aimed at achieving thick description (detailed description of how or why something is as it is) 22 x For a discussion see: Ryle, G. (1949). The Concept of Mind . London: Hutchinson; Lincoln, Y.S. and Guba, E.G. (1985). Naturalistic Inquiry . Newbury Park, CA: Sage Publications; Holloway, I. (1997). Basic Concepts for Qualitative Research . London: Blackwell Science. and/or triangulated findings derived from a range of data sources that develop a new theory or test existing rival theories. It is an intensive study, it requires extremely good planning and design and a robust approach to data analysis too.

• 2. Case Study Method: Research Design

Research design is of paramount importance in achieving a successful case study, especially so given that the study focuses on one or a small number of situations and the researcher’s in-depth knowledge of and immersion within that case may lead more readily to confirmation bias than in some other forms of study. 23 x Confirmation or interpretive bias of data is something we all have grapple with, as the natural human tendency is to place more weight on evidence that confirms our view than on evidence that contradicts it. Strong research design can assist with counter-balancing this to some extent, including the transformation of any expected finding into a hypothesis that one then seeks to falsify rather than to confirm. Research design begins with the choice of research topic, usually then followed by a review of any relevant academic literatures (perhaps beyond the boundaries of one’s own discipline, for example sociology, criminology, political science) to determine an appropriate research question, noting all possible answers to the research question that are posited in the literature. 24 x See Yin, 2014, chapter 1 for more information on the role of the literature review. During this iterative phase the research question will be further refined, so that it may be articulated with precision, which is particularly important for much case study research as the link between the question and the chosen case or cases is usually explicit and explained, consequently a clear research question is considered by many to be an essential starting point to aid the selection of cases to be examined. The rival hypotheses, theories or propositions that may answer the question should, normally, be similarly delineated and clarified, those that remain plausible answers to the research question should be retained and be supplemented with any others that the researcher considers to be alternative viable explanations. Other approaches may be used that are more inductive than deductive, as in the case of many ethnographic case studies such as Latour’s, for example. This phase is an intellectually demanding one, but it sets the foundation for a strong study that is easier to execute at the point of data collection. The literature review also helps to ensure one is up-to-date, that one does not make the same mistakes that earlier researchers have reported as hazards, and to add a theoretical depth to one’s study that aids sophisticated analysis. It may also help to identify useful data collection methods and instruments too. And so time spent on the literature review may be very profitable. So far the discussion has been very general and therefore a little abstract. At this stage it may help to consider a hypothetical research proposal for case study research and work though it as the article progresses. The researcher in our hypothetical scenario is interested in undertaking research on recent reforms to the use of family mediation in the family justice system in England and Wales. She knows that it is now compulsory in most instances for the person who is initiating any court proceedings in a divorce to have participated in at least one mediation information and advice session with the aim of negotiating an outcome in relation to children, money and/or property prior to initiating proceedings in court. She is clear on the law and the procedural issues but not clear on how effective have been these changes, and this is her broad area of interest. After completing her literature review she understands that the key aims of the reforms were to reduce the number of cases going to court by increasing the number of cases that result in negotiated agreements between the divorcing spouses and in doing so to reduce the cost and the time involved in reaching outcomes in divorce cases, reduce the need for people to use lawyers in the negotiating process, to reduce acrimony between the divorcing spouses and to reduce the negative effects on children. Further, the reforms were intended to promote more durable outcomes between divorcing spouses that could be renegotiated effectively if the arrangements for the children needed to be updated to meet changing circumstances. But the researcher still needs to work these insights into a research question before making a final decision on whether a case study is the best method by which to conduct the research. The next sub-section will consider the framing of the research question, and will include examples of how our researcher may draft her question to maximise her chances of undertaking a great study on her area of interest.

A. The Research Question

The process of defining the research question may be a painful, frustrating one but it could also be creative too. It may be necessary to spend a considerable period of time reading the literature so as to narrow down the research topic or statement to a manageable, novel and/or important and scholarly question. 25 x For more assistance with legal research questions refer to Epstein, L. (1995) Studying Law and the Courts in Lee Epstein (ed) Contemplating Courts , Cong Q, 1, 3-5. Some argue it should also seek to address a real world problem, although that is a controversial component and suggests that knowledge for knowledge’s sake is not a legitimate aim. 26 x See King, Keohane and Verba, 1994, 15. The development of a research topic into a research question with reference to the academic literature is sometimes described as the phase in which the researcher has a conversation or dialogue with the literature. This dialogue grounds the study, it also informs the study design, including the case selection and data to be collected. The research question (a statement that ends with a question mark) is made up of two key elements: its substance, the topic or issue that you wish to address and the form of the question ‘who, what, where, how, why’. 27 x See Yin, 2014, at 11, and see further Campbell, J.P., Daft, R.L., Hulin, C. L. (1982) What to Study: Generating and Developing Research Questions (Studying Organizations) , Sage Publications, for further thoughts on research questions The substance of the research question is not simply the topic but the specifics of the topic – is your study to be a contemporary one or a historical one? In what context are you operating? What precisely are you endeavouring to study? The form of the question is also important: as indicated previously, case study method is considered to be better suited to research questions framed in ‘how’ or ‘why’ terms. Single case studies are considered to be an excellent means by which to uncover and understand the processes or mechanisms that influence particular variables (known as process tracing 28 x On process tracing see: Collier, D. ‘Understanding Process Tracing’ Vol. 44 Political Science and Politics 823-830 and George, A. L. and Bennett, A. Case Studies and Theory Development in the Social Sciences , Cambridge, MA, MIT Press, 2005. For an excellent insight into how this has been used in a legal and policy context with reference to changes in Georgia’s tax laws see Ulriksen, M.S, and Dadalauri, N. ‘Single Studies and Theory-testing: The Knots and Dots of the Process-tracing Method’ (2014) International Journal of Social Research Methodology 1- 17. ), why or how different variables are related to each other, for example what influences legislative change or policy formation on a given topic in a given country at a particular time. They are also a sophisticated means through which to test empirically and deductively the congruence of rival explanations (theories or propositions), ‘to what extent’ or ‘how’ and ‘why’ different theories are borne out by the data. 29 x See Blatter, J. and Haverland, M. Designing Case Studies , Basingstoke, Palgrave MacMillan, 2012 at 145 who consider process tracing involves inductive reasoning to build theory and congruence testing involves deductive reasoning to test theories. The form of the initial research question can confound some researchers who initially phrase their question as a ‘what’ question and as a result unnecessarily rule out case study method. Questions can often be reframed, for example: ‘what have the prosecutorial authorities in England and Wales done to integrate victims of domestic violence into the criminal justice process?’ may be rephrased as ‘how have the prosecutorial authorities in England and Wales integrated victims of domestic violence into the criminal justice process?’. At this stage our hypothetical researcher is faced with some choices: should she consider ‘how have the reforms to family mediation used in the divorce context affected the durability and suitability of post-divorce arrangements in England and Wales?’ This would focus on the agreements whether agreed or adjudicated, their longevity, the extent to which they could be made to work after the divorce and how any amendments to arrangements were sought. Alternatively, she could ask ‘how have the reforms to family mediation affected the way in which divorces are conducted in England and Wales?’ This would examine the steps people took so as to get divorced but may also consider the divorcing couples’ perceptions about the process to assist with examining the policy to reduce acrimony, it could also address how much time and money they spent in the process and it could also elicit data on how constructive was their relationship and negotiations subsequent to the initial agreement or adjudication. It could also bring in the role of lawyers and/or consider the children’s experience of the divorce process too. The research design would then follow the focus of the question. Case studies are much easier to design when the research question is expressed clearly, the theory is used to provide possible answers that may be explored or tested and the boundaries of the study are articulated. Some people find it helps to break down a draft research question into its substance and its form, and describe the purpose of the study in a couple of lines too, 30 x Epstein and King suggest a range of possible purposes, at 59, including: to explore something that has not previously been studied; to attempt to settle a debate that has been ongoing within the literature; to examine a well-considered question but in a new way; to collect and analyse new data to seek to confirm or refute previous findings; to analyse an existing data set in a new or better way to seek to confirm or refute previous findings or to develop new ones. and then compare the extent to which all three are congruent and precise before moving on to the next phase of the design process. We shall consider the important role of theory in the next sub-section.

B. The Theory

Case studies afford the opportunity to observe a sequence of events or factors, to evaluate which produce an outcome and why, 31 x Peters, B.G. Comparative Politics: Theory and Method , Basingstoke, Palgrave, 1998 at 14. and to do so in their natural environment. One of the challenges for legal researchers, less so for criminological or sociological researchers who are often trained more fully in this regard, is the need to engage with theory before moving on to the next stage of research design. By theory I mean the explanations that have been posited in the academic literature for why or how something is the way that it is, or claims that suggest relationships between certain things. 32 x But interestingly, stance, or more accurately epistemology is of less significance to this research method than to many others. Case study method links the research question, research design, analysis and logic of inference to such an extent that is can accommodate a range of epistemological traditions from the realist to relativist/interpretivist. And thus scholars who consider that there are facts independent of our interpretation of them (in essence, hard facts operating in an objective reality) and scholars who consider all ‘facts’ to be local interpretations constructed through our own lenses, are able to operate within a case study framework. Having said that their choice of data sources, and their approach to data generation and analysis may well vary considerably. In this context a theory is a relatively precise speculative answer to a research question, which may have been developed by undertaking a study or by analysing others’ studies (a meta-analysis). And theories can be converted into hypotheses when considered in the light of a new research question. The use of theory is exemplified by Uriksen and Dadalauri’s case study on tax policy reform in Georgia which aimed to answer why and how Georgia initiated and managed to implement quite radical and substantial tax reforms between 1991 and 2005 and in doing so sought to interrogate theoretical explanations about the nature of policy reform in developing countries and further to develop a model that could be tested in other post-Soviet states. 33 x Ulriksen and Dadalauri, ibid. See further Dadalauri, N. Tax Policy Formation and the Transnationalizationof the Public Policy Arena; A Case Study of Georgia , Aarhus, Politica, 2011) Georgia was selected as a crucial case. The reasoning for this and also for the methods employed in this study are elegantly set out in the article cited above. In our hypothetical case study it may be possible, for example, to test the theory that mediated agreements lead to less acrimonious relationships between the divorced couple than do lawyer negotiated agreements. One could examine the theory that family mediation is a cheaper and faster alternative to lawyer negotiated settlements and that those mediated agreements are more durable and better suited to family circumstances. In doing so, one may test existing theories and/or to develop a new theory. Or one could test in the chosen context a single theory that is dominant or particularly novel. Our researcher could undertake further reading of the literature to add to these hypotheses and to refine them and eliminate those that are no longer plausible in the light of more detailed investigation. This is known as setting out ‘priors’, prior explanations raised in the academic literature. 34 x On the importance of the identification of priors see Beach, D. and Pedersen, R.B., ‘What is process tracing actually tracing? The three variants of process tracing methods and their uses and limitations’ Sept 1-4 2011 The American Political Science Association Annual Meeting , Seattle, WA as cited by Ulriksen and Dadalauri, ibid; and further Gerring, 2007 ibid. The researcher’s next task would be to consider what she would expect to observe in the study, were any of these hypotheses true (the observable implications of the hypotheses), for example, our researcher would expect to see that divorces conducted using family mediation would be settled through mediation, that the settlement process would cost less and be concluded quicker than in lawyer-led divorces, and that those that used family mediation would be more able to engage in constructive dialogue post-divorce and to renegotiate arrangements in respect of children without the need to resort to lawyers or to the courts. The researcher may also draw up a hypothesis that the agreements would be more durable and the outcomes for children more positive. This pre-emptive delineation of as many possible observable implications, and how they could be measured, would allow the researcher to plan how to conduct the study and to adopt an appropriate design more likely to lead to a robust answer to the research question. 35 x For more assistance on extracting observable implications and considering their measurement see Epstein and King, 2002, 70-76. But one needs to be able to articulate the theory converted into hypotheses with clarity, in order for an observation protocol to be developed. Further, it helps the research design if the researcher is able to pose rival theories or explanations so as to design the study to test for plausible alternative explanations too. For example, one of the rival theories in the family mediation study is that the kind of people who use mediation through to conclusion and the kind of people who either refuse to do so or who drop out without reaching a settlement are different, and those drawn to mediation are more consensus driven and better able to communicate with their spouse than are those who do not. This rival hypothesis would alert the researcher to the need to design the study to examine those who do conclude mediated agreements and those who do not in order to analyse this rival claim. A case study allows for the examination of complex interrelationships between variables in situ, and the theory helps to identify what those variables are.

C. The Selection of the ‘Case’ or ‘Cases’

Definitionally this is when it gets somewhat complicated, as ‘case’ can easily become confused with a ‘legal case’ and further a ‘case‘ can sometimes be confused with the same word used in a different context in quantitative research, a case meaning a single observation or a single data point. This has led some, such as Gerring, to suggest that it may be more accurate to refer to a case study as a unit study so as to underline that this type of study examines multiple things within one unit rather than examining one data source in one context. 36 x See Gerring, 2004, 342. See further King, Keohane, and Verba, 1994, 76-77. The selection of the case or cases is a profound one in any study of this kind. A case may be selected because it is critical to the research question, it is typical, atypical, it provides a longitudinal opportunity (study over time), or it is revelatory meaning that it allows insight where previously this has not be possible. 37 x See Yin, 2014, 51. The nature of the case, its boundaries and features and why it was selected should be set out clearly. 38 x Gerring, 2004, 344. There are often difficulties in establishing the boundaries of the case, the phenomenon under study, and the context that provides a background to the phenomenon but is not itself the object of enquiry. Gerring articulates this as the formal case (the phenomenon) and the informal cases (the penumbra of phenomena which are the context but which will need to be explored in a less formal way so as to distinguish the boundaries of the formal case). The informal units are peripheral, but may have bearing on the formal unit or case, and by considering these informal units at the beginning of the study, and close to its conclusion it will help the researcher to work out what is particular about the unit, and what is transferable to other units. The selection of the case should be guided by the extent to which this location in space, focus and/or time lends itself to construct validity, internal validity, external validity and reliability of design in respect to the research question. 39 x See Yin, 2014, chapter 2. Case studies are particularly prone to selection bias, meaning that the case is selected on the basis of the dependent variable rather than on the basis of the independent variable – selected because of an effect that has been noted rather than its cause when the nature of the cause is the real object of many ‘how’ or ‘why’ research study questions. 40 x See Geddes, B. Paradigms and Sand Castle: Theory Building and Research Design in Comparative Politics , Ann Arbor, University of Michigan Press, 2005. For example, in a legal context if we wanted to examine rival explanations for how a particular legislative reform, for example the introduction of same sex marriage in England and Wales, has had an impact on community cohesion between different religious and community groups, it may seem, on the face of it, a good idea to select a town like Brighton with a vibrant LGBT community as the case to be studied. After-all, the uptake of same-sex marriage has been very high in Brighton and so it could be considered to be a key site of study. However, Brighton is well known as a LGBT friendly town and people drawn to live there would tend to be very positive about the introduction of same-sex marriage. If the reason for the study was to consider whether tensions have emerged between community and religious groups with different views on marriage, then Brighton would not likely give much opportunity to examine these issues. It was LGBT friendly before the reform and it continues to be. And community and religious groups have worked well together before and after the change in the law. By selecting the case on the basis of the effect of the changed legal landscape, the high numbers of gay and lesbian marriages, we may have selected a case that is atypical or simply a poor unit within which to view the causes or the influences that led to the legislative reform. Researchers are prone to make this mistake when undertaking a deductive study to test the congruence of rival hypotheses in a context where they have insufficient knowledge about the independent variable (the causes) that gave rise to, say, the change in the law. There may be other factors to consider too: in our family mediation study, the researcher may choose to steer away from London as the case study location, if she is interested in ‘typical’ divorces given that London has a much greater than average number of high net worth divorces that include very large sums of money and property portfolios, in addition to many divorces involving non-British couples who married abroad. A solid grasp of the literature can help to alleviate this possibility of incorrect case selection along with detailed consideration of the relevant features of a range of possible case studies prior to final selection. Does selecting a multiple-case study limit the likelihood of such problems, further should the study be at one point in time or a repeated measure at different periods of time? A case study may be designed so as to allow for cross sectional analysis between two or more cases, and further a temporal variation may be introduced into this form of analysis too. Our researcher could study family mediation over time: the same divorces pre, during and post settlement and then later again to examine durability. Single, multiple or cross-sectional case studies often serve different purposes. Multiple case studies are more likely to be used when the causal relationship between an independent and dependent variables are being analysed, so that the interaction of the variables in different environments can be examined comparatively in different contexts (in an experimental protocol one would be able to manipulate the conditions so as to test the variables and thus the different hypotheses). For example, if the study was examining the relationship between violent crime rates and criminal justice sentencing policy to examine whether tougher criminal penalties for violent crime lead to a reduction in violent crime rates, and if tougher criminal penalties for lesser offences led to greater imprisonment levels and greater recidivism including an escalation of violent crime, then a multi-jurisdictional case study may allow for a better assessment of those by permitting different combinations of variables to be compared as against each other. In our family mediation study, the researcher may choose to use London as a crucial case study (with its unusual profile of divorcing spouses with a very wide range of asset values) alongside a more typical rural and a more typical urban location to consider the hypotheses under different conditions. However, it may also be possible to test the hypotheses in a single case study by charting the relationship between the variables over time, with particular attention being paid to the points in time when sentencing policy changed or crime rates dropped or raised, or when family mediation was first introduced, when it became established as a compulsory part of the system. 41 x But the difficulty with multi case studies is that specified conditions or features within individual cases may have more influence on the variables being studied than the variables that one are analysing across the studies. This may lead one to draw erroneous conclusions about causality. This single case study also illustrates the independent variable problem: to what extent are violent crime rates and/or sentencing policy more likely attributable to other societal changes evident at different points in time than each other? Without knowledge of this it is difficult to proceed. Sometimes the extent to which a case study is referred to as single or multiple is a matter of nomenclature, for example, Elliott and Kling’s study 42 x Elliott, M. and Kling, R. ‘Organizational Usability of Digital Libraries: Case Study of Legal Research in Civil and Criminal Courts’ (1997) Vol 48 (11) Journal of the American Society for Information Science 1023-1035. on the organisational usability of digital libraries, a case study of legal research in civil and criminal courts, could be described as a single case study (as in their study) because it addresses digital libraries in one context – legal research in courts – it is also geographically bounded to the Los Angeles County, but data is collected from a number of courts and thus it could be argued to be a multiple case study if each court were considered to be a case. The important distinction, however, is how that data are treated: if the data are pooled and analysed as a single unit then the case study is generally considered to be a single unit or single case study, if the data are analysed comparatively as between the sites of collection then it would generally be considered to be a multiple unit or multiple case study. Where comparisons are being made over time but within a unit then the terminology is often that of a single unit as data is both compared and pooled too. Single case study research is considered to be an excellent vehicle for exploratory and developmental research (as evidenced by the Georgia tax policy study and Dnes analysis of the nature of a particular type of contract – franchise contracts in the UK 43 x See Dnes, A.W. ‘A Case-Study Analysis of Franchise Contracts’ (1993) Vol. 28 Journal of Legal Studies 367-393. or Latour’s Conseil d’Etat study mentioned above 44 x See Latour, B. (2010) above. ), confirmatory research necessitates a design that allows the researcher robustly to test a small number of hypotheses forensically and it may be advisable to consider a multiple case study method to achieve this aim. 45 x Although note that Gerring, 2004, at 347 indicates that a single case study may credibly make causal claims, if, for example, the case has been selected as it is particularly representative of others or it is a critical or crucial case, see further: Eckstein, H. (1975) ‘Case Studies and Theory in Political Science’ in Regarding Politics: Essays on Political Theory, Stability, and Change, Berkeley: University of California Press, 1992). The family mediation case study conducted in London and a more typical urban and rural area is a good example of this, given that the types of divorce cases are likely to be quite different, the context is also different too, and so cost, duration, durability and acrimony could be tested under different conditions to see whether they held true in all conditions or were context or divorce type dependent. Sometimes researchers are inclined to use a multiple case study approach in the expectation that more cases (units) will provide more data and more comparable data that can be used to derive robust findings. However, data collected across multiple case studies is less rather than more likely to be comparable as the conditions within the case study cannot be manipulated or controlled by the researcher and yet environment is expected to have an impact on the data. 46 x Gerring indicates that researchers tend to face the choice between knowing more about less or less about more, 2014, 348. Where more than one case is selected, each subsequent addition should provide a more complete and accurate picture in respect of the research question, instead of attempting to provide greater representativeness (as indicated above, this is not the purpose of case study method). 47 x See Small, 2009, 24-26. If one wishes to make comparisons between case studies it is important to adhere closely to comparative methodology in the definition of the cases to be selected, the analysis of the relevant similarities and differences between those cases, the data to be collected, compared and why, and the likely limitations of the cross unit comparison. 48 x See Gerring, 2004 at 348. For guidance on comparative methodology in a legal context see: Van Hoecke, M. (2004) Epistemology and Methodology of Comparative Law , Portland, Oregon: Hart Publishing. Multiple cases studies are more difficult to accomplish successfully, and it is advisable to work out clearly what each of the case studies will contribute to answering the research question before finalising those to be the subject of the enquiry. The most appropriate design will be dependent on the research question selected and the hypotheses or propositions under investigation through the case study method. 49 x For a detailed discussion see Gerring, 2004 at 343.

D. The Selection of Data Sources, Data Generation and Collection

Strong research design logically links the research question(s) with the hypotheses, with the data generation and collection methods, which in turn should be logically linked with the data analysis methods employed too. By now the researcher is likely to have a very good idea of the types of data that may be relevant to the study (derived from documents, people, extant statistics, other artefacts like images), 50 x Yin sets out six sources of evidence: documents, archival records, interviews, direct observations, participant observation, physical artefacts, Yin, 2014, 105-118, and four principles of data collection: multiple sources of data; creation of a case study database; maintain the chain of evidence; exercise care when using data from electronic sources, at 118-129. having identified the substance, form and purpose of the question, the rival hypotheses that may contribute to answering the question, and the observable implications of those hypotheses and how they may be measured. Our researcher having drawn her broad question as ‘how have the reforms to family mediation affected the way in which divorces are conducted?’ and narrowed down the case study to a geographic location(s) or a type of divorcing couples or divorce context, will have considered the possible data sources as including the spouses, their children, the family mediators and lawyers, court files, mediation and lawyer negotiated agreements, official statistics and more. And so it should be possible to chart how the data collection and data analysis methods all fit together so as to allow the observable implications to be explored, the hypotheses proved, amended, or disproved and a rounded, reliable answer to the research question be achieved. But this design phase may also go beyond the identification and selection of data sources, it requires choices to be made about how data will be collected and measured. 51 x See Yin, 2014, chapter 3 for more information on what one needs to do before data collection begins, and chapter 4 on data collection itself. Each choice that is made, consciously, or unconsciously, will have an effect on the data that is captured and the reliability and validity of that data. And this in turn will affect the outcome of the study. Consequently, the design should be scrutinised to uncover the biases that may become entrenched within it, the study redesigned where necessary to eliminate or limit bias and any remaining biases be taken into account during the later analysis and reporting phases. 52 x See Small, 2009, 12-15. This will require a degree of reflection on data type (strengths and weaknesses in allowing observable implications to be explored), data selection (all data, if not all then what process is being used to select it and how may that skew the findings, known as selection bias); data collection (how is the data being derived, and is it raw data or is it material that requires a judgement to be made, for example how will we measure ‘satisfaction or ‘acrimony’ or ‘durability of an agreement’, how reliable and valid is the data collection instrument 53 x For a discussion of reliability and validity in measurement see Webley, 2010 and further Epstein and King, 2002, 80-99. ) and later too data analysis. It is also worth piloting each data collection exercise with a small number of observations so as to allow defects to be worked out, and experience in the field to allow for redesign too. And then one should collect as much data on each of the possible observable implications as is practicable, including data of different types generated or collected via different methods so as to allow for triangulation in respect of each hypothesis. For example, in Elliott and King’s study they collected data via observation, participant observation and interviews, analysed court documents and legal technology documents; 54 x Elliott and Kling, ibid at 1025. in Dnes’ study the data included franchise agreements and contracts, financial accounts and other financial data, interviews; 55 x Dnes, ibid at 369-370. and in Dadalauri’s study data were derived from primary sources (policy proposals, experts’ recommendations and the minutes of parliamentary sessions) and secondary sources (reports, media briefs, statistical sources) plus from semi-structured interviews with key actors in the policy process. 56 x Ulrikesn and Dadalauri, ibid at 13. Case study method necessitates a measure of flexibility in research design to allow for new knowledge to shape and improve the starting design, but that does not reduce the need for a robust design plan at the inception of the study. The design needs to be scrupulously documented, including challenges faced and amendments made so as to aid others to analyse the validity of the research design and to assess the extent to which the study findings are reliable and robust. 57 x For a discussion see King, Keohane and Verba, 1994, 12. Epstein and King suggest that legal scholars give the same attention to the recording, storage and analysis of data as they would expect of the police and prosecutors when securing the chain of evidence in a criminal case. 58 x Epstein and King, 2002, 24. And it is to data analysis that we now turn.

• 3. Case Study Method: Use of the Data, Inferences and Finding Meaning

Case study findings are reached through a process of logical valid inferences regardless of whether the data collected and analysed is qualitative, quantitative or both. 59 x For a discussion on this point see King, Keohane and Verba, 1994, chapter 1 ‘The Science in Social Science’. But first the data must usually be described in summary form, before being subjected to further analysis to consider what the data indicates about the various hypotheses and their observable implications in this case context. Subsequently, it is possible to attempt to derive descriptive inferences that suggest what these data on observable instances indicate about non-observables ones, in other words what findings one considers to be transferable to a non-observed context. The analysis may also allow for causal inferences to be made, that explain what effects would be expected to occur if certain conditions were fulfilled in this or another context. This is not dissimilar to data analysis in other types of empirical legal research and therefore it is considered only briefly here. However, case study method is structured with triangulation of data at the fore, allowing the researcher to reach robust findings reached by integrating analysis from multiple data points gathered using different methods. This section will briefly address data analysis, the drawing of inferences and the importance of demonstrating one’s working out, in turn.

A. Data Analysis

The first stage of data analysis is often validly to summarise the data collected in the light of the research question and hypotheses and anticipated observable implications, to summarise the numbers (mean, median, mode, standard deviation, range) and to summarise the text (for example, categorise and consider relationships between categories, or code and consider the frequency or codes). 60 x See Epstein and King, 2002, 25-29 for more information on quantitative data description. Different types of data will often be analysed using different methods or traditions, as illustrated by the way in which legal cases are analysed according to traditions accepted by lawyers, which is distinct from legal analysis of legislation, and policy analysis of policy documents: survey data would be analysed statistically, text based data (interviews, documents etc.) via the mode of analysis selected to interrogate and derive meaning from language, for example via grounded theory method, thematic coding, content analysis, hermeneutics etc. 61 x For a discussion of the different methods of text based data analysis see Yin, 2014, chapter 5 or Webley, 2010. There are a range of general strategies open to the researchers, some of which focus on the theoretical propositions, others aim to develop thick description, others still examine plausible rival explanations. 62 x See Yin, 2014, 136-142. Findings are considered robust where they are evidenced via multiple stands of data and its analysis. The use of multiple data sources to test each hypothesis allows the researcher to build up a thoroughly nuanced picture of the extent to which each hypothesis is sustained, needs to be refined, or rejected. The analysis will be conducted in the light of the research question parameters and also the hypotheses being examined by the research, as exemplified by the discussion in the Georgia tax policy case study. 63 x Ulriksen and Dadalauri, ibid. This process is likely to be iterative, in that data will often be analysed as one phase of data collection is complete and any lessons learned from that may lead to some reframing of the research question, reconsideration of the hypotheses, and amendments to the next phase of data collection yet to begin. The key is that, as with all social science methods, amendments to the question and methods, the analysis of the data and the inferences drawn from the data should be publicly explained and in sufficient detail so that they are replicable by others on the basis of the information provided in the write-up of the study; King, Keohane and Verba remind us that inferences lead to uncertain conclusions – inferences are not proven facts, they are propositions being advanced that are available to be tested by others. 64 x King, Keohane and Verba, 1994, 8. Conclusions remain tentative until replicated validly and consistently. The science and the rules of inference are important in allowing us to judge the validity and reliability of the findings, and these are closely interwoven with the research design and execution of the study.

B. Inferences

Case studies are often considered to be more useful when seeking to derive descriptive rather than causal inferences, as the researcher is not able to manipulate the environment so as to test propositions in such a way as to be sure that causal relationships have satisfactorily been established. Descriptive inferences are ‘the process of using the facts we know to learn about facts we do not know’ , by describing something that has been observed and inferring under what circumstances a similar pattern or occurrence may occur in a carefully defined unobserved situation. 65 x Epstein and King, 2002, 29. For example, if in our hypothetical family mediation study we learned that greater numbers of the divorcing clients who we interviewed/observed before the introduction of the compulsory mediation information and assessment meetings were aware that there was state funding available for family mediation, compared with the divorcing clients who we interviewed/observed after the introduction of these meetings then we may infer that this finding was likely to apply to divorcing clients outside our observed group too (all other things being equal). We do not know for certain that is accurate, as we only have data from our study participants, but our description of our findings has led us to infer something about those outside our observation group. Many doctoral candidates and early career academics baulk at the suggestion that descriptive inference is a valuable mode of analysis, as they associate ‘descriptive’ with the less positive feedback that they may have received in earlier work. But the pursuit of descriptive inferences is not a low-level aspiration in a context in which little is known about the case under scrutiny. Descriptive inferences allow for categorisation of findings which may lead on to further theory building and theory testing, categorisation goes to the heart of analysis development. So our finding above begs the question ‘why is this so?’ and we could either extend our study to answer this sub-question, or leave that for a later study. In some instances the inferences a researcher wishes to draw may be causal ones that infer an effect that will be caused by a set of defined factors occurring together. As an example, in our family mediation study we may wish to examine whether family mediation is more likely to be successful for couples with relatively similar educational backgrounds, medium to high incomes with both spouses in full-time employment, when compared with those who have unequal educational backgrounds, incomes and job-statutes and with low incomes. Where causal inferences are the point of the study, it may be possible to develop these with a well-chosen cross-case multi-case case study design. However, a causal inference first requires the identification of a causal mechanism (the process by which dependent variable A is affected by independent variable B, for example the causal mechanism for a defendant in the UK to be released from pre-trial detention (variable A) is a bail hearing in court (variable B)). 66 x See Epstein and King, 2002, 34-37 for help distinguishing between causal mechanisms and variables and causal effects. Case studies are often a really good means by which these mechanisms, or processes, may be uncovered – known as ‘process tracing’ whereby the researcher charts in detail the relationships between two or more variables and explores these connections to deduce those that are causal and those more likely to be coincidental. 67 x See Gerring, 2004, 348 and further Roberts, C., The Logic of Historical Explanation, Pennsylvania State University Press 1996, 66. Further, a single case study may allow a researcher to interrogate extant explanations that suggest causal implications, in other words to test predictions about what will happen in particular situations (assuming those situations are observable as part of the case study). This is known as ‘pattern-matching’. 68 x See Gerring, 2004, 348 and further Campbell, D. T. [1975] “‘Degrees of Freedom’ and the Case Study” in E. Samuel Overnman (ed) Methodology and Epistemology in Social Science , Chicago, University of Chicago Press: 1988, 380. This is where clarity about the purpose of the study becomes particularly important, as certain conditions will need to have been built into the research design for some analytical techniques. 69 x Yin, 2014, 142-168, provides five different analytical techniques: pattern-matching; explanation building; time-series analysis; logic models; and cross-case synthesis and suggests that after this phase the researcher will likely move on to work through all plausible alternative conclusions to examine whether the most likely conclusion is the only conclusion. The study will need to be designed with a very clear and narrow focus to achieve its aims. As indicated above, case studies may be entirely self-contained studies that provide in-depth knowledge of a single unit of analysis, but more often than not the researcher will wish for those findings to be considered applicable to situations that she/he has not observed. The challenge is to explain which findings are particular to the case study and which elements of the findings are relevant beyond the case study’s boundaries. 70 x Gerring, 2004, 345. It may be difficult to define this with precision, but where there is ambiguity it is safer to over explain and to over report the ambiguity and the possible range of inferences and their limitations rather than to over simplify and obfuscate the difficulty in reaching definitive findings. 71 x See Gerring, 2004, 346. Legal researchers are sometimes criticised for being vague in their explanations of the target of their inferences (to which other unobserved situations do these findings apply, and why?), or worse still their claims in the absence of evidence to prove that their inference is generalizable to a wide variety of situations. 72 x Epstein and King, 2002, 31. This may be a function of lawyers’ professional training as advocates, who in presentation would seek to persuade others to accept their position and who would gloss over inconvenient precedents. But lawyers are also trained to be forensic in seeking out the weaknesses of their arguments as well as those of their opponents and by harnessing these skills in the presentation of their case study findings; they should be able to display the highest standards of scientific reporting. Some of the ambiguities associated with inferences may be avoided if, as Gerring suggests, the scholar specifies clearly which propositions apply to which novel circumstances and exhibit and explain the evidence upon which this contention is based. 73 x Gerring, J. (2001) Social Science Methodology: A Criterial Framework , Cambridge, Cambridge University Press, 90-99. In other words, do the findings relate only to this case, are they intended to relate more broadly to similar cases and if so what marks out other situations as similar? Is similarity about time frame, location, a certain set of markers such types of participants, socio-economic, legal or political factors? And what is one’s evidence in support of this? The burden of proof always rests with the researcher. We shall turn to this in the next sub-section.

C. Reporting Findings

It can be challenging to know how to report one’s findings in an article or thesis, which is unsurprising when one considers that little attention is paid to this aspect of scholarship on doctoral legal programmes in many jurisdictions. 74 x See further Epstein and King, 2002. For assistance in how to report on cases studies and writing up and presentational considerations, including audience and purpose, see Yin, 2014, chapter 6. The rule is that one must provide as much detail as possible, at least enough to allow someone else to be able to replicate the study using only the information provided. Further, there needs to be sufficient discussion of the decisions taken, challenges faced and the consequent limitations of the findings so as to allow others to evaluate the reliability of one’s findings. As King et al. note: report uncertainty, be sceptical about causality, and consider rival hypotheses. 75 x King et al, 1996, 30-33. The process of interrogating one’s own decisions and inferences and reporting on them in full in the article or thesis may allow one to avoid the invidious charge made of many other legal scholars’ work. 76 x Epstein and King, 2002, 6-7. One suggestion is that legal scholars may wish to look for the weakest link in their chain of reasoning, something which lawyers are trained to do in a legal context, and then estimate how certain they are of their findings taking that weakness into account. 77 x Epstein and King, 2002, 50. However, other aspects of our professional training sometimes come into conflict with this approach: a research study is not an act of advocacy, and training as a lawyer may derail the process of empirical enquiry when lawyers unconsciously act for the client in their head and seek to persuade the outside world that their client’s view is a valid one, rather than to act as a legal social-scientist and demonstrate to other social scientists the extent to which their findings are valid, robust, reliable, and subject to limitation. 78 x See further Miller, A. S. ‘The Myth of Objectivity in Legal Research and Writing’ (1969) Vol. 18 Catholic University Law Review 290. For example, a researcher who is more in favour or less in favour of family mediation may inadvertently confirm their stance and steps need to be taken to lessen this risk. This role conflict is particularly problematic given that empirical legal research may lead to legal reform affecting large sections of the population and the findings confidently exhorted in the literature may be used to justify policy changes. 79 x Epstein and King, 2002, 8-10. Further, even if the research were not to be read outside of an academic environment, it is incumbent on all academics to produce research that is reliable and robust, lawyers are quick to critique legal scholarship that had been poorly executed and socio-legal scholarship should be treated no differently.

• 4. Conclusions: Why (Not to) Use Case Study Method?

Case study method is a powerful and engaging approach to research that has real utility in socio-legal and criminological research even if it has to-date been relatively little used. Our reticence to use it may be explained by the need for a researcher to be sufficiently adept with a range of social science research methods; (non-legal) empirical methods have historically had little treatment within undergraduate legal courses and relatively little attention even at a postgraduate level. 80 x Genn, H., Partington, M, and Wheeler, S. (2006) Law in the Real World: Improving Our Understanding of How Law Works Final Report and Recommendations , London: The Nuffield Foundation. Further, doctoral supervisors may feel inadequate to the task of supervising doctoral students proposing to undertake research through case study method and steer them towards a more standard mixed method approach such as a survey coupled with some interviews, or away from non-legal empirical methods altogether. But with some training, and a high degree of planning it is perfectly possible to undertake a good quality case study in a legal context and we can learn much from them. They are also an ideal means to focus on the particular and yet to draw analytical inferences to similar contexts too, something which lawyers are trained to do throughout their studies and a skill which they can bring to bear on a broader range of data than they otherwise often do. However, case study method is far more than focusing on a single situation, or ‘case’, it is far more than providing a temporal or physical boundary to our research endeavour. It requires us to adopt a structured and reflective approach to research design in many instances, to consider pre-emptively possible explanations (hypotheses) and rival propositions and to engage with theory at an early stage in a study. In a legal context case studies are generally, if not exclusively, more effective when: seeking to make descriptive rather than causal inferences; examining issues in depth rather than broadly and when the researcher is seeking to examine multiple sources of data so as to make comparisons within a case rather than between multiple cases. Further, they are also often more effective for seeking causal mechanisms rather than causal effects; for research that is exploratory rather than confirmatory; and when variations within the case selected are important for the study of the phenomenon. 81 x Gerring, 2004, 352. They are extremely useful when analysing how those involved in law and policy-making, the application of legal rules and procedures perceive these processes, how they react to them and how this influences the effectiveness of those rules, processes and procedures. The research process is an iterative and creative one that engages lawyers’ considerable analytical skills. As such case study method is worthy of a larger presence within the legal academic empirical tool-kit.

1 For insight into the extent to which legal researchers undertake empirical research and the lack of clarity around empirical methods in law see Epstein, L. and King, G. (2002) ‘The Rules of Inference’ Vol. 69 No. 1 The University of Chicago Law Review 1-133 at 3-6, Part I.

2 Yin, R. K. (2014) Case Study Research Design and Methods (5th edn.) Sage Publications, 12-14.

3 See Hamel, J. with Dufour, S. and Fortin, D. (1993) Qualitative Research Methods Volume 2 , Sage Publications, ch 1.

4 See Gerring, J. Case Study Research: Principles and Practices , Cambridge, Cambridge University Press, 2007 at 6. For a further discussion see Gerring, J. ‘What is a case study and what is it good for?’ (2004) Vol. 98 No 2 American Political Science Review 341-354. This looseness in definition in a legal context may perhaps be linked to confusion as between teaching and research case studies; some traditions in legal education employ a teaching method known also as ‘case study method’ which operates quite differently from its research counterpart. For a discussion of the differences between teaching and research case studies see Yin, 2014, 20 and for a discussion of teaching case studies see Ellet, W., (2007) The Case Study Handbook: How to Read, Discuss, and Write Persuasively About Cases , Boston MA, Harvard Business Review Press; Garvin, D. A. (2003) ‘Making the Case: Professional Education for the World of Practice.’ (Sept–Oct) Harvard Magazine 56-65.

5 ‘n’ (number) is used to denote the number of observations in the study, N is used to describe the total number within the population when n denotes the sample observed.

6 For a discussion of the state of empirical research in law see Epstein and King, 2002.

7 See Webley, L. (2010) ‘Part III Doing Empirical Legal Studies Research Chapter 38 - Qualitative Approaches to ELS’ in Cane, P. and Kritzer, H. (eds.) Oxford Handbook of Empirical Legal Studies , Oxford, Oxford University Press.

8 For a discussion about the differences between numerical (quantitative) and non-numerical (qualitative) data see Webley, id; Epstein and King, 2002, at 2-3; King,G., Keohane, R. O., and Verba, S ., Designing Social Inquiry: Scientific Inference in Qualitative Research , Princeton NJ, Princeton University Press, 1994 at 6.

9 Mascini, P., van Oorschot, I., Weenink, D. and Schippers, G., (2016) ‘Understanding judges’ choices of sentence types as interpretative work: An explorative study in a Dutch police court’, (37) (1) Recht der Werkelijkheid 32-49.

10 Yin, 2014: xxxi and further 16-17.

11 Triangulation is the term used to explain that a research question is considered from as many different standpoints as possible, using as many different data types as possible to permit a holistic examination of the question to see which explanations, if any, remain consistent across all data sources.

12 Yin, 2014: 5-6.

13 See Dul, J. and Hak, T. (2008) Case Study Methodology in Business Research , Oxford: Elsevier 8-11, 30-59.

14 Latour, B. (2010) The Making of Law: An Ethnography of the Conseil D’Etat , Cambridge: Polity Press.

15 For a discussion of ethnomethodological aims to study practical life as experienced in context as an end in itself, as experience is subjective and situational, see Small, M.L. ‘‘How many cases do I need?’ On science and the logic of case selection in field-based research’ (2009) Vol. 10 (1) Ethnography 5, 18.

16 For greater insight on this point see Lipset, S. M., Trow, M. and Coleman, J.S. (1956) Union Democracy: The Internal Politics of the International Typographical Union , New York: New York Free Press at 419-420; Yin, 2014, 21. For a discussion of the problems inherent in aping quantitative terminology in qualitative work see, Small, 2009, 10, and at 19 for further reading on the logic of case study selection and further reading on extended case method.

17 Gerring, 2007, 346.

18 Although note that there are some scholars who believe that case study method can include elements of experimental testing, for example, Gerring, J. and McDermott, R. (2007) ‘An Experimental Template for Case Study Research’ Vol. 51 No. 3 American Journal of Political Science 688-701. One such study in law that has been described by some, if not by the researchers themselves, as a case study did include an experimental design within the battery of methods employed see: Moorhead, R., Sherr, A., Webley, L., Rogers, S., Sherr, L., Paterson, A. & Domberger, S. (2001) Quality and Cost: Final Report on the Contracting of Civil Non-Family Advice and Assistance Pilot (Norwich: The Stationery Office).

19 Campbell, D.T. Foreword in Yin, 2014 xviii.

20 Seawright, J. and Gerring, J. (2008) ‘Case Selection Techniques in Case Study Research: A Menu of Qualitative and Quantitative Options’ Vol. 61 No. 2 Political Research Quarterly 294-308.

21 Yin, 2014: chapter 1.

22 For a discussion see: Ryle, G. (1949). The Concept of Mind . London: Hutchinson; Lincoln, Y.S. and Guba, E.G. (1985). Naturalistic Inquiry . Newbury Park, CA: Sage Publications; Holloway, I. (1997). Basic Concepts for Qualitative Research . London: Blackwell Science.

23 Confirmation or interpretive bias of data is something we all have grapple with, as the natural human tendency is to place more weight on evidence that confirms our view than on evidence that contradicts it. Strong research design can assist with counter-balancing this to some extent, including the transformation of any expected finding into a hypothesis that one then seeks to falsify rather than to confirm.

24 See Yin, 2014, chapter 1 for more information on the role of the literature review.

25 For more assistance with legal research questions refer to Epstein, L. (1995) Studying Law and the Courts in Lee Epstein (ed) Contemplating Courts , Cong Q, 1, 3-5.

26 See King, Keohane and Verba, 1994, 15.

27 See Yin, 2014, at 11, and see further Campbell, J.P., Daft, R.L., Hulin, C. L. (1982) What to Study: Generating and Developing Research Questions (Studying Organizations) , Sage Publications, for further thoughts on research questions

28 On process tracing see: Collier, D. ‘Understanding Process Tracing’ Vol. 44 Political Science and Politics 823-830 and George, A. L. and Bennett, A. Case Studies and Theory Development in the Social Sciences , Cambridge, MA, MIT Press, 2005. For an excellent insight into how this has been used in a legal and policy context with reference to changes in Georgia’s tax laws see Ulriksen, M.S, and Dadalauri, N. ‘Single Studies and Theory-testing: The Knots and Dots of the Process-tracing Method’ (2014) International Journal of Social Research Methodology 1- 17.

29 See Blatter, J. and Haverland, M. Designing Case Studies , Basingstoke, Palgrave MacMillan, 2012 at 145 who consider process tracing involves inductive reasoning to build theory and congruence testing involves deductive reasoning to test theories.

30 Epstein and King suggest a range of possible purposes, at 59, including: to explore something that has not previously been studied; to attempt to settle a debate that has been ongoing within the literature; to examine a well-considered question but in a new way; to collect and analyse new data to seek to confirm or refute previous findings; to analyse an existing data set in a new or better way to seek to confirm or refute previous findings or to develop new ones.

31 Peters, B.G. Comparative Politics: Theory and Method , Basingstoke, Palgrave, 1998 at 14.

32 But interestingly, stance, or more accurately epistemology is of less significance to this research method than to many others. Case study method links the research question, research design, analysis and logic of inference to such an extent that is can accommodate a range of epistemological traditions from the realist to relativist/interpretivist. And thus scholars who consider that there are facts independent of our interpretation of them (in essence, hard facts operating in an objective reality) and scholars who consider all ‘facts’ to be local interpretations constructed through our own lenses, are able to operate within a case study framework. Having said that their choice of data sources, and their approach to data generation and analysis may well vary considerably.

33 Ulriksen and Dadalauri, ibid. See further Dadalauri, N. Tax Policy Formation and the Transnationalizationof the Public Policy Arena; A Case Study of Georgia , Aarhus, Politica, 2011) Georgia was selected as a crucial case. The reasoning for this and also for the methods employed in this study are elegantly set out in the article cited above.

34 On the importance of the identification of priors see Beach, D. and Pedersen, R.B., ‘What is process tracing actually tracing? The three variants of process tracing methods and their uses and limitations’ Sept 1-4 2011 The American Political Science Association Annual Meeting , Seattle, WA as cited by Ulriksen and Dadalauri, ibid; and further Gerring, 2007 ibid.

35 For more assistance on extracting observable implications and considering their measurement see Epstein and King, 2002, 70-76.

36 See Gerring, 2004, 342. See further King, Keohane, and Verba, 1994, 76-77.

37 See Yin, 2014, 51.

38 Gerring, 2004, 344. There are often difficulties in establishing the boundaries of the case, the phenomenon under study, and the context that provides a background to the phenomenon but is not itself the object of enquiry. Gerring articulates this as the formal case (the phenomenon) and the informal cases (the penumbra of phenomena which are the context but which will need to be explored in a less formal way so as to distinguish the boundaries of the formal case). The informal units are peripheral, but may have bearing on the formal unit or case, and by considering these informal units at the beginning of the study, and close to its conclusion it will help the researcher to work out what is particular about the unit, and what is transferable to other units.

39 See Yin, 2014, chapter 2.

40 See Geddes, B. Paradigms and Sand Castle: Theory Building and Research Design in Comparative Politics , Ann Arbor, University of Michigan Press, 2005.

41 But the difficulty with multi case studies is that specified conditions or features within individual cases may have more influence on the variables being studied than the variables that one are analysing across the studies. This may lead one to draw erroneous conclusions about causality. This single case study also illustrates the independent variable problem: to what extent are violent crime rates and/or sentencing policy more likely attributable to other societal changes evident at different points in time than each other? Without knowledge of this it is difficult to proceed.

42 Elliott, M. and Kling, R. ‘Organizational Usability of Digital Libraries: Case Study of Legal Research in Civil and Criminal Courts’ (1997) Vol 48 (11) Journal of the American Society for Information Science 1023-1035.

43 See Dnes, A.W. ‘A Case-Study Analysis of Franchise Contracts’ (1993) Vol. 28 Journal of Legal Studies 367-393.

44 See Latour, B. (2010) above.

45 Although note that Gerring, 2004, at 347 indicates that a single case study may credibly make causal claims, if, for example, the case has been selected as it is particularly representative of others or it is a critical or crucial case, see further: Eckstein, H. (1975) ‘Case Studies and Theory in Political Science’ in Regarding Politics: Essays on Political Theory, Stability, and Change, Berkeley: University of California Press, 1992).

46 Gerring indicates that researchers tend to face the choice between knowing more about less or less about more, 2014, 348.

47 See Small, 2009, 24-26.

48 See Gerring, 2004 at 348. For guidance on comparative methodology in a legal context see: Van Hoecke, M. (2004) Epistemology and Methodology of Comparative Law , Portland, Oregon: Hart Publishing.

49 For a detailed discussion see Gerring, 2004 at 343.

50 Yin sets out six sources of evidence: documents, archival records, interviews, direct observations, participant observation, physical artefacts, Yin, 2014, 105-118, and four principles of data collection: multiple sources of data; creation of a case study database; maintain the chain of evidence; exercise care when using data from electronic sources, at 118-129.

51 See Yin, 2014, chapter 3 for more information on what one needs to do before data collection begins, and chapter 4 on data collection itself.

52 See Small, 2009, 12-15.

53 For a discussion of reliability and validity in measurement see Webley, 2010 and further Epstein and King, 2002, 80-99.

54 Elliott and Kling, ibid at 1025.

55 Dnes, ibid at 369-370.

56 Ulrikesn and Dadalauri, ibid at 13.

57 For a discussion see King, Keohane and Verba, 1994, 12.

58 Epstein and King, 2002, 24.

59 For a discussion on this point see King, Keohane and Verba, 1994, chapter 1 ‘The Science in Social Science’.

60 See Epstein and King, 2002, 25-29 for more information on quantitative data description.

61 For a discussion of the different methods of text based data analysis see Yin, 2014, chapter 5 or Webley, 2010.

62 See Yin, 2014, 136-142.

63 Ulriksen and Dadalauri, ibid.

64 King, Keohane and Verba, 1994, 8.

65 Epstein and King, 2002, 29.

66 See Epstein and King, 2002, 34-37 for help distinguishing between causal mechanisms and variables and causal effects.

67 See Gerring, 2004, 348 and further Roberts, C., The Logic of Historical Explanation, Pennsylvania State University Press 1996, 66.

68 See Gerring, 2004, 348 and further Campbell, D. T. [1975] “‘Degrees of Freedom’ and the Case Study” in E. Samuel Overnman (ed) Methodology and Epistemology in Social Science , Chicago, University of Chicago Press: 1988, 380.

69 Yin, 2014, 142-168, provides five different analytical techniques: pattern-matching; explanation building; time-series analysis; logic models; and cross-case synthesis and suggests that after this phase the researcher will likely move on to work through all plausible alternative conclusions to examine whether the most likely conclusion is the only conclusion.

70 Gerring, 2004, 345.

71 See Gerring, 2004, 346.

72 Epstein and King, 2002, 31.

73 Gerring, J. (2001) Social Science Methodology: A Criterial Framework , Cambridge, Cambridge University Press, 90-99.

74 See further Epstein and King, 2002. For assistance in how to report on cases studies and writing up and presentational considerations, including audience and purpose, see Yin, 2014, chapter 6.

75 King et al, 1996, 30-33.

76 Epstein and King, 2002, 6-7.

77 Epstein and King, 2002, 50.

78 See further Miller, A. S. ‘The Myth of Objectivity in Legal Research and Writing’ (1969) Vol. 18 Catholic University Law Review 290.

79 Epstein and King, 2002, 8-10.

80 Genn, H., Partington, M, and Wheeler, S. (2006) Law in the Real World: Improving Our Understanding of How Law Works Final Report and Recommendations , London: The Nuffield Foundation.

81 Gerring, 2004, 352.

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The Law School Case Method

In the majority of your law school courses, and probably in all of your first-year classes, your only texts will be casebooks—collections of written judicial decisions in actual court cases.

The case method eschews explanation and encourages exploration. In a course that relies entirely on the casebook, you will never come across a printed list of "laws."

Indeed, you will learn that in many areas of law there is no such thing as a static set of rules, but only a constantly evolving system of principles. You are expected to understand the law—in all of its ambiguity—through a critical examination of a series of cases that were decided according to such principles. You may feel lost, groping for answers to unarticulated questions. This is not merely normal, it is intended.

How the Case Method Works

In practical terms, the case method works like this: For every class meeting, you will be assigned a number of cases to read. The cases are the written judicial opinions rendered in court cases that were decided at the appellate level. (The reason for reading cases from courts of appeals or supreme courts is that such cases turn on issues of law, not of fact. If you are charged, tried, and convicted of murder and wish to appeal your case, you do not simply get a whole new trial at a higher level. You must argue that your conviction was improper, not that it was inaccurate.)

Your casebook will contain neither instructions nor explanations. Your assignments simply will be to read the cases and be in a position to answer questions based on them. There will be no written homework assignments, just cases, cases, and more cases.

You will write, for your own benefit, briefs of these cases. Briefs are your attempts to summarize the issues and laws around which a particular case revolves and to make sense of the court's findings in terms of similar cases. One way or another, your law school probably will tell you how to brief a case. If there's an optional seminar, you really ought to attend. In the event that you are left in the dark, it's utterly imperative that you find out how to brief a case. Google it. Ask a second year. Unless you are insanely brilliant, good briefing is really a key to getting good grades. Over the course of a semester, you will try to integrate the content of your case-briefs and your notes from in-class lectures, discussions, or dialogues into some kind of cohesive whole.

From Briefs to Outlines

Typically, you will take your copious briefs and class-notes and create an outline from which you will study for your final exams. Since almost all of your grade for a particular course will rest on your performance on the final, it is essential to establish a system that will allow you to recall the case appropriate for a given legal circumstance within an exam period.

This is especially true since most of your exams will be open book. Once you've see your case-books, you'll understand why having them on the day of the test will not be particularly helpful. Unless, of course, you have your outline handy. Outlines, whether you write your own, create them in a study group, or buy the commercial variety, will be an intrinsic part of this system. Don't neglect them. Your academic success rests on it.

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• Discussion Forum

How Law Professors Can Write a Problem Solving Case

by Joseph William Singer

Bussey Professor of Law, Harvard Law School

We all know law professors use the case method to teach law. But the Problem Solving Workshop has adopted a new kind of case method—the kind more typical of business and public policy schools. The old Langdellian case method asks students to read judicial opinions; we do that to teach students how to interpret cases, to read the law, to consider alternative rules of law, to make arguments on both sides of contested questions, to understand the judicial role and legal reasoning. Such cases start at the end when the facts are decided, the legal issues identified and narrowed, and a ruling of law announced and defended.

Professor Joseph Singer

The problem solving case method focuses on the case at the very beginning—before the facts are all known, before the parties’ goals are clarified, before the legal issues have been narrowed, before the dispute has crystallized or run its course. This problem solving case method asks students to consider who the client is and what their goals are or might be, what the facts are and what facts the lawyer needs to find out, what various legal rules affect the client’s ability to achieve the client’s goals, and what options might be available to help the client achieve her goals ethically and within the bounds of the law.

Writing a case like this may seem daunting, but any law professor can do it by following these simple rules:

First , pick a fact situation that arises in your field of law that is both common and interesting and which raises practical or legal problems that must be resolved. In torts, it could be a corporate decision that might avoid potential accidents or it might be responding to a past disaster or accident. In contracts, it could be planning a transaction or dealing with a potential breach of an existing arrangement or a dispute about the terms of an ongoing arrangement. In property, it could be a dispute among neighbors, between landlord and tenant, with zoning officials; it could be planning a real estate deal or the terms of a charitable trust. In criminal law, it could be a question of whether a crime was committed or how a prosecutor should allocate enforcement resources. In procedure, it could be a search for an appropriate remedy for a problem or how to handle ongoing litigation. Every teacher knows many issues that come up in their particular field; all that you need to do is to think about what the issue might look like at the beginning rather than at the end.

Second , choose a client. The new case study method focuses on serving the interests of clients and helping them navigate the law to achieve their goals. This stage also involves choosing the other parties with whom the client may need to deal to achieve the client’s goals.

Third , construct a fact scenario that involves the client wanting something. Either the client wants to achieve a result or the client wants to solve a problem or dispute. Think of the facts a lawyer would need to know to determine what the client’s goals are and what facts would be needed to apply existing rules of law. In writing the problem, withhold some of those facts so that students would learn to look for facts that are not yet known but need to be known to solve the problem.

Fourth , consider various rules of law that are relevant to the situation. This is the part that is closest to what law professors do in their classes. Pick a rule that requires interpretation or a situation that implicates several rules, including those that cross subjects. Pick a fact situation that might prompt a judge to distinguish a precedent, craft an exception to the rule, or to apply a competing rule.

Fifth , consider what options are available to solve the problem or achieve the client’s goals. Think of the rules not as the ending point that decides what happens but as rules of the game that create both constraints and opportunities. The law may prevent the client from doing certain things but may allow her to achieve her goals some other way. Another party may have conflicting goals but there may be ways to help her achieve her underlying interests that also allow your client to serve her interests.

Finally , put it all together. Start with the story or fact situation. A client comes into your office with a story and a problem. That’s part 1. The class discussion would involve talking about who the client is, what the client’s legal obligations or goals are or might be, what facts we need to find out to clarify what happened and what the client wants, what laws might be relevant to solving the client’s problem, constraining the client’s actions, or empowering the client with respect to other actors. Then identify the relevant law: what cases or statutes should the students know about? Either make a list and require them to look up those cases or statutes and report on what the law requires or summarize the law yourself. That’s part 2. Class discussion would entail figuring out what the law is and how it applies to the client’s situation. Finally, think about how to structure a class discussion about potential options, their pros and cons, and how to communicate them to the client.

That’s it. This is easier to do than you might imagine. Perhaps you can start by taking a legal issue you teach in class and imagine how it arises from the client’s perspective in the real world. What is the first meeting with the lawyer like? What was the client’s experience like before the first meeting? Take it from there. Use what you know and you can do this.

About the author: Professor Singer teaches and writes about property law, conflict of laws, and federal Indian law.  He developed the Problem Solving Workshop at Harvard Law School with Professor Todd Rakoff, and has taught this course to first-years since its inception in 2010.

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Case Studies

The program’s portfolio of situational case studies presents narratives of real-life events and asks students to identify and analyze the relevant legal, social, business, ethical, and scientific issues involved. Playing the role of protagonist in each case study—such as a private attorney counseling a biotechnology company facing hazardous waste issues, or a federal official seeking to develop an effective fishery management plan—students formulate appropriate strategies for achieving workable solutions to conflicts, then discuss and debate their recommendations in class. This interactive approach to learning bolsters students’ acquisition of skills in critical areas: factual investigation, legal research, counseling, persuasive oral communication, and recognition and resolution of ethical dilemmas, to name a few.

The Stanford Law School Case Studies Collection is an exciting innovation in law school teaching designed to hone students’ problem-solving skills and stimulate creativity. The Collection includes situational case studies and interactive simulations (collectively referred to as “Case Materials”) that place students in the roles of lawyers and policy makers and teach fundamental lawyering skills such as investigating facts, counseling, and resolving ethical dilemmas.

In June of 1997 the  Environmental and Natural Resources Law Policy Program  hired an experienced environmental lawyer to develop “situational” case studies for use in classroom instruction to better prepare students for the practice of law in the real world. Most of the case studies have been field tested in the classroom and evaluated for effectiveness in increasing student mastery of fundamental lawyering skills and increasing student participation in classroom discussion. Feedback from students has been excellent. Stanford Law School plans to unveil case studies collections in the areas of Law and Business in the coming years.

You can use this site to download Case Materials for examination. With prior permission from Stanford Law School, instructors can also obtain copies of Case Materials they want to use in the classroom for free. This Case Studies Collection will be updated regularly as we add new Case Materials and revise existing Materials, so visit the site from time to time for new developments!

As used in our website, the phrase “case materials” refers to case studies and simulations, as well as accompanying exhibits and teaching notes. While both case studies and simulations can be used as tools in the “case study teaching method,” they are different in form and manner of use. A case study is a narrative that recounts the factual history of an event or series of events. It is typically used as the basis for in-class analysis and discussion. A simulation is a set of facts, roles and rules that establishes the framework for an in-class participatory exercise.

Research has shown that existing law school teaching methods and curricula do not adequately teach students the full complement of “lawyering” skills they need to competently practice law. The traditional appellate case method assumes that a problem has reached a point where litigation is the only alternative, and presents students with a scenario in which all relevant issues have been identified, the questions of law narrowly focused, and the questions of fact resolved. Skills-oriented courses and clinical programs (such as law clinics and externships) have made significant contributions to law schools’9 ability to teach lawyering skills. Their reach, however, has been limited by a combination of factors, including their high cost and the relatively few law students who actually take advantage of these programs.

While we do not envision the case study method displacing the appellate case method or clinical programs, we do believe that the case method can be used in conjunction with existing teaching methods to add considerable educational value. Case studies and simulations immerse students in real-world problems and situations, requiring them to grapple with the vagaries and complexities of these problems in a relatively risk-free environment – the classroom.

Incorporation of case studies and simulations into environmental law school curriculums can bolster student skill acquisition in the critical areas listed below. Based on a 1990-1991 American Bar Association questionnaire, the MacCrate Task Force concluded that traditional law school curricula and teaching methods fall short in teaching these fundamental lawyering skills:

• problem solving
• legal research
• factual investigation
• persuasive oral communications
• negotiation
• recognizing and resolving ethical dilemmas
• organization and management of legal work

The case study teaching method is adapted from the case method developed and used successfully for many years by the nation’s leading business schools. The method uses a narrative of actual events to teach and hone the skills students need to competently practice law. Students identify for themselves the relevant legal, social, business, and scientific issues presented, and identify appropriate responses regarding those issues. Suggested questions for class discussion are prepared in connection with each case study, itself the product of long, probing interviews of the people involved in the actual events. These narratives, or case studies, may be long or short, and portray emotion, character, setting and dialogue. Students present their thoughts on key issues during class discussion, usually from the viewpoint of the key protagonist in the case study.

Simulations are typically used to reinforce and synthesize concepts, skills and substantive law already covered in a course. The simulations are designed for limited instructor and maximum student involvement during the exercise itself. However, once the exercise has drawn to a close, ample time should be allotted for a debriefing session. During the debriefing, instructors and students can engage in a candid discussion of the relative effectiveness of different approaches used during the simulation, clear up any lingering questions about substantive issues, and probe ethical and/or policy issues raised by the simulation.

Requesting Permission to Copy or to Use Materials

Send your request for permission to use or copy Case Materials to  [email protected] . To assist us in reviewing such requests and tracking the actual use of our Case Materials, please provide a description of the course (of up to 500 words) for which the Case Materials will be used. In addition, please include a brief description of the kind of course for which the Case Materials are intended, including:

• Whether the course is an elective or required course, undergraduate, graduate, or continuing education.
• The nature of the academic program and institution in which the course will be taught, such as law school, business school, Earth Sciences department, public interest law firm, etc.
• The number of times the course has been offered.
• Expected enrollment for the course.
• The history of the course’s development.

• DOI: 10.18820/24150517/JJS42.V2.6
• Corpus ID: 67814694

The case for the case study method in international legal research

• Published 1 December 2017
• Law, Political Science
• Journal of Jewish Studies

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Counterfactual reasoning: an effective component of the international law methodological armor, implementation approach in legal research, malaysia–singapore airspace dispute, 2018–2019: a legal and political analysis, 73 references, dissecting international legal compliance: an unfinished odyssey, the case study as research method: a practical handbook, the empirical turn in international legal scholarship, how to select and develop international law case studies: lessons from comparative law and comparative politics, the empirical turn in international economic law, the politics of international law, case study research: principles and practices, the new terrain of international law, interdisciplinarity and the discipline of law, counterfactuals and hypothesis testing in political science, related papers.

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How to select and develop international law case studies: lessons fromcomparative law and comparative politics.

Published online by Cambridge University Press:  20 January 2017

To develop international law claims, it is often critical to compare different countries’ laws. This essay explores how methods drawn from comparative law and comparative politics research can help international lawyers make comparative inquiries more simply and straightforwardly.

International lawyers recognize three main sources of legal authority: treaties, custom, and general principles. Cross-national comparisons are deeply embedded in the very definitions of two of these three sources. To establish international custom, an international lawyer must show that a broad range of states consistently engage in a certain practice out of a sense of legal obligation. To establish a general principle, an international lawyer must show that it is “recognized by civilized nations”; in practice this requires that the principle be found in diverse legal families. Treaty interpretation does not necessitate cross-country comparison as a matter of definition: in theory, the text of the treaty itself could provide the requisite answers. However, in practice, international and domestic courts are typically faced with ambiguous treaty terms. To interpret them, they often turn to the jurisprudence of diverse states and to subsequent state practice, thus implicitly beginning a comparative inquiry. in sum, comparative international law is useful for identifying and applying international law, as this volume’s introduction explains.

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1 Statute of the International Court of Justice art. 38, June 26, 1945, 59 Stat. 1031, 8 Unts 993. As a subsidiary source, “judicial decisions and the teachings of the most highly qualified publicists of the various nations “ can be used (emphasis added). Id.

2 Vienna Convention on the Law of Treaties art. 31(3)(b), opened for signature May 23, 1969, 1155 Unts 331.

3 See generally, Priest , George L. & Klein , Benjamin , The Selection of Disputes for Litigation , 13 J. Legal Stud. 1 ( 1984 ) CrossRef Google Scholar , and works citing this piece.

4 Roberts , Anthea , Is International Law International? (forthcoming 2016 ) Google Scholar .

6 Zaring , David , The use of Foreign Decisions by Federal Courts: An Empirical Analysis , 3 J. Empirical Legal Stud. 297 , 301 ( 2006 ) CrossRef Google Scholar .

7 Voeten , Erik , Borrowing and Nonborrowing Among International Courts , 39 J. Legal Stud. 547 ( 2010 ) CrossRef Google Scholar .

8 Int’l Law Ass’n, London Conference, Final Report of the Committee: Statement of Principles Applicable to the Formation of General Customary International Law 32–34 (2000).

9 See Roberts , Anthea Elizabeth , Traditional and Modern Approaches to Customary International Law: A Reconciliation, 95 AJIL 757 ( 2001 ) CrossRef Google Scholar .

10 For examples of databases that international lawyers might find especially useful, see United Nations Treaty Collection, at https://treaties.un.org (last visited Mar. 29, 2015); Comparative Constitutions Project, at http://comparativeconstitutionsproject.org (last visited Mar. 29, 2015); Doing Business Data, World Bank Group, at http://www.doingbusiness.org (last visited Mar. 29, 2015); and the Correlates of War Project, at http://correlatesofwar.org (last visited Mar. 29, 2015). For a very helpful review of the quantitative literature in comparative law, see Spamann , Holger , Empirical Comparative Law, 11 Ann. Rev. L. & Soc. Sci. (forthcoming 2015 ) Google Scholar , available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2577350 .

11 See Forteau , Mathias , Comparative International Law Within, Not Against, International Law: Lessons from the International Law Commission, 109 AJIL 498 ( 2015 ) CrossRef Google Scholar .

12 See Levy , Jack S. , Case Studies: Types, Designs, and Logics of Inference , 25 Conflict Mgmt. & Peace Sci. 1 , 6–7 ( 2008 ) CrossRef Google Scholar .

13 See, e.g. , Marshall , Martin N. , Sampling for Qualitative Research, 13 Fam. Prac. 522 , 523 ( 1996 ) CrossRef Google Scholar .

14 See, e.g. , Waldron , Jeremy , “ Partly Law Scommon to All Man Kind”: Foreign Law in American Courts 171–76 ( 2012 ) Google Scholar .

15 Confirmation Hearing on the Nomination of John G. Roberts Jr. to be Chief Justice of the United States Before the S. Comm. on the Judiciary , 109th Cong. 200–01 (2005).

16 See, e.g. , Fearon , James D. & Laitin , David D. , Integrating Qualitative and Quantitative Methods , in The Oxford Handbook of Political Methodology 756 ( 2008 ) Google Scholar .

17 See, e.g. , Freedman , David A. , Do the N’s Justify the Means? , 6 Qualitative & Multi-Method Res. 4 ( 2008 ) Google Scholar .

18 See, e.g. , Gerring , John , Techniques for Case Selection: A Response to David Freedman , 6 Qualitative & Multi-Method Res. 7 , 8–9 ( 2008 ) Google Scholar .

19 Theoretically informed sampling, also known as purposive sampling, bears important similarities to stratified random sampling.

20 For a more extensive discussion, see John Gerring, Case Study Research (2007) and Jason Sea wright & Gerring , John , Case Selection Techniques in Case Study Research: A Menu of Qualitative and Quantitative Options , 61 Pol. Res. Q. 294 ( 2008 ) Google Scholar .

21 As noted in part I, the continued relevance of opinio juris is debated; while the U.S. Restatement emphasizes opinio juris , other authorities are more flexible. Relatedly, some scholars argue that, to establish a general principle, deductive, natural-law-like reasoning is appropriate.

22 For more details on this example, see Ohlin , Jens David , Control Matters: Ukraine & Russia and the Downing of Flight 17 , Opinio Juris (July 23, 2014, 8:30 AM) Google Scholar , at http://opiniojuris.org/2014/07/23/control-mattersukraine-russia-downing-flight-17 .

23 See, e.g. , Chayes , Abram & Chayes , Antonia Handler , On Compliance , 47 Int’l Org. 175 , 175–76, 178 ( 1993 ) CrossRef Google Scholar ; Linos , Katerina , How Can International Organizations Shape National Welfare States? Evidence from Compliance with European Union Directives , 40 Comp. Pol. Stud. 547 ( 2007 ) CrossRef Google Scholar .

24 See, e.g. , Krisch , Nico , International Law in Times of Hegemony: Unequal Power and the Shaping of the International Legal Order , 16 Eur. J. Int’l L. 369 ( 2005 ) CrossRef Google Scholar .

25 See, e.g. , La Porta , Rafael et al., The Economic Consequences of Legal Origins , 46 J. Econ. Literature 285 ( 2008 ) CrossRef Google Scholar .

26 See The Paquete Habana, 175 U.S. 677 (1900).

27 See Alexander L. George & Andrew Bennett, Cases Tudies and theory Development in the Social Sciences 153–60 (2005).

28 Ashley Deeks, Intelligence Communities and International Law (working paper).

29 See Gary King, Robert O. Keohane & Sidney Verba, Designing Social Inquiry 168 (1994).

30 For further analysis of whether a case might be more or less likely to confirm a theory, see Eckstein , Harry , Case Study and Theory in Political Science , in 7 Handbook of Political Science 79 ( Greenstein , Fred I. & Polsby , Nelson W. eds., 1975 Google Scholar ).

31 1 Jean-Mariehenckaerts & Louise Doswald-Beck, Customary International Human Itarian Law (2005); 2 Int’l Comm. of the Red Cross, Customary International Humanitarian Law (Jean-Marie Henckaerts & Louise Doswald-Beck eds., 2005).

32 See Rogowski , Ronald , The Role of Theory and Anomaly in Social-Scientific Inference , 89 Am. Pol. Sci. Rev. 467 , 468 ( 1995 ) CrossRef Google Scholar .

33 See George & Bennett, supra note 27, at 20–21.

34 The power resources thesis emphasizes the role of organized labor and organized business opposition to labor in the development of modern welfare states. See, e.g. , Bradley , David et al., Distribution and Redistribution in Post industrial Democracies , 55 World PoL. 193 ( 2003 ) CrossRef Google Scholar .

35 See Linos, supra note 23, at 561.

36 See generally Michaels , Ralf , The Functional Method of Comparative Law , in Oxford Handbook of Comparative Law 342 ( Reimann , Mathias & Zimmermann , Reinhard eds., 2006 ) Google Scholar .

37 See id. at 373. See also Fr. Kruse , Vinding , What Does “Transfer of Property” Mean with Regard to Chattels? A Study in Comparative Law , 7 Am. J. Comp. L. 500 ( 1958 ) CrossRef Google Scholar .

38 See, e.g. , Hansmann , Henry & Mattei , Ugo , The Functions of Trust Law: A Comparative Legal and Economic Analysis , 73 N.Y.U. L. Rev. 434 ( 1998 ) Google Scholar ; von Mehren , Arthur T. , Civil-Law Analogues to Consideration: An Exercise in Comparative Analysis , 72 Harv. L. Rev. 1009 ( 1959 ) CrossRef Google Scholar .

39 See generally Cheng , Bin , General Principles of International Law as Applied by International Courts and Tribunals ( Cambridge Univ. Press 2006 ) Google Scholar (1953).

40 Compare LG&E Energy Corp., LG&E Capital Corp., and LG&E Int’l, Inc. v. Argentine Republic, Icsid Case No. Arb/02/1, Decision on Liability, ¶¶ 229, 245 (Oct. 3, 2006), and Continental Casualty Company v. Argentine Republic, Icsid Case No. Arb/03/9, Award, ¶¶168, 233 (Sept. 5, 2008) (excusing Argentina’s conduct because Argentina found itself in a state of necessity), with CMS Gas Transmission Co. v. Argentine Republic, Icsid Case No. Arb 01/8, Award (May 12, 2005) (holding that the requirements of necessity had not been met).

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• Volume 109, Issue 3
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• DOI: https://doi.org/10.5305/amerjintelaw.109.3.0475

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Home » Blogs, News, Advice » Legal Education » Legal Research Techniques for Finding Relevant Case Law

Legal Research Techniques for Finding Relevant Case Law

• Aug 8, 2023
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Legal research is a systematic finding or ascertainment of law on an identified topic or in a given area. Additionally, it is a legal inquiry into the existing scholarship to advance the science of law.

Case law research and analysis is a prerequisite in the process of legal research. The method of acquiring this skill starts as soon as one embarks upon the journey of learning, studying, exploring and most importantly applying the law in a practical scenario.

Reading a case law, comprehending the rationale behind the decision and relating it to the present case to build a compelling and coherent argument is a skill every lawyer not only aspires to acquire. In order to become proficient and accomplished in their chosen profession, every lawyer must be skilled in finding relevant case laws through different means. One can learn several legal research techniques to find relevant case laws in legal databases.

Read on to find out several tools and techniques of Legal Research.

What are the different types of Legal Research?

Different types of research are crucial in case law research as they provide varied perspectives and information. Legal research helps identify relevant statutes, regulations, and precedents.

By utilizing these different research methods, researchers can obtain a comprehensive understanding of the legal landscape and make well-informed arguments or decisions in case law research. There are several legal research methodologies available for researchers to pursue their research.

1. Descriptive & Analytical Research

Descriptive research methodology focuses more on the “what” of the subject than the “why” of the research question. It is a description-based methodology that studies the characteristics of the population or phenomenon. The analytical research, however, uses the facts and information available to make a critical evaluation.

2. Qualitative & Quantitative Research

Qualitative legal research is a subjective method that relies on the researcher’s analysis of the controlled observations. In Quantitative Legal Research, one collects data from existing and potential data using sampling techniques like online surveys, polls, & questionnaires. The researcher can represent the outcomes of the quantitative study numerically.

3. Doctrinal & Empirical Research

In doctrinal legal research, the researcher analyses the existing statutory data to find the relevant answer to “What is the Law?” However, in empirical research, the researcher creates new data using several data collection methods and uses statistical tools to analyze it.

What is the Case Law Technique in Legal Research?

Case laws are the primary sources, i.e., the most original source, used in all legal research methodologies.

The case law technique in legal research methodology studies judicial opinions or decisions, and it is the technique of finding relevant legal precedents and principles. This is more challenging than it sounds because finding applicable case laws from legal databases is confusing and time-consuming, if the researcher is not well-versed with the tools.

Like legislation, case law can also be challenged and consequently change over time, as per the changing needs of the society. An earlier decision does not guarantee that it will always remain the law of the land.

Therefore, a lawyer must be skilled at finding, reading, and ascertaining the relevance, applicability and legal standing of any case law at a given point of time. . Thus, the importance of case law technique in legal research is quite significant as there can be no legal research without delving deep into judicial decisions.

How to Do Legal Research for Case Laws?

Before the time of the web, legal databases were in the form of multi-volume bulky books and digests. Researchers had to locate the cases manually with the help of case citations which was extremely time consuming. Though these periodicals are still available, online legal databases have overpowered them owing to their easy accessibility and time-saving tendency.

The Offline Tools for Legal Research

The researcher can locate case laws using the citations in printed law reporters. For example, the citation of a case is AIR 2017 SC 57, here the name of the Law Reporter in which the case law is published is AIR (All India Reporter), the year of the judgment is 2017, SC (Supreme Court) is the name of the Court, and the page number of the printed reporter on which the judgment can be found is 57.

The format of citation differs for every law reporter. Thus, the first step for locating the proper case law using citation is to decode the name of the law reporter.

The law reporters also categorize all the case laws. Thus, if the researcher does not know the case citation, they can find the case law as per its category.

The Online Tools for Legal Research

Using online tools for finding case laws is relatively easy. Even if the researcher does not know the name, citation, or year of the judgment, they can still find the same or similar judgments, thanks to these online tools’ intelligent features.

The only drawback is the majority of these tools require a heavy subscription fee which is not ideal for everyone.

What are the Methods of Locating Relevant Case Laws?

A researcher can locate relevant case laws if they know either of the following:

The identity of the case in law reporters, usually denoted in a combination of words & numbers.

For example: (1973) 4 SCC 225; AIR 1973 SC 1461

Case number

The official number the Court gives to a particular case.

For example: W.P.(C) 135 OF 1970

Name of the Parties

Either party’s name can be used for finding the case law.

For example: Petitioner’s name- Kesavananda Bharati Sripadagalvaru

Respondent’s name- State of Kerala

Jurisdiction

A researcher can filter their finding by deciding which Court’s judgment they want to look for.

A researcher can refer to various statute-based legal databases while finding a case law pertaining to a particular statute.

For example: The Labour Law Reporter publishes judgments specifically related to the Labour Laws of India.

How to Find Relevant Case Laws in India?

The offline tools.

The Supreme Court Reports (SCR) are the only authorized Indian law report series, and Supreme Court decisions should be cited from here whenever possible. However, Supreme Court Reporters are about four years behind in publishing the cases. Because of the long delay in the publication of the SCR. Therefore, it is entirely acceptable to cite a few unauthorized reports in academic and judicial work.

All India Reporter (AIR) is often cited in preference to the SCR, and in the Indian courts it has the status of an authorized series. The Law Library has the AIRs in print.

Online Tools

• Supreme Court of India at main.sci.gov.in . All the latest judgments by the Supreme Court of India are available here.
• Judgment Search Portal at judgments.ecourts.gov.in/pdfsearch/index.php : You can find the old Supreme Court Judgments here by entering any related keyword. It can be the citation of the case, name of the parties, case number, nature of the case, etc.
• SCC Online at www.scconline.com : India’s premier legal database with access to complete coverage of the Supreme Court, all High Courts, Tribunals and Commissions, Statutory Material and many foreign jurisdictions’ and International material. Individual registration is required to use this online legal database .
• AIROnline at www.aironline.in : Again, a subscription-based legal database which covers the judgments of all Supreme Courts, all High Courts, Tribunals and Commissions. The subscribers can find the case laws through citations, individual words, or exact phrases.
• Manupatra at www.manupatrafast.com : Indian case law coverage includes full-text decisions from the Supreme Court, all High Courts, the Federal Court, Privy Council and many tribunals. It covers judgments from the inception of each Court. The legislations covered include bare acts, amending acts, repealed legislation, subordinate legislation and bills from all jurisdictions. The primary material is grouped by topic; the secondary material comprises annotated legislation and commentary.
• Indian Kanoon at indiankanoon.org contains unreported decisions and is more up-to-date by a few days than the unreported cases on Manupatra or SCC Online. It goes back further (for example, Supreme Court cases started in 1947 in Kanoon and 1950 in Manupatra).

If you are looking for very recent decisions or if it is optional to access a reported version of the case, use Kanoon. Citation, party names, keywords, Court, date range etc., can search it. Researchers can also browse Indian Kanoon by Court and year. Indian Kanoon is also free!

However, Indian Kanoon tends to provide fewer parallel citations than Manupatra. It relies on user-generated content, lacks official verification, may contain outdated or inaccurate information, and sometimes does not provide comprehensive access to all relevant legal materials and judgments.

The approach to case law research has changed globally and in India due to technological advancement. According to statistics, roughly 33.9% of lawyers begin their research by using Google. Because Google is a generic search engine, the search results may sometimes be vague. Hence, case law databases or search engines that are tailor-made for lawyers emerge.

Lawctopus Law School’s Legal Research & Writing Course helps law students and legal professionals in understanding a crisp way to conduct Legal Research of different techniques and the right way to use legal databases.

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Home » Case Study – Methods, Examples and Guide

Case Study – Methods, Examples and Guide

Table of Contents

A case study is a research method that involves an in-depth examination and analysis of a particular phenomenon or case, such as an individual, organization, community, event, or situation.

It is a qualitative research approach that aims to provide a detailed and comprehensive understanding of the case being studied. Case studies typically involve multiple sources of data, including interviews, observations, documents, and artifacts, which are analyzed using various techniques, such as content analysis, thematic analysis, and grounded theory. The findings of a case study are often used to develop theories, inform policy or practice, or generate new research questions.

Types of Case Study

Types and Methods of Case Study are as follows:

Single-Case Study

A single-case study is an in-depth analysis of a single case. This type of case study is useful when the researcher wants to understand a specific phenomenon in detail.

For Example , A researcher might conduct a single-case study on a particular individual to understand their experiences with a particular health condition or a specific organization to explore their management practices. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a single-case study are often used to generate new research questions, develop theories, or inform policy or practice.

Multiple-Case Study

A multiple-case study involves the analysis of several cases that are similar in nature. This type of case study is useful when the researcher wants to identify similarities and differences between the cases.

For Example, a researcher might conduct a multiple-case study on several companies to explore the factors that contribute to their success or failure. The researcher collects data from each case, compares and contrasts the findings, and uses various techniques to analyze the data, such as comparative analysis or pattern-matching. The findings of a multiple-case study can be used to develop theories, inform policy or practice, or generate new research questions.

Exploratory Case Study

An exploratory case study is used to explore a new or understudied phenomenon. This type of case study is useful when the researcher wants to generate hypotheses or theories about the phenomenon.

For Example, a researcher might conduct an exploratory case study on a new technology to understand its potential impact on society. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as grounded theory or content analysis. The findings of an exploratory case study can be used to generate new research questions, develop theories, or inform policy or practice.

Descriptive Case Study

A descriptive case study is used to describe a particular phenomenon in detail. This type of case study is useful when the researcher wants to provide a comprehensive account of the phenomenon.

For Example, a researcher might conduct a descriptive case study on a particular community to understand its social and economic characteristics. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a descriptive case study can be used to inform policy or practice or generate new research questions.

Instrumental Case Study

An instrumental case study is used to understand a particular phenomenon that is instrumental in achieving a particular goal. This type of case study is useful when the researcher wants to understand the role of the phenomenon in achieving the goal.

For Example, a researcher might conduct an instrumental case study on a particular policy to understand its impact on achieving a particular goal, such as reducing poverty. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of an instrumental case study can be used to inform policy or practice or generate new research questions.

Case Study Data Collection Methods

Here are some common data collection methods for case studies:

Interviews involve asking questions to individuals who have knowledge or experience relevant to the case study. Interviews can be structured (where the same questions are asked to all participants) or unstructured (where the interviewer follows up on the responses with further questions). Interviews can be conducted in person, over the phone, or through video conferencing.

Observations

Observations involve watching and recording the behavior and activities of individuals or groups relevant to the case study. Observations can be participant (where the researcher actively participates in the activities) or non-participant (where the researcher observes from a distance). Observations can be recorded using notes, audio or video recordings, or photographs.

Documents can be used as a source of information for case studies. Documents can include reports, memos, emails, letters, and other written materials related to the case study. Documents can be collected from the case study participants or from public sources.

Surveys involve asking a set of questions to a sample of individuals relevant to the case study. Surveys can be administered in person, over the phone, through mail or email, or online. Surveys can be used to gather information on attitudes, opinions, or behaviors related to the case study.

Artifacts are physical objects relevant to the case study. Artifacts can include tools, equipment, products, or other objects that provide insights into the case study phenomenon.

How to conduct Case Study Research

Conducting a case study research involves several steps that need to be followed to ensure the quality and rigor of the study. Here are the steps to conduct case study research:

• Define the research questions: The first step in conducting a case study research is to define the research questions. The research questions should be specific, measurable, and relevant to the case study phenomenon under investigation.
• Select the case: The next step is to select the case or cases to be studied. The case should be relevant to the research questions and should provide rich and diverse data that can be used to answer the research questions.
• Collect data: Data can be collected using various methods, such as interviews, observations, documents, surveys, and artifacts. The data collection method should be selected based on the research questions and the nature of the case study phenomenon.
• Analyze the data: The data collected from the case study should be analyzed using various techniques, such as content analysis, thematic analysis, or grounded theory. The analysis should be guided by the research questions and should aim to provide insights and conclusions relevant to the research questions.
• Draw conclusions: The conclusions drawn from the case study should be based on the data analysis and should be relevant to the research questions. The conclusions should be supported by evidence and should be clearly stated.
• Validate the findings: The findings of the case study should be validated by reviewing the data and the analysis with participants or other experts in the field. This helps to ensure the validity and reliability of the findings.
• Write the report: The final step is to write the report of the case study research. The report should provide a clear description of the case study phenomenon, the research questions, the data collection methods, the data analysis, the findings, and the conclusions. The report should be written in a clear and concise manner and should follow the guidelines for academic writing.

Examples of Case Study

Here are some examples of case study research:

• The Hawthorne Studies : Conducted between 1924 and 1932, the Hawthorne Studies were a series of case studies conducted by Elton Mayo and his colleagues to examine the impact of work environment on employee productivity. The studies were conducted at the Hawthorne Works plant of the Western Electric Company in Chicago and included interviews, observations, and experiments.
• The Stanford Prison Experiment: Conducted in 1971, the Stanford Prison Experiment was a case study conducted by Philip Zimbardo to examine the psychological effects of power and authority. The study involved simulating a prison environment and assigning participants to the role of guards or prisoners. The study was controversial due to the ethical issues it raised.
• The Challenger Disaster: The Challenger Disaster was a case study conducted to examine the causes of the Space Shuttle Challenger explosion in 1986. The study included interviews, observations, and analysis of data to identify the technical, organizational, and cultural factors that contributed to the disaster.
• The Enron Scandal: The Enron Scandal was a case study conducted to examine the causes of the Enron Corporation’s bankruptcy in 2001. The study included interviews, analysis of financial data, and review of documents to identify the accounting practices, corporate culture, and ethical issues that led to the company’s downfall.
• The Fukushima Nuclear Disaster : The Fukushima Nuclear Disaster was a case study conducted to examine the causes of the nuclear accident that occurred at the Fukushima Daiichi Nuclear Power Plant in Japan in 2011. The study included interviews, analysis of data, and review of documents to identify the technical, organizational, and cultural factors that contributed to the disaster.

Application of Case Study

Case studies have a wide range of applications across various fields and industries. Here are some examples:

Business and Management

Case studies are widely used in business and management to examine real-life situations and develop problem-solving skills. Case studies can help students and professionals to develop a deep understanding of business concepts, theories, and best practices.

Case studies are used in healthcare to examine patient care, treatment options, and outcomes. Case studies can help healthcare professionals to develop critical thinking skills, diagnose complex medical conditions, and develop effective treatment plans.

Case studies are used in education to examine teaching and learning practices. Case studies can help educators to develop effective teaching strategies, evaluate student progress, and identify areas for improvement.

Social Sciences

Case studies are widely used in social sciences to examine human behavior, social phenomena, and cultural practices. Case studies can help researchers to develop theories, test hypotheses, and gain insights into complex social issues.

Law and Ethics

Case studies are used in law and ethics to examine legal and ethical dilemmas. Case studies can help lawyers, policymakers, and ethical professionals to develop critical thinking skills, analyze complex cases, and make informed decisions.

Purpose of Case Study

The purpose of a case study is to provide a detailed analysis of a specific phenomenon, issue, or problem in its real-life context. A case study is a qualitative research method that involves the in-depth exploration and analysis of a particular case, which can be an individual, group, organization, event, or community.

The primary purpose of a case study is to generate a comprehensive and nuanced understanding of the case, including its history, context, and dynamics. Case studies can help researchers to identify and examine the underlying factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and detailed understanding of the case, which can inform future research, practice, or policy.

Case studies can also serve other purposes, including:

• Illustrating a theory or concept: Case studies can be used to illustrate and explain theoretical concepts and frameworks, providing concrete examples of how they can be applied in real-life situations.
• Developing hypotheses: Case studies can help to generate hypotheses about the causal relationships between different factors and outcomes, which can be tested through further research.
• Providing insight into complex issues: Case studies can provide insights into complex and multifaceted issues, which may be difficult to understand through other research methods.
• Informing practice or policy: Case studies can be used to inform practice or policy by identifying best practices, lessons learned, or areas for improvement.

Advantages of Case Study Research

There are several advantages of case study research, including:

• In-depth exploration: Case study research allows for a detailed exploration and analysis of a specific phenomenon, issue, or problem in its real-life context. This can provide a comprehensive understanding of the case and its dynamics, which may not be possible through other research methods.
• Rich data: Case study research can generate rich and detailed data, including qualitative data such as interviews, observations, and documents. This can provide a nuanced understanding of the case and its complexity.
• Holistic perspective: Case study research allows for a holistic perspective of the case, taking into account the various factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and comprehensive understanding of the case.
• Theory development: Case study research can help to develop and refine theories and concepts by providing empirical evidence and concrete examples of how they can be applied in real-life situations.
• Practical application: Case study research can inform practice or policy by identifying best practices, lessons learned, or areas for improvement.
• Contextualization: Case study research takes into account the specific context in which the case is situated, which can help to understand how the case is influenced by the social, cultural, and historical factors of its environment.

Limitations of Case Study Research

There are several limitations of case study research, including:

• Limited generalizability : Case studies are typically focused on a single case or a small number of cases, which limits the generalizability of the findings. The unique characteristics of the case may not be applicable to other contexts or populations, which may limit the external validity of the research.
• Biased sampling: Case studies may rely on purposive or convenience sampling, which can introduce bias into the sample selection process. This may limit the representativeness of the sample and the generalizability of the findings.
• Subjectivity: Case studies rely on the interpretation of the researcher, which can introduce subjectivity into the analysis. The researcher’s own biases, assumptions, and perspectives may influence the findings, which may limit the objectivity of the research.
• Limited control: Case studies are typically conducted in naturalistic settings, which limits the control that the researcher has over the environment and the variables being studied. This may limit the ability to establish causal relationships between variables.
• Time-consuming: Case studies can be time-consuming to conduct, as they typically involve a detailed exploration and analysis of a specific case. This may limit the feasibility of conducting multiple case studies or conducting case studies in a timely manner.
• Resource-intensive: Case studies may require significant resources, including time, funding, and expertise. This may limit the ability of researchers to conduct case studies in resource-constrained settings.

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The Case Method in Legal Education

Each doctrine has a history. In the case of law, Langdell has argued that students would be better educated if they were asked to draw their own conclusions about the meaning of judicial decisions. Case studies provide students with an overview of the main issue; background of the institution, industry and individuals involved; and the events that had led to the problem or decision. Faculty may assign questions prior to class to facilitate the students to focus on certain important issues. Principles of law are taught by making the students analyse abridgments of appellate cases in combination with the Socratic method.

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The present study is a reflection on the method of case study in learning law. To achieve this purpose we will discuss the traditional method and its limitations to the challenges of law in the era of globalization. We will emphasize the urgent need to implement the case study method in Portuguese law schools, as an instrument that enhances the active participation of the student, protagonist in the process of learning and knowledge acquisition. This study is justified today, especially the challenges triggered by the Bologna process, including the implication in the teaching, learning and assessment. The teacher is assumed as a supervisor of the learning process, calling for the autonomy of the student. It is intended that students develop critical thinking and be able to reflect on their own learning process. Therefore, the need to revise the traditional methodology here rooted in the teaching of law. A review of the literature will be carried out, which will seek to contextualize...

Opolskie Studia Administracyjno-Prawne

The article aims to provide an overview of the most popular law teaching methods in the USA (Langdell’s Case Study together with Socratic Method, Clinical Legal Education, and Problem Solving Method) with reference to the cultural context and philosophical background. First, the characteristic features of the American legal culture with regard to teaching law and ideological grounds of the American legal education are presented. Then the methods are discussed together with the context in which they were developed and the arguments for implementing them.

Marketing in Three Eras, Terence Nevett and …

Jerry Kirkpatrick

Available at SSRN 1585803

Mark Klamberg

Scholars International Journal of Law, Crime and Justice

Kenneth Granle

Legal education has changed very little over the last century. At the same time, there have been significant advances in the field of education leading to several theories. The following will examine the five leading theories of education: connectivism, humanism, constructivism, cognitivism, and behaviorism. Each of these will be evaluated next to the Socratic Method, which is the primary method employed by law school instructors. Specific examples of how some of these theories have surfaced in law school and how the Socratic Method embodies other theories will be noted. The effect of technology on law school instruction will also be addressed. The overall goal of this article is to reveal how these theories can be utilized in the law school setting to produce highly competent graduates who will improve the efficacy of the field as a whole. Anecdotal example from North American and African law schools will underscore the notions put forth in this article.

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• Mar 17, 2023

Top Study Techniques that Work Best for Law Students

I am one thousand per cent guilty of being on TikTok for longer than I needed to whilst I had a few unwatched lectures in my back pocket waiting for me. Sometimes I find the algorithm will expose me and start dropping not-so-subtle hints about how to study effectively or show pages of dark academia content from Cambridge or USYD. Yes, I'd love to be able to study in buildings dripping with history and pay for an overpriced kombucha lasagne. (Just kidding)

But I am curious, what study techniques actually work for law students? We are chronically time-poor, needing rest and still trying to achieve the best grades we've ever had. But how do we achieve that? Does one study method work for all of us? We road-tested and rated the most popular ones to help expose the best ones for you. Our reviews highlighted the pros and cons, and our ratings suggest how applicable the original study method is for law students.

The SQ3R method

The SQ3R method is a study technique that is designed to help students read and retain information from textbooks more effectively. SQ3R stands for Survey, Question, Read, Recite, and Review, which are the five steps of the method.

Survey: In the survey step, you quickly skim through the chapter or section you are going to read, looking at headings, subheadings, and any visual aids, such as charts or graphs. This helps you get an overview of what the material is about.

Question: After surveying the material, you should come up with questions about what you are going to read. This can help you focus your attention and give you a purpose for reading.

Read: Read the material actively, taking notes and looking for answers to your questions. Trying to understand the material is more important rather than simply memorising it.

Recite: After reading a section, close the book and try to recall the information. This can help you identify what you do and don't understand, and reinforce your memory.

Review: Finally, review the material periodically to reinforce your memory and to help you remember the key concepts.

The SQ3R method is a popular and effective way to study, and it can be used with any reading material, not just textbooks.

The pros of this study method include the willingness to challenge your existing knowledge and learn through questions and answers.

The cons are that it's way too time-consuming to try and find questions yourself. We suggest using AI software to help generate questions for you (a huge time saver) and/or reading your tutorial questions and answering them first.

The PQ4R method

The PQR4 method is a study technique that can help students improve their comprehension and retention of information while reading. PQR4 stands for Preview, Question, Read, Reflect, and Review, which are the five steps of the method.

Preview: In the preview step, you quickly skim through the material, looking at headings, subheadings, and any visual aids, such as charts or graphs. This helps you get an overview of what the material is about.

Question: After previewing the material, you should generate questions about what you are going to read. This can help you focus your attention and give you a purpose for reading.

Reflect: After reading a section, reflect on what you've read for a few moments. This can help you identify what you do and don't understand, and reinforce your memory.

The PQR4 method is similar to the SQ3R method, but it adds the step of reflection, which encourages students to think more deeply about the material they are reading. This can help students make connections between different concepts and improve their understanding of the material.

The pros of this study method include skimming through the material, although this is not always applicable depending on the density of your readings.

The cons are assuming that I have time to reflect. The audacity. #injustice

Retrieval practice

Retrieval practice, also known as the testing effect, is a learning technique that involves actively recalling information from memory rather than simply rereading or reviewing it. It involves practising the process of recalling information from memory, which has been shown to improve long-term retention and retrieval of that information.

In retrieval practice, learners actively retrieve information from their memory, whether it be through testing, quizzing, or self-assessment. The process of retrieval strengthens the neural pathways in the brain that are associated with that information, making it easier to recall that information in the future.

Retrieval practice can be used in a variety of learning contexts, including classrooms, online learning, and self-study. It has been shown to be a highly effective learning strategy, especially when combined with other techniques such as spaced repetition and interleaving.

Overall, retrieval practice is a powerful tool for improving long-term memory retention and recall and is an essential component of any effective study or learning strategy.

The pros of this study method are that it can show you what you know, and what you don't know.

The cons are that you find out what you don't know. You can expect an increase in anxiety and the need for another coffee.

Spaced practice

Spaced practice, also known as distributed practice or spaced repetition, is a learning technique that involves spreading out study or practice sessions over time, rather than cramming all of the material into a single session. This approach allows learners to space out their learning and practice sessions over time, with the goal of promoting better long-term retention and retrieval of the material.

The basic idea behind spaced practice is that by spacing out study or practice sessions, learners can improve the strength and durability of the neural connections in their brain that are associated with that material. By regularly revisiting the material, learners are more likely to remember it in the long term.

There are several different ways to incorporate spaced practice into your learning or study routine. One approach is to schedule multiple study or practice sessions over time, with each session building on the material from the previous session. Another approach is to use spaced repetition software, which schedules review sessions based on a learner's performance and progress.

Spaced practice has been shown to be an effective learning strategy for a wide range of topics and subject areas. By spacing out learning and practice sessions over time, learners can increase their retention and recall of material, leading to better academic performance and a deeper understanding of the material.

The pros of this study method are that it can help you be more consistent since it's easier to recall your information if you maintain the same spaced practice schedule each week.

The cons are you might be too time-pressed to have a consistent schedule. Although, the results are cumulative so, perhaps even half an hour per day could make a difference.

The Feynman technique

The Feynman Technique is a learning method named after the Nobel Prize-winning physicist Richard Feynman. It is a four-step process that helps you understand and retain a concept in your memory. The four steps are:

Choose a concept: Select a concept or idea that you want to learn or understand.

Teach the concept: Imagine you are explaining the concept to someone who has no prior knowledge of the subject. Use simple language and examples to convey the concept.

Identify gaps: As you explain the concept, identify any gaps in your understanding or areas where you struggle to explain the concept clearly.

Review and simplify: Go back to your sources and review the concept to fill in any gaps in your understanding. Then, simplify the concept using analogies or examples until you can explain it clearly and concisely.

The Feynman Technique is a powerful tool for learning and understanding complex ideas. It can be applied to a wide range of subjects, from science and mathematics to literature and history.

The pros of this study method include that it builds your confidence in what you know and what you don't know. Also, you can double-check what you're teaching yourself by posting on your student discussion forum.

The cons are pretty negligible. The Feynman technique reminds me of Einstein's famous quote- "If you can't explain it, then you don't understand it well enough."

⚖️ ⚖️ ⚖️ ⚖️

The Leitner system

The Leitner system is a study method designed to improve long-term memory retention. It involves using flashcards and a spaced repetition schedule to help you review information at increasing intervals of time.

Here is how the Leitner System works:

Create flashcards: Create a set of flashcards with questions or prompts on one side and answers on the other.

Divide the flashcards into boxes: Divide the flashcards into several boxes, with Box 1 being the easiest and Box 4 is the most difficult.

Start studying: Begin studying with Box 1. Review each flashcard, and if you answer the question correctly, move the card to the next box. If you answer incorrectly, return the card to Box 1.

Adjust the schedule: As you progress, review the cards in each box at increasing intervals. For example, review the cards in Box 1 every day, Box 2 every two days, Box 3 every five days, and Box 4 every 10 days. If you answer a card incorrectly during a review, move it back to Box 1.

The Leitner System is based on the idea that the more you review information at spaced intervals, the better you will remember it in the long term. By gradually increasing the intervals between reviews, you can improve your retention of the material and avoid forgetting it over time.

The pros of this study method are that it allows you to recognise which areas of law you struggle to understand and why - especially since you can rank your questions from easiest to hardest.

The cons are that this method can bring out your inner perfectionist. One of the problems I've encountered with creating my flashcards is that it diverted my study from understanding the law to classical art theory. I got way too invested in having good notes rather than an in-depth understanding of why certain legal concepts were so important. However, we do offer digital study notes for law students on our Instagram.

Colour-coded notes

Colour-coded notes can have several study benefits, including:

Improved organization: You can quickly and easily identify the information you need by assigning different colours to different topics or categories.

Enhanced memory retention: Associating different colours with specific pieces of information can help you remember and recall them more easily.

Increased engagement: Using colourful notes can make studying more visually appealing and engaging, which can help you stay focused and motivated.

Faster information processing: Color-coding can help you quickly process information and identify key points, allowing you to study more efficiently.

Reduced stress: By keeping your notes organized and easy to read, you can reduce the stress and anxiety that can come with disorganized study materials.

Overall, colour-coded notes can be a powerful tool for improving your study habits and achieving academic success.

The pros of this study method are that once you pick a particular colour for a subject, it's a lot easier to remember key cases or bits of information from those colour-coded subjects.

The cons include the presumption that sticky notes work for everyone. You can highlight your notes on your iPad too. That's still a massive win.

Mind mapping

Mind mapping is a technique used to organize information visually, and it has several benefits, including:

Improved creativity: Mind mapping can help stimulate the brain's creative thinking, encouraging brainstorming and generating new ideas.

Better organization: Mind mapping can help organize information in a more logical and structured way, making it easier to understand and remember.

Enhanced memory retention: The use of visual cues and imagery in mind mapping can help improve memory retention and recall.

Increased productivity: Mind mapping can help break down complex tasks into smaller, more manageable components, making planning and prioritising tasks easier.

Better communication: Mind maps can be used to communicate complex ideas and concepts clearly, concisely and visually.

Greater clarity: Mind mapping can help you see relationships and connections between different ideas or pieces of information that may not be immediately obvious.

Mind mapping is a powerful tool for improving creativity, organization, memory retention, productivity, communication, and clarity. It can be used in a wide range of settings, including education, business, and personal development.

The pros of this study method are that it could help you visualise relationships in your hypothetical questions for property, family or contract law.

The cons are that it's not particularly helpful in getting a deeper understanding of the legal principles that arise from the common law.

If you've read this far, we know you're a law student who can speed read like nobody's business. I hope you enjoyed reading this article. There's so much "self-help" advice out there for law students, but not all of it is relevant to us. The top study methods that I've found most helpful include the Feynman technique, colour-coded notes, writing case summaries and having a system in place for how to answer legal hypotheticals. What methods do you like to use when you study?

Let us know at [email protected]

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A proposed methodology for the dynamic standard evaluation of water quality in estuaries: a case study of the pearl river estuary, 1. introduction, 2. method construction, 2.1. classification of seawater quality in the seawater quality standards, 2.2. surface water function and standard classification in surface water environmental quality standards, 2.3. construction of dynamic standard methods for water quality in estuarine areas, 3. application example: evaluation of water quality in the pre (pb, ph, pi, do, cu, zn, cd, and hg), 3.1. description of the monitoring area, 3.2. sample collection and analysis, 3.3. analytical quality assurance, 3.4. results, 4. discussion, 5. conclusions, author contributions, institutional review board statement, informed consent statement, data availability statement, acknowledgments, conflicts of interest.

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Wang, Z.; Zhang, H. A Proposed Methodology for the Dynamic Standard Evaluation of Water Quality in Estuaries: A Case Study of the Pearl River Estuary. J. Mar. Sci. Eng. 2024 , 12 , 1039. https://doi.org/10.3390/jmse12071039

Wang Z, Zhang H. A Proposed Methodology for the Dynamic Standard Evaluation of Water Quality in Estuaries: A Case Study of the Pearl River Estuary. Journal of Marine Science and Engineering . 2024; 12(7):1039. https://doi.org/10.3390/jmse12071039

Wang, Zhongyuan, and Hongkang Zhang. 2024. "A Proposed Methodology for the Dynamic Standard Evaluation of Water Quality in Estuaries: A Case Study of the Pearl River Estuary" Journal of Marine Science and Engineering 12, no. 7: 1039. https://doi.org/10.3390/jmse12071039

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Analysis of Raise Boring with Grouting as an Optimal Method for Ore Pass Construction in Incompetent Rock Mass—A Case Study

• Published: 21 June 2024

Cite this article

• Cluber Rojas 1 ,
• Angelina Anani   ORCID: orcid.org/0000-0001-9125-6877 2 ,
• Eduardo Cordova 1 ,
• Wedam Nyaaba 3 ,
• Edward Wellman 2 &
• Sefiu O. Adewuyi 2  

The construction of ore pass systems in underground mines is a high-risk activity, especially in an environment with incompetent rock mass. This study aims to investigate the optimal method for ore pass construction in incompetent rock masses. We evaluated the conventional and raise boring (RB) methods based on safety, efficiency, excavation control, and ground support for ore pass construction. We also performed a stability analysis using analytical Q-raise ( Q R method) and kinematic analysis methods for ore pass construction with a Raise Borer before and after grout injection of the rock mass. As a case study, an ore pass (diameter, 3 m; depth, 100 m) within an incompetent rock mass was considered to gain further insight. The rock mass was characterized according to the classification methods Q Barton, rock quality designation (RQD), rock mass rating (RMR), and geological strength index (GSI). The grout intensity number (GIN) method of grout injection is used. The safety factor (<1.075) obtained before injection was lower than the acceptance criteria in all sections of the rock mass. However, grout injection before Raise Borer excavation resulted in a rock mass safety factor greater than 1.5. Using RB without pre-grouting in the case study indicated that the maximum unsupported diameter (MUSD) of the ore pass was less than the required 3 m. On the contrary, an MUSD of the rock mass post-grouting was equal to or larger than 3 m at all depths.

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Data Availability

The datasets analyzed during the current study are available from the corresponding author upon reasonable request.

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Rojas, C., Anani, A., Cordova, E. et al. Analysis of Raise Boring with Grouting as an Optimal Method for Ore Pass Construction in Incompetent Rock Mass—A Case Study. Mining, Metallurgy & Exploration (2024). https://doi.org/10.1007/s42461-024-01023-0

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Published on 19.6.2024 in Vol 12 (2024)

Effect of Implementing an Informatization Case Management Model on the Management of Chronic Respiratory Diseases in a General Hospital: Retrospective Controlled Study

Authors of this article:

• Yi-Zhen Xiao 1 , MBBS ; 
• Xiao-Jia Chen 1 , MBBS ; 
• Xiao-Ling Sun 1 , MBBS ; 
• Huan Chen 1 , MM ; 
• Yu-Xia Luo 1 , MBBS ; 
• Yuan Chen 1 , MBBS ; 
• Ye-Mei Liang 2 , MM

1 Department of Pulmonary and Critical Care Medicine, Yulin First People’s Hospital, , Yulin, , China

2 Department of Nursing, Yulin First People’s Hospital, , Yulin, , China

Corresponding Author:

Ye-Mei Liang, MM

Background: The use of chronic disease information systems in hospitals and communities plays a significant role in disease prevention, control, and monitoring. However, there are several limitations to these systems, including that the platforms are generally isolated, the patient health information and medical resources are not effectively integrated, and the “Internet Plus Healthcare” technology model is not implemented throughout the patient consultation process.

Objective: The aim of this study was to evaluate the efficiency of the application of a hospital case management information system in a general hospital in the context of chronic respiratory diseases as a model case.

Methods: A chronic disease management information system was developed for use in general hospitals based on internet technology, a chronic disease case management model, and an overall quality management model. Using this system, the case managers provided sophisticated inpatient, outpatient, and home medical services for patients with chronic respiratory diseases. Chronic respiratory disease case management quality indicators (number of managed cases, number of patients accepting routine follow-up services, follow-up visit rate, pulmonary function test rate, admission rate for acute exacerbations, chronic respiratory diseases knowledge awareness rate, and patient satisfaction) were evaluated before (2019‐2020) and after (2021‐2022) implementation of the chronic disease management information system.

Results: Before implementation of the chronic disease management information system, 1808 cases were managed in the general hospital, and an average of 603 (SD 137) people were provided with routine follow-up services. After use of the information system, 5868 cases were managed and 2056 (SD 211) patients were routinely followed-up, representing a significant increase of 3.2 and 3.4 times the respective values before use ( U =342.779; P <.001). With respect to the quality of case management, compared to the indicators measured before use, the achievement rate of follow-up examination increased by 50.2%, the achievement rate of the pulmonary function test increased by 26.2%, the awareness rate of chronic respiratory disease knowledge increased by 20.1%, the retention rate increased by 16.3%, and the patient satisfaction rate increased by 9.6% (all P <.001), while the admission rate of acute exacerbation decreased by 42.4% (P <.001) after use of the chronic disease management information system.

Conclusions: Use of a chronic disease management information system improves the quality of chronic respiratory disease case management and reduces the admission rate of patients owing to acute exacerbations of their diseases.

Introduction

Chronic obstructive pulmonary disease (COPD) and asthma are examples of common chronic respiratory diseases. The prevalence of COPD among people 40 years and older in China is estimated to be 13.7%, with the total number of patients reaching nearly 100 million. The lengthy disease cycle, recurrent acute exacerbations, and low control rate were found to have a significant impact on the prognosis and quality of life of middle-aged and older patients with COPD [ 1 , 2 ]. Therefore, to decrease the morbidity and disability rates and enhance the quality of life of all patients with chronic respiratory diseases, it is crucial to investigate effective prevention and treatment methods and establish a life cycle management model for chronic respiratory diseases.

Since the development of information technology, the internet and medical technology have been applied to the management of chronic diseases [ 3 ]. The chronic disease information systems adopted in hospitals and communities, along with mobile medical apps, can enhance the self-management capabilities of patients and play a significant role in disease prevention, control, and monitoring [ 4 - 9 ]. However, the existing platforms are generally isolated, the patient health information and medical resources are not effectively integrated, and the Internet Plus Healthcare technology model is not implemented throughout the patient consultation process [ 3 , 9 ].

Yulin First People’s Hospital developed a chronic disease management information system based on the hospital information system (HIS) to fully and effectively utilize the medical resources in hospitals and to better support and adapt the system to the needs of patients with chronic diseases. In this study, we evaluated the impact of the use of this system on the efficacy of case management for patients with chronic respiratory diseases.

Chronic Respiratory Diseases Case Management Model Prior to Implementation of the Chronic Disease Management Information System

Yulin First People’s Hospital is a public grade-3 general hospital with 2460 open beds, a specialty clinic in the Department of Pulmonary and Critical Care Medicine, and 180 beds in the Inpatient Department. Chronic respiratory diseases case management was initiated in 2019, which did not involve the use of an information system and was implemented by a chronic respiratory diseases case management team led by two nurses qualified as case managers, one chief physician, two supervisor nurses, and one technician. Under this system, patients with COPD, bronchial asthma, bronchiectasis, pulmonary thromboembolism, lung cancer, and lung nodules were managed using the traditional inpatient-outpatient-home chronic respiratory diseases case management model, including 1024 cases managed from 2019 to 2020. Except for medical prescriptions and electronic medical records, the patient case management information such as the basic information form, follow-up form, patient enrollment form, inpatient follow-up register, patient medication and inhalation device use records, smoking cessation and vaccination records, and pulmonary rehabilitation and health education records was managed using Microsoft Excel forms that were regularly printed for filing.

Establishment of a Management Information System for Chronic Diseases

The information carrier forming the basis of the management information system is constituted by the model of internet technology, chronic disease case management models, and overall quality management. The key technology is to establish a scientific, refined, and feasible follow-up pathway according to the methods and procedures of chronic disease case management based on the guidelines for the diagnosis and treatment of single chronic diseases. The closed-loop management of the clinical pathway was conducted in accordance with the Deming cycle (plan-do-check-act), and dynamic monitoring of single-disease health-sensitive and quality-sensitive indicators was carried out. The successfully developed system was installed on the hospital server to connect personal terminals (medical terminals and customer apps) to the existing HIS, which includes electronic medical records and medical advice.

Using the single-disease path assessment or plan scale as a framework, the system can automatically collect and integrate the majority of the medical information of patients with chronic respiratory diseases and provide these patients with inpatient, outpatient, and home intelligent medical services. Patients with chronic diseases who enroll in use of the system can use the app to schedule appointments for medical guidance, payment, and result queries; receive health guidance information; perform self-health assessments; write a treatment diary; and obtain medical communication materials.

The medical terminal consists of five functional modules: user entry, data statistics and query, quality control, knowledge base, and module management. As the core of the system, the user entry module can manage case information in seven steps: enrollment, assessment, planning, implementation, feedback, evaluation, and settlement [ 10 - 14 ]. Each step has a corresponding assessment record scale as well as the health-sensitive and quality-sensitive indicators. The structure of the HIS-based chronic disease management information system is shown in Figure 1 .

Implementation of the Chronic Disease Information Management System

Using the chronic disease management information system, two full-time case managers oversaw the case management of 2747 patients diagnosed with six diseases among chronic respiratory diseases between 2021 and 2022. The operation process was broken down into enrollment, assessment, planning, implementation, evaluation, feedback, and settlement stages.

Case managers entered the system through the medical app, selected a disease and an enrolled patient from the list of patients (the system automatically captures the patient’s name and ID number according to the International Classification of Diseases [ ICD ] code) in accordance with the chronic respiratory diseases diagnostic criteria to sign the enrollment contract and determine the relationship between the personal information and data [ 15 - 19 ].

The system can be seamlessly integrated with multiple workstations on the HIS to automatically capture the basic information, electronic medical records, medical advice, and inspection materials, and can generate questionnaires or assessment scales for patients with chronic respiratory diseases such as the COPD Assessment Test, Asthma Control Test, modified Medical Research Council scale, form for lung function test results, inhalation device technique evaluation form, 6-minute walk test record, rehabilitation assessment form, health promotion form, and nutritional assessment form. The above materials can be added or removed based on the requirements for individual patients.

The case managers drafted the follow-up plan based on the patient assessment criteria and included the patients on the 1-, 3-, 6-, and 12-month follow-up lists. If the patient satisfied the self-management and indicator control requirements after follow-up, they could be settled and included in the annual follow-up cohort. Case managers can set up follow-up warning and treatment, involving the return visit plan, health education, follow-up content, pathway, and time, and notify the patients and nurses on day 7 and at months 1, 3, 6, and 12 after discharge. The nurses should promptly deal with patients who miss their scheduled follow-up visit.

Implementation

During the inpatient or outpatient care, supervising physicians, nurses, and patients collaborated with each other to implement the treatment. Case managers monitored the patients, evaluated them, documented the results, interpreted various test indicators, and provided health guidance. The chronic disease management information system acquired the corresponding data for chronic disease–sensitive indicators from outpatient and inpatient orders and medical records automatically. The chronic respiratory diseases management team reviewed the patients’ conditions and the dynamics of chronic disease–sensitive indicators to make accurate decisions based on the current situation. The outpatient physicians obtained the single-disease package advice and personalized prescriptions to modify the diagnosis and treatment scheme.

Case managers highlighted evaluation and health education. First, they assessed and examined the content of the previous education and recorded and analyzed the patients’ conditions, medication, diet, nutrition, rehabilitation exercises, and self-management. Second, they prepared the personalized health education plan, return visit plan, and rehabilitation plan, and used standardized courseware, educational videos, and health prescriptions to provide the patients with one-on-one health guidance. Finally, they sent the management tasks and educational contents to the phones of the patients for consolidating the learning in the hospital, as an outpatient, and at home.

Patients can access their biochemical, physical, and chemical data as well as chronic disease–sensitive indicators in the hospital, as an outpatient, and at home for self-health management. Case managers can also perform online assessment, appraisal, and guidance via telephone, WeChat, and the chronic disease information system and record the data. Client mobile terminals can receive SMS text message alerts and the main interface of the chronic disease information system would display reminders of follow-up and return visits within ±7 days.

If a patient was out of contact for 3 months, died, or refused to accept the treatment, case managers could settle the case.

Evaluation of the Effect of Implementing the Chronic Disease Management Information System

Evaluation method.

In accordance with case quality management indicators [ 20 ], two full-time case managers collected and evaluated data in the process of the follow-up procedure. To reduce the potential for evaluation bias, the case managers consistently communicated and learned to standardize the evaluation method. The cases were divided based on different chronic respiratory diseases case management models (ie, before and after use of the chronic disease information system). The following case management quality indicators were evaluated under the noninformation system management model (2019‐2020) and under the chronic disease management information system model (2021‐2022): number of managed cases, number of patients accepting routine follow-up services, follow-up visit rate, pulmonary function test rate, admission rate for acute exacerbations, chronic respiratory diseases knowledge awareness rate, and patient satisfaction. Excel sheets were used to acquire data prior to incorporation of the chronic disease management information system into the new information system.

Evaluation Indicators

The annual number of cases was calculated as the sum of the number of newly enrolled patients and the number of initially enrolled patients. The number of cases was calculated as the sum of the number of cases in different years. The number of routine follow-up visits represents the number of patients who completed the treatment plan. The follow-up visit rate was calculated as the number of completed follow-up visits in the year divided by the number of planned follow-up visits in the same year. The pulmonary function test rate was calculated as the number of pulmonary function tests completed for patients scheduled for follow-up during the year divided by the number of pulmonary function tests for patients scheduled for follow-up during the year. The admission rate for acute exacerbations was calculated as the number of recorded patients admitted to the hospital due to acute exacerbations divided by the total number of patients recorded. The chronic respiratory diseases knowledge awareness rate was determined by the number of people having sufficient knowledge divided by the total number of people tested. This knowledge indicator was based on the self-prepared chronic respiratory diseases knowledge test scale, which consists of 10 items determined using the Delphi method (following expert consultation) through review of the literature, including common symptoms, disease hazards, treatment medication, diet, living habits, exercise, negative habits affecting the disease, regular review items, effective methods for cough and sputum removal, appointments, and follow-ups. The content of the questionnaire was refined by disease type, and the reviewers included 11 personnel with the title of Deputy Chief Nurse or above in the Internal Medicine Department of the hospital. The expert authority coefficients were 0.85 and 0.87 and the coordination coefficients were 0.50 and 0.67 for the two rounds of review, respectively; the χ 2 test showed a statistically significant value of P =.01. Patient satisfaction was assessed with a self-made questionnaire that showed good internal reliability (Cronbach α=0.78) and content validity (0.86). The questionnaire items included the reminder of return visits, practicability of health education content, and service attitude of medical staff; the full-time case managers surveyed the patients (or their caregivers) at the time of return visits after the third quarter of each year. Satisfaction items were rated using a 5-point Likert scale with a score of 1‐5, and a mean ≥4 points for an individual indicated satisfaction. Patient satisfaction was then calculated as the number of satisfied patients divided by the total number of managed patients.

Statistical Analysis

SPSS 16.0 software was used for data analysis. The Mann-Whitney U test was performed to compare continuous variables between groups and the χ 2 test was performed to compare categorical variables between groups. P <.05 indicated that the difference was statistically significant.

Ethical Considerations

The study was conducted in accordance with the principles of the Declaration of Helsinki. This study received approval from the Ethics Committee of Yulin First People’s Hospital (approval number: YLSY-IRB-RP-2024005). The study did not interfere with routine diagnosis and treatment, did not affect patients’ medical rights, and did not pose any additional risks to patients. Therefore, after discussion with the Ethics Committee of Yulin First People’s Hospital, it was decided to waive the requirement for informed consent from patients. Patients’ personal privacy and data confidentiality have been upheld throughout the study.

Characteristics of Patient Populations Before and After Implementation of the Information System

There was no significant difference in age and gender distributions in the patient populations that received care before and after implementation of the chronic disease management information system ( Table 1 ).

Comparison of Workload Before and After Implementation of the Information Management System

Before use of the system, 1808 cases were managed, with a mean of 603 (SD 137) cases having routine follow-up visits. After use of the system, 5868 cases were managed, with a mean of 2056 (SD 211) routine follow-up visits. Therefore, the number of managed cases and the number of follow-up visits significantly increased by 3.2 and 3.4 times, respectively, after use of the system (U =342.779; P< .001).

Comparison of Quality Indicators of Managed Cases Before and After Implementation of the Information System

The quality indicators in the two groups are summarized in Table 2 . Compared with the corresponding indicators before use of the system, the follow-up visit rate increased by 50.2%, the pulmonary function test rate increased by 26.2%, the chronic respiratory diseases knowledge awareness rate increased by 20.1%, the retention rate increased by 16.3%, and the patient satisfaction increased by 9.6%; moreover, the admission rate for acute exacerbations decreased by 42.4%.

a CRD: chronic respiratory disease.

Principal Findings

The main purpose of this study was to build a chronic disease management information system and apply it to the case management of chronic respiratory diseases. Our evaluation showed that the chronic disease management information system not only improves the efficiency and quality of case management but also has a benefit for maintaining the stability of the condition for patients with respiratory diseases, reduces the number of acute disease exacerbations, increases the rate of outpatient return, and improves patients’ adherence with disease self-management. Thus, a chronic disease management information system is worth popularizing and applying widely.

Value of the HIS-Based Chronic Disease Management Information System

Chronic diseases constitute a significant public health issue in China. Public hospitals play important roles in the health service system, particularly large-scale public hospitals with the most advanced technologies, equipment, and enormous medical human resources, which can greatly aid in the diagnosis and treatment of diseases and also serve as important hubs for the graded treatment of chronic diseases. Moreover, a significant number of patients with chronic diseases visit large hospitals, making them important sources of big data on chronic diseases [ 21 ]. Adoption of an HIS-based chronic disease management information system can make full use of and exert the advantages of large-scale public hospitals in terms of labor, technology, and equipment in the diagnosis, treatment, and prevention of chronic diseases; enhance the cohesiveness of the case management team in chronic disease management; and achieve prehospital, in-hospital, and posthospital continuity of care for patients with chronic diseases. Overall, use of a chronic disease management information system can enhance the quality and efficiency of chronic disease management and lay a good foundation for teaching and research on chronic diseases.

Improved Efficiency of Case Management

China was relatively late in applying case management practices, and chronic disease management has traditionally been primarily conducted offline [ 14 , 20 ] or supplemented by management with apps and WeChat [ 7 , 8 ]. Traditional case management methods require case managers to manually search, record, store, query, count, and analyze information. This manual process necessitates substantial time and makes it challenging to realize a comprehensive, systematic, and dynamic understanding of patient information, resulting in a small number of managed cases and follow-up visits. With the application of information technology, use of an HIS-based chronic disease monitoring and case management system can automatically extract and integrate patient information, thereby increasing the efficiency of chronic disease management and reduce costs [ 4 , 22 ]. In this study, two case managers played leading roles both before and after implementation of the information system; however, compared with the situation before the use of the system, the numbers of both managed cases and of follow-up visits increased, reaching 3.2 and 3.4 times the preimplementation values, respectively. The information system can automatically obtain a patient’s name and ID number based on the ICD code, which can expand the range of enrollment screening and appoint the register of patients as planned. In addition, the information system can automatically obtain outpatient, inpatient, and home medical information for the postillness life cycle management of patients. Moreover, the intuitive, clear, and dynamic indicator charts on the system can save a significant amount of time for diagnosis and treatment by medical staff, while the paperless office and online data-sharing functions can essentially solve the problem of managing files by case managers to ultimately enhance efficiency.

Improved Quality of Case Management

According to evidence-based medicine, the seven steps of case management represent the optimal clinical pathway [ 10 - 14 , 22 ]. In this study, the concept of an Internet-Plus medical service was introduced; that is, the chronic disease management information system was established based on the HIS data and case management model [ 22 ] and the function of a mobile medical terminal app was incorporated in the system [ 6 , 7 ]. Compared with the noninformation system case management model, this system has several advantages. First, owing to the swift management mode, it can overcome the limitations of time and space [ 4 - 8 ]. Second, multichannel health education and communication can enhance patients’ knowledge and skills, as well as their compliance with self-management, based on diversified forms of image data such as graphics and audio [ 6 , 22 ]. Third, the use of intelligent management can remind doctors and patients to complete management work and follow-up visits as planned, and to perform intelligent pushes of patient outcome indicators to improve confidence in the treatment [ 22 ]. Fourth, this system enables information sharing and big data analysis, as well as multidisciplinary diagnosis and treatment based on the matching of doctor-patient responsibility management, which can be more conducive to the precise health management of patients.

Compared with the traditional case management model, information-based case management significantly increased the follow-up visit rate, lung function test rate, chronic respiratory diseases knowledge awareness rate of patients, patient satisfaction rate, and retention rate. Among these indicators, the follow-up visit rate and lung function test rate represent aspects related to the patients’ own management of their condition [ 1 ]. The results of this study are consistent with previous findings related to information-based management of chronic diseases in China, demonstrating that such a management system was more conducive to planned, systematic, and personalized education and follow-up by the case management team, thereby promoting the virtuous cycle of compliance with self-management and reducing the number of acute exacerbations among patients with chronic respiratory diseases, ultimately enhancing the precision of medical resource allocation and hospital management [ 22 , 23 ].

Helping Patients With COPD Maintain Stability of Their Condition

The admission rate for acute exacerbations serves as a common indicator of the quality of the treatment of chronic respiratory diseases [ 23 ]. The deployment of a clinical pathway–based hospital case management information system significantly reduced the admission rate for acute exacerbations and enhanced the quality of treatment for chronic respiratory diseases, indicating its high clinical significance. There are several reasons for these observed benefits. First, home care and self-management are essential in the management of chronic respiratory diseases. The information-based case management model improved the patients’ knowledge and skills along with their compliance with self-management. Consequently, the standardized self-management process helped to reduce the number of acute exacerbations of chronic respiratory diseases and thus lowered the admission rate. Second, the information-based case management model increased the regular return rate, which allowed the medical staff to identify the potential risk factors for acute exacerbations in a timely manner, deal with them when they occur, and prepare personalized treatment plans and precise health management schemes. This consequently enabled adjustment of treatment schemes in real time, reduced the number of admissions due to acute exacerbations, and lowered the readmission rate. For hospitals interested in implementing a similar model, we suggest first conducting a detailed review of the current situation prior to making adequate changes based on the relevant disease and patient populations.

Consequently, the HIS-based case information management model could improve efficiency, enhance the quality of case management, and aid in stabilizing the conditions of patients with chronic respiratory diseases. In contrast to the hospital case management information system reported by Yuan et al [ 22 ], the system described in this study includes a personal terminal app. Previous studies confirmed that a stand-alone mobile health app could improve patient compliance and disease control [ 6 - 8 ]; thus, whether this system can be used to manage specialized disease cohorts for patients with chronic diseases remains to be determined. In this study, the effect on the retention rate of patients was confirmed; however, the overall operational indicators for the diagnosis and treatment of chronic diseases should be further determined.

With the advancement of information technology, the internet and medical technology have been applied to the management of chronic diseases. As an information-based platform for the case management of patients with chronic respiratory diseases, a newly developed chronic disease management information system was introduced in this study. This system is capable of designing the follow-up time registration, follow-up content, approaches, methods, quality control, and feedback process for a single chronic respiratory disease via the single-disease clinical pathway following the case management process (enrollment, assessment, planning, implementation, feedback, and evaluation). Use of this system can encourage patients with chronic respiratory diseases to adhere to regular follow-up and form an outpatient-inpatient-home chronic disease management strategy. This can help in reducing the admission rate for acute exacerbations, increase the return visit rate, and improve the correctness and compliance of home self-management of patients with chronic respiratory diseases. Owing to these benefits, wide adoption of such information systems for the management of chronic diseases can offer substantial economic and social value.

Acknowledgments

We are particularly grateful to all the people who provided help with our article. This study was supported by a grant from Yulin City Science and Technology Planning Project (20202002).

Data Availability

The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Authors' Contributions

YML, YZX, XLS, and YXL designed this study. XLS and XJC wrote the draft of the paper. YML, YZX, and YC contributed final revisions to the article. XJC, HC, and YC collected the data. XJC, YML, YXL, and HC performed the statistical analysis. YML received funding support. All authors read and approved the final draft of the article.

Conflicts of Interest

None declared.

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Abbreviations

Edited by Christian Lovis; submitted 15.06.23; peer-reviewed by Kuang-Ming Kuo; final revised version received 14.04.24; accepted 17.04.24; published 19.06.24.

© Yi-Zhen Xiao, Xiao-Jia Chen, Xiao-Ling Sun, Huan Chen, Yu-Xia Luo, Yuan Chen, Ye-Mei Liang. Originally published in JMIR Medical Informatics (https://medinform.jmir.org), 19.6.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/ ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Medical Informatics, is properly cited. The complete bibliographic information, a link to the original publication on https://medinform.jmir.org/ , as well as this copyright and license information must be included.

• Open access
• Published: 20 June 2024

Association of interleukin-2 and interleukin-10 with the pathophysiology and development of generalized anxiety disorder: a case-control study

• Nisat Sarmin 1   na1 ,
• A. S. M. Roknuzzaman 2   na1 ,
• Rapty Sarker 1   na1 ,
• Mamun -or-Rashid 1 ,
• MMA Shalahuddin Qusar 3 ,
• Sitesh Chandra Bachar 4 ,
• Eva Rahman Kabir 5 ,
• Md. Rabiul Islam 5 &
• Zobaer Al Mahmud 1  

BMC Psychiatry volume  24 , Article number:  462 ( 2024 ) Cite this article

Metrics details

Generalized anxiety disorder (GAD) is a devastating mental health condition characterized by constant, uncontrolled worrying. Recent hypotheses indicate that pro-inflammatory cytokines and chemokines are potential contributors to the pathogenesis of GAD. Here, we aimed to assess the role of interleukin-2 (IL-2) and interleukin-10 (IL-10) in the pathophysiology and development of GAD.

This study recruited 50 GAD patients diagnosed according to the DSM-5 criteria and 38 age-sex-matched healthy controls (HCs). A qualified psychiatrist evaluated all study subjects. The socio-demographic and clinical characteristics of the study population were determined using pre-structured questionnaires or interviews, and cytokine serum levels were estimated using commercially available ELISA kits.

We observed reduced serum IL-10 levels in GAD patients compared to HCs (33.69 ± 1.37 pg/ml vs. 44.12 ± 3.16 pg/ml). Also, we observed a significant negative correlation between altered IL-10 levels and GAD-7 scores ( r =-0.315, p  = 0.039). Moreover, IL-10 serum measurement exhibited good predictive value in receiver operating characteristics (ROC) analysis with an area under the curve (AUC) value of 0.793 ( p  < 0.001) with 80.65% sensitivity and 62.79% specificity at a cutoff value of 33.93 pg/ml. Conversely, we noticed elevated serum IL-2 levels in GAD patients than in HCs (14.81 ± 2.88 pg/ml vs. 8.08 ± 1.1 pg/ml); however, it failed to maintain any significant association with GAD-7 scores, implying that IL-2 might not be involved in GAD pathogenesis. The lower AUC value (0.640; p  > 0.05) exhibited by IL-2 serum measurement in ROC analysis further supported that IL-2 might not be associated with GAD.

This study provides new insights into the complex interplay between anti-inflammatory cytokines and GAD pathogenesis. Based on the present findings, we can assume that IL-10 but not IL-2 may be associated with the pathophysiology and development of GAD. However, further research with a larger population size and longitudinal design is required to confirm the potential diagnostic efficacy of IL-10.

Peer Review reports

Generalized anxiety disorder (GAD) is a chronic neuropsychiatric disorder characterized by persistent and excessive uncontrollable fear or worry (occurs for at least 6 months) about various aspects/activities of daily life, affecting the educational, occupational, or social lives of the affected people [ 1 ]. If a person is excessively worried about anything for most days over at least 6 months, he/she is considered to have GAD. Though currently the prevalence rate of GAD is 3–6% worldwide [ 1 , 2 , 3 ], the prevalence is increasing day by day due to the complexity of modern lifestyles and thus warrants attention from national and international authorities to take interventions for mitigating and managing this disorder properly. If it remains undiagnosed or untreated, the uncontrollable and persistently intense anxiety can lead to a marked reduction in cognitive functions or a reduced capacity to work properly in all spheres of life, including educational, family, social, and individual routine work. As such, chronic GAD leads to a reduced quality of life and thereby poses a significant mental health concern globally.

Despite its high prevalence, significant morbidity, and socioeconomic burden, GAD remains poorly characterized in terms of its pathophysiology or effective treatment options. Though the precise cause and mechanism of pathogenesis are still unknown, evidence suggests that multiple factors, including disrupted serotonergic, dopaminergic, and GABAergic neurotransmission and excessive glutamatergic neurotransmission in the brain, genetic factors, family or environmental stress, chronic diseases, hyperthyroidism, childhood trauma, and special personality traits, are linked to GAD. Alterations in monoaminergic neurotransmissions in limbic systems (cingulate gyrus, hippocampus, amygdala, thalamus, and hypothalamus) due to the lower synaptic availability of serotonin, norepinephrine, and dopamine are thought to be associated with anxiety symptoms. Besides, decreased GABA-mediated inhibitory neurotransmission in the amygdala or excessive activation of excitatory glutamatergic neurotransmission are also suggested to be involved in GAD pathology.

Currently, available pharmacotherapies for GAD include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), pregabalin, and benzodiazepines, which act by reversing these altered monoaminergic neurotransmitter systems. Alongside these drug treatments, non-pharmacological therapies such as several psychological interventions, including cognitive-behavioral therapy, and the acquisition and application of stress management skills, including relaxation and mindfulness skills are also widely used for the management of GAD. However, currently, available pharmacotherapies (SSRIs, SNRIs, pregabalin, and benzodiazepines) have failed to demonstrate the required efficacy in treating anxiety disorders, as 50% of patients failed to respond to these drugs, and at least in 30% of cases, there is a recurrence of the disease following the pharmacological treatment [ 1 , 4 , 5 ]. Moreover, studies reported a higher rate of discontinuity from these pharmacotherapies with low patient adherence or compliance due to the adverse effects, including sexual dysfunction for SSRIs and SNRIs, nausea and dizziness for pregabalin, demonstrating an urgent need for searching for novel anxiolytics [ 3 ]. These findings raised questions about the validity of the currently available mechanism of pathogenesis and suggested that the altered monoaminergic neurotransmitter system might not fully explain the molecular mechanism of GAD development, suggesting other pathophysiological factors might be involved in GAD. Recently, dysregulated immune systems have attracted great interest as an important pathophysiological factor for the development of GAD [ 4 , 6 , 7 , 8 ]. Several clinical and preclinical studies suggest a link between the altered immune system and GAD pathology. Preclinical studies in mice also demonstrated that administration of pro-inflammatory cytokines (including IL-1β, TNF-α, and IL-6) in mice resulted in anxiety-like behaviors that were attenuated or normalized after injecting either anti-inflammatory cytokines or antagonists for the concerned cytokines [ 9 , 10 , 11 , 12 , 13 ]. A recent prospective cohort study conducted by Hou et al., (2019) demonstrated that administration of selective serotonin reuptake inhibitors (escitalopram or sertraline) resulted in a significant reduction in peripheral pro-inflammatory cytokines, and the authors suggested that the anxiolytic effects of these SSRIs might partly be based on their acute anti-inflammatory activities [ 14 ], implicating a significant association between dysregulated peripheral immune systems and GAD development. The development of anxiety-like symptoms in IL-4 gene knock-out mice, reduced levels of IL-4 in anxious mice, and the significant attenuation of anxiety-like behaviors following IL-4 injection demonstrated a positive association between anti-inflammatory cytokines, IL-4 levels, and anxiety pathology [ 15 , 16 , 17 , 18 ]. This immune hypothesis of GAD development is further potentiated by findings from several clinical studies that reported that GAD patients showed significantly higher levels of pro-inflammatory cytokines ( IL-1Ra, IL-1, IL-6, TNF-α, etc.) compared to healthy controls (HCs) [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ] along with decreased levels of anti-inflammatory cytokines, including IL-4 and IL-10 [ 25 ]. Besides, pro-inflammatory cytokines such as TNF-α, and IL-6 were significantly associated with anxiety scores [ 29 ]. Consistent with this, a randomized clinical trial in humans demonstrated that LPS administration resulted in enhanced anxiety scores, and the authors suggested a significant correlation between pro-inflammatory cytokine levels and anxiety severity [ 30 ]. LPS-mediated microglia activation causes enhanced release of excessive pro-inflammatory cytokines in the basolateral amygdala, which ultimately leads to neuroinflammation in mice, resulting in the development of anxiety and depression-like behaviors by modulating neuronal plasticity. The authors found that anxiety pathogenesis was due to the excessive release of excitatory neurotransmitter glutamate from presynaptic axonal terminals of the prefrontal cortex, leading to neuroplasticity [ 31 ]. However, some studies reported either no significant variation in pro-inflammatory or anti-inflammatory cytokine serum levels between GAD patients and HCs [ 32 ] or that pro-inflammatory cytokines including IL-1, IL-2, and IL-6 were significantly reduced in GAD patients than HCs [ 33 , 34 ]. This discrepancy in altered levels of inflammatory cytokines across clinical studies necessitates a further examination of the role of these cytokines in GAD pathophysiology.

Interleukin-2 (IL-2) is one of the major pro-inflammatory cytokines implicated in T cell activation, proliferation, and differentiation and is thus linked to excessive neuro-inflammatory processes [ 35 ]. IL-2 has been shown to impair synaptic plasticity and cause neuroinflammation, which ultimately leads to neuronal damage in neurocircuits associated with fear and anxiety signal transduction. IL-2 was also reported to act as a potent modulator of NMDA and kainite-mediated excitability in mesolimbic or mesostriatal systems [ 36 , 37 , 38 ] and thus affect neuroplasticity. As IL-2 was found to be positively associated with major depressive disorder [ 38 , 39 ], probably, IL-2 might also be correlated with anxiety disorders like GAD, as MDD and GAD are highly co-morbid themselves and thus might share common pathophysiological factors. Recently, a preclinical study conducted by Gilio et al., (2022) observed that IL-2 administration in experimentally healthy mice triggered marked anxiety and depression-like behaviors, and the authors suggested that inhibition of GABA-mediated synaptic inhibitory neurotransmission was involved in the pathology of anxiety [ 40 ].

Interleukin-10 (IL-10) is one of the major anti-inflammatory cytokines that is secreted from Treg cells, Th2 cells, CD4 + T cells, CD8 + T cells, monocytes, macrophages, dendritic cells, B cells, neutrophils in the peripheral nervous system, and from microglia, astrocytes in the central nervous system (CNS) [ 41 ]. IL-10 signaling triggers anti-inflammatory, immunosuppressive, and immunoregulatory activities, including downregulating the production and secretion of pro-inflammatory cytokines and chemokines from activated macrophages, neutrophils, mast cells, Th1 cells, and DCS, decreasing the expression of MHC class II and co-stimulatory molecules on macrophages, and thereby suppressing the antigen presentation capacity of APCS [ 42 , 43 , 44 , 45 , 46 ]. In the CNS, it inhibits the production of such cytokines and chemokines by activated microglia and thereby counteracts cellular and tissue damage in response to excessive neuroinflammation [ 47 , 48 ]. IL-10 has also been shown to stimulate axonal regeneration and activate wound healing through tissue repair [ 48 ]. Research also indicates its role as an inhibitor for microglial hyperactivation in response to LPS-induced inflammatory stimulus [ 49 ]. Based on its anti-inflammatory and immunoregulatory functions, researchers suggested an intricate role for IL-10 in several auto-immune and neuropsychiatric disorders. For example, Mesquita et al., (2008) observed that IL-10 KO mice developed markedly enhanced depressive-like behavior, which was attenuated after IL-10 administration, and that overexpression of IL-10 resulted in reduced depressive behaviors in mice [ 50 ]. Moreover, administration of IL-10 into rats attenuated the pro-inflammatory cytokine IL-1β-induced anxiety-like symptoms in male rats [ 10 ], demonstrating that IL-10 possesses anxiolytic activities. Preclinical research using an experimental animal model also suggests that the observed anxiolytic effect of several anti-anxiety drugs, including 3’-deoxyadenosine (3’-dA), imipramine, fluoxetine, and chlordiazepoxide, stems from their ability to upregulate anti-inflammatory cytokine (IL-4, IL-10) expression in the prefrontal cortex and locus coeruleus and simultaneous down-regulation of proinflammatory cytokine gene expression, leading to a correction of the imbalance between proinflammatory and anti-inflammatory states [ 51 , 52 ]. Though several preclinical studies suggest a potential link between IL-10 levels and anxiety disorder, there is a scarcity of clinical studies aimed at evaluating such an association between IL-10 and GAD development [ 10 ].

Currently, there is no objective and cost-effective diagnostic or prognostic biomarker for GAD, which poses challenges in early diagnosis or risk prediction and leads to misdiagnosis or underdiagnosis, hampering the proper management of the disease. Currently available diagnostic tools, including self-reported symptoms and scoring severity based on the patient’s response to the 7-item questionnaire (GAD-7 scores), are subjective. Though neuroimaging techniques such as positron emission tomography (PET) and functional MRI can be used for the proper and objective diagnosis of GAD, due to their high cost and sophistication or complexities, these diagnostic tools are not suitable for either mass-level screening or are not easy to conduct multiple times to monitor the disease progression or therapeutic drug response. As such, the investigation of cost-effective objective biomarkers for GAD is one of the major focuses of current research on GAD. Finding a suitable biomarker is essential for early diagnosis and initiating psychotherapy and pharmacotherapy as early as possible [ 3 ]. Several studies were performed investigating the potential association between altered pro-inflammatory cytokines or anti-inflammatory cytokines and the pathogenesis of GAD. However, the actual role of inflammatory cytokines in GAD patients is not well explained. Therefore, the present study aims to explore the role of pro-inflammatory cytokines (IL-2) and anti-inflammatory cytokines (IL-10) in the pathophysiology and development of GAD. Also, we aim to find the potential associations of IL-2 and IL-10 with the severity of GAD patients. We believe the present study results would help to understand the pathophysiology and development of GAD.

Study population

We recruited 88 participants for this case-control study (50 GAD patients and 38 HCs matched by age and sex). Patients were collected from the Department of Psychiatry, Bangabandhu Sheikh Mujib Medical University Hospital, Dhaka, Bangladesh, and HCs from nearby areas of Dhaka city. A professional psychiatrist diagnosed patients and evaluated HCs based on DSM-5 criteria. We applied a 7-item GAD scale to assess the severity of anxiety symptoms [ 53 ]. The total scores range from 0 to 21, and it classifies the anxiety severity into four categories: minimal anxiety (0–4 scores), mild anxiety (5–9 scores), moderate anxiety (10–14 scores), and severe anxiety (15–21 scores). We excluded subjects with a co-morbidity of other psychiatric disorders, such as MDD, panic disorder, post-traumatic stress disorder, and social phobia, from the study. Additional exclusion criteria for participants were chronic liver and kidney diseases, infectious diseases, and alcohol or substance abuse. We also excluded patients who were exposed to anxiolytics or antidepressant medications within at least two weeks prior to the study that might have an impact on cytokine levels. We recorded the sociodemographic profile of the study population using a pre-designed questionnaire. The objectives of the study were explained to each participant, and informed written consent was obtained from them before their participation in this study. The study was conducted in accordance with the Declaration of Helsinki.

Blood sample collection and serum isolation

A 5 ml blood sample was collected from the cephalic vein of each participant. The blood samples were kept at room temperature for 1 hour to ensure coagulation and were then subjected to centrifugation at 3000 rpm for 15 minutes at room temperature to collect serum samples. The collected serum was then placed in the Eppendorf tube and stored at -80 °C until further analysis.

Estimation of serum cytokine levels

We estimated the serum levels of IL-2 and IL-10 by ELISA methods (Boster Bio, USA). We followed the manufacturer’s protocol for the ELISA assays. At first, we added 100 µl of standard cytokine solution, samples, and controls to each well of a pre-coated 96-well microplate. The microplates were covered with a plate sealer and incubated for 90 min at 37⁰C. After that, the cover was removed, and the liquid in each well was discarded. Subsequently, 100 µl of biotinylated anti-IL-2 antibody or anti-IL-10 antibody was incorporated into each well and incubated for 60 min at 37⁰C. After discarding the liquid from each well and washing it three times with 300 µl of wash buffer, 100 µl of avidin-biotin-peroxidase complex was added to each well, and the microplate was then again incubated for 30 min at 37⁰C. After the incubation period, the liquid was again discarded, and the plate was washed again with 300 µl of wash buffer five times. Following the addition of 90 µl color-developing reagent (TMB) into each well, the plate was incubated in a dark place for 30 min at RT, followed by the addition of 90 µl of stop solution to each well to stop the reaction process. We measured the absorbance with a microplate reader at 450 nm. We calculated the cytokine levels using standard curves and expressed them as pg/ml.

Data presentation and statistical analysis

GraphPad Prism (version 8.0.1) and Statistical Package for the Social Sciences (version 24.0) were used for data analysis. We used descriptive statistics to find the variations in sociodemographic profiles and clinical characteristics between the groups. A T-test and a Chi-square test were employed to determine the statistical level of significance between the mean differences for variables across patients versus HC groups in the case of continuous variables and categorical variables, respectively. We used boxplot graphs for comparisons of analyzed cytokines between patients and HCs. We also generated scatter plot graphs for several clinical variables in GAD patients to show the correlations among the clinical parameters. A correlation analysis was performed to assess the potential association between several demographic and clinical variables in GAD patients. Receiver operating characteristics (ROC) analysis was conducted to determine the diagnostic efficacy of serum IL-2 or IL-10 levels in discriminating GAD patients from HCs. In all cases, statistical significance was considered at p  < 0.05.

Sociodemographic characteristics of the study population

The sociodemographic characteristics of the study population are presented in Table  1 . The GAD patients and HCs were similar in terms of their age, sex, and BMI. Among the participants, about 60% were male and from urban areas. The majority of patients (60.00%) and HCs (68.42%) were unmarried. There was no significant variation between patients and HCs for their education level, occupation, economic status, or smoking status. In contrast, there was a difference between patients and HCs for their family history and previous history of the disease. In GAD patients, 20.00% had a family history, and 40.00% had a previous history of the disease.

Clinical characteristics and laboratory findings

Clinical characteristics and laboratory analysis results are presented in Table  2 . GAD patients displayed markedly higher serum levels of IL-2 (14.81 ± 2.88 pg/ml) compared to HCs (8.08 ± 1.10 pg/ml), and the difference reached the statistically significant level ( p  = 0.037, two-tailed unpaired t-test) (Table  2 ; Fig.  1 ). Though male GAD patients exhibited markedly higher levels of IL-2 compared to male HCs ( p  = 0.048), there was no significant variation in IL-2 levels between female patients and female HCs ( p  > 0.05) (Fig.  1 ). Though some 1.8-fold higher IL-2 serum levels were observed in male GAD patients compared to female GAD patients, the difference did not reach the statistical significance level ( p  = 0.198, two-tailed unpaired t-test). In contrast to the results obtained for IL-2, IL-10 showed a statistically significant ( p  < 0.001) reduction in GAD patients (33.69 ± 1.37 pg/ml) compared to HCs (44.12 ± 3.16 pg/ml) (Fig.  1 ). Similar to the results obtained for IL-2, IL-10 levels showed a statistically significant difference between patients versus HCs when male people were considered (Fig.  1 ). In contrast, there was no significant variation in IL-10 levels between female GAD patients and female HCs ( p  > 0.05).

Distribution of serum IL-2 ( a i ) and IL-10 ( b i ) levels in GAD patients and healthy controls. Comparison of IL-2 and IL-10 levels between GAD patients and their counterparts in control subjects are showed in a i and b i . Comparison of IL-2 and IL-10 levels between male or female GAD patients and their counterparts in control subjects are presented in a ii and b ii

Correlation analysis among different study parameters

We then performed a series of correlation analyses to investigate the association of altered cytokine serum levels with several demographic and clinical variables, such as age, BMI, DSM-5, and GAD-7 scores (Table  3 ). Serum IL-2 levels did not show any positive or negative association with either DSM-5 or GAD-7 scores ( p  > 0.05), suggesting that despite its significant enhancement in GAD patients compared to HCs, IL-2 may not associate with GAD pathophysiology. We also observed no significant association between the ages of the patients and IL-2 serum levels. In contrast, the IL-2 levels of GAD patients maintained a significant and positive correlation with BMI levels of patients ( r  = 0.390, p  < 0.05) which is consistent with the intricate relationship between body mass and enhanced pro-inflammatory responses. Contrary to the results obtained for IL-2, reduced serum IL-10 levels maintained a significant but negative association with both DSM-5 scores ( r =-0.300, p  = 0.045) and GAD-7 scores ( r =-0.315, p  = 0.039), implicating that altered IL-10 levels are linked to GAD development or pathogenesis. However, the age and BMI levels of GAD patients failed to show any positive or negative association with IL-10 serum levels. Analysis also showed a significant and strong positive association between IL-2 and IL-10 serum levels ( r  = 0.471, p  = 0.011) in GAD patients, which might be due to the compensatory enhancement of anti-inflammatory cytokine, IL-10 in response to elevated pro-inflammatory cytokine, IL-2 levels. Also, we displayed these correlations among several clinical variables of GAD patients by scatter plot graphs (Fig.  2 ).

Scatter plot graphs for several clinical variables of GAD patients showing existence or absence of correlation between the clinical parameters. Scatter plot for serum IL-2 levels versus GAD-7 scores ( a ) or DSM-5 scores ( b ) expressing no significant association between IL-2 and both clinical parameters. Scatter plot graphs showing significant association between IL-2 levels and BMI ( c ), IL-10 levels and GAD-7 scores ( d ), IL-10 levels and DSM-5 scores and IL-10 and IL-2 levels ( f )

Receiver operating characteristic curve analysis

Serum IL-10 measurement showed a good performance in differentiating GAD patients from HCs, which was evidenced by its significantly higher area under the curve (AUC) value of 0.793 ( p  < 0.001) with 80.65% sensitivity and 62.79% specificity at a cut-off value of 33.93 pg/ml, in which the cytokine levels below this point indicate disease states (Table  4 ; Fig.  3 ). ROC analysis of serum IL-2 levels failed to discriminate GAD patients from HCs as the AUC value was below the acceptable range (AUC: 0.640; p  = 0.108) with 54.17% sensitivity and 68.18% specificity at a cut-off value of 8.83 pg/ml) (Fig.  3 ; Table  4 ).

Receiver operating characteristic curve (ROC) for serum IL-2 ( a ) and IL-10 levels ( b )

To the best of our knowledge, this is the first case-control study to investigate the potential association between the pathophysiology of GAD and the pro-inflammatory cytokine, IL-2, and the anti-inflammatory cytokine, IL-10, among the Bangladeshi population. We observed that IL-10 serum levels were significantly lower in GAD patients than in HCs, and this reduction was found to be significantly but negatively associated with both DSM-5 scores and GAD-7 scores, demonstrating potential involvement of this anti-inflammatory cytokine in disease severity and symptoms. Our results of a significant reduction in IL-10 levels in GAD patients are in good agreement with those observed in other studies [ 23 , 25 ]. In contrast, our results diverge from those reported by others [ 33 , 54 ] who either reported no significant variation in IL-10 levels between GAD patients and HCs or that IL-10 levels were enhanced in GAD patients compared to HCs. ROC analysis also demonstrated the good predictive value of IL-10 serum measurement in discriminating diseased patients from HCs, suggesting that IL-10 serum level might be a potential biomarker for diagnosis, anti-anxiety drug response monitoring, or disease progression monitoring. Recently, Hou et al. (2019) demonstrated that peripheral serum levels of the pro-inflammatory cytokine IL-6 could be used to monitor the treatment response of SSRIs in GAD [ 14 ]. Similarly, IL-10 might be used as a marker for therapeutic drug monitoring in GAD. However, further longitudinal studies are required to find any causal relationship between IL-10 and disease severity or pathogenesis. On the other hand, serum IL-2 levels were significantly elevated in GAD patients compared to HCs, but they failed to demonstrate any significant association with either DSM-5 scores or GAD-7 scores in Pearson correlation analysis, implying that IL-2 levels might not be associated with the pathophysiology and development of GAD. Consistent with this, ROC analysis showed that IL-2 levels have no significant diagnostic efficacy in differentiating GAD patients from HCs. Further analysis with a larger population size is required to explore the role of IL-2 in the context of GAD severity. Our results are consistent with those reported by Tang et al. (2018), who also observed that GAD patients exhibited significantly higher serum levels of IL-2 compared to HCs [ 19 ]. However, our results are not in agreement with those reported by others who observed either no significant variation in IL-2 levels [ 54 ] or a significant reduction in GAD patients compared to HCs [ 25 , 33 , 34 , 55 ]. We also observed a significant positive correlation between IL-2 and IL-10 levels in GAD patients, which indicates a compensatory mechanism [ 56 ].

Our study provides some valuable insights into the complex and intricate relationship between the dysregulated immune system and GAD. The observed reduction in IL-10 levels in GAD patients in our study suggests a potential immunoregulatory imbalance in GAD, with IL-10 playing a role in modulating anxiety severity. The lack of a significant association between IL-2 serum levels and anxiety severity highlights the nuanced nature of immune dysregulation in GAD, warranting further exploration into the specific mechanisms involved. Elevated levels of pro-inflammatory cytokine, IL-2, and decreased levels of anti-inflammatory cytokine, IL-10, in GAD patients compared to HCs indicate that GAD individuals of the Bangladeshi cohort are characterized by heightened inflammatory responses derived from the imbalance between pro-inflammatory and anti-inflammatory states. Our study finding provides further support for the cytokine hypothesis of anxiety disorder, which proposes that pro-inflammatory cytokine-mediated neuroinflammatory processes can lead to anxiety symptoms or behaviors by downregulating serotonin biosynthesis or enhancing the reuptake of serotonin, resulting in an altered serotonergic neurotransmitter system in the CNS [ 15 ]. The observed significant negative correlation between IL-10 and DSM-5 scores or GAD-7 scores suggests that lowering IL-10 levels might be involved in the pathogenesis of GAD. One of the major implications of our study findings is that IL-10 signaling might be targeted to explore potential novel immunological/immunomodulatory therapies against GAD. The diminished IL-10 levels and their negative correlation with GAD severity suggest a potential avenue for therapeutic intervention. IL-10 might also be used as an anti-inflammatory adjunctive therapy with other pharmacotherapies including SSRIs/SNRIs. However, at this moment, we don’t know the exact mechanism by which lowered levels of IL-10 are linked to higher anxiety severity in GAD patients.

As IL-10 has anti-inflammatory and immunoregulatory activities such as suppression of production of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α) from microglia and astrocytes, reduction in IL-10 levels in GAD patients in our study led to an imbalance between pro-inflammatory and anti-inflammatory states and resulted in enhanced pro-inflammatory responses, which might be the cause of enhanced anxiety symptoms as inflammatory cytokine-mediated neuroinflammation was reported to be linked with disrupted monoaminergic neurotransmission in the brain. Besides, elevated levels of IL-10 were shown to attenuate anxiety-like behaviors by modulating GABAergic neurotransmission in the amygdala (Patel et al., 2021). IL-10 was also reported to display some neuroprotective activities and has been shown to inhibit neuronal apoptosis and promote neurite outgrowth, axonal outgrowth, and synapse formation in the brain by the JAK1-STAT3 signaling pathway [ 57 ]. In a preclinical study, IL-4 has been shown to cause the shifting of microglia and macrophages from pro-inflammatory to anti-inflammatory neuroprotective phenotypes characterized by excessive production of arginase-1 and PPARγ receptor expression in microglia and macrophage and thereby attenuating brain-injury-mediated anxiety by inhibiting neuronal loss and nerve tracts in the limbic system [ 58 ]. A similar mechanism might be involved in IL-10-mediated anxiety symptom improvement in GAD patients. Further research is required to unravel the exact mechanisms of IL-10-mediated anxiety symptom attenuation in GAD patients.

In terms of diagnostic marker development, as IL-10 serum level measurement demonstrated good performance in discriminating GAD patients from HCs and as IL-10 levels maintained a significant and negative correlation with disease severity, IL-10 serum level raised the possibility of being an objective biomarker for GAD. However, the diagnostic efficacy of this cytokine should be investigated thoroughly using a range of longitudinal studies. Despite this, at this time we can conclude that IL-10 might be used as a risk indicator for assessment of susceptibility to anxiety disorder, resulting in early detection of the disease and prompting the initiation of intervention strategies. This early detection will reduce treatment costs and decrease the prevalence and morbidity associated with this chronic disorder.

The strength of our study is that we designed a set of inclusion and exclusion criteria for the recruitment of participants and followed those criteria in such a way that homogenous population data could be obtained. The strict study design helped us enormously to minimize the potential impact of several confounding variables, including age, sex, BMI, co-morbid diseases, and immunomodulatory drugs, on cytokine levels. However, our study also has some limitations that should be acknowledged. The major limitation of this study is the smaller sample size. We recruited 50 patients and 38 HCs, which does not represent the whole Bangladeshi demographic. It would be better if we could enroll an equal number of cases and controls. For example, we observed that cytokine levels maintained a statistically significant difference between male GAD patients and male HCs. In contrast, no significant variation in cytokine levels was observed when female data were considered. As we have included more male participants (60%) than female participants (40%), the lower sample size of female participants might generate a higher background noise, resulting in lower statistical power, warranting further studies recruiting a larger population size to investigate sex-specific differences in cytokine levels in GAD patients. Our case-control study design is inherently correlational and thus not able to evaluate the causal relationship between altered cytokine levels and GAD. So, at this moment, we cannot conclude whether the altered levels of serum cytokines are the causes of anxiety development or just the outcome of pathophysiological changes.

Longitudinal studies are required to investigate whether altered cytokine levels precede GAD or if it’s just a mere reflection of GAD pathology. Though we have restricted the impacts of several co-variates, other confounding variables, including genetic polymorphism in cytokine genes, the effect of lifestyle or xenobiotics, and dietary habits, were not considered, which might have modulatory effects on serum cytokine levels.

The study provides valuable insights for understanding the pathogenesis of GAD. Despite having elevated IL-2 levels in GAD patients compared to HCs, it failed to demonstrate a significant association with anxiety severity as assessed by GAD-7 scores. In contrast, serum IL-10 levels were significantly reduced in GAD patients compared to HCs and showed a significant negative correlation with anxiety severity, implicating a potential link with the GAD pathophysiology. Our results support the immune hypothesis of GAD development. Our study findings also suggest that IL-10 serum level measurement might offer an objective blood-based biomarker or risk assessment indicator for GAD. We recommend further research employing a larger population size and homogenous data from different areas of Bangladesh to confirm our study findings.

Data availability

All the relevant data and information will be available from the corresponding author upon reasonable request.

Abbreviations

Body mass index

Chronic energy deficiency

Confidence interval

Central nervous system

Diagnostic and statistical manual for mental disorders, 5th edition

Enzyme-linked immunosorbent assay

• Generalized anxiety disorder

Generalized anxiety disorder 7-item scores

Healthy control

• Interleukin-2
• Interleukin-10

Receiver operating characteristic

Standard error mean

Statistical package for social science

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Acknowledgements

The authors are thankful to all the participants of this study. They are also thankful to the staff and physicians at the Department of Psychiatry, BSMMU, for their technical and administrative support. The authors are also thankful for the laboratory support provided by the Department of Pharmacy, University of Asia Pacific, Dhaka Bangladesh.

This research received no specific grant from any funding agency. However, we received partial funding from University of Dhaka, Bangladesh (Centennial Research grant (2nd Phase) for the year of 2020–2021, project title: “Investigation of peripheral pro-inflammatory and anti-inflammatory cytokines and immune balance in Bangladeshi patients with Generalized Anxiety Disorder”).

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Nisat Sarmin, A. S. M. Roknuzzaman and Rapty Sarker contributed equally to this work.

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Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka, 1000, Bangladesh

Nisat Sarmin, Rapty Sarker, Mamun -or-Rashid & Zobaer Al Mahmud

Department of Pharmacy, University of Asia Pacific, Dhaka, 1205, Bangladesh

A. S. M. Roknuzzaman

Department of Psychiatry, Bangabandhu Sheikh Mujib Medical University, Shahabagh, Dhaka, 1000, Bangladesh

MMA Shalahuddin Qusar

Department of Pharmacy, Faculty of Pharmacy, University of Dhaka, Dhaka, 1000, Bangladesh

Sitesh Chandra Bachar

School of Pharmacy, BRAC University, Kha 224 Bir Uttam Rafiqul Islam Avenue, Merul Badda, Dhaka, 1212, Bangladesh

Eva Rahman Kabir & Md. Rabiul Islam

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NS, ASMR, RS, MRI, and ZAM: Conceptualization, Data curation, Investigation, Writing – original draft. MR, MMASQ, SCB, and ZAM: Funding acquisition, Project administration, Validation. ERK, MRI, and ZAM: Conceptualization, Formal analysis, Methodology, Supervision, Writing – review & editing.

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Sarmin, N., Roknuzzaman, A.S.M., Sarker, R. et al. Association of interleukin-2 and interleukin-10 with the pathophysiology and development of generalized anxiety disorder: a case-control study. BMC Psychiatry 24 , 462 (2024). https://doi.org/10.1186/s12888-024-05911-z

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Associations between deep venous thrombosis and thyroid diseases: a two-sample bidirectional Mendelian randomization study

• Lifeng Zhang 1   na1 ,
• Kaibei Li 2   na1 ,
• Qifan Yang 1 ,
• Yao Lin 1 ,
• Caijuan Geng 1 ,
• Wei Huang 1 &
• Wei Zeng 1  

European Journal of Medical Research volume  29 , Article number:  327 ( 2024 ) Cite this article

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Metrics details

Some previous observational studies have linked deep venous thrombosis (DVT) to thyroid diseases; however, the findings were contradictory. This study aimed to investigate whether some common thyroid diseases can cause DVT using a two-sample Mendelian randomization (MR) approach.

This two-sample MR study used single nucleotide polymorphisms (SNPs) identified by the FinnGen genome-wide association studies (GWAS) to be highly associated with some common thyroid diseases, including autoimmune hyperthyroidism (962 cases and 172,976 controls), subacute thyroiditis (418 cases and 187,684 controls), hypothyroidism (26,342 cases and 59,827 controls), and malignant neoplasm of the thyroid gland (989 cases and 217,803 controls. These SNPs were used as instruments. Outcome datasets for the GWAS on DVT (6,767 cases and 330,392 controls) were selected from the UK Biobank data, which was obtained from the Integrative Epidemiology Unit (IEU) open GWAS project. The inverse variance weighted (IVW), MR-Egger and weighted median methods were used to estimate the causal association between DVT and thyroid diseases. The Cochran’s Q test was used to quantify the heterogeneity of the instrumental variables (IVs). MR Pleiotropy RESidual Sum and Outlier test (MR-PRESSO) was used to detect horizontal pleiotropy. When the causal relationship was significant, bidirectional MR analysis was performed to determine any reverse causal relationships between exposures and outcomes.

This MR study illustrated that autoimmune hyperthyroidism slightly increased the risk of DVT according to the IVW [odds ratio (OR) = 1.0009; p  = 0.024] and weighted median methods [OR = 1.001; p  = 0.028]. According to Cochran’s Q test, there was no evidence of heterogeneity in IVs. Additionally, MR-PRESSO did not detect horizontal pleiotropy ( p  = 0.972). However, no association was observed between other thyroid diseases and DVT using the IVW, weighted median, and MR-Egger regression methods.

Conclusions

This study revealed that autoimmune hyperthyroidism may cause DVT; however, more evidence and larger sample sizes are required to draw more precise conclusions.

Introduction

Deep venous thrombosis (DVT) is a common type of disease that occurs in 1–2 individuals per 1000 each year [ 1 ]. In the post-COVID-19 era, DVT showed a higher incidence rate [ 2 ]. Among hospitalized patients, the incidence rate of this disease was as high as 2.7% [ 3 ], increasing the risk of adverse events during hospitalization. According to the Registro Informatizado Enfermedad Tromboembolica (RIETE) registry, which included data from ~ 100,000 patients from 26 countries, the 30-day mortality rate was 2.6% for distal DVT and 3.3% for proximal DVT [ 4 ]. Other studies have shown that the one-year mortality rate of DVT is 19.6% [ 5 ]. DVT and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE), constitute a major global burden of disease [ 6 ].

Thyroid diseases are common in the real world. Previous studies have focused on the relationship between DVT and thyroid diseases, including thyroid dysfunction and thyroid cancer. Some case reports [ 7 , 8 , 9 ] have demonstrated that hyperthyroidism is often associated with DVT and indicates a worse prognosis [ 10 ]. The relationship between thyroid tumors and venous thrombosis has troubled researchers for many years. In 1989, the first case of papillary thyroid carcinoma presenting with axillary vein thrombosis as the initial symptom was reported [ 11 ]. In 1995, researchers began to notice the relationship between thyroid tumors and hypercoagulability [ 12 ], laying the foundation for subsequent extensive research. However, the aforementioned observational studies had limitations, such as small sample sizes, selection bias, reverse causality, and confounding factors, which may have led to unreliable conclusions [ 13 ].

Previous studies have explored the relationship of thyroid disease and DVT and revealed that high levels of thyroid hormones may increase the risk of DVT. Hyperthyroidism promotes a procoagulant and hypofibrinolytic state by affecting the von Willebrand factor, factors VIII, IV, and X, fibrinogen, and plasminogen activator inhibitor-1 [ 14 , 15 ]. At the molecular level, researchers believe that thyroid hormones affect coagulation levels through an important nuclear thyroid hormone receptor (TR), TRβ [ 16 ], and participate in pathological coagulation through endothelial dysfunction. Thyroid hormones may have non-genetic effects on the behavior of endothelial cells [ 17 , 18 ]. In a study regarding tumor thrombosis, Lou [ 19 ] found that 303 circular RNAs were differentially expressed in DVT using microarray. Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis revealed that the most significantly enriched pathways included thyroid hormone-signaling pathway and endocytosis, and also increased level of proteoglycans in cancer. This indicated that tumor cells and thyroid hormones might interact to promote thrombosis. Based on these studies, we speculated that thyroid diseases, including thyroid dysfunction and thyroid tumors, may cause DVT.

Mendelian randomization (MR) research is a causal inference technique that can be used to assess the causal relationship and reverse causation between specific exposure and outcome factors. If certain assumptions [ 20 ] are fulfilled, genetic variants can be employed as instrumental variables (IVs) to establish causal relationships. Bidirectional MR analysis can clarify the presence of reverse causal relationships [ 21 ], making the conclusions more comprehensive. Accordingly, we aimed to apply a two-sample MR strategy to investigate whether DVT is related to four thyroid diseases, including autoimmune hyperthyroidism, subacute thyroiditis, hypothyroidism, and thyroid cancer.

Study design

MR relies on single nucleotide polymorphisms (SNPs) as IVs. The IVs should fulfill the following three criteria [ 22 ]: (1) IVs should be strongly associated with exposure. (2) Genetic variants must be independent of unmeasured confounding factors that may affect the exposure–outcome association. (3) IVs are presumed to affect the outcome only through their associations with exposure (Fig.  1 ). IVs that met the above requirements were used to estimate the relationship between exposure and outcome. Our study protocol conformed to the STROBE-MR Statement [ 23 ], and all methods were performed in accordance with the relevant guidelines and regulations.

The relationship between instrumental variables, exposure, outcome, and confounding factors

Data sources and instruments

Datasets (Table  1 ) in this study were obtained from a publicly available database (the IEU open genome-wide association studies (GWAS) project [ 24 ] ( https://gwas.mrcieu.ac.uk )). There was no overlap in samples between the data sources of outcome and exposures. Using de-identified summary-level data, privacy information such as overall age and gender were hidden. Ethical approval was obtained for all original work. This study complied with the terms of use of the database.

MR analysis was performed using the R package “TwoSampleMR”. SNPs associated with each thyroid disease at the genome-wide significance threshold of p  < 5.0 × 10 –8 were selected as potential IVs. To ensure independence between the genetic variants used as IVs, the linkage disequilibrium (LD) threshold for grouping was set to r 2  < 0.001 with a window size of 10,000 kb. The SNP with the lowest p -value at each locus was retained for analyses.

Statistical analysis

Multiple MR methods were used to infer causal relationships between thyroid diseases and DVT, including the inverse variance weighted (IVW), weighted median, and MR-Egger tests, after harmonizing the SNPs across the GWASs of exposures and outcomes. The main analysis was conducted using the IVW method. Heterogeneity and pleiotropy were also performed in each MR analysis. Meanwhile, the MR-PRESSO Global test [ 25 ] was utilized to detect horizontal pleiotropy. The effect trend of SNP was observed through a scatter plot, and the forest plot was used to observe the overall effects. When a significant causal relationship was confirmed by two-sample MR analysis, bidirectional MR analysis was performed to assess reverse causal relationships by swapping exposure and outcome factors. Parameters were set the same as before. All abovementioned statistical analyses were performed using the package TwoSampleMR (version 0.5.7) in the R program (version 4.2.1).

After harmonizing the SNPs across the GWASs for exposures and outcomes, the IVW (OR = 1.0009, p  = 0.024, Table  2 ) and weighted median analyses (OR = 1.001, p  = 0.028) revealed significant causal effects between autoimmune hyperthyroidism and DVT risk. Similar results were observed using the weighted median approach Cochran’s Q test, MR-Egger intercept, and MR-PRESSO tests suggested that the results were not influenced by pleiotropy and heterogeneity (Table  2 ). However, the leave-one-out analysis revealed a significant difference after removing some SNPs (rs179247, rs6679677, rs72891915, and rs942495, p  < 0.05, Figure S2a), indicating that MR results were dependent on these SNPs (Figure S2, Table S1). No significant effects were observed in other thyroid diseases (Table  2 ). The estimated scatter plot of the association between thyroid diseases and DVT is presented in Fig.  2 , indicating a positive causal relationship between autoimmune hyperthyroidism and DVT (Fig.  2 a). The forest plots of single SNPs affecting the risk of DVT are displayed in Figure S1.

The estimated scatter plot of the association between thyroid diseases and DVT. MR-analyses are derived using IVW, MR-Egger, weighted median and mode. By fitting different models, the scatter plot showed the relationship between SNP and exposure factors, predicting the association between SNP and outcomes

Bidirectional MR analysis was performed to further determine the relationship between autoimmune hyperthyroidism and DVT. The reverse causal relationship was not observed (Table S2), which indicated that autoimmune hyperthyroidism can cause DVT from a mechanism perspective.

This study used MR to assess whether thyroid diseases affect the incidence of DVT. The results showed that autoimmune hyperthyroidism can increase the risk of DVT occurrence, but a reverse causal relationship was not observed between them using bidirectional MR analysis. However, other thyroid diseases, such as subacute thyroiditis, hypothyroidism, and thyroid cancer, did not show a similar effect.

Recently, several studies have suggested that thyroid-related diseases may be associated with the occurrence of DVT in the lower extremities, which provided etiological clues leading to the occurrence of DVT in our subsequent research. In 2006, a review mentioned the association between thyroid dysfunction and coagulation disorders [ 26 ], indicating a hypercoagulable state in patients with hyperthyroidism. In 2011, a review further suggested a clear association between hypothyroidism and bleeding tendency, while hyperthyroidism appeared to increase the risk of thrombotic events, particularly cerebral venous thrombosis [ 27 ]. A retrospective cohort study [ 28 ] supported this conclusion, but this study only observed a higher proportion of concurrent thyroid dysfunction in patients with cerebral venous thrombosis. The relationship between thyroid function and venous thromboembolism remains controversial. Krieg VJ et al. [ 29 ] found that hypothyroidism has a higher incidence rate in patients with chronic thromboembolic pulmonary hypertension and may be associated with more severe disease, which seemed to be different from previous views that hyperthyroidism may be associated with venous thrombosis. Alsaidan [ 30 ] also revealed that the risk of developing venous thrombosis was almost increased onefold for cases with a mild-to-moderate elevation of thyroid stimulating hormone and Free thyroxine 4(FT4). In contrast, it increased twofold for cases with a severe elevation of thyroid stimulating hormone and FT4. Raised thyroid hormones may increase the synthesis or secretion of coagulation factors or may decrease fibrinolysis, which may lead to the occurrence of coagulation abnormality.

Other thyroid diseases are also reported to be associated with DVT. In a large prospective cohort study [ 31 ], the incidence of venous thromboembolism was observed to increase in patients with thyroid cancer over the age of 60. However, other retrospective studies did not find any difference compared with the general population [ 32 ]. In the post-COVID-19 era, subacute thyroiditis has received considerable attention from researchers. New evidence suggests that COVID-19 may be associated with subacute thyroiditis [ 33 , 34 ]. Mondal et al. [ 35 ] found that out of 670 COVID-19 patients, 11 presented with post-COVID-19 subacute thyroiditis. Among them, painless subacute thyroiditis appeared earlier and exhibited symptoms of hyperthyroidism. Another case report also indicated the same result, that is, subacute thyroiditis occurred after COVID-19 infection, accompanied by thyroid function changes [ 36 ]. This led us to hypothesize that subacute thyroiditis may cause DVT through alterations in thyroid function.

This study confirmed a significant causal relationship between autoimmune hyperthyroidism and DVT ( p  = 0.02). The data were tested for heterogeneity and gene pleiotropy using MR-Egger, Cochran’s Q, and MR-PRESSO tests. There was no evidence that the results were influenced by pleiotropy or heterogeneity. In the leave-one-out analysis, four of the five selected SNPs showed significant effects of autoimmune hyperthyroidism on DVT, suggesting an impact of these SNPs on DVT outcome. Previous studies have focused on the relationship between hyperthyroidism and its secondary arrhythmias and arterial thromboembolism [ 37 , 38 ]. This study emphasized the risk of DVT in patients with hyperthyroidism, which has certain clinical implications. Prophylactic anticoagulant therapy was observed to help prevent DVT in patients with hyperthyroidism. Unfortunately, the results of this study did not reveal any evidence that suggests a relationship between other thyroid diseases and DVT occurrence. This may be due to the limited database, as this study only included the GWAS data from a subset of European populations. Large-scale multiracial studies are needed in the future.

There are some limitations to this study. First, it was limited to participants of European descent. Consequently, further investigation is required to confirm these findings in other ethnicities. Second, this study did not reveal the relationship between complications of hyperthyroidism and DVT. Additionally, this study selected IVs from the database using statistical methods rather than selecting them from the real population. This may result in weaker effects of the screened IVs and reduce the clinical significance of MR analysis. Moreover, the definitions of some diseases in this study were not clear in the original database, and some of the diseases were self-reported, which may reduce the accuracy of diagnosis. Further research is still needed to clarify the causal relationship between DVT and thyroid diseases based on prospective cohort and randomized controlled trials (RCTs).

This study analyzed large-scale genetic data and provided evidence of a causal relationship between autoimmune hyperthyroidism and the risk of DVT, Compared with the other thyroid diseases investigated. Prospective RCTs or MR studies with larger sample sizes are still needed to draw more precise conclusions.

Availability of data and materials

The IEU open gwas project, https://gwas.mrcieu.ac.uk/

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Lifeng Zhang and Kaibei Li have contributed equally to this work and share the first authorship.

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Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, No. 39, Shierqiao Road, Jinniu District, Chengdu, 610072, Sichuan, People’s Republic of China

Lifeng Zhang, Qifan Yang, Yao Lin, Caijuan Geng, Wei Huang & Wei Zeng

Disinfection Supply Center, Hospital of Chengdu University of Traditional Chinese Medicine, No. 39, Shierqiao Road, Jin Niu District, Chengdu, 610072, Sichuan, People’s Republic of China

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Conception and design: LFZ and WZ. Analysis and interpretation: LFZ, KBL and WZ. Data collection: LFZ, QFY, YL, CJG and WH. Writing the article: LFZ, KBL. Critical revision of the article: LFZ, GFY and WZ. Final approval of the article: LFZ, KBL, YL, CJG, WH, QFY and WZ. Statistical analysis: YL, QFY.

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Zhang, L., Li, K., Yang, Q. et al. Associations between deep venous thrombosis and thyroid diseases: a two-sample bidirectional Mendelian randomization study. Eur J Med Res 29 , 327 (2024). https://doi.org/10.1186/s40001-024-01933-1

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Received : 12 September 2023

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DOI : https://doi.org/10.1186/s40001-024-01933-1

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