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What Is a Case Study?

Weighing the pros and cons of this method of research

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

Cara Lustik is a fact-checker and copywriter.

Verywell / Colleen Tighe

• Pros and Cons

What Types of Case Studies Are Out There?

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

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

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

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

At a Glance

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

What Are the Benefits and Limitations of Case Studies?

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

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

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

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

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

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

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

Case Study Examples

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

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

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

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

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

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

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

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

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

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

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

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

Section 1: A Case History

This section will have the following structure and content:

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

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

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

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

Section 2: Treatment Plan

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

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

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

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

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

Need More Tips?

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

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

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

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

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

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

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

Chapter 3: Research Methods

This study seeks to provide insight into the process of conducting community-based research.  In order to do so, the study utilizes a qualitative case study approach to examine the methodology of community-based research. Two contrasting cases of CBR are described and analyzed in order to understand the issues that arise when conducting CBR, the factors that facilitate or hinder the process, and the benefits of conducting CBR.  Finally, these contrasting cases are considered to determine what this study can contribute to the field of CBR.  This chapter details case study methodology as well as multiple case design.  It also describes the methodology of community-based research, the participants of the study, data collection and analysis, and issues around credibility, including my own subjectivities that may have influenced the research. 

Methodological Framework

In order to explore the collaborative process of conducting community-based research, this study utilizes a qualitative case study approach.  Case studies can be particularly useful for studying a process, program or individual in an in-depth, holistic way that allows for deep understanding (Merriam, 1998).  As Merriam points out,

A case study design is employed to gain an in-depth understanding of the situation and meaning for those involved.  The interest is in process rather than outcomes, in context rather than a specific variable, in discovery rather than confirmation (p. 19).

There are some differences in how researchers define case study.  Some researchers think of case study as the object to be studied (Stake, 2000), while others define case study as a process of investigation (Creswell, 2002).  Creswell defines case study as "an in-depth exploration of a bounded system (e.g., an activity, event, process, or individuals) based on extensive data collection" (p. 485).  Creswell recommends case study as a methodology if the problem to be studied "relates to developing an in-depth understanding of a 'case' or bounded system" (p. 496) and if the purpose is to understand "an event, activity, process, or one or more individuals" (p. 496).  Patton (1990) suggests that case studies are valuable in creating deep understanding of particular people, problems or situations in comprehensive ways.  

This study is particularly suitable for a case study design because it is a bounded system, it is contextual, and it is a study of process (Merriam, 1998).  Like Creswell (2002), Stake (2000) defines case study as the study of a "bounded system" (p. 436).  According to Creswell (2002), "'Bounded' means that the case is separated out for research in terms of time, place, or some physical boundaries" (p. 485).  In other words, it is possible to create limits around the object to be studied (Merriam, 1998).  A case study can focus on a variety of different things.  A case could be an individual, a group, a school, a community (Merriam, 1998), or a case could also include "a program, events, or activities" (Creswell, 2002, p. 485).  The bounded systems in my contrasting case studies are my collaboration with the Coalition for Schools [2] in a western city and my collaboration with community members in a small, rural, mountain community to carry out community-based research.  The boundaries of these two cases are determined by the people and groups that I collaborate with in the CBR process.  

I chose a case study design because it involves "detailed, in-depth data collection involving multiple sources of information rich in context" (Creswell, 1998, p. 61).  Context is a key factor.  According to Merriam (1998), in focusing on a particular phenomenon in a case study, it is impossible to separate the phenomenon from its context.  However, in this study, it is important that the context is understood as part of the process.  As Yin (2003) says, "you would use the case study method because you deliberately wanted to cover contextual conditions-believing that they might be highly pertinent to your phenomenon of study" (p. 13).  Thus, using a case study approach allows for the possibility of gaining significant knowledge about the process of conducting community-based research in particular contexts.   According to Sanders (1981), "Case studies help us to understand processes of events, projects, and programs and to discover context characteristics that will shed light on an issue or object" (p. 44). 

The two case studies each took place over an extended period of time.  The first CBR project lasted nine months, and the second CBR project lasted eight months.  I worked with my collaborative partners to define research problems and questions, develop research designs, collect data, and analyze data.  However, this study does not focus on the data that I collected as part of that CBR work.  Instead, this study focuses on the process of the collaborative experience.  Since the study focuses primarily on the procedures of conducting community-based research, the study is considered a process study.  According to Patton (1990), when carrying out a process study, the "focus is on how something happens rather than on the outcomes or results obtained" (p.94).  And, as Merriam (1998) points out, "Case study is a particularly suitable design if you are interested in process" (p.33).  Therefore, case study was chosen since it allows for detailed monitoring of the collaborative process (Merriam, 1998). 

Types of Case Studies

Stake (2000) delineates three types of case studies: intrinsic, instrumental, and collective.  Intrinsic case studies focus on a case that is unusual and is of particular interest to the researcher (Creswell, 1998; Stake, 2000).  The intent is not to build theory (Stake, 2000).  An instrumental case study is pursued in order to provide insight about a particular issue that may be generalizable (Creswell, 2002).  The primary purpose of an instrumental case study is to help advance understanding (Stake, 2000).  The collective case study encompasses more than one case "in order to investigate a phenomenon, population, or general condition" (Stake, 2000, p. 437).  Since the purpose is to help advance understanding, a collective case study is a grouping of instrumental case studies (Stake, 2000).  Using a collective case study approach can allow for the possibility of stronger interpretation and "perhaps better theorizing" (Stake, 2000, p. 437). 

Though Stake (2000) uses the terminology "collective case study," this approach is known by other names such as, multiple case studies, cross-case studies, comparative case studies, and contrasting cases (Merriam, 1998; Yin, 2003).  With multiple case studies, data are analyzed for insights both within each case and across cases (Merriam, 1998).  Yin (2003) points out that multiple cases may be chosen to try to replicate insights that you find within individuals cases or to represent contrasting situations.  Regardless of whether the purpose is replication or contrast, multiple case studies are "considered more compelling, and the overall study is therefore regarded as more robust" (Yin, 2003, p. 46). 

When this study was first proposed, the original intent was to pursue a single case study of my experience of collaboration in carrying out a community-based research project.  After completing my work with the Coalition for Schools, I felt dissatisfied with the experience in that I did not view it to be a success.  Instead of focusing on that one experience, I decided to pursue another research option in the small town in which I live in order to have a contrasting experience to write about.  It turned out that the project I completed in my small town was more successful, therefore allowing me to present contrasting cases.  Since this study seeks to add insight to the field of methodology in CBR, it is important to understand the factors that impact the process of collaboration and the factors that support successful collaborations (Strand et al., 2003a). 

Methodology of Community-Based Research

Since the purpose of this study is to explore the process of carrying out CBR, it is important to understand the methodology of community-based research.  As mentioned in chapter two, community-based research is not as concerned with methods as it is with methodology (Hills & Mullett, 2000; Strand et al., 2003a).  Either quantitative or qualitative methods may be used; the choice depends on what would obtain the most useful data for the community (Greenwood & Levin, 2000).  The methodology of CBR is guided by the three principles outlined by Strand et al. (2003a): 1) collaboration, 2) validation of the knowledge of community members and the multiple ways of collecting and distributing information, and 3) "social action and social change for the purpose of achieving social justice" (p. 8).  Though community-based research is not limited to specific methods, it does follow the typical stages of research that most traditional academic research would follow: defining the research question, developing a research design, collecting data, analyzing data, and writing up the results.  The difference is that the researcher collaborates closely with the community throughout the research process (Strand et al., 2003a).  The community is involved in determining the problem and research questions, creating the research design, collecting data, analyzing data, and creating a presentation of findings (Strand et al., 2003a).  The researcher also continues to play a role in the final stage by assisting with the enactment of solutions to create change (Greenwood & Levin, 1998). 

Regarding knowledge, community-based research seeks to redefine how we conceptualize knowledge in relation to academic research (Strand et al., 2003a).  Researchers who conduct CBR projects recognize the important knowledge that community members possess on the subject of their environment and the issues they are dealing with (Cordes, 1998a, No Concrete section, para. 2; Hills & Mullett, 2000, p. 1), what Strand (2000) calls "local knowledge" (p. 88).  This knowledge is key throughout the research process.  This acceptance of community knowledge does require the researcher to rethink his or her role.  As Stringer (1996) says, "The role of the researcher is not that of an expert who does research, but that of a resource person" (p. 22).  The expertise that the researcher brings to the equation is still valued; however, the local knowledge that the community brings is recognized as integral to the research process (Strand et al., 2003a). 

I have provided a brief overview of the methodology of CBR.  However, the purpose of this chapter is to describe the case study methods that I used to carry out this process study.  The descriptions of data collection and data analysis that are included in this chapter pertain to the data that were collected and analyzed for the contrasting case studies.  A description of the data collection and analysis that was conducted for the CBR projects in each case study will be included in the case descriptions in chapters four and five. 

Participants and Setting

Though I came into contact with a variety of people in each case study, my primary research collaborators are the main participants of my study.  In the first case study that I carried out, my collaboration with the Coalition for Schools, there were initially two primary collaborators, one of the co-chairs of the Coalition, Marge Bowline, and the director of the Coalition, Lisa Brown.  As my collaboration progressed, I worked primarily with Lisa Brown. 

The Coalition for Schools is an organization that has been created to support greater academic achievement in an urban school district in a western city.  The Coalition has focused its efforts toward a feeder pattern of schools in a quadrant of the city that has a high percentage of students who are eligible for free or reduced lunches, a high percentage of minority students, and a high percentage of English language learners.  This feeder pattern includes five elementary schools, two middle schools, and three small high schools that were originally part of one large high school and that are housed in one building.  The Coalition is an alliance of non-profit organizations, foundations, parent organizations, universities and colleges, and the school district working together to support achievement in these low performing schools.  The Business and Schools United (BSU) organization is the lead partner for the Coalition, and the Coalition is housed at BSU.  Marge Bowline is the director of BSU and one of the co-chairs of the Coalition for Schools.  She helped to create the Coalition and to procure funding for the organization.  The Coalition was a year old when I began my work with them.  Lisa Brown was hired to direct the Coalition and replaced the first director.  She had been in her position for about six months when I began my work with the Coalition. 

The two primary collaborators in my work in a small, western, mountain town are John Brewer and Maria Swenson.  The town is a small rural community that has a rapidly growing immigrant population from Mexico, about half of which are Indians from a remote area of the country.  Both John Brewer and Maria Swenson work in positions that have direct contact with this population.  John Brewer is the director of the literacy program which offers free English courses for English as a Second Language (ESL) students.  He is also a member of the city council.  Marge Swenson, who is herself a former immigrant from South America, is the coordinator of the diversity office which provides services to immigrants in town.  The case descriptions in chapters four and five provide greater detail of the participants and setting. 

Data Collection

As I progressed through each case study, I pursued two streams of data collection; the data collected to pursue the CBR projects and data that were collected as part of this case study to study CBR.  This section describes only the data that were collected for the case studies.  A description of the CBR data that were collected for each collaboration is included in the case descriptions in chapters four and five. 

Since the purpose of case study research is to provide an in-depth exploration of the person, program, or process under study, it requires intensive data collection (Merriam, 1998; Yin, 2003) using "multiple forms of data" (Creswell, 2002, p. 486).  Data collection for case studies usually focuses on three sources of data: observations, interviews, and documents (Merriam, 1998).  Though all qualitative research is to some extent based on the idea of emergent design, this study was truly emergent.  Though the research questions that this study proposed to address did not shift throughout the study, the methods of data collection changed to accommodate emerging issues or ideas.  According to Patton (1990),

What is certain is that different methods produce quite different information.  The challenge is to find out which information is most needed and most useful in a given situation, and then employ those methods best suited to producing the needed information (p. 196).

Though I collected all three forms of data (observations, interviews, and documents) for each study, there are some variations that are detailed in the following sections.  Appendix A provides a list showing the dates of meetings and interviews for each case study. 

Observations

My primary source of data collection for both case studies was observation.  Since I was essentially observing myself as I collaborated with my community partner, all of the observations that I completed for my case study data collection were participant observations.  Creswell (2002) defines participant observation as "an observational role adopted by researchers when they take part in activities in the setting they observe" (p. 200).  In this role, the researcher "actually engages in activities at the site begin studied" (p. 200).  Glesne (1999) describes a continuum of participation that "ranges from mostly observation to mostly participation" (p. 44).  Based on this continuum, I was what Glesne (1999) describes as a "full participant" in every interaction relating to my collaborative work with my community partners since I was concurrently a member of the collaborative partnership as well as the researcher investigating the process.  

In all of the meetings that I conducted with my community partners in relation to our CBR work, I collected data around those interactions.  I utilized Merriam's (1998) checklist of elements to structure my observations: physical setting, participants, activities and interactions, conversation, subtle factors, and my own behavior (pp. 97-98).  When working on my first CBR project with the Coalition, I initially only maintained field notes.  I was concerned that if I taped our meetings that it would be intrusive and would impact the openness of our conversations (Merriam, 1998).  However, as my study progressed I realized that it was difficult to take effective notes while participating in the conversation.  I then asked my community partners if I could tape subsequent meetings.  After that, most of the meetings I had with Lisa Brown or Marge Bowline were taped and then transcribed.  As part of the transcription process, I added notes that clarified or contextualized the dialogue.  When I began my work with my community partners in my small town, I asked during the first meeting if I could tape all of our meetings; both John Brewer and Maria Swenson readily agreed.  I found that after the use of the tape recorder became routine, they did not seem to be inhibited by being recorded.  Using the tape recorder allowed me to collect much more extensive data from my observations of our meetings. 

            Interviews

As part of the data collection for both case studies, I collected both formal and informal interview data (Patton, 1990).  Informal conversational interview questions were interwoven into meetings that we had in relation to ongoing research (Merriam, 1998) and were recorded as part of observation transcriptions.  These informal questions typically addressed how the community partner felt the research process was progressing, whether the research was meeting their needs, or addressed immediate questions that arose through the process of continued interaction. 

I also collected formal interview data for both case studies; however, I conducted fewer formal interviews with my community partners from the Coalition for Schools.  As my work with the Coalition progressed, I sought to determine particular data collection procedures that would address my research questions.  Since I was working within a collaborative relationship, part of the consideration when choosing methods was the impact that various methods would have on the relationship with my community partner.  In this first case study, as I show in more detail in chapter four, it was challenging to develop a collaborative relationship with my community partners.  The lack of trust and communication within this relationship made it difficult to carry out formal interviews discussing our collaboration.  I felt that these kinds of interviews would create greater distance between us.  Instead I relied primarily on other forms of data collection, observations and documents.  However, I did interview both Lisa Brown and Marge Bowline once formally toward the end of our partnership.  This interview included questions about the work of the Coalition as well as questions relating to community-based research (Appendix B).  I also conducted a follow-up email interview with Lisa Brown after beginning the process of data analysis (Appendix B).   

In my collaboration with John Brewer and Maria Swenson in my small town, I was able to develop a much more honest and open relationship from the beginning and felt very comfortable conducting formal interviews about the process.  I interviewed John and Maria individually three times throughout our collaboration (Appendix B).  I used a semi-structured approach (Rubin & Rubin, 1995) when designing the interview protocols.  I prepared questions as a starting point, but allowed the conversation to flow in whatever direction was helpful to providing insight.  The first interview focused on getting a sense of their background and experiences with research, their expectations for our research, and strategies for effective communication.  The second interview focused on their satisfaction with how things were proceeding, whether they felt we were communicating effectively, and whether they were having the input they wanted to have in the process.  The final interview focused primarily on the research questions of the case study: what were the issues that arose, what helped or hindered our collaboration, and what benefits did they receive from the research.  I transcribed each interview and added additional notes for interpretation. 

As part of the data collection process, I also collected or created a variety of documents including: email communications, a reflective journal, a phone call log, and other items that were provided by my community partners such as newsletters and meeting minutes.  As part of my collaboration with the Coalition for Schools, we relied extensively on email for communication since I found it difficult to schedule face-to-face meetings with Marge Bowline and Lisa Brown.  These email conversations are an important source of data in compiling a picture of our collaborative experience.  I also collected email data during my second case study.  However, these email communications focused primarily on setting up logistics.  Most important conversations were conducted face-to-face. 

Throughout both case studies, I sought to engage in a reflective stance toward my role in the research process.  In order to aid my reflection, I maintained a journal in which I transcribed my thinking in relation to my experiences and the perceived experiences of my community partners.  Merriam (1998) expresses some concern about using personal documents such as journals as data.  Merriam (1998) says,

Personal documents are a reliable source of data concerning a person's attitudes, beliefs, and view of the world.  But because they are personal documents, the material is highly subjective in that the writer is the only  one to select what he or she considers important to record.  Obviously these documents are not representative or necessarily reliable accounts of what actually may have occurred (p. 116).

However, Merriam (1998) does point out that one of the goals of qualitative research is to "reflect the participant's perspective" (p. 116).  Since this is a process study, the perceptions of all participants are a key consideration (Patton, 1990).  As I am a participant in this study, my perceptions of my experience of the process are important. 

The other documents I collected consisted of a phone call log and documents obtained when meeting with my community partners.  The phone call log consisted of a brief description of phone calls that were made during the research process.  If the conversation was extensive, I tried to recreate the conversation as closely as possible.  The phone call log was used primarily during my collaboration with John Brewer and Maria Swenson.  I also obtained various documents from my community partners.  These mostly included newsletters, meeting minutes, and data collected from previous research.  Most of the documents related to the CBR work we were conducting; yet some of the documents also provided information for my case study research. 

Data Analysis

After completing both case studies, I had accumulated large volumes of data (more than 500 pages of data for each case study).  I organized the data from both cases into what Yin (2003) calls a case study data base .   I organized my case study data base in a chronological order so that I could move through the data from the beginning to the end of the process.  This allowed me to perceive the progression of the process and my changing views throughout.  However, I felt that I needed an additional frame from which to organize the data. 

Data analysis was an ongoing process throughout the implementation of each case study.  Periodically I composed analytic memos to begin to formulate ideas around particular findings.  As each study progressed, I looked for events with common elements within the data that had "issue-relevant meaning" (Creswell, 1998, p. 154) or significance for the study.  As I recognized these common elements, I focused on determining whether they continued to be supported throughout the data collection process.  Creswell (1998) calls this process categorical aggregation.  As categories within the data began to emerge, I began to look for patterns or themes that connected these categories.  Based on the literature and the categories and themes that emerged while conducting the cases, I created an analytic framework from which to organize and think about the data. 

Analytic Framework      

The analytic framework is composed of four categories: community, collaboration, knowledge creation, and change.  In creating this framework, I was influenced by Stoecker's (2003) delineation of radical and mainstream CBR.  I view each of the four constructs of my framework as existing on a continuum.  At one end, there is radical CBR, in the middle, mainstream CBR, and at the other end the professional expert model or consulting (see Figure 1).  Based on how I conceptualize this framework, the closer on the continuum the researcher moves toward radical CBR, the greater the potential for change that will benefit the community with which the researcher is collaborating. 

When considering the category of community, the goal is to work as closely as possible with the community.  Since the ultimate goal of CBR is "social change for social justice" (Stoecker, 2002a, p. 9), the closer the researcher is to the members of the community who are dealing with the problem (Stoecker, 2003), the greater the potential to empower.  The community continuum includes grassroots organizations on one end and organizations which do not represent the community or use practices that "disempower the community" (Strand et al., 2003a. p. 73) on the other (see Figure 1).  In between are organizations that are a level removed from grassroots organizations but still seek to represent the community democratically, what Strand et al. (2003a) call "midlevel organizations" (p. 74).  Conducting CBR projects with midlevel organizations is what Strand et al. (2003a) label " doing CBR in the middle " (p. 73). 

Within this analytic framework, I conceptualize collaboration as shared decision making.  The goal is that the community should have equal power with the researcher and that decision making should be a shared process throughout (Strand et al., 2003a).  When considering this concept within the continuum, shared decision making is at one end of the continuum and at the other end the decisions are made primarily by the researcher (see Figure 1).  A companion to collaboration is the concept of participation in knowledge creation.  The primary goal in relation to this aspect of the framework is that the community assists in the creation of all knowledge that is generated during the CBR process, thus leading to community empowerment.  This point of the framework is based on the principle that the knowledge of community members is valid (Strand et al., 2003a) and integral to creating strong results.  At one end of the continuum, the community is involved in all aspects of knowledge creation, at the other end, the researcher controls the creation of knowledge (see Figure 1). 

The final point of the analytic framework is change (see Figure 1).  If you consider CBR within the radical framework described by Stoecker (2003), the goal for change is "massive structural changes in the distribution of power and resources through far-reaching changes in governmental policy, economic practices, or cultural norms" (p. 36).  This goal can be difficult to achieve.  More often, CBR work leads to programmatic changes within an organization or other more limited changes (Strand et al., 2003a).  However, each change within a community can have a cumulative effect that can lead to broader change.  Community-based research that does not involve the community in close collaboration and knowledge creation is less likely to create change that benefits the community.

Analysis of Contrasting Cases

Since this study utilizes contrasting cases, data analysis occurs at two levels: within-case and across cases (Merriam, 1998).  Merriam (1998) describes this process:            

For the within-case analysis , each case is first treated as a comprehensive case in and of itself.  Data are gathered so the researcher can learn as much about the contextual variables as possible that might have a bearing on the case...Once the analysis of each case is completed, cross-case analysis begins.  A qualitative, inductive, multicase study seeks to build abstractions across cases (pp. 194-195).

For each case, I analyzed observations, interviews, and documents to develop a description of the case. This description depicts the setting and participants as well as a general chronology of events and provides the reader with an understanding of the particulars of the case (Creswell, 1998).  This allows the reader to develop an understanding of the case within the larger context (Creswell, 2002).  Then using the analytic framework I developed, I did some within-case analysis and organized the categories that emerged during each study around the four constructs of my analytic framework.  This within-case analysis focused on answering the primary research question: What is the process of collaborating with a community partner on a community-based research project?  Thus each case analysis consists of  "both description and thematic development" (Creswell, 2002, p. 486).           

After completing the within-case analysis, I focused on the cross-case analysis to address three of the sub-questions of the study: What kinds of issues arise when collaborating on a community-based research project? What facilitates or hinders the process of collaboration? and, What does the researcher gain through this collaborative process, and what are the benefits for the community?  In the cross-case analysis, I used data from both case studies to address these questions.  I explored the categories that had emerged throughout each case study and then compared to see if these categories were supported in both cases.  I used the categories and themes that emerged during the within-case analysis and the cross-case analysis to determine "naturalistic generalizations" (Creswell, 1998, p. 154) concerning the field of community-based research.  Creswell (1998) defines naturalistic generalizations as "generalizations that people can learn from the case either for themselves or for applying it to a population of cases" (p. 154).  These naturalistic generalizations address the final question of the study: What can we learn from these experiences to inform the field of CBR?

In order to lend credibility to the findings of my study, I incorporated a variety of validity procedures.  The first validity procedure I employed was prolonged engagement in the field (Creswell & Miller, 2000) or what Merriam (1998) calls "long-term observation" (p. 204).  I worked on my case study with the Coalition for a period of nine months, and I worked with John and Maria for a period of eight months.  During each of these case studies, I had consistent contact with my community partners.  Collaborating with my community partners for this length of time allowed me to develop tentative categories in my findings and then follow up on these preliminary findings through observations or interviews (Creswell & Miller, 2000).  Therefore, the length of each case study and the consistent contact I had with my community partners lends credibility to my perceptions of this experience.

In addition to prolonged engagement in the field, another important validity procedure I employed, which is integral to case study design, was triangulation (Creswell, 1998).  Merriam (1998) defines triangulation as "using multiple investigators, multiple sources of data, or multiple methods to confirm the emerging findings" (p. 204).  I employed methodological triangulation (Creswell & Miller, 2000) since I collected three forms of data: observations, interviews, and documents.  I also employed multiple sources of data since interviews were conducted with several participants (Creswell & Miller, 2000).  I used the process of triangulation to seek convergence in the data and to confirm or disconfirm emerging categories and themes (Creswell & Miller, 2000).  As part of this process, I employed another validity strategy, disconfirming evidence (Creswell &  Miller, 2000).  Categories or themes that emerged in the within-case analysis were compared across cases.  If a category did not hold true across cases, it was generally deemed to be unreliable.  However, I did utilize what Creswell (1998) calls direct interpretation.  In direct interpretation, "the case study researcher looks at a single instance and draws meaning from it without looking for multiple instances" (p. 154).  I did recognize that there were single incidents specific to only one case that were significant to the study as well. 

Since this case study focused on the study of process, my perceptions were an integral component of the research.  However, since I did write interpretations of what I considered to be the perceptions of others, I used member checking to ensure accurate portrayal (Creswell & Miller, 2000).  I conducted member checking toward the end of the study so that it would not potentially disrupt the collaborative process.  I shared an outline of findings with Lisa Brown with the Coalition and also John Brewer and Maria Swenson in my small town and allowed them the opportunity to provide feedback.  Lisa Brown responded to the findings through email and said, "Thanks for sharing [these findings].  I feel it is accurate, and that it was a learning experience for all of us."  Maria Swenson also responded to the findings that I shared with she and John.  She said, "I looked at [the findings] and it sounds good.  I agree with all said."  John also said that he thought that the findings looked good. 

Finally, I used the validity procedure of thick description when writing about the study in order to give the reader a sense of being there and to capture the essence of the experience (Creswell & Miller, 2000).  This is an important feature in case study design that is presented to the reader through the case description.  The case description for each contrasting case is included in chapters four and five.  

            Subjectivity

Another method of creditability I used continuously throughout the research process was researcher reflexivity (Creswell & Miller, 2000).  I incorporated researcher reflexivity by constantly questioning my assumptions about what I thought was happening.  I sought to maintain a heightened sense of awareness of the biases that I brought to the study and maintained this awareness when adding contextual data to field notes, observations transcriptions, and interview transcriptions, and also when writing journal entries. 

Since my perceptions of the research process played a major part in the findings of the study, it was important that I attend to the idea of subjectivity.  Peshkin (1988), defines subjectivity as "the quality of the investigator that affects the results of observational investigation" (p. 17).  Peshkin (1988) points out that an individual's subjectivity is not something that can be removed, and it is therefore something researchers need to be aware of throughout the research process.  Peshkin (1988) identified the various facets of his subjectivities through a series of I's, for example, the "justice-seeking I" (p. 18) and "the community-maintenance I" (p. 18).  Though Peshkin does not view subjectivity as necessarily negative, he does feel it is something that researchers need to realize and acknowledge.  It was important to examine my own subjectivities throughout the research process so that I was aware of how these subjectivities could influence my interpretations and portrayal of events.  As Strand (2000) points out, "the researcher's values, experiences, and personal points of view are as much a part of the research process as those of the people studied, and they should be discussed and acknowledged" (p. 91). 

Since the two CBR projects I worked on were in different settings and related to different types of work, I dealt with different subjectivities within each case study.  In my work with the Coalition for Schools many of the subjectivities that I brought to that collaboration arose from my past experience as a classroom teacher.  I hold the perception that people who do not have experience in a K-12 classroom do not generally understand the issues that classroom teachers have to address.  I can be defensive and overly sensitive to criticism that I feel puts the blame on teachers.  There were many times during my partnership with the Coalition that I realized this subjectivity was influencing my reactions to statements made by Lisa Brown or Marge Bowline.  I also think that this perception at times clouded my view of the knowledge that Lisa brought to the equation.  Though I felt that she was very knowledgeable in certain areas, I questioned her understanding of what was actually happening in the schools that are part of the Coalition.  I tried to be aware of my bias in this area, though I do not believe I was always successful in controlling how this bias influenced my work with Lisa. 

Another bias that I brought to my work with the Coalition was the idea that a successful partnership should not have conflict.  I tend to avoid conflict in my personal life.  I have difficulty at times recognizing the benefits that conflict can bring.  Because of this, I did not communicate as effectively with Lisa as I could have.  If had been more willing to risk conflict, we may have been able to develop a more productive working relationship.  When I began my work with John Brewer and Maria Swenson, I determined that I would not avoid conflict in this collaboration.  When a situation did arise where John and I disagreed, I engaged him, and we talked through the matter.  The outcome was that we both were able to see the value of the other's viewpoint. 

Though I was able to address the issue of conflict avoidance in my work in John Brewer and Maria Swenson, there were other subjectivities and biases of which I had to be aware.  I am liable to have the perception that small towns tend to discriminate against minorities.  Since all of the projects that I completed with John and Maria involved the immigrant population in town, I felt at times that I was waiting for someone to say something that would demonstrate their prejudice.  At times, I would jump to the conclusion that a particular statement was pejorative.  When looking back again at the statement in the context of the full conversation, I realized at times that I may have misinterpreted particular statements.  I had to make a concerted effort not to single out statements just because they supported my bias.  Nevertheless, this subjectivity did influence whom I chose to partner with during this case study.  I had originally planned to include Maria's supervisor, Jennifer Payton, in our collaboration.  However, after meeting with Jennifer in October 2003, I decided not to collaborate with her since she made several comments during the meeting that I perceived to be pejorative.  If I had decided to work with Jennifer, I may have found that these comments did not represent discrimination but rather a lack of understanding of the impact of language choices. 

Two other subjectivities that I brought into my work on both projects related to my experience with previous CBR projects.  As I was involved in another community-based research project before working on my dissertation, I already had an initial perception of how the process works.  One concern that arose during my previous experience was the issue of communicating with my community partner.  I had difficulty developing a research question because the conversations that I shared with my community partner seemed circuitous.  We talked around questions during several meetings before I was finally able to gain a sense of what she was hoping to achieve from the research.  Though these past experiences with community-based research helped me to anticipate some of the issues that arose, I tried to make sure that the anticipation of issues did not create issues. 

When entering into CBR projects, it is important to me that I am doing work that I view as meaningful.  Work that is meaningful to me would be research that allows me to consistently interact with members of the community on a personal level.  However, I tried to maintain the awareness that the research that I wished to pursue was not necessarily the research that the people I was collaborating with wished to pursue.  I continued to remind myself that these discrepancies should not interfere with the development of a research design that was beneficial to my community partner and had the potential to bring about effective change.  Since change is the goal of community-based research, I needed to be sure that the change I was assisting to create was the change that the community partner was seeking to make rather than the change that I would have liked to pursue. 

Finally, when a researcher carries out a qualitative study, it is also important to attend to the subjectivities that the researcher brings based on gender, age, ethnicity, and socioeconomic status.  I feel at times that I lack self-awareness of how these orientations impact the way that I view the world.  Though I tried to be conscious of these factors while doing my research, I am not sure that I was successful in completely exploring how these subjectivities may have influenced my research.  I do feel, however, that my status was an issue in the work that I conducted with the Coalition for Schools.  My status in relation to my age (under 40) and my position as a graduate student influenced how my community partners at the Coalition viewed my role, and my socioeconomic background impacted the level of confidence that I felt when working with members of the Coalition.  I come from a working class background while my community partners at the Coalition come from backgrounds of higher status both in relation to levels of education and socioeconomic status.  At times, I did feel out of place moving through the world of the Coalition in that I often felt that I was from a lower class than many of the people with which I came into contact.  I felt most comfortable when interacting with teachers or parents. 

In order to minimize the impact of my subjectivities, I closely monitored my feelings as I carried out my research.  I looked for situations where I felt uncomfortable or that I wanted to avoid as well as situations where I felt comfortable and that I wanted to continue.  When these feelings arose, I realized that I was usually being influenced by subjectivity (Glesne, 1999; Peshkin, 1988).  I analyzed my feelings and considered how they related to my subjectivities, then took note of these occurrences in my journal (Peshkin, 1988).  Throughout the research process, I was mindful of previously identified subjectivities.  I also tried to be aware of newly emerging subjectivities that I may not have considered (Peshkin, 1988) that would potentially influence my research. 

Limitations of This Study

This study seeks to compare two cases of conducting community-based research.  However, there are differences between the two experiences that may have impacted the findings of the study.  In my work with the Coalition, I was a paid employee.  Though I was hired with the understanding that I would be a collaborative researcher, I believe my position as an employee impacted how Marge Bowline and Lisa Brown viewed my role, and it also impacted my reactions to various situations.  The fact that I was an employee in the first case study when collaborating with the Coalition but in the second case study I was independent, may have created some of the differences that were apparent in the two cases. 

Another limitation of this study is that it primarily focuses on the researcher's experience of this process.  Though I did interview my community partners, the number of interviews in the first case study was more limited.  If I had conducted additional interviews throughout the first case study, I might have additional information to support or contradict some of my observations.  However, the purpose of this study is to provide insight into this process for practitioners in the field of community-based research, thus it is beneficial to explore the researcher's perspective of these two experiences. 

The final limitation of this study relates to the timeline of the completion of the study.  Since I only recently finalized data collection in relation to my work with John Brewer and Maria Swenson, I am not really able to make an assessment at this point as to whether any of the work we completed will affect change.  My work with the Coalition was completed almost a year ago so it easier to assess the impact of that work.  However, even with the first case study, there is a possibility that some of the work that I completed could eventually lead to change.  If I were to conduct a long-term case study in relation to either of these collaborations, it would be more feasible to assess the impact of our work. 

This chapter provided an overview to the case study methods that were used to conduct this study.  I detailed a rationale for choosing this method, then described data collection, analysis, and procedures in relation to validity.  Since this is a process study of the methodology of CBR, I also described the foundations of this methodology.  The next three chapters will present the findings of this study.  Chapters four and five provide a synopsis of the within-case analysis of each of the contrasting cases.  I begin each chapter with a chronological overview of the major events of the case and then present within-case analysis organized around the four concepts of my analytic framework.  In chapter six, I present the findings from the cross-case analysis that address the sub-questions of the study and identify the "naturalistic generalizations" (Creswell, 1998, p. 154) that emerged from the study with recommendations for further research. 

Center for Teaching

Case studies.

Print Version

Case studies are stories that are used as a teaching tool to show the application of a theory or concept to real situations. Dependent on the goal they are meant to fulfill, cases can be fact-driven and deductive where there is a correct answer, or they can be context driven where multiple solutions are possible. Various disciplines have employed case studies, including humanities, social sciences, sciences, engineering, law, business, and medicine. Good cases generally have the following features: they tell a good story, are recent, include dialogue, create empathy with the main characters, are relevant to the reader, serve a teaching function, require a dilemma to be solved, and have generality.

Instructors can create their own cases or can find cases that already exist. The following are some things to keep in mind when creating a case:

• What do you want students to learn from the discussion of the case?
• What do they already know that applies to the case?
• What are the issues that may be raised in discussion?
• How will the case and discussion be introduced?
• What preparation is expected of students? (Do they need to read the case ahead of time? Do research? Write anything?)
• What directions do you need to provide students regarding what they are supposed to do and accomplish?
• Do you need to divide students into groups or will they discuss as the whole class?
• Are you going to use role-playing or facilitators or record keepers? If so, how?
• What are the opening questions?
• How much time is needed for students to discuss the case?
• What concepts are to be applied/extracted during the discussion?
• How will you evaluate students?

To find other cases that already exist, try the following websites:

• The National Center for Case Study Teaching in Science , University of Buffalo. SUNY-Buffalo maintains this set of links to other case studies on the web in disciplines ranging from engineering and ethics to sociology and business
• A Journal of Teaching Cases in Public Administration and Public Policy , University of Washington

For more information:

• World Association for Case Method Research and Application

Book Review :  Teaching and the Case Method , 3rd ed., vols. 1 and 2, by Louis Barnes, C. Roland (Chris) Christensen, and Abby Hansen. Harvard Business School Press, 1994; 333 pp. (vol 1), 412 pp. (vol 2).

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Case Study Research Method in Psychology

Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

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

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

Learn about our Editorial Process

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

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

On This Page:

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

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

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

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

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

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

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

 Famous Case Studies

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

Clinical Case Studies

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

Child Psychology Case Studies

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

Types of Case Studies

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

Where Do You Find Data for a Case Study?

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

1. Primary sources

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

2. Secondary sources

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

3. Archival records

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

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

4. Organizational records

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

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

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

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

How do I Write a Case Study in Psychology?

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

1. Introduction

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

2. Case Presentation

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

3. Management and Outcome

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

4. Discussion

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

5. Additional Items

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

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

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

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

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

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

Limitations

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

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

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

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

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

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

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

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

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

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

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

Harlow J. M. (1848). Passage of an iron rod through the head.  Boston Medical and Surgical Journal, 39 , 389–393.

Harlow, J. M. (1868).  Recovery from the Passage of an Iron Bar through the Head .  Publications of the Massachusetts Medical Society. 2  (3), 327-347.

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

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

Further Information

• Case Study Approach
• Case Study Method
• Enhancing the Quality of Case Studies in Health Services Research
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• Case Study | Definition, Examples & Methods

Case Study | Definition, Examples & Methods

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

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

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

Table of contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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How to Write a Case Study Analysis

Step-By-Step Instructions

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When writing a business case study analysis , you must first have a good understanding of the case study . Before you begin the steps below, read the business case carefully, taking notes all the while. It may be necessary to read the case several times to get all of the details and fully grasp the issues facing the group, company, or industry.

As you are reading, do your best to identify key issues, key players, and the most pertinent facts. After you are comfortable with the information, use the following step-by-step instructions (geared toward a single-company analysis) to write your report. To write about an industry, just adapt the steps listed here to discuss the segment as a whole.

Step 1: Investigate the Company’s History and Growth

A company’s past can greatly affect the present and future state of the organization. To begin, investigate the company’s founding, critical incidents, structure, and growth. Create a timeline of events, issues, and achievements. This timeline will come in handy for the next step. 

Step 2: Identify Strengths and Weaknesses

Using the information you gathered in step one, continue by examining and making a list of the value creation functions of the company. For example, the company may be weak in product development but strong in marketing. Make a list of problems that have occurred and note the effects they have had on the company. You should also list areas where the company has excelled. Note the effects of these incidents as well.

You're essentially conducting a partial SWOT analysis to get a better understanding of the company's strengths and weaknesses. A SWOT analysis involves documenting things like internal strengths (S) and weaknesses (W) and external opportunities (O) and threats (T). 

Step 3: Examine the External Environment

The third step involves identifying opportunities and threats within the company’s external environment. This is where the second part of the SWOT analysis (the O and the T) comes into play. Special items to note include competition within the industry, bargaining powers, and the threat of substitute products. Some examples of opportunities include expansion into new markets or new technology. Some examples of threats include increasing competition and higher interest rates.

Step 4: Analyze Your Findings

Using the information in steps 2 and 3, create an evaluation for this portion of your case study analysis. Compare the strengths and weaknesses within the company to the external threats and opportunities. Determine if the company is in a strong competitive position, and decide if it can continue at its current pace successfully.

Step 5: Identify Corporate-Level Strategy

To identify a company’s corporate-level strategy, identify and evaluate the company’s mission , goals, and actions toward those goals. Analyze the company’s line of business and its subsidiaries and acquisitions. You also want to debate the pros and cons of the company strategy to determine whether or not a change might benefit the company in the short or long term.​

Step 6: Identify Business-Level Strategy

Thus far, your case study analysis has identified the company’s corporate-level strategy. To perform a complete analysis, you will need to identify the company’s business-level strategy. (Note: If it is a single business, without multiple companies under one umbrella, and not an industry-wide review, the corporate strategy and the business-level strategy are the same.) For this part, you should identify and analyze each company’s competitive strategy, marketing strategy, costs, and general focus.

Step 7: Analyze Implementations

This portion requires that you identify and analyze the structure and control systems that the company is using to implement its business strategies. Evaluate organizational change, levels of hierarchy, employee rewards, conflicts, and other issues that are important to the company you are analyzing.

Step 8: Make Recommendations

The final part of your case study analysis should include your recommendations for the company. Every recommendation you make should be based on and supported by the context of your analysis. Never share hunches or make a baseless recommendation.

You also want to make sure that your suggested solutions are actually realistic. If the solutions cannot be implemented due to some sort of restraint, they are not realistic enough to make the final cut.

Finally, consider some of the alternative solutions that you considered and rejected. Write down the reasons why these solutions were rejected. 

Step 9: Review

Look over your analysis when you have finished writing. Critique your work to make sure every step has been covered. Look for grammatical errors , poor sentence structure, or other things that can be improved. It should be clear, accurate, and professional.

Business Case Study Analysis Tips

Keep these strategic tips in mind:

• Know the case study ​backward and forward before you begin your case study analysis.
• Give yourself enough time to write the case study analysis. You don't want to rush through it.
• Be honest in your evaluations. Don't let personal issues and opinions cloud your judgment.
• Be analytical, not descriptive.
• Proofread your work, and even let a test reader give it a once-over for dropped words or typos that you no longer can see.
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Classroom Approaches The Role of the Educator

Often teaching is turned into a performance where we feel we must be “the sage on the stage”. A major difference between teaching with decision cases and traditional approaches is that the teacher acts as a facilitator of the learning process rather than a performer.

Case teaching is not easy. A teacher must be able to think ahead, reorganize and listen at the same time. Case teaching is not a rambling process without focus. The teacher must have a plan in mind before beginning the case discussion. Seldom are two decision case discussions the same.

Preparing for Decision Case Discussions Objectives and Material

Preparing Objectives Objectives are vital to case teaching. They are the glue that hold the discussion together and prevents it from turning into a “bull session.” Familiarizing yourself with the material Decision case teaching requires students to reason from the facts presented in the case. They are more able to do this if the case teacher is sure of the facts and attempts to present the essential aspects of the case. A conceptual outline which parallels the objectives may be helpful. This helps the teacher think and prepare for various topics or concepts that may be covered during the discussion. However, a good discussion rarely proceeds in the logical pattern of a structured outline.

Preparing a question outline

Prepare a question outline to match the concept outline. Questioning is the single most important skill case teachers must develop. Questions should promote discussion about the concepts to be understood rather than solicit the correct answer. Most students have been trained to think there is only one right answer to a question. They think the teacher knows it and that they will be rewarded when they say it. This kind of mindset can kill case discussions. The best way to encourage creative answers is to phrase questions that do not call for right answers.

Teaching Socratically

Only when answers generate further questions does thought remain alive. Only students who have questions are really thinking and learning. The quality of the questions we ask determines the quality of the thinking we do.   Socratic questioning recognizes that questions, not answers, are the driving force in thinking.

Preparing for Decision Case Discussions

Foundation questions

There are five basic questions that serve as a foundation of case discussions:

What makes this case a dilemma? What are the objectives of the decision maker in resolving the dilemma? What are the issues involved in this case? What are the options of the decision maker? What decision should the decision maker make?

I t is helpful to think through these questions ahead of time and determine which points you would like to see discussed.

Using a board outline

An effective strategy for case teachers is to make use of the chalkboard to help organize discussions that may at times seem to be going off in many directions at once. By doing so, students will also have a chance to see their contributions to the discussion validated. Teachers can organize the outline by the key questions asked or by topic of the discussion. The Teaching Note may contain other options.

Arranging the Classroom

Most classrooms are arranged in rows so that the teacher is the focal point; however, this physical setting can stifle effective case teaching.

The ideal situation is to arrange the seats in a “U” or horseshoe shape so the students can easily see one another and the case teacher can get close to the students and move to the blackboard.

Special recognition:

These thoughts and examples were compiled from a variety of sources. Those sources include: Decision Cases for Secondary Education t, Brakke, Dunrud, Peterson, Marla Reicks, & Simmons with Bakkum, Bowman, Pitzl, and Stanford (1994) . College of Agriculture , University of Minnesota, Critical Thinking Website—Foundation for Critical Thinking , Methods of Teaching Agriculture , Newcomb, McCracken and Warmbrod (1993) and The Power of Positive Teaching , McCormick (1994).

All You Wanted to Know About How to Write a Case Study

What do you study in your college? If you are a psychology, sociology, or anthropology student, we bet you might be familiar with what a case study is. This research method is used to study a certain person, group, or situation. In this guide from our dissertation writing service , you will learn how to write a case study professionally, from researching to citing sources properly. Also, we will explore different types of case studies and show you examples — so that you won’t have any other questions left.

What Is a Case Study?

A case study is a subcategory of research design which investigates problems and offers solutions. Case studies can range from academic research studies to corporate promotional tools trying to sell an idea—their scope is quite vast.

What Is the Difference Between a Research Paper and a Case Study?

While research papers turn the reader’s attention to a certain problem, case studies go even further. Case study guidelines require students to pay attention to details, examining issues closely and in-depth using different research methods. For example, case studies may be used to examine court cases if you study Law, or a patient's health history if you study Medicine. Case studies are also used in Marketing, which are thorough, empirically supported analysis of a good or service's performance. Well-designed case studies can be valuable for prospective customers as they can identify and solve the potential customers pain point.

Case studies involve a lot of storytelling – they usually examine particular cases for a person or a group of people. This method of research is very helpful, as it is very practical and can give a lot of hands-on information. Most commonly, the length of the case study is about 500-900 words, which is much less than the length of an average research paper.

The structure of a case study is very similar to storytelling. It has a protagonist or main character, which in your case is actually a problem you are trying to solve. You can use the system of 3 Acts to make it a compelling story. It should have an introduction, rising action, a climax where transformation occurs, falling action, and a solution.

Here is a rough formula for you to use in your case study:

Problem (Act I): > Solution (Act II) > Result (Act III) > Conclusion.

Types of Case Studies

The purpose of a case study is to provide detailed reports on an event, an institution, a place, future customers, or pretty much anything. There are a few common types of case study, but the type depends on the topic. The following are the most common domains where case studies are needed:

• Historical case studies are great to learn from. Historical events have a multitude of source info offering different perspectives. There are always modern parallels where these perspectives can be applied, compared, and thoroughly analyzed.
• Problem-oriented case studies are usually used for solving problems. These are often assigned as theoretical situations where you need to immerse yourself in the situation to examine it. Imagine you’re working for a startup and you’ve just noticed a significant flaw in your product’s design. Before taking it to the senior manager, you want to do a comprehensive study on the issue and provide solutions. On a greater scale, problem-oriented case studies are a vital part of relevant socio-economic discussions.
• Cumulative case studies collect information and offer comparisons. In business, case studies are often used to tell people about the value of a product.
• Critical case studies explore the causes and effects of a certain case.
• Illustrative case studies describe certain events, investigating outcomes and lessons learned.

Need a compelling case study? EssayPro has got you covered. Our experts are ready to provide you with detailed, insightful case studies that capture the essence of real-world scenarios. Elevate your academic work with our professional assistance.

Case Study Format

The case study format is typically made up of eight parts:

• Executive Summary. Explain what you will examine in the case study. Write an overview of the field you’re researching. Make a thesis statement and sum up the results of your observation in a maximum of 2 sentences.
• Background. Provide background information and the most relevant facts. Isolate the issues.
• Case Evaluation. Isolate the sections of the study you want to focus on. In it, explain why something is working or is not working.
• Proposed Solutions. Offer realistic ways to solve what isn’t working or how to improve its current condition. Explain why these solutions work by offering testable evidence.
• Conclusion. Summarize the main points from the case evaluations and proposed solutions. 6. Recommendations. Talk about the strategy that you should choose. Explain why this choice is the most appropriate.
• Implementation. Explain how to put the specific strategies into action.
• References. Provide all the citations.

How to Write a Case Study

Let's discover how to write a case study.

Setting Up the Research

When writing a case study, remember that research should always come first. Reading many different sources and analyzing other points of view will help you come up with more creative solutions. You can also conduct an actual interview to thoroughly investigate the customer story that you'll need for your case study. Including all of the necessary research, writing a case study may take some time. The research process involves doing the following:

• Define your objective. Explain the reason why you’re presenting your subject. Figure out where you will feature your case study; whether it is written, on video, shown as an infographic, streamed as a podcast, etc.
• Determine who will be the right candidate for your case study. Get permission, quotes, and other features that will make your case study effective. Get in touch with your candidate to see if they approve of being part of your work. Study that candidate’s situation and note down what caused it.
• Identify which various consequences could result from the situation. Follow these guidelines on how to start a case study: surf the net to find some general information you might find useful.
• Make a list of credible sources and examine them. Seek out important facts and highlight problems. Always write down your ideas and make sure to brainstorm.
• Focus on several key issues – why they exist, and how they impact your research subject. Think of several unique solutions. Draw from class discussions, readings, and personal experience. When writing a case study, focus on the best solution and explore it in depth. After having all your research in place, writing a case study will be easy. You may first want to check the rubric and criteria of your assignment for the correct case study structure.

Read Also: ' WHAT IS A CREDIBLE SOURCES ?'

Although your instructor might be looking at slightly different criteria, every case study rubric essentially has the same standards. Your professor will want you to exhibit 8 different outcomes:

• Correctly identify the concepts, theories, and practices in the discipline.
• Identify the relevant theories and principles associated with the particular study.
• Evaluate legal and ethical principles and apply them to your decision-making.
• Recognize the global importance and contribution of your case.
• Construct a coherent summary and explanation of the study.
• Demonstrate analytical and critical-thinking skills.
• Explain the interrelationships between the environment and nature.
• Integrate theory and practice of the discipline within the analysis.

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Case Study Outline

Let's look at the structure of an outline based on the issue of the alcoholic addiction of 30 people.

Introduction

• Statement of the issue: Alcoholism is a disease rather than a weakness of character.
• Presentation of the problem: Alcoholism is affecting more than 14 million people in the USA, which makes it the third most common mental illness there.
• Explanation of the terms: In the past, alcoholism was commonly referred to as alcohol dependence or alcohol addiction. Alcoholism is now the more severe stage of this addiction in the disorder spectrum.
• Hypotheses: Drinking in excess can lead to the use of other drugs.
• Importance of your story: How the information you present can help people with their addictions.
• Background of the story: Include an explanation of why you chose this topic.
• Presentation of analysis and data: Describe the criteria for choosing 30 candidates, the structure of the interview, and the outcomes.
• Strong argument 1: ex. X% of candidates dealing with anxiety and depression...
• Strong argument 2: ex. X amount of people started drinking by their mid-teens.
• Strong argument 3: ex. X% of respondents’ parents had issues with alcohol.
• Concluding statement: I have researched if alcoholism is a disease and found out that…
• Recommendations: Ways and actions for preventing alcohol use.

Writing a Case Study Draft

After you’ve done your case study research and written the outline, it’s time to focus on the draft. In a draft, you have to develop and write your case study by using: the data which you collected throughout the research, interviews, and the analysis processes that were undertaken. Follow these rules for the draft:

• Your draft should contain at least 4 sections: an introduction; a body where you should include background information, an explanation of why you decided to do this case study, and a presentation of your main findings; a conclusion where you present data; and references.
• In the introduction, you should set the pace very clearly. You can even raise a question or quote someone you interviewed in the research phase. It must provide adequate background information on the topic. The background may include analyses of previous studies on your topic. Include the aim of your case here as well. Think of it as a thesis statement. The aim must describe the purpose of your work—presenting the issues that you want to tackle. Include background information, such as photos or videos you used when doing the research.
• Describe your unique research process, whether it was through interviews, observations, academic journals, etc. The next point includes providing the results of your research. Tell the audience what you found out. Why is this important, and what could be learned from it? Discuss the real implications of the problem and its significance in the world.
• Include quotes and data (such as findings, percentages, and awards). This will add a personal touch and better credibility to the case you present. Explain what results you find during your interviews in regards to the problem and how it developed. Also, write about solutions which have already been proposed by other people who have already written about this case.
• At the end of your case study, you should offer possible solutions, but don’t worry about solving them yourself.

Use Data to Illustrate Key Points in Your Case Study

Even though your case study is a story, it should be based on evidence. Use as much data as possible to illustrate your point. Without the right data, your case study may appear weak and the readers may not be able to relate to your issue as much as they should. Let's see the examples from essay writing service :

‍ With data: Alcoholism is affecting more than 14 million people in the USA, which makes it the third most common mental illness there. Without data: A lot of people suffer from alcoholism in the United States.

Try to include as many credible sources as possible. You may have terms or sources that could be hard for other cultures to understand. If this is the case, you should include them in the appendix or Notes for the Instructor or Professor.

Finalizing the Draft: Checklist

After you finish drafting your case study, polish it up by answering these ‘ask yourself’ questions and think about how to end your case study:

• Check that you follow the correct case study format, also in regards to text formatting.
• Check that your work is consistent with its referencing and citation style.
• Micro-editing — check for grammar and spelling issues.
• Macro-editing — does ‘the big picture’ come across to the reader? Is there enough raw data, such as real-life examples or personal experiences? Have you made your data collection process completely transparent? Does your analysis provide a clear conclusion, allowing for further research and practice?

Problems to avoid:

• Overgeneralization – Do not go into further research that deviates from the main problem.
• Failure to Document Limitations – Just as you have to clearly state the limitations of a general research study, you must describe the specific limitations inherent in the subject of analysis.
• Failure to Extrapolate All Possible Implications – Just as you don't want to over-generalize from your case study findings, you also have to be thorough in the consideration of all possible outcomes or recommendations derived from your findings.

How to Create a Title Page and Cite a Case Study

Let's see how to create an awesome title page.

Your title page depends on the prescribed citation format. The title page should include:

• A title that attracts some attention and describes your study
• The title should have the words “case study” in it
• The title should range between 5-9 words in length
• Your name and contact information
• Your finished paper should be only 500 to 1,500 words in length.With this type of assignment, write effectively and avoid fluff

Here is a template for the APA and MLA format title page:

There are some cases when you need to cite someone else's study in your own one – therefore, you need to master how to cite a case study. A case study is like a research paper when it comes to citations. You can cite it like you cite a book, depending on what style you need.

Citation Example in MLA ‍ Hill, Linda, Tarun Khanna, and Emily A. Stecker. HCL Technologies. Boston: Harvard Business Publishing, 2008. Print.

Citation Example in APA ‍ Hill, L., Khanna, T., & Stecker, E. A. (2008). HCL Technologies. Boston: Harvard Business Publishing.

Citation Example in Chicago Hill, Linda, Tarun Khanna, and Emily A. Stecker. HCL Technologies.

Case Study Examples

To give you an idea of a professional case study example, we gathered and linked some below.

Eastman Kodak Case Study

Case Study Example: Audi Trains Mexican Autoworkers in Germany

To conclude, a case study is one of the best methods of getting an overview of what happened to a person, a group, or a situation in practice. It allows you to have an in-depth glance at the real-life problems that businesses, healthcare industry, criminal justice, etc. may face. This insight helps us look at such situations in a different light. This is because we see scenarios that we otherwise would not, without necessarily being there. If you need custom essays , try our research paper writing services .

Get Help Form Qualified Writers

Crafting a case study is not easy. You might want to write one of high quality, but you don’t have the time or expertise. If you’re having trouble with your case study, help with essay request - we'll help. EssayPro writers have read and written countless case studies and are experts in endless disciplines. Request essay writing, editing, or proofreading assistance from our custom case study writing service , and all of your worries will be gone.

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What Is A Case Study?

How to cite a case study in apa, how to write a case study.

Daniel Parker

is a seasoned educational writer focusing on scholarship guidance, research papers, and various forms of academic essays including reflective and narrative essays. His expertise also extends to detailed case studies. A scholar with a background in English Literature and Education, Daniel’s work on EssayPro blog aims to support students in achieving academic excellence and securing scholarships. His hobbies include reading classic literature and participating in academic forums.

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Types of Case Studies

There are several different types of case studies, as well as several types of subjects of case studies. We will investigate each type in this article.

Different Types of Case Studies

There are several types of case studies, each differing from each other based on the hypothesis and/or thesis to be proved. It is also possible for types of case studies to overlap each other.

Each of the following types of cases can be used in any field or discipline. Whether it is psychology, business or the arts, the type of case study can apply to any field.

Explanatory

The explanatory case study focuses on an explanation for a question or a phenomenon. Basically put, an explanatory case study is 1 + 1 = 2. The results are not up for interpretation.

A case study with a person or group would not be explanatory, as with humans, there will always be variables. There are always small variances that cannot be explained.

However, event case studies can be explanatory. For example, let's say a certain automobile has a series of crashes that are caused by faulty brakes. All of the crashes are a result of brakes not being effective on icy roads.

What kind of case study is explanatory? Think of an example of an explanatory case study that could be done today

When developing the case study, the researcher will explain the crash, and the detailed causes of the brake failure. They will investigate what actions caused the brakes to fail, and what actions could have been taken to prevent the failure.

Other car companies could then use this case study to better understand what makes brakes fail. When designing safer products, looking to past failures is an excellent way to ensure similar mistakes are not made.

The same can be said for other safety issues in cars. There was a time when cars did not have seatbelts. The process to get seatbelts required in all cars started with a case study! The same can be said about airbags and collapsible steering columns. They all began with a case study that lead to larger research, and eventual change.

Exploratory

An exploratory case study is usually the precursor to a formal, large-scale research project. The case study's goal is to prove that further investigation is necessary.

For example, an exploratory case study could be done on veterans coming home from active combat. Researchers are aware that these vets have PTSD, and are aware that the actions of war are what cause PTSD. Beyond that, they do not know if certain wartime activities are more likely to contribute to PTSD than others.

For an exploratory case study, the researcher could develop a study that certain war events are more likely to cause PTSD. Once that is demonstrated, a large-scale research project could be done to determine which events are most likely to cause PTSD.

Exploratory case studies are very popular in psychology and the social sciences. Psychologists are always looking for better ways to treat their patients, and exploratory studies allow them to research new ideas or theories.

Multiple-Case Studies or Collective Studies

Multiple case or collective studies use information from different studies to formulate the case for a new study. The use of past studies allows additional information without needing to spend more time and money on additional studies.

Using the PTSD issue again is an excellent example of a collective study. When studying what contributes most to wartime PTSD, a researcher could use case studies from different war. For instance, studies about PTSD in WW2 vets, Persian Gulf War vets, and Vietnam vets could provide an excellent sampling of which wartime activities are most likely to cause PTSD.

If a multiple case study on vets was done with vets from the Vietnam War, the Persian Gulf War, and the Iraq War, and it was determined the vets from Vietnam had much less PTSD, what could be inferred?

Furthermore, this type of study could uncover differences as well. For example, a researcher might find that veterans who serve in the Middle East are more likely to suffer a certain type of ailment. Or perhaps, that veterans who served with large platoons were more likely to suffer from PTSD than veterans who served in smaller platoons.

An intrinsic case study is the study of a case wherein the subject itself is the primary interest. The "Genie" case is an example of this. The study wasn't so much about psychology, but about Genie herself, and how her experiences shaped who she was.

Genie is the topic. Genie is what the researchers are interested in, and what their readers will be most interested in. When the researchers started the study, they didn't know what they would find.

They asked the question…"If a child is never introduced to language during the crucial first years of life, can they acquire language skills when they are older?" When they met Genie, they didn't know the answer to that question.

Instrumental

An instrumental case study uses a case to gain insights into a phenomenon. For example, a researcher interested in child obesity rates might set up a study with middle school students and an exercise program. In this case, the children and the exercise program are not the focus. The focus is learning the relationship between children and exercise, and why certain children become obese.

What is an example of an instrumental case study?

Focus on the results, not the topic!

Types of Subjects of Case Studies

There are generally five different types of case studies, and the subjects that they address. Every case study, whether explanatory or exploratory, or intrinsic or instrumental, fits into one of these five groups. These are:

Person – This type of study focuses on one particular individual. This case study would use several types of research to determine an outcome.

The best example of a person case is the "Genie" case study. Again, "Genie" was a 13-year-old girl who was discovered by social services in Los Angeles in 1970. Her father believed her to be mentally retarded, and therefore locked her in a room without any kind of stimulation. She was never nourished or cared for in any way. If she made a noise, she was beaten.

When "Genie" was discovered, child development specialists wanted to learn as much as possible about how her experiences contributed to her physical, emotional and mental health. They also wanted to learn about her language skills. She had no form of language when she was found, she only grunted. The study would determine whether or not she could learn language skills at the age of 13.

Since Genie was placed in a children's hospital, many different clinicians could observe her. In addition, researchers were able to interview the few people who did have contact with Genie and would be able to gather whatever background information was available.

This case study is still one of the most valuable in all of child development. Since it would be impossible to conduct this type of research with a healthy child, the information garnered from Genie's case is invaluable.

Group – This type of study focuses on a group of people. This could be a family, a group or friends, or even coworkers.

An example of this type of case study would be the uncontacted tribes of Indians in the Peruvian and Brazilian rainforest. These tribes have never had any modern contact. Therefore, there is a great interest to study them.

Scientists would be interested in just about every facet of their lives. How do they cook, how do they make clothing, how do they make tools and weapons. Also, doing psychological and emotional research would be interesting. However, because so few of these tribes exist, no one is contacting them for research. For now, all research is done observationally.

If a researcher wanted to study uncontacted Indian tribes, and could only observe the subjects, what type of observations should be made?

Location – This type of study focuses on a place, and how and why people use the place.

For example, many case studies have been done about Siberia, and the people who live there. Siberia is a cold and barren place in northern Russia, and it is considered the most difficult place to live in the world. Studying the location, and it's weather and people can help other people learn how to live with extreme weather and isolation.

Location studies can also be done on locations that are facing some kind of change. For example, a case study could be done on Alaska, and whether the state is seeing the effects of climate change.

Another type of study that could be done in Alaska is how the environment changes as population increases. Geographers and those interested in population growth often do these case studies.

Organization/Company – This type of study focuses on a business or an organization. This could include the people who work for the company, or an event that occurred at the organization.

An excellent example of this type of case study is Enron. Enron was one of the largest energy company's in the United States, when it was discovered that executives at the company were fraudulently reporting the company's accounting numbers.

Once the fraud was uncovered, investigators discovered willful and systematic corruption that caused the collapse of Enron, as well as their financial auditors, Arthur Andersen. The fraud was so severe that the top executives of the company were sentenced to prison.

This type of case study is used by accountants, auditors, financiers, as well as business students, in order to learn how such a large company could get away with committing such a serious case of corporate fraud for as long as they did. It can also be looked at from a psychological standpoint, as it is interesting to learn why the executives took the large risks that they took.

Most company or organization case studies are done for business purposes. In fact, in many business schools, such as Harvard Business School, students learn by the case method, which is the study of case studies. They learn how to solve business problems by studying the cases of businesses that either survived the same problem, or one that didn't survive the problem.

Event – This type of study focuses on an event, whether cultural or societal, and how it affects those that are affected by it. An example would be the Tylenol cyanide scandal. This event affected Johnson & Johnson, the parent company, as well as the public at large.

The case study would detail the events of the scandal, and more specifically, what management at Johnson & Johnson did to correct the problem. To this day, when a company experiences a large public relations scandal, they look to the Tylenol case study to learn how they managed to survive the scandal.

A very popular topic for case studies was the events of September 11 th . There were studies in almost all of the different types of research studies.

Obviously the event itself was a very popular topic. It was important to learn what lead up to the event, and how best to proven it from happening in the future. These studies are not only important to the U.S. government, but to other governments hoping to prevent terrorism in their countries.

Planning A Case Study

You have decided that you want to research and write a case study. Now what? In this section you will learn how to plan and organize a research case study.

Selecting a Case

The first step is to choose the subject, topic or case. You will want to choose a topic that is interesting to you, and a topic that would be of interest to your potential audience. Ideally you have a passion for the topic, as then you will better understand the issues surrounding the topic, and which resources would be most successful in the study.

You also must choose a topic that would be of interest to a large number of people. You want your case study to reach as large an audience as possible, and a topic that is of interest to just a few people will not have a very large reach. One of the goals of a case study is to reach as many people as possible.

Who is your audience?

Are you trying to reach the layperson? Or are you trying to reach other professionals in your field? Your audience will help determine the topic you choose.

If you are writing a case study that is looking for ways to lower rates of child obesity, who is your audience?

If you are writing a psychology case study, you must consider whether your audience will have the intellectual skills to understand the information in the case. Does your audience know the vocabulary of psychology? Do they understand the processes and structure of the field?

You want your audience to have as much general knowledge as possible. When it comes time to write the case study, you may have to spend some time defining and explaining terms that might be unfamiliar to the audience.

Lastly, when selecting a topic you do not want to choose a topic that is very old. Current topics are always the most interesting, so if your topic is more than 5-10 years old, you might want to consider a newer topic. If you choose an older topic, you must ask yourself what new and valuable information do you bring to the older topic, and is it relevant and necessary.

Determine Research Goals

What type of case study do you plan to do?

An illustrative case study will examine an unfamiliar case in order to help others understand it. For example, a case study of a veteran with PTSD can be used to help new therapists better understand what veterans experience.

An exploratory case study is a preliminary project that will be the precursor to a larger study in the future. For example, a case study could be done challenging the efficacy of different therapy methods for vets with PTSD. Once the study is complete, a larger study could be done on whichever method was most effective.

A critical instance case focuses on a unique case that doesn't have a predetermined purpose. For example, a vet with an incredibly severe case of PTSD could be studied to find ways to treat his condition.

Ethics are a large part of the case study process, and most case studies require ethical approval. This approval usually comes from the institution or department the researcher works for. Many universities and research institutions have ethics oversight departments. They will require you to prove that you will not harm your study subjects or participants.

This should be done even if the case study is on an older subject. Sometimes publishing new studies can cause harm to the original participants. Regardless of your personal feelings, it is essential the project is brought to the ethics department to ensure your project can proceed safely.

Developing the Case Study

Once you have your topic, it is time to start planning and developing the study. This process will be different depending on what type of case study you are planning to do. For thissection, we will assume a psychological case study, as most case studies are based on the psychological model.

Once you have the topic, it is time to ask yourself some questions. What question do you want to answer with the study?

For example, a researcher is considering a case study about PTSD in veterans. The topic is PTSD in veterans. What questions could be asked?

Do veterans from Middle Eastern wars suffer greater instances of PTSD?

Do younger soldiers have higher instances of PTSD?

Does the length of the tour effect the severity of PTSD?

Each of these questions is a viable question, and finding the answers, or the possible answers, would be helpful for both psychologists and veterans who suffer from PTSD.

Research Notebook

1. What is the background of the case study? Who requested the study to be done and why? What industry is the study in, and where will the study take place?

2. What is the problem that needs a solution? What is the situation, and what are the risks?

3. What questions are required to analyze the problem? What questions might the reader of the study have? What questions might colleagues have?

4. What tools are required to analyze the problem? Is data analysis necessary?

5. What is your current knowledge about the problem or situation? How much background information do you need to procure? How will you obtain this background info?

6. What other information do you need to know to successfully complete the study?

7. How do you plan to present the report? Will it be a simple written report, or will you add PowerPoint presentations or images or videos? When is the report due? Are you giving yourself enough time to complete the project?

The research notebook is the heart of the study. Other organizational methods can be utilized, such as Microsoft Excel, but a physical notebook should always be kept as well.

Planning the Research

The most important parts of the case study are:

1. The case study's questions

2. The study's propositions

3. How information and data will be analyzed

4. The logic behind the propositions

5. How the findings will be interpreted

The study's questions should be either a "how" or "why" question, and their definition is the researchers first job. These questions will help determine the study's goals.

Not every case study has a proposition. If you are doing an exploratory study, you will not have propositions. Instead, you will have a stated purpose, which will determine whether your study is successful, or not.

How the information will be analyzed will depend on what the topic is. This would vary depending on whether it was a person, group, or organization.

When setting up your research, you will want to follow case study protocol. The protocol should have the following sections:

1. An overview of the case study, including the objectives, topic and issues.

2. Procedures for gathering information and conducting interviews.

3. Questions that will be asked during interviews and data collection.

4. A guide for the final case study report.

When deciding upon which research methods to use, these are the most important:

1. Documents and archival records

2. Interviews

3. Direct observations

4. Indirect observations, or observations of subjects

5. Physical artifacts and tools

Documents could include almost anything, including letters, memos, newspaper articles, Internet articles, other case studies, or any other document germane to the study.

Archival records can include military and service records, company or business records, survey data or census information.

Research Strategy

Before beginning the study you want a clear research strategy. Your best chance at success will be if you use an outline that describes how you will gather your data and how you will answer your research questions.

The researcher should create a list with four or five bullet points that need answers. Consider the approaches for these questions, and the different perspectives you could take.

The researcher should then choose at least two data sources (ideally more). These sources could include interviews, Internet research, and fieldwork or report collection. The more data sources used, the better the quality of the final data.

The researcher then must formulate interview questions that will result in detailed and in-depth answers that will help meet the research goals. A list of 15-20 questions is a good start, but these can and will change as the process flows.

Planning Interviews

The interview process is one of the most important parts of the case study process. But before this can begin, it is imperative the researcher gets informed consent from the subjects.

The process of informed consent means the subject understands their role in the study, and that their story will be used in the case study. You will want to have each subject complete a consent form.

The researcher must explain what the study is trying to achieve, and how their contribution will help the study. If necessary, assure the subject that their information will remain private if requested, and they do not need to use their real name if they are not comfortable with that. Pseudonyms are commonly used in case studies.

Informed Consent

The process by which permission is granted before beginning medical or psychological research

A fictitious name used to hide ones identity

It is important the researcher is clear regarding the expectations of the study participation. For example, are they comfortable on camera? Do they mind if their photo is used in the final written study.

Interviews are one of the most important sources of information for case studies. There are several types of interviews. They are:

Open-ended – This type of interview has the interviewer and subject talking to each other about the subject. The interviewer asks questions, and the subject answers them. But the subject can elaborate and add information whenever they see fit.

A researcher might meet with a subject multiple times, and use the open-ended method. This can be a great way to gain insight into events. However, the researcher mustn't rely solely on the information from the one subject, and be sure to have multiple sources.

Focused – This type of interview is used when the subject is interviewed for a short period of time, and answers a set of questions. This type of interview could be used to verify information learned in an open-ended interview with another subject. Focused interviews are normally done to confirm information, not to gain new information.

Structured – Structured interviews are similar to surveys. These are usually used when collecting data for large groups, like neighborhoods. The questions are decided before hand, and the expected answers are usually simple.

When conducting interviews, the answers are obviously important. But just as important are the observations that can be made. This is one of the reasons in-person interviews are preferable over phone interviews, or Internet or mail surveys.

Ideally, when conducing in-person interviews, more than one researcher should be present. This allows one researcher to focus on observing while the other is interviewing. This is particularly important when interviewing large groups of people.

The researcher must understand going into the case study that the information gained from the interviews might not be valuable. It is possible that once the interviews are completed, the information gained is not relevant.

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Case Study-Based Learning

Enhancing learning through immediate application.

By the Mind Tools Content Team

If you've ever tried to learn a new concept, you probably appreciate that "knowing" is different from "doing." When you have an opportunity to apply your knowledge, the lesson typically becomes much more real.

Adults often learn differently from children, and we have different motivations for learning. Typically, we learn new skills because we want to. We recognize the need to learn and grow, and we usually need – or want – to apply our newfound knowledge soon after we've learned it.

A popular theory of adult learning is andragogy (the art and science of leading man, or adults), as opposed to the better-known pedagogy (the art and science of leading children). Malcolm Knowles , a professor of adult education, was considered the father of andragogy, which is based on four key observations of adult learners:

• Adults learn best if they know why they're learning something.
• Adults often learn best through experience.
• Adults tend to view learning as an opportunity to solve problems.
• Adults learn best when the topic is relevant to them and immediately applicable.

This means that you'll get the best results with adults when they're fully involved in the learning experience. Give an adult an opportunity to practice and work with a new skill, and you have a solid foundation for high-quality learning that the person will likely retain over time.

So, how can you best use these adult learning principles in your training and development efforts? Case studies provide an excellent way of practicing and applying new concepts. As such, they're very useful tools in adult learning, and it's important to understand how to get the maximum value from them.

What Is a Case Study?

Case studies are a form of problem-based learning, where you present a situation that needs a resolution. A typical business case study is a detailed account, or story, of what happened in a particular company, industry, or project over a set period of time.

The learner is given details about the situation, often in a historical context. The key players are introduced. Objectives and challenges are outlined. This is followed by specific examples and data, which the learner then uses to analyze the situation, determine what happened, and make recommendations.

The depth of a case depends on the lesson being taught. A case study can be two pages, 20 pages, or more. A good case study makes the reader think critically about the information presented, and then develop a thorough assessment of the situation, leading to a well-thought-out solution or recommendation.

Why Use a Case Study?

Case studies are a great way to improve a learning experience, because they get the learner involved, and encourage immediate use of newly acquired skills.

They differ from lectures or assigned readings because they require participation and deliberate application of a broad range of skills. For example, if you study financial analysis through straightforward learning methods, you may have to calculate and understand a long list of financial ratios (don't worry if you don't know what these are). Likewise, you may be given a set of financial statements to complete a ratio analysis. But until you put the exercise into context, you may not really know why you're doing the analysis.

With a case study, however, you might explore whether a bank should provide financing to a borrower, or whether a company is about to make a good acquisition. Suddenly, the act of calculating ratios becomes secondary – it's more important to understand what the ratios tell you. This is how case studies can make the difference between knowing what to do, and knowing how, when, and why to do it.

Then, what really separates case studies from other practical forms of learning – like scenarios and simulations – is the ability to compare the learner's recommendations with what actually happened. When you know what really happened, it's much easier to evaluate the "correctness" of the answers given.

When to Use a Case Study

As you can see, case studies are powerful and effective training tools. They also work best with practical, applied training, so make sure you use them appropriately.

Remember these tips:

• Case studies tend to focus on why and how to apply a skill or concept, not on remembering facts and details. Use case studies when understanding the concept is more important than memorizing correct responses.
• Case studies are great team-building opportunities. When a team gets together to solve a case, they'll have to work through different opinions, methods, and perspectives.
• Use case studies to build problem-solving skills, particularly those that are valuable when applied, but are likely to be used infrequently. This helps people get practice with these skills that they might not otherwise get.
• Case studies can be used to evaluate past problem solving. People can be asked what they'd do in that situation, and think about what could have been done differently.

Ensuring Maximum Value From Case Studies

The first thing to remember is that you already need to have enough theoretical knowledge to handle the questions and challenges in the case study. Otherwise, it can be like trying to solve a puzzle with some of the pieces missing.

Here are some additional tips for how to approach a case study. Depending on the exact nature of the case, some tips will be more relevant than others.

• Read the case at least three times before you start any analysis. Case studies usually have lots of details, and it's easy to miss something in your first, or even second, reading.
• Once you're thoroughly familiar with the case, note the facts. Identify which are relevant to the tasks you've been assigned. In a good case study, there are often many more facts than you need for your analysis.
• If the case contains large amounts of data, analyze this data for relevant trends. For example, have sales dropped steadily, or was there an unexpected high or low point?
• If the case involves a description of a company's history, find the key events, and consider how they may have impacted the current situation.
• Consider using techniques like SWOT analysis and Porter's Five Forces Analysis to understand the organization's strategic position.
• Stay with the facts when you draw conclusions. These include facts given in the case as well as established facts about the environmental context. Don't rely on personal opinions when you put together your answers.

Writing a Case Study

You may have to write a case study yourself. These are complex documents that take a while to research and compile. The quality of the case study influences the quality of the analysis. Here are some tips if you want to write your own:

• Write your case study as a structured story. The goal is to capture an interesting situation or challenge and then bring it to life with words and information. You want the reader to feel a part of what's happening.
• Present information so that a "right" answer isn't obvious. The goal is to develop the learner's ability to analyze and assess, not necessarily to make the same decision as the people in the actual case.
• Do background research to fully understand what happened and why. You may need to talk to key stakeholders to get their perspectives as well.
• Determine the key challenge. What needs to be resolved? The case study should focus on one main question or issue.
• Define the context. Talk about significant events leading up to the situation. What organizational factors are important for understanding the problem and assessing what should be done? Include cultural factors where possible.
• Identify key decision makers and stakeholders. Describe their roles and perspectives, as well as their motivations and interests.
• Make sure that you provide the right data to allow people to reach appropriate conclusions.
• Make sure that you have permission to use any information you include.

A typical case study structure includes these elements:

• Executive summary. Define the objective, and state the key challenge.
• Opening paragraph. Capture the reader's interest.
• Scope. Describe the background, context, approach, and issues involved.
• Presentation of facts. Develop an objective picture of what's happening.
• Description of key issues. Present viewpoints, decisions, and interests of key parties.

Because case studies have proved to be such effective teaching tools, many are already written. Some excellent sources of free cases are The Times 100 , CasePlace.org , and Schroeder & Schroeder Inc . You can often search for cases by topic or industry. These cases are expertly prepared, based mostly on real situations, and used extensively in business schools to teach management concepts.

Case studies are a great way to improve learning and training. They provide learners with an opportunity to solve a problem by applying what they know.

There are no unpleasant consequences for getting it "wrong," and cases give learners a much better understanding of what they really know and what they need to practice.

Case studies can be used in many ways, as team-building tools, and for skill development. You can write your own case study, but a large number are already prepared. Given the enormous benefits of practical learning applications like this, case studies are definitely something to consider adding to your next training session.

Knowles, M. (1973). 'The Adult Learner: A Neglected Species [online].' Available here .

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The concentration of the growth regulators in the medium, namely auxin and cytokinin, seems to be the critical factor for determining whether a tissue culture is initiated, and how it subsequently develops. The explant should initially form a callus, from which it is possible to generate multiple embryos and then shoots, forming the basis for plant regeneration and thus the technology of micropropagation. The first stage of tissue culture initiation is vital for information on what combination of media components will give a friable, fast-growing callus, or a green chlorophyllous callus, or embryo, root or shoot formation. 

There is at present no way to predict the exact growth medium, and growth protocol, to generate a particular type of callus. These characteristics have to be determined through a carefully designed and observed experiment for each new plant species, and frequently also for each new variety of the species which is taken into tissue culture. The basis of the experiment will be media and protocols that give the desired effect in other plant species, and experience.

The demonstration The strategy for designing a medium to initiate tissue culture, showing how growth regulators and other factors modulate development, can be demonstrated using the African Violet, a popular house plant. Leaf sections are the source of explants. This demonstration is regularly carried out by a student class, and gives reliable results. Sterile supplies are provided from central facilities, and provision of sterile working areas (for example, in laminar flow hoods) is an advantage, although cultures can be initiated in an open laboratory with careful aseptic technique. The standard precautions used during any laboratory work involving chemicals or microbes should be adopted. If you are in any doubt about safety hazards associated with this demonstration, you should consult your local safety adviser.  

Step 1 - selection of the leaves Leaves are cut from healthy plants, leaving a short length of petiole attached. They should be selected to each yield several explants of leaf squares with approximately 1 cm sides. The youngest and oldest leaves should be avoided. 

Wash the dust off the leaves in a beaker of distilled water, holding the leaf stalk with forceps.

Step 2 - surface sterilisation and preparation of the explants This part of the procedure should be carried out in a sterile working area, or with meticulous aseptic technique. 

The leaf, with the petiole still attached, should be immersed in 70% ethanol for 30 seconds, then transferred to a sterile petri dish. Sterile scissors and forceps are then used to cut squares from the leaf as explants, each with approximately 1 cm sides.

The explants are transferred into a 10% hypochlorite bleach solution for 5 minutes, gently agitating once or twice during this time. They are then washed free of bleach by immersing in four successive beakers of sterile distilled water, leaving them for 2-3 minutes in each.

Three explants are placed on each petri dish of growth medium (see table and  below), with the upper epidermis pressed gently against the surface of the agar to make good contact. 

The petri dishes are sealed with plastic film to prevent moisture loss, and incubated at 25 o C in 16h light/8h dark.

Step 3 - assessment of tissue culture development The explants are incubated for 4 - 6 weeks, and inspected at weekly or fortnightly intervals. The growth of obvious bacterial or fungal colonies indicates contamination, and data from such cultures is obviously suspect. The development of dark brown tissue cultures can also be a consequence of contamination. 

The media used in the demonstration are designed to show the effects of auxin, cytokinin, sucrose and mineral salts on development. The media were based on the well-known Murashige and Skoog inorganic medium, with additions as shown in this table . 

Typical results

These pictures show typical results, after about 8 weeks on each medium. To summarise, multiple adventitious buds form on the control medium,  leading to many small shoots on the upper surface where the leaf is not in contact with the medium.

Absence of sucrose inhibits this production. Shoot production is also limited on the low sucrose concentration, but comparable with the control at high sucrose.

At zero and low levels of cytokinin , callus forms where the leaf surface is in contact with the medium, while at high levels, shoot formation is stimulated.

At zero and low levels of auxins there is a stimulus to shoot formation,  but at high concentrations, large numbers of roots are formed.

At low and zero levels of MS salts, there is no growth at all.

These very obvious variations demonstrate the importance of a carbon and inorganic salt source for plant growth, as well as the effect of the auxin:cytokinin ration on the control of plant development.

For publications describing this work, follow this link

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How to write a case study — examples, templates, and tools

It’s a marketer’s job to communicate the effectiveness of a product or service to potential and current customers to convince them to buy and keep business moving. One of the best methods for doing this is to share success stories that are relatable to prospects and customers based on their pain points, experiences, and overall needs.

That’s where case studies come in. Case studies are an essential part of a content marketing plan. These in-depth stories of customer experiences are some of the most effective at demonstrating the value of a product or service. Yet many marketers don’t use them, whether because of their regimented formats or the process of customer involvement and approval.

A case study is a powerful tool for showcasing your hard work and the success your customer achieved. But writing a great case study can be difficult if you’ve never done it before or if it’s been a while. This guide will show you how to write an effective case study and provide real-world examples and templates that will keep readers engaged and support your business.

In this article, you’ll learn:

What is a case study?

How to write a case study, case study templates, case study examples, case study tools.

A case study is the detailed story of a customer’s experience with a product or service that demonstrates their success and often includes measurable outcomes. Case studies are used in a range of fields and for various reasons, from business to academic research. They’re especially impactful in marketing as brands work to convince and convert consumers with relatable, real-world stories of actual customer experiences.

The best case studies tell the story of a customer’s success, including the steps they took, the results they achieved, and the support they received from a brand along the way. To write a great case study, you need to:

• Celebrate the customer and make them — not a product or service — the star of the story.
• Craft the story with specific audiences or target segments in mind so that the story of one customer will be viewed as relatable and actionable for another customer.
• Write copy that is easy to read and engaging so that readers will gain the insights and messages intended.
• Follow a standardized format that includes all of the essentials a potential customer would find interesting and useful.
• Support all of the claims for success made in the story with data in the forms of hard numbers and customer statements.

Case studies are a type of review but more in depth, aiming to show — rather than just tell — the positive experiences that customers have with a brand. Notably, 89% of consumers read reviews before deciding to buy, and 79% view case study content as part of their purchasing process. When it comes to B2B sales, 52% of buyers rank case studies as an important part of their evaluation process.

Telling a brand story through the experience of a tried-and-true customer matters. The story is relatable to potential new customers as they imagine themselves in the shoes of the company or individual featured in the case study. Showcasing previous customers can help new ones see themselves engaging with your brand in the ways that are most meaningful to them.

Besides sharing the perspective of another customer, case studies stand out from other content marketing forms because they are based on evidence. Whether pulling from client testimonials or data-driven results, case studies tend to have more impact on new business because the story contains information that is both objective (data) and subjective (customer experience) — and the brand doesn’t sound too self-promotional.

Case studies are unique in that there’s a fairly standardized format for telling a customer’s story. But that doesn’t mean there isn’t room for creativity. It’s all about making sure that teams are clear on the goals for the case study — along with strategies for supporting content and channels — and understanding how the story fits within the framework of the company’s overall marketing goals.

Here are the basic steps to writing a good case study.

1. Identify your goal

Start by defining exactly who your case study will be designed to help. Case studies are about specific instances where a company works with a customer to achieve a goal. Identify which customers are likely to have these goals, as well as other needs the story should cover to appeal to them.

The answer is often found in one of the buyer personas that have been constructed as part of your larger marketing strategy. This can include anything from new leads generated by the marketing team to long-term customers that are being pressed for cross-sell opportunities. In all of these cases, demonstrating value through a relatable customer success story can be part of the solution to conversion.

2. Choose your client or subject

Who you highlight matters. Case studies tie brands together that might otherwise not cross paths. A writer will want to ensure that the highlighted customer aligns with their own company’s brand identity and offerings. Look for a customer with positive name recognition who has had great success with a product or service and is willing to be an advocate.

The client should also match up with the identified target audience. Whichever company or individual is selected should be a reflection of other potential customers who can see themselves in similar circumstances, having the same problems and possible solutions.

Some of the most compelling case studies feature customers who:

• Switch from one product or service to another while naming competitors that missed the mark.
• Experience measurable results that are relatable to others in a specific industry.
• Represent well-known brands and recognizable names that are likely to compel action.
• Advocate for a product or service as a champion and are well-versed in its advantages.

Whoever or whatever customer is selected, marketers must ensure they have the permission of the company involved before getting started. Some brands have strict review and approval procedures for any official marketing or promotional materials that include their name. Acquiring those approvals in advance will prevent any miscommunication or wasted effort if there is an issue with their legal or compliance teams.

3. Conduct research and compile data

Substantiating the claims made in a case study — either by the marketing team or customers themselves — adds validity to the story. To do this, include data and feedback from the client that defines what success looks like. This can be anything from demonstrating return on investment (ROI) to a specific metric the customer was striving to improve. Case studies should prove how an outcome was achieved and show tangible results that indicate to the customer that your solution is the right one.

This step could also include customer interviews. Make sure that the people being interviewed are key stakeholders in the purchase decision or deployment and use of the product or service that is being highlighted. Content writers should work off a set list of questions prepared in advance. It can be helpful to share these with the interviewees beforehand so they have time to consider and craft their responses. One of the best interview tactics to keep in mind is to ask questions where yes and no are not natural answers. This way, your subject will provide more open-ended responses that produce more meaningful content.

4. Choose the right format

There are a number of different ways to format a case study. Depending on what you hope to achieve, one style will be better than another. However, there are some common elements to include, such as:

• An engaging headline
• A subject and customer introduction
• The unique challenge or challenges the customer faced
• The solution the customer used to solve the problem
• The results achieved
• Data and statistics to back up claims of success
• A strong call to action (CTA) to engage with the vendor

It’s also important to note that while case studies are traditionally written as stories, they don’t have to be in a written format. Some companies choose to get more creative with their case studies and produce multimedia content, depending on their audience and objectives. Case study formats can include traditional print stories, interactive web or social content, data-heavy infographics, professionally shot videos, podcasts, and more.

5. Write your case study

We’ll go into more detail later about how exactly to write a case study, including templates and examples. Generally speaking, though, there are a few things to keep in mind when writing your case study.

• Be clear and concise. Readers want to get to the point of the story quickly and easily, and they’ll be looking to see themselves reflected in the story right from the start.
• Provide a big picture. Always make sure to explain who the client is, their goals, and how they achieved success in a short introduction to engage the reader.
• Construct a clear narrative. Stick to the story from the perspective of the customer and what they needed to solve instead of just listing product features or benefits.
• Leverage graphics. Incorporating infographics, charts, and sidebars can be a more engaging and eye-catching way to share key statistics and data in readable ways.
• Offer the right amount of detail. Most case studies are one or two pages with clear sections that a reader can skim to find the information most important to them.
• Include data to support claims. Show real results — both facts and figures and customer quotes — to demonstrate credibility and prove the solution works.

6. Promote your story

Marketers have a number of options for distribution of a freshly minted case study. Many brands choose to publish case studies on their website and post them on social media. This can help support SEO and organic content strategies while also boosting company credibility and trust as visitors see that other businesses have used the product or service.

Marketers are always looking for quality content they can use for lead generation. Consider offering a case study as gated content behind a form on a landing page or as an offer in an email message. One great way to do this is to summarize the content and tease the full story available for download after the user takes an action.

Sales teams can also leverage case studies, so be sure they are aware that the assets exist once they’re published. Especially when it comes to larger B2B sales, companies often ask for examples of similar customer challenges that have been solved.

Now that you’ve learned a bit about case studies and what they should include, you may be wondering how to start creating great customer story content. Here are a couple of templates you can use to structure your case study.

Template 1 — Challenge-solution-result format

• Start with an engaging title. This should be fewer than 70 characters long for SEO best practices. One of the best ways to approach the title is to include the customer’s name and a hint at the challenge they overcame in the end.
• Create an introduction. Lead with an explanation as to who the customer is, the need they had, and the opportunity they found with a specific product or solution. Writers can also suggest the success the customer experienced with the solution they chose.
• Present the challenge. This should be several paragraphs long and explain the problem the customer faced and the issues they were trying to solve. Details should tie into the company’s products and services naturally. This section needs to be the most relatable to the reader so they can picture themselves in a similar situation.
• Share the solution. Explain which product or service offered was the ideal fit for the customer and why. Feel free to delve into their experience setting up, purchasing, and onboarding the solution.
• Explain the results. Demonstrate the impact of the solution they chose by backing up their positive experience with data. Fill in with customer quotes and tangible, measurable results that show the effect of their choice.
• Ask for action. Include a CTA at the end of the case study that invites readers to reach out for more information, try a demo, or learn more — to nurture them further in the marketing pipeline. What you ask of the reader should tie directly into the goals that were established for the case study in the first place.

Template 2 — Data-driven format

• Start with an engaging title. Be sure to include a statistic or data point in the first 70 characters. Again, it’s best to include the customer’s name as part of the title.
• Create an overview. Share the customer’s background and a short version of the challenge they faced. Present the reason a particular product or service was chosen, and feel free to include quotes from the customer about their selection process.
• Present data point 1. Isolate the first metric that the customer used to define success and explain how the product or solution helped to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Present data point 2. Isolate the second metric that the customer used to define success and explain what the product or solution did to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Present data point 3. Isolate the final metric that the customer used to define success and explain what the product or solution did to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Summarize the results. Reiterate the fact that the customer was able to achieve success thanks to a specific product or service. Include quotes and statements that reflect customer satisfaction and suggest they plan to continue using the solution.
• Ask for action. Include a CTA at the end of the case study that asks readers to reach out for more information, try a demo, or learn more — to further nurture them in the marketing pipeline. Again, remember that this is where marketers can look to convert their content into action with the customer.

While templates are helpful, seeing a case study in action can also be a great way to learn. Here are some examples of how Adobe customers have experienced success.

Juniper Networks

One example is the Adobe and Juniper Networks case study , which puts the reader in the customer’s shoes. The beginning of the story quickly orients the reader so that they know exactly who the article is about and what they were trying to achieve. Solutions are outlined in a way that shows Adobe Experience Manager is the best choice and a natural fit for the customer. Along the way, quotes from the client are incorporated to help add validity to the statements. The results in the case study are conveyed with clear evidence of scale and volume using tangible data.

The story of Lenovo’s journey with Adobe is one that spans years of planning, implementation, and rollout. The Lenovo case study does a great job of consolidating all of this into a relatable journey that other enterprise organizations can see themselves taking, despite the project size. This case study also features descriptive headers and compelling visual elements that engage the reader and strengthen the content.

Tata Consulting

When it comes to using data to show customer results, this case study does an excellent job of conveying details and numbers in an easy-to-digest manner. Bullet points at the start break up the content while also helping the reader understand exactly what the case study will be about. Tata Consulting used Adobe to deliver elevated, engaging content experiences for a large telecommunications client of its own — an objective that’s relatable for a lot of companies.

Case studies are a vital tool for any marketing team as they enable you to demonstrate the value of your company’s products and services to others. They help marketers do their job and add credibility to a brand trying to promote its solutions by using the experiences and stories of real customers.

When you’re ready to get started with a case study:

• Think about a few goals you’d like to accomplish with your content.
• Make a list of successful clients that would be strong candidates for a case study.
• Reach out to the client to get their approval and conduct an interview.
• Gather the data to present an engaging and effective customer story.

Adobe can help

There are several Adobe products that can help you craft compelling case studies. Adobe Experience Platform helps you collect data and deliver great customer experiences across every channel. Once you’ve created your case studies, Experience Platform will help you deliver the right information to the right customer at the right time for maximum impact.

To learn more, watch the Adobe Experience Platform story .

Keep in mind that the best case studies are backed by data. That’s where Adobe Real-Time Customer Data Platform and Adobe Analytics come into play. With Real-Time CDP, you can gather the data you need to build a great case study and target specific customers to deliver the content to the right audience at the perfect moment.

Watch the Real-Time CDP overview video to learn more.

Finally, Adobe Analytics turns real-time data into real-time insights. It helps your business collect and synthesize data from multiple platforms to make more informed decisions and create the best case study possible.

Request a demo to learn more about Adobe Analytics.

https://business.adobe.com/blog/perspectives/b2b-ecommerce-10-case-studies-inspire-you

https://business.adobe.com/blog/basics/business-case

https://business.adobe.com/blog/basics/what-is-real-time-analytics

Case Study III

Ms. M. M. is a 36-year-old executive for a high-profile accounting firm. She spends much of her time behind the desk working on her computer. Ms. M.M. states that recently her job has become more stressful and lately she has noticed her heart "skipping a beat" every now and then.

Ms. M. M. smokes cigarettes 1ppd and drinks at least 5 cups of coffee daily. She states she is tired of being overweight and is taking an herbal diet pill. Ms M. M. states that she has not been sleeping well lately due to increased stress at her job.

Physical Assessment:

Neuro : AAOx3, follows all commands and exhibits equal strength in all extremities. Pulmonary : Bilateral breath sounds with decreased bases. Ms. M. M. tells you she has a "smoker’s cough" in the mornings. GI : No complaints, abdomen soft, nontender with active bowel sounds. GU : Denies any GU problems. Exhibits clear, yellow urine. CV : Slightly irregular heart rate. Pulses strong in all extremities, no edema, nail beds pink, and heart sounds are normal s1 and s2. Vitals Pulse 88, BP 154/88, Respiratory rate 22, temp. 98.4 F. Height 5’4", weight 182 lb.

History Ms. M.M. has been smoking 1ppd for the past 10 years. She states she tried to quit, but just kept gaining weight. Ms M. M. began taking herbal diet pills 2 weeks ago in an attempt to lose weight. She doesn’t like to exercise because it is "embarrassing".

Medications : Ms. M.M. states that she takes an OTC herbal weight loss supplements that the sales clerk said is "just as good or better than ephedra". She states that she takes 1 tablet QID. Diagnostic studies :

CXR : normal, Labs :Blood chemistry and hematology are normal. EKG rhythm strip:

( IMPORTANT! See instructions below*)

The basic dysrhythmia course that is recommended as background for this Cardiac Case Studies course is the RnCeus.com course:

EKG Strip Indentification and Evaluation

* IMPORTANT!

Please write down and save your answers to the above questions. The questions will be repeated on the "Exam and Evaluation", but the scenarios and strips will not be repeated.

© RnCeus.com

Sarcophagus of Ramses the Great Discovered Over 3,000 Years After the Pharaoh's Death

Archaeologists have discovered a long-lost sarcophagus that belongs to the most powerful pharaoh of ancient Egypt.

They re-examined a granite burial beneath the floor of a religious center in the east-central area of Egypt and found that it belonged to Ramses the Great.

Sarcophagus of Ramses the Great

Ramesses II, who has also been referred to as Ramses the Great, reigned from B.C. 1279 to B.C. 1213. This period saw the stemming of massive statues and buildings in what was known to be the last peak of the imperial power of Egypt.

Originally, a high priest's remains were discovered in the sarcophagus. However, the newer discovery suggested that the  pharaoh's mummy and coffin  were removed in order for the burial to be reused.

Frédéric Payraudeau, an Egyptologist, researcher, and teacher from Sorbonne University, discovered this just this month after examining a granite fragment that was found in Abydos in 2009.

Payraudeau found that the five-feet-long and three-inch-thick stone had an  overlooked engraving  of the inscription "of Ramses II himself." The Egyptologist shared that upon reading these findings, he was filled with doubt. He asked his American colleague to re-examine it, considering the case's complexity.

The Egyptologist's colleagues thought that the cartouche was preceded by the word "king," which designated the Menkheperre high priest who ruled over south Egypt in B.C. 1000.

However, the cartridge was actually from an earlier engraving. Therefore, it designated the earlier owner.

The sarcophagus also apparently featured engravings of the Book of Doors, which is an initiatory story that was meant for kings during Ramses' time.

Payraudeau explained that the royal cartouche has Ramses II's coronation name that is specific to him. However, this was apparently masked by the stone's condition and by another engraving that was added during the burial's reuse.

For a long time, archaeologists have known that Ramses II was kept in a golden coffin that was stolen within Antiquity. He was also moved to a sarcophagus of alabaster that was destroyed later on.

A thousand pieces were placed within the huge granite sarcophagus that Menkheperre stole 200 years later for the burial's reuse.

Payraudeau explained that the discovery shows that during this time, the Valley of the Kinds was focused not just on looting but on funerary object reuse.

ALSO READ:  Visualizing Ramesses II: Researchers Digitally Disect Remains To Know How the Greatest Pharaoh Could Have Looked Like

Ramses the Great

Ramses the Great was considered ancient Egypt's most celebrated and powerful ruler. His successors refer to him as the "Great Ancestor." Ramses II was the  3rd ruler  of Egypt's 19th Dynasty.

The ancient pharaoh led various military expeditions and expanded the Empire of Egypt to go from Syria to Nubia.

In 2022, scientists from England and Egypt recreated the ancient ruler's face with a 3D model of his skull. They then reversed his aging by nearly a century to show the prehistoric ruler's face when he was at the peak of his power.

Such a result served as the pharaoh's first scientific facial reconstruction based on his skull's CT scan.

RELATED ARTICLE: Pharaoh-sphinx Statues Unearthed in Ancient Egyptian Sun Temple: What Do They Symbolize?

Check out more news and information on Ancient Egypt  in Science Times.

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• Policy & Compliance
• Clinical Trials

NIH Definition of Clinical Trial Case Studies

The case studies provided below are designed to help you identify whether your study would be considered by NIH to be a clinical trial. Expect the case studies and related guidance to evolve over the upcoming year. For continuity and ease of reference, case studies will retain their original numbering and will not be renumbered if cases are revised or removed.

The simplified case studies apply the following four questions to determine whether NIH would consider the research study to be a clinical trial:

• Does the study involve human participants?
• Are the participants prospectively assigned to an intervention?
• Is the study designed to evaluate the effect of the intervention on the participants?
• Is the effect being evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is “yes,” then the clinical study would be considered a clinical trial according to the NIH definition.

See this page for more information about the NIH definition of a clinical trial.

General Case Studies

Institute or center specific case studies.

The study involves the recruitment of research participants who are randomized to receive one of two approved drugs. It is designed to compare the effects of the drugs on the blood level of a protein.

• Does the study involve human participants? Yes, the study involves human participants.
• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, one of two drugs.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the drugs on the level of the protein in the participants’ blood.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the level of a protein, is a health-related biomedical outcome.

The study involves the recruitment of research participants with condition Y to receive a drug that has been approved for another indication. It is designed to measure the drug’s effects on the level of a biomarker associated with the severity of condition Y.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the approved drug.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the drug’s effect on the level of the biomarker.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the level of a biomarker, is a health-related biomedical outcome.

The study involves the recruitment of research participants with condition X to receive investigational compound A. It is designed to assess the pharmacokinetic properties of compound A.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, compound A.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate how the body interacts with compound A
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, pharmacokinetic properties, is a health-related biomedical outcome.

The study involves the recruitment of research participants with disease X to receive an investigational drug. It is designed to assess safety and determine the maximum tolerated dose of the drug.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to assess safety and determine the maximum tolerated dose of the investigational drug.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, safety and maximum tolerated dose, is a health-related biomedical outcome.

The study involves the recruitment of research participants with disease X to receive a chronic disease management program. It is designed to assess usability and to determine the maximum tolerated dose of the chronic disease program (e.g., how many in-person and telemedicine visits with adequate adherence).

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the chronic disease management program.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine the maximum tolerated dose of the program to obtain adequate adherence.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, tolerable intensity and adequate adherence of the intervention, is a health-related outcome.

The study involves the recruitment of research participants with disease X to receive either an investigational drug or a placebo. It is designed to evaluate the efficacy of the investigational drug to relieve disease symptoms.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug or placebo.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the investigational drug on the participants’ symptoms.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, relief of symptoms, is a health-related outcome.

The study involves the recruitment of research participants with disease X to receive an investigational drug. It is designed to assess whether there is a change in disease progression compared to baseline. There is no concurrent control used in this study.

• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the investigational drug on the subject’s disease progression.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, disease progression, is a health-related outcome.

The study involves the recruitment of research participants with disease X to test an investigational in vitro diagnostic device (IVD). It is designed to evaluate the ability of the device to measure the level of an antibody in blood.

• Are the participants prospectively assigned to an intervention? No, in this context the IVD would not be considered an intervention. The IVD is being used to test its ability to measure antibody levels, but not to test its effects on any health-related biomedical or behavioral outcomes. 

The study involves the recruitment of research participants with disease X to be evaluated with an investigational in vitro diagnostic device (IVD). The study is designed to evaluate how knowledge of certain antibody levels impacts clinical management of disease.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, measurement of an antibody level, with the idea that knowledge of that antibody level might affect clinical management.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate how knowledge of the level of an antibody might inform treatment.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being measured, how blood antibody levels inform treatment, is a health-related outcome.

The study involves the recruitment of healthy volunteers who will be randomized to different durations of sleep deprivation (including no sleep deprivation as a control) and who will have stress hormone levels measured. It is designed to determine whether the levels of stress hormones in blood rise in response to different durations of sleep deprivation.

• Does the study involve human participants? Yes, the healthy volunteers are human participants.
• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, different durations of sleep deprivation followed by a blood draw.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to measure the effect of different durations of sleep deprivation on stress hormone levels.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, stress hormone levels, is a health-related biomedical outcome.

The study involves the analysis of de-identified, stored blood samples and de-identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.

• Does the study involve human participants? No, the study does not involve human participants because only de-identified samples and information are used.

The study involves the analysis of identifiable, stored blood samples and identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.

• Does the study involve human participants? Yes, patients are human participants because the blood and information are identifiable.
• Are the participants prospectively assigned to an intervention? No, secondary research with biospecimens or health information is not a clinical trial.

The study involves the recruitment of a healthy volunteers whose blood is drawn for genomic analysis. It is designed to identify the prevalence of a genetic mutation in the cohort and evaluate potential association between the presence of the mutation and the risk of developing a genetic disorder.

• Are the participants prospectively assigned to an intervention? No, sample collection (blood draw) is not an intervention in this context.

Physicians report that some patients being treated with drug A for disease X are also experiencing some improvement in a second condition, condition Y. The study involves the recruitment of research participants who have disease X and condition Y and are being treated with drug A. The participants are surveyed to ascertain whether they are experiencing an improvement in condition Y.

• Are the participants prospectively assigned to an intervention? No, participants are not prospectively assigned to receive an intervention as they are receiving drugs as part of their clinical care. The surveys are being used for measurement, not to modify a biomedical or behavioral outcome.

The study involves the recruitment of patients with disease X who are receiving one of three standard therapies as part of their clinical care. It is designed to assess the relative effectiveness of the three therapies by monitoring survival rates using medical records over a few years.

• Are the participants prospectively assigned to an intervention? No, there is no intervention. The therapies are prescribed as part of clinical care; they are not prospectively assigned for the purpose of the study. The study is observational.

The study involves the recruitment of research participants with disease X vs. healthy controls and comparing these participants on a range of health processes and outcomes including genomics, biospecimens, self-report measures, etc. to explore differences that may be relevant to the development of disease X.

• Are the participants prospectively assigned to an intervention? No, the measures needed to assess the outcomes are not interventions in this context, as the study is not intended to determine whether the measures modify a health-related biomedical or behavioral outcome.

The study involves the recruitment of healthy volunteers for a respiratory challenge study; participants are randomized to receive different combinations of allergens. The study evaluates the severity and mechanism of the immune response to different combinations of allergens introduced via inhalation.

• Does the study involve human participants? Yes, healthy volunteers are human participants.
• Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to randomly selected combinations of allergens.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of different combinations of allergens on the immune response in healthy individuals.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates the severity and mechanism of the immune reaction to allergens, which are health-related biomedical outcomes.

The study involves the recruitment of research participants with Alzheimer’s disease (AD) to evaluate the effects of an investigational drug on memory, and retention and recall of information.

• Are the participants prospectively assigned to an intervention? Yes, participants are prospectively assigned to receive the investigational drug.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of the drug on participants’ memory.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates memory, and retention and recall of information in the context of AD.

The study involves the recruitment of individuals to receive a new behavioral intervention for sedentary behavior. It is designed to measure the effect of the intervention on hypothesized differential mediators of behavior change.

• Are the participants prospectively assigned to an intervention? Yes, participants are prospectively assigned to receive a behavioral intervention.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of the intervetion on mediators of behavior change.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, mediators of behavior change, are behavioral outcomes relevant to health.

The study involves the recruitment of patients with disease X to be evaluated with a new visual acuity task. It is designed to evaluate the ability of the new task to measure visual acuity as compared with the gold standard Snellen Test

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, the new visual acuity test.
• Is the study designed to evaluate the effect of the intervention on the participants? No, the study is designed to evaluate the ability of the new visual acuity test to measure visual acuity as compared to the gold standard Snellen Test, but not to modify visual acuity.

The study involves the recruitment of research participants with CHF who were hospitalized before or after implementation of the Medicare incentives to reduce re-hospitalizations. Morbidity, mortality, and quality of life of these participants are evaluated to compare the effects of these Medicare incentives on these outcomes.

• Are the participants prospectively assigned to an intervention? No, the intervention (incentives to reduce re-hospitalization) were assigned by Medicare, not by the research study.

The study involves the recruitment of healthcare providers to assess the extent to which being provided with genomic sequence information about their patients informs their treatment of those patients towards improved outcomes.

• Does the study involve human participants? Yes, both the physicians and the patients are human participants.
• Are the participants prospectively assigned to an intervention? Yes, physicians are prospectively assigned to receive genomic sequence information, which is the intervention.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of intervening with physicians, on the treatment they provide to their patients.
• Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the extent to which providing specific information to physicians informs the treatment of patients, is a health-related outcome.

The study involves the recruitment of research participants with a behavioral condition to receive either an investigational behavioral intervention or a behavioral intervention in clinical use. It is designed to evaluate the effectiveness of the investigational intervention compared to the intervention in clinical use in reducing the severity of the obsessive compulsive disorder.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, either the investigational intervention or an intervention in clinical use.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate whether the investigational intervention is as effective as the standard intervention, at changing behavior.
• Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the interventions’ effectiveness in reducing the severity of the condition, is a health-related behavioral outcome.

The study involves the recruitment of physicians who will be randomly assigned to use a new app or an existing app, which cues directed interviewing techniques. The study is designed to determine whether the new app is better than the existing app at assisting physicians in identifying families in need of social service support. The number of community service referrals will be measured.

• Does the study involve human participants? Yes, both the physicians and the families are human participants.
• Are the participants prospectively assigned to an intervention? Yes, physicians are prospectively assigned to use one of two apps, which are the interventions.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of intervening with physicians, on social service support referral for families.
• Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the number of referrals, is a health-related outcome.

The study involves the recruitment of parents to participate in focus groups to discuss topics related to parental self-efficacy and positive parenting behaviors. It is designed to gather information needed to develop an intervention to promote parental self-efficacy and positive parenting behaviors.

• Does the study involve human participants? Yes, the parents are human participants.
• Are the participants prospectively assigned to an intervention? No, a focus group is not an intervention.

The study involves the recruitment of healthy volunteers to test a new behavioral intervention. It is designed to evaluate the effect of a meditation intervention on adherence to exercise regimens and quality of life to inform the design of a subsequent, fully-powered trial.

• Does the study involve human participants? Yes, study participants are human participants.
• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to a behavioral intervention.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the intervention on adherence, and quality of life.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, adherence and quality of life are health-related outcomes.

A study will test the feasibility a mobile phone app designed to increase physical activity. A group of sedentary individuals will use the app for a week while their interactions with the app are monitored. The number of interactions with the app will be measured, as well as any software issues. Participants will also complete a survey indicating their satisfaction with and willingness to use the app, as well as any feedback for improvement. The app’s effect on physical activity, weight, or cardiovascular fitness will not be evaluated.

• Does the study involve human participants? Yes, sedentary individuals will be enrolled.
• Are the participants prospectively assigned to an intervention? The participants will interact with the app for a week.
• Is the study designed to evaluate the effect of the intervention on the participants? No. While the participants’ interactions are monitored (steps or heart rate may be recorded in this process), the study is NOT measuring the effect of using the app ON the participant. The study is only measuring the usability and acceptability of the app, and testing for bugs in the software. The effect on physical activity is NOT being measured.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? N/A

The study involves the recruitment of healthy family members of patients hospitalized for disease X to test two CPR training strategies. Participants will receive one of two training strategies. The outcome is improved CPR skills retention.

• Does the study involve human participants? Yes, family members of patients are human participants.
• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to one of two CPR educational strategies.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of educational strategies on CPR skills.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, retention of CPR skills is a health-related behavioral outcome.

The study involves the recruitment of research participants in three different communities (clusters) to test three CPR training strategies. The rate of out-of- hospital cardiac arrest survival will be compared.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive one of three types of CPR training, which is the intervention.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of different CPR training strategies on patient survival rates post cardiac arrest.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, out-of-hospital cardiac arrest survival is a health-related outcome.

A study involves the recruitment of school children to evaluate two different tools for monitoring food intake. Food consumption behavior will be measured by asking children to activate a pocket camera during meals and to use a diary to record consumed food. The accuracy of the two food monitoring methods in measuring energy intake will be assessed.

• Does the study involve human participants? Yes, children are human participants.
• Are the participants prospectively assigned to an intervention? No, in this context the monitoring methods would not be considered an intervention. The study is designed to test the accuracy of two monitoring methods, but not to test the effect on any health-related biomedical or behavioral outcomes. 

A study involves the recruitment of school children to evaluate two different tools for monitoring food intake. Food consumption behavior will be measured by asking children to activate a pocket camera during meals and to use a diary to record consumed food. Changes to eating behavior will be assessed.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to two food monitoring methods.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether using the monitoring methods changes eating behavior.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, eating behavior is a health-related outcome.

A study involves the recruitment of children at two schools to monitor eating behavior. Children’s food choices will be monitored using a remote food photography method. Food consumption and the accuracy of food monitoring methods will be assessed.

• Does the study involve human participants? Yes, the children participating in this study are human participants.
• Are the participants prospectively assigned to an intervention? No, not in this context. The study involves observing and measuring eating behavior, but not modifying it. This is an observational study.

A study involves the recruitment of children at two schools to evaluate their preferences for graphics and colors used in healthy food advertisements. Children will be presented with multiple health advertisements and their preferences for graphics and colors will be assessed.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to see different advertisements.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the advertisements.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? No, preferences are not health-related biomedical or behavioral outcomes.

The study involves ambulatory patients who have new-onset stable angina and who are recruited from community practices. They are randomized to undergo CT angiography or an exercise stress test of the doctor’s choice. To keep the trial pragmatic, the investigators do not prescribe a protocol for how physicians should respond to test results. The study is designed to determine whether the initial test (CT angiography or stress test) affects long-term rates of premature death, stroke, or myocardial infarctions.

• Are the participants prospectively assigned to an intervention? Yes, the participants are randomized to undergo CT angiography or an exercise stress test.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether the initial test done affects long-term rates of certain clinical events.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, premature death, stroke, and myocardial infarction are health-related biomedical outcomes.

The study involves patients who present with stable angina to community practices. As part of their routine care some of their physicians refer them for CT angiography, while others refer them for exercise stress tests. The study is designed to see whether or not there's an association between the type of test that is chosen and long-term risk of death, stroke, or myocardial infarction.

• Are the participants prospectively assigned to an intervention? No, the intervention is not prospectively assigned by the investigators. Rather, the intervention, in this case diagnostic study, occurs as part of routine clinical care.

The investigators conduct a longitudinal study of patients with schizophrenia. Their physicians, as part of their standard clinical care, prescribe antipsychotic medication. The investigators conduct an imaging session before starting treatment; they repeat imaging 4-6 weeks later.

• Does the study involve human participants? Yes.
• Are the participants prospectively assigned to an intervention? No, not in this context.  Antipsychotic medications are given as part of clinical care, not as part of a prospective, approved research protocol.  

The investigators conduct a longitudinal study of patients with schizophrenia. Their physicians, as part of their standard clinical care, prescribe antipsychotic medication. As part of the research protocol, all participants will be prescribed the same dose of the antipsychotic medication. The investigators conduct an imaging session before starting treatment; they repeat imaging 4-6 weeks later.

• Are the participants prospectively assigned to an intervention? Yes, although participants are all receiving antipsychotic medication as part of their standard medical care, the dose of the antipsychotic medication is determined by the research protocol, rather than individual clinical need.
• Is the study designed to evaluate the effect of the intervention on the participants?  Yes, the study is designed to evaluate the effect of a dose of antipsychotic medication on brain function.
• Is the effect being evaluated a health-related biomedical or behavioral outcome ? Yes, brain function measured by imaging is a health-related outcome.

The study involves recruitment of healthy volunteers who will wear a thermal compression device around their legs. This pilot study is designed to examine preliminary performance and safety of a thermal compression device worn during surgery. Investigators will measure core temperature, comfort, and presence of skin injury in 15-minute intervals.

• Are the participants prospectively assigned to an intervention? Yes, participants are assigned to wear a thermal compression device.
• Is the study designed to evaluate the effect of the intervention on the participants?  Yes, the study is designed to evaluate the effect of the thermal compression device on participant core temperature, comfort, and presence of skin injury.
• Is the effect being evaluated a health-related biomedical or behavioral outcome ? Yes, participant core temperature, comfort, and presence of skin injury are health-related biomedical outcomes.

The study involves collection of data on hospitalizations for various acute illnesses among people who live close to a border between two states that have recently implemented different laws related to public health (e.g. smoking regulations, soda taxes). The investigators want to take advantage of this “natural experiment” to assess the health impact of the laws.

• Does the study involve human participants?  Yes, the study involves human participants.
• Are the participants prospectively assigned to an intervention?  No, the interventions were assigned by state laws and state of residence, not by the research study.

The study involves recruitment of healthy volunteers to engage in working memory tasks while undergoing transcranial magnetic stimulation (TMS) to induce competing local neuronal activity. The study is measuring task performance to investigate the neural underpinnings of working memory storage and processing.

• Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to receive TMS stimulation protocols during a working memory task.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of local TMS stimulation on working memory performance and oscillatory brain activity in healthy individuals.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates working memory processes, which are health-related biomedical outcomes.

The study involves recruitment of healthy volunteers to engage in a social valuation task while dopamine tone in the brain is manipulated using tolcapone, an FDA-approved medication. The study aims to understand the role of dopamine in social decision-making and to search for neural correlates of this valuation using fMRI.

• Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to receive tolcapone during a social valuation task.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of modulating dopamine tone on social decision-making. Although this study uses an FDA-approved drug to modulate dopamine tone, the goal of this intervention is to understand the role of dopamine in a fundamental phenomenon (social valuation), and not to study the mechanism of action of the drug or its clinical effects.

The career development candidate proposes to independently lead a study to test a new drug A on patients with disease X. Patients will be randomized to a test and control group, with the test group receiving one dose of drug A per week for 12 months and controls receiving placebo. To assess presence, number, and type of any polyps, a colonoscopy will be performed. To assess biomarkers of precancerous lesions, colon mucosal biopsies will be collected. Complete blood count will be measured, and plasma will be stored for potential biomarker evaluation.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, drug A or placebo.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of drug A and placebo on the presence and type of polyps.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the presence and type of polyps, is a health-related biomedical outcome.

Ancillary Study to Case Study #42b: Some types of drug A being evaluated in Case Study #42a have been reported to impact renal function. An internal medicine fellow performs an ancillary study where stored plasma from Case Study #42a will be evaluated for multiple biomarkers of renal function.

• Does the study involve human participants? Yes, patients are human participants because the plasma and information are identifiable.
• Are the participants prospectively assigned to an intervention? No, because the assignment of participants to an intervention occurs as part of an existing, separately funded clinical trial. This proposal would be considered an ancillary study that is not an independent clinical trial.

Ancillary Study to Case Study #42a: An internal medicine fellow designs an independent ancillary trial where a subset of patients from the parent trial in Case Study #42a will also receive drug B, based on the assumption that a two-drug combination will work significantly better than a single drug at both improving renal function and reducing polyps. The test subjects will be evaluated for renal function via plasma clearance rates at 6 and 12 months after initiation of drugs A and B.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, drugs A and B.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of drugs A and B on renal function.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, renal function, is a health-related biomedical outcome.

A group of healthy young adults will perform a Go/No-Go task while undergoing fMRI scans. The purpose of the study is to characterize the pattern of neural activation in the frontal cortex during response inhibition, and the ability of the participant to correctly withhold a response on no-go

• Does the study involve human participants? Yes, healthy young adults will be enrolled in this study.
• Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to perform a Go/No-Go task, which involves different levels of inhibitory control.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the Go/No-Go task on neural activation in the frontal cortex. The study will measure inhibitory control and the neural systems being engaged. In this study, the Go/No-Go task is the independent variable, and behavioral performance and the associated fMRI activations are the dependent variables.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the neural correlates of inhibitory control and behavioral performance are health-related biomedical outcomes.

A group of adolescents will participate in a longitudinal study examining changes in executive function over the course of a normal school year. Color naming performance on the standard version of the Stroop test will be obtained. All measures will be compared at multiple time points during the school year to examine changes in executive function. The purpose is to observe changes in executive function and to observe if differences exist in the Stroop effect over the course of the school year for these adolescents.

• Does the study involve human participants? Yes, adolescents will be enrolled in this study.
• Are the participants prospectively assigned to an intervention? No, there is no intervention in this study and no independent variable manipulated. The adolescents are not prospectively assigned to an intervention, but instead the investigator will examine variables of interest (including the Stroop test) over time. The Stroop effect is used as a measurement of point-in-time data.
• Is the study designed to evaluate the effect of the intervention on the participants? No, there is no intervention. Performance on the Stroop test is a well-established measure of executive function and the test is not providing an independent variable of interest here. It is not being used to manipulate the participants or their environment. The purpose is simply to obtain a measure of executive function in adolescents over the course of the school year.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? N/A. No effect of an intervention is being evaluated.

A group of participants with social anxiety will perform an experimentally manipulated Stroop test. In this variant of the Stroop test, the stimuli presented are varied to include emotional and neutral facial expressions presented in different colors. Participants are instructed to name the colors of the faces presented, with the expectation that they will be slower to name the color of the emotional face than the neutral face. The purpose of the study is to examine the degree to which participants with social anxiety will be slower to process emotional faces than neutral faces.

• Does the study involve human participants? Yes, participants with social anxiety will be enrolled in this study.
• Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to perform a modified Stroop test using different colored emotional/neutral faces to explore emotional processing in people with social anxiety. Note that the independent variable is the presentation of emotional vs neutral faces.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to measure the effect of emotional valence (i.e. emotional faces) on participant response time to name the color. The purpose is to determine whether the response time to emotional faces is exaggerated for people with social anxiety as compared to neutral faces. Note that the response time to name the colors is the dependent variable in this study.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the processing of emotional information is a health-related biomedical outcome.

The study involves healthy volunteers and compares temporal SNR obtained with a new fMRI pulse sequence with that from another sequence.

• Are the participants prospectively assigned to an intervention? No, in this context the different pulse sequences would not be considered an intervention. The pulse sequences are not being used to modify any biomedical or behavioral outcome; rather the investigator is comparing performance characteristics of the two pulse sequences.

The study is designed to demonstrate that a new imaging technology (e.g. MRI, PET, ultrasound technologies, or image processing algorithm) is equivalent to, or has better sensitivity/specificity than a standard of care imaging technology. Aim one will use the new imaging technology and the gold standard in ten healthy volunteers. Aim Two will use the new imaging technology and the gold standard before and after a standard care procedure in ten patients. In both aims the performance of the new technology will be compared to the gold standard. No clinical care decisions will be made based on the use of the device in this study.

• Does the study involve human participants? YES. Aim one will study ten healthy volunteers, and aim two will study ten patient volunteers.
• Are the participants prospectively assigned to an intervention? Yes, participants will be prospectively assigned to be evaluated with a new imaging technology and the gold standard technology.
• Is the study designed to evaluate the effect of the intervention on the participants? No, the study is not measuring the effect of the technologies ON the human subjects. The study is determining if the new technology is equivalent or better than the gold standard technology. No effect on the participant is being measured.

An investigator proposes to add secondary outcomes to an already funded clinical trial of a nutritional intervention. The trial is supported by other funding, but the investigator is interested in obtaining NIH funding for studying oral health outcomes. Participants in the existing trial would be assessed for oral health outcomes at baseline and at additional time points during a multi-week dietary intervention. The oral health outcomes would include measures of gingivitis and responses to oral health related quality of life questionnaires. Oral fluids would be collected for analysis of inflammatory markers and microbiome components.

• Are the participants prospectively assigned to an intervention? No, because the assignment of participants to an intervention (and the administration of the intervention) occur as part of an existing, separately funded clinical trial. This proposal would be considered an ancillary study that leverages an already existing clinical trial.

The goal of the project is to use functional neuroimaging to distinguish patients with temporomandibular disorders (TMD) who experience TMD pain through centralized pain processes from those with TMD related to peripheral pain. Pain processing in a study cohort of TMD patients and healthy controls will be measured through functional magnetic resonance neuroimaging (fMRI) following transient stimulation of pain pathways through multimodal automated quantitative sensory testing (MAST QST). TMD patients will receive study questionnaires to better correlate the extent to which TMD pain centralization influences TMD prognosis and response to standard of care peripherally targeted treatment (prescribed by physicians, independently of the study).

• Are the participants prospectively assigned to an intervention? No, not in this context. The transient stimulation of pain pathways and the fMRI are being performed to measure and describe brain activity, but not to modify it.

An investigator proposes to perform a study of induced gingivitis in healthy humans, to study microbial colonization and inflammation under conditions of health and disease. During a 3-week gingivitis induction period, each study participant will use a stent to cover the teeth in one quadrant during teeth brushing. A contralateral uncovered quadrant will be exposed to the individual's usual oral hygiene procedures, to serve as a control. Standard clinical assessments for gingivitis will be made and biospecimens will be collected at the point of maximal induced gingivitis, and again after normal oral hygiene is resumed. Biospecimens will be assessed for microbial composition and levels of inflammation-associated chemokines.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, abstaining from normal oral hygiene for a portion of the mouth, to induce gingivitis.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the induced gingivitis on microbial composition and levels of inflammatory chemokines in oral samples.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the microbial composition and chemokine levels in oral samples are health-related biomedical outcomes.

The study will enroll older adults with hearing loss, comparing the effectiveness of enhanced hearing health care (HHC) to usual HHC. In addition to routine hearing-aid consultation and fitting, participants randomized to enhanced HCC will be provided patient-centered information and education about a full range of hearing assistive technologies and services. Study outcomes include the utilization of technology or services, quality of life, communication abilities, and cognitive function.

• Does the study involve human participants? Yes, the study enrolls older adults with hearing loss.
• Are the participants prospectively assigned to an intervention? Yes, participants are randomized to receive enhanced HCC or usual HCC interventions.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study will evaluate enhanced HCC’s effectiveness in modifying participant behavior and biomedical outcomes.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, rate of technology/service utilization is a behavioral outcome and quality of life, communications, and cognition are biomedical outcomes that may be impacted by the interventions.

The study involves the recruitment of obese individuals who will undergo a muscle biopsy before and after either exercise training or diet-induced weight loss. Sarcolemmal 1,2-disaturated DAG and C18:0 ceramide species and mitochondrial function will be measured. Levels will be correlated with insulin sensitivity.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to either exercise training or a diet.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the interventions on muscle metabolism.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, muscle metabolism/signaling is a health-related outcome.

The study involves the recruitment of participants with type 2 diabetes who will undergo a muscle biopsy before and after a fast to measure acetylation on lysine 23 of the mitochondrial solute carrier adenine nucleotide translocase 1 (ANT1). Levels will be related to rates of fat oxidation.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to undergo a fast.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the fast on molecular parameters of metabolism.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, metabolism is a health-related outcome.

Insulin-resistant and insulin-sensitive nondiabetic adults who have a parent with type 2 diabetes will be followed over time to understand the role of mitochondrial dysfunction in the development of diabetes. Oral glucose tolerance tests will be performed annually to measure insulin sensitivity and glycemic status. Participants will also undergo a brief bout of exercise, and mitochondrial ATP synthesis rates will be measured by assessing the rate of recovery of phosphocreatine in the leg muscle, using 31P magnetic resonance spectroscopy.

• Are the participants prospectively assigned to an intervention? No, the participants are not assigned to an intervention; the OGTT and 31P MRS are measures.

Participants with chronic kidney disease will be recruited to receive one of two drug agents. After 6 weeks of therapy, subjects will undergo vascular function testing and have measures of oxidative stress evaluated in their plasma and urine. Results of the function testing and the oxidative stress biomarkers will be related to drug treatment.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive two different drugs.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the drugs on vascular function.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, vascular function is a health-related outcome.

Participants with Autosomal Dominant Polycystic Kidney Disease will be recruited to receive an oral curcumin therapy or placebo and the participants will undergo vascular function testing, renal imaging to assess kidney size, and assessment of oxidative stress biomarkers in urine and plasma after an ascorbic acid challenge. Changes in these outcomes will be related to oral therapy.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive medication or placebo.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the drugs on vascular function and kidney size.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, vascular function and kidney size are health-related outcomes.

Kidney transplant recipients will be recruited to undergo an experimental imaging procedure at several timepoints up to 4 months post-transplantation. Output from the images will be related to pathological assessments of the transplant as well as clinical measures of renal function.

• Are the participants prospectively assigned to an intervention? No, the participants are not assigned to receive an intervention. They undergo transplantation as part of their routine clinical care. The imaging procedure is a measure and not an intervention.

The study proposes the development of a novel probe to assess clearance of a nutritional metabolite in a given disease state. The probe is a GMP grade, deuterated, intravenously administered tracer and clearance is assessed by mass spectrometry analysis of serial blood draws. Participants will either receive a micronutrient supplement or will receive no supplementation. The clearance rate of the probe will be compared in the two groups, to understand the performance of the probe.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive either a micronutrient supplement or nothing.
• Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention is being used to assess the performance of the probe and is not looking at an effect on the participant.
• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive a controlled diet for three days.
• Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention (controlled diet) is being used to minimize exogenous dietary sources of oxalate in the participants prior to the labeled tracer infusion. The study will not be evaluating the effect of the diet on the participants.

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Child Abuse and Neglect

James Lukefahr MD. previously with Dept. of Pediatrics, University of Texas Medical Branch. Now at Dept. Pediatrics, University of Texas Health Science Center - San Antonio. Essentials of Pediatrics. (c) 2008

• Open access
• Published: 03 June 2024

The use of evidence to guide decision-making during the COVID-19 pandemic: divergent perspectives from a qualitative case study in British Columbia, Canada

• Laura Jane Brubacher   ORCID: orcid.org/0000-0003-2806-9539 1 , 2 ,
• Chris Y. Lovato 1 ,
• Veena Sriram 1 , 3 ,
• Michael Cheng 1 &
• Peter Berman 1  

Health Research Policy and Systems volume  22 , Article number:  66 ( 2024 ) Cite this article

Metrics details

The challenges of evidence-informed decision-making in a public health emergency have never been so notable as during the COVID-19 pandemic. Questions about the decision-making process, including what forms of evidence were used, and how evidence informed—or did not inform—policy have been debated.

We examined decision-makers' observations on evidence-use in early COVID-19 policy-making in British Columbia (BC), Canada through a qualitative case study. From July 2021- January 2022, we conducted 18 semi-structured key informant interviews with BC elected officials, provincial and regional-level health officials, and civil society actors involved in the public health response. The questions focused on: (1) the use of evidence in policy-making; (2) the interface between researchers and policy-makers; and (3) key challenges perceived by respondents as barriers to applying evidence to COVID-19 policy decisions. Data were analyzed thematically, using a constant comparative method. Framework analysis was also employed to generate analytic insights across stakeholder perspectives.

Overall, while many actors’ impressions were that BC's early COVID-19 policy response was evidence-informed, an overarching theme was a lack of clarity and uncertainty as to what evidence was used and how it flowed into decision-making processes. Perspectives diverged on the relationship between 'government' and public health expertise, and whether or not public health actors had an independent voice in articulating evidence to inform pandemic governance. Respondents perceived a lack of coordination and continuity across data sources, and a lack of explicit guidelines on evidence-use in the decision-making process, which resulted in a sense of fragmentation. The tension between the processes involved in research and the need for rapid decision-making was perceived as a barrier to using evidence to inform policy.

Conclusions

Areas to be considered in planning for future emergencies include: information flow between policy-makers and researchers, coordination of data collection and use, and transparency as to how decisions are made—all of which reflect a need to improve communication. Based on our findings, clear mechanisms and processes for channeling varied forms of evidence into decision-making need to be identified, and doing so will strengthen preparedness for future public health crises.

Peer Review reports

The challenges of evidence-informed decision-making Footnote 1 in a public health emergency have never been so salient as during the COVID-19 pandemic, given its unprecedented scale, rapidly evolving virology, and multitude of global information systems to gather, synthesize, and disseminate evidence on the SARS-CoV-2 virus and associated public health and social measures [ 1 , 2 , 3 ]. Early in the COVID-19 pandemic, rapid decision-making became central for governments globally as they grappled with crucial decisions for which there was limited evidence. Critical questions exist, in looking retrospectively at these decision-making processes and with an eye to strengthening future preparedness: Were decisions informed by 'evidence'? What forms of evidence were used, and how, by decision-makers? [ 4 , 5 , 6 ].

Scientific evidence, including primary research, epidemiologic research, and knowledge synthesis, is one among multiple competing influences that inform decision-making processes in an outbreak such as COVID-19 [ 7 ]. Indeed, the use of multiple forms of evidence has been particularly notable as it applies to COVID-19 policy-making. Emerging research has also documented the important influence of ‘non-scientific’ evidence such as specialized expertise and experience, contextual information, and level of available resources [ 8 , 9 , 10 ]. The COVID-19 pandemic has underscored the politics of evidence-use in policy-making [ 11 ]; what evidence is used and how can be unclear, and shaped by political bias [ 4 , 5 ]. Moreover, while many governments have established scientific advisory boards, the perspectives of these advisors were reportedly largely absent from COVID-19 policy processes [ 6 ]. How evidence and public health policy interface—and intersect—is a complex question, particularly in the dynamic context of a public health emergency.

Within Canada, a hallmark of the public health system and endorsed by government is evidence-informed decision-making [ 12 ]. In British Columbia (BC), Canada, during the early phases of COVID-19 (March—June 2020), provincial public health communication focused primarily on voluntary compliance with recommended public health and social measures, and on supporting those most affected by the pandemic. Later, the response shifted from voluntary compliance to mandatory enforceable government orders [ 13 ]. Like many other jurisdictions, the government’s public messaging in BC asserted that the province took an approach to managing the COVID-19 pandemic and developing related policy that was based on scientific evidence, specifically. For example, in March 2021, in announcing changes to vaccination plans, Dr. Bonnie Henry, the Provincial Health Officer, stated, " This is science in action " [ 14 ]. As a public health expert with scientific voice, the Provincial Health Officer has been empowered to speak on behalf of the BC government across the COVID-19 pandemic progression. While this suggests BC is a jurisdiction which has institutionalized scientifically-informed decision-making as a core tenet of effective public health crisis response, it remains unclear as to whether BC’s COVID-19 response could, in fact, be considered evidence-informed—particularly from the perspectives of those involved in pandemic decision-making and action. Moreover, if evidence-informed, what types of evidence were utilized and through what mechanisms, how did this evidence shape decision-making, and what challenges existed in moving evidence to policy and praxis in BC’s COVID-19 response?

The objectives of this study were: (1) to explore and characterize the perspectives of BC actors involved in the COVID-19 response with respect to evidence-use in COVID-19 decision-making; and (2) to identify opportunities for and barriers to evidence-informed decision-making in BC’s COVID-19 response, and more broadly. This inquiry may contribute to identifying opportunities for further strengthening the synthesis and application of evidence (considered broadly) to public health policy and decision-making, particularly in the context of future public health emergencies, both in British Columbia and other jurisdictions.

Study context

This qualitative study was conducted in the province of British Columbia (BC), Canada, a jurisdiction with a population of approximately five million people [ 15 ]. Within BC’s health sector, key actors involved in the policy response to COVID-19 included: elected officials, the BC Government’s Ministry of Health (MOH), the Provincial Health Services Authority (PHSA), Footnote 2 the Office of the Provincial Health Officer (PHO), Footnote 3 the BC Centre for Disease Control (BCCDC), Footnote 4 and Medical Health Officers (MHOs) and Chief MHOs at regional and local levels.

Health research infrastructure within the province includes Michael Smith Health Research BC [ 16 ] and multiple post-secondary research and education institutions (e.g., The University of British Columbia). Unlike other provincial (e.g., Ontario) and international (e.g., UK) jurisdictions, BC did not establish an independent, formal scientific advisory panel or separate organizational structure for public health intelligence in COVID-19. That said, a Strategic Research Advisory Council was established, reporting to the MOH and PHO, to identify COVID-19 research gaps and commission needed research for use within the COVID-19 response [ 17 ].

This research was part of a multidisciplinary UBC case study investigating the upstream determinants of the COVID-19 response in British Columbia, particularly related to institutions, politics, and organizations and how these interfaced with, and affected, pandemic governance [ 18 ]. Ethics approval for this study was provided by the University of British Columbia (UBC)’s Institutional Research Ethics Board (Certificate #: H20-02136).

Data collection

From July 2021 to January 2022, 18 semi-structured key informant interviews were conducted with BC elected officials, provincial and regional-level health officials, and civil society actors (e.g., within non-profit research organizations, unions) (Table 1 ). Initially, respondents were purposively sampled, based on their involvement in the COVID-19 response and their positioning within the health system organizational structure. Snowball sampling was used to identify additional respondents, with the intent of representing a range of organizational roles and actor perspectives. Participants were recruited via email invitation and provided written informed consent to participate.

Interviews were conducted virtually using Zoom® videoconferencing, with the exception of one hybrid in-person/Zoom® interview. Each interview was approximately one hour in duration. One to two research team members led each interview. The full interview protocol focused on actors’ descriptions of decision-making processes across the COVID-19 pandemic progression, from January 2020 to the date of the interviews, and they were asked to identify key decision points (e.g., emergency declaration, business closures) [see Additional File 1 for the full semi-structured interview guide]. For this study, we used a subset of interview questions focused on evidence-use in the decision-making process, and the organizational structures or actors involved, in BC's early COVID-19 pandemic response (March–August 2020). Questions were adapted to be relevant to a respondent’s expertise and particular involvement in the response. ‘Evidence’ was left undefined and considered broadly by the research team (i.e., both ‘scientific’/research-based and ‘non-scientific’ inputs) within interview questions, and therefore at the discretion of the participant as to what inputs they perceived and described as ‘evidence’ that informed or did not inform pandemic decision-making. Interviews were audio-recorded over Zoom® with permission and transcribed using NVivo Release 1.5© software. Each transcript was then manually verified for accuracy by 1–2 members of the research team.

Data analysis

An inductive thematic analysis was conducted, using a constant comparative method, to explore points of divergence and convergence across interviews and stakeholder perspectives [ 19 ]. Transcripts were inductively coded in NVivo Release 1.5© software, which was used to further organize and consolidate codes, generate a parsimonious codebook to fit the data, and retrieve interview excerpts [ 20 ]. Framework analysis was also employed as an additional method for generating analytic insights across stakeholder perspectives and contributed to refining the overall coding [ 21 ]. Triangulation across respondents and analytic methods, as well as team collaboration in reviewing and refining the codebook, contributed to validity of the analysis [ 22 ].

How did evidence inform early COVID-19 policy-making in BC?

Decision-makers described their perceptions on the use of evidence in policy-making; the interface between researchers and policy-makers; and specific barriers to evidence-use in policy-making within BC’s COVID-19 response. In discussing the use of evidence, respondents focused on ‘scientific’ evidence; however, they noted a lack of clarity as to how and what evidence flowed into decision-making. They also acknowledged that ‘scientific’ evidence was one of multiple factors influencing decisions. The themes described below reflect the narrative underlying their perspectives.

Perceptions of evidence-use

Multiple provincial actors generally expressed confidence or had an overall impression that decisions were evidence-based (IDI5,9), stating definitively that, "I don’t think there was a decision we made that wasn’t evidence-informed" (IDI9) and that "the science became a driver of decisions that were made" (IDI5). However, at the regional health authority level, one actor voiced skepticism that policy decisions were consistently informed by scientific evidence specifically, stating, "a lot of decisions [the PHO] made were in contrast to science and then shifted to be by the science" ( IDI6). The evolving nature of the available evidence and scientific understanding of the virus throughout the pandemic was acknowledged. For instance, one actor stated that, "I’ll say the response has been driven by the science; the science has been changing…from what I’ve seen, [it] has been a very science-based response" (IDI3).

Some actors narrowed in on certain policy decisions they believed were or were not evidence-informed. Policy decisions in 2020 that actors believed were directly informed by scientific data included the early decision to restrict informal, household gatherings; to keep schools open for in-person learning; to implement a business safety plan requirement across the province; and to delay the second vaccine dose for maximum efficacy. One provincial public health actor noted that an early 2020 decision made, within local jurisdictions, to close playgrounds was not based on scientific evidence. Further, the decision prompted public health decision-makers to centralize some decision-making to the provincial level, to address decisions being made 'on the ground' that were not based on scientific evidence (IDI16). Similarly, they added that the policy decision to require masking in schools was not based on scientific evidence; rather, "it's policy informed by the noise of your community." As parents and other groups within the community pushed for masking, this was "a policy decision to help schools stay open."

Early in the pandemic response, case data in local jurisdictions were reportedly used for monitoring and planning. These "numerator data" (IDI1), for instance case or hospitalization counts, were identified as being the primary mode of evidence used to inform decisions related to the implementation or easing of public health and social measures. The ability to generate epidemiological count data early in the pandemic due to efficient scaling up of PCR testing for COVID-19 was noted as a key advantage (IDI16). As the pandemic evolved in 2020, however, perspectives diverged in relation to the type of data that decision-makers relied on. For example, it was noted that BCCDC administered an online, voluntary survey to monitor unintended consequences of public health and social measures and inform targeted interventions. Opinions varied on whether this evidence was successfully applied in decision-making. One respondent emphasized this lack of application of evidence and perceived that public health orders were not informed by the level and type of evidence available, beyond case counts: "[In] a communicable disease crisis like a pandemic, the collateral impact slash damage is important and if you're going to be a public health institute, you actually have to bring those to the front, not just count cases" (IDI1).

There also existed some uncertainty and a perceived lack of transparency or clarity as to how or whether data analytic ‘entities’, such as BCCDC or research institutions, fed directly into decision-making. As a research actor shared, "I’m not sure that I know quite what all those channels really look like…I’m sure that there’s a lot of improvement that could be driven in terms of how we bring strong evidence to actual policy and practice" (IDI14). Another actor explicitly named the way information flowed into decision-making in the province as "organic" (IDI7). They also noted the lack of a formal, independent science advisory panel for BC’s COVID-19 response, which existed in other provincial and international jurisdictions. Relatedly, one regional health authority actor perceived that the committee that was convened to advise the province on research, and established for the purpose of applying research to the COVID-19 response, "should have focused more on knowledge translation, but too much time was spent commissioning research and asking what kinds of questions we needed to ask rather than looking at what was happening in other jurisdictions" (IDI6). Overall, multiple actors noted a lack of clarity around application of evidence and who is responsible for ensuring evidence is applied. As a BCCDC actor expressed, in relation to how to prevent transmission of COVID-19:

We probably knew most of the things that we needed to know about May of last year [2020]. So, to me, it’s not even what evidence you need to know about, but who’s responsible for making sure that you actually apply the evidence to the intervention? Because so many of our interventions have been driven by peer pressure and public expectation rather than what we know to be the case [scientifically] (IDI1).

Some described the significance of predictive disease modelling to understand the COVID-19 trajectory and inform decisions, as well as to demonstrate to the public the effectiveness of particular measures, which "help[ed] sustain our response" (IDI2). Others, however, perceived that "mathematical models were vastly overused [and] overvalued in decision-making around this pandemic" (IDI1) and that modellers stepped outside their realm of expertise in providing models and policy recommendations through the public media.

Overall, while many actors’ impressions were that the response was evidence-informed, an overarching theme was a lack of clarity and uncertainty with respect to how evidence actually flowed into decision-making processes, as well as what specific evidence was used and how. Participants noted various mechanisms created or already in place prior to COVID-19 that fed data into, and facilitated, decision-making. There was an acknowledgement that multiple forms of evidence—including scientific data, data on public perceptions, as well as public pressure—appeared to have influenced decision-making.

Interface between researchers and policy-makers

There was a general sense that the Ministry supported the use of scientific and research-based evidence specifically. Some actors identified particular Ministry personnel as being especially amenable to research and focused on data to inform decisions and implementation. More broadly, the government-research interface was characterized by one actor as an amicable one, a "research-friendly government", and that the Ministry of Health (MOH), specifically, has a research strategy whereby, "it’s literally within their bureaucracy to become a more evidence-informed organization" (IDI11). The MOH was noted to have funded a research network intended to channel evidence into health policy and practice, and which reported to the research side of the MOH.

Other actors perceived relatively limited engagement with the broader scientific community. Some perceived an overreliance on 'in-house expertise' or a "we can do that [ourselves] mentality" within government that precluded academic researchers’ involvement, as well as a sense of "not really always wanting to engage with academics to answer policy questions because they don’t necessarily see the value that comes" (IDI14). With respect to the role of research, an actor stated:

There needs to be a provincial dialogue around what evidence is and how it gets situated, because there’s been some tension around evidence being produced and not used or at least not used in the way that researchers think that it should be (IDI11).

Those involved in data analytics within the MOH acknowledged a challenge in making epidemiological data available to academic researchers, because "at the time, you’re just trying to get decisions made" (IDI7). Relatedly, a research actor described the rapid instigation of COVID-19 research and pivoting of academic research programs to respond to the pandemic, but perceived a slow uptake of these research efforts from the MOH and PHSA for decision-making and action. Nevertheless, they too acknowledged the challenge of using research evidence, specifically, in an evolving and dynamic pandemic:

I think we’ve got to be realistic about what research in a pandemic situation can realistically contribute within very short timelines. I mean, some of these decisions have to be made very quickly...they were intuitive decisions, I think some of them, rather than necessarily evidence-based decisions (IDI14).

Relatedly, perspectives diverged on the relationship between 'government' and public health expertise, and whether or not public health actors had an independent voice in articulating evidence to inform governance during the pandemic. Largely from Ministry stakeholders, and those within the PHSA, the impressions were that Ministry actors were relying on public health advice and scientific expertise. As one actor articulated, "[the] government actually respected and acknowledged and supported public health expertise" (IDI9). Others emphasized a "trust of the people who understood the problem" (IDI3)—namely, those within public health—and perceived that public health experts were enabled "to take a lead role in the health system, over politics" (IDI12). This perspective was not as widely held by those in the public health sector, as one public health actor expressed, "politicians and bureaucrats waded into public health practice in a way that I don't think was appropriate" and that, "in the context of a pandemic, it’s actually relatively challenging to bring true expert advice because there’s too many right now. Suddenly, everybody’s a public health expert, but especially bureaucrats and politicians." They went on to share that the independence of public health to speak and act—and for politicians to accept independent public health advice—needs to be protected and institutionalized as "core to good governance" (IDI1). Relatedly, an elected official linked this to the absence of a formal, independent science table to advise government and stated that, "I think we should have one established permanently. I think we need to recognize that politicians aren't always the best at discerning scientific evidence and how that should play into decision-making" (IDI15).

These results highlight the divergent perspectives participants had as to the interface between research and policy-making and a lack of understanding regarding process and roles.

Challenges in applying evidence to policy decisions

Perspectives converged with respect to the existence of numerous challenges with and barriers to applying evidence to health policy and decision-making. These related to the quality and breadth of available data, both in terms of absence and abundance. For instance, as one public health actor noted in relation to health policy-making, "you never have enough information. You always have an information shortage, so you're trying to make the best decisions you can in the absence of usually really clear information" (IDI8). On the other hand, as evidence emerged en masse across jurisdictions in the pandemic, there were challenges with synthesizing evidence in a timely fashion for 'real-time' decision-making. A regional health authority actor highlighted this challenge early in the COVID-19 pandemic and perceived that there was not a provincial group bringing new synthesized information to decision-makers on a daily basis (IDI6). Other challenges related to the complexity of the political-public health interface with respect to data and scientific expertise, which "gets debated and needs to be digested by the political process. And then decisions are made" (IDI5). This actor further expressed that debate among experts needs to be balanced with efficient crisis response, that one has to "cut the debate short. For the sake of expediency, you need to react."

It was observed that, in BC’s COVID-19 response, data was gathered from multiple sources with differing data collection procedures, and sometimes with conflicting results—for instance, 'health system data' analyzed by the PHSA and 'public health data' analyzed by the BCCDC. This was observed to present challenges from a political perspective in discerning "who’s actually getting the 'right' answers" (IDI7). An added layer of complexity was reportedly rooted in how to communicate such evidence to the public and "public trust in the numbers" (IDI7), particularly as public understanding of what evidence is, how it is developed, and why it changes, can influence public perceptions of governance.

Finally, as one actor from within the research sector noted, organizationally and governance-wise, the system was "not very well set up to actually use research evidence…if we need to do better at using evidence in practice, we need to fix some of those things. And we actually know what a lot of those things are." For example , "there’s no science framework for how organizations work within that" and " governments shy away from setting science policy " (IDI11). This challenge was framed as having a macro-level dimension, as higher-level leadership structures were observed to not incentivize the development and effective use of research among constituent organizations, and also micro-level implications. From their perspective, researchers will struggle without such policy frameworks to obtain necessary data-sharing agreements with health authorities, nor will they be able to successfully navigate other barriers to conducting action-oriented research that informs policy and practice.

Similarly, a research actor perceived that the COVID-19 pandemic highlighted pre-existing fragmentation, "a pretty disjointed sort of enterprise" in how research is organized in the province:

I think pandemics need strong leadership and I think pandemic research response needed probably stronger leadership than it had. And I think that’s to do with [how] no one really knew who was in charge because no one really was given the role of being truly in charge of the research response (IDI14).

This individual underscored that, at the time of the interview, there were nearly 600 separate research projects being conducted in BC that focused on COVID-19. From their perspective, this reflected the need for more centralized direction to provide leadership, coordinate research efforts, and catalyze collaborations.

Overall, respondents perceived a lack of coordination and continuity across data sources, and a lack of explicit guidelines on evidence-use in the decision-making process, which resulted in a sense of fragmentation. The tension between the processes involved in research and the need for rapid decision-making was perceived as a barrier to using evidence to inform policy.

This study explored the use of evidence to inform early COVID-19 decision-making within British Columbia, Canada, from the perspectives of decision-makers themselves. Findings underscore the complexity of synthesizing and applying evidence (i.e., ‘scientific’ or research-based evidence most commonly discussed) to support public health policy in 'real-time', particularly in the context of public health crisis response. Despite a substantial and long-established literature on evidence-based clinical decision-making [ 23 , 24 ], understanding is more limited as to how public health crisis decision-making can be evidence-informed or evidence-based. By contributing to a growing global scholarship of retrospective examinations of COVID-19 decision-making processes [ 25 , 26 , 27 , 28 ], our study aimed to broaden this understanding and, thus, support the strengthening of public health emergency preparedness in Canada, and globally.

Specifically, based on our findings on evidence-based public health practice, we found that decision-makers clearly emphasized ‘evidence-based’ or ‘evidence-informed’ as meaning ‘scientific’ evidence. They acknowledged other forms of evidence such as professional expertise and contextual information as influencing factors. We identified four key points related to the process of evidence-use in BC's COVID-19 decision-making, with broader implications as well:

Role Differences: The tensions we observed primarily related to a lack of clarity among the various agencies involved as to their respective roles and responsibilities in a public health emergency, a finding that aligns with research on evidence-use in prior pandemics in Canada [ 29 ]. Relatedly, scientists and policy-makers experienced challenges with communication and information-flow between one another and the public, which may reflect their different values and standards, framing of issues and goals, and language [ 30 ].

Barriers to Evidence-Use: Coordination and consistency in how data are collected across jurisdictions reportedly impeded efficiency and timeliness of decision-making. Lancaster and Rhodes (2020) suggest that evidence itself should be treated as a process, rather than a commodity, in evidence-based practice [ 31 ]. Thus, shifting the dialogue from 'barriers to evidence use' to an approach that fosters dialogue across different forms of evidence and different actors in the process may be beneficial.

Use of Evidence in Public Health versus Medicine: Evidence-based public health can be conflated with the concept of evidence-based medicine, though these are distinct in the type of information that needs to be considered. While ‘research evidence’ was the primary type of evidence used, other important types of evidence informed policy decisions in the COVID-19 public health emergency—for example, previous experience, public values, and preferences. This concurs with Brownson’s (2009) framework of factors driving decision-making in evidence-based public health [ 32 ]. Namely, that a balance between multiple factors, situated in particular environmental and organizational context, shapes decision-making: 1) best available research evidence; 2) clients'/population characteristics, state, needs, values, and preferences; and 3) resources, including a practitioner’s expertise. Thus, any evaluation of evidence-use in public health policy must take into consideration this multiplicity of factors at play, and draw on frameworks specific to public health [ 33 ]. Moreover, public health decision-making requires much more attention to behavioural factors and non-clinical impacts, which is distinct from the largely biology-focused lens of evidence-based medicine.

Transparency: Many participants emphasized a lack of explanation about why certain decisions were made and a lack of understanding about who was involved in decisions and how those decisions were made. This point was confirmed by a recent report on lessons learned in BC during the COVID-19 pandemic in which the authors describe " the desire to know more about the reasons why decisions were taken " as a " recurring theme " (13:66). These findings point to a need for clear and transparent mechanisms for channeling evidence, irrespective of the form used, into public health crisis decision-making.

Our findings also pointed to challenges associated with the infrastructure for utilizing research evidence in BC policy-making, specifically a need for more centralized authority on the research side of the public health emergency response to avoid duplication of efforts and more effectively synthesize findings for efficient use. Yet, as a participant questioned, what is the realistic role of research in a public health crisis response? Generally, most evidence used to inform crisis response measures is local epidemiological data or modelling data [ 7 ]. As corroborated by our findings, challenges exist in coordinating data collection and synthesis of these local data across jurisdictions to inform 'real-time' decision-making, let alone to feed into primary research studies [ 34 ].

On the other hand, as was the case in the COVID-19 pandemic, a 'high noise' research environment soon became another challenge as data became available to researchers. Various mechanisms have been established to try and address these challenges amid the COVID-19 pandemic, both to synthesize scientific evidence globally and to create channels for research evidence to support timely decision-making. For instance: 1) research networks and collaborations are working to coordinate research efforts (e.g., COVID-END network [ 35 ]); 2) independent research panels or committees within jurisdictions provide scientific advice to inform decision-making; and 3) research foundations, funding agencies, and platforms for knowledge mobilization (e.g., academic journals) continue to streamline funding through targeted calls for COVID-19 research grant proposals, or for publication of COVID-19 research articles. While our findings describe the varied forms of evidence used in COVID-19 policy-making—beyond scientific evidence—they also point to the opportunity for further investments in infrastructure that coordinates, streamlines, and strengthens collaborations between health researchers and decision-makers that results in timely uptake of results into policy decisions.

Finally, in considering these findings, it is important to note the study's scope and limitations: We focused on evidence use in a single public health emergency, in a single province. Future research could expand this inquiry to a multi-site analysis of evidence-use in pandemic policy-making, with an eye to synthesizing lessons learned and best practices. Additionally, our sample of participants included only one elected official, so perspectives were limited from this type of role. The majority of participants were health officials who primarily referred to and discussed evidence as ‘scientific’ or research-based evidence. Further work could explore the facilitators and barriers to evidence-use from the perspectives of elected officials and Ministry personnel, particularly with respect to the forms of evidence—considered broadly—and other varied inputs, that shape decision-making in the public sphere. This could include a more in-depth examination of policy implementation and how the potential societal consequences of implementation factor into public health decision-making.

We found that the policy decisions made during the initial stages of the COVID-19 pandemic were perceived by actors in BC's response as informed by—not always based on—scientific evidence, specifically; however, decision-makers also considered other contextual factors and drew on prior pandemic-related experience to inform decision-making, as is common in evidence-based public health practice [ 32 ]. The respondents' experiences point to specific areas that need to be considered in planning for future public health emergencies, including information flow between policy-makers and researchers, coordination in how data are collected, and transparency in how decisions are made—all of which reflect a need to improve communication. Furthermore, shifting the discourse from evidence as a commodity to evidence-use as a process will be helpful in addressing barriers to evidence-use, as well as increasing understanding about the public health decision-making process as distinct from clinical medicine. Finally, there is a critical need for clear mechanisms that channel evidence (whether ‘scientific’, research-based, or otherwise) into health crisis decision-making, including identifying and communicating the decision-making process to those producing and synthesizing evidence. The COVID-19 pandemic experience is an opportunity to reflect on what needs to be done to guild our public health systems for the future [ 36 , 37 ]. Understanding and responding to the complexities of decision-making as we move forward, particularly with respect to the synthesis and use of evidence, can contribute to strengthening preparedness for future public health emergencies.

Availability of data and materials

The data that support the findings of this study are not publicly available to maintain the confidentiality of research participants.

The terms 'evidence-informed' and 'evidence-based' decision-making are used throughout this paper, though are distinct. The term 'evidence-informed' suggests that evidence is used and considered, though not necessarily solely determinative in decision-making [ 38 ].

The Provincial Health Services Authority (PHSA) works with the Ministry of Health (MOH) and regional health authorities to oversee the coordination and delivery of programs.

The Office of the Provincial Health Officer (PHO) has binding legal authority in the case of an emergency, and responsibility to monitor the health of BC’s population and provide independent advice to Ministers and public offices on public health issues.

The British Columbia Centre for Disease Control (BCCDC) is a program of the PHSA and provides provincial and national disease surveillance, detection, treatment, prevention, and consultation.

Abbreviations

British Columbia

British Columbia Centre for Disease Control

Coronavirus Disease 2019

Medical Health Officer

Ministry of Health

Provincial Health Officer

Provincial Health Services Authority

Severe Acute Respiratory Syndrome Coronavirus—2

University of British Columbia

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Acknowledgements

We would like to extend our gratitude to current and former members of the University of British Columbia Working Group on Health Systems Response to COVID-19 who contributed to various aspects of this study, including Shelly Keidar, Kristina Jenei, Sydney Whiteford, Dr. Md Zabir Hasan, Dr. David M. Patrick, Dr. Maxwell Cameron, Mahrukh Zahid, Dr. Yoel Kornreich, Dr. Tammi Whelan, Austin Wu, Shivangi Khanna, and Candice Ruck.

Financial support for this work was generously provided by the University of British Columbia's Faculty of Medicine (Grant No. GR004683) and Peter Wall Institute for Advanced Studies (Grant No. GR016648), as well as a Canadian Institutes of Health Research Operating Grant (Grant No. GR019157). These funding bodies were not involved in the design of the study, the collection, analysis or interpretation of data, or in the writing of this manuscript.

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CYL, PB, and VS obtained funding for and designed the study. LJB, MC, and PB conducted data collection. LJB and VS analyzed the qualitative data. CYL and LJB collaboratively wrote the manuscript. All authors read and approved the final manuscript.

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Correspondence to Laura Jane Brubacher .

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This case study received the approval of the UBC Behavioural Research Ethics Board (Certificate # H20-02136). Participants provided written informed consent.

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Brubacher, L.J., Lovato, C.Y., Sriram, V. et al. The use of evidence to guide decision-making during the COVID-19 pandemic: divergent perspectives from a qualitative case study in British Columbia, Canada. Health Res Policy Sys 22 , 66 (2024). https://doi.org/10.1186/s12961-024-01146-2

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Received : 08 February 2023

Accepted : 29 April 2024

Published : 03 June 2024

DOI : https://doi.org/10.1186/s12961-024-01146-2

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Here’s Where Trump’s Other Cases Stand

After being convicted in a Manhattan courtroom, the former president still faces charges in three criminal prosecutions, all of which are tangled up in procedural delays.

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By Alan Feuer and Danny Hakim

Former President Donald J. Trump’s criminal trial in Manhattan came to an end this week when a jury found him guilty of 34 counts of falsifying business records in an effort to cover up a sex scandal that threatened to upset his 2016 presidential campaign.

But Mr. Trump is still facing federal charges, brought by a special counsel, in two cases: one in Florida, where he is accused of illegally holding on to classified documents after leaving office and obstructing government efforts to retrieve them, and one in Washington, D.C., where he’s accused of plotting to overturn the results of the 2020 election. He faces similar election-tampering charges in a third case brought by a local prosecutor in Georgia.

The proceedings — all of which are bogged down in delays — can be confusing to keep track of. Here are updates on where each of them stands.

Federal Documents Case

In this case, Mr. Trump is accused of illegally holding on to a large amount of sensitive national security material after leaving office and then plotting to obstruct repeated efforts by the government to get it back. The charges were brought by Jack Smith, the special counsel appointed to oversee the federal investigations into Mr. Trump.

The case is tied up in efforts by Mr. Trump’s lawyers to have the charges against him dismissed before they go to trial. To that end, the lawyers have filed a barrage of motions attacking the indictment on a number of grounds. Those include claims that Mr. Smith was improperly appointed to his job and that he filed the charges as part of a politicized effort to harm Mr. Trump.

Judge Aileen M. Cannon , who is overseeing the case, recently scrapped the trial’s start date — it had been set to begin in May — and has not yet scheduled a new one. In doing so, she cited the “myriad and interconnected” legal issues she has yet to resolve.

It appears increasingly unlikely that the case will go in front of a jury before the election in November. That is largely because of Judge Cannon’s habit of holding time-consuming hearings on arguments raised by the defense that many other judges would have decided on the merits of written filings.

Should Mr. Trump be elected, he could seek to have his Justice Department dismiss the charges. Even without that step, department policy forbids prosecuting a sitting president.

Federal Election Subversion Case

Last summer, Mr. Smith charged Mr. Trump with conspiring to subvert democracy and stay in power against the will of voters following his loss in the 2020 election.

The case has been frozen in place since early December as a series of courts in Washington have considered an expansive and novel claim he has raised in his own defense: that he is immune to all of the charges in the indictment because they arose from official acts he took while he was president.

In a few weeks, the Supreme Court is expected to render a final decision on the question of immunity, and the ruling by the justices will go a long way in determining whether the case will go to trial sooner rather than later.

There is a narrow path for a trial to be held before November. But it is probably more likely that the case will be sent back to the district court judge, Tanya S. Chutkan, to determine which of the charges stemmed from official acts and which should be thought of as strictly private ones. That process, which could affect the scope of the charges a jury ends up hearing, could take weeks or even months to complete.

The Supreme Court is expected to rule soon on another case that could affect the scope and timing of the election interference prosecution. That case concerns the viability of a federal obstruction law that prosecutors have used to accuse Mr. Trump of encouraging a mob of his supporters to disrupt the certification of the election that took place at the Capitol on Jan. 6, 2021.

Georgia Election Case

Mr. Trump and 18 of his allies were indicted in Fulton County, Ga., last August, in a broad election interference case. The case was brought by the Fulton County district attorney, Fani T. Willis.

But the complex racketeering case is highly unlikely to go to trial this year. Part of the delay stems from recent revelations of an affair between Ms. Willis and the lawyer she hired to run the case, Nathan Wade. Defense lawyers said it created an untenable conflict of interest.

The presiding judge, Scott McAfee , held a number of hearings on the topic earlier this year, but ultimately decided not to disqualify Ms. Willis, as long as Mr. Wade stepped aside, which he did.

Those hearings are hardly the only matter weighing on the case. Dozens of pretrial motions have yet to be resolved, including recent sparring over the precedent in a legal case from the 1890s. Then there are appeals. Defense lawyers have appealed the disqualification decision to the Georgia Court of Appeals, while Ms. Willis’s office has appealed Judge McAfee’s decision to quash a few charges.

Legal observers think a trial is likely to take place sometime next year, but if Mr. Trump is elected president, it may take place without him. Whether a sitting president can be tried in a state court is an untested legal matter that is sure to be fought out in higher courts.

Four of the 19 original defendants have already pleaded guilty and taken deals with the prosecution, including Sidney Powell, once one of Mr. Trump’s most vocal and outspoken defenders, and Kenneth Chesebro, a legal architect of the plan to deploy fake electors who has become a witness in five different state election inquiries.

Jenna Ellis, another defendant and a former Trump lawyer, said in court during her tearful guilty plea : “If I knew then what I know now, I would have declined to represent Donald Trump in these postelection challenges,” adding, “I look back on this experience with deep remorse.”

Alan Feuer covers extremism and political violence for The Times, focusing on the criminal cases involving the Jan. 6 attack on the Capitol and against former President Donald J. Trump.  More about Alan Feuer

Danny Hakim is a reporter on the Investigations team at The Times, focused primarily on politics. More about Danny Hakim

StarTribune

Minneapolis' dundry house was vandalized, burned down and demolished — and affordable housing providers are worried.

In a desolate crook of south Minneapolis bounded by Interstates 35 and 94, a three-story building housing people emerging from homelessness began its collapse in early 2022.

A large encampment emerged in a vacant lot next door to the building known as the Dundry House, and soon there were significant problems with vandalism, including the theft of the building's pipes. Hope Community, the Dundry's nonprofit owner, spent about $24,000 a month on security — canceling out the $23,000 it generated in monthly rent.

By mid-2023, Hope relocated tenants, boarded up the Dundry and searched for another affordable housing provider willing to buy it. But after two fires, including a major blaze this April , the building was condemned; last month, it was demolished.

Reduced to rubble were 25 units of deeply affordable housing stock meant to keep some of Minneapolis' most vulnerable people off the streets — providing a case study in what happens when constructing new affordable housing is prioritized over maintaining older buildings.

Will Delaney, Hope's co-executive director, said what happened at the Dundry is an extreme example of systemic failures in how Minnesota finances affordable housing for the poorest tenants.

Various government agencies are pouring money into new housing without sufficiently funding the operation of existing buildings, Delaney and other affordable providers said. As a result, buildings in marginalized neighborhoods with high crime rates, serving communities hardest-hit by the opioid crisis, see security expenses outpace their initial financial assumptions at an unsustainable clip.

Part of the difficulty is how Minneapolis' encampment closure practices often result in people with limited options simply moving around to different sites, Delaney said. Meanwhile, Hennepin County's Coordinated Entry system of housing homeless people in order of greatest need inadvertently leaves units vacant for long periods of time as caseworkers meticulously match individuals with homes. Those vacancies mean lost rental revenue for those housing providers operating on razor-thin margins.

As a result, housing nonprofits face hard decisions about how long they can maintain older buildings, even as they open new complexes elsewhere to the confusion of tenants awaiting essential repairs .

"Essentially, the way the model works is you get a subsidy to build it and keep your rents lower, but particularly in an environment with high inflation, higher costs with security, especially when you're dealing with folks who might have higher needs, the rents don't pay for upkeep," Delaney said.

"It is really difficult, if not impossible, to get money to support operations."

Various government agencies provide gap funding for affordable housing development, touting record rates of construction in recent years. But there's no central tracking of the affordable units lost or vacated because of disrepair and conversion to market-rate housing.

"A lot of providers are starting to have these very difficult conversations about this unfortunate bind, that in order to keep their mission and keep their organization focused, they actually have to reduce their footprint to save the rest," said Caroline Hood, CEO of RS Eden, which operates 630 units of permanent supportive housing for people in recovery programs and re-entering society after prison.

"It's such a terrible position to b­e in for our community, as those affordable units would go away and likely become market-rate, which only perpetuates the housing issues that we see."

When buildings fall into disrepair, tensions flare among affordable housing providers, existing tenants and the surrounding neighborhood. No organization wants to tell the public they're in dire straits, Hood said. But a coalition of providers, including CommonBond, Project for Pride in Living and Hope Community, are raising the long-term unsustainability of imbalanced financing for affordable housing as a sector-wide problem unsolvable with private fundraising alone.

"None of us sign up for these deals to make money. We're just trying to make the math work to make a building possible so we can serve residents," said Chris LaTondresse, CEO of Beacon Interfaith.

The nonprofit Beacon Interfaith has 750 units of permanent supportive housing serving youth, families that have been involved with the child protection system and people exiting encampments with histories of mental health and addiction.

LaTondresse, a former Hennepin County commissioner, said he wished he had greater awareness of the need for operating support alongside new construction capital when he was a policymaker. Last year, the Lonoke , a Beacon building in Stevens Square, underwent the same sort of compounding crises of squatters, drugs and soaring security costs and deferred repairs that the Dundry had experienced.

In many cases, people who were doing well before the pandemic have recovered economically, LaTondresse said. But those who were struggling are doing worse, needing more services and rent assistance even as Beacon and its peers are dealing with declining revenue and growing expenses.

"At all levels of government, but especially at the state and with local governments that do housing work, we need a rebalancing of priorities that, against the backdrop of our housing crisis continues to prioritize new housing production, but alongside of that brings dollars to draw a circle of protection around the units that already exist in our ecosystem," he said.

Hennepin County offers low-interest deferred loans for the preservation of affordable housing. The city doesn't fund ongoing maintenance. But when the Dundry went under, just five years after $2 million in public funding was spent rehabbing the building, Minneapolis and county forgave more than $1 million of their loans.

Last year, the Legislature passed a historic $1 billion investment in affordable housing, including $50 million in one-time funding to help nonprofit providers continue operating properties that don't generate enough rent revenues to cover costs. The relief helped but wasn't enough to truly stabilize buildings.

This year, the Legislature approved another $50 million for the preservation of existing housing and created a task force to further explore the topic.

Commissioner Jennifer Ho of Minnesota Housing, the state's housing finance agency, said while there remains a great need for more construction of affordable housing, the task force should try to establish shared facts around what's killing existing buildings and which of those drivers are temporary versus permanent shifts in projects' financial presumptions.

"The fact is that the amount of public resources ... even with a huge year like last year, still feel horribly finite compared to what we need to do," Ho said. "I'm really hopeful about our ability to think more clearly about our work and think about it systemically, to think about how the future of affordable housing could be a more stable endeavor."

Susan Du covers the city of Minneapolis for the Star Tribune.

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Local disparities may prevent national vaccination efforts for rubella

When public health officials make policies about when and how vaccination programs are implemented, they must weigh the benefits and risks of how infectious diseases spread throughout the country. However, these analyses are often based on national-level data and, in some countries, may overlook nuances at the local level.

A new analysis by an international team, including Penn State researchers, revealed that the resulting recommendations may keep some countries from realizing the benefits of vaccination and globally eradicating diseases, such as rubella -- a contagious viral infection that causes mild symptoms in children. The team examined data from Nigeria, one of 19 countries that hasn't yet introduced rubella vaccination, as a case study. Their findings were published in the journal Vaccine.

"It's this interesting challenge where rubella is a mild disease if you get it as a kid, but it's high risk if you get it as an adult," said senior author Matthew Ferrari, professor of biology and director of the Center for Infectious Disease Dynamics at the Huck Institutes of Life Sciences at Penn State. "All of the policy surrounding rubella vaccination has been guided by that risk in adults, which has been holding back the benefit of rubella vaccination in some countries."

The primary concern among adults is the potential risk for congenital rubella syndrome (CRS), a serious health condition that can occur if a pregnant person contracts the virus. When an infectious disease like rubella is common, people are more likely to contract it earlier in life. And because the rubella virus is immunizing, those who are infected as children won't have pregnancies at risk of CRS when they are older.

Vaccination, on the other hand, reduces the amount of circulating virus, meaning individuals who were not vaccinated as children are less likely to be infected with rubella by adolescence or adulthood, Ferrari explained. As a result, even as the total number of rubella cases goes down with vaccination, the number of rubella infections in people of reproductive age -- who were neither infected nor vaccinated as children -- increases, putting those pregnancies at risk of CRS. Because of this complex dynamic, the World Health Organization (WHO) recommends that countries demonstrate that they can achieve a coverage level of 80% or greater, through either routine immunization or supplemental campaigns, before introducing rubella vaccination. The conventional wisdom has been that when vaccination coverage is above this threshold, the reduced risk of CRS due to less rubella virus offsets the paradoxical increase in CRS risk because infections tend to happen later in life, Ferrari explained.

The research team, working in partnership with the U.S. Centers of Disease Control and Prevention and the Nigeria Centre for Disease Control and Prevention, studied the epidemiology of rubella in Nigeria. Rubella is a comparatively rare disease, so it's difficult to quantify the potential harm and risk of CRS. These assessments are further complicated by the fact that Nigeria, Ferrari said, is a country with disparate ranges of wealth, vaccination coverage, health care access and birth rates, all of which play a role in infection and CRS risk.

To gain a better understanding of the factors at play, the team analyzed data from a nationally representative serosurvey, which detects the presence of antibodies in blood. The data allowed the researchers to see how many people, particularly women of reproductive age, had rubella antibodies, how many were potentially at risk of rubella infection and where the infection risk was greatest geographically. They identified regional differences in transmission between the northern versus southern part of the country, finding that transmission in the north was two-times higher compared to the south. They were also able to estimate the number of pregnancies affected by rubella infection today.

"We grounded the current infection risk and potential pregnancies at risk in strong empirical data and real-world phenomena," Ferrari said. "Parts of the country can already vaccinate more than 80% of kids, based on their current rate of measles vaccination, but low vaccination coverage in the north is a barrier to introduction across the whole country under the current recommendation."

What's more, the concern about increased CRS cases may not be as bad as conventionally believed, Ferrari noted. The team's new estimates of transmission rates show that the 80% threshold is conservative and that introducing a rubella vaccination program in Nigeria today could reduce the number of CRS cases by thousands in the first five years. "Some states could see CRS risk increase by hundreds of cases," he said, "but that increased risk would not come to fruition until 10 years down the road" -- providing a decade for public health officials to implement policies and programs to prevent this possibility.

"Strengthening and improving routine immunization programs and advancing them everywhere in the world is a benefit to everyone in the world. The more we do this, the elimination of rubella as a virus on this planet is entirely feasible," Ferrari said.

• Mumps, Measles, Rubella
• Infectious Diseases
• Diseases and Conditions
• Public Health
• Disaster Plan
• Travel and Recreation
• STEM Education
• Public health
• MMR vaccine
• Epidemiology
• Vaccination

Story Source:

Materials provided by Penn State . Original written by Christine Yu. Note: Content may be edited for style and length.

Journal Reference :

• Taishi Nakase, Tenley Brownwright, Oyeladun Okunromade, Abiodun Egwuenu, Oladipo Ogunbode, Bola Lawal, Kayode Akanbi, Gavin Grant, Orji O. Bassey, Melissa M. Coughlin, Bettina Bankamp, Ifedayo Adetifa, C. Jessica E. Metcalf, Matthew Ferrari. The impact of sub-national heterogeneities in demography and epidemiology on the introduction of rubella vaccination programs in Nigeria . Vaccine , 2024; DOI: 10.1016/j.vaccine.2024.05.030

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