Writing A Case Study

Types Of Case Study

Barbara P

Understand the Types of Case Study Here

Published on: Jun 22, 2019

Last updated on: Nov 29, 2023

Types of Case Study

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Case studies are effective research methods that focus on one specific case over time. This gives a detailed view that's great for learning.

Writing a case study is a very useful form of study in the educational process. With real-life examples, students can learn more effectively. 

A case study also has different types and forms. As a rule of thumb, all of them require a detailed and convincing answer based on a thorough analysis.

In this blog, we are going to discuss the different types of case study research methods in detail.

So, let’s dive right in!

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Understanding Case Studies

Case studies are a type of research methodology. Case study research designs examine subjects, projects, or organizations to provide an analysis based on the evidence.

It allows you to get insight into what causes any subject’s decisions and actions. This makes case studies a great way for students to develop their research skills.

A case study focuses on a single project for an extended period, which allows students to explore the topic in depth.

What are the Types of Case Study?

Multiple case studies are used for different purposes. The main purpose of case studies is to analyze problems within the boundaries of a specific organization, environment, or situation. 

Many aspects of a case study such as data collection and analysis, qualitative research questions, etc. are dependent on the researcher and what the study is looking to address. 

Case studies can be divided into the following categories:

Illustrative Case Study

Exploratory case study, cumulative case study, critical instance case study, descriptive case study, intrinsic case study, instrumental case study.

Let’s take a look at the detailed description of each type of case study with examples. 

An illustrative case study is used to examine a familiar case to help others understand it. It is one of the main types of case studies in research methodology and is primarily descriptive. 

In this type of case study, usually, one or two instances are used to explain what a situation is like. 

Here is an example to help you understand it better:

Illustrative Case Study Example

An exploratory case study is usually done before a larger-scale research. These types of case studies are very popular in the social sciences like political science and primarily focus on real-life contexts and situations.

This method is useful in identifying research questions and methods for a large and complex study. 

Let’s take a look at this example to help you have a better understanding:

Exploratory Case Study Example

A cumulative case study is one of the main types of case studies in qualitative research. It is used to collect information from different sources at different times.

This case study aims to summarize the past studies without spending additional cost and time on new investigations. 

Let’s take a look at the example below:

Cumulative Case Study Example

Critical instances case studies are used to determine the cause and consequence of an event. 

The main reason for this type of case study is to investigate one or more sources with unique interests and sometimes with no interest in general. 

Take a look at this example below:

Critical Instance Case Study Example

When you have a hypothesis, you can design a descriptive study. It aims to find connections between the subject being studied and a theory.

After making these connections, the study can be concluded. The results of the descriptive case study will usually suggest how to develop a theory further.

This example can help you understand the concept better:

Descriptive Case Study Example

Intrinsic studies are more commonly used in psychology, healthcare, or social work. So, if you were looking for types of case studies in sociology, or types of case studies in social research, this is it.

The focus of intrinsic studies is on the individual. The aim of such studies is not only to understand the subject better but also their history and how they interact with their environment.

Here is an example to help you understand;

Intrinsic Case Study Example

This type of case study is mostly used in qualitative research. In an instrumental case study, the specific case is selected to provide information about the research question.

It offers a lens through which researchers can explore complex concepts, theories, or generalizations.

Take a look at the example below to have a better understanding of the concepts:

Instrumental Case Study Example

Review some case study examples to help you understand how a specific case study is conducted.

Types of Subjects of Case Study 

In general, there are 5 types of subjects that case studies address. Every case study fits into the following subject categories. 

  • Person: This type of study focuses on one subject or individual and can use several research methods to determine the outcome. 
  • Group: This type of study takes into account a group of individuals. This could be a group of friends, coworkers, or family. 
  • Location: The main focus of this type of study is the place. It also takes into account how and why people use the place. 
  • Organization: This study focuses on an organization or company. This could also include the company employees or people who work in an event at the organization. 
  • Event: This type of study focuses on a specific event. It could be societal or cultural and examines how it affects the surroundings. 

Benefits of Case Study for Students

Here's a closer look at the multitude of benefits students can have with case studies:

Real-world Application

Case studies serve as a crucial link between theory and practice. By immersing themselves in real-world scenarios, students can apply theoretical knowledge to practical situations.

Critical Thinking Skills

Analyzing case studies demands critical thinking and informed decision-making. Students cultivate the ability to evaluate information, identify key factors, and develop well-reasoned solutions – essential skills in both academic and professional contexts.

Enhanced Problem-solving Abilities

Case studies often present complex problems that require creative and strategic solutions. Engaging with these challenges refines students' problem-solving skills, encouraging them to think innovatively and develop effective approaches.

Holistic Understanding

Going beyond theoretical concepts, case studies provide a holistic view of a subject. Students gain insights into the multifaceted aspects of a situation, helping them connect the dots and understand the broader context.

Exposure to Diverse Perspectives

Case studies often encompass a variety of industries, cultures, and situations. This exposure broadens students' perspectives, fostering a more comprehensive understanding of the world and the challenges faced by different entities.

So there you have it!

We have explored different types of case studies and their examples. Case studies act as the tools to understand and deal with the many challenges and opportunities around us.

Case studies are being used more and more in colleges and universities to help students understand how a hypothetical event can influence a person, group, or organization in real life. 

Not everyone can handle the case study writing assignment easily. It is even scary to think that your time and work could be wasted if you don't do the case study paper right. 

Our professional paper writing service is here to make your academic journey easier. 

Let us worry about your essay and buy case study today to ease your stress and achieve academic success.

Barbara P (Literature, Marketing)

Dr. Barbara is a highly experienced writer and author who holds a Ph.D. degree in public health from an Ivy League school. She has worked in the medical field for many years, conducting extensive research on various health topics. Her writing has been featured in several top-tier publications.

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Methodology

Research Methods | Definitions, Types, Examples

Research methods are specific procedures for collecting and analyzing data. Developing your research methods is an integral part of your research design . When planning your methods, there are two key decisions you will make.

First, decide how you will collect data . Your methods depend on what type of data you need to answer your research question :

  • Qualitative vs. quantitative : Will your data take the form of words or numbers?
  • Primary vs. secondary : Will you collect original data yourself, or will you use data that has already been collected by someone else?
  • Descriptive vs. experimental : Will you take measurements of something as it is, or will you perform an experiment?

Second, decide how you will analyze the data .

  • For quantitative data, you can use statistical analysis methods to test relationships between variables.
  • For qualitative data, you can use methods such as thematic analysis to interpret patterns and meanings in the data.

Table of contents

Methods for collecting data, examples of data collection methods, methods for analyzing data, examples of data analysis methods, other interesting articles, frequently asked questions about research methods.

Data is the information that you collect for the purposes of answering your research question . The type of data you need depends on the aims of your research.

Qualitative vs. quantitative data

Your choice of qualitative or quantitative data collection depends on the type of knowledge you want to develop.

For questions about ideas, experiences and meanings, or to study something that can’t be described numerically, collect qualitative data .

If you want to develop a more mechanistic understanding of a topic, or your research involves hypothesis testing , collect quantitative data .

You can also take a mixed methods approach , where you use both qualitative and quantitative research methods.

Primary vs. secondary research

Primary research is any original data that you collect yourself for the purposes of answering your research question (e.g. through surveys , observations and experiments ). Secondary research is data that has already been collected by other researchers (e.g. in a government census or previous scientific studies).

If you are exploring a novel research question, you’ll probably need to collect primary data . But if you want to synthesize existing knowledge, analyze historical trends, or identify patterns on a large scale, secondary data might be a better choice.

Descriptive vs. experimental data

In descriptive research , you collect data about your study subject without intervening. The validity of your research will depend on your sampling method .

In experimental research , you systematically intervene in a process and measure the outcome. The validity of your research will depend on your experimental design .

To conduct an experiment, you need to be able to vary your independent variable , precisely measure your dependent variable, and control for confounding variables . If it’s practically and ethically possible, this method is the best choice for answering questions about cause and effect.

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Your data analysis methods will depend on the type of data you collect and how you prepare it for analysis.

Data can often be analyzed both quantitatively and qualitatively. For example, survey responses could be analyzed qualitatively by studying the meanings of responses or quantitatively by studying the frequencies of responses.

Qualitative analysis methods

Qualitative analysis is used to understand words, ideas, and experiences. You can use it to interpret data that was collected:

  • From open-ended surveys and interviews , literature reviews , case studies , ethnographies , and other sources that use text rather than numbers.
  • Using non-probability sampling methods .

Qualitative analysis tends to be quite flexible and relies on the researcher’s judgement, so you have to reflect carefully on your choices and assumptions and be careful to avoid research bias .

Quantitative analysis methods

Quantitative analysis uses numbers and statistics to understand frequencies, averages and correlations (in descriptive studies) or cause-and-effect relationships (in experiments).

You can use quantitative analysis to interpret data that was collected either:

  • During an experiment .
  • Using probability sampling methods .

Because the data is collected and analyzed in a statistically valid way, the results of quantitative analysis can be easily standardized and shared among researchers.

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types of research methodology case study

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

  • Chi square test of independence
  • Statistical power
  • Descriptive statistics
  • Degrees of freedom
  • Pearson correlation
  • Null hypothesis
  • Double-blind study
  • Case-control study
  • Research ethics
  • Data collection
  • Hypothesis testing
  • Structured interviews

Research bias

  • Hawthorne effect
  • Unconscious bias
  • Recall bias
  • Halo effect
  • Self-serving bias
  • Information bias

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

The research methods you use depend on the type of data you need to answer your research question .

  • If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts and meanings, use qualitative methods .
  • If you want to analyze a large amount of readily-available data, use secondary data. If you want data specific to your purposes with control over how it is generated, collect primary data.
  • If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

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Blog Beginner Guides

What is a Case Study? [+6 Types of Case Studies]

By Ronita Mohan , Sep 20, 2021

What is a Case Study Blog Header

Case studies have become powerful business tools. But what is a case study? What are the benefits of creating one? Are there limitations to the format?

If you’ve asked yourself these questions, our helpful guide will clear things up. Learn how to use a case study for business. Find out how cases analysis works in psychology and research.

We’ve also got examples of case studies to inspire you.

Haven’t made a case study before? You can easily  create a case study  with Venngage’s customizable templates.

CREATE A CASE STUDY

Click to jump ahead:

What is a case study, what is the case study method, benefits of case studies, limitations of case studies, types of case studies, faqs about case studies.

Case studies are research methodologies. They examine subjects, projects, or organizations to tell a story.

Case Study Definition LinkedIn Post

USE THIS TEMPLATE

Numerous sectors use case analyses. The social sciences, social work, and psychology create studies regularly.

Healthcare industries write reports on patients and diagnoses. Marketing case study examples , like the one below, highlight the benefits of a business product.

Bold Social Media Business Case Study Template

CREATE THIS REPORT TEMPLATE

Now that you know what a case study is, we explain how case reports are used in three different industries.

What is a business case study?

A business or marketing case study aims at showcasing a successful partnership. This can be between a brand and a client. Or the case study can examine a brand’s project.

There is a perception that case studies are used to advertise a brand. But effective reports, like the one below, can show clients how a brand can support them.

Light Simple Business Case Study Template

Hubspot created a case study on a customer that successfully scaled its business. The report outlines the various Hubspot tools used to achieve these results.

Hubspot case study

Hubspot also added a video with testimonials from the client company’s employees.

So, what is the purpose of a case study for businesses? There is a lot of competition in the corporate world. Companies are run by people. They can be on the fence about which brand to work with.

Business reports  stand out aesthetically, as well. They use  brand colors  and brand fonts . Usually, a combination of the client’s and the brand’s.

With the Venngage  My Brand Kit  feature, businesses can automatically apply their brand to designs.

A business case study, like the one below, acts as social proof. This helps customers decide between your brand and your competitors.

Modern lead Generation Business Case Study Template

Don’t know how to design a report? You can learn  how to write a case study  with Venngage’s guide. We also share design tips and examples that will help you convert.

Related: 55+ Annual Report Design Templates, Inspirational Examples & Tips [Updated]

What is a case study in psychology?

In the field of psychology, case studies focus on a particular subject. Psychology case histories also examine human behaviors.

Case reports search for commonalities between humans. They are also used to prescribe further research. Or these studies can elaborate on a solution for a behavioral ailment.

The American Psychology Association  has a number of case studies on real-life clients. Note how the reports are more text-heavy than a business case study.

What is a case study in psychology? Behavior therapy example

Famous psychologists such as Sigmund Freud and Anna O popularised the use of case studies in the field. They did so by regularly interviewing subjects. Their detailed observations build the field of psychology.

It is important to note that psychological studies must be conducted by professionals. Psychologists, psychiatrists and therapists should be the researchers in these cases.

Related: What Netflix’s Top 50 Shows Can Teach Us About Font Psychology [Infographic]

What is a case study in research?

Research is a necessary part of every case study. But specific research fields are required to create studies. These fields include user research, healthcare, education, or social work.

For example, this UX Design  report examined the public perception of a client. The brand researched and implemented new visuals to improve it. The study breaks down this research through lessons learned.

What is a case study in research? UX Design case study example

Clinical reports are a necessity in the medical field. These documents are used to share knowledge with other professionals. They also help examine new or unusual diseases or symptoms.

The pandemic has led to a significant increase in research. For example,  Spectrum Health  studied the value of health systems in the pandemic. They created the study by examining community outreach.

What is a case study in research? Spectrum healthcare example

The pandemic has significantly impacted the field of education. This has led to numerous examinations on remote studying. There have also been studies on how students react to decreased peer communication.

Social work case reports often have a community focus. They can also examine public health responses. In certain regions, social workers study disaster responses.

You now know what case studies in various fields are. In the next step of our guide, we explain the case study method.

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A case analysis is a deep dive into a subject. To facilitate this case studies are built on interviews and observations. The below example would have been created after numerous interviews.

Case studies are largely qualitative. They analyze and describe phenomena. While some data is included, a case analysis is not quantitative.

There are a few steps in the case method. You have to start by identifying the subject of your study. Then determine what kind of research is required.

In natural sciences, case studies can take years to complete. Business reports, like this one, don’t take that long. A few weeks of interviews should be enough.

Blue Simple Business Case Study Template

The case method will vary depending on the industry. Reports will also look different once produced.

As you will have seen, business reports are more colorful. The design is also more accessible . Healthcare and psychology reports are more text-heavy.

Designing case reports takes time and energy. So, is it worth taking the time to write them? Here are the benefits of creating case studies.

  • Collects large amounts of information
  • Helps formulate hypotheses
  • Builds the case for further research
  • Discovers new insights into a subject
  • Builds brand trust and loyalty
  • Engages customers through stories

For example, the business study below creates a story around a brand partnership. It makes for engaging reading. The study also shows evidence backing up the information.

Blue Content Marketing Case Study Template

We’ve shared the benefits of why studies are needed. We will also look at the limitations of creating them.

Related: How to Present a Case Study like a Pro (With Examples)

There are a few disadvantages to conducting a case analysis. The limitations will vary according to the industry.

  • Responses from interviews are subjective
  • Subjects may tailor responses to the researcher
  • Studies can’t always be replicated
  • In certain industries, analyses can take time and be expensive
  • Risk of generalizing the results among a larger population

These are some of the common weaknesses of creating case reports. If you’re on the fence, look at the competition in your industry.

Other brands or professionals are building reports, like this example. In that case, you may want to do the same.

Coral content marketing case study template

There are six common types of case reports. Depending on your industry, you might use one of these types.

Descriptive case studies

Explanatory case studies, exploratory case reports, intrinsic case studies, instrumental case studies, collective case reports.

6 Types Of Case Studies List

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We go into more detail about each type of study in the guide below.

Related:  15+ Professional Case Study Examples [Design Tips + Templates]

When you have an existing hypothesis, you can design a descriptive study. This type of report starts with a description. The aim is to find connections between the subject being studied and a theory.

Once these connections are found, the study can conclude. The results of this type of study will usually suggest how to develop a theory further.

A study like the one below has concrete results. A descriptive report would use the quantitative data as a suggestion for researching the subject deeply.

Lead generation business case study template

When an incident occurs in a field, an explanation is required. An explanatory report investigates the cause of the event. It will include explanations for that cause.

The study will also share details about the impact of the event. In most cases, this report will use evidence to predict future occurrences. The results of explanatory reports are definitive.

Note that there is no room for interpretation here. The results are absolute.

The study below is a good example. It explains how one brand used the services of another. It concludes by showing definitive proof that the collaboration was successful.

Bold Content Marketing Case Study Template

Another example of this study would be in the automotive industry. If a vehicle fails a test, an explanatory study will examine why. The results could show that the failure was because of a particular part.

Related: How to Write a Case Study [+ Design Tips]

An explanatory report is a self-contained document. An exploratory one is only the beginning of an investigation.

Exploratory cases act as the starting point of studies. This is usually conducted as a precursor to large-scale investigations. The research is used to suggest why further investigations are needed.

An exploratory study can also be used to suggest methods for further examination.

For example, the below analysis could have found inconclusive results. In that situation, it would be the basis for an in-depth study.

Teal Social Media Business Case Study Template

Intrinsic studies are more common in the field of psychology. These reports can also be conducted in healthcare or social work.

These types of studies focus on a unique subject, such as a patient. They can sometimes study groups close to the researcher.

The aim of such studies is to understand the subject better. This requires learning their history. The researcher will also examine how they interact with their environment.

For instance, if the case study below was about a unique brand, it could be an intrinsic study.

Vibrant Content Marketing Case Study Template

Once the study is complete, the researcher will have developed a better understanding of a phenomenon. This phenomenon will likely not have been studied or theorized about before.

Examples of intrinsic case analysis can be found across psychology. For example, Jean Piaget’s theories on cognitive development. He established the theory from intrinsic studies into his own children.

Related: What Disney Villains Can Tell Us About Color Psychology [Infographic]

This is another type of study seen in medical and psychology fields. Instrumental reports are created to examine more than just the primary subject.

When research is conducted for an instrumental study, it is to provide the basis for a larger phenomenon. The subject matter is usually the best example of the phenomenon. This is why it is being studied.

Purple SAAS Business Case Study Template

Assume it’s examining lead generation strategies. It may want to show that visual marketing is the definitive lead generation tool. The brand can conduct an instrumental case study to examine this phenomenon.

Collective studies are based on instrumental case reports. These types of studies examine multiple reports.

There are a number of reasons why collective reports are created:

  • To provide evidence for starting a new study
  • To find pattens between multiple instrumental reports
  • To find differences in similar types of cases
  • Gain a deeper understanding of a complex phenomenon
  • Understand a phenomenon from diverse contexts

A researcher could use multiple reports, like the one below, to build a collective case report.

Social Media Business Case Study template

Related: 10+ Case Study Infographic Templates That Convert

What makes a case study a case study?

A case study has a very particular research methodology. They are an in-depth study of a person or a group of individuals. They can also study a community or an organization. Case reports examine real-world phenomena within a set context.

How long should a case study be?

The length of studies depends on the industry. It also depends on the story you’re telling. Most case studies should be at least 500-1500 words long. But you can increase the length if you have more details to share.

What should you ask in a case study?

The one thing you shouldn’t ask is ‘yes’ or ‘no’ questions. Case studies are qualitative. These questions won’t give you the information you need.

Ask your client about the problems they faced. Ask them about solutions they found. Or what they think is the ideal solution. Leave room to ask them follow-up questions. This will help build out the study.

How to present a case study?

When you’re ready to present a case study, begin by providing a summary of the problem or challenge you were addressing. Follow this with an outline of the solution you implemented, and support this with the results you achieved, backed by relevant data. Incorporate visual aids like slides, graphs, and images to make your case study presentation more engaging and impactful.

Now you know what a case study means, you can begin creating one. These reports are a great tool for analyzing brands. They are also useful in a variety of other fields.

Use a visual communication platform like Venngage to design case studies. With Venngage’s templates, you can design easily. Create branded, engaging reports, all without design experience.

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Methodology or method? A critical review of qualitative case study reports

Despite on-going debate about credibility, and reported limitations in comparison to other approaches, case study is an increasingly popular approach among qualitative researchers. We critically analysed the methodological descriptions of published case studies. Three high-impact qualitative methods journals were searched to locate case studies published in the past 5 years; 34 were selected for analysis. Articles were categorized as health and health services ( n= 12), social sciences and anthropology ( n= 7), or methods ( n= 15) case studies. The articles were reviewed using an adapted version of established criteria to determine whether adequate methodological justification was present, and if study aims, methods, and reported findings were consistent with a qualitative case study approach. Findings were grouped into five themes outlining key methodological issues: case study methodology or method, case of something particular and case selection, contextually bound case study, researcher and case interactions and triangulation, and study design inconsistent with methodology reported. Improved reporting of case studies by qualitative researchers will advance the methodology for the benefit of researchers and practitioners.

Case study research is an increasingly popular approach among qualitative researchers (Thomas, 2011 ). Several prominent authors have contributed to methodological developments, which has increased the popularity of case study approaches across disciplines (Creswell, 2013b ; Denzin & Lincoln, 2011b ; Merriam, 2009 ; Ragin & Becker, 1992 ; Stake, 1995 ; Yin, 2009 ). Current qualitative case study approaches are shaped by paradigm, study design, and selection of methods, and, as a result, case studies in the published literature vary. Differences between published case studies can make it difficult for researchers to define and understand case study as a methodology.

Experienced qualitative researchers have identified case study research as a stand-alone qualitative approach (Denzin & Lincoln, 2011b ). Case study research has a level of flexibility that is not readily offered by other qualitative approaches such as grounded theory or phenomenology. Case studies are designed to suit the case and research question and published case studies demonstrate wide diversity in study design. There are two popular case study approaches in qualitative research. The first, proposed by Stake ( 1995 ) and Merriam ( 2009 ), is situated in a social constructivist paradigm, whereas the second, by Yin ( 2012 ), Flyvbjerg ( 2011 ), and Eisenhardt ( 1989 ), approaches case study from a post-positivist viewpoint. Scholarship from both schools of inquiry has contributed to the popularity of case study and development of theoretical frameworks and principles that characterize the methodology.

The diversity of case studies reported in the published literature, and on-going debates about credibility and the use of case study in qualitative research practice, suggests that differences in perspectives on case study methodology may prevent researchers from developing a mutual understanding of practice and rigour. In addition, discussion about case study limitations has led some authors to query whether case study is indeed a methodology (Luck, Jackson, & Usher, 2006 ; Meyer, 2001 ; Thomas, 2010 ; Tight, 2010 ). Methodological discussion of qualitative case study research is timely, and a review is required to analyse and understand how this methodology is applied in the qualitative research literature. The aims of this study were to review methodological descriptions of published qualitative case studies, to review how the case study methodological approach was applied, and to identify issues that need to be addressed by researchers, editors, and reviewers. An outline of the current definitions of case study and an overview of the issues proposed in the qualitative methodological literature are provided to set the scene for the review.

Definitions of qualitative case study research

Case study research is an investigation and analysis of a single or collective case, intended to capture the complexity of the object of study (Stake, 1995 ). Qualitative case study research, as described by Stake ( 1995 ), draws together “naturalistic, holistic, ethnographic, phenomenological, and biographic research methods” in a bricoleur design, or in his words, “a palette of methods” (Stake, 1995 , pp. xi–xii). Case study methodology maintains deep connections to core values and intentions and is “particularistic, descriptive and heuristic” (Merriam, 2009 , p. 46).

As a study design, case study is defined by interest in individual cases rather than the methods of inquiry used. The selection of methods is informed by researcher and case intuition and makes use of naturally occurring sources of knowledge, such as people or observations of interactions that occur in the physical space (Stake, 1998 ). Thomas ( 2011 ) suggested that “analytical eclecticism” is a defining factor (p. 512). Multiple data collection and analysis methods are adopted to further develop and understand the case, shaped by context and emergent data (Stake, 1995 ). This qualitative approach “explores a real-life, contemporary bounded system (a case ) or multiple bounded systems (cases) over time, through detailed, in-depth data collection involving multiple sources of information … and reports a case description and case themes ” (Creswell, 2013b , p. 97). Case study research has been defined by the unit of analysis, the process of study, and the outcome or end product, all essentially the case (Merriam, 2009 ).

The case is an object to be studied for an identified reason that is peculiar or particular. Classification of the case and case selection procedures informs development of the study design and clarifies the research question. Stake ( 1995 ) proposed three types of cases and study design frameworks. These include the intrinsic case, the instrumental case, and the collective instrumental case. The intrinsic case is used to understand the particulars of a single case, rather than what it represents. An instrumental case study provides insight on an issue or is used to refine theory. The case is selected to advance understanding of the object of interest. A collective refers to an instrumental case which is studied as multiple, nested cases, observed in unison, parallel, or sequential order. More than one case can be simultaneously studied; however, each case study is a concentrated, single inquiry, studied holistically in its own entirety (Stake, 1995 , 1998 ).

Researchers who use case study are urged to seek out what is common and what is particular about the case. This involves careful and in-depth consideration of the nature of the case, historical background, physical setting, and other institutional and political contextual factors (Stake, 1998 ). An interpretive or social constructivist approach to qualitative case study research supports a transactional method of inquiry, where the researcher has a personal interaction with the case. The case is developed in a relationship between the researcher and informants, and presented to engage the reader, inviting them to join in this interaction and in case discovery (Stake, 1995 ). A postpositivist approach to case study involves developing a clear case study protocol with careful consideration of validity and potential bias, which might involve an exploratory or pilot phase, and ensures that all elements of the case are measured and adequately described (Yin, 2009 , 2012 ).

Current methodological issues in qualitative case study research

The future of qualitative research will be influenced and constructed by the way research is conducted, and by what is reviewed and published in academic journals (Morse, 2011 ). If case study research is to further develop as a principal qualitative methodological approach, and make a valued contribution to the field of qualitative inquiry, issues related to methodological credibility must be considered. Researchers are required to demonstrate rigour through adequate descriptions of methodological foundations. Case studies published without sufficient detail for the reader to understand the study design, and without rationale for key methodological decisions, may lead to research being interpreted as lacking in quality or credibility (Hallberg, 2013 ; Morse, 2011 ).

There is a level of artistic license that is embraced by qualitative researchers and distinguishes practice, which nurtures creativity, innovation, and reflexivity (Denzin & Lincoln, 2011b ; Morse, 2009 ). Qualitative research is “inherently multimethod” (Denzin & Lincoln, 2011a , p. 5); however, with this creative freedom, it is important for researchers to provide adequate description for methodological justification (Meyer, 2001 ). This includes paradigm and theoretical perspectives that have influenced study design. Without adequate description, study design might not be understood by the reader, and can appear to be dishonest or inaccurate. Reviewers and readers might be confused by the inconsistent or inappropriate terms used to describe case study research approach and methods, and be distracted from important study findings (Sandelowski, 2000 ). This issue extends beyond case study research, and others have noted inconsistencies in reporting of methodology and method by qualitative researchers. Sandelowski ( 2000 , 2010 ) argued for accurate identification of qualitative description as a research approach. She recommended that the selected methodology should be harmonious with the study design, and be reflected in methods and analysis techniques. Similarly, Webb and Kevern ( 2000 ) uncovered inconsistencies in qualitative nursing research with focus group methods, recommending that methodological procedures must cite seminal authors and be applied with respect to the selected theoretical framework. Incorrect labelling using case study might stem from the flexibility in case study design and non-directional character relative to other approaches (Rosenberg & Yates, 2007 ). Methodological integrity is required in design of qualitative studies, including case study, to ensure study rigour and to enhance credibility of the field (Morse, 2011 ).

Case study has been unnecessarily devalued by comparisons with statistical methods (Eisenhardt, 1989 ; Flyvbjerg, 2006 , 2011 ; Jensen & Rodgers, 2001 ; Piekkari, Welch, & Paavilainen, 2009 ; Tight, 2010 ; Yin, 1999 ). It is reputed to be the “the weak sibling” in comparison to other, more rigorous, approaches (Yin, 2009 , p. xiii). Case study is not an inherently comparative approach to research. The objective is not statistical research, and the aim is not to produce outcomes that are generalizable to all populations (Thomas, 2011 ). Comparisons between case study and statistical research do little to advance this qualitative approach, and fail to recognize its inherent value, which can be better understood from the interpretive or social constructionist viewpoint of other authors (Merriam, 2009 ; Stake, 1995 ). Building on discussions relating to “fuzzy” (Bassey, 2001 ), or naturalistic generalizations (Stake, 1978 ), or transference of concepts and theories (Ayres, Kavanaugh, & Knafl, 2003 ; Morse et al., 2011 ) would have more relevance.

Case study research has been used as a catch-all design to justify or add weight to fundamental qualitative descriptive studies that do not fit with other traditional frameworks (Merriam, 2009 ). A case study has been a “convenient label for our research—when we ‘can't think of anything ‘better”—in an attempt to give it [qualitative methodology] some added respectability” (Tight, 2010 , p. 337). Qualitative case study research is a pliable approach (Merriam, 2009 ; Meyer, 2001 ; Stake, 1995 ), and has been likened to a “curious methodological limbo” (Gerring, 2004 , p. 341) or “paradigmatic bridge” (Luck et al., 2006 , p. 104), that is on the borderline between postpositivist and constructionist interpretations. This has resulted in inconsistency in application, which indicates that flexibility comes with limitations (Meyer, 2001 ), and the open nature of case study research might be off-putting to novice researchers (Thomas, 2011 ). The development of a well-(in)formed theoretical framework to guide a case study should improve consistency, rigour, and trust in studies published in qualitative research journals (Meyer, 2001 ).

Assessment of rigour

The purpose of this study was to analyse the methodological descriptions of case studies published in qualitative methods journals. To do this we needed to develop a suitable framework, which used existing, established criteria for appraising qualitative case study research rigour (Creswell, 2013b ; Merriam, 2009 ; Stake, 1995 ). A number of qualitative authors have developed concepts and criteria that are used to determine whether a study is rigorous (Denzin & Lincoln, 2011b ; Lincoln, 1995 ; Sandelowski & Barroso, 2002 ). The criteria proposed by Stake ( 1995 ) provide a framework for readers and reviewers to make judgements regarding case study quality, and identify key characteristics essential for good methodological rigour. Although each of the factors listed in Stake's criteria could enhance the quality of a qualitative research report, in Table I we present an adapted criteria used in this study, which integrates more recent work by Merriam ( 2009 ) and Creswell ( 2013b ). Stake's ( 1995 ) original criteria were separated into two categories. The first list of general criteria is “relevant for all qualitative research.” The second list, “high relevance to qualitative case study research,” was the criteria that we decided had higher relevance to case study research. This second list was the main criteria used to assess the methodological descriptions of the case studies reviewed. The complete table has been preserved so that the reader can determine how the original criteria were adapted.

Framework for assessing quality in qualitative case study research.

Adapted from Stake ( 1995 , p. 131).

Study design

The critical review method described by Grant and Booth ( 2009 ) was used, which is appropriate for the assessment of research quality, and is used for literature analysis to inform research and practice. This type of review goes beyond the mapping and description of scoping or rapid reviews, to include “analysis and conceptual innovation” (Grant & Booth, 2009 , p. 93). A critical review is used to develop existing, or produce new, hypotheses or models. This is different to systematic reviews that answer clinical questions. It is used to evaluate existing research and competing ideas, to provide a “launch pad” for conceptual development and “subsequent testing” (Grant & Booth, 2009 , p. 93).

Qualitative methods journals were located by a search of the 2011 ISI Journal Citation Reports in Social Science, via the database Web of Knowledge (see m.webofknowledge.com). No “qualitative research methods” category existed in the citation reports; therefore, a search of all categories was performed using the term “qualitative.” In Table II , we present the qualitative methods journals located, ranked by impact factor. The highest ranked journals were selected for searching. We acknowledge that the impact factor ranking system might not be the best measure of journal quality (Cheek, Garnham, & Quan, 2006 ); however, this was the most appropriate and accessible method available.

International Journal of Qualitative Studies on Health and Well-being.

Search strategy

In March 2013, searches of the journals, Qualitative Health Research , Qualitative Research , and Qualitative Inquiry were completed to retrieve studies with “case study” in the abstract field. The search was limited to the past 5 years (1 January 2008 to 1 March 2013). The objective was to locate published qualitative case studies suitable for assessment using the adapted criterion. Viewpoints, commentaries, and other article types were excluded from review. Title and abstracts of the 45 retrieved articles were read by the first author, who identified 34 empirical case studies for review. All authors reviewed the 34 studies to confirm selection and categorization. In Table III , we present the 34 case studies grouped by journal, and categorized by research topic, including health sciences, social sciences and anthropology, and methods research. There was a discrepancy in categorization of one article on pedagogy and a new teaching method published in Qualitative Inquiry (Jorrín-Abellán, Rubia-Avi, Anguita-Martínez, Gómez-Sánchez, & Martínez-Mones, 2008 ). Consensus was to allocate to the methods category.

Outcomes of search of qualitative methods journals.

In Table III , the number of studies located, and final numbers selected for review have been reported. Qualitative Health Research published the most empirical case studies ( n= 16). In the health category, there were 12 case studies of health conditions, health services, and health policy issues, all published in Qualitative Health Research . Seven case studies were categorized as social sciences and anthropology research, which combined case study with biography and ethnography methodologies. All three journals published case studies on methods research to illustrate a data collection or analysis technique, methodological procedure, or related issue.

The methodological descriptions of 34 case studies were critically reviewed using the adapted criteria. All articles reviewed contained a description of study methods; however, the length, amount of detail, and position of the description in the article varied. Few studies provided an accurate description and rationale for using a qualitative case study approach. In the 34 case studies reviewed, three described a theoretical framework informed by Stake ( 1995 ), two by Yin ( 2009 ), and three provided a mixed framework informed by various authors, which might have included both Yin and Stake. Few studies described their case study design, or included a rationale that explained why they excluded or added further procedures, and whether this was to enhance the study design, or to better suit the research question. In 26 of the studies no reference was provided to principal case study authors. From reviewing the description of methods, few authors provided a description or justification of case study methodology that demonstrated how their study was informed by the methodological literature that exists on this approach.

The methodological descriptions of each study were reviewed using the adapted criteria, and the following issues were identified: case study methodology or method; case of something particular and case selection; contextually bound case study; researcher and case interactions and triangulation; and, study design inconsistent with methodology. An outline of how the issues were developed from the critical review is provided, followed by a discussion of how these relate to the current methodological literature.

Case study methodology or method

A third of the case studies reviewed appeared to use a case report method, not case study methodology as described by principal authors (Creswell, 2013b ; Merriam, 2009 ; Stake, 1995 ; Yin, 2009 ). Case studies were identified as a case report because of missing methodological detail and by review of the study aims and purpose. These reports presented data for small samples of no more than three people, places or phenomenon. Four studies, or “case reports” were single cases selected retrospectively from larger studies (Bronken, Kirkevold, Martinsen, & Kvigne, 2012 ; Coltart & Henwood, 2012 ; Hooghe, Neimeyer, & Rober, 2012 ; Roscigno et al., 2012 ). Case reports were not a case of something, instead were a case demonstration or an example presented in a report. These reports presented outcomes, and reported on how the case could be generalized. Descriptions focussed on the phenomena, rather than the case itself, and did not appear to study the case in its entirety.

Case reports had minimal in-text references to case study methodology, and were informed by other qualitative traditions or secondary sources (Adamson & Holloway, 2012 ; Buzzanell & D'Enbeau, 2009 ; Nagar-Ron & Motzafi-Haller, 2011 ). This does not suggest that case study methodology cannot be multimethod, however, methodology should be consistent in design, be clearly described (Meyer, 2001 ; Stake, 1995 ), and maintain focus on the case (Creswell, 2013b ).

To demonstrate how case reports were identified, three examples are provided. The first, Yeh ( 2013 ) described their study as, “the examination of the emergence of vegetarianism in Victorian England serves as a case study to reveal the relationships between boundaries and entities” (p. 306). The findings were a historical case report, which resulted from an ethnographic study of vegetarianism. Cunsolo Willox, Harper, Edge, ‘My Word’: Storytelling and Digital Media Lab, and Rigolet Inuit Community Government (2013) used “a case study that illustrates the usage of digital storytelling within an Inuit community” (p. 130). This case study reported how digital storytelling can be used with indigenous communities as a participatory method to illuminate the benefits of this method for other studies. This “case study was conducted in the Inuit community” but did not include the Inuit community in case analysis (Cunsolo Willox et al., 2013 , p. 130). Bronken et al. ( 2012 ) provided a single case report to demonstrate issues observed in a larger clinical study of aphasia and stroke, without adequate case description or analysis.

Case study of something particular and case selection

Case selection is a precursor to case analysis, which needs to be presented as a convincing argument (Merriam, 2009 ). Descriptions of the case were often not adequate to ascertain why the case was selected, or whether it was a particular exemplar or outlier (Thomas, 2011 ). In a number of case studies in the health and social science categories, it was not explicit whether the case was of something particular, or peculiar to their discipline or field (Adamson & Holloway, 2012 ; Bronken et al., 2012 ; Colón-Emeric et al., 2010 ; Jackson, Botelho, Welch, Joseph, & Tennstedt, 2012 ; Mawn et al., 2010 ; Snyder-Young, 2011 ). There were exceptions in the methods category ( Table III ), where cases were selected by researchers to report on a new or innovative method. The cases emerged through heuristic study, and were reported to be particular, relative to the existing methods literature (Ajodhia-Andrews & Berman, 2009 ; Buckley & Waring, 2013 ; Cunsolo Willox et al., 2013 ; De Haene, Grietens, & Verschueren, 2010 ; Gratton & O'Donnell, 2011 ; Sumsion, 2013 ; Wimpenny & Savin-Baden, 2012 ).

Case selection processes were sometimes insufficient to understand why the case was selected from the global population of cases, or what study of this case would contribute to knowledge as compared with other possible cases (Adamson & Holloway, 2012 ; Bronken et al., 2012 ; Colón-Emeric et al., 2010 ; Jackson et al., 2012 ; Mawn et al., 2010 ). In two studies, local cases were selected (Barone, 2010 ; Fourie & Theron, 2012 ) because the researcher was familiar with and had access to the case. Possible limitations of a convenience sample were not acknowledged. Purposeful sampling was used to recruit participants within the case of one study, but not of the case itself (Gallagher et al., 2013 ). Random sampling was completed for case selection in two studies (Colón-Emeric et al., 2010 ; Jackson et al., 2012 ), which has limited meaning in interpretive qualitative research.

To demonstrate how researchers provided a good justification for the selection of case study approaches, four examples are provided. The first, cases of residential care homes, were selected because of reported occurrences of mistreatment, which included residents being locked in rooms at night (Rytterström, Unosson, & Arman, 2013 ). Roscigno et al. ( 2012 ) selected cases of parents who were admitted for early hospitalization in neonatal intensive care with a threatened preterm delivery before 26 weeks. Hooghe et al. ( 2012 ) used random sampling to select 20 couples that had experienced the death of a child; however, the case study was of one couple and a particular metaphor described only by them. The final example, Coltart and Henwood ( 2012 ), provided a detailed account of how they selected two cases from a sample of 46 fathers based on personal characteristics and beliefs. They described how the analysis of the two cases would contribute to their larger study on first time fathers and parenting.

Contextually bound case study

The limits or boundaries of the case are a defining factor of case study methodology (Merriam, 2009 ; Ragin & Becker, 1992 ; Stake, 1995 ; Yin, 2009 ). Adequate contextual description is required to understand the setting or context in which the case is revealed. In the health category, case studies were used to illustrate a clinical phenomenon or issue such as compliance and health behaviour (Colón-Emeric et al., 2010 ; D'Enbeau, Buzzanell, & Duckworth, 2010 ; Gallagher et al., 2013 ; Hooghe et al., 2012 ; Jackson et al., 2012 ; Roscigno et al., 2012 ). In these case studies, contextual boundaries, such as physical and institutional descriptions, were not sufficient to understand the case as a holistic system, for example, the general practitioner (GP) clinic in Gallagher et al. ( 2013 ), or the nursing home in Colón-Emeric et al. ( 2010 ). Similarly, in the social science and methods categories, attention was paid to some components of the case context, but not others, missing important information required to understand the case as a holistic system (Alexander, Moreira, & Kumar, 2012 ; Buzzanell & D'Enbeau, 2009 ; Nairn & Panelli, 2009 ; Wimpenny & Savin-Baden, 2012 ).

In two studies, vicarious experience or vignettes (Nairn & Panelli, 2009 ) and images (Jorrín-Abellán et al., 2008 ) were effective to support description of context, and might have been a useful addition for other case studies. Missing contextual boundaries suggests that the case might not be adequately defined. Additional information, such as the physical, institutional, political, and community context, would improve understanding of the case (Stake, 1998 ). In Boxes 1 and 2 , we present brief synopses of two studies that were reviewed, which demonstrated a well bounded case. In Box 1 , Ledderer ( 2011 ) used a qualitative case study design informed by Stake's tradition. In Box 2 , Gillard, Witt, and Watts ( 2011 ) were informed by Yin's tradition. By providing a brief outline of the case studies in Boxes 1 and 2 , we demonstrate how effective case boundaries can be constructed and reported, which may be of particular interest to prospective case study researchers.

Article synopsis of case study research using Stake's tradition

Ledderer ( 2011 ) used a qualitative case study research design, informed by modern ethnography. The study is bounded to 10 general practice clinics in Denmark, who had received federal funding to implement preventative care services based on a Motivational Interviewing intervention. The researcher question focussed on “why is it so difficult to create change in medical practice?” (Ledderer, 2011 , p. 27). The study context was adequately described, providing detail on the general practitioner (GP) clinics and relevant political and economic influences. Methodological decisions are described in first person narrative, providing insight on researcher perspectives and interaction with the case. Forty-four interviews were conducted, which focussed on how GPs conducted consultations, and the form, nature and content, rather than asking their opinion or experience (Ledderer, 2011 , p. 30). The duration and intensity of researcher immersion in the case enhanced depth of description and trustworthiness of study findings. Analysis was consistent with Stake's tradition, and the researcher provided examples of inquiry techniques used to challenge assumptions about emerging themes. Several other seminal qualitative works were cited. The themes and typology constructed are rich in narrative data and storytelling by clinic staff, demonstrating individual clinic experiences as well as shared meanings and understandings about changing from a biomedical to psychological approach to preventative health intervention. Conclusions make note of social and cultural meanings and lessons learned, which might not have been uncovered using a different methodology.

Article synopsis of case study research using Yin's tradition

Gillard et al. ( 2011 ) study of camps for adolescents living with HIV/AIDs provided a good example of Yin's interpretive case study approach. The context of the case is bounded by the three summer camps of which the researchers had prior professional involvement. A case study protocol was developed that used multiple methods to gather information at three data collection points coinciding with three youth camps (Teen Forum, Discover Camp, and Camp Strong). Gillard and colleagues followed Yin's ( 2009 ) principles, using a consistent data protocol that enhanced cross-case analysis. Data described the young people, the camp physical environment, camp schedule, objectives and outcomes, and the staff of three youth camps. The findings provided a detailed description of the context, with less detail of individual participants, including insight into researcher's interpretations and methodological decisions throughout the data collection and analysis process. Findings provided the reader with a sense of “being there,” and are discovered through constant comparison of the case with the research issues; the case is the unit of analysis. There is evidence of researcher immersion in the case, and Gillard reports spending significant time in the field in a naturalistic and integrated youth mentor role.

This case study is not intended to have a significant impact on broader health policy, although does have implications for health professionals working with adolescents. Study conclusions will inform future camps for young people with chronic disease, and practitioners are able to compare similarities between this case and their own practice (for knowledge translation). No limitations of this article were reported. Limitations related to publication of this case study were that it was 20 pages long and used three tables to provide sufficient description of the camp and program components, and relationships with the research issue.

Researcher and case interactions and triangulation

Researcher and case interactions and transactions are a defining feature of case study methodology (Stake, 1995 ). Narrative stories, vignettes, and thick description are used to provoke vicarious experience and a sense of being there with the researcher in their interaction with the case. Few of the case studies reviewed provided details of the researcher's relationship with the case, researcher–case interactions, and how these influenced the development of the case study (Buzzanell & D'Enbeau, 2009 ; D'Enbeau et al., 2010 ; Gallagher et al., 2013 ; Gillard et al., 2011 ; Ledderer, 2011 ; Nagar-Ron & Motzafi-Haller, 2011 ). The role and position of the researcher needed to be self-examined and understood by readers, to understand how this influenced interactions with participants, and to determine what triangulation is needed (Merriam, 2009 ; Stake, 1995 ).

Gillard et al. ( 2011 ) provided a good example of triangulation, comparing data sources in a table (p. 1513). Triangulation of sources was used to reveal as much depth as possible in the study by Nagar-Ron and Motzafi-Haller ( 2011 ), while also enhancing confirmation validity. There were several case studies that would have benefited from improved range and use of data sources, and descriptions of researcher–case interactions (Ajodhia-Andrews & Berman, 2009 ; Bronken et al., 2012 ; Fincham, Scourfield, & Langer, 2008 ; Fourie & Theron, 2012 ; Hooghe et al., 2012 ; Snyder-Young, 2011 ; Yeh, 2013 ).

Study design inconsistent with methodology

Good, rigorous case studies require a strong methodological justification (Meyer, 2001 ) and a logical and coherent argument that defines paradigm, methodological position, and selection of study methods (Denzin & Lincoln, 2011b ). Methodological justification was insufficient in several of the studies reviewed (Barone, 2010 ; Bronken et al., 2012 ; Hooghe et al., 2012 ; Mawn et al., 2010 ; Roscigno et al., 2012 ; Yeh, 2013 ). This was judged by the absence, or inadequate or inconsistent reference to case study methodology in-text.

In six studies, the methodological justification provided did not relate to case study. There were common issues identified. Secondary sources were used as primary methodological references indicating that study design might not have been theoretically sound (Colón-Emeric et al., 2010 ; Coltart & Henwood, 2012 ; Roscigno et al., 2012 ; Snyder-Young, 2011 ). Authors and sources cited in methodological descriptions were inconsistent with the actual study design and practices used (Fourie & Theron, 2012 ; Hooghe et al., 2012 ; Jorrín-Abellán et al., 2008 ; Mawn et al., 2010 ; Rytterström et al., 2013 ; Wimpenny & Savin-Baden, 2012 ). This occurred when researchers cited Stake or Yin, or both (Mawn et al., 2010 ; Rytterström et al., 2013 ), although did not follow their paradigmatic or methodological approach. In 26 studies there were no citations for a case study methodological approach.

The findings of this study have highlighted a number of issues for researchers. A considerable number of case studies reviewed were missing key elements that define qualitative case study methodology and the tradition cited. A significant number of studies did not provide a clear methodological description or justification relevant to case study. Case studies in health and social sciences did not provide sufficient information for the reader to understand case selection, and why this case was chosen above others. The context of the cases were not described in adequate detail to understand all relevant elements of the case context, which indicated that cases may have not been contextually bounded. There were inconsistencies between reported methodology, study design, and paradigmatic approach in case studies reviewed, which made it difficult to understand the study methodology and theoretical foundations. These issues have implications for methodological integrity and honesty when reporting study design, which are values of the qualitative research tradition and are ethical requirements (Wager & Kleinert, 2010a ). Poorly described methodological descriptions may lead the reader to misinterpret or discredit study findings, which limits the impact of the study, and, as a collective, hinders advancements in the broader qualitative research field.

The issues highlighted in our review build on current debates in the case study literature, and queries about the value of this methodology. Case study research can be situated within different paradigms or designed with an array of methods. In order to maintain the creativity and flexibility that is valued in this methodology, clearer descriptions of paradigm and theoretical position and methods should be provided so that study findings are not undervalued or discredited. Case study research is an interdisciplinary practice, which means that clear methodological descriptions might be more important for this approach than other methodologies that are predominantly driven by fewer disciplines (Creswell, 2013b ).

Authors frequently omit elements of methodologies and include others to strengthen study design, and we do not propose a rigid or purist ideology in this paper. On the contrary, we encourage new ideas about using case study, together with adequate reporting, which will advance the value and practice of case study. The implications of unclear methodological descriptions in the studies reviewed were that study design appeared to be inconsistent with reported methodology, and key elements required for making judgements of rigour were missing. It was not clear whether the deviations from methodological tradition were made by researchers to strengthen the study design, or because of misinterpretations. Morse ( 2011 ) recommended that innovations and deviations from practice are best made by experienced researchers, and that a novice might be unaware of the issues involved with making these changes. To perpetuate the tradition of case study research, applications in the published literature should have consistencies with traditional methodological constructions, and deviations should be described with a rationale that is inherent in study conduct and findings. Providing methodological descriptions that demonstrate a strong theoretical foundation and coherent study design will add credibility to the study, while ensuring the intrinsic meaning of case study is maintained.

The value of this review is that it contributes to discussion of whether case study is a methodology or method. We propose possible reasons why researchers might make this misinterpretation. Researchers may interchange the terms methods and methodology, and conduct research without adequate attention to epistemology and historical tradition (Carter & Little, 2007 ; Sandelowski, 2010 ). If the rich meaning that naming a qualitative methodology brings to the study is not recognized, a case study might appear to be inconsistent with the traditional approaches described by principal authors (Creswell, 2013a ; Merriam, 2009 ; Stake, 1995 ; Yin, 2009 ). If case studies are not methodologically and theoretically situated, then they might appear to be a case report.

Case reports are promoted by university and medical journals as a method of reporting on medical or scientific cases; guidelines for case reports are publicly available on websites ( http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/case_report.html ). The various case report guidelines provide a general criteria for case reports, which describes that this form of report does not meet the criteria of research, is used for retrospective analysis of up to three clinical cases, and is primarily illustrative and for educational purposes. Case reports can be published in academic journals, but do not require approval from a human research ethics committee. Traditionally, case reports describe a single case, to explain how and what occurred in a selected setting, for example, to illustrate a new phenomenon that has emerged from a larger study. A case report is not necessarily particular or the study of a case in its entirety, and the larger study would usually be guided by a different research methodology.

This description of a case report is similar to what was provided in some studies reviewed. This form of report lacks methodological grounding and qualities of research rigour. The case report has publication value in demonstrating an example and for dissemination of knowledge (Flanagan, 1999 ). However, case reports have different meaning and purpose to case study, which needs to be distinguished. Findings of our review suggest that the medical understanding of a case report has been confused with qualitative case study approaches.

In this review, a number of case studies did not have methodological descriptions that included key characteristics of case study listed in the adapted criteria, and several issues have been discussed. There have been calls for improvements in publication quality of qualitative research (Morse, 2011 ), and for improvements in peer review of submitted manuscripts (Carter & Little, 2007 ; Jasper, Vaismoradi, Bondas, & Turunen, 2013 ). The challenging nature of editor and reviewers responsibilities are acknowledged in the literature (Hames, 2013 ; Wager & Kleinert, 2010b ); however, review of case study methodology should be prioritized because of disputes on methodological value.

Authors using case study approaches are recommended to describe their theoretical framework and methods clearly, and to seek and follow specialist methodological advice when needed (Wager & Kleinert, 2010a ). Adequate page space for case study description would contribute to better publications (Gillard et al., 2011 ). Capitalizing on the ability to publish complementary resources should be considered.

Limitations of the review

There is a level of subjectivity involved in this type of review and this should be considered when interpreting study findings. Qualitative methods journals were selected because the aims and scope of these journals are to publish studies that contribute to methodological discussion and development of qualitative research. Generalist health and social science journals were excluded that might have contained good quality case studies. Journals in business or education were also excluded, although a review of case studies in international business journals has been published elsewhere (Piekkari et al., 2009 ).

The criteria used to assess the quality of the case studies were a set of qualitative indicators. A numerical or ranking system might have resulted in different results. Stake's ( 1995 ) criteria have been referenced elsewhere, and was deemed the best available (Creswell, 2013b ; Crowe et al., 2011 ). Not all qualitative studies are reported in a consistent way and some authors choose to report findings in a narrative form in comparison to a typical biomedical report style (Sandelowski & Barroso, 2002 ), if misinterpretations were made this may have affected the review.

Case study research is an increasingly popular approach among qualitative researchers, which provides methodological flexibility through the incorporation of different paradigmatic positions, study designs, and methods. However, whereas flexibility can be an advantage, a myriad of different interpretations has resulted in critics questioning the use of case study as a methodology. Using an adaptation of established criteria, we aimed to identify and assess the methodological descriptions of case studies in high impact, qualitative methods journals. Few articles were identified that applied qualitative case study approaches as described by experts in case study design. There were inconsistencies in methodology and study design, which indicated that researchers were confused whether case study was a methodology or a method. Commonly, there appeared to be confusion between case studies and case reports. Without clear understanding and application of the principles and key elements of case study methodology, there is a risk that the flexibility of the approach will result in haphazard reporting, and will limit its global application as a valuable, theoretically supported methodology that can be rigorously applied across disciplines and fields.

Conflict of interest and funding

The authors have not received any funding or benefits from industry or elsewhere to conduct this study.

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types of research methodology case study

Case Study Research: Methods and Designs

Case study research is a type of qualitative research design. It’s often used in the social sciences because it involves…

Case Study Method

Case study research is a type of qualitative research design. It’s often used in the social sciences because it involves observing subjects, or cases, in their natural setting, with minimal interference from the researcher.

In the case study method , researchers pose a specific question about an individual or group to test their theories or hypothesis. This can be done by gathering data from interviews with key informants.

Here’s what you need to know about case study research design .

What Is The Case Study Method?

Main approaches to data collection, case study research methods, how case studies are used, case study model.

Case study research is a great way to understand the nuances of a matter that can get lost in quantitative research methods. A case study is distinct from other qualitative studies in the following ways:

  • It’s interested in the effect of a set of circumstances on an individual or group.
  • It begins with a specific question about one or more cases.
  • It focuses on individual accounts and experiences.

Here are the primary features of case study research:

  • Case study research methods typically involve the researcher asking a few questions of one person or a small number of people—known as respondents—to test one hypothesis.
  • Case study in research methodology may apply triangulation to collect data, in which the researcher uses several sources, including documents and field data. This is then analyzed and interpreted to form a hypothesis that can be tested through further research or validated by other researchers.
  • The case study method requires clear concepts and theories to guide its methods. A well-defined research question is crucial when conducting a case study because the results of the study depend on it. The best approach to answering a research question is to challenge the existing theories, hypotheses or assumptions.
  • Concepts are defined using objective language with no reference to preconceived notions that individuals might have about them. The researcher sets out to discover by asking specific questions on how people think or perceive things in their given situation.

They commonly use the case study method in business, management, psychology, sociology, political science and other related fields.

A fundamental requirement of qualitative research is recording observations that provide an understanding of reality. When it comes to the case study method, there are two major approaches that can be used to collect data: document review and fieldwork.

A case study in research methodology also includes literature review, the process by which the researcher collects all data available through historical documents. These might include books, newspapers, journals, videos, photographs and other written material. The researcher may also record information using video cameras to capture events as they occur. The researcher can also go through materials produced by people involved in the case study to gain an insight into their lives and experiences.

Field research involves participating in interviews and observations directly. Observation can be done during telephone interviews, events or public meetings, visits to homes or workplaces, or by shadowing someone for a period of time. The researcher can conduct one-on-one interviews with individuals or group interviews where several people are interviewed at once.

Let’s look now at case study methodology.

The case study method can be divided into three stages: formulation of objectives; collection of data; and analysis and interpretation. The researcher first makes a judgment about what should be studied based on their knowledge. Next, they gather data through observations and interviews. Here are some of the common case study research methods:

One of the most basic methods is the survey. Respondents are asked to complete a questionnaire with open-ended and predetermined questions. It usually takes place through face-to-face interviews, mailed questionnaires or telephone interviews. It can even be done by an online survey.

2. Semi-structured Interview

For case study research a more complex method is the semi-structured interview. This involves the researcher learning about the topic by listening to what others have to say. This usually occurs through one-on-one interviews with the sample. Semi-structured interviews allow for greater flexibility and can obtain information that structured questionnaires can’t.

3. Focus Group Interview

Another method is the focus group interview, where the researcher asks a few people to take part in an open-ended discussion on certain themes or topics. The typical group size is 5–15 people. This method allows researchers to delve deeper into people’s opinions, views and experiences.

4. Participant Observation

Participant observation is another method that involves the researcher gaining insight into an experience by joining in and taking part in normal events. The people involved don’t always know they’re being studied, but the researcher observes and records what happens through field notes.

Case study research design can use one or several of these methods depending on the context.

Case studies are widely used in the social sciences. To understand the impact of socio-economic forces, interpersonal dynamics and other human conditions, sometimes there’s no other way than to study one case at a time and look for patterns and data afterward.

It’s for the same reasons that case studies are used in business. Here are a few uses:

  • Case studies can be used as tools to educate and give examples of situations and problems that might occur and how they were resolved. They can also be used for strategy development and implementation.
  • Case studies can evaluate the success of a program or project. They can help teams improve their collaboration by identifying areas that need improvements, such as team dynamics, communication, roles and responsibilities and leadership styles.
  • Case studies can explore how people’s experiences affect the working environment. Because the study involves observing and analyzing concrete details of life, they can inform theories on how an individual or group interacts with their environment.
  • Case studies can evaluate the sustainability of businesses. They’re useful for social, environmental and economic impact studies because they look at all aspects of a business or organization. This gives researchers a holistic view of the dynamics within an organization.
  • We can use case studies to identify problems in organizations or businesses. They can help spot problems that are invisible to customers, investors, managers and employees.
  • Case studies are used in education to show students how real-world issues or events can be sorted out. This enables students to identify and deal with similar situations in their lives.

And that’s not all. Case studies are incredibly versatile, which is why they’re used so widely.

Human beings are complex and they interact with each other in their everyday life in various ways. The researcher observes a case and tries to find out how the patterns of behavior are created, including their causal relations. Case studies help understand one or more specific events that have been observed. Here are some common methods:

1. Illustrative case study

This is where the researcher observes a group of people doing something. Studying an event or phenomenon this way can show cause-and-effect relationships between various variables.

2. Cumulative case study

A cumulative case study is one that involves observing the same set of phenomena over a period. Cumulative case studies can be very helpful in understanding processes, which are things that happen over time. For example, if there are behavioral changes in people who move from one place to another, the researcher might want to know why these changes occurred.

3. Exploratory case study

An exploratory case study collects information that will answer a question. It can help researchers better understand social, economic, political or other social phenomena.

There are several other ways to categorize case studies. They may be chronological case studies, where a researcher observes events over time. In the comparative case study, the researcher compares one or more groups of people, places, or things to draw conclusions about them. In an intervention case study, the researcher intervenes to change the behavior of the subjects. The study method depends on the needs of the research team.

Deciding how to analyze the information at our disposal is an important part of effective management. An understanding of the case study model can help. With Harappa’s Thinking Critically course, managers and young professionals receive input and training on how to level up their analytic skills. Knowledge of frameworks, reading real-life examples and lived wisdom of faculty come together to create a dynamic and exciting course that helps teams leap to the next level.

Explore Harappa Diaries to learn more about topics such as Objectives Of Research , What are Qualitative Research Methods , How To Make A Problem Statement and How To Improve your Cognitive Skills to upgrade your knowledge and skills.

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Research-Methodology

Case Studies

Case studies are a popular research method in business area. Case studies aim to analyze specific issues within the boundaries of a specific environment, situation or organization.

According to its design, case studies in business research can be divided into three categories: explanatory, descriptive and exploratory.

Explanatory case studies aim to answer ‘how’ or ’why’ questions with little control on behalf of researcher over occurrence of events. This type of case studies focus on phenomena within the contexts of real-life situations. Example: “An investigation into the reasons of the global financial and economic crisis of 2008 – 2010.”

Descriptive case studies aim to analyze the sequence of interpersonal events after a certain amount of time has passed. Studies in business research belonging to this category usually describe culture or sub-culture, and they attempt to discover the key phenomena. Example: “Impact of increasing levels of multiculturalism on marketing practices: A case study of McDonald’s Indonesia.”

Exploratory case studies aim to find answers to the questions of ‘what’ or ‘who’. Exploratory case study data collection method is often accompanied by additional data collection method(s) such as interviews, questionnaires, experiments etc. Example: “A study into differences of leadership practices between private and public sector organizations in Atlanta, USA.”

Advantages of case study method include data collection and analysis within the context of phenomenon, integration of qualitative and quantitative data in data analysis, and the ability to capture complexities of real-life situations so that the phenomenon can be studied in greater levels of depth. Case studies do have certain disadvantages that may include lack of rigor, challenges associated with data analysis and very little basis for generalizations of findings and conclusions.

Case Studies

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Writing a Case Study

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What is a case study?

A Map of the world with hands holding a pen.

A Case study is: 

  • An in-depth research design that primarily uses a qualitative methodology but sometimes​​ includes quantitative methodology.
  • Used to examine an identifiable problem confirmed through research.
  • Used to investigate an individual, group of people, organization, or event.
  • Used to mostly answer "how" and "why" questions.

What are the different types of case studies?

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Note: These are the primary case studies. As you continue to research and learn

about case studies you will begin to find a robust list of different types. 

Who are your case study participants?

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What is triangulation ? 

Validity and credibility are an essential part of the case study. Therefore, the researcher should include triangulation to ensure trustworthiness while accurately reflecting what the researcher seeks to investigate.

Triangulation image with examples

How to write a Case Study?

When developing a case study, there are different ways you could present the information, but remember to include the five parts for your case study.

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Research Method

Home » Research Methodology – Types, Examples and writing Guide

Research Methodology – Types, Examples and writing Guide

Table of Contents

Research Methodology

Research Methodology

Definition:

Research Methodology refers to the systematic and scientific approach used to conduct research, investigate problems, and gather data and information for a specific purpose. It involves the techniques and procedures used to identify, collect , analyze , and interpret data to answer research questions or solve research problems . Moreover, They are philosophical and theoretical frameworks that guide the research process.

Structure of Research Methodology

Research methodology formats can vary depending on the specific requirements of the research project, but the following is a basic example of a structure for a research methodology section:

I. Introduction

  • Provide an overview of the research problem and the need for a research methodology section
  • Outline the main research questions and objectives

II. Research Design

  • Explain the research design chosen and why it is appropriate for the research question(s) and objectives
  • Discuss any alternative research designs considered and why they were not chosen
  • Describe the research setting and participants (if applicable)

III. Data Collection Methods

  • Describe the methods used to collect data (e.g., surveys, interviews, observations)
  • Explain how the data collection methods were chosen and why they are appropriate for the research question(s) and objectives
  • Detail any procedures or instruments used for data collection

IV. Data Analysis Methods

  • Describe the methods used to analyze the data (e.g., statistical analysis, content analysis )
  • Explain how the data analysis methods were chosen and why they are appropriate for the research question(s) and objectives
  • Detail any procedures or software used for data analysis

V. Ethical Considerations

  • Discuss any ethical issues that may arise from the research and how they were addressed
  • Explain how informed consent was obtained (if applicable)
  • Detail any measures taken to ensure confidentiality and anonymity

VI. Limitations

  • Identify any potential limitations of the research methodology and how they may impact the results and conclusions

VII. Conclusion

  • Summarize the key aspects of the research methodology section
  • Explain how the research methodology addresses the research question(s) and objectives

Research Methodology Types

Types of Research Methodology are as follows:

Quantitative Research Methodology

This is a research methodology that involves the collection and analysis of numerical data using statistical methods. This type of research is often used to study cause-and-effect relationships and to make predictions.

Qualitative Research Methodology

This is a research methodology that involves the collection and analysis of non-numerical data such as words, images, and observations. This type of research is often used to explore complex phenomena, to gain an in-depth understanding of a particular topic, and to generate hypotheses.

Mixed-Methods Research Methodology

This is a research methodology that combines elements of both quantitative and qualitative research. This approach can be particularly useful for studies that aim to explore complex phenomena and to provide a more comprehensive understanding of a particular topic.

Case Study Research Methodology

This is a research methodology that involves in-depth examination of a single case or a small number of cases. Case studies are often used in psychology, sociology, and anthropology to gain a detailed understanding of a particular individual or group.

Action Research Methodology

This is a research methodology that involves a collaborative process between researchers and practitioners to identify and solve real-world problems. Action research is often used in education, healthcare, and social work.

Experimental Research Methodology

This is a research methodology that involves the manipulation of one or more independent variables to observe their effects on a dependent variable. Experimental research is often used to study cause-and-effect relationships and to make predictions.

Survey Research Methodology

This is a research methodology that involves the collection of data from a sample of individuals using questionnaires or interviews. Survey research is often used to study attitudes, opinions, and behaviors.

Grounded Theory Research Methodology

This is a research methodology that involves the development of theories based on the data collected during the research process. Grounded theory is often used in sociology and anthropology to generate theories about social phenomena.

Research Methodology Example

An Example of Research Methodology could be the following:

Research Methodology for Investigating the Effectiveness of Cognitive Behavioral Therapy in Reducing Symptoms of Depression in Adults

Introduction:

The aim of this research is to investigate the effectiveness of cognitive-behavioral therapy (CBT) in reducing symptoms of depression in adults. To achieve this objective, a randomized controlled trial (RCT) will be conducted using a mixed-methods approach.

Research Design:

The study will follow a pre-test and post-test design with two groups: an experimental group receiving CBT and a control group receiving no intervention. The study will also include a qualitative component, in which semi-structured interviews will be conducted with a subset of participants to explore their experiences of receiving CBT.

Participants:

Participants will be recruited from community mental health clinics in the local area. The sample will consist of 100 adults aged 18-65 years old who meet the diagnostic criteria for major depressive disorder. Participants will be randomly assigned to either the experimental group or the control group.

Intervention :

The experimental group will receive 12 weekly sessions of CBT, each lasting 60 minutes. The intervention will be delivered by licensed mental health professionals who have been trained in CBT. The control group will receive no intervention during the study period.

Data Collection:

Quantitative data will be collected through the use of standardized measures such as the Beck Depression Inventory-II (BDI-II) and the Generalized Anxiety Disorder-7 (GAD-7). Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up. Qualitative data will be collected through semi-structured interviews with a subset of participants from the experimental group. The interviews will be conducted at the end of the intervention period, and will explore participants’ experiences of receiving CBT.

Data Analysis:

Quantitative data will be analyzed using descriptive statistics, t-tests, and mixed-model analyses of variance (ANOVA) to assess the effectiveness of the intervention. Qualitative data will be analyzed using thematic analysis to identify common themes and patterns in participants’ experiences of receiving CBT.

Ethical Considerations:

This study will comply with ethical guidelines for research involving human subjects. Participants will provide informed consent before participating in the study, and their privacy and confidentiality will be protected throughout the study. Any adverse events or reactions will be reported and managed appropriately.

Data Management:

All data collected will be kept confidential and stored securely using password-protected databases. Identifying information will be removed from qualitative data transcripts to ensure participants’ anonymity.

Limitations:

One potential limitation of this study is that it only focuses on one type of psychotherapy, CBT, and may not generalize to other types of therapy or interventions. Another limitation is that the study will only include participants from community mental health clinics, which may not be representative of the general population.

Conclusion:

This research aims to investigate the effectiveness of CBT in reducing symptoms of depression in adults. By using a randomized controlled trial and a mixed-methods approach, the study will provide valuable insights into the mechanisms underlying the relationship between CBT and depression. The results of this study will have important implications for the development of effective treatments for depression in clinical settings.

How to Write Research Methodology

Writing a research methodology involves explaining the methods and techniques you used to conduct research, collect data, and analyze results. It’s an essential section of any research paper or thesis, as it helps readers understand the validity and reliability of your findings. Here are the steps to write a research methodology:

  • Start by explaining your research question: Begin the methodology section by restating your research question and explaining why it’s important. This helps readers understand the purpose of your research and the rationale behind your methods.
  • Describe your research design: Explain the overall approach you used to conduct research. This could be a qualitative or quantitative research design, experimental or non-experimental, case study or survey, etc. Discuss the advantages and limitations of the chosen design.
  • Discuss your sample: Describe the participants or subjects you included in your study. Include details such as their demographics, sampling method, sample size, and any exclusion criteria used.
  • Describe your data collection methods : Explain how you collected data from your participants. This could include surveys, interviews, observations, questionnaires, or experiments. Include details on how you obtained informed consent, how you administered the tools, and how you minimized the risk of bias.
  • Explain your data analysis techniques: Describe the methods you used to analyze the data you collected. This could include statistical analysis, content analysis, thematic analysis, or discourse analysis. Explain how you dealt with missing data, outliers, and any other issues that arose during the analysis.
  • Discuss the validity and reliability of your research : Explain how you ensured the validity and reliability of your study. This could include measures such as triangulation, member checking, peer review, or inter-coder reliability.
  • Acknowledge any limitations of your research: Discuss any limitations of your study, including any potential threats to validity or generalizability. This helps readers understand the scope of your findings and how they might apply to other contexts.
  • Provide a summary: End the methodology section by summarizing the methods and techniques you used to conduct your research. This provides a clear overview of your research methodology and helps readers understand the process you followed to arrive at your findings.

When to Write Research Methodology

Research methodology is typically written after the research proposal has been approved and before the actual research is conducted. It should be written prior to data collection and analysis, as it provides a clear roadmap for the research project.

The research methodology is an important section of any research paper or thesis, as it describes the methods and procedures that will be used to conduct the research. It should include details about the research design, data collection methods, data analysis techniques, and any ethical considerations.

The methodology should be written in a clear and concise manner, and it should be based on established research practices and standards. It is important to provide enough detail so that the reader can understand how the research was conducted and evaluate the validity of the results.

Applications of Research Methodology

Here are some of the applications of research methodology:

  • To identify the research problem: Research methodology is used to identify the research problem, which is the first step in conducting any research.
  • To design the research: Research methodology helps in designing the research by selecting the appropriate research method, research design, and sampling technique.
  • To collect data: Research methodology provides a systematic approach to collect data from primary and secondary sources.
  • To analyze data: Research methodology helps in analyzing the collected data using various statistical and non-statistical techniques.
  • To test hypotheses: Research methodology provides a framework for testing hypotheses and drawing conclusions based on the analysis of data.
  • To generalize findings: Research methodology helps in generalizing the findings of the research to the target population.
  • To develop theories : Research methodology is used to develop new theories and modify existing theories based on the findings of the research.
  • To evaluate programs and policies : Research methodology is used to evaluate the effectiveness of programs and policies by collecting data and analyzing it.
  • To improve decision-making: Research methodology helps in making informed decisions by providing reliable and valid data.

Purpose of Research Methodology

Research methodology serves several important purposes, including:

  • To guide the research process: Research methodology provides a systematic framework for conducting research. It helps researchers to plan their research, define their research questions, and select appropriate methods and techniques for collecting and analyzing data.
  • To ensure research quality: Research methodology helps researchers to ensure that their research is rigorous, reliable, and valid. It provides guidelines for minimizing bias and error in data collection and analysis, and for ensuring that research findings are accurate and trustworthy.
  • To replicate research: Research methodology provides a clear and detailed account of the research process, making it possible for other researchers to replicate the study and verify its findings.
  • To advance knowledge: Research methodology enables researchers to generate new knowledge and to contribute to the body of knowledge in their field. It provides a means for testing hypotheses, exploring new ideas, and discovering new insights.
  • To inform decision-making: Research methodology provides evidence-based information that can inform policy and decision-making in a variety of fields, including medicine, public health, education, and business.

Advantages of Research Methodology

Research methodology has several advantages that make it a valuable tool for conducting research in various fields. Here are some of the key advantages of research methodology:

  • Systematic and structured approach : Research methodology provides a systematic and structured approach to conducting research, which ensures that the research is conducted in a rigorous and comprehensive manner.
  • Objectivity : Research methodology aims to ensure objectivity in the research process, which means that the research findings are based on evidence and not influenced by personal bias or subjective opinions.
  • Replicability : Research methodology ensures that research can be replicated by other researchers, which is essential for validating research findings and ensuring their accuracy.
  • Reliability : Research methodology aims to ensure that the research findings are reliable, which means that they are consistent and can be depended upon.
  • Validity : Research methodology ensures that the research findings are valid, which means that they accurately reflect the research question or hypothesis being tested.
  • Efficiency : Research methodology provides a structured and efficient way of conducting research, which helps to save time and resources.
  • Flexibility : Research methodology allows researchers to choose the most appropriate research methods and techniques based on the research question, data availability, and other relevant factors.
  • Scope for innovation: Research methodology provides scope for innovation and creativity in designing research studies and developing new research techniques.

Research Methodology Vs Research Methods

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

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Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

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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.

case study

 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
  • “We do things together” A case study of “couplehood” in dementia
  • Using mixed methods for evaluating an integrative approach to cancer care: a case study

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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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  • Published: 22 February 2024

Understanding implementation of findings from trial method research: a mixed methods study applying implementation frameworks and behaviour change models

  • Taylor Coffey   ORCID: orcid.org/0000-0002-6921-8230 1 ,
  • Paula R. Williamson 2 &
  • Katie Gillies 1

on behalf of the Trials Methodology Research Partnership Working Groups

Trials volume  25 , Article number:  139 ( 2024 ) Cite this article

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Trial method research produces recommendations on how to best conduct trials. However, findings are not routinely implemented into practice. To better understand why, we conducted a mixed method study on the challenges of implementing trial method research findings into UK-based clinical trial units.

Three stages of research were conducted. Firstly, case studies of completed projects that provided methodological recommendations were identified within trial design, conduct, analysis, and reporting. These case studies were used as survey examples to query obstacles and facilitators to implementing method research. Survey participants were experienced trial staff, identified via email invitations to UK clinical trial units. This survey assessed the case studies’ rates of implementation, and demographic characteristics of trial units through the Consolidated Framework for Implementation Research. Further, interviews were conducted with senior members of trial units to explore obstacles and facilitators in more detail. Participants were sampled from trial units that indicated their willingness to participate in interviews following the survey. Interviews, and analysis, were structured via the Capability, Opportunity, Motivation Model of Behaviour. Finally, potential strategies to leverage lessons learned were generated via the Behaviour Change Wheel.

A total of 27 UK trial units responded to the survey. The rates of implementation across the case studies varied, with most trial units implementing recommendations in trial conduct and only few implementing recommendations in reporting. However, most reported implementing recommendations was important but that they lacked the resources to do so. A total of 16 senior members of trial units were interviewed. Several themes were generated from interviews and fell broadly into categories related to the methods recommendations themselves, the trial units, or external factors affecting implementation. Belief statements within themes indicated resources issues and awareness of recommendations as frequent implementation obstacles. Participation in trial networks and recommendations packaged with relevant resources were cited frequently as implementation facilitators. These obstacles and facilitators mirrored results from the survey. Results were mapped, via the Behaviour Change Wheel, to intervention functions likely to change behaviours of obstacles and facilitators identified. These intervention functions were developed into potential solutions to reduce obstacles and enhance facilitators to implementation.

Conclusions

Several key areas affecting implementation of trial method recommendations were identified. Potential methods to enhance facilitators and reduce obstacles are suggested. Future research is needed to refine these methods and assess their feasibility and acceptability.

Peer Review reports

Clinical trials provide evidence to support decisions about practice in many aspects of healthcare. As well as generating evidence to inform decision making, trials need to, themselves, be informed by evidence in how they are designed, conducted, analysed, and reported to ensure they produce the highest quality outputs [ 1 , 2 , 3 ]. This is essential to guarantee not only that trials contribute to evidence-based practice, but that all phases of the trial ‘lifecycle’ also support efforts to minimise research waste by building on best practice for how to design, conduct, analyse, and report trials [ 1 , 2 , 4 , 5 ].

Research into how best to design, conduct, analyse, and report clinical trials, known as trial method research [ 1 , 3 ], has expanded in recent years. For example, a widely studied aspect of trial conduct is recruitment. One project, the Online Resource for Research in Clinical triAls (ORRCA), is an ongoing effort to scope methodological work in recruitment. In their initial publication, the ORRCA team identified 2804 articles, published up to 2015, regarding recruitment [ 6 ]. Their most recent update in February 2023 found 4813 eligible papers, an increase of 70% in less than 5 years from the initial publication [ 6 , 7 ]. As this is just one area of trial methodology, it represents only a fraction of the work being done in this space. With such a large volume of research being generated, coordinated efforts are needed to ensure that learning is shared across research groups to prevent duplication of effort and promote collaboration. There is recognition across the trial method research community that there is significant variability in terms of whether and how the findings from this methodological research influence ‘practice’ with regard to trial design, conduct, analysis, or reporting [ 3 , 8 , 9 ]. Similar to clinical practice, where evidence can fail to be implemented [ 10 , 11 ], it is critical that the challenges and opportunities to implementing trial method research findings into practice are understood. This understanding will then maximise the potential for this research to improve health by improving the trials themselves.

Barriers to implementation are known to be complex and involve multifactorial influences [ 12 , 13 , 14 ]. Whilst this is established for clinical evidence [ 15 ], it is also likely to be the case for methodological evidence—yet the specific challenges may be different. Implementation science (and in particular the use of behavioural approaches which are theory-informed) provides a rigorous method for identifying, diagnosing, and developing solutions to target factors with the potential to enhance or impede behaviour change and subsequent integration of those changes [ 2 , 10 , 14 , 16 ]. Data generated using these theoretical approaches are likely more reproducible and generalisable than alternatives [ 2 , 16 , 17 , 18 ]. The potential for lessons from behavioural science to investigate who needs to do what differently, to whom, when, and where, within the context of clinical trials is receiving attention across various stages of the trial lifecycle [ 2 ]. The overall aim of this study was to generate evidence for the challenges and opportunities trialists experience with regard to implementing the results from trial method projects that target the design, conduct, analysis, or reporting of trials.

Overall study description

We designed a sequential exploratory mixed methods study with three linked components:

Case studies : which identified existing examples of trial method research projects with actionable outputs that were believed to influence trial design, conduct, analysis, or reporting practice. “Actionable outputs” were defined broadly as any resource, generated from these projects, that has led to an actual or potential change in the design, conduct, analysis, or reporting of trials.

Survey : which identified the broad range, and frequency, of challenges and opportunities to the implementation of trial method research. Participants were trialists from across the UK, specifically the Clinical Research Collaboration (UKCRC) Network of Registered Clinical Trials Units (CTUs). The UKCRC was established to “help improve the quality and quantity of available expertise to carry out UK clinical trials.” ( https://www.ukcrc.org/research-infrastructure/clinical-trials-units/registered-clinical-trials-units/ ).

Interviews : which explored in depth the challenges and opportunities for implementing trial method research from case study examples and general experience in CTU management.

Theoretical considerations and rationale

It is important when selecting theoretical frameworks, and even more so when combining them within one study, to provide an explicit rationale for the choice of framework(s) [ 14 ]. This study utilised a combined theoretical approach, with the Consolidated Framework of Implementation Research (CFIR) [ 13 ] guiding the survey development, and the Capability, Motivation, and Opportunity Model of Behaviour (COM-B) [ 18 ] guiding the interview guide and analysis. CFIR was designed to synthesise the key elements that underpin implementation efforts [ 13 ]. It was selected in this study to guide the survey design because it provided a systematic framework to structure our inquiry. The CFIR is comprehensive in its descriptions of constructs and how they affect implementation across different organisational levels [ 13 ]. As the survey was intended to focus more explicitly on the organisational structure of the CTUs, the CFIR possessed the context-specific language and concepts to describe and prioritise our initial findings. The COM-B, in contrast, is broader in its scope as a general theory of behaviour and behaviour change. As implementation efforts largely rely on the adoption and maintenance of new behaviours, or changes to existing ones, behaviour change theory is useful to describe the determinants of behaviour and how they relate to one another [ 18 ]. This latter point is particularly relevant for implementation efforts as they are likely to consist of multiple changed behaviours, across different contexts, within an organisation to deliver the ultimate objective of research findings [ 19 ]. The COM-B’s capacity to accommodate such complexity outside the prescribed constructs of the CFIR ensured that all relevant factors to implementation are considered [ 14 ]. The approaches are further complementary in their conception of the socio-ecological layers within CTUs in which implementation takes place. Again, the CFIR provides the context-specific labels to, and ability to prioritise, these layers, with the COM-B acting as a methodological “safety net” to further describe or categorise findings. And finally, the COM-B is linked to a method of intervention development (and policy functions), known as the Behaviour Change Wheel (BCW). Through the BCW, nine potential categories of interventions are linked to the behavioural domains of the COM-B [ 18 ]. This link allows potential solutions to be identified based on the domains found to be most relevant or targetable for the behaviour intended to change.

Case studies

Participants.

Members of the Trials Methodology Research Partnership (TMRP) Working Groups ( https://www.methodologyhubs.mrc.ac.uk/about/tmrp/ ) were invited to contribute. Members of these working groups specialise in one or more areas of clinic trial methodology, and all have academic and/or professional interests in improving the quality of trials.

Data collection

An email was sent directly to members of the TMRP Working Group co-leads to solicit case studies of trial method implementation projects with actionable outputs. The email included a brief description of the project and aims of the case study selection, followed by two questions. The first question asked for any examples of trial method research that respondents were aware of. Question 2 asked respondents to provide what they believed were the “actionable outputs” (i.e. the resources generated that lead to implementation of findings) of those methods research projects. Examples of potential actionable outputs could include published papers, guidelines or checklists, template documents, or software packages.

Data analysis

Responses were collated and reviewed by the research team (TC, PW, KG) for their relevance to the four aspects of design, conduct, analysis, and reporting of trials. These responses were compared with a list of published outputs collected by the HTMR ( Network Hubs:: Guidance pack (mrc.ac.uk) ) to ensure a wide-reaching range of available trial method research. One case study was chosen for each domain of trial method research through team consensus, resulting in four case studies incorporated into the survey.

Directors (or individuals nominated by Directors) of the 52 UKCRC-registered CTUs were invited to participate via email from a central list server independent to the research team.

Inclusion and exclusion criteria

Participants were included if they had been involved in any aspect of trial design, delivery, analysis, or reporting within the network of UKCRC-registered CTUs. Any individuals identifying as not reading, writing, or speaking English sufficiently well to participate, or those unable to consent, were excluded.

The survey was designed, and data collected, via the online survey platform Snap (Version 11). A weblink was distributed to the 52 UK CRC-registered CTUs, along with a description of the study, and a Word document version of the survey (available in Additional file 1 : Appendix 1). CTU staff were instructed to distribute this Word version of the survey to members of staff and collate their responses. Collated responses were then entered into the survey at the provided weblink. The survey was designed utilising the Inner Domains of the CFIR [ 13 ] to broadly capture participant views on how trial method research informed the design, conduct, analysis, and reporting of trials run through their CTU. It assessed the perceived organizational structure of the CTU and how those demographics influence the adoption of trial method research. It also asked specific questions about each of the case studies selected from the previous phase. Responses consisted of a mixture of single-choice, Likert scales from 1 to 9 (1 being negative valence and 9 being positive valence), and free-text.

Examples of trial method research projects suggested by respondents (or research area, e.g., recruitment, if no specific project name was given) were collated and frequency counts for each generated. Frequency counts for the types of actionable outputs from these projects were also calculated. Likert scale responses (ranging from 1 to 9) were analysed through descriptive statistics (mean, standard deviation) to compare responses within and between CTUs, the unit of analysis. Some CFIR domains were assessed by more than one question, and so responses to those questions were averaged to give an overall score for the domain. Scores across all domains for a given site were averaged to give a “general implementation” score. The individual scores on measures of these constructs are presented below using a coloured heatmap to highlight areas of high (green) to low (red) activity and provide easy comparison across and within sites. Additional free-text data were analysed using a directed content analysis approach [ 20 ]. Terms and phrases that occurred frequently within this data were collated and then themes summarising barriers and opportunities were generated.

Survey responders indicated their willingness to be contacted for participation in an interview. Emails were sent directly to those who indicated interest in participating.

Recruitment and data collection

Interviews were conducted by a trained qualitative researcher (TC) and structured using a theory-informed topic guide. This topic guide (Additional file 2 : Appendix 2) was developed using the COM-B Model of Behaviour [ 18 ]. Questions prompted interview participants to consider the behavioural influences relevant to implementing findings from trial method research generally and from the selected case studies. Interviews were conducted and recorded through Microsoft Teams. Verbal consent to participate in interviews was obtained and recorded prior to interviews beginning. Recordings were transcribed verbatim by a third party (approved by the University of Aberdeen), de-identified, and checked for accuracy.

Data from interviews were imported into NVivo (V12, release 1.6.1) and analysed initially using a theory-based (COM-B) content analysis [ 20 ], which allowed data to be coded deductively informed by the domains of the COM-B. This involved highlighting utterances within the transcripts and assigning them to one of the six behavioural sub-domains: “psychological capability”, “physical capability”, “social opportunity”, “physical opportunity”, “reflective motivation”, or “automatic motivation”. The next phase of analysis was inductive, allowing identification of additional themes that may have been outside the COM-B domains but were still deemed relevant to the research question. One author (TC) completed coding independently for all interviews. A second author (KG) reviewed a 10% sample of interviews and coded them independently. Coding was then compared for agreement and any discrepancies resolved. Data were compared and coded through a process of constant comparison to provide a summary of key points that interview participants considered to be important. Interview data were specifically explored for any difficulties reported by trialists with regard to the challenges, opportunities, and potential strategies to facilitate the implementation of findings. These data were collected under “belief statements”, which collected similar statements made across participants under a descriptive heading informed by the statements’ COM-B domain. For instance, similar statements on the availability of resources could be collected under a belief statement, “We do not have enough resources”, representing a barrier within the COM-B domain of “physical opportunity”. Belief statements were then analysed for themes across COM-B domains. These themes were developed as narrative summaries of recurrent experiences, barriers, and facilitators to implementation of methods findings. Themes are presented below with their component COM-B domains indicated within the theme’s title. This thematic framework was reviewed, refined, and agreed by consensus of the research team.

Identifying potential solutions

Relevant COM-B domains identified during the interviews and agreed by group consensus were mapped to behavioural intervention functions. Mapping of intervention functions was based on instructions within a behavioural intervention guideline known as the Behaviour Change Wheel (BCW) [ 18 ]. The BCW describes the intervention functions that are believed to influence the individual domains of the COM-B. For example, a lack of psychological capability could be targeted with the intervention function “Education”, which is defined as “increasing knowledge or understanding” [ 18 ]. More than one intervention function is available for each COM-B domain and domains often share one or more intervention functions in common. Utilising the definitions and examples of intervention functions applied to interventions, the research team generated potential solutions based on the available intervention functions targeting the relevant COM-B domains. These solutions were additionally based on the research team’s impressions of targetable belief statements within relevant COM-B domains. For example, if a lack of knowledge was identified (and thus psychological capability) a blanket educational intervention would not necessarily be fit for purpose if only a particular group within an organisation lacked that knowledge whilst others did not. The potential solutions were refined through application of the Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Side-effects and safety, Equity (APEASE) criteria. Application of these criteria to the selection of intervention functions is recommended by the BCW so that research teams can reflect on factors that may limit the relevance and suitability of potential solutions to stakeholders [ 18 ].

Six of 16 Working Group co-leads responded with potential case studies for inclusion. Participants identified a number of trial method research projects, and the project’s outputs, via free-text response to the email prompts. A total of 13 distinct projects were reported by the respondents, primarily in the areas of trial design and analysis, with a particular emphasis on statistical and data collection methods. As a result, case studies for methods research targeting the other two areas of a trial lifecycle, conduct, and reporting, were selected from the list collated by the research team. The four case studies [ 21 , 22 , 23 , 24 ] were selected to consider the variability of project focus across the four areas of trial method research. The selected case studies are described below in Table  1 .

Site demographics

A total of 27 UK CTUs (Table  2 ) responded to the survey, just over half of all UK CRC-registered CTUs ( N  = 52). CTUs were primarily in operation from 10 to 20 years (55%) or more than 20 years (30%). The size of CTUs, by staff number, were divided fairly equally between the small (< 50), medium (50–100), and large (100 +) categories. Most sites characterised themselves as moderately ( n  = 12) to highly stable ( n  = 12) in regard to staff turnover.

Inner domains of the CFIR: culture, implementation climate, networks, and communication

Alongside the structural demographic characteristics described above, we assessed other constructs within the CFIR’s Inner domains. The individual scores on our measures of these constructs are presented in Table  3 below using a coloured heatmap to highlight areas of high to low activity and provide easy comparison across and within sites. Most sites ( n  = 24) achieved general implementation scores between 5 and 7. Typically, scores were reduced due to low ratings for available resources (i.e. money, training, time) within the CTU. Time possessed the lowest individual score, with an average of 3.2 (SD = 1.9). The individual item with the highest average score, 8.2 (SD = 1.3), asked whether relevant findings were believed to be important for the CTU to implement. Finally, available training/education resources were the item with the highest variability across sites, with a standard deviation of 2.2.

Implementation of example case studies

The two case studies that were the most widely implemented were the DAMOCLES charter and the guidelines for statistical analysis plans. Both case studies were implemented fully by a majority of sites ( n  = 21) with a further minority implementing them at least partially ( n  = 5). The recommendations for internal pilots was fully implemented in some sites ( n  = 8), partially in others ( n  = 9), but was not implemented at all in still others ( n  = 10). The RECAP guidance was not implemented at all in 20 sites, partially in five, and fully in two.

Survey participants reported several key obstacles and facilitators to implementation of the case studies. These factors are summarised, along with the degree of implementation of each case study across the CTUs, in Table  4 below. Two of the most frequently cited factors to enhance or hinder implementation related to the dissemination of findings. The first concerned how findings were packaged for dissemination, with survey respondents noting the utility of templates and write-ups of examples. The second related to the communication of new findings. Respondents mentioned professional networks and conferences as useful in keeping CTU staff up to date on relevant methods research. Workshops, presentations, and other events within those networks also provided these same opportunities with the additional benefit of being tailored to translating findings into practice. A frequently mentioned barrier described potentially inadequate dissemination efforts, as participants cited a lack of capacity to “ horizon scan ” for new findings. Time and funding constraints were described as leading to this lack of capacity. Finally within communication, participants reported that if a member of their CTU had been involved in methods research, it was more likely to be implemented.

Participant characteristics

Sixteen individuals (Table  5 ) participated in interviews, representing CTUs from across the UK. Participants were primarily directors or other senior members of their respective CTUs. Half of respondents ( n  = 8) had been in these roles for less than 5 years, with a further seven being in their roles from 5 to 10 years. Most ( n  = 11) had been working in trials generally for 20–29 years.

Interview findings

Interviews were conducted remotely and typically lasted 30–45 min. Belief statements were generated under the domains of the COM-B. Those domains were psychological capability, reflective motivation, automatic motivation, physical opportunity, and social opportunity. Cross-domain themes were generated from related belief statements to summarise overall content. Seven themes were identified: “The influence of funders”, “The visibility of findings”, “The relevance and feasibility of findings”, “Perceived value of implementation research”, “Interpersonal communication”, “Existing work commitments”, and “Cultural drivers of implementation”. Themes are presented in detail below with the relevant COM-B domains to which they are linked presented in parentheses. The themes are further organised into the socio-ecological levels for which they are most relevant, i.e. at the level of the CTU (Internal), outside the CTU (External), or to do with the findings themselves (Findings).

External factors

Theme 1—The influence of funders (social/physical opportunity and reflective motivation).

Interview participants spoke of the influence of funders as important to what trial method research findings are implemented. These influences were comprised of both the resource implication of funding allocation (physical opportunity) as well as the cultural influence that funders possess (social opportunity). With regard to resource implications, there were restrictions on what implementation-related activities trial staff could perform based on the lack of protected time within their roles that could be allocated to implementation (physical opportunity). Secondly, limitations on time were superseded by requirements set out by funders on which trial method research findings needed to be implemented within their trials. If particular findings were deemed necessary by bodies like the NIHR, CTU staff had no choice but to find time to implement them (reflective motivation). Related to these beliefs was the idea that clear efforts at implementing relevant trial method research findings could signal to funders that the CTU team possessed the skills required to conduct trials, thereby increasing the opportunities for funding through a sort of “competitive edge” (reflective motivation).

“I think the progression criteria, as I said, I think is being driven more by the funders expectations rather than anything else, and then other people go, “Well, if the funder expects to see it, I just have to do it,” so then... they might grumble, basically, but if you’re going to put your grant application in, and you want it to be competitive, this is what we have to do.” – Site 7, director

Theme 2—The visibility of findings (social/physical opportunity and psychological capability).

One of the main barriers cited by interviewees was simply knowing about trial method research findings. Participants described the limits on their own time and capacity in “horizon scanning” for new publications and resources, which was often compounded by the sheer volume of outputs (psychological capability).

“I mean probably the greatest competing demand is being up to speed on what’s coming out that’s new. That’s probably where I would feel that… yes, trying to… I know everyone feels like they don’t have enough time to just read and be aware of the stuff coming out, so that’s… I’m more anxious, and I know others are, that there’s stuff being done that we don’t even know about to try and implement, so in some ways we might almost be repeating the wheel of trying to improve best practice in a topic area, and actually someone’s done loads of work on it.” – Site 3, director.

However, interviewees highlighted several resources as means to close this knowledge gap. Dedicated channels for dissemination of important trial method research findings were one means to stay on top of emerging literature. These could be newsletters, websites, or meetings where part, or all, of the agenda was set aside for updates on findings (physical opportunity). Other resources mentioned included more social opportunities to hear about the latest research, at conferences like the International Clinical Trials Methodology Conference (ICTMC) or network events like training and workshops. These events were also cited as important venues to share lessons learned in implementing trial method research findings or to air general frustrations on the complexities of trial conduct and management (social opportunity). Finally, these networking opportunities were identified by interviewees as potent incubators for collaborations, inspiring new trial method projects or establishing links to assess existing ones. Interviewees reported that the opportunity to be involved in these methods projects worked to also raise awareness of their outputs as well as increasing the perceived relevance of these outputs to CTU staff (psychological capability).

“Again, I think I was very aware of [statistical analysis plans] in my previous role as well, so I’d been along to some of the stats group meetings that the CTU networks have run where this had been discussed before it was published. I think they certainly involved a lot of the CTUs in developing that as well and in canvassing comments that went into the paper. I think potentially that would have been easier for people to implement because we’d had some involvement in the developmental bit as well as it went along.” – Site 22, academic

Internal factors

Theme 3—Interpersonal communication (psychological capability, social/physical opportunity, and automatic motivation).

As our participants were senior members of their respective CTUs, they often described aspects of their role and how their efforts mesh with the overall culture of the CTU. A recurrent feature reported by interviewees relating to their role was to be the central figure in communicating the importance of implementation convincingly to their staff and trial sites. This meant they had to advocate for the relevance of trial method research findings to their CTU staff and motivate staff on changing their processes to align with the findings (reflective motivation). This aspect of communication could be more challenging with chief investigators if they were not convinced of the utility of implementation within their own trials, particularly if they anticipated opportunity or resource cost to hosting the research itself or the process changes of implementing findings (social/physical opportunity). Regardless of where it originated, such resistance to change could be frustrating and draining to senior members that were attempting to spearhead implementation efforts (automatic motivation).

“R – Was it ever stressful or frustrating to implement certain things? P – Yes, I would say it can definitely be. I would be lying if I said no. Because change is always.. there’s always a resistance to change in every institution, so it’s not easy to change things. Yes, it can be frustrating, and it can be painful. Things that help are probably when it’s a requirement and when it’s... whatever you do it goes into your SOPs, and then you say, ‘This is how I have to do it, so this is how we will do it.’ But getting to the step of the institution to recognise it, and the people you’re working with, it can be frustrating because there could be arguments like are hard to argue back like, ‘We don’t have the resources, we don’t have the time. Now is not the moment, we’re...’ so there’s all of these things, but also there’s the effort that it takes to convince people that it’s worthwhile doing the change. It’s definitely... it can be frustrating and disappointing, and it takes a lot of energy.” – Site 21, group lead

However, some broader cultural aspects of the CTU appeared to reduce such frustrations. Participants described that their CTU members were often open to new ideas and that such receptivity facilitated implementation (social opportunity). This openness to change was leveraged through the communication skills of senior staff that were previously mentioned and their ability to solicit opinions and feedback from their staff (psychological capability). Such discussions often took place at internal trainings or meetings that incorporated some focus on implementation efforts for the CTU staff (physical opportunity). These opportunities not only afforded discourse on the practicalities of implementation but also helped to raise general awareness of trial method research findings as well as potential adaptations of findings to better suit the individual requirements of the CTU.

“Yes, I mean at our Trials Unit, I run our monthly trial methodology meetings, so these are predominantly attended by statisticians, so we do focus more on trial methodology that’s more statistical in flavour, but we do always cover the new updates and any key publications we’ve seen. I find that’s a great format for getting people interested and excited in these new methods and distilling them down. Generally, across the unit, we have wider… they’re like two forums, just where everyone gets together, and we tend to have bitesize sessions there where we can distil something. Actually, they’re quite useful because internally, we can distil something new to people but in a bitesize chunk so that people are aware and then can take it further and develop specific… if it’s something quite big, then we can develop working groups to look into it and come to a more solid plan of how we can actually implement it if it seems useful.” – Site 25, academic

Theme 4—Existing work commitments (physical opportunity).

Whilst openness to implementation at the CTU, driven by leadership advocating for its importance, was often present in the interviews, resource restrictions were still an ever-present factor impacting the opportunities for CTU staff to improve practice. Interviewees reported that because any change to be implemented required time and effort to action, mentions of these opportunity costs were reflected universally across our sample. The CTU staff, according to their directive, must prioritise the design of new trials and the delivery of ongoing trials.

“But you know, it’s real, it’s a real challenge and intention to be able to keep your eye on the ball and the many different competing priorities that there are. It does sound like a bit of a weak excuse when you say it out loud. So, our focus is on doing the trials, but of course we should always be trying to have an eye on what is the evidence that it’s underpinning what we do in those trials. We should. But with the best will in the world, it’s writing applications, responding to board comments, getting contracts done once things are funded, getting trials underway. The focus is just constantly on that work of trying to win funding and delivering on what you said you were going to deliver, in amongst all the other business of running a CTU or recruiting staff, managing funding contracts, dealing with our institutions, our universities, our local trusts. All the efforts that go into getting trials underway in terms of writing documents and approvals and recruiting sites, you know?” – Site 10, director

Mitigating these resource restrictions often meant looking to other strategies (mentioned in the next theme) that might allow CTU staff to carve out some capacity towards implementation.

Theme 5—Cultural drivers of implementation (psychological capability, physical opportunity, reflective motivation).

As senior members of their respective CTUs, our participants displayed clear motivations to implement trial method research. They expressed that they would like to see the staff in the CTU improve both the uptake of trial method research findings, as well as generating their own method research. This was part of a larger desire to create a culture within their CTUs that encourages and supports research (reflective motivation).

“I hope that within the Trials Unit, I also create an environment where I’m trying to encourage people to not always work to capacity, so they do have the headroom to go away and explore things and to try things and to develop their own research ideas, so that we can say to people okay. Whether it’s looking at different patient information sheets, whether it’s looking at different recruitment strategies, whether it’s looking at different ways of doing data cleaning across sites, looking at different ways of delivering training to people for data entry because we’ve lots of different ways of delivering training and we still get a very high error rate. I’m sure there are other Trials Units that are doing the same thing, so we should be publishing and sharing that with Trials Units. I’m trying to create that environment.” – Site 1, director

Some potential avenues to promote that development were offered by participants. Firstly, participants were confident in their team’s expertise and ability to either generate or implement trial method research findings. This was evidenced through ongoing work being done within their CTU or discussions with their staff on areas they would like to dedicate time to (psychological capability). An important role for the senior members of staff is then to set out expectations for their teams around how they can leverage their expertise within implementing or generating trial method research findings and for senior members to offer the necessary support for that to happen. One option put forward to facilitate this leveraging of expertise was to provide career development opportunities centred on implementation. This could simply be allocating staff’s time to focus on implementation projects, protecting their time from usual work commitments. A further development opportunity would be appointing so-called “ champions ” within the CTU whose explicit role is to identify trial method research findings and coordinate their implementation (physical opportunity).

“Because sometimes what I think is [...] you need a champion, you need every CTU to implement these things and because every trial or every trials unit is composed of different people, so I would probably champion the SAPs part because I’m the statistician, and I make sure that that goes ahead, but someone else needs to champion the one on the patients, probably. Not necessarily. I would champion for all of these things, but because... I think it's finding these people that are the ones that see the value and then be the drivers of the unit. I think that will probably help. […] But I honestly think the best way is just reaching a champion for each of these areas and reaching out to them and saying, ‘Can you... what do you think of this, and what would you do to implement it in your own unit?’” – Site 21, group lead

Factors related to findings

Theme 6—Relevance and feasibility of findings (physical opportunity, reflective motivation, and psychological capability).

Not all findings from trial method research are applicable to all trials and there to all CTUs. For instance, some of our participants mentioned that the progression criteria recommendations were not widely implemented by their CTU staff because they did not often include internal pilots in their trials. So, once the challenges of knowing about trial method research findings are overcome, CTU staff then need to make decisions on what is most relevant to their trial portfolio and what they would like to prioritise implementing (reflective motivation). This prioritisation was dependent on two factors, the CTU staff’s ability to adapt findings to their needs and the implementation resources that findings are packaged with. These factors appeared to be interconnected as sufficient resources to aid implementation, such as training workshops, could reduce the burden of adaptation (physical opportunity). Conversely, staff that perceived their CTU as capable of adaptation could do so even when implementation resources were lacking, such as when trial method research findings are only shared via publication (psychological capability).

“I think that resources that are guidance types widely available, well-advertised, are probably the most... the easiest way. Everything that makes it easier for a person that has this little win of saying, ‘Oh, yes, we’ve probably considered doing things differently,’ anything that minimises that burden in a system I do. For example, with the SAPs, it’s not just the paper and the guidance, but it’s the templates and the little things that you say, ‘Oh, I can start from here, and then if I just use this and this, then the work is so much less […]’ It’s just that thinking of resources that at least create an easy start point for a person that is the right person. I think that would be the best strategy for me, and make them widely available and well-advertised and probably, I don’t know, distribute them, contact the CTUs and say, ‘By the way, here’s a nice resource that you can use if you want to improve this and that.’ I think anything like that could probably be the way I would go around improving the implementation and the uptake because I feel that the goodwill is there.” – Site 21, group lead

Theme 7—Perceived value of implementation (reflective motivation).

Following on from the idea that there is the “ goodwill ” to implement trial method research findings, it was unsurprising that our participants reported believing that implementation research is important. Many believed that uptake of findings had clear benefits to improving the practice of their CTU. Even for those findings of trial method research that were less enthusiastically received, this appeared to be because the CTU staff were already operating at a high standard and that trial method research findings served to simply reassure them of the quality of their practices.

“I guess yes, I would say so, they help enhance them. Thinking about the first one on progression criteria, we didn’t really have any standard in house guidance on that, so actually reaching out and using that was great because we needed something to base it on. Whereas I’d say for the others, with the Damocles ones and the one on SAP guidance, we did already have in house guidelines for SAPs and DMC charters, but these bits of work have helped to inform them. In a way, they help clarify that most of what you are doing is good practice and then some additional things that could be added in.” – Site 25, academic

Alongside the efficiency and quality benefits to the CTU and its practices, participants also described a desire to implement findings from trial method research because of their promise to improve the quality of trials, and the evidence they generate, more broadly. For example, this could be improved efficiency leading to cost-effective trials to free up funding for other research. It could also be participant-centred improvements that have both ethical implications as well as bolstering the public’s trust in the research process. And, most importantly it seemed, improvements across trials would lead to better evidence to base healthcare decisions on. Finally, implementation of findings from trial method research helps to signal that the CTU is dedicated to best practice and is innovative in pursuing those ideals. There was a perception that it can lead to increased reputation amongst peers and the public as well as making the applications from the CTU attractive to funders.

“I think they maybe come under some of the reasons that you said already, but they are incentives to do [implementing trials methods research findings] because we’re all in the business of trying to produce evidence for interventions that are going to make a difference usually in the NHS, not always, but depending what it is that we’re trialling. But ultimately, you know, we’re all in the business of trying to produce evidence that’s going to get used and make a difference to the patients, and if that can happen more quickly, cheaply, more efficiently, trials that are run better with an evidence base underpinning what happens in the trials, then yeah, that’s why we should be doing it. That’s all incentives to do it.” – Site 10, director

As stated above in “Interview findings”, the COM-B domains identified were psychological capability, reflective motivation, automatic motivation, physical opportunity, and social opportunity. These five domains map to all nine intervention functions within the BCW. Two, “Restriction” and “Coercion”, were eliminated due to limited practicability and acceptability. Potential solutions were generated that targeted specific aspects of beliefs within our themes. The primary factors identified across themes were distilled into three intervention targets. Those targets were as follows: awareness of trial method research findings, the effort required to implement findings, and the culture around implementing findings. Eight potential interventions were generated which are listed in Table  6 .

Awareness of trial method research findings

The first proposed intervention is the incorporation of sessions specific to sharing research findings into the agendas of clinical and methodology conferences. These sessions would serve as a dedicated conduit for trialists to share and receive new methods research findings, giving dedicated time and space to do so. The social elements of these sessions would also benefit implementation through less formal opportunities to share feedback and other comments on recommendations that can then be addressed by the associated researchers present.

Effort required to implement findings

The second proposed intervention would target the effort required to implement findings. As time is at a premium within CTUs, any pre-emptive efforts on the part of the methods research teams to ensure their recommendations are accessible, translatable, and clearly relevant to CTU staff will assist in those recommendations being implemented. This could include template documents, case studies of implementation, software packages, etc. Any resource beyond the publication of results would seem desirable to CTU staff to assist in their efforts at implementation.

Changes to culture

The third potential solution identified would target the cultural changes needed to re-prioritise the directions of CTUs towards implementation of findings. This would proceed mainly through a change in funder attitudes towards the importance of trial method research. Funders would need to provide dedicated funding/time within CTU’s contracts and/or trial grants to allow for the proper conduct and/or implementation of trial method research.

Other potential solutions

As many of our reported barriers are interconnected, so too do several of our proposed solutions target multiple barriers/opportunities to improve implementation. Many of these rely primarily on cultural shifts within the CTUs themselves, where existing structures are modified to accommodate implementation efforts. For example, ensuring that CTU meeting agendas incorporate dedicated time towards discussing implementation efforts or for roles to be established/re-structured that focus on championing these efforts.

This paper presents findings from our mixed methods study on the challenges and opportunities to implementing trial method research findings. Exploration of notable trial method research findings generated four cases studies that were used to solicit implementation experiences from trial staff through survey and interviews. The survey data allowed us to identify trends in the adoption of the case studies in a sample of half of the registered CTUs within the UK. Demographic data from participating CTUs demonstrated some similarities in implementation factors that are consistent across sites, such as a lack of resources. More positive similarities were identified as well, such as the shared belief that implementation research is important. Participants volunteered a number of motivators, such as adhering to best practice, or barriers, such as time/resource limitations, that affected their CTU’s implementation of these case studies and trial method research findings more generally. Our interviews with senior CTU staff further explored these motivators and barriers to implementation through a behavioural lens. A range of relevant themes across three socio-ecological levels (Findings, Internal, and External) were identified from our behavioural analysis.

Findings-level factors that affected implementation related to the quality and accessibility of the research and its outputs, and its perceived relevance to the trials undertaken in the CTUs. Trial method research findings that were ‘well-packaged’ (e.g., included templates or easy to follow guidance) were believed to assist in implementation. Findings that had clear benefits to the work done at a CTU, such as streamlining processes, or the outcomes of the trials themselves, such as improving their quality, were more readily implemented. Factors internal to the CTUs included the interpersonal communication of the staff, their existing workloads, and the culture surrounding implementation. Open communication between members of the CTU, spearheaded by senior staff, seemed to increase buy-in from staff on the relevance of trial method research findings. This buy-in would appear essential to motivate staff that are already stretched thin by their commitments to design and deliver trials. Efforts to improve cultural expectations around implementation were seen as a mechanism to create further opportunities for staff to dedicate to adopting findings. These efforts could be restructuring current staff roles or establishing new ones with a greater focus on implementation rather than strictly trial delivery. External factors affecting implementation of trial method research findings were primarily those linked with the expectations of funders and the availability of findings. Funders were said to drive both cultural expectations related to best practice, as well as creating capacity (or not) for CTU staff through provision of funds that could allow dedicated time for implementation efforts. The availability of findings had to do largely with the channels available for dissemination of findings. The more opportunities trialists had to be exposed to findings, the more likely they were to adopt those findings in their respective CTUs.

Strengths and limitations

Our project has several key strengths. The mixed methods nature of its design allowed for a more complete investigation of implementation factors than either quantitative or qualitative measures alone. The project utilised a combined theoretical approach, taking advantage of the CFIR in survey design and the COM-B in interview design and analysis. The combination of these approaches ensured that our project had the investigative potential to explore the specific implementation factors and general behavioural factors undermining the successful implementation of trial method research. Others have taken a similar epistemological approach in combining the CFIR and COM-B (and the related Theoretical Domains Framework) to investigate challenges in other contexts [ 14 , 25 , 26 , 27 ].

Our project solicited input from a variety of stakeholders in CTUs across the UK to ensure a diverse perspective on implementation challenges. However, our sample was primarily those with a statistics background, along with the number of responses to identify case studies being relatively low. We attempted to correct for this low response rate and homogeneity of response by agreeing as a team which case studies to include outside those offered by our respondents. However, we cannot say how selection of other case studies may have affected our responses to the surveys and interviews. It may be that particular projects had inherently different challenges to implementation that are not represented here. However, by including general organisational-level factors that may influence implementation, we have identified factors that are likely to be generalisable to a range of implementation efforts. A further bias is one of self-selection. It is possible that the CTUs and members that responded to our invitations are more active in implementing trial method research findings and would thus be more interested in participating in the project. It may also be that those CTUs that face the most challenges did not have the capacity or motivation to respond to our invitation due to the time it would take away from trial delivery. This may help to explain our response rate of about half of the 52 registered CTUs. Responses could have also been limited in our surveys as we asked CTUs to collate their answers. This may have led to unintended desirability effects, with some staff feeling unable to offer honest opinions on their CTU.

Recommendations for future

This project has identified a number of areas for future efforts in improving the implementation of trial method research findings. The themes described here can provide a starting point for trial method researchers to consider when implementing and/or disseminate findings from method research. This could include creating plans for how the findings will reach the appropriate CTU teams, how to articulate the importance of findings to those teams, or how to best package those findings to make them more readily accessible, and thus implementable, for the CTU teams. Further, it could prompt methods researchers to consider who should be involved in their research and when, potentially incorporating members from different institutions and organisations who would be required to implement any findings and doing so earlier in the process.

Where these obstacles still exist, future research on the implementation of findings can bridge the gap between research and practice. Our approach describes obstacles and facilitators in a standardised language common to behavioural and implementation science. Along with this clearer articulation of what works, for whom, how, why, and when, links to behavioural theory provides a process to design interventions [ 18 , 28 ]. Although we have identified some preliminary intervention options, future work could produce potential options not accounted for here, but utilising lessons learned from our findings. Further development of these strategies through selection of BCTs targeting one or more of the identified areas for improvement, refined through co-production with stakeholders, would be the next stage of the intervention design process [ 18 , 29 ]. Finally, assessment of the effectiveness of these interventions in improving the implementation of trial method research findings would be warranted. Additionally, as our project was sampled from UK CTUs, further work could explore the generalisability of these findings to settings outside the UK, particularly where trial units are noticeably different in their organisation.

We have presented findings exploring the obstacles and facilitators to the implementation of trial method research findings. Challenges facing CTUs at multiple levels, including demands on time and resources, internal organisational structure, and quality of findings, greatly affect their staff’s ability to incorporate findings into their workflow. We have suggested several potential areas to target with further intervention development based on behavioural theory to maximise the potential for change. These strategies, and others, would need to face refinement and the scrutiny of stakeholders, as well as evaluation of their effectiveness. Ultimately, our project highlights the motivation of trial staff to deliver quality trials underpinned by the latest evidence. However, this motivation is hindered by the realities of ongoing trial logistics and the difficulties faced in identifying this evidence. Trial methodologists will need to work closely with CTU staff, funders, and regulatory bodies to set priorities on what needs to be implemented and how to make that more achievable in light of the challenges faced.

Availability of data and materials

The dataset supporting the conclusions of this article is included within the article (and its additional files). Additional data is available upon reasonable request.

Abbreviations

Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Side-effects and safety, Equity

Behaviour change technique

Behaviour change wheel

Consolidated Framework of Implementation Research

Capability, Motivation, and Opportunity Model of Behaviour

Clinical trial unit

DAta MOnitoring Committees: Lessons, Ethics, Statistics

Enhancing the QUAlity and Transparency Of health Research

Hubs for Trial Methodology Research

International Clinical Trials Methodology Conference

Medical Research Council

National Institute for Health and care Research

Online Resource for Research in Clinical triAls

REporting Clinical trial results Appropriately to Participants

Statistical analysis plans

Trials Methodology Research Partnership

UK Clinical Research Collaboration

Welcome to ORRCA. https://www.orrca.org.uk/ . 2023

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Acknowledgements

We would like to thank the members of the TMRP working groups that participated in the case study exercise. We would also like to thank all the participants within the survey and interviews.

This project was supported by the MRC – NIHR funded Trials Methodology Research Partnership (MR/S014357/1).

The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. They were not involved in the design of the study or the collection, analysis, and interpretation of data.

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TC contributed to the conceptualisation of the study and was responsible for the design and conduct of the case study selection, surveys, and interviews. TC also analysed all data and was the primary author of the manuscript. KG contributed to the conceptualisation of the study, data quality and analysis checks, along with contributing to drafting of the manuscript, providing edits and final approval. PW contributed to the conceptualisation of the study, edits and final approval of the manuscript.

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Supplementary Information

Additional file 1: appendix 1..

Survey with PIL. Word document version of the survey circulated to CTUs, which includes a PIL section.

Additional file 2: Appendix 2.

COM-B topic guide. Topic guide used during interviews.

Additional file 3:

Domain 1. Research team and reflexivity.

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Coffey, T., Williamson, P.R., Gillies, K. et al. Understanding implementation of findings from trial method research: a mixed methods study applying implementation frameworks and behaviour change models. Trials 25 , 139 (2024). https://doi.org/10.1186/s13063-024-07968-3

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The case study approach

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The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. The value of the case study approach is well recognised in the fields of business, law and policy, but somewhat less so in health services research. Based on our experiences of conducting several health-related case studies, we reflect on the different types of case study design, the specific research questions this approach can help answer, the data sources that tend to be used, and the particular advantages and disadvantages of employing this methodological approach. The paper concludes with key pointers to aid those designing and appraising proposals for conducting case study research, and a checklist to help readers assess the quality of case study reports.

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Introduction

The case study approach is particularly useful to employ when there is a need to obtain an in-depth appreciation of an issue, event or phenomenon of interest, in its natural real-life context. Our aim in writing this piece is to provide insights into when to consider employing this approach and an overview of key methodological considerations in relation to the design, planning, analysis, interpretation and reporting of case studies.

The illustrative 'grand round', 'case report' and 'case series' have a long tradition in clinical practice and research. Presenting detailed critiques, typically of one or more patients, aims to provide insights into aspects of the clinical case and, in doing so, illustrate broader lessons that may be learnt. In research, the conceptually-related case study approach can be used, for example, to describe in detail a patient's episode of care, explore professional attitudes to and experiences of a new policy initiative or service development or more generally to 'investigate contemporary phenomena within its real-life context' [ 1 ]. Based on our experiences of conducting a range of case studies, we reflect on when to consider using this approach, discuss the key steps involved and illustrate, with examples, some of the practical challenges of attaining an in-depth understanding of a 'case' as an integrated whole. In keeping with previously published work, we acknowledge the importance of theory to underpin the design, selection, conduct and interpretation of case studies[ 2 ]. In so doing, we make passing reference to the different epistemological approaches used in case study research by key theoreticians and methodologists in this field of enquiry.

This paper is structured around the following main questions: What is a case study? What are case studies used for? How are case studies conducted? What are the potential pitfalls and how can these be avoided? We draw in particular on four of our own recently published examples of case studies (see Tables 1 , 2 , 3 and 4 ) and those of others to illustrate our discussion[ 3 – 7 ].

What is a case study?

A case study is a research approach that is used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context. It is an established research design that is used extensively in a wide variety of disciplines, particularly in the social sciences. A case study can be defined in a variety of ways (Table 5 ), the central tenet being the need to explore an event or phenomenon in depth and in its natural context. It is for this reason sometimes referred to as a "naturalistic" design; this is in contrast to an "experimental" design (such as a randomised controlled trial) in which the investigator seeks to exert control over and manipulate the variable(s) of interest.

Stake's work has been particularly influential in defining the case study approach to scientific enquiry. He has helpfully characterised three main types of case study: intrinsic , instrumental and collective [ 8 ]. An intrinsic case study is typically undertaken to learn about a unique phenomenon. The researcher should define the uniqueness of the phenomenon, which distinguishes it from all others. In contrast, the instrumental case study uses a particular case (some of which may be better than others) to gain a broader appreciation of an issue or phenomenon. The collective case study involves studying multiple cases simultaneously or sequentially in an attempt to generate a still broader appreciation of a particular issue.

These are however not necessarily mutually exclusive categories. In the first of our examples (Table 1 ), we undertook an intrinsic case study to investigate the issue of recruitment of minority ethnic people into the specific context of asthma research studies, but it developed into a instrumental case study through seeking to understand the issue of recruitment of these marginalised populations more generally, generating a number of the findings that are potentially transferable to other disease contexts[ 3 ]. In contrast, the other three examples (see Tables 2 , 3 and 4 ) employed collective case study designs to study the introduction of workforce reconfiguration in primary care, the implementation of electronic health records into hospitals, and to understand the ways in which healthcare students learn about patient safety considerations[ 4 – 6 ]. Although our study focusing on the introduction of General Practitioners with Specialist Interests (Table 2 ) was explicitly collective in design (four contrasting primary care organisations were studied), is was also instrumental in that this particular professional group was studied as an exemplar of the more general phenomenon of workforce redesign[ 4 ].

What are case studies used for?

According to Yin, case studies can be used to explain, describe or explore events or phenomena in the everyday contexts in which they occur[ 1 ]. These can, for example, help to understand and explain causal links and pathways resulting from a new policy initiative or service development (see Tables 2 and 3 , for example)[ 1 ]. In contrast to experimental designs, which seek to test a specific hypothesis through deliberately manipulating the environment (like, for example, in a randomised controlled trial giving a new drug to randomly selected individuals and then comparing outcomes with controls),[ 9 ] the case study approach lends itself well to capturing information on more explanatory ' how ', 'what' and ' why ' questions, such as ' how is the intervention being implemented and received on the ground?'. The case study approach can offer additional insights into what gaps exist in its delivery or why one implementation strategy might be chosen over another. This in turn can help develop or refine theory, as shown in our study of the teaching of patient safety in undergraduate curricula (Table 4 )[ 6 , 10 ]. Key questions to consider when selecting the most appropriate study design are whether it is desirable or indeed possible to undertake a formal experimental investigation in which individuals and/or organisations are allocated to an intervention or control arm? Or whether the wish is to obtain a more naturalistic understanding of an issue? The former is ideally studied using a controlled experimental design, whereas the latter is more appropriately studied using a case study design.

Case studies may be approached in different ways depending on the epistemological standpoint of the researcher, that is, whether they take a critical (questioning one's own and others' assumptions), interpretivist (trying to understand individual and shared social meanings) or positivist approach (orientating towards the criteria of natural sciences, such as focusing on generalisability considerations) (Table 6 ). Whilst such a schema can be conceptually helpful, it may be appropriate to draw on more than one approach in any case study, particularly in the context of conducting health services research. Doolin has, for example, noted that in the context of undertaking interpretative case studies, researchers can usefully draw on a critical, reflective perspective which seeks to take into account the wider social and political environment that has shaped the case[ 11 ].

How are case studies conducted?

Here, we focus on the main stages of research activity when planning and undertaking a case study; the crucial stages are: defining the case; selecting the case(s); collecting and analysing the data; interpreting data; and reporting the findings.

Defining the case

Carefully formulated research question(s), informed by the existing literature and a prior appreciation of the theoretical issues and setting(s), are all important in appropriately and succinctly defining the case[ 8 , 12 ]. Crucially, each case should have a pre-defined boundary which clarifies the nature and time period covered by the case study (i.e. its scope, beginning and end), the relevant social group, organisation or geographical area of interest to the investigator, the types of evidence to be collected, and the priorities for data collection and analysis (see Table 7 )[ 1 ]. A theory driven approach to defining the case may help generate knowledge that is potentially transferable to a range of clinical contexts and behaviours; using theory is also likely to result in a more informed appreciation of, for example, how and why interventions have succeeded or failed[ 13 ].

For example, in our evaluation of the introduction of electronic health records in English hospitals (Table 3 ), we defined our cases as the NHS Trusts that were receiving the new technology[ 5 ]. Our focus was on how the technology was being implemented. However, if the primary research interest had been on the social and organisational dimensions of implementation, we might have defined our case differently as a grouping of healthcare professionals (e.g. doctors and/or nurses). The precise beginning and end of the case may however prove difficult to define. Pursuing this same example, when does the process of implementation and adoption of an electronic health record system really begin or end? Such judgements will inevitably be influenced by a range of factors, including the research question, theory of interest, the scope and richness of the gathered data and the resources available to the research team.

Selecting the case(s)

The decision on how to select the case(s) to study is a very important one that merits some reflection. In an intrinsic case study, the case is selected on its own merits[ 8 ]. The case is selected not because it is representative of other cases, but because of its uniqueness, which is of genuine interest to the researchers. This was, for example, the case in our study of the recruitment of minority ethnic participants into asthma research (Table 1 ) as our earlier work had demonstrated the marginalisation of minority ethnic people with asthma, despite evidence of disproportionate asthma morbidity[ 14 , 15 ]. In another example of an intrinsic case study, Hellstrom et al.[ 16 ] studied an elderly married couple living with dementia to explore how dementia had impacted on their understanding of home, their everyday life and their relationships.

For an instrumental case study, selecting a "typical" case can work well[ 8 ]. In contrast to the intrinsic case study, the particular case which is chosen is of less importance than selecting a case that allows the researcher to investigate an issue or phenomenon. For example, in order to gain an understanding of doctors' responses to health policy initiatives, Som undertook an instrumental case study interviewing clinicians who had a range of responsibilities for clinical governance in one NHS acute hospital trust[ 17 ]. Sampling a "deviant" or "atypical" case may however prove even more informative, potentially enabling the researcher to identify causal processes, generate hypotheses and develop theory.

In collective or multiple case studies, a number of cases are carefully selected. This offers the advantage of allowing comparisons to be made across several cases and/or replication. Choosing a "typical" case may enable the findings to be generalised to theory (i.e. analytical generalisation) or to test theory by replicating the findings in a second or even a third case (i.e. replication logic)[ 1 ]. Yin suggests two or three literal replications (i.e. predicting similar results) if the theory is straightforward and five or more if the theory is more subtle. However, critics might argue that selecting 'cases' in this way is insufficiently reflexive and ill-suited to the complexities of contemporary healthcare organisations.

The selected case study site(s) should allow the research team access to the group of individuals, the organisation, the processes or whatever else constitutes the chosen unit of analysis for the study. Access is therefore a central consideration; the researcher needs to come to know the case study site(s) well and to work cooperatively with them. Selected cases need to be not only interesting but also hospitable to the inquiry [ 8 ] if they are to be informative and answer the research question(s). Case study sites may also be pre-selected for the researcher, with decisions being influenced by key stakeholders. For example, our selection of case study sites in the evaluation of the implementation and adoption of electronic health record systems (see Table 3 ) was heavily influenced by NHS Connecting for Health, the government agency that was responsible for overseeing the National Programme for Information Technology (NPfIT)[ 5 ]. This prominent stakeholder had already selected the NHS sites (through a competitive bidding process) to be early adopters of the electronic health record systems and had negotiated contracts that detailed the deployment timelines.

It is also important to consider in advance the likely burden and risks associated with participation for those who (or the site(s) which) comprise the case study. Of particular importance is the obligation for the researcher to think through the ethical implications of the study (e.g. the risk of inadvertently breaching anonymity or confidentiality) and to ensure that potential participants/participating sites are provided with sufficient information to make an informed choice about joining the study. The outcome of providing this information might be that the emotive burden associated with participation, or the organisational disruption associated with supporting the fieldwork, is considered so high that the individuals or sites decide against participation.

In our example of evaluating implementations of electronic health record systems, given the restricted number of early adopter sites available to us, we sought purposively to select a diverse range of implementation cases among those that were available[ 5 ]. We chose a mixture of teaching, non-teaching and Foundation Trust hospitals, and examples of each of the three electronic health record systems procured centrally by the NPfIT. At one recruited site, it quickly became apparent that access was problematic because of competing demands on that organisation. Recognising the importance of full access and co-operative working for generating rich data, the research team decided not to pursue work at that site and instead to focus on other recruited sites.

Collecting the data

In order to develop a thorough understanding of the case, the case study approach usually involves the collection of multiple sources of evidence, using a range of quantitative (e.g. questionnaires, audits and analysis of routinely collected healthcare data) and more commonly qualitative techniques (e.g. interviews, focus groups and observations). The use of multiple sources of data (data triangulation) has been advocated as a way of increasing the internal validity of a study (i.e. the extent to which the method is appropriate to answer the research question)[ 8 , 18 – 21 ]. An underlying assumption is that data collected in different ways should lead to similar conclusions, and approaching the same issue from different angles can help develop a holistic picture of the phenomenon (Table 2 )[ 4 ].

Brazier and colleagues used a mixed-methods case study approach to investigate the impact of a cancer care programme[ 22 ]. Here, quantitative measures were collected with questionnaires before, and five months after, the start of the intervention which did not yield any statistically significant results. Qualitative interviews with patients however helped provide an insight into potentially beneficial process-related aspects of the programme, such as greater, perceived patient involvement in care. The authors reported how this case study approach provided a number of contextual factors likely to influence the effectiveness of the intervention and which were not likely to have been obtained from quantitative methods alone.

In collective or multiple case studies, data collection needs to be flexible enough to allow a detailed description of each individual case to be developed (e.g. the nature of different cancer care programmes), before considering the emerging similarities and differences in cross-case comparisons (e.g. to explore why one programme is more effective than another). It is important that data sources from different cases are, where possible, broadly comparable for this purpose even though they may vary in nature and depth.

Analysing, interpreting and reporting case studies

Making sense and offering a coherent interpretation of the typically disparate sources of data (whether qualitative alone or together with quantitative) is far from straightforward. Repeated reviewing and sorting of the voluminous and detail-rich data are integral to the process of analysis. In collective case studies, it is helpful to analyse data relating to the individual component cases first, before making comparisons across cases. Attention needs to be paid to variations within each case and, where relevant, the relationship between different causes, effects and outcomes[ 23 ]. Data will need to be organised and coded to allow the key issues, both derived from the literature and emerging from the dataset, to be easily retrieved at a later stage. An initial coding frame can help capture these issues and can be applied systematically to the whole dataset with the aid of a qualitative data analysis software package.

The Framework approach is a practical approach, comprising of five stages (familiarisation; identifying a thematic framework; indexing; charting; mapping and interpretation) , to managing and analysing large datasets particularly if time is limited, as was the case in our study of recruitment of South Asians into asthma research (Table 1 )[ 3 , 24 ]. Theoretical frameworks may also play an important role in integrating different sources of data and examining emerging themes. For example, we drew on a socio-technical framework to help explain the connections between different elements - technology; people; and the organisational settings within which they worked - in our study of the introduction of electronic health record systems (Table 3 )[ 5 ]. Our study of patient safety in undergraduate curricula drew on an evaluation-based approach to design and analysis, which emphasised the importance of the academic, organisational and practice contexts through which students learn (Table 4 )[ 6 ].

Case study findings can have implications both for theory development and theory testing. They may establish, strengthen or weaken historical explanations of a case and, in certain circumstances, allow theoretical (as opposed to statistical) generalisation beyond the particular cases studied[ 12 ]. These theoretical lenses should not, however, constitute a strait-jacket and the cases should not be "forced to fit" the particular theoretical framework that is being employed.

When reporting findings, it is important to provide the reader with enough contextual information to understand the processes that were followed and how the conclusions were reached. In a collective case study, researchers may choose to present the findings from individual cases separately before amalgamating across cases. Care must be taken to ensure the anonymity of both case sites and individual participants (if agreed in advance) by allocating appropriate codes or withholding descriptors. In the example given in Table 3 , we decided against providing detailed information on the NHS sites and individual participants in order to avoid the risk of inadvertent disclosure of identities[ 5 , 25 ].

What are the potential pitfalls and how can these be avoided?

The case study approach is, as with all research, not without its limitations. When investigating the formal and informal ways undergraduate students learn about patient safety (Table 4 ), for example, we rapidly accumulated a large quantity of data. The volume of data, together with the time restrictions in place, impacted on the depth of analysis that was possible within the available resources. This highlights a more general point of the importance of avoiding the temptation to collect as much data as possible; adequate time also needs to be set aside for data analysis and interpretation of what are often highly complex datasets.

Case study research has sometimes been criticised for lacking scientific rigour and providing little basis for generalisation (i.e. producing findings that may be transferable to other settings)[ 1 ]. There are several ways to address these concerns, including: the use of theoretical sampling (i.e. drawing on a particular conceptual framework); respondent validation (i.e. participants checking emerging findings and the researcher's interpretation, and providing an opinion as to whether they feel these are accurate); and transparency throughout the research process (see Table 8 )[ 8 , 18 – 21 , 23 , 26 ]. Transparency can be achieved by describing in detail the steps involved in case selection, data collection, the reasons for the particular methods chosen, and the researcher's background and level of involvement (i.e. being explicit about how the researcher has influenced data collection and interpretation). Seeking potential, alternative explanations, and being explicit about how interpretations and conclusions were reached, help readers to judge the trustworthiness of the case study report. Stake provides a critique checklist for a case study report (Table 9 )[ 8 ].

Conclusions

The case study approach allows, amongst other things, critical events, interventions, policy developments and programme-based service reforms to be studied in detail in a real-life context. It should therefore be considered when an experimental design is either inappropriate to answer the research questions posed or impossible to undertake. Considering the frequency with which implementations of innovations are now taking place in healthcare settings and how well the case study approach lends itself to in-depth, complex health service research, we believe this approach should be more widely considered by researchers. Though inherently challenging, the research case study can, if carefully conceptualised and thoughtfully undertaken and reported, yield powerful insights into many important aspects of health and healthcare delivery.

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Acknowledgements

We are grateful to the participants and colleagues who contributed to the individual case studies that we have drawn on. This work received no direct funding, but it has been informed by projects funded by Asthma UK, the NHS Service Delivery Organisation, NHS Connecting for Health Evaluation Programme, and Patient Safety Research Portfolio. We would also like to thank the expert reviewers for their insightful and constructive feedback. Our thanks are also due to Dr. Allison Worth who commented on an earlier draft of this manuscript.

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AS conceived this article. SC, KC and AR wrote this paper with GH, AA and AS all commenting on various drafts. SC and AS are guarantors.

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Crowe, S., Cresswell, K., Robertson, A. et al. The case study approach. BMC Med Res Methodol 11 , 100 (2011). https://doi.org/10.1186/1471-2288-11-100

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  • Cohort study a nonexperimental design that can be prospective or retrospective. In a prospective cohort study, participants are enrolled before the potential causal event has occurred. In a retrospective cohort study, the study begins after the dependent event occurs. See also "longitudinal study."
  • Cross-sectional design study an experimental design in which multiple measures are collected over a period of time from two or more groups of different ages (birth cohorts), ethnicities, or other factos. These designs combine aspects of longitudinal design and cohort-sequential design.
  • Literature review a narrative summary and evaluation of the findings or theories within a literature base. Also known as "narrative literature review."
  • Longitudinal study a study that involves the observation of a variable or group of variables in the same cases or individuals using the same set of measurements (or attributes) over a period of time (i.e., at multiple times or occasions). A longitudinal study that evaluates a group of randomly chosen individuals is referred to as a panel study, whereas a longitudinal study that evaluates a group of individuals possessing some common characteristic (usually age) is referred to as a cohort study. This multiple observational structure may be combined with almost any other research design—ones with and without experimental manipulations, randomized clinical trials, or any other study type. Also known as "longitudinal research," "longitudinal design."
  • Prospective sampling (cohort) a sampling method in which cases are selected for inclusion in experiments or other research based on their exposure to a risk factor. Participants are then followed to see if a condition of interest develops.
  • Qualitatiive research study approaches to research used to generate knowledge about human experience and/or action, including social processes. These research methods typically produce descriptive (non-numerical) data, such as observations of behavior or personal accounts of experiences. The goal of gathering qualitative data is to examine how individuals perceive the world from different vantage points. Also known as "qualitative design," "qualitative inquiry," "qualitative method," "qualitative study." more... less... Qualitative methods share four central characteristics: Involve the analysis of natural language and other forms of human expression rather than the translation of meaning into numbersCentralize an iterative process in which data are analyzed and meanings are generated in a circular and self-correcting process of checking and refining findingsSeek to present findings in a manner that emphasizes the study's context and situation in timeRecursively combine inquiry with methods that require researchers' reflexivity (i.e., self-examination) about their influence upon the research process.
  • Qualitative meta analysis study a form of inquiry in which qualitative research findings about a process or experience are aggregated or integrated across research studies. Aims can involve synthesizing qualitative findings across primary studies, generating new theoretical or conceptual models, identifying gaps in research, or generating new questions.
  • Quantitative research study approaches to research in which observed outcomes are numerically represented. These research methods rely on measuring variables using a numerical system, analyzing measurements using statistical models, and reporting relationships and associations among the studied variables. The goal of gathering quantitative data is to understand, describe, and predict the nature of a phenomenon, particularly through the development of models and theories. Also known as "quantitative design," "quantitative inquiry," "quantitative method," "quantitative study."
  • Quantitative Meta analysis a technique for synthesizing the results of multiple studies of a phenomenon by combining the effect size estimates from each study into a single estimate of the combined effect size or into a distribution of effect sizes. Effect size estimates from individual studies are the inputs to the analyses. Although meta-analyses are ideally suited for summarizing a body of literature in terms of impact, limitations, and implications, they are limited by having no required minimum number of studies or participants. Information of potential interest may also be missing from the original research reports upon which the procedure must rely.
  • Randomized controlled (clinical) trial an experimental design in which patients are randomly assigned to a group that will receive an experimental treatment, such as a new drug, or to one that will receive a comparison treatment, a standard-of-care treatment, or a placebo. The random assignment occurs after recruitment and assessment of eligibility but before the intervention. There may be multiple experimental and comparison groups, but each patient is assigned to one group only.
  • Retrospective cohort study (sampling) the study begins after the dependent event occurs; a technique in which participants or cases from the general population are selected for inclusion in experiments or other research based on their previous exposure to a risk factor or the completion of some particular process. Participants are then examined in the present to see if a particular condition or state exists, often in comparison to others who were not exposed to the risk or who did not complete the particular process.
  • Please consult the following sources for more information on these types of studies and terminology related to the studies.

    • APA Style JARS Supplemental Glossary This webpage provides supplemental information on the terms used in APA Style JARS. This glossary is meant to supplement Chapter 3 of the Publication Manual of the American Psychological Association, Seventh Edition. It is not an exhaustive list of all terms employed in quantitative, qualitative, or mixed methods research, nor does it include all possible definitions for each term; definitions in addition to or different from those reported in this glossary may be found in other sources.
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    Volume 23 Supplement 1

    Understanding Success: Multi-country implementation research in U5M reduction

    • Open access
    • Published: 28 February 2024

    Reducing the equity gap in under-5 mortality through an innovative community health program in Ethiopia: an implementation research study

    • Laura Drown 1   na1 ,
    • Alemayehu Amberbir 2   na1 ,
    • Alula M. Teklu 3 ,
    • Meseret Zelalem 4 ,
    • Abreham Tariku 4 ,
    • Yared Tadesse 4 ,
    • Solomon Gebeyehu 4 ,
    • Yirdachew Semu 4 ,
    • Jovial Thomas Ntawukuriryayo 2 ,
    • Amelia VanderZanden   ORCID: orcid.org/0000-0001-6984-2132 2 ,
    • Agnes Binagwaho 2 &
    • Lisa R. Hirschhorn 5  

    BMC Pediatrics volume  23 , Article number:  647 ( 2024 ) Cite this article

    Metrics details

    The Ethiopian government implemented a national community health program, the Health Extension Program (HEP), to provide community-based health services to address persisting access-related barriers to care using health extension workers (HEWs). We used implementation research to understand how Ethiopia leveraged the HEP to widely implement evidence-based interventions (EBIs) known to reduce under-5 mortality (U5M) and address health inequities.

    This study was part of a six-country case study series using implementation research to understand how countries implemented EBIs between 2000–2015. Our mixed-methods research was informed by a hybrid implementation science framework using desk review of published and gray literature, analysis of existing data sources, and 11 key informant interviews. We used implementation of pneumococcal conjugate vaccine (PCV-10) and integrated community case management (iCCM) to illustrate Ethiopia’s ability to rapidly integrate interventions into existing systems at a national level through leveraging the HEP and other implementation strategies and contextual factors which influenced implementation outcomes.

    Ethiopia implemented numerous EBIs known to address leading causes of U5M, leveraging the HEP as a platform for delivery to successfully introduce and scale new EBIs nationally. By 2014/15, estimated coverage of three doses of PCV-10 was at 76%, with high acceptability (nearly 100%) of vaccines in the community. Between 2000 and 2015, we found evidence of improved care-seeking; coverage of oral rehydration solution for treatment of diarrhea, a service included in iCCM, doubled over this period. HEWs made health services more accessible to rural and pastoralist communities, which account for over 80% of the population, with previously low access, a contextual factor that had been a barrier to high coverage of interventions.

    Conclusions

    Leveraging the HEP as a platform for service delivery allowed Ethiopia to successfully introduce and scale existing and new EBIs nationally, improving feasibility and reach of introduction and scale-up of interventions. Additional efforts are required to reduce the equity gap in coverage of EBIs including PCV-10 and iCCM among pastoralist and rural communities. As other countries continue to work towards reducing U5M, Ethiopia’s experience provides important lessons in effectively delivering key EBIs in the presence of challenging contextual factors.

    With a population of more than 112 million, Ethiopia is currently the second most populous country in Africa [ 1 ]. About 79% of its population resides in rural areas where communities are typically sparsely distributed [ 2 ]. Health inequities are reflected in notable differences in health outcomes across ethnic-based regions and population groups. Under-5 mortality (U5M), an important area of focus in Ethiopia, decreased from 166 per 1,000 live births in 2000 to 67 in 2016, an impressive decline of about 59% [ 3 ]. However, subnational U5M rates show that this progress was not uniform across the country’s nine regional states and two administrative states. In 2016, U5M rates still ranged widely from 39 per 1,000 live births in Addis Ababa to 125 per 1,000 in the largely pastoralist region of Afar [ 3 ]. There were also differences between residence types, with U5M reported to be about 41% higher in rural areas of the country compared with urban ones [ 3 ]. These inequities mirror differences in coverage of many key health interventions and demonstrate that ensuring equitable access to health services for all is a major challenge in this large and diverse country [ 4 ].

    In 1996, the Government of Ethiopia developed a 20-year plan under the Health Sector Development Program (HSDP), which was divided into four series of 5-year plans (HSDP-I – IV). The assessment of HSDP-I revealed that programs were not reaching the grassroots level, and called for mechanisms to improve access. The Ministry of Health (MOH) of Ethiopia invested in expansion and strengthening of its public health system to improve access to primary health care (PHC) [ 5 ]. This health system features three tiers – the primary, secondary, and tertiary levels (Fig.  1 ). In rural areas, the primary level includes the PHC unit, each of which consists of five health posts are under one health center, which report to one primary hospital in each kebele (Ethiopia’s lowest administrative level). This differs in rural areas, where the primary level simply consists of one health center per woreda or district. The secondary and tertiary levels consist of general and six specialized hospitals, respectively [ 6 ].

    figure 1

    Ethiopia’s three-tiered public health care system

    In 2003/2004 the Health Extension Program (HEP) was started to improve coverage and it became part of HSDP-II [ 7 , 8 ]. This program was designed to provide community-based health services and address persisting barriers to care in rural areas [ 7 ]. Under the HEP, Ethiopia introduced a cadre of full-time, salaried, and primarily female health extension workers (HEWs), selected by the communities they serve. HEWs complete a one-year formal training after finishing high school, which prepares them to offer an initial package of 16 services at the community level, both at a new facility type called the health post and in homes [ 7 ]. This package comprise various EBIs including community-based growth monitoring and promotion, immunization services, maternal health interventions, integrated management of childhood illness (IMCI), promotion of breastfeeding, use of insecticide-treated bed nets, hygiene and sanitation promotion and community-based management of acute malnutrition. This broad package of services goes beyond the typical scope of community health workers in many countries to include services such as vaccination. In subsequent years following the HEP’s introduction, its scope expanded to improve access to key curative health services, including treatment of diseases like malaria, pneumonia, and diarrhea that represented major causes of death in the country [ 7 ]. By 2009/10, the government had trained and deployed 34,482 HEWs across all regions, with HEW-to-population ratios varying widely by region [ 8 ]. In addition it introduced part-time Health Development Army volunteers in 2011 to support HEWs and assist in health promotion activities [ 9 ].

    Implementation research includes the study of how strategies are chosen and used to adopt and integrate evidence-based interventions (EBIs) into real-world settings. It further looks at the contextual factors which serve as facilitators or barriers to improve individual outcomes and population health [ 10 ]. This methodology is of particular importance in improving and sharing lessons from low- and middle-income countries (LMICs) for more effective implementation and improved progress in health outcomes [ 11 , 12 ].Existing literature has extensively described the role of the HEP in improving coverage of health services through increased access at the community level. For example a systematic review by Assefa et al. [ 13 ] found that the program helped Ethiopia achieve major improvements in several key areas such as communicable diseases, maternal and child health, sanitation and hygiene, community knowledge, and health care seeking [ 13 ]. Other studies have reported on the contribution of the HEP in increasing access to and utilization of health services, particularly for maternal and child health [ 14 , 15 , 16 ]. However, much of the current literature on EBIs is focused on effectiveness and coverage and does not explore what was done, what worked, and implementation strategies utilized.

    This paper uses data collected as part of a multi-country implementation research case series to understand successes in addressing amenable U5M deaths through implementation of health system-delivered EBIs between 2000 and 2015. We used case study methodology to understand which implementation strategies Ethiopia utilized alongside leveraging the HEP to implement U5M-targeted health system-delivered EBIs and explore contextual factors that affected the success of the strategies in achieving implementation outcomes. Ethiopia implemented numerous EBIs known to address leading causes of U5M. We specifically used the implementation and role of the HEP in two EBIs, the pneumococcal conjugate vaccine (PCV) and integrated community case management (iCCM), to provide a deeper understanding of the processes and outcomes. The results provide transferable lessons for other countries working to accelerate their U5M reduction efforts by leveraging community-based care delivery while targeting inequity in EBI coverage.

    This study drew from the larger six-country case study series utilizing implementation research methods to understand how countries implemented health-system delivered EBIs known to reduce amenable U5M. Details of the case study methods and our hybrid framework are reported elsewhere [ 17 ]. In brief, this mixed-methods implementation research was informed by a hybrid implementation science framework designed for the project to capture strategies, contextual factors, and implementation outcomes of EBI implementation for reducing U5M in LMICs (Fig.  2 ).This framework included expansion of the Exploration, Preparation, Implementation, Sustainment Framework to include an explicit Adaptation stage (EPIAS) [ 17 , 18 ].

    figure 2

    Implementation research framework for understanding evidence-based interventions to reduce under-5 mortality (Hirschhorn, L. R., et al., Gates Open Research, 2021;5,72)

    Data sources

    Desk review.

    The study team undertook a review of available sources including peer-reviewed and grey literature and program documents focusing on the rates and progress of U5M and implementation of the EBIs known to reduce amenable U5M in countries (Table 1 ). Initial searches were performed through MEDLINE (PubMed) and Google Scholar using the search terms “child mortality” or “under-5 mortality” and Ethiopia. Further searches included specific EBIs, causes of death, or contextual factors as search terms (e.g. “insecticide-treated nets,” “malaria,” or “community health workers”). Initial desk research was completed by the Strategic Analysis, Research, & Training (START) Center at the University of Washington and the study team expanded on the review through an iterative process throughout the case study as additional data sources or information gaps were identified.

    We extracted existing data from sources including the Ethiopian Demographic and Health Survey (DHS, 2001–2016), the World Bank, and WHO/UNICEF to measure changes in EBI coverage, U5M, and trends in health and development indicators related to U5M at the national and subnational levels between 2000 and 2015.

    Key informant interviews

    The study team conducted 11 key informant interviews in Ethiopia reflecting a broad range of experience and viewpoints. Key informants (KIs) were chosen based on the targeted EBIs and areas where additional insight was needed from the desk review. We prioritized KIs who were able to provide information on the EPIAS stages during the period of study. Potential KIs were approached by the in-country principal investigator (AT) by telephone or email. Key informants included current and former MOH employees responsible for high-level strategic direction of the ministry or specific disease or intervention areas, implementing partners, and individuals from multilateral or donor organizations who had managed partner-supported activities during the period of interest (2000–2015). We prioritized individuals active in this work during the study period but were also able to capture some experiences from the periods of 1995–1999 and 2017–2019. The interviews were conducted using a semi-structured interview guide based on the hybrid framework. All interviews were conducted in English and led by the project research associates or the in-country principal investigator, who were trained in qualitative interviewing. Interviews were audio recorded and transcribed prior to analysis.

    Data analysis

    We used a mixed-methods Quant-QUAL approach [ 18 ]. Descriptive statistics were used for EBI coverage at the national and subnational levels. We applied the framework to understand the implementation strategies, contextual factors serving as facilitators and barriers at the local, national, and global levels, and implementation outcomes from the literature. A priori codes for implementation strategies, outcomes, and contextual factors which were adapted and expanded as emerging codes were identified. The study team used the codes to analyze the transcripts and direct content analysis [ 19 ] was used to identify strategies, contextual factors, and implementation outcomes. Qualitative and quantitative data were triangulated to link the strategies, contextual factors, implementation outcomes, and coverage, and to emerge transferable lessons for other countries learning from EBI implementation in Ethiopia.

    Role of health extension program

    We found from the desk review and key informant interviews that for the majority of the targeted EBIs implemented in Ethiopia to reduce U5M the HEP was utilized as an important implementation strategy (Table 1 ). Ethiopia frequently leveraged the HEP as a platform for delivery of new services, with HEWs playing an important role as key implementers. Service delivery by HEWs increased coverage of many EBIs compared to implementation at health facilities alone. HEWs made health services more accessible to rural and pastoralist communities that previously had low access to health facilities and services, a contextual factor that served as a barrier to high coverage of health services and interventions. This strategy of leveraging the HEP improved feasibility and reach of introduction and enabled scale up of interventions in more resource-limited and rural settings in Ethiopia by using the strong, widespread platform. Utilization of the HEP also helped Ethiopia ensure acceptability of new interventions since service delivery involved HEWs already working in communities. The strategy of embedding new interventions into the HEP additionally improved the sustainability of new interventions by building upon an existing service delivery platform rather than relying on new, vertical ones.

    In addition to direct service provision, HEP activities were designed to increase demand and uptake of maternal and child health services based at health facilities. Strategies included regular household visits, conducting community engagement and health promotion activities including sensitization to promote facility-based delivery, an EBI with very low coverage historically. Nationally, the Women Development Army cadre of volunteers were introduced into the HEP in 2011 to enhance the HEP’s ability to reach households. They also helped strengthen HEP activities and improve utilization of services through demand generation activities and linking community members and HEWs [ 9 ].

    We identified several other implementation strategies to introduce and scale up EBIs to reduce U5M. The most common implementation strategies Ethiopia utilized (shown in Table 2 as used for PCV and iCCM) included: national policy and development planning, leveraging and coordinating strong donor and partner support, using data for evidence-based decision-making, and integration into or leveraging of existing programs or platforms.

    The HEP’s role in the implementation of two EBIs, PCV and iCCM, is further described below. These two EBIs were introduced and successfully scaled to a national level during the study period to address major causes of U5M and are discussed to illustrate the role of the HEP in implementation and delivery of vaccines and curative care in Ethiopia.

    Pneumococcal conjugate vaccine

    The PCV-10 vaccine was introduced in late 2011 to prevent severe forms of pneumococcal disease such as pneumonia and meningitis that were previously estimated to account for up to 28% of all deaths among children under 5 in Ethiopia [ 20 ]. The work followed the implementation pathway of the EPIAS framework (Table 2 ). Exploration was followed by an intensive preparation stage typical of new vaccines in the country that included implementation strategies such as obtaining procurement support from Gavi, the Vaccine Alliance. This was leveraged through a new Pneumococcal Advance Market Commitment initiative (which served as a facilitating contextual factor by improving availability of funds targeting the new vaccine), comprehensive cascade training of health workers, and adoption of training manuals. During the preparation phase, HEWs also aided in implementation of community mobilization and advocacy activities, important implementation strategies to create demand for these vaccines [ 21 ]. The strategy of leveraging the HEP as a platform for service delivery allowed Ethiopia to successfully implement and scale PCV-10, supported by these other strategies. In addition to mass vaccination campaigns, a catch-up strategy to vaccinate all children under the age of 1 year was used, and the vaccine was provided through routine, free vaccination services at health facilities, including by HEWs at health posts. This provision of routine immunization services at health posts allowed new vaccines such as PCV-10 and others (such as rotavirus and pentavalent vaccines) to quickly achieve widespread implementation at a national scale and reach rural communities.

    PCV was introduced throughout the country simultaneously and with high levels of general acceptability of vaccines in the community, according to interviewees in a 2015 study [ 22 ]. By 2014/15, WHO/UNICEF estimated coverage of all three doses of PCV-10 to be 76% [ 23 ]. Despite rollout in all regions and implementation strategies targeting national reach, geographic coverage of the vaccine was not equitable, with large regional differences [ 3 ]. According to a key informant, these inequities reflected barrier contextual factors in differences in health system strength and governance between the regions, as well as presence of pastoralist populations in regions such as Afar and Somali. These two largely pastoralist regions had the lowest coverage of three doses of PCV reported by the 2016 DHS – 23.6% and 22.9%, respectively [ 3 ]. We found that other contextual factors such as limited vaccine and resource availability were also hindering factors. Conversely, availability of donor resources, government investment in health, ongoing health systems strengthening efforts, and data availability and use were facilitating factors.

    Integrated community case management of newborn and childhood illness

    Another important EBI introduced during the study period was community-delivered integrated management of childhood illness (IMCI), or integrated community case management (iCCM). Ethiopia previously introduced the facility-based IMCI program to address several leading causes of death in children under 5 in an integrated manner at health centers. However, the government found that access to curative child health services remained lower than expected after scale-up. In response, the MOH began adding selected curative services to the scope of existing HEWs for a more community-based delivery strategy. Ethiopia’s national iCCM program formally launched in early 2010 within the HEP following pilot studies conducted by partners, an implementation strategy that generated local evidence on feasibility, and extensive preparation in collaboration with several partners. As part of iCCM, HEWs provide community-level management of malaria, diarrhea, pneumonia, malnutrition, and, later, essential newborn care and management of common neonatal problems including neonatal sepsis at health posts.

    Similar to many other EBIs implemented in Ethiopia, the program utilized a strategy of phased introduction after the pilot testing to improve feasibility of expansion given Ethiopia’s geography, which was an important barrier contextual factor. ICCM was first implemented at a small scale in two of Ethiopia’s nine regions and eventually scaled to the entire country. Four agrarian regions were initially targeted (Amhara, Oromia, Southern Nations, Nationalities, and People's Region (SNNPR), and Tigray) due to their greater population density and strength of HEP implementation compared with other regions. It was later scaled up throughout the country, including in pastoralist regions after development of a contextualized implementation guide for pastoralist areas. By 2014, iCCM was implemented by almost 30,000 HEWs working at 14,500 health posts in eight regions, representing 86% of the country’s districts [ 24 ]. Notably, the program was not rolled out in the country’s urban areas or two city administrations, Addis Ababa and Dire Dawa.

    Though implementation of iCCM had a significant impact on geographic access to curative child health services in rural areas of the country, we identified important challenges to the program that likely limited coverage, and ultimately the program’s benefits. One significant barrier contextual factor affecting coverage of services was health-seeking behavior in many areas of the country. Home visits by HEWs as part of iCCM enabled early identification of sick children and improved care-seeking behaviors; care-seeking for children with ARI symptoms and diarrhea increased by 48% and 112% respectively from 2000 to 2016. ICCM introduced evidence-based management of common childhood illnesses at the community level. However, uptake remained limited, with fewer than 50% of children under 5 with acute respiratory infection symptoms or diarrhea taken to any health facility, including a health post manned by HEWs, in 2016 [ 3 ]. The 2014 Ethiopia Service Provision Assessment Plus cross-sectional survey identified additional capacity issues at health posts affecting provision of iCCM [ 25 ]. While availability of curative services for children under 5 was very high at health posts, overall quality of care and adherence to iCCM guidelines was found to be poor. Treatment may have been affected by weak supply chain with low availability of essential medicines required for iCCM services – zinc for treatment of diarrhea and antibiotics were both available in fewer than half of health posts assessed [ 26 ]. In response to stock outs of essential medicines, the program later adapted its supply chain management to use a “pull” supply chain system, or integration into the Integrated Pharmaceutical Logistic System (IPLS), that improved access to drugs at the health post level. According to a key informant, “ this adaptation minimized drug wastage, improved access to drugs at the health post level, and improved equity.”

    Despite these challenges, we found evidence of improved care-seeking and coverage and equity of treatment of the conditions by the iCCM program addressed following implementation (Table 3 ). While overall coverage increased across groups, some inequities remained. Though these services were offered for free at the health post and health center level, mitigating some financial barriers to care, children in the highest wealth quintile with diarrhea were more likely to be taken to a health facility (61%) than those in the lowest and second quintiles (40%) (Table 4 ). Oral rehydration solution (ORS) for treatment of diarrhea, a service included in iCCM, doubled over the same period. A notable increase in coverage of ORS in rural areas (Table 4 ) reflected overall improvement in equity. ORS use increased in all regions except Somali, where coverage declined. Despite improvement in most regions, regional differences in coverage persisted, ranging from 23.9% in Oromia to 52.5% in Benishangul-Gumuz in 2016 (Table 4 ) [ 3 ].

    Implementation strategies and contextual factors

    Ethiopia’s successful introduction and national scale-up of key EBIs to reduce U5M utilized various implementation strategies. One commonly used strategy was leveraging existing programs such as the HEP to implement new EBIs, an approach that improved feasibility, reach, and sustainability of new EBIs given the country’s limited resources and geography. Alongside this approach, Ethiopia used several other implementation strategies, including using data for evidence-based decision-making, leveraging donor and partner resources, introducing EBIs via a phased approach, and national policy and development planning. Implementation was also impacted by cross-cutting contextual factors that served as facilitators and barriers. In Ethiopia, we found the presence of a strong community health system, other health systems strengthening efforts, data availability and use, and availability of donor and implementing partner resources were contextual factors that facilitated U5M reduction efforts. We found that, meanwhile, other contextual factors such as geography, supply chain issues, and low utilization of health services served as barriers. For many EBIs, pastoralist culture was a hindering factor affecting coverage in regions including Afar, where the majority of the population is pastoralist and U5M rates are some of the highest in the country.

    We found that most of the EBIs implemented in Ethiopia to reduce U5M between 2000 and 2015 leveraged the HEP as an implementation strategy, using the program as a platform for delivery of new services. Ethiopia also used a number of other strategies to successfully implement and scale up many of the existing and new EBIs, although gaps remained in coverage and in fidelity.

    Prior studies have reported on the contribution of the HEP in increasing access and uptake of health services, including maternal and child health [ 13 , 14 , 15 , 16 ]. They have also found that the program helped Ethiopia achieve improvements in areas such as maternal and child health, communicable diseases, and sanitation and hygiene [ 13 ]. The contributions of this paper allow us to better understand some of the mechanisms through which this strategy worked and other implementation strategies that were used alongside the HEP to implement EBIs and contextual factors that affected their success. For example, implementation strategies such as use of data for evidence-based decision-making and leveraging donor and partner resources were beneficial in introducing and scaling up interventions. Implementation of PCV and iCCM were impacted, however, by contextual factors such as geography, supply chain challenges, and care-seeking behavior.

    Similar to our findings on iCCM, a study on the assessment of success and challenges of HEP in Ethiopia between 2003 to 2018 found readiness and availability of services including staffing, equipment, and adequate supplies at the health post level where the HEP operates and service utilization were key barriers for the successful implementation various EBIs by HEWs [ 13 ].

    Literature on CHW programs in other LMICs is abundant. As in Ethiopia, CHW programs in countries including Brazil, Nepal, and Iran have increased access to health services in rural areas and contributed to improved outcomes in these areas [ 27 , 28 , 29 , 30 ]. CHW programs often share the HEP’s challenges, such as those related to supply chain in Zambia and Pakistan or community care-seeking preferences in India [ 30 , 31 , 32 ]. Literature shows comparative strengths of the HEP that have likely contributed to the program’s success. For example, Accredited Social Health Activists (ASHAs) in India conduct activities like that of HEWs but are considered part-time volunteers. While HEWs are full time and salaried, ASHAs are reported to be dissatisfied with remuneration as they are only paid for a select few interventions in their wide scope [ 32 ]. CHW training in some countries such as Pakistan and Zimbabwe has been reported to be inadequate, though this is a strength in Ethiopia where HEWs receive more than a year of pre-service training [ 31 , 33 ].

    Ethiopia provides a valuable example for other low-resource settings in its utilization of a community health program to improve access to both preventive and curative EBIs. Some countries have not yet adopted a similar approach of utilizing CHWs to provide very decentralized and comprehensive services at the community level. Ethiopia’s implementation strategies demonstrate the importance of building upon existing, widespread programs to introduce new EBIs more feasibly at a large scale or to further expand access and reach of existing ones. It has been well documented that the HEP enabled Ethiopia to improve critical health outcomes in areas of maternal and child health, communicable diseases, hygiene and sanitation, knowledge, and increasing health care-seeking behavior [ 13 ].

    The experience of Ethiopia also demonstrates the importance of efforts to adapt strategies or introduce new ones to encourage uptake and ensure equity of coverage of services offered at the community level reflecting subnational variability in geography, culture, and other contextual factors. Establishment and expansion of the HEP was a key strategy to improve access to health services at the community level, particularly in Ethiopia’s vast rural and pastoralist areas with historically low access to health facilities. There is also evidence of pro-poor public spending on health in Ethiopia which supported the implementation of EBIs by the HEP [ 13 ]. The Ethiopian government allocated nearly 60% of health expenditures at health centers which supports the work of the HEP [ 34 ].

    The challenges we identified in implementation were similar to contextual barriers described elsewhere. A systematic review of the HEP similarly highlighted the role of the HEP in improving maternal and child health services at the health center and community levels [ 13 ]. However, remaining challenges include capacity of health posts related to supplies, variation in performance of HEWs across geography, work overload, and contextual factors related to the wider health system issues [ 13 ]. For facility-based services, HEWs played a role in promoting care-seeking. A similar role was adopted by Health Development Army volunteers in 2011 as an adaptation to the HEP. Since uptake may be related to perceived quality of community-level care, ensuring high quality of care within community health programs should be a priority for countries leveraging them. Ethiopia used a system of supportive supervision during implementation of many EBIs to improve fidelity, a strategy that may be valuable in many settings. However, quality of care remains an area for improvement that became a priority area for the national Health Sector Transformation Plan [ 35 ]. Coverage of many EBIs, even ones such as ORS with expanded community-level access during the study period, still varies greatly by region, residence type, and wealth quintile in Ethiopia. This is an ongoing challenge that other countries are likely to face and should consider during planning and preparation of implementation.

    Our study must be interpreted in light of its limitations. This case study is limited by the fact that publicly available data, reports, and publications often do not describe the implementation outcomes of interest at a subnational level, and data often are either reported at a national level or for a specific subnational population. This was a retrospective study that relied on recall for critical qualitative components, with the corresponding risk of recall bias.

    As LMICs work towards further reducing child mortality, existing community health programs represent a valuable opportunity for introduction and expansion of new EBIs. Ethiopia utilized a strong, widespread community health program, the Health Extension Program, to implement new EBIs, including the pneumococcal vaccine and integrated community case management. Leveraging the HEP as a platform for service delivery allowed Ethiopia to successfully introduce and scale new and existing EBIs nationally. Further effort is required to reduce the equity gap in coverage of EBIs among pastoralist and rural communities. Ethiopia’s work in utilizing the HEP alongside other implementation strategies to effectively deliver key EBIs in the presence of potentially challenging contextual factors provides important lessons for other countries aiming to reduce under-5 mortality.

    Availability of data and materials

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

    Abbreviations

    Acute Respiratory Infection

    Community Health Worker

    Accredited Social Health Activists

    Demographic and Health Survey

    Evidence-Based Intervention

    Exploration, Preparation, Implementation, Adaptation, and Sustainment

    Facility-Based Integrated Management of Childhood Illness

    Health Care Worker

    Health Extension Program

    Health Extension Worker

    Human Immunodeficiency Virus

    Health Sector Development Programme

    Integrated Community Case Management

    Integrated Management of Childhood Illness

    Key Informant

    Low- and Middle-Income Country

    Ministry of Health

    Oral Rehydration Salts

    Pneumococcal Conjugate Vaccine

    Primary Health Care

    Southern Nations, Nationalities, and Peoples' Region

    Strategic Analysis, Research, & Training

    Under-5 Mortality

    University of Global Health Equity

    United Nations Children's Fund

    World Health Organization

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    Acknowledgements

    We would like to acknowledge and thank the key informants and other stakeholders in Ethiopia who provided essential information, historical perspectives and narratives, and feedback on our findings, ensuring we captured as accurate a reflection as possible on Ethiopia’s journey to reducing under-5 mortality.

    About this supplement

    This article has been published as part of BMC Pediatrics Volume 23 Supplement 1, 2023: Understanding Success: Multi-country implementation research in U5M reduction. The full contents of the supplement are available online at https://bmcpediatr.biomedcentral.com/articles/supplements/volume-23-supplement-1 .

    This work was completed as part of a larger case study series funded by the Bill & Melinda Gates Foundation and Gates Ventures. These funding bodies were not directly involved in the development of this manuscript.

    Author information

    Laura Drown and Alemayehu Amberbir contributed equally to this work.

    Authors and Affiliations

    Division of Global Health Equity, Brigham and Women’s Hospital, Boston, MA, USA

    Laura Drown

    University of Global Health Equity, Kigali, Rwanda

    Alemayehu Amberbir, Jovial Thomas Ntawukuriryayo, Amelia VanderZanden & Agnes Binagwaho

    MERQ Consultancy PLC, Arbegnoch Street, Addis Ababa, Ethiopia

    Alula M. Teklu

    Minstry of Health, Addis Ababa, Ethiopia

    Meseret Zelalem, Abreham Tariku, Yared Tadesse, Solomon Gebeyehu & Yirdachew Semu

    Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Lisa R. Hirschhorn

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    Contributions

    LD, AMT, AB, and LRH made substantial contributions to the design of this work. LD, AA, JTN, AMT, AB, and LRH contributed to the data analysis. LD, AA, AMT, MZ, AT, YT, SG, YS, JTN, AV, AB, and LRH interpreted the results to form the manuscript. LD, AA, AMT, MZ, AT, YT, SG, YS, JTN, AV, AB, and LRH contributed to writing and revision of the manuscript. All authors have approved the final version.

    Corresponding author

    Correspondence to Alemayehu Amberbir .

    Ethics declarations

    Ethics approval and consent to participate.

    The study was reviewed by the Institutional Review Board in Ethiopia (Approval number PM23/281). All KIs provided informed consent before interviews were conducted. The overall project was also reviewed by the Rwanda National Ethics Committee and Northwestern University and determined to be non-human-subjects research.

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    Drown, L., Amberbir, A., Teklu, A.M. et al. Reducing the equity gap in under-5 mortality through an innovative community health program in Ethiopia: an implementation research study. BMC Pediatr 23 (Suppl 1), 647 (2024). https://doi.org/10.1186/s12887-023-04388-1

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    DOI : https://doi.org/10.1186/s12887-023-04388-1

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    February 26, 2024

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    Early COVID-19 research was riddled with poor methods and low-quality results, but the pandemic didn't cause the problem

    by Dennis M. Gorman, The Conversation

    bad research

    Early in the COVID-19 pandemic, researchers flooded journals with studies about the then-novel coronavirus. Many publications streamlined the peer-review process for COVID-19 papers while keeping acceptance rates relatively high. The assumption was that policymakers and the public would be able to identify valid and useful research among a very large volume of rapidly disseminated information.

    However, in my review of 74 COVID-19 papers published in 2020 in the top 15 generalist public health journals listed in Google Scholar, I found that many of these studies used poor quality methods . Several other reviews of studies published in medical journals have also shown that much early COVID-19 research used poor research methods.

    Some of these papers have been cited many times. For example, the most highly cited public health publication listed on Google Scholar used data from a sample of 1,120 people, primarily well-educated young women, mostly recruited from social media over three days. Findings based on a small, self-selected convenience sample cannot be generalized to a broader population. And since the researchers ran more than 500 analyses of the data, many of the statistically significant results are likely chance occurrences. However, this study has been cited over 11,000 times .

    A highly cited paper means a lot of people have mentioned it in their own work. But a high number of citations is not strongly linked to research quality , since researchers and journals can game and manipulate these metrics. High citation of low-quality research increases the chance that poor evidence is being used to inform policies, further eroding public confidence in science.

    Methodology matters

    I am a public health researcher with a long-standing interest in research quality and integrity. This interest lies in a belief that science has helped solve important social and public health problems. Unlike the anti-science movement spreading misinformation about such successful public health measures as vaccines, I believe rational criticism is fundamental to science.

    The quality and integrity of research depends to a considerable extent on its methods. Each type of study design needs to have certain features in order for it to provide valid and useful information.

    For example, researchers have known for decades that for studies evaluating the effectiveness of an intervention, a control group is needed to know whether any observed effects can be attributed to the intervention.

    Systematic reviews pulling together data from existing studies should describe how the researchers identified which studies to include, assessed their quality, extracted the data and preregistered their protocols. These features are necessary to ensure the review will cover all the available evidence and tell a reader which is worth attending to and which is not.

    Certain types of studies, such as one-time surveys of convenience samples that aren't representative of the target population, collect and analyze data in a way that does not allow researchers to determine whether one variable caused a particular outcome .

    All study designs have standards that researchers can consult. But adhering to standards slows research down. Having a control group doubles the amount of data that needs to be collected, and identifying and thoroughly reviewing every study on a topic takes more time than superficially reviewing some. Representative samples are harder to generate than convenience samples, and collecting data at two points in time is more work than collecting them all at the same time.

    Studies comparing COVID-19 papers with non-COVID-19 papers published in the same journals found that COVID-19 papers tended to have lower quality methods and were less likely to adhere to reporting standards than non-COVID-19 papers. COVID-19 papers rarely had predetermined hypotheses and plans for how they would report their findings or analyze their data. This meant there were no safeguards against dredging the data to find "statistically significant" results that could be selectively reported.

    Such methodological problems were likely overlooked in the considerably shortened peer-review process for COVID-19 papers. One study estimated the average time from submission to acceptance of 686 papers on COVID-19 to be 13 days, compared with 110 days in 539 pre-pandemic papers from the same journals. In my study, I found that two online journals that published a very high volume of methodologically weak COVID-19 papers had a peer-review process of about three weeks .

    Publish-or-perish culture

    These quality control issues were present before the COVID-19 pandemic. The pandemic simply pushed them into overdrive.

    Journals tend to favor positive, "novel" findings : that is, results that show a statistical association between variables and supposedly identify something previously unknown. Since the pandemic was in many ways novel, it provided an opportunity for some researchers to make bold claims about how COVID-19 would spread, what its effects on mental health would be, how it could be prevented and how it might be treated.

    Academics have worked in a publish-or-perish incentive system for decades, where the number of papers they publish is part of the metrics used to evaluate employment, promotion and tenure. The flood of mixed-quality COVID-19 information afforded an opportunity to increase their publication counts and boost citation metrics as journals sought and rapidly reviewed COVID-19 papers, which were more likely to be cited than non-COVID papers.

    Online publishing has also contributed to the deterioration in research quality. Traditional academic publishing was limited in the quantity of articles it could generate because journals were packaged in a printed, physical document usually produced only once a month. In contrast, some of today's online mega-journals publish thousands of papers a month. Low-quality studies rejected by reputable journals can still find an outlet happy to publish it for a fee.

    Healthy criticism

    Criticizing the quality of published research is fraught with risk. It can be misinterpreted as throwing fuel on the raging fire of anti-science. My response is that a critical and rational approach to the production of knowledge is, in fact, fundamental to the very practice of science and to the functioning of an open society capable of solving complex problems such as a worldwide pandemic.

    Publishing a large volume of misinformation disguised as science during a pandemic obscures true and useful knowledge . At worst, this can lead to bad public health practice and policy.

    Science done properly produces information that allows researchers and policymakers to better understand the world and test ideas about how to improve it. This involves critically examining the quality of a study's designs, statistical methods, reproducibility and transparency, not the number of times it has been cited or tweeted about.

    Science depends on a slow, thoughtful and meticulous approach to data collection, analysis and presentation, especially if it intends to provide information to enact effective public health policies. Likewise, thoughtful and meticulous peer review is unlikely with papers that appear in print only three weeks after they were first submitted for review. Disciplines that reward quantity of research over quality are also less likely to protect scientific integrity during crises.

    Public health heavily draws upon disciplines that are experiencing replication crises , such as psychology, biomedical science and biology. It is similar to these disciplines in terms of its incentive structure, study designs and analytic methods, and its inattention to transparent methods and replication. Much public health research on COVID-19 shows that it suffers from similar poor-quality methods.

    Reexamining how the discipline rewards its scholars and assesses their scholarship can help it better prepare for the next public health crisis.

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    Verywell Mind

    Descriptive Research in Psychology

    Sometimes you need to dig deeper than the pure statistics

    Descriptive research is one of the key tools needed in any psychology researcher’s toolbox in order to create and lead a project that is both equitable and effective. Because psychology, as a field, loves definitions, let’s start with one. The University of Minnesota’s Introduction to Psychology defines this type of research as one that is “...designed to provide a snapshot of the current state of affairs.”

    That's pretty broad, so what does that mean in practice? Dr. Heather Derry-Vick (PhD) , an assistant professor in psychiatry at Hackensack Meridian School of Medicine, helps us put it into perspective.

    "Descriptive research really focuses on defining, understanding, and measuring a phenomenon or an experience," she says. "Not trying to change a person's experience or outcome, or even really looking at the mechanisms for why that might be happening, but more so describing an experience or a process as it unfolds naturally.”

    Types of Descriptive Research and the Methods Used

    Within the descriptive research methodology there are multiple types, including the following.

    Descriptive Survey Research

    This involves going beyond a typical tool like a LIkert Scale —where you typically place your response to a prompt on a one to five scale. We already know that scales like this can be ineffective, particularly when studying pain, for example.

    When that's the case, using a descriptive methodology can help dig deeper into how a person is thinking, feeling, and acting rather than simply quantifying it in a way that might be unclear or confusing.

    Descriptive Observational Research

    Think of observational research like an ethically-focused version of people-watching. One example would be watching the patterns of children on a playground—perhaps when looking at a concept like risky play or seeking to observe social behaviors between children of different ages.

    Descriptive Case Study Research

    A descriptive approach to a case study is akin to a biography of a person, honing in on the experiences of a small group to extrapolate to larger themes. We most commonly see descriptive case studies when those in the psychology field are using past clients as an example to illustrate a point.

    Correlational Descriptive Research

    While descriptive research is often about the here and now, this form of the methodology allows researchers to make connections between groups of people. As an example from her research, Derry-Vick says she uses this method to identify how gender might play a role in cancer scan anxiety, aka scanxiety.

    Dr. Derry-Vick's research uses surveys and interviews to get a sense of how cancer patients are feeling and what they are experiencing both in the course of their treatment and in the lead-up to their next scan, which can be a significant source of stress.

    David Marlon, PsyD, MBA , who works as a clinician and as CEO at Vegas Stronger, and whose research focused on leadership styles at community-based clinics, says that using descriptive research allowed him to get beyond the numbers.

    In his case, that includes data points like how many unhoused people found stable housing over a certain period or how many people became drug-free—and identify the reasons for those changes.

    For the portion of his thesis that was focused on descriptive research, Marlon used semi-structured interviews to look at the how and the why of transformational leadership and its impact on clinics’ clients and staff.

    Advantages & Limitations of Descriptive Research

    So, if the advantages of using descriptive research include that it centers the research participants, gives us a clear picture of what is happening to a person in a particular moment,  and gives us very nuanced insights into how a particular situation is being perceived by the very person affected, are there drawbacks?

    Yes, there are. Dr. Derry-Vick says that it’s important to keep in mind that just because descriptive research tells us something is happening doesn’t mean it necessarily leads us to the resolution of a given problem.

    Another limitation she identifies is that it also can’t tell you, on its own, whether a particular treatment pathway is having the desired effect.

    “Descriptive research in and of itself can't really tell you whether a specific approach is going to be helpful until you take in a different approach to actually test it.”

    Marlon, who believes in a multi-disciplinary approach, says that his subfield—addictions—is one where descriptive research had its limits, but helps readers go beyond preconceived notions of what addictions treatment looks and feels like when it is effective.

    “If we talked to and interviewed and got descriptive information from the clinicians and the clients, a much more precise picture would be painted, showing the need for a client's specific multidisciplinary approach augmented with a variety of modalities," he says. "If you tried to look at my discipline in a pure quantitative approach , it wouldn't begin to tell the real story.”

    Best Practices for Conducting Descriptive Research

    Because you’re controlling far fewer variables than other forms of research, it’s important to identify whether those you are describing, your study participants, should be informed that they are part of a study.

    For example, if you’re observing and describing who is buying what in a grocery store to identify patterns, then you might not need to identify yourself.

    However, if you’re asking people about their fear of certain treatment, or how their marginalized identities impact their mental health in a particular way, there is far more of a pressure to think deeply about how you, as the researcher, are connected to the people you are researching.

    Many descriptive research projects use interviews as a form of research gathering and, as a result, descriptive research that is focused on this type of data gathering also has ethical and practical concerns attached. Thankfully, there are plenty of guides from established researchers about how to best conduct these interviews and/or formulate surveys .

    While descriptive research has its limits, it is commonly used by researchers to get a clear vantage point on what is happening in a given situation.

    Tools like surveys, interviews, and observation are often employed to dive deeper into a given issue and really highlight the human element in psychological research. At its core, descriptive research is rooted in a collaborative style that allows deeper insights when used effectively.

    Read the original article on Verywell Mind .

    FG Trade / E+/ Getty

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    1. Case Study

      Defnition: A case study is a research method that involves an in-depth examination and analysis of a particular phenomenon or case, such as an individual, organization, community, event, or situation. It is a qualitative research approach that aims to provide a detailed and comprehensive understanding of the case being studied.

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      Revised on November 20, 2023. A case study is a detailed study of a specific subject, such as a person, group, place, event, organization, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research. A case study research design usually involves qualitative methods, but quantitative methods are ...

    4. Case Study Methods and Examples

      The purpose of case study research is twofold: (1) to provide descriptive information and (2) to suggest theoretical relevance. Rich description enables an in-depth or sharpened understanding of the case. It is unique given one characteristic: case studies draw from more than one data source. Case studies are inherently multimodal or mixed ...

    5. 7 Types of Case Study Methods

      Case studies are a type of research methodology. Case study research designs examine subjects, projects, or organizations to provide an analysis based on the evidence. It allows you to get insight into what causes any subject's decisions and actions. This makes case studies a great way for students to develop their research skills.

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      VARIATIONS ON CASE STUDY METHODOLOGY. Case study methodology is evolving and regularly reinterpreted. Comparative or multiple case studies are used as a tool for synthesizing information across time and space to research the impact of policy and practice in various fields of social research [].Because case study research is in-depth and intensive, there have been efforts to simplify the method ...

    8. Research Methods

      Research methods are specific procedures for collecting and analyzing data. Developing your research methods is an integral part of your research design. When planning your methods, there are two key decisions you will make. First, decide how you will collect data. Your methods depend on what type of data you need to answer your research question:

    9. The case study approach

      A case study is a research approach that is used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context. It is an established research design that is used extensively in a wide variety of disciplines, particularly in the social sciences. A case study can be defined in a variety of ways (Table 5 ), the ...

    10. What is a Case Study? [+6 Types of Case Studies]

      A business or marketing case study aims at showcasing a successful partnership. This can be between a brand and a client. Or the case study can examine a brand's project. There is a perception that case studies are used to advertise a brand. But effective reports, like the one below, can show clients how a brand can support them.

    11. Methodology or method? A critical review of qualitative case study

      Definitions of qualitative case study research. Case study research is an investigation and analysis of a single or collective case, intended to capture the complexity of the object of study (Stake, 1995).Qualitative case study research, as described by Stake (), draws together "naturalistic, holistic, ethnographic, phenomenological, and biographic research methods" in a bricoleur design ...

    12. Case Study Research: Methods and Designs

      The case study method can be divided into three stages: formulation of objectives; collection of data; and analysis and interpretation. The researcher first makes a judgment about what should be studied based on their knowledge. Next, they gather data through observations and interviews. Here are some of the common case study research methods: 1.

    13. Case Studies

      Case Studies. Case studies are a popular research method in business area. Case studies aim to analyze specific issues within the boundaries of a specific environment, situation or organization. According to its design, case studies in business research can be divided into three categories: explanatory, descriptive and exploratory.

    14. Case Study

      A Case study is: An in-depth research design that primarily uses a qualitative methodology but sometimes includes quantitative methodology. Used to examine an identifiable problem confirmed through research. Used to investigate an individual, group of people, organization, or event. Used to mostly answer "how" and "why" questions.

    15. (PDF) Qualitative Case Study Methodology: Study Design and

      Qualitative case study methodology provides tools for researchers to study complex phenomena within their contexts. When the approach is applied correctly, it becomes a valuable method for health ...

    16. (PDF) Case Study Research

      This study employed a qualitative case study methodology. The case study method is a research strategy that aims to gain an in-depth understanding of a specific phenomenon by collecting and ...

    17. Research Methodology

      Research Methodology Types. Types of Research Methodology are as follows: ... Case Study Research Methodology. This is a research methodology that involves in-depth examination of a single case or a small number of cases. Case studies are often used in psychology, sociology, and anthropology to gain a detailed understanding of a particular ...

    18. (PDF) The case study as a type of qualitative research

      The case study method is a research strategy that aims to gain an in-depth understanding of a specific phenomenon by collecting and analyzing specific data within its true context (Rebolj, 2013 ...

    19. Case Study Research Method in Psychology

      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 ...

    20. Case Study

      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.

    21. Toward Developing a Framework for Conducting Case Study Research

      In terms of defining types of case study research, researchers title them differently. Yin (1989) has identified some specific types of case study research: exploratory, ... Over 344 paper have been published using case study research as a methodology which shows the importance of this methodology in the management of technology and innovation ...

    22. Types of Research Methodology: Uses, Types & Benefits

      Research methodology is classified based on different categories. They include a general category, nature of the study, purpose, research design, and data type. There are also interviews and case studies based on research methodology. In some research, the researcher combines more than two and very few methods. Based on General Category: 1.

    23. Understanding implementation of findings from trial method research: a

      Overall study description. We designed a sequential exploratory mixed methods study with three linked components: 1. Case studies: which identified existing examples of trial method research projects with actionable outputs that were believed to influence trial design, conduct, analysis, or reporting practice."Actionable outputs" were defined broadly as any resource, generated from these ...

    24. The case study approach

      The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. The value of the case study approach is well recognised in the fields of business, law and policy, but somewhat less so in health services research. Based on our experiences of conducting several health-related case studies, we reflect on the different types of case study design ...

    25. Types of Research Studies

      APA Style JARS Supplemental Glossary (2019) This glossary provides supplemental information on terms used in APA Style JARS and is meant to supplement Chapter 3 of the Publication Manual of the American Psychological Association, Seventh Edition. It is not an exhaustive list of all terms employed in quantitative, qualitative, or mixed methods research, nor does it include all possible ...

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      This study was part of a six-country case study series using implementation research to understand how countries implemented EBIs between 2000-2015. Our mixed-methods research was informed by a hybrid implementation science framework using desk review of published and gray literature, analysis of existing data sources, and 11 key informant ...

    27. Early COVID-19 research was riddled with poor methods and low-quality

      The quality and integrity of research depends to a considerable extent on its methods. Each type of study design needs to have certain features in order for it to provide valid and useful information.

    28. Descriptive Research in Psychology

      Descriptive Case Study Research. A descriptive approach to a case study is akin to a biography of a person, honing in on the experiences of a small group to extrapolate to larger themes. We most ...

    29. Dual CTLA‐4 and PD‐1 checkpoint blockade using CS1002 and CS1003

      Methods. The phase 1 study involved phase 1a monotherapy dose-escalation (part 1) and phase 1b combination therapy dose escalation (part 2) and expansion (part 3). Various dosing schedules of CS1002 (0.3, 1, or 3 mg/kg every 3 weeks, or 3 mg/kg every 9 weeks) were evaluated with 200 mg CS1003 every 3 weeks in part 3. Results