case study in evaluation

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A case study evaluation approach can be an incredibly powerful tool for monitoring and evaluating complex programs and policies. By identifying common themes and patterns, this approach allows us to better understand the successes and challenges faced by the program. In this article, we’ll explore the benefits of using a case study evaluation approach in the monitoring and evaluation of projects, programs, and public policies.

Table of Contents

Introduction to Case Study Evaluation Approach

The advantages of a case study evaluation approach, types of case studies, potential challenges with a case study evaluation approach, guiding principles for successful implementation of a case study evaluation approach.

• Benefits of Incorporating the Case Study Evaluation Approach in the Monitoring and Evaluation of Projects and Programs

A case study evaluation approach is a great way to gain an in-depth understanding of a particular issue or situation. This type of approach allows the researcher to observe, analyze, and assess the effects of a particular situation on individuals or groups.

An individual, a location, or a project may serve as the focal point of a case study’s attention. Quantitative and qualitative data are frequently used in conjunction with one another.

It also allows the researcher to gain insights into how people react to external influences. By using a case study evaluation approach, researchers can gain insights into how certain factors such as policy change or a new technology have impacted individuals and communities. The data gathered through this approach can be used to formulate effective strategies for responding to changes and challenges. Ultimately, this monitoring and evaluation approach helps organizations make better decision about the implementation of their plans.

This approach can be used to assess the effectiveness of a policy, program, or initiative by considering specific elements such as implementation processes, outcomes, and impact. A case study evaluation approach can provide an in-depth understanding of the effectiveness of a program by closely examining the processes involved in its implementation. This includes understanding the context, stakeholders, and resources to gain insight into how well a program is functioning or has been executed. By evaluating these elements, it can help to identify areas for improvement and suggest potential solutions. The findings from this approach can then be used to inform decisions about policies, programs, and initiatives for improved outcomes.

It is also useful for determining if other policies, programs, or initiatives could be applied to similar situations in order to achieve similar results or improved outcomes. All in all, the case study monitoring evaluation approach is an effective method for determining the effectiveness of specific policies, programs, or initiatives. By researching and analyzing the successes of previous cases, this approach can be used to identify similar approaches that could be applied to similar situations in order to achieve similar results or improved outcomes.

A case study evaluation approach offers the advantage of providing in-depth insight into a particular program or policy. This can be accomplished by analyzing data and observations collected from a range of stakeholders such as program participants, service providers, and community members. The monitoring and evaluation approach is used to assess the impact of programs and inform the decision-making process to ensure successful implementation. The case study monitoring and evaluation approach can help identify any underlying issues that need to be addressed in order to improve program effectiveness. It also provides a reality check on how successful programs are actually working, allowing organizations to make adjustments as needed. Overall, a case study monitoring and evaluation approach helps to ensure that policies and programs are achieving their objectives while providing valuable insight into how they are performing overall.

By taking a qualitative approach to data collection and analysis, case study evaluations are able to capture nuances in the context of a particular program or policy that can be overlooked when relying solely on quantitative methods. Using this approach, insights can be gleaned from looking at the individual experiences and perspectives of actors involved, providing a more detailed understanding of the impact of the program or policy than is possible with other evaluation methodologies. As such, case study monitoring evaluation is an invaluable tool in assessing the effectiveness of a particular initiative, enabling more informed decision-making as well as more effective implementation of programs and policies.

Furthermore, this approach is an effective way to uncover experiential information that can help to inform the ongoing improvement of policy and programming over time All in all, the case study monitoring evaluation approach offers an effective way to uncover experiential information necessary to inform the ongoing improvement of policy and programming. By analyzing the data gathered from this systematic approach, stakeholders can gain deeper insight into how best to make meaningful and long-term changes in their respective organizations.

Case studies come in a variety of forms, each of which can be put to a unique set of evaluation tasks. Evaluators have come to a consensus on describing six distinct sorts of case studies, which are as follows: illustrative, exploratory, critical instance, program implementation, program effects, and cumulative.

Illustrative Case Study

An illustrative case study is a type of case study that is used to provide a detailed and descriptive account of a particular event, situation, or phenomenon. It is often used in research to provide a clear understanding of a complex issue, and to illustrate the practical application of theories or concepts.

An illustrative case study typically uses qualitative data, such as interviews, surveys, or observations, to provide a detailed account of the unit being studied. The case study may also include quantitative data, such as statistics or numerical measurements, to provide additional context or to support the qualitative data.

The goal of an illustrative case study is to provide a rich and detailed description of the unit being studied, and to use this information to illustrate broader themes or concepts. For example, an illustrative case study of a successful community development project may be used to illustrate the importance of community engagement and collaboration in achieving development goals.

One of the strengths of an illustrative case study is its ability to provide a detailed and nuanced understanding of a particular issue or phenomenon. By focusing on a single case, the researcher is able to provide a detailed and in-depth analysis that may not be possible through other research methods.

However, one limitation of an illustrative case study is that the findings may not be generalizable to other contexts or populations. Because the case study focuses on a single unit, it may not be representative of other similar units or situations.

A well-executed case study can shed light on wider research topics or concepts through its thorough and descriptive analysis of a specific event or phenomenon.

Exploratory Case Study

An exploratory case study is a type of case study that is used to investigate a new or previously unexplored phenomenon or issue. It is often used in research when the topic is relatively unknown or when there is little existing literature on the topic.

Exploratory case studies are typically qualitative in nature and use a variety of methods to collect data, such as interviews, observations, and document analysis. The focus of the study is to gather as much information as possible about the phenomenon being studied and to identify new and emerging themes or patterns.

The goal of an exploratory case study is to provide a foundation for further research and to generate hypotheses about the phenomenon being studied. By exploring the topic in-depth, the researcher can identify new areas of research and generate new questions to guide future research.

One of the strengths of an exploratory case study is its ability to provide a rich and detailed understanding of a new or emerging phenomenon. By using a variety of data collection methods, the researcher can gather a broad range of data and perspectives to gain a more comprehensive understanding of the phenomenon being studied.

However, one limitation of an exploratory case study is that the findings may not be generalizable to other contexts or populations. Because the study is focused on a new or previously unexplored phenomenon, the findings may not be applicable to other situations or populations.

Exploratory case studies are an effective research strategy for learning about novel occurrences, developing research hypotheses, and gaining a deep familiarity with a topic of study.

Critical Instance Case Study

A critical instance case study is a type of case study that focuses on a specific event or situation that is critical to understanding a broader issue or phenomenon. The goal of a critical instance case study is to analyze the event in depth and to draw conclusions about the broader issue or phenomenon based on the analysis.

A critical instance case study typically uses qualitative data, such as interviews, observations, or document analysis, to provide a detailed and nuanced understanding of the event being studied. The data are analyzed using various methods, such as content analysis or thematic analysis, to identify patterns and themes that emerge from the data.

The critical instance case study is often used in research when a particular event or situation is critical to understanding a broader issue or phenomenon. For example, a critical instance case study of a successful disaster response effort may be used to identify key factors that contributed to the success of the response, and to draw conclusions about effective disaster response strategies more broadly.

One of the strengths of a critical instance case study is its ability to provide a detailed and in-depth analysis of a particular event or situation. By focusing on a critical instance, the researcher is able to provide a rich and nuanced understanding of the event, and to draw conclusions about broader issues or phenomena based on the analysis.

However, one limitation of a critical instance case study is that the findings may not be generalizable to other contexts or populations. Because the case study focuses on a specific event or situation, the findings may not be applicable to other similar events or situations.

A critical instance case study is a valuable research method that can provide a detailed and nuanced understanding of a particular event or situation and can be used to draw conclusions about broader issues or phenomena based on the analysis.

Program Implementation Program Implementation

A program implementation case study is a type of case study that focuses on the implementation of a particular program or intervention. The goal of the case study is to provide a detailed and comprehensive account of the program implementation process, and to identify factors that contributed to the success or failure of the program.

Program implementation case studies typically use qualitative data, such as interviews, observations, and document analysis, to provide a detailed and nuanced understanding of the program implementation process. The data are analyzed using various methods, such as content analysis or thematic analysis, to identify patterns and themes that emerge from the data.

The program implementation case study is often used in research to evaluate the effectiveness of a particular program or intervention, and to identify strategies for improving program implementation in the future. For example, a program implementation case study of a school-based health program may be used to identify key factors that contributed to the success or failure of the program, and to make recommendations for improving program implementation in similar settings.

One of the strengths of a program implementation case study is its ability to provide a detailed and comprehensive account of the program implementation process. By using qualitative data, the researcher is able to capture the complexity and nuance of the implementation process, and to identify factors that may not be captured by quantitative data alone.

However, one limitation of a program implementation case study is that the findings may not be generalizable to other contexts or populations. Because the case study focuses on a specific program or intervention, the findings may not be applicable to other programs or interventions in different settings.

An effective research tool, a case study of program implementation may illuminate the intricacies of the implementation process and point the way towards future enhancements.

Program Effects Case Study

A program effects case study is a research method that evaluates the effectiveness of a particular program or intervention by examining its outcomes or effects. The purpose of this type of case study is to provide a detailed and comprehensive account of the program’s impact on its intended participants or target population.

A program effects case study typically employs both quantitative and qualitative data collection methods, such as surveys, interviews, and observations, to evaluate the program’s impact on the target population. The data is then analyzed using statistical and thematic analysis to identify patterns and themes that emerge from the data.

The program effects case study is often used to evaluate the success of a program and identify areas for improvement. For example, a program effects case study of a community-based HIV prevention program may evaluate the program’s effectiveness in reducing HIV transmission rates among high-risk populations and identify factors that contributed to the program’s success.

One of the strengths of a program effects case study is its ability to provide a detailed and nuanced understanding of a program’s impact on its intended participants or target population. By using both quantitative and qualitative data, the researcher can capture both the objective and subjective outcomes of the program and identify factors that may have contributed to the outcomes.

However, a limitation of the program effects case study is that it may not be generalizable to other populations or contexts. Since the case study focuses on a particular program and population, the findings may not be applicable to other programs or populations in different settings.

A program effects case study is a good way to do research because it can give a detailed look at how a program affects the people it is meant for. This kind of case study can be used to figure out what needs to be changed and how to make programs that work better.

Cumulative Case Study

A cumulative case study is a type of case study that involves the collection and analysis of multiple cases to draw broader conclusions. Unlike a single-case study, which focuses on one specific case, a cumulative case study combines multiple cases to provide a more comprehensive understanding of a phenomenon.

The purpose of a cumulative case study is to build up a body of evidence through the examination of multiple cases. The cases are typically selected to represent a range of variations or perspectives on the phenomenon of interest. Data is collected from each case using a range of methods, such as interviews, surveys, and observations.

The data is then analyzed across cases to identify common themes, patterns, and trends. The analysis may involve both qualitative and quantitative methods, such as thematic analysis and statistical analysis.

The cumulative case study is often used in research to develop and test theories about a phenomenon. For example, a cumulative case study of successful community-based health programs may be used to identify common factors that contribute to program success, and to develop a theory about effective community-based health program design.

One of the strengths of the cumulative case study is its ability to draw on a range of cases to build a more comprehensive understanding of a phenomenon. By examining multiple cases, the researcher can identify patterns and trends that may not be evident in a single case study. This allows for a more nuanced understanding of the phenomenon and helps to develop more robust theories.

However, one limitation of the cumulative case study is that it can be time-consuming and resource-intensive to collect and analyze data from multiple cases. Additionally, the selection of cases may introduce bias if the cases are not representative of the population of interest.

In summary, a cumulative case study is a valuable research method that can provide a more comprehensive understanding of a phenomenon by examining multiple cases. This type of case study is particularly useful for developing and testing theories and identifying common themes and patterns across cases.

When conducting a case study evaluation approach, one of the main challenges is the need to establish a contextually relevant research design that accounts for the unique factors of the case being studied. This requires close monitoring of the case, its environment, and relevant stakeholders. In addition, the researcher must build a framework for the collection and analysis of data that is able to draw meaningful conclusions and provide valid insights into the dynamics of the case. Ultimately, an effective case study monitoring evaluation approach will allow researchers to form an accurate understanding of their research subject.

Additionally, depending on the size and scope of the case, there may be concerns regarding the availability of resources and personnel that could be allocated to data collection and analysis. To address these issues, a case study monitoring evaluation approach can be adopted, which would involve a mix of different methods such as interviews, surveys, focus groups and document reviews. Such an approach could provide valuable insights into the effectiveness and implementation of the case in question. Additionally, this type of evaluation can be tailored to the specific needs of the case study to ensure that all relevant data is collected and respected.

When dealing with a highly sensitive or confidential subject matter within a case study, researchers must take extra measures to prevent bias during data collection as well as protect participant anonymity while also collecting valid data in order to ensure reliable results

Moreover, when conducting a case study evaluation it is important to consider the potential implications of the data gathered. By taking extra measures to prevent bias and protect participant anonymity, researchers can ensure reliable results while also collecting valid data. Maintaining confidentiality and deploying ethical research practices are essential when conducting a case study to ensure an unbiased and accurate monitoring evaluation.

When planning and implementing a case study evaluation approach, it is important to ensure the guiding principles of research quality, data collection, and analysis are met. To ensure these principles are upheld, it is essential to develop a comprehensive monitoring and evaluation plan. This plan should clearly outline the steps to be taken during the data collection and analysis process. Furthermore, the plan should provide detailed descriptions of the project objectives, target population, key indicators, and timeline. It is also important to include metrics or benchmarks to monitor progress and identify any potential areas for improvement. By implementing such an approach, it will be possible to ensure that the case study evaluation approach yields valid and reliable results.

To ensure successful implementation, it is essential to establish a reliable data collection process that includes detailed information such as the scope of the study, the participants involved, and the methods used to collect data. Additionally, it is important to have a clear understanding of what will be examined through the evaluation process and how the results will be used. All in all, it is essential to establish a sound monitoring evaluation approach for a successful case study implementation. This includes creating a reliable data collection process that encompasses the scope of the study, the participants involved, and the methods used to collect data. It is also imperative to have an understanding of what will be examined and how the results will be utilized. Ultimately, effective planning is key to ensure that the evaluation process yields meaningful insights.

Benefits of Incorporating the Case Study Evaluation Approach in the Monitoring and Evaluation of Projects and Programmes

Using a case study approach in monitoring and evaluation allows for a more detailed and in-depth exploration of the project’s success, helping to identify key areas of improvement and successes that may have been overlooked through traditional evaluation. Through this case study method, specific data can be collected and analyzed to identify trends and different perspectives that can support the evaluation process. This data can allow stakeholders to gain a better understanding of the project’s successes and failures, helping them make informed decisions on how to strengthen current activities or shape future initiatives. From a monitoring and evaluation standpoint, this approach can provide an increased level of accuracy in terms of accurately assessing the effectiveness of the project.

This can provide valuable insights into what works—and what doesn’t—when it comes to implementing projects and programs, aiding decision-makers in making future plans that better meet their objectives However, monitoring and evaluation is just one approach to assessing the success of a case study. It does provide a useful insight into what initiatives may be successful, but it is important to note that there are other effective research methods, such as surveys and interviews, that can also help to further evaluate the success of a project or program.

In conclusion, a case study evaluation approach can be incredibly useful in monitoring and evaluating complex programs and policies. By exploring key themes, patterns and relationships, organizations can gain a detailed understanding of the successes, challenges and limitations of their program or policy. This understanding can then be used to inform decision-making and improve outcomes for those involved. With its ability to provide an in-depth understanding of a program or policy, the case study evaluation approach has become an invaluable tool for monitoring and evaluation professionals.

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• Open access
• Published: 27 November 2020

Designing process evaluations using case study to explore the context of complex interventions evaluated in trials

• Aileen Grant 1 ,
• Carol Bugge 2 &
• Mary Wells 3  

Trials volume  21 , Article number:  982 ( 2020 ) Cite this article

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Process evaluations are an important component of an effectiveness evaluation as they focus on understanding the relationship between interventions and context to explain how and why interventions work or fail, and whether they can be transferred to other settings and populations. However, historically, context has not been sufficiently explored and reported resulting in the poor uptake of trial results. Therefore, suitable methodologies are needed to guide the investigation of context. Case study is one appropriate methodology, but there is little guidance about what case study design can offer the study of context in trials. We address this gap in the literature by presenting a number of important considerations for process evaluation using a case study design.

In this paper, we define context, the relationship between complex interventions and context, and describe case study design methodology. A well-designed process evaluation using case study should consider the following core components: the purpose; definition of the intervention; the trial design, the case, the theories or logic models underpinning the intervention, the sampling approach and the conceptual or theoretical framework. We describe each of these in detail and highlight with examples from recently published process evaluations.

Conclusions

There are a number of approaches to process evaluation design in the literature; however, there is a paucity of research on what case study design can offer process evaluations. We argue that case study is one of the best research designs to underpin process evaluations, to capture the dynamic and complex relationship between intervention and context during implementation. We provide a comprehensive overview of the issues for process evaluation design to consider when using a case study design.

Trial registration

DQIP - ClinicalTrials.gov number, NCT01425502 - OPAL - ISRCTN57746448

Peer Review reports

Contribution to the literature

We illustrate how case study methodology can explore the complex, dynamic and uncertain relationship between context and interventions within trials.

We depict different case study designs and illustrate there is not one formula and that design needs to be tailored to the context and trial design.

Case study can support comparisons between intervention and control arms and between cases within arms to uncover and explain differences in detail.

We argue that case study can illustrate how components have evolved and been redefined through implementation.

Key issues for consideration in case study design within process evaluations are presented and illustrated with examples.

Process evaluations are an important component of an effectiveness evaluation as they focus on understanding the relationship between interventions and context to explain how and why interventions work or fail and whether they can be transferred to other settings and populations. However, historically, not all trials have had a process evaluation component, nor have they sufficiently reported aspects of context, resulting in poor uptake of trial findings [ 1 ]. Considerations of context are often absent from published process evaluations, with few studies acknowledging, taking account of or describing context during implementation, or assessing the impact of context on implementation [ 2 , 3 ]. At present, evidence from trials is not being used in a timely manner [ 4 , 5 ], and this can negatively impact on patient benefit and experience [ 6 ]. It takes on average 17 years for knowledge from research to be implemented into practice [ 7 ]. Suitable methodologies are therefore needed that allow for context to be exposed; one appropriate methodological approach is case study [ 8 , 9 ].

In 2015, the Medical Research Council (MRC) published guidance for process evaluations [ 10 ]. This was a key milestone in legitimising as well as providing tools, methods and a framework for conducting process evaluations. Nevertheless, as with all guidance, there is a need for reflection, challenge and refinement. There have been a number of critiques of the MRC guidance, including that interventions should be considered as events in systems [ 11 , 12 , 13 , 14 ]; a need for better use, critique and development of theories [ 15 , 16 , 17 ]; and a need for more guidance on integrating qualitative and quantitative data [ 18 , 19 ]. Although the MRC process evaluation guidance does consider appropriate qualitative and quantitative methods, it does not mention case study design and what it can offer the study of context in trials.

The case study methodology is ideally suited to real-world, sustainable intervention development and evaluation because it can explore and examine contemporary complex phenomena, in depth, in numerous contexts and using multiple sources of data [ 8 ]. Case study design can capture the complexity of the case, the relationship between the intervention and the context and how the intervention worked (or not) [ 8 ]. There are a number of textbooks on a case study within the social science fields [ 8 , 9 , 20 ], but there are no case study textbooks and a paucity of useful texts on how to design, conduct and report case study within the health arena. Few examples exist within the trial design and evaluation literature [ 3 , 21 ]. Therefore, guidance to enable well-designed process evaluations using case study methodology is required.

We aim to address the gap in the literature by presenting a number of important considerations for process evaluation using a case study design. First, we define the context and describe the relationship between complex health interventions and context.

What is context?

While there is growing recognition that context interacts with the intervention to impact on the intervention’s effectiveness [ 22 ], context is still poorly defined and conceptualised. There are a number of different definitions in the literature, but as Bate et al. explained ‘almost universally, we find context to be an overworked word in everyday dialogue but a massively understudied and misunderstood concept’ [ 23 ]. Ovretveit defines context as ‘everything the intervention is not’ [ 24 ]. This last definition is used by the MRC framework for process evaluations [ 25 ]; however; the problem with this definition is that it is highly dependent on how the intervention is defined. We have found Pfadenhauer et al.’s definition useful:

Context is conceptualised as a set of characteristics and circumstances that consist of active and unique factors that surround the implementation. As such it is not a backdrop for implementation but interacts, influences, modifies and facilitates or constrains the intervention and its implementation. Context is usually considered in relation to an intervention or object, with which it actively interacts. A boundary between the concepts of context and setting is discernible: setting refers to the physical, specific location in which the intervention is put into practice. Context is much more versatile, embracing not only the setting but also roles, interactions and relationships [ 22 ].

Traditionally, context has been conceptualised in terms of barriers and facilitators, but what is a barrier in one context may be a facilitator in another, so it is the relationship and dynamics between the intervention and context which are the most important [ 26 ]. There is a need for empirical research to really understand how different contextual factors relate to each other and to the intervention. At present, research studies often list common contextual factors, but without a depth of meaning and understanding, such as government or health board policies, organisational structures, professional and patient attitudes, behaviours and beliefs [ 27 ]. The case study methodology is well placed to understand the relationship between context and intervention where these boundaries may not be clearly evident. It offers a means of unpicking the contextual conditions which are pertinent to effective implementation.

The relationship between complex health interventions and context

Health interventions are generally made up of a number of different components and are considered complex due to the influence of context on their implementation and outcomes [ 3 , 28 ]. Complex interventions are often reliant on the engagement of practitioners and patients, so their attitudes, behaviours, beliefs and cultures influence whether and how an intervention is effective or not. Interventions are context-sensitive; they interact with the environment in which they are implemented. In fact, many argue that interventions are a product of their context, and indeed, outcomes are likely to be a product of the intervention and its context [ 3 , 29 ]. Within a trial, there is also the influence of the research context too—so the observed outcome could be due to the intervention alone, elements of the context within which the intervention is being delivered, elements of the research process or a combination of all three. Therefore, it can be difficult and unhelpful to separate the intervention from the context within which it was evaluated because the intervention and context are likely to have evolved together over time. As a result, the same intervention can look and behave differently in different contexts, so it is important this is known, understood and reported [ 3 ]. Finally, the intervention context is dynamic; the people, organisations and systems change over time, [ 3 ] which requires practitioners and patients to respond, and they may do this by adapting the intervention or contextual factors. So, to enable researchers to replicate successful interventions, or to explain why the intervention was not successful, it is not enough to describe the components of the intervention, they need to be described by their relationship to their context and resources [ 3 , 28 ].

What is a case study?

Case study methodology aims to provide an in-depth, holistic, balanced, detailed and complete picture of complex contemporary phenomena in its natural context [ 8 , 9 , 20 ]. In this case, the phenomena are the implementation of complex interventions in a trial. Case study methodology takes the view that the phenomena can be more than the sum of their parts and have to be understood as a whole [ 30 ]. It is differentiated from a clinical case study by its analytical focus [ 20 ].

The methodology is particularly useful when linked to trials because some of the features of the design naturally fill the gaps in knowledge generated by trials. Given the methodological focus on understanding phenomena in the round, case study methodology is typified by the use of multiple sources of data, which are more commonly qualitatively guided [ 31 ]. The case study methodology is not epistemologically specific, like realist evaluation, and can be used with different epistemologies [ 32 ], and with different theories, such as Normalisation Process Theory (which explores how staff work together to implement a new intervention) or the Consolidated Framework for Implementation Research (which provides a menu of constructs associated with effective implementation) [ 33 , 34 , 35 ]. Realist evaluation can be used to explore the relationship between context, mechanism and outcome, but case study differs from realist evaluation by its focus on a holistic and in-depth understanding of the relationship between an intervention and the contemporary context in which it was implemented [ 36 ]. Case study enables researchers to choose epistemologies and theories which suit the nature of the enquiry and their theoretical preferences.

Designing a process evaluation using case study

An important part of any study is the research design. Due to their varied philosophical positions, the seminal authors in the field of case study have different epistemic views as to how a case study should be conducted [ 8 , 9 ]. Stake takes an interpretative approach (interested in how people make sense of their world), and Yin has more positivistic leanings, arguing for objectivity, validity and generalisability [ 8 , 9 ].

Regardless of the philosophical background, a well-designed process evaluation using case study should consider the following core components: the purpose; the definition of the intervention, the trial design, the case, and the theories or logic models underpinning the intervention; the sampling approach; and the conceptual or theoretical framework [ 8 , 9 , 20 , 31 , 33 ]. We now discuss these critical components in turn, with reference to two process evaluations that used case study design, the DQIP and OPAL studies [ 21 , 37 , 38 , 39 , 40 , 41 ].

The purpose of a process evaluation is to evaluate and explain the relationship between the intervention and its components, to context and outcome. It can help inform judgements about validity (by exploring the intervention components and their relationship with one another (construct validity), the connections between intervention and outcomes (internal validity) and the relationship between intervention and context (external validity)). It can also distinguish between implementation failure (where the intervention is poorly delivered) and intervention failure (intervention design is flawed) [ 42 , 43 ]. By using a case study to explicitly understand the relationship between context and the intervention during implementation, the process evaluation can explain the intervention effects and the potential generalisability and optimisation into routine practice [ 44 ].

The DQIP process evaluation aimed to qualitatively explore how patients and GP practices responded to an intervention designed to reduce high-risk prescribing of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or antiplatelet agents (see Table  1 ) and quantitatively examine how change in high-risk prescribing was associated with practice characteristics and implementation processes. The OPAL process evaluation (see Table  2 ) aimed to quantitatively understand the factors which influenced the effectiveness of a pelvic floor muscle training intervention for women with urinary incontinence and qualitatively explore the participants’ experiences of treatment and adherence.

Defining the intervention and exploring the theories or assumptions underpinning the intervention design

Process evaluations should also explore the utility of the theories or assumptions underpinning intervention design [ 49 ]. Not all theories underpinning interventions are based on a formal theory, but they based on assumptions as to how the intervention is expected to work. These can be depicted as a logic model or theory of change [ 25 ]. To capture how the intervention and context evolve requires the intervention and its expected mechanisms to be clearly defined at the outset [ 50 ]. Hawe and colleagues recommend defining interventions by function (what processes make the intervention work) rather than form (what is delivered) [ 51 ]. However, in some cases, it may be useful to know if some of the components are redundant in certain contexts or if there is a synergistic effect between all the intervention components.

The DQIP trial delivered two interventions, one intervention was delivered to professionals with high fidelity and then professionals delivered the other intervention to patients by form rather than function allowing adaptations to the local context as appropriate. The assumptions underpinning intervention delivery were prespecified in a logic model published in the process evaluation protocol [ 52 ].

Case study is well placed to challenge or reinforce the theoretical assumptions or redefine these based on the relationship between the intervention and context. Yin advocates the use of theoretical propositions; these direct attention to specific aspects of the study for investigation [ 8 ] can be based on the underlying assumptions and tested during the course of the process evaluation. In case studies, using an epistemic position more aligned with Yin can enable research questions to be designed, which seek to expose patterns of unanticipated as well as expected relationships [ 9 ]. The OPAL trial was more closely aligned with Yin, where the research team predefined some of their theoretical assumptions, based on how the intervention was expected to work. The relevant parts of the data analysis then drew on data to support or refute the theoretical propositions. This was particularly useful for the trial as the prespecified theoretical propositions linked to the mechanisms of action on which the intervention was anticipated to have an effect (or not).

Tailoring to the trial design

Process evaluations need to be tailored to the trial, the intervention and the outcomes being measured [ 45 ]. For example, in a stepped wedge design (where the intervention is delivered in a phased manner), researchers should try to ensure process data are captured at relevant time points or in a two-arm or multiple arm trial, ensure data is collected from the control group(s) as well as the intervention group(s). In the DQIP trial, a stepped wedge trial, at least one process evaluation case, was sampled per cohort. Trials often continue to measure outcomes after delivery of the intervention has ceased, so researchers should also consider capturing ‘follow-up’ data on contextual factors, which may continue to influence the outcome measure. The OPAL trial had two active treatment arms so collected process data from both arms. In addition, as the trial was interested in long-term adherence, the trial and the process evaluation collected data from participants for 2 years after the intervention was initially delivered, providing 24 months follow-up data, in line with the primary outcome for the trial.

Defining the case

Case studies can include single or multiple cases in their design. Single case studies usually sample typical or unique cases, their advantage being the depth and richness that can be achieved over a long period of time. The advantages of multiple case study design are that cases can be compared to generate a greater depth of analysis. Multiple case study sampling may be carried out in order to test for replication or contradiction [ 8 ]. Given that trials are often conducted over a number of sites, a multiple case study design is more sensible for process evaluations, as there is likely to be variation in implementation between sites. Case definition may occur at a variety of levels but is most appropriate if it reflects the trial design. For example, a case in an individual patient level trial is likely to be defined as a person/patient (e.g. a woman with urinary incontinence—OPAL trial) whereas in a cluster trial, a case is like to be a cluster, such as an organisation (e.g. a general practice—DQIP trial). Of course, the process evaluation could explore cases with less distinct boundaries, such as communities or relationships; however, the clarity with which these cases are defined is important, in order to scope the nature of the data that will be generated.

Carefully sampled cases are critical to a good case study as sampling helps inform the quality of the inferences that can be made from the data [ 53 ]. In both qualitative and quantitative research, how and how many participants to sample must be decided when planning the study. Quantitative sampling techniques generally aim to achieve a random sample. Qualitative research generally uses purposive samples to achieve data saturation, occurring when the incoming data produces little or no new information to address the research questions. The term data saturation has evolved from theoretical saturation in conventional grounded theory studies; however, its relevance to other types of studies is contentious as the term saturation seems to be widely used but poorly justified [ 54 ]. Empirical evidence suggests that for in-depth interview studies, saturation occurs at 12 interviews for thematic saturation, but typically more would be needed for a heterogenous sample higher degrees of saturation [ 55 , 56 ]. Both DQIP and OPAL case studies were huge with OPAL designed to interview each of the 40 individual cases four times and DQIP designed to interview the lead DQIP general practitioner (GP) twice (to capture change over time), another GP and the practice manager from each of the 10 organisational cases. Despite the plethora of mixed methods research textbooks, there is very little about sampling as discussions typically link to method (e.g. interviews) rather than paradigm (e.g. case study).

Purposive sampling can improve the generalisability of the process evaluation by sampling for greater contextual diversity. The typical or average case is often not the richest source of information. Outliers can often reveal more important insights, because they may reflect the implementation of the intervention using different processes. Cases can be selected from a number of criteria, which are not mutually exclusive, to enable a rich and detailed picture to be built across sites [ 53 ]. To avoid the Hawthorne effect, it is recommended that process evaluations sample from both intervention and control sites, which enables comparison and explanation. There is always a trade-off between breadth and depth in sampling, so it is important to note that often quantity does not mean quality and that carefully sampled cases can provide powerful illustrative examples of how the intervention worked in practice, the relationship between the intervention and context and how and why they evolved together. The qualitative components of both DQIP and OPAL process evaluations aimed for maximum variation sampling. Please see Table  1 for further information on how DQIP’s sampling frame was important for providing contextual information on processes influencing effective implementation of the intervention.

Conceptual and theoretical framework

A conceptual or theoretical framework helps to frame data collection and analysis [ 57 ]. Theories can also underpin propositions, which can be tested in the process evaluation. Process evaluations produce intervention-dependent knowledge, and theories help make the research findings more generalizable by providing a common language [ 16 ]. There are a number of mid-range theories which have been designed to be used with process evaluation [ 34 , 35 , 58 ]. The choice of the appropriate conceptual or theoretical framework is, however, dependent on the philosophical and professional background of the research. The two examples within this paper used our own framework for the design of process evaluations, which proposes a number of candidate processes which can be explored, for example, recruitment, delivery, response, maintenance and context [ 45 ]. This framework was published before the MRC guidance on process evaluations, and both the DQIP and OPAL process evaluations were designed before the MRC guidance was published. The DQIP process evaluation explored all candidates in the framework whereas the OPAL process evaluation selected four candidates, illustrating that process evaluations can be selective in what they explore based on the purpose, research questions and resources. Furthermore, as Kislov and colleagues argue, we also have a responsibility to critique the theoretical framework underpinning the evaluation and refine theories to advance knowledge [ 59 ].

Data collection

An important consideration is what data to collect or measure and when. Case study methodology supports a range of data collection methods, both qualitative and quantitative, to best answer the research questions. As the aim of the case study is to gain an in-depth understanding of phenomena in context, methods are more commonly qualitative or mixed method in nature. Qualitative methods such as interviews, focus groups and observation offer rich descriptions of the setting, delivery of the intervention in each site and arm, how the intervention was perceived by the professionals delivering the intervention and the patients receiving the intervention. Quantitative methods can measure recruitment, fidelity and dose and establish which characteristics are associated with adoption, delivery and effectiveness. To ensure an understanding of the complexity of the relationship between the intervention and context, the case study should rely on multiple sources of data and triangulate these to confirm and corroborate the findings [ 8 ]. Process evaluations might consider using routine data collected in the trial across all sites and additional qualitative data across carefully sampled sites for a more nuanced picture within reasonable resource constraints. Mixed methods allow researchers to ask more complex questions and collect richer data than can be collected by one method alone [ 60 ]. The use of multiple sources of data allows data triangulation, which increases a study’s internal validity but also provides a more in-depth and holistic depiction of the case [ 20 ]. For example, in the DQIP process evaluation, the quantitative component used routinely collected data from all sites participating in the trial and purposively sampled cases for a more in-depth qualitative exploration [ 21 , 38 , 39 ].

The timing of data collection is crucial to study design, especially within a process evaluation where data collection can potentially influence the trial outcome. Process evaluations are generally in parallel or retrospective to the trial. The advantage of a retrospective design is that the evaluation itself is less likely to influence the trial outcome. However, the disadvantages include recall bias, lack of sensitivity to nuances and an inability to iteratively explore the relationship between intervention and outcome as it develops. To capture the dynamic relationship between intervention and context, the process evaluation needs to be parallel and longitudinal to the trial. Longitudinal methodological design is rare, but it is needed to capture the dynamic nature of implementation [ 40 ]. How the intervention is delivered is likely to change over time as it interacts with context. For example, as professionals deliver the intervention, they become more familiar with it, and it becomes more embedded into systems. The OPAL process evaluation was a longitudinal, mixed methods process evaluation where the quantitative component had been predefined and built into trial data collection systems. Data collection in both the qualitative and quantitative components mirrored the trial data collection points, which were longitudinal to capture adherence and contextual changes over time.

There is a lot of attention in the recent literature towards a systems approach to understanding interventions in context, which suggests interventions are ‘events within systems’ [ 61 , 62 ]. This framing highlights the dynamic nature of context, suggesting that interventions are an attempt to change systems dynamics. This conceptualisation would suggest that the study design should collect contextual data before and after implementation to assess the effect of the intervention on the context and vice versa.

Data analysis

Designing a rigorous analysis plan is particularly important for multiple case studies, where researchers must decide whether their approach to analysis is case or variable based. Case-based analysis is the most common, and analytic strategies must be clearly articulated for within and across case analysis. A multiple case study design can consist of multiple cases, where each case is analysed at the case level, or of multiple embedded cases, where data from all the cases are pulled together for analysis at some level. For example, OPAL analysis was at the case level, but all the cases for the intervention and control arms were pulled together at the arm level for more in-depth analysis and comparison. For Yin, analytical strategies rely on theoretical propositions, but for Stake, analysis works from the data to develop theory. In OPAL and DQIP, case summaries were written to summarise the cases and detail within-case analysis. Each of the studies structured these differently based on the phenomena of interest and the analytic technique. DQIP applied an approach more akin to Stake [ 9 ], with the cases summarised around inductive themes whereas OPAL applied a Yin [ 8 ] type approach using theoretical propositions around which the case summaries were structured. As the data for each case had been collected through longitudinal interviews, the case summaries were able to capture changes over time. It is beyond the scope of this paper to discuss different analytic techniques; however, to ensure the holistic examination of the intervention(s) in context, it is important to clearly articulate and demonstrate how data is integrated and synthesised [ 31 ].

There are a number of approaches to process evaluation design in the literature; however, there is a paucity of research on what case study design can offer process evaluations. We argue that case study is one of the best research designs to underpin process evaluations, to capture the dynamic and complex relationship between intervention and context during implementation [ 38 ]. Case study can enable comparisons within and across intervention and control arms and enable the evolving relationship between intervention and context to be captured holistically rather than considering processes in isolation. Utilising a longitudinal design can enable the dynamic relationship between context and intervention to be captured in real time. This information is fundamental to holistically explaining what intervention was implemented, understanding how and why the intervention worked or not and informing the transferability of the intervention into routine clinical practice.

Case study designs are not prescriptive, but process evaluations using case study should consider the purpose, trial design, the theories or assumptions underpinning the intervention, and the conceptual and theoretical frameworks informing the evaluation. We have discussed each of these considerations in turn, providing a comprehensive overview of issues for process evaluations using a case study design. There is no single or best way to conduct a process evaluation or a case study, but researchers need to make informed choices about the process evaluation design. Although this paper focuses on process evaluations, we recognise that case study design could also be useful during intervention development and feasibility trials. Elements of this paper are also applicable to other study designs involving trials.

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Abbreviations

Data-driven Quality Improvement in Primary Care

Medical Research Council

Nonsteroidal anti-inflammatory drugs

Optimizing Pelvic Floor Muscle Exercises to Achieve Long-term benefits

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We would like to thank Professor Shaun Treweek for the discussions about context in trials.

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Grant, A., Bugge, C. & Wells, M. Designing process evaluations using case study to explore the context of complex interventions evaluated in trials. Trials 21 , 982 (2020). https://doi.org/10.1186/s13063-020-04880-4

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Case study research for better evaluations of complex interventions: rationale and challenges

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The need for better methods for evaluation in health research has been widely recognised. The ‘complexity turn’ has drawn attention to the limitations of relying on causal inference from randomised controlled trials alone for understanding whether, and under which conditions, interventions in complex systems improve health services or the public health, and what mechanisms might link interventions and outcomes. We argue that case study research—currently denigrated as poor evidence—is an under-utilised resource for not only providing evidence about context and transferability, but also for helping strengthen causal inferences when pathways between intervention and effects are likely to be non-linear.

Case study research, as an overall approach, is based on in-depth explorations of complex phenomena in their natural, or real-life, settings. Empirical case studies typically enable dynamic understanding of complex challenges and provide evidence about causal mechanisms and the necessary and sufficient conditions (contexts) for intervention implementation and effects. This is essential evidence not just for researchers concerned about internal and external validity, but also research users in policy and practice who need to know what the likely effects of complex programmes or interventions will be in their settings. The health sciences have much to learn from scholarship on case study methodology in the social sciences. However, there are multiple challenges in fully exploiting the potential learning from case study research. First are misconceptions that case study research can only provide exploratory or descriptive evidence. Second, there is little consensus about what a case study is, and considerable diversity in how empirical case studies are conducted and reported. Finally, as case study researchers typically (and appropriately) focus on thick description (that captures contextual detail), it can be challenging to identify the key messages related to intervention evaluation from case study reports.

Whilst the diversity of published case studies in health services and public health research is rich and productive, we recommend further clarity and specific methodological guidance for those reporting case study research for evaluation audiences.

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The need for methodological development to address the most urgent challenges in health research has been well-documented. Many of the most pressing questions for public health research, where the focus is on system-level determinants [ 1 , 2 ], and for health services research, where provisions typically vary across sites and are provided through interlocking networks of services [ 3 ], require methodological approaches that can attend to complexity. The need for methodological advance has arisen, in part, as a result of the diminishing returns from randomised controlled trials (RCTs) where they have been used to answer questions about the effects of interventions in complex systems [ 4 , 5 , 6 ]. In conditions of complexity, there is limited value in maintaining the current orientation to experimental trial designs in the health sciences as providing ‘gold standard’ evidence of effect.

There are increasing calls for methodological pluralism [ 7 , 8 ], with the recognition that complex intervention and context are not easily or usefully separated (as is often the situation when using trial design), and that system interruptions may have effects that are not reducible to linear causal pathways between intervention and outcome. These calls are reflected in a shifting and contested discourse of trial design, seen with the emergence of realist [ 9 ], adaptive and hybrid (types 1, 2 and 3) [ 10 , 11 ] trials that blend studies of effectiveness with a close consideration of the contexts of implementation. Similarly, process evaluation has now become a core component of complex healthcare intervention trials, reflected in MRC guidance on how to explore implementation, causal mechanisms and context [ 12 ].

Evidence about the context of an intervention is crucial for questions of external validity. As Woolcock [ 4 ] notes, even if RCT designs are accepted as robust for maximising internal validity, questions of transferability (how well the intervention works in different contexts) and generalisability (how well the intervention can be scaled up) remain unanswered [ 5 , 13 ]. For research evidence to have impact on policy and systems organisation, and thus to improve population and patient health, there is an urgent need for better methods for strengthening external validity, including a better understanding of the relationship between intervention and context [ 14 ].

Policymakers, healthcare commissioners and other research users require credible evidence of relevance to their settings and populations [ 15 ], to perform what Rosengarten and Savransky [ 16 ] call ‘careful abstraction’ to the locales that matter for them. They also require robust evidence for understanding complex causal pathways. Case study research, currently under-utilised in public health and health services evaluation, can offer considerable potential for strengthening faith in both external and internal validity. For example, in an empirical case study of how the policy of free bus travel had specific health effects in London, UK, a quasi-experimental evaluation (led by JG) identified how important aspects of context (a good public transport system) and intervention (that it was universal) were necessary conditions for the observed effects, thus providing useful, actionable evidence for decision-makers in other contexts [ 17 ].

The overall approach of case study research is based on the in-depth exploration of complex phenomena in their natural, or ‘real-life’, settings. Empirical case studies typically enable dynamic understanding of complex challenges rather than restricting the focus on narrow problem delineations and simple fixes. Case study research is a diverse and somewhat contested field, with multiple definitions and perspectives grounded in different ways of viewing the world, and involving different combinations of methods. In this paper, we raise awareness of such plurality and highlight the contribution that case study research can make to the evaluation of complex system-level interventions. We review some of the challenges in exploiting the current evidence base from empirical case studies and conclude by recommending that further guidance and minimum reporting criteria for evaluation using case studies, appropriate for audiences in the health sciences, can enhance the take-up of evidence from case study research.

Case study research offers evidence about context, causal inference in complex systems and implementation

Well-conducted and described empirical case studies provide evidence on context, complexity and mechanisms for understanding how, where and why interventions have their observed effects. Recognition of the importance of context for understanding the relationships between interventions and outcomes is hardly new. In 1943, Canguilhem berated an over-reliance on experimental designs for determining universal physiological laws: ‘As if one could determine a phenomenon’s essence apart from its conditions! As if conditions were a mask or frame which changed neither the face nor the picture!’ ([ 18 ] p126). More recently, a concern with context has been expressed in health systems and public health research as part of what has been called the ‘complexity turn’ [ 1 ]: a recognition that many of the most enduring challenges for developing an evidence base require a consideration of system-level effects [ 1 ] and the conceptualisation of interventions as interruptions in systems [ 19 ].

The case study approach is widely recognised as offering an invaluable resource for understanding the dynamic and evolving influence of context on complex, system-level interventions [ 20 , 21 , 22 , 23 ]. Empirically, case studies can directly inform assessments of where, when, how and for whom interventions might be successfully implemented, by helping to specify the necessary and sufficient conditions under which interventions might have effects and to consolidate learning on how interdependencies, emergence and unpredictability can be managed to achieve and sustain desired effects. Case study research has the potential to address four objectives for improving research and reporting of context recently set out by guidance on taking account of context in population health research [ 24 ], that is to (1) improve the appropriateness of intervention development for specific contexts, (2) improve understanding of ‘how’ interventions work, (3) better understand how and why impacts vary across contexts and (4) ensure reports of intervention studies are most useful for decision-makers and researchers.

However, evaluations of complex healthcare interventions have arguably not exploited the full potential of case study research and can learn much from other disciplines. For evaluative research, exploratory case studies have had a traditional role of providing data on ‘process’, or initial ‘hypothesis-generating’ scoping, but might also have an increasing salience for explanatory aims. Across the social and political sciences, different kinds of case studies are undertaken to meet diverse aims (description, exploration or explanation) and across different scales (from small N qualitative studies that aim to elucidate processes, or provide thick description, to more systematic techniques designed for medium-to-large N cases).

Case studies with explanatory aims vary in terms of their positioning within mixed-methods projects, with designs including (but not restricted to) (1) single N of 1 studies of interventions in specific contexts, where the overall design is a case study that may incorporate one or more (randomised or not) comparisons over time and between variables within the case; (2) a series of cases conducted or synthesised to provide explanation from variations between cases; and (3) case studies of particular settings within RCT or quasi-experimental designs to explore variation in effects or implementation.

Detailed qualitative research (typically done as ‘case studies’ within process evaluations) provides evidence for the plausibility of mechanisms [ 25 ], offering theoretical generalisations for how interventions may function under different conditions. Although RCT designs reduce many threats to internal validity, the mechanisms of effect remain opaque, particularly when the causal pathways between ‘intervention’ and ‘effect’ are long and potentially non-linear: case study research has a more fundamental role here, in providing detailed observational evidence for causal claims [ 26 ] as well as producing a rich, nuanced picture of tensions and multiple perspectives [ 8 ].

Longitudinal or cross-case analysis may be best suited for evidence generation in system-level evaluative research. Turner [ 27 ], for instance, reflecting on the complex processes in major system change, has argued for the need for methods that integrate learning across cases, to develop theoretical knowledge that would enable inferences beyond the single case, and to develop generalisable theory about organisational and structural change in health systems. Qualitative Comparative Analysis (QCA) [ 28 ] is one such formal method for deriving causal claims, using set theory mathematics to integrate data from empirical case studies to answer questions about the configurations of causal pathways linking conditions to outcomes [ 29 , 30 ].

Nonetheless, the single N case study, too, provides opportunities for theoretical development [ 31 ], and theoretical generalisation or analytical refinement [ 32 ]. How ‘the case’ and ‘context’ are conceptualised is crucial here. Findings from the single case may seem to be confined to its intrinsic particularities in a specific and distinct context [ 33 ]. However, if such context is viewed as exemplifying wider social and political forces, the single case can be ‘telling’, rather than ‘typical’, and offer insight into a wider issue [ 34 ]. Internal comparisons within the case can offer rich possibilities for logical inferences about causation [ 17 ]. Further, case studies of any size can be used for theory testing through refutation [ 22 ]. The potential lies, then, in utilising the strengths and plurality of case study to support theory-driven research within different methodological paradigms.

Evaluation research in health has much to learn from a range of social sciences where case study methodology has been used to develop various kinds of causal inference. For instance, Gerring [ 35 ] expands on the within-case variations utilised to make causal claims. For Gerring [ 35 ], case studies come into their own with regard to invariant or strong causal claims (such as X is a necessary and/or sufficient condition for Y) rather than for probabilistic causal claims. For the latter (where experimental methods might have an advantage in estimating effect sizes), case studies offer evidence on mechanisms: from observations of X affecting Y, from process tracing or from pattern matching. Case studies also support the study of emergent causation, that is, the multiple interacting properties that account for particular and unexpected outcomes in complex systems, such as in healthcare [ 8 ].

Finally, efficacy (or beliefs about efficacy) is not the only contributor to intervention uptake, with a range of organisational and policy contingencies affecting whether an intervention is likely to be rolled out in practice. Case study research is, therefore, invaluable for learning about contextual contingencies and identifying the conditions necessary for interventions to become normalised (i.e. implemented routinely) in practice [ 36 ].

The challenges in exploiting evidence from case study research

At present, there are significant challenges in exploiting the benefits of case study research in evaluative health research, which relate to status, definition and reporting. Case study research has been marginalised at the bottom of an evidence hierarchy, seen to offer little by way of explanatory power, if nonetheless useful for adding descriptive data on process or providing useful illustrations for policymakers [ 37 ]. This is an opportune moment to revisit this low status. As health researchers are increasingly charged with evaluating ‘natural experiments’—the use of face masks in the response to the COVID-19 pandemic being a recent example [ 38 ]—rather than interventions that take place in settings that can be controlled, research approaches using methods to strengthen causal inference that does not require randomisation become more relevant.

A second challenge for improving the use of case study evidence in evaluative health research is that, as we have seen, what is meant by ‘case study’ varies widely, not only across but also within disciplines. There is indeed little consensus amongst methodologists as to how to define ‘a case study’. Definitions focus, variously, on small sample size or lack of control over the intervention (e.g. [ 39 ] p194), on in-depth study and context [ 40 , 41 ], on the logic of inference used [ 35 ] or on distinct research strategies which incorporate a number of methods to address questions of ‘how’ and ‘why’ [ 42 ]. Moreover, definitions developed for specific disciplines do not capture the range of ways in which case study research is carried out across disciplines. Multiple definitions of case study reflect the richness and diversity of the approach. However, evidence suggests that a lack of consensus across methodologists results in some of the limitations of published reports of empirical case studies [ 43 , 44 ]. Hyett and colleagues [ 43 ], for instance, reviewing reports in qualitative journals, found little match between methodological definitions of case study research and how authors used the term.

This raises the third challenge we identify that case study reports are typically not written in ways that are accessible or useful for the evaluation research community and policymakers. Case studies may not appear in journals widely read by those in the health sciences, either because space constraints preclude the reporting of rich, thick descriptions, or because of the reported lack of willingness of some biomedical journals to publish research that uses qualitative methods [ 45 ], signalling the persistence of the aforementioned evidence hierarchy. Where they do, however, the term ‘case study’ is used to indicate, interchangeably, a qualitative study, an N of 1 sample, or a multi-method, in-depth analysis of one example from a population of phenomena. Definitions of what constitutes the ‘case’ are frequently lacking and appear to be used as a synonym for the settings in which the research is conducted. Despite offering insights for evaluation, the primary aims may not have been evaluative, so the implications may not be explicitly drawn out. Indeed, some case study reports might properly be aiming for thick description without necessarily seeking to inform about context or causality.

Acknowledging plurality and developing guidance

We recognise that definitional and methodological plurality is not only inevitable, but also a necessary and creative reflection of the very different epistemological and disciplinary origins of health researchers, and the aims they have in doing and reporting case study research. Indeed, to provide some clarity, Thomas [ 46 ] has suggested a typology of subject/purpose/approach/process for classifying aims (e.g. evaluative or exploratory), sample rationale and selection and methods for data generation of case studies. We also recognise that the diversity of methods used in case study research, and the necessary focus on narrative reporting, does not lend itself to straightforward development of formal quality or reporting criteria.

Existing checklists for reporting case study research from the social sciences—for example Lincoln and Guba’s [ 47 ] and Stake’s [ 33 ]—are primarily orientated to the quality of narrative produced, and the extent to which they encapsulate thick description, rather than the more pragmatic issues of implications for intervention effects. Those designed for clinical settings, such as the CARE (CAse REports) guidelines, provide specific reporting guidelines for medical case reports about single, or small groups of patients [ 48 ], not for case study research.

The Design of Case Study Research in Health Care (DESCARTE) model [ 44 ] suggests a series of questions to be asked of a case study researcher (including clarity about the philosophy underpinning their research), study design (with a focus on case definition) and analysis (to improve process). The model resembles toolkits for enhancing the quality and robustness of qualitative and mixed-methods research reporting, and it is usefully open-ended and non-prescriptive. However, even if it does include some reflections on context, the model does not fully address aspects of context, logic and causal inference that are perhaps most relevant for evaluative research in health.

Hence, for evaluative research where the aim is to report empirical findings in ways that are intended to be pragmatically useful for health policy and practice, this may be an opportune time to consider how to best navigate plurality around what is (minimally) important to report when publishing empirical case studies, especially with regards to the complex relationships between context and interventions, information that case study research is well placed to provide.

The conventional scientific quest for certainty, predictability and linear causality (maximised in RCT designs) has to be augmented by the study of uncertainty, unpredictability and emergent causality [ 8 ] in complex systems. This will require methodological pluralism, and openness to broadening the evidence base to better understand both causality in and the transferability of system change intervention [ 14 , 20 , 23 , 25 ]. Case study research evidence is essential, yet is currently under exploited in the health sciences. If evaluative health research is to move beyond the current impasse on methods for understanding interventions as interruptions in complex systems, we need to consider in more detail how researchers can conduct and report empirical case studies which do aim to elucidate the contextual factors which interact with interventions to produce particular effects. To this end, supported by the UK’s Medical Research Council, we are embracing the challenge to develop guidance for case study researchers studying complex interventions. Following a meta-narrative review of the literature, we are planning a Delphi study to inform guidance that will, at minimum, cover the value of case study research for evaluating the interrelationship between context and complex system-level interventions; for situating and defining ‘the case’, and generalising from case studies; as well as provide specific guidance on conducting, analysing and reporting case study research. Our hope is that such guidance can support researchers evaluating interventions in complex systems to better exploit the diversity and richness of case study research.

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Abbreviations

Qualitative comparative analysis

Quasi-experimental design

Randomised controlled trial

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This work was funded by the Medical Research Council - MRC Award MR/S014632/1 HCS: Case study, Context and Complex interventions (TRIPLE C). SP was additionally funded by the University of Oxford's Higher Education Innovation Fund (HEIF).

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Paparini, S., Green, J., Papoutsi, C. et al. Case study research for better evaluations of complex interventions: rationale and challenges. BMC Med 18 , 301 (2020). https://doi.org/10.1186/s12916-020-01777-6

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Case Study Evaluation: Past, Present and Future Challenges: Volume 15

Table of contents, case study evaluation: past, present and future challenges, advances in program evaluation, copyright page, list of contributors, introduction, case study, methodology and educational evaluation: a personal view.

This chapter gives one version of the recent history of evaluation case study. It looks back over the emergence of case study as a sociological method, developed in the early years of the 20th Century and celebrated and elaborated by the Chicago School of urban sociology at Chicago University, starting throughout the 1920s and 1930s. Some of the basic methods, including constant comparison, were generated at that time. Only partly influenced by this methodological movement, an alliance between an Illinois-based team in the United States and a team at the University of East Anglia in the United Kingdom recast the case method as a key tool for the evaluation of social and educational programmes.

Letters from a Headmaster ☆ Originally published in Simons, H. (Ed.) (1980). Towards a Science of the Singular: Essays about Case Study in Educational Research and Evaluation. Occasional Papers No. 10. Norwich, UK: Centre for Applied Research, University of East Anglia.

Story telling and educational understanding ☆ previously published in occasional papers #12, evaluation centre, university of western michigan, 1978..

The full ‘storytelling’ paper was written in 1978 and was influential in its time. It is reprinted here, introduced by an Author's reflection on it in 2014. The chapter describes the author’s early disenchantment with traditional approaches to educational research.

He regards educational research as, at best, a misnomer, since little of it is preceded by a search . Entitled educational researchers often fancy themselves as scientists at work. But those whom they attempt to describe are often artists at work. Statistical methodologies enable educational researchers to measure something, but their measurements can neither capture nor explain splendid teaching.

Since such a tiny fraction of what is published in educational research journals influences school practitioners, professional researchers should risk trying alternative approaches to uncovering what is going on in schools.

Story telling is posited as a possible key to producing insights that inform and ultimately improve educational practice. It advocates openness to broad inquiry into the culture of the educational setting.

Case Study as Antidote to the Literal

Much programme and policy evaluation yields to the pressure to report on the productivity of programmes and is perforce compliant with the conditions of contract. Too often the view of these evaluations is limited to a literal reading of the analytical challenge. If we are evaluating X we look critically at X1, X2 and X3. There might be cause for embracing adjoining data sources such as W1 and Y1. This ignores frequent realities that an evaluation specification is only an approximate starting point for an unpredictable journey into comprehensive understanding; that the specification represents only that which is wanted by the sponsor, and not all that may be needed ; and that the contractual specification too often insists on privileging the questions and concerns of a few. Case study evaluation proves an alternative that allows for the less-than-literal in the form of analysis of contingencies – how people, phenomena and events may be related in dynamic ways, how context and action have only a blurred dividing line and how what defines the case as a case may only emerge late in the study.

Thinking about Case Studies in 3-D: Researching the NHS Clinical Commissioning Landscape in England

What is our unit of analysis and by implication what are the boundaries of our cases? This is a question we grapple with at the start of every new project. We observe that case studies are often referred to in an unreflective manner and are often conflated with geographical location. Neat units of analysis and clearly bounded cases usually do not reflect the messiness encountered during qualitative fieldwork. Others have puzzled over these questions. We briefly discuss work to problematise the use of households as units of analysis in the context of apartheid South Africa and then consider work of other anthropologists engaged in multi-site ethnography. We have found the notion of ‘following’ chains, paths and threads across sites to be particularly insightful.

We present two examples from our work studying commissioning in the English National Health Service (NHS) to illustrate our struggles with case studies. The first is a study of Practice-based Commissioning groups and the second is a study of the early workings of Clinical Commissioning Groups. In both instances we show how ideas of what constituted our unit of analysis and the boundaries of our cases became less clear as our research progressed. We also discuss pressures we experienced to add more case studies to our projects. These examples illustrate the primacy for us of understanding interactions between place, local history and rapidly developing policy initiatives. Understanding cases in this way can be challenging in a context where research funders hold different views of what constitutes a case.

The Case for Evaluating Process and Worth: Evaluation of a Programme for Carers and People with Dementia

A case study methodology was applied as a major component of a mixed-methods approach to the evaluation of a mobile dementia education and support service in the Bega Valley Shire, New South Wales, Australia. In-depth interviews with people with dementia (PWD), their carers, programme staff, family members and service providers and document analysis including analysis of client case notes and client database were used.

The strengths of the case study approach included: (i) simultaneous evaluation of programme process and worth, (ii) eliciting the theory of change and addressing the problem of attribution, (iii) demonstrating the impact of the programme on earlier steps identified along the causal pathway (iv) understanding the complexity of confounding factors, (v) eliciting the critical role of the social, cultural and political context, (vi) understanding the importance of influences contributing to differences in programme impact for different participants and (vii) providing insight into how programme participants experience the value of the programme including unintended benefits.

The broader case of the collective experience of dementia and as part of this experience, the impact of a mobile programme of support and education, in a predominately rural area grew from the investigation of the programme experience of ‘individual cases’ of carers and PWD. Investigation of living conditions, relationships, service interactions through observation and increased depth of interviews with service providers and family members would have provided valuable perspectives and thicker description of the case for increased understanding of the case and strength of the evaluation.

The Collapse of “Primary Care” in Medical Education: A Case Study of Michigan’s Community/University Health Partnerships Project

This chapter describes a case study of a social change project in medical education (primary care), in which the critical interpretive evaluation methodology I sought to use came up against the “positivist” approach preferred by senior figures in the medical school who commissioned the evaluation.

I describe the background to the study and justify the evaluation approach and methods employed in the case study – drawing on interviews, document analysis, survey research, participant observation, literature reviews, and critical incidents – one of which was the decision by the medical school hierarchy to restrict my contact with the lay community in my official evaluation duties. The use of critical ethnography also embraced wider questions about circuits of power and the social and political contexts within which the “social change” effort occurred.

Central to my analysis is John Gaventa’s theory of power as “the internalization of values that inhibit consciousness and participation while encouraging powerlessness and dependency.” Gaventa argued, essentially, that the evocation of power has as much to do with preventing decisions as with bringing them about. My chosen case illustrated all three dimensions of power that Gaventa originally uncovered in his portrait of self-interested Appalachian coal mine owners: (1) communities were largely excluded from decision making power; (2) issues were avoided or suppressed; and (3) the interests of the oppressed went largely unrecognized.

The account is auto-ethnographic, hence the study is limited by my abilities, biases, and subject positions. I reflect on these in the chapter.

The study not only illustrates the unique contribution of case study as a research methodology but also its low status in the positivist paradigm adhered to by many doctors. Indeed, the tension between the potential of case study to illuminate the complexities of community engagement through thick description and the rejection of this very method as inherently “flawed” suggests that medical education may be doomed to its neoliberal fate for some time to come.

‘Lead’ Standard Evaluation

This is a personal narrative, but I trust not a self-regarding one. For more years than I care to remember I have been working in the field of curriculum (or ‘program’) evaluation. The field by any standards is dispersed and fragmented, with variously ascribed purposes, roles, implicit values, political contexts, and social research methods. Attempts to organize this territory into an ‘evaluation theory tree’ (e.g. Alkin, M., & Christie, C. (2003). An evaluation theory tree. In M. Alkin (Ed.), Evaluation roots: Tracing theorists’ views and influences (pp. 12–65). Thousand Oaks, CA: Sage) have identified broad types or ‘branches’, but the migration of specific characteristics (like ‘case study’) or individual practitioners across the boundaries has tended to undermine the analysis at the level of detail, and there is no suggestion that it represents a cladistic taxonomy. There is, however, general agreement that the roots of evaluation practice tap into a variety of cultural sources, being grounded bureaucratically in (potentially conflicting) doctrines of accountability and methodologically in discipline-based or pragmatically eclectic formats for systematic social enquiry.

In general, this diversity is not treated as problematic. The professional evaluation community has increasingly taken the view (‘let all the flowers grow’) that evaluation models can be deemed appropriate across a wide spectrum, with their appropriateness determined by the nature of the task and its context, including in relation to hybrid studies using mixed models or displaying what Geertz (Geertz, C. (1980/1993). Blurred genres: The refiguration of social thought. The American Scholar , 49(2), 165–179) called ‘blurred genres’. However, from time to time historic tribal rivalries re-emerge as particular practitioners feel the need to defend their modus operandi (and thereby their livelihood) against paradigm shifts or governments and other sponsors of program evaluation seeking for ideological reasons to prioritize certain types of study at the expense of others. The latter possibility poses a potential threat that needs to be taken seriously by evaluators within the broad tradition showcased in this volume, interpretive qualitative case studies of educational programs that combine naturalistic description (often ‘thick’; Geertz, C. (1973). Thick description: Towards an interpretive theory of culture. In The interpretation of culture (pp. 3–30). New York, NY: Basic Books.) description with a values-orientated analysis of their implications. Such studies are more likely to seek inspiration from anthropology or critical discourse analysis than from the randomly controlled trials familiar in medical research or laboratory practice in the physical sciences, despite the impressive rigour of the latter in appropriate contexts. It is the risk of ideological allegiance that I address in this chapter.

Freedom from the Rubric

Twice-told tales how public inquiry could inform n of 1 case study research.

This chapter considers the usefulness and validity of public inquiries as a source of data and preliminary interpretation for case study research. Using two contrasting examples – the Bristol Inquiry into excess deaths in a children’s cardiac surgery unit and the Woolf Inquiry into a breakdown of governance at the London School of Economics (LSE) – I show how academics can draw fruitfully on, and develop further analysis from, the raw datasets, published summaries and formal judgements of public inquiries.

Academic analysis of public inquiries can take two broad forms, corresponding to the two main approaches to individual case study defined by Stake: instrumental (selecting the public inquiry on the basis of pre-defined theoretical features and using the material to develop and test theoretical propositions) and intrinsic (selecting the public inquiry on the basis of the particular topic addressed and using the material to explore questions about what was going on and why).

The advantages of a public inquiry as a data source for case study research typically include a clear and uncontested focus of inquiry; the breadth and richness of the dataset collected; the exceptional level of support available for the tasks of transcribing, indexing, collating, summarising and so on; and the expert interpretations and insights of the inquiry’s chair (with which the researcher may or may not agree). A significant disadvantage is that whilst the dataset collected for a public inquiry is typically ‘rich’, it has usually been collected under far from ideal research conditions. Hence, while public inquiries provide a potentially rich resource for researchers, those who seek to use public inquiry data for research must justify their choice on both ethical and scientific grounds.

Evaluation as the Co-Construction of Knowledge: Case Studies of Place-Based Leadership and Public Service Innovation

This chapter introduces the notion of the ‘Innovation Story’ as a methodological approach to public policy evaluation, which builds in greater opportunity for learning and reflexivity.

The Innovation Story is an adaptation of the case study approach and draws on participatory action research traditions. It is a structured narrative that describes a particular public policy innovation in the personalised contexts in which it is experienced by innovators. Its construction involves a discursive process through which involved actors tell their story, explain it to others, listen to their questions and co-construct knowledge of change together.

The approach was employed to elaborate five case studies of place-based leadership and public service innovation in the United Kingdom, The Netherlands and Mexico. The key findings are that spaces in which civic leaders come together from different ‘realms’ of leadership in a locality (community, business, professional managers and political leaders) can become innovation zones that foster inventive behaviour. Much depends on the quality of civic leadership, and its capacity to foster genuine dialogue and co-responsibility. This involves the evaluation seeking out influential ideas from below the level of strategic management, and documenting leadership activities of those who are skilled at ‘boundary crossing’ – for example, communicating between sectors.

The evaluator can be a key player in this process, as a convenor of safe spaces for actors to come together to discuss and deliberate before returning to practice. Our approach therefore argues for a particular awareness of the political nature of policy evaluation in terms of negotiating these spaces, and the need for politically engaged evaluators who are skilled in facilitating collective learning processes.

Evaluation Noir: The Other Side of the Experience

What are the boundaries of a case study, and what should new evaluators do when these boundaries are breached? How does a new evaluator interpret the breakdown of communication, how do new evaluators protect themselves when the evaluation fails? This chapter discusses the journey of an evaluator new to the field of qualitative evaluative inquiry. Integrating the perspective of a senior evaluator, the authors reflect on three key experiences that informed the new evaluator. The authors hope to provide a rare insight into case study practice as emotional issues turn out to be just as complex as the methodology used.

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15.7 Evaluation: Presentation and Analysis of Case Study

Learning outcomes.

By the end of this section, you will be able to:

• Revise writing to follow the genre conventions of case studies.
• Evaluate the effectiveness and quality of a case study report.

Case studies follow a structure of background and context , methods , findings , and analysis . Body paragraphs should have main points and concrete details. In addition, case studies are written in formal language with precise wording and with a specific purpose and audience (generally other professionals in the field) in mind. Case studies also adhere to the conventions of the discipline’s formatting guide ( APA Documentation and Format in this study). Compare your case study with the following rubric as a final check.

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Access for free at https://openstax.org/books/writing-guide/pages/1-unit-introduction

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• Publisher/website: OpenStax
• Book title: Writing Guide with Handbook
• Publication date: Dec 21, 2021
• Location: Houston, Texas
• Book URL: https://openstax.org/books/writing-guide/pages/1-unit-introduction
• Section URL: https://openstax.org/books/writing-guide/pages/15-7-evaluation-presentation-and-analysis-of-case-study

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• Section 1. A Framework for Program Evaluation: A Gateway to Tools

Chapter 36 Sections

• Section 2. Community-based Participatory Research
• Section 3. Understanding Community Leadership, Evaluators, and Funders: What Are Their Interests?
• Section 4. Choosing Evaluators
• Section 5. Developing an Evaluation Plan
• Section 6. Participatory Evaluation
• Main Section

This section is adapted from the article "Recommended Framework for Program Evaluation in Public Health Practice," by Bobby Milstein, Scott Wetterhall, and the CDC Evaluation Working Group.

Around the world, there exist many programs and interventions developed to improve conditions in local communities. Communities come together to reduce the level of violence that exists, to work for safe, affordable housing for everyone, or to help more students do well in school, to give just a few examples.

But how do we know whether these programs are working? If they are not effective, and even if they are, how can we improve them to make them better for local communities? And finally, how can an organization make intelligent choices about which promising programs are likely to work best in their community?

Over the past years, there has been a growing trend towards the better use of evaluation to understand and improve practice.The systematic use of evaluation has solved many problems and helped countless community-based organizations do what they do better.

Despite an increased understanding of the need for - and the use of - evaluation, however, a basic agreed-upon framework for program evaluation has been lacking. In 1997, scientists at the United States Centers for Disease Control and Prevention (CDC) recognized the need to develop such a framework. As a result of this, the CDC assembled an Evaluation Working Group comprised of experts in the fields of public health and evaluation. Members were asked to develop a framework that summarizes and organizes the basic elements of program evaluation. This Community Tool Box section describes the framework resulting from the Working Group's efforts.

Before we begin, however, we'd like to offer some definitions of terms that we will use throughout this section.

By evaluation , we mean the systematic investigation of the merit, worth, or significance of an object or effort. Evaluation practice has changed dramatically during the past three decades - new methods and approaches have been developed and it is now used for increasingly diverse projects and audiences.

Throughout this section, the term program is used to describe the object or effort that is being evaluated. It may apply to any action with the goal of improving outcomes for whole communities, for more specific sectors (e.g., schools, work places), or for sub-groups (e.g., youth, people experiencing violence or HIV/AIDS). This definition is meant to be very broad.

Examples of different types of programs include:

• Direct service interventions (e.g., a program that offers free breakfast to improve nutrition for grade school children)
• Community mobilization efforts (e.g., organizing a boycott of California grapes to improve the economic well-being of farm workers)
• Research initiatives (e.g., an effort to find out whether inequities in health outcomes based on race can be reduced)
• Surveillance systems (e.g., whether early detection of school readiness improves educational outcomes)
• Advocacy work (e.g., a campaign to influence the state legislature to pass legislation regarding tobacco control)
• Social marketing campaigns (e.g., a campaign in the Third World encouraging mothers to breast-feed their babies to reduce infant mortality)
• Infrastructure building projects (e.g., a program to build the capacity of state agencies to support community development initiatives)
• Training programs (e.g., a job training program to reduce unemployment in urban neighborhoods)
• Administrative systems (e.g., an incentive program to improve efficiency of health services)

Program evaluation - the type of evaluation discussed in this section - is an essential organizational practice for all types of community health and development work. It is a way to evaluate the specific projects and activities community groups may take part in, rather than to evaluate an entire organization or comprehensive community initiative.

Stakeholders refer to those who care about the program or effort. These may include those presumed to benefit (e.g., children and their parents or guardians), those with particular influence (e.g., elected or appointed officials), and those who might support the effort (i.e., potential allies) or oppose it (i.e., potential opponents). Key questions in thinking about stakeholders are: Who cares? What do they care about?

This section presents a framework that promotes a common understanding of program evaluation. The overall goal is to make it easier for everyone involved in community health and development work to evaluate their efforts.

Why evaluate community health and development programs?

The type of evaluation we talk about in this section can be closely tied to everyday program operations. Our emphasis is on practical, ongoing evaluation that involves program staff, community members, and other stakeholders, not just evaluation experts. This type of evaluation offers many advantages for community health and development professionals.

For example, it complements program management by:

• Helping to clarify program plans
• Improving communication among partners
• Gathering the feedback needed to improve and be accountable for program effectiveness

It's important to remember, too, that evaluation is not a new activity for those of us working to improve our communities. In fact, we assess the merit of our work all the time when we ask questions, consult partners, make assessments based on feedback, and then use those judgments to improve our work. When the stakes are low, this type of informal evaluation might be enough. However, when the stakes are raised - when a good deal of time or money is involved, or when many people may be affected - then it may make sense for your organization to use evaluation procedures that are more formal, visible, and justifiable.

How do you evaluate a specific program?

Before your organization starts with a program evaluation, your group should be very clear about the answers to the following questions:.

• What will be evaluated?
• What criteria will be used to judge program performance?
• What standards of performance on the criteria must be reached for the program to be considered successful?
• What evidence will indicate performance on the criteria relative to the standards?
• What conclusions about program performance are justified based on the available evidence?

To clarify the meaning of each, let's look at some of the answers for Drive Smart, a hypothetical program begun to stop drunk driving.

• Drive Smart, a program focused on reducing drunk driving through public education and intervention.
• The number of community residents who are familiar with the program and its goals
• The number of people who use "Safe Rides" volunteer taxis to get home
• The percentage of people who report drinking and driving
• The reported number of single car night time crashes (This is a common way to try to determine if the number of people who drive drunk is changing)
• 80% of community residents will know about the program and its goals after the first year of the program
• The number of people who use the "Safe Rides" taxis will increase by 20% in the first year
• The percentage of people who report drinking and driving will decrease by 20% in the first year
• The reported number of single car night time crashes will decrease by 10 % in the program's first two years
• A random telephone survey will demonstrate community residents' knowledge of the program and changes in reported behavior
• Logs from "Safe Rides" will tell how many people use their services
• Information on single car night time crashes will be gathered from police records
• Are the changes we have seen in the level of drunk driving due to our efforts, or something else? Or (if no or insufficient change in behavior or outcome,)
• Should Drive Smart change what it is doing, or have we just not waited long enough to see results?

The following framework provides an organized approach to answer these questions.

A framework for program evaluation

Program evaluation offers a way to understand and improve community health and development practice using methods that are useful, feasible, proper, and accurate. The framework described below is a practical non-prescriptive tool that summarizes in a logical order the important elements of program evaluation.

The framework contains two related dimensions:

• Steps in evaluation practice, and
• Standards for "good" evaluation.

The six connected steps of the framework are actions that should be a part of any evaluation. Although in practice the steps may be encountered out of order, it will usually make sense to follow them in the recommended sequence. That's because earlier steps provide the foundation for subsequent progress. Thus, decisions about how to carry out a given step should not be finalized until prior steps have been thoroughly addressed.

However, these steps are meant to be adaptable, not rigid. Sensitivity to each program's unique context (for example, the program's history and organizational climate) is essential for sound evaluation. They are intended to serve as starting points around which community organizations can tailor an evaluation to best meet their needs.

• Engage stakeholders
• Describe the program
• Focus the evaluation design
• Gather credible evidence
• Justify conclusions
• Ensure use and share lessons learned

Understanding and adhering to these basic steps will improve most evaluation efforts.

The second part of the framework is a basic set of standards to assess the quality of evaluation activities. There are 30 specific standards, organized into the following four groups:

• Feasibility

These standards help answer the question, "Will this evaluation be a 'good' evaluation?" They are recommended as the initial criteria by which to judge the quality of the program evaluation efforts.

Engage Stakeholders

Stakeholders are people or organizations that have something to gain or lose from what will be learned from an evaluation, and also in what will be done with that knowledge. Evaluation cannot be done in isolation. Almost everything done in community health and development work involves partnerships - alliances among different organizations, board members, those affected by the problem, and others. Therefore, any serious effort to evaluate a program must consider the different values held by the partners. Stakeholders must be part of the evaluation to ensure that their unique perspectives are understood. When stakeholders are not appropriately involved, evaluation findings are likely to be ignored, criticized, or resisted.

However, if they are part of the process, people are likely to feel a good deal of ownership for the evaluation process and results. They will probably want to develop it, defend it, and make sure that the evaluation really works.

That's why this evaluation cycle begins by engaging stakeholders. Once involved, these people will help to carry out each of the steps that follows.

Three principle groups of stakeholders are important to involve:

• People or organizations involved in program operations may include community members, sponsors, collaborators, coalition partners, funding officials, administrators, managers, and staff.
• People or organizations served or affected by the program may include clients, family members, neighborhood organizations, academic institutions, elected and appointed officials, advocacy groups, and community residents. Individuals who are openly skeptical of or antagonistic toward the program may also be important to involve. Opening an evaluation to opposing perspectives and enlisting the help of potential program opponents can strengthen the evaluation's credibility.

Likewise, individuals or groups who could be adversely or inadvertently affected by changes arising from the evaluation have a right to be engaged. For example, it is important to include those who would be affected if program services were expanded, altered, limited, or ended as a result of the evaluation.

• Primary intended users of the evaluation are the specific individuals who are in a position to decide and/or do something with the results.They shouldn't be confused with primary intended users of the program, although some of them should be involved in this group. In fact, primary intended users should be a subset of all of the stakeholders who have been identified. A successful evaluation will designate primary intended users, such as program staff and funders, early in its development and maintain frequent interaction with them to be sure that the evaluation specifically addresses their values and needs.

The amount and type of stakeholder involvement will be different for each program evaluation. For instance, stakeholders can be directly involved in designing and conducting the evaluation. They can be kept informed about progress of the evaluation through periodic meetings, reports, and other means of communication.

It may be helpful, when working with a group such as this, to develop an explicit process to share power and resolve conflicts . This may help avoid overemphasis of values held by any specific stakeholder.

Describe the Program

A program description is a summary of the intervention being evaluated. It should explain what the program is trying to accomplish and how it tries to bring about those changes. The description will also illustrate the program's core components and elements, its ability to make changes, its stage of development, and how the program fits into the larger organizational and community environment.

How a program is described sets the frame of reference for all future decisions about its evaluation. For example, if a program is described as, "attempting to strengthen enforcement of existing laws that discourage underage drinking," the evaluation might be very different than if it is described as, "a program to reduce drunk driving by teens." Also, the description allows members of the group to compare the program to other similar efforts, and it makes it easier to figure out what parts of the program brought about what effects.

Moreover, different stakeholders may have different ideas about what the program is supposed to achieve and why. For example, a program to reduce teen pregnancy may have some members who believe this means only increasing access to contraceptives, and other members who believe it means only focusing on abstinence.

Evaluations done without agreement on the program definition aren't likely to be very useful. In many cases, the process of working with stakeholders to develop a clear and logical program description will bring benefits long before data are available to measure program effectiveness.

There are several specific aspects that should be included when describing a program.

Statement of need

A statement of need describes the problem, goal, or opportunity that the program addresses; it also begins to imply what the program will do in response. Important features to note regarding a program's need are: the nature of the problem or goal, who is affected, how big it is, and whether (and how) it is changing.

Expectations

Expectations are the program's intended results. They describe what the program has to accomplish to be considered successful. For most programs, the accomplishments exist on a continuum (first, we want to accomplish X... then, we want to do Y...). Therefore, they should be organized by time ranging from specific (and immediate) to broad (and longer-term) consequences. For example, a program's vision, mission, goals, and objectives , all represent varying levels of specificity about a program's expectations.

Activities are everything the program does to bring about changes. Describing program components and elements permits specific strategies and actions to be listed in logical sequence. This also shows how different program activities, such as education and enforcement, relate to one another. Describing program activities also provides an opportunity to distinguish activities that are the direct responsibility of the program from those that are conducted by related programs or partner organizations. Things outside of the program that may affect its success, such as harsher laws punishing businesses that sell alcohol to minors, can also be noted.

Resources include the time, talent, equipment, information, money, and other assets available to conduct program activities. Reviewing the resources a program has tells a lot about the amount and intensity of its services. It may also point out situations where there is a mismatch between what the group wants to do and the resources available to carry out these activities. Understanding program costs is a necessity to assess the cost-benefit ratio as part of the evaluation.

Stage of development

A program's stage of development reflects its maturity. All community health and development programs mature and change over time. People who conduct evaluations, as well as those who use their findings, need to consider the dynamic nature of programs. For example, a new program that just received its first grant may differ in many respects from one that has been running for over a decade.

At least three phases of development are commonly recognized: planning , implementation , and effects or outcomes . In the planning stage, program activities are untested and the goal of evaluation is to refine plans as much as possible. In the implementation phase, program activities are being field tested and modified; the goal of evaluation is to see what happens in the "real world" and to improve operations. In the effects stage, enough time has passed for the program's effects to emerge; the goal of evaluation is to identify and understand the program's results, including those that were unintentional.

A description of the program's context considers the important features of the environment in which the program operates. This includes understanding the area's history, geography, politics, and social and economic conditions, and also what other organizations have done. A realistic and responsive evaluation is sensitive to a broad range of potential influences on the program. An understanding of the context lets users interpret findings accurately and assess their generalizability. For example, a program to improve housing in an inner-city neighborhood might have been a tremendous success, but would likely not work in a small town on the other side of the country without significant adaptation.

Logic model

A logic model synthesizes the main program elements into a picture of how the program is supposed to work. It makes explicit the sequence of events that are presumed to bring about change. Often this logic is displayed in a flow-chart, map, or table to portray the sequence of steps leading to program results.

Creating a logic model allows stakeholders to improve and focus program direction. It reveals assumptions about conditions for program effectiveness and provides a frame of reference for one or more evaluations of the program. A detailed logic model can also be a basis for estimating the program's effect on endpoints that are not directly measured. For example, it may be possible to estimate the rate of reduction in disease from a known number of persons experiencing the intervention if there is prior knowledge about its effectiveness.

The breadth and depth of a program description will vary for each program evaluation. And so, many different activities may be part of developing that description. For instance, multiple sources of information could be pulled together to construct a well-rounded description. The accuracy of an existing program description could be confirmed through discussion with stakeholders. Descriptions of what's going on could be checked against direct observation of activities in the field. A narrow program description could be fleshed out by addressing contextual factors (such as staff turnover, inadequate resources, political pressures, or strong community participation) that may affect program performance.

Focus the Evaluation Design

By focusing the evaluation design, we mean doing advance planning about where the evaluation is headed, and what steps it will take to get there. It isn't possible or useful for an evaluation to try to answer all questions for all stakeholders; there must be a focus. A well-focused plan is a safeguard against using time and resources inefficiently.

Depending on what you want to learn, some types of evaluation will be better suited than others. However, once data collection begins, it may be difficult or impossible to change what you are doing, even if it becomes obvious that other methods would work better. A thorough plan anticipates intended uses and creates an evaluation strategy with the greatest chance to be useful, feasible, proper, and accurate.

Among the issues to consider when focusing an evaluation are:

Purpose refers to the general intent of the evaluation. A clear purpose serves as the basis for the design, methods, and use of the evaluation. Taking time to articulate an overall purpose will stop your organization from making uninformed decisions about how the evaluation should be conducted and used.

There are at least four general purposes for which a community group might conduct an evaluation:

• To gain insight .This happens, for example, when deciding whether to use a new approach (e.g., would a neighborhood watch program work for our community?) Knowledge from such an evaluation will provide information about its practicality. For a developing program, information from evaluations of similar programs can provide the insight needed to clarify how its activities should be designed.
• To improve how things get done .This is appropriate in the implementation stage when an established program tries to describe what it has done. This information can be used to describe program processes, to improve how the program operates, and to fine-tune the overall strategy. Evaluations done for this purpose include efforts to improve the quality, effectiveness, or efficiency of program activities.
• To determine what the effects of the program are . Evaluations done for this purpose examine the relationship between program activities and observed consequences. For example, are more students finishing high school as a result of the program? Programs most appropriate for this type of evaluation are mature programs that are able to state clearly what happened and who it happened to. Such evaluations should provide evidence about what the program's contribution was to reaching longer-term goals such as a decrease in child abuse or crime in the area. This type of evaluation helps establish the accountability, and thus, the credibility, of a program to funders and to the community.
• Empower program participants (for example, being part of an evaluation can increase community members' sense of control over the program);
• Supplement the program (for example, using a follow-up questionnaire can reinforce the main messages of the program);
• Promote staff development (for example, by teaching staff how to collect, analyze, and interpret evidence); or
• Contribute to organizational growth (for example, the evaluation may clarify how the program relates to the organization's mission).

Users are the specific individuals who will receive evaluation findings. They will directly experience the consequences of inevitable trade-offs in the evaluation process. For example, a trade-off might be having a relatively modest evaluation to fit the budget with the outcome that the evaluation results will be less certain than they would be for a full-scale evaluation. Because they will be affected by these tradeoffs, intended users have a right to participate in choosing a focus for the evaluation. An evaluation designed without adequate user involvement in selecting the focus can become a misguided and irrelevant exercise. By contrast, when users are encouraged to clarify intended uses, priority questions, and preferred methods, the evaluation is more likely to focus on things that will inform (and influence) future actions.

Uses describe what will be done with what is learned from the evaluation. There is a wide range of potential uses for program evaluation. Generally speaking, the uses fall in the same four categories as the purposes listed above: to gain insight, improve how things get done, determine what the effects of the program are, and affect participants. The following list gives examples of uses in each category.

Some specific examples of evaluation uses

To gain insight:.

• Assess needs and wants of community members
• Identify barriers to use of the program
• Learn how to best describe and measure program activities

To improve how things get done:

• Refine plans for introducing a new practice
• Determine the extent to which plans were implemented
• Improve educational materials
• Enhance cultural competence
• Verify that participants' rights are protected
• Set priorities for staff training
• Make mid-course adjustments
• Clarify communication
• Determine if client satisfaction can be improved
• Compare costs to benefits
• Find out which participants benefit most from the program
• Mobilize community support for the program

To determine what the effects of the program are:

• Assess skills development by program participants
• Compare changes in behavior over time
• Decide where to allocate new resources
• Document the level of success in accomplishing objectives
• Demonstrate that accountability requirements are fulfilled
• Use information from multiple evaluations to predict the likely effects of similar programs

To affect participants:

• Reinforce messages of the program
• Stimulate dialogue and raise awareness about community issues
• Broaden consensus among partners about program goals
• Teach evaluation skills to staff and other stakeholders
• Gather success stories
• Support organizational change and improvement

The evaluation needs to answer specific questions . Drafting questions encourages stakeholders to reveal what they believe the evaluation should answer. That is, what questions are more important to stakeholders? The process of developing evaluation questions further refines the focus of the evaluation.

The methods available for an evaluation are drawn from behavioral science and social research and development. Three types of methods are commonly recognized. They are experimental, quasi-experimental, and observational or case study designs. Experimental designs use random assignment to compare the effect of an intervention between otherwise equivalent groups (for example, comparing a randomly assigned group of students who took part in an after-school reading program with those who didn't). Quasi-experimental methods make comparisons between groups that aren't equal (e.g. program participants vs. those on a waiting list) or use of comparisons within a group over time, such as in an interrupted time series in which the intervention may be introduced sequentially across different individuals, groups, or contexts. Observational or case study methods use comparisons within a group to describe and explain what happens (e.g., comparative case studies with multiple communities).

No design is necessarily better than another. Evaluation methods should be selected because they provide the appropriate information to answer stakeholders' questions, not because they are familiar, easy, or popular. The choice of methods has implications for what will count as evidence, how that evidence will be gathered, and what kind of claims can be made. Because each method option has its own biases and limitations, evaluations that mix methods are generally more robust.

Over the course of an evaluation, methods may need to be revised or modified. Circumstances that make a particular approach useful can change. For example, the intended use of the evaluation could shift from discovering how to improve the program to helping decide about whether the program should continue or not. Thus, methods may need to be adapted or redesigned to keep the evaluation on track.

Agreements summarize the evaluation procedures and clarify everyone's roles and responsibilities. An agreement describes how the evaluation activities will be implemented. Elements of an agreement include statements about the intended purpose, users, uses, and methods, as well as a summary of the deliverables, those responsible, a timeline, and budget.

The formality of the agreement depends upon the relationships that exist between those involved. For example, it may take the form of a legal contract, a detailed protocol, or a simple memorandum of understanding. Regardless of its formality, creating an explicit agreement provides an opportunity to verify the mutual understanding needed for a successful evaluation. It also provides a basis for modifying procedures if that turns out to be necessary.

As you can see, focusing the evaluation design may involve many activities. For instance, both supporters and skeptics of the program could be consulted to ensure that the proposed evaluation questions are politically viable. A menu of potential evaluation uses appropriate for the program's stage of development could be circulated among stakeholders to determine which is most compelling. Interviews could be held with specific intended users to better understand their information needs and timeline for action. Resource requirements could be reduced when users are willing to employ more timely but less precise evaluation methods.

Gather Credible Evidence

Credible evidence is the raw material of a good evaluation. The information learned should be seen by stakeholders as believable, trustworthy, and relevant to answer their questions. This requires thinking broadly about what counts as "evidence." Such decisions are always situational; they depend on the question being posed and the motives for asking it. For some questions, a stakeholder's standard for credibility could demand having the results of a randomized experiment. For another question, a set of well-done, systematic observations such as interactions between an outreach worker and community residents, will have high credibility. The difference depends on what kind of information the stakeholders want and the situation in which it is gathered.

Context matters! In some situations, it may be necessary to consult evaluation specialists. This may be especially true if concern for data quality is especially high. In other circumstances, local people may offer the deepest insights. Regardless of their expertise, however, those involved in an evaluation should strive to collect information that will convey a credible, well-rounded picture of the program and its efforts.

Having credible evidence strengthens the evaluation results as well as the recommendations that follow from them. Although all types of data have limitations, it is possible to improve an evaluation's overall credibility. One way to do this is by using multiple procedures for gathering, analyzing, and interpreting data. Encouraging participation by stakeholders can also enhance perceived credibility. When stakeholders help define questions and gather data, they will be more likely to accept the evaluation's conclusions and to act on its recommendations.

The following features of evidence gathering typically affect how credible it is seen as being:

Indicators translate general concepts about the program and its expected effects into specific, measurable parts.

Examples of indicators include:

• The program's capacity to deliver services
• The participation rate
• The level of client satisfaction
• The amount of intervention exposure (how many people were exposed to the program, and for how long they were exposed)
• Changes in participant behavior
• Changes in community conditions or norms
• Changes in the environment (e.g., new programs, policies, or practices)
• Longer-term changes in population health status (e.g., estimated teen pregnancy rate in the county)

Indicators should address the criteria that will be used to judge the program. That is, they reflect the aspects of the program that are most meaningful to monitor. Several indicators are usually needed to track the implementation and effects of a complex program or intervention.

One way to develop multiple indicators is to create a "balanced scorecard," which contains indicators that are carefully selected to complement one another. According to this strategy, program processes and effects are viewed from multiple perspectives using small groups of related indicators. For instance, a balanced scorecard for a single program might include indicators of how the program is being delivered; what participants think of the program; what effects are observed; what goals were attained; and what changes are occurring in the environment around the program.

Another approach to using multiple indicators is based on a program logic model, such as we discussed earlier in the section. A logic model can be used as a template to define a full spectrum of indicators along the pathway that leads from program activities to expected effects. For each step in the model, qualitative and/or quantitative indicators could be developed.

Indicators can be broad-based and don't need to focus only on a program's long -term goals. They can also address intermediary factors that influence program effectiveness, including such intangible factors as service quality, community capacity, or inter -organizational relations. Indicators for these and similar concepts can be created by systematically identifying and then tracking markers of what is said or done when the concept is expressed.

In the course of an evaluation, indicators may need to be modified or new ones adopted. Also, measuring program performance by tracking indicators is only one part of evaluation, and shouldn't be confused as a basis for decision making in itself. There are definite perils to using performance indicators as a substitute for completing the evaluation process and reaching fully justified conclusions. For example, an indicator, such as a rising rate of unemployment, may be falsely assumed to reflect a failing program when it may actually be due to changing environmental conditions that are beyond the program's control.

Sources of evidence in an evaluation may be people, documents, or observations. More than one source may be used to gather evidence for each indicator. In fact, selecting multiple sources provides an opportunity to include different perspectives about the program and enhances the evaluation's credibility. For instance, an inside perspective may be reflected by internal documents and comments from staff or program managers; whereas clients and those who do not support the program may provide different, but equally relevant perspectives. Mixing these and other perspectives provides a more comprehensive view of the program or intervention.

The criteria used to select sources should be clearly stated so that users and other stakeholders can interpret the evidence accurately and assess if it may be biased. In addition, some sources provide information in narrative form (for example, a person's experience when taking part in the program) and others are numerical (for example, how many people were involved in the program). The integration of qualitative and quantitative information can yield evidence that is more complete and more useful, thus meeting the needs and expectations of a wider range of stakeholders.

Quality refers to the appropriateness and integrity of information gathered in an evaluation. High quality data are reliable and informative. It is easier to collect if the indicators have been well defined. Other factors that affect quality may include instrument design, data collection procedures, training of those involved in data collection, source selection, coding, data management, and routine error checking. Obtaining quality data will entail tradeoffs (e.g. breadth vs. depth); stakeholders should decide together what is most important to them. Because all data have limitations, the intent of a practical evaluation is to strive for a level of quality that meets the stakeholders' threshold for credibility.

Quantity refers to the amount of evidence gathered in an evaluation. It is necessary to estimate in advance the amount of information that will be required and to establish criteria to decide when to stop collecting data - to know when enough is enough. Quantity affects the level of confidence or precision users can have - how sure we are that what we've learned is true. It also partly determines whether the evaluation will be able to detect effects. All evidence collected should have a clear, anticipated use.

By logistics , we mean the methods, timing, and physical infrastructure for gathering and handling evidence. People and organizations also have cultural preferences that dictate acceptable ways of asking questions and collecting information, including who would be perceived as an appropriate person to ask the questions. For example, some participants may be unwilling to discuss their behavior with a stranger, whereas others are more at ease with someone they don't know. Therefore, the techniques for gathering evidence in an evaluation must be in keeping with the cultural norms of the community. Data collection procedures should also ensure that confidentiality is protected.

Justify Conclusions

The process of justifying conclusions recognizes that evidence in an evaluation does not necessarily speak for itself. Evidence must be carefully considered from a number of different stakeholders' perspectives to reach conclusions that are well -substantiated and justified. Conclusions become justified when they are linked to the evidence gathered and judged against agreed-upon values set by the stakeholders. Stakeholders must agree that conclusions are justified in order to use the evaluation results with confidence.

The principal elements involved in justifying conclusions based on evidence are:

Standards reflect the values held by stakeholders about the program. They provide the basis to make program judgments. The use of explicit standards for judgment is fundamental to sound evaluation. In practice, when stakeholders articulate and negotiate their values, these become the standards to judge whether a given program's performance will, for instance, be considered "successful," "adequate," or "unsuccessful."

Analysis and synthesis

Analysis and synthesis are methods to discover and summarize an evaluation's findings. They are designed to detect patterns in evidence, either by isolating important findings (analysis) or by combining different sources of information to reach a larger understanding (synthesis). Mixed method evaluations require the separate analysis of each evidence element, as well as a synthesis of all sources to examine patterns that emerge. Deciphering facts from a given body of evidence involves deciding how to organize, classify, compare, and display information. These decisions are guided by the questions being asked, the types of data available, and especially by input from stakeholders and primary intended users.

Interpretation

Interpretation is the effort to figure out what the findings mean. Uncovering facts about a program's performance isn't enough to make conclusions. The facts must be interpreted to understand their practical significance. For example, saying, "15 % of the people in our area witnessed a violent act last year," may be interpreted differently depending on the situation. For example, if 50% of community members had watched a violent act in the last year when they were surveyed five years ago, the group can suggest that, while still a problem, things are getting better in the community. However, if five years ago only 7% of those surveyed said the same thing, community organizations may see this as a sign that they might want to change what they are doing. In short, interpretations draw on information and perspectives that stakeholders bring to the evaluation. They can be strengthened through active participation or interaction with the data and preliminary explanations of what happened.

Judgments are statements about the merit, worth, or significance of the program. They are formed by comparing the findings and their interpretations against one or more selected standards. Because multiple standards can be applied to a given program, stakeholders may reach different or even conflicting judgments. For instance, a program that increases its outreach by 10% from the previous year may be judged positively by program managers, based on standards of improved performance over time. Community members, however, may feel that despite improvements, a minimum threshold of access to services has still not been reached. Their judgment, based on standards of social equity, would therefore be negative. Conflicting claims about a program's quality, value, or importance often indicate that stakeholders are using different standards or values in making judgments. This type of disagreement can be a catalyst to clarify values and to negotiate the appropriate basis (or bases) on which the program should be judged.

Recommendations

Recommendations are actions to consider as a result of the evaluation. Forming recommendations requires information beyond just what is necessary to form judgments. For example, knowing that a program is able to increase the services available to battered women doesn't necessarily translate into a recommendation to continue the effort, particularly when there are competing priorities or other effective alternatives. Thus, recommendations about what to do with a given intervention go beyond judgments about a specific program's effectiveness.

If recommendations aren't supported by enough evidence, or if they aren't in keeping with stakeholders' values, they can really undermine an evaluation's credibility. By contrast, an evaluation can be strengthened by recommendations that anticipate and react to what users will want to know.

Three things might increase the chances that recommendations will be relevant and well-received:

• Sharing draft recommendations
• Soliciting reactions from multiple stakeholders
• Presenting options instead of directive advice

Justifying conclusions in an evaluation is a process that involves different possible steps. For instance, conclusions could be strengthened by searching for alternative explanations from the ones you have chosen, and then showing why they are unsupported by the evidence. When there are different but equally well supported conclusions, each could be presented with a summary of their strengths and weaknesses. Techniques to analyze, synthesize, and interpret findings might be agreed upon before data collection begins.

Ensure Use and Share Lessons Learned

It is naive to assume that lessons learned in an evaluation will necessarily be used in decision making and subsequent action. Deliberate effort on the part of evaluators is needed to ensure that the evaluation findings will be used appropriately. Preparing for their use involves strategic thinking and continued vigilance in looking for opportunities to communicate and influence. Both of these should begin in the earliest stages of the process and continue throughout the evaluation.

The elements of key importance to be sure that the recommendations from an evaluation are used are:

Design refers to how the evaluation's questions, methods, and overall processes are constructed. As discussed in the third step of this framework (focusing the evaluation design), the evaluation should be organized from the start to achieve specific agreed-upon uses. Having a clear purpose that is focused on the use of what is learned helps those who will carry out the evaluation to know who will do what with the findings. Furthermore, the process of creating a clear design will highlight ways that stakeholders, through their many contributions, can improve the evaluation and facilitate the use of the results.

Preparation

Preparation refers to the steps taken to get ready for the future uses of the evaluation findings. The ability to translate new knowledge into appropriate action is a skill that can be strengthened through practice. In fact, building this skill can itself be a useful benefit of the evaluation. It is possible to prepare stakeholders for future use of the results by discussing how potential findings might affect decision making.

For example, primary intended users and other stakeholders could be given a set of hypothetical results and asked what decisions or actions they would make on the basis of this new knowledge. If they indicate that the evidence presented is incomplete or irrelevant and that no action would be taken, then this is an early warning sign that the planned evaluation should be modified. Preparing for use also gives stakeholders more time to explore both positive and negative implications of potential results and to identify different options for program improvement.

Feedback is the communication that occurs among everyone involved in the evaluation. Giving and receiving feedback creates an atmosphere of trust among stakeholders; it keeps an evaluation on track by keeping everyone informed about how the evaluation is proceeding. Primary intended users and other stakeholders have a right to comment on evaluation decisions. From a standpoint of ensuring use, stakeholder feedback is a necessary part of every step in the evaluation. Obtaining valuable feedback can be encouraged by holding discussions during each step of the evaluation and routinely sharing interim findings, provisional interpretations, and draft reports.

Follow-up refers to the support that many users need during the evaluation and after they receive evaluation findings. Because of the amount of effort required, reaching justified conclusions in an evaluation can seem like an end in itself. It is not . Active follow-up may be necessary to remind users of the intended uses of what has been learned. Follow-up may also be required to stop lessons learned from becoming lost or ignored in the process of making complex or political decisions. To guard against such oversight, it may be helpful to have someone involved in the evaluation serve as an advocate for the evaluation's findings during the decision -making phase.

Facilitating the use of evaluation findings also carries with it the responsibility to prevent misuse. Evaluation results are always bounded by the context in which the evaluation was conducted. Some stakeholders, however, may be tempted to take results out of context or to use them for different purposes than what they were developed for. For instance, over-generalizing the results from a single case study to make decisions that affect all sites in a national program is an example of misuse of a case study evaluation.

Similarly, program opponents may misuse results by overemphasizing negative findings without giving proper credit for what has worked. Active follow-up can help to prevent these and other forms of misuse by ensuring that evidence is only applied to the questions that were the central focus of the evaluation.

Dissemination

Dissemination is the process of communicating the procedures or the lessons learned from an evaluation to relevant audiences in a timely, unbiased, and consistent fashion. Like other elements of the evaluation, the reporting strategy should be discussed in advance with intended users and other stakeholders. Planning effective communications also requires considering the timing, style, tone, message source, vehicle, and format of information products. Regardless of how communications are constructed, the goal for dissemination is to achieve full disclosure and impartial reporting.

Along with the uses for evaluation findings, there are also uses that flow from the very process of evaluating. These "process uses" should be encouraged. The people who take part in an evaluation can experience profound changes in beliefs and behavior. For instance, an evaluation challenges staff members to act differently in what they are doing, and to question assumptions that connect program activities with intended effects.

Evaluation also prompts staff to clarify their understanding of the goals of the program. This greater clarity, in turn, helps staff members to better function as a team focused on a common end. In short, immersion in the logic, reasoning, and values of evaluation can have very positive effects, such as basing decisions on systematic judgments instead of on unfounded assumptions.

Additional process uses for evaluation include:

• By defining indicators, what really matters to stakeholders becomes clear
• It helps make outcomes matter by changing the reinforcements connected with achieving positive results. For example, a funder might offer "bonus grants" or "outcome dividends" to a program that has shown a significant amount of community change and improvement.

Standards for "good" evaluation

There are standards to assess whether all of the parts of an evaluation are well -designed and working to their greatest potential. The Joint Committee on Educational Evaluation developed "The Program Evaluation Standards" for this purpose. These standards, designed to assess evaluations of educational programs, are also relevant for programs and interventions related to community health and development.

The program evaluation standards make it practical to conduct sound and fair evaluations. They offer well-supported principles to follow when faced with having to make tradeoffs or compromises. Attending to the standards can guard against an imbalanced evaluation, such as one that is accurate and feasible, but isn't very useful or sensitive to the context. Another example of an imbalanced evaluation is one that would be genuinely useful, but is impossible to carry out.

The following standards can be applied while developing an evaluation design and throughout the course of its implementation. Remember, the standards are written as guiding principles, not as rigid rules to be followed in all situations.

The 30 more specific standards are grouped into four categories:

The utility standards are:

• Stakeholder Identification : People who are involved in (or will be affected by) the evaluation should be identified, so that their needs can be addressed.
• Evaluator Credibility : The people conducting the evaluation should be both trustworthy and competent, so that the evaluation will be generally accepted as credible or believable.
• Information Scope and Selection : Information collected should address pertinent questions about the program, and it should be responsive to the needs and interests of clients and other specified stakeholders.
• Values Identification: The perspectives, procedures, and rationale used to interpret the findings should be carefully described, so that the bases for judgments about merit and value are clear.
• Report Clarity: Evaluation reports should clearly describe the program being evaluated, including its context, and the purposes, procedures, and findings of the evaluation. This will help ensure that essential information is provided and easily understood.
• Report Timeliness and Dissemination: Significant midcourse findings and evaluation reports should be shared with intended users so that they can be used in a timely fashion.
• Evaluation Impact: Evaluations should be planned, conducted, and reported in ways that encourage follow-through by stakeholders, so that the evaluation will be used.

Feasibility Standards

The feasibility standards are to ensure that the evaluation makes sense - that the steps that are planned are both viable and pragmatic.

The feasibility standards are:

• Practical Procedures: The evaluation procedures should be practical, to keep disruption of everyday activities to a minimum while needed information is obtained.
• Political Viability : The evaluation should be planned and conducted with anticipation of the different positions or interests of various groups. This should help in obtaining their cooperation so that possible attempts by these groups to curtail evaluation operations or to misuse the results can be avoided or counteracted.
• Cost Effectiveness: The evaluation should be efficient and produce enough valuable information that the resources used can be justified.

Propriety Standards

The propriety standards ensure that the evaluation is an ethical one, conducted with regard for the rights and interests of those involved. The eight propriety standards follow.

• Service Orientation : Evaluations should be designed to help organizations effectively serve the needs of all of the targeted participants.
• Formal Agreements : The responsibilities in an evaluation (what is to be done, how, by whom, when) should be agreed to in writing, so that those involved are obligated to follow all conditions of the agreement, or to formally renegotiate it.
• Rights of Human Subjects : Evaluation should be designed and conducted to respect and protect the rights and welfare of human subjects, that is, all participants in the study.
• Human Interactions : Evaluators should respect basic human dignity and worth when working with other people in an evaluation, so that participants don't feel threatened or harmed.
• Complete and Fair Assessment : The evaluation should be complete and fair in its examination, recording both strengths and weaknesses of the program being evaluated. This allows strengths to be built upon and problem areas addressed.
• Disclosure of Findings : The people working on the evaluation should ensure that all of the evaluation findings, along with the limitations of the evaluation, are accessible to everyone affected by the evaluation, and any others with expressed legal rights to receive the results.
• Conflict of Interest: Conflict of interest should be dealt with openly and honestly, so that it does not compromise the evaluation processes and results.
• Fiscal Responsibility : The evaluator's use of resources should reflect sound accountability procedures and otherwise be prudent and ethically responsible, so that expenditures are accounted for and appropriate.

Accuracy Standards

The accuracy standards ensure that the evaluation findings are considered correct.

There are 12 accuracy standards:

• Program Documentation: The program should be described and documented clearly and accurately, so that what is being evaluated is clearly identified.
• Context Analysis: The context in which the program exists should be thoroughly examined so that likely influences on the program can be identified.
• Described Purposes and Procedures: The purposes and procedures of the evaluation should be monitored and described in enough detail that they can be identified and assessed.
• Defensible Information Sources: The sources of information used in a program evaluation should be described in enough detail that the adequacy of the information can be assessed.
• Valid Information: The information gathering procedures should be chosen or developed and then implemented in such a way that they will assure that the interpretation arrived at is valid.
• Reliable Information : The information gathering procedures should be chosen or developed and then implemented so that they will assure that the information obtained is sufficiently reliable.
• Systematic Information: The information from an evaluation should be systematically reviewed and any errors found should be corrected.
• Analysis of Quantitative Information: Quantitative information - data from observations or surveys - in an evaluation should be appropriately and systematically analyzed so that evaluation questions are effectively answered.
• Analysis of Qualitative Information: Qualitative information - descriptive information from interviews and other sources - in an evaluation should be appropriately and systematically analyzed so that evaluation questions are effectively answered.
• Justified Conclusions: The conclusions reached in an evaluation should be explicitly justified, so that stakeholders can understand their worth.
• Impartial Reporting: Reporting procedures should guard against the distortion caused by personal feelings and biases of people involved in the evaluation, so that evaluation reports fairly reflect the evaluation findings.
• Metaevaluation: The evaluation itself should be evaluated against these and other pertinent standards, so that it is appropriately guided and, on completion, stakeholders can closely examine its strengths and weaknesses.

Applying the framework: Conducting optimal evaluations

There is an ever-increasing agreement on the worth of evaluation; in fact, doing so is often required by funders and other constituents. So, community health and development professionals can no longer question whether or not to evaluate their programs. Instead, the appropriate questions are:

• What is the best way to evaluate?
• What are we learning from the evaluation?
• How will we use what we learn to become more effective?

The framework for program evaluation helps answer these questions by guiding users to select evaluation strategies that are useful, feasible, proper, and accurate.

To use this framework requires quite a bit of skill in program evaluation. In most cases there are multiple stakeholders to consider, the political context may be divisive, steps don't always follow a logical order, and limited resources may make it difficult to take a preferred course of action. An evaluator's challenge is to devise an optimal strategy, given the conditions she is working under. An optimal strategy is one that accomplishes each step in the framework in a way that takes into account the program context and is able to meet or exceed the relevant standards.

This framework also makes it possible to respond to common concerns about program evaluation. For instance, many evaluations are not undertaken because they are seen as being too expensive. The cost of an evaluation, however, is relative; it depends upon the question being asked and the level of certainty desired for the answer. A simple, low-cost evaluation can deliver information valuable for understanding and improvement.

Rather than discounting evaluations as a time-consuming sideline, the framework encourages evaluations that are timed strategically to provide necessary feedback. This makes it possible to make evaluation closely linked with everyday practices.

Another concern centers on the perceived technical demands of designing and conducting an evaluation. However, the practical approach endorsed by this framework focuses on questions that can improve the program.

Finally, the prospect of evaluation troubles many staff members because they perceive evaluation methods as punishing ("They just want to show what we're doing wrong."), exclusionary ("Why aren't we part of it? We're the ones who know what's going on."), and adversarial ("It's us against them.") The framework instead encourages an evaluation approach that is designed to be helpful and engages all interested stakeholders in a process that welcomes their participation.

Evaluation is a powerful strategy for distinguishing programs and interventions that make a difference from those that don't. It is a driving force for developing and adapting sound strategies, improving existing programs, and demonstrating the results of investments in time and other resources. It also helps determine if what is being done is worth the cost.

This recommended framework for program evaluation is both a synthesis of existing best practices and a set of standards for further improvement. It supports a practical approach to evaluation based on steps and standards that can be applied in almost any setting. Because the framework is purposefully general, it provides a stable guide to design and conduct a wide range of evaluation efforts in a variety of specific program areas. The framework can be used as a template to create useful evaluation plans to contribute to understanding and improvement. The Magenta Book - Guidance for Evaluation  provides additional information on requirements for good evaluation, and some straightforward steps to make a good evaluation of an intervention more feasible, read The Magenta Book - Guidance for Evaluation.

Online Resources

Are You Ready to Evaluate your Coalition? prompts 15 questions to help the group decide whether your coalition is ready to evaluate itself and its work.

The  American Evaluation Association Guiding Principles for Evaluators  helps guide evaluators in their professional practice.

CDC Evaluation Resources  provides a list of resources for evaluation, as well as links to professional associations and journals.

Chapter 11: Community Interventions in the "Introduction to Community Psychology" explains professionally-led versus grassroots interventions, what it means for a community intervention to be effective, why a community needs to be ready for an intervention, and the steps to implementing community interventions.

The  Comprehensive Cancer Control Branch Program Evaluation Toolkit  is designed to help grantees plan and implement evaluations of their NCCCP-funded programs, this toolkit provides general guidance on evaluation principles and techniques, as well as practical templates and tools.

Developing an Effective Evaluation Plan  is a workbook provided by the CDC. In addition to information on designing an evaluation plan, this book also provides worksheets as a step-by-step guide.

EvaluACTION , from the CDC, is designed for people interested in learning about program evaluation and how to apply it to their work. Evaluation is a process, one dependent on what you’re currently doing and on the direction in which you’d like go. In addition to providing helpful information, the site also features an interactive Evaluation Plan & Logic Model Builder, so you can create customized tools for your organization to use.

Evaluating Your Community-Based Program  is a handbook designed by the American Academy of Pediatrics covering a variety of topics related to evaluation.

GAO Designing Evaluations  is a handbook provided by the U.S. Government Accountability Office with copious information regarding program evaluations.

The CDC's  Introduction to Program Evaluation for Publilc Health Programs: A Self-Study Guide  is a "how-to" guide for planning and implementing evaluation activities. The manual, based on CDC’s Framework for Program Evaluation in Public Health, is intended to assist with planning, designing, implementing and using comprehensive evaluations in a practical way.

McCormick Foundation Evaluation Guide  is a guide to planning an organization’s evaluation, with several chapters dedicated to gathering information and using it to improve the organization.

A Participatory Model for Evaluating Social Programs from the James Irvine Foundation.

Practical Evaluation for Public Managers  is a guide to evaluation written by the U.S. Department of Health and Human Services.

Penn State Program Evaluation  offers information on collecting different forms of data and how to measure different community markers.

Program Evaluaton  information page from Implementation Matters.

The Program Manager's Guide to Evaluation  is a handbook provided by the Administration for Children and Families with detailed answers to nine big questions regarding program evaluation.

Program Planning and Evaluation  is a website created by the University of Arizona. It provides links to information on several topics including methods, funding, types of evaluation, and reporting impacts.

User-Friendly Handbook for Program Evaluation  is a guide to evaluations provided by the National Science Foundation.  This guide includes practical information on quantitative and qualitative methodologies in evaluations.

W.K. Kellogg Foundation Evaluation Handbook  provides a framework for thinking about evaluation as a relevant and useful program tool. It was originally written for program directors with direct responsibility for the ongoing evaluation of the W.K. Kellogg Foundation.

Print Resources

This Community Tool Box section is an edited version of:

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Qualitative Research: Case study evaluation

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• Peer review
• Justin Keen , research fellow, health economics research group a ,
• Tim Packwood a
• Brunel University, Uxbridge, Middlesex UB8 3PH
• a Correspondence to: Dr Keen.

Case study evaluations, using one or more qualitative methods, have been used to investigate important practical and policy questions in health care. This paper describes the features of a well designed case study and gives examples showing how qualitative methods are used in evaluations of health services and health policy.

This is the last in a series of seven articles describing non-quantitative techniques and showing their value in health research

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Introduction

The medical approach to understanding disease has traditionally drawn heavily on qualitative data, and in particular on case studies to illustrate important or interesting phenomena. The tradition continues today, not least in regular case reports in this and other medical journals. Moreover, much of the everyday work of doctors and other health professionals still involves decisions that are qualitative rather than quantitative in nature.

This paper discusses the use of qualitative research methods, not in clinical care but in case study evaluations of health service interventions. It is useful for doctors to understand the principles guiding the design and conduct of these evaluations, because they are frequently used by both researchers and inspectorial agencies (such as the Audit Commission in the United Kingdom and the Office of Technology Assessment in the United States) to investigate the work of doctors and other health professionals.

We briefly discuss the circumstances in which case study research can usefully be undertaken in health service settings and the ways in which qualitative methods are used within case studies. Examples show how qualitative methods are applied, both in purely qualitative studies and alongside quantitative methods.

Case study evaluations

Doctors often find themselves asking important practical questions, such as should we be involved in the management of hospitals and, if so, how? how will new government policies affect the lives of our patients? and how can we cope with changes in practice in our local setting? There are, broadly, two ways in which such questions can usefully be addressed. One is to analyse the proposed policies themselves, by investigating whether they are internally consistent and by using theoretical frameworks to predict their effects on the ground. National policies, including the implementation of the NHS internal market 1 and the new community care arrangements 2 have been examined in this way by using economic theory to analyse their likely consequences.

The other approach, and the focus of this article, is to study implementation empirically. Empirical evaluative studies are concerned with placing a value on an intervention or policy change, and they typically involve forming judgments, firstly about the appropriateness of an intervention for those concerned (and often by implication also for the NHS as a whole) and, secondly about whether the outputs and outcomes of interventions are justified by their inputs and processes.

Case study evaluations are valuable where broad, complex questions have to be addressed in complex circumstances. No one method is sufficient to capture all salient aspects of an intervention, and case studies typically use multiple methods.

The methods used in case studies may be qualitative or quantitative, depending on the circumstances. Case studies using qualitative methods are most valuable when the question being posed requires an investigation of a real life intervention in detail, where the focus is on how and why the intervention succeeds or fails, where the general context will influence the outcome and where researchers asking the questions will have no control over events. As a result, the number of relevant variables will be far greater than can be controlled for, so that experimental approaches are simply not appropriate.

Other conditions that enhance the value of the case study approach concern the nature of the intervention being investigated. Often an intervention is ill defined, at least at the outset, and so cannot easily be distinguished from the general environment. Even where it is well defined, an intervention may not be discrete but consist of a complex mix of changes that occur over different timescales. This is a pervasive problem in health services in many countries, which are experiencing many parallel and interrelated changes. The doctor weighing up whether or how to become involved in hospital management would have to assess the various impacts on the managerial role of clinical audit, resource management, consultant job plans, and a raft of government legislation. Secondly, any intervention will typically depend for its success on the involvement of several different interested groups. Each group may have a legitimate, but different, interpretation of events; capturing these different views is often best achieved by using interviews or other qualitative methods within a case study design. Thirdly, it is not clear at the outset whether an intervention will be fully implemented by the end of a study period--accounts of major computer system failures show this. 3 Yet study of these failures may provide invaluable clues for future success.

Taken together, these conditions exclude experimental approaches to evaluation. The case study is an alternative approach--in effect, a different way of thinking about complex situations which takes the conditions into account, but is nevertheless rigorous and facilitates informed judgments about success or failure.

The design of case studies

As noted earlier, case studies using qualitative methods are used by bodies that inspect and regulate public services. Examples include the work of the National Audit Office and the Audit Commission 4 in the United Kingdom and the Office of Technology Assessment in the United States. 5 Sometimes these studies are retrospective, particularly in investigations of failed implementations of policies. Increasingly, though, these bodies use prospective studies designed to investigate the extent to which centrally determined standards or initiatives have been implemented. For example, the National Audit Office recently examined hospital catering in England, focusing on the existence of, and monitoring of, standards as required by the citizen's charter and on the application of central policy and guidance in the areas of nutritional standards and cost control. 6

Prospective studies have also been used by academic researchers, for example, to evaluate the introduction of general management 7 in Britain after the Griffiths report, 8 in the studies of specific changes following the 1989 NHS review 9 which were commissioned by the King's Fund, 10 and in the introduction of total quality management in hospitals in the United States. 11 In these cases the investigators were interested in understanding what happened in a complex environment where they had no control over events. Their research questions emerged from widespread concerns about the implications of new policies or management theories, and were investigated with the most appropriate methods at their disposal.

THE NATURE OF RESEARCH QUESTIONS

Once a broad research question has been identified, there are two approaches to the design of case study research, with appropriateness depending on the circumstances. In the first approach, precise questions are posed at the outset of the research and data collection and analysis are directed towards answering them. These studies are typically constructed to allow comparisons to be drawn. 12 The comparison may be between different approaches to implementation, or a comparison between sites where an intervention is taking place and ones where normal practice prevails.

An example is the recent study by Glennerster et al of the implementation of general practitioner fundholding. 13 Starting with a broad question about the value of general practitioner fundholding, the researchers narrowed down to precise questions about the extent to which the fundholding scheme promoted efficiency and preserved equity. They used one qualitative method, semistructured interviews, with the general practitioners and practice managers and also with people responsible for implementing the policy at national and regional level. The interviews were complemented by the collection of quantitative data such as financial information from the practices (box 1).

Box 1 Outline of case study of GPfundholding 13

Mix of qualitative and quantitative methods

Fundholding and non-fundholding practices

Programme of interviews with key staff at practices

Interviews with people responsible for imple-menting national policy

Study found that the general practitioner fund-holding scheme was achieving the aims set for it bygovernment and that adverse selection (“creamskimming”) of patients was less likely than some commentators had feared

The second approach is more open and in effect starts by asking broad questions such as what is happening here? and, what are the important features and relationships that explain the impact of this intervention? These questions are then refined and become more specific in the course of fieldwork and a parallel process of data analysis. This type of design, in which the eventual research questions emerge during the research, is termed ethnography and has been advocated for use in the study of the impact of government policies in the health system. 14 15 In some ways it is similar to the way in which consultations are conducted in that it involves initial exploration, progressing over time towards a diagnosis inferred from the available data.

The evaluation of resource management in the NHS, 16 which investigated the progress of six pilot hospitals in implementing new management arrangements, focused particularly on identifying ways in which doctors and general managers could jointly control the allocation and commitment of resources (box 2). At the outset the nature of resource management was unclear--sites were charged with finding ways of involving doctors in management, but how this would be achieved and, if achieved, how successful it would be in improving patient care were open questions. The researchers selected major specialties within each site and conducted interviews with relevant staff, observed meetings, and analysed documentation. Over time, the data were used to develop a framework which captured the essential features of resource management at the time and which was used to evaluate each site's progress in implementing it.

Box 2 Evaluation of resourcemanagement 16

Six hospitals, a mix of teaching and non-teaching

Focus on major specialties: general surgery and general medicine

Methods and data sources independent of each other

Qualitative methods included interviews, non-participant observation of meetings, analysis of documentation

Evaluation found that there were important changes in management processes, but little evidence of improvement in patient care

SELECTION OF SITES

The process of selecting sites for study is central to the case study approach. Researchers have developed a number of selection strategies, the objectives of which, as in any good research study, are to ensure that misinterpretation of results is as far as possible avoided. Criteria include the selection of cases that are typical of the phenomenon being investigated, those in which a specific theory can be tested, or those that will confirm or refute a hypothesis.

Researchers will benefit from expert advice from those with knowledge of the subject being investigated, and they can usefully build into the initial research design the possibility of testing findings at further sites. Replication of results across sites helps to ensure that findings are not due to characteristics of particular sites; hence it increases external validity. 17

SELECTION OF METHODS

The next step is to select research methods, the process being driven by criteria of validity and reliability. 18 A distinctive but not unique feature of case study research is the use of multiple methods and sources of evidence to establish construct validity. The use of particular methods is discussed in other papers in this series; the validity and reliability of individual methods is discussed in more detail by Mays and Pope. 19

Case studies often use triangulation 20 to ensure the validity of findings. In triangulation all data items are corroborated from at least one other source and normally by another method of data collection. The fundholding study referred to earlier 13 used interviews in combination with several different quantitative sources of data to establish an overall picture. The evaluation of resource management, in contrast, used a wider range of qualitative and quantitative methods. 16

Case studies are used by bodiesthat inspect public services--to monitor standards in hospital catering, for example

Any one of these methods by itself might have produced results of weak validity, but the different methods were used to obtain data from different sources. When they all suggested the emergence of an important development, therefore, they acted to strengthen the researchers' belief in the validity of their observations.

Another technique is to construct chains of evidence; these are conceptual arguments that link phenomena to one another in the following manner: “if this occurs then some other thing would be expected to occur; and if not, then it would not be expected.” For example, if quantitative evidence suggested that there had been an increase or decrease in admission rates in several specialties within a resource management site and if an interview programme revealed that the involvement of doctors in management (if developed as part of the resource management initiative) had led to a higher level of coordination of admissions policies, then this is evidence that resource management may facilitate the introduction of such policies. This type of argument is not always appropriate, but it can be valuable where it is important to investigate causation in complex environments.

ANALYTICAL FRAMEWORKS

The collection of data should be directed towards the development of an analytical framework that will facilitate interpretation of findings. Again, there are several ways in which this might be done. In the study of fundholding 13 the data were organised to “test” hypotheses which were derived from pre-existing economic theories. In the case of resource management there was no obvious pre-existing theory that could be used; the development of a framework during the study was crucial to help organise and evaluate the data collected. The framework was not imposed on the data but derived from it in an iterative process over the course of the evaluation; each was used to refine the other over time (box 3). 15

Framework: five interrelated elements of resource management 16

The target should be a reduction in the consumption itself

Commitment to resource management by the relevant personnel at each level in the organisation

Devolution of authority for the management ofresources

Collaboration within and between disciplines insecuring the objectives of resource management

Management infrastructure, particularly in termsof organisational structure and provision of information

A clear focus for the local resource management strategy

The investigator is finally left with the difficult task of making a judgment about the findings of a study. The purpose of the steps in designing and building the case study research is to maximise confidence in the findings, but interpretation inevitably involves value judgments. The findings may well include divergences of opinion among those involved about the value of the intervention, and the results will often point towards different conclusions.

The extent to which research findings can be assembled into a single coherent account of events varies widely. In some circumstances widely differing opinions are themselves very important and should be reflected in any report. Where an evaluation is designed to inform policy making, however, some attempt has to be made at an overall judgment of success or failure; this was the case in the evaluation of resource management, where it was important to indicate to policy makers and the NHS whether it was worth while.

The complexity of the issues that health professionals have to deal with and the increasing recognition by policy makers, academics, and practitioners of the value of case studies in evaluating health service interventions suggest that the use of such studies is likely to increase in the future. Qualitative methods can be used within case study designs to address many practical and policy questions that impinge on the lives of professionals, particularly where those questions are concerned with how or why events take a particular course.

• Committee of Public Accounts
• Audit Commission
• Office of Technology Assessment
• National Audit Office
• Pollitt C ,
• Harrison S ,
• Griffiths R
• Secretaries of State
• Robinson R ,
• Berwick D ,
• Godfrey AB ,
• St Leger A ,
• Schneider H ,
• Walsworth-Bell J
• Glennerster H ,
• Matsaganis M ,
• Packwood T ,

Case Study Research Method in Psychology

Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

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

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

Learn about our Editorial Process

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

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

On This Page:

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

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

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

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

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

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

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

 Famous Case Studies

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

Clinical Case Studies

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

Child Psychology Case Studies

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

Types of Case Studies

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

Where Do You Find Data for a Case Study?

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

1. Primary sources

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

2. Secondary sources

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

3. Archival records

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

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

4. Organizational records

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

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

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

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

How do I Write a Case Study in Psychology?

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

1. Introduction

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

2. Case Presentation

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

3. Management and Outcome

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

4. Discussion

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

5. Additional Items

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

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

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

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

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

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

Limitations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Further Information

• Case Study Approach
• Case Study Method
• Enhancing the Quality of Case Studies in Health Services Research
• “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

PERSPECTIVE article

This article is part of the research topic.

Reducing Animal Use in Carcinogenicity Testing

ICH S1 Prospective Evaluation Study and Weight of Evidence Assessments: Commentary from Industry Representatives Provisionally Accepted

• 1 Lilly Research Laboratories, Eli Lilly (United States), United States
• 2 Alnylam Pharmaceuticals (United States), United States
• 3 Organon, United States
• 4 ASKA Pharmaceutical Co., Ltd., Japan
• 5 Merck (United States), United States
• 6 Boehringer Ingelheim (Germany), Germany
• 7 Takeda Development Centers Americas, United States
• 8 Astellas Pharma (Japan), Japan

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Industry representatives on the ICH S1B(R1) Expert Working Group (EWG) worked closely with colleagues from the Drug Regulatory Authorities to develop an addendum to the ICH S1B guideline on carcinogenicity studies that allows for a weight-of-evidence (WoE) carcinogenicity assessment in some cases, rather than conducting a 2-year rat carcinogenicity study. A subgroup of the EWG composed of regulators have published in this issue a detailed analysis of the Prospective Evaluation Study (PES) conducted under the auspices of the ICH S1B(R1) EWG. Based on the experience gained through the Prospective Evaluation Study (PES) process, industry members of the EWG have prepared the following commentary to aid sponsors in assessing the standard WoE factors, considering how novel investigative approaches may be used to support a WoE assessment, and preparing appropriate documentation of the WoE assessment for presentation to regulatory authorities. The commentary also reviews some of the implementation challenges sponsors must consider in developing a carcinogenicity assessment strategy. Finally, case examples drawn from previously marketed products are provided as a supplement to this commentary to provide additional examples of how WoE criteria may be applied. The information and opinions expressed in this commentary are aimed at increasing the quality of WoE assessments to ensure the successful implementation of this approach.  

Keywords: carcinogenicity testing1, rat carcinogenicity2, rasH2-Tg mouse dose selection3, regulatory toxicology4, carcinogenicity weight-of-evidence criteria5, best practice6

Received: 28 Jan 2024; Accepted: 03 May 2024.

Copyright: © 2024 Vahle, Dybowski, Graziano, Hisada, Lebron, Nolte, Steigerwalt, Tsubota and Sistare. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Mx. John Vahle, Lilly Research Laboratories, Eli Lilly (United States), Indianapolis, United States Mx. Frank Sistare, Merck (United States), Kenilworth, 07033, New Jersey, United States

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• Published: 02 May 2024

Melanotic neuroectodermal tumor of infancy: a case report

• Mesfin Asefa 1 &
• Tedros Hailu 2  

Journal of Medical Case Reports volume  18 , Article number:  230 ( 2024 ) Cite this article

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Melanotic neuroectodermal tumor of infancy (MNTI) is a rare clinically benign, pigmented, tumor of neural crest origin which commonly occurs in the maxilla. It is a rare tumor that may pose difficulty in differentiating from other malignant round cell tumors.

Case presentation

A 5-month-old Ethiopian infant presented with a mass on his forehead. A wide excision of the lesion was done and subjected to histopathologic evaluation. The histologic and immunohistochemistry for synaptophysin studies confirmed that the infant was having MNTI. The patient was followed and there was no sign of recurrence at the 6th and 9th months of follow-up.

MNTI should be considered as a differential diagnosis for tumors occurring in the head region in infants and prolonged follow-up may be needed to check for possible recurrence of the tumor.

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Introduction

MNTI is a rare clinically benign tumor in infants that needs to be differentiated from other malignant childhood tumors like neuroblastoma and alveolar rhabdomyosarcoma [ 1 , 2 ]. It commonly occurs in the alveolar ridges of the maxilla and less commonly in the skull and extremities [ 3 ]. Computed tomography (CT) and FNA are the choices of initial diagnosis. A histopathologic examination can confirm the diagnosis based on the findings of the two cell populations; small round cells and larger melanocyte-like cells containing dark brown pigment in a fibrillary and collagenized vascular stromal background. The treatment is wide-margin excision and follow-up for a possibility of recurrence and malignant transformation. A classic, rare, case of melanotic neuroectodermal tumor of infancy is presented and its clinical, radiological, pathological, therapeutic, and prognostic aspects are discussed.

Patient information

A 5-month-old Ethiopian male infant presented with a firm, non-tender mass on the forehead at the midline. The swelling was initially noticed at the age of one month by his mother which progressively increased in size. The child was brought to Tikur Anbesa Specialized Teaching Hospital, Addis Ababa, to the Department of Pediatrics. The pregnancy and delivery had been normal and there was no history of medication during pregnancy. The growth and development of the neonate were adequate for his age. There was not any other mass identified on physical examination and by abdominal ultrasound.

Clinical findings and diagnostic assessment

The smooth swelling measures 6 × 6 cm. The overlying skin was intact but stretched. No pulse/thrill was elicited. On palpation it was firm to hard, non-tender and non-fluctuant. The results of routine laboratory studies were within normal limits (urinary vanillylmandelic acid was not possible to determine). Plain radiographs of the skull (posteroanterior and lateral projection) and plain and contrast computed tomography (CT) of the skull were taken. The skull radiographs revealed a soft tissue swelling with sclerosis of the underlying frontal bone along the midline. Plain and contrast computed tomography (CT) of the skull showed a midline frontal (16 × 16 mm) cystic mass with peripheral reactive bone cuffing (hyperostosis) but no underlying bone defect. Dermoid cyst was entertained radiologically (Fig.  1 ). FNAC from the mass revealed small round (Neuroblast-like) cells and reported as small round cell tumor with a suggestion for biopsy confirmation.

Computed tomography showing forehead mass with peripheral bone cuffing (hyperostostic) (arrow)

Therapeutic intervention

At the age of 5 months, wide-based excision and curettage of the area down to the normal bone were done under general anesthesia. The infant tolerated the anesthetic and surgical procedures well and was discharged in good condition on the 6th postoperative day. The removed mass was subjected to histopathologic examination.

Follow-up and outcomes

Histopathologic examination of the excised tissue revealed the characteristic biphasic pattern of cell distribution: (1) smaller round cells with scanty cytoplasm and hyperchromatic nuclei in a fibrillary & vascularized fibrocollagenous background (Fig.  2 A–C) and (2) cell population consisting of larger cells with vesicular nuclei and eosinophilic cytoplasm containing brownish pigment which cluster in alveolar and pseudoglandular patterns (Fig.  2 D, E). Immunohistochemical confirmation of the tumor for neural origin in our case was also done by synaptophysin and chromogranin with control. The small round cells stained strongly for synaptophysin, except few focal areas (Fig.  3 ), and weakly stained for chromogranin. The pigmented larger cells remained pigmented in both cases. No anaplasia or mitosis was noted. This histopathologic examination of the tissue confirmed the diagnosis of MNTI. The postoperative course was uneventful. Three weeks after surgery, the patient was reevaluated and no re-growth was noted. The patient had a follow-up subsequently with no recurrence at the 6th and 9th months of visits.

Predominant small neuroblast-like cells in a collagenized stroma ( A ) (Haematoxylin & Eosin stain(H&E), × 20); High power (H&E, × 40) view of the small round neuroblast-like cells ( B ); The small round cells in a neurofibrillary background, ( window) ( C ); Small round cells & larger pigmented cells in alveolar patterns in a collagenized stromal background ( D ) (H&E, × 10); Larger pigmented cells in a pseudoglandular pattern (arrow) ( E ) (H&E, × 40)

Synaptophysin positivity in the small round cells (dark brown)

Melanotic Neuroectodermal Tumor of Infancy, also named Pigmented Neuroectodermal Tumor of Infancy, is a rare, fast-growing, locally aggressive, clinically benign neoplasm of neuroectodermal origin [ 3 , 4 , 5 ]. It was first described by Krompecher in 1918 as ‘congenital Melanocarcinoma’ thereafter different names were used till the term MNTI was coined by Borello and Gorlin after confirmation of the nature & neuroectodermal origin of the tumor by immunocytochemistry & electromicroscopic study [ 2 , 4 , 6 ]. To date, a few hundred cases have been reported in worldwide literature.

The tumor commonly occurs in ages less than one year characteristically in infants of an average age of five months, with no variation in sex, predominantly in the maxillary alveolar process(~ 70%) as a cystic mass imposing difficulty in making a distinction from dermoid cyst radiographically [ 2 , 7 , 8 ]. In tumors occurring on the skull, plain radiographs may show adjacent bone sclerosis and hyperostosis [ 8 ]. Other less commonly reported sites of occurrence include the skull (~ 10.6%), especially the temporal area, and very few cases on the anterior fontanelle area, mandible, genital organs, and lower extremities [ 7 , 8 , 9 ]. MNTI is very rarely described in adolescents [ 10 ].

The neoplasm is histologically characterized by the presence of two groups of cells in a vascularized fibrocollagenous stroma. Small round cells (neuroblast-like) in sheets and small nests and larger cells with moderate to abundant cytoplasm containing coarse dark-brown pigment which represents a CNS-type melanin according to molecular studies on similar neoplasms. These cells frequently form pseudoglandular and alveolar spaces which are characteristic of this tumor and very useful to rule out other tumors like neuroblastoma and alveolar rhabdomyosarcoma [ 8 , 11 ].

MNTI is known to recur with a reported risk of recurrence reaching 10 to 15%, especially in those where the tumor most probably was not excised completely [ 1 ]. Most recurrences occurred within the first or second month after primary surgical intervention because of incomplete (retrospectively) first resection [ 12 ]. Recurrence is reported after 3 months of the initial surgery in orbital MNTI in one case and after 4 months of the initial resection in mandibular tumor in another case [ 12 , 13 ]. There is a similar description of MNTI on the anterior fontanelle with no recurrence after 10 months of excision [ 14 ]. However, a follow-up of at least two years is recommended by some authors based on the cumulative findings in tumors occurring on the skull [ 15 ]. A primary malignant MNTI is very rare and is usually reported as a component of immature teratoma and in tumors occurring in the thigh [ 7 ]. Rare cases of skull tumors pursuing a malignant course with secondary brain invasion are described [ 8 ].

MNTI being a rare lesion poses a challenge to clinicians not only in its diagnosis but also in management. Total excision including up to 1 cm free margin is recommended without adjuvant chemotherapy or radiotherapy by most authors to achieve a cure [ 2 ].

To the best of our knowledge, this kind of tumor is the first to be reported from Ethiopia. While the most common site of the tumor is the maxillary area, the tumor in this case was on the midline of the frontal skull. The classic histologic findings and the supportive positive immunohistochemistry tests for synaptophysin and chromogranin confirm the diagnosis. The clinical and radiographic findings are also compatible with findings in other reported cases in the skull and other locations. The absence of re-growth on follow-up foretells indeed the benign nature of the tumor in this case.

Melanotic neuroectodermal tumor of infancy should be suspected by clinicians in infants presenting with head and neck tumors. A high index of suspicion is required to diagnose this tumor and should be differentiated from other round-cell tumors. Wide-margin excision is associated with a cure, but patients should be followed for possible recurrence and rare malignant transformation.

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Acknowledgements

We acknowledge the staff of the Department of Neurosurgery who participated in the care of the patient and Professor Jacob Scheinider who prepared the histologic pictures of the case.

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Department of Pathology, St. Paul’s Hospital Millennium Medical College (SPHMMC), Addis Ababa, Ethiopia

Mesfin Asefa

Department of Pediatrics, Medical Faculty, Tikur Anbesa Specialized Hospital, Addis Ababa University, Addis Ababa, Ethiopia

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Contributions

Dr.Tedros Hailu is the primary care physician of the patient before and after the surgery including follow-up of the patient. He has prepared the drafting of the clinical presentation part of the case report. Dr. Mesfin Asefa has contributed to the histopathologic diagnosis of the patient and the writing up of the final case.

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Correspondence to Mesfin Asefa .

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Asefa, M., Hailu, T. Melanotic neuroectodermal tumor of infancy: a case report. J Med Case Reports 18 , 230 (2024). https://doi.org/10.1186/s13256-024-04550-y

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Received : 26 August 2022

Accepted : 27 March 2024

Published : 02 May 2024

DOI : https://doi.org/10.1186/s13256-024-04550-y

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