importance of inclusion and exclusion criteria in literature review

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Developing the review question and inclusion criteria

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This article is the second in a new series on the systematic review from the Joanna Briggs Institute, an international collaborative supporting evidence-based practice in nursing, medicine, and allied health fields. The purpose of the series is to show nurses how to conduct a systematic review-one step at a time. This article details the process of articulating a review question to guide the search for relevant studies and discusses how to define inclusion criteria for the study-selection phase of the review.

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Systematic Reviews

Inclusion/Exclusion Criteria

Inclusion criteria.

Identify the criteria that will be used to determine which research studies will be included. The inclusion and exclusion criteria must be decided before you start the review. Inclusion criteria is everything a study must have to be included. Exclusion criteria are the factors that would make a study ineligible to be included. Criteria that should be considered include:

Type of studies: It is important to select articles with an appropriate study design for the research question. Dates for the studies and a timeline of the problem/issue being examined may need to be identified.

Type of participants: Identify the target population characteristics. It is important to define the target population's age, sex/gender, diagnosis, as well as any other relevant factors.

Types of intervention: Describe the intervention being investigated. Consider whether to include interventions carried out globally or just in the United States. Eligibility criteria for interventions should include things such as the dose, delivery method, and duration of the investigated intervention. The interventions that are to be excluded may also need to be described here.

Types of outcome measures: Outcome measures usually refer to measurable outcomes or ‘clinical changes in health’. For example, these could include body structures and functions like pain and fatigue, activities as in functional abilities, and participation or quality of life questionnaires.

Exclusion Criteria

A balance of specific inclusion and exclusion criteria is paramount. For some systematic reviews, there may already be a large pre-existing body of literature. The search strategy may retrieve thousands of results that must be screened. Having explicit exclusion criteria from the beginning allows those conducting the screening process, an efficient workflow. For the final product there should be a section in the review dedicated to 'Characteristics of excluded studies.' It is important to summarize why studies were excluded, especially if to a reader the study would appear to be eligible for the systematic review.

For example, a team is conducting a systematic review regarding intervention options for the treatment of opioid addiction. The research team may want to exclude studies that also involve alcohol addiction to isolate the conditions for treatment interventions solely for opioid addiction.

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Implementing evidence into practice requires nurses to identify, critically appraise and synthesise research. This may require a comprehensive literature review: this article aims to outline the approaches and stages required and provides a working example of a published review.

Are there different approaches to undertaking a literature review?

What stages are required to undertake a literature review.

The rationale for the review should be established; consider why the review is important and relevant to patient care/safety or service delivery. For example, Noble et al 's 4 review sought to understand and make recommendations for practice and research in relation to dialysis refusal and withdrawal in patients with end-stage renal disease, an area of care previously poorly described. If appropriate, highlight relevant policies and theoretical perspectives that might guide the review. Once the key issues related to the topic, including the challenges encountered in clinical practice, have been identified formulate a clear question, and/or develop an aim and specific objectives. The type of review undertaken is influenced by the purpose of the review and resources available. However, the stages or methods used to undertake a review are similar across approaches and include:

Formulating clear inclusion and exclusion criteria, for example, patient groups, ages, conditions/treatments, sources of evidence/research designs;

Justifying data bases and years searched, and whether strategies including hand searching of journals, conference proceedings and research not indexed in data bases (grey literature) will be undertaken;

Developing search terms, the PICU (P: patient, problem or population; I: intervention; C: comparison; O: outcome) framework is a useful guide when developing search terms;

Developing search skills (eg, understanding Boolean Operators, in particular the use of AND/OR) and knowledge of how data bases index topics (eg, MeSH headings). Working with a librarian experienced in undertaking health searches is invaluable when developing a search.

Once studies are selected, the quality of the research/evidence requires evaluation. Using a quality appraisal tool, such as the Critical Appraisal Skills Programme (CASP) tools, 5 results in a structured approach to assessing the rigour of studies being reviewed. 3 Approaches to data synthesis for quantitative studies may include a meta-analysis (statistical analysis of data from multiple studies of similar designs that have addressed the same question), or findings can be reported descriptively. 6 Methods applicable for synthesising qualitative studies include meta-ethnography (themes and concepts from different studies are explored and brought together using approaches similar to qualitative data analysis methods), narrative summary, thematic analysis and content analysis. 7 Table 1 outlines the stages undertaken for a published review that summarised research about parents’ experiences of living with a child with a long-term condition. 8

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An example of rapid evidence assessment review

In summary, the type of literature review depends on the review purpose. For the novice reviewer undertaking a review can be a daunting and complex process; by following the stages outlined and being systematic a robust review is achievable. The importance of literature reviews should not be underestimated—they help summarise and make sense of an increasingly vast body of research promoting best evidence-based practice.

Twitter Follow Joanna Smith at @josmith175

Competing interests None declared.

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Systematic Reviews for Health Sciences and Medicine

Inclusion and Exclusion Criteria

Inclusion and exclusion criteria set the boundaries for the systematic review. They are determined after setting the research question usually before the search is conducted, however scoping searches may need to be undertaken to determine appropriate criteria. Many different factors can be used as inclusion or exclusion criteria. Information about the inclusion and exclusion criteria is usually recorded as a paragraph or table within the methods section of the systematic review. It may also be necessary to give the definitions, and source of the definition, used for particular concepts in the research question (e.g. adolescence, depression).

Other inclusion/exclusion criteria can include the sample size, method of sampling or availability of a relevant comparison group in the study. Where a single study is reported across multiple papers the findings from the papers may be merged or only the latest data may be included.

Why is it important to have inclusion and exclusion criteria?

Defining inclusion and exclusion criteria increases the likelihood of producing reliable and reproducible results, minimizes the likelihood of harm to the subjects, and guards against exploitation of vulnerable persons.

What is inclusion and exclusion criteria in literature review?

Inclusion criteria is everything that a study must have in order to be included in your review. Exclusion criteria are the factors that would make a study ineligible to be included in your review. These criteria can include dates, how a study was designed, population, outcomes, etc.

What is the purpose of developing inclusion and exclusion criteria in your review?

Inclusion and exclusion criteria are used to define those articles of interest. These criteria are usually applied to the results of a search and are not used to limit the search results.

Why is inclusion criteria important in research?

Proper selection of inclusion criteria will optimize the external and internal validity of the study, improve its feasibility, lower its costs, and minimize ethical concerns; specifically, good selection criteria will ensure the homogeneity of the sample population, reduce confounding, and increase the likelihood of …

How do you explain inclusion criteria?

Inclusion criteria are defined as the key features of the target population that the investigators will use to answer their research question. 2 Typical inclusion criteria include demographic, clinical, and geographic characteristics.

What is exclusion criteria example?

Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing to sign informed consent), to overcome practical issues related to the study itself (e.g., not being able to read, when questionnaires are used …

How do you define inclusion criteria?

How do you set inclusion criteria for a systematic review?

How do you explain exclusion criteria?

Exclusion criteria are a set of predefined definitions that is used to identify subjects who will not be included or who will have to withdraw from a research study after being included.

How do you use inclusion criteria in a sentence?

The inclusion criteria included the following. Inclusion criteria included an FEV1%-predicted >40%. The inclusion criteria included diagnosed metastatic sacral tumor.

How are inclusion and exclusion criteria determined in systematic review?

What makes a study ineligible for inclusion in a review?

Which is an example of an exclusion criteria?

Exclusion criteria are the elements of an article that disqualify the study from inclusion in a literature review. For example, excluded studies: are a certain publication type (e.g., systematic reviews)

What are the criteria for a literature review?

Inclusion criteria are the elements of an article that must be present in order for it to be eligible for inclusion in a literature review. Some examples are: Included studies must have compared certain treatments

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Systematic Reviews: Inclusion and Exclusion Criteria

Defining Inclusion/Exclusion Criteria

An important part of the SR process is defining what will and will not be included in your review.

Inclusion and exclusion criteria are developed after a research question is finalized but before a search is carried out. They determine the limits for the evidence synthesis and are typically reported in the methods section of the publication. For unfamiliar or unclear concepts, a definition may be necessary to adequately describe the criterion for readers.

Some examples of common inclusion/exclusion criteria might be:

*note of caution: research is published all over the world and in multiple languages. Limiting to just English can be considered a bias to your research.

Common Inclusion/Exclusion Criteria from the University of Melbourne

What happens if no study meets my inclusion/exclusion criteria?

Empty reviews are when no studies meet the inclusion criteria for a SR. Empty reviews are more likely to subject to publication bias, however, they are important in identifying gaps in the literature.

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Literature Reviews

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Inclusion and Exclusion Criteria

Establishing inclusion and exclusion criteria helps with designing search strategies and deciding which studies are relevant to your research question. Possible criteria to consider include

The following 6-minute video explains the relationship between inclusion and exclusion criteria and database searches.

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Specifying the inclusion and exclusion criteria for systematic literature review

Starting your inclusion and exclusion criteria before you conduct the review is important. This section is Where you describe the criteria that you will be using to include any research studies in your review. Torgerson (2003) suggests that a high quality systematic review should have inclusion and exclusion Criteria that are ‘rigorously and transparently reported a priori (before you start the review) ‘(Torgerson 2003:26). You may well ask ‘ Why is it necessary’? The reason is so that your search can target the Papers that will answer your questions and exclude any irrelevant ones. The criteria need to be explicit And applied stringently. The criteria you will need to describe the types of research studies you will be Including , the participants, the interventions, comparative groups and outcome measures. PICO now Becomes PICOT. For qualitative systematic reviews use PEO( which will now become PEOT).

Please note that whether you are writing a qualitative or quantitative review, all of these steps are same With the expectation that for qualitative reviews for qualitative reviews the data extraction and Presentation of results are conducted a little differently from quantitative reviews.Further details on these Differences can be found in Chapters 7&8. How to specify the inclusion and exclusion criteria for each Components (PICOT or PEOT) of your review question will now be discussed.

Specifying the types of studies to be included and excluded

When selecting your primary research papers, it is important to select papers with the appropriate design For your particular review question.If you are effectiveness of an intervention, the highest quality research Design for your particular review question. If you are evaluating the effectiveness of an intervention , the Highest quality research designs will be randomized controlled trials or clinical controlled trials (CCTs). (Please refer to the research design section in Chapter 2 to go over the research designs if you are still Uncertain about this).You could also use another research designs that do not include a control Intervention, but these will be lower on the hierarchical scale of quality of evidence.

In the Cochrane systematic review that I conducted with international team of colleagues,we included Both RCTs and CCTs; we also included prospective cohort studies because we knew there were not Many RCTs(Negrini et al.2010).

In the case studies, Cheryl and Mary will be seeking similar papers as they have excluded case studies Because case studies are very low down on the quality of evidence scale . If there was very little Information available , however it may be worth considering the inclusion of the case studies designs.

In contrast, Sue will be evaluating people’s lived experiences of witnessed resuscitation and will be Conducting a qualitative review. If you plan to conduct a qualitative review , you will be searching for Primary qualitative papers . The specific type of qualitative paper will depend on your specific qualitative review question.These can be presented in tables or in Narrative format as you prefer.

Literature searching (SHPS)

Establish your Inclusion and Exclusion criteria

You use these criteria to guide your searching for information and help decide which materials will/will not be included in your work.

This is particularly important for literature reviews in health because you have to determine which primary research studies can/cannot be included in your final analysis based on as unbiased, transparent and ethical approach as possible.

Establishing your inclusion/exclusion criteria can also help turn a topic of interest into a viable research question, or to think about how broad or narrow your question is: a narrow topic could potentially be quicker to research, but you may have problems finding enough relevant studies to review.

How to establish your Inclusion and Exclusion criteria

To establish your criteria you need to define each aspect of your question clearly to clarify what you are focusing on and consider if there are any variations you also wish to explore. This is where using a framework such as a PICO helps:

Example: Alternatives to drugs for controlling headaches in children

Using the PICO structure you clarify what aspects you are most interested in. Here are some examples to consider:

The aspects of the topic you decide to focus on are the Inclusion criteria.

The aspects you don't wish to include are the Exclusion criteria.

Systematic Reviews: Study selection and appraisal

Study selection: PRISMA Item 9

Inclusion/Exclusion criteria

See http://unimelb.libguides.com/c.php?g=492361&p=3368110

First level screening - title and abstract review

At the initial screening stage read just the title and abstract of the candidate studies and make a decision to include or exclude the study from your review.

For small reviews of a few studies (e.g. <100)

T he research team should agree on the inclusion and exclusion criteria for studies you wish to review and put together a study screening form. To help identify your inclusion/exclusion criteria, r evisit the PICOS of interest you came up with for your search strategy and gain agreement/approval from your colleagues or supervisor . The screening form may look similar to Table 3 of Brown et al (2013) . You may write down your decision to include or exclude an article on an Excel spreadsheet like this one , or if you have a small number of records you may choose to print out one copy for each record, although printing will be impractical for larger numbers of records . S creen each potentially useful article identified in the literature search as follows:

For large reviews of many studies (e.g. >100) - in case you need to partially automate the screening process

There are three web-based software applications that can help with screening and tracking your selection decisions:

Second level screening - full text review

Having excluded candidate studies that did not meet your inclusion/exclusion criteria you should have a smaller number of potentially relevant studies. GW affiliates at GW and Children's National Health System can use Box to store and share the full text PDF's of copyrighted journal articles https://it.gwu.edu/backup-storage-document-management . Read and critically appraise the full text of each study you selected at the first pass screening stage to determine whether you wish to include them in your discussion and analysis. Specifically each study must be evaluated based on the following criteria:

Does this study address a clearly focused question? Did the study use valid methods to address this question? Are the valid results of this study important? Are these valid, important results applicable to my patient or population?

If the answer to any of these questions is “no”, you may wish to read no further and exclude the study, or you may decide to include the study to inform your discussion but not include the results in your analysis.

To help with this process you may wish to download and apply one of the example Critical Appraisal Worksheets from the Center for Evidence Based Medicine to each study - choose a worksheet that matches the type of study: Systematic Review article Critical Appraisal Sheet Diagnosis study Critical Appraisal Sheet Prognosis study Critical Appraisal Sheet Therapy / Randomized Controlled Trial Critical Appraisal Sheet

Or you can use one of the CASP: Critical Appraisal Skills Checklists that are eight critical appraisal tools designed to be used when reading and evaluating the quality of Systematic Reviews, Randomised Controlled Trials, Cohort Studies, Case Control Studies, Economic Evaluations, Diagnostic Studies, Qualitative studies and Clinical Prediction Rule.

Make a decision on whether or not to include the study in your review, and write your decision and reasons for inclusion/exclusion at this second level/full text review stage on the study screening form. You will summarise the reasons for exclusion on the PRISMA flow diagram - see Study Selection PRISMA item # 17 below.

Reporting your screening decisions

In the final report in the methods section the PRISMA checklist Item 9 study selection will be reported as:

Study selection PRISMA Item 17

Researchers must keep the screening forms to create a summary descriptive flow diagram of study selection.

In the final report in the results section the PRISMA checklist Item 17 study selection should be reported as follows:

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Inclusion and Exclusion Criteria

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A systematic literature search can yield hundreds or thousands of records, each a potential relevant study. Sustained attention to detail is a pre-requisite for identifying relevant research. Well-constructed, clear, and explicit inclusion and exclusion criteria assist decision making consistency. In this chapter, I focus on inclusion and exclusion criteria, explain their benefits, provide guidelines on their construction and use, and illustrate with examples from sport, exercise, and physical activity research.

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Tod, D. (2019). Inclusion and Exclusion Criteria. In: Conducting Systematic Reviews in Sport, Exercise, and Physical Activity. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-030-12263-8_5

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How to Conduct a Literature Review (Health Sciences and Beyond)

Selection criteria.

Inclusion Criteria

Exclusion criteria.

You may want to think about criteria that will be used to select articles for your literature review based on your research question. These are commonly known as inclusion criteria and exclusion criteria . Be aware that you may introduce bias into the final review if these are not used thoughtfully.

Inclusion criteria are the elements of an article that must be present in order for it to be eligible for inclusion in a literature review. Some examples are:

Exclusion criteria are the elements of an article that disqualify the study from inclusion in a literature review. Some examples are:

Selecting Studies for Systematic Review: Inclusion and Exclusion Criteria

Automate every stage of your literature review to produce evidence-based research faster and more accurately.

One factor that can help make sure your review is of high quality, is the effective and appropriate selection of inclusion and exclusion criteria to be used in the systematic review. This vital factor has an impact on what is discussed and debated in your review. In this article, we explore what these criteria actually are, how you establish them, and why they are critical to the final publication.

What Are Inclusion And Exclusion Criteria?

Before identifying what criteria to include and what to exclude, it is always beneficial to establish what exactly is meant by both of those terms. In short, inclusion criteria are the characteristics that define the population eligible for a study, or that define the studies that will be eligible for inclusion in a systematic review. In contrast, exclusion criteria are a set of characteristics of studies that will not be included in the review. These inclusion and exclusion criteria help to evaluate the merit of the review in question.

How Do You Choose Inclusion And Exclusion Criteria?

Generally speaking, it is best to choose the inclusion criteria of your systematic review after you have determined what research question you are hoping to answer. When you choose the criteria to both to include and (importantly) exclude studies, your research question sets boundaries to it, so that the eligibility criteria are neither too broad nor too narrow.

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Why are Inclusion And Exclusion Criteria Important In Systematic Review?

When you define what your inclusion criteria are, and outline what your exclusion criteria are, you are improving the chances of your systematic review producing reliable results. By identifying what can and cannot be included in your review, you reduce any ambiguity in your findings. When you reduce ambiguity, your findings are far more persuasive and less subject to debate, or criticism. As a result, you are ensuring that all the time you spent on your systematic review was worthwhile and any costs were worth the expense.

Appropriate choice of inclusion and exclusion criteria is also essential to prevent any inherent selection bias. Again, such biases can result in your final review losing its persuasive power, as your results are not considered reliable. An inherent bias can mean your findings and results are liable to a ‘data mining’ style scenario, where your research question cannot be answered fairly. It could mean that your research does not take into account key variables that may have better informed your final discussion.

In short, inclusion and exclusion criteria selection is not only important it is essential. By making effective selections, you guarantee that your research’s validity cannot be questioned.

Selecting Studies for Systematic Reviews

Conducting a systematic review can be a time-consuming process to generate evidence around specific areas of research. As a result, it may be tempting for some authors to make quick selections with regard to inclusion and exclusion criteria. This lapse in judgment could prove detrimental to the review process. Exclusion and inclusion criteria optimize the scope of your research and provide the necessary merit to your research question.

3 Reasons to Connect

Systematic Reviews

Inclusion and exclusion criteria

Inclusion and exclusion criteria are a list of pre-defined characteristics to which literature must adhere to be included in a study. They are vital for the decision-making progress on what to review when undertaking a systematic review and will also help with systematic literature reviews.

You should be able to establish your inclusion/exclusion criteria during the process of defining your question. These criteria clearly demonstrate the scope of the study and provide justification for the exclusion of any information that does not meet these characteristics.

Example criteria

E.g. stage 4 lung disease patients

E.g. whether the study's reported outcomes are relevant to your study and have been presented objectively

E.g. randomised control trial

E.g. age, sex ethnicity etc.

E.g. last 5 years

E.g. over 100 participants

E.g. UK based

E.g. primary research, peer-reviewed

E.g. community-based care

E.g. English

Precision vs Sensitivity

You should aim to be as extensive as possible when conducting searches for systematic reviews. However, it may be necessary to strike a balance between the sensitivity and precision of your search.

Increasing the comprehensiveness of a search will reduce its precision and will retrieve more non-relevant results. However,

... at a conservatively-estimated reading rate of two abstracts per minute, the results of a database search can be ‘scanread’ at the rate of 120 per hour (or approximately 1000 over an 8-hour period), so the high yield and low precision associated with systematic review searching is not as daunting as it might at first appear in comparison with the total time to be invested in the review. ( Cochrane Handbook for Systematic Reviews of Interventions, 2008, Section 6.4.4 )

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Inclusion and exclusion criteria in research studies: definitions and why they matter

Critérios de inclusão e exclusão em estudos de pesquisa: definições e por que eles importam, cecilia maria patino.

1 . Methods in Epidemiologic, Clinical, and Operations Research-MECOR-program, American Thoracic Society/Asociación Latinoamericana del Tórax, Montevideo, Uruguay.

2 . Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

Juliana Carvalho Ferreira

3 . Divisão de Pneumologia, Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo (SP) Brasil.

PRACTICAL SCENARIO

A cross-sectional multicenter study evaluated self-reported adherence to inhaled therapies among patients with COPD in Latin America. 1 Inclusion and exclusion criteria for the study are shown in Chart 1 . The authors found that self-reported adherence was low in 20% of the patients, intermediate in 29%, and high in 51%; and that poor adherence was associated with more exacerbations in the past year, a lower smoking history, and a lower level of education. The authors concluded that suboptimal adherence to inhaled therapies among COPD patients was common and that interventions to improve adherence are warranted.

Establishing inclusion and exclusion criteria for study participants is a standard, required practice when designing high-quality research protocols. Inclusion criteria are defined as the key features of the target population that the investigators will use to answer their research question. 2 Typical inclusion criteria include demographic, clinical, and geographic characteristics. In contrast, exclusion criteria are defined as features of the potential study participants who meet the inclusion criteria but present with additional characteristics that could interfere with the success of the study or increase their risk for an unfavorable outcome. Common exclusion criteria include characteristics of eligible individuals that make them highly likely to be lost to follow-up, miss scheduled appointments to collect data, provide inaccurate data, have comorbidities that could bias the results of the study, or increase their risk for adverse events (most relevant in studies testing interventions).

It is very important that investigators not only define the appropriate inclusion and exclusion criteria when designing a study but also evaluate how those decisions will impact the external validity of the results of the study. Common errors regarding inclusion and exclusion criteria include the following: using the same variable to define both inclusion and exclusion criteria (for example, in a study including only men, listing being a female as an exclusion criterion); selecting variables as inclusion criteria that are not related to answering the research question; and not describing key variables in the inclusion criteria that are needed to make a statement about the external validity of the study results.

IMPACT OF THE INCLUSION AND EXCLUSION CRITERIA ON THE EXTERNAL VALIDITY OF THE STUDY

In our example, the investigators described the inclusion criteria related to demographic characteristics (age ≥ 40 years of age and male or female gender), clinical characteristics (diagnosis of COPD, stable disease, outpatient, and current or former smoker); and exclusion criteria related to comorbidities that could bias the results (sleep apnea, other chronic respiratory diseases, and acute or chronic conditions that could limit the ability of the patient to participate in the study). On the basis of these inclusion and exclusion criteria, we can make a judgment regarding their impact on the external validity of the results. Making those judgments requires in-depth knowledge of the area of research, as well as of in what direction each criterion could affect the external validity of the study. As an example, the authors excluded patients with comorbidities, and it is therefore possible that the levels of nonadherence reported would not be generalizable to COPD patients with comorbidities, who most likely would show higher levels of nonadherence due to their more complex medication regimens.

REFERÊNCIAS

Developing NICE guidelines: the manual

Process and methods [PMG20] Published: 31 October 2014 Last updated: 18 January 2022

5 Identifying the evidence: literature searching and evidence submission

Process and methods

5.1 introduction, 5.2 search protocols, 5.3 sources, 5.4 developing search strategies, 5.5 calls for evidence from stakeholders, 5.6 health inequalities and equality and diversity, 5.7 quality assurance, 5.8 reference management, 5.9 documenting the search, 5.10 re-running searches, 5.11 references and further reading.

The systematic identification of evidence is an essential step in developing NICE guidelines . Literature searches should be systematic, transparent and reproducible to minimise 'dissemination biases'. These may affect the results of reviews and include publication bias and database bias.

This chapter provides advice on the sources to search and on how to develop strategies for systematic literature searches to identify the best available evidence. It also provides advice on other areas of information management that form an important part of guideline development. These include quality assurance , re‑running searches, documenting the search process, and the use of reference management or systematic review software. The methods for undertaking scoping searches are described in the chapter on the scope . For information on searching for economic evidence, see the chapter on incorporating economic evaluation . For information on searching for surveillance evidence, see the chapter on ensuring that published guidelines are current and accurate .

NICE encourages the use of search methods that balance recall and precision. The aim is to identify the best available evidence to address a particular question without producing an unmanageable volume of results. If review questions are so broad that the information specialist has to restrict the searches to complete the review in the time available, this should be acknowledged as a limitation in the final review document.

A flexible approach to the search for evidence should be adopted, guided by the subject of the question and type of evidence sought. When the guideline is an update, the approach can also be informed by searches for the existing guideline and subsequent surveillance review. Searching includes:

tailoring the search approach to the eligibility or inclusion criteria of the review question , as specified in the review protocol

selecting appropriate sources according to the eligibility or inclusion criteria of the review question, as specified in the review protocol

using additional search techniques, such as citation searching , as appropriate

continuous review of how best to find evidence and where.

A flexible approach will allow evidence to be identified both systematically and in the most efficient manner. For example, for a review question on the effectiveness of a pharmacological intervention it may be possible to search a relatively small number of sources (see the section on sources ) and to develop a systematic search strategy using the PICO framework (see the section on developing search strategies ). For questions about complex interventions, the evidence may be more widely scattered across sources and less consistently described. In these cases it may be necessary to search a wider range of sources and consider other question frameworks and search approaches, including the use of additional searching techniques.

The chapter on searching for and selecting studies in the Cochrane handbook for systematic reviews of interventions and the Campbell Collaboration's searching for studies methods guide offer good overviews of literature searching (Lefebvre et al. 2021; Kugley et al. 2017). The SuRe Info resource also provides research-based advice on information retrieval for systematic reviews and is updated twice a year.

Search protocols should be developed by the information specialist and agreed with the other members of the developer's team before undertaking a systematic search. Search protocols are part of the review protocol (see the appendix on the review protocol template ), which is signed off by the committee . When developing search protocols, the information specialist may ask the committee for expert advice (for example, when a condition is described in many different ways in the literature).

Search protocols pre‑define how the evidence is identified and provide a basis for developing the search strategies. Search protocols should include the following elements:

search approach, tailored to the review question

sources to be searched (see the section on sources )

plans to use any additional or alternative search techniques , when known at the protocol development stage, and the reasons for their use

limits to be applied to the search.

Searches should include a mix of bibliographic databases, websites and other sources depending on the subject of the review question and the type of evidence sought.

For most searches there will be key sources that should be prioritised, and other potentially relevant sources that could be considered. It is important to ensure adequate coverage of the relevant literature and to search a range of sources, but there should be clear reasons, with only those likely to yield relevant results included. (See also the section on reviewing economic evaluations in the chapter on incorporating economic evaluation for information on searching for economic literature.)

The selection of sources will vary according to the requirements of the review question. For reviews of the effectiveness of pharmacological interventions the following should be prioritised for searching:

the Cochrane Central Register of Controlled Trials (CENTRAL)

the Cochrane Database of Systematic Reviews (CDSR)

the Medicines and Healthcare products Regulatory Agency (MHRA) – for drug safety information.

For other questions, it might be as or more important to search other sources. Examples of other sources include, but are not limited to:

PsycINFO (psychology and psychiatry)

ASSIA (Applied Social Sciences Index and Abstracts)

Social Policy and Practice, Social Care Online

Sociological Abstracts

HMIC (Health Management Information Consortium)

HealthTalk.

For service delivery questions, some of the evidence may be in the form of modelling studies published in journals related to operational research, statistical and mathematical methods rather than in health journals. These are less likely to be indexed in healthcare databases such as MEDLINE, and consideration should be given to sources likely to retrieve this evidence.

The following sources may be useful for service delivery questions:

Science Citation Index

Social Care Online or Social Policy Online

Kings Fund.

Evidence may also be primary data needed to inform parameters identified in the design-oriented conceptual model . For information on searching for model inputs, see the chapter on incorporating economic evaluation .

For some review questions, for example, where evidence is likely to be published in non-journal sources, it may be appropriate to search for grey literature . Useful sources of grey literature include:

Reports from organisations such as the European Medicines Agency and the US Food and Drug Administration may also be of value. The Canadian Agency for Drugs and Technology in Health (CADTH) Grey Matters may also be useful for identifying sources for grey literature, as may web search tools, such as NICE Evidence Search and TRIP . Topic experts on the committee may also be able to suggest appropriate sources for grey literature.

A list is provided in the appendix on sources for evidence reviews as a starting point for identifying potential relevant sources.

Devising a search strategy

The approach to devising and structuring search strategies should be informed by the review question. For example, the PICO (population, intervention, comparator and outcome) or the SPICE (setting, perspective, intervention, comparison, evaluation; Booth 2006) framework can be used to structure a search strategy for an intervention question. For other types of question, other frameworks may be more suitable. It may also be appropriate for the search framework to differ from that of the review question, and the choice should reflect the question type and search approach. Davies (2011) undertook a review of possible frameworks and SuRe Info has a useful summary of alternatives to PICO which have been evaluated. When using a framework, it is important to consider which concepts to include in the strategy because some concepts may not be mentioned in the titles, abstracts or subject headings of a database record. This is a particular challenge when the literature is less well defined and/or indexed. It is important to ensure that relevant studies are not missed as a result of an overly complex search structure.

Some topics are complex, for example, where search requirements evolve as evidence is identified and it is important to balance recall and precision. One approach, when the relevant literature for a question is less well defined or indexed, is to use a multi-stranded method. This involves developing several shorter search strategies (strands) with an emphasis on precision. Each strand should reflect 1 way in which the relevant literature may be described. The strands are then combined.

Another approach is to use an iterative and/or 'stepped' method. Searching is done in several stages, with each search taking into account the evidence that has already been retrieved. Searching in stages allows the reviewers to review the most relevant, high-quality information first. It also gives the opportunity to stop searching, omitting some steps if this is felt appropriate for the topic. Additional steps are added if the developer decides that the quantity or quality of the evidence already gathered is not sufficient. It may also be appropriate to add an additional search step to identify literature published between the final search date of a study and its inclusion in a systematic review. If the developer then finds there are topics of interest not covered by existing reviews, it would be appropriate to carry out additional searching on specific topics. A decision to use a stepped or iterative approach should be agreed by the developer and NICE staff with responsibility for quality assurance because it can affect timelines.

Some topics may have multiple information needs, for example, sometimes indirect evidence is needed for network meta-analyses . This may involve developing iterative searches for a set of relevant comparators as opposed to a search for pre-determined comparators (Hawkins et al. 2009). This type of searching can be time consuming and the developer should agree a decision to do this with NICE staff with responsibility for quality assurance. Searching for observational data for service delivery questions can also be very time consuming. For example, registry data can be a source of estimates of treatment effects, but if the committee cannot estimate the extent or direction of any biases, the value of the data is greatly reduced and the usefulness of searching is low.

For some types of review question, for example, questions for which qualitative research is more appropriate, it may not be necessary to identify all the literature on a topic. The objective may be to reach theoretical saturation, where any additional studies identified merely support the existing line of argument, rather than identify all relevant studies. In this context, it may be possible to undertake searches which are more precise. The search approaches for this type of evidence have been reviewed and summarised by Booth (2016) and can be used to guide practice.

Review questions that overlap and can be grouped together should be identified for searching purposes. For example, questions with the same population may involve comparing several interventions. This should make it possible to carry out a single search that covers all the interventions, although this approach may retrieve a large number of studies.

Identifying search terms

Search strategies should usually consist of a combination of subject headings and 'free‑text' terms from the titles and abstracts of relevant studies. When identifying subject headings, variations in thesaurus and indexing terms for each database should be taken into account: for example, MeSH (Medical Subject Headings) in MEDLINE, Emtree in Embase. Not all databases will have indexing terms and some databases will contain records which have not yet been indexed. Also, not all search concepts will have a subject heading, so free-text terms should also be used.

Free‑text terms may include synonyms, acronyms and abbreviations, spelling variants, old and new terminology, brand and generic medicine names, and lay and medical terminology. For a guideline that is being updated, previous search strategies, including surveillance searches, should be reviewed and used to inform search strategy design. New or changed terms should be identified, as well as any changes to indexing terms. This also applies when an existing review, for example, a Cochrane review, is being updated to answer a review question. Known key studies can be a useful source to identify search terms, but additional sources such as reports, guidelines, and topic-specific websites or topic experts can also be helpful.

Comprehensively identifying search terms may present challenges. For example, for public health, social care or implementation reviews, many databases do not use a controlled vocabulary for indexing records. Sometimes controlled vocabularies are used but do not include terms that adequately cover the search concept(s), which often cross a number of disciplines. In addition, the use of natural language varies between studies, and concepts may not be described in a consistent way. In light of these challenges, the development of a search strategy should always be an iterative process between the information specialists), the developer and, when necessary, the committee and NICE staff with responsibility for quality assurance (Alpi 2005, Papaioannou et al. 2010).

A further challenge may arise from websites or certain databases having limited search functionality. It may be necessary to simplify the search strategy, using fewer search terms or undertaking multiple searches of the same resource with different search term combinations.

It may be helpful to use frequency analysis or text mining to develop the search strategy (Stansfield et al. 2017, Hausner et al. 2012). Tools such as PubReMiner and Medline Ranker can help, either by highlighting search terms that might not otherwise be apparent, or by flagging terms of high value when exhaustive synonym searching is unfeasible or inadvisable. This is a rapidly developing area, but in principle NICE supports the use of such technologies to inform search development.

Limits and filters

Searches should be limited to studies reported in English. When there are likely to be animal studies in the evidence base, these can be excluded from the search results in some databases.

Limiting searches by date will depend on the topic and the nature of the evidence base (for example, when most of the research was published). When the guideline is an update, searches may be limited by date, but only if appropriate (for example, the inclusion and exclusion criteria for the update are the same as for the existing guideline). If there are relevant good-quality published systematic reviews (see the chapter on developing review questions and planning the evidence review ), it may be possible to limit additional searching to the time since the searches for the published reviews were conducted. For some databases, restricting the search by date is difficult. When this is the case, searches can be run without date limits, using reference management or systematic review software to separate new results. The date range for the search, and the use of existing reviews, should be agreed before searching and documented in the search protocol (see the section on search protocols ).

Depending on the review question, it may be appropriate to limit searches to particular study designs. For example, for review questions on the effectiveness of interventions, it may be more efficient to search for systematic reviews, followed by controlled trials followed by observational studies. This prevents unnecessary searching and review work. The best way to limit searches by study design is to use an appropriate search filter (strings of search terms), rather than using database publication type field limits, to ensure the search strategy is transparent and reproducible. Additional classifiers, such as the Cochrane RCT classifier, could be used to further attempt to limit the search to particular study types.

Other search filters relating to age, setting, geography, and health inequalities can also be applied as relevant. The most comprehensive list of available search filters is the search filter resource of the InterTASC Information Specialists' Sub-Group . This resource also includes critical appraisal tools, which can be used for filter selection. Additionally, McKibbon (2009) reviews the performance of 38 randomised controlled trial filters. Both sources may be useful when choosing a filter. Search filters should, however, be used with caution because concepts such as study design, age, setting and geography may not be adequately described in the title or abstract of a database record, and may not be captured by the indexing.

NICE is not prescriptive about which search filters should be used because there is often limited evidence on the performance of individual filters. Alternative methods for refining a search to achieve an adequate balance of recall and precision should be used when filters are not appropriate.

Additional or alternative search techniques

Additional or alternative search techniques should be used in addition to database searching when it is known, or reasonably likely, that relevant evidence is either not indexed in bibliographic databases and/or that it is difficult to retrieve from databases in a way that adequately balances recall and precision. These techniques might include forward and backward citation searching, journal hand-searches or contacting experts and stakeholders.

Reviews (for example, systematic reviews, literature reviews and meta-analyses) may provide an additional source of primary studies, with reference lists being used to identify these.

All search techniques should follow the same principles of transparency, rigour and reproducibility as other search methods.

Additional or alternative search techniques should be considered at the outset and documented in the search protocol (see the section on search protocols ), if possible. They should also be documented in the evidence review .

Stakeholders' role in providing evidence

In some topic areas or for some review questions, NICE staff with responsibility for quality assurance, the developer or committee may believe that there is relevant evidence in addition to that identified by the searches. In these situations, the developer may invite stakeholders, and possibly also other relevant organisations or individuals with a significant role or interest (see the section on other attendees at committee meetings in the chapter on decision-making committees on expert witnesses ), to submit evidence. A call for evidence is issued directly to registered stakeholders and via the NICE website. Examples and details of process are included in the appendix on call for evidence and expert witnesses . Confidential information should be kept to an absolute minimum.

All searches should be inclusive, capturing evidence related to health inequalities or impacts on equality relevant to the guideline topic. For example, if the population group is 'older people' a search for 'older people' should pick up subpopulations such as 'disabled older people' or 'black and minority ethnic older people'. Similarly, if the setting is 'communities and religious places', the search terms should cover all relevant faith settings (such as 'church', 'temple' and 'mosque').

Quality assuring the literature search is an important step in guideline development. Studies have shown that errors do occur (Sampson 2006). Although developed specifically for Cochrane reviews, the Methodological Expectations of Cochrane Intervention Reviews (MECIR) manual may be useful to guide practice. They set out the components which can ensure that the identification of the evidence base is comprehensive, transparent and reproducible (Higgins et al. 2021).

For each search (including economic searches), the principal database search strategy should be quality assured by a second information specialist to maintain a consistently high standard for identifying the evidence. A checklist should be used to ensure clarity and consistency when quality assuring search strategies. An example is the PRESS 2015 Guideline Evidence-Based Checklist (McGowan et al. 2016).

Each time the principal database strategy is adapted for use in another database, it is good practice for it to be peer reviewed by a second information specialist to ensure quality and consistency is maintained.

As part of quality assurance, there is also an opportunity to undertake an audit of search results to analyse how the evidence for the guideline was identified. Using the final list of included studies, it is possible to determine the contribution of individual sources and search techniques. This can provide valuable data for informing the search approach for future surveillance and guideline updates.

Electronic records of the references retrieved by searches should be stored using EPPI-Reviewer.

Details of the search are included in the individual evidence reviews, and are available with the consultation on the draft guideline, and the final guideline.

Thorough documentation facilitates future surveillance and updating, and there are several published guides that cover this. NICE uses the PRISMA-S standards to inform search reporting (Rethlefsen et al 2021). Documenting the search begins with creating the search protocol (see the section on search protocols ). If using an emergent 'stepped' approach, initial search strategies, key decision points and the reasons for subsequent search steps should be clearly documented in the search protocol.

Records should be kept of the searches undertaken during guideline development for all review questions to ensure that the process for identifying the evidence base is transparent and reproducible.

For each question, or group of questions, the following information should be documented:

details of search approach with reasons (this should include any notable differences between the searches for an existing guideline and those for an update of the guideline)

dates on which the searches were carried out, including the dates of any re‑run searches (see the section on re-running searches )

names of the databases, database host systems and database coverage dates or specific segments

names of any non-database sources searched and number of citations retrieved

search strategies for all sources and number or citations retrieved (these should be annotated to explain any decisions on included and excluded terms which are not self-explanatory)

details of any supplementary searching undertaken, including the reasons

any limits or search filters applied to the search (for example, language, date, study design).

Searches undertaken to identify evidence for each review question (including economics searches) may be re‑run to identify any further evidence that has been published since the search was last run. For example, searches should be re‑run if the evidence base changes quickly, or if there is reason to believe that substantial new evidence exists, or if the development time is longer than usual. Searching PubMed or OVID's MEDLINE Epub Ahead of Print at this stage, in addition to MEDLINE, is useful to identify 'ahead-of-print' citations.

A decision to re‑run searches will be taken by the developer and members of NICE staff with a quality assurance role.

If undertaken, searches should be re‑run at least 6 to 8 weeks before the final committee meeting before consultation.

If evidence is identified after the last cut‑off date for searching but before publication, a judgement on its impact should be made by the developer and NICE staff with a quality assurance role. In exceptional circumstances, this evidence can be considered if its impact is judged as substantial.

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Beynon R, Leeflang MM, McDonald S et al. (2013) Search strategies to identify diagnostic accuracy studies in MEDLINE and Embase . Cochrane Database of Systematic Reviews 2013, Issue 9

Booth A (2006) Clear and present questions: formulating questions for evidence based practice. Library Hi Tech 24: 355–68

Booth A (2016) Searching for qualitative research for inclusion in systematic reviews: a structured methodological review . Systematic Reviews 5:74

Booth A, Harris J, Croot E et al. (2013) Towards a methodology for cluster searching to provide conceptual and contextual 'richness' for systematic reviews of complex interventions: case study (CLUSTER) . BMC Medical Research Methodology 13: 118

Brunton J, Stansfield C, Thomas J (2017) Finding relevant studies. In: Gough D, Oliver S, Thomas J, editors. Introduction to systematic reviews. London: Sage

Canadian Agency for Drugs and Technologies in Health (2019) Grey Matters: a practical tool for searching health-related grey literature [online; accessed 21 January 2021]

Centre for Reviews and Dissemination (2009) Systematic reviews: CRD's guidance for undertaking reviews in health care . University of York: Centre for Reviews and Dissemination

Davies K (2011) Formulating the evidence based practice question: a review of the frameworks. Evidence Based Library and Information Practice 6: 75–80

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Hawkins N, Scott DA, Woods B. (2009) How far do you go? Efficient searching for indirect evidence. Medical Decision Making 29: 273–81

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McGowan J, Sampson M, Salzwedel DM et al. (2016) PRESS Peer Review of Electronic Search Strategies: 2015 guideline statement . Journal of Clinical Epidemiology 75: 40–6

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Paisley S, Levay P, Ananiadou S et al. Public health, policy and the evidence-based medicine paradigm: challenges and innovations in methods of searching. Research Synthesis Methods (in press)

Papaioannou D, Sutton A, Carroll C et al. (2010) Literature searching for social science systematic reviews: consideration of a range of search techniques. Health Information Libraries Journal 27: 114–22

Rethlefsen M, Kirtley S, Waffenschmidt S et al. (2021) PRISMA-S: an extension to the PRISMA statement for reporting literature searches in systematic reviews . Systematic Reviews 10: 39

Sampson M, McGowan J (2006) Errors in search strategies were identified by type and frequency. Journal of Clinical Epidemiology 59: 1057–63

Stansfield C, O'Mara-Eves A, Thomas J (2017) Text mining for search term development in systematic reviewing: a discussion of some methods and challenges . Research Synthesis Methods 8: 355-65

Summarized research for Information Retrieval in HTA (SuRe Info). [online; accessed 31 August 2018]

IMAGES

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COMMENTS

Inclusion & Exclusion Criteria
Inclusion criteria are the elements of an article that must be present in order for it to be eligible for inclusion in a literature review. Some examples are: Included studies must have compared certain treatments Included studies must be a certain type (e.g., only Randomized Controlled Trials)
Inclusion and Exclusion Criteria
Defining inclusion and exclusion criteria is important in any type of research that examines characteristics of a specific subset of a population. This helps researchers identify the study population in a consistent, reliable, and objective manner.
Inclusion and exclusion criteria in research studies ...
Inclusion and exclusion criteria in research studies: definitions and why they matter J Bras Pneumol. 2018 Apr;44(2):84. doi: 10.1590/s1806-37562018000000088. [Article in Portuguese, English] Authors Cecilia Maria Patino 1 , Juliana Carvalho Ferreira 1 Affiliation 1 Methods in ...
Developing the review question and inclusion criteria
Developing the review question and inclusion criteria This article is the second in a new series on the systematic review from the Joanna Briggs Institute, an international collaborative supporting evidence-based practice in nursing, medicine, and allied health fields.
Criteria for Good Qualitative Research: A Comprehensive Review
From the selected databases, the search retrieved a total of 765 publications. Then, the duplicate records were removed. After that, based on the title and abstract, the remaining 426 publications were screened for their relevance by using the following inclusion and exclusion criteria (see Table 2).Publications focusing on evaluation criteria for good qualitative research were included ...
Designing Inclusion and Exclusion Criteria
Important Aspects of Inclusion/Exclusion Criteria . There are a few important aspects that you should be sure to consider when developing your inclusion/exclusion criteria. First, your criteria should be narrow, yet broad. ... Carefully look through key studies from your literature review. The inclusion/exclusion criteria from other studies ...
Inclusion and Exclusion Criteria
Inclusion criteria is everything a study must have to be included. Exclusion criteria are the factors that would make a study ineligible to be included. Criteria that should be considered include: Type of studies: It is important to select articles with an appropriate study design for the research question.
Reviewing the literature
The type of review undertaken is influenced by the purpose of the review and resources available. However, the stages or methods used to undertake a review are similar across approaches and include: Formulating clear inclusion and exclusion criteria, for example, patient groups, ages, conditions/treatments, sources of evidence/research designs;
5: Inclusion and exclusion criteria
Inclusion and Exclusion Criteria Inclusion and exclusion criteria set the boundaries for the systematic review. They are determined after setting the research question usually before the search is conducted, however scoping searches may need to be undertaken to determine appropriate criteria.
Why is it important to have inclusion and exclusion criteria?
Inclusion criteria is everything that a study must have in order to be included in your review. Exclusion criteria are the factors that would make a study ineligible to be included in your review. These criteria can include dates, how a study was designed, population, outcomes, etc.
Systematic Reviews: Inclusion and Exclusion Criteria
Defining Inclusion/Exclusion Criteria An important part of the SR process is defining what will and will not be included in your review. Inclusion and exclusion criteria are developed after a research question is finalized but before a search is carried out.
Selecting Studies for Systematic Review: Inclusion and Exclusion Criteria
scope and validity of systematic review results. The development of inclusion/exclusion criteria is discussed, and steps in the study selection process are followed from initial evaluation to the final acceptance of studies for systematic review. KEY WORDS: study selection criteria, study quality grading, study evaluation, inclusion/exclusion ...
Define Inclusion/Exclusion Criteria
Tip: Choose your criteria carefully to avoid bias. For example, if you exclude non-English language articles, you may be ignoring relevant studies. The following 6-minute video explains the relationship between inclusion and exclusion criteria and database searches.
Specifying the inclusion and exclusion criteria for systematic
Starting your inclusion and exclusion criteria before you conduct the review is important. This section is Where you describe the criteria that you will be using to include any research studies in your review.
Establish your Inclusion and Exclusion criteria
Establishing your inclusion/exclusion criteria can also help turn a topic of interest into a viable research question, or to think about how broad or narrow your question is: a narrow topic could potentially be quicker to research, but you may have problems finding enough relevant studies to review.
Systematic Reviews: Study selection and appraisal
At the initial screening stage read just the title and abstract of the candidate studies and make a decision to include or exclude the study from your review. For small reviews of a few studies (e.g. <100) The research team should agree on the inclusion and exclusion criteria for studies you wish to review and put together a study screening form.
Inclusion and Exclusion Criteria
Inclusion and exclusion criteria are extensions of a review's purpose, and help investigators describe the specific components in their objectives (e.g., participants, variables, outcomes, etc.). Inclusion and exclusion criteria also contribute to transparency, a key systematic review value (Petticrew & Roberts, 2006 ).
Selection Criteria
Exclusion criteria are the elements of an article that disqualify the study from inclusion in a literature review. Some examples are: Study used an observational design Study used a qualitative methodology Study was published more than 5 years ago Study was published in a language other than English Last Updated: Jul 15, 2022 8:47 AM
Selecting Studies for Systematic Review: Inclusion and Exclusion Criteria
Selecting Studies for Systematic Reviews. Conducting a systematic review can be a time-consuming process to generate evidence around specific areas of research. As a result, it may be tempting for some authors to make quick selections with regard to inclusion and exclusion criteria. This lapse in judgment could prove detrimental to the review ...
Inclusion and exclusion criteria
Inclusion and exclusion criteria. Inclusion and exclusion criteria are a list of pre-defined characteristics to which literature must adhere to be included in a study. They are vital for the decision-making progress on what to review when undertaking a systematic review and will also help with systematic literature reviews.
National Center for Biotechnology Information
National Center for Biotechnology Information
5 Identifying the evidence: literature searching and evidence
It is important to ensure adequate coverage of the relevant literature and to search a range of sources, but there should be clear reasons, with only those likely to yield relevant results included.
What determine inclusion and exclusion criteria of a systematic review
The inclusion/exclusion criteria helps ensure that your question is focused, and prevents bias from selection of studies as the criteria are defined before your literature search, and before you ...