exclusion and inclusion criteria in a literature review

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Eligibility Criteria

Inclusion criteria, exclusion criteria.

• Database Search Strategies
• Study Selection (Screening)
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Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale. 

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 .  You may introduce bias into the final review if these are not used thoughtfully. 

According to the PRISMA-SCcR Checklist , item 6 , authors should "specify characteristics of the sources of evidence used as eligibility criteria (e.g., years considered, language, and publication status), and provide a rationale."

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.  

For example, included studies must:

• have compared certain treatments
• be experimental or observational or both
• have been published in a certain timeframe (must have compelling reason)
• be certain publication type(s)
• have recruited a certain population

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

For example, excluded studies: 

• used qualitative methodology
• used a certain study design (e.g, observational)
• are a certain publication type (e.g., systematic reviews)
• were published before a certain year (must have compelling reason)
• used animal models
• was published in a language other than English
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Chapter 3: defining the criteria for including studies and how they will be grouped for the synthesis.

Joanne E McKenzie, Sue E Brennan, Rebecca E Ryan, Hilary J Thomson, Renea V Johnston, James Thomas

Key Points:

• The scope of a review is defined by the types of population (participants), types of interventions (and comparisons), and the types of outcomes that are of interest. The acronym PICO (population, interventions, comparators and outcomes) helps to serve as a reminder of these.
• The population, intervention and comparison components of the question, with the additional specification of types of study that will be included, form the basis of the pre-specified eligibility criteria for the review. It is rare to use outcomes as eligibility criteria: studies should be included irrespective of whether they report outcome data, but may legitimately be excluded if they do not measure outcomes of interest, or if they explicitly aim to prevent a particular outcome.
• Cochrane Reviews should include all outcomes that are likely to be meaningful and not include trivial outcomes. Critical and important outcomes should be limited in number and include adverse as well as beneficial outcomes.
• Review authors should plan at the protocol stage how the different populations, interventions, outcomes and study designs within the scope of the review will be grouped for analysis.

Cite this chapter as: McKenzie JE, Brennan SE, Ryan RE, Thomson HJ, Johnston RV, Thomas J. Chapter 3: Defining the criteria for including studies and how they will be grouped for the synthesis [last updated August 2023]. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.5. Cochrane, 2024. Available from www.training.cochrane.org/handbook .

3.1 Introduction

One of the features that distinguishes a systematic review from a narrative review is that systematic review authors should pre-specify criteria for including and excluding studies in the review (eligibility criteria, see MECIR Box 3.2.a ).

When developing the protocol, one of the first steps is to determine the elements of the review question (including the population, intervention(s), comparator(s) and outcomes, or PICO elements) and how the intervention, in the specified population, produces the expected outcomes (see Chapter 2, Section 2.5.1 and Chapter 17, Section 17.2.1 ). Eligibility criteria are based on the PICO elements of the review question plus a specification of the types of studies that have addressed these questions. The population, interventions and comparators in the review question usually translate directly into eligibility criteria for the review, though this is not always a straightforward process and requires a thoughtful approach, as this chapter shows. Outcomes usually are not part of the criteria for including studies, and a Cochrane Review would typically seek all sufficiently rigorous studies (most commonly randomized trials) of a particular comparison of interventions in a particular population of participants, irrespective of the outcomes measured or reported. It should be noted that some reviews do legitimately restrict eligibility to specific outcomes. For example, the same intervention may be studied in the same population for different purposes; or a review may specifically address the adverse effects of an intervention used for several conditions (see Chapter 19 ).

Eligibility criteria do not exist in isolation, but should be specified with the synthesis of the studies they describe in mind. This will involve making plans for how to group variants of the PICO elements for synthesis. This chapter describes the processes by which the structure of the synthesis can be mapped out at the beginning of the review, and the interplay between the review question, considerations for the analysis and their operationalization in terms of eligibility criteria. Decisions about which studies to include (and exclude), and how they will be combined in the review’s synthesis, should be documented and justified in the review protocol.

A distinction between three different stages in the review at which the PICO construct might be used is helpful for understanding the decisions that need to be made. In Chapter 2, Section 2.3 , we introduced the ideas of a review PICO (on which eligibility of studies is based), the PICO for each synthesis (defining the question that each specific synthesis aims to answer) and the PICO of the included studies (what was actually investigated in the included studies). In this chapter, we focus on the review PICO and the PICO for each synthesis as a basis for specifying which studies should be included in the review and planning its syntheses. These PICOs should relate clearly and directly to the questions or hypotheses that are posed when the review is formulated (see Chapter 2 ) and will involve specifying the population in question, and a set of comparisons between the intervention groups.

An integral part of the process of setting up the review is to specify which characteristics of the interventions (e.g. individual compounds of a drug), populations (e.g. acute and chronic conditions), outcomes (e.g. different depression measurement scales) and study designs, will be grouped together. Such decisions should be made independent of knowing which studies will be included and the methods of synthesis that will be used (e.g. meta-analysis). There may be a need to modify the comparisons and even add new ones at the review stage in light of the data that are collected. For example, important variations in the intervention may be discovered only after data are collected, or modifying the comparison may facilitate the possibility of synthesis when only one or few studies meet the comparison PICO. Planning for the latter scenario at the protocol stage may lead to less post-hoc decision making ( Chapter 2, Section 2.5.3 ) and, of course, any changes made during the conduct of the review should be recorded and documented in the final report.

3.2 Articulating the review and comparison PICO

3.2.1 defining types of participants: which people and populations.

The criteria for considering types of people included in studies in a review should be sufficiently broad to encompass the likely diversity of studies and the likely scenarios in which the interventions will be used, but sufficiently narrow to ensure that a meaningful answer can be obtained when studies are considered together; they should be specified in advance (see MECIR Box 3.2.a ). As discussed in Chapter 2, Section 2.3.1 , the degree of breadth will vary, depending on the question being asked and the analytical approach to be employed. A range of evidence may inform the choice of population characteristics to examine, including theoretical considerations, evidence from other interventions that have a similar mechanism of action, and in vitro or animal studies. Consideration should be given to whether the population characteristic is at the level of the participant (e.g. age, severity of disease) or the study (e.g. care setting, geographical location), since this has implications for grouping studies and for the method of synthesis ( Chapter 10, Section 10.11.5 ). It is often helpful to consider the types of people that are of interest in three steps.

MECIR Box 3.2.a Relevant expectations for conduct of intervention reviews

First, the diseases or conditions of interest should be defined using explicit criteria for establishing their presence (or absence). Criteria that will force the unnecessary exclusion of studies should be avoided. For example, diagnostic criteria that were developed more recently – which may be viewed as the current gold standard for diagnosing the condition of interest – will not have been used in earlier studies. Expensive or recent diagnostic tests may not be available in many countries or settings, and time-consuming tests may not be practical in routine healthcare settings.

Second, the broad population and setting of interest should be defined . This involves deciding whether a specific population group is within scope, determined by factors such as age, sex, race, educational status or the presence of a particular condition such as angina or shortness of breath. Interest may focus on a particular setting such as a community, hospital, nursing home, chronic care institution, or outpatient setting. Box 3.2.a outlines some factors to consider when developing population criteria.

Whichever criteria are used for defining the population and setting of interest, it is common to encounter studies that only partially overlap with the review’s population. For example, in a review focusing on children, a cut-point of less than 16 years might be desirable, but studies may be identified with participants aged from 12 to 18. Unless the study reports separate data from the eligible section of the population (in which case data from the eligible participants can be included in the review), review authors will need a strategy for dealing with these studies (see MECIR Box 3.2.a ). This will involve balancing concerns about reduced applicability by including participants who do not meet the eligibility criteria, against the loss of data when studies are excluded. Arbitrary rules (such as including a study if more than 80% of the participants are under 16) will not be practical if detailed information is not available from the study. A less stringent rule, such as ‘the majority of participants are under 16’ may be sufficient. Although there is a risk of review authors’ biases affecting post-hoc inclusion decisions (which is why many authors endeavour to pre-specify these rules), this may be outweighed by a common-sense strategy in which eligibility decisions keep faith with the objectives of the review rather than with arbitrary rules. Difficult decisions should be documented in the review, checked with the advisory group (if available, see Chapter 1 ), and sensitivity analyses can assess the impact of these decisions on the review’s findings (see Chapter 10, Section 10.14 and MECIR Box 3.2.b ).

Box 3.2.a Factors to consider when developing criteria for ‘Types of participants’

MECIR Box 3.2.b Relevant expectations for conduct of intervention reviews

Third, there should be consideration of whether there are population characteristics that might be expected to modify the size of the intervention effects (e.g. different severities of heart failure). Identifying subpopulations may be important for implementation of the intervention. If relevant subpopulations are identified, two courses of action are possible: limiting the scope of the review to exclude certain subpopulations; or maintaining the breadth of the review and addressing subpopulations in the analysis.

Restricting the review with respect to specific population characteristics or settings should be based on a sound rationale. It is important that Cochrane Reviews are globally relevant, so the rationale for the exclusion of studies based on population characteristics should be justified. For example, focusing a review of the effectiveness of mammographic screening on women between 40 and 50 years old may be justified based on biological plausibility, previously published systematic reviews and existing controversy. On the other hand, focusing a review on a particular subgroup of people on the basis of their age, sex or ethnicity simply because of personal interests, when there is no underlying biologic or sociological justification for doing so, should be avoided, as these reviews will be less useful to decision makers and readers of the review.

Maintaining the breadth of the review may be best when it is uncertain whether there are important differences in effects among various subgroups of people, since this allows investigation of these differences (see Chapter 10, Section 10.11.5 ). Review authors may combine the results from different subpopulations in the same synthesis, examining whether a given subdivision explains variation (heterogeneity) among the intervention effects. Alternatively, the results may be synthesized in separate comparisons representing different subpopulations. Splitting by subpopulation risks there being too few studies to yield a useful synthesis (see Table 3.2.a and Chapter 2, Section 2.3.2 ). Consideration needs to be given to the subgroup analysis method, particularly for population characteristics measured at the participant level (see Chapter 10 and Chapter 26 , Fisher et al 2017). All subgroup analyses should ideally be planned a priori and stated as a secondary objective in the protocol, and not driven by the availability of data.

In practice, it may be difficult to assign included studies to defined subpopulations because of missing information about the population characteristic, variability in how the population characteristic is measured across studies (e.g. variation in the method used to define the severity of heart failure), or because the study does not wholly fall within (or report the results separately by) the defined subpopulation. The latter issue mainly applies for participant characteristics but can also arise for settings or geographic locations where these vary within studies. Review authors should consider planning for these scenarios (see example reviews Hetrick et al 2012, Safi et al 2017; Table 3.2.b , column 3).

Table 3.2.a Examples of population attributes and characteristics

3.2.2 Defining interventions and how they will be grouped

In some reviews, predefining the intervention ( MECIR Box 3.2.c ) may be straightforward. For example, in a review of the effect of a given anticoagulant on deep vein thrombosis, the intervention can be defined precisely. A more complicated definition might be required for a multi-component intervention composed of dietary advice, training and support groups to reduce rates of obesity in a given population.

The inherent complexity present when defining an intervention often comes to light when considering how it is thought to achieve its intended effect and whether the effect is likely to differ when variants of the intervention are used. In the first example, the anticoagulant warfarin is thought to reduce blood clots by blocking an enzyme that depends on vitamin K to generate clotting factors. In the second, the behavioural intervention is thought to increase individuals’ self-efficacy in their ability to prepare healthy food. In both examples, we cannot assume that all forms of the intervention will work in the same way. When defining drug interventions, such as anticoagulants, factors such as the drug preparation, route of administration, dose, duration, and frequency should be considered. For multi-component interventions (such as interventions to reduce rates of obesity), the common or core features of the interventions must be defined, so that the review authors can clearly differentiate them from other interventions not included in the review.

MECIR Box 3.2.c Relevant expectations for conduct of intervention reviews

In general, it is useful to consider exactly what is delivered, who delivers it, how it is delivered, where it is delivered, when and how much is delivered, and whether the intervention can be adapted or tailored , and to consider this for each type of intervention included in the review (see the TIDieR checklist (Hoffmann et al 2014)). As argued in Chapter 17 , separating interventions into ‘simple’ and ‘complex’ is a false dichotomy; all interventions can be complex in some ways. The critical issue for review authors is to identify the most important factors to be considered in a specific review. Box 3.2.b outlines some factors to consider when developing broad criteria for the ‘Types of interventions’ (and comparisons).

Box 3.2.b Factors to consider when developing criteria for ‘Types of interventions’

Once interventions eligible for the review have been broadly defined, decisions should be made about how variants of the intervention will be handled in the synthesis. Differences in intervention characteristics across studies occur in all reviews. If these reflect minor differences in the form of the intervention used in practice (such as small differences in the duration or content of brief alcohol counselling interventions), then an overall synthesis can provide useful information for decision makers. Where differences in intervention characteristics are more substantial (such as delivery of brief alcohol counselling by nurses versus doctors), and are expected to have a substantial impact on the size of intervention effects, these differences should be examined in the synthesis. What constitutes an important difference requires judgement, but in general differences that alter decisions about how an intervention is implemented or whether the intervention is used or not are likely to be important. In such circumstances, review authors should consider specifying separate groups (or subgroups) to examine in their synthesis.

Clearly defined intervention groups serve two main purposes in the synthesis. First, the way in which interventions are grouped for synthesis (meta-analysis or other synthesis) is likely to influence review findings. Careful planning of intervention groups makes best use of the available data, avoids decisions that are influenced by study findings (which may introduce bias), and produces a review focused on questions relevant to decision makers. Second, the intervention groups specified in a protocol provide a standardized terminology for describing the interventions throughout the review, overcoming the varied descriptions used by study authors (e.g. where different labels are used for the same intervention, or similar labels used for different techniques) (Michie et al 2013). This standardization enables comparison and synthesis of information about intervention characteristics across studies (common characteristics and differences) and provides a consistent language for reporting that supports interpretation of review findings.

Table 3.2.b   outlines a process for planning intervention groups as a basis for/precursor to synthesis, and the decision points and considerations at each step. The table is intended to guide, rather than to be prescriptive and, although it is presented as a sequence of steps, the process is likely to be iterative, and some steps may be done concurrently or in a different sequence. The process aims to minimize data-driven approaches that can arise once review authors have knowledge of the findings of the included studies. It also includes principles for developing a flexible plan that maximizes the potential to synthesize in circumstances where there are few studies, many variants of an intervention, or where the variants are difficult to anticipate. In all stages, review authors should consider how to categorize studies whose reports contain insufficient detail.

Table 3.2.b A process for planning intervention groups for synthesis

3.2.3 Defining which comparisons will be made

When articulating the PICO for each synthesis, defining the intervention groups alone is not sufficient for complete specification of the planned syntheses. The next step is to define the comparisons that will be made between the intervention groups. Setting aside for a moment more complex analyses such as network meta-analyses, which can simultaneously compare many groups ( Chapter 11 ), standard meta-analysis ( Chapter 10 ) aims to draw conclusions about the comparative effects of two groups at a time (i.e. which of two intervention groups is more effective?). These comparisons form the basis for the syntheses that will be undertaken if data are available. Cochrane Reviews sometimes include one comparison, but most often include multiple comparisons. Three commonly identified types of comparisons include the following (Davey et al 2011).

• newer generation antidepressants versus placebo (Hetrick et al 2012); and
• vertebroplasty for osteoporotic vertebral compression fractures versus placebo (sham procedure) (Buchbinder et al 2018).
• chemotherapy or targeted therapy plus best supportive care (BSC) versus BSC for palliative treatment of esophageal and gastroesophageal-junction carcinoma (Janmaat et al 2017); and
• personalized care planning versus usual care for people with long-term conditions (Coulter et al 2015).
• early (commenced at less than two weeks of age) versus late (two weeks of age or more) parenteral zinc supplementation in term and preterm infants (Taylor et al 2017);
• high intensity versus low intensity physical activity or exercise in people with hip or knee osteoarthritis (Regnaux et al 2015);
• multimedia education versus other education for consumers about prescribed and over the counter medications (Ciciriello et al 2013).

The first two types of comparisons aim to establish the effectiveness of an intervention, while the last aims to compare the effectiveness of two interventions. However, the distinction between the placebo and control is often arbitrary, since any differences in the care provided between trials with a control arm and those with a placebo arm may be unimportant , especially where ‘usual care’ is provided to both. Therefore, placebo and control groups may be determined to be similar enough to be combined for synthesis.

In reviews including multiple intervention groups, many comparisons are possible. In some of these reviews, authors seek to synthesize evidence on the comparative effectiveness of all their included interventions, including where there may be only indirect comparison of some interventions across the included studies ( Chapter 11, Section 11.2.1 ). However, in many reviews including multiple intervention groups, a limited subset of the possible comparisons will be selected. The chosen subset of comparisons should address the most important clinical and research questions. For example, if an established intervention (or dose of an intervention) is used in practice, then the synthesis would ideally compare novel or alternative interventions to this established intervention, and not, for example, to no intervention.

3.2.3.1 Dealing with co-interventions

Planning is needed for the special case where the same supplementary intervention is delivered to both the intervention and comparator groups. A supplementary intervention is an additional intervention delivered alongside the intervention of interest, such as massage in a review examining the effects of aromatherapy (i.e. aromatherapy plus massage versus massage alone). In many cases, the supplementary intervention will be unimportant and can be ignored. In other situations, the effect of the intervention of interest may differ according to whether participants receive the supplementary therapy. For example, the effect of aromatherapy among people who receive a massage may differ from the effect of the aromatherapy given alone. This will be the case if the intervention of interest interacts with the supplementary intervention leading to larger (synergistic) or smaller (dysynergistic/antagonistic) effects than the intervention of interest alone (Squires et al 2013). While qualitative interactions are rare (where the effect of the intervention is in the opposite direction when combined with the supplementary intervention), it is possible that there will be more variation in the intervention effects (heterogeneity) when supplementary interventions are involved, and it is important to plan for this. Approaches for dealing with this in the statistical synthesis may include fitting a random-effects meta-analysis model that encompasses heterogeneity ( Chapter 10, Section 10.10.4 ), or investigating whether the intervention effect is modified by the addition of the supplementary intervention through subgroup analysis ( Chapter 10, Section 10.11.2 ).

3.2.4 Selecting, prioritizing and grouping review outcomes

3.2.4.1 selecting review outcomes.

Broad outcome domains are decided at the time of setting up the review PICO (see Chapter 2 ). Once the broad domains are agreed, further specification is required to define the domains to facilitate reporting and synthesis (i.e. the PICO for comparison) (see Chapter 2, Section 2.3 ). The process for specifying and grouping outcomes largely parallels that used for specifying intervention groups.

Reporting of outcomes should rarely determine study eligibility for a review. In particular, studies should not be excluded because they do not report results of an outcome they may have measured, or provide ‘no usable data’ ( MECIR Box 3.2.d ). This is essential to avoid bias arising from selective reporting of findings by the study authors (see Chapter 13 ). However, in some circumstances, the measurement of certain outcomes may be a study eligibility criterion. This may be the case, for example, when the review addresses the potential for an intervention to prevent a particular outcome, or when the review addresses a specific purpose of an intervention that can be used in the same population for different purposes (such as hormone replacement therapy, or aspirin).

MECIR Box 3.2.d Relevant expectations for conduct of intervention reviews

In general, systematic reviews should aim to include outcomes that are likely to be meaningful to the intended users and recipients of the reviewed evidence. This may include clinicians, patients (consumers), the general public, administrators and policy makers. Outcomes may include survival (mortality), clinical events (e.g. strokes or myocardial infarction), behavioural outcomes (e.g. changes in diet, use of services), patient-reported outcomes (e.g. symptoms, quality of life), adverse events, burdens (e.g. demands on caregivers, frequency of tests, restrictions on lifestyle) and economic outcomes (e.g. cost and resource use). It is critical that outcomes used to assess adverse effects as well as outcomes used to assess beneficial effects are among those addressed by a review (see Chapter 19 ).

Outcomes that are trivial or meaningless to decision makers should not be included in Cochrane Reviews. Inclusion of outcomes that are of little or no importance risks overwhelming and potentially misleading readers. Interim or surrogate outcomes measures, such as laboratory results or radiologic results (e.g. loss of bone mineral content as a surrogate for fractures in hormone replacement therapy), while potentially helpful in explaining effects or determining intervention integrity (see Chapter 5, Section 5.3.4.1 ), can also be misleading since they may not predict clinically important outcomes accurately. Many interventions reduce the risk for a surrogate outcome but have no effect or have harmful effects on clinically relevant outcomes, and some interventions have no effect on surrogate measures but improve clinical outcomes.

Various sources can be used to develop a list of relevant outcomes, including input from consumers and advisory groups (see Chapter 2 ), the clinical experiences of the review authors, and evidence from the literature (including qualitative research about outcomes important to those affected (see Chapter 21 )). A further driver of outcome selection is consideration of outcomes used in related reviews. Harmonization of outcomes across reviews addressing related questions facilitates broader evidence synthesis questions being addressed through the use of Overviews of reviews (see Chapter V ).

Outcomes considered to be meaningful, and therefore addressed in a review, may not have been reported in the primary studies. For example, quality of life is an important outcome, perhaps the most important outcome, for people considering whether or not to use chemotherapy for advanced cancer, even if the available studies are found to report only survival (see Chapter 18 ). A further example arises with timing of the outcome measurement, where time points determined as clinically meaningful in a review are not measured in the primary studies. Including and discussing all important outcomes in a review will highlight gaps in the primary research and encourage researchers to address these gaps in future studies.

3.2.4.2 Prioritizing review outcomes

Once a full list of relevant outcomes has been compiled for the review, authors should prioritize the outcomes and select the outcomes of most relevance to the review question. The GRADE approach to assessing the certainty of evidence (see Chapter 14 ) suggests that review authors separate outcomes into those that are ‘critical’, ‘important’ and ‘not important’ for decision making.

The critical outcomes are the essential outcomes for decision making, and are those that would form the basis of a ‘Summary of findings’ table or other summary versions of the review, such as the Abstract or Plain Language Summary. ‘Summary of findings’ tables provide key information about the amount of evidence for important comparisons and outcomes, the quality of the evidence and the magnitude of effect (see Chapter 14, Section 14.1 ). There should be no more than seven outcomes included in a ‘Summary of findings’ table, and those outcomes that will be included in summaries should be specified at the protocol stage. They should generally not include surrogate or interim outcomes. They should not be chosen on the basis of any anticipated or observed magnitude of effect, or because they are likely to have been addressed in the studies to be reviewed. Box 3.2.c summarizes the principal factors to consider when selecting and prioritizing review outcomes.

Box 3.2.c Factors to consider when selecting and prioritizing review outcomes

3.2.4.3 Defining and grouping outcomes for synthesis

Table 3.2.c outlines a process for planning for the diversity in outcome measurement that may be encountered in the studies included in a review and which can complicate, and sometimes prevent, synthesis. Research has repeatedly documented inconsistency in the outcomes measured across trials in the same clinical areas (Harrison et al 2016, Williamson et al 2017). This inconsistency occurs across all aspects of outcome measurement, including the broad domains considered, the outcomes measured, the way these outcomes are labelled and defined, and the methods and timing of measurement. For example, a review of outcome measures used in 563 studies of interventions for dementia and mild cognitive impairment found that 321 unique measurement methods were used for 1278 assessments of cognitive outcomes (Harrison et al 2016). Initiatives like COMET ( Core Outcome Measures in Effectiveness Trials ) aim to encourage standardization of outcome measurement across trials (Williamson et al 2017), but these initiatives are comparatively new and review authors will inevitably encounter diversity in outcomes across studies.

The process begins by describing the scope of each outcome domain in sufficient detail to enable outcomes from included studies to be categorized ( Table 3.2.c Step 1). This step may be straightforward in areas for which core outcome sets (or equivalent systems) exist ( Table 3.2.c Step 2). The methods and timing of outcome measurement also need to be specified, giving consideration to how differences across studies will be handled ( Table 3.2.c Steps 3 and 4). Subsequent steps consider options for dealing with studies that report multiple measures within an outcome domain ( Table 3.2.c Step 5), planning how outcome domains will be used in synthesis ( Table 3.2.c Step 6), and building in contingencies to maximize potential to synthesize ( Table 3.2.c Step 7).

Table 3.2.c A process for planning outcome groups for synthesis

3.3 Determining which study designs to include

Some study designs are more appropriate than others for answering particular questions. Authors need to consider a priori what study designs are likely to provide reliable data with which to address the objectives of their review ( MECIR Box 3.3.a ). Sections 3.3.1 and 3.3.2 cover randomized and non-randomized designs for assessing treatment effects; Chapter 17, Section 17.2.5  discusses other study designs in the context of addressing intervention complexity.

MECIR Box 3.3.a Relevant expectations for conduct of intervention reviews

3.3.1 Including randomized trials

Because Cochrane Reviews address questions about the effects of health care, they focus primarily on randomized trials and randomized trials should be included if they are feasible for the interventions of interest ( MECIR Box 3.3.b ). Randomization is the only way to prevent systematic differences between baseline characteristics of participants in different intervention groups in terms of both known and unknown (or unmeasured) confounders (see Chapter 8 ), and claims about cause and effect can be based on their findings with far more confidence than almost any other type of study. For clinical interventions, deciding who receives an intervention and who does not is influenced by many factors, including prognostic factors. Empirical evidence suggests that, on average, non-randomized studies produce effect estimates that indicate more extreme benefits of the effects of health care than randomized trials. However, the extent, and even the direction, of the bias is difficult to predict. These issues are discussed at length in Chapter 24 , which provides guidance on when it might be appropriate to include non-randomized studies in a Cochrane Review.

Practical considerations also motivate the restriction of many Cochrane Reviews to randomized trials. In recent decades there has been considerable investment internationally in establishing infrastructure to index and identify randomized trials. Cochrane has contributed to these efforts, including building up and maintaining a database of randomized trials, developing search filters to aid their identification, working with MEDLINE to improve tagging and identification of randomized trials, and using machine learning and crowdsourcing to reduce author workload in identifying randomized trials ( Chapter 4, Section 4.6.6.2 ). The same scale of organizational investment has not (yet) been matched for the identification of other types of studies. Consequently, identifying and including other types of studies may require additional efforts to identify studies and to keep the review up to date, and might increase the risk that the result of the review will be influenced by publication bias. This issue and other bias-related issues that are important to consider when defining types of studies are discussed in detail in Chapter 7 and Chapter 13 .

Specific aspects of study design and conduct should be considered when defining eligibility criteria, even if the review is restricted to randomized trials. For example, whether cluster-randomized trials ( Chapter 23, Section 23.1 ) and crossover trials ( Chapter 23, Section 23.2 ) are eligible, as well as other criteria for eligibility such as use of a placebo comparison group, evaluation of outcomes blinded to allocation sequence, or a minimum period of follow-up. There will always be a trade-off between restrictive study design criteria (which might result in the inclusion of studies that are at low risk of bias, but very few in number) and more liberal design criteria (which might result in the inclusion of more studies, but at a higher risk of bias). Furthermore, excessively broad criteria might result in the inclusion of misleading evidence. If, for example, interest focuses on whether a therapy improves survival in patients with a chronic condition, it might be inappropriate to look at studies of very short duration, except to make explicit the point that they cannot address the question of interest.

MECIR Box 3.3.b Relevant expectations for conduct of intervention reviews

3.3.2 Including non-randomized studies

The decision of whether non-randomized studies (and what type) will be included is decided alongside the formulation of the review PICO. The main drivers that may lead to the inclusion of non-randomized studies include: (i) when randomized trials are unable to address the effects of the intervention on harm and long-term outcomes or in specific populations or settings; or (ii) for interventions that cannot be randomized (e.g. policy change introduced in a single or small number of jurisdictions) (see Chapter 24 ). Cochrane, in collaboration with others, has developed guidance for review authors to support their decision about when to look for and include non-randomized studies (Schünemann et al 2013).

Non-randomized designs have the commonality of not using randomization to allocate units to comparison groups, but their different design features mean that they are variable in their susceptibility to bias. Eligibility criteria should be based on explicit study design features, and not the study labels applied by the primary researchers (e.g. case-control, cohort), which are often used inconsistently (Reeves et al 2017; see Chapter 24 ).

When non-randomized studies are included, review authors should consider how the studies will be grouped and used in the synthesis. The Cochrane Non-randomized Studies Methods Group taxonomy of design features (see Chapter 24 ) may provide a basis for grouping together studies that are expected to have similar inferential strength and for providing a consistent language for describing the study design.

Once decisions have been made about grouping study designs, planning of how these will be used in the synthesis is required. Review authors need to decide whether it is useful to synthesize results from non-randomized studies and, if so, whether results from randomized trials and non-randomized studies should be included in the same synthesis (for the purpose of examining whether study design explains heterogeneity among the intervention effects), or whether the effects should be synthesized in separate comparisons (Valentine and Thompson 2013). Decisions should be made for each of the different types of non-randomized studies under consideration. Review authors might anticipate increased heterogeneity when non-randomized studies are synthesized, and adoption of a meta-analysis model that encompasses heterogeneity is wise (Valentine and Thompson 2013) (such as a random effects model, see Chapter 10, Section 10.10.4 ). For further discussion of non-randomized studies, see Chapter 24 .

3.4 Eligibility based on publication status and language

Chapter 4 contains detailed guidance on how to identify studies from a range of sources including, but not limited to, those in peer-reviewed journals. In general, a strategy to include studies reported in all types of publication will reduce bias ( Chapter 7 ). There would need to be a compelling argument for the exclusion of studies on the basis of their publication status ( MECIR Box 3.4.a ), including unpublished studies, partially published studies, and studies published in ‘grey’ literature sources. Given the additional challenge in obtaining unpublished studies, it is possible that any unpublished studies identified in a given review may be an unrepresentative subset of all the unpublished studies in existence. However, the bias this introduces is of less concern than the bias introduced by excluding all unpublished studies, given what is known about the impact of reporting biases (see Chapter 13 on bias due to missing studies, and Chapter 4, Section 4.3 for a more detailed discussion of searching for unpublished and grey literature).

Likewise, while searching for, and analysing, studies in any language can be extremely resource-intensive, review authors should consider carefully the implications for bias (and equity, see Chapter 16 ) if they restrict eligible studies to those published in one specific language (usually English). See Chapter 4, Section 4.4.5 , for further discussion of language and other restrictions while searching.

MECIR Box 3.4.a Relevant expectations for conduct of intervention reviews

3.5 Chapter information

Authors: Joanne E McKenzie, Sue E Brennan, Rebecca E Ryan, Hilary J Thomson, Renea V Johnston, James Thomas

Acknowledgements: This chapter builds on earlier versions of the Handbook . In particular, Version 5, Chapter 5 , edited by Denise O’Connor, Sally Green and Julian Higgins.

Funding: JEM is supported by an Australian National Health and Medical Research Council (NHMRC) Career Development Fellowship (1143429). SEB and RER’s positions are supported by the NHMRC Cochrane Collaboration Funding Program. HJT is funded by the UK Medical Research Council (MC_UU_12017-13 and MC_UU_12017-15) and Scottish Government Chief Scientist Office (SPHSU13 and SPHSU15). RVJ’s position is supported by the NHMRC Cochrane Collaboration Funding Program and Cabrini Institute. JT is supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care North Thames at Barts Health NHS Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

3.6 References

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Ciciriello S, Johnston RV, Osborne RH, Wicks I, deKroo T, Clerehan R, O’Neill C, Buchbinder R. Multimedia educational interventions for consumers about prescribed and over-the-counter medications. Cochrane Database of Systematic Reviews 2013; 4 : CD008416.

Cochrane Consumers & Communication Group. Outcomes of Interest to the Cochrane Consumers & Communication Group: taxonomy. http://cccrg.cochrane.org/ .

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Davey J, Turner RM, Clarke MJ, Higgins JPT. Characteristics of meta-analyses and their component studies in the Cochrane Database of Systematic Reviews: a cross-sectional, descriptive analysis. BMC Medical Research Methodology 2011; 11 : 160.

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Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Journal of Pain 2014; 15 : 569–585.

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Guise JM, Chang C, Viswanathan M, Glick S, Treadwell J, Umscheid CA. Systematic reviews of complex multicomponent health care interventions. Report No. 14-EHC003-EF . Rockville, MD: Agency for Healthcare Research and Quality; 2014.

Harrison JK, Noel-Storr AH, Demeyere N, Reynish EL, Quinn TJ. Outcomes measures in a decade of dementia and mild cognitive impairment trials. Alzheimer’s Research and Therapy 2016; 8 : 48.

Hedges LV, Tipton E, Johnson M, C. Robust variance estimation in meta-regression with dependent effect size estimates. Research Synthesis Methods 2010; 1 : 39–65.

Hetrick SE, McKenzie JE, Cox GR, Simmons MB, Merry SN. Newer generation antidepressants for depressive disorders in children and adolescents. Cochrane Database of Systematic Reviews 2012; 11 : CD004851.

Higgins JPT, López-López JA, Becker BJ, Davies SR, Dawson S, Grimshaw JM, McGuinness LA, Moore THM, Rehfuess E, Thomas J, Caldwell DM. Synthesizing quantitative evidence in systematic reviews of complex health interventions. BMJ Global Health 2019; 4 : e000858.

Hoffmann T, Glasziou P, Barbour V, Macdonald H. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014; 1687 : 1-13.

Hollands GJ, Shemilt I, Marteau TM, Jebb SA, Lewis HB, Wei Y, Higgins JPT, Ogilvie D. Portion, package or tableware size for changing selection and consumption of food, alcohol and tobacco. Cochrane Database of Systematic Reviews 2015; 9 : CD011045.

Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database of Systematic Reviews 2011; 7 : CD000333.

ICHOM. The International Consortium for Health Outcomes Measurement 2018. http://www.ichom.org/ .

IPDAS. International Patient Decision Aid Standards Collaboration (IPDAS) standards. www.ipdas.ohri.ca .

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Kendrick D, Kumar A, Carpenter H, Zijlstra GAR, Skelton DA, Cook JR, Stevens Z, Belcher CM, Haworth D, Gawler SJ, Gage H, Masud T, Bowling A, Pearl M, Morris RW, Iliffe S, Delbaere K. Exercise for reducing fear of falling in older people living in the community. Cochrane Database of Systematic Reviews 2014; 11 : CD009848.

Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews? A survey of the Co-ordinating Editors of Cochrane Review Groups. Trials 2013; 14 : 21.

Konstantopoulos S. Fixed effects and variance components estimation in three-level meta-analysis. Research Synthesis Methods 2011; 2 : 61–76.

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Lewin S, Hendry M, Chandler J, Oxman AD, Michie S, Shepperd S, Reeves BC, Tugwell P, Hannes K, Rehfuess EA, Welch V, Mckenzie JE, Burford B, Petkovic J, Anderson LM, Harris J, Noyes J. Assessing the complexity of interventions within systematic reviews: development, content and use of a new tool (iCAT_SR). BMC Medical Research Methodology 2017; 17 : 76.

López-López JA, Page MJ, Lipsey MW, Higgins JPT. Dealing with multiplicity of effect sizes in systematic reviews and meta-analyses. Research Synthesis Methods 2018; 9 : 336–351.

Mavridis D, Salanti G. A practical introduction to multivariate meta-analysis. Statistical Methods in Medical Research 2013; 22 : 133–158.

Michie S, van Stralen M, West R. The Behaviour Change Wheel: a new method for characterising and designing behaviour change interventions. Implementation Science 2011; 6 : 42.

Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Annals of Behavioral Medicine 2013; 46 : 81–95.

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O'Neill J, Tabish H, Welch V, Petticrew M, Pottie K, Clarke M, Evans T, Pardo Pardo J, Waters E, White H, Tugwell P. Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health. Journal of Clinical Epidemiology 2014; 67 : 56–64.

Pompoli A, Furukawa TA, Imai H, Tajika A, Efthimiou O, Salanti G. Psychological therapies for panic disorder with or without agoraphobia in adults: a network meta-analysis. Cochrane Database of Systematic Reviews 2016; 4 : CD011004.

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Systematic Reviews for Health Sciences and Medicine

• Systematic Reviews
• The research question
• Common search errors
• Search translation
• Managing results
• Inclusion and exclusion criteria
• Critical appraisal
• Updating a Review
• Resources by Review Stage

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.

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Systematic Reviews: Inclusion and Exclusion Criteria

• What Type of Review is Right for You?
• What is in a Systematic Review
• Finding and Appraising Systematic Reviews
• Formulating Your Research Question
• Inclusion and Exclusion Criteria
• Creating a Protocol
• Results and PRISMA Flow Diagram
• Searching the Published Literature
• Searching the Gray Literature
• Methodology and Documentation
• Managing the Process
• Scoping Reviews

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:

• Date of publication : only articles published in the last ten years
• Exposure to intervention/ or specific health condition : only people who have participated in the DASH diet
• Language of Publication* : only looking at English articles 
• Settings : Hospitals, nursing homes, schools
• Geography : specific locations such as states, countries, or specific populations

*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. 

• Unanswered questions implications of an empty review Slyer, Jason T. Unanswered questions, JBI Database of Systematic Reviews and Implementation Reports: June 2016 - Volume 14 - Issue 6 - p 1-2 doi: 10.11124/JBISRIR-2016-002934
• Rapid Prompting Method and Autism Spectrum Disorder: Systematic Review Exposes Lack of Evidence Schlosser, R.W., Hemsley, B., Shane, H. et al. Rapid Prompting Method and Autism Spectrum Disorder: Systematic Review Exposes Lack of Evidence. Rev J Autism Dev Disord 6, 403–412 (2019).
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Evidence-Based Practice (EBP)

• The EBP Process
• Forming a Clinical Question
• Inclusion & Exclusion Criteria
• Acquiring Evidence
• Appraising the Quality of the Evidence
• Writing a Literature Review
• Finding Psychological Tests & Assessment Instruments

Selection Criteria

Inclusion and exclusion criteria are determined after formulating the research question but usually before the search is conducted (although preliminary scoping searches may need to be undertaken to determine appropriate criteria).  It may be helpful to determine the inclusion criteria and exclusion criteria for each PICO component.

Be aware that you may  introduce bias  into the final review if these are not used thoughtfully. 

Inclusion and exclusion are two sides of the same coin, so—depending on your perspective—a single database filter can be said to either include or exclude. For instance, if articles must be published within the last 3 years, that is inclusion. If articles cannot be more than 3 years old, that is exclusion. 

The most straightforward way to include or exclude results is to use database limiters (filters), usually found on the left side of the search results page.

Inclusion 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)
• Included studies must be located in a certain geographic area
• Included studies must have been published in the last 5 years

Exclusion 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
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• Introduction
• Preamble: Systematic Review: What it is and isn't
• Systematic Review Guidelines
• 1. Formulate a Research Question
• 2. Develop a Research Protocol
• 3. Conduct a Thorough Literature Search
• 4. Apply Inclusion and Exclusion Criteria
• 5. Perform Data Extraction/Abstraction
• 6. Conduct a Quality Appraisal of Included Studies
• 7. Complete Data Analysis and Compile Results
• 8. Interpret Results
• How to Appraise a Systematic Review
• Systematic Review Software and Tools
• Knowledge Synthesis Services This link opens in a new window

Systematic Review Overview : 4. Apply Inclusion and Exclusion Criteria

• Health Science Information Consortium
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• Systematic Review Overview

Table of Contents

• Systematic Review Software

Step 4. Apply Inclusion and Exclusion Criteria

At the beginning of large systematic reviews, researchers discuss and develop a series of inclusion and exclusion criteria to fit in with their review question and/or the brief provided by whoever is funding the project.

Systematic reviews often exclude studies if they do not conform to specific study designs, are not written in English or within a certain time frame. As a researcher, you should be cautious of any bias you might introduce into the review by adding certain inclusion or exclusion criteria. For example: limiting to studies in English may miss important studies published in other languages, leading to language bias.

All decisions to include or exclude certain studies or groups of studies should be documented in the methods section of the research proposal/protocol - this way it can be demonstrated that a systematic process has been followed.

In large systematic reviews, the inclusion/exclusion criteria are applied by at least 2 reviewers to all the studies retrieved by the literature search. A strategy to resolve any disagreements between the reviewers should be outlined in the protocol, such as bringing in a third screener.

There are two levels of the screening process. The first level of screening involves scanning the titles and abstracts of the articles; those that are clearly irrelevant can be excluded.

Full text papers are obtained for the remaining articles and the criteria are applied again for the second level of screening on the full text. Those that meet the criteria are included in the review (although sometimes if too many papers are obtained, the question and criteria are refined and the process repeated). At this stage of screening, the reason for exclusion(s) must be recorded. This process is represented by the following flow diagram ( See PRISMA Flow Diagram ).

Key Points Regarding Study Selection

• Section 1.3.2. Process for Study selection (http://www.york.ac.uk/inst/crd/pdf/Systematic_Reviews.pdf, actual page #35)
• Studies should be selected in an unbiased way, based on selection criteria that flow directly from the review questions, and that have been piloted to check that they can be reliably applied.
• Study selection is a staged process involving sifting through the citations located by the search, retrieving full reports of potentially relevant citations and, from their assessment, identifying those studies that fulfill the inclusion criteria.
• Parallel independent assessments should be conducted to minimize the risk of errors of judgment. If disagreements occur between reviewers, they should be resolved according to a predefined strategy using consensus and arbitration as appropriate.
• The study selection process should be documented, detailing reasons for inclusion and exclusion.

Tips to Improve Inter-Rater Reliability / Screener Selection Accuracy

While awaiting search strategy development and final citation results:

• Provide clear and explicit inclusion and exclusion criteria, with definitions and explanations where warranted.
• Conduct thorough training for all involved.
• Provide clear guidelines which should be reviewed by all prior to starting the activity.
• Provide pilot testing or beta testing of screening tools/procedures, using samples/subsets of real data (with test inter-rater reliability calculations to determine preliminary agreement or variability).
• Optional: pilot or beta test screeners in pairs: one screener with previous experience paired with a more novice screener.
• Conduct ongoing, active surveillance/auditing of activities (can see if/when going off course)
• Provide ongoing opportunities for discussion, education, and training.
• The Screening Phase for Reviews Tutorial (5 min+) This tutorial presents information on the screening process for systematic reviews or other knowledge syntheses, and contains a variety of resources including guidelines, best practices, tips, and tools for successfully preparing to complete this important research stage.
• 1. Slavin RE. Best evidence synthesis: an intelligent alternative to meta-analysis. J Clin Epidemiol. 1995 Jan;48(1):9-18.
• 2. Eysenck HJ. Meta-analysis and its problems. BMJ. 1994 Sep 24;309(6957):789-92.
• 3. Moher D, Fortin P, Jadad AR, Juni P, Klassen T, Le Lorier J, et al. Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews. Lancet. 1996 Feb 10;347(8998):363-6.
• 4. Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials. 1998 Apr;19(2):159-66.
• 5. Moher D, Pham B, Klassen T, Schultz KF, Berlin J, Jadad AR, et al. Does the language of publication of reports of randomized trials influence the estimates of intervention effectiveness reported in meta-analyses? Systematic Reviews: Evidence in Action,
• 6. PRISMA Statement. "The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. It is an evolving document that is subject to change periodically as new evidence emerges. In fact, the PRISMA Statement is an update and expansion of the now-out dated QUORUM Statement. This website contains the current definitive version of the PRISMA Statement."
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Literature searching and finding evidence.

• Literature searching or literature review?
• Use the PICO or PEO frameworks

Establish your Inclusion and Exclusion criteria

• Find related search terms
• Subject Heading/MeSH Searching
• Select databases to search
• Structure your search
• Search techniques
• Search key databases
• Manage results in EBSCOhost and Ovid
• Analyse your search results
• Document your search results
• Training and support

These criteria help you decide which pieces of evidence (for example, which primary research studies) will/will not be included in your work. Using specific criteria will help make sure your final review is as unbiased, transparent and ethical as possible.

How to establish your Inclusion and Exclusion criteria

To establish your criteria you need to define each aspect of your question to clarify what you are focusing on, and consider if there are any variations you also wish to explore. This is where using frameworks like PICO help:

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.

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• v.8(11); 2016 Nov

How to Conduct a Systematic Review: A Narrative Literature Review

Nusrat jahan.

1 Psychiatry, Mount Sinai Chicago

Sadiq Naveed

2 Psychiatry, KVC Prairie Ridge Hospital

Muhammad Zeshan

3 Department of Psychiatry, Bronx Lebanon Hospital Icahn School of Medicine at Mount Sinai, Bronx, NY

Muhammad A Tahir

4 Psychiatry, Suny Upstate Medical University, Syracuse, NY

Systematic reviews are ranked very high in research and are considered the most valid form of medical evidence. They provide a complete summary of the current literature relevant to a research question and can be of immense use to medical professionals. Our goal with this paper is to conduct a narrative review of the literature about systematic reviews and outline the essential elements of a systematic review along with the limitations of such a review.

Introduction and background

A literature review provides an important insight into a particular scholarly topic. It compiles published research on a topic, surveys different sources of research, and critically examines these sources [ 1 ]. A literature review may be argumentative, integrative, historical, methodological, systematic, or theoretical, and these approaches may be adopted depending upon the types of analysis in a particular study [ 2 ].

Our topic of interest in this article is to understand the different steps of conducting a systematic review. Systematic reviews, according to Wright, et al., are defined as a “review of the evidence on a clearly formulated question that uses systematic and explicit methods to identify, select and critically appraise relevant primary research, and to extract and analyze data from the studies that are included in the review” [ 3 ]. A systematic review provides an unbiased assessment of these studies [ 4 ]. Such reviews emerged in the 1970s in the field of social sciences. Systematic reviews, as well as the meta-analyses of the appropriate studies, can be the best form of evidence available to clinicians [ 3 ]. The unsystematic narrative review is more likely to include only research selected by the authors, which introduces bias and, therefore, frequently lags behind and contradicts the available evidence [ 5 ].

Epidemiologist Archie Cochrane played a vital role in formulating the methodology of the systematic review [ 6 ]. Dr. Cochrane loved to study patterns of disease and how these related to the environment. In the early 1970s, he found that many decisions in health care were made without reliable, up-to-date evidence about the treatments used [ 6 ].

A systematic review may or may not include meta-analysis, depending on whether results from different studies can be combined to provide a meaningful conclusion. David Sackett defined meta-analysis as a “specific statistical strategy for assembling the results of several studies into a single estimate” [ 7 - 8 ].

While the systematic review has several advantages, it has several limitations which can affect the conclusion. Inadequate literature searches and heterogeneous studies can lead to false conclusions. Similarly, the quality of assessment is an important step in systematic reviews, and it can lead to adverse consequences if not done properly.

The purpose of this article is to understand the important steps involved in conducting a systematic review of all kinds of clinical studies. We conducted a narrative review of the literature about systematic reviews with a special focus on articles that discuss conducting reviews of randomized controlled trials. We discuss key guidelines and important terminologies and present the advantages and limitations of systematic reviews.

Narrative reviews are a discussion of important topics on a theoretical point of view, and they are considered an important educational tool in continuing medical education [ 9 ]. Narrative reviews take a less formal approach than systematic reviews in that narrative reviews do not require the presentation of the more rigorous aspects characteristic of a systematic review such as reporting methodology, search terms, databases used, and inclusion and exclusion criteria [ 9 ]. With this in mind, our narrative review will give a detailed explanation of the important steps of a systematic review.

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) checklist

Systematic reviews are conducted based on predefined criteria and protocol. The PRISMA-P checklist, developed by Moher, et al., contains 17 items (26 including sub-items) comprising the important steps of a systematic review, including information about authors, co-authors, their mailing and email addresses, affiliations, and any new or updated version of a previous systematic review [ 9 ]. It also identifies a plan for documenting important protocol amendments, registry names, registration numbers, financial disclosures, and other support services [ 10 ]. Moher, et al. also state that methods of systematic reviews involve developing eligibility criteria and describing information sources, search strategies, study selection processes, outcomes, assessment of bias in individual studies, and data synthesis [ 10 ].

Research question

Writing a research question is the first step in conducting a systematic review and is of paramount importance as it outlines both the need and validity of systematic reviews (Nguyen, et al., unpublished data). It also increases the efficiency of the review by limiting the time and cost of identifying and obtaining relevant literature [ 11 ]. The research question should summarize the main objective of a systematic review.

An example research question might read, “How does attention-deficit/hyperactivity disorder (ADHD) affect the academic performance of middle school children in North America?” The question focuses on the type of data, analysis, and topic to be discussed (i.e., ADHD among North American middle school students). Try to avoid research questions that are too narrow or broad—they can lead to the selection of only a few studies and the ability to generalize results to any other populations may be limited. An example of a research question that is too narrow would be, “What is the prevalence of ADHD in children and adolescents in Chicago, IL?” Alternately, if the research question is too broad, it can be difficult to reach a conclusion due to poor methodology. An example of a research question that is too broad in scope would be, “What are the effects of ADHD on the functioning of children and adolescents in North America?”

Different tools that can be used to help devise a research question, depending on the type of question, are: population, intervention, comparator, and outcomes (PICO); sample, phenomenon of interest, design, evaluation, and research type (SPIDER); setting, perspective, intervention, comparison, and evaluation (SPICE); and expectation, client group, location, impact, professionals, and service (ECLIPSE).

The PICO approach is mostly used to compare different interventions with each other. It helps to formulate a research question related to prognosis, diagnosis, and therapies [ 12 ].

Scenario: A 50-year-old white woman visited her psychiatrist with a diagnosis of major depressive disorder. She was prescribed fluoxetine, which she feels has been helpful. However, she experienced some unpleasant side effects of nausea and abdominal discomfort. She has recently been told by a friend about the use of St. John’s wort in treating depression and would like to try this in treating her current depression. (Formulating research questions, unpublished data).

In the above-mentioned scenario, the sample population is a 50-year-old female with major depressive disorder; the intervention is St. John’s wort; the comparison is fluoxetine; and the outcome would be efficacy and safety. In order to see the outcome of both efficacy and safety, we will compare the efficacy and safety of both St. John’s wort and fluoxetine in a sample population for treating depression. This scenario represents an example where we can apply the PICO approach to compare two interventions.

In contrast, the SPIDER approach is focused more on study design and samples rather than populations [ 13 ]. The SPIDER approach can be used in this research question: “What is the experience of psychiatry residents attending a transgender education?” The sample is psychiatry residents; the phenomenon of interest is transgender education; the design is a survey; the evaluation looks at the experience; and the research type is qualitative. 

The SPICE approach can be used to evaluate the outcome of a service, intervention, or project [ 14 ]. The SPICE approach applies to the following research question: “In psychiatry clinics, does the combined use of selective serotonin reuptake inhibitor (SSRI) and psychotherapy reduce depression in an outpatient clinic versus SSRI therapy alone?” The setting is the psychiatry clinic; the perspective/population is the outpatient; the intervention is combined psychotherapy and SSRI; the comparison is SSRI alone; and the evaluation is reduced depression. 

The ECLIPSE approach is useful for evaluating the outcome of a policy or service (Nguyen, et al., unpublished data). ECLIPSE can apply in the following research question: “How can a resident get access to medical records of patients admitted to inpatient from other hospitals?” The expectation is: “What are you looking to improve/change to increase access to medical records for patients admitted to inpatient?” The client group is the residents; the location is the inpatient setting; the impact would be the residents having easy access to medical records from other hospitals; and the professionals in this scenario would be those involved in improving the service experiences such as hospital administrators and IT staff.

Inclusion and exclusion criteria

Establishing inclusion and exclusion criteria come after formulating research questions. The concept of inclusion and exclusion of data in a systematic review provides a basis on which the reviewer draws valid and reliable conclusions regarding the effect of the intervention for the disorder under consideration [ 11 ]. Inclusions and exclusion are based on preset criteria for specific systematic review. It should be done before starting the literature search in order to minimize the possibility of bias.

Eligibility criteria provide the boundaries of the systematic review [ 15 ]. Participants, interventions, and comparison of a research question provide the basis for eligibility criteria [ 15 ]. The inclusion criteria should be able to identify the studies of interest and, if the inclusion criteria are too broad or too narrow, it can lead to an ineffective screening process.

Protocol registration

Developing and registering research protocol is another important step of conducting a systematic review. The research protocol ensures that a systematic review is carefully planned and explicitly documented before the review starts, thus promoting consistency in conduct for the review team and supporting the accountability, research integrity, and transparency of the eventually completed review [ 10 ]. PROSPERO and the Cochrane Database of Systematic Reviews are utilized for registering research protocols and research questions, and they check for prior existing duplicate protocols or research questions. PROSPERO is an international database of prospectively registered systematic reviews related to health care and social sciences (PRISMA, 2016). It is funded by the National Institute for Health Research. The Cochrane Collaboration concentrates on producing systematic reviews of interventions and diagnostic test accuracy but does not currently produce reviews on questions of prognosis or etiology [ 16 ].

A detailed and extensive search strategy is important for the systematic review since it minimizes bias in the review process [ 17 ].

Selecting and searching appropriate electronic databases is determined by the topic of interest. Important databases are: MEDLARS Online (MEDLINE), which is the online counterpart to the Medical Literature Analysis and Retrieval System (MEDLARS); Excerpta Medica Database (EMBASE); and Google Scholar. There are multiple electronic databases available based on the area of interest. Other important databases include: PsycINFO for psychology and psychiatry; Allied and Complementary Medicine Database (AMED) for complementary medicine; Manual, Alternative, and Natural Therapy Index System (MANTIS) for alternative medical literature; and Cumulative Index to Nursing and Allied Health Literature (CINAHL) for nursing and allied health [ 15 ].

Additional studies relevant for the review may be found by looking at the references of studies identified by different databases [ 15 ]. Non-indexed articles may be found by searching the content of journals, conferences proceedings, and abstracts. It will also help with letters and commentaries which may not get indexed [ 15 ]. Reviewing clinical trial registries can provide information about any ongoing trials or unpublished research [ 15 ]. A gray literature search can access unpublished papers, reports, and conference reports, and it generally covers studies that are published in an informal fashion, rather than in an indexed journal [ 15 ]. Further search can be performed by selecting important key articles and going through in-text citations [ 15 ].

Using Boolean operators, truncation, and wildcards

Boolean operators use the relationship between different search words to help with the search strategy. These are simple words (i.e., AND, OR, and NOT) which can help with more focused and productive results (poster, Jahan, et al.: How to conduct a systematic review. APPNA 39th Summer Convention. Washington, DC. 2016). The Boolean operator AND finds articles with all the search words. The use of OR broadens the focus of the search, and it will include articles with at least one search term. The researchers can also ignore certain results from the records by using NOT in the search strategy.

An example of AND would be using “depression” AND “children” in the search strategy with the goal of studying depression in children. This search strategy will include all the articles about both depression and children. The researchers may use OR if the emphasis of the study is mood disorders or affective disorders in adolescents. In that case, the search strategy will be “mood disorders” OR “affective disorders” AND “adolescents.” This search will find all the articles about mood disorders or affective disorders in adolescents. The researchers can use NOT if they only want to study depression in children and want to ignore bipolar disorder from the search. An example search in this scenario would be “depression” NOT “bipolar disorder” AND “children.” This will help ignore studies related to bipolar disorder in children.

Truncation and wildcards are other tools to make search strategy more comprehensive and focused. While the researchers search a database for certain articles, they frequently face terminologies that have the same initial root of a word but different endings. An example would be "autism," "autistic," and "autism spectrum disorder." These words have a similar initial root derived from “autis” but they end differently in each case. The truncation symbol (*) retrieves articles that contain words beginning with “autis” plus any additional characters. Wildcards are used for words with the same meanings but different spellings due to various reasons. For the words with spelling variations of a single letter, wildcard symbols can be used. When the researcher inputs “M+N” in the search bar, this returns results containing both “man” or “men” as the wildcard accounts for the spelling variations between the letters M and N.

Study selection

Study selection should be performed in a systematic manner, so reviewers deal with fewer errors and a lower risk of bias (online course, Li T, Dickersin K: Introduction to systematic review and meta-analysis. 2016. https://www.coursera.org/learn/systematic-review #). Study selection should involve two independent reviewers who select studies using inclusion and exclusion criteria. Any disagreements during this process should be resolved by discussion or by a third reviewer [ 10 ]. Specific study types can be selected depending on the research question. For example, questions on incidence and prevalence can be answered by surveys and cohort studies. Clinical trials can provide answers to questions related to therapy and screening. Queries regarding diagnostic accuracy can be answered by clinical trials and cross-sectional studies (online course, Li T, Dickersin K: Introduction to systematic review and meta-analysis. 2016. https://www.coursera.org/learn/systematic-review #). Prognosis and harm-related questions should use cohort studies and clinical trials, and etiology questions should use case-control and cohort studies (online course, Li T, Dickersin K: Introduction to systematic review and meta-analysis. 2016. https://www.coursera.org/learn/systematic-review #).

Data screening and data extractions are two of the major steps in conducting a systematic review [ 18 ]. Data screening involves searching for relevant articles in different databases using keywords. The next step of data screening is manuscript selection by reviewing each manuscript in the search results to compare that manuscript against the inclusion criteria [ 18 ]. The researchers should also review the references of the papers selected before selecting the final paper, which is the last step of data screening [ 18 ].

The next stage is extracting and appraising the data of the included articles [ 18 ]. A data extraction form should be used to help reduce the number of errors, and more than one person should record the data [ 17 ]. Data should be collected on specific points like population type, study authors, agency, study design, humanitarian crisis, target age groups, research strengths from the literature, setting, study country, type(s) of public health intervention, and health outcome(s) addressed by the public health intervention. All this information should then be put into an electronic database [ 18 ].

Assessing bias

Bias is a systematic error (or deviation from the truth) in results or inferences. Biases can change the results of any study and lead to an underestimation or overestimation of the true intervention effect [ 19 ]. Biases can impact any aspect of a review, including selecting studies, collecting and extracting data, and making a conclusion. Biases can vary in magnitude; some are small, with negligible effect, but some are substantial to a degree where an apparent finding may be entirely due to bias [ 19 ]. There are different types of bias, including, but not limited to, selection, detection, attrition, reporting, and performance.

Selection bias occurs when a sample selected is not representative of the whole general population. If randomization of the sample is done correctly, then chances of selection bias can be minimized [ 20 ].

Detection bias refers to systematic differences between groups in how outcomes are determined. This type of bias is based on knowledge of the intervention provided and its outcome [ 19 ].

Attrition bias refers to systematic differences between groups in withdrawals from a study [ 19 ]. The data will be considered incomplete if some subjects are withdrawn or have irregular visits during data collection.

Reporting bias refers to systematic differences between reported and unreported findings, and it is commonly seen during article reviews. Reporting bias is based on reviewer judgment about the outcome of selected articles [ 20 ].

Performance bias develops due to the knowledge of the allocated interventions by participants and personnel during the study [ 20 ]. Using a double-blind study design helps prevent performance bias, where neither the experimenter nor the subjects know which group contains controls and which group contains the test article [ 14 ].

Last step of systematic review: discussion

The discussion of a systematic review is where a summary of the available evidence for different outcomes is written and discussed [ 10 ]. The limitations of a systematic review are also discussed in detail. Finally, a conclusion is drawn after evaluating the results and considering limitations [ 10 ].

Discussion of the current article

Systematic reviews with or without a meta-analysis are currently ranked to be the best available evidence in the hierarchy of evidence-based practice [ 21 ]. We have discussed the methodology of a systematic review. A systematic review is classified in the category of filtered information because it appraises the quality of the study and its application in the field of medicine [ 21 ]. However, there are some limitations of the systematic review, as we mentioned earlier in our article. A large randomized controlled trial may provide a better conclusion than a systematic review of many smaller trials due to their larger sample sizes [ 22 ], which help the researchers generalize their conclusions for a bigger population. Other important factors to consider include higher dropout rates in large studies, co-interventions, and heterogeneity among studies included in the review.

As we discussed the limitations of the systematic review and its effect on quality of evidence, there are several tools to rate the evidence, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system [ 22 ]. GRADE provides a structured approach to evaluating the risk of bias, serious inconsistency between studies, indirectness, imprecision of the results, and publication bias [ 22 ]. Another approach used to rate the quality of evidence is a measurement tool to assess systematic reviews (AMSTAR) [ 23 ]. It is also available in several languages [ 23 ].

Conclusions

Despite its limitations, a systematic review can add to the knowledge of the scientific community especially when there are gaps in the existing knowledge. However, conducting a systematic review requires different steps that involve different tools and strategies. It can be difficult at times to access and utilize these resources. A researcher can understand and strategize a systematic review following the different steps outlined in this literature review. However, conducting a systematic review requires a thorough understanding of all the concepts and tools involved, which is an extensive endeavor to be summed up in one article.

The Cochrane Handbook for Systematic Reviews of Interventions and the Center for Reviews and Dissemination (CRD) provide excellent guidance through their insightful and detailed guidelines. We recommend consulting these resources for further guidance.

Given that our article is a narrative review of the scholarly literature, it contains the same limitations as noted for any narrative review. We hope that our review of the means and methods for conducting a systematic review will be helpful in providing basic knowledge to utilize the resources available to the scientific community.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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

• What is a Literature Review?
• Developing a Research Question

Selection Criteria

Inclusion criteria, exclusion criteria.

• Database Search
• Documenting Your Search
• Organize Key Findings
• Reference Management

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:

• Included studies must have compared certain treatments
• Included studies must be experimental
• Included studies must have been published in the last 5 years

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
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Literature Review Basics and Searching Skills

• Selecting Criteria
• Getting Started
• Developing Research Questions
• Selecting Databases
• Searching Databases
• Documenting Searches
• Organizing Findings
• Managing Citations & References
• Submitting Your Manuscript
• Finding Help

Selection 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

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 experimental
• Included studies must have been published in the last 5 years

Exclusion 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
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Literature Reviews: Systematic, Scoping, Integrative

• Introduction to Literature Reviews
• Creating a Search Strategy

Using Limits and Inclusion/Exclusion Criteria

Filters and Limits

Inclusion and Exclusion Criteria

Limits and Inclusion Criteria

• Review Protocols
• Elements of a Systematic Review
• Review Tools and Applications
• Writing a Literature Review

Ask A Librarian

Once you have some search results, you will need to decide which articles you will actually use in your literature review. This can be done using filters/limits in the databases, applying inclusion/exclusion criteria, and appraising the articles.

Filters and limits (the name varies by database) are tools the database provides to help you narrow your search results. Different databases offer different filters, but these are some of the more common ones you'll find.

• Publication year
• Language of the article
• Age of study subjects
• Study design

Your search terms and the filters/limits you apply are generally not enough to narrow your results to the most relevant and highest quality studies for your project. The final step to selecting these studies is to apply your inclusion and exclusion criteria. Basically, these are the reasons why you keep (include) or reject (exclude) articles as you look through the results, reading titles and abstracts (and sometimes the whole article)

Examples of types of Inclusion/Exclusion Criteria

• PICO(T) elements - if one of the main elements of your topic does not match those of the study, you may need to exclude it
• Age - if you can't use a filter/limit to exclude studies that do not focus on the age group you require, you may need to exclude those studies yourself.
• Setting - i.e. home, acute care, assisted living facility
• Study Design - sometimes a filter/limit doesn't exist for the study design you're interested in; in that case you'll need to look through articles to find that detail yourself.
• Number of subjects - do you have a minimum study group size? 
• Study drop-out rate  

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Literature Reviews

Determine inclusion and exclusion criteria.

• What is a literature review?
• Steps in the Literature Review Process
• Define your research question
• Choose databases and search
• Review Results
• Synthesize Results
• Analyze Results
• Librarian Support
• Artificial Intelligence (AI) Tools

Once you have a clearly defined research question, make sure you are getting precisely the right search results from searching the databases by making decisions about these items:

• Would the most recent five years be appropriate?
• Is your research from a more historical perspective?
• Where has this type of research taken place?
• Will you confine your results to the United States?
• To English speaking countries?
• Will you translate works if needed?
• Is there a particular methodology, or population that you are focused on?
• Are there adjacent fields in which this type of research has been conducted that you would like to include?
• Is there a controversy or debate in your research field that you want to highlight
• Are you creating a historical overview? Is this background reading for your research?
• Is there new technology that can shed light on an old problem or an old technology that can be used in a new way?
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Conducting your literature review

• Introduction
• Your literature review
• Defining a research question
• Choosing where to search
• Search strings
• Limiters and filters

Developing inclusion/exclusion criteria

• Managing your search results
• Screening, evaluating and recording
• Snowballing and grey literature
• Further information and resources

A feature of the systematic literature review is using pre-specified criteria to include/exclude studies. Through searching the literature and formulating your review questions, for example by using PICO, PEO , etc., you will be able to define the specific attributes that research studies must have to be eligible for inclusion in your review, along with other attributes that will exclude them. These attributes will form your inclusion and exclusion criteria, which you will use to assess the relevance and quality of the studies to be included in your final analysis.

Examples of inclusion/exclusion criteria could be:

• Language, e.g., only include articles published in English.
• Timeframe, e.g., papers published after a certain date.
• Geographic location, e.g., UK only.
• Format, e.g., peer reviewed journal articles.
• Type of research, e.g., case studies, empirical papers, qualitative research.

To justify their use, you will need to provide a rationale for each of your inclusion/exclusion criteria.

You will find examples of inclusion/exclusion criteria in research theses on CERES, Cranfield’s repository. Simply keyword search for “systematic review”.

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• Next: Managing your search results >>
• Last Updated: Jul 23, 2024 4:06 PM
• URL: https://library.cranfield.ac.uk/literature-review

Systematic reviews

• Defining your research topic
• Developing a protocol
• Finding existing systematic reviews and registration sites

Inclusion/exclusion criteria

• Conducting a comprehensive search
• Searching for grey literature
• Handsearching
• Screening your search results
• Critical appraisal
• Extracting data
• Data synthesis and meta-analysis
• Reporting your results
• Managing your citations
• Scoping reviews
• Other Systematic Review tools
• Searching health databases This link opens in a new window
• Additional support This link opens in a new window

Will you restrict by dates, study designs, populations (age, gender, ethnicity, diseases, location, psychosocial or emotional factors), languages of references, interventions, outcomes etc.? Clear eligibility criteria will make it easier to identify relevant articles at the screening stage.

The resources below may assist to better inform your decisions:

• Cochrane: Defining the criteria for including studies Chapter 3 of the Cochrane Handbook provides advice on selecting inclusion and exclusion criteria
• Designing Inclusion and Exclusion Criteria A useful article, published in 2020 by Hornberger & Rangu and available via the Scholarly Commons, University of Pennsylvania
• JBI Manual for Evidence Synthesis Provides guidance to authors for the conduct and preparation of JBI systematic reviews and evidence syntheses.
• << Previous: Finding existing systematic reviews and registration sites
• Next: Conducting a comprehensive search >>
• Last Updated: Jun 27, 2024 10:56 AM
• URL: https://libguides.adelaide.edu.au/systematicreviews

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The relationship between training load and injury risk in basketball: a systematic review.

1. Introduction

2. materials and methods, 2.1. literature search, 2.2. selection criteria, 2.3. quality assessment, 2.4. data extraction and analysis, 3.1. article identification, 3.2. description of the included articles, 3.3. definitions of injury, 3.4. measures of load, 3.5. assessment of article quality, level of evidence, and conflict of interest, 4. discussion, 4.1. load monitoring in basketball, 4.2. training and/or competition time and injury risk, 4.3. relative load, rapid changes in load, and injury risk, 4.4. minutes played per game (mpg) and injury risk, 4.5. sleep and injury risk, 4.6. competition calendar congestion and injury risk, 4.7. limitation, 4.8. practical applications and future direction, 5. conclusions, author contributions, institutional review board statement, informed consent statement, data availability statement, acknowledgments, conflicts of interest.

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Chan, C.-C.; Yung, P.S.-H.; Mok, K.-M. The Relationship between Training Load and Injury Risk in Basketball: A Systematic Review. Healthcare 2024 , 12 , 1829. https://doi.org/10.3390/healthcare12181829

Chan C-C, Yung PS-H, Mok K-M. The Relationship between Training Load and Injury Risk in Basketball: A Systematic Review. Healthcare . 2024; 12(18):1829. https://doi.org/10.3390/healthcare12181829

Chan, Chi-Chung, Patrick Shu-Hang Yung, and Kam-Ming Mok. 2024. "The Relationship between Training Load and Injury Risk in Basketball: A Systematic Review" Healthcare 12, no. 18: 1829. https://doi.org/10.3390/healthcare12181829

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• Open access
• Published: 17 September 2024

Mapping health-related quality of life of children and families receiving pediatric invasive home mechanical ventilation: a scoping review protocol

• Keisha White Makinde   ORCID: orcid.org/0000-0003-2643-1303 1 ,
• Maysara Mitchell 1 ,
• Alexandra F. Merz 1 &
• Michael Youssef 1  

Systematic Reviews volume  13 , Article number:  236 ( 2024 ) Cite this article

Metrics details

Children utilizing invasive home mechanical ventilation (administered via tracheostomy tube) receive intensive care at home without the support of trained staff typically present in an intensive care unit; within the context of worsening home nursing shortages, much of the 24/7 care burden falls to families which are likely under supported. Prior reviews have explored the quality of life of children receiving various forms of mechanical ventilation, without addressing the impact on the family. Additionally, the literature inconsistently differentiates the unique experience of families with children using invasive home mechanical ventilation from non-invasive, which has lower morbidity and mortality and requires less nursing care in the home. Therefore, our study aims to explore and map the existing literature regarding the impact of invasive home mechanical ventilation on the child and family’s quality of life. Identified gaps will inform future research focused on improving the family quality of life of children with invasive home mechanical ventilation.

Five databases will be searched using keywords and controlled vocabulary to identify relevant studies: Ovid Medline, Embase, Scopus, and Cochrane Library. English language studies will meet inclusion criteria if they include primary research studies of children or families of children utilizing invasive home mechanical ventilation at home and assess quality of life. Children and young adults aged 0–25 years will be included. We exclude studies of hospitalized children, studies focused solely on healthcare professional experiences or clinical outcomes, and those focused on the period surrounding discharge from admission for tracheostomy placement. Two independent reviewers will screen studies at the title/abstract and full-text levels. Two independent reviewers will extract data from relevant studies. Disagreements will be resolved by an independent third reviewer. A targeted grey literature search will be performed utilizing ProQuest, clinicaltrials.gov, WHO trial registry, Google Scholar, and professional societies. Findings will be presented in tables and figures along with a narrative summary.

This scoping review seeks to map the literature and provide a descriptive report of the health-related quality of life of children using invasive home mechanical ventilation and their families.

Registration

Open Science Framework https://doi.org/10.17605/OSF.IO/6GB84

Date of Registration: November 29, 2023.

Peer Review reports

The number of children with medical complexity who utilize medical technology is growing [ 1 , 2 , 3 ]. This has resulted in increased survival and longer lifespan [ 4 , 5 ]—two quality metrics frequently used to assess the quality of healthcare received. Yet, stakeholders, payors, and patient advocates have highlighted the importance of quality of life as a critical metric that should also be used to determine the success or failure of a healthcare intervention [ 6 , 7 , 8 ]. Despite this, there has been a lag in the collection of quality of life indicators and integration into metrics for high-quality healthcare, particularly for new pediatric technologies [ 7 , 9 ]. This scoping review protocol focuses on quality of life in regards to a medical technology which provides the highest level of medical life support available in the home setting—pediatric invasive home mechanical ventilation (HMV).

Home mechanical ventilation is a vital intervention for children experiencing chronic respiratory failure, promoting respiratory stability and enhanced longevity in the comfort of a child’s home. HMV has the potential to benefit children with respiratory conditions by improving alveolar ventilation, alleviating symptoms associated with chronic respiratory failure, improving blood gases, reducing morbidity and mortality, and enhancing the child’s quality of life [ 10 ]. HMV can be administered either invasively or noninvasively. Non-invasive HMV (for instance bilevel positive airway pressure (BIPAP)) provides a lower amount of breathing support and is administered via mask. Conversely, invasive ventilation provides a much higher amount of breathing support and is administered via a surgically placed tracheostomy tube which connects to the breathing machine. Originally conceived for pediatric patients with isolated spinal injury or neuromuscular conditions 11, over time the use of invasive HMV has expanded to treat children with more complex diseases and multiple comorbidities. Typical pediatric patients utilizing invasive HMV may have primary lung diseases such as chronic lung disease of prematurity [ 12 , 13 ], underlying genetic conditions such as congenital central hypoventilation syndrome [ 14 ], and cardiopulmonary disease [ 4 , 13 , 15 ]. Invasive HMV is associated with a higher risk for morbidity, frequent and high acuity readmission, and higher mortality compared with non-invasive ventilation [ 4 , 16 ]. Any sudden loss of tracheostomy patency (e.g., mucus plug, accidental tracheostomy decannulation) or loss of ventilator function (e.g., loss of power in the home, unaddressed ventilator alarms) would be imminently life threatening. Due to the tenuousness of maintaining a patent airway, the American Thoracic Society guidelines recommends that optimal care for children with invasive home mechanical ventilation requires 24/7 hands-on nursing care in the home, two trained family caregivers living in the child’s household, along with monitoring equipment and regular multidisciplinary clinic visits [ 8 ]. In reality, the extensive and unrelenting nursing shortages throughout the country [ 17 , 18 ] mean that much of the in-home care falls to parents and families creating a significant burden for which they are underprepared.

Parents of children who utilize HMV are expected to provide extensive and ongoing care for their child—administering medications, managing medical emergencies that may arise, and calling off from work when home nursing services are inaccessible. There are few studies that examine the impacts on the family for children with invasive HMV [ 19 , 20 ]. On preliminary search, available studies focus on the parent [ 19 , 21 ] with little information on siblings or how the family’s functioning is impacted. Studies of HMV (including both invasive and non-invasive) highlight that a parent’s assumption of the primary caregiver role for their ventilator-dependent child can exacerbate financial burdens [ 9 , 10 ], sleep deprivation [ 10 ], and anxiety, impacting the overall family quality of life [ 11 ]. Chan et al. and Wang and Barnard interviewed parents of children who utilize ventilators at home and expose the significant strain on personal and romantic relationships, lack of friends and supports, frequent needs to transition between parent and caregiver, and constant worry that the child might suddenly die [ 22 , 23 ]. Further complicating the situation, nearly half of parents of children with any medical technology use (ranging from nebulizers and glucose monitors to ventilators) endorse having a need for respite care within the past year, yet only half of those needing respite had their needs met, often due to lack of availability or cost [ 24 ]. Considering these are the lived experiences of families of mostly children with non-invasive ventilation, it is imperative to understand more about the family quality of life of children utilizing invasive home mechanical ventilation given its increased demands for nursing, family caregiving, and higher morbidity and mortality.

Health-related quality of life (HRQOL) is a multidimensional concept described by many scholars which can be thought of as an individual’s outlook or perspective on life and its resultant satisfaction (or dissatisfaction) given the presence of a medical condition. This perspective is grounded in the context of the individual’s culture and value systems which are related to their goals, expectations, and concerns [ 25 ]. For the purpose of this review, we focus on the health-related quality of life of children, adolescents, and young adults with invasive home mechanical ventilation. For this protocol, we focus on the following domains [ 26 , 27 ]: (1) physical functioning, (2) psychological functioning, (3) social functioning, (4) cognitive functioning, and (5) general well-being.

We use the theory of health-related family quality of life (HRFQOL) as coined by Radina et al. [ 28 ] as the unifying theory for this review; the theory (see Fig.  1 ) defines HRFQOL as the intersection between the patient’s health-related quality of life and the family’s quality of life. Health-related family quality of life (HRFQOL) comprises 3 concepts: emotional closeness, family sense of coherence, and family functioning (see Fig.  2 ). For this review, we focus on the concepts and sub-concepts delineated by Radina et al. (see Fig.  2 ).

Diagram of domains of quality of life

Conceptual model of the theory of health-related family quality of life

Family can have many definitions. For the purposes of this review, we draw upon the definition of family quality of life offered by Park et al. as “people who think of themselves as part of the family, whether related by blood or marriage or not, and who support and care for each other on a regular basis” [ 29 ].

Tracheostomy is a surgical airway management procedure whereby an incision is made in the trachea to divert the passage of air for breathing. Tracheostomy is used interchangeably with tracheotomy for the purposes of this review. Patients with a tracheostomy may breathe independently or with assistance of a ventilator. For this review, we focus on patients with tracheostomy who utilize mechanical ventilation.

Mechanical ventilation is a type of assisted breathing whereby a medical device (i.e., ventilator) is used to fully or partially provide artificial ventilation. Practically, the support can be positive pressure ventilation (pressure-supported ventilation or bilevel positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP). For this review, we focus on any level of mechanical ventilation that is administered through a tracheostomy. Patients with isolated oxygen use without ventilator support will be excluded. Invasive mechanical ventilation refers to ventilation delivered through a breathing tube—an endotracheal tube or tracheostomy tube. For the purpose of this review, we focus solely on invasive mechanical ventilation delivered via tracheostomy tube.

We define home as a location where the patient primarily lives with family. We exclude long-term care facilities in the definition of home for this study.

A preliminary search of PROSPERO, MEDLINE, the Cochrane Database of Systematic Reviews, and JBI Evidence Synthesis was conducted, and no current or in-progress scoping reviews or systematic reviews on this specific topic of interest. Mattson et al. [ 30 ] recently published a scoping review focused on quality of life of children with home mechanical ventilation; although informative, this review does not differentiate the experience of children living with invasive mechanical ventilation and their families. Our scoping review differs in two key ways. First, we focus on the family’s quality of life instead of the child’s quality of life. Secondly, we spotlight the experiences of children with invasive home mechanical ventilation, given their increased medically fragility, requisite home nursing needs, and higher risk of morbidity and mortality. Additionally, our review is strengthened by the use of a framework definition of health-related family quality of life from Radina et al. [ 28 ]which extends our focus beyond the challenges faced by parents to include the impact on the entire family unity, including siblings and extended family. By utilizing this approach and definition, we have preliminarily identified additional studies meeting our criteria which were not included in the review conducted by Mattson and colleagues, underscoring the differences in our search and screening approaches.

The existing literature predominantly focuses on mortality rates and medical outcomes of children utilizing HMV, with limited attention to the vital issue of family quality of life; though it is significantly impacted when intensive medical care is introduced in the home environment [ 31 ]. In addition to the few studies available, even fewer focus on family-level quality of life indicators or experiences of families with medically complex children. While previous scoping reviews have explored these concepts separately, no scoping review has reviewed both the health-related quality of life of the pediatric patient as well as the family quality of life of the overall family unit. Additionally, we aim to provide an updated overview of the literature, given the most recent scoping reviews assessed studies through 2020 [ 30 , 32 ].

The primary objective of this scoping review is to comprehensively map the existing literature on pediatric invasive mechanical ventilation in the home environment to understand the child’s health-related quality of life (HRQOL) and the health-related family quality of life (HRFQOL).

Authors will utilize the JBI Manual for Evidence Synthesis Chapter 11 entitled “Scoping Reviews” as a guideline for rigorous procedures [ 33 ]. Authors will utilize the Preferred Reporting Items for Systematic Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) as a guideline for reporting the findings of the scoping review [ 34 ].

This review will consider primary studies that include pediatric patients (0–25 years) who utilize invasive HMV, as well as the experiences of their family members. Furthermore, this review will consider studies that explore (1) the relationship between pediatric invasive HMV and health-related family quality of life (HRFQOL), (2) the relationship between pediatric invasive HMV and health-related quality of life (HRQOL) among children, adolescents, and young adults and their families, and (3) studies that address the experiences of children who utilize home mechanical ventilation with a tracheostomy. Studies must be published in English from 2004 to 2024 to meet inclusion criteria. This review will consider studies that explore the presence of invasive mechanical ventilation in the home environment. Studies that address the presence of invasive mechanical ventilation in the healthcare setting or within long-term care facilities will not be included. This scoping review will consider quantitative, qualitative, and mixed methods study designs for inclusion.

The search strategy will aim to locate published primary studies and grey literature, excluding reviews, and text and opinion papers. An initial limited search of the literature was undertaken by the medical librarian to identify studies on the topic. The text words contained in the titles and abstracts of relevant studies, and the index terms used to describe the studies, were used to develop an initial search strategy for Embase. The search strategy, including all identified keywords and index terms, will be adapted for each included information source. The initial search strategy will be piloted and adapted in partnership with the medical librarian to develop the final search strategy (see Appendix 1). Studies published in an English publication between 2004 and 2024 will be included. The databases to be searched include Ovid Medline 1946-, Embase.com 1947-, Scopus 1823-, and Cochrane Library 1996-.

Following the search, all identified records will be collated and uploaded into Endnote v.21 (Clarivate Analytics, PA, USA) and Covidence (Veritas Health Innovation, Melbourne, Australia), and duplicates removed. Covidence will be used to screen and manage the results of the scoping review to optimize collaboration and thoroughness among the research team. Pilot testing of source selection will be conducted prior to screening. The primary investigator will select a random sample ( n  = 20) of studies, which will be independently reviewed by all reviewers. Reviewers will screen the titles and abstracts using the inclusion and exclusion criteria provided in Covidence. After all pilot studies have been reviewed, reviewers will meet to discuss inter-rater reliability. If reliability is > 75%, reviewers will proceed with Screening. If reliability does not reach 75%, reviewers will have an in-depth discussion regarding discrepancies. Inclusion and exclusion criteria will be modified to meet newly shared understanding. Then reviewers will separately pilot the revised criteria. The formal screening will proceed once 75% agreement is reached.

During screening, titles and abstracts will be assessed by 2 independent reviewers against the inclusion criteria. Reviewers 1 and 2 will independently assess the title and abstract of each article using Covidence’s title and abstract screening feature. If there is disagreement among Reviewers 1 and 2, Reviewer 3—the primary investigator—will review the title and abstract to make the final determination on the article’s eligibility. To ensure fidelity to protocol, the primary investigator will provide oversight and review a random selection of screenings completed by Reviewers 1 and 2 to confirm adherence to review protocol. Potentially relevant papers will be retrieved in full and imported into Covidence.

During full-text review, the full text of selected citations will be assessed in detail against the inclusion criteria by 2 independent reviewers. Reasons for exclusion of full-text papers that do not meet the inclusion criteria will be recorded and reported in Covidence. Any disagreements that arise between the reviewers at each stage of the selection process will be resolved through discussion or with a third reviewer. The results of the search will be reported in full in the final scoping review and presented in a PRISMA flow diagram [ 21 ]. To ensure fidelity to protocol, the primary investigator will provide oversight and review a random selection of full texts completed by Reviewers 1 and 2 to confirm adherence to review protocol.

Several sources will be used to inform the grey literature search, which will be an adaptation of methods described by Godin et al. 35 . Utilizing keywords identified previously, we will search ProQuest Dissertations & Theses, National Library of Medicine clinical trials registry (clinicaltrials.gov), World Health Organization International Clinical Trials Registry Platform (trialsearch.who.int), Google Scholar, and relevant professional societies to identify clinical guidelines, dissertations and thesis, reports, and other findings from organizations that fit the inclusion criteria for this scoping review. The intention remains to identify and map the scientific literature and consensus statements from reputable sources while excluding sources with individualistic viewpoints, such as social media and blog postings.

Prior to the start of data extraction, the data extraction instrument will be pilot tested on 3 sources to ensure all relevant results are consistently extracted. Each reviewer will read the pilot studies and extract data using the extraction instrument in Covidence. Team members will then meet to discuss discrepancies, offer clarification, and make any modifications to the extraction instrument. Extraction will begin once consensus on the extraction instrument is reached.

Data will be extracted from papers included in the scoping review by 2 independent reviewers using a data extraction tool developed by the reviewers (see Appendix 2). The data extracted will include specific details about the population, concept, context, methods, and key findings, relevant to the review question. A draft extraction tool is provided (see Appendix 2). The draft data extraction tool will be modified and revised as necessary during the process of extracting data from each included paper. Modifications will be detailed in the full scoping review. Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer. Authors of papers will be contacted to request missing or additional data, where required.

We will first present a flow diagram of our scoping review methodology including the study selection process. Extracted data will be analyzed using figures and tables, frequency counts of concepts, populations, and study characteristics. Then, we will utilize a table to present an overview of study characteristics including year, country, participant characteristics, and methodology. Lastly, we will present in a table an overview of themes and concepts elicited in the included studies.

This scoping review has begun and is in the data selection phase at submission. Inclusion and exclusion criteria were revised following screening. Notably, we exclude conference abstracts; although these are often published in peer-reviewed journals, they many times do not include thorough details of the data and results to allow us to extract findings with confidence that they represent the true and full findings of the primary research. Additionally, conference abstracts often presented preliminary results which may have changed following the abstract acceptance. We conducted a search using the abstract first author to determine if a manuscript was available; none of our conference abstracts had corresponding manuscripts and thus were excluded. We also had several clinical trial registrations returned in our search protocol; these registrations were excluded from review; however, the authors contacted the clinical trial primary investigator to ascertain if the study had concluded and if a published manuscript was available; if manuscripts become available in the process, we will add them to title/abstract screening and perform screening consistent with the full protocol.

Availability of data and materials

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Abbreviations

Bilevel positive airway pressure

Continuous positive airway pressure

Health-related quality of life

Health-related family quality of life

Home mechanical ventilation

Preferred Reporting Items for Systematic Meta-Analyses extension for Scoping Reviews

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Keisha White Makinde, Maysara Mitchell, Alexandra F. Merz & Michael Youssef

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Keisha White Makinde participated in the conception and design of this protocol, drafting and revision of manuscript, and approval of final version. Maysara Mitchell participated in the conception and design of this protocol, drafting and revision of manuscript, and approval of final version. Alexandra Merz participated in the design of this protocol, revision of manuscript, and approval of final version. Michael Youssef participated in the design of this protocol, revision of manuscript, and approval of final version.

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Dr. KWM is a pediatric hospice and palliative medicine physician-scientist interested in understanding racial and ethnic health disparities and promoting health equity in patients facing serious illness. Dr. KWM has extensive educational background focused on the biopsychosocial experiences of individuals with illness, including a bachelor’s degree in Sociology and Medicine, Health, and Society and Master of Public Health. As an attending physician, Dr. KWM cares for children with serious illness including children who utilize home mechanical ventilation seen at St. Louis Children’s Hospital with a focus on interdisciplinary, family-centered, holistic care.

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Appendix 1 Search strategy

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White Makinde, K., Mitchell, M., Merz, A.F. et al. Mapping health-related quality of life of children and families receiving pediatric invasive home mechanical ventilation: a scoping review protocol. Syst Rev 13 , 236 (2024). https://doi.org/10.1186/s13643-024-02658-2

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• Published: 17 September 2024

Reporting nasal pressure injuries in neonates receiving non-invasive ventilation: a scoping review

• Alexander E. Graf   ORCID: orcid.org/0000-0001-7749-1301 1 ,
• Simon Bellido 2 ,
• Chellapriya Vythinathan 3 ,
• Jigar Govind 1 ,
• Lawrence Fordjour 4 ,
• Sydney C. Butts 1 &
• Ann Woodhouse Plum 1  

Journal of Perinatology ( 2024 ) Cite this article

Metrics details

• Physical examination
• Risk factors
• Signs and symptoms

Background/Objectives

Although neonates receiving Non-Invasive Ventilation (NIV) for respiratory support are at risk for nasal pressure injuries, efforts to standardize reporting are limited. A scoping review was conducted to identify the reporting systems used for describing these injuries.

Subjects/Methods

PubMed, Embase, and Web of Science were queried for papers reporting nasal injury with NIV usage in neonates. The primary outcome was reporting system usage.

705 titles and abstracts were screened. 40 papers met inclusion criteria. Most studies were Randomized Clinical Trials (37.5%) or cohort studies (37.5%). Most commonly, nasal injuries were reported using a unique, descriptive scale developed by the authors (10 studies, 25%). The Fischer et al 2010 scale, a three-stage reporting system, was used in 8 studies (20%). While 15 studies (38.0%) reported on specific anatomic subsite injury, only 2 studies (5.0%) employed endoscopy for assessment.

Conclusions

Wide heterogeneity in pressure injury reporting secondary to NIV exists across specialties, institutions, and literature.

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Department of Otolaryngology-Head and Neck Surgery, SUNY Downstate Health Sciences University, Brooklyn, NY, USA

Alexander E. Graf, Jigar Govind, Sydney C. Butts & Ann Woodhouse Plum

College of Medicine, SUNY Downstate Health Sciences University, Brooklyn, NY, USA

Simon Bellido

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Chellapriya Vythinathan

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Alexander E. Graf: design, conduct, analysis, manuscript writing, approved final version, accountable for all work. Simon Bellido: design, conduct, analysis, manuscript writing, approved final version, accountable for all work. Jigar Govind: design, conduct, analysis, manuscript writing, approved final version, accountable for all work. Chellapriya Vythinathan: design, conduct, analysis, manuscript writing, approved final version, accountable for all work. Lawrence Fordjour: design, analysis, manuscript revision, approved final version, accountable for all work. Sydney Butts: design, analysis, manuscript revision, approved final version, accountable for all work. Ann Plum: design, conduct, analysis, manuscript revision, approved final version, accountable for all work.

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Graf, A.E., Bellido, S., Vythinathan, C. et al. Reporting nasal pressure injuries in neonates receiving non-invasive ventilation: a scoping review. J Perinatol (2024). https://doi.org/10.1038/s41372-024-02006-1

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DOI : https://doi.org/10.1038/s41372-024-02006-1

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The role of women and the obstacles to biodiversity conservation in developed and developing countries

• Published: 16 September 2024

Cite this article

• Helyone Sarita das Mercês Lima   ORCID: orcid.org/0000-0003-4866-7528 1 &
• Helenilza Ferreira Albuquerque Cunha   ORCID: orcid.org/0000-0001-7101-9305 1  

Women play several significant roles in biodiversity conservation, be they linked to conservation’s main activities or decision-making. However, there are countless barriers and disparities capable of affecting the performance of their roles. From this perspective, this study aimed to investigate and compare the roles played by women in the conservation and management of biodiversity. Additionally, it sought to evaluate the obstacles and disparities they face in this process, focusing on both developed and developing countries. We carried out a systematic review of the literature, using the PRISMA Protocol to avoid biased data. We reviewed 400 articles. However, only 73 articles were included in this study, as they met the inclusion criteria. We used the Discursive Textual Analysis method to identify the categories of roles and obstacles found in the articles. We have identified 8 categories of roles played by women in biodiversity conservation and 11 obstacles/difficulties faced by them to perform their role. Developed countries did not show conservation’s main activities, only environmental governance categories, biodiversity management, and others (environmentalist movements). Concerning developing countries, ‘management of natural resources’ was the most cited category in the analyzed studies. There were several main activities related to agriculture in developing countries, mainly agroecology, sustainable agriculture, and agrobiodiversity. Developed countries stood out for double shifts, lack of public policies, lack of financing, gender discrimination, cross-sectional factors, and climatic skepticism, as obstacles to biodiversity conservation. We have concluded that there are differences in the roles played by women in developed and developing countries. We understood that the cross-sectional factors, that is, factors that encompass ethnicity, race, age, geographic location, gender, religion, sexual orientation, and/or the condition of a person with a disability, were the most observed obstacle/difficulty in both developing and developed countries.

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The entire dataset supporting the results of this study is available on request from the corresponding author: Name of corresponding author: Helenilza Ferreira Albuquerque Cunha Reason for restriction: the authors understand that they can make the data available upon request, as it would be important for the authors to know the purpose of using these data.

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We are grateful to Programa de Pós-Graduação em Biodiversidade Tropical (PPGBIO) and to PROPESPg of Federal University of Amapá.

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Lima, H.S.M., Cunha, H.F.A. The role of women and the obstacles to biodiversity conservation in developed and developing countries. Environ Dev Sustain (2024). https://doi.org/10.1007/s10668-024-05407-6

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