How to Develop Inclusion/Exclusion Criteria for a Systematic Literature Review or Meta-Analysis, With Examples


Eligibility criteria or inclusion/exclusion criteria in a systematic literature review refer to the specific criteria used to determine which studies are included or excluded from the review. These criteria help ensure that the selected studies are relevant to the research question and meet certain methodological standards. Eligibility criteria typically address key aspects of the study, including the population, intervention or exposure, comparison, outcomes, study design, and publication characteristics.

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Importance of Well-Defined Inclusion/Exclusion Criteria in Systematic Literature Reviews and Meta-Analyses

Eligibility criteria play a crucial role in a systematic review for several reasons:

  • Focus and Relevance: By defining clear eligibility criteria, researchers ensure that the included studies are relevant to the research question and objectives of the review. This helps maintain focus and prevents the inclusion of irrelevant studies that do not contribute to the review’s objectives.
  • Minimizing Bias: Eligibility criteria help minimize selection bias by establishing objective criteria for the inclusion and exclusion of studies. By applying predefined criteria consistently, researchers reduce the risk of subjective judgment influencing study selection, thus enhancing the reliability and validity of the review findings.
  • Standardization: Establishing eligibility criteria promotes standardization in the study selection process. By providing clear guidelines for study inclusion and exclusion, researchers ensure consistency across reviewers and reduce variability in study selection decisions, thereby enhancing the reproducibility of the review.
  • Transparency: Clearly defining eligibility criteria enhances the transparency of the review process. By documenting the criteria used to select studies, researchers enable readers to understand how studies were identified and selected for inclusion, facilitating the evaluation and interpretation of the review findings.
  • Efficiency: Eligibility criteria help researchers efficiently screen and select studies for inclusion in the review. By focusing on studies that meet predefined criteria, researchers can streamline the study selection process and allocate resources more effectively, saving time and effort in the review process.
  • Ethical Considerations: Eligibility criteria can also incorporate ethical considerations, such as the protection of human subjects or the use of appropriate research methods. By excluding studies that do not meet ethical standards or fail to uphold methodological rigor, researchers uphold ethical principles and maintain the integrity of the review.

Major Components of Inclusion/Exclusion Criteria in a Literature Search

By defining these components of eligibility criteria, researchers can systematically identify and select studies that meet the predefined criteria and contribute relevant evidence to the systematic review. These criteria help ensure the focus, relevance, and quality of the included studies, ultimately enhancing the validity and reliability of the review findings.

Here is a breakdown of each component:

  • Population: Specifies the characteristics of the participants or subjects included in the study, such as age, gender, clinical diagnosis (e.g., type 2 diabetes mellitus), or other relevant demographic or clinical factors.
  • Intervention or Exposure: Describes the specific intervention, exposure, or independent variable of interest being evaluated in the study (e.g., nurse-led educational interventions).
  • Comparison: Indicates whether the study includes a comparison group or control condition against which the intervention or exposure is evaluated (e.g., standard care or usual care).
  • Outcomes: Identifies the primary and secondary outcomes of interest that the study aims to measure or evaluate (e.g., improvement in self-management behaviors and glycemic control).
  • Study Design: Specifies the type of study design or methodology used in the study (e.g., randomized controlled trial, cohort study, quasi-experimental study). Systematic reviews often include specific study designs deemed to provide the highest level of evidence (e.g., randomized controlled trials for intervention effectiveness).
  • Publication Characteristics: Includes criteria related to the publication status (e.g., peer-reviewed journals), language of publication, and publication date range.

You are required to define your eligibility criteria before conducting the literature search, and are based on the research question and objectives of the systematic review. They serve to ensure that the selected studies are relevant, valid, and appropriate for addressing the research question and contribute to the overall quality and rigor of the review process.

Example of Inclusion/Exclusion Criteria in a Systematic Review

If a research question of your systematic review was:

Among patients with type 2 diabetes mellitus, what is the effectiveness of nurse-led educational interventions compared to standard care in improving self-management behaviors and glycemic control?

Then this is a good example of a well-defined eligibility criteria for your systematic review:

Example of inclusion/exclusion criteria in a nursing systematic literature review

These criteria are tailored to your specific research question and aim to ensure that the selected studies are relevant, methodologically sound, and contribute to answering the research question effectively. Adjustments to these criteria may be made based on the available literature, the research question, and the specific objectives of your systematic literature review.

Dr. Robertson Prime, Research Fellow
Dr. Robertson Prime, Research Fellow