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PRISMA-P 2015 — Systematic Review Protocol Template

Purpose

Template for writing a systematic review protocol following PRISMA-P 2015 (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols). Complete this template before starting the literature search and register it on PROSPERO or OSF.

Reference: Shamseer et al. (2015). BMJ, 349, g7647. https://doi.org/10.1136/bmj.g7647

ADMINISTRATIVE INFORMATION

Title

[Provide a descriptive title that identifies the report as a protocol for a systematic review. Include "systematic review" and "meta-analysis" if applicable.]

Registration: [PROSPERO / OSF ID, or "To be registered"]

Authors

Amendments

Support

Sources: [Funding source(s) or "No external funding"] Role of funder: [Describe any role of funders in the review, or "None"]

INTRODUCTION

Rationale

[Describe the rationale for the review in the context of what is already known. Explain why this review is needed.]

Key points to address:

• What is the health/education/social problem?
• What is the current state of the evidence?
• Why is a systematic review needed now? (e.g., existing reviews are outdated, conflicting evidence, no previous review exists)

Objectives

[Provide an explicit statement of the question(s) the review will address. Use the PICOS framework.]

• P (Population): [Define the target population]
• I (Intervention/Exposure): [Define the intervention or exposure of interest]
• C (Comparator): [Define the comparison group]
• O (Outcomes): [Define primary and secondary outcomes]
• S (Study design): [Specify eligible study designs]

Research Question: [State the review question in a single sentence]

METHODS

Eligibility Criteria

Study Characteristics

Participants

[Describe the target population in detail. Include age, gender, condition, or other relevant characteristics.]

Interventions/Exposures

[Describe the intervention(s) or exposure(s) of interest. Include dosage, frequency, duration if applicable.]

Comparators

[Describe the comparator(s). This may include no intervention, usual care, placebo, or alternative interventions.]

Outcomes

Primary outcome(s):

1. [Outcome 1] — measured by [instrument/method], at [time point(s)]
2. [Outcome 2] — measured by [instrument/method], at [time point(s)]

Secondary outcome(s):

1. [Outcome 3] — measured by [instrument/method], at [time point(s)]
2. [Outcome 4] — measured by [instrument/method], at [time point(s)]

Timing

[Specify any minimum follow-up duration or time constraints]

Information Sources

Additional sources:

• Reference lists of included studies (backward citation)
• Citation tracking of key studies (forward citation)
• Contact with experts in the field (if applicable)

Search Strategy

[Present the draft search strategy for at least one database. The strategy should be peer-reviewed using the PRESS checklist.]

Example structure for [primary database]:

Search Block 1 (Population):
  "higher education" OR "university" OR "college" OR "postsecondary"

Search Block 2 (Intervention/Exposure):
  "quality assurance" OR "accreditation" OR "program review"

Search Block 3 (Outcome):
  "student outcomes" OR "learning outcomes" OR "graduation rate"

Combined: Block 1 AND Block 2 AND Block 3
Filters: [date range], [language], [document type]

Study Records

Data Management

[Describe the software/tools to be used for managing records. E.g., Covidence, Rayyan, Excel, Zotero]

Selection Process

1. Deduplication: [Method for removing duplicates, e.g., automatic in Covidence + manual check]
2. Title/Abstract screening: [Number of reviewers, independence, process for resolving disagreements]
3. Full-text screening: [Number of reviewers, independence, process for resolving disagreements]
4. Documentation: [How excluded studies and reasons will be recorded]

Pilot: [Describe pilot testing of screening criteria, e.g., "Two reviewers will independently screen 50 records to calibrate criteria before full screening"]

Data Collection Process

1. Data extraction form: [Describe or attach the form. Pilot test with 3-5 studies]
2. Extractors: [Number, independence, process for resolving discrepancies]
3. Missing data: [How missing or unclear data will be handled, e.g., contact authors]

Data Items

Risk of Bias Assessment

Tool: [Specify the tool]

• RCTs: RoB 2 (Sterne et al., 2019)
• Non-randomized studies: ROBINS-I (Sterne et al., 2016)
• Qualitative studies: [e.g., CASP qualitative checklist]

Process: [Number of assessors, independence, consensus process]

Use in synthesis: [How risk of bias results will inform the synthesis, e.g., sensitivity analysis excluding high-risk studies]

Data Synthesis

Quantitative Synthesis (Meta-Analysis)

Conditions for meta-analysis: [Describe when studies will be pooled, e.g., "When ≥ 3 studies report sufficiently similar outcomes measured in comparable populations"]

Effect measure: [Specify, e.g., SMD for continuous outcomes, RR for binary outcomes]

Model: [Fixed-effect / Random-effects, with justification]

Heterogeneity assessment:

• Q-test (significance at p < 0.10)
• I² statistic with 95% CI
• tau² (between-study variance)
• Prediction interval

Subgroup analyses (pre-specified):

1. [Subgroup variable 1] — Rationale: [why]
2. [Subgroup variable 2] — Rationale: [why]

Sensitivity analyses:

1. Leave-one-out analysis
2. Exclude high risk of bias studies
3. [Other planned sensitivity analyses]

Software: [Specify, e.g., R metafor package, RevMan]

Narrative Synthesis

When meta-analysis is not feasible: [Describe the narrative synthesis approach, e.g., SWiM reporting guideline, vote counting, effect direction plot]

Meta-Bias Assessment

Publication bias: [Methods to assess, e.g., funnel plot + Egger's test if ≥ 10 studies]

Selective reporting: [How to detect, e.g., compare protocol to published report, search trial registries]

Confidence in Cumulative Evidence

Framework: GRADE (Grading of Recommendations, Assessment, Development and Evaluations)

[Describe how GRADE will be applied to assess certainty for each outcome]

APPENDICES

Appendix A: Draft Search Strategy

[Complete search strategy for the primary database]

Appendix B: Data Extraction Form

[Include or reference the data extraction form]

Appendix C: PRISMA-P Checklist

[Mark each PRISMA-P item as addressed with the relevant page/section number]

Revision Log