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
[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"]
| # | Name | Affiliation | Role | Contact |
|---|---|---|---|---|
| 1 | [Name] | [Institution] | Guarantor / Lead | [email] |
| 2 | [Name] | [Institution] | Co-reviewer | [email] |
| Date | Section Changed | Description of Change | Rationale |
|---|---|---|---|
| [date] | [section] | [change] | [why] |
Sources: [Funding source(s) or "No external funding"] Role of funder: [Describe any role of funders in the review, or "None"]
[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 (e.g., existing reviews are outdated, conflicting evidence, no previous review exists)
[Provide an explicit statement of the question(s) the review will address. Use the PICOS framework.]
Research Question: [State the review question in a single sentence]
| Criterion | Include | Exclude |
|---|---|---|
| Study design | [e.g., RCTs, quasi-experimental, cohort] | [e.g., case reports, editorials, commentaries] |
| Publication date | [e.g., 2010-present] | [Before cutoff, with justification] |
| Language | [e.g., English and Chinese] | [Other languages, with justification] |
| Publication status | [e.g., published and preprints] | [e.g., conference abstracts only] |
| Setting | [e.g., higher education institutions] | [e.g., K-12, non-formal education] |
[Describe the target population in detail. Include age, gender, condition, or other relevant characteristics.]
[Describe the intervention(s) or exposure(s) of interest. Include dosage, frequency, duration if applicable.]
[Describe the comparator(s). This may include no intervention, usual care, placebo, or alternative interventions.]
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)]
[Specify any minimum follow-up duration or time constraints]
| Database/Source | URL | Coverage | Justification |
|---|---|---|---|
| [e.g., PubMed/MEDLINE] | pubmed.ncbi.nlm.nih.gov | Biomedical | Core database for health research |
| [e.g., Web of Science] | webofscience.com | Multidisciplinary | Citation indexing, broad coverage |
| [e.g., Scopus] | scopus.com | Multidisciplinary | Large abstract database |
| [e.g., ERIC] | eric.ed.gov | Education | Core database for education research |
| [e.g., PsycINFO] | apa.org/pubs/databases/psycinfo | Psychology | Behavioral science coverage |
| [Grey literature] | [specify sources] | — | Reduce publication bias |
| [Trial registries] | clinicaltrials.gov, WHO ICTRP | — | Identify unpublished studies |
Additional sources: - Reference lists of included studies (backward citation) - Citation tracking of key studies (forward citation) - Contact with experts in the field (if applicable)
[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]
[Describe the software/tools to be used for managing records. E.g., Covidence, Rayyan, Excel, Zotero]
Pilot: [Describe pilot testing of screening criteria, e.g., "Two reviewers will independently screen 50 records to calibrate criteria before full screening"]
| Category | Variables to Extract |
|---|---|
| Study metadata | Authors, year, country, journal, study design |
| Participants | Sample size, demographics, setting, inclusion criteria |
| Intervention/Exposure | Description, duration, frequency, comparison group |
| Outcomes | Primary and secondary outcomes, measurement tools, time points |
| Results | Effect sizes, CIs, p-values, means, SDs, counts |
| Quality | Funding, COI declarations, registration status |
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]
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]
When meta-analysis is not feasible: [Describe the narrative synthesis approach, e.g., SWiM reporting guideline, vote counting, effect direction plot]
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]
Framework: GRADE (Grading of Recommendations, Assessment, Development and Evaluations)
[Describe how GRADE will be applied to assess certainty for each outcome]
[Complete search strategy for the primary database]
[Include or reference the data extraction form]
[Mark each PRISMA-P item as addressed with the relevant page/section number]
| Version | Date | Author | Changes |
|---|---|---|---|
| 1.0 | [date] | [name] | Initial protocol |