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249 lines
8.8 KiB
Markdown
# PRISMA-P 2015 — Systematic Review Protocol Template
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## Purpose
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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.
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**Reference**: Shamseer et al. (2015). BMJ, 349, g7647. https://doi.org/10.1136/bmj.g7647
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---
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## ADMINISTRATIVE INFORMATION
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### Title
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**[Provide a descriptive title that identifies the report as a protocol for a systematic review. Include "systematic review" and "meta-analysis" if applicable.]**
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Registration: [PROSPERO / OSF ID, or "To be registered"]
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### Authors
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| # | Name | Affiliation | Role | Contact |
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|---|------|-------------|------|---------|
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| 1 | [Name] | [Institution] | Guarantor / Lead | [email] |
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| 2 | [Name] | [Institution] | Co-reviewer | [email] |
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### Amendments
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| Date | Section Changed | Description of Change | Rationale |
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|------|----------------|----------------------|-----------|
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| [date] | [section] | [change] | [why] |
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### Support
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**Sources**: [Funding source(s) or "No external funding"]
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**Role of funder**: [Describe any role of funders in the review, or "None"]
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---
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## INTRODUCTION
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### Rationale
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**[Describe the rationale for the review in the context of what is already known. Explain why this review is needed.]**
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Key points to address:
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- What is the health/education/social problem?
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- What is the current state of the evidence?
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- Why is a systematic review needed now? (e.g., existing reviews are outdated, conflicting evidence, no previous review exists)
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### Objectives
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**[Provide an explicit statement of the question(s) the review will address. Use the PICOS framework.]**
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- **P** (Population): [Define the target population]
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- **I** (Intervention/Exposure): [Define the intervention or exposure of interest]
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- **C** (Comparator): [Define the comparison group]
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- **O** (Outcomes): [Define primary and secondary outcomes]
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- **S** (Study design): [Specify eligible study designs]
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Research Question: [State the review question in a single sentence]
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---
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## METHODS
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### Eligibility Criteria
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#### Study Characteristics
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| Criterion | Include | Exclude |
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|-----------|---------|---------|
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| **Study design** | [e.g., RCTs, quasi-experimental, cohort] | [e.g., case reports, editorials, commentaries] |
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| **Publication date** | [e.g., 2010-present] | [Before cutoff, with justification] |
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| **Language** | [e.g., English and Chinese] | [Other languages, with justification] |
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| **Publication status** | [e.g., published and preprints] | [e.g., conference abstracts only] |
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| **Setting** | [e.g., higher education institutions] | [e.g., K-12, non-formal education] |
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#### Participants
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[Describe the target population in detail. Include age, gender, condition, or other relevant characteristics.]
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#### Interventions/Exposures
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[Describe the intervention(s) or exposure(s) of interest. Include dosage, frequency, duration if applicable.]
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#### Comparators
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[Describe the comparator(s). This may include no intervention, usual care, placebo, or alternative interventions.]
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#### Outcomes
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**Primary outcome(s)**:
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1. [Outcome 1] — measured by [instrument/method], at [time point(s)]
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2. [Outcome 2] — measured by [instrument/method], at [time point(s)]
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**Secondary outcome(s)**:
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1. [Outcome 3] — measured by [instrument/method], at [time point(s)]
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2. [Outcome 4] — measured by [instrument/method], at [time point(s)]
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#### Timing
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[Specify any minimum follow-up duration or time constraints]
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### Information Sources
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| Database/Source | URL | Coverage | Justification |
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|----------------|-----|----------|---------------|
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| [e.g., PubMed/MEDLINE] | pubmed.ncbi.nlm.nih.gov | Biomedical | Core database for health research |
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| [e.g., Web of Science] | webofscience.com | Multidisciplinary | Citation indexing, broad coverage |
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| [e.g., Scopus] | scopus.com | Multidisciplinary | Large abstract database |
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| [e.g., ERIC] | eric.ed.gov | Education | Core database for education research |
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| [e.g., PsycINFO] | apa.org/pubs/databases/psycinfo | Psychology | Behavioral science coverage |
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| [Grey literature] | [specify sources] | — | Reduce publication bias |
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| [Trial registries] | clinicaltrials.gov, WHO ICTRP | — | Identify unpublished studies |
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Additional sources:
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- Reference lists of included studies (backward citation)
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- Citation tracking of key studies (forward citation)
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- Contact with experts in the field (if applicable)
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### Search Strategy
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**[Present the draft search strategy for at least one database. The strategy should be peer-reviewed using the PRESS checklist.]**
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Example structure for [primary database]:
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```
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Search Block 1 (Population):
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"higher education" OR "university" OR "college" OR "postsecondary"
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Search Block 2 (Intervention/Exposure):
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"quality assurance" OR "accreditation" OR "program review"
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Search Block 3 (Outcome):
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"student outcomes" OR "learning outcomes" OR "graduation rate"
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Combined: Block 1 AND Block 2 AND Block 3
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Filters: [date range], [language], [document type]
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```
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### Study Records
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#### Data Management
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[Describe the software/tools to be used for managing records. E.g., Covidence, Rayyan, Excel, Zotero]
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#### Selection Process
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1. **Deduplication**: [Method for removing duplicates, e.g., automatic in Covidence + manual check]
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2. **Title/Abstract screening**: [Number of reviewers, independence, process for resolving disagreements]
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3. **Full-text screening**: [Number of reviewers, independence, process for resolving disagreements]
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4. **Documentation**: [How excluded studies and reasons will be recorded]
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Pilot: [Describe pilot testing of screening criteria, e.g., "Two reviewers will independently screen 50 records to calibrate criteria before full screening"]
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#### Data Collection Process
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1. **Data extraction form**: [Describe or attach the form. Pilot test with 3-5 studies]
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2. **Extractors**: [Number, independence, process for resolving discrepancies]
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3. **Missing data**: [How missing or unclear data will be handled, e.g., contact authors]
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### Data Items
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| Category | Variables to Extract |
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|----------|---------------------|
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| **Study metadata** | Authors, year, country, journal, study design |
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| **Participants** | Sample size, demographics, setting, inclusion criteria |
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| **Intervention/Exposure** | Description, duration, frequency, comparison group |
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| **Outcomes** | Primary and secondary outcomes, measurement tools, time points |
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| **Results** | Effect sizes, CIs, p-values, means, SDs, counts |
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| **Quality** | Funding, COI declarations, registration status |
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### Risk of Bias Assessment
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**Tool**: [Specify the tool]
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- RCTs: RoB 2 (Sterne et al., 2019)
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- Non-randomized studies: ROBINS-I (Sterne et al., 2016)
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- Qualitative studies: [e.g., CASP qualitative checklist]
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**Process**: [Number of assessors, independence, consensus process]
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**Use in synthesis**: [How risk of bias results will inform the synthesis, e.g., sensitivity analysis excluding high-risk studies]
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### Data Synthesis
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#### Quantitative Synthesis (Meta-Analysis)
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**Conditions for meta-analysis**: [Describe when studies will be pooled, e.g., "When ≥ 3 studies report sufficiently similar outcomes measured in comparable populations"]
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**Effect measure**: [Specify, e.g., SMD for continuous outcomes, RR for binary outcomes]
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**Model**: [Fixed-effect / Random-effects, with justification]
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**Heterogeneity assessment**:
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- Q-test (significance at p < 0.10)
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- I² statistic with 95% CI
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- tau² (between-study variance)
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- Prediction interval
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**Subgroup analyses** (pre-specified):
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1. [Subgroup variable 1] — Rationale: [why]
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2. [Subgroup variable 2] — Rationale: [why]
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**Sensitivity analyses**:
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1. Leave-one-out analysis
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2. Exclude high risk of bias studies
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3. [Other planned sensitivity analyses]
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**Software**: [Specify, e.g., R metafor package, RevMan]
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#### Narrative Synthesis
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**When meta-analysis is not feasible**: [Describe the narrative synthesis approach, e.g., SWiM reporting guideline, vote counting, effect direction plot]
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### Meta-Bias Assessment
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**Publication bias**: [Methods to assess, e.g., funnel plot + Egger's test if ≥ 10 studies]
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**Selective reporting**: [How to detect, e.g., compare protocol to published report, search trial registries]
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### Confidence in Cumulative Evidence
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**Framework**: GRADE (Grading of Recommendations, Assessment, Development and Evaluations)
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[Describe how GRADE will be applied to assess certainty for each outcome]
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---
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## APPENDICES
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### Appendix A: Draft Search Strategy
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[Complete search strategy for the primary database]
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### Appendix B: Data Extraction Form
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[Include or reference the data extraction form]
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### Appendix C: PRISMA-P Checklist
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[Mark each PRISMA-P item as addressed with the relevant page/section number]
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---
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## Revision Log
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| Version | Date | Author | Changes |
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|---------|------|--------|---------|
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| 1.0 | [date] | [name] | Initial protocol |
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