# Systematic Review Protocol Template

<!--
Usage: Complete this protocol before beginning your systematic review.
Based on: PRISMA-P 2015 guidelines for systematic review protocols.
Register at: PROSPERO (https://www.crd.york.ac.uk/prospero/) or OSF (https://osf.io/)
Save to: RESEARCH/[topic]/protocol.md
-->

# Systematic Review Protocol

## Review Title

[Full descriptive title identifying the report as a systematic review protocol]

## Registration

| Field | Value |
|-------|-------|
| **Registry** | [ ] PROSPERO / [ ] OSF / [ ] Other: _____ / [ ] Not registered |
| **Registration ID** | [To be completed after registration] |
| **Registration Date** | [Date] |
| **Protocol DOI** | [If applicable] |

---

## Administrative Information

### Protocol Version

| Version | Date | Changes |
|---------|------|---------|
| 1.0 | [Date] | Initial protocol |
| | | |

### Authors

| Name | Affiliation | Role | ORCID |
|------|-------------|------|-------|
| | | Lead reviewer | |
| | | Co-reviewer | |
| | | Methodologist | |

### Contact

- **Corresponding Author**: [Name]
- **Email**: [Email]
- **Institution**: [Institution]

### Funding

| Source | Grant Number | Role of Funder |
|--------|--------------|----------------|
| | | |

### Conflicts of Interest

[Declare any financial or non-financial conflicts of interest for all authors]

---

## Introduction

### Background/Rationale

[Describe the condition or problem being studied, its significance, and why a systematic review is needed. Include references to key prior work.]

### Objectives

[Provide an explicit statement of the question(s) the review will address. Consider using PICO/PEO framework.]

**Primary Objective:**
> [State the main objective]

**Secondary Objectives:**
1. [Secondary objective 1]
2. [Secondary objective 2]

---

## Methods

### Eligibility Criteria

#### Population/Participants

| Criterion | Include | Exclude |
|-----------|---------|---------|
| Target population | | |
| Age range | | |
| Setting/Context | | |
| Geographic scope | | |

#### Intervention/Exposure (for PICO/PEO)

| Criterion | Include | Exclude |
|-----------|---------|---------|
| Intervention type | | |
| Delivery method | | |
| Duration | | |

#### Comparator (if applicable)

| Criterion | Include | Exclude |
|-----------|---------|---------|
| Comparison group | | |

#### Outcomes

**Primary Outcomes:**
| Outcome | Definition | Measurement |
|---------|------------|-------------|
| | | |

**Secondary Outcomes:**
| Outcome | Definition | Measurement |
|---------|------------|-------------|
| | | |

#### Study Designs

| Include | Exclude |
|---------|---------|
| [ ] Randomized controlled trials | [ ] Case reports |
| [ ] Quasi-experimental | [ ] Editorials/Opinion |
| [ ] Cohort studies | [ ] Reviews (except for reference mining) |
| [ ] Case-control | [ ] Conference abstracts only |
| [ ] Cross-sectional | [ ] Non-English language |
| [ ] Qualitative studies | [ ] Unpublished (grey literature) |
| [ ] Mixed methods | |

#### Time Frame

- **Publication date range**: [Start year] - [End year]
- **Language restrictions**: [English only / No restrictions / Other]

### Information Sources

#### Electronic Databases

| Database | Platform | Justification |
|----------|----------|---------------|
| Semantic Scholar | API | Primary discovery |
| arXiv | API | CS/AI/Physics preprints |
| Google Scholar | Web | Broad coverage |
| PubMed | Web/API | Biomedical (if applicable) |
| [Other] | | |

#### Additional Sources

- [ ] Reference list searching (backward)
- [ ] Citation searching (forward)
- [ ] Grey literature: [Specify sources]
- [ ] Expert consultation
- [ ] Trial registries: [Specify]

### Search Strategy

[Describe the planned search strategy. Attach the full strategy as an appendix or in search_strategy.md]

**Key Concepts:**
| Concept | Terms | Synonyms |
|---------|-------|----------|
| Concept 1 | | |
| Concept 2 | | |
| Concept 3 | | |

**Boolean Structure:**
```
(Concept 1 terms) AND (Concept 2 terms) AND (Concept 3 terms)
```

**Filters/Limits:**
- Date: [Range]
- Language: [Languages]
- Document type: [Types]

### Study Selection

**Screening Process:**
1. **Title/Abstract Screening**: [Describe process, number of reviewers]
2. **Full-text Screening**: [Describe process, number of reviewers]
3. **Disagreement Resolution**: [Describe process]

**Pilot Testing:**
- [ ] Pilot screening on [N] papers before full screening
- [ ] Calibration exercise planned

**Software/Tools:**
- [List any screening software or tools to be used]

### Data Extraction

**Data Items:**

| Category | Data Items |
|----------|-----------|
| Bibliographic | Authors, Year, Title, Journal, DOI |
| Study characteristics | Design, Country, Setting, Sample size |
| Population | Demographics, Inclusion criteria |
| Intervention/Exposure | Description, Duration, Intensity |
| Outcomes | Primary measures, Secondary measures |
| Results | Effect sizes, CIs, p-values |
| Quality indicators | Funding, COI, Limitations noted |

**Extraction Process:**
- Number of extractors: [N]
- Independence: [Yes/No]
- Pilot extraction: [Yes/No, on N papers]
- Discrepancy resolution: [Process]

**Missing Data:**
[Describe how missing data will be handled - contact authors, imputation, exclusion]

### Risk of Bias Assessment

**Tool Selection by Study Design:**

| Study Design | Assessment Tool |
|--------------|-----------------|
| RCTs | RoB 2 |
| Non-randomized interventions | ROBINS-I |
| Diagnostic accuracy | QUADAS-2 |
| Qualitative | CASP Qualitative Checklist |
| Observational | JBI Critical Appraisal |

**Assessment Process:**
- Number of assessors: [N]
- Independence: [Yes/No]
- Disagreement resolution: [Process]

### Data Synthesis

**Synthesis Approach:**
- [ ] Narrative synthesis
- [ ] Meta-analysis (if sufficient homogeneity)
- [ ] Mixed methods synthesis

**If Meta-Analysis:**
- Effect measure: [RR, OR, SMD, MD, etc.]
- Model: [Fixed / Random effects]
- Heterogeneity assessment: [I², Q statistic]
- Subgroup analyses planned: [List]
- Sensitivity analyses planned: [List]

**If Narrative Synthesis:**
- Thematic organization: [Describe themes]
- Synthesis matrix approach: [Yes/No]
- SWiM guidelines followed: [Yes/No]

### Certainty of Evidence

- [ ] GRADE framework will be applied
- [ ] Summary of Findings table will be generated

**GRADE Domains:**
- Risk of bias
- Inconsistency
- Indirectness
- Imprecision
- Publication bias

---

## Amendments

| Date | Section | Original | Amendment | Rationale |
|------|---------|----------|-----------|-----------|
| | | | | |

---

## Timeline

| Phase | Start Date | End Date | Status |
|-------|------------|----------|--------|
| Protocol development | | | |
| Protocol registration | | | |
| Search execution | | | |
| Screening | | | |
| Data extraction | | | |
| Quality assessment | | | |
| Synthesis | | | |
| Manuscript preparation | | | |

---

## Appendices

- [ ] Appendix A: Full search strategies (`search_strategy.md`)
- [ ] Appendix B: Data extraction form (`extraction_table.md`)
- [ ] Appendix C: Quality assessment forms

---

*Protocol version: 1.0*
*Created: [Date]*
*Last updated: [Date]*

*Reference: Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ 2015;349:g7647.*
