clinical-literature-reviewer

Clinical Literature Reviewer Skill

Purpose

The Clinical Literature Reviewer Skill conducts systematic literature reviews for clinical evaluation, supporting medical device regulatory submissions with evidence synthesis per MEDDEV 2.7/1 and FDA guidance.

Capabilities

• Literature search strategy development (PubMed, Embase, Cochrane)
• PICO framework application
• Abstract screening criteria
• Data extraction templates
• Appraisal of clinical data quality
• Evidence synthesis and summary tables
• MEDDEV 2.7/1 compliance checking
• Bias assessment tools
• Meta-analysis support
• Gap analysis for clinical evidence
• Ongoing literature surveillance

Usage Guidelines

When to Use

• Conducting clinical evidence reviews
• Supporting CER development
• Identifying evidence gaps
• Preparing regulatory submissions

Prerequisites

• Clinical claims defined
• Search strategy approved
• Inclusion/exclusion criteria established
• Appraisal methodology selected

Best Practices

• Document search methodology completely
• Apply consistent screening criteria
• Assess study quality systematically
• Synthesize evidence objectively

Process Integration

This skill integrates with the following processes:

• Clinical Evaluation Report Development
• Clinical Study Design and Execution
• EU MDR Technical Documentation
• Post-Market Surveillance System Implementation

Dependencies

• PubMed API
• Cochrane Library
• Embase database
• Systematic review tools
• Reference management software

Configuration

clinical-literature-reviewer:
  databases:
    - PubMed
    - Embase
    - Cochrane
    - Web-of-Science
  review-types:
    - systematic
    - scoping
    - rapid
  appraisal-tools:
    - GRADE
    - Oxford-CEBM
    - Cochrane-RoB

Output Artifacts

• Search strategies
• Screening logs
• Data extraction tables
• Quality appraisal forms
• Evidence synthesis reports
• PRISMA diagrams
• Summary of evidence tables
• Gap analysis reports

Quality Criteria

• Search comprehensive and reproducible
• Screening criteria consistently applied
• Data extraction accurate
• Quality appraisal systematic
• Synthesis methodology appropriate
• Documentation meets MEDDEV 2.7/1