Full-text Appraisal (Step 7)
Overview
Step 7 performs full-text quality appraisal of literature screened as "Relevant" in Step 4, using systematic scoring based on IMDRF clinical evaluation guidance and MDCG evidence grading criteria.
Scoring System
Four-dimension Quality Scoring
Each article is scored across four dimensions, 1-3 points each:
| Dimension | Description | Score |
|---|---|---|
| Design (D) | Study design quality | 1-3 |
| Applicability (A) | Applicability to target device | 1-3 |
| Population (P) | Study population relevance | 1-3 |
| Reporting (R) | Completeness of result reporting | 1-3 |
| Total (SUM) | Composite score | 4-12 |
SOTA Assessment
In addition to the four-dimension scoring, each article undergoes a State of the Art (SOTA) assessment to determine whether the literature reflects current best practices and clinical standards.
Contribution Assessment
Evaluates each article's contribution to clinical evaluation conclusions:
- Contribution to safety argumentation
- Contribution to effectiveness argumentation
- Contribution to benefit-risk evaluation
Ethical Contraindications (Optional)
Same as Step 4 -- if the target indication has ethical constraints preventing RCTs, enable "Ethical Contraindications". When enabled, scoring adjusts requirements for study design level and does not penalize articles for lacking RCT evidence.
Batch Processing
Step 7 also uses batch processing:
- Each batch appraises a group of articles
- Auto-continue mode runs sequentially
- Can pause for manual batch review
- All batch results merge on completion
Output
Each article's appraisal includes:
- Four-dimension scores (D/A/P/R) and composite score
- SOTA assessment conclusion
- Contribution evaluation
- Key findings summary
- Methodological limitations