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A Revised Classification Framework for Studies in Systematic Reviews: Prioritizing Outcome Data Availability Over
Rafael Leite Pacheco1,2,3, Rachel Riera1,2
1Health Technology Assessment Center, Hospital Sírio-Libanês, São Paulo, Brazil.
Journal of Evaluation in Clinical Practice
|August 6, 2026
Summary
This study revises systematic review study classification by prioritizing outcome data availability over study status. This enhances transparency and reduces ambiguity in categorizing clinical trials for reviews.
Area of Science:
- Systematic Review Methodology
- Clinical Trial Management
Background:
- Study classification is crucial for systematic reviews.
- Current Cochrane methods use study status (included, excluded, ongoing, awaiting classification).
- The 'ongoing' status is poorly defined, impacting reproducibility.
Purpose of the Study:
- To propose a revised classification framework for primary studies in systematic reviews.
- To improve the objectivity and reproducibility of study categorization.
Main Methods:
- Replaced study status with outcome data availability as the primary criterion.
- Introduced two new categories for included studies: 'with analysable outcome data' and 'without analysable outcome data'.
- Eliminated the 'ongoing studies' category and redefined 'awaiting classification'.
Main Results:
- The new framework distinguishes between eligible studies based on data analysability.
- The 'ongoing studies' category is integrated into the new framework.
- The 'awaiting classification' category is reserved for studies with undetermined eligibility.
Conclusions:
- The revised framework increases transparency regarding studies not contributing to outcome analysis due to reporting issues.
- This approach reduces ambiguity in the study categorization process.
- Further research is needed to validate the proposed categories through empirical studies on reliability and precision.
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