Intervention Trials

The protocol of a clinical trial is essential for study conduct, review, reporting, and interpretation. SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol.

Systematic Reviews

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. PRISMA-P (the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols) consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review.