Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE).

ABSTRACT:

Objectives

Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist.

Design

Repeated cross sectional study.

Setting

Swiss, German and Canadian research ethics committees (RECs).

Participants

RCT protocols approved by RECs in 2012 (n=257) and 2016 (n=292).

Primary and secondary outcome measures

The primary outcomes were the proportion of reported SPIRIT items per protocol and the proportion of trial prot

SUBMITTER: Gryaznov D 

PROVIDER: S-EPMC9125701 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature