Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study.

ABSTRACT:

Objectives

To determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors.

Design

Methodological study.

Data sources

MEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies.

Eligibility criteria

Protocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language.

Main outcome

Primary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement.

Results

300 RCT p

SUBMITTER: Tan ZW 

PROVIDER: S-EPMC7451949 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature