A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study.

ABSTRACT:

Background

To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline.

Methods

We had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i.e. a total of 64 components of the 33 SPIRIT items). We descriptively analysed the adherence to SPIRIT guidelines as proportion of adequately reported items (median and interquartile range [IQR]) and stratified the results by year of approval and sponsor.

Results

The proportion of reported SPIRIT items increased from a median of 64.9% (IQR, 57.6-69.2%) in 2012

SUBMITTER: Speich B 

PROVIDER: S-EPMC9327179 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature