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

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; pp. 601 - 9
• Main Authors: Speich, Benjamin, Odutayo, Ayodele, Peckham, Nicholas, Ooms, Alexander, Stokes, Jamie R., Saccilotto, Ramon, Gryaznov, Dmitry, von Niederhäusern, Belinda, Copsey, Bethan, Altman, Douglas G., Briel, Matthias, Hopewell, Sally
• Format: Journal Article
• Language: English
• Published: London BioMed Central 27.07.2022; BMC
• Subjects: Biomedicine; Condoms; Corporate sponsorship; Health Sciences; Hypotheses; Medical ethics; Medicine; Medicine & Public Health; Meta-research; Randomised controlled trial; Reporting quality; Research ethics; Statistics for Life Sciences; Trial protocol; Canada; United Kingdom > UK; Switzerland; Germany; Meta-research; Reporting quality; Trial protocol; Randomised controlled trial
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06516-1

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 to a median of 72.5% (IQR, 65.3–78.3%) in 2016. Industry-sponsored RCTs reported more SPIRIT items in 2012 (median 67.4%; IQR, 64.1–69.4%) compared to non-industry-sponsored trials (median 59.8%; IQR, 46.5–67.7%). This gap between industry- and non-industry-sponsored trials increased in 2016 (industry-sponsored: median 75.6%; IQR, 71.2–79.0% vs non-industry-sponsored: median 65.3%; IQR, 51.6–76.3%). Conclusions The adherence to SPIRIT guidelines has improved in the UK from 2012 to 2016 but remains on a modest level, especially for non-industry-sponsored RCTs.