A survey of knowledge, perceptions and use of core outcome sets among clinical trialists

Abstract

Background Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical trialists’ knowledge, perceptions and experiences of COS. Methods An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 1 January 2019 and 21 July 2020. Survey items assessed clinical trialists’ familiarity with and understanding of COS, along with experiences of COS use and development. Results Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. Forty (65%) participants were familiar with COS and, of those familiar with COS, 21 (55%) had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (n = 9, 41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (n = 43, 69%) and difficulties identifying relevant COS (n = 42, 68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (n = 51, 82%) and perceived importance of COS (n = 44, 71%). Conclusions Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists. Education and training may further promote awareness and understanding of COS.

Taking a chance on outcome standardisation: A cross‐sectional analysis assessing the uptake of the prevention of preterm birth core outcome set in randomised controlled trials

“…20 However, education may not be the sole barrier, as some trialists prefer to measure their own outcomes instead of using a standardised set. 20 While trialists' preferences may explain the use of outcomes not listed in our COS, it is important to recognise that a COS is not intended to limit trialists from including their own outcomes. COMET encourages the use of additional outcomes while maintaining the COS as the minimum set.…”

“…Other factors contributing to the lack of increased outcome measurement may include limited awareness of COS usage. A survey study by Belluci et al revealed that 35% of clinical trial researchers were not familiar with COSs, suggesting that education on COSs could be of benefit to trialists 20 . However, education may not be the sole barrier, as some trialists prefer to measure their own outcomes instead of using a standardised set 20 .…”

Outcome sets in orthopaedics: defining ‘what’ and ‘how’ to measure

“…29 A lack of awareness of core outcome sets among researchers may be responsible. 30 The lack of validated PROM instruments is also a concern, with sometimes only poor-quality evidence existing to support an instrument’s validity. 31,32…”

COS-Speech: protocol to develop a core outcome set for dysarthria after stroke for use in clinical practice and research

“…In 2019, a COS for aphasia (language impairment) after stroke was successfully developed [ 14 ]. There are challenges to implementation of COS [ 15 – 17 ] and uptake across different areas of health is variable. Some of the challenges related to the lack of appropriate measures, limited involvement of key stakeholders and a lack of awareness of the COS once developed [ 16 ].…”

“…The aim of our study is to develop a consensus-based COS for dysarthria after stroke to agree ‘what’ outcomes of speech to measure and ‘how’ best to measure them. We intend to recruit relevant key stakeholders, establish what measures are appropriate and ensure we disseminate this COS in both clinical and research communities [ 15 ]. A COS for dysarthria would improve consistent and relevant outcome reporting for people with dysarthria in both clinical and research settings.…”