A Survey of Knowledge, Perceptions and Use of Core Outcome Sets among Clinical Trialists

Abstract

Introduction: 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 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 01/01/2019 and 21/07/2020. 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. 65% of participants were familiar with COS and, of those familiar with COS, 55% had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (69%) and difficulties identifying relevant COS (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 (82%) and perceived importance of COS (71%). Conclusion: Education and training can further promote awareness and understanding of COS. 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.

Use of core outcome sets was low in clinical trials published in major medical journals

“…Identification of low COS use in this cohort of trials is consistent with previous examinations 13,14 . One possible explanation may be low levels of knowledge about the existence and value of COS 15 . This is reflected in survey responses indicating that knowledge about COS is important for COS use.…”

“…The COMET guidelines recommend measuring and reporting all COS outcomes as the minimum in trials 3 . A previous survey of trialists with a trial registered on the ISRCTN repository found that fewer than half of respondents who had used a COS in a trial reported including all COS outcomes 15 . In addition to poor COS knowledge, lack of full COS use and/or reporting in the current study may be due to trialists perceiving identified COS as not relevant or valid for use.…”

“…Analysis of funding applications submitted to the National Institute for Health Research Technology Assessment (NIHR HTA) found that 38% of applicants searched for a COS to inform outcome choice 13 . Similarly, in a survey of trialists with trials registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository, most trialists had not been involved in a trial that included a COS 15 . Of those trialists who had used a COS, in the majority of instances not all COS outcomes were used 15 .…”

“…Similarly, in a survey of trialists with trials registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository, most trialists had not been involved in a trial that included a COS 15 . Of those trialists who had used a COS, in the majority of instances not all COS outcomes were used 15 .…”

“…To date, examinations have been conducted on uptake of COS for individual COS use in specific health areas 16 , funding applications 13 , and trial registrations 15 . We are not aware of an examination of COS uptake in a general unselected cohort of published clinical trials.…”