Methods to assess and improve the uptake of core outcome sets



Hughes, Karen
(2021) Methods to assess and improve the uptake of core outcome sets. Doctor of Philosophy thesis, University of Liverpool.

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Abstract

Introduction and aims Core outcomes sets (COS) are agreed, standardised sets of outcomes that should be measured and reported, as a minimum, in all clinical trials of a specific area of health or health care. COS have the potential to reduce research waste by improving the selection and reporting of outcomes in randomised controlled trials (RCTs), but this reduction in waste will only be realised if researchers choosing outcomes for RCTs include COS in their studies. The continuous development of COS, without uptake, could itself result in research waste. This thesis examined the extent to which COS are used across different areas of health, also investigating the methods used to assess uptake, and explored barriers and facilitators to the implementation of COS to inform the development of interventions to improve uptake. Methods A systematic review to identify studies that had evaluated the uptake of a COS was undertaken. An assessment of citation analysis as an approach to assess COS uptake was carried out. A review of National Institute for Health Research Health Technology Assessment (NIHR HTA) RCT funding applications was undertaken, followed by a survey of chief investigators (CIs), to investigate the impact of a funder’s recommendation to use COS. Qualitative interviews with CIs of NIHR HTA-funded RCTs explored the barriers and facilitators to COS uptake. Results The systematic review identified 26 studies that had assessed uptake of 17/337 (5%) COS. Uptake rates varied across health areas with 0% RCTs (gout) and 82% RCTs (rheumatoid arthritis) having measured the full COS. Variation was also found in the uptake of individual COS outcomes. The assessment of citation analysis to evaluate COS uptake found that RCTs measuring the COS made up a small proportion of the citations received by COS reports. Not all RCTs citing a COS report measured all of the recommended outcomes. Some RCTs cited the COS reports for other design issues that had been addressed. Ninety-five RCT funding applications submitted to the NIHR HTA for 2012-2015 were examined and nine applicants (10%) stated in their application that they had searched the Core Outcome Measures for Effectiveness Trials (COMET) Initiative database for a COS as recommended by the funder. In a follow up survey, a further eight applicants (8%) stated that they had searched the database. An additional 19 applicants (20%) searched for a COS using another source, e.g. a literature search. Thirteen interviews were conducted with CIs of NIHR HTA-funded RCTs. Barriers and facilitators to COS uptake were identified relating to the behaviour of CIs, such as their awareness of COS, the characteristics of COS, such as patient burden, and the opportunities provided by organisations in the wider health research system, such as funders. Conclusions Few studies have assessed the uptake of COS and further studies are needed across more areas of health. Funders of RCTs can have an impact on the uptake of COS but more steps can be taken to increase this impact. The barriers and facilitators to COS uptake can be addressed by behaviour change interventions, the COS development process and the wider research system.

Item Type: Thesis (Doctor of Philosophy)
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 07 Sep 2021 12:53
Last Modified: 03 Aug 2022 00:16
DOI: 10.17638/03128102
Supervisors:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3128102