Abstract

Objective: Core outcome sets (COS) are an agreed standardised collection of outcomes created with representation from all key stakeholders (such as patients, clinicians, researchers), which should be reported as a minimum for all trials in that corresponding clinical area. There has been little research investigating the use of core outcomes in Health technology assessments (HTAs) and none in non-oncology HTAs. This study aimed to assess the similarity between COS and HTA outcomes. Methods: Ten COS published between 2015 and 2019 were selected, with patient participation taken as a proxy measure for a high quality COS. The INAHTA database was used as a source to identify relevant HTAs, which were accessed through the hyperlinks provided. Outcomes selected for these assessments were categorised as either a specific, partial or no match compared to the COS. An additional cohort of non-oncology HTAs published between 2019 and 2021 were identified from the NICE website and compared against a relevant COS. Results: Six hundred and fifty-one HTAs were matched to the ten COS areas, of which 119 were reviewed. Of a possible 1318 core outcome matches, there were 562 (43%) matches, 413 (31%) specific and 149 (11%) partial. NICE HTA matches against corresponding COS ranged from 44% to 100%, with a total of 78% (73/94) matches, 57 (61%) specific and 16 (17%) partial. Conclusion: Further work is required to promote the awareness and implementation of COS within HTAs. Improved uptake across NICE HTAs is encouraging, demonstrating acceptance of COS by HTA producers.

Highlights

  • Clinical trials are performed to evaluate the effects of treatment interventions, with the gold standard being randomised controlled trials.[1]

  • We considered a match between an Health technology assessments (HTAs) outcome and a core outcome to exist if they were either or partially related

  • Ten Core outcome sets (COS) were selected to assess against the INAHTA database

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Summary

Introduction

Clinical trials are performed to evaluate the effects of treatment interventions, with the gold standard being randomised controlled trials.[1]. There are questions concerning whether trial outcomes are always relevant to patients or clinicians, meaning statistically significant results may have limited clinical bearing, not translating into improved clinical care.[7]

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