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'The impact of patient-reported outcome data from clinical trials: perspectives from international stakeholders'

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Rivera, S.C., McMullan, C., Jones, L., Kyte, Derek ORCID: https://orcid.org/0000-0002-7679-6741, Slade, A. and Calvert, M. (2020) 'The impact of patient-reported outcome data from clinical trials: perspectives from international stakeholders'. Journal of Patient-Reported Outcomes, 4 (51). ISSN 2509-8020

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Official URL: https://jpro.springeropen.com/articles/10.1186/s41...

Abstract

Background
Patient-reported outcomes (PROs) are increasingly collected in clinical trials as they provide unique information on the physical, functional and psychological impact of a treatment from the patient’s perspective. Recent research suggests that PRO trial data have the potential to inform shared decision-making, support pharmaceutical labelling claims and influence healthcare policy and practice. However, there remains limited evidence regarding the actual impact associated with PRO trial data and how to maximise PRO impact to benefit patients and society. Thus, our objective was to qualitatively explore international stakeholders’ perspectives surrounding: a) the impact of PRO trial data, b) impact measurement metrics, and c) barriers and facilitators to effectively maximise the impact of PRO trial data upon patients and society.

Methods
Semi-structured interviews with 24 international stakeholders were conducted between May and October 2018. Data were coded and analysed using reflexive thematic analysis.

Results
International stakeholders emphasised the impact of PRO trial data to benefit patients and society. Influence on policy-impact, including changes to clinical healthcare practice and guidelines, drug approval and promotional labelling claims were common types of PRO impact reported by interviewees. Interviewees suggested impact measurement metrics including: number of pharmaceutical labelling claims and interviews with healthcare practitioners to determine whether PRO data were incorporated in clinical decision-making. Key facilitators to PRO impact highlighted by stakeholders included: standardisation of PRO tools; consideration of health utilities when selecting PRO measures; adequate funding to support PRO research; improved reporting and dissemination of PRO trial data by key opinion leaders and patients; and development of legal enforcement of the collection of PRO data.

Conclusions
Determining the impact of PRO trial data is essential to better allocate funds, minimise research waste and to help maximise the impact of these data for patients and society. However, measuring the impact of PRO trial data through metrics is a challenging task, as current measures do not capture the total impact of PRO research. Broader international multi-stakeholder engagement and collaboration is needed to standardise PRO assessment and maximise the impact of PRO trial data to benefit patients and society.

Item Type:	Article
Additional Information:	© The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. A pdf file of this article is available to download from this WRaP record.
Uncontrolled Discrete Keywords:	Patient-reported outcomes (PROs), clinical trials, impact
Divisions:	College of Health, Life and Environmental Sciences > School of Allied Health and Community
Related URLs:	https://jpro.springeropen.com/
Copyright Info:	Open Access article
Depositing User:	Derek Kyte
Date Deposited:	27 Aug 2021 08:16
Last Modified:	27 Aug 2021 08:16
URI:	https://eprints.worc.ac.uk/id/eprint/11194

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