Abstract

BackgroundTrials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation.MethodsWe used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.ResultsA total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.ConclusionsThe study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies’ experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement.Trial registrationThe study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

Highlights

  • Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decisionmakers, usually a family member, to make decisions about participation

  • The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials

  • Aims and objectives The aim of this study was to develop a core outcome set for the evaluation of interventions that are intended to improve proxy decisions about trial participation on behalf of adults who lack capacity to consent, using the definition outlined in the Mental Capacity Act 2005 (MCA) [6]

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Summary

Introduction

Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decisionmakers, usually a family member, to make decisions about participation. In England and Wales, research involving adults who lack capacity to consent is governed by the Mental Capacity Act which has provisions for a consultee to provide advice about what, in their opinion, would be the person’s wishes and preferences about participating in the study [6]. Unlike conventional consent, consultees and legal representatives are required to represent the person’s wishes and preferences rather than their own This can be challenging for family members acting as consultee or legal representative, who often experience an emotional and decisional burden as a result [10]. Concerns about the burden of making proxy decisions, together with broader ethical concerns about who should act as proxy and the ethical basis for their decision, contribute to the methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent in trials [11]

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