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Development of a core outcome set for interventions to enhance proxy decisions about research on behalf of adults who lack capacity to consent.


There has been a growing focus on interventions to improve the informed consent process for decisions about trial participation. Some people with problems with their memory or understanding may lack capacity to provide informed consent for themselves. In these situations, a substitute or proxy decision-maker is involved in any decision about their participation in trials. The DECISION Study explored how family members made decisions about research on behalf of someone unable to provide their own consent. It was found that it was difficult for some family members to make a decision, and they experienced an emotional and decisional burden as a result. Families thought that greater support when making decisions about research would help.

A first decision support intervention for family members making decisions about research has now been developed and needs to be tested to ascertain whether it is an effective form of support. To do this, it is necessary to establish which outcomes matter, to whom, and why.

Study aim

The aim of this project (part of a larger programme of work) is to develop a core outcome set for the evaluation of interventions to enhance proxy decisions about research on behalf of adults who lack capacity to consent.

Study design

The project will be conducted in three stages:

1. Concept synthesis

First, establish what makes a ‘good’ or high-quality proxy decision about research. Review the literature and previous research to explore aspects of decision quality relating to proxy decision-making for research and identify candidate outcome domains.

2. Scoping review

Then conduct a scoping review to identify candidate outcomes and outcome measures used in other trials of relevant decision support interventions. The outcomes will be collated for the third part of the project.

3. Stakeholder consultation

Lastly, recruit a group of around 20 stakeholders (e.g. research nurses, researchers, people with conditions such as dementia and their families/carers, and people with an interest in informed consent/trials) to take part in an online Delphi survey. The aim is to reach agreement on which are the most relevant and important outcomes. A face-to-face meeting will then be held with key stakeholder participants from the Delphi survey to reach a final consensus on the items to be included in the core outcome set.

Involving the public and patients

By involving patients and carers the aim is to ensure that the outcomes are relevant and important to those involved in caring for people with problems with their memory or understanding who might be involved in making decisions about research.

Related publications

Shepherd V, et al. Development of a complex intervention to support informed decision-making by family members of adults lacking capacity to consent to trials. Abstract from International Clinical Trial Methodology Conference 2019 (PS2C-03) Trials