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Proxy decision-making for research involving adults who lack capacity to consent: cognitive testing of a novel decision support intervention.


Some people living with conditions such as dementia may have problems with their memory or understanding which affects their ability to make decisions for themselves. Involving people with impaired decision-making in research may require asking a family member to decide on their behalf whether they should take part or not.

Our previous study (DECISION Study) explored how family members made decisions about research on behalf of someone unable to provide their own consent. We found that some family members found it difficult to decide and they worried about whether it was a ‘good’ decision. Participants suggested that providing support for family members when making such decisions about research would help.

Watch an animation of the findings from the DECISION Study

Decision support tools, also known as decision aids, can help people to make decisions that are more informed and consistent with their own values. They are increasingly being used to support patients who are making choices about their healthcare by providing information about their options and the associated benefits and harms. More recently, decision support tools have been used to help people make decisions about whether to participate in a clinical trial or not.

We have developed a new decision support tool (a 12 page colour booklet) to help family members make a decision about participation in a study that best reflects the values of the person they represent, and reduce the burden families may feel when they are involved in decision-making. We need to test whether it is an effective form of support. However, we first need to know if family members can understand the tool and how it should be used.

Project aims

The aims of the study are to:

  1. Establish the acceptability, comprehension, interpretation and completion of the decision support tool
  2. Explore participants’ understanding of the main message of the decision support tool and any missing information
  3. Refine the decision support tool in preparation for future testing of its effectiveness

Study design

We will ask around 15 family members of people living with dementia (or other conditions which can affect memory and understanding) to take part in an interview. The interviews will be conducted online using video conferencing (Zoom) at a time that is convenient for those taking part. During the interview we will show them the decision support booklet.

We will ask them to talk through what they think about the booklet, a technique called ‘think aloud’, and ask them questions about what they think it is telling them, what might be missing from the booklet, and what further changes could make it better. We will then use this to improve the tool ahead of testing its effectiveness in a future trial.

Involving the public and patients

The study (and the previous research which led up to it) has benefited from a Lay Advisory Group who contributed to the design of the study to ensure it is practical and relevant to family members of people living with conditions such as dementia.

Related publications

Shepherd V, et al. ‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK. Age and Ageing, 2019 Volume 48, Issue 6, November 2019, Pages 903–909, https://doi.org/10.1093/ageing/afz115

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 2019 579 https://doi.org/10.1186/s13063-019-3688-6


What we did

We asked family members of people with dementia or other conditions which can affect memory and understanding to take part in an interview via Zoom.

During the interview we asked them to talk through what they thought about the booklet, a technique called ‘think aloud’, and asked them what might be missing from the booklet, and what further changes could make it better.

What we found

We interviewed 18 family members (3 men, 15 women) from England and Wales who were a range of different ages and either a partner (or ex-partner), child or grandchild of someone living with dementia. The interviews lasted an average of 42 minutes.

Participants generally liked the appearance of the booklet and described the contents as informative and well balanced. They thought that the language was accessible and had a warm and friendly tone, although some changes to the text were suggested. Participants thought that the sections on advantages and disadvantages and the six-step decision-making process were very helpful. They also liked the reminder that they were making a decision based on what the person they represented would want to do, which might be different to what they would do.

The message that there was no right or wrong answer was viewed as reassuring, as were reminders that they could take time to make a decision and that the person they represented could be withdrawn from the study at a later stage if they felt that was needed.

There were differing opinions about the ‘values clarification’ exercise which was designed to help family members consider the different aspects of a study, including any advantages and disadvantages, and reflect on what the person they represented would think about them. Some participants were unsure how to complete the exercise and thought that clearer instructions on how to complete the exercise were needed.

Next steps

This study has given us important information that will help us to support family members making decisions for people with conditions such as dementia in the future. Following on from these interviews, the next step is to make changes to the booklet where needed.

We then need to find out whether it is effective in supporting families making decisions about research in practice. To test this, we will ask family members who are making real-life decisions about research studies to use the booklet and compare their experiences with family members who are not given the booklet. We will also look at when and why it is effective or not.

We would like to thank all those who generously gave up their time to take part in the interviews.

Key facts

Start date 1 Feb 2020
End date 31 Dec 2020
Grant value £50,000
  • Published

General enquiries

Victoria Shepherd
+44 (0)29 2068 7641

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