What is 'impaired capacity' and why do we include people with impaired capacity in research?
How do families make decisions about research on behalf of a family member?
Support for families
How can we support families making decisions about research?
How can we use and improve the decision-support tool we have developed?
Feedback from discussion groups and questionnaire
Final thoughts from the day and the next steps for this research
Some people living with conditions such as dementia may experience impaired decision-making capacity, particularly as the condition progresses. It may mean that the person is not able to make some decisions, even when supported to do so, at the time that the decision is needed.. In these situations, family members may be asked to be involved in important decisions such as about the person's care or medical treatment.
Decisions about taking part in a research study are different to those about treatment or care. This is because research is not necessarily intended to benefit those taking part directly, but to generate knowledge to help people with similar conditions in the future.
We know from previous research that making decisions on behalf of other people can be difficult. This is particularly the case for decisions about research which can raise ethical, legal, and practical issues. Our research has explored some of these issues,
Research is important to ensure the best evidence-based care is available, including for people with conditions such as dementia. Our research aims to address some of the challenges encountered when including people with impaired capacity in research. This report is from a discussion and feedback event we held in Cardiff in March 2019.
Around 2 million people in the UK have significantly impaired decision-making ability.
The role of families in decisions about research
When someone is unable to provide consent to take part in a research study, a family member or close friend may be approached to act as a 'consultee' on their behalf. They are asked to advise the researchers what the person's wishes and feelings would be about taking part in the study. If it is a clinical trial of a medicine they act as a 'legal representative' and provide consent on the person's behalf based on the person's wishes.
Families provide advice about what the person's wishes and feelings would be about taking part
We interviewed family members who had been involved in a decision about research for someone in their family who had impaired decision-making. Some had decided 'yes' they should/would have wanted to take part and some had said 'no'.
The DECISION Study
Families worry about making a 'bad' or 'wrong' decision
Knowing the person's values is important
Decision-making can involve an emotional burden
Family members we interviewed thought that being supported when making a decision would help in the future. They suggested that this could be a form of information sheet that talked about their role in making the decision, and included ways to help the family member think about what the person's wishes and feelings would be about taking part. in the study.
A wide range of factors are taken into consideration
Support for families
Making decisions for others
Why research includes people with impaired capacity
Different types of decisions for different research
Receiving information about the research study
Weighing up advantages and disadvantages
Knowing the person’s wishes and feelings (values clarification exercise)
Our decision-support tool
4 Stages of our Process
The decision-support tool will supplement information about the research study itself and be used during a consultation between the researcher and the family member(s).
Development frameworks and guides
Qualitative research with families
Reviewing similar decision-support tools
Input from a lay advisory group
Decision-support tools can help people to make an informed decision that is in line with preferences and values. They can clarify what those preferences are and which option fits them best. We developed a decision-support tool for families making decisions about research using:
We included information about:
other decision-support tools
lay advisory group
Discussion and feedback - what did you think?
Discussions with researchers, research nurses and those with experience of caring for people with dementia found that the format of the decision-support tool was good. They liked the simplicity of the language used, and the presentation and ‘flow’ of the information.
The colour-coding of sections was thought to be particularly good, although different colour combinations were suggested that it was thought would increase the readability of the text. The ‘people’ illustrations were generally well received although the lack of diversity in the ethnicity and age of the characters was widely commented on.
thought it will be useful in practice
said it contains the right amount of information
thought the decision-support tool was the right length
Welcome to Aberdare Hall
Those attending the event thought that the tool would be best used as part of a discussion, although it could also be made available online.
It was described as 'empowering' family members to make a decision that was more informed.
The tool could be helpful for families of people living with dementia, but might also be useful in other contexts such as intensive care.
Care would be needed that it wouldn't add to the time and information burden on family members.
What did you say?
The discussions and feedback showed that the decision-support tool is acceptable to researchers, research nurses, and those with experience of caring for people with conditions such as dementia. We need to carry out further research to see if it useful for families making decisions.
Does the decision-support tool help family members?
Further research is needed in several areas before we could recommend the decision-support tool for use by families making decisions about research for someone who has impaired decision-making ability.
Our plans for the future
We need to know how to measure whether it helps support decision-making
We need to test whether it is feasible to use in practice
A trial is needed to test whether it is an effective form or support or not.
If the decision-support tool helps families such as those caring for people living with dementia, we could then see whether it might be useful for families of other groups who experience impaired capacity. This might include patients in intensive care.
It might also be useful in different formats such as being available online or in an interactive format.