Feedback on research: Participant views are vital

From the Autumn 2016 edition of Care and cure magazine, we hear how listening to participants led to a major grant that could help to improve the success of clinical trials in Alzheimer's Disease.

Research studies often require a high level of commitment from participants and so it is crucial that we understand how people are willing to be involved.

One of the obstacles to finding ways to treat Alzheimer's disease is the difficulty in knowing how well a treatment is working during a clinical trial. To be able to do this, researchers want to measure some of the changes that Alzheimer's produces in the body and how these develop over time. These changes can be in the brain, blood or cerebrospinal fluid, which fills the spine and covers the brain. These are not easy to access or monitor regularly, making it harder to understand how the disease affects them.

Professor Simon Lovestone at the University of Oxford proposed a research project to test for biological changes regularly in people with preclinical Alzheimer's disease. These are people who are experiencing memory loss that wouldn't qualify as full dementia, but who do have early signs of damage in their brains. 'We needed to know whether people would be willing to take part in a study like this, requiring regular visits to the hospital for scans or lumbar punctures,' says Simon.

To show that this approach could work, he set up a test study in 2014 with 22 people who had dementia.

Matt Murray, Research Engagement Manager at Alzheimer's Society, led work to understand how acceptable these tests would be for participants.

He says, 'We recruited people with the early stages of Alzheimer's for the feasibility study, even though the full study was intended to be for people with preclinical dementia. For ethical reasons, we needed to show that someone with undiagnosed dementia would still be able to remain in the study.

'Feedback from participants encouraged the researchers to rethink aspects of the study, even the time of day for certain tests. For the electroencephalogram, or EEG, you have to wear a cap with electrodes attached. By doing the EEG later on in the day, participants didn't have to spend the day with messed-up hair.'

Although untidy hair may seem like a trivial concern, it is important to make the process as easy as possible to avoid participants dropping out of the study.

'People were mostly worried about the lumbar puncture to sample spinal fluid,' says Matt. 'So we checked people's expectations of procedures against their actual experiences. For the lumbar puncture, all but one had a better experience than they had expected. In the case where it wasn't better, this seemed to be because the person hadn't followed the doctor's instructions and was too active afterwards.'

By showing how to make the study acceptable to participants, this work has played a vital role in securing funding for the full Deep and Frequent Phenotyping study. Professor Lovestone has recently been awarded £6 million by the Medical Research Council and National Institute for Health Research to perform up to 50 tests each on 250 people in the preclinical stages of Alzheimer's disease.

'The feedback we received allowed us to improve the study and demonstrate that people are willing and able to help us to gain a unique insight into Alzheimer's disease,' says Simon.

Alzheimer's Society is supporting the new study by making videos of each procedure to make it easier for participants to see what they are agreeing to. People who take part will be offered the chance to take part in a clinical trial afterwards, as part of a partnership with the European Prevention of Alzheimer's Disease Consortium.

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