LEARN

Listening to the experience of participants in neurosurgical trials.

Background

Parkinson’s disease (PD) is a neurodegenerative condition, most well-known for the movement problems that it causes. However, those living with PD can experience a range of symptoms including changes in mood, behaviour and thinking. There are few medicines available that can help with the symptoms of PD and there is no medicine that can slow down or stop the progression of the disease. In the search for treatments that can have a beneficial and long lasting effect on slowing down the course of PD, research has moved away from the traditional drug led approach to more novel strategies such as cell replacement or the direct administration of growth factors to the affected area of the brain.

Voice of participants

There have already been some clinical trials aimed at investigating these new types of therapies. These trials often require participants to undergo complex procedures such as brain surgery, or special forms of brain imaging. This is also combined with repeated and prolonged testing of disease symptoms and progression, sometimes requiring participants to stop using their normal medications. These studies can be challenging for both the doctors and scientists involved, as well as the people who volunteer to tale part. Whilst there is discussion between experts as to the best approach for designing and running such trials, the voice of the participants and those that support and care for them are often not heard.

Capturing experiences

The LEARN study aims to capture the experience of people with PD who have taken part in a complex trial of a new therapy for PD. We will interview trial participants and their family members or carers to gain their views on the trial processes and how taking part in the trial has affected them. We hope that by capturing the experience of trial participants and understanding the challenges they face, we can improve the design of and how similar future studies are run. We will use the information we gather, in partnership with the people we interview to produce resources for; future trial participants to help them make decisions about taking part in trials; doctors and scientists designing future trials and the people who review and approve trials to take place.

Results

The LEARN study (‘listening to the experiences of participants on neurosurgical trials’ ) sought to understand both the experiences and any barriers to participating in trials involving neurosurgery to administer both pharmacological and advanced therapies. Researchers interviewed previous trial participants and were able to identify key issues affecting their experience. Informative resources were then created with the aim of improving the experience of participation in future neurosurgical trials and reduce some of the problems that might cause people to drop out of research. Key issues identified were challenges associated with brain imaging, taking part in clinical trials when ‘off’ medication and support for support partners, plus the need to understand and retain a lot of information about the trial. Participants, funders, and chief investigators came together to discuss the main findings of the LEARN study in a webinar, where Chief Investigators, Dr Emma Lane and Dr Cheney Drew were pleased to introduce several information videos and written guides on each of these areas so that participants and their carers may be better supported and prepared in future trials.

“The study has highlighted many issues that need resolution before further neurosurgical trials are designed,” said Lesley Gosden, a LEARN study participant.

Support partner, Jayne Calder said, “Managing the expectations of the participant and their support partner continuously throughout the trial is key. I believe that the LEARN study has create an opportunity to improve the journey of a participant from start to finish.”

The webinar can be viewed in full here: https://youtu.be/ZA2T4nBzUCo