Public involvement in the design of a complex neurosurgical clinical trial (the GDNF trial) and an associated support package: reflections and recommendations

Background:
Neurosurgical trials have a high burden on participants, which underscores the need to involve patients, carers, and the public in trial design to ensure their needs and expectations are met. However, there is currently limited guidance on the establishment, retention, and role of patient and public involvement (PPI) groups in neurosurgical trials, beyond generic guidance, which may contribute to the very low use of PPI in surgical trials. To promote meaningful public involvement in neurosurgical trials based on lived experience, we evaluated our public involvement and developed actionable recommendations. We also co-created a novel support package for neurosurgical trial participants.

Methods:
During the planning of a neurosurgical trial, 14 individuals formed a PPI group, including people with Parkinson’s, care partners, and charity staff. This reflective evaluation of the group used mixed-methods data collected using the PIRIT Tracking Tool, meeting polls/reflections, and reflective diaries. Our PPI group co-created the resulting reflections and recommendations, which follow the UK Standards for Public Involvement framework. The support package was co-designed in two online workshops, with 12 participants, including people with Parkinson’s and care partners.

Results:
Our recommendations for meaningful PPI cover inclusive opportunities, working together, support and learning, governance, communications, and impact. For example, we recommend providing all public contributors with an approachable point of contact, defining a clear plan for evaluation and addressing concerns identified through evaluation, and ensuring co-created tasks have clearly defined, tangible outcomes. The support package for neurosurgical trial participants spans before (psychological assessment and support; trial buddies; videos and written case studies from participants in similar trials), during (medical advice and support; Patient Liaison; psychological support), and after (medical, social, and psychological support) trial support.

Conclusions:
Our practical, generalisable recommendations and novel participant support package aim to strengthen public involvement and enhance care in neurosurgical trials. The support package needs testing within a trial to determine its feasibility and effectiveness.