RT Journal Article
SR Electronic
T1 Achieving effective patient and public involvement in international clinical trials in neurology
JF Neurology: Clinical Practice
FD Lippincott Williams & Wilkins
SP 265
OP 272
DO 10.1212/CPJ.0000000000000739
VO 10
IS 3
A1 Emma C. Tallantyre
A1 Nikos Evangelou
A1 Clare Bale
A1 Burhan Z. Chaudhry
A1 Emma H. Gray
A1 Nicholas LaRocca
A1 Sue Pavitt
A1 Deborah M. Miller
A1 Sarah M. Planchon
A1 Daniel Ontaneda
A1 Ana Manzano
YR 2020
UL http://cp.neurology.org/content/10/3/265.abstract
AB There is a growing need for patient and public involvement (PPI) to inform the way that research is developed and performed. International randomized controlled trials are particularly likely to benefit from PPI, but guidance is lacking on how or when it should be incorporated. In this article, we describe the PPI process that occurred during the design and initiation of an international treatment clinical trial in MS. PPI was incorporated using a structured approach, aiming to minimize bias and achieve equivalence in study design, implementation, and interpretation. Methods included PPI representation within the study research team, and the use of focus groups, analyzed using thematic framework analysis. We report the outcomes of PPI and make recommendations on its use in other neurology clinical trials. By sharing our model for PPI, we aim to maximize effectiveness of future public involvement and to allow its effect to be better evaluated.