Objective: To select a suitable primary outcome for the evaluation of a multicomponent intervention for people with parkinsonism.

Background: The multicomponent PRIME model of care, designed to address limitations in current parkinsonism care, is being evaluated in the UK within a randomised controlled trial (RCT) comparing the PRIME model to usual care over 2 years. We sought an outcome measure which would capture the effect of a holistic intervention acting across multiple symptoms and domains; be suitable for use in participants across the spectrum of disease stage and phenotype, including those with cognitive impairment; and be meaningful to patients, including those with multiple long-term conditions.

Method: We considered the utility and limitations of commonly used outcomes in Parkinson’s, including disease rating scales, quality of life measures and assessment of healthcare use/cost. We identified goal-orientated outcomes as a novel approach and reviewed the literature on their use in parkinsonism. We adapted the Bangor Goal-Setting Interview (BGSI) [1] for use within the PRIME-UK RCT.

Results: Use of goal-orientated outcomes in parkinsonism research to date is limited. The adapted version of the BGSI is being effectively used within the PRIME-UK RCT and includes 4 steps: 1) participants identify an area to work on; 2) describe a specific goal within this domain; 3) rate their current attainment level, motivation to change and the goal’s importance; and 4) attainment is then followed up at 3-monthly intervals by telephone.  Rating progress with 3-5 individualised goals on a standardised scale allows change in attainment from baseline to follow-up to be compared between trial arms.

Conclusion: We demonstrate how a goal-orientated outcome can be operationalised within a complex intervention trial for parkinsonism. Parkinsonism is an exemplar condition that impacts upon multiple organ systems, is highly heterogeneous, and which predominantly affects older people. There is scope to use goal-orientated outcome measures more widely in trials involving patients living with frailty, multimorbidity and/or clinical complexity.

References: Clare L, Nelis S, Kudlicka A. Bangor Goal-Setting Interview Manual: Setting goals with the BGSI Version 2.: Centre for Research in Ageing and Cognitive Health, University of Exeter.; 2016.

« Back to 2023 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/operationalising-goal-setting-as-an-outcome-measure-experience-from-the-prime-uk-randomised-controlled-trial/