Introduction: Clinical trials evaluating the effectiveness of falls prevention interventions for people with Multiple Sclerosis (MS), Parkinson's Disease (PD) and stroke measure heterogeneous outcomes, often omitting those meaningful to patients. A core outcome set (COS) is a standardised set of outcomes that should be assessed in all trials within a research area. The aim of this study was to develop a COS for evaluating mixed-diagnosis falls prevention interventions for people with MS, PD and stroke in non-acute and community settings, with input from relevant stakeholder groups.
Methods: Previously published research undertaken by the team, including a qualitative study with 20 patients and a review of the literature, were used to derive a longlist of potential outcomes. Outcomes were prioritised for inclusion in the COS using a three-round online Delphi survey. A multi-stakeholder, consensus meeting was conducted to agree upon the final COS and to provide a recommendation for a single outcome measure for each outcome in the COS.
Results: Forty-eight participants were recruited across four stakeholder groups (researchers, patients, clinicians, and service-planners/policymakers). A total of 42 participants (87.5%) completed all three rounds of the surveys. Sixty-two outcomes were considered for inclusion in the COS throughout the Delphi process. A total of 15 participants attended the consensus meeting where they agreed upon the final COS and accompanying measurement instruments: fall incidence, injurious fall incidence, quality of life, falls self-efficacy, fear of falling, activity curtailment due to fear of falling, and cost-effectiveness. Attendees at the consensus meeting recommended that the proposed mechanism of impact of an intervention is considered when selecting additional outcomes outside of those in the COS to assess.
Conclusions: This study identified a COS for evaluating the effectiveness of mixed-diagnosis falls prevention interventions for people with MS, PD and stroke. It is recommended that this COS and accompanying measurement instruments be used in all future trials in this research area so that findings can be combined and compared.
Nicola O'Malley - School of Allied Health, Faculty of Education and Health Sciences, Ageing Research Centre, Health Research Institute, University of Limerick, Ireland
Susan Coote - School of Allied Health, Faculty of Education and Health Sciences, Centre of Physical Activity for Health, Health Research Institute, University of Limerick, Multiple Sclerosis Society of Ireland, Ireland (Supervisor)
Amanda M. Clifford - School of Allied Health, Faculty of Education and Health Sciences, Ageing Research Centre, Health Research Institute, University of Limerick, Ireland (Supervisor)
Disease Category: Neurology
Disease Name: Multiple sclerosis (MS), Parkinson's disease, Stroke
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Behavioural , Diet and nutrition, Educational/self-management, Exercise, Prevention
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Policy makers
- Researchers
- Service providers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
This will be a mixed-methods, international, multi-perspective Delphi consensus study with five stages. Stage one will involve the identification of potential outcomes through a systematic literature search, patient focus groups, and consultation with our Public and Patient Involvement (PPI) panel. The second stage will be the development of the Delphi survey using the outcomes elicited from stage one. Stage three will be the prioritisation of outcomes using a two-round online Delphi survey involving patients, clinicians, researchers and policy-makers/service-planners. The fourth stage will be to identify and recommend outcome measures and definitions. The final stage will be a consensus meeting with representatives from each stakeholder group to agree upon the final COS.