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A core outcome set for evaluating the effectiveness of mixed-diagnosis falls prevention interventions for people with Multiple Sclerosis, Parkinson’s Disease and stroke

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O’Malley, Nicola, Coote, Susan, Staunton, Fiona McCullough, O’Connor, Eileen, Clifford, Amanda M.·2023·PLOS ONE
DOI 10.1371/journal.pone.0294193PMC PMC10642845
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Abstract

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.

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  • In the first round, outcomes were organized into three predefined groups (PROs, objective ClinROs, subjective ClinROs) and presented alphabetically within each category to minimize potential question order bias.

    “In the first round of the Delphi process, outcomes were organized into three predefined groups (1. PROs, 2. objective ClinROs and 3. subjective ClinROs) and presented alphabetically within each category to minimize potential question order bias (De Meyer et al. 2019; O'Malley et al. 2023; Zanjir et al. 2025).”

    From 1st Global Consensus for Clinical Guidelines: Identifying a Core Outcome Set for Implant Dentistry in Edentulous Maxilla Rehabilitation (2026) · cites this paper as O'Malley et al. 2023

    Materials and methods > Design, Stage 2 says the Delphi survey presented outcomes alphabetically to avoid potential weighting; Stage 3 confirms that participants rated outcomes in round one. The paper does not say the outcomes were divided into PROs, objective ClinROs, and subjective ClinROs, or that alphabetical ordering was applied within those groups. (LLM, conf=0.88)

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Metadata

Authors
O’Malley, N., Coote, S., Staunton, F. M., O’Connor, E., & Clifford, A. M.
Affiliations
University of Limerick (IE)
Corresponding author
O’Malley, Nicola
ORCID
Venue
PLOS ONE
Publisher
Public Library of Science (PLoS)
Published
2023-11-13
Volume
18
Issue
11
Pages
e0294193
ISSN
1932-6203 (ISSN-L)
DOI
10.1371/journal.pone.0294193
PMC
PMC10642845
OpenAlex
W4388624558
Cited by
13
References
8
Citations by year
2026: 5 · 2025: 6 · 2024: 2
FWCI
0.71
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS ONE (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • RePEc: Research Papers in Economics (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Figshare (submittedVersion, cc-by-nc-sa)
  • University of Limerick Institutional Repository (University of Limerick) (submittedVersion, cc-by-nc-sa)
  • University of Limerick Institutional Repository (University of Limerick)
Funders
Irish Research Council (GOIPG/2018/3379)
Topics
  • Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Balance, Gait, and Falls Prevention
  • Social Sciences › Sociology and Political Science › Delphi Technique in Research
  • Health Sciences › Medicine › Rehabilitation › Stroke Rehabilitation and Recovery
Keywords
core outcome set, fall prevention, multiple sclerosis, Parkinson's disease, stroke, injurious falls, fall incidence, fear of falling, falls efficacy, quality of life, cost-effectiveness, outcome measurement instruments, stakeholder consensus
MeSH terms
Delphi Technique, Fear, Humans, Multiple Sclerosis, Parkinson Disease, Quality of Life, Research Design, Treatment Outcome, Outcome Assessment, Health Care, Stroke

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