The MoXFo initiative - study design: Considerations related to study design and methodology in exercise research for people with multiple sclerosis.


Journal

Multiple sclerosis (Houndmills, Basingstoke, England)
ISSN: 1477-0970
Titre abrégé: Mult Scler
Pays: England
ID NLM: 9509185

Informations de publication

Date de publication:
Nov 2023
Historique:
medline: 10 11 2023
pubmed: 26 10 2023
entrez: 26 10 2023
Statut: ppublish

Résumé

Exercise as a subset of physical activity is a cornerstone in the management of multiple sclerosis (MS) based on its pleiotropic effects, but continued progression of the field requires better future designs and methodologies. This paper outlines the work of the 'Study design and methodology' group of the MoXFo (moving exercise research forward) initiative, and addresses critical aspects and future directions when defining the research question of interest, and subsequently, designing the study and exercise intervention in MS patients. The work is based on the formation of an international expert panel formed within the MoXFo initiative. We provide a structured and concise synthesis of exercise-specific MS research challenges and considerations when designing randomized controlled trials (RCTs). Challenges and considerations are presented using the Patient population, Intervention, Comparator, Outcomes, Timing, Setting (PICOTS) framework, thereby forming a new and specific MS exercise PICOTS framework. We propose that researchers should carefully consider and align all elements of this MS exercise PICOTS framework when developing future research questions and study designs, ultimately improving the quality of new exercise studies in people with MS.

Sections du résumé

BACKGROUND UNASSIGNED
Exercise as a subset of physical activity is a cornerstone in the management of multiple sclerosis (MS) based on its pleiotropic effects, but continued progression of the field requires better future designs and methodologies.
OBJECTIVES UNASSIGNED
This paper outlines the work of the 'Study design and methodology' group of the MoXFo (moving exercise research forward) initiative, and addresses critical aspects and future directions when defining the research question of interest, and subsequently, designing the study and exercise intervention in MS patients.
METHODS UNASSIGNED
The work is based on the formation of an international expert panel formed within the MoXFo initiative. We provide a structured and concise synthesis of exercise-specific MS research challenges and considerations when designing randomized controlled trials (RCTs).
RESULTS UNASSIGNED
Challenges and considerations are presented using the Patient population, Intervention, Comparator, Outcomes, Timing, Setting (PICOTS) framework, thereby forming a new and specific MS exercise PICOTS framework.
CONCLUSION UNASSIGNED
We propose that researchers should carefully consider and align all elements of this MS exercise PICOTS framework when developing future research questions and study designs, ultimately improving the quality of new exercise studies in people with MS.

Identifiants

pubmed: 37880962
doi: 10.1177/13524585231204456
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1561-1568

Déclaration de conflit d'intérêts

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: U.D. has received research support, travel grants and teaching honorary from Biogen Idec, Merck Serono, Novartis, Bayer Schering and Sanofi Aventis, and honoraria from serving on scientific advisory boards of Biogen Idec and Genzyme. S.M.G. reports honoraria from Celgene and Hexal, and research funding from Biogen. M.R., T.E., L.A.P., V.D.G., H.B., J.F., A.K. and R.D. declare no conflicts of interest related to this work.

Auteurs

Ulrik Dalgas (U)

Exercise Biology, Department of Public Health, Aarhus University, Aarhus C, Denmark.

Morten Riemenschneider (M)

Exercise Biology, Department of Public Health, Aarhus University, Aarhus C, Denmark.

Stefan M Gold (SM)

Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Psychiatry and Neurosciences, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Section of Psychosomatic Medicine, Medical Department, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Alon Kalron (A)

Department of Physical Therapy, The Stanley Steyer School of Health Professions, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Sagol School of Neurosciences, Tel Aviv University, Tel Aviv, Israel.
Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel.

Heleen Beckerman (H)

Amsterdam UMC location Vrije Universiteit, Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam, The Netherlands.
Societal Participation & Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.

Vincent de Groot (V)

Amsterdam UMC location Vrije Universiteit, Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam, The Netherlands.
Societal Participation & Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.

Rachel Dennett (R)

School of Health Professions, Faculty of Health, University of Plymouth, Plymouth, UK.

Thomas Edwards (T)

School of Human Kinetics, University of Ottawa, Ottawa, ON, Canada.

Lara A Pilutti (LA)

Interdisciplinary School of Health Sciences, Brain and Mind Research Institute, University of Ottawa, Ottawa, ON, Canada.

Jenny Freeman (J)

School of Health Professions, Faculty of Health, University of Plymouth, Plymouth, UK.

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