Abstract
Objective: In recent years, there has been a significant surge in clinical research focused on sarcopenia, driven by its recognized reversibility. The interest in developing effective interventions is underscored by the need for well-defined outcomes, currently impeded by the absence of a standardized set of outcomes, known as Core Outcome Sets (COS). Utilizing COSs harmonizes assessment criteria, facilitating the comparative analysis of diverse interventions. Establishing a sarcopenia-specific COS is crucial to augment the precision and effectiveness of clinical trials in this field. This project aims to develop a COS for intervention studies in sarcopenia, designed to address unmet needs in sarcopenia research and clinical practice and to pave the way for the development of effective treatments for the disease.
Methods: The methodology for this study adheres to the recommendations outlined in COS-STAD and COS-STAP. The study protocol has been registered in the database of the COMET initiative (https://www.cometinitiative.org/Studies/Details/2991). A Working Group (WG) will be assembled to collaborate on this project, consisting of individuals with sarcopenia, clinicians, and researchers. Subsequently, the study will progress through three key phases. Firstly, the development of an outcome list will be pursued through two distinct methods: a systematic literature review following PRISMA guidelines and semi-structured interviews with 5 to 10 participants aged 65 years and older, diagnosed with
sarcopenia. The literature review will comprehensively identify potential outcomes reported in phase III clinical trials on sarcopenia, while the interviews will delve into the values and preferences of the participants. Following the outcome list development, a two-round modified Delphi process will be initiated, engaging key stakeholders to identify and prioritize relevant outcomes. Finally, a consensus meeting involving the Working Group will be convened to validate the results.
Results: Ongoing project, results are not available yet.
Conclusion: A core outcome set of sarcopenia would improve the efficiency of research and allow direct and indirect comparisons of sarcopenia clinical trials. This protocol aims to define the scope and methodology, stakeholder involvement, procedures and consensus processes of the COS for sarcopenia intervention
trials. Our ultimate goal is to improve the lives of people with sarcopenia.
Methods: The methodology for this study adheres to the recommendations outlined in COS-STAD and COS-STAP. The study protocol has been registered in the database of the COMET initiative (https://www.cometinitiative.org/Studies/Details/2991). A Working Group (WG) will be assembled to collaborate on this project, consisting of individuals with sarcopenia, clinicians, and researchers. Subsequently, the study will progress through three key phases. Firstly, the development of an outcome list will be pursued through two distinct methods: a systematic literature review following PRISMA guidelines and semi-structured interviews with 5 to 10 participants aged 65 years and older, diagnosed with
sarcopenia. The literature review will comprehensively identify potential outcomes reported in phase III clinical trials on sarcopenia, while the interviews will delve into the values and preferences of the participants. Following the outcome list development, a two-round modified Delphi process will be initiated, engaging key stakeholders to identify and prioritize relevant outcomes. Finally, a consensus meeting involving the Working Group will be convened to validate the results.
Results: Ongoing project, results are not available yet.
Conclusion: A core outcome set of sarcopenia would improve the efficiency of research and allow direct and indirect comparisons of sarcopenia clinical trials. This protocol aims to define the scope and methodology, stakeholder involvement, procedures and consensus processes of the COS for sarcopenia intervention
trials. Our ultimate goal is to improve the lives of people with sarcopenia.
| Original language | English |
|---|---|
| Pages | 271 |
| Number of pages | 1 |
| Publication status | Published - Aug 2024 |
| Event | World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO 2024) - London, United Kingdom Duration: 11 Apr 2024 → 14 Apr 2024 |
Scientific committee
| Scientific committee | World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO 2024) |
|---|---|
| Country/Territory | United Kingdom |
| City | London |
| Period | 11/04/24 → 14/04/24 |