Abstract
Intrinsic capacity (IC) is defined as the composite of the physical and mental attributes of an individual and is an emerging construct developed by the WHO in 2016. IC interventions may improve the aging process, towards Healthy Aging. Core outcome sets (COS) enhance efficiency of research, because harmonize endpoints and facilitate comparison among interventions. To date, as IC is relatively new, no COS for IC intervention studies is available yet, and its development is urgently needed. This protocol aims to outline the scope and methodology, stakeholders involvement, procedures, and consensus processes of the COS for IC intervention studies.
Methods:
The COS-STAndards for Development (COS-STAD) recommendations and COS-STAndardised Protocol Items (COS-STAP) Statement have been followed to conduct this research, and this study protocol has been registered in the Core Outcome Measures in Effectiveness Trials (COMET) database. A working group was gathered under the auspices of the WHO Collaborating Centre for Public Health Aspects of Musculo-Skeletal Health and Ageing, University of Liège, Liège (Belgium) and the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO), involving multiple international experts and a group of patient participants. First, a scoping review (ScR) will be conducted, to identify the outcomes and measurement tools used in IC intervention studies. The review was registered in the International prospective register of systematic reviews (PROSPERO_CRD42023437223) and will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). The review will consider randomized controlled trials published in Medline, Scopus, Embase, Cochrane Central Register of Controlled Trials, and clinicaltrials.gov, until June 2023. Second, as patients’ values and preferences should be taken into consideration, the insight from adult population in midlife and beyond and older people’s will be obtained fom direct interviews. Third, the results of the ScR and the interviews will be discussed within a larger group of key stakeholders and international experts from scientific societies during a Delphi process in two consecutive rounds, to achieve a consensus on the most relevant outcomes and measurement tools. Fourth, a consensus meeting among the working group members will be held to validate results from the ScR, the patient interviews, and the Delphi process. Finally, the COS-STAndards for Reporting (COS-STAR) will be followed. It is expected that the outcomes identified by the COS are taken into consideration in IC trials, to facilitate comparisons among interventions, enhance transparency, and guide clinical and Public Health actions towards Healthy aging.
There is no COS for IC intervention studies registered in the COMET initiative, and also there is no similar initiative registered in PROSPERO or any other registry.
Co-PI: Dolores Sanchez-Rodriguez, MD PhD
Geriatrics Department, Brugmann University Hospital, Université Libre de Bruxelles, Place A. Van Gehuchten 4, 1020 Brussels, Belgium. Tel: +32 493 43 27 50; Email: dolo.sanchezr@gmail.com and DoloresMaria.SANCHEZ-RODRIGUEZ@chu-brugmann.be
World Health Organization Collaborating Center for Public Health aspects of Musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Campus Sart Tilman, Quartier Hôpital, Avenue Hippocrate 13 (Bât. B23), 4000 Liège, Belgium.
Geriatrics Department, Rehabilitation Research Group, Parc Salut Mar, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.
Co-PI: Charlotte Beaudart, PhD
Research Institute for Life Sciences (NARILIS), Faculty of Medicine, University of Namur, Namur, Belgium
World Health Organization Collaborating Center for Public Health aspects of Musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Campus Sart Tilman, Quartier Hôpital, Avenue Hippocrate 13 (Bât. B23), 4000 Liège, Belgium. Tel: +32 495 73 96 12: Tel: +32 493 43 27 50; Email: c.beaudart@uliege.be
Contributors
• Prof. Olivier Bruyère
• Prof. Jean-Yves Reginster
WHO Collaborating Centre for Public Health Aspects of Musculo-Skeletal Health and Ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium
• Prof. Murielle Surquin
Medicine Department, Geriatrics Department, Brugmann University Hospital, Université Libre de Bruxelles, Brussels, Belgium
Disease Category: Public health
Disease Name: N/A
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Epidemiologists
- Families
- Methodologists
- Researchers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Survey
- Systematic review
1. Development and registration of the COS study protocol
The study protocol followed the COS-STAP and has been registered in the COMET Initiative database in June 2023.
2. Scoping review to identify frequently reported outcomes.
A scoping review aimed to identify the outcomes (and measurement tools) used in IC intervention studies, both in published literature and in registries was scheduled as first step towards a core outcome set (COS) for IC trials. The review has been registered in the International prospective register of systematic reviews (PROSPERO_CRD42023437223) database in June 2023. The Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) will be followed. The review will consider randomized controlled trials published in Medline, Scopus, Embase, Cochrane Central Register of Controlled Trials, and clinicaltrials.gov, until June 2023.
3. Reporting outcomes in the adult population in midlife and beyond and older people
As there is growing interest in involving patients in Public Health decisions, and in their own’s health, therefore, the participation of the adult population in midlife and beyond will be requested. Their insight and perspectives will be identified by qualitative interviews about the outcomes they considered important from their opinion as end-users.
The older volunteers and patients’ values and preferences will be assessed by direct interviews both to 5 healthy participants and 5 patients with declines in IC. These 10 direct interviews to the 10 volunteers =65-year-old will be conducted in Brugmann university hospital, Brussels. The insight from these interviews will be assessed by qualitative research methods. Further details about the patient interviews will be available in Open Science Framework.
4. An international Delphi consensus process in two consecutive rounds
In summary, after the ScR and the patient interviews have been conducted and the outcomes (and measurement tools) have been identified and listed, an international Delphi consensus process in two consecutive rounds, in English, will be conducted. The objective of the Delphi process is to achieve expert consensus about the clinically and scientifically meaningful outcomes and measurement tools to be used in IC intervention studies, based on the findings of the review. The Delphi will focus in answering two major questions,
Q1. Which outcomes should be measured in IC intervention studies AND
Q2. How these outcomes should be measured?
Participants in the Delphi. The Delphi consensus process will involve key stakeholders, i.e., international researchers with background in the field of IC, epidemiologist and Public Health researchers, methodologist, clinical trial designers, professionals in the study of aging and its effects in individuals and society (gerontologist), and clinical experts (e.g., rehabilitation specialists, geriatricians, primary physicians, etc.), as potential end-users and consumers.
Sampling. A purposing sampling strategy, aimed to have a balanced representation across different stakeholders, including both clinical and research experts, gender balance, and representativeness of different countries will be conducted. Based on published literature about a recent COS development process [4], the study aims to recruit 100 participants for the Delphi, to allow attrition and increase the probability of having the 2-round Delphi process completed for at least 50 participants.
Recruitment. Presidents or directors of scientific entities in the field of ageing and IC will be contacted to inform about the COS initiative and ask if the survey could be sent to the members of the society they represent. Likewise, permission will be sent to Special Interest Groups leaders within those societies, requesting their permission to share the invitation for the Delphi among their members. Once the permission has been obtained, the Delphi process will be launched by addressing a mail invitation to registered members of the scientific societies, Special Interest Groups members, etc. Moreover, the advertisement to participate in the Delphi process may be posted in the website of the scientific societies, before and during the time the Delphi is ongoing, to help visibility and enhance inclusive participation. Moreover, other stakeholders and experts from our networks with clinical and/or scientific expertise in IC and/or geriatric care would be invited.
The potential respondent/experts will be given a 4-week timeframe to reply. A reminder to those interested in participation without any reply and the non-respondents will be sent after 14 days. Further details about the Delphi consensus process will be available in Open Sciences Framework.
5. Consensus meeting(s)
One or more consensus meetings among the working group members would be held once the 2-round Delphi process is available (expected to be completed before October 2024). The aim is to share the findings among the working group (and the participants of the voting process who may wish to participate), take final decisions about the COS, and discuss potential further steps.
6. Final reporting and publishing of results of the COS
The final reporting of the COS will follow the COS-STAR recommendations. It is expected that the results will be published, and the findings shared in scientific meetings/congress (Expected EuGMS September 2024 and/or ESCEO congress April 2025, if possible).
7. Ethical aspects
Data will be treated in accordance the General Data Protection Regulation 2016/679 of the European Parliament and Council. The ScR and the consensus process do not involve any participants’ data. The study protocol, information file, and informed consent for the qualitative assessment and direct interviews to 10 older participants will be submitted to the Brugmann Ethics Committee for approval. The study will be conducted according to the Good Clinical Practice Guidelines, the Declaration of Helsinki, and its later amendments.
8. Funding
No funding has been received to conduct this research.
9. Conflicts of interest
DS-R, OB, Y-IR, and CB serve as Senior Advisors to the World Health Organization (WHO) Collaborating Center for Epidemiology of Musculoskeletal Health and Aging, Division of Public Health, Epidemiology, and Health Economics, University of Liège, Liège, Belgium. Y-IR serves as a member of the Board of Directors of the Clinical Consortium on Healthy Ageing (CCHA) of the WHO, Geneve, Switzerland. authors declare they do not have any personal or financial relationships with other organizations or people that could inappropriately influence their work.