Cited by 1,027Frailty in Older AdultsStatistical Methods in Clinical TrialsEthics in Clinical Research

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Designing Randomized, Controlled Trials Aimed at Preventing or Delaying Functional Decline and Disability in Frail, Older Persons: A Consensus Report

Ferrucci, Luigi, Guralnik, Jack M., Studenski, Stephanie, Fried, Linda P., Cutler, Gordon B., Walston, Jeremy D., The Interventions on Frailty Working Group·2004·Journal of the American Geriatrics Society

DOI 10.1111/j.1532-5415.2004.52174.x

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Abstract

The discovery of effective interventions to prevent or delay disability in older persons is a public health priority. Most likely to benefit from such interventions are frail individuals who are not yet disabled and those with early disability who are at high risk of progression. In spite of this frail older persons have often been excluded from research on the assumption that they would not tolerate testing or benefit from treatment. The Interventions on Frailty Working Group developed recommendations to screen, recruit, evaluate, and retain frail older persons in clinical trials. Specific recommendations are: Eligibility screening should include a multistage process, to quickly exclude those who are too well and those who are too sick. Inclusion criteria should target those most likely to benefit, be meaningful to clinicians, and reflect advancements in the frailty research area. Disability outcome measures should include self‐reported, objective, and proxy measures. Strategies to improve retention and compliance and to monitor their effectiveness should be an integral part of the study design. Estimation of cost and sample size should contemplate high dropout rates and interference bycompeting outcomes. Additional research is needed to refine criteria for screening frail older persons, identify objective measures of disability that are reliable and valid in frail older persons, and improve the informed consent process for high‐risk participants, recognizing that research in this subgroup is essential to improving their health outcomes.

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Method
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Method
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Background
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Vulnerable Older People in the Community: Relationship Between the Vulnerable Elders Survey and Health Service Use
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The aging population – Is there a role for endocrine interventions?
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Dynamics of frailty and ADL dependence in a five-year longitudinal study of octogenarians
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Prevalence of frailty and associated factors among Saudi community-dwelling older adults: a cross-sectional study
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Authors: Ferrucci, L., Guralnik, J. M., Studenski, S., Fried, L. P., Cutler, G. B., Walston, J. D., & The Interventions on Frailty Working Group
Affiliations: National Institutes of Health (US)
ORCID: Ferrucci, Luigi
Guralnik, Jack M.
Studenski, Stephanie
Fried, Linda P.
Cutler, Gordon B.
Walston, Jeremy D.
Venue: Journal of the American Geriatrics Society
Publisher: Wiley
Published: 2004-03-30
Volume: 52
Issue: 4
Pages: 625-634
ISSN: 0002-8614 (ISSN-L)
1532-5415
DOI: 10.1111/j.1532-5415.2004.52174.x
OpenAlex: W1562992882
Cited by: 1,027
References: 79
Citations by year: 2026: 19 · 2025: 31 · 2024: 24 · 2023: 22 · 2022: 22 · 2021: 31 · 2020: 48 · 2019: 58 · 2018: 49 · 2017: 49 · 2016: 51 · 2015: 55 · 2014: 62 · 2013: 72 · 2012: 70
FWCI: 18.73
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Journal of the American Geriatrics Society (publishedVersion)
PubMed (publishedVersion)
Funders: Eli Lilly and Company
Topics: Health Sciences › Medicine › Geriatrics and Gerontology › Frailty in Older Adults
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Keywords: frailty, older adults, disability prevention, functional decline, clinical trial design, participant recruitment, participant retention, sample size determination, dropout, informed consent
MeSH terms: Activities of Daily Living, Aged, Chronic Disease, Geriatrics, Persons with Disabilities, Health Priorities, Humans, Mass Screening, Periodicals as Topic, Planning Techniques, Primary Prevention, Public Health, Publishing, Research Design, Risk Factors, Geriatric Assessment, Randomized Controlled Trials as Topic, Frail Elderly, Outcome Assessment, Health Care, Sample Size, Disease Progression, Patient Selection

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Designing Randomized, Controlled Trials Aimed at Preventing or Delaying Functional Decline and Disability in Frail, Older Persons: A Consensus Report

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