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Designing Randomized, Controlled Trials Aimed at Preventing or Delaying Functional Decline and Disability in Frail, Older Persons: A Consensus Report
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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Metadata
- 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
- 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
- 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
- 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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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