The DOI matches its Crossref record; 76 of the 79 references it cites were found in a registry or an index.
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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“The study is in accord with recent recommendations that geriatric rehabilitation research should focus on high-risk groups, use an interdisciplinary team approach and assess the outcome with standardized measures (Wells et al., 2003; Ferrucci et al., 2004).”
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Ávila‐Funes, J. A., Aguilar-Navarro, S. G., & Melano‐Carranza, E. (2008) · PubMed · Cited by 17
Arnold, P., Njemini, R., Vantieghem, S., Gorus, E., Pool‐Goudzwaard, A., Buyl, R., & Bautmans, I. (2018) · Experimental Gerontology · doi:10.1016/j.exger.2018.04.002 · Cited by 15
“Stable morbidity was not an exclusion criterion per se (Ferrucci et al., 2004).”
Alqahtani, B. A., Abdelbasset, W. K., & Alenazi, A. M. (2020) · Archives of Gerontology and Geriatrics · doi:10.1016/j.archger.2020.104128 · Cited by 15
Westgård, T., Hammar, I. O., Dahlin‐Ivanoff, S., & Wilhelmson, K. (2020) · Geriatrics · doi:10.3390/geriatrics5040101 · Cited by 15
“As a consequence, people who are frail have a higher prevalence of the risk of falling, hospitalization, and institutionalization [9,10].”
BackgroundCezar, N. O. D. C., Aprahamian, I., Ansai, J. H., de Oliveira, M. P. B., da Silva, D. C. P., Gomes, W. D. L., Barreiros, B. A., Langelli, T. D. C. O., & de Andrade, L. P. (2021) · Experimental Gerontology · doi:10.1016/j.exger.2021.111390 · Cited by 15
“Frail individuals commonly have impaired mobility, balance, strength, cognition, nutrition and physical activity (Ferrucci et al., 2004), exerting a negative impact on functioning and increasing the risk of falls (Zidan et al., 2012).”
BackgroundBrach, M., Moschny, A., Bücker, B., Klaaßen‐Mielke, R., Trampisch, M., Wilm, S., Platen, P., & Hinrichs, T. (2013) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph10126611 · Cited by 15
“This also is in line with a consensus report on preventive interventional trials in older persons [19].”
BackgroundResultInfluentialTurunen, K. M., Sipilä, S., Rantanen, T., Seppänen, J., Lavikainen, P., Sulkava, R. O., & Hartikainen, S. A. (2012) · Aging Clinical and Experimental Research · doi:10.1007/bf03325264 · Cited by 15
Chen, N., Li, X., Wang, J., Zhou, C., & Wang, C. (2018) · Archives of Gerontology and Geriatrics · doi:10.1016/j.archger.2018.12.002 · Cited by 15
Life satisfaction and participation among community-dwelling older adults: Data from the FIBRA study
Bertelli-Costa, T., & Neri, A. L. (2019) · Journal of Health Psychology · doi:10.1177/1359105319893020 · Cited by 16
“Following the guidelines of Ferrucci et al. (2004), the following exclusion criteria were used: presence of memory, attention, communication, or spatial and time orientation problems suggestive of cognitive impairment; permanent or temporary inability to walk without using walking aids; localized…”
MethodBeyer, I., Njemini, R., Bautmans, I., Demanet, C. J., & Mets, T. F. (2011) · Cell Stress and Chaperones · doi:10.1007/s12192-011-0304-4 · Cited by 15
Sieber, F. E., & Pauldine, R. W. (2010) · Elsevier eBooks · doi:10.1016/b978-0-443-06959-8.00071-6 · Cited by 15
Dismore, L. L., Hurst, C., Granic, A., Tullo, E., Witham, M. D., Dodds, R. M., Sayer, A. A., & Robinson, S. M. (2023) · Journal of Frailty Sarcopenia and Falls · doi:10.22540/jfsf-08-230 · Cited by 17
“The Interventions on Frailty Group developed recommendations to screen, recruit, evaluate and retain older adults with frailty in clinical trials 60 .”
BackgroundAli, T. F., Warkentin, L. M., Gazala, S., Wagg, A., Padwal, R. S., Khadaroo, R. G., & the Acute Care and Emergency Surgery (ACES) Group (2015) · Journal of the American Geriatrics Society · doi:10.1111/jgs.13783 · Cited by 14
Self-citationFrailty Syndrome in Heart Failure Patients who are Receiving Cardiac Resynchronization
Młynarska, A., Młynarski, R., Biernat, J., Sosnowski, M., & Golba, K. S. (2015) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.12800 · Cited by 14
Neuromotor training in older women living in long-term care setting: A pilot study
Brustio, P. R., Magistro, D., Ivaldi, S., Caglio, M., Rabaglietti, E., & Liubicich, M. E. (2015) · Geriatric Nursing · doi:10.1016/j.gerinurse.2015.05.002 · Cited by 14
Wilhelmson, K., & Eklund, K. (2013) · Health Psychology Research · doi:10.4081/hpr.2013.636 · Cited by 14
Soares, L. M., Cachioni, M., Falcão, D. V. D. S., Batistoni, S. S. T., Lopes, A., Neri, A. L., & Yassuda, M. S. (2012) · Archives of Gerontology and Geriatrics · doi:10.1016/j.archger.2011.11.014 · Cited by 14
“The inclusion and exclusion criteria were adapted from the CHS (Ferrucci et al., 2004).”
BackgroundMcNally, M., & Lahey, W. (2015) · Interdisciplinary topics in gerontology and geriatrics · doi:10.1159/000381235 · Cited by 14
Jáuregui, J. R., & Rubin, R. (2024) · Revista Ocronos · doi:10.58842/khqw9097 · Cited by 14
White, M. C., Randall, K., Alcorn, D., Greenland, R., Glasgo, C., & Shrime, M. G. (2018) · BMC Health Services Research · doi:10.1186/s12913-018-3112-z · Cited by 14
Bjerk, M., Brovold, T., Davis, J. C., Skelton, D. A., & Bergland, A. (2019) · European Journal of Public Health · doi:10.1093/eurpub/ckz106 · Cited by 14
de Jonghe, A., van de Glind, E. M. M., Munster, B. C. V., & de Rooij, S. E. (2014) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2013.12.007 · Cited by 14
Yang, R., Donaldson, G. W., Edelman, L. S., Cloyes, K. G., Sanders, N. A., & Pepper, G. A. (2020) · Journal of Advanced Nursing · doi:10.1111/jan.14473 · Cited by 13
THE EUROPEAN UNION GERIATRIC MEDICINE SOCIETY (EUGMS) WORKING GROUP ON FRAILTY IN OLDER PERSONS
Cesari, M., van Kan, G. A., Arıoğul, S., Baeyens, J., Bauer, J. M., Cankurtaran, M., CEDERHOLM, T., Cherubini, A., Cruz-Jentoft, A. J., Çurgunlu, A., et al. (2013) · The Journal of Frailty & Aging · doi:10.14283/jfa.2013.15 · Cited by 13
A mobile proposal for frailty monitoring by rehabilitation and physical daily activity
Bravo, J., Fontecha, J., Navarro, F. J., & Hervás, R. (2011) · IEEE International Conference on Consumer Electronics - Berlin (ICCE-Berlin) · doi:10.1109/icce-berlin.2011.6031839 · Cited by 13
“It determines, in an objective way, the physical state of pre-frailty or fragility of an elderly people, from quantifiable values of different physical components used to determine the frailty syndrome [12]: mobility, balance, endurance and physical activity.”
BackgroundPereira, A. A., Borim, F. S. A., & Neri, A. L. (2017) · Cadernos de Saúde Pública · doi:10.1590/0102-311x00194115 · Cited by 13
Laddu, D., Wertheim, B. C., Garcia, D. O., Woods, N. F., LaMonte, M. J., Chen, B. H., Anton‐Culver, H., Zaslavsky, O., Cauley, J. A., Chlebowski, R. T., et al. (2018) · Journal of the American Geriatrics Society · doi:10.1111/jgs.15273 · Cited by 13
“The Medical Outcomes Study 36-item Short-Form Physical Function Index (SF-36 PF)(5) is a commonly used, validated questionnaire method with high sensitivity to detect functional status, among other aspects of quality of life.(10,11) Clinical PCMD and self-reported assessments of mobility disabilities have been shown t…”
Błaszczyszyn, M., Szczęsna, A., & Piechota, K. (2019) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph16224307 · Cited by 13
“A report on a research project conducted by a group of Italian and American geriatricians recommended that the following factors should be included in the assessment of FS in physiological areas: mobility, balance, muscle strength, walking, cognitive function, nutrition, and physical activity [4].”
BackgroundInfluential
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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