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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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Daniëls, R., van Rossum, E., Metzelthin, S., Sipers, W. M. W. H., Habets, H., Hobma, S., van den Heuvel, W. J., & de Witte, L. (2011) · Clinical Rehabilitation · doi:10.1177/0269215511410728 · Cited by 47
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“Large scale RCTs, therefore, need to be powered to assess the effects of PSTupon a more comprehensive set of outcomes more relevant to older people, particularly functioning (a key frailty outcome) (Ferrucci et al., 2004) and quality of life (Lenze et al., 2016), especially in the long term.”
BackgroundAssessment of frailty in Saudi community-dwelling older adults: validation of measurements
Alqahtani, B. A., & Nasser, T. A. (2019) · Annals of Saudi Medicine · doi:10.5144/0256-4947.2019.197 · Cited by 39
Gibbs, J. C., McArthur, C., Wark, J. D., Thabane, L., Scherer, S. C., Prasad, S., Παπαϊωάννου, Α., Mittmann, N., Laprade, J., Kim, S. S. Y., et al. (2019) · Physical Therapy · doi:10.1093/ptj/pzz188 · Cited by 42
Cordes, T., Zwingmann, K., Rudisch, J., Voelcker‐Rehage, C., & Wollesen, B. (2021) · Experimental Gerontology · doi:10.1016/j.exger.2021.111484 · Cited by 38
Fattori, A., Santimaria, M. R., Alves, R. M., Guariento, M. E., & Neri, A. L. (2012) · Archives of Gerontology and Geriatrics · doi:10.1016/j.archger.2012.08.004 · Cited by 38
“However, whereas in FIBRA the most common criterion was reduced grip strength, in The Women’s Health and Aging Study and The Cardiovascular Health Study (Bandeen-Roche et al., 2006; Fried et al., 2001) reduced gait speed predominated.”
MethodInfluentialPerceived social support following myocardial infarction and long-term development of frailty
Lurie, I., Myers, V., Goldbourt, U., & Gerber, Y. (2014) · European Journal of Preventive Cardiology · doi:10.1177/2047487314544575 · Cited by 38
“Frailty is a multidimensional age-related syndrome that indicates increasing vulnerability and decreasing physiological reserves and resistance to stressors, resulting from a generalized decline or accumulation of deficits in multiple physiological systems.(1,2) Frailty is associated with adverse health outcomes, whic…”
BackgroundYamanashi, H., Shimizu, Y., Higashi, M., Koyamatsu, J., Sato, S., Nagayoshi, M., Kadota, K., Kawashiri, S., Tamai, M., Takamura, N., et al. (2017) · Geriatrics and gerontology international/Geriatrics & gerontology international · doi:10.1111/ggi.13166 · Cited by 39
“Frailty is defined as increased vulnerability to stress and increased susceptibility to adverse outcomes due to declines in multiple body systems with age [1].”
BackgroundGajic‐Veljanoski, O., Παπαϊωάννου, Α., Kennedy, C. C., Ioannidis, G., Berger, C., Wong, A. K. O., Rockwood, K. J., Kirkland, S., Raina, P. S., Thabane, L., et al. (2018) · BMC Geriatrics · doi:10.1186/s12877-017-0692-0 · Cited by 38
“Current research has been mainly focused on examining causes, pharmacological and non-pharmacological treatments for sarcopenia [32, 33].”
BackgroundDance as Prevention of Late Life Functional Decline Among Nursing Home Residents
Macháčová, K., Vaňková, H., Volicer, L., Veleta, P., & Holmerová, I. (2015) · Journal of Applied Gerontology · doi:10.1177/0733464815602111 · Cited by 37
“Residents of NHs represent one of the most vulnerable, often functionally impaired, populations of older adults who are at high risk of further decline leading to a complete loss of independence and other related deleterious consequences (Ferrucci et al., 2004).”
BackgroundNormative data for the Brief Cognitive Screening Battery stratified by age and education
Yassuda, M. S., da Silva, H. S., da Silva, T. B. L., Cachioni, M., Falcão, D. V. D. S., Lopes, A., Batistoni, S. S. T., & Neri, A. L. (2017) · Dementia & Neuropsychologia · doi:10.1590/1980-57642016dn11-010008 · Cited by 37
A comparison of the relationship of 14 performance-based measures with frailty in older women
Theou, O., Jones, G. R., Jakobi, J. M., Mitnitski, A., & Vandervoort, A. A. (2011) · Applied Physiology, Nutrition, and Metabolism · doi:10.1139/h11-116 · Cited by 38
“Frailty is an age-related state of vulnerability to adverse outcomes, which has a devastating impact on older adults, their family, and society (Fried et al. 2004).”
BackgroundSuijker, J. J., Buurman, B. M., ter Riet, G., van Rijn, M., de Haan, R. J., de Rooij, S. E., & van Charante, E. P. M. (2012) · BMC Health Services Research · doi:10.1186/1472-6963-12-85 · Cited by 41
“Attrition of vulnerable older persons is frequently encountered in trials conducted in this population [25].”
BackgroundGazala, S., Tul, Y., Wagg, A., Widder, S. L., & Khadaroo, R. G. (2013) · World Journal of Emergency Surgery · doi:10.1186/1749-7922-8-23 · Cited by 36
“Assessment of function and frailty in the elderly is gaining popularity as a predictor of outcomes in older patients undergoing surgery [7,8].”
BackgroundLohman, M. C., Resciniti, N. V., Wirth, M. D., Shivappa, N., & Hébert, J. R. (2019) · Journal of Nutrition in Gerontology and Geriatrics · doi:10.1080/21551197.2018.1552226 · Cited by 37
“Several frailty prevention approaches have been developed, focusing on nutritional supplementation, education, and counseling, but their efficacy in preventing frailty or frailty symptoms is mixed.(46,49) Few nutritional interventions specifically target dietary inflammation or obesity reduction, instead attempting to…”
BackgroundMeerkerk, C. D. A., Chargi, N., de Jong, P. A., van den Bos, F., & de Bree, R. (2020) · Journal of Geriatric Oncology · doi:10.1016/j.jgo.2020.10.002 · Cited by 36
Lee, D. U., Kwon, J., Han, J., Fan, G. H., Hastie, D. J., Lee, K. J., & Karagozian, R. (2021) · Gastric Cancer · doi:10.1007/s10120-021-01265-7 · Cited by 36
Denkinger, M. D., Igl, W., Coll‐Planas, L., Bleicher, J., Nikolaus, T., & Jamour, M. (2008) · Journal of the American Geriatrics Society · doi:10.1111/j.1532-5415.2008.02095.x · Cited by 36
“In addition, a recent consensus report on designing trials in frail older persons, indicated that standardized and well-defined self-reported measures of physical function and disability should accompany performance-based outcomes.(4) It further emphasized the importance of being able to differentiate between assessme…”
BackgroundDrug treatment in an ageing population: Practical implications
Wynne, H., & Blagburn, J. (2010) · Maturitas · doi:10.1016/j.maturitas.2010.03.004 · Cited by 35
Multimorbidity, frailty and chronic obstructive pulmonary disease
Holland, A. E., Harrison, S. L., & Brooks, D. (2016) · Chronic Respiratory Disease · doi:10.1177/1479972316670104 · Cited by 35
“In the geriatric literature, physical frailty is based on a definition provided by ‘the interventions on frailty working group’ including mobility, strength, balance, motor processing, cognition, nutrition, endurance and physical activity.(12) Until recently, frailty had not been considered in individuals with COPD, n…”
BackgroundThe need of operational paradigms for frailty in older persons: the SPRINTT project
Cesari, M., Marzetti, E., Calvani, R., Vellas, B. J., Bernabei, R., Bordes, P., Roubenoff, R., Landi, F., & Cherubini, A. (2017) · Aging Clinical and Experimental Research · doi:10.1007/s40520-016-0712-5 · Cited by 35
Thibeau, S., McDermott, K. L., McFall, G. P., Rockwood, K. J., & Dixon, R. A. (2019) · Alzheimer s Research & Therapy · doi:10.1186/s13195-019-0509-9 · Cited by 36
“For each participant, the frailty index tallied the total number of physical health deficits from 50 variables (see Table 3) which previous work suggests is sufficient for accurately predicting adverse outcomes [28].”
MethodFrailty—A promising concept to evaluate disease vulnerability
Ribeiro, A. R., Howlett, S. E., & Fernandes, A. M. A. (2020) · Mechanisms of Ageing and Development · doi:10.1016/j.mad.2020.111217 · Cited by 37
Síndrome da fragilidade no idoso: importância da fisioterapia
Macedo, C., Gazzola, J. M., & Najas, M. S. (2008) · Arquivos Brasileiros de Ciências da Saúde · doi:10.7322/abcs.v33i3.154 · Cited by 35
van Dalen, M. T., Suijker, J. J., Vroomen, J. L. M., van Rijn, M., van Charante, E. P. M., de Rooij, S. E., & Buurman, B. M. (2014) · PLoS ONE · doi:10.1371/journal.pone.0093372 · Cited by 35
“In longitudinal studies on frail older persons, it is important to note that attrition may be directly related to the primary outcome [20].”
BackgroundMänty, M., Heinonen, A. O., Viljanen, A., Pajala, S., Koskenvuo, M., Kaprio, J. A., & Rantanen, T. (2009) · Osteoporosis International · doi:10.1007/s00198-009-0950-x · Cited by 35
Economic evaluation of a geriatric rehabilitation programme: A randomized controlled trial
Kehusmaa, S., Autti-Rämö, I., Valaste, M., Hinkka, K., & Rissanen, P. (2010) · Journal of Rehabilitation Medicine · doi:10.2340/16501977-0623 · Cited by 35
Under-representation of the elderly in clinical trials
Rehman, H. U. (2005) · European Journal of Internal Medicine · doi:10.1016/j.ejim.2005.08.001 · Cited by 35
“A consensus report on designing randomised controlled trials in frail, elderly people recommended ‘‘that traditional exclusion criteria (such as co-morbidity and poor cognitive function) should be avoided or at least minimised’’ [16].”
BackgroundAging in Place in Late Life: Theory, Methodology, and Intervention
Fänge, A. M., Oswald, F., & Clemson, L. M. (2012) · Journal of Aging Research · doi:10.1155/2012/547562 · Cited by 34
Physical Performance and Quality of Life of Nursing-Home Residents with Mild and Moderate Dementia
Telenius, E. W., Engedal, K., & Bergland, A. (2013) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph10126672 · Cited by 41
“Functional status affects the QoL in old age [42].”
BackgroundKuzuya, M. (2012) · PubMed Central · doi:10.18999/nagjms.74.1-2.31 · Cited by 34
Gait Variability Detects Women in Early Postmenopause With Low Bone Mineral Density
Palombaro, K. M., Hack, L. M., Mangione, K. K., Barr, A. E., Newton, R. A., Magri, F., & Speziale, T. (2009) · Physical Therapy · doi:10.2522/ptj.20080401 · Cited by 35
Short-Term Impact of Income on Cognitive Function: Evidence From a Sample of Mexican Older Adults
Aguila, E., & Casanova, M. (2019) · Journal of Aging and Health · doi:10.1177/0898264319841155 · Cited by 36
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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