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 by competing 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.

Multi-component health promotion and disease prevention for community-dwelling frail elderly persons: a systematic review

“…There is a growing need of interventions targeting elderly people at risk for decline, particularly frail elderly persons who are suffering from co-morbidity, facing functional decline and at risk of, or already, losing their ability to manage everyday activities (Tinetti et al 1994;Ferrucci et al 2004;Gill 2005;Vass et al 2005). It is a heterogeneous group of people at various stages in the process of declining functional ability, and their need of care and rehabilitation varies according to their overall health and functional status.…”

“…Several reports suggest that there is no single approach that effectively addresses functional problems. Similar to other geriatric syndromes, a multi-component approach may more effectively address functional difficulties (Elkan et al 2001;Stuck et al 2002;Ferrucci et al 2004). Consequently, a multi-component health-promoting and disease-preventive intervention programme (HPDP programme) could avert and delay dependence in ADL and the development of functional decline.…”

“…Frailty has become an established concept in research in recent years (Fried et al 2001;Hogan et al 2003;Ferrucci et al 2004;Rockwood 2005a, b;Socialstyrelsen 2007). Notwithstanding, there is no consensus definition (Fried et al 2001;Hogan et al 2003;Ferrucci et al 2004;Rockwood 2005a, b), and different terms are used for defining the concept (Hogan et al 2003).…”

“…Notwithstanding, there is no consensus definition (Fried et al 2001;Hogan et al 2003;Ferrucci et al 2004;Rockwood 2005a, b), and different terms are used for defining the concept (Hogan et al 2003). Frailty becomes more prevalent with age and is associated with an elevated risk for adverse health outcomes including falls, hospitalisation, institutionalisation and mortality (Fried et al 2001;Rockwood 2005a, b).…”

“…Frailty becomes more prevalent with age and is associated with an elevated risk for adverse health outcomes including falls, hospitalisation, institutionalisation and mortality (Fried et al 2001;Rockwood 2005a, b). One definition of frailty is: a state of decreased reserve resistance to stressors as a result of cumulative decline across multiple physiological systems, causing vulnerability to different outcomes (Ferrucci et al 2004). This definition of frailty is related to disability and co-morbidity, factors occasionally included in the concept itself and at times explained in relation to frailty (Hogan et al 2003).…”