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      Evaluation of Clinically Meaningful Changes in Measures of Frailty

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          Abstract

          Background

          To determine the clinically meaningful changes and responsiveness of widely used frailty measures.

          Methods

          We analyzed data from a prospective cohort study of 1,135 community-dwelling older adults who underwent assessments of frailty and health-related quality of life using the EuroQol-5D at baseline and 1 year later. Frailty measures included deficit-accumulation frailty index (FI); frailty phenotype; Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale; and the Study of Osteoporotic Fracture (SOF) index. We determined the clinically meaningful changes by the distribution-based method and the anchor-based method using the EuroQol-5D score and responsiveness indices.

          Results

          Frailty measures were available in 925 participants at 1 year (81.5%). Based on the distribution-based method, small and large clinically meaningful changes were 0.019 and 0.057 for FI, 0.249 and 0.623 for frailty phenotype, 0.235 and 0.587 for FRAIL scale, and 0.116 and 0.289 for SOF index, respectively. The anchor-based estimates of small and large changes were 0.028 and 0.076 for FI, 0.097 and 0.607 for frailty phenotype, 0.269 and 0.368 for FRAIL scale, and 0.023 and 0.287 for SOF index, respectively. Based on the responsiveness index, per-group sample sizes to achieve 80% power in clinical trials, ranged from 51 (FI) to 7,272 (SOF index) for a small change and 9 (FI) to 133 (FRAIL scale) for a large change.

          Conclusions

          The estimates of clinically meaningful change of frailty measures can inform the choice of frailty measures to track longitudinal changes of frailty in clinical trials and clinical care of community-dwelling older adults.

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          Most cited references12

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          Frailty: an emerging research and clinical paradigm--issues and controversies.

          Clinicians and researchers have shown increasing interest in frailty. Yet, there is still considerable uncertainty regarding the concept and its definition. In this article, we present perspectives on key issues and controversies discussed by scientists from 13 different countries, representing a diverse range of disciplines, at the 2006 Second International Working Meeting on Frailty and Aging. The following fundamental questions are discussed: What is the distinction, if any, between frailty and aging? What is its relationship with chronic disease? Is frailty a syndrome or a series of age-related impairments that predict adverse outcomes? What are the critical domains in its operational definition? Is frailty a useful concept? The implications of different models and approaches are examined. Although consensus has yet to be attained, work accomplished to date has opened exciting new horizons. The article concludes with suggested directions for future research.
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            Frailty assessment instruments: Systematic characterization of the uses and contexts of highly-cited instruments.

            The medical syndrome of frailty is widely recognized, yet debate remains over how best to measure it in clinical and research settings. This study reviewed the frailty-related research literature by (a) comprehensively cataloging the wide array of instruments that have been utilized to measure frailty, and (b) systematically categorizing the different purposes and contexts of use for frailty instruments frequently cited in the research literature. We identified 67 frailty instruments total; of these, nine were highly-cited (≥ 200 citations). We randomly sampled and reviewed 545 English-language articles citing at least one highly-cited instrument. We estimated the total number of uses, and classified use into eight categories: risk assessment for adverse health outcomes (31% of all uses); etiological studies of frailty (22%); methodology studies (14%); biomarker studies (12%); inclusion/exclusion criteria (10%); estimating prevalence as primary goal (5%); clinical decision-making (2%); and interventional targeting (2%). The most common assessment context was observational studies of older community-dwelling adults. Physical Frailty Phenotype was the most used frailty instrument in the research literature, followed by the Deficit Accumulation Index and the Vulnerable Elders Survey. This study provides an empirical evaluation of the current uses of frailty instruments, which may be important to consider when selecting instruments for clinical or research purposes. We recommend careful consideration in the selection of a frailty instrument based on the intended purpose, domains captured, and how the instrument has been used in the past. Continued efforts are needed to study the validity and feasibility of these instruments.
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              South Korean time trade-off values for EQ-5D health states: modeling with observed values for 101 health states.

              This study establishes the South Korean population-based preference weights for EQ-5D based on values elicited from a representative national sample using the time trade-off (TTO) method. The data for this paper came from a South Korean EQ-5D valuation study where 1307 representative respondents were invited to participate and a total of 101 health states defined by the EQ-5D descriptive system were directly valued. Both aggregate and individual level modeling were conducted to generate values for all 243 health states defined by EQ-5D. Various regression techniques and model specifications were also examined in order to produce the best fit model. Final model selection was based on minimizing the difference between the observed and estimated value for each health state. The N3 model yielded the best fit for the observed TTO value at the aggregate level. It had a mean absolute error of 0.029 and only 15 predictions out of 101 had errors exceeding 0.05 in absolute magnitude. The study successfully establishes South Korean population-based preference weights for the EQ-5D. The value set derived here is based on a representative population sample, limiting the interpolation space and possessing better model performance. Thus, this EQ-5D value set should be given preference for use with the South Korean population.
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                Author and article information

                Contributors
                Role: Decision Editor
                Journal
                J Gerontol A Biol Sci Med Sci
                J. Gerontol. A Biol. Sci. Med. Sci
                gerona
                The Journals of Gerontology Series A: Biological Sciences and Medical Sciences
                Oxford University Press (US )
                1079-5006
                1758-535X
                May 2020
                07 March 2020
                07 March 2020
                : 75
                : 6
                : 1143-1147
                Affiliations
                [1 ] Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine , Seoul, Republic of Korea
                [2 ] PyeongChang Health Center and County Hospital , PyeongChang, Gangwon-Do, Republic of Korea
                [3 ] Department of Internal Medicine, Seoul National University Hospital , Seoul, Republic of Korea
                [4 ] Marcus Institute for Aging Research, Hebrew SeniorLife , Boston, MA
                [5 ] Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center , Boston, MA
                Author notes
                Address correspondence to: Eunju Lee, MD, PhD, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea. E-mail: eunjulee@ 123456amc.seoul.kr
                Author information
                http://orcid.org/0000-0003-3617-3301
                http://orcid.org/0000-0002-5328-0144
                http://orcid.org/0000-0001-7290-6838
                Article
                glaa003
                10.1093/gerona/glaa003
                7243580
                32145016
                2bfb6800-11fd-4f96-bf9e-b177adcf521d
                © The Author(s) 2020. Published by Oxford University Press on behalf of The Gerontological Society of America.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 09 May 2019
                : 01 January 2020
                : 07 March 2020
                Page count
                Pages: 5
                Funding
                Funded by: Ministry of Health and Welfare, DOI 10.13039/100008903;
                Funded by: Republic of Korea through the Korea Health Industry Institute;
                Award ID: HI18C2400
                Funded by: Harald;
                Award ID: R01AG056368
                Award ID: P30AG031679
                Award ID: P30AG048785
                Funded by: National Institute on Aging, DOI 10.13039/100000049;
                Categories
                THE JOURNAL OF GERONTOLOGY: Medical Sciences
                Frailty
                AcademicSubjects/MED00280
                AcademicSubjects/SCI00960

                Geriatric medicine
                frailty,clinically meaningful change,responsiveness
                Geriatric medicine
                frailty, clinically meaningful change, responsiveness

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