An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials

References

• Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013;381(9868):752–762. doi:10.1016/S0140-6736(12)62167-9
   PubMed Web of Science ®Google Scholar
• Walston J, Hadley EC, Ferrucci L, et al. Research agenda for frailty in older adults: toward a better understanding of physiology and etiology: summary from the American Geriatrics Society/National Institute on aging research conference on frailty in older adults. J Am Geriatr Soc. 2006;54(6):991–1001. doi:10.1111/j.1532-5415.2006.00745.x
   PubMed Web of Science ®Google Scholar
• Rockwood K. Medical management of frailty: confessions of a gnostic. CMAJ. 1997;157(8):1081–1084.
   Web of Science ®Google Scholar
• Andrew MK, McElhaney JE, McGeer AA, et al. Influenza surveillance case definitions miss a substantial proportion of older adults hospitalized with laboratory-confirmed influenza: a report from the Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS) network. Infect Control Hosp Epidemiol. 2020;41(5):499–504. doi:10.1017/ice.2020.22
   Web of Science ®Google Scholar
• Andrew MK, Shinde V, Ye L, et al. The Importance of frailty in the assessment of influenza vaccine effectiveness against influenza-related hospitalization in elderly people. J Infect Dis. 2017;216(4):405–414. doi:10.1093/infdis/jix282
   PubMed Web of Science ®Google Scholar
• Maltese G, Corsonello A, Di Rosa M, et al. Frailty and COVID-19: a systematic scoping review. J Clin Med. 2020;9(7):2106. doi:10.3390/jcm9072106
   Web of Science ®Google Scholar
• EMA. Reflection paper on frailty: instruments for baseline characterisation of clinical trial older populations. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP);. 2018. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-physical-frailty-instruments-baseline-characterisation-older-populations-clinical_en.pdf. Accessed March 3, 2022.
   Google Scholar
• King SJ, Raine KA, Peel NM, Hubbard RE. Interventions for frail older inpatients: a systematic review of frailty measures and reported outcomes in randomised controlled trials. Australas J Ageing. 2021;40(2):129–144. doi:10.1111/ajag.12951
   Web of Science ®Google Scholar
• Theou O, Brothers TD, Mitnitski A, Rockwood K. Operationalization of frailty using eight commonly used scales and comparison of their ability to predict all-cause mortality. J Am Geriatr Soc. 2013;61(9):1537–1551. doi:10.1111/jgs.12420
   PubMed Web of Science ®Google Scholar
• Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol a Biol Sci Med Sci. 2001;56(3):M146–156. doi:10.1093/gerona/56.3.M146
   PubMed Web of Science ®Google Scholar
• Rockwood K, Song X, MacKnight C, et al. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005;173(5):489–495. doi:10.1503/cmaj.050051
   PubMed Web of Science ®Google Scholar
• Church S, Rogers E, Rockwood K, Theou O. A scoping review of the clinical frailty scale. BMC Geriatr. 2020;20(1):393. doi:10.1186/s12877-020-01801-7
   PubMed Web of Science ®Google Scholar
• Rockwood K, Theou O. Using the clinical frailty scale in allocating scarce health care resources. Can Geriatr J. 2020;23(3):210–215. doi:10.5770/cgj.23.463
   PubMed Web of Science ®Google Scholar
• Curran D, Andrew MK, Levin MJ, et al. Evaluation of two frailty indices, with practical application in a vaccine clinical trial. Hum Vaccin Immunother. 2019;15(12):2960–2968. doi:10.1080/21645515.2019.1622974
   PubMed Web of Science ®Google Scholar
• Curran D, Kim JH, Matthews S, et al. Recombinant zoster vaccine is efficacious and safe in frail individuals. J Am Geriatr Soc. 2021;69(3):744–752. doi:10.1111/jgs.16917
   PubMed Web of Science ®Google Scholar
• Cunningham AL, Lal H, Kovac M, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019–1032. doi:10.1056/NEJMoa1603800
   PubMed Web of Science ®Google Scholar
• Lal H, Cunningham AL, Godeaux O, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087–2096. doi:10.1056/NEJMoa1501184
   PubMed Web of Science ®Google Scholar
• Ware JE. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute; 1993.
   Google Scholar
• Rabin R, De Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–343. doi:10.3109/07853890109002087
   PubMed Web of Science ®Google Scholar
• Song X, Mitnitski A, Rockwood K. Prevalence and 10-year outcomes of frailty in older adults in relation to deficit accumulation. J Am Geriatr Soc. 2010;58(4):681–687. doi:10.1111/j.1532-5415.2010.02764.x
   PubMed Web of Science ®Google Scholar
• Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008;8:24. doi:10.1186/1471-2318-8-24
   PubMedGoogle Scholar
• Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. Sci World J. 2001;1:323–336. doi:10.1100/tsw.2001.58
   Google Scholar
• Andrew MK, Mitnitski A, Rockwood K. Social vulnerability, frailty, and mortality in elderly people. PLoS One. 2008;3(5):e2232. doi:10.1371/journal.pone.0002232
   PubMed Web of Science ®Google Scholar
• Theou O, Brothers TD, Pena FG, Mitnitski A, Rockwood K. Identifying common characteristics of frailty across seven scales. J Am Geriatr Soc. 2014;62(5):901–906. doi:10.1111/jgs.12773
   PubMed Web of Science ®Google Scholar
• Rockwood K, Mitnitski A. Limits to deficit accumulation in elderly people. Mech Ageing Dev. 2006;127(5):494–496. doi:10.1016/j.mad.2006.01.002
   PubMed Web of Science ®Google Scholar
• Mitnitski A, Song X, Skoog I, et al. Relative fitness and frailty of elderly men and women in developed countries, in relation to mortality. JAGS. 2005;53(12):2184–2189. doi:10.1111/j.1532-5415.2005.00506.x
   PubMed Web of Science ®Google Scholar
• Hubbard RE. Sex differences in frailty. Interdiscip Top Gerontol Geriatr. 2015;41:41–53.
   PubMedGoogle Scholar
• Gordon EH, Hubbard RE. Differences in frailty in older men and women. Med J Aust. 2020;212(4):183–188. doi:10.5694/mja2.50466
   Web of Science ®Google Scholar
• Ellis G, Gardner M, Tsiachristas A, et al. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2017;9:CD006211. doi:10.1002/14651858.CD006211.pub3
   PubMed Web of Science ®Google Scholar
• Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993;342(8878):1032–1036. doi:10.1016/0140-6736(93)92884-V
   PubMed Web of Science ®Google Scholar
• Mitnitski AB, Song X, Rockwood K. The estimation of relative fitness and frailty in community-dwelling older adults using self-report data. J Gerontol. 2004;59(6):M627–632. doi:10.1093/gerona/59.6.M627
   Google Scholar
• Rockwood K, Mitnitski A. How might deficit accumulation give rise to frailty? J Frailty Aging. 2012;1(1):8–12. doi:10.14283/jfa.2012.2
   PubMedGoogle Scholar
• Navarrete-Villanueva D, Gomez-Cabello A, Marin-Puyalto J, Moreno LA, Vicente-Rodriguez G, Casajus JA. Frailty and physical fitness in elderly people: a systematic review and meta-analysis. Sports Med. 2021;51(1):143–160. doi:10.1007/s40279-020-01361-1
   PubMed Web of Science ®Google Scholar
• Looman WM, Fabbricotti IN, Blom JW, et al. The frail older person does not exist: development of frailty profiles with latent class analysis. BMC Geriatr. 2018;18(1):84. doi:10.1186/s12877-018-0776-5
   Web of Science ®Google Scholar
• Wilkinson C, Wu J, Searle SD, et al. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med. 2020;18(1):401. doi:10.1186/s12916-020-01870-w
   PubMed Web of Science ®Google Scholar
• Dewan P, Jackson A, Jhund PS, et al. The prevalence and importance of frailty in heart failure with reduced ejection fraction - an analysis of PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020;22(11):2123–2133. doi:10.1002/ejhf.1832
   Web of Science ®Google Scholar
• Farooqi MAM, Gerstein H, Yusuf S, Leong DP. Accumulation of deficits as a key risk factor for cardiovascular morbidity and mortality: a pooled analysis of 154 000 individuals. J Am Heart Assoc. 2020;9(3):e014686. doi:10.1161/JAHA.119.014686
   Web of Science ®Google Scholar
• Hanlon P, Butterly E, Lewsey J, Siebert S, Mair FS, McAllister DA. Identifying frailty in trials: an analysis of individual participant data from trials of novel pharmacological interventions. BMC Med. 2020;18(1):309. doi:10.1186/s12916-020-01752-1
   PubMed Web of Science ®Google Scholar
• Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol. 2007;62(7):722–727.
   Google Scholar
• Mitnitski A, Song X, Skoog I, et al. Relative fitness and frailty of elderly men and women in developed countries and their relationship with mortality. J Am Geriatr Soc. 2005;53(12):2184–2189.
   PubMed Web of Science ®Google Scholar
• Salmeron Rios S, Mas Romero M, Cortes Zamora EB, et al. Immunogenicity of the BNT162b2 vaccine in frail or disabled nursing home residents: COVID-A study. J Am Geriatr Soc. 2021;69(6):1441–1447. doi:10.1111/jgs.17153
   PubMed Web of Science ®Google Scholar
• Andrew MK, McElhaney JE. Age and frailty in COVID-19 vaccine development. Lancet. 2021;396(10267):1942–1944. doi:10.1016/S0140-6736(20)32481-8
   PubMed Web of Science ®Google Scholar