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Clinical Trial
. 2019;15(12):2960-2968.
doi: 10.1080/21645515.2019.1622974. Epub 2019 Jun 21.

Evaluation of two frailty indices, with practical application in a vaccine clinical trial

Desmond Curran  1 , Melissa K Andrew  2 , Myron J Levin  3 , Elisa Turriani  1 , Sean Matthews  4 , Charles Fogarty  5 , Nicola P Klein  6 , Katrijn Grupping  1 , Lidia Oostvogels  1 , Kenneth E Schmader  7
Affiliations
Clinical Trial

Evaluation of two frailty indices, with practical application in a vaccine clinical trial

Desmond Curran et al. Hum Vaccin Immunother. 2019.

Abstract

Frail older adults are at increased risk of poor clinical outcomes. Frailty assessment is therefore important in clinical trials to understand the benefits and harms of interventions. However, consensus is lacking on how frailty should be assessed.We developed a prospectively specified index using a battery of formal tests and instruments and a retrospectively generated index using medical comorbidities and patient reported outcomes (PROs) within an adjuvanted recombinant zoster vaccine (RZV) trial (NCT02979639). For both frailty indices (FIs), a total deficit score was calculated as the accumulation of deficits and participants were categorized as non-frail, pre-frail and frail. We assessed (1) the feasibility and validity of both FIs; (2) the impact of RZV vaccine reactogenicity by frailty status on Short Form-36 [SF-36] physical functioning (PF) scores.Of 401 participants, aged ≥50 years, 236 (58.9%) were categorized non-frail, 143 (35.7%), pre-frail, and 22 (5.5%) frail using the prospective FI. Corresponding numbers for the retrospective FI were 192 (47.9%), 169 (42.1%) and 40 (10.0%), respectively. Strong concordance was observed between the frailty status assessments (P < .001). The proportion defined as frail increased from 1.5%, to 10.4% in participants aged 50-59, and ≥70 years, respectively, for the prospective FI. Corresponding numbers for the retrospective FI were 3.7%, and 17.2%, respectively. RZV vaccination was associated with a transient, non-clinically meaningful, decrease on the SF-36 PF score in frail participants.Both frailty indices provided similar results. The retrospectively generated FI offers the advantage of being easier to incorporate into vaccine clinical trials of older adults.

Keywords: Varicella-zoster virus; adjuvanted recombinant zoster vaccine; frailty; herpes zoster; older adult; reactogenicity.

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Figures

Figure 1.
Figure 1.
Distribution of the retrospectively generated frailty index.
Figure 2.
Figure 2.
Mean frailty index by age and type of frailty index, assuming a linear model.
Figure 3.
Figure 3.
Mean SF-36 Physical functioning score (Panel A) and Mean EQ-5D Utility score (Panel B) by days post-dose 1 by prospectively specified frailty status.
See this image and copyright information in PMC

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References

    1. 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. - DOI - PMC - PubMed
    1. Mitnitski A, Song X, Skoog I, Broe GA, Cox JL, Grunfeld E, Rockwood K.. Relative fitness and frailty of elderly men and women in developed countries and their relationship with mortality. J Am Geriatr Soc. 2005;53:2184–89. doi:10.1111/j.1532-5415.2005.00506.x. - DOI - PubMed
    1. Looman WM, Fabbricotti IN, Blom JW, Jansen APD, Lutomski JE, Metzelthin SF, Huijsman R and on behalf of the TOPICS-MDS Research Consortium. The frail older person does not exist: development of frailty profiles with latent class analysis. BMC Geriatr. 2018;18:84. doi:10.1186/s12877-018-0776-5. - DOI - PMC - PubMed
    1. Rodríguez-Rodero S, Fernández-Morera JL, Menéndez-Torre E, Calvanese V, Fernández AF, Fraga MF. Aging genetics and aging. Aging Dis. 2011;2:186–95. - PMC - PubMed
    1. McElhaney JE, Dutz JP. Better influenza vaccines for older people: what will it take? J Infect Dis. 2008;198:632–34. doi:10.1086/590435. - DOI - PubMed

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