Abstract
Purpose: Despite being among those most in need of protection, frail older adults are often not well represented in clinical trials. Although frailty likely influences responses to treatments and vaccines, frailty may not be explicitly considered in trials even when frail participants are enrolled due to the perception that frailty is difficult to measure effectively and efficiently without adding to participant or data collection burden. We developed an easy-to-implement frailty index, the Clinical Trial-Frailty Index (CT-FI), based on baseline medical history and standard patient-reported outcomes using data from clinical trials of recombinant Zoster vaccine (the ZOE-50 and ZOE-70 studies). Our objective was to demonstrate that the CT-FI is a robust measure that may be used retrospectively or prospectively in clinical trials where sufficient patient data have been collected. Methods: The CT-FI was based on baseline medical history and Quality of Life questionnaires (SF-36 and EQ-5D). Items meeting criteria for inclusion were scored from 0 to 1, then summed for each participant and divided by the total number of deficits considered. Validation analyses included descriptive verification of distribution and age-and sex-associations in relation to usual patterns of the frailty index, regressions in relation to outcomes hypothesized to be related to frailty, and resampling methods within the index. Results: The CT-FI distribution was well represented by a gamma distribution with a range of 0–0.70. Deficit accumulation increased with chronological age and was higher for females. Multivariate Cox regression survival analysis showed that the CT-FI, age, and sex were significant predictors of mortality. Jackknife and Bootstrap resampling methods highlighted the robustness of the CT-FI, which was not sensitive to inclusion/exclusion of specific individual or groups of variables. Conclusion: We have developed a reliable, robust and easy-to-implement CT-FI with potential retrospective or prospective application in other clinical trials.
| Original language | English |
|---|---|
| Pages (from-to) | 1261-1274 |
| Number of pages | 14 |
| Journal | Clinical Interventions in Aging |
| Volume | 17 |
| DOIs | |
| Publication status | Published - 2022 |
Bibliographical note
Funding Information:This work was sponsored by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study conduct and analysis, and took responsibility for all costs associated with the development and publishing of the present manuscript. GlaxoSmithKline Biologicals SA does not veto ongoing publications or control the decision about what journal to submit to, with ultimate decision on the target journal made by the coauthors. The lead and corresponding author MKA received no payment related to any aspect of this study.
Funding Information:
MKA reports grant funding from the GSK group of companies for this study, grants from Sanofi, the GSK group of companies, Pfizer, Merck, the Canadian Frailty Network, Canadian Institutes of Health Research, Foundation for Influenza Epidemiology, and Public Health Agency of Canada, not related to the present study, and honoraria for advisory work from Sanofi, Seqirus, and Pfizer outside the submitted work. JHK, MER, and DC are employees of the GSK group of companies. JHK and DC own the GSK group of companies shares/stock options as part of their employee remuneration. SM works as a freelance consultant on behalf of the GSK group of companies. The authors declare no other non-financial relationships and activities or conflicts of interest in this work.
Publisher Copyright:
© 2022 The GSK group of companies.
ASJC Scopus Subject Areas
- Geriatrics and Gerontology
PubMed: MeSH publication types
- Clinical Trial
- Journal Article
