An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials
Melissa K Andrew,1 Sean Matthews,2 Joon Hyung Kim,3 Megan E Riley,3 Desmond Curran4 1Department of Medicine (Division of Geriatric Medicine), Dalhousie University, Halifax, Nova Scotia, Canada; 2Freelance C/O GSK, Wavre, Belgium; 3GSK, Rockville, MD, USA; 4GSK, Wavre, BelgiumCorrespondence: Melissa...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2022-08-01
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| Series: | Clinical Interventions in Aging |
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| Online Access: | https://www.dovepress.com/an-easy-to-implement-clinical-trial-frailty-index-based-on-accumulatio-peer-reviewed-fulltext-article-CIA |
| _version_ | 1811340077676101632 |
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| author | Andrew MK Matthews S Kim JH Riley ME Curran D |
| author_facet | Andrew MK Matthews S Kim JH Riley ME Curran D |
| author_sort | Andrew MK |
| collection | DOAJ |
| description | Melissa K Andrew,1 Sean Matthews,2 Joon Hyung Kim,3 Megan E Riley,3 Desmond Curran4 1Department of Medicine (Division of Geriatric Medicine), Dalhousie University, Halifax, Nova Scotia, Canada; 2Freelance C/O GSK, Wavre, Belgium; 3GSK, Rockville, MD, USA; 4GSK, Wavre, BelgiumCorrespondence: Melissa K Andrew, C/O Department of Medicine (Division of Geriatric Medicine), Dalhousie University, Veterans Memorial Building, 5955 Veterans Memorial Drive, Halifax, NS, Canada, Tel +1 902 473-4995, Fax +1 902 473-7133, Email mandrew@dal.caPurpose: 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.Keywords: frailty, frail elderly, older adults, herpes zoster, quality of life, vaccine, clinical trial |
| first_indexed | 2024-04-13T18:36:08Z |
| format | Article |
| id | doaj.art-5c38d82c4b7e479d81994256dd28b71e |
| institution | Directory Open Access Journal |
| issn | 1178-1998 |
| language | English |
| last_indexed | 2024-04-13T18:36:08Z |
| publishDate | 2022-08-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Interventions in Aging |
| spelling | doaj.art-5c38d82c4b7e479d81994256dd28b71e2022-12-22T02:34:52ZengDove Medical PressClinical Interventions in Aging1178-19982022-08-01Volume 171261127477504An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical TrialsAndrew MKMatthews SKim JHRiley MECurran DMelissa K Andrew,1 Sean Matthews,2 Joon Hyung Kim,3 Megan E Riley,3 Desmond Curran4 1Department of Medicine (Division of Geriatric Medicine), Dalhousie University, Halifax, Nova Scotia, Canada; 2Freelance C/O GSK, Wavre, Belgium; 3GSK, Rockville, MD, USA; 4GSK, Wavre, BelgiumCorrespondence: Melissa K Andrew, C/O Department of Medicine (Division of Geriatric Medicine), Dalhousie University, Veterans Memorial Building, 5955 Veterans Memorial Drive, Halifax, NS, Canada, Tel +1 902 473-4995, Fax +1 902 473-7133, Email mandrew@dal.caPurpose: 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.Keywords: frailty, frail elderly, older adults, herpes zoster, quality of life, vaccine, clinical trialhttps://www.dovepress.com/an-easy-to-implement-clinical-trial-frailty-index-based-on-accumulatio-peer-reviewed-fulltext-article-CIAfrailtyfrail elderlyolder adultsherpes zosterquality of lifevaccineclinical trial |
| spellingShingle | Andrew MK Matthews S Kim JH Riley ME Curran D An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials Clinical Interventions in Aging frailty frail elderly older adults herpes zoster quality of life vaccine clinical trial |
| title | An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials |
| title_full | An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials |
| title_fullStr | An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials |
| title_full_unstemmed | An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials |
| title_short | An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials |
| title_sort | easy to implement clinical trial frailty index based on accumulation of deficits validation in zoster vaccine clinical trials |
| topic | frailty frail elderly older adults herpes zoster quality of life vaccine clinical trial |
| url | https://www.dovepress.com/an-easy-to-implement-clinical-trial-frailty-index-based-on-accumulatio-peer-reviewed-fulltext-article-CIA |
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