Trial reportHuman vaccines & immunotherapeutics2019
Evaluation of two frailty indices, with practical application in a vaccine clinical trial.
Trial report in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02979639 (Study to Evaluate the Impact of Reactogenicity on Quality of Life), which is not on this map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GSK Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age
Who cites it
9 citing papers in PubMed, 12 citations in OpenAlex.
- An Easy-to-Implement Clinical-Trial Frailty Index Based on Accumulation of Deficits: Validation in Zoster Vaccine Clinical Trials.Clinical interventions in aging · 2022Trial
- Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals.Journal of the American Geriatrics Society · 2021Trial
- Impact of Reactogenicity After Two Doses of Recombinant Zoster Vaccine Upon Physical Functioning and Quality of Life: An Open Phase III Trial in Older Adults.The journals of gerontology. Series A, Biological sciences and medical sciences · 2021Trial
- Frailty, trajectories of frailty, and cognitive impairment: evidence from five longitudinal cohort studies.BMC public health · 2026Article
- Recombinant zoster vaccine in immunocompetent and immunocompromised adults: A review of clinical studies.Human vaccines & immunotherapeutics · 2023Review
- Efficacy and safety of the recombinant zoster vaccine: A systematic review and meta-analysis.Vaccine: X · 2023Review
- Patient-reported outcomes in vaccines research: relevance for decision-making.Human vaccines & immunotherapeutics · 2022Review
- Age and frailty in COVID-19 vaccine development.Lancet (London, England) · 2021Article
- Considering Frailty in SARS-CoV-2 Vaccine Development: How Geriatricians Can Assist.Clinical interventions in aging · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 3 countries.
Funding
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 (
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.