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• W2055961808 abstract "To the Editor: Stroke is a disease affecting predominantly older adults; in the national stroke audits in the United Kingdom and Ireland, three-quarters of those admitted to hospital with acute stroke are aged 65 and older.1, 2 Existing research is indicative of ageism in the clinical management of older adults with acute stroke.3 The data collected as part of the U.K. National Sentinel Audit of Stroke in 2004 show that older adults are less likely to be treated in a stroke unit than younger individuals (≥85 vs <65, risk ratio = 0.82, 95% confidence interval = 0.75–0.90), and neuroimaging was performed within 24 hours of stroke in 71% of individuals younger than 65 but in 51% of those aged 85 and older. It is undocumented as to whether ageism is also a factor in the design and implementation of interventional research studies in stroke, studies on which treatment guidelines are increasingly based. In other areas of medical research, alarming trends have been noted of the exclusion of older people from clinical trials for other conditions, leading to the paradox that a demographic group in whom medications have been least well evaluated for efficacy and side-effects are most likely to receive them.4 This ageism can manifest in at least two different forms: an arbitrary cutoff at an upper age or recruitment of samples that fail to represent the demographic profile of those affected by stroke. It was therefore decided to review the inclusion and exclusion criteria and the mean age of participants in a U.S. government database of clinical trials in stroke. Data were obtained from the National Institutes of Health online database of clinical trials, Clinicaltrials.gov. All closed and completed interventional stroke clinical trials up to May 2012 that had reported results for any evidence of arbitrary age cutoff in inclusion and exclusion criteria and the mean age of participants were reviewed. The age profiles of the studies were compared with the results of the Irish National Audit of Stroke Care (INASC) from 20081 and the U.K. National Sentinel Stroke Audit from 2010.2 There were 110 closed interventional clinical trials with results available under the search word “stroke.” After review of the trial description, only 49 studies in the database were directly related to an interventional study in stroke. Thirteen of the trials (26.6%) had an upper age cutoff: 80 (n = 7), 85 (n = 4), 86 (n = 1), and 95 (n = 1). The mean of the mean age of all participants in these 49 trials was 65.8 ± 5.1; the mean of participants in trials without an upper age cutoff (n = 36) was 66.9. Both of these mean ages are significantly lower than the mean age of individuals who had a stroke in Irish hospitals in INASC (75 ± 13)1 and the U.K. National Sentinel Stroke Audit in 2010 (75.8 ± 13.1).2 The current study confirms that the average age of participants in interventional trials is more than 10 years younger than the mean age of individuals in the population-based stroke audits performed in the United Kingdom and Ireland. Although complexity and consent challenges in the older population may in part explain this, the treatment being provided to this most vulnerable group should be based on evidence from data collected from individuals of a similar age. One encouraging sign is the emergence of trials that focus on increasing involvement of older adults in clinical research,4 including trials in stroke such as the Third International Stroke Trial,5 specifically designed to investigate the safety and efficacy for thrombolysis for ischemic stroke in individuals aged 80 and older. This demonstrates that the evaluation of medicines can become more attuned to age and more focused on older adults. The involvement of geriatricians in stroke care may also be important in raising consciousness in attuning the age of stroke care6 and promoting greater awareness among stroke physicians, researchers, and the pharmaceutical industry of the need to mandate that the age profile of participants in trials in the testing and licensing of drugs must reflect the needs of the eventual consumer groups more accurately, and in particular older people. Conflict of Interest: The editor in chief has reviewed the conflict of interest checklist provided by the authors and has determined that the authors have no financial or any other kind of personal conflicts with this paper. Author Contributions: Both authors were directly involved in study concept and design, acquisition of data, analysis and interpretation of data, and preparation of manuscript. Sponsor's Role: There was no involvement of any sponsors in this study." @default.
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• W2055961808 date "2013-11-01" @default.
• W2055961808 modified "2023-09-29" @default.
• W2055961808 title "Ageism in Interventional Stroke Studies" @default.
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• W2055961808 doi "https://doi.org/10.1111/jgs.12537" @default.
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