We have located links that may give you full text access.
ENGLISH ABSTRACT
JOURNAL ARTICLE
[Influenza vaccination in the elderly: is a trial on mortality ethically acceptable?]
Nederlands Tijdschrift Voor Geneeskunde 2018 September 7
The effectiveness of influenza vaccination in the elderly has long been a topic of debate, fueled by the absence of direct evidence on its effect on mortality. It is argued that new placebo-controlled trials should be undertaken to resolve this uncertainty. However, such trials may be ethically questionable. We provide an overview of the ethical challenges of an influenza vaccine efficacy trial designed to evaluate mortality in the elderly. An important condition in the justification of a trial is the existence of genuine uncertainty regarding the answer to a research question. Therefore an extensive analysis of the existing levels of knowledge is needed to support the conclusion that an effect of vaccination on mortality is uncertain. Even if a so-called 'clinical equipoise' status applies, denying a control group vaccination would be problematic because vaccination is considered 'competent care' and withholding vaccination could substantially increase patients' risk for influenza and its complications. Given the high burden of disease and proven benefits of vaccination, the importance of a trial is unlikely to outweigh the risk patients are exposed to. While a placebo-controlled trial in vaccine refusers may be considered, such a trial is unlikely to meet methodological standards regarding trial size and generalizability. We conclude that a new trial is unlikely to provide a direct answer, let alone change current policy. At the same time, given the lack of consensus on this topic, we invite researchers considering vaccine efficacy trials on mortality to address the ethical challenges as discussed.
Full text links
Related Resources
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app