TY - JOUR
T1 - Effect in influenzavaccinatie op sterfte onder ouderen
T2 - Is placebo-gecontroleerd onderzoek hiernaar ethisch te rechtvaardigen?
AU - Verhees, Ruud
AU - Dondorp, Wybo
AU - Thijs, Carel
AU - Dinant, Geert
AU - Knottnerus, Andre
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
M3 - Article
SN - 0028-2162
VL - 162
JO - Nederlands Tijdschrift voor Geneeskunde
JF - Nederlands Tijdschrift voor Geneeskunde
M1 - D3177
ER -