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AuthorXu, Chang
AuthorZhang, Fengying
AuthorDoi, Suhail A R
AuthorFuruya-Kanamori, Luis
AuthorLin, Lifeng
AuthorChu, Haitao
AuthorYang, Xi
AuthorLi, Sheyu
AuthorZorzela, Liliane
AuthorGolder, Su
AuthorLoke, Yoon
AuthorVohra, Sunita
Available date2024-04-28T08:47:19Z
Publication Date2024-03-07
Publication NameBMC Medicine
Identifierhttp://dx.doi.org/10.1186/s12916-024-03300-7
CitationXu, C., Zhang, F., Doi, S. A., Furuya-Kanamori, L., Lin, L., Chu, H., ... & Vohra, S. (2024). Influence of lack of blinding on the estimation of medication-related harms: a retrospective cohort study of randomized controlled trials. BMC medicine, 22(1), 83.
URIhttp://hdl.handle.net/10576/54307
AbstractEmpirical evidence suggests that lack of blinding may be associated with biased estimates of treatment benefit in randomized controlled trials, but the influence on medication-related harms is not well-recognized. We aimed to investigate the association between blinding and clinical trial estimates of medication-related harms. We searched PubMed from January 1, 2015, till January 1, 2020, for systematic reviews with meta-analyses of medication-related harms. Eligible meta-analyses must have contained trials both with and without blinding. Potential covariates that may confound effect estimates were addressed by restricting trials within the comparison or by hierarchical analysis of harmonized groups of meta-analyses (therefore harmonizing drug type, control, dosage, and registration status) across eligible meta-analyses. The weighted hierarchical linear regression was then used to estimate the differences in harm estimates (odds ratio, OR) between trials that lacked blinding and those that were blinded. The results were reported as the ratio of OR (ROR) with its 95% confidence interval (CI). We identified 629 meta-analyses of harms with 10,069 trials. We estimated a weighted average ROR of 0.68 (95% CI: 0.53 to 0.88, P < 0.01) among 82 trials in 20 meta-analyses where blinding of participants was lacking. With regard to lack of blinding of healthcare providers or outcomes assessors, the RORs were 0.68 (95% CI: 0.53 to 0.87, P < 0.01 from 81 trials in 22 meta-analyses) and 1.00 (95% CI: 0.94 to 1.07, P = 0.94 from 858 trials among 155 meta-analyses) respectively. Sensitivity analyses indicate that these findings are applicable to both objective and subjective outcomes. Lack of blinding of participants and health care providers in randomized controlled trials may underestimate medication-related harms. Adequate blinding in randomized trials, when feasible, may help safeguard against potential bias in estimating the effects of harms.
SponsorThis work was supported by an Australian National Health and Medical Research Council Fellowship (APP1158469), and by Program Grant #NPRP-BSRA01-0406–210030 from the Qatar National Research Fund.
Languageen
PublisherSpringer Nature
SubjectAdverse effects
Blinding
Harms
Randomized controlled trials
TitleInfluence of lack of blinding on the estimation of medication-related harms: a retrospective cohort study of randomized controlled trials.
TypeArticle
Issue Number1
Volume Number22
ESSN1741-7015
dc.accessType Open Access


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