Autor: |
Chang Xu, Fengying Zhang, Doi, Suhail A. R., Luis Furuya‑Kanamori, Lifeng Lin, Haitao Chu, Xi Yang, Sheyu Li, Zorzela, Liliane, Golder, Su, Yoon Loke, Vohra, Sunita |
Zdroj: |
BMC Medicine; 3/7/2024, Vol. 22 Issue 1, p1-10, 10p, 2 Diagrams, 3 Charts |
Abstrakt: |
Background Empirical evidence suggests that lack of blinding may be associated with biased estimates of treatment beneft in randomized controlled trials, but the infuence on medication-related harms is not well-recognized. We aimed to investigate the association between blinding and clinical trial estimates of medication-related harms. Methods 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 efect estimates were addressed by restricting trials within the comparison or by hierarchical analysis of harmonized groups of meta-analyses (therefore harmonizing drug type, control, dos‑ age, and registration status) across eligible meta-analyses. The weighted hierarchical linear regression was then used to estimate the diferences 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% confdence interval (CI). Results We identifed 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 fndings are applicable to both objective and subjective outcomes. Conclusions Lack of blinding of participants and health care providers in randomized controlled trials may under‑ estimate medication-related harms. Adequate blinding in randomized trials, when feasible, may help safeguard against potential bias in estimating the efects of harms. [ABSTRACT FROM AUTHOR] |
Databáze: |
Complementary Index |
Externí odkaz: |
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