Influence of lack of blinding on the estimation of medication-related harms: a retrospective cohort study of randomized controlled trials

被引：3

作者：

Xu, Chang ^{[1
]}

Zhang, Fengying ^{[2
]}

Doi, Suhail A. R. ^{[3
]}

Furuya-Kanamori, Luis ^{[4
]}

Lin, Lifeng ^{[5
]}

Chu, Haitao ^{[6
,7
]}

Yang, Xi ^{[1
]}

Li, Sheyu ^{[8
]}

Zorzela, Liliane ^{[9
]}

Golder, Su ^{[10
]}

Loke, Yoon ^{[11
]}

Vohra, Sunita ^{[12
,13
]}

机构：

[1] Second Mil Med Univ, Naval Med Univ, Affiliated Hosp 3, Proof Concept Ctr,Eastern Hepatobiliary Surg Hosp, Shanghai, Peoples R China

[2] Sichuan Univ, West China Hosp, Chinese Evidence Based Med Ctr, Chengdu, Peoples R China

[3] Qatar Univ, Coll Med, Dept Populat Med, QU Hlth, Doha, Qatar

[4] Univ Queensland, UQ Ctr Clin Res, Herston, Australia

[5] Univ Arizona, Dept Epidemiol & Biostat, Tucson, AZ USA

[6] Pfizer Inc, Stat Res & Innovat, Global Biometr & Data Management, New York, NY USA

[7] Univ Minnesota, Sch Publ Hlth, Div Biostat & Hlth Data Sci, Minneapolis, MN USA

[8] Sichuan Univ, West China Hosp, MAGIC China Ctr, Dept Endocrinol & Metab, Chengdu, Peoples R China

[9] Univ Alberta, Fac Med & Dent, Dept Pediat, Edmonton, AB, Canada

[10] Univ York, Dept Hlth Sci, York, England

[11] Univ East Anglia, Norwich Med Sch, Norwich, England

[12] Univ Alberta, Fac Med & Dent, Dept Pediat, Edmonton, AB, Canada

[13] Univ Alberta, Fac Med & Dent, Dept Psychiat, Edmonton, AB, Canada

来源：

BMC MEDICINE | 2024年 / 22卷 / 01期

基金：

中国国家自然科学基金;

关键词：

Randomized controlled trials; Blinding; Harms; Adverse effects; EMPIRICAL-EVIDENCE; CLINICAL-TRIALS; BIAS; ASSOCIATION; OUTCOMES; QUALITY; SUCCESS;

D O I：

10.1186/s12916-024-03300-7

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Empirical 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. 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 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). Results 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. Conclusions 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

引用

页数：10

共 40 条

[31] Empirical evidence of study design biases in nutrition randomised controlled trials: a meta-epidemiological study [J].