Cited by 300Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsAdvanced Causal Inference Techniques

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Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

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Moustgaard, Helene, Clayton, Gemma L, Jones, Hayley E, Boutron, Isabelle, Jørgensen, Lars, Laursen, David R T, Olsen, Mette F, Paludan-Müller, Asger, Ravaud, Philippe, Savović, Jelena, Sterne, Jonathan A C, Higgins, Julian P T, Hróbjartsson, Asbjørn·2020·BMJ

DOI 10.1136/bmj.l6802PMC PMC7190062

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Abstract

Objectives: To study the impact of blinding on estimated treatment effects, and their variation between trials; differentiating between blinding of patients, healthcare providers, and observers; detection bias and performance bias; and types of outcome (the MetaBLIND study). Design: Meta-epidemiological study. Data source: Cochrane Database of Systematic Reviews (2013-14). Eligibility criteria for selecting studies: Meta-analyses with both blinded and non-blinded trials on any topic. Review methods: Blinding status was retrieved from trial publications and authors, and results retrieved automatically from the Cochrane Database of Systematic Reviews. Bayesian hierarchical models estimated the average ratio of odds ratios (ROR), and estimated the increases in heterogeneity between trials, for non-blinded trials (or of unclear status) versus blinded trials. Secondary analyses adjusted for adequacy of concealment of allocation, attrition, and trial size, and explored the association between outcome subjectivity (high, moderate, low) and average bias. An ROR lower than 1 indicated exaggerated effect estimates in trials without blinding. Results: The study included 142 meta-analyses (1153 trials). The ROR for lack of blinding of patients was 0.91 (95% credible interval 0.61 to 1.34) in 18 meta-analyses with patient reported outcomes, and 0.98 (0.69 to 1.39) in 14 meta-analyses with outcomes reported by blinded observers. The ROR for lack of blinding of healthcare providers was 1.01 (0.84 to 1.19) in 29 meta-analyses with healthcare provider decision outcomes (eg, readmissions), and 0.97 (0.64 to 1.45) in 13 meta-analyses with outcomes reported by blinded patients or observers. The ROR for lack of blinding of observers was 1.01 (0.86 to 1.18) in 46 meta-analyses with subjective observer reported outcomes, with no clear impact of degree of subjectivity. Information was insufficient to determine whether lack of blinding was associated with increased heterogeneity between trials. The ROR for trials not reported as double blind versus those that were double blind was 1.02 (0.90 to 1.13) in 74 meta-analyses. Conclusion: No evidence was found for an average difference in estimated treatment effect between trials with and without blinded patients, healthcare providers, or outcome assessors. These results could reflect that blinding is less important than often believed or meta-epidemiological study limitations, such as residual confounding or imprecision. At this stage, replication of this study is suggested and blinding should remain a methodological safeguard in trials.

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Fig 1 Study flow diagram. *Meta-analyses contributing with trials that had outcome measures categorised as “mixed” (that is, it was not possible to classify them as patient reported, healthcare provider decision, or observer reported because they contained elements from more than one of these types) were not counted. Mixed outcome trials did not contribute to the main analysesCC BY-NC · PubMed Central

Fig 2 Estimated ratios of odds ratios and effects on heterogeneity associated with blinding status of patients, healthcare providers, and outcome assessors. Unadjusted analyses. *Increase in standard deviation between trials: (Ia) 0.22 (95% credible interval 0.02 to 0.60), (Ib) 0.10 (0.01 to 0.30), (IIa) 0.06 (0.01 to 0.30), (IIb) 0.10 (0.01 to 0.59), (III) 0.05 (0.01 to 0.22). †Standard deviation between meta-analyses: (Ia) 0.20 (95% credible interval 0.01 to 0.74), (Ib) 0.11 (0.01 to 0.55), (IIa) 0.06 (0.01 to 0.26), (IIb) 0.13 (0.01 to 0.82), (III) 0.09 (0.01 to 0.31)CC BY-NC · PubMed Central

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“Blinding may be difficult to achieve though: it is costly, can discourage recruitment and continuation in clinical trials(4,44), or can simply be unfeasible in critical-care settings.”
Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis
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“Nonetheless, a recent study assessing the impact of participants’ awareness of the intervention (i.e., lack of blinding) on studies’ results did not find evidence that this design limitation impacted the results (Moustgaard et al., 2020).”
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“This confirms the finding by Moustgaard et al (71) who reviewed 142 meta-analyses and found no significant effect of blinding or placebo use on estimated treatment effects.”
Better Short‐Term Outcomes After Rotator Cuff Repair in Studies With Poorer Mean Shoulder Scores and Predominantly Small to Medium‐Sized Tears at Baseline: A Systematic Review and Meta‐analysis
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The effect of osteopathic medicine on pain in musicians with nonspecific chronic neck pain: a randomized controlled trial
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Efficacy and Tolerability of Seven Antipsychotic Drugs in Acutely Ill Patients With Schizophrenia: A Randomized, Multicenter, Assessor-Blinded Trial
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“Comorbidity Heart disease 6 (4) 9 (6) Diabetes 6 (4) 7 (5) Chronic respiratory condition 12 (8) 11 (7) Hepatic, hematologic, neurological, 2 (1) 0 (0) neurodevelopmental condition Stroke/transient ischaemic attack 1 (1) 1 (1) Overnight hospital stay in preceding year 5 (3) 4 (3)”
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Overall Reporting Descriptions of Acupuncture for Chronic Pain in Randomized Controlled Trials in English Journals
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“In clinical studies, there is also a risk of certain expectations influencing research outcomes, and blinding eliminates such bias, especially when the response criteria are subjective, as is the case in pain alleviation [36].”
Background

Authors: Moustgaard, H., Clayton, G. L., Jones, H. E., Boutron, I., Jørgensen, L., Laursen, D. R. T., Olsen, M. F., Paludan-Müller, A., Ravaud, P., Savović, J., Sterne, J. A. C., Higgins, J. P. T., & Hróbjartsson, A.
Affiliations: Odense University Hospital (DK)
University of Bristol (GB)
Hôtel-Dieu de Paris (FR)
Cochrane (DK)
University Hospitals Bristol NHS Foundation Trust (GB)
University of Southern Denmark (DK)
Corresponding author: Moustgaard, Helene
ORCID: Moustgaard, Helene
Clayton, Gemma L
Jones, Hayley E
Boutron, Isabelle
Jørgensen, Lars
Laursen, David R T
Olsen, Mette F
Ravaud, Philippe
Savović, Jelena
Sterne, Jonathan A C
Higgins, Julian P T
Hróbjartsson, Asbjørn
Venue: BMJ
Publisher: BMJ
Published: 2020-01-21
Volume: 368
Issue: 2
Pages: l6802
ISSN: 1756-1833 (ISSN-L)
DOI: 10.1136/bmj.l6802
PMC: PMC7190062
OpenAlex: W3001993019
Cited by: 300
References: 36
Citations by year: 2026: 21 · 2025: 45 · 2024: 55 · 2023: 50 · 2022: 49 · 2021: 50 · 2020: 27
FWCI: 9.08
Type: journal article
Language: en
Update notices: correction (2020-02-05)
Open access: hybrid
doi.org
Licence: cc-by-nc
creativecommons.org/licenses/by-nc/4.0/ (unspecified)
Locations: BMJ (publishedVersion, cc-by-nc)
PubMed Central (publishedVersion, cc-by-nc)
PubMed (publishedVersion)
Bristol Research (University of Bristol) (publishedVersion, cc-by)
University of Southern Denmark Research Portal (University of Southern Denmark) (acceptedVersion, cc-by-nc)
HAL (submittedVersion)
HighWire Press Open Archive (submittedVersion)
Funders: University Hospitals Bristol NHS Foundation Trust
NIHR Bristol Biomedical Research Centre (NF-SI-0617-10145)
National Institute for Health and Care Research (NF-SI-0611-10168, NF-SI-0616-10111, NIHR200268, NF-SI-0617-10145)
Department of Health and Social Care
University of Bristol
Medical Research Council (MR/K025643/1, MR/M014533/1, MR/L004933/1, MR/L004933/2)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords: blinding, randomized controlled trials, treatment effect estimation, detection bias, performance bias, trial heterogeneity, meta-analysis bias, double blinding, allocation concealment, attrition, meta-epidemiology, patient-reported outcomes
MeSH terms: Clinical Trials as Topic, Humans, Research Design, Epidemiologic Research Design, Observer Variation, Outcome Assessment, Health Care

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Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

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