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

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Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials

Boutron, Isabelle, Tubach, Florence, Giraudeau, Bruno, Ravaud, Philippe·2004·Journal of Clinical Epidemiology

DOI 10.1016/j.jclinepi.2003.12.010

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Abstract

Objective To compare the feasibility of blinding and the perceived risk of unblinding in trials evaluating pharmacologic (PT) and nonpharmacologic treatments (NPT) of hip or knee osteoarthritis.Study design and setting Two independent reviewers assessed the feasibility of blinding patients, care providers, and outcome assessors, the perceived risk of unblinding, and whether blinding was reported in 110 reports of randomized controlled trials (RCTs) evaluating PT and NPT in patients with hip or knee osteoarthritis.Results Blinding was considered to be possible less often in NPT trials than in PT trials for patients (42 vs. 96%; P <.001), care providers (12 vs. 96%; P <.001), and outcome assessors (34 vs. 98%; P <.001). When blinding was judged feasible, the perceived risk of unblinding was more often considered moderate or important in NPT than PT trials for patients (35 vs. 14%, P=.02) and outcome assessors (44 vs. 10%, P=.0004). When blinding was judged feasible, it was reported less often in NPT reports than in PT reports for patients (46 vs. 98%, P <.001), care providers (43 vs. 83%, P=.03), and outcome assessors (72 vs. 98%, P=.0006).Conclusion Blinding appears to be more difficult to achieve and unblinding may occur more often in NPT than PT trials.

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“These include difficulties in blinding participants and providers, 59 the development and application of sham therapies, and even the widespread use of complex, individualized therapeutic approaches.”
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Authors: Boutron, I., Tubach, F., Giraudeau, B., & Ravaud, P.
Affiliations: Inserm (FR)
Corresponding author: Boutron, Isabelle
ORCID: Boutron, Isabelle
Tubach, Florence
Giraudeau, Bruno
Ravaud, Philippe
Venue: Journal of Clinical Epidemiology
Publisher: Elsevier BV
Published: 2004-06
Volume: 57
Issue: 6
Pages: 543-550
ISSN: 0895-4356 (ISSN-L)
DOI: 10.1016/j.jclinepi.2003.12.010
OpenAlex: W1996966348
Cited by: 300
References: 28
Citations by year: 2026: 12 · 2025: 17 · 2024: 13 · 2023: 16 · 2022: 19 · 2021: 17 · 2020: 16 · 2019: 21 · 2018: 28 · 2017: 14 · 2016: 22 · 2015: 8 · 2014: 14 · 2013: 12 · 2012: 12
FWCI: 8.89
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Clinical Epidemiology (publishedVersion)
PubMed (publishedVersion)
Funders: Assistance Publique - Hôpitaux de Paris
Assistance publique-Hôpitaux de Paris
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, unblinding, non-pharmacological treatment, pharmacotherapy, hip osteoarthritis, knee osteoarthritis, randomized controlled trials, trial reporting quality, care providers
MeSH terms: Double-Blind Method, Drug Therapy, Feasibility Studies, Humans, Osteoarthritis, Hip, Epidemiologic Research Design, Randomized Controlled Trials as Topic, Single-Blind Method, Treatment Outcome, Osteoarthritis, Knee

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Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials

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