Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials
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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Low rates of reported blinding checks are a known issue in nonpharmacologic treatments, including DTx.
“In general, low rates of reported blinding checks are a known issue in nonpharmacologic treatments which DTx (58).”
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- Authors
- Boutron, I., Tubach, F., Giraudeau, B., & Ravaud, P.
- Affiliations
- Inserm (FR)
- Corresponding author
- Boutron, Isabelle
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2004-06
- Volume
- 57
- Issue
- 6
- Pages
- 543-550
- ISSN
- 0895-4356 (ISSN-L)
- 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
- 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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