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Cited by 389Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsPain Management and Placebo Effect

The DOI matches its Crossref record; 55 of the 55 references it cites were found in a registry or an index.

Reporting Methods of Blinding in Randomized Trials Assessing Nonpharmacological Treatments

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Boutron, Isabelle, Guittet, Lydia, Estellat, Candice, Moher, David, Hróbjartsson, Asbjørn, Ravaud, Philippe·2007·PLoS Medicine
DOI 10.1371/journal.pmed.0040061PMC PMC1800311
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Abstract

BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard) methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs) assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment), or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography), or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

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Crossref · 10.1371/journal.pmed.0040061

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Figure 1 Flow of Records, Citations, and Articles through the Cross-Sectional Study
Figure 1 Flow of Records, Citations, and Articles through the Cross-Sectional StudyCC BY · PubMed Central
Figure 2 Sham Procedure Performed According to the Category of Treatment Assessed
Figure 2 Sham Procedure Performed According to the Category of Treatment AssessedCC BY · PubMed Central
Figure 3 Methods of Blinding Participants, Health Care Providers, or Other Caregivers That Rely on the Category of Treatment and Comparator Assessed
Figure 3 Methods of Blinding Participants, Health Care Providers, or Other Caregivers That Rely on the Category of Treatment and Comparator AssessedCC BY · PubMed Central
Figure 4 Methods of Blinding Outcome Assessors Depending on the Primary Outcome Considered
Figure 4 Methods of Blinding Outcome Assessors Depending on the Primary Outcome ConsideredCC BY · PubMed Central

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Metadata

Authors
Boutron, I., Guittet, L., Estellat, C., Moher, D., Hróbjartsson, A., & Ravaud, P.
Affiliations
  • Inserm (FR)
  • University of Ottawa (CA)
  • Rigshospitalet (DK)
Corresponding author
Boutron, Isabelle
ORCID
Venue
PLoS Medicine
Publisher
Public Library of Science (PLoS)
Published
2007-02-20
Volume
4
Issue
2
Pages
e61
ISSN
  • 1549-1277 (ISSN-L)
  • 1549-1676
DOI
10.1371/journal.pmed.0040061
PMC
PMC1800311
OpenAlex
W2118789584
Cited by
389
References
55
Citations by year
2026: 34 · 2025: 27 · 2024: 14 · 2023: 21 · 2022: 20 · 2021: 27 · 2020: 27 · 2019: 24 · 2018: 36 · 2017: 17 · 2016: 16 · 2015: 24 · 2014: 20 · 2013: 20 · 2012: 18
FWCI
10.56
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS Medicine (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • HAL (submittedVersion, other-oa)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Figshare (submittedVersion, cc-by)
Funders
University of Ottawa
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
Keywords
blinding, randomization, non-pharmacological treatment, sham procedure, placebo, rehabilitation, psychotherapy, trial reporting quality
MeSH terms
Double-Blind Method, Humans, Research Design, Randomized Controlled Trials as Topic

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