Document Detail

A review of blinding in randomized controlled trials found results inconsistent and questionable.
MedLine Citation:
PMID:  16291465     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND OBJECTIVE: To determine methods to assess the success of blinding in randomized controlled trials (RCTs). METHODS: We searched MEDLINE, the Cochrane Controlled Trials Register, and the Cochrane Method Register and performed a manual search to target studies that attempt to assess blinding and describe the methods used in those studies. RESULTS: A total of 90 reports were selected. Reports assessed the success of blinding participants (n = 58), care providers (n = 36), and outcome assessors (n = 15). Of the 58 reports assessing the success of blinding participants, 54 (93%) reported asking participants to guess their treatment assignment. There was no consistency in timing of assessment (e.g., once at the end of the trial, 57%, or several times during the trial, 26%) or modalities of answering (e.g., "do not know" answers, 43%, or participants forced to guess, 31%). A statistical analysis was performed in 57% of reports. The statistical analysis mainly compared the proportion of correct guesses to those produced by chance (32%) or checked for a relation between participants' guesses and treatment assignment (23%). CONCLUSIONS: Methods of assessing the success of blinding, analysis and reporting the results were inconsistent and questionable.
Isabelle Boutron; Candice Estellat; Philippe Ravaud
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2005-09-30
Journal Detail:
Title:  Journal of clinical epidemiology     Volume:  58     ISSN:  0895-4356     ISO Abbreviation:  J Clin Epidemiol     Publication Date:  2005 Dec 
Date Detail:
Created Date:  2005-11-18     Completed Date:  2006-01-10     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8801383     Medline TA:  J Clin Epidemiol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1220-6     Citation Subset:  IM    
INSERM, U738, Paris, France.
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MeSH Terms
Data Interpretation, Statistical
Double-Blind Method*
Randomized Controlled Trials as Topic / methods,  standards*
Sensitivity and Specificity

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