Document Detail

The importance of allocation concealment and patient blinding in osteoarthritis trials: a meta-epidemiologic study.
MedLine Citation:
PMID:  19950329     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the association of adequate allocation concealment and patient blinding with estimates of treatment benefits in osteoarthritis trials.
METHODS: We performed a meta-epidemiologic study of 16 meta-analyses with 175 trials that compared therapeutic interventions with placebo or nonintervention control in patients with hip or knee osteoarthritis. We calculated effect sizes from the differences in means of pain intensity between groups at the end of followup divided by the pooled SD and compared effect sizes between trials with and trials without adequate methodology.
RESULTS: Effect sizes tended to be less beneficial in 46 trials with adequate allocation concealment compared with 112 trials with inadequate or unclear concealment of allocation (difference -0.15; 95% confidence interval [95% CI] -0.31, 0.02). Selection bias associated with inadequate or unclear concealment of allocation was most pronounced in meta-analyses with large estimated treatment benefits (P for interaction < 0.001), meta-analyses with high between-trial heterogeneity (P = 0.009), and meta-analyses of complementary medicine (P = 0.019). Effect sizes tended to be less beneficial in 64 trials with adequate blinding of patients compared with 58 trials without (difference -0.15; 95% CI -0.39, 0.09), but differences were less consistent and disappeared after accounting for allocation concealment. Detection bias associated with a lack of adequate patient blinding was most pronounced for nonpharmacologic interventions (P for interaction < 0.001).
CONCLUSION: Results of osteoarthritis trials may be affected by selection and detection bias. Adequate concealment of allocation and attempts to blind patients will minimize these biases.
Eveline Nüesch; Stephan Reichenbach; Sven Trelle; Anne W S Rutjes; Katharina Liewald; Rebekka Sterchi; Douglas G Altman; Peter Jüni
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Arthritis and rheumatism     Volume:  61     ISSN:  0004-3591     ISO Abbreviation:  Arthritis Rheum.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-16     Completed Date:  2010-01-21     Revised Date:  2014-03-17    
Medline Journal Info:
Nlm Unique ID:  0370605     Medline TA:  Arthritis Rheum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1633-41     Citation Subset:  AIM; IM    
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MeSH Terms
Bias (Epidemiology)
Clinical Trials as Topic
Complementary Therapies
Data Collection / methods*
Epidemiologic Studies
Osteoarthritis, Hip / physiopathology,  therapy*
Osteoarthritis, Knee / physiopathology,  therapy*
Pain / physiopathology
Pain Measurement
Single-Blind Method
Treatment Outcome
Grant Support
10859//Cancer Research UK

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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