The importance of allocation concealment and patient blinding in osteoarthritis trials: a meta-epidemiologic study

Nüesch, Eveline; Reichenbach, Stephan; Trelle, Sven; Rutjes, Anne W S; Liewald, Katharina; Sterchi, Rebekka; Altman, Douglas G; Jüni, Peter (2009). The importance of allocation concealment and patient blinding in osteoarthritis trials: a meta-epidemiologic study. Arthritis & rheumatism, 61(12), pp. 1633-1641. Hoboken, N.J.: Wiley-Blackwell 10.1002/art.24894

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Rheumatology, Clinical Immunology and Allergology

UniBE Contributor:

Nüesch, Eveline; Reichenbach, Stephan; Trelle, Sven; Liewald, Katharina; Sterchi, Rebekka and Jüni, Peter

ISSN:

0004-3591

ISBN:

19950329

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Factscience Import

Date Deposited:

04 Oct 2013 15:09

Last Modified:

30 Jun 2015 13:31

Publisher DOI:

10.1002/art.24894

PubMed ID:

19950329

Web of Science ID:

000279276100005

BORIS DOI:

10.7892/boris.30332

URI:

https://boris.unibe.ch/id/eprint/30332 (FactScience: 192781)

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