Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

作者: Asbjørn Hróbjartsson , Julie Pildal , An-Wen Chan , Mette T. Haahr , Douglas G. Altman

DOI: 10.1016/J.JCLINEPI.2009.04.003

关键词:

摘要: Abstract Objective To compare the reporting on blinding in protocols and articles describing randomized controlled trials. Study Design Setting We studied 73 of trials approved by scientific/ethical committees for Copenhagen Frederiksberg, 1994 1995, their corresponding publications. Results Three out (4%) reported protocol that contradicted publication (e.g., “open” vs. “double blind”). The proportion “double-blind” with a clear description participants increased from 11 58 (19%) when based publications alone to 39 (67%) adding information protocol. similar proportions health care providers were 2 (3%) 22 (38%); data collectors, they 8 (14%) 14 (24%). In 52 (90%), it was unclear whether all patients, providers, collectors had been blinded. 4 (7%), clarified three key trial persons Conclusions both is often inadequate. suggest developing international guidelines public access protocols.

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