Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study.

ABSTRACT:

Objectives

To compare how allocation concealment is described in publications of randomised clinical trials and corresponding protocols, and to estimate how often trial publications with unclear allocation concealment have adequate concealment according to the protocol.

Design

Cohort study of 102 sets of trial protocols and corresponding publications.

Setting

Protocols of randomised trials approved by the scientific and ethical committees for Copenhagen and Frederiksberg, 1994 and 1995.

Main outcome measures

Frequency of adequate, unclear, and inadequate allocation concealment and sequence generation in trial publications compared with protocols, and the proportion of protocols where methods were reported to be adequate but descriptions were unclear in the tria

SUBMITTER: Pildal J 

PROVIDER: S-EPMC557221 | biostudies-literature | 2005 May

REPOSITORIES: biostudies-literature