PMID: 8605459Mar 23, 1996Paper

Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology

BMJ : British Medical Journal
K F SchulzR J Hayes

Abstract

To assess the methodological quality of approaches to blind ing and to handling of exclusions as reported in randomised trials from one medical specialty. Survey of published, parallel group randomised controlled trials. A random sample of 110 reports in which allocation was described as randomised from 1990 and 1991 volumes of four journals of obstetrics and gynaecology. The adequacy of the descriptions of double blinding and exclusions after randomisation. Through 31 trials reported being double blind, about twice as many could have been. Of the 31 trials only eight (26%) provided information on the protection of the allocation schedule and only five (16%) provided some written assurance of successful implementation of double blinding. Of 38 trials in which the authors provided sufficient information for readers to infer that no exclusions after randomisation had occurred, six (16%) reported adequate allocation concealment and none stated that an intention to treat analysis had been performed. That compared with 14 (27%) and six (12%), respectively, for the 52 trials that reported exclusions. Investigators could have double blinded more often. When they did double blind, they reported poorly and rarely evaluated it. Paradoxic...Continue Reading

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