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Hum. Reprod. Advance Access first published online on June 22, 2006
This version published online on July 20, 2006
Human Reproduction, doi:10.1093/humrep/del236
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© The Author 2006. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
Received March 27, 2006
Revised May 15, 2006
Accepted May 19, 2006

Article

Evidence of improving quality of reporting of randomized controlled trials in subfertility

Sofia Dias 1 *, Roseanne McNamee 1, and Andy Vail 1

1 Biostatistics Group, University of Manchester, Manchester, UK

* To whom correspondence should be addressed.
Sofia Dias, E-mail: sofia.dias{at}manchester.ac.uk


  Abstract

BACKGROUND: The quality of randomized controlled trials (RCTs) in subfertility and their suitability for inclusion in meta-analyses have been assessed in the past and found to be insufficient. Our aim was to assess whether this quality has improved over time, particularly since the publication of the Consolidated Standards of Reporting Trials (CONSORT) statement, and to assess what proportion of trials could be included in the meta-analyses of pregnancy outcomes such as those included in Cochrane Reviews. METHODS: A selection of subfertility trials published in 1990, 1996 and 2002 was collected from the Cochrane Menstrual Disorder and Subfertility Group (MDSG) database. Only trials published in English as full journal articles, claiming to be randomized and reporting on pregnancy outcomes, were included. RESULTS: One hundred and sixty-four trials met our inclusion criteria. Twenty-four (15%) were found not to be randomized, despite claims, and only 10 trials (6%) provided adequate details on the methods of randomization and allocation concealment. Of these, only three had sufficient details extractable to allow for an intention-to-treat analysis of the outcome ‘live birth’. CONCLUSIONS: Although an improvement in some subfertility-specific issues was observed, the quality of reporting of RCTs still needs to improve to make them suitable for inclusion in meta-analyses such as those in the Cochrane Library.

Keywords: methodological quality/statistics/subfertility/systematic review.

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