Quality of reporting of randomized controlled trials in polycystic ovary syndrome
1 Department of Biomathematics, University of Thessaly School of Medicine, Larissa, Greece
2 Center for Clinical Evidence Synthesis, The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, USA
Trials 2009, 10:106 doi:10.1186/1745-6215-10-106Published: 20 November 2009
Inadequate reporting of randomized controlled trials (RCTs) is associated with biased estimates of treatment effects. The reporting quality of RCTs involving patients with polycystic ovary syndrome (PCOS) is unknown. The purpose of this study was to assess the reporting quality of RCTs involving patients with PCOS using a standardized tool based on the Consolidated Standards of Reporting Trials (CONSORT) statement.
We searched PubMed database for English-language RCTs involving patients with PCOS. Quality of reporting was assessed using a 24-item questionnaire based on the revised CONSORT checklist. Reporting was evaluated overall, and for pre- and post-CONSORT periods. RCTs on PCOS associated with fertility and non-fertility disturbances were also evaluated separately.
Nine of the 24 items were reported in less than 50% of the studies, while a significant improvement (P < 0.05) was detected in 12 of 24 items (50%) over the two CONSORT periods. The RCTs on PCOS with reference to fertility seem to have adhered better to CONSORT statement than RCTs not associated to fertility.
There is empirical evidence of suboptimal reporting quality of RCTs in PCOS. Endorsement of the CONSORT statement may optimize the reporting quality and enhance the validity of research.