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Improvement of quality of reporting in randomised controlled trials to prevent hypotension after spinal anaesthesia for caesarean section
Authors:A Herdan  R Roth  D Grass  M Klimek  S Will  B Schauf  R Rossaint  M Heesen
Institution:(1) Department of Anesthesia, Sozialstiftung Bamberg, Buger Str. 80, 96049 Bamberg, Germany;(2) Department of Anesthesia, Erasmus Medical Center, Dr. Molewaterplein, 1101 Rotterdam, The Netherlands;(3) Department of Obstetrics, Sozialstiftung Bamberg, Buger Str. 80, 96049 Bamberg, Germany;(4) Department of Anesthesia, University Hospital of RWTH Aachen, Pauwelsstr. 50, 52074 Aachen, Germany;(5) Klinik f?r An?sthesie, Klinikum Bamberg, Buger Str.80, 96049 Bamberg, Germany;
Abstract:Hypotension is a frequent complication of spinal anaesthesia for caesarean section and can threaten the well-being of the unborn child. Numerous randomised controlled trials (RCTs) dealt with measures to prevent hypotension. The aim of this study was to determine the reporting quality of RCTs using the Consolidated Standards of Reporting Trials (CONSORT) statement since low quality can lend false credibility to a study and overestimate the effect of an intervention. We performed a systematic literature search in PubMed to identify relevant RCTs in a pre-CONSORT period (1990–1994) and a post-CONSORT period (2004–2008). A comparative evaluation was done between the two periods, and the trials were assessed for compliance with each of the 22 CONSORT items. A total of 37 RCTs was identified. The CONSORT score increased significantly (p < 0.05) from 66.7% (±12.5%) in the pre-CONSORT period to 87.4% (±6.9%) in the post-CONSORT period. A statistically significant improvement was found for eight items, including randomization, blinding and intention-to-treat analysis. The CONSORT score in the post-CONSORT era was fairly good, also in comparison to other medical fields. In the post-CONSORT era, reporting of important items improved, in particular in the domains that are crucial to avoid bias and to improve internal validity. Use of CONSORT should be encouraged in order to keep or even improve the reporting quality.
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