Improvement of quality of reporting in randomised controlled trials to prevent hypotension after spinal anaesthesia for caesarean section

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.

Assessment of the Reporting Quality of Randomized Controlled Trials on the Treatment of Diabetes Mellitus with Traditional Chinese Medicine: A Systematic Review

“…None of the studies stated who generated the allocation sequence and whether the same person enrolled the participants. In our opinion (and that of others), a marked improvement in the items relating to randomization was found [55]. Just over half the studies (n = 15) fully described the methods used to generate the allocation sequence.…”

“…Reporting of a priori sample size calculation is an indicator of adequate trial planning and indicates whether a trial ends earlier than planned. However, Herdan A. et al [55] reported that sample size calculation showed a sharp increase over time, i.e. the percentage of trials correctly reporting this item increased from 23% (three of 13 reports) to 71% (17 of 27 reports) in the post-CONSORT period.…”

Systematic evaluation of therapeutic effects of stem cell transplantation trials for heart diseases in China

“…In addition, an unpredictable and unknown allocation schedule can minimize selection and confounding biases. 41 However, we found none of the trials reported detailed information on the implementation of randomization. None of the studies stated who generated the allocation sequence and who enrolled the participants.…”

“…Randomization reduces confounding by equalizing so‐called factors (independent variables) that have not been accounted for in the RCT. In addition, an unpredictable and unknown allocation schedule can minimize selection and confounding biases 41 . However, we found none of the trials reported detailed information on the implementation of randomization.…”

Studying the Effect of Wearing Compression Socks on Hypotension and the Amount of Administrated Ephedrine after Spinal Anesthesia in the Candidates for Cesarean Section

“…Since the severity and persistence of hypotension will lead to acidosis in the fetus, appropriate measures should be taken to prevent the onset or the continuation of hypotension in the mother during the process of anesthesia and C-section. Several pharmaceutical and non-pharmaceutical strategies have been introduced for preventing the spinal anesthesia-induced hypotension [18,19]. Administration of colloidal fluid before surgery, injection of crystalloid fluid during surgery and administration of vasopressors are among the pharmaceutical methods, while use of bandages in lower extremities and alternating compression devices are among the non-pharmaceutical methods [20][21][22][23].…”