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Open Access Highly Accessed Research article

The quality of reporting of RCTs used within a postoperative pain management meta-analysis, using the CONSORT statement

Victoria Borg Debono12, Shiyuan Zhang12, Chenglin Ye2, James Paul1, Aman Arya4, Lindsay Hurlburt5, Yamini Murthy1 and Lehana Thabane23*

Author affiliations

1 Department of Anesthesia, McMaster University, 2U1-1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada

2 Department of Clinical Epidemiology and Biostatistics, McMaster University, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada

3 Biostatistics Unit, Father Sean O'Sullivan Research Centre 3rd Floor Martha, Room H325, St. Joseph's Healthcare Hamilton, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada

4 Department of Medicine, Schulich School of Medicine, University of Western Ontario, 339 Windermere Road, London, ON, N6G 2 K3, Canada

5 Department of Anesthesia, University of Toronto, Room 121, Fitzgerald Building, 150 College Street, Toronto, ON, M5S 3E2, Canada

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Citation and License

BMC Anesthesiology 2012, 12:13  doi:10.1186/1471-2253-12-13

Published: 4 July 2012

Abstract

Background

Randomized controlled trials (RCTs) are routinely used in systematic reviews and meta-analyses that help inform healthcare and policy decision making. The proper reporting of RCTs is important because it acts as a proxy for health care providers and researchers to appraise the quality of the methodology, conduct and analysis of an RCT. The aims of this study are to analyse the overall quality of reporting in 23 RCTs that were used in a meta-analysis by assessing 3 key methodological items, and to determine factors associated with high quality of reporting. It is hypothesized that studies with larger sample sizes, that have funding reported, that are published in journals with a higher impact factor and that are in journals that have adopted or endorsed the CONSORT statement will be associated with better overall quality of reporting and reporting of key methodological items.

Methods

We systematically reviewed RCTs used within an anesthesiology related post-operative pain management meta-analysis. We included all of the 23 RCTs used, all of which were parallel design that addressed the use of femoral nerve block in improving outcomes after total knee arthroplasty. Data abstraction was done independently by two reviewers. The two main outcomes were: 1) 15 point overall quality of reporting score (OQRS) based on the Consolidated Standards for Reporting Trials (CONSORT) and 2) 3 point key methodological item score (KMIS) based on allocation concealment, blinding and intention-to-treat analysis.

Results

Twenty-three RCTs were included. The median OQRS was 9.0 (Interquartile Range = 3). A multivariable regression analysis did not show any significant association between OQRS or KMIS and our four predictor variables hypothesized to improve reporting. The direction and magnitude of our results when compared to similar studies suggest that the sample size and impact factor are associated with improved key methodological item reporting.

Conclusions

The quality of reporting of RCTs used within an anesthesia related meta-analysis is poor to moderate. The information gained from this study should be used by journals to register the urgency for RCTs to be clear and transparent in reporting to help make literature accessible and comparable.