Systematic Review
The quality of safety reporting in trials is still suboptimal: Survey of major general medical journals

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Abstract

Objective

To evaluate whether the quality of reporting harms improved after the publication of the Extension of the Consolidated Standards of Reporting Trials (CONSORT) statement and predictors that influence the safety reporting in randomized controlled trials (RCTs)

Study Design and Setting

Systematic survey of published RCTs assessing drugs. In MEDLINE, we identified 228 RCTs published in Annals of Internal Medicine, British Medical Journal, Journal of American Medical Association, The Lancet, and The New England Journal of Medicine in 2003 and 2006.

Results

The reporting of harms have improved over time both in quality and extent of space. However, the mean score as an overall measure of adequacy in reporting harms was 0.58 in 2003 and increased to 0.67 in 2006, indicating a moderate safety reporting. Safety was more adequate in trials with statistically significant results for efficacy, private funding, primary harms outcome, and anti-infective, antineoplasmatic, or immunosuppressive agents.

Conclusion

The use of the Extension of the CONSORT statement may be associated with improving the quality of safety reporting in RCTs, but there are still deficiencies that need to be corrected to use quantitative objective evidence for harms in performing meta-analyses and making therapeutic decisions.

Introduction

What is new?

Key finding

  1. The quality of safety reporting in randomized controlled trials (RCTs) published in five major main medical journals is still suboptimal after the publication of the Extension of the Consolidated Standards of Reporting Trials (CONSORT) statement with recommendations for better reporting of harms.

What this adds to what was known
  1. Considerable evidence suggested that reporting of harms-related data from RCTs is often neglected. This is true even after the publication of the Extension of the CONSORT statement, although there seemed to be an improvement over time. Additionally, a mean score is introduced as an overall measure of adequacy in reporting harms, ranging from 0 to 1. A value of 1 indicates perfect safety reporting, and lower values show poorer quality of harms-related data.

What is the implication and what should change now?
  1. Authors should give more attention to writing harms and follow the 10 new recommendations about reporting harms-related issues according to the Extension of the CONSORT statement. This would help to use quantitative objective evidence for harms in performing meta-analyses and making therapeutic decisions.

The Consolidated Standards of Reporting Trials (CONSORT) statement is aimed at standardizing and thereby improving the quality of published reports of randomized controlled trials (RCTs) [1]. In the first version of the CONSORT statement that was published in 1996, there was no item referring to reporting of adverse events [2]. In its revised version, 5 years later, the reporting of safety was first added as an item together with some other important methodological features of RCTs [3]. However, there was still considerable evidence that reporting of harms-related data from RCTs also needed improvement [4], [5], [6], [7]. Therefore, at the end of 2004, an Extension of the CONSORT statement was published that suggested 10 new recommendations with accompanying explanations for the appropriate reporting of harms-related issues [8].

Since the publication of the CONSORT statement, several review articles have investigated its impact on the quality of reports of RCTs [9], [10], [11], [12], [13], [14]. However, these studies showed that the quality of reporting of trials was improved but there was no examination on the safety reporting. Recently, two surveys were published, the one of which investigated the quality of reporting of trial abstracts, where there is only a mention of the proportion of abstracts that describes harms or side effects [15]. The second one evaluated the reporting of adverse events after the dissemination of the Extension for harms of the CONSORT statement, but there was no comparison before the publication of this extended guideline [16]. In the present study, we assessed the impact of the Extension of the CONSORT statement with the 10 new recommendations on the reporting of harms in trial reports published before and after its release. We also sought to understand the settings and predictors that influence the quality in reporting harms and gain insight for improving important deficiencies in this area.

Section snippets

Study RCTs

Published RCTs in 2003 (pre-CONSORT harm-reporting recommendations) and 2006 (post-CONSORT harm-reporting recommendations) were selected from the Annals of Internal Medicine, British Medical Journal, Journal of American Medical Association, The Lancet, and The New England Journal of Medicine (NEJM). These medical journals are prestigious and likely to publish clinical trials with major impact on medical practice, and they adopt the CONSORT statement with the only exception of NEJM that adopted

Characteristics of eligible trials

Of the 310 RCTs identified and published in 2003, 126 were included in the final analyses, and of the 332 RCTs identified and published in 2006, 102 were finally analyzed. The references of the included and excluded studies are given in the Appendix on the journal's web site at www.jclinepi.com. Fig. 1, Fig. 2 show the flow of the RCTs by year and journal.

Trial characteristics of the included studies are presented in Tables 1 and 2/Appendix on the journal's web site at www.jclinepi.com. The

Discussion

The safety reporting in randomized trials in four out of five journals included in this study and as well as an overall improved over time both in quality and extent of space. On the other hand, the mean score, as an overall measure of adequacy in reporting harms, was 0.58 in 2003 and increased to 0.67 in 2006, indicating a moderate reporting of safety. Safety was more adequate in trials that report statistically significant results for efficacy, when private funding was involved, when harms

Acknowledgments

The authors would like to thank the teacher of English, Effie Kariotaki, MSc, for linguistic revision of the article.

References (28)

  • J.P. Ioannidis et al.

    Improving safety reporting from randomized trials

    Drug Saf

    (2002)
  • J.P. Ioannidis et al.

    Better reporting of harms in randomized trials: an extension of the CONSORT statement

    Ann Intern Med

    (2004)
  • D. Moher et al.

    Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation

    JAMA

    (2001)
  • M. Egger et al.

    Value of flow diagrams in reports of randomized controlled trials

    JAMA

    (2001)
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