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Updated Consolidated Standards of Reporting Trials (CONSORT): it just gets better
Journal of Clinical Epidemiology 63 (2010) 813e814
COMMENTARIES
Updated Consolidated Standards of Reporting Trials (CONSORT): it just gets better Maarten Boers* Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands Accepted 15 January 2010
In this issue of the Journal of Clinical Epidemiology, the Consolidated Standards of Reporting Trials (CONSORT) Group present [3] and elaborate on [4] their updated guidelines. These articles are truly landmark publications, and we should congratulate the group with this achievement. Increasingly, journals are endorsing the standards, in turn, leading to improvements in clinical trial reporting. Although the authors claim that their efforts are not targeted at the conduct but only at the reporting of trials, the elaboration document reads like a modern textbook on how to perform trials. This last document is especially well written and contains many useful examples that will help authors both in the planning and in the reporting stages of their trials. Obviously, the standard was set with the first publication in 1996; subsequent updates in 2001 and now this one serve mainly to clarify, to remove inconsistencies, and to strengthen and report the empirical evidence underlying the recommendations. So, how to comment or critique this ‘‘biblical’’ document? I would like to focus on two topics that probably deserve more attention: document length and formatting of tables and graphs. Document length is becoming a pressing problem for authors. The typical word count for a clinical trial to be published in a major journal is about 3,000 (plus or minus a few hundred words). To put this into perspective, the CONSORT elaboration is almost 20,000 words long, and the sum of the example texts in it (taking the longest example where there were two or more on one topic) amounts to 2,425 words (of which over 1,400 are on methods). For authors striving to publish, for example, in the New England Journal of Medicine, with its 2,700-word limit, including all the proper example text would leave less than 300 words
* Corresponding author. Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 165, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Tel.: þ3120-444-4474; fax: þ3120444-4475. E-mail address: [email protected] 0895-4356/$ e see front matter Ó 2010 Elsevier Inc. All rights reserved. doi: 10.1016/j.jclinepi.2010.01.002
of text specific to their trial. Likewise, a properly worded structured abstract invariably runs beyond the word limit set by many journals. Hence, although editors declare full endorsement of the guidelines, their specific journal requirements often prevent the manuscript to be written in such a way that all CONSORT guidelines can be met. In addition, the attempt to comply both to CONSORT and the word limitation leads to extremely dense and often ugly text. Fortunately, the Web is offering increasing opportunities to address these problems. Many journals are now offering (or even requiring authors) to put additional material on the Web. However, the implementation is somewhat haphazard, often leaving the interested reader to hunt and seek for the material most relevant to him or her. In a report on an ad hoc survey among journal editors, Schwarzman has thoughtfully outlined the challenges inherent in publishing additional material, including the lack of a uniform definition, guidelines on peer reviewing, formatting, and preservation; this is accessible on the Web site of the American Geophysical Union [1]. The British Medical Journal (BMJ) has implemented a structure that I find most promising: a 1,000-word abridged report (termed ‘‘BMJ pico’’) in print and the full report online only. In this case, it is actually the print version that is ‘‘supplementary,’’ whereas the online version is the ‘‘real’’ one. BMJ bravely states that there is no word limit on the full report. This might invite authors to become wordy, but the principle is sound and should lead to articles in a better style and conforming fully to the guidelines. I would invite all journals to follow this example. The second point is the formatting of tables and graphs. Doug Altman, one of the authors of both the CONSORT articles, together with colleagues recently completed a review on the quality of tables and graphs in major publications [2]. By applying a structured assessment tool, they were able to spot many flaws, leading to less than 50% of both tables and figures judged by the authors to have realized their full potential. In my view, summary tables and graphs are essential in conveying the principal messages of a study,
814
M. Boers / Journal of Clinical Epidemiology 63 (2010) 813e814
so it is a pity that nothing of these results and considerations have made it into the CONSORT guidelines. In fact, in the discussion, the authors of the aforementioned review actually suggest that some form of guidance in this topic would be appropriate for CONSORT but consider this to be unfeasible because of the lack of empirical evidence that any guideline does more good than harm. I beg to differ: much like style guidelines, we might try to raise the bar for tables and figures without becoming too restrictive. It is high time to start thinking about a subset of guidelines to address this problem. In all, this update of the CONSORT guidelines is an extremely solid set of standards for the reporting of clinical trials.
References [1] Schwartzman S. Supporting material. Available at http://www.agu.org/ dtd/Presentations/supporting-material.htm 2009;. Accessed January 5, 2010. [2] Schriger DL, Sinha R, Schroter S, Liu PY, Altman DG. From submission to publication: a retrospective review of the tables and figures in a cohort of randomized controlled trials submitted to the British Medical Journal. Ann Emerg Med 2006;48:750e6. 756.e1e21. [3] Schulz KF, Altman DG. Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:834e40. [4] Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:e1e37.
COMMENTARIES
Updated Consolidated Standards of Reporting Trials (CONSORT): it just gets better Maarten Boers* Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands Accepted 15 January 2010
In this issue of the Journal of Clinical Epidemiology, the Consolidated Standards of Reporting Trials (CONSORT) Group present [3] and elaborate on [4] their updated guidelines. These articles are truly landmark publications, and we should congratulate the group with this achievement. Increasingly, journals are endorsing the standards, in turn, leading to improvements in clinical trial reporting. Although the authors claim that their efforts are not targeted at the conduct but only at the reporting of trials, the elaboration document reads like a modern textbook on how to perform trials. This last document is especially well written and contains many useful examples that will help authors both in the planning and in the reporting stages of their trials. Obviously, the standard was set with the first publication in 1996; subsequent updates in 2001 and now this one serve mainly to clarify, to remove inconsistencies, and to strengthen and report the empirical evidence underlying the recommendations. So, how to comment or critique this ‘‘biblical’’ document? I would like to focus on two topics that probably deserve more attention: document length and formatting of tables and graphs. Document length is becoming a pressing problem for authors. The typical word count for a clinical trial to be published in a major journal is about 3,000 (plus or minus a few hundred words). To put this into perspective, the CONSORT elaboration is almost 20,000 words long, and the sum of the example texts in it (taking the longest example where there were two or more on one topic) amounts to 2,425 words (of which over 1,400 are on methods). For authors striving to publish, for example, in the New England Journal of Medicine, with its 2,700-word limit, including all the proper example text would leave less than 300 words
* Corresponding author. Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 165, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Tel.: þ3120-444-4474; fax: þ3120444-4475. E-mail address: [email protected] 0895-4356/$ e see front matter Ó 2010 Elsevier Inc. All rights reserved. doi: 10.1016/j.jclinepi.2010.01.002
of text specific to their trial. Likewise, a properly worded structured abstract invariably runs beyond the word limit set by many journals. Hence, although editors declare full endorsement of the guidelines, their specific journal requirements often prevent the manuscript to be written in such a way that all CONSORT guidelines can be met. In addition, the attempt to comply both to CONSORT and the word limitation leads to extremely dense and often ugly text. Fortunately, the Web is offering increasing opportunities to address these problems. Many journals are now offering (or even requiring authors) to put additional material on the Web. However, the implementation is somewhat haphazard, often leaving the interested reader to hunt and seek for the material most relevant to him or her. In a report on an ad hoc survey among journal editors, Schwarzman has thoughtfully outlined the challenges inherent in publishing additional material, including the lack of a uniform definition, guidelines on peer reviewing, formatting, and preservation; this is accessible on the Web site of the American Geophysical Union [1]. The British Medical Journal (BMJ) has implemented a structure that I find most promising: a 1,000-word abridged report (termed ‘‘BMJ pico’’) in print and the full report online only. In this case, it is actually the print version that is ‘‘supplementary,’’ whereas the online version is the ‘‘real’’ one. BMJ bravely states that there is no word limit on the full report. This might invite authors to become wordy, but the principle is sound and should lead to articles in a better style and conforming fully to the guidelines. I would invite all journals to follow this example. The second point is the formatting of tables and graphs. Doug Altman, one of the authors of both the CONSORT articles, together with colleagues recently completed a review on the quality of tables and graphs in major publications [2]. By applying a structured assessment tool, they were able to spot many flaws, leading to less than 50% of both tables and figures judged by the authors to have realized their full potential. In my view, summary tables and graphs are essential in conveying the principal messages of a study,
814
M. Boers / Journal of Clinical Epidemiology 63 (2010) 813e814
so it is a pity that nothing of these results and considerations have made it into the CONSORT guidelines. In fact, in the discussion, the authors of the aforementioned review actually suggest that some form of guidance in this topic would be appropriate for CONSORT but consider this to be unfeasible because of the lack of empirical evidence that any guideline does more good than harm. I beg to differ: much like style guidelines, we might try to raise the bar for tables and figures without becoming too restrictive. It is high time to start thinking about a subset of guidelines to address this problem. In all, this update of the CONSORT guidelines is an extremely solid set of standards for the reporting of clinical trials.
References [1] Schwartzman S. Supporting material. Available at http://www.agu.org/ dtd/Presentations/supporting-material.htm 2009;. Accessed January 5, 2010. [2] Schriger DL, Sinha R, Schroter S, Liu PY, Altman DG. From submission to publication: a retrospective review of the tables and figures in a cohort of randomized controlled trials submitted to the British Medical Journal. Ann Emerg Med 2006;48:750e6. 756.e1e21. [3] Schulz KF, Altman DG. Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:834e40. [4] Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:e1e37.