AJPH Endorsement of Transparency, Clarity, and Rigor

In March 2004, AJPH published an article by Des Jarlais et al. presenting and supporting the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement and checklist for reporting standards of behavioral and public health intervention evaluations involving nonrandomized designs.¹ With the publication of this editorial and the inclusion of links and instructions on our “Instructions for Authors” page, we are making two important changes to our submission policy for randomized controlled trials (RCTs): First, the Journal joins a growing list of health and medical journals to endorse the Consolidated Standards of Reporting Trials (CONSORT) statement for randomized controlled trials. Second, we will support the International Committee of Medical Journal Editors (ICMJE) policy requiring RCT registration in an approved registry as a condition for publication consideration in the Journal.

These policies apply to any RCT, defined by the ICMJE and World Health Organization as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”² We describe the CONSORT statement and RCT registration in detail below.

The CONSORT statement, or the Consolidated Standards of Reporting Trials statement, was originally developed by an international group of biostatisticians, epidemiologists, biomedical editors, and experts in clinical trials, in an effort to increase the quality and transparency of the reporting of information from 2-group RCTs.³ The standards were revised in 2001, and continue to be modified and improved,^4–7 and current guidelines and instructions are provided on the CONSORT statement Web site (http://www.consort-statement.org). Often referred to as CONSORT, the statement includes a checklist to help authors ensure that their report is as clear as possible (Figure 1), as well as a flow diagram to help authors explicitly present the path of those targeted for inclusion in the study as they move from eligibility to enrollment to analysis (Figure 2). The checklist is to be submitted along with the manuscript for editorial review, but only the figure is to be included in the body of the manuscript.

The CONSORT statement should be used by our authors as a tool to help present, and have his or her audience appreciate, the importance and applicability of the study results.⁸ For each of the 22 items in the checklist, the CONSORT Web site provides many examples of good reporting, and all are easily adaptable to most research settings. The flow diagram is self-explanatory, but easy definitions are also available on the CONSORT Web site to help guide the investigator. In addition, there is an online tool that can help generate the downloadable chart for inclusion in the manuscript.

Not surprisingly, the CONSORT statement checklist focuses on the parts of papers that occupy the fewest manuscript pages: the Methods and Results. In fact, over 75% of the CONSORT checklist points deal with these sections. All the better, we believe, as it provides authors with another opportunity to ensure that those parts of the manuscript are as concise and as accurate as possible. Following the CONSORT checklist and guidelines enhances RCT transparency by making clear to the reader the operationalizations of constructs, the a priori declarations of meaningful and important effect sizes, and the number of participants at each phase of the study. But transparency is about allowing the audience and our peers to judge for themselves what the results of the study mean, and presenting clear operationalizations of constructs and measures, making explicit a priori declarations about meaningful effect sizes, and documenting the number and type of participant at each phase of the study—all of which goes a long way toward allowing a more objective assessment to happen.

The CONSORT guidelines have been expanded and are now available for other designs and other forms of presentations, namely cluster randomized designs,⁹ noninferiority or equivalence trials,¹⁰ herbal medicine,¹¹ nonpharmacological treatments,¹² harms,¹³ and abstracts.¹⁴ Along with our prior publication of the TREND statement, models of transparent and informative data presentation are now readily available and we have encouraged, and now require, their use.

In 2004, an editorial published simultaneously in all ICMJE member journals announced that as a condition for publication consideration, the RCT on which a submitted manuscript was based must be registered (prior to the enrollment of a single participant in that trial) in a public registry.¹⁵ The five most common acceptable registries are clinicaltrials.gov, the Australian-New Zealand Clinical Trials Registry (http://www.actr.org.au), the International Standard Randomised Controlled Trial Number Register (http://www.ISRCTN.org), the University Hospital Medical Information Network (http://www.umin.ac.jp/ctr/index/htm), and the Netherlands Trial Register (http://www.trialregister.nl), although other approved primary registries exist (for instance, the International Clinical Trials Registry Platform; http://www.who.int/ictrp/network/primary/en/index.html). The purpose of this registration policy is clear; selective reporting or submission for publication of only those trials where desired outcomes were achieved is misleading and unethical. Shedding light on the number of trials being conducted for a given intervention or outcome can inform our judgment as to whether the results are “selected” in a way that impacts their representativeness or generalizability.

Beginning December 1, 2009, the Journal will neither accept nor send for review the results of RCTs that have not been previously registered with one of the above-mentioned public registries. Trials that have already started enrolling patients by that date should register as soon as possible but not later than March 1, 2010. RCT registration in a public registry is fast becoming the norm rather than the exception, and the Journal now strongly supports this effort.¹⁶

We all benefit from the implementation of these two important additions to our submission policy. Through this and similar efforts, we can begin to more easily compare the results of RCTs across journals, meta-analytic studies can include our published studies (as the presentation of information becomes uniform), and the universe of RCTs on a particular topic can be enumerated so the correct number of attempts and type of outcome can be observed. This transparency motivates us to hold the quality of our research to the highest standards, in support of the public's health and to the benefit of all.