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Editorials |
We wish that you could have been with us at our PTJ meeting following APTA's Combined Sections Meeting in Nashville. We have assembled an incredible group of talented Steering Committee members, Editorial Board members, and Reviewers, all of whom have worked diligently to reduce our time from submission to publication, to attract new authors, and to develop special features both in print and online. But we are never satisfied.
For our meeting, we reviewed the randomized controlled trials (RCTs) that were published in PTJ between January 2007 and January 2008. Chris Maher pointed out that it was common to find reports of RCTs that did not include the kind of information that would allow readers to judge (1) the veracity of the results and (2) whether the results applied to their patients. Some of the problems he noted included an emphasis on P values rather than on effect sizes, the absence of a trial flow diagram, and insufficient information on how missing data were handled. Beck Craik's reaction to this report surprised her—she was delighted that we had 18 RCTs reported in a 1-year period! Her glee was short-lived, however, because Chris' report highlighted a gap between our standard of excellence and current practice in the reporting of RCTs published in PTJ.
Others have written eloquently about the need for improved reporting of RCTs, including the need for transparency in the reporting of methods and for clear descriptions of study limitations.1,2 The reason for clear reporting goes beyond following a proper guide for scientific conduct. Quantitative systematic reviews, such as metaanalyses, synthesize the results across trials, in turn leading to the development of clinical guidelines. All of this is done to assist the clinician in making an informed decision about the most effective diagnostic tool or intervention.3–6 A principal reason for improving our reports of clinical trials, then, is to enhance the consistency and quality of care delivery.
Effective January 1, 2008, PTJ began to "raise the bar" for reporting clinical trials. We are proud to be among the first rehabilitation journals to endorse the CONSORT (Consolidated Standards of Reporting Trials) Statement, which was developed to alleviate the problems arising from inadequate reporting of RCTs.1 The CONSORT Statement (www.consort-statement.org) provides a template for authors to follow when preparing reports of trial findings and is included in PTJ's submission guidelines at www.ptjournal.org/misc/ifora.dtl. The statement facilitates complete and transparent reporting and aids critical appraisal, interpretation, and, importantly, application to practice.
A limitation of the original CONSORT Statement was that it arose from a consideration of the reporting of drug trials and, therefore, did not adequately cover some of the issues that arise in the conduct of physical therapy trials—for example, the complexity of physical therapy interventions, the difficulties with blinding, and the need to consider the level of expertise of the physical therapist who is delivering the intervention. Earlier this year, the CONSORT Group announced an extension to the CONSORT Statement to include guidelines for reporting nonpharmacologic treatments, including surgery, technical interventions, rehabilitation, psychotherapy, behavioral interventions, and implantable and complementary medicine.7 (Our authors and readers will be much more pleased with the new checklist and flow diagram.) PTJ endorsed the statement extension in February, and we have modified our submission guidelines to include it. Ultimately, the extension will assist authors in more clearly reporting their clinical trials, allow readers to more readily understand the methods and results, and guide clinicians in integrating the trial results into practice. PTJ believes that implementation is critical, and we will work with authors to provide additional online materials, such as videoclips and trial manuals, to comprehensively describe the physical therapy interventions evaluated in trials.
This month, we are joining yet another initiative to ensure transparency and accountability in the reporting of clinical trials: clinical trial registration. As defined by the International Committee of Medical Journal Editors (ICMJE), a clinical trial is any research project that prospectively assigns human subjects to intervention or comparison groups to examine a cause-and-effect relationship between an intervention and an outcome.8 Eleven ICMJE member journals, including Annals of Internal Medicine and New England Journal of Medicine, started the registration movement when they required authors to register their clinical trials in a public register in order for manuscripts to be considered for publication.9,10 The ICMJE encouraged other journals to follow their lead, and now it is time for PTJ to join them. Our requirement is as follows:
Why is registration so important? Trials with negative results are much less likely to be published than trials with positive results, so it is highly likely that we currently are judging treatment efficacy on a biased sample of the evidence. In addition, some authors may change from their prespecified analysis plan if results are not positive, using a "shotgun" approach to analysis in order to find something positive and then reporting only that positive finding. In our view, the only way to deal with these potential problems is the prospective registration of trials.
There are a growing number of trial registries. Two large registries are the International Standard Randomized Controlled Trial Number (http://www.controlled-trials.com/isrctn/) and ClinicalTrials.gov (www.clinicaltrials.gov), which have been recording trial information since 2000. An acceptable registry includes at least the following information: a unique identifying number, a statement of the intervention (or interventions) and comparison (or comparisons) studied, a statement of the study hypothesis, definitions of the primary and secondary outcome measures, eligibility criteria, key trial dates (registration date, anticipated or actual start date, anticipated or actual date of last follow-up, planned or actual date of closure to data entry, and date trial data considered complete), target number of subjects, funding source, and contact information for the principal investigator. Trial registration is free and typically takes no more than 30 minutes.
There is still a large gap between the goal of public registration of clinical trials and actual registration.11 The literature supports the growing trend internationally for clinical trial registration. It is PTJ's responsibility to adopt a trials registration policy for publication.
We understand that these changes might take some getting used to. Keep your eye on the goal—the best possible patient outcome!
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