The CONSORT Statement and Plastic Surgery

Sir: In 1993, two independent initiatives to improve the quality of reports of randomized controlled trials led to the formation of the Consolidated Standards of Reporting Trials (CONSORT).1 It was developed by an international group of clinical trialists, statisticians, epidemiologists, and biomedical editors. Actually, a growing number of medical and health care journals and editorial groups support it (www.consort-statement.org). The ethical and institutional review board of our university hospital supervises biomedical publications endorsed by academic physicians through the CONSORT statement, offering a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, aiding their critical appraisal, interpretation, and also preventing problems arising from inadequate reporting of randomized controlled trials.2 The CONSORT statement is an evidence-based 22-item checklist (Fig. 1) to report how the trial was designed, analyzed, and interpreted and a flow chart (Fig. 2) that displays the progress of all participants through the trial. It forms part of a broader effort to improve reporting and enhance quality of research used in decision-making in medicine.Fig. 1.: The CONSORT checklist.Fig. 2.: The CONSORT flow chart.Randomized controlled trials are considered the standard means for evaluation of drugs, devices, and surgical procedures.3,4 The original CONSORT Statement proposed guidelines for reporting two-group parallel randomized controlled trials.1,2 Subsequently, it has been extended to cover specific variants of this design, such as nonpharmacologic treatments3 that cover a wide range of interventions, including plastic surgery in technical procedures (lipoplasty), implanted devices (breast implants), nonimplantable devices (vacuum-assisted closure), rehabilitation (use of external ultrasound), physiotherapy, behavioral therapy (psychiatry and psychotherapy), and complementary alternative medicine used sometimes in our speciality. Other extensions were made to include cluster-randomized trials, noninferiority and equivalence trials, herbal therapies, and data such as reporting of harms. The discussion of the CONSORT statement in our academic group of plastic surgery was initially focused on randomized controlled trials and special issues, such as cost, time scale, complexity of the intervention, learning curves, expertise of the care provider, difficulties with blinding, and the ethical dilemma that surrounds randomization in plastic surgery, because plastic surgeons tend to rely less on data and more on intuition and experience than most other physicians in making therapeutic decisions.4 However, we strongly think that use of randomized controlled trials is the most reliable method for assessment of the efficacy of an intervention because randomization eliminates selection biases. The academic background gives the possibility of evading ethical discontent produced with randomization of surgical procedures when surgeons of the unit feel that they are not necessarily experts in that particular operation. The way to surmount the problem of differential-expertise bias is an expertise-based randomized controlled trial where the patients are randomized to two different surgeons, each an expert in the procedures being compared.5 It is obvious that these trials should be published quickly to produce a rapid and efficient transfer of information for disseminating and implementing the deductions from these randomized controlled trials. The first impression we had when we were called by the university board was “surveillance” of our surgical investigations, which was probably being done with low methodologic standards. However, after a simple explanation of CONSORT, we were able to understand “the importance of the quality of the design and conduct of a trial” and that this could be done with the aid of a checklist and controlled through a flow chart without major problems. In conclusion, CONSORT is a good tool used to clearly describe methodology, sample size determination, how the treatment is allocated, eligibility criteria, withdrawals, dropouts, and inclusion of intention-to-treat analysis, and is able to express the essence of evidence-based plastic surgery. Arturo S. Prado, M.D. Stefan Danilla, M.D. Patricio Andrades, M.D. Francisco Parada, M.D. Plastic Surgery Division Department of Surgery Jose Joaquin Aguirre Clinical Hospital University of Chile School of Medicine Santiago, Chile DISCLOSURE None of the authors has any conflicts of interest to disclose.