The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review.

Randomized clinical trials (RCTs) are usually considered the gold standard for therapeutic evaluation.1 However, surgical trials, because the intervention is multifactorial, separates them from the vastly more common pharmaceutical intervention,2 pose special challenges in their conduct and reporting. Some examples, include blinding, influence of care providers' and centers' volume, present special difficulties for randomized trials.3 A clear definition and description of the treatment assessed are a prerequisite of therapeutic evaluation.4 As an example, the revised CONSORT statement5 recommends reporting “precise details of the interventions intended for each group and how and when they were actually administered.” Contrary to pharmacologic treatments, surgical procedures can be very difficult to describe with any degree of precision. Indeed, surgical interventions are complex and involve several components such as preoperative care, the anesthetic procedure, the main surgical intervention(s), and postoperative care (eg, rehabilitation, nursing cares, physiotherapy). Further, several care providers (eg, surgeons, anesthetists, nurses, physiotherapists) actively participate in the care of the patient. As such, separating their unique contributions to the “success” of an intervention can be difficult to describe. Moreover, contrary to pharmacologic treatment, in which the effect of the healthcare professional can be regarded as secondary, in general, in surgery, the healthcare professional is an integral part of the intervention. The success of the intervention depends on care providers' skill, experience, and training. Variation between care providers' skills in each arm of the trial can be confounded with the treatment effect.6–9 In addition, the setting and hospital volume of interventions can also influence the results of surgery.10–13 To our knowledge, reporting the description of the experimental intervention in RCTs of surgery has not been reported previously,14 whereas variation in the quality of administration of intervention may explain some variability in the estimates of effects between trials in systematic reviews.15 The aim of the present study was to evaluate the quality of reporting of RCTs assessing a surgical intervention and how data on the experimental surgical interventions, and care providers are reported.