Recognizing that often knowledge gaps are identified and high-quality evidence does not exist to guide practice, we plan to complete the “evidence cycle” through the establishment of a collaborative group to conduct pragmatic, practice-changing trials in surgery.
Our plan is to establish a Steering Committee including representation from each U of T affiliated hospital (7), a methodologist/statistician, and a patient representative (Figure 2). The Steering Committee will oversee the selection of trials to conduct through an iterative, consensus-based framework including broad stakeholders (Figure 3). We will invite academic and community surgeons, trainees, and patients to submit ideas for potential trials, supplemented by knowledge gaps identified through Best Practice in Surgery. Each potential trial will be assessed by the Steering Committee for feasibility, applicability, and importance and to the broader community for endorsement. A Steering Committee will be established for each clinical trial, and protocols will be developed. We will leverage existing mechanisms for data collection where possible, including the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). As a guiding principle, trials will be pragmatic, simple, and non-regulated (ie not new drugs/devices) to maximize applicability and feasibility.
Randomized Controlled Trials (RCTs) are the most rigorous and informative research design to evaluate the effectiveness of a medical intervention. RCTs are resource-intense compared to other research designs, but are far more likely to yield reliable, accurate information that can be incorporated into clinical care. Regulatory agencies such as Health Canada and the US Food and Drug Administration (FDA) require that new medications undergo evaluation in an RCT prior to approval. These regulations do not apply to surgical interventions, which are essentially left to the discretion of surgeons. As a result, surgical therapies are less than half as likely to be based on evidence from RCTs compared to medical therapies, and tremendous heterogeneity exists in surgical practice patterns. There is a dearth of strong evidence to guide surgeons in the conduct of even fundamental practices, such as location of incisions for surgery, selection of appropriate antibiotics to prevent infection, and technique of wound closure. These core elements of surgical decision-making occur thousands of times daily across Canada, but are predominantly guided by anecdotal experience and surgeon preference.