A history of the McGill Department of Surgery: the first 100 years (1923-2023).

SummaryIn 1923, just over 100 years ago, Edward William Archibald was appointed the first chair of surgery in McGill University's Faculty of Medicine. This milestone provides an opportunity to reflect on where the department has come from and how it has progressed to the present day. Although the size, breadth, and diversity of the department members have changed notably over the century, the core values of innovative clinical care, research, and education established a century ago continue to this day. To reflect his values, the Archibald Chair of Surgery was established in 1990 and is today held by the department chair.

Evaluation and stages of surgical innovations.

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

No surgical innovation without evaluation: the IDEAL recommendations.

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.

Challenges in evaluating surgical innovation.

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

The rules of evidence-based medicine: can they be generalized to improve GI surgical practice?

Evidence-based surgical practice (EBSP) must be integrated into the educational curriculum for all surgeons. Independent of the compelling need for best practice, there are at least three compelling drivers: the exploding cost of health care demands evidence-based practice, patient safety is best supported by best evidence, and the medico-legal environment uses EBSP to pursue its goals.

Evidence-based surgery.

Understanding the issues associated with surgical epidemiology,knowledge management, and evidence-based surgical practice has implications for clinicians in the community, surgeons in large metropolitan hospitals, surgeon scholars, and the academic surgeon. All need to have some understanding of not only the evaluation of the evidence and how to find it but, in addition, application of those concepts to continuous quality improvement and to closing a circle of surgical audit. If the surgical profession has an obligation to redefine clinical modus operandi and educational processes, the argument for formal training in aspects of clinical epidemiology during the surgical residency program is obvious,because all surgeons will benefit from those educational exercises.

Evidence-based surgical practice and patient-centered care: inevitable.

Evidence-based medicine provides a well-developed framework for evaluation of clinical research. Well-designed and adequately powered randomized controlled trials provide the best information on therapeutic efficacy; however, extrapolation of the trials' conclusions to individual patients may be difficult, and for many important surgical problems, trial data are unavailable. A complementary approach of inferential decision-making helps address these limitations, and increases the clinician's confidence in the safety of an approach of unknown efficacy. Experience establishes norms and expectations, and emphasizes events that are uncommon but clinically important. Although it cannot eliminate uncertainty or controversy, the integration of analytic techniques of evidence, inference, and experience provides the surgeon with the best means of adapting treatment to the unique circumstances of the individual patient.

Innovation in surgery: the rules of evidence.

The intellectual infrastructures of evidence-based medicine (EBM) are the levels of evidence and the grades of recommendation for the following types of research articles: therapy/prevention, etiology/harm, prognosis, diagnosis, differential diagnosis/symptom prevalence study, economic analysis/decision analysis. The levels of evidence for therapy (1 to 5) progress from systematic reviews (with homogeneity) of randomized control trials (RCT) of high quality, level 1, to level 5-expert opinion without explicit critical appraisal, or based on physiology, bench research, or "first principles." The grades of recommendation (A, B, C, D) are founded on the quality of the evidence defined by its level. These grades are aimed at helping clinicians understand the source from whence came statements in, for example, guidelines. The development of surgical procedures and their introduction into practice has not depended upon the RCT but rather upon an enthusiast performing a case series, sometimes with clearly defined results. Should all operations and procedures be evaluated by an RCT? Clearly not, and the levels of evidence support this quite clearly with the "all or none" research category as level 1c. This relates to frequent clinical situations requiring a solution often immediate, eg, pus, a ruptured aneurysm, a sucking chest wound, that do not lend themselves to a trial, as the control regimen (doing nothing) would lead to death. Techniques evolve with experience usually based on an understanding of pathophysiology. At what point should an RCT enter into the resolution of surgical therapies? Can observational studies correctly designed and carried out do the job? Two new study classifications have been introduced: in level 1, category c "all or none" studies; and in level 2, category c "outcomes" research. In neither is there much definition. Are these the areas into which the evaluation of new surgical procedures and technology should be placed? The surgical community is faced with dramatic changes in technology and evolving techniques, and needs to define the rules of evidence applicable to their discipline with the same rigor that the EBM gurus have used, in order for surgeons to define evidence-based surgical practice.

Silver and new technology: dressings and devices.

BACKGROUND: Silver has long been known for its antimicrobial properties, and has been used with success for more than a century in informal medical applications. Recently, silver has been incorporated into medical devices and dressings. METHODS: Review of pertinent medical literature. RESULTS: Little or no evidence supports the use of silver on or in implanted devices, long-term transcutaneous devices, or topical dressings. Short-term transcutaneous devices (e.g., implantation for 2-10 days) may be afforded protection from infection. CONCLUSION: There is limited evidence of efficacy of silver in preventing infection of short-term implantable medical devices.