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.Jeffrey S Barkun, Jeffrey K Aronson, Liane S Feldman, Guy J Maddern and Steven M Strasber

School English, literature and the knowledge‐base question

This article takes up questions about knowledge and the school curriculum with respect to literary studies within subject English. Its intention is to focus on literary studies in English from the context of current waves of curriculum reform, rather than as part of the conversations primarily within the field of English, to raise questions about the knowledge agenda, and the knowledge-base agenda for teaching and teacher education. The selection of texts and form of study of literature within the English curriculum has long been an area of controversy. Without assuming a particular position on knowledge in this area, this article shows that important questions of what knowledge-base teachers are expected to bring to their work are elided both in current regulations and debates, and in research on ‘good teaching’ in this area. If ‘literary studies’ (as a discipline or university major) is itself an unstable and changing field, what kind of knowledge does a good English teacher bring to their work? This paper takes up these questions in the context of the Australian Curriculum and standards for teacher registration, but it also points to the way these issues about knowledge are of broader relevance for researchers and teacher education

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