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.

Elevating the uses of storytelling approaches within Indigenous health research: a critical and participatory scoping review protocol involving Indigenous people and settlers.

BACKGROUND: There is a complicated and exploitative history of research with Indigenous peoples and accompanying calls to meaningfully and respectfully include Indigenous knowledge in healthcare. Storytelling approaches that privilege Indigenous voices can be a useful tool to break the hold that Western worldviews have within the research. Our collaborative team of Indigenous and non-Indigenous researchers, and Indigenous patients, Elders, healthcare providers, and administrators, will conduct a critical participatory, scoping review to identify and examine how storytelling has been used as a method in Indigenous health research. METHODS: Guided by two-eyed seeing, we will use Bassett and McGibbon's adaption of Arksey and O'Malley's scoping review methodology. Relevant articles will be identified through a systematic search of the gray literature, core Indigenous health journals, and online databases including Scopus, MEDLINE, Embase, CINAHL, AgeLine, Academic Search Complete, Bibliography of Native North Americans, Canadian Reference Centre, and PsycINFO. Qualitative and mixed-methods research articles will be included if the researchers involved Indigenous participants or their healthcare professionals living in Turtle Island (i.e., Canada and the USA), Australia, or Aotearoa (New Zealand); use storytelling as a research method; focus on healthcare phenomena; and are written in English. Two reviewers will independently screen titles/abstracts and full-text articles. We will extract data, identify the array of storytelling approaches, and critically examine how storytelling was valued and used. An intensive collaboration will be woven throughout all review stages as academic researchers co-create this work with Indigenous patients, Elders, healthcare professionals, and administrators. Participatory strategies will include four relational gatherings throughout the project. Based on our findings, we will co-create a framework to guide the respectful use of storytelling as a method in Indigenous health research involving Indigenous and non-Indigenous peoples. DISCUSSION: This work will enable us to elucidate the extent, range, and nature of storytelling within Indigenous health research, to critically reflect on how it has been and could be used, and to develop guidance for the respectful use of this method within research that involves Indigenous peoples and settlers. Our findings will enable the advancement of storytelling methods which meaningfully include Indigenous perspectives, practices, and priorities to benefit the health and wellbeing of Indigenous communities. SYSTEMATIC REVIEW PROTOCOL REGISTRATION: Open Science Framework ( https://osf.io/rvf7q ).