Administration of antibiotics before incising the skin (‘surgical antimicrobial prophylaxis’) is a critical infection prevention strategy in surgery. Extending doses of prophylaxis into the postoperative period is a common practice in cardiac surgery; however, the benefit has not been clearly established and may lead to emergence of antimicrobial resistance and patient harm. We present the protocol for a large international multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial to compare the incidence of surgical site infection after three different durations of postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery.
This adaptive, multi-arm multistage non-inferiority trial will compare intraoperative only (Arm A), to intraoperative and 24 hours (Arm B) and, to intraoperative and 48 hours (Arm C) of intravenous cefazolin and placebo as surgical antimicrobial prophylaxis in 9180 patients undergoing cardiac surgery. The adaptive design allows for potential dropping of any of the three arms if clear inferiority is indicated at any of the scheduled interim analyses. The trial will evaluate the clinical and cost-effectiveness of the three different antibiotic prophylaxis durations.
Ethics approval will be obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences. Patients and members of the public will also be involved in the dissemination and translation of the trial results.
Primary care nurses (PCNs) are the second largest workforce in primary care and play a critical role in facilitating access to coordinated care and reducing health disparities. There is renewed interest in team-based primary care as a solution for health workforce challenges. Some team models enable PCNs (ie, nurse practitioners, registered nurses, licensed/registered practical nurses) to leverage one another’s expertise to work to optimal scope; the extent to which this happens depends on multiple context-dependent factors. We will conduct an umbrella review to synthesise and compare international knowledge syntheses focused on scope of practice enactment (ie., roles and activities) of PCNs in primary care.
We will conduct the umbrella review according to the Joanna Briggs Institute methodology, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines, and using the Nursing Care Organization Framework as guidance. We will search a wide range of scientific electronic databases and grey literature sources, and consider articles published in English and French by the Organization for Economic Cooperation and Development and designated key partner countries for inclusion, with no publication date limits. Two independent reviewers will screen titles, abstracts and full-text articles, and any disagreements will be resolved through discussion or by a third reviewer. We will use the Risk of Bias Assessment Tool for Systematic Reviews to assess the quality and risk of bias in the included systematic and scoping reviews.
Results will be presented in a PRISMA Scoping Review flow diagram. We will synthesise data from included studies in a detailed literature review table and develop visual aids to communicate the shared and unique roles and activities of PCN scope of practice. We will disseminate the results of the review through peer-reviewed publications and conferences related to this field. Ethics approval is not required.