Background: Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. Methods: This is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups. Discussion: If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284
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Aims: Prescribing errors among junior doctors are common in clinical practice because many lack prescribing competence after graduation. This is in part due to inadequate education in clinical pharmacology and therapeutics (CP&T) in the undergraduate medical curriculum. To support CP&T education, it is important to determine which drugs medical undergraduates should be able to prescribe safely and effectively without direct supervision by the time they graduate. Currently, there is no such list with broad-based consensus. Therefore, the aim was to reach consensus on a list of essential drugs for undergraduate medical education in the Netherlands. Methods: A two-round modified Delphi study was conducted among pharmacists, medical specialists, junior doctors and pharmacotherapy teachers from all eight Dutch academic hospitals. Participants were asked to indicate whether it was essential that medical graduates could prescribe specific drugs included on a preliminary list. Drugs for which ≥80% of all respondents agreed or strongly agreed were included in the final list. Results: In all, 42 (65%) participants completed the two Delphi rounds. A total of 132 drugs (39%) from the preliminary list and two (3%) newly proposed drugs were included. Conclusions: This is the first Delphi consensus study to identify the drugs that Dutch junior doctors should be able to prescribe safely and effectively without direct supervision. This list can be used to harmonize and support the teaching and assessment of CP&T. Moreover, this study shows that a Delphi method is suitable to reach consensus on such a list, and could be used for a European list.
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Purpose: The aims of this study were to investigate how a variety of research methods is commonly employed to study technology and practitioner cognition. User-interface issues with infusion pumps were selected as a case because of its relevance to patient safety. Methods: Starting from a Cognitive Systems Engineering perspective, we developed an Impact Flow Diagram showing the relationship of computer technology, cognition, practitioner behavior, and system failure in the area of medical infusion devices. We subsequently conducted a systematic literature review on user-interface issues with infusion pumps, categorized the studies in terms of methods employed, and noted the usability problems found with particular methods. Next, we assigned usability problems and related methods to the levels in the Impact Flow Diagram. Results: Most study methods used to find user interface issues with infusion pumps focused on observable behavior rather than on how artifacts shape cognition and collaboration. A concerted and theorydriven application of these methods when testing infusion pumps is lacking in the literature. Detailed analysis of one case study provided an illustration of how to apply the Impact Flow Diagram, as well as how the scope of analysis may be broadened to include organizational and regulatory factors. Conclusion: Research methods to uncover use problems with technology may be used in many ways, with many different foci. We advocate the adoption of an Impact Flow Diagram perspective rather than merely focusing on usability issues in isolation. Truly advancing patient safety requires the systematic adoption of a systems perspective viewing people and technology as an ensemble, also in the design of medical device technology.
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