BACKGROUND: Prophylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear.METHODS: In this European, multicenter, parallel-group, blinded trial, we randomly assigned adults who had been admitted to the ICU for an acute condition (i.e., an unplanned admission) and who were at risk for gastrointestinal bleeding to receive 40 mg of intravenous pantoprazole (a proton-pump inhibitor) or placebo daily during the ICU stay. The primary outcome was death by 90 days after randomization.RESULTS: A total of 3298 patients were enrolled; 1645 were randomly assigned to the pantoprazole group and 1653 to the placebo group. Data on the primary outcome were available for 3282 patients (99.5%). At 90 days, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died (relative risk, 1.02; 95% confidence interval [CI], 0.91 to 1.13; P=0.76). During the ICU stay, at least one clinically important event (a composite of clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection, or myocardial ischemia) had occurred in 21.9% of patients assigned to pantoprazole and 22.6% of those assigned to placebo (relative risk, 0.96; 95% CI, 0.83 to 1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, as compared with 4.2% in the placebo group. The number of patients with infections or serious adverse reactions and the percentage of days alive without life support within 90 days were similar in the two groups.CONCLUSIONS: Among adult patients in the ICU who were at risk for gastrointestinal bleeding, mortality at 90 days and the number of clinically important events were similar in those assigned to pantoprazole and those assigned to placebo. (Funded by Innovation Fund Denmark and others; SUP-ICU ClinicalTrials.gov number, NCT02467621 .).
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.
Prophylactic replacement therapy is the cornerstone of treatment in severe haemophilia. Regular infusions with clotting factor concentrate have been proven effective to prevent bleeding, subsequent (joint) damage, and positively affect the impact of haemophilia on daily life [1]. Patients or parents of younger patients learn to infuse clotting factor concentrate in a peripheral vein (i.v.) or a central venous access device (CVAD) [2].
