Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial.

BACKGROUND: Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. METHODS AND DESIGN: The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. DISCUSSION: This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01209663.

Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial.

CONTEXT: Use of 80% oxygen during surgery has been suggested to reduce the risk of surgical wound infections, but this effect has not been consistently identified. The effect of 80% oxygen on pulmonary complications has not been well defined. OBJECTIVE: To assess whether use of 80% oxygen reduces the frequency of surgical site infection without increasing the frequency of pulmonary complications in patients undergoing abdominal surgery. DESIGN, SETTING, AND PATIENTS: The PROXI trial, a patient- and observer-blinded randomized clinical trial conducted in 14 Danish hospitals between October 2006 and October 2008 among 1400 patients undergoing acute or elective laparotomy. INTERVENTIONS: Patients were randomly assigned to receive either 80% or 30% oxygen during and for 2 hours after surgery. MAIN OUTCOME MEASURES: Surgical site infection within 14 days, defined according to the Centers for Disease Control and Prevention. Secondary outcomes included atelectasis, pneumonia, respiratory failure, and mortality. RESULTS: Surgical site infection occurred in 131 of 685 patients (19.1%) assigned to receive 80% oxygen vs 141 of 701 (20.1%) assigned to receive 30% oxygen (odds ratio [OR], 0.94; 95% confidence interval [CI], 0.72-1.22; P = .64). Atelectasis occurred in 54 of 685 patients (7.9%) assigned to receive 80% oxygen vs 50 of 701 (7.1%) assigned to receive 30% oxygen (OR, 1.11; 95% CI, 0.75-1.66; P = .60), pneumonia in 41 (6.0%) vs 44 (6.3%) (OR, 0.95; 95% CI, 0.61-1.48; P = .82), respiratory failure in 38 (5.5%) vs 31 (4.4%) (OR, 1.27; 95% CI, 0.78-2.07; P = .34), and mortality within 30 days in 30 (4.4%) vs 20 (2.9%) (OR, 1.56; 95% CI, 0.88-2.77; P = .13). CONCLUSION: Administration of 80% oxygen compared with 30% oxygen did not result in a difference in risk of surgical site infection after abdominal surgery. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00364741.

Evaluation of a national process of reforming curricula in postgraduate medical education.

CONTEXT: A national reform of the postgraduate medical education in Denmark introduced (1) Outcome-based education, (2) The CanMEDS framework of competence related to seven roles of the doctor, and (3) In-training assessment. OBJECTIVES: The purpose of the study was to evaluate the process of developing new curricula for 38 specialist training programmes. The research question was: which conditions promote and which conditions impede the process? METHODS: Evaluation of the process was conducted among 76 contact-persons, who were chairing the curriculum development process within the specialties. Quantitative and qualitative data from a questionnaire survey and telephone interviews were triangulated for data analysis. RESULTS: The response rate of the questionnaire survey was 83% (63/76). Twenty-six telephone interviews were conducted. Identified promoting factors included positive attitude and motivation in faculty and support from written guidelines and seminars. Identified impeding factors included insufficient pedagogical support, poor introduction to the task, changing and inconsistent information from authorities, replacement of advisors, and stressful deadlines. CONCLUSIONS: This study identified promoting and impeding factors in a national postgraduate curriculum development process. Surprisingly the study indicates that pedagogical support provided throughout a process in some aspects might not be useful. General suggestions regarding curriculum reform processes are formulated.

[Peer tutorial programme as a part of the medical curriculum]. / Studieintroduktion som en del af curriculum.

This article shows the possible effects of an integrated intensive introduction to medical school using older students as tutors for first-year students. Our project resulted in a significant decrease in the average time to completion of the first five semesters of the medical bachelor' degree.