Approaches to prioritising research for clinical trial networks: a scoping review.

BACKGROUND: Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critically appraise approaches to research prioritisation applicable to clinical trials, to inform best practice guidelines for clinical trial networks and funders. METHODS: A scoping review of English-language published literature and research organisation websites (January 2000 to January 2020) was undertaken to identify primary studies, approaches and criteria for research prioritisation. Data were extracted and tabulated, and a narrative synthesis was employed. RESULTS: Seventy-eight primary studies and 18 websites were included. The majority of research prioritisation occurred in oncology and neurology disciplines. The main reasons for prioritisation were to address a knowledge gap (51 of 78 studies [65%]) and to define patient-important topics (28 studies, [35%]). In addition, research organisations prioritised in order to support their institution's mission, invest strategically, and identify best return on investment. Fifty-seven of 78 (73%) studies used interpretative prioritisation approaches (including Delphi surveys, James Lind Alliance and consensus workshops); six studies used quantitative approaches (8%) such as prospective payback or value of information (VOI) analyses; and 14 studies used blended approaches (18%) such as nominal group technique and Child Health Nutritional Research Initiative. Main criteria for prioritisation included relevance, appropriateness, significance, feasibility and cost-effectiveness. CONCLUSION: Current research prioritisation approaches for groups conducting and funding clinical trials are largely interpretative. There is an opportunity to improve the transparency of prioritisation through the inclusion of quantitative approaches.

Low tidal volume ventilation during anaesthesia for major surgery: protocol and statistical analysis plan.

BACKGROUND: Mechanical ventilation is mandatory in patients undergoing general anaesthesia for major surgery. Tidal volumes higher than 10 mL/kg of predicted body weight have been advocated for intraoperative ventilation, but recent evidence suggests that low tidal volumes may benefit surgical patients. To date, the impact of low tidal volume compared with conventional tidal volume during surgery has only been assessed in clinical trials that also combine different levels of positive end-expiratory pressure (PEEP) in each arm. We aimed to assess the impact of low tidal volume compared with conventional tidal volume during general anaesthesia for surgery on the incidence of postoperative respiratory complications in adult patients receiving moderate levels of PEEP. STUDY DESIGN AND METHODS: Single-centre, two-arm, randomised clinical trial. In total, 1240 adult patients older than 40 years scheduled for at least 2 hours of surgery under general anaesthesia and routinely monitored with an arterial line were included. Patients were ventilated intraoperatively with a moderate level of PEEP (5 cmH2O) and randomly assigned to tidal volume of 6 mL/kg predicted body weight (low tidal volume) or 10 mL/kg predicted body weight (conventional tidal volume in Australia). MAIN OUTCOME MEASURE: The primary outcome is the occurrence of postoperative respiratory complications, recorded as a composite endpoint of adverse respiratory events during the first 7 postoperative days. RESULTS AND CONCLUSIONS: This is the first well powered study comparing the effect of low tidal volume ventilation versus high tidal volume ventilation during surgery on the incidence of postoperative respiratory complications in adult patients receiving moderate levels of PEEP. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12614000790640).

Giant right coronary artery aneurysm presenting with non-ST elevation myocardial infarction and severe mitral regurgitation: a case report.

INTRODUCTION: Coronary artery aneurysms are seen in 1.5-5% of patients presenting for coronary angiography, but giant aneurysms, defined as being greater than 2 cm in diameter, are rare. Given the paucity of cases and limited experience in diagnosis and management of the disease, each case is a learning tool in itself. CASE PRESENTATION: We report the rare case of a 78-year-old Caucasian man who presented to a peripheral emergency department with chest pain and was subsequently found to have a giant right coronary artery aneurysm. Following initial investigation and treatment he was referred to our hospital for definitive management. CONCLUSION: The case described illustrates one of the varied presentations and subsequent management of an ill-defined and heterogeneous disease process. Given the limited experience with giant aneurysms in the coronary circulation, this case provides valuable insight into the clinical presentation of the disease and gives an example of the management of the most recent such case at our hospital.