A randomized, crossover comparison of ketamine and electroconvulsive therapy for treatment of major depressive episodes: a Canadian biomarker integration network in depression (CAN-BIND) study protocol.

BACKGROUND: Recent evidence underscores the utility of rapid-acting antidepressant interventions, such as ketamine, in alleviating symptoms of major depressive episodes (MDE). However, to date, there have been limited head-to-head comparisons of intravenous (IV) ketamine infusions with other antidepressant treatment strategies in large randomized trials. This study protocol describes an ongoing multi-centre, prospective, randomized, crossover, non-inferiority trial comparing acute treatment of individuals meeting diagnostic criteria for a major depressive episode (MDE) with ketamine and electroconvulsive therapy (ECT) on efficacy, speed of therapeutic effects, side effects, and health care resource utilization. A secondary aim is to compare a 6-month maintenance strategy for ketamine responders to standard of care ECT maintenance. Finally, through the measurement of clinical, cognitive, neuroimaging, and molecular markers we aim to establish predictors and moderators of treatment response as well as treatment-elicited effects on these outcomes. METHODS: Across four participating Canadian institutions, 240 patients with major depressive disorder or bipolar disorder experiencing a MDE are randomized (1:1) to a course of ECT or racemic IV ketamine (0.5 mg/kg) administered 3 times/week for 3 or 4 weeks. Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) crossover to receive the alternate treatment. Responders during the randomization or crossover phases then enter the 6-month maintenance phase during which time they receive clinical assessments at identical intervals regardless of treatment arm. ECT maintenance follows standard of care while ketamine maintenance involves: weekly infusions for 1 month, then bi-weekly infusions for 2 months, and finally monthly infusions for 3 months (returning to bi-weekly in case of relapse). The primary outcome measure is change in MADRS scores after randomized treatment as assessed by raters blind to treatment modality. DISCUSSION: This multi-centre study will help identify molecular, imaging, and clinical characteristics of patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy. In addition to informing clinical practice and influencing health care delivery, this trial will add to the robust platform and database of CAN-BIND studies for future research and biomarker discovery. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03674671. Registered September 17, 2018.

Iranian public hospitals' challenges regarding revenue deficits: A mixed-method study.

Background: The main part of hospitals' funding comes from insurance organizations. In some cases, for different reasons such as not filed services or unpaid health insurance bills, a part of these funding cannot be derived from health insurance companies. This study aims to describe different aspects of the hospitals' revenue deficits in Iranian public hospitals. Methods: This was a mixed-method study consisting of qualitative and quantitative studies. Qualitative data were collected through 17 semi-structured interviews and were analyzed using the analytical framework by MAXQDA.10. Quantitative data were analyzed by the TOPSIS method and Smart TOPSIS Solver.3.2.0. Results: Based on the framework analysis, five sets of the underlying causes of hospital revenue deficits were identified and categorized in 5 themes: bottlenecks, direct causes of revenue deficits, root causes of revenue deficits, revenue deficits management strategies, and challenges and barriers to managing revenue deficits. Through inadequate clinical documentation and failed to provide the insurance organization's requirements, the surgical units, operating rooms, and inpatient units were found as the main sources of revenue deficit. Lack of senior management commitment and inconsistency of insurance organizations for evaluating claims are often listed as the major barriers to effective implementation of corrective interventions. Conclusion: Revenue deficits occurs in most hospital departments and in all stages of converting services into revenue, and a variety of human and organizational factors contribute to them. Therefore, focusing on the main causes of deductions and the participation of all individuals and departments involved in it is critical to reducing deductions.