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Background: Surgical patients with previous depression frequently experience postoperative depressive symptoms. This study's objective was to determine the feasibility of a placebo-controlled trial testing the impact of a sustained ketamine infusion on postoperative depressive symptoms. Methods: This single-centre, triple-blind, placebo-controlled randomised clinical trial included adult patients with depression scheduled for inpatient surgery. After surgery, patients were randomly allocated to receive ketamine (0.5 mg kg-1 over 10 min followed by 0.3 mg kg-1 h-1 for 3 h) or an equal volume of normal saline. Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale. On post-infusion day 1, participants guessed which intervention they received. Feasibility endpoints included the fraction of patients approached who were randomised, the fraction of randomised patients who completed the study infusion, and the fraction of scheduled depression assessments that were completed. Results: In total, 32 patients were allocated a treatment, including 31/101 patients approached after a protocol change (31%, 1.5 patients per week). The study infusion was completed without interruption in 30/32 patients (94%). In each group, 7/16 participants correctly guessed which intervention they received. Depression assessments were completed at 170/192 scheduled time points (89%). Between baseline and post-infusion day 4 (pre-specified time point of interest), median depressive symptoms decreased in both groups, with difference-in-differences of -1.00 point (95% confidence interval -3.23 to 1.73) with ketamine compared with placebo. However, the between-group difference did not persist at other time points. Conclusions: Patient recruitment, medication administration, and clinical outcome measurement appear to be highly feasible, with blinding maintained. A fully powered trial may be warranted. Clinical trial registration: NCT05233566.
RESUMO
OBJECTIVE: To explore barriers and facilitators to implementing and sustaining Healthy Choices, a 3-year multicomponent obesity prevention intervention implemented in middle schools in Massachusetts. METHODS: Using purposive sampling, 56 in-depth interviews were conducted with middle school employees representing different positions (administrators, teachers, food service personnel, and employees serving as intervention coordinators). Interviews were recorded and transcribed. Emergent themes were identified using thematic analyses. RESULTS: State-mandated testing, budget limitations, and time constraints were viewed as implementation barriers, whereas staff buy-in, external support, and technical assistance were seen as facilitating implementation. Respondents thought that intervention sustainability depended on external funding and expert assistance. CONCLUSIONS AND IMPLICATIONS: Results confirm the importance of gaining faculty and staff support. Schools implementing large-scale interventions should consider developing sustainable partnerships with organizations that can provide resources and ongoing training. Sustainability of complex interventions may depend on state-level strategies that provide resources for implementation and technical assistance.