RESUMO
Objective: The study design included the double-blind, parallel, randomized controlled trial. The aim of this randomized controlled trial was to compare the efficacy and safety of sertraline and escitalopram in participants with moderate to severe major depressive disorder (MDD). Methods: The study was conducted in South Asian participants. A total of 744 participants with moderate to severe MDD were randomly assigned to receive either sertraline or escitalopram for 8 weeks. Drug dosages and titration schedules were based on the recommendations of the prescribing information for each product and according to the judgment of the clinicians involved in the study. The primary outcome measures were changes from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) and the clinical global impression (CGI) scale as well as the frequency of adverse events in both groups. Baseline MADRS scores in the escitalopram and sertraline groups were 28.2±0.47 (mean±SD) and 29.70±0.46 (mean±SD) respectively, and was no variability in the baseline assessments. Changes in MADRS as well as CGI scales at the end of the study were significant only for the sertraline group whereas they remained statistically nonsignificant for the escitalopram group. Results: The results of the study showed that sertraline was more efficacious than escitalopram in reducing depression rating scales such as MADRS and CGI, and that participants subjectively felt better regarding their symptoms in the sertraline group. Sertraline displays enhanced safety or tolerability than other groups of antidepressants, which frequently cause high levels of drowsiness, dizziness, blurred vision, and other undesirable effects. Adverse events were seen in both groups, but delayed ejaculation was the most frequent adverse event seen in both groups. However, a greater number of participants reported having nausea and insomnia in the sertraline group compared to the escitalopram group. Conclusion: Our study clearly highlights that there is a statistically significant difference in efficacy between sertraline and escitalopram at the doses used in our study. Sertraline was able to significantly lower the depression rating scales like MADRS and CGI in participants with moderate to severe MDD. Participants subjectively felt better regarding their symptoms in the sertraline group. The most frequent adverse event in both groups was delayed ejaculation. From an efficacy standpoint, sertraline was more efficacious than escitalopram. The study indicates that the prevalence of depressive disorders in South Asia is comparable to the global estimate, and Bangladesh and India has higher proportions of people with depressive disorders in South Asia. Additionally, females and older adults (75-79 years) have the highest burden of depressive disorders across all countries in the region. This study's limitation included the absence of a placebo arm. An additional limitation of the current study was the lack of an evaluation of inter-rater reliability and the research sample could not have been uniform in terms of the kind of depressive disorders and bipolarity.
RESUMO
Background: Operating teams can decrease the likelihood of patient risk by using the WHO Surgical Safety Checklist. To ascertain the impact of demographic factors on behaviorally anchored ratings and investigate operating room (OR) staff attitudes toward checklist administration, we set out to better understand how OR personnel use the checklist in a tertiary care hospital in Pakistan. Materials and methods: A monocentric sequential mixed-methods study employing a quantitative approach of using World Health Organization Behaviorally Anchored Rating Scale (WHOBARS) assessments of surgical cases by OR personnel and two independent observers, who were certified surgeons having extensive experience in the rating of the WHOBARS scale for more than 1 year, followed by a qualitative approach of staff interviews were carried out in a tertiary care setting. In June and July 2022, over the period of 8 weeks, an intervention (training delivery) was implemented and evaluated. The information, skills, and behavior adjustments required to apply the checklist were taught in the course using lectures, videos, small group breakouts, participant feedback, and simulations. Results: After the introduction of WHOBARS, 50.81% of respondents reported always using the checklist, with another 30.81% using it in part. Participants' years in practice, hospital size, or surgical volume did not predict checklist use. Checklist use was associated with always counting instruments (51.08%), patient identity (67.83%), difficult intubation risk (39.72%), the risk of blood loss (51.08%), prophylactic administration of an antibiotic (52.43%), and the use of pulse oximeter (46.75%). Interviewees felt that the checklist could promote teamwork and a safe culture, particularly enabling speaking up. Senior staff were of key importance in setting the appropriate tone. Conclusion: The use of a multi-disciplinary course for checklist implementation resulted in 50.81% of participants always using the checklist and an increase in counting surgical instruments. Successful checklist implementation was not predicted by the participant's length of medical service, hospital size, or surgical volume. If reproducible in other countries, widespread implementation in LMICs becomes a realistic possibility.
