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Macrosomic fetuses are at increased risk of shoulder dystocia. We aimed to compare induction of labour with expectant management for large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity associated with macrosomia. We did this pragmatic, randomised controlled trial between Oct 1, 2002, and Jan 1, 2009, in 19 tertiary-care centres in France, Switzerland, and Belgium. Women with singleton fetuses whose estimated weight exceeded the 95th percentile, were randomly assigned (1:1), via computer-generated permuted-block randomisation (block size of four to eight) to receive induction of labour within 3 days between 37+0 weeks and 38+6 weeks of gestation, or expectant management. Randomisation was stratified by centre. Participants and caregivers were not masked to group assignment. Our primary outcome was a composite of clinically significant shoulder dystocia, fracture of the clavicle, brachial plexus injury, intracranial haemorrhage, or death. We did analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00190320. We randomly assigned 409 women to the induction group and 413 women to the expectant management group, of whom 407 women and 411 women, respectively, were included in the final analysis. Mean birthweight was 3831 g (SD 324) in the induction group and 4118 g (392) in the expectant group. Induction of labour significantly reduced the risk of shoulder dystocia or associated morbidity (n=8) compared with expectant management (n=25; relative risk [RR] 0·32, 95% CI 0·15–0·71; p=0·004). We recorded no brachial plexus injuries, intracranial haemorrhages, or perinatal deaths. The likelihood of spontaneous vaginal delivery was higher in women in the induction group than in those in the expectant management group (RR 1·14, 95% CI 1·01–1·29). Caesarean delivery and neonatal morbidity did not differ significantly between the groups. Induction of labour for suspected large-for-date fetuses is associated with a reduced risk of shoulder dystocia and associated morbidity compared with expectant management. Induction of labour does not increase the risk of caesarean delivery and improves the likelihood of spontaneous vaginal delivery. These benefits should be balanced with the effects of early-term induction of labour. Assistance Publique–Hôpitaux de Paris and the University of Geneva.

Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies. Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression. 9-week single-blind randomized control trial with a 12-week maintenance phase (intervention-medical groups; control-primary care provider visit). Academic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers. 159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms. IMGV intervention- 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks. Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization. There were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18-0.98) compared to controls. Absence of treatment assignment concealment for patients and disproportionate group attendance in IMGV. Results demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group. clinicaltrials.gov NCT02262377.

Abstract Rationale We compared three policy options for the use of medical masks and N95 respirators in healthcare workers (HCWs). Objectives A cluster randomized clinical trial of 1,669 hospital-based HCWs in Beijing, China in the winter of 2009–2010. Methods Participants were randomized to medical masks, N95 respirators, or targeted use of N95 respirators while doing high-risk procedures or barrier nursing. Outcomes included clinical respiratory illness (CRI) and laboratory-confirmed respiratory pathogens in symptomatic subjects. Measurements and Main Results The rate of CRI was highest in the medical mask arm (98 of 572; 17%), followed by the targeted N95 arm (61 of 516; 11.8%), and the N95 arm (42 of 581; 7.2%) (P < 0.05). Bacterial respiratory tract colonization in subjects with CRI was highest in the medical mask arm (14.7%; 84 of 572), followed by the targeted N95 arm (10.1%; 52 of 516), and lowest in the N95 arm (6.2%; 36 of 581) (P = 0.02). After adjusting for confounders, only continuous use of N95 remained significant against CRI and bacterial colonization, and for just CRI compared with targeted N95 use. Targeted N95 use was not superior to medical masks. Conclusions Continuous use of N95 respirators was more efficacious against CRI than intermittent use of N95 or medical masks. Most policies for HCWs recommend use of medical masks alone or targeted N95 respirator use. Continuous use of N95s resulted in significantly lower rates of bacterial colonization, a novel finding that points to more research on the clinical significance of bacterial infection in symptomatic HCWs. This study provides further data to inform occupational policy options for HCWs. Clinical trial registered with Australian New Zealand Clinical Trials Registry http://www.anzctr.org.au (ACTRN 12609000778280).

Respectful provision of care is an integral component of quality maternity care service. The objective of the present study was to assess the status of respectful maternity care and its associated factors in public and private hospitals in Bangladesh. A cross-sectional study was conducted at a tertiary care public hospital and a tertiary care private hospital in Chittagong, Bangladesh from October 2023 to September 2024. Face-to-face interviews using a structured questionnaire was conducted to collect data from postnatal women. Respectful maternity care was measured using a validated 15-item tool with four domains (friendly, abuse-free, timely, and discrimination-free care). Logistic regression analysis was used to identify factors associated with respectful maternity care. A number of 264 postnatal women from the public hospital and 334 from the private hospital were included in the study. Overall, 55.5% of them received respectful maternity care, with significant differences between public (33.7%) and private (72.8%) hospitals (p-value <0.001). Women in private hospitals reported higher standards across all domains, with the largest disparity in discrimination-free care (98% in private vs. 56% in public hospitals, p < 0.001). Logistic regression showed that women in private hospitals (adjusted odds ratio, aOR 18.10; 95% confidence interval, CI 8.43-42.0), those with facility-level referrals (aOR 2.88; 95% CI 1.59-5.31), and cesarean deliveries (aOR 2.45; 95% CI 1.26-5.07) were significantly more likely to receive respectful maternity care. Respectful maternity care was significantly more likely among women delivering in private hospitals, through facility-level referrals, and by cesarean section, indicating gaps in public hospital practices that require attention to ensure respectful care for all mothers.

Functional rehabilitation is commonly used for patients with chronic ankle instability (CAI). Digital training (DT) systems have become increasingly popular in postoperative rehabilitation; however, their effectiveness for CAI patients after modified Brostrom surgery (MBS) is uncertain. Furthermore, specialized physiotherapy resources for CAI are limited in some regions, highlighting the need for effective digital home-based rehabilitation alternatives. This trial aimed to evaluate whether individually tailored physiotherapeutic ankle-specific training (PAST) delivered via a DT system is noninferior to conventional face-to-face physiotherapy in clinical outcomes and to compare their cost-effectiveness in CAI patients following MBS in China. We conducted a 2-arm, single-blinded (assessor), noninferiority randomized controlled trial at a tertiary hospital in Shanghai, China, from January 2022 to January 2024. A total of 84 postsurgery CAI patients were randomly assigned to a DT group (n=42), which received a 12-week individualized PAST program via a digital system, or a physiotherapy group (n=42), which received standard face-to-face physiotherapy for 12 weeks. Assessments were performed at baseline, 12 weeks, and 24 weeks postoperatively. The primary outcomes were 2 subscales of the Foot and Ankle Ability Measure, with a noninferiority margin of 8 points for Foot and Ankle Ability Measure-Activities of Daily Living (FAAM-ADL) and 9 points for Foot and Ankle Ability Measure-Sports (FAAM-S). Secondary outcomes included balance tests (time-in-balance, foot-lift, and star excursion balance), functional tests (ankle dorsiflexion range of motion, side-hop, and figure-8 hop), and quality of life (FAAM questionnaire). We also collected intervention costs to evaluate cost-effectiveness. Statistical analyses included between-group comparisons of outcomes and nonparametric bootstrapping to calculate incremental cost-effectiveness ratios. Baseline characteristics were similar between groups (except for a difference in foot-lift test performance). By the 24-week follow-up, improvements in the primary outcomes were comparable between the DT and physiotherapy groups, with adjusted between-group differences of 0.36 (95% CI -1.01 to 1.72) for FAAM-ADL and 1.67 (95% CI -0.61 to 3.96) for FAAM-S. These differences fell within the predefined noninferiority margins, demonstrating noninferiority of the digital program. No significant between-group differences were observed in secondary outcomes (all P>.05). The average cost per patient was lower in the DT group (CNY 53,551; an exchange rate of US $1=CNY 7 was applied) than in the physiotherapy group (CNY 59,372), yielding an incremental cost of CNY -14,451 in favor of the digital intervention. The bootstrapped incremental cost-effectiveness ratios were CNY -16,396 for FAAM-ADL and CNY -114,131 for FAAM-S, indicating that DT was more cost-effective. Individually tailored PAST delivered via a DT system was found to be clinically noninferior to conventional face-to-face physiotherapy and more cost-effective, supporting its use as a viable rehabilitation alternative for CAI patients after MBS.

\"Push\" or \"pull\" techniques with the use of snares, forceps, baskets, and grasping devices are conventionally used to manage esophageal food bolus impaction (FBI). A novel cap-assisted technique has recently been advocated to reduce time taken for food bolus (FB) removal. This study aimed to compare the effectiveness of the cap-assisted technique against conventional methods of esophageal FB removal in a randomized controlled trial. Consecutive patients with esophageal FBI requiring endoscopic removal, from 3 Australian tertiary hospitals between 2017 and 2019, were randomized to either the cap-assisted technique or the conventional technique. Primary outcomes were technical success and FB retrieval time. Secondary outcomes were technical success rate, en bloc removal rate, procedure-related complication, length of hospital stay, and cost of consumables. Over 24 months, 342 patients with esophageal FBI were randomized to a cap-assisted (n = 171) or conventional (n = 171) technique. Compared with the conventional approach, the cap-assisted technique was associated with (i) shorter FB retrieval time (4.5 ± 0.5 minutes vs 21.7 ± 0.9 minutes, P < 0.001), (ii) shorter total procedure time (23.0 ± 0.6 minutes vs 47.0 ± 1.3 minutes, P < 0.0001), (iii) higher technical success rate (170/171 vs 160/171, P < 0.001), (iv) higher rate of en bloc removal (159/171 vs 48/171, P < 0.001), and (v) lower rate of procedure-related mucosal tear and bleeding (0/171 vs 13/171, P < 0.001). There were no major adverse events or deaths within 30 days in either group. The total cost of consumables was higher in the conventional group (A$19,644.90 vs A$6,239.90). This multicenter randomized controlled trial confirmed that the cap-assisted technique is more effective and less costly than the conventional approach and should be first-line treatment for esophageal FBI.

To evaluate the cost-effectiveness of a program intended to reduce intrapartum and neonatal mortality in Accra, Ghana. Quasi-experimental, time-sequence intervention, retrospective cost-effectiveness analysis. A program integrating leadership development, clinical skills and quality improvement training was piloted at the Greater Accra Regional Hospital from 2013 to 2016. The number of intrapartum and neonatal deaths prevented were estimated using the hospital's 2012 stillbirth and neonatal mortality rates as a steady-state assumption. The cost-effectiveness of the intervention was calculated as cost per disability-adjusted life year (DALY) averted. In order to test the assumptions included in this analysis, it was subjected to probabilistic and one-way sensitivity analyses. Incremental cost-effectiveness ratio (ICER), which measures the cost per disability-adjusted life-year averted by the intervention compared to status quo. From 2012 to 2016, there were 45,495 births at the Greater Accra Regional Hospital, of whom 5,734 were admitted to the newborn intensive care unit. The budget for the systems strengthening program was US $1,716,976. Based on program estimates, 307 (±82) neonatal deaths and 84 (±35) stillbirths were prevented, amounting to 12,342 DALYs averted. The systems strengthening intervention was found to be highly cost effective with an ICER of US $139 (±$44), an amount significantly lower than the established threshold of cost-effectiveness of the per capita gross domestic product, which averaged US $1,649 between 2012-2016. The results were found to be sensitive to the following parameters: DALYs averted, number of neonatal deaths, and number of stillbirths. An integrated approach to system strengthening in referral hospitals has the potential to reduce neonatal and intrapartum mortality in low resource settings and is likely to be cost-effective. Sustained change can be achieved by building organizational capacity through leadership and clinical training.

The correlation between myocardial injury and clinical outcome in COVID-19 patients is gaining attention in the literature. The aim of the present study was to evaluate the role of cardiac involvement and of respiratory failure in a cohort of COVID-19 patients hospitalized in an academic hospital in Lombardy, one of the most affected Italian (and worldwide) regions by the epidemic. The study included 405 consecutive patients with confirmed COVID-19 admitted to a medical ward from February 25th to March 31st, 2020. Follow-up of surviving patients ended either at hospital discharge or by July 30th, 2020. Myocardial injury was defined on the basis of the presence of blood levels of hs-TnI above the 99th percentile upper reference limit. Respiratory function was assessed as PaO2/FiO2 (P/F) ratio. The primary end-point was death for any cause. During hospitalization, 124 patients died. Death rate increased from 7.9% in patients with normal hs-TnI plasma levels and no cardiac comorbidity to 61.5% in patients with elevated hs-TnI and cardiac involvement (p < 0.001). At multivariable analysis, older age, P/F ratio < 200 (both p < 0.001) and hs-TnI plasma levels were independent predictors of death. However, it must be emphasized that the median values of hs-TnI were within normal range in non-survivors. Cardiac involvement at presentation was associated with poor prognosis in COVID-19 patients, but, even in a population of COVID-19 patients who did not require invasive ventilation at hospital admission, mortality was mainly driven by older age and respiratory failure.

Antimicrobial resistance, which is commonly observed in the management of pneumonia, is a major threat to public health and is driven by inappropriate antimicrobial use. The aim of this study was therefore to assess the current practice of antimicrobial utilization and clinical outcomes in the management of adult pneumonia at Tikur Anbessa Specialized Hospital. A prospective observational study was conducted in the internal medicine wards of Tikur Anbessa Specialized Hospital. The study was conducted from 1 September 2016 to 30 June 2017 and patients aged ≥ 14 years and diagnosed with pneumonia were included. Chart review and self-administered questionnaire were used to collect data regarding pneumonia diagnosis and management as well as clinical outcomes (stable, complications, and in-hospital mortality). Descriptive statistics and binary logistic regressions were performed for data analyses. Out of 200 enrolled patients, clinical diagnosis was supported by microbiologic testing and imaging in 75 (37.5%) and 122 (61.0%) cases, respectively. The treatment approach in almost all patients (99.5%) was empirical and no de-escalation therapy was made even after acquiring culture results. The total duration of antimicrobial therapy was 12.05±5.09 days and vancomycin was the most commonly prescribed antimicrobial agent (25%), with 70% of the patients receiving this drug empirically. Nearly, 30% of the patients missed their antimicrobial doses during the course of treatment and stock-out (36.7%) was the major reason. Close to 113 (66%) of the treating physicians used reference books to prescribe antimicrobial agents. Patients' outcomes were found to be stable (66%), in-hospital mortality (18.5%), and ending up in complications (17%). Poor clinical outcome (death and complicated cases) was found to be associated with recent antimicrobial use history (p = 0.007, AOR 2.86(1.33-6.13)), cancer (p = 0.023, AOR 3.46(1.18-10.13)), recent recurrent upper respiratory tract infection (p = 0.046, AOR 3.70(1.02-13.40)), respiratory rate >24 breaths/min or <12 breaths/min (p = 0.013, AOR 2.45(1.21-4.95)) and high level of serum creatinine after initiation of antimicrobial therapy (>1.4mg/dl) (p = 0.032, AOR 2.37(1.07-5.20)). Antimicrobials are empirically prescribed without sufficient evidence of indication and microbiological or radiological findings. The practice also is not based on local guidelines and no multidisciplinary approach is apparent. [How about: \"It is likely that these factors contributed to higher rates of mortality (18.5%) when compared with similar studies in other countries\" instead of this \"As a result, there were higher rates of mortality (18.5%) when compared with other similar studies\"]. Hence, the hospital requires a coordinated intervention to improve rational use of antimicrobials and clinical outcomes through establishing an antimicrobial stewardship program.

PurposeTo compare the effect of ‘intermittent’ central venous oxygen saturation (ScvO2) monitoring with ‘continuous’ ScvO2 monitoring on shock resolution and mortality in children with septic shock.MethodsPrimary outcome was the achievement of therapeutic goals or shock resolution in the first 6 h. We randomly assigned children < 17 years’ age with septic shock to ‘intermittent ScvO2’ or ‘continuous ScvO2’ groups. All children were subjected to subclavian/internal jugular line insertion and managed as per Surviving Sepsis Campaign Guidelines. To guide resuscitation, we used ScvO2 estimated at other clinical and laboratory parameters were monitored similarly in both groups.ResultsWe enrolled 75 and 77 children [median (IQR) age: 6 (1.5–10) years] in the ‘intermittent’ and ‘continuous’ groups, respectively. Baseline characteristics were comparable between the groups. When compared to the ‘continuous’ group, fewer children in the ‘intermittent’ group achieved shock resolution within first 6 h [19% vs. 36%; relative risk (RR) 0.51; 95% CI 0.29–0.89; risk difference − 18.0%; 95% CI − 32.0 to − 4.0]. The lower bound of confidence interval, however, crossed the pre-specified non-inferiority margin. There was no difference in the proportion of children attaining shock resolution within 24 h (63% vs. 69%; RR 0.86; 95% CI 0.68–1.08) or risk of mortality between the groups (47% vs. 43%; RR 1.06; 95% CI 0.74–1.51).ConclusionsGiven that a greater proportion of children attained therapeutic end points in the first 6 h, continuous monitoring of ScvO2 should preferably be used to titrate therapy in the first few hours in children with septic shock. In the absence of such facility, intermittent monitoring of ScvO2 can be used to titrate therapy in these children, given the lack of difference in the proportion of patients achieving shock resolution at 24 h or in risk of mortality between the intermittent and continuous groups.