Functional recovery after cesarean delivery: a prospective cohort study in rural Rwanda.

INTRODUCTION: Women who deliver via cesarean section (c-section) experience short- and long-term disability that may affect their physical health and their ability to function normally. While clinical complications are assessed, postpartum functional outcomes are not well understood from a patient's perspective or well-characterized by previous studies. In Rwanda, 11% of rural women deliver via c-section. This study explores the functional recovery of rural Rwandan women after c-section and assesses factors that predict poor functionality at postoperative day (POD) 30. METHODS: Data were collected prospectively on POD 3, 11, and 30 from women delivering at Kirehe District Hospital between October 2019 and March 2020. Functionality was measured by self-reported overall health, energy level, mobility, self-care ability, and ability to perform usual activities; and each domain was rated on a 4-point likert scale, lower scores reflecting higher level of difficulties. Using the four functionality domains, we computed composite mean scores with a maximum score of 4.0 and we defined poor functionality as composite score of ≤ 2.0. We assessed functionality with descriptive statistics and logistic regression. RESULTS: Of 617 patients, 54.0%, 25.9%, and 26.8% reported poor functional status at POD3, POD11, and POD30, respectively. At POD30, the most self-reported poor functionality dimensions were poor or very poor overall health (48.1%), and inability to perform usual activities (15.6%). In the adjusted model, women whose surgery lasted 30-45 min had higher odds of poor functionality (aOR = 1.85, p = 0.01), as did women who experienced intraoperative complications (aOR = 4.12, 95% CI (1.09, 25.57), p = 0.037). High income patients had incrementally lower significant odds of poor physical functionality (aOR = 0.62 for every US$1 increase in monthly income, 95% CI (0.40, 0.96) p = 0.04). CONCLUSION: We found a high proportion of poor physical functionality 30 days post-c-section in this Rwandan cohort. Surgery lasting > 30 min and intra-operative complications were associated with poor functionality, whereas a reported higher income status was associated with lower odds of poor functionality. Functional status assessments, monitoring and support should be included in post-partum care for women who delivered via c-section. Effective risk mitigating intervention should be implemented to recover functionality after c-section, particularly among low-income women and those undergoing longer surgical procedures or those with intraoperative complications.

Partners in research: The success with therapies research consortium and the CF community unite to improve self-management.

BACKGROUND: The daily treatment regimen for an individual with cystic fibrosis (CF) can take more than 2 h to complete, and chronic treatment adherence rates are low. Developing partnerships between CF clinical researchers and the CF community is essential in developing acceptable, feasible, and effective strategies to improve self-management and adherence. METHODS: The Success with Therapies Research Consortium (STRC) was formed as a multi-center US collaborative to conduct rigorous research studies of adherence to CF treatments. A multidisciplinary team of researchers from 15 sites, collaborating with members of the CF community, is charged with developing, implementing, and disseminating real-world, patient-centered interventions for people living with CF. RESULTS: Since 2014, the STRC has conducted 8 studies. The CF community, people with CF (pwCF), and caregivers have come to serve in multiple valuable capacities on the STRC, including as members of the Steering Committee and Co-Principal Investigators. Additionally, while people with CF are irreplaceable participants in STRC studies, their influence, and that of their families and healthcare professionals, extends beyond the traditional research participant role. CONCLUSIONS: Engaging broadly with the CF community is the optimal model for developing interventions to support those living with CF in sustaining daily care. Input and direct involvement from people with CF, their families, and their caregivers has enabled the STRC to advance its mission through innovative clinical research approaches.

mHealth-community health worker telemedicine intervention for surgical site infection diagnosis: a prospective study among women delivering via caesarean section in rural Rwanda.

BACKGROUND: Surgical site infections (SSIs) cause a significant global public health burden in low and middle-income countries. Most SSIs develop after patient discharge and may go undetected. We assessed the feasibility and diagnostic accuracy of an mHealth-community health worker (CHW) home-based telemedicine intervention to diagnose SSIs in women who delivered via caesarean section in rural Rwanda. METHODS: This prospective cohort study included women who underwent a caesarean section at Kirehe District Hospital between September 2019 and March 2020. At postoperative day 10 (±3 days), a trained CHW visited the woman at home, provided wound care and transmitted a photo of the wound to a remote general practitioner (GP) via WhatsApp. The GP reviewed the photo and made an SSI diagnosis. The next day, the woman returned to the hospital for physical examination by an independent GP, whose SSI diagnosis was considered the gold standard for our analysis. We describe the intervention process indicators and report the sensitivity and specificity of the telemedicine-based diagnosis. RESULTS: Of 787 women included in the study, 91.4% (n=719) were located at their home by the CHW and all of them (n=719, 100%) accepted the intervention. The full intervention was completed, including receipt of GP telemedicine diagnosis within 1 hour, for 79.0% (n=623). The GPs diagnosed 30 SSIs (4.2%) through telemedicine and 38 SSIs (5.4%) through physical examination. The telemedicine sensitivity was 36.8% and specificity was 97.6%. The negative predictive value was 96.4%. CONCLUSIONS: Implementation of an mHealth-CHW home-based intervention in rural Rwanda and similar settings is feasible. Patients' acceptance of the intervention was key to its success. The telemedicine-based SSI diagnosis had a high negative predictive value but a low sensitivity. Further studies must explore strategies to improve accuracy, such as accompanying wound images with clinical data or developing algorithms using machine learning.

The Effect and Feasibility of mHealth-Supported Surgical Site Infection Diagnosis by Community Health Workers After Cesarean Section in Rural Rwanda: Randomized Controlled Trial.

BACKGROUND: The development of a surgical site infection (SSI) after cesarean section (c-section) is a significant cause of morbidity and mortality in low- and middle-income countries, including Rwanda. Rwanda relies on a robust community health worker (CHW)-led, home-based paradigm for delivering follow-up care for women after childbirth. However, this program does not currently include postoperative care for women after c-section, such as SSI screenings. OBJECTIVE: This trial assesses whether CHW's use of a mobile health (mHealth)-facilitated checklist administered in person or via phone call improved rates of return to care among women who develop an SSI following c-section at a rural Rwandan district hospital. A secondary objective was to assess the feasibility of implementing the CHW-led mHealth intervention in this rural district. METHODS: A total of 1025 women aged ≥18 years who underwent a c-section between November 2017 and September 2018 at Kirehe District Hospital were randomized into the three following postoperative care arms: (1) home visit intervention (n=335, 32.7%), (2) phone call intervention (n=334, 32.6%), and (3) standard of care (n=356, 34.7%). A CHW-led, mHealth-supported SSI diagnostic protocol was delivered in the two intervention arms, while patients in the standard of care arm were instructed to adhere to routine health center follow-up. We assessed intervention completion in each intervention arm and used logistic regression to assess the odds of returning to care. RESULTS: The majority of women in Arm 1 (n=295, 88.1%) and Arm 2 (n=226, 67.7%) returned to care and were assessed for an SSI at their local health clinic. There were no significant differences in the rates of returning to clinic within 30 days (P=.21), with high rates found consistently across all three arms (Arm 1: 99.7%, Arm 2: 98.4%, and Arm 3: 99.7%, respectively). CONCLUSIONS: Home-based post-c-section follow-up is feasible in rural Africa when performed by mHealth-supported CHWs. In this study, we found no difference in return to care rates between the intervention arms and standard of care. However, given our previous study findings describing the significant patient-incurred financial burden posed by traveling to a health center, we believe this intervention has the potential to reduce this burden by limiting patient travel to the health center when an SSI is ruled out at home. Further studies are needed (1) to determine the acceptability of this intervention by CHWs and patients as a new standard of care after c-section and (2) to assess whether an app supplementing the mHealth screening checklist with image-based machine learning could improve CHW diagnostic accuracy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03311399; https://clinicaltrials.gov/ct2/show/NCT03311399.

Antibiotics prior to age 2 years have limited association with preschool growth trajectory.

BACKGROUND: Prior studies of early antibiotic use and growth have shown mixed results, primarily on cross-sectional outcomes. This study examined the effect of oral antibiotics before age 24 months on growth trajectory at age 2-5 years. METHODS: We captured oral antibiotic prescriptions and anthropometrics from electronic health records through PCORnet, for children with ≥1 height and weight at 0-12 months of age, ≥1 at 12-30 months, and ≥2 between 25 and 72 months. Prescriptions were grouped into episodes by time and by antimicrobial spectrum. Longitudinal rate regression was used to assess differences in growth rate from 25 to 72 months of age. Models were adjusted for sex, race/ethnicity, steroid use, diagnosed asthma, complex chronic conditions, and infections. RESULTS: 430,376 children from 29 health U.S. systems were included, with 58% receiving antibiotics before 24 months. Exposure to any antibiotic was associated with an average 0.7% (95% CI 0.5, 0.9, p < 0.0001) greater rate of weight gain, corresponding to 0.05 kg additional weight. The estimated effect was slightly greater for narrow-spectrum (0.8% [0.6, 1.1]) than broad-spectrum (0.6% [0.3, 0.8], p < 0.0001) drugs. There was a small dose response relationship between the number of antibiotic episodes and weight gain. CONCLUSION: Oral antibiotic use prior to 24 months of age was associated with very small changes in average growth rate at ages 2-5 years. The small effect size is unlikely to affect individual prescribing decisions, though it may reflect a biologic effect that can combine with others.

Implementation and Adaptation of a Combined Economic Empowerment and Peer Support Program Among Youth Living With HIV in Rural Rwanda.

Background: Youth living with HIV in rural Rwanda experience poor clinical outcomes. In 2017, we implemented Adolescent Support Groups (ASGs), which provided economic incentives and peer support to youth aged 15-25. Methods: We assessed the ASG program using programmatic and electronic medical records. We described group composition and achievement on three indicators used to determine economic incentive levels: (1) quarterly pharmacy visit attendance, (2) biannual savings target achievement, and (3) annual viral suppression. Results: In total, 324 members enrolled in 34 ASGs. Group size and member ages varied more than anticipated. Groups performed well on pharmacy visit attendance (median quarterly group attendance range 91-100%) and on achieving savings targets (median biannual achievement range 80-83%). The viral suppression indicator could not be implemented as planned. Conclusion: To reflect contextual realities, adaptations in enrollment, indicator evaluation, and awarding of incentives occurred during implementation. Future research should assess whether these adaptations affected results.

Empowering Surgeons, Anesthesiologists, and Obstetricians to Incorporate Environmental Sustainability in the Operating Room.

OBJECTIVE: We review the existing research on environmentally sustainable surgical practices to enable SAO to advocate for improved environmental sustainability in operating rooms across the country. SUMMARY OF BACKGROUND DATA: Climate change refers to the impact of greenhouse gases emitted as a byproduct of human activities, trapped within our atmosphere and resulting in hotter and more variable climate patterns.1 As of 2013, the US healthcare industry was responsible for 9.8% of the country's emissions2; if it were itself a nation, US healthcare would rank 13th globally in emissions.3 As one of the most energy-intensive and wasteful areas of the hospital, ORs drive this trend. ORs are 3 to 6 times more energy intensive than clinical wards.4 Further, ORs and labor/delivery suites produce 50%-70% of waste across the hospital.5,6 Due to the adverse health impacts of climate change, the Lancet Climate Change Commission (2009) declared climate change "the biggest global health threat of the 21st century" and predicted it would exacerbate existing health disparities for minority groups, children and low socioeconomic patients.7. METHODS/RESULTS: We provide a comprehensive narrative review of published efforts to improve environmental sustainability in the OR while simultaneously achieving cost-savings, and highlight resources for clinicians interested in pursuing this work. CONCLUSION: Climate change adversely impacts patient health, and disproportionately impacts the most vulnerable patients. SAO contribute to the problem through their resource-intensive work in the OR and are uniquely positioned to lead efforts to improve the environmental sustainability of the OR.

Longitudinal Improvements in Radiation Exposure in Cardiac Catheterization for Congenital Heart Disease: A Prospective Multicenter C3PO-QI Study.

BACKGROUND: The C3PO-QI (Congenital Cardiac Catheterization Project on Outcomes - Quality Improvement), a multicenter registry launched in 2015, instituted quality improvement (QI) initiatives to reduce patient radiation exposure. Through regular collaboration, this initiative would allow for harmony among active participants, maximizing efforts and efficiency at achieving radiation best practices. This study sought to report these efforts with a detailed methodology for which institutions can target initiatives, reducing radiation exposure, and increasing patient safety. METHODS: Data were collected prospectively by 8 C3PO-QI institutions between January 1, 2015 and December 31, 2017. Radiation exposure was measured in dose area product per body weight (dose area product/kg; µGy*m2/kg) and reported by expected radiation exposure categories (REC) and institution for 40 published unique procedure types. Targeted interventions addressing selected strategic domains for radiation reduction were implemented in the pediatric catheterization labs of the C3PO-QI institutions. RESULTS: The study consisted of 15 257 unique cases. Median exposure (dose area product/kg) was decreased by 30% for all procedures. Dose area product/kg was reduced in all 3 REC, with the greatest improvement observed in REC I (REC I, -37%; REC II, -23%; REC III, -27%). Although the baseline radiation exposures and exact percent decrease varied across all C3PO-QI sites, each institution demonstrated improvements in radiation dose over time. These improvements occurred with the implementation of institution-specific QI interventions accelerated by participation in the C3PO-QI multicenter collaborative. CONCLUSIONS: Substantial radiation dose reductions can be achieved using targeted QI methodology and interventions. Participation in a multicenter QI collaborative may accelerate improvement across all centers due to enhanced engagement and shared learning between sites.

Adverse Events, Radiation Exposure, and Reinterventions Following Transcatheter Pulmonary Valve Replacement.

BACKGROUND: Transcatheter pulmonary valve replacement (TPVR) is associated with a risk of procedural serious adverse events (SAE) and exposure to ionizing radiation. OBJECTIVES: The purpose of this study was to define the risk of, and associations with, SAE and high-dose radiation exposure using large-scale registry data. METHODS: The analysis of the multicenter C3PO-QI registry was limited to patients who underwent TPVR from January 1, 2014, to December 31, 2016. SAE were defined as the occurrence of ≥1 moderate, major, or catastrophic events. Radiation dose was reported as dose area product adjusted for weight. Associations with outcome measures were explored in univariate and multivariable analyses. RESULTS: A total of 530 patients (59% male) underwent TPVR at a median age of 18.3 years (interquartile range [IQR]: 12.9 to 27.3 years) and weight of 58 kg (IQR: 43 to 77 kg) at 14 centers. Implant substrate included homograft (41%), bioprosthesis (30%), native right ventricular outflow tract (RVOT) (27%) and other (2%). TPVR indications were pulmonary insufficiency (28%), stenosis (23%), and mixed (49%). AE and SAE occurred in 26% and 13% of cases, respectively, including 1 mortality. SAE were more frequent in homograft conduit than other RVOT substrates, although SAE type and severity differed between implant substrates. Median radiation dose was 198 µGy·m2/kg (IQR: 94 to 350 µGy·m2/kg). Higher radiation dose was associated with older age, greater RVOT obstruction, and concomitant interventions (p < 0.001). During a median follow-up duration of 1 year, 13.3% underwent catheterization, surgery, or both, unrelated to infection. Younger age, smaller size, and hemodynamic and anatomic factors indicative of greater RVOT obstruction were associated with TPV reintervention. CONCLUSIONS: The incidence of SAE during TPVR in the C3PO-QI registry is high, but mortality is uncommon. Radiation dose is greater than for other congenital interventions and is associated with patient and procedural factors. Reintervention is common during early follow-up.

Radiation Risk Categories in Cardiac Catheterization for Congenital Heart Disease: A Tool to Aid in the Evaluation of Radiation Outcomes.

To stratify diverse procedure types into categories with similar radiation exposure in cardiac catheterization for congenital heart disease. Radiation exposures for a comprehensive list of specific procedure types and stratification of outcomes based on radiation risk are not currently available. Data between January 2014 and December 2015 were collected on all cases performed at sites participating in C3PO-QI (Congenital Cardiac Catheterization Outcomes Project-Quality Improvement Initiative) and 9 centers were included. Using expert consensus, 40 unique procedure types were defined by diagnostic characteristics or the intervention(s) performed, and dose area product (DAP) per kilogram of body weight (µGy × m2/kg) was summarized. Using empiric and consensus methods, three radiation risk categories were created. A total of 11,735 cases were included for analysis. Thirteen (n = 7918) procedure types with median DAP/kg < 100 were categorized in the low radiation exposure category (median DAP/kg 39). The medium exposure category (n = 1807) consisted of 16 procedure types with median DAP/kg values ranging 100 to < 200 (overall median DAP/kg 131). Finally, the high radiation exposure category (n = 1073) consisted of 11 procedure types with median DAP/kg ≥ 200 (overall median DAP/kg of 231). The radiation exposure risk categories created in this multi-center dataset are a critical step towards the development of a robust risk adjustment methodology for radiation exposure in catheterization for congenital heart disease.