Defining and estimating effects in cluster randomized trials: A methods comparison.

Across research disciplines, cluster randomized trials (CRTs) are commonly implemented to evaluate interventions delivered to groups of participants, such as communities and clinics. Despite advances in the design and analysis of CRTs, several challenges remain. First, there are many possible ways to specify the causal effect of interest (eg, at the individual-level or at the cluster-level). Second, the theoretical and practical performance of common methods for CRT analysis remain poorly understood. Here, we present a general framework to formally define an array of causal effects in terms of summary measures of counterfactual outcomes. Next, we provide a comprehensive overview of CRT estimators, including the t-test, generalized estimating equations (GEE), augmented-GEE, and targeted maximum likelihood estimation (TMLE). Using finite sample simulations, we illustrate the practical performance of these estimators for different causal effects and when, as commonly occurs, there are limited numbers of clusters of different sizes. Finally, our application to data from the Preterm Birth Initiative (PTBi) study demonstrates the real-world impact of varying cluster sizes and targeting effects at the cluster-level or at the individual-level. Specifically, the relative effect of the PTBi intervention was 0.81 at the cluster-level, corresponding to a 19% reduction in outcome incidence, and was 0.66 at the individual-level, corresponding to a 34% reduction in outcome risk. Given its flexibility to estimate a variety of user-specified effects and ability to adaptively adjust for covariates for precision gains while maintaining Type-I error control, we conclude TMLE is a promising tool for CRT analysis.

Adapting the preterm birth phenotyping framework to a low-resource, rural setting and applying it to births from Migori County in western Kenya.

BACKGROUND: Preterm birth is the leading cause of neonatal and under-five mortality worldwide. It is a complex syndrome characterized by numerous etiologic pathways shaped by both maternal and fetal factors. To better understand preterm birth trends, the Global Alliance to Prevent Prematurity and Stillbirth published the preterm birth phenotyping framework in 2012 followed by an application of the model to a global dataset in 2015 by Barros, et al. Our objective was to adapt the preterm birth phenotyping framework to retrospective data from a low-resource, rural setting and then apply the adapted framework to a cohort of women from Migori, Kenya. METHODS: This was a single centre, observational, retrospective chart review of eligible births from November 2015 - March 2017 at Migori County Referral Hospital. Adaptations were made to accommodate limited diagnostic capabilities and data accuracy concerns. Prevalence of the phenotyping conditions were calculated as well as odds of adverse outcomes. RESULTS: Three hundred eighty-seven eligible births were included in our study. The largest phenotype group was none (no phenotype could be identified; 41.1%), followed by extrauterine infection (25.1%), and antepartum stillbirth (16.7%). Extrauterine infections included HIV (75.3%), urinary tract infections (24.7%), malaria (4.1%), syphilis (3.1%), and general infection (3.1%). Severe maternal condition was ranked fourth (15.6%) and included anaemia (69.5%), chronic respiratory distress (22.0%), chronic hypertension prior to pregnancy (5.1%), diabetes (3.4%), epilepsy (3.4%), and sickle cell disease (1.7%). Fetal anaemia cases were the most likely to transfer to the newborn unit (OR 5.1, 95% CI 0.8, 30.9) and fetal anomaly cases were the most likely to result in a pre-discharge mortality (OR 3.9, 95% CI 0.8, 19.2). CONCLUSIONS: Using routine data sources allowed for a retrospective analysis of an existing dataset, requiring less time and fewer resources than a prospective study and demonstrating a feasible approach to preterm phenotyping for use in low-resource settings to inform local prevention strategies.

Preterm birth is a complex syndrome, yet it is the leading cause of death in children worldwide. To help unravel the clinical complexities, preterm birth phenotyping is a framework that considers multiple diagnoses in the mother, helping to evaluate trends in causes of preterm birth in a given region. In our study, we adapted this international phenotyping framework to accommodate a rural, low-resource setting where obstetrical and neonatal technologies were limited, but preterm birth rates were high. We evaluated data from the patient records of a large hospital in Migori, Kenya, in the southwestern region of the country. By lowering the threshold of diagnostic criteria, we were able to apply this framework to our dataset and see that maternal infection and maternal chronic illness appear to be a significant driving forces of preterm birth. Given high rates of HIV and malaria in the region, this is not a surprising finding, but one that can inform antenatal care practices, mainly the need to test and treat for common infections (HIV, malaria, as well as urinary and reproductive tract infections), and to increase the frequency of antenatal care interactions per the World Health Organization recommendations.

The role of informational support from women's social networks on antenatal care initiation: qualitative evidence from pregnant women in Uganda.

BACKGROUND: Early and appropriate use of antenatal care services is critical for reducing maternal and neonatal mortality and morbidity. Yet most women in sub-Saharan Africa, including Uganda, do not seek antenatal care until later during pregnancy. This qualitative study explored pregnant women's reliance on social ties for information about initiation of antenatal care. METHODS: We conducted semi-structured, in-depth interviews with 30 pregnant women seeking their first antenatal care visit at Kawempe Referral Hospital in Kampala, Uganda. Recruitment was done purposively to obtain variation by parity and whether women currently had a male partner. Study recruitment occurred from August 25th 2020 - October 26th, 2020. We used thematic analysis following a two-stage coding process, with both deductive and inductive codes. Deductive codes followed the key domains of social network and social support theory. RESULTS: We found that the most important source of information about antenatal care initiation was these women's mothers. Other sources included their mothers-in-law, female elders including grandmothers, and male partners. Sisters and female friends were less influential information sources about antenatal initiation. One of the primary reasons for relying on their own mothers, mothers-in-law, and elder women was due to these women's lived experience with pregnancy and childbirth. Trust in the relationship was also an important factor. Some pregnant women were less likely to rely on their sisters or female friends, either due to lack of trust or these women's lack of experience with pregnancy and childbirth. The advice that pregnant women received from their mothers and others on the ideal timing for antenatal care initiation varied significantly, including examples of misinformation about when to initiate antenatal care. Pregnant women seemed less likely to delay care when more than one social tie encouraged early antenatal care. CONCLUSIONS: Educating women's social networks, especially their mothers, mothers-in-law, and community elders, about the importance of early antenatal care initiation is a promising avenue for encouraging pregnant women to seek care earlier in pregnancy.

Is respectful care provided by community health workers associated with infant feeding practices? A cross sectional analysis from India.

OBJECTIVES: Breastfeeding and complementary feeding practices in India do not meet recommendations. Community health care workers (CHWs) are often the primary source of information for pregnant and postpartum women about Infant and Young Child Feeding (IYCF) practices. While existing research has evaluated the effectiveness of content and delivery of information through CHWs, little is known about the quality of the interpersonal communication (respectful care). We analyzed the effect of respectful interactions on recommended IYCF practices. METHODS: We use data from evaluation of an at-scale mHealth intervention in India that serves as a job aid to the CHWs (n = 3266 mothers of children < 12 m from 841 villages in 2 Indian states). The binary indicator variable for respectful care is constructed using a set of 7 questions related to trust, respect, friendliness during these interactions. The binary outcomes variables are exclusive breastfeeding, timely introduction of complimentary feeding, and minimum diet diversity for infants. We also explore if most of the pathway from respectful care to improved behaviors is through better recall of messages (mediation analysis). All models controlled for socio-economic-demographic characteristics and number of interactions with the CHW. RESULTS: About half of women reported positive, respectful interactions with CHWs. Interactions that are more respectful were associated with better recall of appropriate health messages. Interactions that are more respectful were associated with a greater likelihood of adopting all child-feeding behaviors except timely initiation of breastfeeding. After including recall in the model, the effect of respectful interactions alone reduced. CONCLUSIONS: Respectful care from CHWs appears to be significantly associated with some behaviors around infant feeding, with the primary pathway being through better recall of messages. Focusing on improving social and soft skills of CHWs that can translate into better CHW-beneficiary interactions can pay rich dividends. FUNDING: This study is funded by Grant No. OPP1158231 from Bill and Melinda Gates Foundation. TRIAL REGISTRATION NUMBER: https://doi.org/10.1186/ISRCTN83902145.

Implementing the WHO Safe Childbirth Checklist modified for preterm birth: lessons learned and experiences from Kenya and Uganda.

BACKGROUND: The WHO Safe Childbirth Checklist (SCC) contains 29 evidence-based practices (EBPs) across four pause points spanning admission to discharge. It has been shown to increase EBP uptake and has been tailored to specific contexts. However, little research has been conducted in East Africa on use of the SCC to improve intrapartum care, particularly for preterm birth despite its burden. We describe checklist adaptation, user acceptability, implementation and lessons learned. METHODS: The East Africa Preterm Birth Initiative (PTBi EA) modified the SCC for use in 23 facilities in Western Kenya and Eastern Uganda as part of a cluster randomized controlled trial evaluating a package of facility-based interventions to improve preterm birth outcomes. The modified SCC (mSCC) for prematurity included: addition of a triage pause point before admission; focus on gestational age assessment, identification and management of preterm labour; and alignment with national guidelines. Following introduction, implementation lasted 24 and 34 months in Uganda and Kenya respectively and was supported through complementary mentoring and data strengthening at all sites. PRONTO® simulation training and quality improvement (QI) activities further supported mSCC use at intervention facilities only. A mixed methods approach, including checklist monitoring, provider surveys and in-depth interviews, was used in this analysis. RESULTS: A total of 19,443 and 2229 checklists were assessed in Kenya and Uganda, respectively. In both countries, triage and admission pause points had the highest rates of completion. Kenya's completion was greater than 70% for all pause points; Uganda ranged from 39 to 75%. Intervention facilities exposed to PRONTO and QI had higher completion rates than control sites. Provider perceptions cited clinical utility of the checklist, particularly when integrated into patient charts. However, some felt it repeated information in other documentation tools. Completion was hindered by workload and staffing issues. CONCLUSION: This study highlights the feasibility and importance of adaptation, iterative modification and complementary activities to reinforce SCC use. There are important opportunities to improve its clinical utility by the addition of prompts specific to the needs of different contexts. The trial assessing the PTBi EA intervention package was registered at ClinicalTrials.gov NCT03112018 Registered December 2016, retrospectively registered.

Super Divya to the rescue! Exploring Nurse Mentor Supervisor perceptions on a digital tool to support learning and engagement for simulation educators in Bihar, India.

BACKGROUND: Since 2014, the Government of Bihar and CARE India have implemented a nurse mentoring program that utilizes PRONTO International's simulation and team trainings to improve obstetric and neonatal care. Together they trained simulation educators known as Nurse Mentor Supervisors to conduct simulation trainings in rural health facilities across the state. Sustaining the knowledge and engagement of these simulation educators at a large-scale has proven difficult and resource intensive. To address this, the University of Utah with PRONTO International and with input from the University of California San Francisco, created an interactive, virtual education module based on a comic superhero named Super Divya to reinforce simulation educator concepts. This study examined the perceptions of Nurse Mentor Supervisors on Super Divya's accessibility, usefulness, and potential after implementation of Super Divya: Origin Story. METHODS: We conducted qualitative interviews with 17 Nurse Mentor Supervisors in Bihar, India. In light of the COVID-19 pandemic, interviews were conducted virtually via Zoom™ using a semi-structured interview guide in Hindi and English. Participants were identified with strict inclusion criteria and convenience sampling methods. Interviews were analyzed using a framework analysis. RESULTS: Nurse Mentor Supervisors found Super Divya to be engaging, innovative, relatable, and useful in teaching tips and tricks for simulation training. Supervisors thought the platform was largely accessible with some concerns around internet connectivity and devices. The majority reacted positively to the idea of distributing Super Divya to other simulation educators in the nurse mentoring program and had suggestions for additional clinical and simulation educator training topics. CONCLUSIONS: This study demonstrates the potential of Super Divya to engage simulation educators in continuous education. At a time when virtual education is increasingly important and in-person training was halted by the COVID-19 pandemic, Super Divya engaged Supervisors in the nurse mentoring program. We have incorporated suggestions for improvement of Super Divya into future modules. Further research can help understand how knowledge from Super Divya can improve simulation facilitation skills and behaviors, and explore potential for reinforcing clinical skills via this platform. ETHICAL APPROVAL: This study was approved by the institutional review board at the University of California San Francisco (IRB # 20-29902).

Training nurse simulation educators at scale to improve maternal and newborn health: a case study from Bihar, India.

BACKGROUND: Simulation has been shown to improve clinical and behavioral skills of birth attendants in low-resource settings at a low scale. Populous, low-resource settings such as Bihar, India, require large cadres of simulation educators to improve maternal and newborn health. It's unknown if simulation facilitation skills can be adopted through a train of trainers' cascade. To fill this gap, we designed a study to evaluate the simulation and debrief knowledge, attitudes and skills of a third generation of 701 simulation educators in Bihar, India. In addition, we assessed the physical infrastructure where simulation takes place in 40 primary healthcare facilities in Bihar, India. METHODS: We performed a 1 year before-after intervention study to assess the simulation facilitation strengths and weaknesses of a cadre of 701 nurses in Bihar, India. The data included 701 pre-post knowledge and attitudes self-assessments; videos of simulations and associated debriefs conducted by 701 providers at 40 primary healthcare centers. RESULTS: We observed a statistically significant difference in knowledge and attitude scores before and after the 4-day PRONTO simulation educator training. The average number of participants in a simulation video was 5 participants (range 3-8). The average length of simulation videos was 10:21 minutes. The simulation educators under study, covered behavioral in 90% of debriefs and cognitive objectives were discussed in all debriefs. CONCLUSION: This is the first study assessing the simulation and debrief facilitation knowledge and skills of a cadre of 701 nurses in a low-resource setting. Simulation was implemented by local nurses at 353 primary healthcare centers in Bihar, India. Primary healthcare centers have the physical infrastructure to conduct simulation training. Some simulation skills such as communication via whiteboard were widely adopted. Advanced skills such as eliciting constructive feedback without judgment require practice.

Provider perceptions of lack of supportive care during childbirth: A mixed methods study in Kenya.

Supportive care is a key component of person-centered maternity care (PCMC), and includes aspects such as timely and attentive care, pain control, and the health facility environment. Yet, few researchers have explored the degree of supportive care delivered or providers' perceptions on supportive care practices during childbirth. The researchers' aim is to evaluate the extent of supportive care provided to women during childbirth and to identify the drivers behind the lack of supportive care from the perspective of maternity providers in a rural county in Western Kenya. Data are from a mixed-methods study in Migori County in Western Kenya with 49 maternity providers (32 clinical and 17 non-clinical). Providers were asked structured questions on various aspects of supportive care followed by open ended questions on why certain practices were performed or not. We conducted descriptive analysis of the quantitative data and thematic analysis of the qualitative data. We analyzed data and found inconsistent and suboptimal practices with regards to supportive care. Some providers reported long patient wait times in their facilities as well as the inability to provide the best care due to staff shortages in their facilities. Others also reported low interest and inquiry about women's experience of pain during childbirth, which was driven by perceptions of pain during childbirth as normal, facility culture and norms, and lack of pain medicine. For the facility environment, providers reported relatively clean facilities. They, however, noted inconsistent water and electricity as well as inadequate safety. We conclude that many drivers of the lack of supportive care are caused by structural health systems issues, therefore a health system strengthening approach can be useful for improving the supportive care dimension of PCMC, and thus quality of care overall.

Person-centered antenatal care and associated factors in Rwanda: a secondary analysis of program data.

BACKGROUND: Research suggests that women's experience of antenatal care is an important component of high-quality antenatal care. Person-centered antenatal care (PCANC) reflects care that is both respectful of, and responsive to, the preferences, needs, and values of pregnant women. Little is known in Rwanda about either the extent to which PCANC is practiced or the factors that might determine its use. This is the first study to quantitatively examine the extent of and the factors associated with PCANC in Rwanda. METHODS: We used quantitative data from a randomized control trial in Rwanda. A total of 2150 surveys were collected and analyzed from 36 health centers across five districts. We excluded women who were less than 16 years old, were referred to higher levels of antenatal care or had incomplete survey responses. Both bivariate and multivariate logistic regression analyses were used to test the hypothesis that certain participant characteristics would predict high PCANC. RESULTS: PCANC level was found to be sub-optimal with one third of women leaving antenatal care (ANC) with questions or confused and one fourth feeling disrespected. In bivariate analysis, social support, greater parity, being in the traditional care (control group), and being from Burera district significantly predict high PCANC. Additionally, in the multivariate analysis, being in the traditional care group and the district in which women received care were significantly associated with PCANC. CONCLUSIONS: This quantitative analysis indicates sub-optimal levels of PCANC amongst our study population in Rwanda. We find lower levels of PCANC to be regional and defined by the patient characteristics parity and social support. Given the benefits of PCANC, improvements in PCANC through provider training in Rwanda might promote an institutional culture shift towards a more person-centered model of care.

Causes of preterm and low birth weight neonatal mortality in a rural community in Kenya: evidence from verbal and social autopsy.

BACKGROUND: Under-five mortality in Kenya has declined over the past two decades. However, the reduction in the neonatal mortality rate has remained stagnant. In a country with weak civil registration and vital statistics systems, there is an evident gap in documentation of mortality and its causes among low birth weight (LBW) and preterm neonates. We aimed to establish causes of neonatal LBW and preterm mortality in Migori County, among participants of the PTBI-K (Preterm Birth Initiative-Kenya) study. METHODS: Verbal and social autopsy (VASA) interviews were conducted with caregivers of deceased LBW and preterm neonates delivered within selected 17 health facilities in Migori County, Kenya. The probable cause of death was assigned using the WHO International Classification of Diseases (ICD-10). RESULTS: Between January 2017 to December 2018, 3175 babies were born preterm or LBW, and 164 (5.1%) died in the first 28 days of life. VASA was conducted among 88 (53.7%) of the neonatal deaths. Almost half (38, 43.2%) of the deaths occurred within the first 24 h of life. Birth asphyxia (45.5%), neonatal sepsis (26.1%), respiratory distress syndrome (12.5%) and hypothermia (11.0%) were the leading causes of death. In the early neonatal period, majority (54.3%) of the neonates succumbed to asphyxia while in the late neonatal period majority (66.7%) succumbed to sepsis. Delay in seeking medical care was reported for 4 (5.8%) of the neonatal deaths. CONCLUSION: Deaths among LBW and preterm neonates occur early in life due to preventable causes. This calls for enhanced implementation of existing facility-based intrapartum and immediate postpartum care interventions, targeting asphyxia, sepsis, respiratory distress syndrome and hypothermia.

Association between supportive supervision and performance of community health workers in India: a longitudinal multi-level analysis.

INTRODUCTION: Community health workers (CHWs) deliver services at-scale to reduce maternal and child undernutrition, but often face inadequate support from the health system to perform their job well. Supportive supervision is a promising intervention that strengthens the health system and can enable CHWs to offer quality services. OBJECTIVES: We examined if greater intensity of supportive supervision as defined by monitoring visits to Anganwadi Centre, CHW-supervisor meetings, and training provided by supervisors to CHWs in the context of Integrated Child Services Development (ICDS), a national nutrition program in India, is associated with higher performance of CHWs. Per program guidelines, we develop the performance of CHWs measure by using an additive score of nutrition services delivered by CHWs. We also tested to see if supportive supervision is indirectly associated with CHW performance through CHW knowledge. METHODS: We used longitudinal survey data of CHWs from an impact evaluation of an at-scale technology intervention in Madhya Pradesh and Bihar. Since the inception of ICDS, CHWs have received supportive supervision from their supervisors to provide services in the communities they serve. Mixed-effects logistic regression models were used to test if higher intensity supportive supervision was associated with improved CHW performance. The model included district fixed effects and random intercepts for the sectors to which supervisors belong. RESULTS: Among 809 CHWs, the baseline proportion of better performers was 45%. Compared to CHWs who received lower intensity of supportive supervision, CHWs who received greater intensity of supportive supervision had 70% higher odds (AOR 1.70, 95% CI 1.16, 2.49) of better performance after controlling for their baseline performance, CHW characteristics such as age, education, experience, caste, timely payment of salaries, Anganwadi Centre facility index, motivation, and population served in their catchment area. A test of mediation indicated that supportive supervision is associated indirectly with CHW performance through improvement in CHW knowledge. CONCLUSION: Higher intensity of supportive supervision is associated with improved CHW performance directly and through knowledge of CHWs. Leveraging institutional mechanisms such as supportive supervision could be important in improving service delivery to reach beneficiaries and potentially better infant and young child feeding practices and nutritional outcomes. TRIAL REGISTRATION: Trial registration number:  https://doi.org/10.1186/ISRCTN83902145.

Predictors of postpartum family planning in Rwanda: the influence of male involvement and healthcare experience.

BACKGROUND: Strengthened efforts in postpartum family planning (PPFP) is a key priority to accelerate progress in reproductive, maternal, newborn, and child health outcomes. This secondary data analysis explores factors associated with PPFP uptake in Rwanda. The purpose of this study was to explore variables that may influence PPFP use for postpartum women in Rwanda including health facility type, respectful maternity care, locus of control, and mental health status. METHODS: This secondary analysis of data from a cluster randomized control trial used information abstracted from questionnaires administered to women (≥ 15 years of age) at two time points-one during pregnancy (baseline) and one after delivery of the baby (follow-up). The dependent variable, PPFP uptake, was evaluated against the independent variables: respectful care, locus of control, and mental health status. These data were abstracted from linked questionnaires completed from January 2017 to February 2019. The sample size provided 97% power to detect a change at a 95% significance level with a sample size of 640 at a 15% effect size. Chi-square testing was applied for the bivariate analyses. A logistic regression model using the generalized linear model function was performed; odds ratio and adjusted (by age group and education group) odds ratio with 95% confidence interval were reported. RESULTS: Of the 646 respondents, although 92% reported not wanting another pregnancy within the next year, 72% used PPFP. Antenatal care wait time (p = < 0.01; Adj OR (Adj 95% CI) 21-40 min: 2.35 (1.46,3.79); 41-60 min: 1.50 (0.84,2.69); 61-450 min: 5.42 (2.86,10.75) and reporting joint healthcare decision-making between the woman and her partner (male) (p = 0.04; Adj OR (Adj 95% CI) husband/partner: 0.59 (0.35,0.97); mother and partner jointly: 1.06 (0.66,1.72) were associated with PPFP uptake. CONCLUSIONS: These results illustrate that partner (male) involvement and improved quality of maternal health services may improve PPFP utilization in Rwanda.

Anganwadi worker time use in Madhya Pradesh, India: a cross-sectional study.

BACKGROUND: Anganwadi Workers (AWWs) are a group of 1.4 million community health workers that operate throughout rural India as a part of the Integrated Child Development Services program. AWWs are responsible for disseminating key health information regarding nutrition, family planning, and immunizations to the women and children in their catchment area, while maintaining detailed registers that track key beneficiary data, updates on health status, and supply inventory beneficiaries. There is a need to understand how AWWs spend their time on all of these activities given all of their responsibilities, and the factors that are associated with their time use. METHODS: This cross-sectional study conducted in Madhya Pradesh, collected time use data from AWWs using a standard approach in which we asked participants how much time they spent on various activities. Additionally, we estimated a logistic regression model to elucidate what AWW characteristics are associated with time use. RESULTS: We found that AWWs spend substantial amounts of time on administrative tasks, such as filling out their paper registers. Additionally, we explored the associations between various AWW characteristics and their likelihood of spending the expected amount of time on preschool work, filling out their registers, feeding children, and conducting home visits. We found a positive significant association between AWW education and their likelihood of filling out their registers. CONCLUSIONS: AWWs spend substantial amounts of time on administrative tasks, which could take away from their ability to spend time on providing direct care. Additionally, future research should explore why AWW characteristics matter and how such factors can be addressed to improve AWWs' performance and should explore the associations between Anganwadi Center characteristics and AWW time use.

Training in obstetric and neonatal emergencies in Mexico: effect on knowledge and self-efficacy by gender, age, shift, and profession.

BACKGROUND: Continuing education is essential for healthcare workers. Education interventions can help to maintain and improve competency and confidence in the technical skills necessary to address adverse events. However, characteristics of the health provider such as age (related to more critical and reflexive attitude); sex (relationship with gender socialization), profession and work conditions might have an influence on the effect of continuing education efforts. METHODS: A training in the management of obstetric and neonatal emergencies (PRONTO, Spanish acronym for Neonatal and Obstetric Rescue Program: Optimal and Timely treatment) was implemented in 14 hospitals in six Mexican states between 2013 and 2014, with a before-after evaluation design. A total of 351 health providers including physicians, interns, nurses and midwives completed the training and were included in the analytic sample. Mixed-effects regression models were fitted to model changes in knowledge and self-efficacy scores after the training for each training topic. Interaction terms of training with age, gender, profession, and shift were included to evaluate possible heterogeneities of effect. All models considered the within-hospital clustering of participants. RESULTS: After training, all participants showed a significant knowledge gain by an average of 19 percentage points for hemorrhage, 23 for neonatal resuscitation, 19 for shoulder dystocia, and 15 for preeclampsia/eclampsia (p < 0.001). Participants who worked night shifts showed lower scores for overall knowledge, compared with morning shift workers. Interns perceived the lowest self-efficacy while they scored very high in knowledge. Self-efficacy in managing obstetric and neonatal emergencies increased significantly by 16 percentage points in average. CONCLUSIONS: Our results show that PRONTO is generally successful in increasing knowledge and self-efficacy on all topics but knowledge and self efficacy levels vary greatly by factors such as work shift. Training should be particularly aimed at personnel working during weekends and night shifts, as well as interns and nurses.

Training and evaluating simulation debriefers in low-resource settings: lessons learned from Bihar, India.

BACKGROUND: To develop effective and sustainable simulation training programs in low-resource settings, it is critical that facilitators are thoroughly trained in debriefing, a critical component of simulation learning. However, large knowledge gaps exist regarding the best way to train and evaluate debrief facilitators in low-resource settings. METHODS: Using a mixed methods approach, this study explored the feasibility of evaluating the debriefing skills of nurse mentors in Bihar, India. Videos of obstetric and neonatal post-simulation debriefs were assessed using two known tools: the Center for Advanced Pediatric and Perinatal Education (CAPE) tool and Debriefing Assessment for Simulation in Healthcare (DASH). Video data was used to evaluate interrater reliability and changes in debriefing performance over time. Additionally, twenty semi-structured interviews with nurse mentors explored perceived barriers and enablers of debriefing in Bihar. RESULTS: A total of 73 debriefing videos, averaging 18 min each, were analyzed by two raters. The CAPE tool demonstrated higher interrater reliability than the DASH; 13 of 16 CAPE indicators and two of six DASH indicators were judged reliable (ICC > 0.6 or kappa > 0.40). All indicators remained stable or improved over time. The number of 'instructors questions,' the amount of 'trainee responses,' and the ability to 'organize the debrief' improved significantly over time (p < 0.01, p < 0.01, p = 0.04). Barriers included fear of making mistakes, time constraints, and technical challenges. Enablers included creating a safe learning environment, using contextually appropriate debriefing strategies, and team building. Overall, nurse mentors believed that debriefing was a vital aspect of simulation-based training. CONCLUSION: Simulation debriefing and evaluation was feasible among nurse mentors in Bihar. Results demonstrated that the CAPE demonstrated higher interrater reliability than the DASH and that nurse mentors were able to maintain or improve their debriefing skills overtime. Further, debriefing was considered to be critical to the success of the simulation training. However, fear of making mistakes and logistical challenges must be addressed to maximize learning. Teamwork, adaptability, and building a safe learning environment enhanced the quality enhanced the quality of simulation-based training, which could ultimately help to improve maternal and neonatal health outcomes in Bihar.

Simulation-enhanced nurse mentoring to improve preeclampsia and eclampsia care: an education intervention study in Bihar, India.

BACKGROUND: Inadequately treated, preeclampsia and eclampsia (PE/E) may rapidly lead to severe complications in both mothers and neonates, and are estimated to cause 60,000 global maternal deaths annually. Simulation-based training on obstetric and neonatal emergency management has demonstrated promising results in low- and middle-income countries. However, the impact of simulation training on use of evidence-based practices for PE/E diagnosis and management in low-resource settings remains unknown. METHODS: This study was based on a statewide, high fidelity in-situ simulation training program developed by PRONTO International and implemented in collaboration with CARE India on PE/E management in Bihar, India. Using a mixed methods approach, we evaluated changes over time in nurse mentees' use of evidence-based practices during simulated births at primary health clinics. We compared the proportion and efficiency of evidence-based practices completed during nurse mentees' first and last participation in simulated PE/E cases. Twelve semi-structured interviews with nurse mentors explored barriers and enablers to high quality PE/E care in Bihar. RESULTS: A total of 39 matched first and last simulation videos, paired by facility, were analyzed. Videos occurred a median of 62 days apart and included 94 nurses from 33 primary health centers. Results showed significant increases in the median number of 'key history questions asked,' (1.0 to 2.0, p = 0.03) and 'key management steps completed,' (2.0 to 3.0, p = 0.03). The time from BP measured to magnesium sulfate given trended downwards by 3.2 min, though not significantly (p = 0.06). Key barriers to high quality PE/E care included knowledge gaps, resource shortages, staff hierarchy between physicians and nurses, and poor relationships with patients. Enablers included case-based and simulation learning, promotion of teamwork and communication, and effective leadership. CONCLUSION: Simulation training improved the use of evidence-based practices in PE/E simulated cases and has the potential to increase nurse competency in diagnosing and managing complex maternal complications such as PE/E. However, knowledge gaps, resource limitations, and interpersonal barriers must be addressed in order to improve care. Teamwork, communication, and leadership are key mechanisms to facilitate high quality PE/E care in Bihar.

Can an integrated obstetric emergency simulation training improve respectful maternity care? Results from a pilot study in Ghana.

BACKGROUND: Few evidence-based interventions exist on how to improve respectful maternity care (RMC) in low-resource settings. We sought to evaluate the effect of an integrated simulation-based training on provision of RMC. METHODS: The pilot project was in East Mamprusi District in northern Ghana. We integrated specific components of RMC, emphasizing dignity and respect, communication and autonomy, and supportive care, into a simulation training to improve identification and management of obstetric and neonatal emergencies. Forty-three providers were trained. For evaluation, we conducted surveys at baseline (N = 215) and endline (N = 318) 6 months later, with recently delivered women to assess their experiences of care using the person-centered maternity care scale. Higher scores on the scale represent more respectful care. RESULTS: Compared to the baseline, women in the endline reported more respectful care. The average person-centered maternity care score increased from 50 at baseline to 72 at endline, a relative increase of 43%. Scores on the subscales also increased between baseline and endline: 15% increase for dignity and respect, 87% increase for communication and autonomy, and 55% increase for supportive care. These differences remained significant in multivariate analysis controlling for several potential confounders. CONCLUSIONS: The findings suggest that integrated provider trainings that give providers the opportunity to learn, practice, and reflect on their provision of RMC in the context of stressful emergency obstetric simulations have the potential to improve women's childbirth experiences in low-resource settings. Incorporating such trainings into preservice and in-service training of providers will help advance global efforts to promote RMC.

Before and after implementation of group antenatal care in Rwanda: a qualitative study of women's experiences.

BACKGROUND: The Preterm Birth Initiative-Rwanda is conducting a 36-cluster randomized controlled trial of group antenatal and postnatal care. In the context of this trial, we collected qualitative data before and after implementation. The purpose was two-fold. First, to inform the design of the group care program before implementation and second, to document women's experiences of group care at the mid-point of the trial to make ongoing programmatic adjustments and improvements. METHODS: We completed 8 focus group discussions among women of reproductive age before group care implementation and 6 focus group discussions among women who participated in group antenatal care and/or postnatal care at 18 health centers that introduced the model, approximately 9 months after implementation. RESULTS: Before implementation, focus group participants reported both enthusiasm for the potential for support and insight from a group of peers and concern about the risk of sharing private information with peers who may judge, mock, or gossip. After implementation, group care participants reported benefits including increased knowledge, peer support, and more satisfying relationships with providers. When asked about barriers to group care participation, none of them cited concern about privacy but instead cited lack of financial resources, lack of cooperation from a male partner, and long distances to the health center. Finally, women stated that the group care experience would be improved if all participants and providers arrived on time and remained focused on the group care visit throughout. DISCUSSION: These results are consistent with other published reports of women's perceptions of group antenatal care, especially increased pregnancy- and parenting-related knowledge, peer support, and improved relationships with health care providers. Some results were unexpected, especially the consequences of staff allocation patterns that resulted in providers arriving late for group visits or having to leave during group visits to attend to other facility services, which diminished women's experiences of care. CONCLUSION: Group antenatal and postnatal care provide compelling benefits to women and families. If the model requires the addition of human resources at the health center, intensive reminder communications, and large-scale community outreach to benefit the largest number of pregnant and postnatal mothers, those additional resources required must be factored into any future decision to scale a group care model. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov as NCT03154177 .

Health providers pass knowledge and abilities acquired by training in obstetric emergencies to their peers: the average treatment on the treated effect of PRONTO on delivery attendance in Mexico.

BACKGROUND: A significant proportion of newborn and maternal deaths can be prevented through simple and cost-effective strategies. The main aim of this study was to evaluate the impact of the PRONTO obstetric-emergency management training for improving evidence-based birth attendance practices among providers attending the training at 12 hospitals in three states of Mexico from 2010 to 2012, and to estimate dissemination of the training within the hospitals. METHODS: The average treatment on the treated effect of the PRONTO intervention for the probability of performing certain practices during birth attendance was estimated in a sample of 310 health providers. Impact estimates were obtained by performing provider-level matching using a mixed Mahalanobis distance one-to-one nearest-neighbor and exact matching approach. A secondary analysis estimated the positive externalities caused by the intervention in the treated hospitals using the same analytical approach. Provider-level fixed effects regression models were used to estimate the rate of decay of the probability of performing the examined practices. RESULTS: Providers attending the PRONTO training showed significant increases in the probability of performing the complete active management of the third stage of labor, especially the first and third steps, and skin-to-skin-contact. There was a negative and significant effect on the probability of performing uterine sweeping. Providers who did not attend the training in treated hospitals also showed marked significant changes in the same practices, except for uterine sweeping. There was no evidence of a significant decay of the probability of performing the routine practices over time among the treated providers. CONCLUSIONS: PRONTO is efficacious in changing trained providers' behavior, but not on all practices, suggesting that some practices are deeply ingrained. The results also suggest that information on practices is effectively transmitted to peers within treated hospitals. Previous findings of the dilution of the effect of PRONTO on some practices seem to be more related to the rotation of personnel (mainly interns) rather than providers returning to their former habits. TRIAL REGISTRATION: NCT01477554 . Registered on November 18, 2011; retrospectively registered.

Companionship during facility-based childbirth: results from a mixed-methods study with recently delivered women and providers in Kenya.

BACKGROUND: Research suggests that birth companionship, and in particular, continuous support during labor and delivery, can improve women's childbirth experience and birth outcomes. Yet, little is known about the extent to which birth companionship is practiced, as well as women and providers' perceptions of it in low-resource settings. This study aimed to assess the prevalence and determinants of birth companionship, and women and providers' perceptions of it in health facilities in a rural County in Western Kenya. METHODS: We used quantitative and qualitative data from 3 sources: surveys with 877 women, 8 focus group discussions with 58 women, and in-depth interviews with 49 maternity providers in the County. Eligible women were 15 to 49 years old and delivered in the 9 weeks preceding the study. RESULTS: About 88% of women were accompanied by someone from their social network to the health facility during their childbirth, with 29% accompanied by a male partner. Sixty-seven percent were allowed continuous support during labor, but only 29% were allowed continuous support during delivery. Eighteen percent did not desire companionship during labor and 63% did not desire it during delivery. Literate, wealthy, and employed women, as well as women who delivered in health centers and did not experience birth complications, were more likely to be allowed continuous support during labor. Most women desired a companion during labor to attend to their needs. Reasons for not desiring companions included embarrassment and fear of gossip and abuse. Most providers recommended birth companionship, but stated that it is often not possible due to privacy concerns and other reasons mainly related to distrust of companions. Providers perceive companions' roles more in terms of assisting them with non-clinical tasks than providing emotional support to women. CONCLUSION: Although many women desire birth companionship, their desires differ across the labor and delivery continuum, with most desiring companionship during labor but not at the time of delivery. Most, however, don't get continuous support during labor and delivery. Interventions with women, companions, and providers, as well as structural and health system interventions, are needed to promote continuous support during labor and delivery.