Underrepresentation of racial and ethnic minority groups in gynecologic oncology: An analysis of over 250 trials.

OBJECTIVE: To describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials. METHODS: Gynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data. RESULTS: 2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013-2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years - REMGs made up 19.6% of trial participants in 2007-2009 compared to 38.1% in 2016-2018 (p < 0.0001). CONCLUSION: Less than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials.

Molecular subtyping in endometrial cancer: A promising strategy to guide fertility preservation.

OBJECTIVES: To investigate the association of molecular subtype with progesterone response in patients with endometrial cancer (EC) or atypical endometrial hyperplasia (AEH). METHODS: Premenopausal patients aged ≤48 years with tumor-normal sequencing data who received progesterone for EC/AEH from 1/1/2010-6/30/2021 were identified. Tumors were classified as POLE-ultramutated, microsatellite instability-high (MSI-H), copy number-high (CN-H), or copy number-low (CN-L) molecular subtype. Best response to progesterone was compared by subtype. Appropriate statistical tests were performed. RESULTS: Of 20 patients, 7 (35%) had AEH and 13 (65%) had EC. Sixteen tumors (80%) were CN-L, 3 (15%) were MSI-H, and 1 (5%) was POLE-ultramutated. Median time on progesterone was 22 months (range, 3-115). Ten patients (50%) had complete response (CR); median time to CR was 9 months (range, 3-32). Four patients (20%) had stable disease (SD) and 6 (30%) had progressive disease (PD). For CN-L tumors, 10 patients (62%) had CR, 3 (19%) had SD, and 3 (19%) had PD. For MSI-H tumors, 1 patient (33%) had SD and 2 (66%) had PD. For POLE-ultramutated tumors, 1 patient had PD. Median follow-up was 48 months (range, 12-123). Four of 10 patients (40%) with CR recurred; median time from CR to recurrence was 16 months (range, 5-102). CONCLUSION: Molecular subtype may be associated with progesterone response in patients with EC/AEH. CN-L tumors had the best response, and MSI-H tumors had the poorest. Recurrence after CR is common, and close surveillance is warranted. Larger studies investigating the role of molecular classification in medical management of EC/AEH are needed.

Large Publication Gap for Gynecologic Cancers in High-Impact Factor Journals.

OBJECTIVE: To analyze research publication trends in high-impact factor journals, comparing gynecologic cancers with other cancers from 2000 to 2018. METHODS: Abstracts from the 55 journals with the highest impact factors, as measured by Clarivate, from 2000 to 2018 were extracted from PubMed. We developed an algorithm to search the title of the abstract to determine whether the abstract was about cancer and to identify the cancer type. The algorithm was validated against the gold standard of human review in 1,143 abstracts. Article proportion was compared with site-specific incidence, mortality, and lethality from the National Cancer Institute's Surveillance, Epidemiology and End Results database using scatterplots and nonparametric Wilcoxon signed-rank test. RESULTS: We identified 128,377 articles; 31,045 (24.1%) were about cancer and 1,189 (3.8%) were about gynecologic cancers. Gynecologic cancers (ovarian, cervical, and uterine) were all poorly represented in high-impact factor journals compared with their incidence, mortality, and lethality. Ovarian, uterine, and cervical cancers ranked in the bottom half of Article-to-Lethality scores ( P <.01 for all comparisons). Analyses of the trends for gynecologic cancers over the past 18 years showed no change over time in Article-to-Lethality scores. Comparison of rankings by lethality with rankings by funding indicates relative underfunding of the gynecologic cancers. CONCLUSION: Research publications in high-impact factor journals by cancer site are not proportionate with individual cancer burden on society. Gynecologic cancers are significantly underrepresented in research publications relative to their disease burden, indicating a disparity that persists over the past 18 years. Relative underfunding of gynecologic cancers likely contributes to this publication gap.

Enrollment of Racial and Ethnic Minoritized Groups in Gynecologic Oncology Clinical Trials: A Review of the Scope of the Problem, Contributing Factors, and Strategies to Improve Inclusion.

Racial inequities are well-documented across the gynecologic oncology care continuum, including the representation of racial and ethnic minoritized groups (REMGs) in gynecologic oncology clinical trials. We specifically reviewed the scope of REMG disparities, contributing factors, and strategies to improve inclusion. We found systematic and progressively worsening under-enrollment of REMGs, particularly of Black and Latinx populations. In addition, race/ethnicity data reporting is poor, yet a prerequisite for accountability to recruitment goals. Trial participation barriers are multifactorial, and successful remediation likely requires multi-level strategies. More rigorous, transparent data on trial participants and effectiveness studies on REMG recruitment strategies are needed to improve enrollment.

Systematic review of international studies evaluating MDRD and CKD-EPI estimated glomerular filtration rate (eGFR) equations in Black adults.

Use of race adjustment in estimating glomerular filtration rate (eGFR) has been challenged given concerns that it may negatively impact the clinical care of Black patients, as it results in Black patients being systematically assigned higher eGFR values than non-Black patients. We conducted a systematic review to assess how well eGFR, with and without race adjustment, estimates measured GFR (mGFR) in Black adults globally. A search across multiple databases for articles published from 1999 to May 2021 that compared eGFR to mGFR and reported outcomes by Black race was performed. We included studies that assessed eGFR using the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPICr) creatinine equations. Risk of study bias and applicability were assessed with the QUality Assessment of Diagnostic Accuracy Studies-2. Of 13,167 citations identified, 12 met the data synthesis criteria (unique patient cohorts in which eGFR was compared to mGFR with and without race adjustment). The studies included patients with and without kidney disease from Africa (n = 6), the United States (n = 3), Europe (n = 2), and Brazil (n = 1). Of 11 CKD-EPI equation studies, all assessed bias, 8 assessed accuracy, 6 assessed precision, and 5 assessed correlation/concordance. Of 7 MDRD equation studies, all assessed bias, 6 assessed accuracy, 5 assessed precision, and 3 assessed correlation/concordance. The majority of studies found that removal of race adjustment improved bias, accuracy, and precision of eGFR equations for Black adults. Risk of study bias was often unclear, but applicability concerns were low. Our systematic review supports the need for future studies to be conducted in diverse populations to assess the possibility of alternative approaches for estimating GFR. This study additionally provides systematic-level evidence for the American Society of Nephrology-National Kidney Foundation Task Force efforts to pursue other options for GFR estimation.

Medical Student Mobilization During a Crisis: Lessons From a COVID-19 Medical Student Response Team.

PROBLEM: On March 17, 2020, the Association of American Medical Colleges recommended the suspension of all direct patient contact responsibilities for medical students because of the COVID-19 pandemic. Given this change, medical students nationwide had to grapple with how and where they could fill the evolving needs of their schools' affiliated clinical sites, physicians, patients, and the community. APPROACH: At Harvard Medical School (HMS), student leaders created a COVID-19 Medical Student Response Team to: (1) develop a student-led organizational structure that would optimize students' ability to efficiently mobilize interested peers in the COVID-19 response, both clinically and in the community, in a strategic, safe, smart, and resource-conscious way; and (2) serve as a liaison with the administration and hospital leaders to identify evolving needs and rapidly engage students in those efforts. OUTCOMES: Within a week of its inception, the COVID-19 Medical Student Response Team had more than 500 medical student volunteers from HMS and had shared the organizational framework of the response team with multiple medical schools across the country. The HMS student volunteers joined any of the 4 virtual committees to complete this work: Education for the Medical Community, Education for the Broader Community, Activism for Clinical Support, and Community Activism. NEXT STEPS: The COVID-19 Medical Student Response Team helped to quickly mobilize hundreds of students and has been integrated into HMS's daily workflow. It may serve as a useful model for other schools and hospitals seeking medical student assistance during the COVID-19 pandemic. Next steps include expanding the initiative further, working with the leaders of response teams at other medical schools to coordinate efforts, and identifying new areas of need at local hospitals and within nearby communities that might benefit from medical student involvement as the pandemic evolves.

A framework for learning about improvement: embedded implementation and evaluation design to optimize learning.

Improving health care involves many actors, often working in complex adaptive systems. Interventions tend to be multi-factorial, implementation activities diverse, and contexts dynamic and complicated. This makes improvement initiatives challenging to describe and evaluate as matching evaluation and program designs can be difficult, requiring collaboration, trust and transparency. Collaboration is required to address important epidemiological principles of bias and confounding. If this does not take place, results may lack credibility because the association between interventions implemented and outcomes achieved is obscure and attribution uncertain. Moreover, lack of clarity about what was implemented, how it was implemented, and the context in which it was implemented often lead to disappointment or outright failure of spread and scale-up efforts. The input of skilled evaluators into the design and conduct of improvement initiatives can be helpful in mitigating these potential problems. While evaluation must be rigorous, if it is too rigid necessary adaptation and learning may be compromised. This article provides a framework and guidance on how improvers and evaluators can work together to design, implement and learn about improvement interventions more effectively.

Appropriateness and timeliness of care-seeking for complications of pregnancy and childbirth in rural Ethiopia: a case study of the Maternal and Newborn Health in Ethiopia Partnership.

BACKGROUND: In 2014, USAID and University Research Co., LLC, initiated a new project under the broader Translating Research into Action portfolio of projects. This new project was entitled Systematic Documentation of Illness Recognition and Appropriate Care Seeking for Maternal and Newborn Complications. This project used a common protocol involving descriptive mixed-methods case studies of community projects in six low- and middle-income countries, including Ethiopia. In this paper, we present the Maternal and Newborn Health in Ethiopia Partnership (MaNHEP) case study. METHODS: Methods included secondary analysis of data from MaNHEP's 2010 baseline and 2012 end line surveys, health program inventory and facility mapping to contextualize care-seeking, and illness narratives to identify factors influencing illness recognition and care-seeking. Analyses used descriptive statistics, bivariate tests, multivariate logistic regression, and thematic content analysis. RESULTS: Maternal illness awareness increased between 2010 and 2012 for major obstetric complications. In 2012, 45% of women who experienced a major complication sought biomedical care. Factors associated with care-seeking were MaNHEP CMNH Family Meetings, health facility birth, birth with a skilled provider, or health extension worker. Between 2012 and 2014, the Ministry of Health introduced nationwide initiatives including performance review, ambulance service, increased posting of midwives, pregnant women's conferences, user-friendly services, and maternal death surveillance. By 2014, most facilities were able to provide emergency obstetric and newborn care. Yet in 2014, biomedical care-seeking for perceived maternal illness occurred more often compared with care-seeking for newborn illness-a difference notable in cases in which the mother or newborn died. Most families sought care within 1 day of illness recognition. Facilitating factors were health extension worker advice and ability to refer upward, and health facility proximity; impeding factors were time of day, weather, road conditions, distance, poor cell phone connectivity (to call for an ambulance), lack of transportation or money for transport, perceived spiritual or physical vulnerability of the mother and newborn and associated culturally determined postnatal restrictions on the mother or newborn's movement outside of the home, and preference for traditional care. Some families sought care despite disrespectful, poor quality care. CONCLUSIONS: Improvements in illness recognition and care-seeking observed during MaNHEP have been reinforced since that time and appear to be successful. There is still need for a concerted effort focusing on reducing identified barriers, improve quality of care and provider counseling, and contextualize messaging behavior change communications and provider counseling.

Community-Based ART Programs: Sustaining Adherence and Follow-up.

The advent of antiretroviral therapy (ART) in 1996 brought with it an urgent need to develop models of health care delivery that could enable its effective and equitable delivery, especially to patients living in poverty. Community-based care, which stretches from patient homes and communities-where chronic infectious diseases are often best managed-to modern health centers and hospitals, offers such a model, providing access to proximate HIV care and minimizing structural barriers to retention. We first review the recent literature on community-based ART programs in low- and low-to-middle-income country settings and document two key principles that guide effective programs: decentralization of ART services and long-term retention of patients in care. We then discuss the evolution of the community-based programs of Partners In Health (PIH), a nongovernmental organization committed to providing a preferential option for the poor in health care, in Haiti and several countries in sub-Saharan Africa, Latin America, Russia and Kazakhstan. As one of the first organizations to treat patients with HIV in low-income settings and a pioneer of the community-based approach to ART delivery, PIH has achieved both decentralization and excellent retention through the application of an accompaniment model that engages community health workers in the delivery of medicines, the provision of social support and education, and the linkage between communities and clinics. We conclude by showing how PIH has leveraged its HIV care delivery platforms to simultaneously strengthen health systems and address the broader burden of disease in the places in which it works.

How do we learn about improving health care: a call for a new epistemological paradigm.

PURPOSE: The field of improving health care has been achieving more significant results in outcomes at scale in recent years. This has raised legitimate questions regarding the rigor, attribution, generalizability and replicability of the results. This paper describes the issue and outlines questions to be addressed in order to develop an epistemological paradigm that responds to these questions. QUESTIONS: We need to consider the following questions: (i) Did the improvements work? (ii) Why did they work? (iii) How do we know that the results can be attributed to the changes made? (iv) How can we replicate them? (Note, the goal is not to copy what was done, but to affect factors that can yield similar results in a different context.) NEXT STEPS: Answers to these questions will help improvers find ways to increase the rigor of their improvements, attribute the results to the changes made and better understand what is context specific and what is generalizable about the improvement.

An evaluation of equitable access to a community-based maternal and newborn health program in rural Ethiopia.

INTRODUCTION: The Maternal and Newborn Health in Ethiopia Partnership (MaNHEP) aimed to promote equitable access to safe childbirth and postnatal care through a community-based educational intervention. This study evaluates the extent to which MaNHEP reached women who are socially and materially disadvantaged and, thus, at high risk for inadequate access to care. METHODS: The data used in this analysis are from MaNHEP's cross-sectional 2010 baseline and 2012 endline surveys of women who gave birth in the prior year. A logistic regression model was fit to examine the effects of sociodemographic characteristics on participation in the MaNHEP program. Descriptive statistics of select characteristics by birth and postnatal care provider were also calculated to explore trends in services use. RESULTS: Using data from the endline survey (N = 1019), the regression model showed that age, parity, education, and geographic residence were not significantly associated with MaNHEP exposure. However, women who were materially disadvantaged were still less likely to have participated in the program than their better-off counterparts. From the baseline survey (N = 1027) to the endline survey, women's use of skilled and semiskilled providers for birth care and postnatal care increased substantially, while use of untrained providers or no provider decreased. These shifts were greater for women with less personal wealth than for women with more personal wealth. DISCUSSION: MaNHEP appears to have succeeded in meeting its equity goals to a degree. However, this study also supports the intractable relationship between wealth inequality and access to maternal and newborn health services. Strategies targeting the poor in diverse contexts may eventually prove consistently effective in equitable services delivery. Until that time, a critical step that all maternal and newborn health programs can take is to monitor and evaluate to what extent they are reaching disadvantaged groups within the populations they serve.

Knowledge and skills retention among frontline health workers: community maternal and newborn health training in rural Ethiopia.

INTRODUCTION: We examined the degree to which the skills and knowledge of health workers in Ethiopia were retained 18 months after initial maternal and newborn health training and sought to identify factors associated with 18-month skills assessment performance. METHODS: A nonexperimental, descriptive design was employed to assess 18-month skills performance on the topics of Prevent Problems Before Baby Is Born and Prevent Problems After Baby Is Born. Assessment was conducted by project personnel who also received the maternal and newborn health training and additional training to reliably assess health worker performance. RESULTS: Among the 732 health workers who participated in maternal and newborn health training in 6 rural districts of the Amhara and Oromia regions of Ethiopia (including pretesting before training and a posttraining posttest), 75 health extension workers (78%) and 234 guide team members (37%) participated in 18-month posttest. Among health extension workers in both regions, strong knowledge retention was noted in 10 of 14 care steps for Prevent Problems Before Baby Is Born and in 14 of 16 care steps of Prevent Problems After Baby Is Born. Lower knowledge retention was observed among guide team members in the Amhara region. Across regions, health workers scored lowest on steps that involved nonaction (eg, do not give oxytocin). Educational attainment and age were among the few variables found to significantly predict test performance, although participants varied substantially by other sociodemographic characteristics. DISCUSSION: Results demonstrated an overall strong retention of knowledge and skills among health extension workers and highlighted the need for improvement among some guide team members. Refresher training and development of strategies to improve knowledge of retention of low-performing steps were recommended.

The effect of community maternal and newborn health family meetings on type of birth attendant and completeness of maternal and newborn care received during birth and the early postnatal period in rural Ethiopia.

INTRODUCTION: Maternal and newborn deaths occur predominantly in low-resource settings. Community-based packages of evidence-based interventions and skilled birth attendance can reduce these deaths. The Maternal and Newborn Health in Ethiopia Partnership (MaNHEP) used community-level health workers to conduct prenatal Community Maternal and Newborn Health family meetings to build skills and care-seeking behaviors among pregnant women and family caregivers. METHODS: Baseline and endline surveys provided data on a random sample of women with a birth in the prior year. An intention-to-treat analysis, plausible net effect calculation, and dose-response analysis examined increases in completeness of care (mean percentage of 17 maternal and newborn health care elements performed) over time and by meeting participation. Regression models assessed the relationship between meeting participation, completeness of care, and use of skilled providers or health extension workers for birth care-controlling for sociodemographic and health service utilization factors. RESULTS: A 151% increase in care completeness occurred from baseline to endline. At endline, women who participated in 2 or more meetings had more complete care than women who participated in fewer than 2 meetings (89% vs 76% of care elements; P < .001). A positive dose-response relationship existed between the number of meetings attended and greater care completeness (P < .001). Women with any antenatal care were nearly 3 times more likely to have used a skilled provider or health extension worker for birth care. Women who had additionally attended 2 or more meetings with family members were over 5 times as likely to have used these providers, compared to women without antenatal care and who attended fewer than 2 meetings (odds ratio, 5.19; 95% confidence interval, 2.88-9.36; P < .001). DISCUSSION: MaNHEP's family meetings complemented routine antenatal care by engaging women and family caregivers in self-care and care-seeking, resulting in greater completeness of care and more highly skilled birth care.

Improving coverage of postnatal care in rural Ethiopia using a community-based, collaborative quality improvement approach.

INTRODUCTION: Ethiopia has high maternal and neonatal mortality and low use of skilled maternity care. The Maternal and Newborn Health in Ethiopia Partnership (MaNHEP), a 3.5-year learning project, used a community collaborative quality improvement approach to improve maternal and newborn health care during the birth-to-48-hour period. This study examines how the promotion of community maternal and newborn health (CMNH) family meetings and labor and birth notification contributed to increased postnatal care within 48 hours by skilled providers or health extension workers. METHODS: Baseline and endline surveys, monthly quality improvement data, and MaNHEP's CMNH change package, a compendium of the most effective changes developed and tested by communities, were reviewed. Logistic regression assessed factors associated with postnatal care receipt. Monthly postnatal care receipt was plotted with control charts. RESULTS: The baseline (n = 1027) and endline (n = 1019) surveys showed significant increases in postnatal care, from 5% to 51% and from 15% to 47% in the Amhara and Oromiya regions, respectively (both P < .001). Notification of health extension workers for labor and birth within 48 hours was closely linked with receipt of postnatal care. Women with any antenatal care were 1.7 times more likely to have had a postnatal care visit (odds ratio [OR], 1.67; 95% confidence interval [CI], 1.10-2.54; P < .001). Women who had additionally attended 2 or more CMNH meetings with family members and had access to a health extension worker's mobile phone number were 4.9 times more likely to have received postnatal care (OR, 4.86; 95% CI, 2.67-8.86; P < .001). DISCUSSION: The increase in postnatal care far exceeds the 7% postnatal care coverage rate reported in the 2011 Ethiopian Demographic and Health Survey (EDHS). This result was linked to ideas generated by community quality improvement teams for labor and birth notification and cooperation with community-level health workers to promote antenatal care and CMNH family meetings.

Use of mobile video show for community behavior change on maternal and newborn health in rural Ethiopia.

INTRODUCTION: A number of factors affect Ethiopia's efforts to meet Millennium Development Goals 4 and 5 to reduce maternal and newborn mortality. The Maternal and Newborn Health in Ethiopia Partnership (MaNHEP) project, as part of its overall strategy, implemented behavior change communication interventions to increase women's demand for and use of antenatal, birth, and postnatal services. Seeking to reach "media-dark" areas, MaNHEP implemented a mobile video show focused on maternal and newborn health. We report on the effect of the mobile video show on community knowledge, attitudes, and beliefs regarding maternal and newborn health, especially regarding care-seeking behavior and use of a skilled attendant for birth and postnatal care. METHODS: Two main data sources are used: qualitative data gathered through mobile video show participant discussions in 31 randomly selected kebeles (villages with about 1000 households) and focus groups in 4 kebeles (2 from each region), and quantitative data generated from 510 randomly selected adults participating in MaNHEP's endline survey. Qualitative data were thematically analyzed by the research team, and the accuracy of the transcriptions and categorization was also checked. RESULTS: The mobile video show reached a total of 28,389 mostly young or adult females in 51 kebeles. At endline, mobile video show attendees (vs nonattendees) reported significantly (P < .001) higher rates of recall of key MaNHEP messages about use of health extension workers for pregnancy registration, labor and birth notification, and postnatal care. Qualitative analysis yielded 3 overarching themes: mirrors to the community (the portrayal is accurate); call to action (we have to change this); and improvement ideas (suggested positive actions). DISCUSSION: The entertaining nature and local organization of the mobile video show event encouraged attendance. Building the video around recognizable characters (particularly the husbands) contributed to bringing about desired changes in people's knowledge and beliefs. Making the show readily available (through the mobile van) and bundling it with facilitated reflection sessions had a considerable impact on people's knowledge and confidence.

A regional comparison of distribution strategies and women's awareness, receipt, and use of misoprostol to prevent postpartum hemorrhage in rural Amhara and Oromiya regions of Ethiopia.

INTRODUCTION: In Ethiopia, postpartum hemorrhage is a leading cause of maternal death. The Maternal Health in Ethiopia Partnership (MaNHEP) project developed a community-based model of maternal and newborn health focusing on birth and early postpartum care. Implemented in the Amhara and Oromiya regions, the model included misoprostol to prevent postpartum hemorrhage. This article describes regional trends in women's use of misoprostol; their awareness, receipt, and use of misoprostol at project's endline; and factors associated with its use. METHODS: The authors assessed trends in use of misoprostol using monthly data from MaNHEP's quality improvement database; and awareness, receipt, use, and correct use of misoprostol using data from MaNHEP's endline survey of 1019 randomly sampled women who gave birth during the year prior to the survey. RESULTS: Misoprostol use increased rapidly and was relatively stable over 20 months, but regional differences were stark. At endline, significantly more women in Oromiya were aware of misoprostol compared with women who resided in Amhara (94% vs 59%); significantly more had received misoprostol (80% vs 35%); significantly more had received it during pregnancy (93% vs 48%); and significantly more had received it through varied sources. Most women who received misoprostol used it (> 95%) irrespective of age, parity, or education. Factors associated with use were Oromiya residence (odds ratio [OR] 9.48; 95% confidence interval [CI], 6.78-13.24), attending 2 or more Community Maternal and Newborn Health (CMNH) family meetings (OR 2.62; 95% CI, 1.89-3.63), receiving antenatal care (OR 1.67; 95% CI, 1.08-2.58) and being attended at birth by a skilled provider or trained health extension worker, community health development agent, or traditional birth attendant versus an untrained caregiver or no one. Correct use was associated with having attended 2 or more CMNH family meetings (OR 2.02; 95% CI, 1.35-3.03). DISCUSSION: Multiple distribution channels increase women's access to misoprostol. Most women who have access to misoprostol use it. Early distribution to pregnant women who are educated to use misoprostol appears to be safe and unrelated to choice of birthplace.

Building district-level capacity for continuous improvement in maternal and newborn health.

INTRODUCTION: The Maternal and Newborn Health in Ethiopia Partnership (MaNHEP) adapted a collaborative improvement strategy to develop woreda (district) leadership capacity to support and facilitate continuous improvement of community maternal and neonatal health (CMNH) and to provide a model for other woredas, dubbed "lead" woredas. Community-level quality improvement (QI) teams tested solutions to improve CMNH care supported by monthly coaching and regular meetings to share experiences. This study examines the extent of the capacity built to support continuous improvement in CMNH care. METHODS: Surveys and in-depth interviews assessed the extent to which MaNHEP developed improvement capacity. A survey questionnaire evaluated woreda culture, leadership support, motivation, and capacity for improvement activities. Interviews focused on respondents' understanding and perceived value of the MaNHEP improvement approach. Bivariate analyses and multivariate linear regression models were used to analyze the survey data. Interview transcripts were organized by region, cadre, and key themes. RESULTS: Respondents reported significant positive changes in many areas of woreda culture and leadership, including involving a cross-section of community stakeholders (increased from 3.0 to 4.6 on 5-point Likert scale), using improvement data for decision making (2.8-4.4), using locally developed and tested solutions to improve CMNH care (2.5-4.3), demonstrating a commitment to improve the health of women and newborns (2.6-4.2), and creating a supportive environment for coaches and QI teams to improve CMNH (2.6-4.0). The mean scores for capacity were 3.7 and higher, reflecting respondents' agreement that they had gained capacity in improvement skills. Interview respondents universally recognized the capacity built in the woredas. The themes of community empowerment and focused improvement emerged strongly from the interviews. DISCUSSION: MaNHEP was able to build capacity for continuous improvement and develop lead woredas. The multifaceted approach to building capacity was critical for the success in creating lead woredas able to serve as models for other districts.

Traditional birth attendant training for improving health behaviours and pregnancy outcomes.

BACKGROUND: Between the 1970s and 1990s, the World Health Organization promoted traditional birth attendant (TBA) training as one strategy to reduce maternal and neonatal mortality. To date, evidence in support of TBA training is limited but promising for some mortality outcomes. OBJECTIVES: To assess the effects of TBA training on health behaviours and pregnancy outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (18 June 2012), citation alerts from our work and reference lists of studies identified in the search. SELECTION CRITERIA: Published and unpublished randomised controlled trials (RCT), comparing trained versus untrained TBAs, additionally trained versus trained TBAs, or women cared for/living in areas served by TBAs. DATA COLLECTION AND ANALYSIS: Three authors independently assessed study quality and extracted data in the original and first update review. Three authors and one external reviewer independently assessed study quality and two extracted data in this second update. MAIN RESULTS: Six studies involving over 1345 TBAs, more than 32,000 women and approximately 57,000 births that examined the effects of TBA training for trained versus untrained TBAs (one study) and additionally trained TBA training versus trained TBAs (five studies) are included in this review. These studies consist of individual randomised trials (two studies) and cluster-randomised trials (four studies). The primary outcomes across the sample of studies were perinatal deaths, stillbirths and neonatal deaths (early, late and overall).Trained TBAs versus untrained TBAs: one cluster-randomised trial found a significantly lower perinatal death rate in the trained versus untrained TBA clusters (adjusted odds ratio (OR) 0.70, 95% confidence interval (CI) 0.59 to 0.83), lower stillbirth rate (adjusted OR 0.69, 95% CI 0.57 to 0.83) and lower neonatal death rate (adjusted OR 0.71, 95% CI 0.61 to 0.82). This study also found the maternal death rate was lower but not significant (adjusted OR 0.74, 95% CI 0.45 to 1.22).Additionally trained TBAs versus trained TBAs: three large cluster-randomised trials compared TBAs who received additional training in initial steps of resuscitation, including bag-valve-mask ventilation, with TBAs who had received basic training in safe, clean delivery and immediate newborn care. Basic training included mouth-to-mouth resuscitation (two studies) or bag-valve-mask resuscitation (one study). There was no significant difference in the perinatal death rate between the intervention and control clusters (one study, adjusted OR 0.79, 95% CI 0.61 to 1.02) and no significant difference in late neonatal death rate between intervention and control clusters (one study, adjusted risk ratio (RR) 0.47, 95% CI 0.20 to 1.11). The neonatal death rate, however, was 45% lower in intervention compared with the control clusters (one study, 22.8% versus 40.2%, adjusted RR 0.54, 95% CI 0.32 to 0.92).We conducted a meta-analysis on two outcomes: stillbirths and early neonatal death. There was no significant difference between the additionally trained TBAs versus trained TBAs for stillbirths (two studies, mean weighted adjusted RR 0.99, 95% CI 0.76 to 1.28) or early neonatal death rate (three studies, mean weighted adjusted RR 0.83, 95% CI 0.68 to 1.01).  AUTHORS' CONCLUSIONS: The results are promising for some outcomes (perinatal death, stillbirth and neonatal death). However, most outcomes are reported in only one study. A lack of contrast in training in the intervention and control clusters may have contributed to the null result for stillbirths and an insufficient number of studies may have contributed to the failure to achieve significance for early neonatal deaths. Despite the additional studies included in this updated systematic review, there remains insufficient evidence to establish the potential of TBA training to improve peri-neonatal mortality.