Publications

OBJECTIVES: While some medical indications for cesarean delivery are clear, subjective provider and patient factors contribute to the rising cesarean delivery rates and marked disparities between racial/ethnic groups. We aimed to determine the association between language preference and risk of primary cesarean delivery.

METHODS: We conducted a retrospective cohort study of nulliparous, term, singleton, vertex (NTSV) deliveries of patients over 18 years old from 2011-2016 at an academic medical center, supplemented with data from the Massachusetts Department of Public Health. We used modified Poisson regression with robust error variance to calculate risk ratios for cesarean delivery between patients with English language preference and other language preference, with secondary outcomes of Apgar score, maternal readmission, blood transfusion, and NICU admission.

RESULTS: Of the 11,298 patients included, 10.3% reported a preferred language other than English, including Mandarin and Cantonese (61.7%), Portuguese (9.7%), and Spanish (7.5%). The adjusted risk ratio for cesarean delivery among patients with a language preference other than English was 0.85 (95% CI 0.72-0.997; p = 0.046) compared to patients with English language preference. No significant differences in risk of secondary outcomes between English and other language preference were found.

DISCUSSION: After adjusting for confounders, this analysis demonstrates a decreased risk of cesarean delivery among women who do not have an English language preference at one institution. This disparity in cesarean delivery rates in an NTSV population warrants future research, raising the question of what clinical and social factors may be contributing to these lower cesarean delivery rates.

BACKGROUND: Low birthweight (LBW) (< 2500 g) is a significant determinant of infant morbidity and mortality worldwide. In low-income settings, the quality of birthweight data suffers from measurement and recording errors, inconsistent data reporting systems, and missing data from non-facility births. This paper describes birthweight data quality and the prevalence of LBW before and after implementation of a birthweight quality improvement (QI) initiative in Amhara region, Ethiopia.

METHODS: A comparative pre-post study was performed in selected rural health facilities located in West Gojjam and South Gondar zones. At baseline, a retrospective review of delivery records from February to May 2018 was performed in 14 health centers to collect birthweight data. A birthweight QI initiative was introduced in August 2019, which included provision of high-quality digital infant weight scales (precision 5 g), routine calibration, training in birth weighing and data recording, and routine field supervision. After the QI implementation, birthweight data were prospectively collected from late August to early September 2019, and December 2019 to June 2020. Data quality, as measured by heaping (weights at exact multiples of 500 g) and rounding to the nearest 100 g, and the prevalence of LBW were calculated before and after QI implementation.

RESULTS: We retrospectively reviewed 1383 delivery records before the QI implementation and prospectively measured 1371 newborn weights after QI implementation. Heaping was most frequently observed at 3000 g and declined from 26% pre-initiative to 6.7% post-initiative. Heaping at 2500 g decreased from 5.4% pre-QI to 2.2% post-QI. The percentage of rounding to the nearest 100 g was reduced from 100% pre-initiative to 36.5% post-initiative. Before the QI initiative, the prevalence of recognized LBW was 2.2% (95% confidence interval [CI]: 1.5-3.1) and after the QI initiative increased to 11.7% (95% CI: 10.1-13.5).

CONCLUSIONS: A QI intervention can improve the quality of birthweight measurements, and data measurement quality may substantially affect estimates of LBW prevalence.

OBJECTIVE: To understand the prevalence of intrapartum oxytocin use, assess associated perinatal and maternal outcomes, and evaluate the impact of a WHO Safe Childbirth Checklist intervention on oxytocin use at primary-level facilities in Uttar Pradesh, India.

DESIGN: Secondary analysis of a cluster-randomised controlled trial.

SETTING: Thirty Primary and Community public health facilities in Uttar Pradesh, India from 2014 to 2017.

POPULATION: Women admitted to a study facility for childbirth at baseline, 2, 6 or 12 months after intervention initiation.

METHODS: The BetterBirth intervention aimed to increase adherence to the WHO Safe Childbirth Checklist. We used Rao-Scott Chi-square tests to compare (1) timing of oxytocin use between study arms and (2) perinatal mortality and resuscitation of infants whose mothers received intrapartum oxytocin versus who did not.

MAIN OUTCOME MEASURES: Intrapartum and postpartum oxytocin administration, perinatal mortality, use of neonatal bag and mask.

RESULTS: We observed 5484 deliveries. At baseline, intrapartum oxytocin was administered to 78.2% of women. Two months after intervention initiation, intrapartum oxytocin (I) was administered to 32.1% of women compared with 70.6% in the control (C) (P < 0.01); this difference diminished after the end of the intervention (I = 48.2%, C = 74.7%, P = 0.03). Partograph use remained at <1% at all facilities. Resuscitation was performed on 7.5% of infants whose mother received intrapartum oxytocin versus 2.0% who did not (P < 0.0001).

CONCLUSIONS: In this setting, intrapartum oxytocin use was high despite limited maternal/fetal monitoring or caesarean capability, and was associated with increased neonatal resuscitation. The BetterBirth intervention was successful at decreasing intrapartum oxytocin use. Ongoing support is needed to sustain these practices.

TWEETABLE ABSTRACT: Coaching + WHO Safe Childbirth Checklist reduces intrapartum oxytocin use and need for newborn resuscitation.

BACKGROUND: The BetterBirth trial tested the effect of a peer coaching program around the WHO Safe Childbirth Checklist for birth attendants in primary-level facilities in Uttar Pradesh, India on a composite measure of perinatal and maternal mortality and maternal morbidity. This study aimed to examine the adherence to essential birth practices between two different cadres of birth attendants-nurses and auxiliary nurse midwives (ANMs)-during and after a peer coaching intervention for the WHO Safe Childbirth Checklist.

METHODS: This is a secondary analysis of birth attendant characteristics, coaching visits, and behavior uptake during the BetterBirth trial through birth attendant surveys, coach observations, and independent observations. Descriptive statistics were calculated overall, and by staffing cadre (staff nurses and ANMs) for demographic characteristics. Logistic regression using the Pearson overdispersion correction (to account for clustering by site) was used to assess differences between staff nurses and ANMs in the intervention group during regular coaching (2-month time point) and 4 months after the coaching program ended (12-month time point).

RESULTS: Of the 570 birth attendants who responded to the survey in intervention and control arms, 474 were staff nurses (83.2%) and 96 were ANMs (16.8%). In the intervention arm, more staff nurses (240/260, 92.3%) received coaching at all pause points compared to ANMs (40/53, 75.5%). At baseline, adherence to practices was similar between ANMs and staff nurses (  30%). Overall percent adherence to essential birth practices among ANMs and nurses was highest at 2 months after intervention initiation, when frequent coaching visits occurred (68.1% and 64.1%, respectively, p = 0.76). Practice adherence tapered to 49.2% among ANMs and 56.1% among staff nurses at 12 months, which was 4 months after coaching had ended (p = 0.68).

CONCLUSIONS: Overall, ANMs and nurses responded similarly to the coaching intervention with the greatest increase in percent adherence to essential birth practices after 2 months of coaching and subsequent decrease in adherence 4 months after coaching ended. While coaching is an effective strategy to support some aspects of birth attendant competency, the structure, content, and frequency of coaching may need to be customized according to the birth attendant training and competency.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT2148952; Universal Trial Number: U1111-1131-5647.

Compared to other Mexican states, Chiapas possessed the lowest rate of contraception use among women 15-49 years old (44.6%) in 2018. This convergent mixed-methods study assessed family planning use, perceptions, and decision-making processes among women and men in rural communities where Compañeros En Salud (CES) works in Chiapas, Mexico. We conducted surveys of reproductive-aged women and semi-structured interviews with reproductive-aged women, men, and physicians completing their social-service year in CES communities from 2016 to 2017. Of the 625 survey respondents, 368 (58.9%) reported using contraception. The most common methods were female sterilization (27.7%), bimonthly injection (10.9%), and the implant (10.9%). Interviews were completed with 27 women, 24 men, and 5 physicians and analyzed through an inductive approach. Common reasons for contraception use were preventing pregnancy, lack of resources for additional children, and birth spacing. Adverse effects, influence of male partners, and perceived lack of need emerged as reasons for non-use. Male partners often made the final decision about contraceptive use, while women often chose what method. Physicians reported adverse effects, misconceptions about methods, and lack of women's autonomy as barriers to contraception use. Given misconceptions about contraception methods and the dominant role of men in contraception decision-making, our study illustrates the importance of effective counseling and equitable gender dynamics for family planning programming in rural Chiapas.

BACKGROUND: Despite extensive efforts to develop and refine intervention packages, complex interventions often fail to produce the desired health impacts in full-scale evaluations. A recent example of this phenomenon is BetterBirth, a complex intervention designed to implement the World Health Organization's Safe Childbirth Checklist and improve maternal and neonatal health. Using data from the BetterBirth Program and its associated trial as a case study, we identified lessons to assist in the development and evaluation of future complex interventions.

METHODS: BetterBirth was refined across three sequential development phases prior to being tested in a matched-pair, cluster randomized trial in Uttar Pradesh, India. We reviewed published and internal materials from all three development phases to identify barriers hindering the identification of an optimal intervention package and identified corresponding lessons learned. For each lesson, we describe its importance and provide an example motivated by the BetterBirth Program's development to illustrate how it could be applied to future studies.

RESULTS: We identified three lessons: (1) develop a robust theory of change (TOC); (2) define optimization outcomes, which are used to assess the effectiveness of the intervention across development phases, and corresponding criteria for success, which determine whether the intervention has been sufficiently optimized to warrant full-scale evaluation; and (3) create and capture variation in the implementation intensity of components. When applying these lessons to the BetterBirth intervention, we demonstrate how a TOC could have promoted more complete data collection. We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial. Finally, we show how variation in components' implementation intensities could have been used to identify effective intervention components.

CONCLUSION: These lessons learned can be applied during both early and advanced stages of complex intervention development and evaluation. By using examples from a real-world study to demonstrate the relevance of these lessons and illustrating how they can be applied in practice, we hope to encourage future researchers to collect and analyze data in a way that promotes more effective complex intervention development and evaluation.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT02148952; registered on May 29, 2014.

BACKGROUND: Despite the growing number of patients with limited English proficiency in the United States, not all medical schools offer medical language courses to train future physicians in practicing language-concordant care. Little is known about the long-term use of non-English languages among physicians who took language courses in medical school. We conducted a cross-sectional study to characterize the professional language use of Harvard Medical School (HMS) alumni who took a medical language course at HMS and identify opportunities to improve the HMS Medical Language Program.

METHODS: Between October and November 2019, we sent an electronic survey to 803 HMS alumni who took a medical language course at HMS between 1991 and 2019 and collected responses. The survey had questions about the language courses and language use in the professional setting. We analyzed the data using descriptive statistics and McNemar's test for comparing proportions with paired data. The study was determined not to constitute human subjects research.

RESULTS: The response rate was 26% (206/803). More than half of respondents (n = 118, 57%) cited their desire to use the language in their future careers as the motivation for taking the language courses. Twenty-eight (14%) respondents indicated a change from not proficient before taking the course to proficient at the time of survey whereas only one (0.5%) respondent changed from proficient to not proficient (McNemar's p-value < 0.0001). Respondents (n = 113, 56%) reported that clinical electives abroad influenced their cultural understanding of the local in-country population and their language proficiency. Only 13% (n = 27) of respondents have worked in a setting that required formal assessments of non-English language proficiency.

CONCLUSIONS: HMS alumni of the Medical Language Program reported improved language proficiency after the medical language courses' conclusion, suggesting that the courses may catalyze long-term language learning. We found that a majority of respondents reported that the medical language courses influenced their desire to work with individuals who spoke the language of the courses they took. Medical language courses may equip physicians to practice language-concordant care in their careers.

BACKGROUND: Sexually transmitted infections (STI), such as chlamydial, gonorrheal, and trichomonal infections, are prevalent in pregnant women in many countries and are widely reported to be associated with increased risk of poor maternal and neonatal outcomes. Syndromic STI management is frequently used in pregnant women in low- and middle-income countries, yet its low specificity and sensitivity lead to both overtreatment and undertreatment. Etiologic screening for chlamydial, gonorrheal, and/or trichomonal infection in all pregnant women combined with targeted treatment might be an effective intervention. However, the evidence base is insufficient to support the development of global recommendations. We aimed to describe key considerations and knowledge gaps regarding chlamydial, gonorrheal, and trichomonal screening during pregnancy to inform future research needed for developing guidelines for low- and middle-income countries.

METHODS: We conducted a narrative review based on PubMed and clinical trials registry searches through January 20, 2020, guidelines review, and expert opinion. We summarized our findings using the frameworks adopted by the World Health Organization for guideline development.

RESULTS: Adverse maternal-child health outcomes of potential interest are wide-ranging and variably defined. No completed randomized controlled trials on etiologic screening and targeted treatment were identified. Evidence from observational studies was limited, and trials of presumptive STI treatment have shown mixed results. Subgroups that might benefit from specific recommendations were identified. Evidence on harms was limited. Cost-effectiveness was influenced by STI prevalence and availability of testing infrastructure and high-accuracy/low-cost tests. Preliminary data suggested high patient acceptability.

DISCUSSION: Preliminary data on harms, acceptability, and feasibility and the availability of emerging test technologies suggest that etiologic STI screening deserves further evaluation as a potential tool to improve maternal and neonatal health outcomes worldwide.

IMPORTANCE: Resource limitations because of pandemic or other stresses on infrastructure necessitate the triage of time-sensitive care, including cancer treatments. Optimal time to treatment is underexplored, so recommendations for which cancer treatments can be deferred are often based on expert opinion.

OBJECTIVE: To evaluate the association between increased time to definitive therapy and mortality as a function of cancer type and stage for the 4 most prevalent cancers in the US.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study assessed treatment and outcome information from patients with nonmetastatic breast, prostate, non-small cell lung (NSCLC), and colon cancers from 2004 to 2015, with data analyzed January to March 2020. Data on outcomes associated with appropriate curative-intent surgical, radiation, or medical therapy were gathered from the National Cancer Database.

EXPOSURES: Time-to-treatment initiation (TTI), the interval between diagnosis and therapy, using intervals of 8 to 60, 61 to 120, 121 to 180, and greater than 180 days.

MAIN OUTCOMES AND MEASURES: 5-year and 10-year predicted all-cause mortality.

RESULTS: This study included 2 241 706 patients (mean [SD] age 63 [11.9] years, 1 268 794 [56.6%] women, 1 880 317 [83.9%] White): 1 165 585 (52.0%) with breast cancer, 853 030 (38.1%) with prostate cancer, 130 597 (5.8%) with NSCLC, and 92 494 (4.1%) with colon cancer. Median (interquartile range) TTI by cancer was 32 (21-48) days for breast, 79 (55-117) days for prostate, 41 (27-62) days for NSCLC, and 26 (16-40) days for colon. Across all cancers, a general increase in the 5-year and 10-year predicted mortality was associated with increasing TTI. The most pronounced mortality association was for colon cancer (eg, 5 y predicted mortality, stage III: TTI 61-120 d, 38.9% vs. 181-365 d, 47.8%), followed by stage I NSCLC (5 y predicted mortality: TTI 61-120 d, 47.4% vs 181-365 d, 47.6%), while survival for prostate cancer was least associated (eg, 5 y predicted mortality, high risk: TTI 61-120 d, 12.8% vs 181-365 d, 14.1%), followed by breast cancer (eg, 5 y predicted mortality, stage I: TTI 61-120 d, 11.0% vs. 181-365 d, 15.2%). A nonsignificant difference in treatment delays and worsened survival was observed for stage II lung cancer patients-who had the highest all-cause mortality for any TTI regardless of treatment timing.

CONCLUSIONS AND RELEVANCE: In this cohort study, for all studied cancers there was evidence that shorter TTI was associated with lower mortality, suggesting an indirect association between treatment deferral and mortality that may not become evident for years. In contrast to current pandemic-related guidelines, these findings support more timely definitive treatment for intermediate-risk and high-risk prostate cancer.