Person:

Gawande, Atul

Background: Most maternal deaths, intrapartum-related stillbirths, and newborn deaths in low income countries are preventable but simple, effective methods for improving safety in institutional births have not been devised. Checklist-based interventions aid management of complex or neglected tasks and have been shown to reduce harm in healthcare. We hypothesized that implementation of the WHO Safe Childbirth Checklist program, a novel childbirth safety program for institutional births incorporating a 29-item checklist, would increase delivery of essential childbirth practices linked with improved maternal and perinatal health outcomes. Methods and Findings A pilot, pre-post-intervention study was conducted in a sub-district level birth center in Karnataka, India between July and December 2010. We prospectively observed health workers that attended to women and newborns during 499 consecutively enrolled birth events and compared these with observed practices during 795 consecutively enrolled birth events after the introduction of the WHO Safe Childbirth Checklist program. Twenty-nine essential practices that target the major causes of childbirth-related mortality, such as hand hygiene and uterotonic administration, were evaluated. The primary end point was the average rate of successful delivery of essential childbirth practices by health workers. Delivery of essential childbirth-related care practices at each birth event increased from an average of 10 of 29 practices at baseline (95%CI 9.4, 10.1) to an average of 25 of 29 practices afterwards (95%CI 24.6, 25.3; p<0.001). There was significant improvement in the delivery of 28 out of 29 individual practices. No adverse outcomes relating to the intervention occurred. Study limitations are the pre-post design, potential Hawthorne effect, and focus on processes of care versus health outcomes. Conclusions: Introduction of the WHO Safe Childbirth Checklist program markedly improved delivery of essential safety practices by health workers. Future study will determine if this program can be implemented at scale and improve health outcomes.:

David Studdert and colleagues identified disputes over informed consent among malpractice claims and serious health care complaints in Australia and provide an analysis of disagreements between patients and doctors over whether particular clinical risks should have been disclosed before treatment.

Background: The reliable availability of health technologies, defined as equipment, medicines, and consumable supplies, is essential to ensure successful childbirth practices proven to prevent avoidable maternal and newborn mortality. The majority of global maternal and newborn deaths take place in Africa and Asia, yet few data exist that describe the availability of childbirth-related health technologies in these regions. We conducted a cross-sectional survey of health workers in Africa and Asia in order to profile the availability of health technologies considered to be essential to providing safe childbirth care. Methods: Health workers in Africa and Asia were surveyed using a web-based questionnaire. A list of essential childbirth-related health technologies was drawn from World Health Organization guidelines for preventing and managing complications associated with the major causes of maternal and newborn mortality globally. Demographic data describing each birth center were obtained and health workers reported on the availability of essential childbirth-related health technologies at their centers. Comparison analyses were conducted using Rao-Scott chi-square test statistics. Results: Health workers from 124 birth centers in 26 African and 15 Asian countries participated. All facilities exhibited gaps in the availability of essential childbirth-related health technologies. Availability was significantly reduced in birth centers that had lower birth volumes and those from lower income countries. On average across all centers, health workers reported the availability of 18 of 23 essential childbirth-related health technologies (79%; 95% CI, 74%, 84%). Low-volume facilities suffered severe shortages; on average, these centers reported reliable availability of 13 of 23 technologies (55%; 95% CI, 39%, 71%). Conclusions: Substantial gaps exist in the availability of essential childbirth-related health technologies across health sector levels in Africa and Asia. Strategies that facilitate reliable access to vital health technologies in these regions are an urgent priority.

Background: Audits provide a rational framework for quality improvement by systematically assessing clinical practices against accepted standards with the aim to develop recommendations and interventions that target modifiable deficiencies in care. Most childbirth-associated mortality audits in developing countries are focused on a single facility and, up to now, the avoidable factors in maternal and perinatal deaths cataloged in these reports have not been pooled and analyzed. We sought to identity the most frequent avoidable factors in childbirth-related deaths globally through a systematic review of all published mortality audits in low and lower-middle income countries. Methods: We performed a systematic review of published literature from 1965 to November 2011 in Pubmed, Embase, CINAHL, POPLINE, LILACS and African Index Medicus. Inclusion criteria were audits from low and lower-middle income countries that identified at least one avoidable factor in maternal or perinatal mortality. Each study included in the analysis was assigned a quality score using a previously published instrument. A meta-analysis was performed for each avoidable factor taking into account the sample sizes and quality score from each individual audit. The study was conducted and reported according to PRISMA guidelines for systematic reviews. Results: Thirty-nine studies comprising 44 datasets and a total of 6,205 audited deaths met inclusion criteria. The analysis yielded 42 different avoidable factors, which fell into four categories: health worker-oriented factors, patient-oriented factors, transport/referral factors, and administrative/supply factors. The top three factors by attributable deaths were substandard care by a health worker, patient delay, and deficiencies in blood transfusion capacity (accounting for 688, 665, and 634 deaths attributable, respectively). Health worker-oriented factors accounted for two-thirds of the avoidable factors identified. Conclusions: Audits provide insight into where systematic deficiencies in clinical care occur and can therefore provide crucial direction for the targeting of interventions to mitigate or eliminate health system failures. Given that the main causes of maternal and perinatal deaths are generally consistent across low resource settings, the specific avoidable factors identified in this review can help to inform the rational design of health systems with the aim of achieving continued progress towards Millennium Development Goals Four and Five. Electronic supplementary material The online version of this article (doi:10.1186/1471-2393-14-280) contains supplementary material, which is available to authorized users.

Background: Oncogenic mutations are common in thyroid cancers. While the frequently detected RAS-oncogene mutations have been studied for diagnostic use in cytologically indeterminate thyroid nodules, no investigation has studied such mutations in an unselected population of thyroid nodules. No long-term study of RAS-positive thyroid nodules has been performed. Methods: We performed a prospective, blinded cohort study in 362 consecutive patients presenting with clinically relevant (>1 cm) thyroid nodules. Fine needle aspiration cytology and mutational testing were obtained for all nodules. Post-operative histopathology was obtained for malignant or indeterminate nodules, and benign nodules were sonographically followed. Histopathological features were compared between RAS- and BRAF-positive malignancies. RAS-positive benign nodules were analyzed for growth or cellular change from prior aspirations. Results: Overall, 17 of 362 nodules were RAS-positive. Nine separate nodules were BRAF-positive, of which eight underwent surgery and all proved malignant (100 %). Out of the 17 RAS-positive nodules, ten underwent surgery, of which eight proved malignant (47 %). All RAS-positive malignancies were low risk – all follicular variants of papillary carcinoma, without extrathyroidal extension, metastases, or lymphovascular invasion. RAS-positivity was associated with malignancy in younger patients (P = 0.028). Of the nine RAS-positive benign nodules, five had long-term prospective sonographic follow-up (mean 8.3 years) showing no growth or signs of malignancy. Four of these nodules also had previous aspirations (mean 5.8 years prior), all with similar benign results. Conclusions: While RAS-oncogene mutations increase malignancy risk, these data demonstrate a low-risk phenotype for most RAS-positive cancers. Furthermore, cytologically benign, yet RAS-positive nodules behave in an indolent fashion over years. RAS-positivity alone should therefore not dictate clinical decisions.

Background: Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India. Methods: Initially, we trained a local team of physicians and nurses to coach birth attendants in SCC use at two public facilities for 4–6 weeks. Trained observers evaluated adherence to EBPs before and after coaching. Using mixed methods and a systematic adaptation process, we modified and strengthened the intervention. The modified intervention was implemented in three additional facilities. Pre/post-change in EBP prevalence aggregated across facilities was analyzed. Results: In the first two facilities, limited improvement was seen in EBPs with the exception of post-partum oxytocin. Checklists were used <25 % of observations. We identified challenges in physicians coaching nurses, need to engage district and facility leadership to address system gaps, and inadequate strategy for motivating SCC uptake. Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness. These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01. Further adaptations were implemented to increase the effectiveness prior to full trial launch. Conclusions: The adaptive study design of implementation, evaluation, and feedback drove iterative redesign and successfully developed a SCC-focused coaching intervention that improved EBPs in UP facilities. This work was critical to develop a replicable BetterBirth package tailored to the local context. The multi-center pragmatic trial is underway measuring impact of the BetterBirth program on EBP and maternal-neonatal morbidity and mortality. Trial registration Clinical trials identifier: NCT02148952.

Abstract Objective: To evaluate the cost–effectiveness of pulse oximetry – compared with no peri-operative monitoring – during surgery in low-income countries. Methods: We considered the use of tabletop and portable, hand-held pulse oximeters among patients of any age undergoing major surgery in low-income countries. From earlier studies we obtained baseline mortality and the effectiveness of pulse oximeters to reduce mortality. We considered the direct costs of purchasing and maintaining pulse oximeters as well as the cost of supplementary oxygen used to treat hypoxic episodes identified by oximetry. Health benefits were measured in disability-adjusted life-years (DALYs) averted and benefits and costs were both discounted at 3% per year. We used recommended cost–effectiveness thresholds – both absolute and relative to gross domestic product (GDP) per capita – to assess if pulse oximetry is a cost–effective health intervention. To test the robustness of our results we performed sensitivity analyses. Findings: In 2013 prices, tabletop and hand-held oximeters were found to have annual costs of 310 and 95 United States dollars (US$), respectively. Assuming the two types of oximeter have identical effectiveness, a single oximeter used for 22 procedures per week averted 0.83 DALYs per annum. The tabletop and hand-held oximeters cost US$ 374 and US$ 115 per DALY averted, respectively. For any country with a GDP per capita above US$ 677 the hand-held oximeter was found to be cost–effective if it prevented just 1.7% of anaesthetic-related deaths or 0.3% of peri-operative mortality. Conclusion: Pulse oximetry is a cost–effective intervention for low-income settings.

Background: Reducing maternal and neonatal mortality is essential to improving population health. Demand-side interventions are designed to increase uptake of critical maternal health services, but associated change in service uptake and outcomes is varied. We undertook a literature review to understand current evidence of demand-side intervention impact on improving utilization and outcomes for mothers and newborn children. Methods: We completed a rapid review of literature in PubMed. Title and abstracts of publications identified from selected search terms were reviewed to identify articles meeting inclusion criteria: demand-side intervention in low or middle-income countries (LMIC), published after September 2004 and before March 2014, study design describing and reporting on >1 priority outcome: utilization (antenatal care visits, facility-based delivery, delivery with a skilled birth attendant) or health outcome measures (maternal mortality ratio (MMR), stillbirth rate, perinatal mortality rate (PMR), neonatal mortality rate (NMR)). Bibliographies were searched to identify additional relevant papers. Articles were abstracted using a standardized data collection template with double extraction on a sample to ensure quality. Quality of included studies was assessed using McMaster University’s Quality Assessment Tool from the Effective Public Health Practice Project (EPHPP). Results: Five hundred and eighty two articles were screened with 50 selected for full review and 16 meeting extraction criteria (eight community mobilization interventions (CM), seven financial incentive interventions (FI), and one with both). We found that demand-side interventions were effective in increasing uptake of key services with five CM and all seven FI interventions reporting increased use of maternal health services. Association with health outcome measures were varied with two studies reporting reductions in MMR and four reporting reduced NMR. No studies found a reduction in stillbirth rate. Only four of the ten studies reporting on both utilization and outcomes reported improvement in both measures. Conclusions: We found strong evidence that demand-side interventions are associated with increased utilization of services with more variable evidence of their impact on reducing early neonatal and maternal mortality. Further research is needed to understand how to maximize the potential of demand-side interventions to improve maternal and neonatal health outcomes including the role of quality improvement and coordination with supply-side interventions.

Background: Adherence to evidence-based essential birth practices is critical for improving health outcomes for mothers and newborns. The WHO Safe Childbirth Checklist (SCC) incorporates these practices, which occur during 4 critical pause points: on admission, before pushing (or cesarean delivery), soon after birth, and before discharge. A peer-coaching strategy to support consistent use of the SCC may be an effective approach to increase birth attendants' adherence to these practices. Methods: We assessed data from 60 public health facilities in Uttar Pradesh, India, that received an 8-month staggered coaching intervention from December 2014 to September 2016 as part of the BetterBirth Trial, which is studying effectiveness of an SCC-centered intervention on maternal and neonatal harm. Nurse coaches recorded birth attendants' adherence to 39 essential birth practices. Practice adherence was calculated for each intervention month. After 2 months of coaching, a subsample of 15 facilities was selected for independent observation when the coach was not present. We compared adherence to the 18 practices recorded by both coaches and independent observers. Results: Coaches observed birth attendants' behavior during 5,971 deliveries. By the final month of the intervention, 35 of 39 essential birth practices had achieved >90% adherence in the presence of a coach, compared with only 7 of 39 practices during the first month. Key behaviors with the greatest improvement included explanation of danger signs, temperature measurement, assessment of fetal heart sounds, initiation of skin-to-skin contact, and breastfeeding. Without a coach present, birth attendants' average adherence to practices and checklist use was 24 percentage points lower than when a coach was present (range: −1% to 62%). Conclusion: Implementation of the WHO Safe Childbirth Checklist with coaching improved uptake of and adherence to essential birth practices. Coordination and communication among facility staff, as well as behaviors with an immediate, tangible benefit, showed the greatest improvement. Difficult-to-perform behaviors and those with delayed or theoretical benefits were less likely to be sustained without a coach present. Coaching may be an important component in implementing the Safe Childbirth Checklist at scale. Note: At the time of publication of this article, the results of evaluation of the impact of the BetterBirth intervention were pending publication in another journal. After the impact findings have been published, we will update this article on the effect of the intervention on birth practices with a reference to the impact findings.

Shifting childbirth into facilities has not improved health outcomes for mothers and newborns as significantly as hoped. Improving the quality and safety of care provided during facility-based childbirth requires helping providers to adhere to essential birth practices—evidence-based behaviors that reduce harm to and save lives of mothers and newborns. To achieve this goal, we developed the BetterBirth Program, which we tested in a matched-pair, cluster-randomized controlled trial in Uttar Pradesh, India. The goal of this intervention was to improve adoption and sustained use of the World Health Organization Safe Childbirth Checklist (SCC), an organized collection of 28 essential birth practices that are known to improve the quality of facility-based childbirth care. Here, we describe the BetterBirth Program in detail, including its 4 main features: implementation tools, an implementation strategy of coaching, an implementation pathway (Engage-Launch-Support), and a sustainability plan. This coaching-based implementation of the SCC motivates and empowers care providers to identify, understand, and resolve the barriers they face in using the SCC with the resources already available. We describe important lessons learned from our experience with the BetterBirth Program as it was tested in the BetterBirth Trial. For example, the emphasis on relationship building and respect led to trust between coaches and birth attendants and helped influence change. In addition, the cloud-based data collection and feedback system proved a valuable asset in the coaching process. More research on coaching-based interventions is required to refine our understanding of what works best to improve quality and safety of care in various settings. Note: At the time of publication of this article, the results of evaluation of the impact of the BetterBirth Program were pending publication in another journal. After the impact findings have been published, we will update this article with a reference to the impact findings.