Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings

BACKGROUND: The absence of robust evidence of safety of medicines in pregnancy, particularly those for major diseases provided by public health programmes in developing countries, has resulted in cautious recommendations on their use. We describe a protocol for a Pregnancy Registry adapted to resource-limited settings aimed at providing evidence on the safety of medicines in pregnancy.METHODS/DESIGN:Sentinel health facilities are chosen where women come for prenatal care and are likely to come for delivery. Staff capacity is improved to provide better care during the pregnancy, to identify visible birth defects at delivery and refer infants with major anomalies for surgical or clinical evaluation and treatment. Consenting women are enrolled at their first antenatal visit and careful medical, obstetric and drug-exposure histories taken; medical record linkage is encouraged. Enrolled women are followed up prospectively and their histories are updated at each subsequent visit. The enrolled woman is encouraged to deliver at the facility, where she and her baby can be assessed.DISCUSSION:In addition to data pooling into a common WHO database, the WHO Pregnancy Registry has three important features: First is the inclusion of pregnant women coming for antenatal care, enabling comparison of birth outcomes of women who have been exposed to a medicine with those who have not. Second is its applicability to resource-poor settings regardless of drug or disease. Third is improvement of reproductive health care during pregnancies and at delivery. Facility delivery enables better health outcomes, timely evaluation and management of the newborn, and the collection of reliable clinical data. The Registry aims to improve maternal and neonatal care and also provide much needed information on the safety of medicines in pregnancy

Pregnancy outcomes after first-trimester treatment with artemisinin derivatives versus non-artemisinin antimalarials: A systematic review and individual patient data meta-analysis

Background Malaria in the first trimester of pregnancy is associated with adverse pregnancy outcomes. Artemisinin-based combination therapies (ACTs) are a highly effective, first-line treatment for uncomplicated Plasmodium falciparum malaria, except in the first trimester of pregnancy, when quinine with clindamycin is recommended due to concerns about the potential embryotoxicity of artemisinins. We compared adverse pregnancy outcomes after artemisinin-based treatment (ABT) versus non-ABTs in the first trimester of pregnancy. Methods For this systematic review and individual patient data (IPD) meta-analysis, we searched MEDLINE, Embase, and the Malaria in Pregnancy Library for prospective cohort studies published between Nov 1, 2015, and Dec 21, 2021, containing data on outcomes of pregnancies exposed to ABT and non-ABT in the first trimester. The results of this search were added to those of a previous systematic review that included publications published up until November, 2015. We included pregnancies enrolled before the pregnancy outcome was known. We excluded pregnancies with missing estimated gestational age or exposure information, multiple gestation pregnancies, and if the fetus was confirmed to be unviable before antimalarial treatment. The primary endpoint was adverse pregnancy outcome, defined as a composite of either miscarriage, stillbirth, or major congenital anomalies. A one-stage IPD meta-analysis was done by use of shared-frailty Cox models. This study is registered with PROSPERO, number CRD42015032371. Findings We identified seven eligible studies that included 12 cohorts. All 12 cohorts contributed IPD, including 34 178 pregnancies, 737 with confirmed first-trimester exposure to ABTs and 1076 with confirmed first-trimester exposure to non-ABTs. Adverse pregnancy outcomes occurred in 42 (5·7%) of 736 ABT-exposed pregnancies compared with 96 (8·9%) of 1074 non-ABT-exposed pregnancies in the first trimester (adjusted hazard ratio [aHR] 0·71, 95% CI 0·49–1·03). Similar results were seen for the individual components of miscarriage (aHR=0·74, 0·47–1·17), stillbirth (aHR=0·71, 0·32–1·57), and major congenital anomalies (aHR=0·60, 0·13–2·87). The risk of adverse pregnancy outcomes was lower with artemether–lumefantrine than with oral quinine in the first trimester of pregnancy (25 [4·8%] of 524 vs 84 [9·2%] of 915; aHR 0·58, 0·36–0·92). Interpretation We found no evidence of embryotoxicity or teratogenicity based on the risk of miscarriage, stillbirth, or major congenital anomalies associated with ABT during the first trimester of pregnancy. Given that treatment with artemether–lumefantrine was associated with fewer adverse pregnancy outcomes than quinine, and because of the known superior tolerability and antimalarial effectiveness of ACTs, artemether–lumefantrine should be considered the preferred treatment for uncomplicated P falciparum malaria in the first trimester. If artemether–lumefantrine is unavailable, other ACTs (except artesunate–sulfadoxine–pyrimethamine) should be preferred to quinine. Continued active pharmacovigilance is warranted

The resident experience with psychological safety during interprofessional critical event debriefings

ObjectivesInterprofessional feedback and teamwork skills training are important in graduate medical education. Critical event debriefing is a unique interprofessional team training opportunity in the emergency department. While potentially educational, these varied, high-stakes events can threaten psychological safety for learners. This is a qualitative study of emergency medicine resident physicians' experience of interprofessional feedback during critical event debriefing to characterize factors that impact their psychological safety.MethodsThe authors conduced semistructured interviews with resident physicians who were the physician team leader during a critical event debriefing. Interviews were coded and themes were generated using a general inductive approach and concepts from social ecological theory.ResultsEight residents were interviewed. The findings suggest that cultivating a safe learning environment for residents during debriefings involves the following: (1) allowing space for validating statements, (2) supporting strong interprofessional relationships, (3) providing structured opportunities for interprofessional learning, (4) encouraging attendings to model vulnerability, (5) standardizing the process of debriefing, (6) rejecting unprofessional behavior, and (7) creating the time and space for the process in the workplace.ConclusionsGiven the numerous intrapersonal, interpersonal, and institutional factors at play, educators should be sensitive to times when a resident cannot engage due to unaddressed threats to their psychological safety. Educators can address these threats in real time and over the course of a resident's training to enhance psychological safety and the potential educational impact of critical event debriefing

Multicenter plastic surgery outreach services for underserved Ghanaian communities

Abstract This paper describes the efforts of one plastic surgery team composed of Ghanaians from one of the major metropolitan areas in Ghana to meet the plastic surgery needs of rural Ghanaian communities. The aim was to analyze retrospectively the cases managed by the team, the difficulties which arose over a 14-year period, and the provision of recommendations for such future work. This study reviewed the medical records of patients treated during 86 outreach visits to nine centers from October 1995 to September 2009. The team, drawn from three hospitals, comprised a plastic surgeon and surgical support staff. They mostly treated Buruli ulcers, postburns scar contractures, chronic ulcers, facial clefts, tumors, and breast diseases. In all, 2,284 patients were managed during the period under review, giving an average of 163 patients per year and 254 per center. Buruli ulcers accounted for the largest group of cases treated during the outreaches (41%). Other common diagnoses were postburn scar contractures and cleft lip and palate deformities. This paper provides an example of the possibilities for surgical outreach work that exist and how challenges that come up during surgical outreach visits can be handled effectively. It also highlights the need for outreach medical work in developing countries like Ghana, especially since there is a reduction in foreign outreach medical missions. The authors encourage all stakeholders involved in health care delivery to initiate and support local medical outreach teams to provide care to rural communities

An observational study of adults seeking emergency care in Cambodia

Objective To describe the characteristics and chief complaints of adults seeking emergency care at two Cambodian provincial referral hospitals. Methods Adults aged 18 years or older who presented without an appointment at two public referral hospitals were enrolled in an observational study. Clinical and demographic data were collected and factors associated with hospital admission were identified. Patients were followed up 48 hours and 14 days after presentation. Findings In total, 1295 hospital presentations were documented. We were able to follow up 85% (1098) of patients at 48 hours and 77% (993) at 14 days. The patients’ mean age was 42 years and 64% (823) were females. Most arrived by motorbike (722) or taxi or tuk-tuk (312). Most common chief complaints were abdominal pain (36%; 468), respiratory problems (15%; 196) and headache (13%; 174). Of the 1050 patients with recorded vital signs, 280 had abnormal values, excluding temperature, on arrival. Performed diagnostic tests were recorded for 539 patients: 1.2% (15) of patients had electrocardiography and 14% (175) had diagnostic imaging. Subsequently, 783 (60%) patients were admitted and 166 of these underwent surgery. Significant predictors of admission included symptom onset within 3 days before presentation, abnormal vital signs and fever. By 14-day follow-up, 3.9% (39/993) of patients had died and 19% (192/993) remained functionally impaired. Conclusion In emergency admissions in two public hospitals in Cambodia, there is high admission-to-death ratio and limited application of diagnostic techniques. We identified ways to improve procedures, including better documentation of vital signs and increased use of diagnostic techniques

Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings

Abstract Background The absence of robust evidence of safety of medicines in pregnancy, particularly those for major diseases provided by public health programmes in developing countries, has resulted in cautious recommendations on their use. We describe a protocol for a Pregnancy Registry adapted to resource-limited settings aimed at providing evidence on the safety of medicines in pregnancy. Methods/Design Sentinel health facilities are chosen where women come for prenatal care and are likely to come for delivery. Staff capacity is improved to provide better care during the pregnancy, to identify visible birth defects at delivery and refer infants with major anomalies for surgical or clinical evaluation and treatment. Consenting women are enrolled at their first antenatal visit and careful medical, obstetric and drug-exposure histories taken; medical record linkage is encouraged. Enrolled women are followed up prospectively and their histories are updated at each subsequent visit. The enrolled woman is encouraged to deliver at the facility, where she and her baby can be assessed. Discussion In addition to data pooling into a common WHO database, the WHO Pregnancy Registry has three important features: First is the inclusion of pregnant women coming for antenatal care, enabling comparison of birth outcomes of women who have been exposed to a medicine with those who have not. Second is its applicability to resource-poor settings regardless of drug or disease. Third is improvement of reproductive health care during pregnancies and at delivery. Facility delivery enables better health outcomes, timely evaluation and management of the newborn, and the collection of reliable clinical data. The Registry aims to improves maternal and neonatal care and also provide much needed information on the safety of medicines in pregnancy.</p

Characteristics and outcomes of pediatric patients presenting at Cambodian referral hospitals without appointments: an observational study

Abstract Background Emergency medicine is a young specialty in many low- and middle-income countries (LMICs). Although many patients seeking emergency or acute care are children, little information is available about the needs and current treatment of this group in LMICs. In this observational study, we sought to describe characteristics, chief complaints, management, and outcomes of children presenting for unscheduled visits to two Cambodian public hospitals. Methods Children enrolled in the study presented without appointment for treatment at one of two Cambodian public referral hospitals during a 4-week period in 2012. Researchers used standardized questionnaires and hospital records to collect demographic and clinical data. Patients were followed up at 48 h and 14 days after initial presentation. Multivariate logistic regression identified factors associated with hospital admission. Results This study included 867 unscheduled visits. Mean patient age was 5.7 years (standard deviation 4.8 years). Of the 35 different presenting complaints, fever (63%), respiratory problems (25%), and skin complaints (24%) were most common. The majority of patients were admitted (51%), while 1% were transferred to another facility. Seven patients (1%) died within 14 days. Follow-up rates were 83% at 48 h and 75% at 14 days. Predictors of admission included transfer or referral from another health provider, seeking prior care for the presenting problem, low socioeconomic status, onset of symptoms within 24 h of seeking care, abnormal vital signs or temperature, and chief complaint of abdominal pain or fever. Conclusions While the admission rate in this study was high, mortality was low. More effective identification and management of children who can be treated and released may free up scarce inpatient resources for children who warrant admission

2021 SAEM Consensus Conference Proceedings: Research Priorities for Implementing Emergency Department Screening for Social Risks and Needs

Introduction: Despite literature on a variety of social risks and needs screening interventions in emergency department (ED) settings, there is no universally accepted or evidence-based process for conducting such interventions. Many factors hamper or promote implementation of social risks and needs screening in the ED, but the relative impact of these factors and how best to mitigate/leverage them is unknown.&nbsp; Methods: Drawing on an extensive literature review, expert assessment, and feedback from participants in the 2021 Society for Academic Emergency Medicine Consensus Conference through moderated discussions and follow-up surveys, we identified research gaps and rated research priorities for implementing screening for social risks and needs in the ED. We identified three main knowledge gaps: 1) screening implementation mechanics; 2) outreach and engagement with communities; and 3) addressing barriers and leveraging facilitators to screening. Within these gaps, we identified 12 high-priority research questions as well as research methods for future studies.&nbsp; Results: Consensus Conference participants broadly agreed that social risks and needs screening is generally acceptable to patients and clinicians and feasible in an ED setting. Our literature review and conference discussion identified several research gaps in the specific mechanics of screening implementation, including screening and referral team composition, workflow, and use of technology. Discussions also highlighted a need for more collaboration with stakeholders in screening design and implementation.&nbsp; Additionally, discussions identified the need for studies using adaptive designs or hybrid effectiveness-implementation models to test multiple strategies for implementation and sustainability.&nbsp; Conclusion: Through a robust consensus process we developed an actionable research agenda for implementing social risks and needs screening in EDs. Future work in this area should use implementation science frameworks and research best practices to further develop and refine ED screening for social risks and needs and to address barriers as well as leverage facilitators to such screening