Comparison of Masimo Total Hemoglobin SpHb® continuous non-invasive hemoglobin monitoring device with laboratory complete blood count measurement using venous sample: Protocol for an observational substudy of the Pregnancy Risk and Infant Surveillance and Measurement Alliance Maternal and Newborn Health (PRISMA MNH) study.

Background: The Masimo Total Hemoglobin SpHb® is a continuous and non-invasive handheld device to measure hemoglobin levels. Previous research has found that SpHb is able to accurately detect hemoglobin levels in adult patients with a similar degree of bias and standard deviation to point-of-care invasive method measurements. Generally, limited clinical evidence, lack of validation of Masimo at higher than and lower than hemoglobin threshold values, and scientific consensus supporting the use of Masimo for accurate hemoglobin testing for the diagnosis of anemia during pregnancy calls for further research. Methods and analysis: The proposed prospective cohort will be nested within the ongoing Pregnancy Risk and Infant Surveillance and Measurement Alliance (PRISMA) Maternal and Newborn Health (MNH) study. Three study sites (located in Zambia, Kenya, and Pakistan) will participate and collect hemoglobin data at five time points (<20 weeks, 20 weeks, 28 weeks, 36 weeks' gestation, and six weeks postpartum). We will measure hemoglobin using a venous blood sample via hematology auto-analyzer complete blood count (gold standard) and the non-invasive device. The primary objective is to assess agreement between Masimo total hemoglobin and complete blood count and on a continuous scale using Intraclass Correlation Coefficient and Bland-Altman Analysis. The second objective is to assess agreement between the two measures on a binary scale using Positive Percentage Agreement and Negative Percentage Agreement, Cohen's Kappa, and McNemar Test. On an ordinal scale, agreement will be measured using Weighted Cohen's Kappa and Harrel's Concordance Index. Lastly, we will assess factors that might affect the accuracy of Masimo total hemoglobin using linear mixed models. Conclusions: The primary aim of this study is to assess the validity of the non-invasive Masimo device compared to the gold standard method of invasive hemoglobin measurements during pregnancy and postpartum periods for the diagnosis of anemia.

Maternal mid-upper arm circumference to predict small for gestational age: Findings in a Zambian cohort.

OBJECTIVE: To compare the performance of mid upper arm circumference (MUAC) and body mass index (BMI) for prediction of small for gestational age (SGA) in Zambia. METHODS: This is a secondary analysis of an ongoing clinical cohort that included women with a single gestation and MUAC measured before 24 weeks of pregnancy. We assessed relationships between maternal MUAC and birth weight centile using regression. The performance of MUAC and BMI to predict SGA was compared using receiver operating characteristic curves and the effect of maternal HIV was investigated in sub-group analyses. RESULTS: Of 1117 participants, 847 (75%) were HIV-negative (HIV-) and 270 (24%) were HIV-positive (HIV+). Seventy-four (7%) delivered severe SGA infants (<3rd centile), of whom 56 (76%) were HIV- and 18 (24%) were HIV+ (odds ratio [OR] 1.01, 95% confidence interval [CI] 0.58-1.75). MUAC was associated with higher birth weight centile (+1.2 centile points, 95% CI 0.7-1.6; P < 0.001); this relationship was stronger among HIV+ women (+1.7 centile points, 95% CI 0.8-2.6; P < 0.001) than HIV- women (+0.9 centile points, 95% CI 0.4-1.4; P = 0.001). The discriminatory power was similar, albeit poor (area under the curve [AUC] < 0.7), between MUAC and BMI for the prediction of SGA. In stratified analysis, MUAC and BMI showed excellent discrimination predicting severe SGA among HIV+ (AUC 0.83 and 0.81, respectively) but not among HIV- women (AUC 0.64 and 0.63, respectively). CONCLUSION: Maternal HIV infection increased the discrimination of both early pregnancy MUAC and BMI for prediction of severe SGA in Zambia. CLINICAL TRIAL NUMBER: ClinicalTrials.gov (NCT02738892).

Interpersonal therapy versus antidepressant medication for treatment of postpartum depression and anxiety among women with HIV in Zambia: a randomized feasibility trial.

INTRODUCTION: Postpartum depression (PPD) is a prevalent and debilitating disease that may affect medication adherence and thus maternal health and vertical transmission among women with HIV. We assessed the feasibility of a trial of interpersonal psychotherapy (IPT) versus antidepressant medication (ADM) to treat PPD and/or anxiety among postpartum women with HIV in Lusaka, Zambia. METHODS: Between 29 October 2019 and 8 September 2020, we pre-screened women 6-8 weeks after delivery with the Edinburgh Postnatal Depression Scale (EPDS) and diagnosed PPD or anxiety with the Mini International Neuropsychiatric Interview. Consenting participants were randomized 1:1 to up to 11 sessions of IPT or daily self-administered sertraline and followed for 24 weeks. We assessed EPDS score, Clinical Global Impression-Severity of Illness (CGI-S) and medication side effects at each visit and measured maternal HIV viral load at baseline and final study visit. Retention, visit adherence, change in EPDS, CGI-S and log viral load were compared between groups with t-tests and Wilcoxon signed rank tests; we report mean differences, relative risks and 95% confidence intervals. A participant satisfaction survey assessed trial acceptability. RESULTS: 78/80 (98%) participants were retained at the final study visit. In the context of the COVID-19 pandemic, visit adherence was greater among women allocated to ADM (9.9 visits, SD 2.2) versus IPT (8.9 visits, SD 2.4; p = 0.06). EPDS scores decreased from baseline to final visit overall, though mean change was greater in the IPT group (-13.8 points, SD 4.7) compared to the ADM group (-11.4 points, SD 5.5; p = 0.04). Both groups showed similar changes in mean log viral load from baseline to final study visit (mean difference -0.43, 95% CI -0.32, 1.18; p = 0.48). In the IPT group, viral load decreased significantly from baseline (0.9 log copies/ml, SD 1.7) to final visit (0.2 log copies/ml, SD 0.9; p = 0.01). CONCLUSIONS: This pilot study demonstrates that a trial of two forms of PPD treatment is feasible and acceptable among women with HIV in Zambia. IPT and ADM both improved measures of depression severity; however, a full-scale trial is required to determine whether treatment of PPD and anxiety improves maternal-infant HIV outcomes.

Limiting adverse birth outcomes in resource-limited settings (LABOR): protocol of a prospective intrapartum cohort study.

Background: Each year, nearly 300,000 women and 5 million fetuses or neonates die during childbirth or shortly thereafter, a burden concentrated disproportionately in low- and middle-income countries. Identifying women and their fetuses at risk for intrapartum-related morbidity and death could facilitate early intervention. Methods: The Limiting Adverse Birth Outcomes in Resource-Limited Settings (LABOR) Study is a multi-country, prospective, observational cohort designed to exhaustively document the course and outcomes of labor, delivery, and the immediate postpartum period in settings where adverse outcomes are frequent. The study is conducted at four hospitals across three countries in Ghana, India, and Zambia. We will enroll approximately 12,000 women at presentation to the hospital for delivery and follow them and their fetuses/newborns throughout their labor and delivery course, postpartum hospitalization, and up to 42 days thereafter. The co-primary outcomes are composites of maternal (death, hemorrhage, hypertensive disorders, infection) and fetal/neonatal adverse events (death, encephalopathy, sepsis) that may be attributed to the intrapartum period. The study collects extensive physiologic data through the use of physiologic sensors and employs medical scribes to document examination findings, diagnoses, medications, and other interventions in real time. Discussion: The goal of this research is to produce a large, sharable dataset that can be used to build statistical algorithms to prospectively stratify parturients according to their risk of adverse outcomes. We anticipate this research will inform the development of new tools to reduce peripartum morbidity and mortality in low-resource settings.

Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings.

Vital signs monitoring is a fundamental component of ensuring the health and safety of women and newborns during pregnancy, labor, and childbirth. This monitoring is often the first step in early detection of pregnancy abnormalities, providing an opportunity for prompt, effective intervention to prevent maternal and neonatal morbidity and mortality. Contemporary pregnancy monitoring systems require numerous devices wired to large base units; at least five separate devices with distinct user interfaces are commonly used to detect uterine contractility, maternal blood oxygenation, temperature, heart rate, blood pressure, and fetal heart rate. Current monitoring technologies are expensive and complex with implementation challenges in low-resource settings where maternal morbidity and mortality is the greatest. We present an integrated monitoring platform leveraging advanced flexible electronics, wireless connectivity, and compatibility with a wide range of low-cost mobile devices. Three flexible, soft, and low-profile sensors offer comprehensive vital signs monitoring for both women and fetuses with time-synchronized operation, including advanced parameters such as continuous cuffless blood pressure, electrohysterography-derived uterine monitoring, and automated body position classification. Successful field trials of pregnant women between 25 and 41 wk of gestation in both high-resource settings (n = 91) and low-resource settings (n = 485) demonstrate the system's performance, usability, and safety.

Increase in Drug Overdose Deaths Involving Fentanyl-Rhode Island, January 2012-March 2014.

Objective: This study identified sociodemographic, substance use, and multiple opioid prescriber and dispenser risk factors among drug overdose decedents in Rhode Island, in response to an increase in overdose deaths (ODs) involving fentanyl. Methods: This cross-sectional investigation comprised all ODs reviewed by Rhode Island's Office of the State Medical Examiners (OSME) during January 2012 to March 2014. Data for 536 decedents were abstracted from OSME's charts, death certificates, toxicology reports, and Prescription Monitoring Program (PMP) databases. Decedents whose cause of death involved illicit fentanyl (N = 69) were compared with decedents whose causes of death did not involve fentanyl (other drug decedents; N = 467). Results: Illicit-fentanyl decedents were younger than other drug decedents (P = 0.005). While more other-drug decedents than illicit fentanyl decedents had postmortem toxicological evidence of consuming heroin (31.9% vs 19.8%, P < 0.001) and various pharmaceutical substances (P = 0.002-0.027), third party reports indicated more recent heroin use among illicit fentanyl decedents (62.3% vs 45.6%, P = 0.002). Approximately 35% of decedents filled an opioid prescription within 90 days of death; of these, one-third had a mean daily dosage greater than 100 morphine milligram equivalents (MME/day). Most decedents' opioid prescriptions were filled at one to two dispensers (83.9%) and written by one to two prescribers (75.8%). Notably, 29.2% of illicit fentanyl and 10.5% of other drug decedents filled prescriptions for buprenorphine, which is used to treat opioid use disorders. Conclusions: Illicit-fentanyl deaths frequently involved other illicit drugs (e.g., cocaine, heroin). The proportion of all decedents acquiring greater than 100 MME/day prescription dosages written and/or filled by few prescribers and dispensers is concerning. To protect patients, prescribers and dispensers should review PMP records and substance abuse history prior to providing opioids.

Student-Led Training Day Increases Student Confidence in Women's Primary Care Skills.

BACKGROUND AND OBJECTIVES: Medical students are often apprehensive in approaching basic women's health concepts, including wellness exams, reproductive health concerns, and patient counseling. This study evaluates a novel student-developed and student-run Women's Health Training Day (WHTD) as a means of cultivating medical student confidence in women's primary care early in medical training. METHODS: Sixty-six first-year medical students participated in WHTD, a voluntary 6-hour weekend day of interactive workshops. Students were divided into groups of six to eight students that rotated together through five workshops focused on the breast exam, pelvic exam, microscopy, family planning, and patient interviews. Before participating in WHTD, students completed surveys indicating their confidence in performing skills related to women's health on a 5-point Likert scale. Students completed an identical survey after participating in all of the WHTD workshops. Changes in pre- and post-training day confidence scores were assessed. RESULTS: Students reported increased confidence in all of the composite sessions that were assessed. The specific skillsets demonstrating the greatest increases in student confidence were speculum handling during pelvic examinations, detecting abnormal breast masses, and recognizing the clinical presentations of common sexually transmitted infections. All but one of the evaluated skills, using a microscope, demonstrated a significant increase in student confidence. CONCLUSIONS: These results indicate that the student-implemented and student-run Women's Health Training Day increases student confidence in women's primary care skills. Further studies are needed to determine whether this perceived increase in confidence is associated with increased objective knowledge pertaining to primary care and women's health.

Use of Naloxone by Emergency Medical Services during Opioid Drug Overdose Resuscitation Efforts.

Naloxone administration is an important component of resuscitation attempts by emergency medical services (EMS) for opioid drug overdoses. However, EMS providers must first recognize the possibility of opioid overdose in clinical encounters. As part of a public health response to an outbreak of opioid overdoses in Rhode Island, we examined missed opportunities for naloxone administration and factors potentially influencing EMS providers' decision to administer naloxone. We reviewed medical examiner files on all individuals who died of an opioid-related drug overdose in Rhode Island from January 1, 2012 through March 31, 2014, underwent attempted resuscitation by EMS providers, and had records available to assess for naloxone administration. We evaluated whether these individuals received naloxone as part of their resuscitation efforts and compared patient and scene characteristics of those who received naloxone to those who did not receive naloxone via chi-square, t-test, and logistic regression analyses. One hundred and twenty-four individuals who underwent attempted EMS resuscitation died due to opioid overdose. Naloxone was administered during EMS resuscitation attempts in 82 (66.1%) of cases. Females were nearly three-fold as likely not to receive naloxone as males (OR 2.9; 95% CI 1.2-7.0; p-value 0.02). Additionally, patients without signs of potential drug abuse also had a greater than three-fold odds of not receiving naloxone (OR 3.3; 95% CI 1.2-9.2; p-value 0.02). Older individuals, particularly those over age 50, were more likely not to receive naloxone than victims younger than age 30 (OR 4.8; 95% CI 1.3-17.4; p-value 0.02). Women, older individuals, and those patients without clear signs of illicit drug abuse, were less likely to receive naloxone in EMS resuscitation attempts. Heightened clinical suspicion for opioid overdose is important given the recent increase in overdoses among patients due to prescription opioids.

Notes from the field: increase in fentanyl-related overdose deaths - Rhode Island, November 2013-March 2014.

During November 2013-March 2014, twice as many all-intent drug overdose deaths were reported in Rhode Island as were reported during the same period in previous years. Most deaths were among injection-drug users, and a large percentage involved fentanyl, a synthetic opioid that is 50-100 times more potent than morphine. Clusters of fentanyl-related deaths have been reported recently in several states. From April 2005 to March 2007, time-limited active surveillance from CDC and the Drug Enforcement Administration identified 1,013 deaths caused by illicit fentanyl use in New Jersey; Maryland; Chicago, Illinois; Detroit, Michigan; and Philadelphia, Pennsylvania. Acetyl fentanyl, an illegally produced fentanyl analog, caused a cluster of overdose deaths in northern Rhode Island in 2013.

Ethics of resuscitation at different stages of life: a survey of perinatal physicians.

OBJECTIVE: We surveyed US neonatologists and high-risk obstetricians about preferences for resuscitation in ethically difficult situations to determine whether (1) their responses adhered to traditional ethical principles of best interests and patient autonomy and (2) physician specialty seemed to influence the response. METHODS: In an electronic survey, we presented 8 vignettes with varying prognoses for survival and long-term outcome. Respondents were provided outcome data for mortality and morbidity in each vignette. We asked whether resuscitation was in the patient's best interest and whether the physician would accede to requests for nonresuscitation. RESULTS: We analyzed surveys for 587 neonatologists and 108 high-risk obstetricians (15% overall response rate, 75% of web site visitors). There were no statistically significant differences in responses between the 2 physician subspecialty groups. As expected, in most cases there were inverse relationships between valuation of best interest and deferred resuscitation at the family's request. For example, for the oldest patient (an 80-year-old), 9.9% found resuscitation to be in the patient's best interest and 94.3% would allow nonresuscitation; for a 2-month-old, 93.9% found resuscitation to be in the patient's best interest and 24.5% would allow nonresuscitation. However, this pattern was not observed in the 2 newborn cases, in which resuscitation and nonresuscitation were both acceptable. In the triage scenario, the 7-year-old with cerebral palsy and acute trauma was consistently resuscitated first despite others having equivalent or better short- and long-term prognoses. CONCLUSIONS: On the basis of our results, physicians' decisions to resuscitate seem to be context-specific, rather than based on prognosis or consistent application of best-interest or autonomy principles. Despite their different professional perspectives, neonatologists and high-risk obstetricians seemed to converge on these judgments.