Racial bias in cesarean decision-making.

BACKGROUND: Category II fetal heart tracing noted during continuous external fetal monitoring is a frequent indication for cesarean delivery in the United States despite its somewhat subjective interpretation. Black patients have higher rates of cesarean delivery and higher rates for this indication. Racial bias in clinical decision-making has been demonstrated throughout medicine, including in obstetrics. OBJECTIVE: We sought to examine if racial bias affects providers' decisions about cesarean delivery for an indication of category II fetal heart tracings. STUDY DESIGN: We constructed an online survey study consisting of 2 clinical scenarios of patients in labor with category II tracings. Patient race was randomized to Black and White; the vignettes were otherwise identical. Participants had the option to continue with labor or to proceed with a cesarean delivery at 3 decision points in each scenario. Participants reported their own demographics anonymously. This survey was distributed to obstetrical providers via email, listserv, and social media. Data were analyzed using chi-square tests at each decision point in the overall sample and in subgroup analyses by various participant demographics. RESULTS: A total of 726 participants contributed to the study. We did not find significant racial bias in cesarean delivery decision-making overall. However, in a scenario of a patient with a previous cesarean delivery, Fisher's exact tests showed that providers <40 years old (n=322; P=.01) and those with <10 years of experience (n=239; P=.050) opted for a cesarean delivery for Black patients more frequently than for White patients at the first decision point. As labor progressed in this scenario, the rates of cesarean delivery equalized across patient race. CONCLUSION: Younger providers and those with fewer years of clinical experience demonstrated racial bias in cesarean delivery decision-making at the first decision point early in labor. Providers did not show racial bias as labor progressed, nor in the scenario with a patient without a previous cesarean delivery. This bias may be the consequence of provider training with the Maternal-Fetal Medicine Unit Network Vaginal Birth After Cesarean Calculator, developed in 2007, and widely used to estimate the probability of successful vaginal birth after a cesarean delivery. This calculator used race as a predictive factor until it was removed in June 2021. Future studies should investigate if this bias persists following this change, while also focusing on interventions to address these findings.

Associations between provider-assigned Apgar score and neonatal race.

BACKGROUND: For decades, the Apgar scoring system has been used to evaluate neonatal status and determine need for resuscitation or escalation in care, such as admission to a neonatal intensive care unit. However, the variation and accuracy of provider-assigned Apgar scores across neonatal racial groups have yet to be evaluated. OBJECTIVE: This study aimed to investigate how provider-assigned Apgar scores vary by neonatal race independently of clinical factors and umbilical cord gas values. STUDY DESIGN: We conducted a retrospective cohort study at an urban academic medical center. All live births at ≥23 weeks and 0 days of gestation from January 1, 2019 through December 31, 2019 with complete data available were included. Data were queried from the electronic medical record and included race, ethnicity, gestational age of neonate, umbilical cord gas values (umbilical artery pH and base deficit), admission to the neonatal intensive care unit, and presence of maternal-fetal complications. Primary outcome measures were neonates' Apgar scores at 1 and 5 minutes. Color Apgar score and admission to the neonatal intensive care unit served as secondary outcome measures. We performed 3 partially proportional ordinal regression models controlling for an increasing number of covariates, with Model 1, the baseline model, adjusted for gestational age, Model 2 additionally adjusted for umbilical cord gases, and Model 3 additionally adjusted for maternal medical conditions and pregnancy complications. RESULTS: A total of 977 neonates met selection criteria; 553 (56.6%) were Black. Providers assigned Black neonates significantly lower Apgar scores at 1 minute (odds ratio, 0.63; 95% confidence interval, 0.49-0.80) and 5 minutes (odds ratio, 0.64; 95% confidence interval, 0.47-0.87), when controlling for umbilical artery gases, gestational age, and maternal-fetal complications. This difference seemed related to significantly lower assigned color Apgar scores at 1 minute when controlling for all the above factors (odds ratio, 0.52; 95% confidence interval, 0.39-0.68). Providers admitted full-term Black neonates to the neonatal intensive care unit at higher rates than non-Black neonates when controlling for all factors (odds ratio, 1.29; 95% confidence interval, 0.94-1.77). Black neonates did not have more abnormal cord gas values (mean umbilical artery pH of 7.259 for Black vs 7.256 for non-Black neonates), which would have supported their admission to the neonatal intensive care unit. CONCLUSION: Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores. These inaccuracies may be a factor in unnecessary admissions to neonatal intensive care units, and suggest that colorism and racial biases exist among healthcare providers.

Immersion in water during the second stage of labor: a randomized controlled trial.

BACKGROUND: Current obstetrical guidelines in the United States caution firmly against birth in water, but patients remain interested in this intervention. Limited data are available to evaluate the safety and efficacy of water immersion in the second stage of labor for patients and neonates. OBJECTIVE: This study aimed to ascertain the effects of water use during the second stage of labor on maternal outcomes. Second, it aimed to propose guidelines for midwives conducting the second stage of labor in water. STUDY DESIGN: A randomized, prospective design was used to evaluate the primary outcomes of maternal experience in labor and trauma to the birth canal and several secondary neonatal and maternal outcomes when participants delivered in water vs in a conventional setting. Participants were recruited at 2 academic state hospitals serving the same low- to middle-income group urban population in the midwestern suburbs of Johannesburg, South Africa over a period of 2 years. Individuals in active labor without exclusion criteria were asked to participate in the study. A total of 120 participants were enrolled, with 60 randomized to water birth and 60 to conventional birth. Outcomes were compared using the chi-square and Fisher exact tests. RESULTS: The use of water during birth significantly reduced the participants' perception of experienced pain than what they expected it to be (P=.006) and enhanced their satisfaction with their ability to cope with labor (P=.010). No differences were noted in trauma to the birth canal. No adverse maternal effects were noted. One early neonatal death occurred in the water group. The most likely cause of death was preexisting intrauterine fetal infection. CONCLUSION: Participants who delivered in water were significantly more satisfied with their birthing experience. The possible harmful effect of inhalation of fresh water by a baby is not resolved, and a large randomized controlled trial is recommended. It is recommended that immersion in water during the second stage of labor should only be offered by competent birth attendants who follow specific guidelines until clear evidence is available on the possible beneficial or harmful effects. Pending further evidence, we recommend adding salt to the bath to produce a physiological saline solution to reduce theoretical risks associated with fresh water inhalation by the neonate.

Blood type and postpartum hemorrhage by mode of delivery: A retrospective cohort study.

OBJECTIVE: To assess the relationship between postpartum hemorrhage and ABO blood type for vaginal delivery and cesarean delivery. STUDY DESIGN: This is a retrospective cohort study of data abstracted from the PeriBank database regarding demographics and delivery outcomes. All live singleton deliveries from January 2011 until March 2018 were included in this study. Exclusion criteria were sickle cell disease and multiple gestations. Analyses were conducted separately for cesarean delivery and vaginal delivery. Quantitative variables were analyzed with analysis of variance testing and categorical variables with chi square testing. Significant demographic differences between groups were controlled for using multivariate logistical regression. The primary outcome was the rate of postpartum hemorrhage by blood type (A, B, AB, and O), defined as blood loss >500 mL in vaginal delivery and >1000 mL in cesarean delivery. 43,437 patients were screened and 32,023 women met inclusion criteria (22,484 vaginal deliveries (70.2%) and 9539 cesarean deliveries (29.8%)). RESULTS: In the vaginal delivery group there were differences in age, parity, race, use of regional anesthesia, rate of induction of labor, and thrombocytopenia between blood types. In the cesarean delivery group, age, parity, and race were significantly different between blood types. There was no observed difference in the rate of postpartum hemorrhage by blood type for those who delivered via vaginal delivery when controlling for demographic differences (p = 0.2). In the cesarean delivery group, there was a significantly higher rate of postpartum hemorrhage in women with type O blood (5.2% type O vs 3.8% type A vs 4.4% type B vs 4.2% type AB, p = 0.035), including when controlling for demographic differences (p = 0.02). In both vaginal and cesarean delivery groups, there was no difference in rates of any of the secondary outcomes, including blood transfusion, hysterectomy, intrapartum dilation and curettage, and intensive care unit admission. CONCLUSION: Although this study found no statistically significant difference in clinical outcomes between blood types, type O blood may be an additional risk factor to consider for postpartum hemorrhage at the time of cesarean delivery.

Medication nonadherence and treatment outcome in patients with schizophrenia or schizoaffective disorder with suboptimal prior response.

OBJECTIVE: To examine the impact of medication nonadherence on treatment outcome in schizophrenia and potential risk factors for nonadherence. METHOD: A post hoc analysis of a randomized, double-blind, 8-week, fixed-dose study comparing olanzapine 10, 20, and 40 mg/day for patients with schizophrenia or schizoaffective disorder (DSM-IV criteria) with suboptimal response to current treatment (N = 599) was conducted between September 12, 2003, and November 3, 2005, at 55 study centers in the United States. Nonadherence was defined as not taking medication as prescribed based on daily pill counts. Because there was no significant difference in nonadherence between dose groups, effects of nonadherence on efficacy and safety outcomes were examined using all 3 groups combined. Baseline demographics and symptom severity were investigated as potential risk factors for nonadherence. RESULTS: During the 8-week study, 34.5% of patients were nonadherent at least once. Nonadherent patients had significantly less improvement compared to adherent patients as measured by change in Positive and Negative Syndrome Scale total score (-22.57 vs. -26.84, p = .002). Longer duration of nonadherence was associated with reduced likelihood of treatment response (odds ratio = 0.94, 95% CI = 0.90 to 0.99, p = .008). The early treatment discontinuation rate was higher in nonadherent compared to adherent patients (40.8% vs. 24.5%, p < .001). Adherent and nonadherent patients had comparable outcomes in most safety measures, except for weight change, for which adherent patients had greater weight gain than nonadherent patients (2.63 kg vs. 1.96 kg, p = .02). Greater depression severity at baseline (p = .01) and greater hostility level during the study were significant risk factors for nonadherence (p = .02). CONCLUSIONS: Medication nonadherence had a significantly negative impact on treatment response, highlighting the importance of adherence to achieve satisfactory treatment outcome. Findings may also help clinicians identify patients at risk for nonadherence and utilize interventions to improve adherence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00100776.

Depression and pain.

Depression and pain disorders are often diagnosed in the same patients. Here we summarize the shared pathophysiology between both disorders and the importance of addressing all symptoms in patients with comorbid pain and depression. We describe anatomical structures that are activated and/or altered in response to both depression and pain--examples include the insular cortex, the prefrontal cortex, the anterior cingulate cortex, the amygdala, and the hippocampus. Both disorders activate common neurocircuitries (e.g. the hypothalamic-pituitary-adrenal axis, limbic and paralimbic structures, ascending and descending pain tracks), common neurochemicals (e.g. monoamines, cytokines, and neurotrophic factors), and are associated with common psychological alterations. One explanation for the interaction and potentiation of the disease burden experienced by patients affected by both pain and depression is provided by the concept of allostasis. In this model, patients accumulate allostatic load through internal and external stressors, which makes them more susceptible to disease. To break this cycle, it is important to treat all symptoms of a patient. Therapeutic approaches that address symptoms of both depression and pain include psychotherapy, exercise, and pharmacotherapy.

Safety and efficacy of duloxetine in the treatment of diabetic peripheral neuropathic pain in older patients.

OBJECTIVE: We present a post-hoc analysis of the safety and efficacy of duloxetine, a selective serotonin/norepinephrine reuptake inhibitor, for treatment of diabetic peripheral neuropathic pain (DPNP) in older patients. METHODS: Data from three double-blind, placebo-controlled trials in adult patients with DPNP were pooled and stratified by age (<65, >or=65 years). Patients were randomized to duloxetine (DLX) 60 mg once-daily, 60 mg twice-daily, or placebo for 12 weeks, followed by a 52-week extension phase (re-randomization to routine care or DLX 120 mg/day). Intent-to-treat analyses were used for safety and efficacy assessment. RESULTS: In the acute phase, overall TEAE rates did not differ significantly by age. A greater percentage of older patients discontinued due to TEAEs (P<0.001), regardless of treatment group. Duloxetine improved weekly mean 24-hour average pain scores versus placebo in both age groups (P<0.01). In the extension phase, a significant therapy-by-age interaction (P<0.05) was observed in overall TEAE rate; with routine care, 86.6% of older patients had >or=1 TEAE versus 74.6% of younger patients. CONCLUSIONS: Although TEAEs more frequently lead to discontinuation in older patients, duloxetine was well tolerated and efficacious for treatment of DPNP regardless of age. These data suggest duloxetine may be beneficial for treatment of DPNP in patients>or=65.

Standard and higher dose of olanzapine in patients with schizophrenia or schizoaffective disorder: a randomized, double-blind, fixed-dose study.

The objective of this study was to assess the dose-response relationship of standard and higher doses of olanzapine in a randomized, double-blind, 8-week, fixed-dose study comparing olanzapine 10 (n = 199), 20 (n = 200), and 40 mg/d (n = 200) for patients with schizophrenia or schizoaffective disorder and suboptimal response to current treatment. Patients meeting criteria for antipsychotic treatment resistance were excluded. Dose-response relationship was assessed by linear regression analysis with log-transformed dose (independent variable) and Positive and Negative Syndrome Scale (PANSS) total score (dependent variable). There were no significant dose group differences in patients completing the study (overall, 67.8%). All dose groups showed statistically significant improvement in PANSS total scores from baseline to end point without significant dose-response relationship (P = 0.295). Post hoc analysis of response showed significant interaction between baseline PANSS and dose (P = 0.023), indicating better response at higher doses for patients with higher baseline PANSS. There was a significant dose response for mean change in weight (P = 0.003) with significant difference between the 10- and 40-mg-dose groups (P = 0.002; 1.9 [10 mg/d], 2.3 [20 mg/d], and 3.0 kg [40 mg/d]). There was a significant dose response for change in prolactin (P < 0.001) with a significant difference between each group (-10.5 [10 mg/d], -1.7 [20 mg/d], and 4.9 ng/mL [40 mg/d]; P < or = 0.018). Over 8 weeks, non-treatment-resistant patients with schizophrenia or schizoaffective disorder responded to all 3 doses of olanzapine, without a statistically significant dose-response relationship, suggesting that for many patients with schizophrenia or schizoaffective disorder, particularly those who are mildly or moderately ill, 10 mg/d should be the initial dose of choice.

Double-blind, randomized trial comparing efficacy and safety of continuing olanzapine versus switching to quetiapine in overweight or obese patients with schizophrenia or schizoaffective disorder.

We examined the potential risks and benefits of switching from olanzapine to quetiapine in mentally stable, obese, or overweight patients with schizophrenia or schizoaffective disorder. Patients receiving olanzapine were randomized to continuing olanzapine treatment (N =68; 7.5-20 mg/day) or switching to quetiapine (N =65; 300-800 mg/day). Time to relapse was the primary study objective; secondary objectives included changes in weight, metabolic parameters, and psychiatric symptoms, and discontinuation rates. No significant difference in time to relapse was observed (p =0.293), but significantly more patients remained on treatment in the olanzapine group compared with the quetiapine group (70.6% vs 43.1%; p =0.002). Olanzapine-treated patients had significantly lower rates of study discontinuation for lack of efficacy and psychiatric adverse events (AEs) compared to quetiapine (2.94% vs 15.38%, p =0.015). Significantly more patients in the olanzapine group experienced an increase in BMI ≥1 kg/m(2). Olanzapine-treated patients experienced significantly greater increases in weight from Weeks 2 through 13. Switching patients with stable disease from olanzapine to quetiapine did not significantly shorten time to relapse, but produced more frequent study discontinuations due to lack of efficacy or psychiatric AEs with moderate but variable improvement in weight and no significant between-group differences in mean changes in metabolic laboratory parameters.