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BACKGROUND AND OBJECTIVES Bilateral subthalamic nucleus deep brain stimulation (STN DBS) in Parkinson's disease (PD) can have detrimental effects on eye movement inhibitory control. To investigate this detrimental effect of bilateral STN DBS, we examined the effects of manipulating STN DBS amplitude on inhibitory control during the antisaccade task. The prosaccade error rate during the antisaccade task, that is, directional errors, was indicative of impaired inhibitory control. We hypothesized that as stimulation amplitude increased, the prosaccade error rate would increase. MATERIALS AND METHODS Ten participants with bilateral STN DBS completed the antisaccade task on six different stimulation amplitudes (including zero amplitude) after a 12-hour overnight withdrawal from antiparkinsonian medication. RESULTS We found that the prosaccade error rate increased as stimulation amplitude increased (p

Distinguishing postpartum women with bipolar from unipolar depression remains challenging, particularly in obstetrical and primary care settings. The post-birth period carries the highest lifetime risk for the onset or recurrence of Bipolar Disorder (BD). Characterization of differences between unipolar and bipolar depression symptom presentation and severity is critical to differentiate the two disorders.We performed a secondary analysis of a study of 10,000 women screened by phone with the Edinburgh Postnatal Depression Scale at 4-6 weeks post-birth. Screen-positive mothers completed the Structured Clinical Interview for DSM-4 and those diagnosed with BD and unipolar Major Depressive Disorder (UD) were included. Depressive symptoms were assessed with the 29-item Structured Interview Guide for the Hamilton Rating Scale for Depression (SIGH-ADS).The sample consisted of 728 women with UD and 272 women with BD. Women with BD had significantly elevated levels of depression severity due to the higher scores on 8 of the 29 SIGH-ADS symptoms. Compared to UD, women with BD had significantly higher rates of comorbid anxiety disorders and were twice as likely to report sexual and/or physical abuse.Only women who screened positive for depression were included in this analysis. Postpartum women with unstable living situations, who were hospitalized or did not respond to contact attempts did not contribute data.Severity of specific symptom constellations may be a useful guide for interviewing postpartum depressed women along with the presence of anxiety disorder comorbidity and physical and/or sexual abuse.

Minimization is among the most common methods for controlling baseline covariate imbalance at the randomization phase of clinical trials. Previous studies have found that minimization does not preserve allocation randomness as well as other methods, such as minimal sufficient balance, making it more vulnerable to allocation predictability and selection bias. Additionally, minimization has been shown in simulation studies to inadequately control serious covariate imbalances when modest biased coin probabilities (≤0.65) are used. This current study extends the investigation of randomization methods to the analysis phase, comparing the impact of treatment allocation methods on power and bias in estimating treatment effects on a binary outcome using logistic regression. Power and bias in the estimation of treatment effect was found to be comparable across complete randomization, minimization, and minimal sufficient balance in unadjusted analyses. Further, minimal sufficient balance was found to have the most modest impact on power and the least bias in covariate-adjusted analyses. The minimal sufficient balance method is recommended for use in clinical trials as an alternative to minimization when covariate-adaptive subject randomization takes place.

Major depressive disorder (MDD) is more common in women than in men, and evidence of gender-related subtypes of depression is emerging. Previously identified blood-based transcriptomic biomarkers distinguished male and female subjects with MDD from those without the disorder. In the present pilot study, we investigated the performance of these biomarkers in pregnant and postpartum women with prior major depressive episodes, some of whom had current symptomatology. The symptom scores of 13 pregnant and 15 postpartum women were identified by the Inventory of Depressive Symptoms (IDS-SR-30) at the time of blood sampling. Blood levels of the 20 transcriptomic biomarkers and that of estrogen receptor 2 (ESR2), membrane progesterone receptor alpha and beta (mPRα, mPRβ) were measured. In pregnant women, transcript levels of ADCY3, ASAH1, ATP11C, CDR2, ESR2, FAM46A, mPRβ, NAGA, RAPH1, TLR7, and ZNF291/SCAPER showed significant association with IDS-SR-30 scores, of which ADCY3, FAM46A, RAPH1, and TLR7 were identified in previous studies for their diagnostic potential for major depression. ASAH1 and ATP11C were previously also identified as potential markers of treatment efficacy. In postpartum women, transcript levels of CAT, CD59, and RAPH1 demonstrated a trend of association with IDS-SR-30 scores. Transcript levels of ADCY3, ATP11C, FAM46A, RAPH1, and ZNF291/SCAPER correlated with ESR2 and mPRβ expressions in pregnant women, whereas these associations only existed for mPRβ in postpartum women. These results suggest that a blood biomarker panel can identify depression symptomatology in pregnant women and that expression of these biomarker genes are affected by estrogen and/or progesterone binding differently during pregnancy and postpartum.

Major depressive disorder (MDD) is a common disorder in pregnancy. Although sertraline is the most frequently prescribed antidepressant for pregnant people in the United States, limited information about its pharmacokinetics in pregnancy is available. Our objectives were to characterize plasma sertraline concentration to dose (C/D) ratios across pregnancy and postpartum and investigate the effect of pharmacogenetic variability on sertraline elimination. We performed a prospective observational cohort study in people with a singleton pregnancy ≤ 18 weeks gestation and a lifetime diagnosis of MDD at the 3 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)-funded Obstetrical-Fetal Pharmacology Research Center sites. Subjects (N = 47) were receiving maintenance sertraline therapy and chose to continue it during pregnancy. Blood samples were obtained 24-hours postdose every 4 weeks across pregnancy and twice postpartum for measurement of plasma concentrations of sertraline and desmethylsertraline. Overall mean sertraline C/D ratios were decreased at study onset and remained consistently low until after delivery. During the last 4 weeks of pregnancy the mean sertraline C/D ratio (95% confidence interval (CI)), 0.25 (95% CI, 0.19, 0.3) ng/mL/dose (mg/day), was smaller than the mean ratio at ≥ 8 weeks after delivery, 0.32 (95% CI, 0.27, 0.37) ng/mL/dose (mg/day), a 22% difference. Mean sertraline/desmethylsertraline ratios were highest after birth, which confirmed increased sertraline elimination during pregnancy. Sertraline C/D ratios in participants with functional CYP2C19 activity did not change significantly during pregnancy, whereas ratios in participants with poor or intermediate CYP2C19 activity decreased by 51%. Exploratory pharmacogenomic analysis indicated that pregnant people with poor or intermediate CYP2C19 activity are at risk for subtherapeutic sertraline concentrations during pregnancy.

Over half of patients with elevated blood pressure require multi-drug treatment to achieve blood pressure control. However, multi-drug treatment may lead to lower adherence and more adverse drug effects compared with monotherapy.The Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET) USA trial was designed to evaluate whether initiating treatment with ultra-low-dose quadruple-combination therapy will lower office blood pressure more effectively, and with fewer side effects, compared with initiating standard dose monotherapy in treatment naive patients with SBP180 and DBP110 mm Hg and patients on monotherapy with SBP160 and DBP100 mm Hg.QUARTET USA was a prospective, randomized, double-blind trial (ClinicalTrials.gov NCT03640312) conducted in federally qualified health centers in a large city in the US. Patients were randomly assigned (1:1) to either ultra-low-dose quadruple combination therapy or standard dose monotherapy. The primary outcome was mean change from baseline in office systolic blood pressure at 12-weeks, adjusted for baseline values. Secondary outcomes included measures of blood pressure change and variability, medication adherence, and health related quality of life. Safety outcomes included occurrence of serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. A process evaluation aimed to understand provider experiences of implementation and participant experiences around side effects, adherence, and trust with clinical care.QUARTET USA was designed to evaluate whether a novel approach to blood pressure control would lower office blood pressure more effectively, and with fewer side effects, compared with standard dose monotherapy. QUARTET USA was conducted within a network of federally qualified healthcare centers with the aim of generating information on the safety and efficacy of ultra-low-dose quadruple-combination therapy in diverse groups that experience a high burden of hypertension.

Background Communication in the pediatric intensive care unit (PICU) between families and the health care team affects the family experience, caregiver psychological morbidity, and patient outcomes. Objective To test the feasibility of studying and implementing a PICU communication intervention called PICU Supports, and to assess families’ and health care teams’ perceptions of the intervention. Methods This study involved patients requiring more than 24 hours of PICU care. An interventionist trained in PICU-focused health care navigation, a “navigator,” met with parents and the health care team to discuss communication, decision-making, emotional, informational, and discharge or end-of-life care needs; offered weekly family meetings; and checked in with parents after PICU discharge. The feasibility of implementing the intervention was assessed by tracking navigator activities. Health care team and family perceptions were assessed using surveys, interviews, and focus groups. Results Of 53 families approached about the study, 35 (66%) agreed to participate. The navigator met with parents on 71% and the health care team on 85% of possible weekdays, and completed 86% of the postdischarge check-ins. Family meetings were offered to 95% of eligible patients. The intervention was rated as helpful by 97% of parents, and comments during interviews were positive. Conclusions The PICU Supports intervention is feasible to implement and study and is viewed favorably by parents.

IMPORTANCE: The extent of clinician-level variation in the overuse of testing or treatment in older adults is not well understood. OBJECTIVE: To examine clinician-level variation for three new measures of potentially inappropriate use of medical services in older adults. DESIGN: Retrospective analysis of overall means and clinician-level variation in performance on three new measures. SUBJECTS: Adults aged 65 years and older who had office visits with outpatient primary or immediate care clinicians within a single academic medical center health system between July 1, 2016, and June 30, 2017. MEASURES: Two electronic clinical quality measures representing potentially inappropriate use of medical services in older adults: prostate-specific antigen testing against guidelines (PSA) in men aged 76 and older; urinalysis or urine culture for non-specific reasons in women aged 65 and older; and one intermediate outcome measure: hemoglobin A1c less than 7.0 in adults aged 75 and older with diabetes mellitus treated with insulin or oral hypoglycemic medication. RESULTS: Sixty-nine clinicians and 2009 patients contributed observations to the PSA measure, 144 clinicians and 5933 patients contributed to the urinalysis/urine culture measure, and 42 clinicians and 665 patients contributed to the diabetes measure. Meaningful clinician-level performance variation was greatest for the PSA measure (intraclass correlation coefficient [ICC] = 0.27), followed by the urinalysis/urine culture measure (ICC = 0.18), and the diabetes measure (ICC = 0.024). The range of possible overuse across clinician quartiles was 8–54% for the PSA measure, 3–35% for the urinalysis/urine culture measure, and 13–49% for the diabetes measure. The odds ratios of overuse in the highest quartile compared with the lowest for the PSA, urinalysis/urine culture, and diabetes measures were 99.3 (95% CI 43 to 228), 15.7 (10 to 24), and 6.0 (3.3 to 11), respectively. CONCLUSIONS: Within the same health system, rates of potential overuse in elderly patients varied greatly across clinicians, particularly for the process measures examined. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-020-05748-8) contains supplementary material, which is available to authorized users.

Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression. An ongoing cluster-randomized trial is comparing the effectiveness of the six-session MB group intervention led by paraprofessionals versus mental health professionals. Twenty percent of all audio-recorded intervention sessions were randomly selected for fidelity checks. Analyses assessed mean facilitator adherence and competency overall, by study arm, and by session; and, examined site, facilitator, and client-specific effects. There were no significant differences found between study arms. Findings show paraprofessionals can deliver MB with similar fidelity as mental health professionals. Electronic supplementary material The online version of this article (10.1007/s10488-020-01022-5) contains supplementary material, which is available to authorized users.

Background Young men who have sex with men (YMSM) are disproportionately impacted by the HIV epidemic in the USA, and a large number of new infections among YMSM occur in the context of main or primary partnerships. At the same time, healthy romantic relationships promote health and wellbeing by improving social support and encouraging healthy behaviors. Thus, we created 2GETHER: a relationship education and HIV prevention program for young male couples. 2GETHER is delivered face-to-face in a university setting and is composed of two group sessions and two individualized skills coaching sessions. We observed strong support of the feasibility, acceptability, and preliminary efficacy of 2GETHER in a pilot trial. Methods We are conducting an attention-matched randomized controlled trial (RCT) to test the efficacy of 2GETHER relative to a control condition based on a well-validated positive affect enhancement program. Enrollment occurred between August 2017 and March 2021 in Chicago and surrounding areas, and we enrolled and randomized 128 dyads (N = 256 individuals). Follow-up is ongoing and we will examine primary and secondary behavioral outcomes at 12 months post-intervention, with interim follow-up at 3, 6, and 9 months post-intervention. The primary biomedical outcome is sexually transmitted infection incidence at a 12-month follow-up. Discussion 2GETHER is innovative in that it places an equal emphasis on relationship skill building and HIV prevention. Thus, the program has the potential to impact numerous health-related outcomes. Despite challenges related to the recruitment of couples and the COVID-19 pandemic, we were able to enroll a robust sample of young male couples with sufficient power to detect effects on study outcomes. Trial registration ClinicalTrials.gov NCT03186534.

Tracking perinatal mood and anxiety disorders is championed by the American Psychiatric Association and the International Marcé Society for Perinatal Mental Health. We conducted this study to examine trajectories of monthly depressive and anxiety symptoms through pregnancy and postpartum.This is a prospective longitudinal observational cohort study of pregnant women interviewed at baseline (≤18th gestational week), every four weeks through delivery and at 6 and 14 weeks postpartum at three urban academic medical centers (Three relatively stable depression trajectories emerged, described as Minimal, Mild, and Subthreshold, in each group across pregnancy. Two of the four anxiety trajectories were stable, including Asymptomatic and Minimal, while the third, termed Breakthrough, was ascending with increasing symptoms and the fourth trajectory, described as Mild, had descending symptoms.Screening for anxiety with depression for pregnant women will yield a comprehensive view of psychiatric symptoms and treatment targets in perinatal women.

To examine associations between high sensitivity C-reactive protein (CRP) concentrations and depressive symptoms in reproductive-aged women with mood disorders. Women (N = 86) with major depressive or bipolar disorder in a specialized mood disorders program provided plasma samples which were analyzed for CRP concentrations and categorized by tertiles (T1, low; T2, middle; T3 high). Depressive symptoms were assessed with the Inventory of Depressive Symptoms. We hypothesized that CRP concentrations would be significantly associated with the following: (1) depressive symptoms; (2) pregnancy, (3) body mass index, and (4) counts of white blood cells and absolute neutrophils and percentage of segmented neutrophils. The distribution of CRP concentrations was highly skewed with a median of 2.45 mg/L and an interquartile range 0.90 - 8.17 mg/L. Elevated plasma levels of CRP were not associated with depressive symptoms, which did not differ by tertile group either before or after adjusting for BMI, pregnancy status, and their interactions. Women in T3 had 5 times greater odds of pregnancy compared to women in T1 (p = .021). However, women in T2 had 11% greater BMI on average (p = 0.023), and women in T3 had 47% greater BMI compared to those in T1 (p 0.001). Women in T3 had higher mean white blood cell counts than those in T1 and T2, the percentage of neutrophils was higher in T2 and T3 compared to T1, and women in T3 had higher absolute neutrophil counts compared to T1. CRP concentrations varied widely and were significantly elevated in reproductive-aged women with high BMI and current pregnancy, but not with depressive symptoms in this sample of depressed women.

Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician’s input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies.

Background Perinatal depression is a pervasive public health concern that disproportionately affects low-income women and can have negative impacts on parenting and child developmental outcomes. Few interventions focus on preventing perinatal depression. Previous studies suggest that Mothers and Babies is efficacious in preventing the worsening of depressive symptoms and the onset of postpartum depression. This manuscript presents the protocol of the EPIC study (Effects of a Prenatal Depression Preventive Intervention on parenting and young children’s Self-Regulation and Functioning) to test the effects of Mothers and Babies on parenting and child developmental outcomes through 54 months postpartum. EPIC is an observational study that builds on a completed cluster-randomized trial (CRT). Innovations of this study are direct observations of a subsample of mother-child dyads and the inclusion of fathers/caregivers’ variables as moderators of maternal mental health. Methods For this study, we plan to enroll 738 women with children under 30 months old, ≥18 years old, and who speak English or Spanish. Additionally, 429 fathers, partners, or other adult caregivers will be recruited through women participating in the study. Women will be recruited through the parent study (intervention and control participants) or through one of 10 home visiting programs in Illinois (control participants). Data collection will take place through maternal self-report at five time points (when the child is 30, 36, 42, 48, and 54 months), paternal self-report at three time points (when the child is 30, 42, and 54 months), and through mother-child observations at three time points (when the child is 36, 42, and 48 months). Outcome domains include maternal mental health, cognitive-behavioral and parenting skills, and child self-regulation and functioning. Moderators include the contributions of fathers/caregivers, race-ethnicity, and socioeconomic disadvantage. Power and sample size were calculated assuming a two-sided 5% type I error rate and assumed analyses on the individual level. Discussion This study has several key strengths and innovations, as well as great potential significance to influence the long-term trajectories of parenting and child development via prenatal intervention. Trial registration The study was retrospectively registered at ClinicalTrials.gov (Identifier: NCT04296734) on March 5, 2020.

Background Effective quality improvement (QI) strategies are needed for small practices. Objective The objective of this study was to compare practice facilitation implementing point-of-care (POC) QI strategies alone versus facilitation implementing point-of-care plus population management (POC+PM) strategies on preventive cardiovascular care. Design Two arm, practice-randomized, comparative effectiveness study. Participants Small and mid-sized primary care practices. Interventions Practices worked with facilitators on QI for 12 months to implement POC or POC+PM strategies. Measures Proportion of eligible patients in a practice meeting "ABCS" measures: (Aspirin) Aspirin/antiplatelet therapy for ischemic vascular disease, (Blood pressure) Controlling High Blood Pressure, (Cholesterol) Statin Therapy for the Prevention and Treatment of Cardiovascular Disease, and (Smoking) Tobacco Use: Screening and Cessation Intervention, and the Change Process Capability Questionnaire. Measurements were performed at baseline, 12, and 18 months. Results A total of 226 practices were randomized, 179 contributed follow-up data. The mean proportion of patients meeting each performance measure was greater at 12 months compared with baseline: Aspirin 0.04 (95% confidence interval: 0.02-0.06), Blood pressure 0.04 (0.02-0.06), Cholesterol 0.05 (0.03-0.07), Smoking 0.05 (0.02-0.07); P 0.05 for all. Change Process Capability Questionnaire improved slightly, mean change 0.30 (0.09-0.51) but did not significantly differ across arms. Conclusion Facilitator-led QI promoting population management approaches plus POC improvement strategies was not clearly superior to POC strategies alone.

BackgroundNew-onset headache after stroke is common among adult stroke survivors. However, pediatric data are limited. The primary aim of this study was to investigate the prevalence of new-headache after pediatric ischemic stroke. Secondary outcomes were to describe the characteristics of patients experiencing poststroke headache and the association between poststroke headache and stroke recurrence.MethodsWe conducted a single-center retrospective study on children aged 30 days to 18 years with a confirmed radiographic diagnosis of arterial ischemic stroke (AIS) from January 1, 2008, to December 31, 2016. Patients were identified from an internal database, with additional data abstracted from the electronic medical record. Poststroke headache (occurring >30 days after stroke) was identified through electronic searches of the medical record and confirmed by chart review.ResultsOf 115 patients with confirmed AIS, 41 (36%) experienced poststroke headache, with headache developing a median of 6 months after stroke. Fifty-one percent of patients with poststroke headache presented to the emergency department for headache evaluation; 81% of the patients had an inpatient admission for headache. Older age at stroke (odds ratio [OR] 21.5; p = 0.0001) and arteriopathy (OR 8.65; p = 0.0029) were associated with development of poststroke headache in a multivariable analysis. Seventeen patients (15%) had a recurrent stroke during the study period. Poststroke headache was associated with greater risk for stroke recurrence (p = 0.049).ConclusionsRemote poststroke headache is a common morbidity among pediatric stroke survivors, particularly in older children. Headaches may increase health care utilization, including neuroimaging and hospital admissions. We identified a possible association between poststroke headache and stroke recurrence.

Background Postpartum depression is a heterogeneous disorder in phenotype and etiology. Characterizing the longitudinal course of depressive symptoms over the first year after birth and identifying variables that predict distinct symptom trajectories will expedite efficient mental health treatment planning. The purpose was to determine 12-month trajectories of postpartum depressive symptoms, identify characteristics that predict the trajectories, and provide a computational algorithm that predicts trajectory membership. Methods A prospective cohort of women delivering at an academic medical center (2006-2011) was recruited from an urban women's hospital in Pittsburgh, PA. Women with a postpartum depressive disorder (n = 507) participated and completed symptom severity assessments at 4-8 weeks (intake), 3 months, 6 months, and 12 months. Women were predominantly Caucasian (71.8%), married (53.3%), and college educated (38.7%). Clinician interviews of depressive symptom severity, medical and psychiatric history, assessment of function, obstetric experience, and infant status were conducted. Results Analyses resulted in identification of three distinct trajectories of depressive symptoms: (1) gradual remission (50.4%), (2) partial improvement (41.8%), and (3) chronic severe (7.8%). Key predictive characteristics of the chronic severe versus gradual remission and partial improvement trajectories included parity, education, and baseline global functioning and depression severity. We were able to predict trajectory membership with 72.8% accuracy from these characteristics. Conclusions Four maternal characteristics predicted membership in the chronic severe versus gradual remission and partial improvement trajectories with 72.8% accuracy. The trajectory groups comprise clinically relevant subgroups with the potential for tailored treatments to reduce the disease burden of postpartum depression.

The study evaluated whether implementation of perinatal collaborative care is associated with improvements in screening and treatment recommendations for perinatal depression by obstetric clinicians.This cohort study, conducted from January 2015 to January 2019, included all women who received prenatal care in five obstetric clinics and delivered at a single quaternary care hospital in Chicago. In January 2017, a perinatal collaborative care program (COMPASS) was implemented. Completion of depression screening and recommendations for treatment following a positive depression screen were compared before and after COMPASS implementation. Adjusted analyses included inverse probability weighting by using propensity scores to impose control over imbalance between exposure groups with respect to prespecified covariates.A total of 7,028 women were included in these analyses: 3,227 (46%) before and 3,801 (54%) after COMPASS implementation. Women who received obstetric care after implementation were significantly more likely than those who received care before implementation to receive antenatal screening for depression (81% versus 33%; adjusted odds ratio [aOR]=8.5, 95% confidence interval [CI]=7.6-9.5). After implementation, women with a positive antenatal screen for depression were more likely to receive a treatment recommendation (61% versus 44%; aOR=2.1, 95% CI=1.2-3.7). After implementation of perinatal collaborative care, combined psychotherapy and pharmacotherapy were more frequently recommended, compared with before implementation.Implementation of a perinatal collaborative care program was associated with improvements in perinatal depression screening and recommendations for treatment by obstetric clinicians.

The objective of this study was to identify differences in the longitudinal course anhedonia symptoms during postpartum in women diagnosed with unipolar or bipolar disorder. Female participants diagnosed with either bipolar (n = 104) or unipolar (n = 136) depression at week 20 during pregnancy were evaluated prospectively at weeks 2, 12, 26, and 52 postpartum using clinical interviews. A semi-parametric, group-based mixture model was applied to separate distinct longitudinal patterns of symptoms of anhedonia. Across time, among those who reported anhedonia, twice as many women had the diagnoses of bipolar depression relative to unipolar depression (65.03% versus 39.47%, respectively). Moreover, the rate and stability of anhedonia was higher in women with bipolar relative to unipolar depression. Across groups, anhedonia was associated with significantly higher depressive symptom severity. Anhedonia is a more stable and frequent symptom in women with postpartum bipolar relative to unipolar depressive disorder.

The purpose of this study was to examine Electronic Nicotine Delivery Systems (ENDS) use among nonusers in diverse college students. Participants: Participants were college students enrolled at a H...

BACKGROUND The prevention of postpartum depression is an important area of investigation given its association with major maternal and neonatal sequelae, yet few evidence-based treatments to reduce the frequency of postpartum depression are used. Recent data suggest that N-methyl-D-aspartate receptor antagonists may lead to rapid improvement of depressive symptoms lasting up to 2 weeks. We hypothesized that the N-methyl-D-aspartate receptor antagonist magnesium sulfate would elicit antidepressant effects subsequent to its receipt by women receiving peripartum seizure prophylaxis for a hypertensive disorder of pregnancy. OBJECTIVE This study aimed to compare the frequency of depressive symptoms at 2 weeks and 6 weeks after delivery between women who did and did not receive peripartum magnesium sulfate for a hypertensive disorder of pregnancy. STUDY DESIGN This prospective cohort study included women with a hypertensive disorder of pregnancy at ≥34 weeks’ gestation with singleton gestations. Magnesium sulfate for seizure prophylaxis was administered at the obstetrician's discretion. The Quick Inventory of Depressive Symptomatology survey was administered before hospital discharge and again at 2 weeks and 6 weeks after delivery to assess for postpartum depressive symptoms. The primary outcome for this study was the change in Quick Inventory of Depressive Symptomatology score from baseline to 2 weeks after delivery, which was analyzed both continuously and categorically (any symptom worsening vs stability or improvement). Secondary outcomes included the change in Quick Inventory of Depressive Symptomatology score from baseline to 6 weeks after delivery and the proportion of women who experienced an increase in Quick Inventory of Depressive Symptomatology score at 6 weeks after delivery. RESULTS Of the 342 women enrolled, 39% (n=134) received magnesium sulfate. Compared with women who did not receive magnesium, women who received magnesium had a significantly smaller change in their mean Quick Inventory of Depressive Symptomatology score (0.6±3.4 vs 1.6±3.0; P=.015) and also were less likely to have an increase in Quick Inventory of Depressive Symptomatology score at 2 weeks after delivery (52% vs 67%; P=.022). These differences were not present at 6 weeks after delivery. After controlling for potential confounders, women who received magnesium continued to have a lower odds of having an increased Quick Inventory of Depressive Symptomatology score from baseline at 2 weeks after delivery than women who did not receive magnesium (adjusted odds ratio, 0.88; 95% confidence interval, 0.78–0.98). CONCLUSION Peripartum magnesium was associated with less of an exacerbation in depressive symptoms in the immediate postpartum period. Given the implications of postpartum depression on maternal and child health and the lack of existing prophylaxis, randomized trials should examine this novel potential prophylactic therapy.

To determine whether pregnant women receiving the Mothers and Babies group–based intervention exhibited greater depressive symptom reductions and fewer new cases of major depression than women receiving usual community-based services, and to examine whether groups run by paraprofessional home visitors and mental health professionals yielded similar depressive symptom reductions and prevention of major depression. Using a cluster-randomized design, 37 home visiting programs were randomized to usual home visiting, Mothers and Babies delivered via home visiting paraprofessionals, or Mothers and Babies delivered via mental health professionals. Baseline assessments were conducted prenatally with follow-up extending to 24 weeks postpartum. Eligibility criteria were ≥ 16 years old, ≤ 33 gestation upon referral, and Spanish/English speaking. Depressive symptoms at 24 weeks postpartum was the primary outcome. Eight hundred seventy-four women were enrolled. Neither intervention arm was superior to usual care in decreasing depressive symptoms across the sample (p = 0.401 home visiting paraprofessional vs. control; p = 0.430 mental health professional vs. control). Post hoc analyses suggest a positive intervention effect for women exhibiting mild depressive symptoms at baseline. We have evidence of non-inferiority, as the model-estimated mean difference in depressive symptoms between intervention arms (0.01 points, 95% CI: −0.79, 0.78) did not surpass our pre-specified margin of non-inferiority of two points. Although we did not find statistically significant differences between intervention and control arms, non-inferiority analyses found paraprofessional home visitors generated similar reductions in depressive symptoms as mental health professionals. Additionally, Mothers and Babies appears to reduce depressive symptoms among women with mild depressive symptoms when delivered by mental health professionals. This trial is registered on ClinicalTrials.gov (initial post: December 1, 2016; identifier: NCT02979444).

Some women are vulnerable to developing new onset obsessive–compulsive disorder (OCD) or having an exacerbation of pre-existing OCD during reproductive cycle events. Reports on the impact of the peripartum period on pre-existing OCD are inconsistent, with both worsening and improving symptom severity described. Studies have primarily been retrospective or have collected few data points, which limits the investigators’ ability to capture the range of OCD symptoms during this time period, systematically and prospectively. The objective of this investigation was to add to the existing literature on the impact of the peripartum period on the course of pre-existing OCD. We conducted a secondary analysis of a subset data from the Brown Longitudinal Obsessive Compulsive Study, a prospective, observational study of OCD course. Nineteen women who experienced a pregnancy during the course of the study (9.5% of overall sample of women) were followed on average for 486 ± 133 weeks. Weekly psychiatric status ratings (PSRs) of OCD severity were compared between peripartum and non-peripartum periods. We found that the peripartum period did not significantly impact the course of OCD severity in the majority of women (N = 13, 69%). Of the minority of women with measurable variability in OCD symptoms, no statistically significant difference in PSR scores was observed between peripartum and non-peripartum periods. In this novel yet small dataset, the severity of OCD does not appear to worsen for most women during the peripartum period.

Objectives Communication breakdowns in PICUs contribute to inadequate parent support and poor post-PICU parent outcomes. No interventions supporting communication have demonstrated improvements in parental satisfaction or psychologic morbidity. We compared parent-reported outcomes from parents receiving a navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure. Design Patient-level, randomized trial. Setting Two university-based, tertiary-care children's hospital PICUs. Participants Parents of patients requiring more than 24 hours in the PICU. Interventions PICU Supports included adding a trained navigator to the patient's healthcare team. Trained navigators met with parents and team members to assess and address communication, decision-making, emotional, informational, and discharge or end-of-life care needs; offered weekly family meetings; and did a post-PICU discharge parent check-in. The comparator arm received an informational brochure providing information about PICU procedures, terms, and healthcare providers. Measurements and main results The primary outcome was percentage of "excellent" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge. Secondary outcomes included parental psychologic and physical morbidity and perceptions of team communication. We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure. Fifty-seven percent (216/382) completed the 3-5 weeks post-PICU discharge survey. The mean percentage of excellent responses to the Pediatric Family Satisfaction in the ICU 24 decision-making items was 60.4% for PICU Supports versus 56.1% for the brochure (estimate, 3.57; SE, 4.53; 95% CI, -5.77 to 12.90; p = 0.44). Differences in secondary outcomes were not statistically significant. Most parents (91.1%; 113/124) described PICU Supports as "extremely" or "somewhat" helpful. Conclusions Parents who received PICU Supports rated the intervention positively. Differences in decision-making satisfaction scores between those receiving PICU Supports and a brochure were not statistically significant. Interventions like PICU Supports should be evaluated in larger studies employing enhanced recruitment and retention of subjects.

Covariate constrained randomization (CCR) is a method of controlling imbalance in important baseline covariates in cluster-randomized trials (CRT). We use simulated CRTs to investigate the performance (control of imbalance) of CCR relative to simple randomization (SR) under conditions of misspecification of the cluster-level variable used in the CCR algorithm. We use data from a Patient-Centered Outcomes Research Institute (PCORI)-funded CRT evaluating the Mothers and Babies (MB) intervention (AD-1507-31,473). CCR methodology was used in the MB study to control imbalance in, among other baseline variables, the percent minority (i.e., non-White) participants at each study site. Simulation schemes explored variation in degree of misspecification in the baseline covariate of interest, and include correct report, observed misspecification, and a range of simulated misspecification for intervals within and beyond that observed in the MB study. We also consider three within-site sample size scenarios: that observed in the MB study, small (mean 10) and large (mean 50). Simulations at every level of baseline covariate misspecification suggest that use of the CCR strategy provides between-arm imbalance that is simultaneously lower and less variable, on average, than that produced from the SR strategy. We find that the gains to using CCR over SR are nearly twice as high with accurate reporting (Δ = −5.33) compared to the observed study-level misspecification (Δ = −3.03). Although CCR still outperforms SR as the level of misspecification increases, the gains to using CCR over SR decrease; thus, every effort should still be made to obtain high-quality baseline data.

Objective Low back pain accounts for nearly 4 million emergency department (ED) visits annually and is a significant source of disability. Physical therapy has been suggested as a potentially effective nonopioid treatment for low back pain; however, no studies to our knowledge have yet evaluated the emerging resource of ED-initiated physical therapy. The study objective was to compare patient-reported outcomes in patients receiving ED-initiated physical therapy and patients receiving usual care for acute low back pain. Methods This was a prospective observational study of ED patients receiving either physical therapy or usual care for acute low back pain from May 1, 2018, to May 24, 2019, at a single academic ED (>91,000 annual visits). The primary outcome was pain-related functioning, assessed with Oswestry Disability Index (ODI) and Patient-Reported Outcomes Measurement Information System pain interference (PROMIS-PI) scores. The secondary outcome was use of high-risk medications (opioids, benzodiazepines, and skeletal muscle relaxants). Outcomes were compared over 3 months using adjusted linear mixed and generalized estimating equation models. Results For 101 participants (43 receiving ED-initiated physical therapy and 58 receiving usual care), the median age was 40.5 years and 59% were women. Baseline outcome scores in the ED-initiated physical therapy group were higher than those in the usual care group (ODI = 51.1 vs 36.0; PROMIS-PI = 67.6 vs 62.7). Patients receiving ED-initiated physical therapy had greater improvements in both ODI and PROMIS-PI scores at the 3-month follow-up (ODI = −14.4 [95% CI = −23.0 to −5.7]; PROMIS-PI = −5.1 [95% CI = −9.9 to −0.4]) and lower use of high-risk medications (odds ratio = 0.05 [95% CI = 0.01 to 0.58]). Conclusion In this single-center observational study, ED-initiated physical therapy for acute low back pain was associated with improvements in functioning and lower use of high-risk medications compared with usual care; the causality of these relationships remains to be explored. Impact ED-initiated physical therapy is a promising therapy for acute low back pain that may reduce reliance on high-risk medications while improving patient-reported outcomes. Lay Summary Emergency department–initiated physical therapy for low back pain was associated with greater improvement in functioning and lower use of high-risk medications over 3 months.