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Background : Studies exploring disability in bipolar disorder (BD) have primarily assessed clinical samples of full-threshold BD-I and BD-II alongside so-called objective criteria such as unemployment or receipt of government disability payments. This study extends research on disability by examining externally determined and self-identified disability in a community sample and by including subthreshold BD (BDS). Methods : Data were extracted from the USA Collaborative Psychiatric Epidemiology Surveys about individuals who met recognized criteria for BD-I, BD-II and BDS who had completed self-ratings of physical and mental disability, comorbidities, and health risk factors (e.g., obesity). Rates of disability were estimated, and logistic regression analyses were used to determine demographic and clinical variables associated with externally determined and self-identified of disability. Results : Of 408 individuals who met eligibility criteria (BD-I = 100; BD-II=104; BDS=204), 35% met criteria for externally determined disability, about 40% self-reported mental disability and about 23% self-reported physical disability. The odds were three-fold (Odds Ratio (OR): 3.05; 95% Confidence Intervals (CI): 1.69, 5.53) that someone with self-identified physical disability would meet criteria for externally determined disability, but associations with mental disability were non-significant (OR: 1.06; 95% CI: 0.63, 1.80). Regression analyses demonstrated that mental disability was associated with being a current or past smoker and physical disability was associated with BD-I. Limitations : the adequacy of the assessments of disability and definition of BDS can be questioned. Conclusions : Future clinical and community studies need to consider both externally determined and self-identified disability across the entire Bd spectrum.

Non-response to first-line treatment for major depressive disorder (MDD) is common; for such individuals, quality of life (QoL) impairments can be severe. Identifying predictors of QoL changes may support the management of cases with persistent depressive symptoms despite adequate initial pharmacological/psychological treatment. The present study aimed to explore predictors of domain-specific QoL improvement following adjunctive aripiprazole treatment for inadequate response to initial antidepressant therapy. We evaluated secondary QoL outcomes from a CAN-BIND (Canadian Biomarker Integration Network in Depression) study in patients with MDD who did not respond to an initial 8 weeks of escitalopram and received a further 8 weeks of adjunctive aripiprazole (n = 96). Physical, psychological, social, and environmental QoL domains were assessed using the World Health Organization QoL Scale Brief Version (WHOQOL-BREF). Clinician-rated depressive symptoms were assessed using the Montgomery–Asberg Depression Rating Scale (MADRS). Functioning was measured with the Sheehan Disability Scale (SDS). Satisfaction with medication was assessed with a single item from the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF). Exploratory t-tests were used to describe domain score changes. A hierarchical linear regression was used to explore demographic, clinical, and treatment-related predictors of improvement. Across domains, QoL improved with adjunctive aripiprazole treatment. Satisfaction with medication and MADRS and SDS scores similarly improved. Symptom reduction was a predictor for positive change to physical and psychological QoL; functioning improvements were predictive of increases to all QoL domains. Satisfaction with medication predicted improvements to physical and psychological domains, whereas number of medication trials was a predictor of worsening QoL in the physical domain. The final model explained the most variance in psychological (68%) and physical (67%) QoL. Less variance was explained for environmental (43%) and social QoL (33%), highlighting a need for further exploration of predictors in these domains. Strategies such as functional remediation may have potential to support QoL for individuals with persistent depressive symptoms. ClinicalTrials.gov identifier: NCT016557.

Introduction Many individuals with major depressive disorder (MDD) do not respond to initial antidepressant monotherapy. Adjunctive aripiprazole is recommended for treatment non-response; however, the impacts on quality of life (QoL) for individuals who receive this second-line treatment strategy have not been described. Methods We evaluated secondary QoL outcomes in patients with MDD (n=179). After 8 weeks of escitalopram, non-responders ( Results Escitalopram responders experienced the most QoL improvements in the first treatment phase. For non-responders, QoL improved with a large effect during adjunctive aripiprazole treatment. At the endpoint, 47% of patients achieving symptomatic remission still had impaired QoL. Discussion Individuals who were treated with adjunctive aripiprazole after non-response to escitalopram experienced improved QoL, but a substantial degree of QoL impairment persisted. Since QoL deficits may predict MDD recurrence, attention to ways to support this outcome is required.

Curriculum models and training activities in medical education have been markedly enhanced to prepare physicians to address the health needs of diverse populations and to advance health equity. While different teaching and experiential learning activities in the public health and population health sciences have been implemented, there is no existing framework to measure the effectiveness of public and population health (PPH) education in medical education programs. In 2015, the Association of American Medical Colleges established the Expert Panel on Public and Population Health in Medical Education, which convened 20 U.S. medical faculty members whose goal was to develop an evaluation framework adapted from the New World Kirkpatrick Model. Institutional leaders can use this framework to assess the effectiveness of PPH curricula for learners, faculty, and community partners. It may also assist institutions with identifying opportunities to improve the integration of PPH content into medical education programs. In this article, the authors present outcomes metrics and practical curricular or institutional illustrations at each Kirkpatrick training evaluation level to assist institutions with the measurement of (1) reaction to the PPH education content, (2) learning accomplished, (3) application of knowledge and skills to practice, and (4) outcomes achieved as a result of PPH education and practice. A fifth level was added to measure the benefit of PPH curricula on the health system and population health. The framework may assist with developing a locally relevant evaluation to further integrate and support PPH education at U.S. medical schools and teaching hospitals.

Objective To investigate the anxiolytic properties of a standardized extract of Sceletium tortuosum (trademarked-Zembrin® ). Methods Two studies utilized a placebo-controlled, double-blind, between-subject experimental design to investigate the effects of a single dose of Sceletium tortuosum (25 mg, Zembrin® ) on laboratory stress/anxiety responding in 20 young healthy volunteers. To elicit feelings of stress/anxiety, participants completed 20 min of the multitasking framework in study 1 and a 5-min simulated public speaking task in study 2. Study 1 measured subjective experiences of mood at baseline, prestress induction, and poststress induction. Study 2 measured subjective experiences of anxiety and physiological indicators of stress (heart rate [HR] and galvanic skin response) at baseline, prestress induction, during stress induction, and poststress induction. Results A series of analysis of covariances (baseline entered as the covariate) revealed no treatment effect in study 1; however, study 2 revealed subjective anxiety levels to be significantly lower in the Zembrin® group at the prestress induction point and a significant interaction between treatment and time on HR. Taken together, results indicate that a single dose of Zembrin® can ameliorate laboratory stress/anxiety responding in healthy volunteers. Conclusion We provide the first tentative behavioral evidence to support the anxiolytic properties of Sceletium tortuosum (25 mg Zembrin® ).

Background Hepatitis B virus (HBV) screening during pregnancy is standard of care to prevent vertical transmission to infants, yet the mothers themselves may not receive appropriate follow-up. Goals Using a national database, we sought to determine rates of maternal peripartum follow-up with a HBV specialist and identify factors associated with a lack of follow-up. Materials and methods We identified women who delivered in 2000 to 2012 and were diagnosed with HBV according to International Classification of Diseases-9 codes using a national database (Optum) derived from commercial insurance claims with ∼46 million members ages 0 to 64 in all 50 states. Our primary outcome was follow-up during or after pregnancy with a HBV specialist (gastroenterology/infectious diseases). Results The prevalence of HBV was 0.27% (2558/959,747 pregnancies), and median follow-up was 45 months. Only 21% of women had peripartum HBV specialist follow-up. On multivariable regression, predictors of peripartum follow-up at 1-year included younger age [odds ratio (OR), 0.97/y; 95% confidence interval (CI), 0.94, 0.99], Asian race/ethnicity (OR, 1.56 vs. white; 95% CI, 1.13, 2.17), and residing in the Northeast (OR, 1.70; 95% CI, 1.09, 2.66) and Midwest (OR, 1.73; 95% CI, 1.07, 2.81) versus West. Predictors of testing for HBV DNA and alanine aminotransferase at 1 year included Asian race (OR, 1.72; 95% CI, 1.23, 2.41), a primary care physician visit within 2 years of delivery (OR, 1.63; 95% CI, 1.19, 2.22), and peripartum HBV specialist follow-up within 1 year (OR, 15.68; 95% CI, 11.38, 21.60). Conclusions Maternal HBV specialist follow-up rates were extremely low in this large, diverse cohort representing all United States regions. Referral to a HBV specialist was the strongest predictor of appropriate postpartum HBV laboratory testing. Follow-up rates may be even lower in uninsured populations.

Objective: The goal of this study was to validate the French version of the Quality of Life in Bipolar Disorder (QoL.BD) scale, a condition-specific measure for bipolar disorder (BD). Method: The QoL.BD scale was translated into French in accordance with the recommendations for transcultural adaptation. It was administered to 125 participants with BD living in Quebec, Canada. Construct validity was evaluated through correlations with other measures of self-reported quality of life (QoL), functioning, and symptoms. Factorial structure was examined through an exploratory factor analysis. Results: Internal reliability and test–retest reliability standards were met. Correlations in expected directions with other QoL, functioning, and depressive symptom scales supported convergent validity. The item loadings structure of the French QoL.BD largely replicated the original English version, with some modifications. Conclusion: The French version of the QoL.BD (full and brief) is comparable in its psychometric properties to the English version. It is a valid and sound measure for the evaluation of the QoL of French-speaking patients with BD.

Objective: Bright light therapy is increasingly recommended (alone or in combination with antidepressant medication) to treat symptoms of nonseasonal major depressive disorder (MDD). However, little is known about its impacts on quality of life (QoL), a holistic, patient-valued outcome. Methods: This study utilizes secondary outcome data from an 8-week randomized, controlled, double blind trial comparing light monotherapy ( n = 32), fluoxetine monotherapy ( n = 30), and the combination of these ( n = 27) to placebo ( n = 30). QoL was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF). Treatment-related differences in QoL improvements were assessed using a repeated measures analysis of variance. The influence of potential predictors of QoL (demographic variables and change in depressive symptoms) were investigated via hierarchical linear regression. Results: Q-LES-Q-SF scores significantly improved across all treatment conditions; however, no significant differences were observed between treatment arms. QoL remained poor relative to community norms by the end of the trial period: Across conditions, 70.6% of participants had significantly impaired QoL at the 8-week assessment. Reduction in depressive scores was a significant predictor of improved QoL, with the final model accounting for 54% of variance in QoL change scores. Conclusion: The findings of this study emphasize that improvement in QoL and reduction in depressive symptoms in MDD, while related, cannot be taken to be synonymous. Adjunctive therapies may be required to address unmet QoL needs in patients with MDD receiving antidepressant or light therapies. Further research is required to explore additional predictors of QoL in order to better refine treatments for MDD.

Sleep and circadian rhythms have been implicated in the onset, course, and treatment of bipolar disorder. The aim of the present review is to provide an update on emerging understandings of the role of sleep in BD. Recent research in this population has provided further clarity around the prevalence of sleep problems and comorbidities, their relationship to mood symptoms and other clinical features, and their assessment and treatment. A number of important trends are highlighted: the need for more granularity in the characterisation of sleep problems, the potentially disruptive role of commercial sleep monitoring technologies in assessment and treatment, and the urgent need for further research into pharmacological and psychosocial strategies to treat sleep problems in bipolar disorder.

Background Few studies have examined sex-specific associations of maternal gestational glycemia with cord blood hormones, which might predict later health. Methods In 976 women without pre-existing diabetes in the Project Viva cohort, we used linear regression to examine associations of maternal gestational glycemia with cord hormone concentrations, adjusted for maternal characteristics and stratified by infant sex. Results A total of 6.1% of women had gestational diabetes mellitus (GDM), 8.8% isolated hyperglycemia, 3.2% gestational impaired glucose tolerance, and 81.9% were normoglycemic. In boys, compared with infants of normoglycemic mothers, infants of GDM mothers had higher cord levels of IGF-2 (β 35.55 ng/mL; 95% CI: 2.60, 68.50), IGFBP-3 (111.2 ng/mL; 5.53, 216.8), insulin (4.66 uU/mL; 2.38, 6.95), C-peptide (0.46 ng/mL; 0.25, 0.67), and leptin (3.51 ng/mL; 1.37, 5.64), but lower IGF-1 (−6.71 ng/mL; −12.7, − 0.76, adjusted for IGFBP-3). In girls, GDM offspring had higher cord blood levels of IGF-1 adjusted for IGFBP-3 (12.45 ng/mL; 4.85, 20.04). Boys, but not girls, of mothers with abnormal glucose tolerance but not GDM also had higher levels of some hormones. Conclusion GDM was associated with growth factors and adipokines in cord blood from boys, but only IGF-1 in girls. These findings suggest sex differences in responses to fetal overnutrition.

OBJECTIVE To investigate the association among public health insurance, preconception care, and pregnancy outcomes in pregnant women with pregestational diabetes. METHODS This is a retrospective cohort of pregnant women with pregestational type 1 or type 2 diabetes from 2006 to 2011 in Massachusetts-a state with universal insurance coverage since 2006. Women delivering after 24 weeks of gestation and receiving endocrinology and obstetric care in a multidisciplinary clinic were included. Rates of preconception consultation, our primary outcome of interest, were then compared between publicly and privately insured women. We used univariate analysis followed by logistic regression to compare receipt of preconception consultation and other secondary diabetes care measures and pregnancy outcomes according to insurance status. RESULTS Fifty-four percent (n=106) of 197 women had public insurance. Publicly insured women were younger (median age 30.4 compared with 35.3 years, P

Historical literature reports risk of fetal demise after diabetic ketoacidosis (DKA) in pregnancy as high as 25–60% (1,2). However, estimates have generally been based on small sample sizes, with limited investigation of other fetal outcomes or risk factors associated with poor fetal outcomes. We aimed to provide an updated assessment of the incidence and risk factors for fetal demise and other adverse outcomes in women with DKA during pregnancy. This retrospective cohort study included pregnancies between 1996 and 2015 with at least one DKA event in women with type 1 diabetes at one of three teaching hospitals in Boston. Data were collected through medical record review. Pregnancies were excluded if information on birth status (live or demise) and gestational age at birth or demise were unknown. Among the 77 DKA events in 64 pregnancies in 62 women included in the study, fetal demise, preterm …

Objectives We sought to review the effect of immediate provision of postpartum contraception on postpartum follow-up and screening for type 2 diabetes in women with gestational diabetes mellitus (GDM). Study design We performed multivariate logistic regression to identify the association between immediate provision of postpartum contraception and attendance at the 6-week postpartum visit and performance of a 6- to 12-week oral glucose tolerance test, controlling for age, type of insurance, parity and race. Results Women who received contraception prior to hospital discharge were less likely to attend their postpartum visit [adjusted odds ratio (aOR) 0.59, 95% confidence interval (CI) 0.39–0.88], but just as likely to participate in postpartum diabetes screening (adjusted odds ratio (aOR) 1.27, 95% confidence interval (CI) 0.78–2.06). Attendance at the postpartum visit was associated with private insurance (OR 1.93, 95% CI 1.31–2.99). Conclusion Receiving contraception while admitted postpartum did not affect follow-up for diabetes screening for women with GDM.

Homicide-suicide is a form of fatal violence in which an individual commits homicide and subsequently kills him- or herself. One hundred and sixteen homicide-suicide events involving 119 female homicide victims in North Carolina from 1988-1992 were identified through state medical examiner files. Case files were reviewed retrospectively to identify event characteristics, precursors, and typologies. In 86% of cases the perpetrator was the current or former partner of the victim. During the study period, 24% of men who killed their female partners in North Carolina subsequently committed suicide and another 3% attempted suicide but survived. Victim separation from the perpetrator was the most prevalent precursor (41%), followed by a history of domestic violence (29%). In nearly half of the cases with a history of domestic violence, the victim had previously sought protection from the perpetrator in the form of an arrest warrant, restraining order, or intervention by a law enforcement officer. Children of the victim (and/or perpetrator) witnessed the homicide-suicide, were in the immediate vicinity, found their parents’ bodies, or were killed, in 43% of cases. The prevalence of separation and domestic violence suggests several potential points of intervention, including stronger domestic violence legislation. Future research should place priority on assessing the impact of partner homicidesuicides on the families in which they occur. Such studies are essential for the informed development of preventive and therapeutic interventions for the families of both the victims and perpetrators of these fatal events. In addition, research focused on assisting men in coping with issues of control and separation is needed.

INTRODUCTION: Effective contraception allows women with gestational diabetes mellitus (GDM) time to optimize their health before future pregnancies. We therefore sought to evaluate use of long-acting reversible contraception (LARC) in women with GDM compared with women with preexisting DM. METHODS: We identified 404 pregnancies with GDM and 232 with preexisting DM cared for at Brigham and Womens Hospital between 2006 and 2011. We compared the likelihood of receiving LARC in women with GDM compared with women with preexisting DM with bivariate analyses using Fishers exact test or t tests as appropriate. We performed multivariate logistic regression to identify factors associated with LARC uptake. RESULTS: Women with GDM were less likely to have had a planned pregnancy than women with preexisting DM (P=.04). Of 404 pregnancies with GDM 21.5% with A1GDM and 21.6% with A2GDM received LARC. Of 232 pregnancies with preexisting DM 24.4% with type 1 DM and 18.5% with type 2 DM received LARC. There was no significant difference among the groups (P=.79). Women who had received contraception during their postpartum hospitalization were less likely to attend their postpartum visit (odds ratio 0.58 95% confidence interval 0.39-0.86). CONCLUSION: Although women with GDM were as likely as women with preexisting DM to receive LARC postpartum they were more likely to have an unplanned pregnancy highlighting the need for effective contraception in this population. Our findings suggest that further study is needed to understand how best to provide contraception while still engaging women in postpartum care.

In January 2006 the US Food and Drug Administration approved the first inhalable insulin preparation for treatment of types 1 and 2 diabetes mellitus. This preparation, marketed by Pfizer, is a dry, powdered, human, regular insulin that is made into an aerosol mechanically by a handheld device at the time of inhalation. The powder is prepackaged in 1 mg foil packets that deliver 3 units of insulin and 3 mg packets that deliver 9 units. Because one unit of subcutaneous insulin corresponds to about 30 μg insulin, the activity of inhaled insulin is only about 10% of injected insulin on a weight basis. This “inefficiency” in comparison to subcutaneous insulin brings up the reproducibility of dosing. Firstly, in clinical trials the overall incidence of hypoglycaemia seems comparable with inhaled and subcutaneous insulin when comparable levels of glycaemic control are obtained. However, severe hypoglycaemia was more common and mild hypoglycaemia less common with the inhaled product in some trials. This will bear watching in longer term follow-up studies. Secondly, pulmonary factors (specifically smoking status and asthma) affect the absorption of inhaled insulin, with increased absorption in smokers and decreased absorption with asthma. Therefore, populations in whom the variability of absorption is greatest (current and recent smokers) are not considered appropriate candidates for inhaled insulin therapy. Inhaled insulin is rapid acting, with a peak plasma exposure between 30 and 90 minutes after dosage (similar to rapid acting insulin analogues). However, inhaled insulin taken before a meal has been observed to have a more marked effect on fasting glycaemia in humans than pre-meal subcutaneous insulin,1 suggesting a prolonged action. Also, in animal studies, inhaled insulin seems to have a lesser effect on hepatic glucose production, with a correspondingly greater effect on peripheral glucose disposal, than intravenously infused regular insulin.2 Whether this will apply to humans is not known. Considering efficacy, phase 3 trials are reasonably convincing that overall glycaemic control as assessed by haemoglobin A1c is similar with pre-meal subcutaneous regular insulin and the inhaled product in patients with type 1 diabetes or type 2 diabetes. In patients with type 1 diabetes, preprandial inhaled insulin has been studied in combination with insulin glargine, bedtime ultralente,3 and twice daily isophane insulin (NPH).4 Efficacy in patients with type 2 diabetes has been assessed in patients suboptimally controlled by diet and exercise randomised to maximal dose rosiglitazone versus pre-meal inhaled insulin5 as well as those receiving stable basal or bolus insulin treatment.6 The effect of pre-meal inhaled insulin when added to an existing oral regimen was studied in a phase 2 trial of patients in whom oral treatment with sulfonylurea or metformin had failed.7 For type 1 diabetes, inhaled insulin is likely to be accepted by both the public and the medical community. It is perhaps surprising how frequently individuals with longstanding type 1 diabetes, who seem to have adapted to multiple daily injections, are excited by the potential of needing only a single, long acting insulin injection daily, with inhaled insulin replacing pre-meal injections. The market for inhaled insulin in type 2 diabetes is more complex. Inhaled insulin has been under development for a number of years. Thus it will enter a very different therapeutic landscape for type 2 diabetes than was evident at the time of its initial study. In addition to the newer thiazolidenediones, the recent introduction of both exenatide (Byetta) and pramlintide (Symlin) and the likely imminent introduction of the dipeptidyl peptidase-4 (DPP-4) inhibitors allow additional therapeutic combinations with established oral hypoglycaemic agents. Why then consider insulin? One reason relates to potency. Insulin, regardless of route of administration, remains our most potent glucose lowering therapy. A second reason may be safety. Insulin has been used for 80 years and its side effects are well known; therefore, inhaled insulin has the potential to be beneficial in the long term too. The effect of treating hyperglycaemia for even four or five years with DPP-4 inhibitors or exenatide is unknown. But do we know all the risks of inhaled insulin, or does the route of insulin delivery affect the risk of adverse events? Approval was delayed substantially so that the clinical importance of increases of anti-insulin antibody production and small decreases in lung function seen during phase 3 trials could be evaluated.8,9 Current evidence indicates that these adverse findings are not clinically worrisome, although longer term monitoring is planned. Other potential barriers to acceptance of inhaled insulin include cost and patient satisfaction. The cost of inhaled insulin and the accompanying delivery device is not set, but it will certainly substantially exceed that of injectable insulin. Regarding patient satisfaction, perception of tolerability of the regimen and ease of use were significantly greater in patients randomised to inhaled insulin, and a large proportion of patients randomised to inhaled insulin chose to continue with that regimen. These findings held regardless of type of diabetes or whether inhaled insulin was added to subcutaneous insulin therapy or oral agents.10-12 Given the comparable glycaemic control and safety profile seen with the inhaled insulin preparation in comparison to subcutaneous administration, patient acceptance may prove to be the primary determinant of marketplace success. For some patients, doctors and budget holders, the issue of drug costs, cost effectiveness, and uncertainty regarding potential long term adverse effects related to pulmonary route of delivery will outweigh the perceived benefits of ease of administration. Both considerations contributed to the recent decision by NICE (the National Institute for Health and Clinical Excellence) to decline funding for inhaled insulin for the NHS. This opinion will be revisited after several months of public commentary.13 However, patients with type 1 diabetes or insulin dependent type 2 diabetes who are distressed by frequent injections may be able to improve their blood sugar control substantially and avoid complications from diabetes with this new product. For patients with type 2 diabetes with failing oral agents who are reluctant to start treatment with insulin, inhaled insulin offers the same efficacy as subcutaneous insulin, without multiple daily injections. When added to oral agents, it may obviate the need for subcutaneous insulin entirely.