A Pilot, Randomized Clinical Trial of Bedtime Doses of Prazosin Versus Placebo in Suicidal Posttraumatic Stress Disorder Patients With Nightmares.

PURPOSE/BACKGROUND: Observational studies show an association between nightmares and suicide. Prazosin is proposed as a nightmare treatment. This pilot, randomized clinical trial tested whether treatment of nightmares with prazosin would reduce suicidal ideas in suicidal posttraumatic stress disorder (PTSD) patients. METHODS/PROCEDURES: Twenty adult, suicidal PTSD patients with nightmares were blindly and randomly assigned 1:1 to escalating doses of prazosin versus placebo at bedtime only for 8 weeks. All participants had comorbid mood disorders and received stable doses of mood disorder medication. Outcomes of interest were measured weekly and included severity of suicidal ideation, nightmares, PTSD, insomnia, and depression. Longitudinal mixed-effects models assessed change in outcomes over time. FINDINGS/RESULTS: All psychometric measures improved over 8 weeks. However, nighttime measures of nightmares and insomnia showed significantly less improvement in the prazosin group, whereas there was no significant change in daytime measures of suicidal ideation and daytime-only PTSD symptoms. Two patients required emergency psychiatric hospitalization, but there were no suicide attempts and no deaths. IMPLICATIONS/CONCLUSIONS: This study confirmed an effect of nighttime-only prazosin on nighttime symptoms of insomnia and nightmares in suicidal PTSD patients who are experiencing nightmares. Surprisingly, the effect was in the direction opposite of what we expected. Furthermore, prazosin showed no signal on daytime measures including suicidal ideation. The results do not support a larger study of nighttime-only prazosin in suicidal PTSD patients but leave open the possibility of benefit from daytime administration of prazosin.

Vascular Access in Critically Ill Pediatric Patients With Obesity.

OBJECTIVES: Pediatric obesity is highly prevalent and has been associated with poor outcomes for hospitalized children. Vascular access is essential in critically ill patients. The aim of this study was to evaluate whether critically ill children with obesity are more likely to undergo vascular device insertion (excluding peripheral IV catheters) and develop related complications. DESIGN: Multi-institutional retrospective observational cohort study. SETTING: Ninety-four U.S. PICUs included in the Virtual Pediatric Systems, LLC database. PATIENTS: 120,272 unique patients 2 to less than 18 years old admitted between January 2009 and December 2014. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients were categorized into normal weight, overweight, and obese (class 1, 2, or 3); underweight patients were excluded. We used mixed-effects multivariable logistic regression to test body mass index category as an independent predictor of vascular device placement and associated complications, adjusted for age, sex, severity of illness, primary diagnosis, presence of a complex chronic condition, and admission related to trauma or surgery. A total of 73,964 devices were placed in 45,409 patients (37.8% of the total cohort received a vascular device). Most device types placed differed significantly by weight status. Subjects with class 3 obesity were less likely (odds ratio, 0.74; 95% CI, 0.67-0.81) to undergo placement of any device compared with normal weight patients. Patients with all classes of obesity were more likely to undergo placement of a peripherally inserted central catheter, with the strongest association in those with class 2 obesity (odds ratio, 1.26; 95% CI, 1.14-1.40). Class 1 and class 3 obesity were independent risk factors for developing a complication, with odds ratio of 1.31 (95% CI, 1.11-1.53) and 1.45 (95% CI, 1.07-1.99), respectively. CONCLUSIONS: Severe obesity is associated with decreased overall likelihood of placement of a vascular access device but increased likelihood of peripherally inserted central catheter placement and of device-related complications.

A multi-site randomized clinical trial to reduce suicidal ideation in suicidal adult outpatients with Major Depressive Disorder: Development of a methodology to enhance safety.

BACKGROUND/AIMS: Suicide is a major public health concern, yet there are very few randomized clinical trials that have been conducted to reduce suicidal ideation in patients at risk of suicide. We describe the rationale and refinements of such a trial that is designed to assess the effect of a hypnotic medication on suicidal ideation in adult outpatients currently experiencing suicidal ideation. METHODS: "Reducing Suicidal Ideation Through Insomnia Treatment" is a multi-site randomized clinical trial that includes three recruiting sites and one data management site. This 4-year study is in its second year of recruitment. The purpose of the study is to compare hypnotic medication versus placebo as an add-on treatment to a selective serotonin reuptake inhibitor as a means of reducing suicidal ideation in depressed adult outpatients with insomnia and suicidal ideation. The safety features of the study follow the 2001 National Institutes of Health guidelines for studies that include patients at risk of suicide. RESULTS: In total, 584 potential participants have undergone telephone screening; 67% of these failed the phone screen, most often due to an absence of expressed suicidal ideation (26% of the telephone screen fails). A total of 115 people appeared for a face-to-face baseline assessment, and 40 of these had completed a taper off of their ineffective psychotropic medications before the baseline assessments. In all, 64% of those who completed baseline assessments failed to proceed to randomization, most commonly because of no clinically significant suicidal ideation (51% of those excluded at baseline). One participant was offered and accepted voluntary psychiatric hospitalization in lieu of study participation. Thus far, 40 participants have been randomized into the study and 88.7% of scheduled visits have been attended, with 93.8% adherence to the selective serotonin reuptake inhibitor and 91.6% adherence to the randomized hypnotic versus placebo. None of the randomized participants have required hospitalization or had a suicide attempt. CONCLUSION: By carefully considering the inclusion and exclusion criteria and other safety features, the safe conduct of randomized clinical trials in suicidal adult patients is possible, including the inclusion of participants who have undergone a prescribed tapering off of psychotropic medications prior to baseline assessment.

Analysis of salivary fluid and chemosensory functions in patients treated for primary malignant brain tumors.

OBJECTIVES: The frequency and causes of chemosensory (taste and smell) disorders in cancer patients remain under-reported. This study examined the impact of cancer therapy on taste/smell functions and salivary constituents in brain tumor patients. MATERIALS AND METHODS: Twenty-two newly diagnosed patients with primary malignant gliomas underwent 6 weeks of combined modality treatment (CMD) with radiation and temozolomide followed by six monthly cycles of temozolomide. Chemosensory functions were assessed at 0, 3, 6, 10, 18, and 30 weeks with paired samples of saliva collected before and after an oral rinse with ferrous-spiked water. Iron (Fe)-induced oxidative stress was measured by salivary lipid oxidation (SLO); salivary proteins, electrolytes, and metals were determined. Parallel salivary analyses were performed on 22 healthy subjects. RESULTS: Chemosensory complaints of cancer patients increased significantly during treatment (p = 0.04) except at 30 weeks. Fe-induced SLO increased at 10 and 18 weeks. When compared with healthy subjects, SLO, total protein, Na, K, Cu, P, S, and Mg levels, as averaged across all times, were significantly higher (p < 0.05), whereas salivary Zn, Fe, and oral pH levels were significantly lower in cancer patients (p < 0.05). Neither time nor treatment had a significant impact on these salivary parameters in cancer patients. CONCLUSIONS: Impact of CMT treatment on chemosensory functions can range from minimal to moderate impairment. Analysis of SLO, metals, and total protein do not provide for reliable measures of chemosensory dysfunctions over time. CLINICAL RELEVANCE: Taste and smell functions are relevant in health and diseases; study of salivary constituents may provide clues on the causes of their dysfunctions.

A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.

BACKGROUND: Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits. OBJECTIVES: We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL). Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time. RESULTS: Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28-85 years), pathologic stage (stage 0, 91%; stage 1, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 microg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 microg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy-Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy-Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies-Depression scale (11.6 vs 12.3, P = .632). CONCLUSIONS: Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

A phase II trial of thalidomide and procarbazine in adult patients with recurrent or progressive malignant gliomas.

Thalidomide and procarbazine have demonstrated single agent activity against malignant gliomas (MG). We evaluated the combination of thalidomide and procarbazine with a single arm phase II trial in adults with recurrent or progressive MG. Procarbazine was given at a dose of 250 mg/m(2)/d × 5day q 28 days. Thalidomide was administered at a dose of 200 mg/day continuously. Intrapatient dose escalation of thalidomide was attempted (increase by 100 mg/day weekly as tolerated) to a maximum of 800 mg/day. The primary outcome was tumor response, assessed by MRI and CT. Secondary outcomes were progression free survival (PFS), overall survival (OS) and toxicity. In addition, quality of life questionnaires were performed at baseline and prior to each odd cycle in all treated patients. Eighteen patients (median age of 50) were accrued and received a total of 36 cycles (median 2) of therapy. The median maximum thalidomide dose achieved was 400 mg (range 0-800). No complete or partial responses were seen. One patient (6%) experienced stable disease, fourteen (78%) progressed as best response and three (17%) were not evaluable for response. Median time to progression was 2.1 months (95% CI, 1.5-2.5). Seventeen patients have died (one patient lost to follow-up after progression); median survival from enrollment was 7.6 months (95% CI, 3.5-9.4). Grade 3/4 drug related toxicity was minimal. Quality of life diminished over time. The combination of thalidomide and procarbazine demonstrated no efficacy in this trial.

A randomized, controlled trial of Panax quinquefolius extract (CVT-E002) to reduce respiratory infection in patients with chronic lymphocytic leukemia.

BACKGROUND: Chronic lymphocytic leukemia (CLL) patients are at high risk for acute respiratory illness (ARI). OBJECTIVE: We evaluated the safety and efficacy of a proprietary extract of Panax quinquefolius, CVT-E002, in reducing ARI. METHODS: This was a double-blind, placebo-controlled, randomized trial of 293 subjects with early-stage, untreated CLL conducted January-March 2009. RESULTS: ARI was common, occurring on about 10% of days during the study period. There were no significant differences of the 2 a priori primary end points: ARI days (8.5 ± 17.2 for CVT-E002 vs 6.8 ± 13.3 for placebo) and severe ARI days (2.9 ± 9.5 for CVT-E002 vs 2.6 ± 9.8 for placebo). However, 51% of CVT-E002 vs 56% of placebo recipients experienced at least 1 ARI (difference, -5%; 95% confidence interval [CI], -16% to 7%); more intense ARI occurred in 32% of CVT-E002 vs 39% of placebo recipients (difference, -7%; 95% CI, -18% to 4%), and symptom-specific evaluation showed reduced moderate to severe sore throat (P = .004) and a lower rate of grade ≥3 toxicities (P = .02) in CVT-E002 recipients. Greater seroconversion (4-fold increases in antibody titer) vs 9 common viral pathogens was documented in CVT-E002 recipients (16% vs 7%, P = .04). LIMITATIONS: Serologic evaluation of antibody titers was not tied to a specific illness, but covered the entire study period. CONCLUSION: CVT-E002 was well tolerated. It did not reduce the number of ARI days or antibiotic use; however, there was a trend toward reduced rates of moderate to severe ARI and significantly less sore throat, suggesting that the increased rate of seroconversion most likely reflects CVT-E002-enhanced antibody responses.

Prevalence of tobacco use and association between cardiometabolic risk factors and cigarette smoking in youth with type 1 or type 2 diabetes mellitus.

OBJECTIVES: To examine prevalence of tobacco use and coexistence of cardiometabolic risk factors according to smoking status in youth with diabetes mellitus. STUDY DESIGN: Youth aged 10 to 22 years who participated in the SEARCH for Diabetes in Youth study (n = 3466) were surveyed about their tobacco use and examined for cardiometabolic risk factors: waist circumference, systolic and diastolic blood pressure, physical activity, and lipid profile. RESULTS: The prevalence of tobacco use in youth aged 10 to 14 years, 15 to 19 years, and ≥20 years with type 1 diabetes mellitus was 2.7%, 17.1%, and 34.0%, respectively, and the prevalence in youth with type 2 diabetes mellitus was 5.5%, 16.4%, and 40.3%, respectively. Smoking was more likely in youth with annual family incomes <$50 000, regardless of diabetes mellitus type. Cigarette smoking was associated with higher odds of high triglyceride levels and physical inactivity in youth with type 1 diabetes mellitus. Less than 50% of youth aged 10 to 14 years (52.2% of participants) reported having ever been counseled by their healthcare provider to not smoke or to stop smoking. CONCLUSIONS: Tobacco use is prevalent in youth with diabetes mellitus. Aggressive tobacco prevention and cessation programs should be a high priority to prevent or delay the development of cardiovascular disease.

Sentinel lymph node intraoperative imprint cytology in patients with breast cancer-costly or cost effective?

BACKGROUND: Sentinel lymph node (SLN) biopsy is now standard of care for breast cancer patients. Intraoperative imprint cytology (IIC) provides results to the surgeon, which may lead to a lymphadenectomy under the same anesthetic when it is positive for metastases. Thus, a positive IIC can spare the patient a second operation and the charges associated with it. The aim of this study is to assess the cost effectiveness of IIC in breast cancer patients. MATERIALS AND METHODS: This study evaluated 98 patients who underwent a SLN biopsy between July 2008 and May 2009. The patients were divided into 1 of 3 groups based on the results of IIC and permanent sections: (1) true-negative (TN) IIC, (2) true-positive (TP) IIC, and (3) false-negative (FN) IIC. Total charges for each patient were extracted retrospectively, and nonparametric tests assessed differences in the charges between the three groups. RESULTS: The median total charges per patient for each population were the following: (1) $14,764.62, (2) $19,025.89, and (3) $29,750.64 (P < 0.05). A difference of more than $10,000 exists in total charges per patient between the node-positive population who did not benefit from IIC (FN) and the node-positive population who did benefit from IIC (TP). CONCLUSIONS: IIC is a cost-effective evaluation of breast cancer patients. The difference in total charges between the FN and TP groups outweighs the cost of the IIC. In addition to the reduced costs incurred by the patient and the hospital, IIC spares the patient the psychological and physical stress of a second operation.

Eccentric contractions induce rapid isometric torque drop in dystrophin-deficient dogs.

We tested the hypothesis that eccentric contractions (ECCs) rapidly induce greater-than-normal isometric torque drop in dystrophin-deficient golden retriever muscular dystrophy (GRMD) muscles. ECCs were imposed by forcibly stretching activated muscles. The results indicate that isometric torque drop was greater in GRMD versus controls (P < 0.0001). Our findings support the hypothesis that ECCs induce greater-than-normal isometric torque drop in GRMD muscles. The magnitude of ECC-induced isometric torque loss may be an ideal clinical endpoint in the GRMD model.

Stress cardiac magnetic resonance imaging with observation unit care reduces cost for patients with emergent chest pain: a randomized trial.

STUDY OBJECTIVE: We determine whether imaging with cardiac magnetic resonance imaging (MRI) in an observation unit would reduce medical costs among patients with emergent non-low-risk chest pain who otherwise would be managed with an inpatient care strategy. METHODS: Emergency department patients (n=110) at intermediate or high probability for acute coronary syndrome without electrocardiographic or biomarker evidence of a myocardial infarction provided consent and were randomized to stress cardiac MRI in an observation unit versus standard inpatient care. The primary outcome was direct hospital cost calculated as the sum of hospital and provider costs. Estimated median cost differences (Hodges-Lehmann) and distribution-free 95% confidence intervals (Moses) were used to compare groups. RESULTS: There were 110 participants with 53 randomized to cardiac MRI and 57 to inpatient care; 8 of 110 (7%) experienced acute coronary syndrome. In the MRI pathway, 49 of 53 underwent stress cardiac MRI, 11 of 53 were admitted, 1 left against medical advice, 41 were discharged, and 2 had acute coronary syndrome. In the inpatient care pathway, 39 of 57 patients initially received stress testing, 54 of 57 were admitted, 3 left against medical advice, and 6 had acute coronary syndrome. At 30 days, no subjects in either group experienced acute coronary syndrome after discharge. The cardiac MRI group had a reduced median hospitalization cost (Hodges-Lehmann estimate $588; 95% confidence interval $336 to $811); 79% were managed without hospital admission. CONCLUSION: Compared with inpatient care, an observation unit strategy involving stress cardiac MRI reduced incident cost without any cases of missed acute coronary syndrome in patients with emergent chest pain.

A Comparison of Smoking History in the Electronic Health Record With Self-Report.

INTRODUCTION: Knowing patients' smoking history helps guide who may benefit from preventive services such as lung cancer screening. The accuracy of smoking history electronic health records remains unclear. METHODS: This was a secondary analysis of data collected from a portal-based lung cancer screening decision aid. Participants of an academically affiliated health system, aged 55-76 years, completed an online survey that collected a detailed smoking history including years of smoking, years since quitting, and smoking intensity. Eligibility for lung cancer screening was defined using the Centers for Medicare and Medicaid Services criteria. Data analysis was performed May-December 2018, and data collection occurred between November 2016 and February 2017. RESULTS: A total of 336 participants completed the survey and were included in the analysis. Of 175 participants with self-reported smoking intensity, 72% had packs per day and 62% had pack-years recorded in the electronic health record. When present, smoking history in the electronic health records correlated well with self-reported years of smoking (r =0.78, p≤0.0001) and years since quitting (r =0.94, p≤0.0001). Self-reported smoking intensity, including pack-years (r =0.62, p<0.0001) and packs per day (r =0.65, p≤0.0001), was less correlated. Of those participants eligible for lung cancer screening by self-report, only 35% met criteria for screening by electronic health records data alone. Others were either incorrectly classified as ineligible (23%) or had incomplete data (41%). CONCLUSIONS: The electronic health records frequently misses critical elements of a smoking history, and when present, it often underestimates smoking intensity, which may impact who receives lung cancer screening.

Prevalence of obstructive sleep apnea in suicidal patients with major depressive disorder.

In this paper, we report the rate of previously undiagnosed obstructive sleep apnea (OSA) in a randomized clinical trial (RCT) of suicidal patients with major depressive disorder (MDD). One hundred and twenty-five suicidal adults with MDD were recruited into a RCT. None were suspected to have OSA. Fourteen percent met diagnostic criteria for OSA. The Apnea Hypopnea Index (AHI) was predicted by increasing age, male sex, and higher Body Mass Index. However, neither the degree of daytime sleepiness nor the degree of insomnia predicted AHI severity. A high degree of suspicion is warranted for OSA in suicidal patients with MDD, and for patients with treatment-resistant depression. ClinicalTrials.gov identifier: NCT01689909.

Bedtime doses of prazosin do not affect daytime salivary amylase markers in PTSD.

Overactivity of the noradrenergic (NE) system within the central nervous system (CNS) has been postulated as a key pathophysiology of posttraumatic stress disorder (PTSD). The activity of the enzyme salivary α-amylase (sAA) has been proposed as an indirect measure of CNS NE activity, and sAA is elevated in PTSD. As an antagonist of the α-1 NE receptor, prazosin would be expected to alter sAA values in PTSD patients. However, given its short half-life, it is not clear whether bedtime doses would have an effect on daytime sAA. In the present study, we assayed daytime sAA in 20 suicidal PTSD patients who were randomized to prazosin versus placebo at bedtime-only, and found no effect in daytime sAA. These findings are consistent with studies showing an advantage for twice daily dosing of prazosin in PTSD.

Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT): A Randomized Clinical Trial.

OBJECTIVE: The authors sought to determine whether targeted treatment of insomnia with controlled-release zolpidem (zolpidem-CR) in suicidal adults with insomnia would provide a reduction in suicidal ideation superior to placebo. METHODS: Reducing Suicidal Ideation Through Insomnia Treatment was an 8-week three-site double-blind placebo-controlled parallel-group randomized controlled trial of zolpidem-CR hypnotic therapy compared with placebo, in conjunction with an open-label selective serotonin reuptake inhibitor. Participants were medication-free 18- to 65-year-olds with major depressive disorder, insomnia, and suicidal ideation. Suicidal ideation was the main outcome, measured first by the Scale for Suicide Ideation and second by the Columbia-Suicide Severity Rating Scale (C-SSRS). RESULTS: A total of 103 participants were randomly assigned to receive zolpidem-CR (N=51) or placebo (N=52) (64 women and 39 men; mean age=40.5 years). Zolpidem-CR had a robust anti-insomnia effect, especially in patients with the most severe insomnia symptoms. No significant treatment effect was observed on the Scale for Suicide Ideation (least squares mean estimate=-0.56, SE=0.83, 95% CI=-2.19, 1.08), but the reduction in scores was significantly positively related to improvement in insomnia after accounting for the effect of other depression symptoms. The C-SSRS indicated that zolpidem-CR had a significant treatment effect (least squares mean estimate=-0.26, SE=0.12, 95% CI=-0.50, -0.02). The advantage for zolpidem-CR in reducing suicidal ideation on the C-SSRS was greater in patients with more severe insomnia. No deaths or suicide attempts occurred. CONCLUSIONS: Although the results do not support the routine prescription of hypnotic medication for mitigating suicidal ideation in all depressed outpatients with insomnia, they suggest that coprescription of a hypnotic during initiation of an antidepressant may be beneficial in suicidal outpatients, especially in patients with severe insomnia.

Voiding pattern analysis as a surrogate for cystometric evaluation in uroplakin II knockout mice.

PURPOSE: Previous study has shown that the absence of uroplakin II can cause urinary tract dysfunction, including vesicoureteral reflux and renal abnormalities, as well as micturition pattern changes. We developed a simple surrogate measure of bladder function using ultraviolet visualization of urinary voiding patterns in a uroplakin II knockout mouse animal model. MATERIALS AND METHODS: Three male and 3 female WT mice, and 3 male and 3 female uroplakin II knockout mice were evaluated by cystometric analysis and voiding pattern markings. Voiding pattern markings were graded by independent observers on a scale of 1 to 5 according to the degree of dispersion of voided urine. Statistical analysis was then used to correlate voiding dispersion grades with cystometric parameters in the same mice. RESULTS: The degree of dispersion of voiding pattern markings correlated with several measures of bladder function. Specifically the Pearson correlation coefficients for the observed voiding patterns highly correlated with baseline pressure, threshold pressure and intermicturition pressure measurements made during conscious cystometry in these mice (p <0.05). CONCLUSIONS: Ultraviolet visualization of urinary voiding patterns of mice correlated well with certain measures of standard cystometric evaluations. As such, this method provides a simple, noninvasive method of evaluating mouse bladder function. Implementation of this methodology, which can potentially be automated for high throughput analysis, can accelerate the development of novel therapy for certain important aspects of bladder disease/dysfunction.

The relationship of person-specific eveningness chronotype, greater seasonality, and less rhythmicity to suicidal behavior: A literature review.

BACKGROUND: Epidemiological data have demonstrated seasonal and circadian patterns of suicidal deaths. Several reviews and meta-analyses have confirmed the relationship between sleep disturbance and suicidality. However, these reviews/meta-analyses have not focused on seasonal and circadian dysfunction in relation to suicidality, despite the common presence of this dysfunction in patients with mood disorders. Thus, the current literature review analyzed studies investigating person-specific chronotype, seasonality, and rhythmicity in relation to suicidal thoughts and behaviors. METHODS: Study authors reviewed articles related to individual-level chronotype, seasonality, and rhythmicity and suicidality that were written in English and not case reports or reviews. RESULTS: This review supports a relationship between an eveningness chronotype, greater seasonality, and decreased rhythmicity with suicidal thoughts and behaviors in those with unipolar depression, as well as in other psychiatric disorders and in children/adolescents. LIMITATIONS: These findings need to be explored more fully in mood disordered populations and other psychiatric populations, in both adults and children, with objective measurement such as actigraphy, and with chronotype, seasonality, and rhythmicity as well as broader sleep disturbance measurement all included so the construct(s) most strongly linked to suicidality can be best identified. CONCLUSIONS: Eveningness, greater seasonality, and less rhythmicity should be considered in individuals who may be at risk for suicidal thoughts and behaviors and may be helpful in further tailoring assessment and treatment to improve patient outcome.

Predicted risk of coronary heart disease among persons with type 2 diabetes.

BACKGROUND: Diabetes is an independent risk factor for the development of coronary heart disease (CHD). We evaluated whether there are racial/ethnic differences in predicted probability of CHD among persons with type 2 diabetes from the 1999-2002 National Health and Nutrition Examination Survey. METHODS: Adults with type 2 diabetes without cardiovascular disease (n=585) were evaluated; the United Kingdom Prospective Diabetes Study (UKPDS) Risk Engine was used to develop estimates of CHD and Framingham Risk Score (FRS) was used to assess the 10-year CHD risk. Chi-square tests and analysis of variance were used to assess differences between racial/ethnic groups in risk factors and predicted probability for CHD. RESULTS: Risk factors for CHD differed significantly amongst the three racial/ethnic groups. Whites had lower mean A1C concentrations (7.3%+/-0.2) than blacks (8.1%+/-0.2, P<0.05) or Mexican Americans (8.1%+/-0.2, P<0.05). Systolic blood pressure was higher in blacks compared with whites (P<0.05) and in Mexican American men compared with white men (P<0.05). Total cholesterol differed insignificantly by race/ethnicity whereas high-density lipoprotein cholesterol was higher in blacks compared with whites and Mexican Americans. Blacks had the greatest 5, 10, 15, and 20-year predicted risks of CHD among men, whereas whites had the greatest predicted risks among women. When evaluated by the FRS, the 10-year predicted risk of CHD was estimated to be 22.5% by UKPDS and 17% using FRS. CONCLUSIONS: UKPDS estimates of probability of CHD were similar across race/ethnicities, indicating that the risk factors tended to balance out. Despite differences in individual risk factors, the estimated risk for CHD was similar for all persons with diabetes.

Problems Experienced by Ovarian Cancer Survivors During Treatment.

OBJECTIVE: To identify problems at different treatment points (early treatment, mid-treatment, early posttreatment, and late posttreatment) among women with ovarian cancer. DESIGN: Longitudinal and cross-sectional study design. SETTING: An academic and community clinical cancer center in the Southeastern United States. PARTICIPANTS: Sixty-eight women with Stage I to IV ovarian cancer. METHODS: Variables assessed included reported problems (physical, psychosocial, pain, marital, medical interaction), social support, optimism, and responses to open-ended questions. Analysis involved mixed models for longitudinal repeated measures and unpaired t tests and content analysis to describe responses to open-ended questions. RESULTS: Physical and psychosocial problems were greatest during early treatment and decreased throughout the treatment trajectory. Women with greater levels of social support and optimism at baseline had fewer problems over time. Women who did not have trouble paying for basics had fewer problems related to pain and psychological problems. CONCLUSION: Problems across all domains must be addressed throughout the treatment trajectory, even after chemotherapy has ended. Nurses are well positioned to refer women appropriately to social workers and clinical navigators across all domains of care and should consider systematic assessment of patient-reported problems as a routine form of practice.

Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

OBJECTIVE: Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. METHOD: This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. RESULTS: Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. CONCLUSIONS: The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.