SUICIDAL IDEATION IN PSORIASIS

Background . Psoriasis has been associated with depressive disease and case reports of completed suicide. Methods . 217 consenting psoriasis patients completed the Carroll Rating Scale for Depression (CRSD), a 52-item self-rated scale, with four of the Items directly addressing wishes to be dead and suicidal ideation. The patients also self-rated the severity of their psoriasis. Results . 9.7% of patients reported a wish to be dead, and 5.5% reported active suicidal ideation at the time of the study. The death wish and suicidal ideation were associated with higher depression scores (P < 0.0001) and higher patient self-ratings of psoriasis severity (P < 0,05). Patient self-reports of psoriasis severity correlated directly with the overall depression scores (r = 0.39), P < 0.0001). Conclusions . The comorbidity between depressive symptoms, suicidal ideation, and psoriasis severity is in contrast with reports that severe depression and suicidal ideation are mainly a feature of life-threatening medical disorders such as malignancies. Our finding may have important implications in the management of psoriasis.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/65854/1/j.1365-4362.1993.tb02790.x.pd

Evaluation of different recall periods for the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Aims—The U.S. National Cancer Institute recently developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE is a library of questions for clinical trial participants to self-report symptomatic adverse events (e.g., nausea). The objective of this study is to inform evidence-based selection of a recall period when PRO-CTCAE is included in a trial. We evaluated differences between 1-week, 2-week, 3-week, and 4-week recall periods, using daily reporting as the reference. Methods—English-speaking patients with cancer receiving chemotherapy and/or radiotherapy were enrolled at four U.S. cancer centers and affiliated community clinics. Participants completed 27 PRO-CTCAE items electronically daily for 28 days, and then weekly over 4 weeks, using 1-week, 2-week, 3-week, and 4-week recall periods. For each recall period, mean differences, effect sizes, and intraclass correlation coefficients were calculated to evaluate agreement between the maximum of daily ratings and the corresponding ratings obtained using longer recall periods (e.g., maximum of daily scores over 7 days vs. 1-week recall). Analyses were repeated using the average of daily scores within each recall period rather than the maximum of daily scores. Results—127 subjects completed questionnaires (57% male; median age 57). The median of the 27 mean differences in scores on the PRO-CTCAE 5-point response scale comparing the maximum daily versus the longer recall period (and corresponding effect size), was −0.20 (−0.20) for 1-week recall; −0.36 (−0.31) for 2-week recall; −0.45 (−0.39) for 3-week recall; and −0.47 (−0.40) for 4-week recall. The median intraclass correlation across 27 items between the maximum of daily ratings and the corresponding longer recall ratings for 1-week recall was 0.70 (range: 0.54–0.82); 2-week recall: 0.74 (range: 0.58–0.83); 3-week recall: 0.72 (range: 0.61–0.84); and 4-week recall: 0.72 (range: 0.64–0.86). Similar results were observed for all analyses using the average of daily scores rather than the maximum of daily scores. Conclusions—1-week recall corresponds best to daily reporting. Although intraclass correlations remain stable over time, there are small but progressively larger differences between daily and longer recall periods at 2, 3, and 4 weeks, respectively. The preferred recall period for the PRO-CTCAE is the past 7 days, although investigators may opt for recall periods of 2, 3, or 4 weeks with an understanding that there may be some information loss

Modeling Distillers Dried Grains with Solubles (DDGS) Mass Flow Rate as Affected by Drying and Storage Conditions

Ethanol production in 2015 was over 15 million gallons in the United States, and it is projected to increase in the next few years to meet market demands. With the continued growth in the ethanol industry, there has been enormous expansion in distillers grains production. Because the local market for distillers dried grains with solubles (DDGS) is often saturated, it is essential to transport DDGS long distances, across the United States and to international markets. Caking and agglomeration of DDGS particles in hoppers and other storage structures are typical during transportation. The current study deals with DDGS prepared by combining condensed distillers solubles (CDS) with distillers wet grains and then drying at varying temperatures. DDGS was stored in conical hoppers under varying ambient temperature, consolidation pressure, and time conditions. We investigated the effects of CDS (10, 15, and 20% wb), drying temperature (100, 200, and 300°C), drying time (20, 40, and 60 min), cooling temperature (0, 25, and 50°C), consolidation pressure (0, 1.72, and 3.43 kPa), and consolidation time (0, 3, and 6 days) levels on various flow parameters. To examine these factors, Taguchi’s experimental design with an L18 orthogonal array was implemented. Response surface modeling yielded mass flow rate = f(Hausner ratio, angle of repose) with R2 = 0.99, and it predicted moisture content for good, fair, and poor flow. Results showed that drying temperature, drying time, and cooling type were the main factors in predicting mass flow rate. The Johansson model for predicted mass flow rate was calibrated with experimental data, and a new parameter, compressibility factor, with a value of 0.96 g2/(min cm3), was determined to quantify the divergence of compressible and cohesive materials (such as DDGS) for free-flowing bulk solids. Thus, the predicted models may be beneficial for quantitative understanding of DDGS flow

A systematic review of the evidence on the treatment of rapid cycling bipolar disorder

Fountoulakis KN, Kontis D, Gonda X, Yatham LN. A systematic review of the evidence on the treatment of rapid cycling bipolar disorder. Bipolar Disord 2013: 15: 115-137. (c) 2013 John Wiley & Sons A/S.Published by Blackwell Publishing Ltd. Objective: Rapid cycling is associated with longer illness duration and greater illness severity in bipolar disorder. The aim of the present study was to review the existing published randomized trials investigating the effect of treatment on patients with rapid cycling bipolar disorder. Methods: A MEDLINE search was conducted using combinations of the following key words: bipolar and rapid or rapid-cycling or rapid cycling and randomized. The search was conducted through July 16, 2011, and no conference proceedings were included. Results: The search returned 206 papers and ultimately 25 papers were selected for review. Only six randomized, controlled trials specifically designed to study a rapid cycling population were found. Most data were derived from post hoc analyses of trials that had included rapid cyclers. The literature suggested that: (i) rapid cycling patients perform worse in the follow-up period; (ii) lithium and anticonvulsants have comparable efficacies; (iii) there is inconclusive evidence on the comparative acute or prophylactic efficacy of the combination of anticonvulsants versus anticonvulsant monotherapy; (iv) aripiprazole, olanzapine, and quetiapine are effective against acute bipolar episodes; (v) olanzapine and quetiapine appear to be equally effective to anticonvulsants during acute treatment; (vi) aripiprazole and olanzapine appear promising for the maintenance of response of rapid cyclers; and (vii) there might be an association between antidepressant use and the presence of rapid cycling. Conclusion: The literature examining the pharmacological treatment of rapid cycling is still sparse and therefore there is no clear consensus with respect to its optimal pharmacological management. Clinical trials specifically studying rapid cycling are needed in order to unravel the appropriate management of rapid cycling bipolar disorder

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PROCTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

Purpose—To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials—Patients enrolled in Trial XXXX (XXXX) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly x4 during treatment; 12-weeks post-treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results—Among 226 study sites participating in Trial XXXX, 100% completed 35-minute PROCTCAE training for clinical research associates (CRAs); 80 sites enrolled patients of which 34 (43%) required tablet computers to be provided. All 152 patients in Trial XXXX agreed to selfreport using the PRO-CTCAE (median age 66; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range 30–240), and median time for CRAs to teach a patient to self-report was 10 minutes (range 2–60). Compliance was high, particularly during active treatment when patients self-reported at 86% of expected time points, although compliance was lower post-treatment (72%). Common reasons for non-compliance were institutional errors such as forgetting to provide computers to participants; patients missing clinic visits; internet connectivity; and patients feeling “too sick”. Conclusions—Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic adverse events at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between-visits, and by employing central compliance monitoring. These approaches are being incorporated into ongoing studies

The Bipolar Affective Disorder Dimension Scale (BADDS) – a dimensional scale for rating lifetime psychopathology in Bipolar spectrum disorders

BACKGROUND: Current operational diagnostic systems have substantial limitations for lifetime diagnostic classification of bipolar spectrum disorders. Issues include: (1) It is difficult to operationalize the integration of diverse episodes of psychopathology, (2) Hierarchies lead to loss of information, (3) Boundaries between diagnostic categories are often arbitrary, (4) Boundaries between categories usually require a major element of subjective interpretation, (5) Available diagnostic categories are relatively unhelpful in distinguishing severity, (6) "Not Otherwise Specified (NOS)" categories are highly heterogeneous, (7) Subclinical cases are not accommodated usefully within the current diagnostic categories. This latter limitation is particularly pertinent in the context of the increasing evidence for the existence of a broader bipolar spectrum than has been acknowledged within existing classifications. METHOD: We have developed a numerical rating system, the Bipolar Affective Disorder Dimension Scale, BADDS, that can be used as an adjunct to conventional best-estimate lifetime diagnostic procedures. The scale definitions were informed by (a) the current concepts of mood syndrome recognized within DSMIV and ICD10, (b) the literature regarding severity of episodes, and (c) our own clinical experience. We undertook an iterative process in which we initially agreed scale definitions, piloted their use on sets of cases and made modifications to improve utility and reliability. RESULTS: BADDS has four dimensions, each rated as an integer on a 0 – 100 scale, that measure four key domains of lifetime psychopathology: Mania (M), Depression (D), Psychosis (P) and Incongruence (I). In our experience it is easy to learn, straightforward to use, has excellent inter-rater reliability and retains the key information required to make diagnoses according to DSMIV and ICD10. CONCLUSIONS: Use of BADDS as an adjunct to conventional categorical diagnosis provides a richer description of lifetime psychopathology that (a) can accommodate sub-clinical features, (b) discriminate between illness severity amongst individuals within a single conventional diagnostic category, and (c) demonstrate the similarity between the illness experience of individuals who have been classified into different disease categories but whose illnesses both fall near the boundaries between the two categories. BADDS may be useful for researchers and clinicians who are interested in description and classification of lifetime psychopathology of individuals with disorders lying on the bipolar spectrum

Clinical management and burden of bipolar disorder: a multinational longitudinal study (WAVE-bd Study)

BACKGROUND: Studies in bipolar disorder (BD) to date are limited in their ability to provide a whole-disease perspective--their scope has generally been confined to a single disease phase and/or a specific treatment. Moreover, most clinical trials have focused on the manic phase of disease, and not on depression, which is associated with the greatest disease burden. There are few longitudinal studies covering both types of patients with BD (I and II) and the whole course of the disease, regardless of patients' symptomatology. Therefore, the Wide AmbispectiVE study of the clinical management and burden of Bipolar Disorder (WAVE-bd) (NCT01062607) aims to provide reliable information on the management of patients with BD in daily clinical practice. It also seeks to determine factors influencing clinical outcomes and resource use in relation to the management of BD. METHODS: WAVE-bd is a multinational, multicentre, non-interventional, longitudinal study. Approximately 3000 patients diagnosed with BD type I or II with at least one mood event in the preceding 12 months were recruited at centres in Austria, Belgium, Brazil, France, Germany, Portugal, Romania, Turkey, Ukraine and Venezuela. Site selection methodology aimed to provide a balanced cross-section of patients cared for by different types of providers of medical aid (e.g. academic hospitals, private practices) in each country. Target recruitment percentages were derived either from scientific publications or from expert panels in each participating country. The minimum follow-up period will be 12 months, with a maximum of 27 months, taking into account the retrospective and the prospective parts of the study. Data on demographics, diagnosis, medical history, clinical management, clinical and functional outcomes (CGI-BP and FAST scales), adherence to treatment (DAI-10 scale and Medication Possession Ratio), quality of life (EQ-5D scale), healthcare resources, and caregiver burden (BAS scale) will be collected. Descriptive analysis with common statistics will be performed. DISCUSSION: This study will provide detailed descriptions of the management of BD in different countries, particularly in terms of clinical outcomes and resources used. Thus, it should provide psychiatrists with reliable and up-to-date information about those factors associated with different management patterns of BD. TRIAL REGISTRATION NO: ClinicalTrials.gov: NCT01062607

Decreasing the minimum length criterion for an episode of hypomania: evaluation using self-reported data from patients with bipolar disorder

Brief hypomania lasting less than 4 days may impair functioning and help to detect bipolarity. This study analyzed brief hypomania that occurred in patients with bipolar disorder who were diagnosed according to the DSM-IV criteria. Daily self-reported mood ratings were obtained from 393 patients (247 bipolar I and 146 bipolar II) for 6 months (75,284 days of data, mean 191.6 days). Episodes of hypomania were calculated using a 4, 3, 2, and single day length criterion. Brief hypomania occurred frequently. With a decrease in the minimum criterion from 4 days to 2 days, there were almost twice as many patients with an episode of hypomania (102 vs. 190), and more than twice as many episodes (305 vs. 863). Single days of hypomania were experienced by 271 (69%) of the sample. With a 2-day episode length, 33% of all hypomania remained outside of an episode. There was no significant difference in the percent of hypomanic days outside of an episode between patients with bipolar I and II disorders. There were no significant differences in the demographic characteristics of patients who met the 4-day minimum as compared with those who only experienced episodes of hypomania using a shortened length criterion. Decreasing the minimum length criterion for an episode of hypomania will cause a large increase in the number of patients who experience an episode and in the aggregate number of episodes, but will not distinguish subgroups within a sample who meet the DSM-IV criteria for bipolar disorder. Frequency may be an important dimensional aspect of brief hypomania. Clinicians should regularly probe for brief hypomania

Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Background PRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system. Methods Participants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0–4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed. Results 103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55–0.90); tablet vs paper: 0.81 (0.62–0.96); IVRS vs paper: 0.78 (0.60–0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = −0.04 [−0.16–0.22]; tablet vs paper = −0.02 [−0.11–0.14]; IVRS vs paper = 0.02 [−0.07–0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/−0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported “no problems” responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper. Conclusions Mode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration. Trial registration NCT Clinicaltrials.gov identifier: NCT0215863