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Introduction/aims ASP0367, or bocidelpar sulfate, is an orally administered small molecule that potently and selectively modulates peroxisome proliferator-activated receptor δ (PPARδ) to address mitochondrial dysfunction occurring in diseases including primary mitochondrial myopathy and Duchenne muscular dystrophy. The objectives of this first-in-human trial were to evaluate the safety/tolerability, pharmacokinetics, and pharmacodynamics of ASP0367 in healthy participants. Methods In this double-blind phase 1 study, adult participants were randomized to single or multiple ascending oral doses of ASP0367 or placebo. The study duration was 1 and 14 days, respectively. Pharmacokinetic parameters under fed conditions were also evaluated. Results A total of 64 (single-dose cohort) and 37 (multiple-dose cohort) participants were included in the study. After single doses of 1 to 120 mg, ASP0367 was rapidly absorbed, with median time to maximum plasma concentration (tmax ) of 1.50 to 2.24 hours under fasting conditions; ASP0367 concentrations declined in a multiphasic manner after reaching maximum plasma concentration. Under fed conditions, tmax was delayed 1.7 hours. After multiple once-daily doses, mean half-life of ASP0367 10 to 75 mg ranged from 14.1 to 17.5 hours; steady state was reached after 4 days. Negligible accumulation was observed after repeated dosing. No participants receiving ASP0367 discontinued treatment, and all treatment-emergent adverse events were mild to moderate in severity; none were considered drug-related. No clinically significant changes were observed on laboratory or electrocardiographic evaluation. Treatment- and dose-dependent upregulation of six PPARδ target genes was observed with single and multiple doses of ASP0367. Discussion ASP0367, or bocidelpar sulfate, was well tolerated; rapid absorption, roughly dose-proportional bioavailability, and effects on PPARδ target genes were demonstrated in healthy adult participants.

The Attitudes Toward Persons with Obesity (ATOP) scale is widely used to assess stigmatization toward persons with obesity. The measure has previously been suggested to assess three facets—self-esteem, personality, and social difficulties—however, psychometric support for this has been inconsistent and warrants further study if the measure intends to be scored this way. Explore and confirm the factor structure of the ATOP in people assessed prior to bariatric surgery and reassessed 1 year postoperatively Midwestern hospital in the USA. Three-hundred sixteen people who were seeking bariatric surgery were assessed preoperatively, and 161 of those people were reassessed 1 year after surgery with a battery of measures including the ATOP. Exploratory factor analysis (EFA) was performed on ATOP data from a random split-half of people before surgery, and confirmatory factor analysis (CFA) was performed on the second randomly selected half. With the postoperative sample, a CFA was performed, testing the best-fitting model from the preoperative CFA findings. The EFA suggested a two-factor structure interpreted as self-esteem and personality/social difficulties. This structure was supported by CFA performed on the second randomly selected half of people at preoperative assessment and by CFA performed on people 1 year following surgery. Tests of measurement invariance suggested that the two-factor structure was similar at both time points. Only two factors for the ATOP were empirically supported in the current sample (self-esteem and personality/social difficulties), which is slightly different from the three factors that were originally proposed when the measure was developed. This factor structure is supported both prior to bariatric surgery and 1 year after bariatric surgery.

Chronic pain has become a significant medical issue. The Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) is a broadband psychological test that has been validated for use across various medical settings and can aid in the assessment and treatment planning of chronic pain. In the current investigation, it was hypothesized that the somatic complaints scales of the MMPI-2-RF would demonstrate good convergent validity from a structured psychodiagnostic interview and other measures of pain and somatization, and lack gender bias. Patients (n = 200) who produced valid MMPI-2-RFs in an outpatient chronic pain clinic were included in the study. Patients were also administered the Modified Somatic Perception Questionnaire (MSPQ), Pain Disability Index (PDI), and the Structured Clinical Interview for DSM-IV-TR (SCID). Zero-order and partial correlations (controlling for gender) were calculated between MMPI-2-RF scale scores and other criteria. Stepdown hierarchical regression analyses were used to detect bias. By and large, higher scale scores on the somatic/cognitive scales of the MMPI-2-RF were modestly or substantially correlated with MSPQ scores, PDI scores, and SCID Somatization symptom count, even after controlling for gender. Regression analyses suggested that the MMPI-2-RF scale scores were not biased as a function of gender. These findings support the validity of specific MMPI-2-RF scales to help identify somatization and psychosocial functioning among patients with chronic pain. Identification of somatization early within the course of treatment of chronic pain may help focus treatment targets, including referrals for psychological interventions such as cognitive behavior therapy for chronic pain.

A considerable number of post-bariatric surgery patients report problematic eating behaviors (PEBs) and/or eating disorders (EDs). Examining psychosocial variables associated with ED symptoms may identify targets for postoperative interventions to reduce these behaviors and improve surgical outcomes. A total of 161 participants completed the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) and the Eating Disorder Examination-Questionnaire (EDE-Q). Participants were classified into ED risk or no ED risk groups and subjective binge eating (SBE) or no SBE groups. Independent-sample t tests were computed to examine mean differences in total weight loss (%TWL) and MMPI-2-RF scale scores between the ED groups. Relative Risk Ratios (RRRs) were computed to determine which MMPI-2-RF scales were associated with increased risk of ED group membership. The ED risk group lost significantly less weight (19.36% TWL) than the no ED risk group (25.18% TWL). The SBE group lost significantly less weight (17.98% TWL) than the no SBE group (25.57% TWL). Participants in the ED groups scored significantly higher on internalizing and externalizing MMPI-2-RF scales than the no ED groups. These scales were associated with increased risk (1.55–2.55 times the risk) of being classified into the ED groups. Patients who experienced postoperative ED symptoms lost significantly less weight than patients without ED symptoms. Postoperative ED symptoms are related to, and may be impacted by, higher levels of internalizing and externalizing dysfunction after surgery. Postoperative assessment of and interventions targeting psychosocial dysfunction could decrease ED symptoms. III: Evidence obtained from well-designed cohort or case–control analytic studies.

Rationale Previous research suggests that sleep polysomnography and EEG endpoints can be used to assess GABAergic activity; however, the impact of GABAB receptor positive allosteric modulators on sleep endpoints remains unclear. Objectives This phase 1 study compared a single dose of ASP8062 (35 mg or 70 mg), a GABAB receptor positive allosteric modulator, with placebo and paroxetine (40 mg). Methods Healthy adult volunteers were randomized to four treatments (35 mg ASP8062, 70 mg ASP8062, paroxetine 40 mg, or matching placebo), each separated by a 14-day washout. Primary endpoints obtained by polysomnography were time in stage N3 or SWS and time in rapid eye movement (REM) sleep. Secondary endpoints included impact on sleep stages and electroencephalography parameters, pharmacokinetics, nighttime growth hormone (GH), and safety/tolerability. Results In 20 randomized volunteers, ASP8062 led to a significant and seemingly dose-dependent increase in SWS over the entire night; this increase was mainly observed during the first third of the night. ASP8062 did not impact time in REM sleep. Paroxetine had no effect on SWS but produced a significant reduction in time spent in REM sleep. A dose-dependent trend in increased GH release was also observed with ASP8062. Headache and nausea were the most commonly reported treatment-emergent adverse events (TEAEs) for ASP8062; most TEAEs were mild in severity. Conclusions Single-dose ASP8062 (35 and 70 mg) appeared to result in CNS penetration and enhanced GABAergic activity as measured by increases in slow-wave sleep and growth hormone release.

Purpose ASP0819 is a novel, non-opioid KCa3.1 channel opener that reverses abnormal nerve firing of primary sensory afferent nerves. Currently available treatments for fibromyalgia provide only modest relief and are accompanied by a host of adverse side effects. Patients and Methods In this phase 2a, double-blind trial (NCT03056690), adults meeting fibromyalgia diagnostic criteria were randomized 1:1 to receive either 15 mg/day of oral ASP0819 (n=91) or placebo (n=95). The primary endpoint was the change from baseline to Week 8 in the mean daily average pain score. Changes in the Fibromyalgia Impact Questionnaire Revised (FIQR) symptoms, function, and overall impact subscales, as well as changes in the patients’ global impression of change, were secondary endpoints; treatment effects on FIQR total score and impact on sleep were exploratory analyses. Results There was no statistically significant difference between ASP0819 and placebo for the primary endpoint (P=0.086); however, ASP0819 versus placebo significantly improved daily average pain at Weeks 2, 6, and 7 (all P

ASP4345, a novel dopamine D1 receptor positive allosteric modulator, is being evaluated for the treatment of cognitive impairment associated with schizophrenia (CIAS). This phase 1 multiple ascending-dose study (NCT02720263) assessed the safety, tolerability, and pharmacodynamics of ASP4345 in patients with schizophrenia/schizoaffective disorder. Pharmacodynamic assessments were Cogstate cognitive tests and electrophysiological biomarkers, including gamma-band power and phase synchronization in response to 40-Hz auditory steady-state stimulation, as well as mismatch negativity (MMN) and P3a event-related potentials. The sample size determination was based on standard practice in assessing safety and tolerability of a new chemical entity. Data were summarized by conversion of this data into effect sizes using descriptive and inferential statistics. A total of 36 randomized patients received ASP4345 (3, 15, 50, and 150 mg; n = 9 each dose) and 12 patients received placebo. Patients in the ASP4345 group experienced 73 treatment-emergent adverse events (TEAEs) and 34 TEAEs were reported for the placebo group. The most common TEAEs were headache and somnolence and nearly all TEAEs were mild in severity. No changes in mood or self-reports of suicidal ideation/behavior were observed. Improvements in performance on cognitive tests were noted, which suggests a potential improvement in psychomotor function and visual attention. Furthermore, positive changes in neurophysiological biomarkers (auditory steady-state response [ASSR] and MMN) suggest improvement in information processing. The findings need to be confirmed in studies with a larger patient population. Nonetheless, the trends in safety and pharmacodynamic data support further clinical development of ASP4345 for the treatment of CIAS.

Eating pathology is common pre-operatively and continues to be prevalent following bariatric surgery. A new version of the Minnesota Multiphasic Personality Inventory (MMPI), the MMPI-3, contains a new scale called Eating Concerns (EAT) that aims to assess problematic eating behaviors. The current investigation seeks to establish preliminary convergent validity of the MMPI-3 EAT scale in a postoperative bariatric surgery sample. Thirty-eight consecutive participants took the MMPI-3 and the Eating Disorder Examination–Questionnaire (EDE-Q). Higher MMPI-3 EAT scale scores were meaningfully associated with %Weight Regain (r = .37) and scale scores on the EDE-Q [Eating Concerns (r = .67), Weight Concerns (r = .39), Shape Concerns (r = .54), and the EDE total score (r = .59)]. Initial examination of the EAT Specific Problem Scale of the MMPI-3 yields good clinical utility in assessing eating pathology in a postoperative bariatric surgery sample.

Mental health professionals routinely assess psychosocial risk factors prior to bariatric surgery to help identify factors that may impede surgical outcomes. Data regarding longer-term psychosocial functioning postoperatively are needed. Assess the psychosocial functioning of patients who obtained bariatric surgery approximately 6 years ago. A total of 161 patients consented to participate in the outcome study. Participants were compensated for their time and participation. Participants were weighed by the research/clinical staff and asked to complete a battery of self-report measures, including the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF). Other measures targeted adherence, eating behaviors/body image, alcohol use, and quality of life. Postoperative MMPI-2-RF scores indicate psychosocial functioning is largely similar to previously published pre-surgical functioning data. Six-year weight loss outcomes were lower than previous studies reported for a similar postoperative time period (mean %total weight loss = 22.98%; standard deviation = 11.71), though quality of life scores were relatively high. Postoperative MMPI-2-RF scale scores were associated with poorer psychosocial functioning, reduced adherence, greater eating behaviors/body image concerns, greater alcohol use severity, lower quality of life, and less overall weight loss. Psychological dysfunction 6 years after surgery is associated with various adverse outcomes. Ongoing, postoperative treatment may result in better long-term functioning for patients.

ASP8062 is an orally active γ-amino-butyric acid type B (GABAB ) receptor positive allosteric modulator currently in phase 2 development. Safety and pharmacokinetic (PK) profiles of ASP8062 were evaluated in 2 studies in healthy subjects. The first study (a first-in-human study) evaluated single ascending doses (SAD) of ASP8062. The second study was composed of 2 parts: part 1 evaluated multiple ascending doses (MAD) of ASP8062 for 14 days, and part 2 was a single-dose arm to assess the PK of ASP8062 in cerebrospinal fluid (CSF). Fifty-six men (SAD) and 56 subjects (24 women and 32 men; MAD) were enrolled. Across the SAD dosing range, area under the concentration-time curve was dose proportional; increases in maximum plasma concentration appeared linear but were slightly less than dose proportional. Time to maximal concentration and half-life were 1-4 hours and ∼40-50 hours, respectively; no food effect was observed. ASP8062 PK properties at steady state were similar to those following a single dose. Steady state was achieved by ∼day 9 with ∼2-fold accumulation, and ASP8062 was detected in CSF. ASP8062 was well tolerated; no clear evidence of ASP8062's effects on safety, cognition, drug withdrawal, or suicidal ideation/behavior was observed. These data support the development of ASP8062 in indications where the GABAB receptor is a target.

Healthcare in the United States has increasingly benefited from the adoption of multidisciplinary providers. Many multidisciplinary teams include psychologists who often conduct psychological and personality assessments in their practice. This special section highlights areas of personality and psychological assessment in applied healthcare contexts. Nghiem and colleagues review the psychometric performance of various personality and psychopathology instruments and provide recommendations for the assessment of solid organ transplant evaluations. Gottschling and colleagues present a culturally adapted screener for anxiety-related symptoms in geriatric adults that can easily be administered in various healthcare settings. Perry and colleagues provide a rationale and method for including a brief personality assessment for patients with cancer. McCord presents a broadband screener, the Multidimensional Behavioral Health Screen (MBHS), that assesses 9 components of psychopathology. Mitchell and colleagues provide evidence for using the MBHS in primary care clinics as an alternative to the Patient Health Questionnaire-9. This special section provides evidence-based information regarding personality and psychological assessments that will likely be useful in varied healthcare contexts.

Inhibition of the enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) represents a potential mechanism for improving pain conditions. ASP3662 is a potent and selective inhibitor of 11β-HSD1. Two phase I clinical studies were conducted to assess the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of single and multiple ascending doses of ASP3662 in healthy young and elderly non-Japanese and young Japanese subjects. Nonlinear, more than dose-proportional PKs were observed for ASP3662 after single-dose administration, particularly at lower doses (≤ 6 mg); the PKs at steady state were dose proportional, although the time to ASP3662 steady state was dose dependent at lower doses (≤ 2 mg). Similar PKs were observed among young Japanese, young non-Japanese, and elderly non-Japanese subjects. Specific inhibition of 11β-HSD1 occurred after both single and multiple doses of ASP3662. A marked dissociation between PKs and PDs was observed after single but not multiple doses of ASP3662. ASP3662 was generally safe and well tolerated.

Background Bariatric surgery usually results in substantial weight loss and a reduction in medical comorbidities. Many patients, as a consequence of the weight loss, subsequently evidence loose, redundant skin. Objectives This investigation seeks to examine the prevalence of body contouring surgery (BCS) by patients approximately 4 to 5 years after Roux-en-Y gastric bypass surgery. Demographics, change in BMI, and psychosocial variables were also used to predict body dissatisfaction, desire for BCS, and patients who reported obtaining BCS. Setting The clinical sites involved in the Longitudinal Assessment of Bariatric Surgery project, which included 10 hospitals across the United States. Methods The sample comprised 1159 patients who underwent Roux-en-Y gastric bypass and were enrolled in the Longitudinal Assessment of Bariatric Surgery-2 study. Participants were surveyed using the Excessive Skin Survey and other psychosocial measures at their 4- or 5-year postoperative outcome. The participants were predominately women (80.5%), Caucasian (88.3%), and middle-aged (mean = 46.1 yr, standard deviation = 11.11 yr). Results Participants reported modest degrees of being bothered by excessive skin, primarily in their waist/abdomen, thighs, and chest/breasts body areas. Only 11.2% of the sample had undergone any BCS procedure, and a majority of those participants paid "out of pocket" for BCS. Desire for BCS and body dissatisfaction 4 to 5 years postsurgery was associated with higher depression scores and poorer quality of life scores. Conclusions Excessive skin is associated with poorer psychosocial functioning. Despite reporting modest levels of being bothered by excessive skin and body dissatisfaction, only a small fraction of participants underwent BCS. Cost of BCS was reported to be a primary barrier for not obtaining BCS. All rights reserved.

Background Research identifying preoperative psychosocial predictors of bariatric surgery outcomes has yielded inconsistent results with minimal examination of longer-term outcomes. Utilizing a broadband measure of personality and psychopathology during the preoperative evaluation helps to identify preoperative risk factors for suboptimal bariatric surgery outcomes. Objective Examine predictors of outcome and the incremental contribution of presurgical psychological testing to various long-term bariatric surgery outcomes. Setting Academic medical center. Method A total of 168 postoperative patients (average of 6 postoperative years) consented to participate in the outcome study. Participants were weighed by the trained research/clinical staff and completed a battery of self-report questionnaires, including measures assessing eating attitudes and behaviors and weight-related quality-of-life (QoL). Patients had completed the Minnesota Multiphasic Personality Inventory–2–Restructured Form (MMPI-2-RF) as part of the institution’s routine preoperative psychosocial evaluation. Weight loss was calculated as percent total weight loss (%TWL) and percent weight regain (%WR) was calculated as a percentage of maximum weight loss. Other preoperative data were obtained from a review of each patient’s electronic medical record (EMR). From the initial sample, 145 patients were retained for analyses in the present study. Results Preoperative problematic eating variables predicted long-term postoperative problematic eating behaviors and body image concerns. Scores on preoperative MMPI-2-RF scales measuring Demoralization, Dysfunctional Negative Emotions, Antisocial Behaviors, and Hypomanic Activation were consistent incremental predictors of 6-year outcomes, accounting for an additional 3%–24% of the variability in postoperative eating behaviors and QoL. Conclusions The preoperative psychological evaluation can be used to identify predictors of long-term bariatric surgery outcomes. Identification of these risk factors provides important targets for pre- and postoperative clinical interventions to maximize surgical outcomes.

BackgroundAlthough lifestyle modifications are an integral part of treatment and prevention of hemorrhoidal disease, it is largely unknown how lifestyle factors like diet and physical activity are characterized in patients with a history of advanced and invasively treated hemorrhoidal disease.MethodsIn a Northern German cross-sectional study, clinical characteristics and dietary and physical activity data of 386 patients were assessed via questionnaires at median 10 years after their first invasive hemorrhoidal treatment. Food and nutrient intake and physical activity levels of the hemorrhoid patients were compared with general population controls. Additionally, within the hemorrhoid patient cohort, dietary intake and physical activity were related to clinical characteristics using logistic regression analyses.resultsWhereas in men, there were no statistically significant differences in food intake between hemorrhoids patients and controls, women with a history of hemorrhoids had a significantly higher consumption of potatoes, nuts and animal fat, and a lower consumption of fruits, compared to women from the control group. Hemorrhoid patients reported slightly more gardening activities and less TV watching than controls. Within the hemorrhoid patient cohort, hemorrhoid grade, type of first therapy, need for further treatment, patients’ compliance for another surgery if necessary and current anal afflictions revealed individual associations with fiber, alcohol, animal fat and potato consumption and the amounts of home repair activities and sleeping time.ConclusionsAlthough we could identify some statistically significant differences in dietary and physical activity behavior between hemorrhoid patients and controls and observed associations between clinical characteristics and lifestyle factors, some findings are, in parts, still inconsistent. Whether patients are following lifestyle recommendations as part of conservative hemorrhoid treatment and tertiary prevention and which patients are more adherent than others (e.g., high-grade vs. low-grade) needs further investigation.

Background Cognitive impairment is a core feature of schizophrenia. While first- and second-generation antipsychotic drugs treat psychotic exacerbations, no treatment is approved for the cognitive dysfunction. We have identified ASP4345, a positive allosteric modulator of the dopamine type 1 (D1) receptor that selectively binds to, and enhances the activity of, D1 receptors. ASP4345 has the potential to be an effective and well-tolerated treatment option for cognitive impairment associated with schizophrenia. Objective The objective of this study was to determine the pharmacokinetics of ASP4345 in two phase I single ascending-dose and multiple ascending-dose studies. Methods Both phase I studies were randomized, double blind, and placebo controlled. The single dose-ascending study assessed pharmacokinetics of single oral doses of 3–900 mg of ASP4345 or placebo in the fasted state in healthy adult volunteers. This study also assessed cerebrospinal fluid pharmacokinetics, as well as the effects of food on pharmacokinetic parameters. The multiple ascending-dose study (NCT02720263) assessed the pharmacokinetics of multiple oral doses of 3–150 mg of ASP4345 in patients with schizophrenia or schizoaffective disorder receiving stable antipsychotic drug treatment. The pharmacokinetic data from both studies were summarized using descriptive statistics. Results The plasma concentration–time profile in both studies showed a rapid increase in concentrations of ASP4345. The median time to maximum concentration range was 1.00–2.26 h in the single ascending-dose study in the fasted state and 1.25–3.02 h in the multiple ascending-dose study at steady state. There were less than dose-proportional increases in maximum concentration and area under the curve in the single ascending-dose study, where doses had a range from 3 to 900 mg, and in the multiple ascending-dose study in patients with stabilized schizophrenia or schizoaffective disorder, where doses had a range from 3 to 150 mg. The mean terminal elimination half-life was dose independent and had a range from 9.12 to 14.3 h in the single ascending-dose study and from 11.1 to 26.8 h in the multiple ascending-dose study. Additionally, in the single ascending-dose study, absorption of 300 mg of ASP4345 was slightly delayed when administered in the fed state compared with the fasted state; median time to maximum concentration was 1.5 h under the fasting state and 4.0 h under fed states. All other pharmacokinetic parameters were comparable for both conditions. ASP4345 appeared in the cerebrospinal fluid with some delay; time to maximum concentration range was from 2.48 to 7.98 h in cerebrospinal fluid compared with 0.75 to 1.03 h in plasma (median cerebrospinal fluid/plasma = 0.188). The ratio of cerebrospinal fluid to total plasma for area under the curve from 0 to 24 h (0.157–0.573%) and maximum concentration (0.0899–0.311%) and the ratio of cerebrospinal fluid to unbound plasma for maximum concentration (25.0–86.4%) confirm the distribution of ASP4345 into the brain. Conclusions The pharmacokinetics of ASP4345 suggest that single daily dosing is appropriate for ASP4345. Furthermore, the concentration of ASP4345 in cerebrospinal fluid compared to free drug concentrations in plasma provides evidence of penetration of ASP4345 into the brain.

CLINICAL RELEVANCE Proper selection of phakic intraocular lens diameter is necessary to avoid complications related with excessive vaulting after its implantation. BACKGROUND Horizontal corneal diameter, measured as white-to-white distance, is one of the parameters used for phakic intraocular lens diameter calculation. Agreement was assessed between three parameters: white-to-white distance obtained with swept source optical coherence tomography, and white-to-white distance obtained with Scheimpflug camera and angle-to-angle parameter obtained with anterior segment optical coherence tomography. METHODS This study included 55 eyes of 43 patients. The white-to-white distance was measured with two biometry techniques: swept source optical coherence tomography and Scheimpflug camera. The angle-to-angle was measured with anterior segment optical coherence tomography. Analysis of agreement was performed by the Bland-Altman method. For every patient, simulation of Visian Implantable Collamer Lens (ICL) sizing was performed using the Online Calculation and Ordering System with different white-to-white distance or angle-to-angle. RESULTS Statistically significant differences were found between swept source optical coherence tomography biometer and anterior segment optical coherence tomography (p = 0.001) and between swept source optical coherence tomography and Scheimpflug camera (p

Previous studies suggest the importance of understanding what factors increase risk of lack of physical activity (PA) prior to bariatric surgery, which may increase risk of suboptimal postoperative outcomes. Therefore, the current study sought to explore which Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) scales were associated with lack of pre-surgical PA. The mean age of the sample (N = 1170) was 45.97 years [standard deviation (SD) = 11.59]. Bivariate correlations and relative risk ratios were utilized to examine associations between MMPI-2-RF scale scores and regular preoperative PA. Of the ten hypothesized associations, seven MMPI-2-RF scales in the internalizing and somatic domains were associated with increased risk of preoperative lack of PA. Interventions designed to increase levels of preoperative PA are especially important because individuals with higher levels of preoperative cardiorespiratory fitness experience less complications in surgery and greater weight loss postoperatively.

The aim of this study was to evaluate the use of a mobile application (app) in patients already using total body photography (TBP) to increase skin self-examination (SSE) rates and pilot the effectiveness of examination reminders and accountability partners. Randomized controlled trial with computer generated randomization table to allocate interventions. University of Pennsylvania pigmented lesion clinic. 69 patients aged 18 years or older with an iPhone/iPad, who were already in possession of TBP photographs. A mobile app loaded with digital TBP photos for all participants, and either (1) the mobile app only, (2) skin examination reminders, (3) an accountability partner, or (4) reminders and an accountability partner. Change in SSE rates as assessed by enrollment and end-of-study surveys 6 months later. Eighty one patients completed informed consent, however 12 patients did not complete trial enrollment procedures due to device incompatibility, leaving 69 patients who were randomized and analyzed [mean age 54.3 years, standard deviation 13.9). SSE rates increased significantly from 58% at baseline to 83% at 6 months (odds ratio 2.64, 95% confidence interval 1.20–4.09), with no difference among the intervention groups. The group with examination reminders alone had the highest (94%) overall satisfaction, and the group with accountability partners alone accounted for the lowest (71%). A mobile app alone, or with reminders and/or accountability partners, was found to be an effective tool that can help to increase SSE rates. Skin examination reminders may help provide a better overall experience for a subset of patients. ClinicalTrials.gov Identifier: NCT02520622.

Background The current investigation aims to predict 3-year postoperative percent total weight loss among a sample of bariatric surgery patients with super-super obesity. Objective Previous research implies that persons with presurgical super-super obesity (body mass index [BMI] ≥60 kg/m2) tend to have poorer loss outcomes compared with those with a lower presurgical BMI after bariatric surgery. Setting Cleveland Clinic, Bariatric & Metabolic Institute, Cleveland, OH. Methods Bariatric surgery candidates (N = 1231; 71.9% female; 65.8% Caucasian) completed a presurgical psychological evaluation and the Minnesota Multiphasic Personality Inventory–2–Restructured Form. Participants with a baseline BMI ≥60 (n = 164) were compared with BMI Results Patients with a BMI ≥60 were younger, less educated, and more likely to be male compared with lower BMI patients. Patients with a BMI ≥60 had greater psychosocial sequelae as evidenced by being more likely to have a history of sexual abuse, history of psychiatric hospitalization, more binge eating episodes, and higher prevalence of major depression disorder and binge eating disorder. On the Minnesota Multiphasic Personality Inventory–2–Restructured Form, those with BMI ≥60 reported greater demoralization, low positive emotions, ideas of persecution, and dysfunctional negative emotions. After controlling for surgery type, weight loss for individuals with BMI ≥60 did not greatly differ from weight loss in patients with BMI Conclusion Although patients with BMI ≥60 evidenced more psychopathology before surgery, findings suggest that the relationship between higher BMI and poorer outcome may better be explained by other co-morbid factors.

Objective Focusing on average weight loss (WL) from interventions provides useful efficacy data but masks large variability across patients. In this study, parameters of weight loss trajectories were determined that differentiated individuals during a 15-week clinical lifestyle intervention. Methods Patients (n = 595) were in a fee-for-service WL lifestyle program with a partial meal replacement diet and lifestyle change counseling. Parameters used in latent class analyses were percent WL (%WL), weight nadir, number of weekly weight gains, maximum weekly percent weight gain, standard deviation of weekly weight changes, linear slope values, and change in slope. Results Average %WL was 9.73%. Latent class analyses revealed three groups with considerable overlap in %WL ranges but differing significantly on all trajectory parameters (Ps

Background Thirty-day readmissions occur in 5% or more of bariatric surgery patients. Some readmissions relate directly to surgical risks, whereas others relate to more nonspecific complaints or nonadherence and may reflect risks outside of the surgical procedure. Objective To investigate whether presurgical psychosocial factors are related to readmission. Setting Tertiary/quaternary academic referral center. Methods Bariatric surgery patients readmitted within 30 days of surgery during 2012–2015 were identified (n = 102). Patients were matched (2:1) on body mass index, age, sex, and race to 204 nonreadmitted patients. Psychiatric variables and psychological testing (Minnesota Multiphasic Personality Inventory-2-Restructured Form) at intake were compared between the 2 groups. Among those readmitted, the indication for readmission was investigated. Those with specific complications (n = 61) were delineated from those with nonspecific indications (n = 33). Results Those with nonspecific readmissions were younger and more likely to be female. These patients were also less likely to be in outpatient psychiatric care than nonreadmitted patients. Significant differences were found on the Uncommon Virtues scale of the Minnesota Multiphasic Personality Inventory-2-Restructured Form, which reflects a tendency to underreport disinhibited behaviors. Those with nonspecific readmissions had significantly higher underreporting scores compared to those with specific indications or those not readmitted. Conclusions Readmitted patients, particularly those with nonspecific indications, were more likely to presurgically present themselves in an overly positive manner. The tendency to underreport may affect the team's ability to identify risk factors that could be ameliorated before surgery. Readmitted patients were also less likely to be receiving mental health care. Such ongoing treatment may increase monitoring and/or adherence after surgery.

The present study investigated the comparability of laptop computer- and tablet-based administration modes for the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF). Employing a counterbalanced within-subjects design, the MMPI-2-RF was administered via both modes to a sample of college undergraduates ( N = 133). Administration modes were compared in terms of mean scale scores, internal consistency, test-retest consistency, external validity, and administration time. Mean scores were generally similar, and scores produced via both methods appeared approximately equal in terms of internal consistency and test-retest consistency. Scores from the two modalities also evidenced highly similar patterns of associations with external criteria. Notably, tablet administration of the MMPI-2-RF was substantially longer than laptop administration in the present study (mean difference 7.2 minutes, Cohen's d = .95). Overall, results suggest that varying administration mode between laptop and tablet has a negligible influence on MMPI-2-RF scores, providing evidence that these modes of administration can be considered psychometrically equivalent.

Prospective data are needed to ascertain the impact of iron chelation therapy in patients with myelodysplastic syndromes. The present 5-year prospective registry analysis was conducted to compare clinical outcomes between chelated and nonchelated patients with lower-risk myelodysplastic syndromes and transfusional iron overload. In an interim analysis at 24 months, we previously reported that chelation therapy was associated with longer median overall survival and a tendency toward longer leukemia-free survival and fewer cardiac events. In the present report, we detail findings from the final analysis at 5 years. We confirm, at the conclusion of this 5-year, prospective, non-interventional study, that overall survival was significantly longer in patients who received iron chelation therapy vs those who did not. Causes of death in the overall population were predominantly myelodysplastic syndromes/acute myeloid leukemia followed by cardiac disease. Time to progression to acute myeloid leukemia was also significantly longer in patients receiving chelation therapy, and significantly fewer patients progressed to leukemia vs those not receiving chelation therapy. Limitations of the study include a potential for clinical bias, as patients with longer predicted survival may have been chosen for chelation therapy, the differences present in concomitant conditions at baseline, and the possibility that some high-risk patients were not identified due to limited cytogenetic classification.

Background The reasons why some patients who begin the presurgical process for bariatric surgery fail to complete the procedure are understudied. Previous research implies that psychological factors play a role. Objectives To examine whether scores from baseline psychological testing incrementally predict failure to proceed with bariatric surgery beyond demographic information in patients' medical charts and data derived from a clinical interview. Setting Cleveland Clinic Bariatric and Metabolic Institute. Methods The sample (n = 1160) was mainly female (72.41%), middle aged (mean age=46.07 yr, SD=11.70) and of Caucasian descent (65.76%). Hierarchical logistic regressions were conducted to test the incremental validity of baseline Minnesota Multiphasic Personality Inventory-2 Restructured Form scores after controlling for information gathered from the psychological interview and medical charts. Relative risk ratios were calculated to reflect the clinical utility of the results. Results In total, 27.16% of patients failed to proceed with bariatric surgery after 1 year or more after a recommendation for surgery from their psychological evaluations. Psychological test scores were substantially associated with failure to proceed with surgery and significantly accounted for up to 6% of additional variance after controlling for psychological interview variables and medical chart data. Elevated scores on Minnesota Multiphasic Personality Inventory-2 Restructured Form scales, such as anxiety and substance use, identify patients at up to 2.5 times greater risk for failing to proceed with bariatric surgery. Conclusions Objective psychological test data—notably, scale scores assessing for substance abuse, anxiety, and demoralization—add to information obtained from a clinical interview and medical records in identifying patients at risk for failing to proceed with bariatric surgery.

Background Outcome of Mitral Valve Prolapse (MVP) was controversial for long time. Many studies reported great differences in the incidence of cardiovascular events due, above all, to heterogeneous and small studied populations. Most of theme were also published to late '80 of the last century till early '00. Purpose To make a contemporary survey on the incidence of cardiovascular events in a selected population of patients affected by primary MVP referred to a tertiary cardiovascular center for the medical and surgical care of valvular heart disease. Methods We reviewed our MVP database; patients with at least 2 cardiologic evaluations inclusive of echocardiographic examination and at least 6 months follow up were enrolled. A total of 250 patients (126 F) were selected. Their mean age was 52.1 years (ranging from 13 to 88 yo). The average follow-up time was 100 months (8,33 yrs). Results At the first medical and echocardiographic examination 8 patients (3,2%) had no mitral regurgitation (MR), 104 (41.6%) have a trace/mild MR, 93 (37,2%) a moderate MR and 46 (18,4%) a severe MR. They were widely asymptomatic (NYHA I 205-82%, NYHA II 44-17.60%, NYHA III 1- 0.40%). Most of theme presented a bileaflet (140-55.8%) or a posterior MVP (94 - 37.6%); an isolated anterior MVP was rare (16 - 6,4%). Flail leaflet was present in 8 (3,2%) and 25 (10%) had a chordal rupture. Respectively 165 (65,6%) and 115 (46,1%) patients had thick and redundant leaflets. Mean antero-posterior mitral annulus diameter was 37 mm. During the follow up 7 patients died of non-cardiac cause and 5 (2%) of suspected cardiac cause (2 because of acute coronary syndrome and 3 died suddenly). MR progresses in 43 (17,2%) patients and finally we observed 81 (32,4%) moderate/severe and severe MR. 12 new chordal rupture occurred during the follow up in most cases concerning mitral chordae linked to posterior mitral leaflet (10 cases-83,3%). The worsening of MR provoked an evolution of the clinical condition of 48 patients (19.2%) which developed Dyspnea On Excertion (DOE) with 42 new NYHA II and 6 new NYHA III. At the end of the follow up the amount of patients symptomatic for DOE was 93 (37.2% vs 18% at the initial evaluation). A total of 45 patients (18%) underwent mitral valve surgery. 40 needed in-hospital treatment in most cases due to the development of atrial fibrillation (19 -7.6%) or heart failure ( 8- 3,2%). Endocarditis occurred in 4 patients (1.6%) and cerebrovascular accidents/cardioembolic event in 6 (2.4%). The overall cardiovascular event rate was 4,33/100 patients-year, significantly higher than reported in community based studies. Conclusions The prognosis of a MVP population referred to a tertiary cardiovascular center is not benign. The most frequent complications are progression of MR and MV surgery. Sudden death is also more frequent than in general population. More studies are needed to identify what patients with MVP are at risk for it.

Background Since the UN Human Rights Council's recognition on the subject in 2011, the right to access the Internet and information is now considered one of the most basic human rights of global citizens [1,2]. Despite this, an information gap between developed and resource-limited countries remains, and there is scant research on actual information needs of workers themselves. The Republic of Botswana represents a fertile ground to address existing gaps in research, policy, and practice, due to its demonstrated gap in access to information and specialists among rural health care workers (HCWs), burgeoning mHealth capacity, and a timely offer from Orange Telecommunications to access Wikipedia for free on mobile platforms for Botswana subscribers. Objectives In this study, we sought to identify clinical information needs of HCWs of Botswana and their perception of Wikipedia as a clinical tool. Methods Twenty-eight facilitated focus groups, consisting of 113 HCWs of various cadres based at district hospitals, clinics, and health posts around Botswana, were employed. Transcription and thematic analysis were performed for those groups. Results Access to the Internet is limited at most facilities. Most HCWs placed high importance upon using Botswana Ministry of Health (MoH) resources for obtaining credible clinical information. However, the clinical applicability of these materials was limited due to discrepancies amongst sources, potentially outdated information, and poor optimization for time-sensitive circumstances. As a result, HCWs faced challenges, such as loss of patient trust and compromises in patient care. Potential solutions posed by HCWs to address these issues included: multifaceted improvements in Internet infrastructure, access to up-to-date information, transfer of knowledge from MoH to HCW, and improving content and applicability of currently available information. Topics of clinical information needs were broad and encompassed: HIV, TB (Tuberculosis), OB/GYN (Obstetrics and Gynecology), and Pediatrics. HCW attitudes towards Wikipedia were variable; some trusted Wikipedia as a reliable point of care information resource whereas others thought that its use should be restricted and monitored by the MoH. Conclusions There is a demonstrated need for accessible, reliable, and up-to-date information to aid clinical practice in Botswana. Attitudes towards Wikipedia as an open information resource tool are at best, split. Therefore, future studies are necessary to determine the accuracy, currency, and relevancy of Wikipedia articles on the health topics identified by health care workers as areas of information need. More broadly speaking, future efforts should be dedicated to configure a quality-controlled, readily accessible mobile platform based clinical information application tool fitting for Botswana.

The opioid crisis challenges the health care system in North America. Overdose deaths due to opioid use were estimated to reach 47,600 in 2017 ([Scholl et al., 2019][1]); more than the number of deaths due to gun violence. In addition to this frighteningly high number of overdose deaths, over 2

Summary Objective Research suggests that individuals seeking weight loss treatment do so for a variety of reasons. Limited work has explored relations of reasons for weight loss to patient characteristics or to weight loss outcomes. The current study examined these relations. Methods The sample consisted of 588 patients in a 15‐week fee‐for‐service weight loss programme. Prior to the intervention, patients completed questionnaires including items on reasons for weight loss, demographic characteristics, and a variety of weight‐based characteristics. Patients' weight change outcomes were expressed as percent weight loss and also categorized into one of three previously described weight loss trajectories. Results The results of chi‐squared and t‐test analyses suggested that endorsement of health concerns, mobility concerns, or another person's recommendation was associated with higher body mass index (BMI) and older age. These reasons were more likely to be endorsed by White patients than Black patients and by male patients than female patients. Endorsement of doctor recommendation was more likely to be seen among Black patients than White patients. There was no significant relation of any weight loss reason with weight loss outcome. Conclusions While certain reasons for weight loss were more often cited by certain patient groups, no specific reason predicted a better or worse outcome.

While many effective antidepressant drugs treat major depressive disorder (MDD), many patients still suffer from residual depressive/anxiety symptoms, poor sleep, cognitive dysfunction, suicidality, or the lack of significant response. Translational or experimental medicine approaches are required to promote or terminate programs for objective data-driven results. This review will discuss translational paradigms that are agnostic with respect to indication such as target occupancy and are especially useful for antagonists/inhibitors. However, there is less certainty regarding required target occupancy for agonists or positive allosteric modulators (PAMs). Thus a range of functional biomarkers are needed including polysomnography (PSG), measuring biasing of emotional response, cognition, impulsivity, and a speculative discussion on microRNAs (miRs). A number of different examples will be described for how these types of biomarkers can be applied to drug development where the most pressing decision is whether to invest $15–20 million on a Phase 2 proof-of-concept (PoC) trial. These biomarkers may also support clinical meaningful differentiation.

Aims The EURO-ENDO registry aimed to study the management and outcomes of patients with infective endocarditis (IE). Methods and results Prospective cohort of 3116 adult patients (2470 from Europe, 646 from non-ESC countries), admitted to 156 hospitals in 40 countries between January 2016 and March 2018 with a diagnosis of IE based on ESC 2015 diagnostic criteria. Clinical, biological, microbiological, and imaging [echocardiography, computed tomography (CT) scan, 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT)] data were collected. Infective endocarditis was native (NVE) in 1764 (56.6%) patients, prosthetic (PVIE) in 939 (30.1%), and device-related (CDRIE) in 308 (9.9%). Infective endocarditis was community-acquired in 2046 (65.66%) patients. Microorganisms involved were staphylococci in 1085 (44.1%) patients, oral streptococci in 304 (12.3%), enterococci in 390 (15.8%), and Streptococcus gallolyticus in 162 (6.6%). 18F-fluorodeoxyglucose positron emission tomography/computed tomography was performed in 518 (16.6%) patients and presented with cardiac uptake (major criterion) in 222 (42.9%) patients, with a better sensitivity in PVIE (66.8%) than in NVE (28.0%) and CDRIE (16.3%). Embolic events occurred in 20.6% of patients, and were significantly associated with tricuspid or pulmonary IE, presence of a vegetation and Staphylococcus aureus IE. According to ESC guidelines, cardiac surgery was indicated in 2160 (69.3%) patients, but finally performed in only 1596 (73.9%) of them. In-hospital death occurred in 532 (17.1%) patients and was more frequent in PVIE. Independent predictors of mortality were Charlson index, creatinine > 2 mg/dL, congestive heart failure, vegetation length > 10 mm, cerebral complications, abscess, and failure to undertake surgery when indicated. Conclusion Infective endocarditis is still a life-threatening disease with frequent lethal outcome despite profound changes in its clinical, microbiological, imaging, and therapeutic profiles.

Strengthening and expanding of production capacity during the last 20 years have led to a need for modernisation in control centres like control rooms and dispatching. However, the use of new I&C technologies induced an explosion of information and new functions, which are available at these workplaces. However, hand in hand higher demands in performance of operators occurred, which finally influenced even the reliability and safety of controlled processes. To cope with this situation, it requires not only responsible control system design, but also implementation of ergonomic aspects in operators' interface design, in working station construction and in parameters of the control centre environment. Pressure in applications of approach with respect to human factors and needs (so called Human-Centred Design) has grown significantly stronger in recent years. This issue has made its way into discussion held by ergonomists, engineers and operation management, and it induces many specific questions. Th...

Background Graze eating is defined as repetitive, unplanned eating of small amounts of food throughout the day. Little consensuses exist regarding whether graze eating, like binge eating disorder (BED), is characterized by feelings of loss of control (LOC). Furthermore, little is known about how patients who graze eat with and without LOC differ psychologically. Objectives The present study seeks to better characterize graze eating by examining differences between graze eating with LOC (+LOC) and without LOC (–LOC) among presurgical bariatric patients. Setting A large, Midwestern academic medical center. Methods The sample consisted of 288 adult bariatric surgery candidates (mean age 45.8, standard deviation [SD] 12.57) who underwent a presurgical psychological evaluation. Graze eating, BED, and other mental health diagnoses were evaluated using a semistructured interview. Participants were also administered the Minnesota Multiphasic Personality Inventory–2–Restructured Form (MMPI-2-RF) and binge eating scale (BES). Data were collected using a retrospective chart review. Results Among the 33% (n = 95) of the sample who reported preoperative graze eating, 32% (n = 30) also endorsed LOC. Graze eating, particularly with LOC, was associated with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnoses of anxiety disorders and BED, and multiple measures of internalizing dysfunction on the MMPI-2-RF. Conclusions Bariatric surgery candidates who graze eat experience a greater degree of overall distress and psychopathology including anxiety and depression. The minority who experience grazing+LOC appear to have even greater risk of psychopathology. Moreover, there appears to be significant overlap with BED. Future research should explore whether these 2 maladaptive eating patterns benefit from similar treatment.

Bariatric surgery is the most effective treatment for morbid obesity; however, a subset of patients who undergo this procedure regain weight or achieve suboptimal weight loss results. A large number of studies have examined whether psychological variables play a role in weight loss surgery outcome. Although presurgical psychopathology has been found to be associated with suboptimal results in some studies, this literature is equivocal. These inconsistent findings are reviewed and considered in the context of contemporary models of psychopathology. More specifically, the review focuses on the limitations of atheoretical, descriptive diagnostic systems and examines whether comorbidity within the mood/anxiety disorders, impulse control/substance use disorders and thought disorders can account for the inconsistent findings reported to date. Contemporary models of psychopathology are highlighted and linked to the Research Domain Criteria, which have been advanced by the National Institute of Health. Means for assessing psychological constructs congruent with these models are reviewed. Recommendations are made for standardizing approaches to investigating how psychopathology contributes to suboptimal bariatric surgery outcomes.

There is a need for simple, fast, efficient and sensitive methods of analysis for glyphosate and its degradate aminomethylphosphonic acid (AMPA) in diverse matrices such as water, plant materials and soil to facilitate environmental research needed to address the continuing concerns related to increasing glyphosate use. A variety of water-based solutions have been used to extract the chemicals from different matrices. Many methods require extensive sample preparation, including derivatization and clean-up, prior to analysis by a variety of detection techniques. This review summarizes methods used during the past 15 years for analysis of glyphosate and AMPA in water, plant materials and soil. The simplest methods use aqueous extraction of glyphosate and AMPA from plant materials and soil, no derivatization, solid-phase extraction (SPE) columns for clean-up, guard columns for separation and confirmation of the analytes by mass spectrometry and quantitation using isotope-labeled internal standards. They have levels of detection (LODs) below the regulatory limits in North America. These methods are discussed in more detail in the review.

Background The Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) has empirically validated utility in presurgical psychological evaluations of bariatric surgery patients. However, clinicians may prefer shorter, symptom-focused measures. Objectives The purpose of the present study is to evaluate the feasibility and potential administration time savings of a proposed flexible and conditional (FCA) administration of the MMPI-2-RF in presurgical evaluations of bariatric surgery candidates. Setting Bariatric surgery candidates evaluated at a large hospital as well as a private practice in the Midwest. Methods MMPI-2-RF scores were available for a total of 4099 adult bariatric surgery candidates from 2 separate samples. The hospital sample included 911 males and 2430 females. The average BMI was 49.3 kg/m2 (SD = 11.0). The private practice sample included 105 males, 640 females, and 13 individuals who did not report gender. The average BMI was 48.8 kg/m2 (SD = 8.4). The authors used a simulation design in which existing MMPI-2-RF responses were used to simulate an FCA administration. Results The findings indicated that an FCA of the MMPI-2-RF closely approximates the amount of information typically gained from a full administration of the test in the 2 samples of bariatric surgery candidates. Items savings and estimated time savings ranged from 44% to 88% in both samples, depending on the number of conditionally administered scales. Conclusions The present study supports the feasibility of an FCA of the MMPI-2-RF, potentially shortening administration time and reducing patient burden. However, the findings are limited because the accuracy and time savings are based on a simulation, not actual FCA administrations.

Although spine surgery (SS) and spinal cord stimulators (SCSs) can provide significant relief for patients with intractable pain, their effectiveness is variable. Previously, a number of pre-operative psychosocial risk factors have predicted suboptimal outcomes of these procedures. However, recent research has found that “patient activation”—the extent to which patients are engaged and active in their own health care—can predict positive surgical results. The purpose of the current investigation was to determine whether patient activation helps explain associations between established psychosocial risk factors and suboptimal outcomes. Candidates for SS and SCS (n = 1254; 56.3% women, mean age 50.4 years) consented to participate in an outcome study prior to their pre-surgical psychological evaluation. Of those, 46.3% returned self-report measures an average of 180 days (SD = 79.1) post-surgery. Bootstrapped mediation analyses indicated that patient activation mediates numerous associations between psychosocial risk factors and suboptimal outcomes. That is, patients’ involvement in obtaining information, decision making, and their resilience can explain why some patients do not experience adverse surgical results when pre-surgical psychosocial risk factors are present. Pre-surgical psychological evaluations should include examination of patient strengths in addition to psychosocial risk factors, so that treatments can be appropriately individualized and the most effective surgical results obtained.

Objective Pituitary adenoma MRI T2 signal intensity associates with tumor characteristics including responsiveness to somatostatin analogs (SSAs). These analyses determined whether baseline T2 signal intensity predicts response to primary medical treatment with long-acting SSA. Design Post hoc analyses of the prospective multicenter, open-label, single-arm PRIMARYS study in which patients with treatment-naïve GH-secreting pituitary macroadenomas received fixed-dose lanreotide autogel (120 mg) every 4 weeks for 48 weeks. Methods Associations were investigated between adenoma T2-signal hypo/iso/hyperintensity and treatment responses at week 48/last visit: hormonal control (GH ≤2.5 μg/L and IGF-1 normalization); tumor response (tumor volume reduction (TVR) ≥20%); separate GH/IGF-1 control and change from baseline in GH/IGF-1 and tumor volume. Results Adenomas were hypointense at baseline in 50/85 (59%) patients using visual assessment. Of these, 40% achieved hormonal control and 76% achieved a tumor response. Significant univariate associations arose for hypo- vs isointensity with tumor response and achievement of GH ≤2.5 μg/L, but not IGF-1 normalization or overall hormonal control. In multivariate analysis, tumor response was six times more likely for hypo- vs iso-intense tumors (= 6.15; 95% CI: 1.36–27.88). In univariate change-from-baseline analyses, hypo- vs isointensity was associated with greater TVR and IGF-1 reduction but not change in GH. In multivariate analysis, IGF-1 decreased by an estimated additional 65 μg/L (P = 0.0026)) for hypo- vs isointense. Conclusions Patients with hypointense vs isointense GH-secreting macroadenomas had greater reductions in IGF-1 following primary treatment with lanreotide autogel and were more likely to achieve tumor response. Assessment of T2 signal intensity at baseline may help to predict long-term responses to primary treatment with SSAs.

Background The Binge Eating Scale (BES) is a widely-used self-report measure of binge eating severity. Hood et al. [1] reported a 2-factor structure for the BES in a sample of bariatric surgery candidates, with factors labeled feelings/cognitions and behavioral manifestations. The present study aims to replicate and extend the factor structure obtained by Hood et al. [1] by testing the utility of a bifactor model that removes binge eating severity variance, which the total BES score purports to assess, in another sample of bariatric surgery candidates. Methods Bariatric surgery candidates (n = 517; 71.2% women; mean body mass index=49.50 kg/m 2 ; SD=10.17) were sampled. Twenty-four percent met DSM-IV-TR diagnostic criteria for binge eating disorder. Results Consistent with previous research, a 2-factor structure for the BES was supported; however, the 2 factors were substantially correlated ( r = .89). A bifactor model significantly improved model fit, supporting the presence of a higher-order severity factor accounting for a significant amount of variance. This factor was primarily marked by binge eating severity as demonstrated by associations with number of objective binge eating episodes and DSM-IV-TR diagnosis. In the bifactor model, the feelings/cognitions factor was modestly associated with self-reported mood psychopathology. However, contrary to expectations, the behavioral manifestation factor was not associated with empirically derived behavioral problems. Conclusions The current findings partially converge with those of Hood et al. [1] However, the use of the BES as a 2-factor measure is not recommended at this point because of lack of incremental validity demonstrated by the behavioral manifestation factor. Continued use of the BES as a unidimensional measure of binge eating severity, in conjunction with a comprehensive clinical interview, can provide useful guidance for presurgical treatment recommendations.

Background Presurgical psychological screening is used to identify factors that may impact postoperative adherence and surgical outcomes in bariatric surgery candidates. Minnesota Multiphasic Personality Inventory – 2 Restructured Form (MMPI-2-RF) findings have demonstrated utility for this task. Objectives To explore whether there are clinically meaningful gender, ethnicity, or age differences in presurgical MMPI-2-RF scores and the validity of these scores in bariatric surgery candidates. Methods The sample was composed of 872 men and 2337 women. Ethnicity/race groups included 2,204 Caucasian, 744 African American, and 96 Hispanic individuals. A sample of 165 were not included in the ethnicity/race analyses because they were of another descent. Ages groups included 18–35 year olds (n = 454), 36–49 year olds (n = 1154), 50–64 year olds, (n = 1246), and 65 years old or older (n = 355). Validity data, obtained via a retrospective chart review, were available for a subset patients (n = 1,268) who were similarly distributed. Step-down hierarchical regression analyses were conducted to assess for differential validity. Results Bariatric surgery candidates produced comparable MMPI-2-RF scores in all subsamples, indicating that the test norms generalize across demographic groups. Validity findings were also generally comparable, indicating that MMPI-2-RF scores have the same interpretive implications in demographically diverse subgroups of bariatric surgery candidates. Conclusions The MMPI-2-RF can assist in presurgical psychological screening of demographically diverse bariatric surgery candidates.

ObjectiveTo evaluate the efficacy and safety of coadministered lanreotide Autogel (LA; 120 mg/month) and pegvisomant (40–120 mg/week) in acromegaly.DesignThis is a 28-week, multicenter, open-label, single-arm sequential study.MethodsPatients (n=92) biochemically uncontrolled, on somatostatin analogs (SSAs) or using pegvisomant monotherapy entered a 4-month run-in taking LA (120 mg/month). Patients uncontrolled after the run-in period (n=57) entered a 28-week coadministration period, receiving LA 120 mg/month plus pegvisomant (60 mg once weekly, adapted every 8 weeks based on IGF1 levels to 40–80 mg once weekly or 40 or 60 mg twice weekly).ResultsIn total, 33 (57.9%) patients had normalized IGF1 following coadministration (PP5×upper limit of normal with normalization after withdrawal).ConclusionsIn patients partially controlled by SSAs, LA (120 mg/month) plus pegvisomant normalized IGF1 in 57.9% of patients after 7 months, at a median effective pegvisomant dose of 60 mg/week, and 78.9% at any time. In these patients, results suggest a pegvisomant-sparing effect versus daily pegvisomant monotherapy.

This 5-year, prospective registry enrolled 600 lower-risk MDS patients (pts) with transfusional iron overload. Clinical outcomes were compared between chelated and nonchelated pts. At baseline, cardiovascular comorbidities were more common in non-chelated pts, and MDS therapy was more common in chelated pts. At 24 months, chelation was associated with longer median overall survival (52.2 months vs. 104.4 months; p

Presurgical psychological screening of bariatric surgery candidates includes some form of standardized psychological assessment. However, associations between presurgical psychological screening and postoperative outcome have not been extensively studied. Here, we explore associations between presurgical Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-RF) scores and early postoperative Somatic Concerns, Psychological Distress, and Maladaptive Eating Behaviors.The sample consisted of male (n = 238) and female (n = 621) patients who were administered the MMPI-2-RF at their presurgical psychological evaluation and received bariatric surgery. Patients were evaluated at their 1- and 3-month postoperative appointments.Confirmatory factor analysis indicated that three latent constructs-somatic concerns, psychological distress, and maladaptive eating behaviors-were represented by responses to a postoperative assessment and that these constructs could be measured consistently over time. Presurgical scores on MMPI-2-RF scales measuring internalizing dysfunction were associated with more psychological distress at postoperative follow-ups, scores on scales measuring somatization were associated with more postoperative somatic concerns, and scores on scales assessing emotional/internalizing, behavioral/externalizing, cognitive complaints, and thought dysfunction prior to surgery were associated with maladaptive eating behaviors after surgery.In conjunction with a presurgical psychological interview, the MMPI-2-RF provides information that can assist in anticipating postoperative outcomes and inform efforts to prevent them.