Weight changes before and after lurasidone treatment: a real-world analysis using electronic health records.

BACKGROUND: Severe and persistent mental illnesses, such as schizophrenia and bipolar disorder, are associated with increased risk of obesity compared to the general population. While the association of lurasidone and lower risk of weight gain has been established in short and longer-term clinical trial settings, information about lurasidone's association with weight gain in usual clinical care is limited. This analysis of usual clinical care evaluated weight changes associated with lurasidone treatment in patients with schizophrenia or bipolar disorder. METHODS: A retrospective, longitudinal analysis was conducted using de-identified electronic health records from the Humedica database for patients who initiated lurasidone monotherapy between February 2011 and November 2013. Weight data were analyzed using longitudinal mixed-effects models to estimate the impact of lurasidone on patient weight trajectories over time. Patients' weight data (kg) were tracked for 12-months prior to and up to 12-months following lurasidone initiation. Stratified analyses were conducted based on prior use of second-generation antipsychotics with medium/high risk (clozapine, olanzapine, quetiapine, or risperidone) versus low risk (aripiprazole, ziprasidone, first-generation antipsychotics, or no prior antipsychotics) for weight gain. RESULTS: Among the 439 included patients, the mean age was 42.2 years, and 69.7% were female. The average duration of lurasidone treatment across all patients was 55.2 days and follow-up duration after the index date was 225.1 days. The estimated impact of lurasidone on weight was - 0.77 kg at the end of the 1-year follow-up. Patients who had received a prior second-generation antipsychotic with medium/high risk for weight gain were estimated to lose an average of 1.68 kg at the end of the 1-year follow-up. CONCLUSIONS: Lurasidone was associated with a reduction in weight at 1 year following its initiation in patients with schizophrenia or bipolar disorder. Stratified analyses indicated that weight reduction was more pronounced among patients who had received second-generation antipsychotics associated with a higher risk of weight gain prior to lurasidone treatment. These findings are consistent with the results of prior short- and long-term prospective studies and suggest that lurasidone is associated with low risk for weight gain in patients with schizophrenia or bipolar disorder.

Cardiometabolic comorbidities, readmission, and costs in schizophrenia and bipolar disorder: a real-world analysis.

BACKGROUND: Serious mental illnesses are associated with increased risk of cardiometabolic comorbidities. The objective of this study was to evaluate the prevalence of cardiometabolic comorbidity and its association with hospitalization outcomes and costs among inpatients with schizophrenia or bipolar disorder. METHODS: This retrospective database analysis reviewed patients with an inpatient diagnosis of schizophrenia or bipolar disorder from the Premier Perspective® Database (4/1/2010-6/30/2012). Patients were categorized into 4 cohorts based on the number of ICD-9-CM cardiometabolic comorbidities (i.e., 0, 1, 2, or 3+). Outcomes included length of stay, mortality during the index hospitalization, healthcare costs, and 30-day all-cause readmission rates. RESULTS: Of 57,506 patients with schizophrenia, 66.1% had at least one cardiometabolic comorbidity; 39.3% had two or more comorbidities. Of 124,803 patients with bipolar disorder, 60.5% had at least one cardiometabolic comorbidity; 33.4% had two or more. Average length of stay was 8.5 (for patients with schizophrenia) and 5.2 (for patients with bipolar disorder) days. Each additional cardiometabolic comorbidity was associated with an increase in length of stay for patients with bipolar disorder (p < .001) but not for patients with schizophrenia. Mortality rates during the index hospitalization were 1.2% (schizophrenia) and .7% (bipolar disorder). Each additional cardiometabolic comorbidity was associated with a significant increase in mortality for patients with bipolar disorder (OR 1.218, p < .001), and a numerical increase in mortality for patients with schizophrenia (OR 1.014, p = .727). Patients with more cardiometabolic comorbidities were more likely to have a 30-day readmission (schizophrenia = 9-13%; bipolar disorder = 7-12%), and to incur higher costs (schizophrenia = $10,606-15,355; bipolar disorder = $7126-13,523) (all p < .01). CONCLUSIONS: Over 60% of inpatients with schizophrenia or bipolar disorder had cardiometabolic comorbidities. Greater cardiometabolic comorbidity burden was associated with an increased likelihood of readmission and higher costs among patients with schizophrenia or bipolar disorder, and an increase in length of stay and mortality for patients with bipolar disorder.

Results of a 2-year retrospective cohort study of newly prescribed triptan users in European nationwide practice databases.

OBJECTIVE: This study was conducted to characterize prescription refill patterns for triptans among European patients with new prescriptions of triptans. BACKGROUND: Persistency with prescriptions of triptan monotherapy for migraine headache among newly prescribed users in European primary-care practices has not been well described. METHODS: Using electronic medical databases in the UK (N = 3618), France (N = 2051) and Germany (N = 954), we conducted a retrospective cohort analysis to identify refill patterns over 2 years among migraineurs receiving new prescriptions of triptan monotherapy in 2006. RESULTS: Of all patients, >33% of migraineurs with new triptan prescriptions received ≥1 refill of their index triptan prescriptions (UK, 44.3%; France, 34.2%; Germany, 37.7%). More than 50% never received index-triptan refill prescriptions (UK, 55.7%; France, 65.8%; Germany, 63.3%). Small proportions of patients (<7.0%) switched to alternative triptans, and even fewer switched to different prescription-medication classes (UK and Germany, 2.3%; France, 4.0%). More than 48% of patients received no further prescriptions for migraine after index prescriptions (UK, 48.5%; France, 54.9%; Germany, 54.7%). After the second year, >83.0% of patients in each country had no further prescriptions for migraine medications, <14.0% remained persistent with index prescriptions, <4.0% switched to other triptans, and <3.0% switched to alternative medication classes. CONCLUSIONS: In migraine patients who received new prescriptions of triptan monotherapy from their primary-care physicians, poor triptan prescription refill frequency was observed in Europe. Although consistent with potential clinical challenges in migraine management, our findings should be interpreted with caution given certain inherent limitations associated with the database study design. Further research is warranted to confirm our findings and to identify reasons for, or predictors of, triptan discontinuation.

Opioid use and dependence among persons with migraine: results of the AMPP study.

OBJECTIVE: To assess the frequency of opioid use for acute migraine treatment and characterize use groups by sociodemographics, health-care resource utilization (HRU), comorbidities and probable dependence within a large, US population-based sample of persons with migraine. BACKGROUND: Opioids are used in the acute treatment of migraine. However, their use is controversial. METHODS: Data from the 2009 American Migraine Prevalence and Prevention (AMPP) study were used to categorize persons with migraine into 4 groups based on reported opioid use: nonusers (between 2005 and 2009), previous users (history of use between 2005 and 2008 but no-use in 2009), and current opioid users (those reporting use of opioids in the 3 months preceding the 2009 American Migraine Prevalence and Prevention survey). Current opioid users were divided into nondependent and probable dependence users according to criteria for dependence adapted for inclusion in the survey from the Diagnostic and Statistical Manual of Mental Disorders-4th edition. All opioid-use groups were contrasted by sociodemographics, headache characteristics, medical and psychiatric comorbidities (depression [measured by the Patient Health Questionnaire-9], anxiety [measured by the Primary Care Evaluation of Mental Health Disorders, PRIME-MD], and cardiovascular events and risk factors), and headache-related HRU. RESULTS: In a sample of 5796 migraineurs, 4076 (70.3%) were opioid nonusers, 798 (13.8%) were previous users, and 922 (15.9%) were current opioid users. Among current opioid users, 153 (16.6%) met criteria for probable dependence and 769 (83.4%) did not. Headache-related disability (Migraine Disability Assessment sum scores) increased across groups as follows: nonusers: 7.8, previous users: 13.3, current nondependent users: 19.1, and current probable dependence users: 44.4, as did monthly headache frequency: nonusers: 3.2 days/month, previous users: 4.3 days/month, current nondependent users: 5.6 days/month, and current probable dependence users: 8.6 days/month. The prevalence of depression and anxiety was highest among current users with probable dependence. Rates of headache-related HRU were higher for all opioid-use groups for emergency department/urgent care, primary care, and specialty care visits compared to nonusers. CONCLUSIONS: Opioid use for migraine is associated with more severe headache-related disability, symptomology, comorbidities (depression, anxiety, and cardiovascular disease and events), and greater HRU for headache. Longitudinal studies are needed to further assess the directionality and causality between opioid use and the outcomes we examined.

EQ-5D™-derived utility values for different levels of migraine severity from a UK sample of migraineurs.

BACKGROUND: To estimate utility values for different levels of migraine pain severity from a United Kingdom (UK) sample of migraineurs. METHODS: One hundred and six migraineurs completed the EQ-5D to evaluate their health status for mild, moderate and severe levels of migraine pain severity for a recent migraine attack, and for current health defined as health status within seven days post-migraine attack. Statistical tests were used to evaluate differences in mean utility scores by migraine severity. RESULTS: Utility scores for each health state were significantly different from 1.0 (no problems on any EQ-5D dimension) (p < 0.0001) and one another (p < 0.0001). The lowest mean utility, - 0.20 (95% confidence interval [CI]: -0.27 - -0.13), was for severe migraine pain. The smallest difference in mean utility was between mild and moderate migraine pain (0.13) and the largest difference in mean utility was between current health (without migraine) and severe migraine pain (1.07). CONCLUSIONS: Results indicate that all levels of migraine pain are associated with significantly reduced utility values. As severity worsened, utility decreased and severe migraine pain was considered a health state worse than death. Results can be used in cost-utility models examining the relative economic value of therapeutic strategies for migraine in the UK.

Costs associated with outpatient, emergency room and inpatient care for migraine in the USA.

BACKGROUND: Data on the average US costs of an outpatient visit, emergency room (ER) visit or hospitalization for migraine are scant, with the most recent available values based on healthcare charges reported from 1994 data. METHODS: We estimated healthcare costs associated with outpatient and ER visits and inpatient hospitalizations related to migraine retrospectively obtained from the 2007 Medstat MarketScan Commercial Claims & Encounters database. Tabulated costs reflected payments from insurers, patients and other sources. All costs were adjusted to 2010 US dollars. RESULTS: The estimated mean cost (95% CI) for migraine-related care per outpatient visit (N = 680,946) was $139.88 ($139.35-140.41); per ER visit (N = 88,128) was $775.09 ($768.10-782.09); and per inpatient hospitalization (N = 5516) was $7317.07 ($7134.96-7499.17). The most frequently coded procedures at outpatient and ER visits were subcutaneous or intra-muscular injection, and for hospitalizations was computed tomography. Estimated annual US healthcare costs in 2010 for migraine associated with: outpatient visits were $3.2 billion, ER visits were $700 million, and inpatient hospitalizations were $375 million. CONCLUSIONS: Direct healthcare costs associated with patient visits and hospitalizations for migraine headaches have increased since previously published estimates. Further research is needed to understand the current overall healthcare cost burden per patient and within the US population.

Key concepts of migraine postdrome: a qualitative study to develop a post-migraine questionnaire.

OBJECTIVE: To understand migraine postdrome by directly interviewing migraine patients with postdrome symptoms. To document these symptoms, as well as impacts, as a prelude to developing a postdrome migraine questionnaire. BACKGROUND: Migraine attacks are traditionally divided into 4 phases. Of these, the postdrome is the least studied, and no patient-reported outcomes to assess symptoms and impacts of this migraine phase have been published. METHODS: Qualitative concept elicitation focus groups were conducted with 34 patients in 3 geographically diverse US cities to elicit the symptoms and burden of migraine postdrome. Data elicited from focus groups were coded using Atlas.ti software to facilitate identification of concepts and terminologies of migraine postdrome. A draft questionnaire was developed based on the symptoms and impacts of migraine postdrome described by patients. Cognitive debriefing interviews were conducted with 15 patients in Connecticut and Chicago to confirm content validity, relevance, and comprehension. RESULTS: Patients defined the onset of postdrome as when they no longer experienced the migraine pain. Postdrome was often described as "[being] or [feeling] wiped out" and "headache hangover." The symptoms most frequently reported by the patients who participated in the focus groups and included in the draft post-migraine questionnaire were: tiredness, difficulty concentrating, weakness, dizziness, lightheadedness, and decreased energy. Patients also reported decreased activity level as a result of experiencing postdrome symptoms. Postdrome symptoms were reported to impact the ability to work, to affect family interactions and social life, and to cause cognitive impairment. A preliminary questionnaire measuring severity and duration of symptoms and severity of impacts of the post-migraine experience, with an 11-point (0 to 10) response scale, was developed. This preliminary questionnaire was tested for content validity, relevance, and comprehension using cognitive debriefing interviews. All patients reported that the questionnaire was relevant to their condition. Irrelevant and redundant items such as body tension and annoyance were eliminated. CONCLUSIONS: Migraine postdrome is debilitating for those who experience it. Concept elicitation and cognitive debriefing research support the relevance of the items in the post-migraine questionnaire. Future research will provide evidence of the post-migraine questionnaire's psychometric properties and interpretation guidelines.

Psychiatrist and Psychiatric Pharmacists Beliefs and Preferences for Atypical Antipsychotic Treatments in Patients With Schizophrenia and Bipolar Disorders.

BACKGROUND: Selection of schizophrenia or bipolar disorder treatments is complicated by treatment-effect heterogeneity. OBJECTIVES: This study assessed how clinicians' beliefs and health system/ insurace policies impact choice of atypical antipsychotic agent in schizophrenia and bipolar disorder. METHODS: A cross-sectional survey was conducted of members of the American College of Clinical Pharmacy and College of Psychiatric & Neurologic Pharmacists. Beliefs regarding atypical antipsychotic effectiveness and safety, impact of comorbidity on drug selection, and factors influencing atypical antipsychotic therapy selection were assessed. RESULTS: Twenty-four psychiatric pharmacists and 18 psychiatrists participated. Mean age was 39.6 years, 57.1% were female. Most clinicians (64.3%) believed medication effectiveness and safety equally important, while 26.2% believed safety and 9.4% believed effectiveness more important. The most important medication properties for schizophrenia were reducing positive symptoms (92.7%) and hospitalizations (87.8%) and for bipolar disorder were reducing manic episodes (87.8%), episode relapse (53.7%), and hospitalizations (53.7%). Agranulocytosis (78.1%), arrhythmias (70.7%), and extrapyramidal side effects (68.3%) were most concerning. Restrictions affected antipsychotic choice at 80.5% of sites and were believed to affect medication adherence (55.0%) and outcomes (53.4%). CONCLUSION: Efficacy and safety were considered equally important when choosing atypical antipsychotics. Formulary restrictions were perceived as impacting treatment choice and outcomes.

Migraine treatment with rizatriptan and almotriptan: a crossover study.

BACKGROUND: Rizatriptan and almotriptan are effective and well-tolerated triptans that have not been compared directly. OBJECTIVE: To evaluate the effectiveness of rizatriptan 10 mg and almotriptan for the acute treatment of migraine, in a real-world setting. METHODS: Of a large, multicenter, open-label, crossover study, we conducted a substudy to contrast the effectiveness of rizatriptan 10 mg and almotriptan 12.5 mg for the acute treatment of 2 migraine attacks in a sequential, crossover manner. Time to outcome was assessed using stopwatches. Mean and median times to onset of pain relief (PR) and pain freedom (PF) for rizatriptan and almotriptan were compared. The effect of rizatriptan on times to onset of PR and PF, adjusting for potential confounding factors (treatment sequence, treatment order, and use of rescue medication), was computed via a Cox proportional hazard model. RESULTS: Out of the 146 patients taking almotriptan as their usual care medication, 79 used stopwatch for both attacks. Significantly more patients taking rizatriptan achieved onset of PR within 2 hours after dosing than those taking almotriptan (88.6% vs 73.4%, P = .007). A higher proportion of patients taking rizatriptan achieved PF within 2 hours after dosing than those taking almotriptan (55.7% vs 45.6%, P = .10). Times to onset of PR and PF were significantly shorter with those patients taking rizatriptan than with those taking almotriptan (median time to PR: 45 vs 60 minutes, P = .002; median time to PF: 100 vs 135 minutes, P = .004). The adjusted proportional hazard ratios (rizatriptan vs almotriptan) for times to onset of PR and PF were 1.51 (95% confidence interval 1.20 to 1.88) and 1.42 (95% confidence interval 1.15 to 1.76), respectively. More patients were very satisfied when treating their attacks with rizatriptan than with almotriptan. Rizatriptan was preferred by most patients. CONCLUSIONS: Times to achieve PR and PF were significantly shorter for patients using rizatriptan, as compared with those using almotriptan.

Acute migraine treatment with oral triptans and NSAIDs in a managed care population.

OBJECTIVE: To describe the use of oral triptans with or without nonsteroidal anti-inflammatory drugs (NSAIDs) for acute migraine treatment in a managed care population and its potential impact on functionality. BACKGROUND: Prescription or over-the-counter NSAIDs with or without oral triptans are commonly used for treatment of acute migraine pain. Little is known about patients' treatment strategy when they have had experiences using NSAIDs and oral triptan cotherapy and the relationship between treatment strategy and migraine symptoms and functionality. METHOD: Migraineurs identified from an administrative claims database were surveyed for their use of oral triptans and NSAIDs during their last attack in the screening phase and during the subsequent migraine attack in the follow-up phase of the study. Treatment regimens were classified into 6 categories: simultaneous coadministration of triptans and NSAIDs (T and N); triptans first followed by NSAIDs (T N); NSAIDs first followed by triptans (N T); triptans only (TRP only); NSAIDs only (NSAID only); and others. Headache experience, reasons for treatment regimens, and treatment satisfaction were cross-tabulated by treatment regimens. The log-rank test was used for the analysis of time-to-event data. RESULTS: Among 8440 oral triptan users surveyed during the screening phase, 2307 (27%) reported using triptans and NSAIDs combination therapy during their last migraine attack. Of those, 1502 experienced a subsequent migraine attack and completed the follow-up survey; 38% of these 1502 patients who used triptans and NSAIDs cotherapy during their last migraine attack continued to use combination therapy for their next attack. The most common treatment regimen, excluding "others" (n = 354, 24%), was TRP only (n = 403, 27%), followed by N T (n = 345, 23%), NSAID only (n = 170, 11%), T&N (n = 152, 10%), and T N (n = 75, 5.0%). More TRP only patients became nausea-free within 1 h after an initial dosing. TRP only, T&N, and N T had significantly shorter median hours of suffering from migraine and limited functioning, as compared with other treatment regimens. Substantially more patients taking TRP only (34.7%) were very satisfied with their current treatment regimen than other regimens. CONCLUSIONS: Migraine patients frequently change their treatment regimens in response to headache profiles. For patients with migraine associated nausea symptom, combination of therapy with triptan and NSAIDs appears to be less effective in relieving nausea than triptan monotherapy. Triptan montherapy remains a common and an effective migraine treatment strategy.

Use of a Web-Based Shared Decision-Making Program: Impact on Ongoing Treatment Engagement and Antipsychotic Adherence.

OBJECTIVE: The authors examined the impact of a Web-based shared decision-making application, MyCHOIS-CommonGround, on ongoing outpatient mental health treatment engagement (all users) and antipsychotic medication adherence (users with schizophrenia). METHODS: An intervention study was conducted by comparing Medicaid-enrolled MyCHOIS-CommonGround users in 12 participating mental health clinics (N=472) with propensity score-matched adults receiving services in nonparticipating clinics (N=944). Medicaid claims were used to assess ongoing treatment engagement and antipsychotic adherence (among individuals with schizophrenia) one year prior to and after entry into the cohort. Multilevel linear models were conducted to estimate the effects of the MyCHOIS-CommonGround program over time. RESULTS: No differences during the baseline year were found between the MyCHOIS-CommonGround group and the matched control group on demographic, diagnostic, or service use characteristics. At one-year follow-up, engagement in outpatient mental health services was significantly higher for MyCHOIS-CommonGround users than for the control group (months with a service, 8.54±.22 versus 6.95±.15; ß=1.40, p<.001). Among individuals with schizophrenia, antipsychotic medication adherence was also higher during the follow-up year among MyCHOIS-CommonGround users compared with the control group (proportion of days covered by medication, .78±.04 versus .69±.03; ß=.06, p<.01). CONCLUSIONS: These findings provide new evidence that shared decision-making tools may promote ongoing mental health treatment engagement for individuals with serious mental illness and improved antipsychotic medication adherence for those with schizophrenia.

Adolescent suicidal behavior: associations with preadolescent physical abuse and selected risk and protective factors.

OBJECTIVES: To determine whether preadolescent physical abuse raises the risk of adolescent suicidal behavior, to examine potential mediators and moderators of the relationship between preadolescent abuse and adolescent suicidality, and to examine whether distal (preadolescent) risk factors add to proximal (adolescent) factors in predicting suicidality. METHOD: Seventy-five physically abused preadolescents on the New York City Maltreatment Register and 78 controls were studied at ages 10.5 and 16.5 years. Adolescent suicidal ideation and attempts and hypothesized risk and protective factors were assessed by self-report, parent interview, and teacher ratings. Data were analyzed by logistic regression. RESULTS: Preadolescent physical abuse was a robust, largely unmediated, independent predictor of adolescent suicidality. Only adolescent internalizing problems mediated the relationship. No risk factors moderated the relationship. Adolescent attachment to parents and internalizing problems contributed independently to the prediction of suicidality risk in abused and control subjects. No preadolescent risk or protective factors added to the predictions beyond risk deriving from preadolescent abuse. CONCLUSIONS: The association between preadolescent physical abuse and adolescent suicidality is largely unmediated and unmoderated by well-documented risk factors for suicidality. Therefore, comprehensive interventions to reduce abusive parenting must begin when families enter the child protection system, along with therapeutic interventions with the children and adolescents themselves.

Outpatient Follow-Up Care and Risk of Hospital Readmission in Schizophrenia and Bipolar Disorder.

OBJECTIVE: Although outpatient care within 30 days of mental health hospital discharge is an established quality indicator, little is known about the clinical implications of not receiving such care. This study evaluated whether receipt of outpatient care within 30 days of discharge was associated with a reduced risk of readmission during days 31-120 postdischarge among adult inpatients with schizophrenia or bipolar disorder. METHODS: Retrospective longitudinal cohort analyses were performed with Truven MarketScan Commercial (2010-2014) and Medicaid (2010-2013) databases. Among inpatients with schizophrenia (N=25,401) or bipolar disorder (N=46,375), overall and stratified associations were examined between receipt of an outpatient follow-up visit in the 30 days postdischarge and hospital readmission during days 31-120 postdischarge. RESULTS: Receipt of a follow-up visit within 30 days of discharge was associated with a slightly lower adjusted odds ratio (AOR) of hospital readmission during days 31-120 postdischarge (schizophrenia, AOR=.88, 95% confidence interval [CI]=.81-.96; bipolar disorder, AOR=.91, CI=.85-.98). For patients with schizophrenia, the strongest observed inverse association of follow-up care with readmission risk was among inpatients whose index admissions were 13 to 30 days long (AOR=.73, CI=.61-.89). For patients with bipolar disorder, the strongest corresponding inverse association was among those in the manic phase of illness at the index discharge (AOR=.73, CI=.63-.86). CONCLUSIONS: Outpatient visits during the 30 days after discharge were associated with a lower hospital readmission risk during the following 90 days. Assertive hospital discharge planning to secure outpatient visits after hospital discharge is needed for these patient populations.

Normalization of violence among inner-city youth: a formulation for research.

A causal model is formulated for the thesis that in inner-city youth exposed to high levels of violence, cognitions that normalize violence mitigate affective effects of exposure while increasing risk for violent behavior, thus perpetuating violence in the very process of adapting to it psychologically. Gender differences in the cognitive normalization of violence may explain gender differences in affective and behavioral effects of exposure. Empirical studies are needed to directly test this model.

Pathologic adaptation to community violence among inner-city youth.

The study tests the thesis of pathologic adaptation for youth exposed to community violence, where high levels of exposure to community violence lead to increased aggressive behavior but decreased psychological distress. Four hundred seventy-one 6th graders and 1 of their parents were interviewed. The results showed, for a small but important subgroup of youth, that high levels of exposure to community violence were associated with more child- and parent-reported aggressive behavior and less child-reported psychological distress. Targeted prevention strategies for these high-risk youth are especially needed.

Efficacy and safety of the adjustable gastric band - pooled interim analysis of the APEX and HERO studies at 48 weeks.

OBJECTIVE: This 48 week combined analysis reports safety and clinical effectiveness of the LAP-BAND AP * laparoscopic adjustable gastric band (LAGB) in severely obese patients enrolled in the 5 year, prospective, observational, open-label APEX (NCT00501085) and HERO (NCT00953173) studies. METHODS: The studies enrolled 1620 patients (APEX: N = 514; HERO: N = 1106), 1140 patients in the US (including all APEX patients), and 480 patients in the European Union (EU), Canada or Australia. APEX and HERO are non-randomized, non-comparator, open-label studies with differences in study management practices and follow-up. Notably, laboratory data were not collected during the APEX study. RESULTS: After 48 weeks, mean (SD) percentage weight loss (%WL) was for APEX: 18.7% (7.9); HERO-US: 17.9% (8.5); HERO-EU: 16.5% (10.3); HERO-Canada: 13.4% (8.9); and HERO-Australia: 12.3% (6.9). After 48 weeks, there were no significant differences in %WL for APEX vs. HERO-US. After 48 weeks in the combined analysis (APEX + HERO): (1) patients without vs. with type 2 diabetes at baseline had greater %WL (18% [8.7] vs. 16% [8.5], p = 0.002); (2) female patients had greater %WL vs. male patients (17.9% [8.5] vs. 15.9% [9.3], p = 0.003); (3) younger patients had greater %WL vs. older patients (<50 years: 17.8% [8.7] vs. ≥50 years: 16.7% [8.6], p = 0.035); (4) baseline BMI did not affect %WL (≤35 to ≤45 kg/m(2): 17.7% [8.4] vs. >45 kg/m(2): 17.1% [9.1], p = 0.272). Device-related serious adverse events and adverse events were reported in 1.9% and 17.7% of patients, respectively. Revision and explantation surgeries were carried out on 3.4% and 2.3% of patients, respectively during the 48 weeks of follow-up. CONCLUSIONS: This analysis demonstrates the effective weight loss and safety profile of the current LAGB system, with US patients achieving better weight loss than patients from outside the US.

Quality of life after laparoscopic adjustable gastric banding (LAP-BAND): APEX interim 3-year analysis.

BACKGROUND: Obesity is often associated with diminished health-related quality of life (HRQOL), but significant gains in HRQOL have been observed after bariatric surgery. Laparoscopic adjustable gastric banding has been established as a safe, effective treatment to reduce weight in patients with obesity. This report summarizes interim 3-year changes in HRQOL and body weight, as well as safety postimplantation of the LAP-BAND AP (LBAP) system. METHODS: The LAP-BAND AP EXperience (APEX) trial, an ongoing, prospective, 5-year, open-label study, assessed changes in HRQOL (Obesity and Weight-Loss Quality of Life [OWLQOL] questionnaire) and body weight, and safety after placement of LBAP. This interim analysis represents patients with evaluable OWLQOL data at baseline and at 3 years (n = 183). RESULTS: The OWLQOL total score and individual scores significantly improved within 6 months post-LBAP and continued to improve during a 3 year period (P < 0.0001, both). Total score improved from 71.0 to 34.0 (mean improvement from baseline, 52%; range, 18%-65%); mean change in individual scores was -2.2 (range, -0.7 to -3.0). Percent weight loss was maintained through 3 years (19.4%; n = 174). Improvement in OWLQOL was associated with percent weight loss at 3 years (r = -0.5407; P < 0.0001). Revisions and explants were performed in 7 (3.8%) and 20 (10.9%) out of 183 patients, respectively. CONCLUSIONS: Meaningful improvement in quality of life occurred through clinically significant weight loss after LBAP placement, extending throughout the 3 years of this analysis.

Role of Parent and Peer Relationships and Individual Characteristics in Middle School Children's Behavioral Outcomes in the Face of Community Violence.

This study examines processes linking inner-city community violence exposure to subsequent internalizing and externalizing problems. Hypothesized risk and protective factors from three ecological domains -- children's parent and peer relationships and individual characteristics -- were examined for mediating, moderating or independent roles in predicting problem behavior among 667 children over three years of middle school. Mediation was not found. However, parent and peer variables moderated the association between exposure and internalizing problems. Under high exposure, normally protective factors (e.g., attachment to parents) were less effective in mitigating exposure's effects than under low exposure; attachment to friends was more effective. Individual competence was independently associated with decreased internalizing problems. Variables from all domains, and exposure, were independently associated with externalizing problems. Protective factors (e.g., parent attachment) predicted decreased problems; risk factors (e.g., friends' delinquency) predicted increased problems. Results indicate community violence reduction as essential in averting inner-city adolescents' poor behavioral outcomes.

Intervening processes between youths' exposure to community violence and internalizing symptoms over time: the roles of social support and coping.

The roles of social support and coping as intervening processes between exposure to community violence and internalizing symptoms were examined longitudinally among a community sample of 667 middle school students in the inner city. After controlling for potential confounders (e.g., social desirability, victimization and witnessing of family violence, guardian's psychological symptomatology), internalizing symptoms at Year 2 were predicted by hypothesized changes over 1 year, such that increased community violence exposure, decreased guardian and peer support, and increased use of defensive and confrontational behavioral coping were related to more internalizing symptoms of anxiety, depression and PTSD, although some of these relations varied by gender. The relations between internalizing symptoms at Year 3 and increased changes in exposure to community violence over 2 years were moderated by social support and/or coping, such that decreased guardian support and increased use of defensive and confrontational coping were generally associated with more symptoms for boys exposed to community violence. Girls who witnessed increased community violence and who increased their use of defensive or confrontational coping experienced more internalizing symptoms. The findings underscore the importance of developmental and contextual considerations in the design and implementation of interventions.

Can migraineurs accurately identify their headaches as "migraine" at attack onset?

BACKGROUND: While treating migraine early when the headache is mild is believed to link to improved treatment outcomes, it is not clear whether patients can correctly self-identify a headache as a migraine at onset in real-world settings. OBJECTIVE: This study aims to assess the likelihood that patients can correctly self-identify a headache as a migraine at onset, and to evaluate cues that patients use to correctly identify migraine attacks. METHODS: Adult migraineurs were recruited from 14 headache clinics across the United States. Patients recorded their headache experiences via an electronic diary daily over a period of 30 days. On days when they experienced headaches, patients were asked to recall the types of headache they experienced at both onset and peak. Patients also identified cues for deciding whether the headache was a migraine or not. Using identification of migraine at headache peak as the criterion, we examined the sensitivity and specificity of migraine identification at onset. We employed generalized estimating equation (GEE) to evaluate factors identified at headache onset that predicted migraine identified at headache peak. RESULTS: Of the 192 enrolled patients, 182 patients recorded a total of 1197 headache episodes over 30 days. At headache onset, 888 episodes were deemed by patients as migraine and 309 episodes not migraine; a majority (92%) of these early migraine identifications were confirmed at headache peak. Sensitivity and specificity of self-identification of migraine at onset were 91% and 97%, respectively. A number of factors at headache onset were predictive of a migraine identified at peak: sensitivity to light (OR = 3.1, 95% CI: 1.9-5.0), headache severity (OR = 2.0, 95% CI: 1.4-2.8), nausea symptoms (OR = 2.6, 95% CI: 1.5-4.5), and visual disturbance (OR = 2.3, 95% CI: 1.1-4.9). Patients who ruled out tension-type headache at onset were twice (OR = 2.0, 95% CI: 1.5-2.8) as likely to conclude a migraine at peak. CONCLUSIONS: Most migraineurs in tertiary care settings can correctly self-identify a headache as a migraine at onset. Factors such as headache severity, presence of nausea, visual disturbance, sensitivity to light, and no tension-type headache, appeared to augment the correct identification.