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Background: Treating hepatitis C virus (HCV) in people who inject drugs (PWID) has been associated with increased health-related quality of life (HRQOL). Polysubstance use (PSU) is common among PWID, but no studies have investigated PSU influence on PWID's HRQOL HCV treatment. Methods: Participants included 150 PWID receiving HCV treatment at opioid agonist treatment clinics in Bronx, NY. The EQ-5D-3 L measurement tool assessed five health dimensions producing an index of HRQOL measured at baseline, 4-, 8-, and 12-weeks during treatment and 12- and 24-weeks post-treatment. PSU was determined at baseline. Generalized estimating equations assessed the influence of baseline PSU on changes in mean EQ-5D-3 L index over time. Results: Of the 150 participants, 46 (30.7%) reported PSU and mean HRQOL overall was 0.655, indicating moderate HRQOL. Mean HRQOL was lower at all time-points for the PSU group compared to the non-PSU group. Though PSU group showed improvements in mean HRQOL from baseline (0.614) to 4-, 12- and follow-up week 24 (0.765, 0.768, and 0.731, respectively), the mean change of HRQOL scores was not significantly associated with PSU (p-value =.956). Conclusions: For individuals with PWID, our study showed no difference in HRQOL between those who did and did not engage in PSU following HCV treatment. [ABSTRACT FROM AUTHOR]

Introduction: Behavioral and mental health conditions present significant challenges in the United States where access to care is limited. Family medicine physicians play a crucial role in addressing these challenges, often serving as frontline clinicians for behavioral and mental health conditions. Methods: This study examined the current behavioral and mental health system in a predominantly rural 10-county region in the Southeastern United States through gap analysis in addition to a survey of preparedness and barriers among family medicine physicians in the region. Results: Gap analysis results indicated that (1) stigma and lack of accessible education about behavioral and mental health, (2) fragmented resources, (3) inaccessible care, and (4) workforce shortage and burnout were primary drivers of poor outcomes in the region. Survey results indicated that physicians feel prepared to treat anxiety and depression but feel less prepared to manage bipolar disorder, schizophrenia, and substance use disorders. Respondents disagreed that there are adequate local resources and referral options for patients with behavioral and mental health conditions. Lack of timely access, distance, cost/insurance status, were all cited by respondents as barriers to appropriate care. Conclusion and Recommendations: Findings underscore the importance of supporting family medicine physicians to enhance behavioral and mental healthcare outcomes. Behavioral health integration in primary care settings is a promising strategy to improve care accessibility and clinician preparedness. Bridging gaps in health care outcomes requires collaborative efforts, enhanced training, and policy advocacy within the family medicine community to ensure comprehensive and equitable behavioral and mental healthcare delivery. [ABSTRACT FROM AUTHOR]

Simple Summary: Galectins play a role in cancer angiogenesis, growth, and metastasis. Our pilot study aims to explore the role of galectins in non-small cell lung cancer (NSCLC) by assessing their correlation with treatment, metastasis, and survival. Galectin-1, -3, and -9 levels were measured in the sera of NSCLC patients using ELISA and analyzed by histology, previous treatment, metastasis, and overall survival (OS). Galectin-3 level was elevated in patients with adenocarcinoma compared to squamous cell carcinoma patients and lower in patients exposed to chemotherapy. Galectin-1 levels were significantly lower in patients with previous metastasis but did not correlate with future metastasis. Abnormal galectin-1 levels were significantly correlated with decreased OS; however, a loss of significance occurred when abnormal galectin-1 levels were examined in multivariable analysis. These preliminary findings may hold clinical importance, given the current development of galectin-3 inhibitors for NSCLC, and they underscore the potential of galectin-1 as a prognostic biomarker. Galectins play a pivotal role in lung cancer oncogenic pathways, influencing apoptosis, angiogenesis, and tumor metastasis. Biomarkers that diagnose, prognose, and guide cancer treatment are crucial, with galectins having the biomarker potential for non-small cell lung cancer (NSCLC). Using enzyme-linked immunosorbent assay (ELISA), we assessed serum galectin-1, -3, and -9 levels in NSCLC patients. A retrospective chart review was performed to examine patient demographics, cancer stage, tumor biology, cancer treatment, and patient outcomes. Galectin levels were then compared across these factors. In this exploratory analysis, galectin-3 levels were significantly lower in patients with squamous cell lung cancer (p = 0.0019) and in patients exposed to chemotherapy (p = 0.0375). Galectin-1 levels were significantly lower in patients with previous metastasis but had no correlation with future metastasis. Abnormal galectin-1 levels were significantly correlated with decreased overall survival (OS) in NSCLC (p = 0.0357) and specifically in patients with surgically resectable NSCLC (p = 0.0112). However, abnormal galectin-1 levels were not found to correlate with decreased OS in multivariable analysis (p = 0.0513). These findings may have clinical implications as galectin-3 inhibitors are in trials for NSCLC. Additionally, they suggest that galectin-1 has potential as a prognostic marker for surgically resectable NSCLC. [ABSTRACT FROM AUTHOR]

Objective To determine the effect of a uniform, reduced, default dispense quantity for new opioid analgesic prescriptions on the quantity of opioids prescribed in dentistry practices. Methods We conducted a cluster-randomized controlled trial within a health system in the Bronx, NY, USA. We randomly assigned three dentistry sites to a 10-tablet default, a 5-tablet default, or no change (control). The primary outcome was the quantity of opioid analgesics prescribed in the new prescription. Secondary outcomes were opioid analgesic reorders and health service utilization within 30 days after the new prescription. We analyzed outcomes from 6 months before implementation through 18 months after implementation. Results Overall, 6,309 patients received a new prescription. Compared with the control site, patients at the 10-tablet-default site had a significantly larger change in prescriptions for 10 tablets or fewer (38.7 percentage points; confidence interval [CI]: 11.5 to 66.0), lower number of tablets prescribed (–3.3 tablets; CI: –5.9 to –0.7), and lower morphine milligram equivalents (MME) prescribed (–14.1 MME; CI: –27.8 to –0.4), which persisted in the 30 days after the new prescription despite a higher percentage of reorders (3.3 percentage points; CI: 0.2 to 6.4). Compared with the control site, patients at the 5-tablet-default site did not have a significant difference in any outcomes except for a significantly higher percentage of reorders (2.6 percentage points; CI: 0.2 to 4.9). Conclusions Our findings further support the efficacy of strategies that lower default dispense quantities, although they indicate that caution is warranted in the selection of the default. Trial registration ClinicalTrials.org ID: NCT03030469. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to test the hypothesis that youths with obesity, when removed from structured school activities and confined to their homes during the coronavirus disease 2019 pandemic, will display unfavorable trends in lifestyle behaviors.Methods: The sample included 41 children and adolescents with obesity participating in a longitudinal observational study located in Verona, Italy. Lifestyle information including diet, activity, and sleep behaviors was collected at baseline and 3 weeks into the national lockdown during which home confinement was mandatory. Changes in outcomes over the two study time points were evaluated for significance using paired t tests.Results: There were no changes in reported vegetable intake; fruit intake increased (P = 0.055) during the lockdown. By contrast, potato chip, red meat, and sugary drink intakes increased significantly during the lockdown (P value range, 0.005 to < 0.001). Time spent in sports activities decreased by 2.30 (SD 4.60) h/wk (P = 0.003), and sleep time increased by 0.65 (SD 1.29) h/d (P = 0.003). Screen time increased by 4.85 (SD 2.40) h/d (P < 0.001).Conclusions: Recognizing these adverse collateral effects of the coronavirus disease 2019 pandemic lockdown is critical in avoiding depreciation of weight control efforts among youths afflicted with excess adiposity. Depending on duration, these untoward lockdown effects may have a lasting impact on a child's or adolescent's adult adiposity level. [ABSTRACT FROM AUTHOR]

Background/objectives: Three-dimensional optical (3DO) imaging systems that rapidly and accurately provide body shape and composition information are increasingly available in research and clinical settings. Recently, relatively low-cost and space efficient 3DO systems with the ability to report and track individual assessments were introduced to the consumer market for home use. This study critically evaluated the first 3DO imaging device intended for personal operation, the Naked Body Scanner (NBS), against reference methods.Participants/methods: Circumferences at six standardized anatomic sites were measured with a flexible tape in 90 participants ranging in age (5-74 years), ethnicity, and adiposity. Regression analysis and Bland-Altman plots compared these direct measurements and dual-energy X-ray absorptiometry (DXA) %fat estimates to corresponding NBS values. Method precision was analyzed from duplicate anthropometric and NBS measurements in a subgroup of 51 participants.Results: The NBS exhibited greater variation in test-retest reliability (CV, 0.4-2.7%) between the six measured anatomic locations when compared with manually measured counterparts (0.2-0.4%). All six device-derived circumferences correlated with flexible tape references (R2s, 0.84-0.97; p < 0.0001). Measurement bias was apparent for three anatomic sites while mean differences were present for five. The NBS's %fat estimates also correlated with DXA results (R2 = 0.73, p < 0.0001) with no significant bias.Conclusions: This system opens a new era of digital home-based assessments that can be incorporated into weight loss or exercise interventions accessible to clinical investigators as well as individual users. [ABSTRACT FROM AUTHOR]

Background: Opioid tapering is increasingly utilized by providers to decrease risks of chronic opioid therapy, but it is unknown whether tapering is associated with termination of care.Objective: To determine whether patients taking chronic opioid therapy who experienced opioid tapers were at greater risk of subsequently terminating their care compared with those who were continued on their doses.Design: Retrospective cohort study of patients in a large, urban health system between 2008 and 2012 with 2 years of follow-up.Participants: Adult patients prescribed a stable baseline dose of chronic opioid therapy of at least 25 morphine milligram equivalents per day during a baseline year.Main Measures: An opioid taper during an exposure year, defined as a reduction in the average daily dose of at least 30% from the baseline dose in both of the two 6-month periods in the year following the baseline year. Opioid dose continuation was defined as any increase in dose, no change in dose, or any decrease up to 30% compared with baseline dose in the exposure year. The primary outcome was termination of care, defined as no outpatient encounters in the health system, in the year following the exposure year.Key Results: Of 1624 patients on chronic opioid therapy, 207 (15.5%) experienced an opioid taper and 78 (4.8%) experienced termination of care. Compared with opioid dose continuation, opioid taper was significantly associated with termination of care (AOR 4.3 [95% CI 2.2-8.5]).Conclusions: Opioid taper is associated with subsequent termination of care. These findings invite caution and demonstrate the need to fully understand the risks and benefits of opioid tapers. [ABSTRACT FROM AUTHOR]

Background: Many people who inject drugs (PWID) are denied treatment for hepatitis C virus (HCV) infection, even if they are receiving opioid agonist therapy (OAT). Research suggests that HCV in PWID may be treated effectively, but optimal models of care for promoting adherence and sustained virologic response (SVR) have not been evaluated in the direct-acting antiviral (DAA) era.Objective: To determine whether directly observed therapy (DOT) and group treatment (GT) are more effective than self-administered individual treatment (SIT) in promoting adherence and achieving SVR among PWID receiving OAT.Design: Three-group, randomized controlled trial conducted from October 2013 to April 2017. (ClinicalTrials.gov: NCT01857245).Setting: Three OAT programs in Bronx, New York.Participants: Persons aged 18 years and older with genotype 1 HCV infection who were willing to receive HCV therapy on site in the OAT program. Of 190 persons screened, 158 were randomly assigned to a study group and 150 initiated treatment: DOT (n = 51), GT (n = 48), and SIT (n = 51).Intervention: 2 intensive interventions (DOT and GT) and 1 control condition (SIT).Measurements: Primary: adherence, measured by using electronic blister packs. Secondary: HCV treatment completion and SVR 12 weeks after treatment completion.Results: Mean age was 51 years; 65% of participants had positive results on urine drug testing during the 6 months before treatment, and 75% reported ever injecting drugs. Overall adherence, estimated from mixed-effects models using the daily timeframe, was 78% (95% CI, 75% to 81%) and was greater among participants randomly assigned to DOT (86% [CI, 80% to 92%]) than those assigned to SIT (75% [CI, 70% to 81%]; difference, 11% [CI, 5% to 18%]; Bonferroni-corrected P = 0.001). No significant difference in adherence was observed between participants randomly assigned to GT (80% [CI, 74% to 86%]) and those assigned to SIT (difference, 4.7% [CI, -2% to 11%]; Bonferroni-corrected P = 0.29). The HCV treatment completion rate was 97%, with no differences among groups (P = 0.53). Overall SVR was 94% (CI, 89% to 97%); the SVR rate was 98% in the DOT group, 94% in the GT group, and 90% in the SIT group (P = 0.152).Limitation: These findings may not be generalizable to PWID not enrolled in OAT programs.Conclusion: All models of onsite HCV care delivered to PWID in OAT programs resulted in high SVR, despite ongoing drug use. Directly observed therapy was associated with greater adherence than SIT.Primary Funding Source: National Institute on Drug Abuse and Gilead Sciences. [ABSTRACT FROM AUTHOR]

We derived sample size formulae for detecting main effects in group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms. Such designs are necessary when experimental interventions need to be administered to groups of subjects whereas control conditions need to be administered to individual subjects. This type of trial, often referred to as a partially nested or partially clustered design, has been implemented for management of chronic diseases such as diabetes and is beginning to emerge more commonly in wider clinical settings. Depending on the research setting, the level of hierarchy of data structure for the experimental arm can be three or two, whereas that for the control arm is two or one. Such different levels of data hierarchy assume correlation structures of outcomes that are different between arms, regardless of whether research settings require two or three level data structure for the experimental arm. Therefore, the different correlations should be taken into account for statistical modeling and for sample size determinations. To this end, we considered mixed-effects linear models with different correlation structures between experimental and control arms to theoretically derive and empirically validate the sample size formulae with simulation studies. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the percentage of body fat (%BF)-BMI relationship, identify %BF levels corresponding to adult BMI cut points, and examine %BF-BMI agreement in a diverse Hispanic/Latino population.Methods: %BF by bioelectrical impedance analysis was corrected against %BF by (18) O dilution in 434 participants of the ancillary Hispanic Community Health Study/Study of Latinos. Corrected %BF was regressed against 1/BMI in the parent study (n = 15,261), fitting models for each age group, by sex, and Hispanic/Latino background; predicted %BF was then computed for each BMI cut point.Results: Bioelectrical impedance analysis underestimated %BF by 8.7 ± 0.3% in women and 4.6 ± 0.3% in men (P < 0.0001). The %BF-BMI relationship was nonlinear and linear for 1/BMI. Sex- and age-specific regression parameters between %BF and 1/BMI were consistent across Hispanic/Latino backgrounds (P > 0.05). The precision of the %BF-1/BMI association weakened with increasing age in men but not women. The proportion of participants classified as nonobese by BMI but as having obesity by %BF was generally higher among women and older adults (16.4% in women vs. 12.0% in men aged 50-74 years).Conclusions: %BF was linearly related to 1/BMI with consistent relationship across Hispanic/Latino backgrounds. BMI cut points consistently underestimated the proportion of Hispanics/Latinos with excess adiposity. [ABSTRACT FROM AUTHOR]

This review identifies 10 common errors and problems in the statistical analysis, design, interpretation, and reporting of obesity research and discuss how they can be avoided. The 10 topics are: 1) misinterpretation of statistical significance, 2) inappropriate testing against baseline values, 3) excessive and undisclosed multiple testing and "P-value hacking," 4) mishandling of clustering in cluster randomized trials, 5) misconceptions about nonparametric tests, 6) mishandling of missing data, 7) miscalculation of effect sizes, 8) ignoring regression to the mean, 9) ignoring confirmation bias, and 10) insufficient statistical reporting. It is hoped that discussion of these errors can improve the quality of obesity research by helping researchers to implement proper statistical practice and to know when to seek the help of a statistician. [ABSTRACT FROM AUTHOR]

ABSTRACT BACKGROUND HealthCorps provides school wellness programming using curricula to promote changes in nutrition, mental health, and physical activity behaviors. The research objective was to evaluate effects of implementing its curricula on nutrition, mental health, and physical activity knowledge and behavior. METHODS Pre- and postsurvey data were collected (N = 2255) during the 2012-2013 academic year from 14 New York City public high schools. An 18-item knowledge questionnaire addressed 3 domains; 26 behavioral items were analyzed by factor analysis to identify 6 behavior domains, breakfast being a seventh 1-item domain. We examined the effects stratified by sex, applying mixed-effects models to take into account clustering effects of schools and participants adjusted for age. RESULTS The HealthCorps program significantly increased all 3 knowledge domains (p < .05), and significantly changed several key behavioral domains. Boys significantly increased fruits/vegetables intake (p = .03). Girls increased acceptance of new fruits/vegetables (p = .03) and breakfast consumption (p = .04), and decreased sugar-sweetened beverages and energy dense food intake (p = .03). The associations between knowledge and behavior were stronger in boys than girls. CONCLUSION The HealthCorps program significantly increased participants' knowledge on nutrition, mental health, and physical activity. It also improved several key behavioral domains, which are targets of the 2010 Dietary Guidelines to address obesity in youth. [ABSTRACT FROM AUTHOR]

Background: In countless number of clinical trials, measurements of outcomes rely on instrument questionnaire items which however often suffer measurement error problems which in turn affect statistical power of study designs. The Cronbach alpha or coefficient alpha, here denoted by C(α), can be used as a measure of internal consistency of parallel instrument items that are developed to measure a target unidimensional outcome construct. Scale score for the target construct is often represented by the sum of the item scores. However, power functions based on C(α) have been lacking for various study designs.Methods: We formulate a statistical model for parallel items to derive power functions as a function of C(α) under several study designs. To this end, we assume fixed true score variance assumption as opposed to usual fixed total variance assumption. That assumption is critical and practically relevant to show that smaller measurement errors are inversely associated with higher inter-item correlations, and thus that greater C(α) is associated with greater statistical power. We compare the derived theoretical statistical power with empirical power obtained through Monte Carlo simulations for the following comparisons: one-sample comparison of pre- and post-treatment mean differences, two-sample comparison of pre-post mean differences between groups, and two-sample comparison of mean differences between groups.Results: It is shown that C(α) is the same as a test-retest correlation of the scale scores of parallel items, which enables testing significance of C(α). Closed-form power functions and samples size determination formulas are derived in terms of C(α), for all of the aforementioned comparisons. Power functions are shown to be an increasing function of C(α), regardless of comparison of interest. The derived power functions are well validated by simulation studies that show that the magnitudes of theoretical power are virtually identical to those of the empirical power.Conclusion: Regardless of research designs or settings, in order to increase statistical power, development and use of instruments with greater C(α), or equivalently with greater inter-item correlations, is crucial for trials that intend to use questionnaire items for measuring research outcomes.Discussion: Further development of the power functions for binary or ordinal item scores and under more general item correlation strutures reflecting more real world situations would be a valuable future study. [ABSTRACT FROM AUTHOR]

Background: Obesity is a risk factor for several cancers in postmenopausal women. We attempted to determine cutoffs of adiposity measures in relation to risk of obesity-related cancers among postmenopausal women and to examine the effects of hormone therapy (HT) use on the cutoffs, neither of which has been broadly studied. Methods: We used data from the Women's Health Initiative cohort (n=144,701) and applied Cox-proportional hazards regressions to each combination of 17 cancer types and 6 anthropometric measures (weight, body mass index [BMI], weight to height ratio, waist circumference, waist to hip ratio [WHR], and waist to height ratio). Interactions between the anthropometric measures and HT use were also examined. Cutoffs were determined by applying a grid search followed by a two-fold cross validation method. Survival ROC analysis of 5- and 10-year incidence followed. Results: Breast, colorectal, colon, endometrium, kidney, and all cancers combined were significantly positively associated with all six anthropometric measures, whereas lung cancer among ever smokers was significantly inversely associated with all measures except WHR. The derived cutoffs of each obesity measure varied across cancers (e.g., BMI cutoffs for breast and endometrium cancers were 30 kg/m2 and 34 kg/m2, respectively), and also depended on HT use. The Youden indices of the cutoffs for predicting 5- and 10-year cancer incidence were higher among HT never users. Conclusion: Using a panel of different anthropometric measures, we derived optimal cut-offs categorizing populations into high- and low-risk groups, which differed by cancer type and HT use. Although the discrimination abilities of these risk categories were generally poor, the results of this study could serve as a starting point from which to determine adiposity cutoffs for inclusion in risk prediction models for specific cancer types. [ABSTRACT FROM AUTHOR]

Background: Interferon-based regimens exacerbated depressive symptoms, which interfered with treating hepatitis C virus (HCV) among people who inject drugs (PWID). Direct-acting antivirals (DAA) are not associated with worsening depressive symptoms; however, the impact of depressive symptoms on adherence remains little known. We examined the association between depressive symptoms and adherence to DAA among HCV-infected PWID. A secondary aim was to identify the optimal cut-off for major depressive disorder for this population.Methods: Participants were 150 HCV-infected PWID on maintenance treatment enrolled in a randomized clinical trial testing three HCV care models. Severity of depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) at baseline and every 4 weeks during treatment. Current major depressive disorder at baseline was diagnosed by the Mini-International Neuropsychiatric Interview. Adherence was measured during treatment (weeks 1-12) using electronic blister packs RESULTS: BDI-II scores ≥ 18 were identified as the optimal threshold for diagnosing major depressive disorder. Participants with BDI scores ≥ 18 at baseline had significantly lower adherence rates at weeks 1-4 of treatment compared to those with BDI scores < 18 (b = -0.23, 95% CI: 0.45-0.01, p = 0.044), but not in any other time intervals (weeks 5-8, b = -0.03, 95% CI: -0.32, 0.26, p = 0.825; weeks 9-12, b = -0.33, 95% CI -0.70, 0.02, p = 0.066).Conclusions: Elevated depressive symptoms were associated with lower adherence to DAA only during the first 4 weeks of HCV treatment. Neither severe depressive symptoms nor major depressive disorder appears to be a barrier to DAA adherence among PWID. [ABSTRACT FROM AUTHOR]

Many studies have examined the associations of body mass index (weight (kg)/height (m)2) with risk of various cancers. However, optimal scaling of weight for height may depend on the population studied. The authors used data from a large cohort study of women (Canadian National Breast Cancer Screening Study, 1980–2000; n = 89,835) to examine how the scaling of weight for height (W/Hx) influenced the association with risk of 19 different cancers. Cox proportional hazards models were used to estimate the hazard ratio for each cancer site with W/Hx, with x increasing from 0 to 3.0 by increments of 0.1. The correlation between weight and W/Hx decreased monotonically with increasing x, whereas W/Hx was minimally correlated with height when x = 1.4. W/Hx showed significant positive associations with postmenopausal breast cancer, endometrial cancer, kidney cancer, and lung cancer in never smokers. W/Hx was inversely associated with lung cancer in ever smokers. The value of x for which W/Hx produced the largest statistically significant hazard ratio ranged from 0.8 (endometrial cancer) to 1.7 (postmenopausal breast cancer). For lung cancer in ever smokers, the inverse association was statistically significant for all values of x. These findings suggest that the scaling of weight for height may vary depending on the cancer site and that optimal scaling may be considerably different from W/H2 or, alternatively, that a range of scaling should be considered when examining the association of body weight with risk of disease. [ABSTRACT FROM PUBLISHER]

Adherence counseling can improve antiretroviral adherence and related health outcomes in HIV-infected individuals. However, little is known about how much counseling is necessary to achieve clinically significant effects. We investigated antiretroviral adherence and HIV viral load relative to the number of hours of adherence counseling received by 60 HIV-infected drug users participating in a trial of directly observed antiretroviral therapy delivered in methadone clinics. Our adherence counseling intervention combined motivational interviewing and cognitive-behavioral counseling, was designed to include six 30 minute individual counseling sessions with unlimited “booster” sessions, and was offered to all participants in the parent trial. We found that, among those who participated in adherence counseling, dose of counseling had a significant positive relationship with antiretroviral adherence measured after the conclusion of counseling. Specifically, a liner mixed-effects model revealed that each additional hour of counseling was significantly associated with a 20% increase in post-counseling adherence. However, the number of cumulative adherence counseling hours was not significantly associated with HIV viral load, also measured after the conclusion of counseling. Our findings suggest that more intensive adherence counseling interventions may have a greater impact on antiretroviral adherence than less intensive interventions; however, it remains unknown how much counseling is required to impact HIV viral load. [ABSTRACT FROM PUBLISHER]

Background/objective: Experts recommend close oversight of patients receiving opioid analgesics for chronic non-cancer pain (CNCP), especially those at increased risk of misuse. We hypothesized that physicians employ opioid risk reduction strategies more frequently in higher risk patients.Design: Retrospective cohort using electronic medical records.Participants: Patients on long-term opioids (≥3 monthly prescriptions in 6 months) treated for CNCP in eight primary care practices.Methods: We examined three risk reduction strategies: (1) any urine drug test; (2) regular office visits (at least once per 6 months and within 30 days of modifying opioid treatment); and (3) restricted early refills (one or fewer opioid refills more than a week early). Risk factors for opioid misuse included: age <45 years old, drug or alcohol use disorder, tobacco use, or mental health disorder. Associations of risk factors with each outcome were assessed in non-linear mixed effects models adjusting for patient clustering within physicians, demographics and clinical factors.Main Results: Of 1,612 patients, 8.0% had urine drug testing, 49.8% visited the office regularly, and 76.6% received restricted (one or fewer) early refills. Patient risk factors were: age <45 (29%), drug use disorder (7.6%), alcohol use disorder (4.5%), tobacco use (16.1%), and mental health disorder (48.4%). Adjusted odds ratios (AOR) of urine drug testing were significantly increased for patients with a drug use disorder (3.18; CI 1.94, 5.21) or a mental health disorder (1.73; CI 1.14, 2.65). However, the AOR for restricted early refills was significantly decreased for patients with a drug use disorder (0.56; CI 0.34, 0.92). After adjustment, no risk factor was significantly associated with regular office visits. An increasing number of risk factors was positively associated with urine drug testing (p < 0.001), but negatively associated with restricted early refills (p = 0.009).Conclusion: Primary care physicians' adoption of opioid risk reduction strategies is limited, even among patients at increased risk of misuse. [ABSTRACT FROM AUTHOR]

Background: People who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York.Methods/design: In this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control - self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness.Discussion: This paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack technology will help us determine the role of adherence in successful cure of HCV. Moreover, the trial methodology outlined here can serve as a template for the development of future programs and studies among HCV-infected drug users receiving opioid agonist therapy, as well as the cost-effectiveness of such programs.Trial Registration: This trial was registered with ClinicalTrials.gov ( NCT01857245 ). Trial registration was obtained prospectively on May 20th, 2013. [ABSTRACT FROM AUTHOR]

Introduction: The rising prevalence of rapid response teams has led to a demand for risk-stratification tools that can estimate a ward patient's risk of clinical deterioration and subsequent need for intensive care unit (ICU) admission. Finding such a risk-stratification tool is crucial for maximizing the utility of rapid response teams. This study compares the ability of nine risk prediction scores in detecting clinical deterioration among non-ICU ward patients. We also measured each score serially to characterize how these scores changed with time.Methods: In a retrospective nested case-control study, we calculated nine well-validated prediction scores for 328 cases and 328 matched controls. Our cohort included non-ICU ward patients admitted to the hospital with a diagnosis of infection, and cases were patients in this cohort who experienced clinical deterioration, defined as requiring a critical care consult, ICU admission, or death. We then compared each prediction score's ability, over the course of 72 hours, to discriminate between cases and controls.Results: At 0 to 12 hours before clinical deterioration, seven of the nine scores performed with acceptable discrimination: Sequential Organ Failure Assessment (SOFA) score area under the curve of 0.78, Predisposition/Infection/Response/Organ Dysfunction Score of 0.76, VitalPac Early Warning Score of 0.75, Simple Clinical Score of 0.74, Mortality in Emergency Department Sepsis of 0.74, Modified Early Warning Score of 0.73, Simplified Acute Physiology Score II of 0.73, Acute Physiology and Chronic Health Evaluation II of 0.72, and Rapid Emergency Medicine Score of 0.67. By measuring scores over time, it was found that average SOFA scores of cases increased as early as 24 to 48 hours prior to deterioration (P = 0.01). Finally, a clinical prediction rule which also accounted for the change in SOFA score was constructed and found to perform with a sensitivity of 75% and a specificity of 72%, and this performance is better than that of any SOFA scoring model based on a single set of physiologic variables.Conclusions: ICU- and emergency room-based prediction scores can also be used to prognosticate risk of clinical deterioration for non-ICU ward patients. In addition, scoring models that take advantage of a score's change over time may have increased prognostic value over models that use only a single set of physiologic measurements. [ABSTRACT FROM AUTHOR]

Background: People who inject drugs (PWID) constitute 10 million people globally with hepatitis C virus, including many opioid agonist treatment patients. Little data exist describing clinical outcomes for patients receiving HCV treatment with direct-acting antiviral agents (DAAs) in opioid agonist treatment settings.Methods: In this retrospective observational study, we describe clinical outcomes for 50 genotype-1 patients receiving HCV treatment with triple therapy: telaprevir (n=42) or boceprevir (n=8) in combination with pegylated interferon and ribavirin on-site in an opioid agonist treatment program.Results: Overall, 70% achieved an end of treatment response (ETR) and 62% achieved a sustained virological response (SVR). These treatment outcomes are nearly equivalent to previously published HCV outcomes shown in registration trials, despite high percentages of recent drug use prior to treatment (52%), ongoing drug use during treatment (45%) and psychiatric comorbidity (86%). Only 12% (n=6) discontinued antiviral treatment early for non-virological reasons. Four patients received a blood transfusion, and one discontinued telaprevir due to severe rash.Conclusions: These data demonstrate that on-site HCV treatment with direct-acting antiviral agents is effective in opioid agonist treatment patients including patients who are actively using drugs. Future interferon-free regimens will likely be even more effective. Opioid agonist treatment programs represent an opportunity to safely and effectively treat chronic hepatitis C, and PWID should have unrestricted access to DAAs. [ABSTRACT FROM AUTHOR]