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A footnote in Adolphe Quetelet's classic 1835 Treatise on Man described his algebraic analysis of how body weight ( W $$ W $$ ) varies with height ( H $$ H $$ ) in adult males and females. Using data on 12 short and 12 tall subjects of each sex, Quetelet established the rule that W $$ W $$ is approximately proportional ( ∝ $$ \propto $$ ) to H 2 in adults; that is, W ∝ H 2 $$ W\propto {H}^2 $$ when W ≈ α H 2 $$ W\approx \alpha {H}^2 $$ for some constant α $$ \alpha $$ . Quetelet's Rule ( W ∝ H 2 $$ W\propto {H}^2 $$ ), transformed and renamed in the twentieth century to body mass index ( BMI = W / H 2 $$ \mathrm{BMI}=W/{H}^2 $$ ), is now a globally applied phenotypic descriptor of adiposity at the individual and population level. The journey from footnote to ubiquitous adiposity measure traveled through hundreds of scientific reports and many more lay publications. The recent introduction of highly effective pharmacologic weight loss treatments has heightened scrutiny of BMI's origins and appropriateness as a gateway marker for diagnosing and monitoring people with obesity. This contemporary context prompted the current report that delves into the biological and mathematical paradigms that underlie the simple index BMI = W / H 2 $$ \mathrm{BMI}=W/{H}^2 $$ . Students and practitioners can improve or gain new insights into their understanding of BMI's historical origins and quantitative underpinning from the provided overview, facilitating informed use of BMI and related indices in research and clinical settings., (© 2024 The Author(s). Obesity Reviews published by John Wiley & Sons Ltd on behalf of World Obesity Federation.)

Background: Self-efficacy, a patient-level factor, has been shown to facilitate patient engagement in treatment and optimize treatment-related outcomes in various health contexts. Research on interventions supporting hepatitis C virus (HCV) direct-acting antiviral (DAA) treatment uptake and adherence among persons who inject drugs (PWID) is needed, but whether self-efficacy factors influence DAA treatment cascade outcomes in this population has been less studied., Methods: Using the HERO study data, we analyzed a subset of participants with any general health self-efficacy data (n=708) measured at baseline and end-of-treatment time points using a 5-items instrument (facets: 'goal setting', 'goal attainment', 'having a positive effect', 'being in control', and 'working to improve'). The cascade outcomes included DAA treatment initiation, duration, adherence, completion, and sustained virologic response (SVR). The effect of baseline and change (Δ) scores for composite and item-level self-efficacy on the cascade outcomes was assessed using logistic regression and generalized linear models., Results: Higher baseline composite self-efficacy [adjusted odds ratio (95 % confidence interval) =1.57 (1.07, 2.29)], 'goal attainment' [1.31 (1.03, 1.67)] and 'having a positive effect' [1.33 (1.03, 1.74)] were associated with greater likelihood of treatment initiation. 'Δ Goal attainment' was significantly associated with SVR [1.63 (1.04, 2.53)]. 'Δ Being in control' and 'Δ working to improve' were associated with treatment adherence and duration, respectively., Conclusions: General health self-efficacy positively influences DAA treatment initiation among PWID. 'Goal attainment' facilitates the achievement of DAA treatment-related outcomes. Further studies should assess the effect of self-efficacy related to performing healthcare tasks specific to DAAs on the treatment-related outcomes., Competing Interests: Declaration of Competing Interest JF has received research grant support from Gilead Sciences. AYK has served on advisory boards for BioMarin. AHL has served on advisory boards for Gilead Sciences and Merck Pharmaceuticals and received research funding from Gilead Sciences. SHM has received speaker fees from Gilead Sciences. All other authors declare no competing interests., (Copyright © 2024. Published by Elsevier B.V.)

This study is a secondary analysis of a randomized clinical trial (October 2013-April 2017) involving 150 People Who Inject Drugs (PWIDs) with hepatitis C virus (HCV) seen in opioid agonist treatment programs in the Bronx, New York, and investigates the impact of distrust in the healthcare system on adherence to Direct-Acting Antivirals (DAAs) HCV treatment therapy among PWIDs. The distrust was scaled on a 9-item instrument and the adherence to DAA medications was measured using electronic blister packs. This study demonstrated a significant inverse relationship between levels of distrust and medication adherence: 71.8 ± 2.2% (se) vs. 77.9 ± 1.8%, p = 0.024 between participants with higher and lower distrust levels. Despite the absence of significant association of distrust with sociodemographic or substance use characteristics, these findings suggest that building trust within the healthcare system is paramount for improving adherence to DAAs among PWIDs. The results call for a healthcare approach that emphasizes trust-building through patient-centered care, sensitivity training, peer support, and health system reform to effectively address the treatment needs of this marginalized population.

Importance: Hepatitis C virus (HCV) reinfection after curative treatment remains a concern for people who inject drugs., Objective: To assess the incidence of HCV reinfection and associated risk factors., Design, Setting, and Participants: This cohort study is a secondary analysis of a randomized clinical trial that was conducted across opioid treatment programs and community health centers in the US between September 2016 and August 2018. The current analyses were performed in March 2022. People who inject drugs who achieved sustained virologic response (SVR) were followed for up to 42 months., Exposure: Patients were randomly assigned to receive modified directly observed therapy or patient navigation., Main Outcomes and Measures: The primary outcome was rate of HCV reinfection. Change in reinfection rates over time was assessed using a Poisson regression model., Results: A total of 415 participants (mean [SD] age, 44.7 [11.5] years; 302 male [72.8%]) achieved a SVR and had 1 or more post-SVR assessments for HCV RNA. Overall, 302 (72.8%) reported recent injection drug use, 192 (46.3%) were living in unstable housing, and 313 (75.4%) had received recent methadone or buprenorphine for opioid use disorder. The overall reinfection rate was 11.4 per 100 person-years at risk (95% CI, 8.7-14.7 per 100 person-years at risk) over 518 person-years of follow-up. Reinfection rates varied significantly across sites, ranging from 2.9 per 100 person-years at risk (95% CI, 0.1-16.3 per 100 person-years) to 25.2 per 100 person-years at risk (95% CI, 15.6-38.5 per 100 person-years at risk) (P = .006). There was a significant decrease in incident reinfection with increasing post-SVR follow-up (weeks 0-24, 15.5 per 100 person-years; 95% CI, 10.3-22.3 per 100 person-years; weeks 73-144, 4.3 per 100 person-years; 95% CI, 0.9-12.5 per 100 person-years; P = .008). Reinfection rates were lower for participants aged 40 years or older than for younger participants (adjusted incidence rate ratio, 0.32; 95% CI, 0.18-0.57) and for participants for whom methamphetamine was not detected in urinary drug screening compared with participants for whom methamphetamine was detected (adjusted incidence rate ratio, 0.41; 95% CI, 0.21-0.82). Participants who reported injection drug use within the preceding 3 months had higher risk of reinfection than those who did not have recent injection drug use (adjusted incidence rate ratio, 3.33; 95% CI, 1.86-5.97)., Conclusions and Relevance: In this cohort study of people who injected drugs and were treated for HCV infection in community settings, reinfection was high in the period immediately after SVR but decreased significantly over time. These findings highlight the importance of early intervention to prevent reinfection., Trial Registration: ClinicalTrials.gov Identifier: NCT02824640.

Background & Aims: Direct-acting antivirals (DAAs) are highly effective for treating HCV infection even among people who inject drugs (PWID). Yet, little is known about patients' adherence patterns and their association with sustained virologic response (SVR) rates. We aimed to summarize various adherence patterns and determine their associations with SVR., Methods: Electronic blister packs were used to measure daily adherence to once-a-day sofosbuvir/velpatasvir during the 12-week treatment period among active PWIDs. Blister pack data were available for 496 participants who initiated DAAs for whom SVR status was known. Adherence was summarized in multiple patterns, such as total adherent days, consecutive missed days, and early discontinuations. Thresholds for adherence patterns associated with >90% SVR rates were also determined., Results: The overall SVR rate was 92.7%, with a median adherence rate of 75%. All adherence patterns indicating greater adherence were significantly associated with achieving SVR. Participant groups with ≥50% (>42/84) adherent days or <26 consecutive missed days achieved an SVR rate of >90%. Greater total adherent days during 9-12 weeks and no early discontinuation were significantly associated with higher SVR rates only in those with <50% adherence. Participants with first month discontinuation and ≥2 weeks of treatment interruption had low SVR rates, 25% and 85%, respectively. However, greater adherent days were significantly associated with SVR (adjusted odds ratio 1.10; 95% CI 1.04-1.16; p <0.001) even among participants with ≥14 consecutive missed days., Conclusions: High SVR rates can be achieved in the PWID population despite suboptimal adherence. Encouraging patients to take as much medication as possible, with <2 weeks consecutive missed days and without early discontinuation, was found to be important for achieving SVR., Impact and Implications: People who inject drugs can be cured of HCV in >90% of cases, even with relatively low adherence to direct-acting antivirals, but early discontinuations and long treatment interruptions can significantly reduce the likelihood of achieving cure. Clinicians should encourage people who inject drugs who are living with HCV to adhere daily to direct-acting antivirals as consistently as possible, but if any days are interrupted, to continue and complete treatment. These results from the HERO study are important for patients living with HCV, clinicians, experts writing clinical guidelines, and payers., Clinical Trial Number: NCT02824640., (Copyright © 2024 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Background: This study evaluates a novel multidisciplinary program providing expanded access to hepatitis C virus (HCV) treatment for rural Appalachian patients in South Carolina. This program identified patients via an opt-out emergency department screening program, and it aimed to achieve HCV cure by using community paramedics (CPs) to link and monitor patients from treatment initiation through 12-week sustained virologic response (SVR)., Methods: Patients aged ≥18 years who were HCV RNA positive were eligible for enrollment if they failed to appear for a scheduled HCV appointment or reported barriers to accessing office-based treatment. CPs provided home visits (initial and 4, 12, and 24 weeks) using a mobile Wi-Fi hotspot to support telemedicine appointments (compliant with the Health Insurance Portability and Accountability Act) and perform focused physical assessments, venipuncture, and coordinated home delivery of medications. Statistics described participant characteristics, prevalence of SVR, and patient satisfaction results at 12 weeks posttreatment., Results: Thirty-four patients were eligible for SVR laboratory tests by 31 August 2023; the majority were male (61.7%) and White (64.7%) with an average age of 56 years (SD, 11.7). Twenty-eight (82.4%) completed treatment and achieved 12-week SVR. Six (17.6%) were lost to follow-up. Two-thirds strongly agreed that they were satisfied with the overall care that they received, and half strongly agreed that their overall health had improved., Conclusions: This CP-augmented treatment program demonstrated success curing HCV for rural patients who lacked access to office-based treatment. Other health care systems may consider this novel delivery model to treat hard-to-reach individuals who are HCV positive., Competing Interests: Potential conflicts of interest. A. H. L. has served on advisory board for Merck Pharmaceuticals, AbbVie and Gilead Sciences. A. H. L. has received research grants from Merck Pharmaceuticals and Gilead Sciences. P. M. has received research grants from Gilead Sciences. No other authors declared any conflict of interest related to this work., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

The Mini-Mental State Examination (MMSE) is a widely employed screening tool for the severity of cognitive impairment. Among the MMSE items, the pentagon copying test (PCT) requires participants to accurately replicate a sample of two interlocking pentagons. While the PCT is traditionally scored on a binary scale, there have been limited developments of granular scoring scale to assess task performance. In this paper, we present a novel three-stage algorithm, called Quantification of Interlocking Pentagons (QIP) which quantifies PCT performance by computing the areas of individual pentagons and their intersection areas, and a balance ratio between the areas of the two individual pentagons. The three stages of the QIP algorithm include: (1) detection of line segments, (2) unraveling of the interlocking pentagons, and (3) quantification of areas. A set of 497 PCTs from 84 participants including their baseline and follow-up PCTs from the Rush Memory and Aging Project was selected blinded about their cognitive and clinical status. Analysis of the quantified data revealed a significant inverse relationship between age and balance ratio (beta = - 0.49, p = 0.0033), indicating that older age was associated with a smaller balance ratio. In addition, balance ratio was associated with perceptual speed (r = 0.71, p = 0.0135), vascular risk factors (beta = - 3.96, p = 0.0269), and medical conditions (beta = - 2.78, p = 0.0389). The QIP algorithm can serve as a useful tool for enhancing the scoring of performance in the PCT., (© 2024. The Author(s).)

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.

Background: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold., Methods: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold., Results: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis., Conclusions: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence., (© 2024. The Author(s).)

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Objective adherence measures, such as electronic blister pack (BP), for direct-acting antivirals (DAAs) for hepatitis C virus (HCV) treatment have high accuracy, but their use is limited in real practice settings. We examined the association of self-reported adherence using a visual analogue scale (VAS) with objective BP adherence and sustained virologic response (SVR) among people who inject drugs., Methods: We conducted secondary analyses using a subset of participants (N = 493) from the per-protocol sample of the HERO study, a pragmatic randomized trial of HCV treatment interventions that used both VAS and BP to measure adherence to a 12-week sofosbuvir/velpatasvir DAA regimen. Multivariable mixed-effects regression models tested the association of self-report adherence level with longitudinal weekly objective adherence. Multivariable logistic regression tested the association of self-report adherence with SVR., Results: The average VAS and BP adherences were 95.1 % (SD = 8.9 %) and 76.0 % (16.0 %), respectively, and the proportion of the participants achieving SVR was 92.9 %. The estimated adjusted mean objective adherence was significantly different (-16 %; 95 % CI: -22 %, -11 %, p < .001) between participants with 100 % and <80 % VAS adherence. The likelihood of SVR was significantly lower for those with <80 % VAS adherence [adjusted OR = 0.07; 95 % CI: 0.02, 0.24; p < .001] compared to those with 100 %., Conclusion: Self-reported adherence overestimated objective adherence. However, higher self-report adherence was significantly associated with higher objective adherence. Also, self-reported adherence ≥80 % was significantly associated with SVR. Thus, the self-report measure has utility as a monitoring tool for adherence during DAA treatment., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

Transitional care programs (TCPs), where hospital care team members repeatedly follow up with discharged patients, aim to reduce post-discharge hospital or emergency department (ED) utilization and healthcare costs. We examined the effectiveness of TCPs at reducing healthcare costs, hospital readmissions, and ED visits. Centers for Medicare and Medicaid Services Bundled Payments for Care Improvement (BPCI) program adjudicated claims files and electronic health records from Greenville Memorial Hospital, Greenville, SC, were accessed. Data on post-discharge 30- and 90-day ED visits and readmissions, total costs, and episodes with costs over BPCI target prices were extracted from November 2017 to July 2020 and compared between the "TCP-Graduates" (N = 85) and "Did Not Graduate" (DNG) (N = 1310) groups. As compared to the DNG group, the TCP-Graduates group had significantly fewer 30-day (7.1% vs. 14.9%, p = 0.046) and 90-day (15.5% vs. 26.3%, p = 0.025) readmissions, episodes with total costs over target prices (25.9% vs. 36.6%, p = 0.031), and lower total cost/episode (USD 22,439 vs. USD 28,633, p = 0.018), but differences in 30-day (9.4% vs. 11.2%, p = 0.607) and 90-day (20.0% vs. 21.9%, p = 0.680) ED visits were not significant. TCP was associated with reduced post-discharge hospital readmissions, total care costs, and episodes exceeding target prices. Further studies with rigorous designs and individual-level data should test these findings.

Background: Psycho-social experiences including shame and experienced and internalized stigma have been associated with substance use, HCV infection, and reluctance to disclose HCV status and pursue treatment. These psycho-social barriers have been examined independently for many chronic diseases, including HCV, but to our knowledge have not been quantitatively explored in a large multi-site US-based sample of people who inject drugs (PWID) in HCV treatment., Methods: We examine baseline relationships with HCV-stigma and engagement across the HCV treatment cascade as well as baseline and longitudinal relationships between shame and engagement across the HCV treatment cascade including treatment initiation, adherence, completion, and sustained virologic response (SVR) among a multi-site sample of PWID with HCV, where N=755 were randomized to the pragmatic trial comparing HCV treatment outcomes in modified directly observed treatment (mDOT) or patient navigation, and N=623 initiated treatment., Results: While cross-sectional assessments of shame and HCV-stigma were not associated with engagement across the HCV treatment cascade, those whose shame scores decreased compared to those who reported consistently high and increasing levels of shame were significantly more likely to complete HCV treatment (aOR=5.29; 95%CI: 1.56,18.00) and achieve SVR (aOR=6.32; 95%CI: 1.61, 24.87)., Conclusion: Results underscore the relationships between lower levels of shame and health-related behavior and treatment outcomes among PWID and suggest SVR achievement may contribute to reductions in shame or that reductions in shame may contribute to continued treatment and thus SVR., Competing Interests: Declaration of Competing Interest A.H.L. is a consultant/advisor and has received research grants from AbbVie, Gilead Sciences, and Merck Pharmaceuticals., (Copyright © 2023. Published by Elsevier B.V.)

We conducted a critical review of the article "Effects on Children's Physical and Mental Well-Being of a Physical-Activity-Based School Intervention Program: A Randomized Study", published in the International Journal of Environmental Research and Public Health in 2023 as part of the Special Issue "Psychomotricity and Physical Education in School Health". We identified multiple mistakes in the statistical analyses applied. First, the authors claim to have found a statistically significant association between the proposed intervention and change in body composition (body mass index (BMI) percentiles, relative fat mass, and BMI classes) by way of exhibiting differences in nominal significance between the pre- and post-intervention changes within the control and intervention groups, instead of exhibiting a significant difference between groups. Furthermore, the analysis described fails to account for clustering and nesting in the data. The reporting of the statistical methods and results include multiple elements that are variously incorrect, incoherent, or impossible. Revised statistical analyses are proposed which can render the study's methods valid and its results substantiated, whereas the current methods and results are invalid and unsubstantiated, respectively.

Introduction: An intersectionality framework recognizes individuals as simultaneously inhabiting multiple intersecting social identities embedded within systems of disadvantage and privilege. Previous research links perceived discrimination with worsened health outcomes yet is limited by a focus on racial discrimination in isolation. We applied an intersectional approach to the study of discrimination to examine the association with adverse perinatal health outcomes., Methods: We analyzed data from a cohort of 2,286 pregnant participants (Black, n = 933; Hispanic, n = 471; White, n = 853; and Other, n = 29) from the Centering and Racial Disparities trial. Perceived discrimination was assessed via the Everyday Discrimination Scale (EDS) and perinatal health outcomes collected via electronic medical record review. Latent class analysis was used to identify subgroups of discrimination based on EDS item response and the rate of adverse perinatal health outcomes compared between subgroups using a Bolck, Croon and Hagenaars 3-step approach., Results: Four discrimination subgroups were identified: no discrimination, general discrimination, discrimination attributed to one or several social identities, and discrimination attributed to most or all social identities. Experiencing general discrimination was associated with postpartum depression symptoms when compared with experiencing no discrimination among Black (9% vs 5%, P = .04) and White participants (18% vs 9%, P = .01). White participants experiencing general discrimination gave birth to low birthweight infants at a higher rate than those experiencing no discrimination (11% vs 6%, P = .04). No significant subgroup differences were observed among Hispanic participants., Conclusion: Perceived discrimination may play an influential role in shaping perinatal health. More research applying an intersectional lens to the study of discrimination and perinatal health outcomes is needed.

Background: Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome., Methods: We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models. Depressive symptoms (primary outcome) were measured using the Patient Health Questionnaire (PHQ-9) at baseline, end of treatment (EOT), and at follow-up 12 and 24 weeks after EOT. Sustained virologic response (SVR) was defined as undetectable HCV RNA at ≥12 weeks following EOT. Baseline drug use was defined as having a positive urine screening test for amphetamine, methamphetamine, benzodiazepine, cocaine, cannabis, opiate, or oxycodone., Results: The sample (n = 498) was 72.3% male, 64.2% White, and on average 43.9 years old. In patients who achieved SVR (F(3432) = 4.58; P = .004) and those with drug use at baseline (F(3478) = 5.11; P < .01), PHQ-9 scores significantly declined over time, with scores lower at EOT and both follow-ups as compared with baseline. Mean PHQ-9 scores at EOT and follow-ups were significantly lower than at baseline, except for those with no depression or mild depression at baseline., Conclusions: This study showed that HCV treatment in PWID is associated with sustained declines in depression up to 24 weeks post-treatment among those who achieve SVR and that drug use does not interfere with improvement in depressive symptoms., Competing Interests: Potential conflicts of interest. J.F. has received research grant support from Gilead Sciences. A.Y.K. has served on advisory boards for Biomarin. A.F.L. has received research grant support from Gilead and Merck. The Task Force for Global Health receives funds for the general support of the Coalition for Global Hepatitis Elimination from Abbott, Gilead, AbbVie, Merck, Siemens, Roche, Pharco, Zydus-Cadila, governmental agencies, and philanthropic organizations. A.H.L. has served on advisory boards for Gilead Sciences and Merck Pharmaceuticals and received research funding from Gilead Sciences. S.H.M. has received speaker fees from Gilead Sciences. All other authors declare no competing interests., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

People on buprenorphine maintenance treatment (BMT) commonly present cognitive deficits that have been associated with illicit drug use and dropout from buprenorphine treatment. This study has compared cognitive responses to the Stroop Task and the Continuous Performance Task (CPT) among individuals on BMT, with recent drug use, and healthy controls and explored the associations between cognitive responses and drug use, craving, and buprenorphine use among participants on BMT. The participants were 16 individuals on BMT and 23 healthy controls. All participants completed a 60 min laboratory session in which they completed the Stroop Task and the CPT, a saliva drug test, a brief clinical history that collected substance-use- and treatment-related information, and the Opioid Craving Scale. The results showed that the BMT participants presented more commission errors (MBMT participants = 2.49; Mhealthy controls = 1.38; p = 0.048) and longer reaction times (MBMT participants = 798.09; Mhealthy controls = 699.09; p = 0.047) in the Stroop Task than did the healthy controls. More days on buprenorphine were negatively associated with reaction time in the CPT (-0.52) and the number of commission errors (-0.53), simple reaction time (-0.54), and reaction time correct (-0.57) in the Stroop Task. Neither drug use nor craving was significantly associated with the results for the cognitive tasks. Relative to the control participants, the BMT individuals performed worse in terms of longer reaction times and more commission errors in the Stroop Task. Within the BMT participants, longer times on buprenorphine were associated with better cognitive results in terms of faster reaction times for both tasks and lower commission errors for the Stroop Task.

Delay discounting describes how rapidly delayed rewards lose value as a function of delay and serves as one measure of impulsive decision-making. Nicotine deprivation among combustible cigarette smokers can increase delay discounting. We aimed to explore changes in discounting following nicotine deprivation among electronic nicotine delivery systems (ENDS) users. Thirty young adults (aged 18-24 years) that exclusively used ENDS participated in two laboratory sessions: one with vaping as usual and another after 16 hr of nicotine deprivation (biochemically assessed). At each session, participants completed a craving measure and three hypothetical delay discounting tasks presenting choices between small, immediate rewards and large, delayed ones (money-money; e-liquid-e-liquid; e-liquid-money). Craving for ENDS significantly increased during short-term nicotine deprivation relative to normal vaping. Delay discounting rates in the e-liquid now versus money later task increased (indicating a shift in preference for smaller, immediate rewards) following short-term nicotine deprivation relative to vaping as usual, but no changes were observed in the other two discounting tasks. Short-term nicotine deprivation increased the preference for smaller amounts of e-liquid delivered immediately over larger, monetary awards available after a delay in this first study of its kind. As similar preference shifts for drug now versus money later have been shown to be indicative of increased desire to use drug as well as relapse risk, the findings support the utility of the current model as a platform to explore interventions that can mitigate these preference shifts. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Background: Persons who inject drugs (PWID) are a key population for hepatitis C virus (HCV) treatment. Study aims were to describe injection practices of PWID during HCV treatment with direct-acting antivirals (DAAs) and assess whether injection practices were associated with not achieving a sustained virologic response (SVR)., Methods: Secondary analysis of the HERO Study (ClinicalTrials.gov, NCT02824640), a pragmatic randomized trial in 8 U.S. states to evaluate the effectiveness of HCV care models among active PWID seen in opioid treatment programs and community clinics. Frequency, sharing and reuse of injecting equipment were assessed at baseline, end-of-treatment (EOT) and quarterly visits up to 60 weeks post-treatment. Generalized Estimating Equations logistic regression models with linear spline were used to compare trends in injecting behaviors during vs. post-treatment. Multivariable logistic regression models explored associations between injecting behaviors during treatment and lack of SVR., Results: Among 501 participants, 27% were female, 35% were non-white, mean age was 44 (SD 11.5) years and nearly half (49%) were unhoused. At baseline, 41% reported receptive sharing of injecting equipment, declining to 16% at EOT visit. Receptive sharing of cookers, rinses, or needles/syringes during treatment was associated with a nearly 5-fold increase in not achieving SVR (adjusted odds ratio (aOR)=4.83; 95% CI: 2.26, 10.28) as was reuse of one's own needles/syringes (aOR=2.37; 95% CI: 1.11, 4.92)., Conclusions: PWID in the HERO study adopted safer injecting behaviors during DAA treatment; receptive sharing of injecting equipment and reuse of one's own equipment during treatment were associated with not achieving cure., Competing Interests: Declaration of Competing Interest FN has served on advisory panels for Gilead Sciences and reports research funds from AbbVie paid to Johns Hopkins University. JF has received research grant support from Gilead Sciences. AYK has served on advisory boards for Biomarin. AFL received research grant support from Gilead and Merck. The Task Force for Global Health receives funds for the general support of the Coalition for Global Hepatitis Elimination from Abbott, Gilead, AbbVie, Merck, Siemens, Roche, Pharco, Zydus-Cadila, governmental agencies, and philanthropic organizations. AHL has served on advisory boards for Gilead Sciences and Merck Pharmaceuticals and received research funding from Gilead Sciences. Dr. Mehta has received speaker fees from Gilead Sciences. LT has received UpToDate Royalties for peer review of viral hepatitis topics. All other authors had nothing to disclose., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background/objectives: Fat-free mass (FFM) often serves as a body composition outcome variable in weight loss studies. An important assumption is that the proportions of components that make up FFM remain stable following weight loss; some body composition models rely on these "constants". This exploratory study examined key FFM component proportions before and following weight loss in two studies of participants with overweight and obesity., Subjects/methods: 201 men and women consumed calorie-restricted moderate- or very-low carbohydrate diets leading to 10-18% weight loss in 9-15 weeks. Measured total body fat, lean mass, bone mineral, total body water (TBW), and body weight at baseline and follow-up were used to derive FFM and its chemical proportions using a four-component model., Results: A consistent finding in both studies was a non-significant reduction in bone mineral and a corresponding increase (p < 0.001) in bone mineral/FFM; FFM density increased significantly in one group of women and in all four participant groups combined (both, p < 0.05). FFM hydration (TBW/FFM) increased in all groups of men and women, one significantly (p < 0.01), and in the combined sample (borderline, p < 0.10). The proportion of FFM as protein decreased across all groups, two significantly (p < 0.05-0.01) and in the combined sample (p < 0.05)., Conclusion: FFM relative proportions of chemical components may not be identical before and after short-term weight loss, an observation impacting some widely used body composition models and methods. Caution is thus needed when applying FFM as a safety signal or to index metabolic evaluations in clinical trials when these body composition approaches are used., (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)

Background and Objectives: Cognitive benefits of longitudinal curricula and interleaving have been demonstrated in several disciplines. However, most residency curricula are structured in a block format. There is no consensus definition as to what constitutes a longitudinal program, making comparative research on curricular efficacy a challenge. The objective of our study was to arrive at a consensus definition of Longitudinal Interleaved Residency Training (LIRT) in family medicine., Methods: A national workgroup was convened and utilized a Delphi method between October 2021 and March 2022 to arrive at a consensus definition., Results: Twenty-four invitations were sent, and 18 participants initially accepted. The final workgroup (n=13) was representative of the nationwide diversity of family medicine residency programs in terms of geographic location (P=.977) and population density (P=.123). The following definition was approved: "LIRT is a curricular design and program structure that offers graduated, concurrent clinical experiences in the core competencies of the specialty. LIRT models the comprehensive scope of practice and continuity that defines the specialty; applies training methods that enhance long-term retention of knowledge, skills, and attitudes across all dimensions and locations of care delivery; and accomplishes program objectives through employment of longitudinal curricular scheduling and interleaving with spaced repetition." Additional technical criteria and definitions of terms are elucidated in the body of this article., Conclusions: A representative national workgroup crafted a consensus definition of Longitudinal Interleaved Residency Training (LIRT) in family medicine, a program structure with a basis in emerging evidence-based cognitive science.

Background: Rural areas in the United States (US) are ravaged by the opioid overdose epidemic. Oconee County, an entirely rural county in northwest South Carolina, is likewise severely affected. Lack of harm reduction and recovery resources (e.g., social capital) that could mitigate the worst outcomes may be exacerbating the problem. We aimed to identify demographic and other factors associated with support for harm reduction and recovery services in the community., Methods: The Oconee County Opioid Response Taskforce conducted a 46-item survey targeting a general population between May and June in 2022, which was mainly distributed through social media networks. The survey included demographic factors and assessed attitudes and beliefs toward individuals with opioid use disorder (OUD) and medications for OUD, and support for harm reduction and recovery services, such as syringe services programs and safe consumption sites. We developed a Harm Reduction and Recovery Support Score (HRRSS), a composite score of nine items ranging from 0 to 9 to measure level of support for placement of naloxone in public places and harm reduction and recovery service sites. Primary statistical analysis using general linear regression models tested significance of differences in HRRSS between groups defined by item responses adjusting for demographic factors., Results: There were 338 survey responses: 67.5% were females, 52.1% were 55 years old or older, 87.3% were Whites, 83.1% were non-Hispanic, 53.0% were employed, and 53.8% had household income greater than US$50,000. The overall HRRSS was relatively low at a mean of 4.1 (SD = 2.3). Younger and employed respondents had significantly greater HRRSS. Among nine significant factors associated with HRRSS after adjusting for demographic factors, agreement that OUD is a disease had the greatest adjusted mean difference in HRSSS (adjusted diff = 1.22, 95% CI=(0.64, 1.80), p < 0.001), followed by effectiveness of medications for OUD (adjusted diff = 1.11, 95%CI=(0.50, 1.71), p < 0.001)., Conclusions: Low HRRSS indicates low levels of acceptance of harm reduction potentially impacting both intangible and tangible social capital as it relates to mitigation of the opioid overdose epidemic. Increasing community awareness of the disease model of OUD and the effectiveness of medications for OUD, especially among older and unemployed populations, could be a step toward improving community uptake of the harm reduction and recovery service resources critical to individual recovery efforts., (© 2023. The Author(s).)

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., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The United States has persistently high rates of preterm birth and low birthweight and is characterized by significant racial disparities in these rates. Innovative group prenatal care models, such as CenteringPregnancy, have been proposed as a potential approach to improve the rates of preterm birth and low birthweight and to reduce disparities in these pregnancy outcomes., Objective: This study aimed to test whether participation in group prenatal care would reduce the rates of preterm birth and low birthweight compared with individual prenatal care and whether group prenatal care would reduce the racial disparity in these rates between Black and White patients., Study Design: This was a randomized controlled trial among medically low-risk pregnant patients at a single study site. Eligible patients were stratified by self-identified race and ethnicity and randomly allocated 1:1 between group and individual prenatal care. The primary outcomes were preterm birth at <37 weeks of gestation and low birthweight of <2500 g. The primary analysis was performed according to the intent-to-treat principle. The secondary analyses were performed according to the as-treated principle using modified intent-to-treat and per-compliance approaches. The analysis of effect modification by race and ethnicity was planned., Results: A total of 2350 participants were enrolled, with 1176 assigned to group prenatal care and 1174 assigned to individual prenatal care. The study population included 952 Black (40.5%), 502 Hispanic (21.4%), 863 White (36.8%), and 31 "other races or ethnicity" (1.3%) participants. Group prenatal care did not reduce the rate of preterm birth (10.4% vs 8.7%; odds ratio, 1.22; 95% confidence interval, 0.92-1.63; P=.17) or low birthweight (9.6% vs 8.9%; odds ratio, 1.08; 95% confidence interval, 0.80-1.45; P=.62) compared with individual prenatal care. In subgroup analysis, greater attendance in prenatal care was associated with lower rates of preterm birth and low birthweight. This effect was most noticeable for the rates of low birthweight for Black participants in group care: intent to treat (51/409 [12.5%]), modified intent to treat (36/313 [11.5%]), and per compliance (20/240 [8.3%]). Although the rates of low birthweight were significantly higher for Black participants than White participants seen in individual care (adjusted odds ratio, 2.00; 95% confidence interval, 1.14-3.50), the difference was not significant for Black participants in group care compared with their White counterparts (adjusted odds ratio, 1.58; 95% confidence interval, 0.74-3.34)., Conclusion: There was no difference in the overall rates of preterm birth or low birthweight between group and individual prenatal care. With increased participation in group prenatal care, lower rates of preterm birth and low birthweight for Black participants were observed. The role of group care models in reducing racial disparities in these birth outcomes requires further study., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use., Methods: We did a pragmatic randomised controlled trial at eight US cities in eight opioid treatment programmes and 15 community health centres. PWID actively injecting within 90 days of study entry were randomly assigned (1:1) to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status. The randomisation code was concealed, in a centralised REDCap database platform, from all investigators and research staff except for an authorised data manager at the data coordinating centre. All participants received a fixed-dose combination tablet (sofosbuvir 400 mg plus velpatasvir 100 mg) orally once daily for 12 weeks. The primary outcome was sustained virological response (SVR; determined by chart review between 70 days and 365 days after end of treatment and if unavailable, by study blood draws), and secondary outcomes were treatment initiation, adherence (measured by electronic blister packs), and treatment completion. Analyses were conducted within the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomised), and per-protocol populations. This trial is registered with ClinicalTrials.gov, NCT02824640., Findings: Between Sept 15, 2016, and Aug 14, 2018, 1891 individuals were screened and 1136 were excluded (213 declined to participate and 923 did not meet the eligibility criteria). We randomly assigned 755 participants to patient navigation (n=379) or mDOT (n=376). In the mITT sample of participants who were randomised and initiated treatment (n=623), 226 (74% [95% CI 69-79]) of 306 participants in the mDOT group and 236 (76% [69-79]) of 317 in the patient navigation group had an SVR, with no significant difference between the groups (adjusted odds ratio [AOR] 0·97 [95% CI 0·66-1·42]; p=0·35). In the ITT sample (n=755), 226 (60% [95% CI 55-65]) of 376 participants in the mDOT group and 236 (62% [57-67]) of 379 in the patient navigation group had an SVR (AOR 0·92 [0·68-1·25]; p=0·61) and in the per-protocol sample (n=501), 226 (91% [87-94]) of 248 participants in the mDOT group and 235 (93% [89-96]) of 253 in the patient navigation group had an SVR (AOR 0·79 [0·41-1·55]; p=0·44). 306 (81%) of 376 participants in the mDOT group and 317 (84%) of 379 participants in the patient navigation group initiated treatment (AOR 0·86 [0·58-1·26]; p=0·44) and, among those, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (AOR 0·90 [0·58-1·39]; p=0·63). Mean daily adherence was higher in the mDOT group (78% [95% CI 75-81]) versus the patient navigation group (73% [70-77]), with a difference of 4·7% ([1·9-7·4]; p=0·0010). 421 serious adverse events were reported (217 in the mDOT group and 204 in the patient navigation group), with the most common being hospital admission (176 in the mDOT group vs 161 in the patient navigation group)., Interpretation: In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR. These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support., Funding: Patient-Centered Outcomes Research Institute, Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies., Competing Interests: Declaration of interests OF-N has served on advisory panels for Gilead Sciences and reports research funds from AbbVie paid to Johns Hopkins University. JF has received research grant support from Gilead Sciences. AYK has served on advisory boards for Biomarin. AFL received research grant support from Gilead and Merck. The Task Force for Global Health receives funds for the general support of the Coalition for Global Hepatitis Elimination from Abbott, Gilead, AbbVie, Merck, Siemens, Roche, Pharco, Zydus-Cadila, governmental agencies, and philanthropic organisations. AHL has served on advisory boards for Gilead Sciences and Merck Pharmaceuticals and received research funding from Gilead Sciences. SHM has received speaker fees from Gilead Sciences. LET has received UpToDate Royalties for peer review of viral hepatitis topics. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

People who inject drugs (PWID) are a vulnerable population at high risk for acquiring hepatitis C virus (HCV) and frequently suffer from comorbid alcohol use. This study examines the characteristics and correlates of alcohol use among study participants, the association between alcohol consumption and sustained virologic response (SVR) in patients receiving HCV treatment, changes in drinking behaviours during HCV treatment and associations of drinking over time with specific models of HCV treatment. Participants were 150 PWID with HCV who were receiving opioid agonist therapy (OAT) and enrolled in a randomized clinical trial exploring the effectiveness of three models of care for HCV treatment. The addiction severity index was the primary measure of alcohol consumption. Days of alcohol intake were evaluated longitudinally and across three treatment groups. At baseline, 31% (47/150) reported having at least one drink in the last 30 days including 24% (36/150) who reported drinking to intoxication in the last 30 days. There was no difference in SVR rates between groups. There was a significant decrease in overall days of drinking from baseline (7.78 ± 7.86) to follow-up at Week 24 (5.78 ± 8.83) (p = 0.041), but there were no significant changes among those who drank to intoxication; modified directly observed therapy (mDOT) was the only group with a significant decline in days of alcohol consumption (p = 0.041). In this cohort of PWID on OAT, baseline alcohol consumption did not affect SVR rates. HCV treatment was overall associated with decreased alcohol consumption. In particular, mDOT was associated with decreased alcohol consumption. Given the additive effect of alcohol and HCV on the development of cirrhosis, studies should be done to investigate the complimentary effects of the mDOT model of care on alcohol cessation., (© 2022 The Authors. Journal of Viral Hepatitis published by John Wiley & Sons Ltd.)

Among people who inject drugs (PWID), 60% have HCV and 50-90% of HIV-infected PWID are co-infected with HCV. Data comparing adherence to direct-acting antiviral (DAA) therapy among HCV mono-infected and HIV/HCV co-infected PWID is limited. The impact of HCV treatment initiation on HIV antiretroviral therapy (ART) adherence is also poorly understood. We assessed DAA adherence in HCV mono-infected and HIV/HCV co-infected PWID and examined changes in ART adherence and HIV outcomes following HCV treatment. Study was conducted in three Medication for Opioid use Disorder (MOUD) programs in Bronx, New York. HCV treatment adherence was measured using electronic blister packs. 2-week DAA adherence rates were compared and controlled for study arm, psychiatric illness and alcohol intoxication within the past 30 days. ART adherence was measured using participant self-report and dichotomized to "excellent" or "other". ART adherence, CD4 count, and HIV viral load were identified six months prior to, during, and six months after HCV treatment. Statistical significance was assessed with mixed-effects regression linear or logistic models. Overall DAA adherence rates among HCV mono-infected and HIV/HCV co-infected PWID were 74% (95% CI=71-78%) and 76% (95%CI=70-83%), respectively ( p =.55). There were no significant changes in ART adherence, CD4 counts, or HIV viral loads prior to, during, or after HCV treatment. This is the first study assessing the impact of DAA therapy on ART adherence and HIV treatment outcomes among PWID. It is one of the first to compare DAA adherence among HCV and HIV/HCV co-infected PWID. Our data demonstrate no significant difference in DAA adherence and no significant impact of HCV treatment on ART adherence or HIV outcomes.

Background: Inpatient surgical site infections (SSIs) cause morbidity in children. The SSI rate among pediatric ambulatory surgery patients is less clear. To fill this gap, we conducted a multiple-institution, retrospective epidemiologic study to identify incidence, risk factors, and outcomes., Methods: We identified patients aged <22 years with ambulatory visits between October 2010 and September 2015 via electronic queries at 3 medical centers. We performed sample chart reviews to confirm ambulatory surgery and adjudicate SSIs. Weighted Poisson incidence rates were calculated. Separately, we used case-control methodology using multivariate backward logistical regression to assess risk-factor association with SSI., Results: In total, 65,056 patients were identified by queries, and we performed complete chart reviews for 13,795 patients; we identified 45 SSIs following ambulatory surgery. The weighted SSI incidence following pediatric ambulatory surgery was 2.00 SSI per 1,000 ambulatory surgeries (95% confidence interval [CI], 1.37-3.00). Integumentary surgeries had the highest weighted SSI incidence, 3.24 per 1,000 ambulatory surgeries (95% CI, 0.32-12). The following variables carried significantly increased odds of infection: clean contaminated or contaminated wound class compared to clean (odds ratio [OR], 9.8; 95% CI, 2.0-48), other insurance type compared to private (OR, 4.0; 95% CI, 1.6-9.8), and surgery on weekend day compared to weekday (OR, 30; 95% CI, 2.9-315). Of the 45 instances of SSI following pediatric ambulatory surgery, 40% of patients were admitted to the hospital and 36% required a new operative procedure or bedside incision and drainage., Conclusions: Our findings suggest that morbidity is associated with SSI following ambulatory surgery in children, and we also identified possible targets for intervention.

Objectives: Although medical workers were prioritized to receive the coronavirus disease 2019 (COVID-19) vaccination, many have declined. Even though studies have investigated differences in COVID-19-related attitudes and vaccination for workers in hospitals and long-term care facilities, none have included emergency medical services (EMS) personnel. We investigated the association between type of medical worker (EMS vs healthcare worker [HCW]) and COVID-19 vaccination, vaccine beliefs, vaccine motivators, personal protection behaviors, and risk perceptions., Methods: The data for self-identified HCWs came from surveys distributed to randomly selected residents of South Carolina and EMS personnel recruited at a targeted surveillance testing event during the South Carolina EMS Symposium. Pearson χ 2 and Fisher exact tests analyzed differences in the distribution of demographic characteristics and self-reported COVID-19 vaccination attitudes by medical workers. Multivariable logistic regression assessed the association between COVID-19 vaccination and type of medical worker, adjusting for age, sex, race, and frontline status, and assessed the associations among vaccine beliefs, vaccine motivators, personal protection behaviors, and risk perceptions by type of medical worker, adjusting for age, sex, race, frontline status, and vaccination status., Results: Of the 126 respondents 57.9% were EMS, 42.1% were HCWs, and 73.6% of the cohort were self-reported frontline medical workers. Approximately two-thirds of respondents received a vaccine for COVID-19, with no significant differences between EMS and HCWs; however, EMS workers were significantly less likely to receive the vaccination out of concern about exposures at work/school (adjusted odds ratio [aOR] 0.22, 95% confidence interval [CI] 0.08-0.57), concern about exposures within the community (aOR 0.18, 95% CI 0.07-0.48), or to do their part to control the pandemic (aOR 0.20, 95% CI 0.06-0.69). EMS workers also were significantly less likely to wear a mask all/most of the time when outside the home (aOR 0.04, 95% CI 0.0-0.21) and less concerned about the spread of COVID-19 in their community as compared with HCWs (aOR 0.19, 95% CI 0.06-0.56)., Conclusions: EMS personnel were significantly less concerned about the spread of COVID-19 in their community and significantly less likely to wear a mask all/most of the time while outside the home as compared with HCWs. Differences in the COVID-19-related attitudes and personal protection behaviors of EMS personnel should be used to develop targeted interventions to increase vaccine motivation and adherence to personal protection protocols.

Background: Opioid use disorder (OUD) has led to a staggering death toll in terms of drug-related overdoses. Despite the demonstrated benefits and effectiveness of buprenorphine, retention is suboptimal, and patients typically present with high rates of ongoing polysubstance use during treatment. A pilot trial provided preliminary support for the efficacy of computer-based cognitive-behavioral therapy (CBT4CBT) as an add-on to buprenorphine in reducing substance use. Recovery coaching services provided by individuals with substance use experience and successful recovery have also shown to positively influence recovery outcomes for people with OUD by increasing buprenorphine initiation and reducing opioid use., Methods: The OVERCOME study is a randomized clinical trial (RCT) aimed to tests an integrated intervention combining CBT4CBT and Recovery Coaching relative to treatment- as -usual (TAU) among individuals with OUD on buprenorphine. The primary outcome measure is the percentage of samples with any drug tested as positive at each research visit conducted during treatment (visits 1 to 8). Secondary outcomes include the percentage of samples with any drug tested as positive at 1- and 3- month follow-up and retention to buprenorphine at 3- month follow-up., Results: We describe the rationale, design, and methodology of the OVERCOME Study., Conclusion: This trial will provide evidence of the efficacy of an integrated intervention combining CBT4CBT and Recovery Coaching for reducing substance use and increasing buprenorphine adherence which has the potential to reduce mortality among people with OUD., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work presented in this manuscript., (© 2022 Published by Elsevier Inc.)

Background: Although efforts to treat hepatitis C virus (HCV) in people who inject drugs (PWID) yield high rates of sustained virologic response (SVR), the relationship between successful HCV treatment and health-related quality of life (HRQOL) among PWID is poorly understood. We examined HRQOL changes throughout HCV treatment and post-treatment for PWID achieving SVR., Methods: Participants included 141 PWID who achieved SVR following HCV treatment onsite at 3 opioid agonist treatment (OAT) clinics in the Bronx, New York. EQ-5D-3L assesses 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), producing an index of HRQOL ranging from 0 to 1. EQ-5D-3L was measured at baseline; 4, 8, and 12 weeks during treatment; and 12 and 24 weeks post-treatment. Linear mixed effects regression models assessed changes in the mean EQ-5D-3L index over time., Results: Mean EQ-5D-3L index baseline was 0.66 (standard error [SE] = 0.02). While over half the population reported no baseline problems with self-care (85.1%), usual activities (56.0%), and mobility (52.5%), at least two-thirds reported problems with pain/discomfort (78.0%) and anxiety/depression (66.0%). Twenty-four weeks post-treatment, proportions reporting pain/discomfort and anxiety/depression decreased by 25.7% and 24.0%, respectively. Mean EQ-5D-3L index significantly improved during treatment (P < .0001), and improvement was sustained following treatment completion, with mean EQ-5D-3L index of 0.77 (SE = 0.02) 12 weeks post-SVR., Conclusions: HCV treatment led to sustained improvement in HRQOL for PWID on OAT who achieved SVR. Future research is necessary to determine whether improvements in HRQOL can be sustained beyond 12 weeks post-SVR., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

The SARS-CoV-2 outbreak from October 2020 through February 2021 was the largest outbreak as of February 2021, and timely information on current representative prevalence, vaccination, and loss of prior antibody protection was unknown. In February 2021, the South Carolina Department of Health and Environmental Control conducted a random sampling point prevalence investigation consisting of viral and antibody testing and an associated health survey, after selecting participants aged ≥5 years using a population proportionate to size of South Carolina residents. A total of 1917 residents completed a viral test, 1803 completed an antibody test, and 1463 completed ≥1 test and a matched health survey. We found an incidence of 2.16 per 100 residents and seroprevalence of 16.4% among South Carolina residents aged ≥5 years. Undetectable immunoglobulin G and immunoglobulin M antibodies were noted in 28% of people with a previous positive test result, highlighting the need for targeted education among people who may be susceptible to reinfection. We also found a low rate of vaccine hesitancy in the state (13%). The results of this randomly selected surveillance and associated health survey have important implications for prospective COVID-19 public health response efforts. Most notably, this article provides a feasible framework for prompt rollout of a statewide evidence-based surveillance initiative.

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., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Objectives: To evaluate community attitudes concerning syringe exchange programs (SEPs) in a rural community as part of an effort to implement evidence-based harm reduction strategies and improve health outcomes related to opioid use disorder., Methods: Dissemination of a 24-item survey to individuals living in a rural community followed by comparative analysis of survey results based on support for SEPs., Results: Three hundred and sixty-one individuals responded. Overall, 49.3% of respondents indicated support for syringe exchange. Individuals who support syringe exchange as a harm reduction service are more likely to: agree that opioid use disorder is a real illness ( p  < 0.0001); agree that anyone can become addicted to pain medications ( p  = 0.01); agree that medication assisted treatment is effective ( p  < 0.0001); agree that individuals with OUD have the same right to a job ( p  < 0.0001); be willing to administer naloxone to a stranger ( p  < 0.0001); support HIV and HCV screening ( p  < 0.0001), condom distribution ( p  < 0.0001), and medication for opioid use disorder ( p  < 0.0001). They are less likely to believe that harm reduction services encourage drug use ( p  < 0.0001)., Conclusions: Positive correlations exist between support for SEPs, awareness of OUD as a chronic illness, less stigmatizing attitudes toward individuals with OUD, and support for other harm reduction strategies. Efforts to increase awareness of OUD as a chronic illness may lead to greater acceptance of harm reduction strategies in rural areas, easing evolution of evidence-based healthy policy.

Background: Body mass is the primary metabolic compartment related to a vast number of clinical indices and predictions. The extent to which skeletal muscle (SM), a major body mass component, varies between people of the same sex, weight, height, and age is largely unknown. The current study aimed to explore the magnitude of muscularity variation present in adults and to examine if variation in muscularity associates with other body composition and metabolic measures., Methods: Muscularity was defined as the difference (residual) between a person's actual and model-predicted SM mass after controlling for their weight, height, and age. SM prediction models were developed using data from a convenience sample of 492 healthy non-Hispanic (NH) White adults (ages 18-80 years) who had total body SM and SM surrogate, appendicular lean soft tissue (ALST), measured with magnetic resonance imaging and dual-energy X-ray absorptiometry, respectively; residual SM (SM R ) and ALST were expressed in kilograms and kilograms per square meter. ALST mass was also evaluated in a population sample of 8623 NH-White adults in the 1999-2006 National Health and Nutrition Examination Survey. Associations between muscularity and variation in the residual mass of other major organs and tissues and resting energy expenditure were evaluated in the convenience sample., Results: The SM, on average, constituted the largest fraction of body weight in men and women up to respective BMIs of 35 and 25 kg/m 2 . SM in the convenience sample varied widely with a median of 31.2 kg and an SM R inter-quartile range/min/max of 3.35 kg/-10.1 kg/9.0 kg in men and 21.1 kg and 2.59 kg/-7.2 kg/7.5 kg in women; per cent of body weight as SM at 25th and 75th percentiles for men were 33.1% and 39.6%; corresponding values in women were 24.2% and 30.8%; results were similar for SM R indices and for ALST measures in the convenience and population samples. Greater muscularity in the convenience sample was accompanied by a smaller waist circumference (men/women: P < 0.001/=0.085) and visceral adipose tissue (P = 0.014/0.599), larger liver (P = 0.065/<0.001), kidneys (P = 0.051/<0.009), and bone mineral (P < 0.001/<0.001), and larger magnitude resting energy expenditure (P < 0.001/<0.001) than predicted for the same sex, age, weight, and height., Conclusions: Muscle mass is the largest body compartment in most adults without obesity and is widely variable in mass across people of similar body size and age; and high muscularity is accompanied by distinct body composition and metabolic characteristics. This previously unrecognized heterogeneity in muscularity in the general population has important clinical and research implications., (© 2022 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of Society on Sarcopenia, Cachexia and Wasting Disorders.)

Purpose: The aim of this study was (1) to assess AT through 13 different mathematical approaches and to compare their results; and (2) to understand if AT occurs after moderate WL., Methods: Ninety-four participants [mean (SD); BMI, 31.1 (4.3) kg/m 2 ; age, 43.0 (9.4) years; 34% females] underwent a 1-year lifestyle intervention (clinicaltrials.gov ID: NCT03031951) and were randomized to intervention (IG, n = 49) or control groups (CG, n = 45), and all measurements were made at baseline and after 4 months. Fat mass (FM) and fat-free mass (FFM) were measured by dual-energy X-ray absorptiometry and REE by indirect calorimetry. AT was assessed through 13 different approaches, varying in how REE was predicted and/or how AT was assessed., Results: IG underwent a mean negative energy balance (EB) of 270 (289) kcal/day, p < 0.001), resulting in a WL of - 4.8 (4.9)% and an FM loss of - 11.3 (10.8)%. Regardless of approach, AT occurred in the IG, ranging from ~ - 65 to ~ - 230 kcal/day and three approaches showed significant AT in the CG., Conclusions: Regardless of approach, AT occurred after moderate WL in the IG. AT assessment should be standardized and comparisons among studies with different methodologies to assess AT must be avoided., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Objectives: To assess pediatrician adherence to the 2017 American Academy of Pediatrics' clinical practice guideline for high blood pressure (BP)., Study Design: Pediatric primary care practices (n = 59) participating in a quality improvement collaborative submitted data for patients with high BP measured between November 2018 and January 2019. Baseline data included patient demographics, BP, body mass index (BMI), and actions taken. Logistic regression was used to test associations between patient BP level and BMI with provider adherence to guidelines (BP measurement, counseling, follow-up, evaluation)., Results: A total of 2677 patient charts were entered for analysis. Only 2% of patients had all BP measurement steps completed correctly, with fewer undergoing 3-limb and ambulatory BP measurement. Overall, 46% of patients received appropriate weight, nutrition, and lifestyle counseling. Follow-up for high BP was recommended or scheduled in 10% of encounters, and scheduled at the appropriate interval in 5%. For patients presenting with their third high BP measurement, 10% had an appropriate diagnosis documented, 2% had appropriate screening laboratory tests conducted, and none had a renal ultrasound performed. BMI was independently associated with increased odds of counseling, but higher BP was associated with lower odds of counseling. Higher BP was independently associated with an increased likelihood of documentation of hypertension., Conclusions: In this multisite study, adherence to the 2017 American Academy of Pediatrics' guideline for high BP was low. Given the long-term health implications of high BP in childhood, it is important to improve primary care provider recognition and management., Trial Registration: ClinicalTrials.gov: NCT03783650., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: Routine screening for HIV and hepatitis C virus (HCV) among specified age cohorts is recommended. New York State requires consent before screening for HIV but not HCV. We sought to estimate the effect of the consent requirement on screening rates for HIV., Methods: We performed a retrospective study of patients hospitalized in 2015-2016 at a tertiary care hospital in the Bronx, New York, during a period when prompts in the electronic health record facilitated screening for HIV and HCV among specified age cohorts. We compared proportions of patients eligible for screening for HIV and/or HCV who underwent screening and used generalized estimating equations and a meta-analytic weighted average to estimate an adjusted risk difference between undergoing HIV screening and undergoing HCV screening., Results: Among 11 938 hospitalized patients eligible for HIV and/or HCV screening, 38.5% underwent screening for HIV and 59.1% underwent screening for HCV. The difference in screening rates persisted after adjusting for patient and admission characteristics (adjusted risk difference = 22.0%; 95% CI, 20.6%-23.4%)., Conclusions: Whereas the requirement for consent was the only difference in the processes of screening for HIV compared with screening for HCV, differences in how the 2 viruses are perceived may also have contributed to the difference in screening rates. Nevertheless, our findings suggest that requiring consent continues to impede progress toward the public health goal of routine HIV screening.

Objective: A previous report from our group identified directionally unfavorable dietary and lifestyle behavior trends in longitudinally monitored children and adolescents with obesity early in the COVID-19 pandemic lockdown. The current study aimed at extending these previous observations in youths with obesity on the dietary and lifestyle behavioral consequences of the extended COVID-19 lockdown in Verona, Italy., Methods: The sample included 32 children and adolescents with obesity participating in the longitudinal OBELIX study. Diet and lifestyle information were collected pre-pandemic, 3 weeks into the national lockdown, and 9 months later when home confinement continued to be mandatory. Changes in outcomes over the study time points were evaluated for significance using repeated-measures ANOVA and post-hoc pairwise t -tests with Bonferroni corrections., Results: As previously reported, meals/day, fried potato intake, and red meat ingestion increased significantly ( p  < 0.001) during the initial lockdown. Sleep time and screen time increased and sports participation decreased significantly ( p  < 0.001) during the initial lockdown. These changes in health behaviors remained significantly different from baseline at the second lockdown assessment, with the exception sleep time returned to baseline levels., Conclusions: Unfavorable diet and lifestyle behavioral changes in response to the initial COVID-19 lockdown in children and adolescents with obesity have largely been sustained over the course of the pandemic. There is an urgent need to intervene on these behaviors to prevent further deleterious effects on long-term child health; access to weight management care is critically important for these children. In addition to intervening on these behaviors, our findings should help to inform ongoing lockdown policies., Competing Interests: The authors declared no conflict of interest., (© 2021 The Authors. Obesity Science & Practice published by World Obesity and The Obesity Society and John Wiley & Sons Ltd.)

Background: Adequate medication adherence is critical for achieving sustained viral response (SVR) of hepatitis C virus (HCV) among people who inject drugs (PWID). However, it is less known which patterns of direct-acting antiviral (DAA) treatment adherence are associated with SVR in this population or what factors are associated with each pattern., Methods: The randomized 3-arm PREVAIL study used electronic blister packs to obtain daily time frame adherence data in opiate agonist therapy program settings. Exact logistic regressions were applied to test the associations between SVR and 6 types of treatment adherence patterns., Results: Of the 113 participants treated with combination DAAs, 109 (96.5%) achieved SVR. SVR was significantly associated with all pattern parameters except for number of switches between adherent and missed days: total adherent daily doses (exact adjusted odds ratio [AOR] = 1.12; 95% confidence interval [CI] = 1.04-1.22), percent total doses (1.09; 1.03-1.16), days on treatment (1.16; 1.05-1.32), maximum consecutive adherent days (1.34; 1.06-2.04), and maximum consecutive nonadherent days (0.85; .74-.95 = 0.003). SVR was significantly associated with total adherent doses in the first 2 months of treatment, it was not in the last month. While alcohol intoxication was significantly associated with frequent switches, drug use was not associated with any adherence pattern., Conclusions: Consistent maintenance of adequate total dose adherence over the entire course of HCV treatment is important in achieving SVR among PWID. Additional integrative addiction and medical care may be warranted for treating PWID who experience alcohol intoxication., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Guidelines for treatment of central line-associated bloodstream infection (CLABSI) recommend removing central venous catheters (CVCs) in many cases. Clinicians must balance these recommendations with the difficulty of obtaining alternate access and subjecting patients to additional procedures. In this study, we evaluated CVC salvage in pediatric patients with ambulatory CLABSI and associated risk factors for treatment failure., Methods: This study was a secondary analysis of 466 ambulatory CLABSIs in patients <22 years old who presented to 5 pediatric medical centers from 2010 to 2015. We defined attempted CVC salvage as a CVC left in place ≥3 days after a positive blood culture result. Salvage failure was removal of the CVC ≥3 days after CLABSI. Successful salvage was treatment of CLABSI without removal of the CVC. Bivariate and multivariable logistic regression analyses were used to test associations between risk factors and attempted and successful salvage., Results: A total of 460 ambulatory CLABSIs were included in our analysis. CVC salvage was attempted in 379 (82.3%) cases. Underlying diagnosis, CVC type, number of lumens, and absence of candidemia were associated with attempted salvage. Salvage was successful in 287 (75.7%) attempted cases. Underlying diagnosis, CVC type, number of lumens, and absence of candidemia were associated with successful salvage. In patients with malignancy, neutropenia within 30 days before CLABSI was significantly associated with both attempted salvage and successful salvage., Conclusions: CVC salvage was often attempted and was frequently successful in ambulatory pediatric patients presenting with CLABSI., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2021 by the American Academy of Pediatrics.)

Background: Peer recovery support services (PRSS) have been increasingly incorporated during the recovery process for opioid use disorder (OUD), yet little is known about the effects of PRSS on clinical outcomes of individuals who misuse opioids. This study systematically synthesized existing literature reporting the effectiveness of PRSS interventions on stages of the OUD treatment cascade., Methods: A search conducted on five databases identified studies from database inception to January 26th 2021 that evaluated the effects of PRSS on PRSS engagement, medication for OUD (MOUD) initiation, MOUD retention, opioid and non-opioid misuse, and remission. Characteristics of PRSS interventions, study design, and clinical outcomes were extracted. Methodological quality was assessed with the quality assessment tool for quantitative studies by the Effective Public Health Practice Project., Results: Of 123 titles, 22 were subjected to full-text review and 12 ultimately met inclusion criteria. Only two studies were randomized control trials, half compared the outcomes of PRSS participants to those of a counterfactual group. Most PRSS were unstandardized and broadly described, involving linkage to treatment (91.7%) or follow-up support (91.7%). MOUD initiation was reported the most often (66.7%), followed by PRSS engagement (33.3%) and opioid use (25.0%). No studies reported findings for MOUD retention or remission. Findings for available outcomes were inconsistent and difficult to compare due to the heterogeneity of PRSS interventions and methodological limitations., Conclusion: Effectiveness of PRSS interventions on stages of the OUD treatment cascade remain inconclusive. Additional research is necessary before supporting the implementation of PRSS on a broad scale., (Copyright © 2021. Published by Elsevier B.V.)

Randomization is an important tool used to establish causal inferences in studies designed to further our understanding of questions related to obesity and nutrition. To take advantage of the inferences afforded by randomization, scientific standards must be upheld during the planning, execution, analysis, and reporting of such studies. We discuss ten errors in randomized experiments from real-world examples from the literature and outline best practices for their avoidance. These ten errors include: representing nonrandom allocation as random, failing to adequately conceal allocation, not accounting for changing allocation ratios, replacing subjects in nonrandom ways, failing to account for non-independence, drawing inferences by comparing statistical significance from within-group comparisons instead of between-groups, pooling data and breaking the randomized design, failing to account for missing data, failing to report sufficient information to understand study methods, and failing to frame the causal question as testing the randomized assignment per se. We hope that these examples will aid researchers, reviewers, journal editors, and other readers to endeavor to a high standard of scientific rigor in randomized experiments within obesity and nutrition research., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: Laboratory models have been useful in identifying the motivational processes underlying tobacco use. This pilot study aimed at (1)validating a human laboratory model initially developed for smokers to e-cigarette users; (2)applying this model to examine the effects of stress on the reinforcing value of nicotine among young adults., Methods: Using a randomized cross-over design, young e-cigarette users (n = 30) who were nicotine deprived were exposed to a stress or a non-stress task, and then engaged in a laboratory task assessing vaping's reward value on two separate days. During the first part of the task, participants had the option of initiating an e-cigarette self-administration session or delaying initiation for up to 50 min in exchange for money. During the second part of the task, participants chose between vaping or receiving money. The length of the delay and the number of e-cigarette uses consumed were the primary outcomes. Craving and puff topography were secondary outcomes., Results: There was no difference in the length of time that participants were able to refrain from vaping in the stress and control task (p = .90). Participants purchased and consumed more puffs after being exposed to the stress task compared to the control task (p<.001), puff topography and craving were unaffected., Conclusions: Exposure to a stressor did not undermine the ability to resist vaping among deprived e-cigarette users (first part), but it influenced the number of uses purchased once users decided to vape (second part). This study evidences that these two parts of the task for assessing reward value are differentially sensitive to the stress manipulation., (Copyright © 2021 Elsevier B.V. All rights reserved.)

People who inject drugs (PWID) have a high prevalence of hepatitis C virus (HCV). Group treatment is a practical option for addressing barriers to treatment in this population. Prior research on group treatment has resulted in mixed conclusions about its effectiveness in addressing barriers to treatment. A patient's perception of the group environment may help to explain this variability. This study sought to explore the association between indicators of group treatment environment and improved outcomes in HCV-infected PWID. This secondary analysis of a randomized controlled trial exploring different models of treatment for HCV in a PWID population consisted of 42 participants randomized to the group treatment branch of the trial. Independent variables consisted of group sessions attended and group climate constructs of engagement, conflict, and avoidance. Dependent variables consisted of medication adherence, social support, and health-related quality of life. The study implemented generalized estimating equations to assess associations with the outcomes at the end of treatment. Factors indicative of group treatment environment were related to medication adherence and other barriers to health for HCV-infected PWID: social support and health-related quality of life. Perceptions of conflict or avoidance were associated with worse outcomes, while increased session attendance was generally associated with better outcomes. The study attests to the importance of examining group environment factors during treatment interventions. Although preliminary, the study provides specific indicators of treatment success for HCV-infected PWID and practical implications to improve patients' health outcomes and better tailor treatment to the patient., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Though people who inject drugs (PWID) make up the majority of the hepatitis C virus (HCV) epidemic, concerns about adherence often exclude PWID from receiving direct-acting antiviral (DAA) medication. The most effective models of HCV care to promote sustained virologic response (SVR) and high adherence need to be evaluated., Methods: We conducted a prospective cohort study in three opioid treatment programs (OTPs) in the Bronx, NY. Participants, in collaboration with providers, chose one of three models of onsite care: directly observed therapy (mDOT), group treatment (GT), or self-administered individual treatment (SIT).  SVR12, daily adherence, and participant characteristics were compared between groups., Results: Of 61 participants, the majority were male (62%) and Latino (67%), with a mean age of 53 (SD 9). Participants received DAAs via one of three models of care: mDOT (21%), GT (25%), or SIT (54%). The majority (59%) used illicit drugs during treatment. Overall, SVR12 was 98% with no differences between models of care: mDOT (100%), GT (100%), and SIT (97%) (p = 1.0). Overall, daily adherence was 73% (SD 16); 86% among those who chose mDOT compared to 71% among those who chose GT (p<0.01) and 73% among those who chose SIT (p<0.01)., Conclusion: Despite ongoing illicit drug use and suboptimal adherence, SVR12 was high among PWID treated onsite at an OTP using any one of three models of care. Shared decision making in real world settings may be key to choosing the appropriate model of care for PWID., Competing Interests: Declarations of Interest This study was approved by the Einstein College of Medicine Institutional Review Board. This manuscript is original work and has not been submitted elsewhere for publication. All authors meet criteria for authorship, have contributed significantly to the work, and have seen and approved the manuscript. Declarations: Dr. Alain Litwin is on advisory boards for Gilead and Merck. This study received support from Gilead Sciences and NIDA R01 034086.This study was also supported by the Prisma Health and Health Sciences Center Addiction Research Center., (Copyright © 2021. Published by Elsevier B.V.)

Importance: Interventions to improve judicious prescribing of opioid analgesics for acute pain are needed owing to the risks of diversion, misuse, and overdose., Objective: To assess the effect of modifying opioid analgesic prescribing defaults in the electronic health record (EHR) on prescribing and health service use., Design, Setting, and Participants: A cluster randomized clinical trial with 2 parallel arms was conducted between June 13, 2016, and June 13, 2018, in a large urban health care system comprising 32 primary care and 4 emergency department (ED) sites in the Bronx, New York. Data were analyzed using a difference-in-differences method from 6 months before implementation through 18 months after implementation. Data were analyzed from January 2019 to February 2020., Interventions: A default dispense quantity for new opioid analgesic prescriptions of 10 tablets (intervention) vs no change (control) in the EHR., Main Outcomes and Measures: The primary outcome was the quantity of opioid analgesics prescribed with the new default prescription. Secondary outcomes were opioid analgesic reorders and health service use within 30 days after the new prescription. Intention-to-treat analysis was conducted., Results: Overall, 21 331 patients received a new opioid analgesic prescription from 490 prescribers. Comparing the intervention and control arms, site, prescriber, and patient characteristics were similar. For the new prescription, compared with the control arm, patients in the intervention arm had significantly more prescriptions for 10 tablets or fewer (7.6 percentage points; 95% CI, 6.1-9.2 percentage points), a lower number of tablets prescribed (-2.1 tablets; 95% CI, -3.3 to -0.9 tablets), and lower morphine milligram equivalents (MME) prescribed (-14.6 MME; 95% CI, -22.6 to -6.6 MME). Within 30 days after the new prescription, significant differences remained in the number of tablets prescribed (-2.7 tablets; 95% CI, -4.8 to -0.6 tablets), but not MME (-15.8 MME; 95% CI, -33.8 to 2.2 MME). Within this 30-day period, there were no significant differences between the arms in health service use., Conclusions and Relevance: In this study, implementation of a uniform reduced default dispense quantity of 10 tablets for opioid analgesic prescriptions led to a modest reduction in the quantity prescribed initially, without significantly increasing health service use. However, during 30 days after implementation, the influence on prescribing was mixed. Reducing EHR default dispense quantities for opioid analgesics is a feasible strategy that can be widely disseminated and may modestly reduce prescribing., Trial Registration: ClinicalTrials.gov Identifier: NCT03003832.

Background: Beginning in 2019, stepped-wedge designs (SWDs) were being used in the investigation of interventions to reduce opioid-related deaths in communities across the United States. However, these interventions are competing with external factors such as newly initiated public policies limiting opioid prescriptions, media awareness campaigns, and the COVID-19 pandemic. Furthermore, control communities may prematurely adopt components of the intervention as they become available. The presence of time-varying external factors that impact study outcomes is a well-known limitation of SWDs; common approaches to adjusting for them make use of a mixed effects modeling framework. However, these models have several shortcomings when external factors differentially impact intervention and control clusters., Methods: We discuss limitations of commonly used mixed effects models in the context of proposed SWDs to investigate interventions intended to reduce opioid-related mortality, and propose extensions of these models to address these limitations. We conduct an extensive simulation study of anticipated data from SWD trials targeting the current opioid epidemic in order to examine the performance of these models in the presence of external factors. We consider confounding by time, premature adoption of intervention components, and time-varying effect modification- in which external factors differentially impact intervention and control clusters., Results: In the presence of confounding by time, commonly used mixed effects models yield unbiased intervention effect estimates, but can have inflated Type 1 error and result in under coverage of confidence intervals. These models yield biased intervention effect estimates when premature intervention adoption or effect modification are present. In such scenarios, models incorporating fixed intervention-by-time interactions with an unstructured covariance for intervention-by-cluster-by-time random effects result in unbiased intervention effect estimates, reach nominal confidence interval coverage, and preserve Type 1 error., Conclusions: Mixed effects models can adjust for different combinations of external factors through correct specification of fixed and random time effects. Since model choice has considerable impact on validity of results and study power, careful consideration must be given to how these external factors impact study endpoints and what estimands are most appropriate in the presence of such factors.