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Adequate adherence to direct‐acting antivirals (DAAs) for hepatitis C virus (HCV) is critical to attaining sustained virologic response (SVR). In this PREVAIL study's secondary analyses, we explored the association between self‐reported and objective DAAs adherence among a sample of people who inject drugs (PWID) receiving medications for opioid use disorder (MOUD) (N = 147). Self‐reported adherence was recoded 3 times during treatment (weeks 4, 8 and 12) using a visual analog scale (VAS), whereas objective adherence was collected continuously during treatment using electronic blister packs. Participants who reported being perfectly adherent had significantly higher blister pack adherence in each period (weeks 4, 8 and 12; ps <.05) and over the 12‐week study (p <.001) compared to those who reported being non‐perfectly adherent. Whites were more likely to report perfect adherence (91.7%) than Blacks (48.7%), Latinos (52.2%) and other (75.0%) race groups. Participants who reported recent use of cocaine (63.9%) or polysubstance use (60.0%) and those who had a positive result for cocaine (62.8%) were more likely to be non‐perfectly adherent, although none of these factors were associated with blister pack adherence. This study showed that the VAS could serve as a reliable option for assessing DAAs adherence among PWID on MOUD. The implementation of VAS may be an ideal option for monitoring adherence among PWID on MOUD, especially in clinical settings with limited resources. PWID on MOUD who are Black or other races than White, as well as those who report recent cocaine or polysubstance use may require additional support to maintain optimal DAA adherence. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate community attitudes concerning opioid use disorder (OUD) and medication for opioid use disorder (MOUD) in a rural community, and to plan educational initiatives to reduce stigma surrounding OUD and treatment. Methods: Dissemination of a 24‐question survey to people living in a rural community followed by comparative analysis of survey results between 2 groups classified by recognition of OUD as a real illness. Findings: Three hundred sixty‐one individuals responded. Overall, 69% agreed that OUD is a real illness. Respondents recognizing OUD as a real illness were less likely to agree that individuals with OUD are dangerous (P =.014), more likely to agree that MOUD is effective (P <.001), that individuals with OUD should have the same right to a job (P <.001), and that naloxone should be administered for every overdose every time (P =.002). Conclusions: Significant stigma exists toward individuals with OUD in rural communities, and recognizing OUD as a real illness is associated with less stigmatizing attitudes and better understanding of MOUD. Further study should focus on how to effectively convince communities that OUD is a real illness. [ABSTRACT FROM AUTHOR]

Abstract Background To estimate the association between body-mass index (BMI: kg/m2) and colorectal cancer (CRC) screening among US adults aged ≥ 50 years. Methods Population-based data from the 2001 Behavioral Risk Factor Surveillance Survey. Adults (N = 84,284) aged ≥ 50 years were classified by BMI as normal weight (18.5–1 year since last screening vs. 1 = screened within the past year), and screening sigmoidoscopy (SIG): (0 = > 5 years since last screening vs. 1 = within the past 5 years) were the outcomes. Results Results differed between men and women. After adjusting for age, health insurance, race, and smoking, we found that, compared to normal weight men, men in the overweight (odds ratio [OR] 1.25, 95% CI = 1.05–1.51) and obesity class I (OR = 1.21, 95% CI = 1.03–1.75) categories were more likely to have obtained a screening SIG within the previous 5 years, while women in the obesity class I (OR = 0.86, 95%CI = 0.78–0.94) and II (OR = 0.88, 95%CI = 0.79–0.99) categories were less likely to have obtained a screening SIG compared to normal weight women. BMI was not associated with FOBT. Conclusion Weight may be a correlate of CRC screening behavior but in a different way between men and women.

Abstract Background To evaluate the intermediate-term health outcomes associated with a soy-based meal replacement, and to compare the weight loss efficacy of two distinct patterns of caloric restriction. Methods Ninety overweight/obese (28 < BMI ≤ 41 kg/m2) adults received a single session of dietary counseling and were randomized to either 12 weeks at 1200 kcal/day, 16 weeks at 1500 kcal/d and 12 weeks at 1800 kcal/d (i.e., the 12/15/18 diet group), or 28 weeks at 1500 kcal/d and 12 weeks at 1800 kcal/d (i.e., the 15/18 diet group). Weight, body fat, waist circumference, blood pressure and serum lipid concentrations were measured at 4-week intervals throughout the 40-week trial. Results Subjects in both treatments showed statistically significant improvements in outcomes. A regression model for weight change suggests that subjects with larger baseline weights tended to lose more weight and subjects in the 12/15/18 group tended to experience, on average, an additional 0.9 kg of weight loss compared with subjects in the 15/18 group. Conclusion Both treatments using the soy-based meal replacement program were associated with significant and comparable weight loss and improvements on selected health variables.

Background Direct-acting antiviral (DAA) therapy is highly effective in people who inject drugs (PWID); however, rates, specific injection behaviors, and social determinants associated with hepatitis C virus (HCV) reinfection following DAA therapy among PWID on opioid agonist therapy (OAT) are poorly understood. Methods PREVAIL was a randomized controlled trial that assessed models of HCV care for 150 PWID on OAT. Those who achieved sustained virologic response (SVR) (n = 141; 94%) were eligible for this extension study. Interviews and assessments of recurrent HCV viremia occurred at 6-month intervals for up to 24 months following PREVAIL. We used survival analysis to analyze variables associated with time to reinfection. Results Of 141 who achieved SVR, 114 had a least 1 visit in the extension study (62% male; mean age, 52 years). Injection drug use (IDU) was reported by 19% (n = 22) in the extension study. HCV reinfection was observed in 3 participants. Over 246 person-years of follow-up, the incidence of reinfection was 1.22/100 person-years (95% CI, 0.25–3.57). All reinfections occurred among participants reporting ongoing IDU. The incidence of reinfection in participants reporting ongoing IDU (41 person-years of follow-up) was 7.4/100 person-years (95% CI, 1.5–21.6). Reinfection was associated with reporting ongoing IDU in the follow-up period (P <.001), a lack confidence in the ability to avoid contracting HCV (P <.001), homelessness (P =.002), and living with a PWID (P =.007). Conclusions HCV reinfection was low overall, but more common among people with ongoing IDU following DAA therapy on OAT, as well as those who were not confident in the ability to avoid contracting HCV, homeless, or living with a PWID. Interventions to mediate these risk factors following HCV therapy are warranted. [ABSTRACT FROM AUTHOR]

The Model for Understanding Success in Quality (MUSIQ) is a framework of contextual factors for quality improvement (QI) projects. We sought to determine which MUSIQ contextual factors were associated with successful QI initiatives. In a cross-sectional survey study, at a 21-site, ambulatory, urban primary care network, a modified MUSIQ survey tool questionnaire was administered to QI team members. The primary analysis associated objective measures of QI success with MUSIQ contextual factors. Objective QI success was defined as reaching goal percentages of adult patients with diabetes achieving glycated hemoglobin less than 8% and/or pediatric patients who had received combination toddler vaccines. Objective outcomes were compared with a subjective, self-reported outcome measure of QI success because previous literature found subjective outcomes were associated with specific MUSIQ factors. In the 143 survey responses collected, across 21 sites, no contextual factors from the MUSIQ survey were associated with either the adult or pediatric objective measure of QI project success. In a post hoc analysis, objective and subjective measures of success were often not associated and/or negatively correlated. In conclusion, contextual factors were not associated with objective measures of QI outcomes, in contrast to previous studies finding associations with subjective QI outcome measures. [ABSTRACT FROM AUTHOR]

Objective Among patients with chronic pain, risk of opioid use is elevated with high opioid dose or concurrent benzodiazepine use. This study examined whether these clinical factors, or sociodemographic factors of race and gender, are associated with opioid dose reduction. Design and Setting A retrospective cohort study of outpatients prescribed chronic opioid therapy between 2007 and 2012 within a large, academic health care system in Bronx, New York, using electronic medical record data. Included patients were prescribed a stable dose of chronic opioid therapy over a one-year "baseline period" and did not have cancer. Methods The primary outcome was opioid dose reduction (≥30% reduction from baseline) within two years. Multivariable logistic regression tested the associations of two clinical variables (baseline daily opioid dose and concurrent benzodiazepine prescription) and two sociodemographic variables (race/ethnicity and gender) with opioid dose reduction. Results Of 1,097 patients, 463 (42.2%) had opioid dose reduction. High opioid dose (≥100 morphine-milligram equivalents [MME]) was associated with lower odds of opioid dose reduction compared with an opioid dose <100 MME (adjusted odds ratio [AOR] = 0.69, 95% confidence interval [CI] = 0.54–0.89). Concurrent benzodiazepine prescription was not associated with opioid dose reduction. Black (vs white) race and female (vs male) gender were associated with greater odds of opioid dose reduction (AOR = 1.82, 95% CI = 1.22–2.70; and AOR = 1.43, 95% CI = 1.11–1.83, respectively). Conclusions Black race and female gender were associated with greater odds of opioid dose reduction, whereas clinical factors of high opioid dose and concurrent benzodiazepine prescription were not. Efforts to reduce opioid dose should target patients based on clinical factors and address potential biases in clinical decision-making. [ABSTRACT FROM AUTHOR]

Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions. [ABSTRACT FROM AUTHOR]