Search

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Hepatitis C virus (HCV) frequently co-occurs with symptoms of depression, which are aggravated on interferon-based regimens. However, it is unknown whether HCV treatment with direct-acting antivirals (DAAs) has effects on depressive symptoms among people who inject drugs (PWID). In this study, we examined changes in depressive symptoms during and after HCV treatment among PWID on opioid agonist therapies (OATs). Methods Participants were 141 PWID who achieved sustained viral response after on-site HCV treatment at 3 OAT programs. Depressive symptoms were assessed using the Beck Depression Inventory–II (BDI-II) at baseline, every 4 weeks during treatment, and 12 and 24 weeks after treatment completion. Current diagnosis of depression or other psychiatric diagnoses were obtained through chart review. Use of illicit drugs was measured by urine toxicology screening. Alcohol use was measured using the Addiction Severity Index–Lite. Results Of the 141 PWID infected with HCV, 24.1% had severe, 9.9% had moderate, 15.6% had mild, and 50.4% had minimal levels of depression as per BDI-II scores at baseline. HCV treatment was significantly associated with reductions in depressive symptoms that persisted long term, regardless of symptom severity (P  < .001) or presence of depression (P  ≤ .01) or other psychiatric diagnoses (P  ≤ .01) at baseline. Concurrent drug use (P  ≤ .001) or hazardous alcohol drinking (P  ≤ .001) did not interfere with reductions in depressive symptoms. Conclusions Depressive symptoms are highly prevalent among HCV-infected PWID. HCV treatment was associated with sustained reductions in depressive symptoms. HCV therapy with DAAs may have important implications for PWID that go beyond HCV cure. [ABSTRACT FROM AUTHOR]

This study evaluated health outcomes among people who inject drugs who are infected with hepatitis C virus using an artificial intelligence platform. Mean (SD) cumulative adherence (visual confirmation of administration) was 91.3% (10.5%). Most subjects (88.2%) achieved ≥80% adherence to treatment, and 88.2% (15 of 17) achieved a sustained virologic response. [ABSTRACT FROM AUTHOR]

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]

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]

Background: In some upper eyelid blepharoplasties, maximal skin removal may not result in desired outcomes; raising crease height can therefore be considered. Currently, there is no method to determine the amount of skin to be excised and/or crease elevation required to achieve a specific outcome.Objective: This study extrapolated an equation to determine amount of skin excision and/or lid crease elevation needed to achieve a specific eyelid margin to fold distance (MFD).Methods: This institutional review board-approved, HIPAA-compliant study was a prospective, nonrandomized clinical trial. Patients were included if aged 30 to 100 years old and underwent upper eyelid blepharoplasty with one surgeon between 2012 and 2014. Exclusion criteria were thyroid eye disease, myasthenia gravis, myotonic dystrophy, pregnancy, blepharoptosis, prior eyelid surgery or trauma, concurrent brow surgery, and topical alpha-agonists. The following data were collected preoperatively and at postoperative months 1 and 6: age, gender, BMI, brow position, MFD, margin to crease distance (distance between eyelid margin and crease, MCD), and vertical skin distance (distance between eyelid margin and brow, VSD).Results: A total 322 eyelids of 164 patients underwent 208 skin excisions, 26 crease elevations, and 88 combined skin excision and crease elevation. Age, gender, and BMI category were all nonsignificant and excluded from the final model. This equation was extrapolated with regression analysis: Change in MFD = -0.40 + (-0.28 × Change VSD) + (0.53 × Change MCD) with |R| = 0.28.Conclusion: To better predict and obtain desired upper eyelid blepharoplasty outcomes, the authors created an equation.Level Of Evidence4: [ABSTRACT FROM AUTHOR]

We measured hepatitis C virus (HCV) adherence via electronic blister packs for 145 people who inject drugs treated on-site in a methadone program. The overall sustained virologic response (SVR) rate was 96% (95% CI, 91%–98%), and overall daily adherence was 78% (95% CI, 76%–81%). Participants who achieved at least 50% adherence had an overall SVR rate of 99%, with each 5% adherence interval >50% achieving at least 90% adherence. Suboptimal adherence may still lead to cure in the direct-acting antiviral era. [ABSTRACT FROM AUTHOR]

We conducted a systematic review and meta-analysis to determine the yield household contact investigation of drug-resistant tuberculosis source cases. The pooled yield was 7.8% (95% CI, 5.6%–10.0%) for active tuberculosis and 47.2% (95 CI%, 30.0%–61.4%) for latent tuberculosis.Contact investigations among individuals living with drug-susceptible tuberculosis patients (source cases) have shown a high yield of tuberculosis disease and latent tuberculosis, but the yield of such investigations in households of drug-resistant tuberculosis source cases is unknown. In this systematic review and meta-analysis, we found 25 studies that evaluated a median of 111 (interquartile range, 21–302) household contacts of drug-resistant tuberculosis source cases. The pooled yield was 7.8% (95% CI, 5.6%–10.0%) for active tuberculosis and 47.2% (95% CI, 30.0%–61.4%) for latent tuberculosis, although there was significant statistical heterogeneity (P < .0001). More than 50% of secondary cases with drug susceptibility test results were concordant with those of the source case. Among studies that followed household members, the majority of secondary cases were detected within 1 year of the source case's diagnosis. Household contact investigation around drug-resistant tuberculosis patients is a high-yield intervention for detection of drug-resistant tuberculosis and prevention of ongoing transmission. [ABSTRACT FROM PUBLISHER]

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

Summary. An advantage of randomization tests for small samples is that an exact P -value can be computed under an additive model. A disadvantage with very small sample sizes is that the resulting discrete distribution for P -values can make it mathematically impossible for a P -value to attain a particular degree of significance. We investigate a distribution of P -values that arises when several thousand randomization tests are conducted simultaneously using small samples, a situation that arises with microarray gene expression data. We show that the distribution yields valuable information regarding groups of genes that are differentially expressed between two groups: a treatment group and a control group. This distribution helps to categorize genes with varying degrees of overlap of genetic expression values between the two groups, and it helps to quantify the degree of overlap by using the P -value from a randomization test. Moreover, a statistical test is available that compares the actual distribution of P -values with an expected distribution if there are no genes that are differentially expressed. We demonstrate the method and illustrate the results by using a microarray data set involving a cell line for rheumatoid arthritis. A small simulation study evaluates the effect that correlated gene expression levels could have on results from the analysis. [ABSTRACT FROM AUTHOR]

Discusses five published papers in the `Genetics Society of America,' pertaining to the evidence of linkage of body mass index (BMI) to the region of the human genome containing the OB gene, while presenting meta-analytic techniques that can be used under worst-case conditions. Reference to Lander and Kruglyak's (1995) theory for obtaining the raw data from each study and conducting a pooled analysis; Results and discussion.

Methods for the estimation of the effects of chronic disease risk factors on mortality continue to be an area that generates confusion and controversy. In response to the frequently observed U- or J-shaped relations between risk factors and mortality, some authors suggest that subjects dying during the first k years of follow-up (where k is some positive number less than the total length of follow-up) be excluded from statistical analyses. By excluded, the authors mean completely removed from the data set. The rationale is that persons dying during the first k years are likely to have a preexisting occult disease that confounds the relation between the risk factor under study and mortality. Excluding persons dying during the first k years of follow-up purportedly reduces this confounding. However, the authors are aware of no demonstration that this procedure effectively accomplishes its goal. They show that excluding subjects who die during the first k years of follow-up does not necessarily lead to a reduction in bias in the estimated effect of a risk factor on mortality when this relation is confounded by the presence of occult disease. Moreover, it is possible for such exclusion to exacerbate the confounding due to preexisting disease. Thus, excluding subjects dying during the first k years of follow-up is not necessarily an effective strategy for dealing with confounding due to occult disease. Investigators are encouraged to pursue alternative methods. [ABSTRACT FROM AUTHOR]

Numerous studies have documented a U- or J-shaped association between body mass index (BMI) (kg/m2) and mortality, such that increased mortality rate is associated with relatively low and high BMI values. It has been argued elsewhere that the elevated mortality rate observed at lower BMI values actually results from the effects of unmeasured confounding variables, in particular smoking status and preexisting disease. In this paper, the authors present an additional explanation for the phenomenon, i.e., nonspecific measurement. They propose that differential health consequences of fat mass and fat-free mass can be masked by the use of BMI when studied in relation to mortality. To illustrate this point, they use body composition data from 1,137 healthy adults and specify a hypothetical underlying BMI-mortality model in which the logit of death increased linearly with fat mass and decreased linearly with fat-free mass, and % fat increased monotonically with BMI. The results indicate that, even under these specifications, the authors can recover a U-shaped association between BMI and mortality. Consistent with previous suggestions in the literature, future epidemiologic studies that examine the association between adiposity and mortality should prioritize the use of body composition measures. Am J Epidemiol 1997;146:339-49. [ABSTRACT FROM AUTHOR]

In contrast to prior studies, mild malaria infection had no impact on HIV Viral Loads(VL) in Rwanda. Over fifty percent of patients prescribed ARV had detectable VL; 25% had genotypic resistance. Eleven percent of patients with mild malaria were newly diagnosed with HIV.Background. Plasmodium falciparum infection has been reported to increase human immunodeficiency virus (HIV) viral load (VL), which can facilitate HIV transmission. We prospectively studied the impact of mild P falciparum coinfection on HIV VL in Rwanda.Methods. We measured plasma HIV VL at presentation with malaria infection and weekly for 4 weeks after artemether-lumefantrine treatment in Rwandan adults infected with HIV with P falciparum malaria. Regression analyses were used to examine associations between malaria infection and HIV VL changes. Samples with detectable virus underwent genotypic drug-resistance testing.Results. We enrolled 28 HIV-malaria coinfected patients and observed 27 of them for 5 weeks. Three patients (11%) were newly diagnosed with HIV. Acute P falciparum infection had no significant effect on HIV VL slope over 28 days of follow-up. Ten patients with VL <40 copies/mL at enrollment maintained viral suppression throughout. Seventeen patients had a detectable VL at enrollment including 9 (53%) who reported 100% adherence to ARVs; 3 of these had detectable genotypic drug resistance.Conclusions. Unlike studies from highly malaria-endemic areas, we did not identify an effect of P falciparum infection on HIV VL; therefore, malaria is not likely to increase HIV-transmission risk in our setting. However, routine HIV testing should be offered to adults presenting with acute malaria in Rwanda. Most importantly, we identified a large percentage of patients with detectable HIV VL despite antiretroviral (ARV) therapy. Some of these patients had HIV genotypic drug resistance. Larger studies are needed to define the prevalence and factors associated with detectable HIV VL in patients prescribed ARVs in Rwanda. [ABSTRACT FROM PUBLISHER]