Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study.

BACKGROUND: Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs. METHODS: HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs). RESULTS: We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients. CONCLUSIONS: This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.

Study protocol for a systematic review of evidence for digital interventions for comorbid excessive drinking and depression in community-dwelling populations.

INTRODUCTION: Excessive drinking and depression are frequently comorbid and make a substantial contribution to the global non-communicable disease burden. A range of effective interventions and treatments exist for either excessive drinking or depression alone, including a positive emerging evidence base for the use of digital interventions. Computerised and/or smartphone delivered advice could provide flexible, coordinated support for patients with comorbid excessive drinking and depression. However, to date, no systematic review of the evidence has been conducted focused on the effectiveness of digital interventions for this specific comorbid population. This systematic review will identify and evaluate the effectiveness of digital interventions for reducing comorbid excessive drinking and depression in community-dwelling populations. METHODS AND ANALYSIS: We will search MEDLINE, The Cochrane Library, CENTRAL, CINAHL, PsycINFO, ERIC and SCI from inception to end of July 2019 for randomised controlled trials that evaluate any personalised digital intervention for comorbid excessive drinking and depression and published in any language. Primary outcomes will be changes in quantity of alcohol consumed and depressive symptoms. Screening, data extraction and risk of bias assessment will be undertaken independently by two reviewers, with disagreements resolved through discussion. Meta-analytic methods will be used to synthesise the data collected relating to the primary outcomes of interest. ETHICS AND DISSEMINATION: As a systematic review, ethical approval is not needed. Findings will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: CRD42019130134.

Non-prescribed use of opioid substitution medication: Patterns and trends in sub-populations of opioid users in Germany.

BACKGROUND: Non-prescribed use of opioid substitution medication (NPU) appears to represent a relevant source of opioids among European drug users. Little is known about the prevalence of NPU in Germany and possible differences between subgroups of opioid users. The present study examines NPU and other drug use patterns among drug consumption room (DCR) clients, opioid substituted DCR clients, and patients recruited in opioid substitution treatment (OST) practices. METHODS: Cross-sectional data was collected in 2011 from 842 opioid users in 10 DCRs and 12 OST practices across 11 German cities. Structured interviews comprised indicators for socio-demographics, health status, drug use, motives for NPU, and the availability and price of illicit substitution medication. Group differences were examined with one-way ANOVAs, chi-square tests, or t-tests, and factors for NPU were included in a multivariate model. Over-time comparisons were performed with similar data collected in 2008. RESULTS: Lifetime, 30-day and 24-h NPU prevalence for the total sample was 76.5%, 21.9%, and 9.3%, respectively, with methadone being the most frequently used substance. NPU, poly-drug use and injection drug use were more common among DCR clients, especially among DCR clients not in OST. The three groups featured distinct socio-demographic characteristics, with substituted patients being more socially integrated, while few differences in health parameters emerged. Motives for NPU were mostly related to potential shortcomings of OST, such as insufficient dosages, difficulties with transportation, and lack of access. NPU prevalence was found to be higher than in 2008, while injection rate of substitution medication was similarly low. Main factors associated with NPU were not being in OST, past 24-h use of other drugs, and younger age. CONCLUSION: Although diverted methadone or buprenorphine are rarely used as main drugs, NPU is prevalent among opioid users, particularly among DCR clients not in OST. OST reduces NPU if opioid users' needs are met.

Advanced analysis of free visual exploration patterns in schizophrenia.

BACKGROUND: Visual scanpath analyses provide important information about attention allocation and attention shifting during visual exploration of social situations. This study investigated whether patients with schizophrenia simply show restricted free visual exploration behavior reflected by reduced saccade frequency and increased fixation duration or whether patients use qualitatively different exploration strategies than healthy controls. METHODS: Scanpaths of 32 patients with schizophrenia and age-matched 33 healthy controls were assessed while participants freely explored six photos of daily life situations (20 s/photo) evaluated for cognitive complexity and emotional strain. Using fixation and saccade parameters, we compared temporal changes in exploration behavior, cluster analyses, attentional landscapes, and analyses of scanpath similarities between both groups. RESULTS: We found fewer fixation clusters, longer fixation durations within a cluster, fewer changes between clusters, and a greater increase of fixation duration over time in patients compared to controls. Scanpath patterns and attentional landscapes in patients also differed significantly from those of controls. Generally, cognitive complexity and emotional strain had significant effects on visual exploration behavior. This effect was similar in both groups as were physical properties of fixation locations. CONCLUSIONS: Longer attention allocation to a given feature in a scene and less attention shifts in patients suggest a more focal processing mode compared to a more ambient exploration strategy in controls. These visual exploration alterations were present in patients independently of cognitive complexity, emotional strain or physical properties of visual cues implying that they represent a rather general deficit. Despite this impairment, patients were able to adapt their scanning behavior to changes in cognitive complexity and emotional strain similar to controls.