Since 2015 slow-release oral morphine (SROM) is approved for opioid substitution treatment (OST) in Germany. The SROMOS study (efficacy and tolerability of slow-release oral morphine in opioid ...substitution treatment) evaluates the efficacy and safety of SROM in routine care. This article describes the switching process from racemic methadone, levomethadone and buprenorphine to SROM.
Between July 2016 and November 2017 180 patients in 23 study centers in Germany were included in the prospective, non-interventional, naturalistic observational study. Patients were already in OST and switched from a previous medication to SROM. The switching process was analyzed during a period of fourteen days.
Data were available for 169 participants. The switching process had a different progression depending on premedication and pre dosage. On the fourteenth day of SROM treatment patients switched from racemic methadone took an average dosage of 922.2 mg/day, from levomethadone 801.0 mg/day and from buprenorphine 626.7 mg/day. Average conversion ratio racemic methadone to SROM was 1:11.8, levomethadone to SROM 1:17.4 and buprenorphine to SROM 1:58.0.
This study provides the first data on the switching process from buprenorphine to SROM. Average dose ratio racemic methadone to SROM on the fourteenth day of treatment was considerably higher than recommended in the prescribing information.
Although many individuals with alcohol dependence (AD) are recognized in the German healthcare system, only a few utilize addiction-specific treatment services. Those who enter treatment are not well ...characterized regarding their prospective pathways through the highly fragmented German healthcare system. This paper aims to (1) identify typical care pathways of patients with AD and their adherence to treatment guidelines and (2) explore the characteristics of these patients using routine data from different healthcare sectors.
We linked routinely collected register data of individuals with a documented alcohol-related diagnosis in the federal state of Bremen, Germany, in 2016/2017 and their addiction-specific health care: two statutory health insurance funds (outpatient pharmacotherapy for relapse prevention and inpatient episodes due to AD with and without qualified withdrawal treatment (QWT)), the German Pension Insurance (rehabilitation treatment) and a group of communal hospitals (outpatient addiction care). Individual care pathways of five different daily states of utilized addiction-specific treatment following an index inpatient admission due to AD were analyzed using state sequence analysis and cluster analysis. The follow-up time was 307 days (10 months). Individuals of the clustered pathways were compared concerning current treatment recommendations (1: QWT followed by postacute treatment; 2: time between QWT and rehabilitation). Patients' characteristics not considered during the cluster analysis (sex, age, nationality, comorbidity, and outpatient addiction care) were then compared using a multinomial logistic regression.
The analysis of 518 individual sequences resulted in the identification of four pathway clusters differing in their utilization of acute and postacute treatment. Most did not utilize subsequent addiction-specific treatment after their index inpatient episode (n = 276) or had several inpatient episodes or QWT without postacute treatment (n = 205). Two small clusters contained pathways either starting rehabilitation (n = 26) or pharmacotherapy after the index episode (n = 11). Overall, only 9.3% utilized postacute treatment as recommended.
A concern besides the generally low utilization of addiction-specific treatment is the implementation of postacute treatments for individuals after QWT.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Hepatitis C virus (HCV) infection is highly prevalent among people who inject drugs (PWID). Accurate data on HCV prevalence and incidence rates among patients receiving opioid substitution treatment ...(OST) are needed to estimate the current and future burden of HCV infections in this high-risk population.
Baseline data from routine care were collected between October 2014 and June 2016 from randomly selected OST facilities in Germany. The primary outcome measure was the HCV status (antibody and RNA prevalence). Patients who were HCV antibody-negative at baseline were followed up after 12 months to calculate the HCV incidence rate.
Sixty-three facilities from 14 German Federal States provided clinical data for a total of 2466 OST patients. HCV antibody and HCV RNA prevalence were 58.8% (95% confidence interval CI, 56.8%-60.8%) and 27.3% (95% CI, 25.5%-29.2%), respectively. At baseline, a total of 528 patients (21.4%) had previously undergone antiviral treatment. Moreover, lower HCV RNA prevalence was associated with female gender, employment, younger age, and shorter duration of OST and opioid dependence. The HCV incidence rate was 2.5 cases per 100 person-years.
The low HCV RNA prevalence and HCV incidence rates confirm that OST in Germany is an effective setting both for treating chronic HCV infections and for preventing new infections among PWID. Scaling up the provision of OST, HCV testing, and HCV treatment among OST patients are important public health strategies for reducing HCV infections in this high-risk population.
In Germany, most individuals with alcohol dependence are recognized by the health care system and about 16% per year receive addiction-specific care. This paper aimed to analyze the prevalence and ...treatment utilization rate of people with alcohol dependence by type of addiction-specific care in the federal state of Bremen using routine and survey data.
The number of individuals with alcohol dependence was estimated using data from the 2018 Epidemiological Survey of Substance Abuse (ESA). Furthermore, linked routine data of two statutory health insurances (SHIs), the German pension insurance (GPI), and the communal hospital group Gesundheit Nord - Bremen Hospital Group (GeNo), from 2016/2017, were analyzed. Based on SHI data, the administrative prevalence of various alcohol-related diagnoses according to the International Classification of Diseases (ICD-10), in various treatment settings, was extrapolated to the total population of Bremen. Based on all routine data sources, treatment and care services for individuals with alcohol dependence were also extrapolated to Bremen's total population. Care services included outpatient addiction care visits and addiction-specific treatments, i.e., qualified withdrawal treatment (QWT), outpatient pharmacotherapy as relapse prevention, and rehabilitation treatment.
Of the survey-estimated 15,792 individuals with alcohol dependence in Bremen, 72.4% (
= 11,427) had a diagnosis documented with an ICD-10 code for alcohol dependence (F10.2) or withdrawal state (F10.3-4). One in 10 individuals with alcohol dependence (
= 1,577) used one or more addiction-specific care services during the observation period. Specifically, 3.7% (
= 675) received outpatient addiction care, 3.9% (
= 736) initiated QWT, 0.8% (
= 133) received pharmacotherapy, and 2.6% (
= 405) underwent rehabilitation treatment. The share of seeking addiction-specific treatment after diagnosis was highest among younger and male patients.
Although more than half of the individuals with alcohol dependence are documented in the health system, utilization rates of addiction-specific treatments are low. These low utilization rates suggest that there are existing barriers to transferring patients with alcohol dependence into addiction-specific care. Strengthening primary medical care provision in dealing with alcohol-related disorders and improving networking within the addiction support system appear to be particularly appropriate.
Knowledge of health-related quality of life (HRQOL) of patients receiving opioid substitution treatment (OST) is limited and fragmented. The present study examines the HRQOL of a large national ...sample of OST patients in Germany and sociodemographic and clinical correlates.
Cross-sectional data on the HRQOL of 2176 OST patients was compared with German general population norms. Patients were recruited from 63 OST practices across Germany. To identify correlates of HRQOL, as measured with the SF-12, we performed bi- and multivariate analyses with sociodemographic and clinical variables, including patient- and clinician-reported outcomes on physical and mental health.
Patients' HRQOL was significantly poorer than in the general population, especially their mental HRQOL. Factors associated with lower physical HRQOL were older age, longer duration of opioid dependence, hepatitis C virus infection, and HIV infection. Benzodiazepine use was associated with lower mental HRQOL, and amphetamine use with higher physical HRQOL, compared to non-use of these substances. For both mental and physical HRQOL, the factor with the strongest positive association was employment and the factors with the strongest negative associations were physical and mental health symptom severity, psychiatric diagnosis, and psychopharmacological medication.
Compared to the general population, we found substantially lower HRQOL in OST patients, especially in their mental HRQOL. OST programs can benefit from further improvement, particularly with regard to mental health services, in order to better serve their patients' needs. Clinicians may consider the use of patient-reported outcome measures to identify patients' subjective physical and psychological needs. Further research is needed to determine if employment is a cause or consequence of improved HRQOL.
ClinicalTrials.gov: NCT02395198 , retrospectively registered 16/03/2015.
Background:Use of cocaine is widespread and associated with several cardiovascular diseases. Recent CMR studies indicate frequent myocardial scar/fibrosis in asymptomatic cocaine abusers (CA).Methods ...and Results:This study used a combination of advanced CMR tissue characterization techniques, including late gadolinium enhancement (LGE) for focal, and extracellular volume (ECV) imaging for diffuse myocardial injury/fibrosis, with circulating biomarkers for a comprehensive characterization of myocardial injury. We included 20 cardiac asymptomatic CA and a control group of 20 healthy volunteers. The comprehensive assessment included physical examination, resting ECG, exercise ECG, cardiac biomarkers, transthoracic echocardiogram and CMR. We did not find significant differences between CA and controls either in functional CMR parameters such as LVEDVi, LVESVi, LVEF, LV mass index, or in global myocardial ECV. Neither CA nor controls had evidence of myocardial edema on T2-weighted CMR, but 8 CA (40%), and none of the controls had focal myocardial scar (P<0.01). Interestingly, CA with focal myocardial scar on LGE had significantly higher high-sensitivity troponin I (hs-TNI) compared with CA without focal scar (median, 1.7 ng/L; IQR, 1.3–2.5 ng/L vs. 0.6 ng/L; 0.4–1.3 ng/L; P<0.01).Conclusions:Focal myocardial injury in terms of subtle LGE in 40% of asymptomatic CA was associated with higher hs-TNI. Comprehensive assessment including advanced ECV imaging indicates a focal rather than diffuse pattern of myocardial involvement in asymptomatic CA.
Opioid Use Disorder (OUD) is a substance use disorder with a chronic course associated with comorbid mental and somatic disorders, a high burden of psychosocial problems and opioid maintenance ...treatment (OMT) as a standard treatment. In the US, OUD imposes a significant economic burden on society, with annual societal costs estimated at over 55 billion dollars. Surprisingly, in Europe and especially in Germany, there is currently no detailed information on the healthcare costs of patients with OUD. The goal of the present research is to gather cost information about OUD patients in OMT with a focus on maintenance medication and relapses.
We analysed health claims data of four million persons covered by statutory health insurance in Germany, applying a cost-of-illness approach and aimed at examining the direct costs of OMT patients in Germany. Patients with an ICD-10 code F11.2 and at least one claim of an OMT medication were stratified into the treatment groups buprenorphine, methadone or levomethadone, based on the first prescription in each of the follow-up years. Costs were stratified for years with and without relapses. Group comparisons were performed with ANOVA.
We analysed 3165 patient years, the total annual sickness funds costs were on average 7470 € per year and patient. Comparing costs of levomethadone (8400 €, SD: 11,080 €), methadone (7090 €, SD: 10,900 €) and buprenorphine (6670 €, SD: 7430 €) revealed significant lower costs of buprenorphine compared to levomethadone (p < 0.0001). In years with relapses, costs were higher than in years without relapses (8178 € vs 7409 €; SD: 11,622, resp. 10,378 €). In years with relapses, hospital costs were the major cost driver.
The present study shows the costs of OUD patients in OMT for the first time with a German dataset. Healthcare costs for patients with an OUD in OMT are associated with more than two times the cost of an average German patients. Preventing relapses might have significant impact on costs. Patients in different OMT were dissimilar which may have affected the cost differences.
In the implementation of placement matching guidelines, feasibility has been concerned in previous research. Objectives of this process evaluation were to investigate whether the patient-centered ...matching guidelines (PCPM) are consistently applied in referral decision-making from an inpatient qualified withdrawal program to a level of care in aftercare, which factors affect whether patients actually receive matched aftercare according to PCPM, and whether its use is feasible and accepted by clinic staff.
The study was conducted as process evaluation within an exploratory randomized controlled trial in four German psychiatric clinics offering a 7-to-21 day qualified withdrawal program for patients suffering from alcohol dependence, and with measurements taken during detoxification treatment and six months after the initial assessment. PCPM were used with patients in the intervention group by feeding back to them a recommendation for a level of care in aftercare that had been calculated from Measurements in the Addictions for Triage and Evaluation (MATE) and discussed with the staff on the treatment unit. As measurements, The MATE, the Client Socio-Demographic and Service Receipt Inventory-European Version, a documentation form, the Control Preference Scale, and the Motivation for Treatment Scale were administered. A workshop for the staff at the participating trial sites was conducted after data collection was finished.
Among 250 patients participating in the study, 165 were interviewed at follow-up, and 125 had received aftercare. Although consistency in the application of PCPM was moderate to substantial within the qualified withdrawal program (Cohen's kappa ≥ .41), it was fair from discharge to follow-up. In multifactorial multinomial regression, the number of foregoing substance abuse treatments predicted whether patients received more likely undermatched (Odds Ratio=1.27; p=.018) or overmatched (Odds Ratio=0.78; p=.054) treatment. While the implementation process during the study was evaluated critically by the staff, they stated a potential of quality assurance, more transparency and patient-centeredness in the use of PCPM.
While the use of PCPM has the potential to enhance the quality of referral decision making within treatment, it may not be sufficient to determine referral decisions for aftercare.
German Clinical Trials Register DRKS00005035 . Registered 03/06/2013.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background:
Over the past 15 years, comparative assessments of psychoactive substance harms to both users and others have been compiled by addiction experts. None of these rankings however have ...included synthetic cannabinoids or non-opioid prescription analgesics (NOAs, e.g., gabapentinoids) despite evidence of increasing recreational use. We present here an updated assessment by German addiction medicine experts, considering changing Western consumption trends–including those of NOAs.
Methods:
In an initial survey, 101 German addiction medicine physicians evaluated both physical and psychosocial harms (in 5 dimensions) of 33 psychoactive substances including opioids and NOAs, to both users and others. In a second survey, 36 addiction medicine physicians estimated the relative weight of each health and social harm dimension to determine the overall harm rank of an individual substance. We compared our ranking with the most recent European assessment from 2014.
Results:
Illicit drugs such as methamphetamine, heroin, cocaine and also alcohol were judged particularly harmful, and new psychoactive drugs (cathinones, synthetic cannabinoids) were ranked among the most harmful substances. Cannabis was ranked in the midrange, on par with benzodiazepines and ketamine—somewhat more favorable compared to the last European survey. Prescribed drugs including opioids (in contrast to the USA, Canada, and Australia) were judged less harmful. NOAs were at the bottom end of the ranking.
Conclusion:
In Germany, alcohol and illicit drugs (including new psychoactive substances) continue to rank among the most harmful addictive substances in contrast to prescribed agents including opioid analgesics and NOAs. Current laws are incongruent with these harm rankings. This study is the first of its kind to include comparative harm rankings of several novel abused substances, both licit/prescribed and illicit.
Abstract
Background
Home treatment (HT) is a treatment modality for patients with severe mental illness (SMI) in acute mental crises. It is frequently considered equivalent to psychiatric inpatient ...treatment in terms of treatment outcome. Peer Support (PS) means that people with lived experience of a mental illness are trained to support others on their way towards recovery. While PS is growing in international importance and despite a growing number of studies supporting its benefits, it is still not comprehensively implemented into routine care. The HoPe (Home Treatment with Peer Support) study investigates a combination of both – HT and PS – to provide further evidence for a recovery-oriented treatment of psychiatric patients.
Methods
In our randomized controlled trial (RCT), HT with PS is compared with HT without PS within a network of eight psychiatric clinical centers from the North, South and East of Germany. We investigate the effects of a combination of both approaches with respect to the prevention of relapse/recurrence defined as first hospitalization after randomization (primary outcome), disease severity, general functioning, self-efficacy, psychosocial health, stigma resistance, recovery support, and service satisfaction (secondary outcomes). A sample of 286 patients will be assessed at baseline after admission to HT care (data point t
0
) and randomized into the intervention (HT + PS) and control arm (HT). Follow-Up assessments will be conducted 2, 6 and 12 months after admission (resulting in three further data points, t
1
to t
3
) and will be analyzed via intention-to-treat approach.
Discussion
This study may determine the positive effects of PS added to HT, prove additional evidence for the efficacy of PS and thereby facilitate its further implementation into psychiatric settings. The aim is to improve quality of mental health care and patients’ recovery as well as to reduce the risk of relapses and hospitalizations for patients with SMI.
Trial registration
The trial is registered with ClinicalTrials.gov:
NCT04336527
, April 7, 2020.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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