Exceeding the guideline-recommended maximum daily dose of opioids for long-term treatment of non-cancer pain in Germany - a large retrospective observational study.

BACKGROUND: High-dose long-term opioid therapy (LTOT) has been associated with increased mortality and hospitalizations. Therefore, the evidence-based German guideline on LTOT for chronic non-cancer pain (CNCP) recommends to only exceed the maximum daily dose (MDD) of opioids in exceptional cases. This study aimed to determine the portion of LTOT patients who exceeded the guideline-recommended MDD and identify predictors of exceeding in administrative claims data. METHODS: The retrospective observational analysis of opioid prescriptions in patients receiving LTOT for CNCP was based on administrative claims by a large German statutory health insurance company. Patients with at least two quarters of opioid prescriptions between January 2018 and June 2019 were included and followed up for two years. Predictors were identified by logistic regression. In addition, the number of patients still in opioid therapy and the extent of exceeded MDDs were analyzed over time. RESULTS: The sample consisted of 113,475 patients. Overall, 10.5% of the patients exceeded the guideline-recommended MDD averaged over the observation period. Strong predictors for exceeding the MDD were receiving opioid prescriptions from > 7 physicians (OR = 7.66, p < .001), receiving predominantly strong opioids (OR = 6.79, p < .001) and receiving opioids for at least one year prior to inclusion (OR = 5.35, p < .001). Within the non-exceeding group, 28.1% discontinued opioid therapy. In contrast, 9.9% of patients in the exceeding group discontinued opioid therapy, whereas the vast majority remained on treatment until the end of the observation period. Furthermore, a slight increase in prescribed doses was observed over time. CONCLUSIONS: The results indicate that a moderate proportion of patients exceeded the guideline-recommended MDD. However, certain patient groups were more likely to receive high doses. This applied in particular to those who were already on treatment at the time of inclusion and continued to receive opioids until the end of the observation period. Further research should examine whether the continuous opioid therapy among the patients with exceeding the guideline-recommended MDD might be related to specific indications, a lack of therapeutic options or avoidance of withdrawal. TRIAL REGISTRATION: German Clinical Trials Register (drks.de/search/en). Identifier: DRKS00024854. Registered 28 April 2021.

Preferences for Living Arrangements in Dementia: A Discrete Choice Experiment.

BACKGROUND: Dementia affects about 55 million people worldwide. Demographic change and shifting lifestyles challenge the organization of dementia care. A discrete choice experiment (DCE) was conducted to elicit preferences for living arrangements in dementia in urban and rural regions of Germany. METHODS: Preliminary work included review of previous literature and focus groups. The DCE consists of seven attributes (group size, staff qualifications, organization of care, activities offered, support of religious practice, access to garden, consideration of food preferences) with three levels each. Individuals from the general population between the ages of 50 and 65 years were identified through population registration offices in three rural municipalities and one urban area, and 4390 individuals were approached via postal survey. A hierarchical Bayesian mixed logit model was estimated and interactions with sociodemographic characteristics were investigated. RESULTS: A total of 428 and 412 questionnaires were returned by rural and urban respondents, respectively. Access to a garden was perceived as the most important attribute (average importance 36.0% in the rural sample and 33.4% in the urban sample), followed by consideration of food preferences (15.8%, 17.8%), staff qualification (14.6%, 15.3%), care organization (11.4%, 12.3%), group size (12.2%, 11.1%), and range of activities (8.0%, 10.1%). The attribute relating to religious practice was given the least importance (2.1%, 0%). Preferences vary according to gender, age, religious beliefs, experience as an informal caregiver, and migrant background. CONCLUSION: Heterogeneous preferences for living arrangements for people with dementia were identified. The expansion of concepts with access to natural environments for persons with dementia might be a viable option for the formal care market in Germany. Further research is needed to meet the challenges of setting up and designing innovative living arrangements for people with dementia. Preferences vary by gender, age, religious beliefs, experience as an informal caregiver, and migrant background.

Prescription of Opioid Analgesics for Chronic Non-Cancer Pain in Germany despite Contraindications: Administrative Claims Data Analysis.

In Germany, long-term opioid treatment (L-TOT) for chronic non-tumor pain (CNTP) is discussed as not being performed according to the German guideline on L-TOT for CNTP. In the present analysis, the occurrence and predictors of inappropriate care/overuse in a cohort of German insureds with L-TOT for CNTP by the presence of a contraindication with concurrent opioid analgesic (OA) therapy were investigated. We also analyzed whether prescribing physicians themselves diagnosed a contraindication. The retrospective cohort study was based on administrative claims data from a German statutory health insurance. Eight contraindication groups were defined based on the German guideline. Logistic regressions were performed in order to identify predictors for OA prescriptions despite contraindications. The possible knowledge of the prescribing physician about the contraindication was approximated by analyzing concordant unique physician identification numbers of OA prescriptions and contraindication diagnoses. A total of 113,476 individuals (75% female) with a mean age of 72 years were included. The most common documented contraindications were primary headaches (8.7%), severe mood disorders (7.7%) and pain in somatoform disorders (4.5%). The logistic regressions identified a younger age, longer history of OA therapy, opioid related psychological problems, and outpatient psychosomatic primary care as positive predictors for all contraindication groups.

The PornLoS Treatment Program: Study protocol of a new psychotherapeutic approach for treating pornography use disorder.

Background: The introduction of Compulsive Sexual Behavior Disorder (CSBD) into the 11th International Classification of Diseases has raised expectations for better treatment options for CSBD. Furthermore, the treatment demand has increased, particularly for pornography use disorder (PUD), a subtype of CSBD. Presumably due to the easy access to Internet pornography an increasing prevalence of PUD is observed. Consequently, providing tailored and effective treatment is essential. Methods: This article provides an overview of the manualized short-term PornLoS Treatment Program (Pornografienutzungsstörung effektiv behandeln- Leben ohne Suchtdruck; translation: Treating pornography use disorder effectively - life without craving). The program combines 24 individual and 6 group psychotherapy sessions with an interdisciplinary approach by offering a novel treatment framework. This includes, e.g., a mobile app, establishment of self-help groups, and access to other social services such as couple counseling. The cognitive-behavioral treatment program contains interventions addressing psychoeducation, cue exposure, impulse control, cognitive restructuring, emotional regulation, and relapse management.We here also describe the study protocol of an ongoing four-arm randomized controlled trial. The aim is to test two variants of the PornLoS Treatment Program differing with respect to their treatment goal (abstinence or reduced pornography use) against cognitive-behavioral treatment as usual and against a waitlist control group. The primary outcome is the absence of a PUD diagnosis at the end of therapy. The total target sample size will comprise n = 316 patients with PUD across eight study sites. Results: The results will be presented at international conferences and published in a scientific peer-reviewed journal.

Evaluation criteria for health apps supporting medication adherence in early-stage technology development - a scoping review.

Introduction: Health apps offer an approach to improve the patients' management of their medication. Although the Digital Healthcare Act (DVG) has created a claim in the statutory health insurance (SHI), the large number of health apps available and their varying quality make it difficult for service providers and especially for medical laypersons to select an adequate high-quality medication app. Manufacturers need guidance for the development of high-quality apps right from the start. Various general evaluation concepts for health apps have been available to date. However, the requirements that should be met by healthcare depend largely on the field of application and the type of apps. This article aims to provide an overview of the international evidence on specific criteria for the evaluation of medication apps. Methods: Within the framework of a scoping review, a systematic search was conducted in PubMed and EMBASE on January 29, 2020. The search was limited to publications from 2007 onwards as well as to English and German articles. Additionally, a semi-systematic research of reference lists of the previously included articles as well as a structured search of websites of relevant stakeholders were conducted. Inclusion criteria were the following: the publication deals with health apps that can be used on smartphones and focus on supporting medication intake; the publication does not refer to evaluation criteria for a single app exclusively. The included publications were examined in a qualitative content analysis searching for evaluation criteria and categorizing them according to the framework criteria of the DVG and the Digital Health Applications Ordinance (DiGAV). Results: 2,542 articles were identified in the systematic search (999 in PubMed, 1,543 in EMBASE, 560 duplicates). A total of 16 studies met the inclusion criteria. The semi-systematic research and the structured search identified one further study. A catalog of criteria was developed based on the included 17 studies. This catalog covers the general topics "patient orientation" (data protection and security, consumer protection, user friendliness) and "quality/core functions of medication apps" (reminder, self-monitoring, (drug) information, motivation to change behavior, drug/patient safety, robustness) as well as "interoperability/cooperation". Due to its specific importance for medication apps, the subcategory "motivation for behavioral change" stands out beneath the general topic "quality/core functions of medication apps". This category aims to evaluate the design of individual functions with regard to their potential to actually change the behavior of app users. Discussion: The criteria for the evaluation of health apps mentioned in the DiGAV intersected with the criteria identified in the literature research. However, the area of positive health care effects was hardly covered by the included studies. In the development of the criteria catalog, it was not possible to weight the identified criteria. Therefore, the catalog should be understood as a supporting checklist for service providers, manufacturers, and/or users. Conclusions: A large variety of possible evaluation criteria for medication apps could be shown. Future research should focus on the possibilities of weighting these diverse evaluation criteria, using not only clinical studies but also methods to identify preferences.

Efficacy of a short-term webcam-based telemedicine treatment of internet use disorders (OMPRIS): a multicentre, prospective, single-blind, randomised, clinical trial.

Background: Evidence-based treatments for internet use disorders (IUDs) are limited, and online therapy approaches are poorly studied. We investigated the efficacy of a manualised therapist-guided online intervention (OMPRIS) to reduce IUD symptoms and improve psychological well-being. Methods: In this multicentre, two-arm, single-blinded trial, individuals ≥16 years suffering from IUD symptoms were recruited in Germany from August 16, 2020, to March 11, 2022, through media advertisements and healthcare providers. Participants were randomly allocated by sequential balancing randomisation (1:1) to either the manualised webcam-based OMPRIS intervention or a waitlist control (WLC) group. OMPRIS provided strategies from motivational interviewing, behavioural therapy, and social counselling. The primary outcome at the end of treatment was a reduction in IUD symptoms as measured by the Assessment of Internet and Computer Scale (AICA-S). Follow-up assessments were conducted at 6 weeks and 6 months. Analyses were performed in the intention-to-treat population. This trial was registered (German Clinical Trial Register, DRKS00019925) and has been completed. Findings: A total of 180 individuals were randomly assigned to the OMPRIS intervention (n = 89) or WLC (n = 91) arm. After treatment, 81 (91.0%) participants in the OMPRIS intervention group and 88 (96.7%) in the WLC group completed the outcome assessment. The ANCOVA model showed that OMPRIS participants had a significantly greater reduction in AICA-S scores from baseline (mean score 12.1 [SD 4.6]) to post-treatment (6.8 [5.2]) than those in the WLC group (from 12.6 [5.1] to 11.0 [5.4]; estimated mean difference -3.9; [95% CI -5.2 to -2.6]; p < 0.0001; d = 0.92). No adverse events were reported to the trial team. Interpretation: Webcam-based OMPRIS therapy was effective and superior to waiting list conditions in reducing IUD symptoms. Webcam-based, specialised online therapy thus increases IUD treatment options. Funding: German Innovation Fund of Germany's Federal Joint Committee (G-BA), grant number 01VSF18043.

Health Economic Evaluation of an Online-Based Motivational Program to Reduce Problematic Media Use and Promote Treatment Motivation for Internet Use Disorder-Results of the OMPRIS Study.

Internet Use Disorders (IUD) have a relevant effect on national economies. In the randomized, controlled, multicenter, prospective, and single-blinded OMPRIS study (pre-registration number DRKS00019925; Innovation Fund of the Joint Federal Committee of Germany, grant number 01VSF18043), a four-week online program to reduce media addiction symptoms, was evaluated for cost-effectiveness. The intervention group (IG) was compared to a waiting control group (WCG) from German statutory health insurance (SHI) and a societal perspective. Resource use, namely indirect and direct (non) medical costs, was assessed by a standardized questionnaire at baseline and after the intervention. Additionally, intervention costs were calculated. Determining the Reliable Change Index (RCI) based on the primary outcome, assessed by the "Scale for the Assessment of Internet and Computer Game Addiction" (AICA-S), individuals with and without reliable change (RC) were distinguished. The incremental cost-effectiveness ratio was calculated using the difference-in-difference approach. There were 169 (IG n = 81, WCG n = 88) persons included in the analysis. The mean age was 31.9 (SD 12.1) years. A total of 75.1% were male, and 1.8% diverse. A total of 65% (IG) and 27% (WCG) had an RC. The cost per person with RC was about EUR 860 (SHI) and EUR 1110 (society). The intervention leads to an improvement of media addiction symptoms at moderate additional costs.

Methodological guidance for rapid reviews in healthcare: A scoping review.

The aim of the present work was to identify published methodological guidance for rapid reviews (RRs) and to analyze the recommendations with regard to time-saving measures. A literature search was performed in PubMed and EMBASE in November 2020. In addition, a search based on Google Scholar and websites of governmental and non-governmental organizations was conducted. Literature screening was carried out by two researchers independently. A total of 34 publications were included. These describe 38 distinct RR types. The timeframe to complete the identified RR types ranges from 24 h to 6 months (mean time 2.2 months). For most RR types a specific research question (n = 21) and a prioritizing search (n = 25; preference for e.g., systematic reviews and meta-analyses) is employed. Different approaches such as reduced personnel in literature screening (n = 21) and data extraction (n = 21) are recommended. The majority of RR types include a bias assessment (n = 28) and suggest a narrative report focusing on safety and efficacy. The included RR types are heterogeneous in terms of completion time, considered domains and strategies to alter the standard systematic review methods. A rationale for the recommended shortcuts is rarely presented.

How effective and how expensive are interventions to reduce sedentary behavior? An umbrella review and meta-analysis.

A reduction in sedentary behavior (SB) can contribute to the prevention of chronic diseases. This is the first umbrella review that summarizes the effectiveness and monetary costs of different types of interventions to reduce SB across all age groups and populations in different settings. We comprehensively searched seven databases for systematic reviews and meta-analyses and conducted an umbrella review of the effects of interventions to reduce SB. Additionally, we performed a meta-analysis of primary studies included in the umbrella review. Furthermore, we analyzed health economic aspects of interventions to reduce SB. We included 40 systematic reviews in our umbrella review, with 136 primary studies suitable for further meta-analyses. We found that interventions targeting the physical environment reduce SB most effectively in the majority of populations and settings. Workplace interventions reduced SB by -89.83 min/day (95% CI -124.58 to -55.09; p ≤ 0.0001). Twenty-two of 169 primary studies (13.0%) contained health economic information. The intervention costs per participant ranged from €0 to €3587. Our findings demonstrate that physical environment interventions most effectively reduce SB in a majority of populations and settings. Health economic information was reported in few studies and was mostly restricted to acquisition costs.