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.

Internet-Based Self-Assessment for Symptoms of Internet Use Disorder-Impact of Gender, Social Aspects, and Symptom Severity: German Cross-sectional Study.

BACKGROUND: Internet use disorder (IUD) is a new type of behavioral addiction in the digital age. At the same time, internet applications and eHealth can also provide useful support in medical treatment. OBJECTIVE: The purpose of this study is to examine if an internet-based eHealth service can reach individuals with IUD. In particular, it should be investigated whether both male and female individuals with more severe IUDs can be reached. METHODS: Data were retrieved from the OMPRIS (online-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and internet use disorder) project (DRKS00019925), an internet-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and IUD. During the recruitment process (August 2020-March 2022), a total of 3007 individuals filled out the standardized scale for the assessment of internet and computer game addiction (AICA-S). The assessment was accessible via the project homepage. There was no preselection of participants at this stage of the study; however, the offer was addressed to people with hazardous internet use and IUDs. The web-based assessment was free and could be found via search engines, but attention was also drawn to the service via newspaper articles, radio reports, and podcasts. RESULTS: Out of 3007 who participated in the web-based self-assessment, 1033 (34.4%) are female, 1740 (57.9%) are male, 67 (2.2%) are diverse individuals, and 167 (5.5%) did not disclose their gender. The IUD symptom severity score showed a wide range between the AICA-S extreme values of 0 and 27 points. On average, the total sample (mean 8.19, SD 5.47) was in the range of hazardous IUD behavior (AICA-S cutoff>7.0). Furthermore, 561 individuals (18.7% of the total sample; mean 17.42, SD 3.38) presented severe IUD (AICA-S cutoff>13.5). Focusing on female and male participants, 20.9% (363/1740) of the men and 14.9% (151/1033) of the women scored above 13.5 points, which can be considered pathological IUD behavior (χ22,2773=16.73, P<.001, effect size: Cramér V=0.078). Unemployment, being in vocational training or studying at a university, and being male were significantly associated with high IUD symptoms. CONCLUSIONS: Using a large sample, the study showed that both mildly and severely IUD-affected individuals can be reached via the internet. An internet-based eHealth offer can thus be a good way to reach patients with IUD where they are addicted-on the internet. In addition, eHealth services increase the likelihood of reaching female patients, who hardly ever come to specialized outpatient clinics and hospitals. Since social problems, especially unemployment, have a strong association with disease severity, the integration of social counseling into treatment seems advisable in terms of a multidisciplinary approach. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00019925; https://drks.de/search/de/trial/DRKS00019925.

Seroconversion rate and socio-economic and ethnic risk factors for SARS-CoV-2 infection in children in a population-based cohort, Germany, June 2020 to February 2021.

IntroductionSocio-economic and ethnic background have been discussed as possible risk factors for SARS-CoV-2 infections in children. Improved knowledge could lead to tailored prevention strategies and help improve infection control.AimWe aimed to identify risk factors for SARS-CoV-2 infections in children in the first and second wave of the pandemic.MethodsWe performed an observational population-based cohort study in children (6 months-18 years) scheduled for legally required preventive examination and their parents in a metropolitan region in Germany. Primary endpoint was the SARS-CoV-2 seroconversion rate during the study period. Risk factors assessed included age, pre-existing medical conditions, socio-economic factors and ethnicity.ResultsWe included 2,124 children and their parents. Seroconversion rates among children in all age groups increased 3-4-fold from June 2020 to February 2021. Only 24 of 58 (41%) seropositive children reported symptoms. In 51% of infected children, at least one parent was also SARS-CoV-2-positive. Low level of parental education (OR = 3.13; 95% CI: 0.72-13.69) non-significantly increased the risk of infection. Of the total cohort, 38.5% had a migration background, 9% of Turkish and 5% of Middle Eastern origin, and had the highest risk for SARS-CoV-2 infections (OR = 6.24; 95% CI: 1.38-28.12 and OR = 6.44 (95% CI: 1.14-36.45) after adjustment for other risk factors.ConclusionIn the second half of 2020, seroprevalence for SARS-CoV-2 in children increased especially in families with lower-socioeconomic status. Culture-sensitive approaches are essential to limit transmission and could serve as a blueprint for vaccination strategies.

Assessment of Early Therapy Response of Non-Hodgkin's and Hodgkin's Lymphoma Using B-Mode Ultrasound and Dynamic Contrast-Enhanced Ultrasound.

OBJECTIVES: Here we asked, whether contrast enhanced ultrasound (CEUS) enables to judge early treatment response in malignant lymphoma as a potential guidance for further treatment. METHODS: From May 2017 to May 2018, 21 patients with histologically confirmed diagnosis of lymphoma were examined by B-mode ultrasound (B-US) and CEUS at fixed early time points after commencing therapy (days [d] 0, 15 and 30 after therapy start) and contrast enhancement patterns in target lymphoma lesions were quantified using Bracco-VUE Box® (DCE-US). To estimate the potential value of CEUS-enhancement patterns for early response prediction, patients were grouped according to their best achieved actual response into complete remission (CR) patients, partial remission (PR) patients or progressive disease (PD) patients. RESULTS: Between d0, d15 and d30, CR-patients showed a median lymphoma shrinking by 34% in B-US. PD-patients experienced a median lymphoma size reduction by 44% on day 15, but lymphoma mass again increased by 20% between d15 and d30. In contrast, the median CEUS enhancement intensity, as assessed by the area under the curve (AUC) was increasing at d15 in CR and PD patients (CR to 152%, PD: to 126%), but decreased at d30 to 14% in CR patients and 22% in PD patients. CONCLUSIONS: While early response assessment using B-US might be useful to predict treatment response in lymphoma, CEUS and DCE-US-although often feasible-do not provide additional value in this regard.

Quality Assurance Measures and Mortality After Stroke.

BACKGROUND: Quality assurance for acute in-hospital care in Germany is based on compulsory comparisons between institutions, so-called external quality assurance (EQA). The effectiveness of EQA has not yet been adequately studied. The purpose of the QUASCH project, which is supported by the Innovation Fund of the Federal Joint Committee, is to investigate the association between EQA and health care outcomes, specifically with respect to stroke. METHODS: The analyses were based on data from 379 825 patients insured by the AOK health insurance fund who were acutely admitted to a hospital because of stroke over the period 2007-2017. Data on 47 659 patients were derived from EQA documentation in the state of Hesse, in which stroke EQA had already been introduced in 2003; data on the remaining 332 166 patients were from other federal states, where 117 734 of these patients had been treated under EQA conditions. The association of EQA with mortality over the period of observation was analyzed by multivariate Cox regression, with the following covariates: age, sex, comorbidities, time period of occurrence, nursing care level, type of stroke, socio-economic deprivation in the region of origin, and treatment in a stroke unit. RESULTS: Compared to treatment without EQA, mortality risk under EQA in the state of Hesse was significantly lower (hazard ratio [HR]: 0.93; 95% confidence interval: [0.92; 0.95]). The reduction in mortality risk with EQA was somewhat lower in the other federal states (HR: 0.96 [0.95; 0.97]). Treatment in a stroke unit was associated with a mortality risk that was lower still (HR: 0.86 [0.85; 0.87]). Mortality risk rose with age, comorbidities, and need for nursing care; it was lower in women and in persons whose stroke occurred in a later period. CONCLUSION: Quality assurance measures are associated with lower mortality risk after stroke. The concentration of care in specially qualified institutions is associated with stronger effects than EQA alone.

Effectiveness of the application of an electronic medication management support system in patients with polypharmacy in general practice: a study protocol of cluster-randomised controlled trial (AdAM).

INTRODUCTION: Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy. METHODS AND ANALYSIS: Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. SCOPE: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. POPULATION: patients (≥18 years) with polypharmacy (≥5 prescriptions). SAMPLE SIZE: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. INTERVENTION: complex intervention eMMa. FOLLOW-UP: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. OUTCOMES: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. STATISTICAL ANALYSIS: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints. ETHICS AND DISSEMINATION: Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences. TRIAL REGISTRATION: NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).

Nurse-led care versus physician-led care in the management of rheumatoid arthritis and psoriatic arthritis (StaerkeR): study protocol for a multi-center randomized controlled trial.

BACKGROUND: In Germany, the care of patients with inflammatory arthritis could be improved. Although specialized rheumatology nurses could take over substantial aspects of patient care, this hardly occurs in Germany. Thus, the aim of the study is to examine structured nursing consultation in rheumatology practices. METHODS/DESIGN: In total, 800 patients with a stable course of rheumatoid arthritis or psoriatic arthritis in 20 centers in North Rhine-Westphalia and Lower Saxony will be randomized to either nurse-led care or standard care. Participating nurses will study for a special qualification in rheumatology and trial-specific issues. It is hypothesized that nurse-led care is non-inferior to standard care provided by rheumatologists with regard to a reduction of disease activity (DAS28) while it is hypothesized to be superior regarding changes in health-related quality of life (EQ-5D-5L) after 1 year. Secondary outcomes include functional capacity, patient satisfaction with treatment, and resource consumption. DISCUSSION: Since there is insufficient care of rheumatology patients in Germany, the study may be able to suggest improvements. Nurse-led care has the potential to provide more efficient and effective patient care. This includes a more stringent implementation of the treat-to-target concept, which may lead to a higher percentage of patients reaching their treatment targets, thereby improving patient-related outcomes, such as quality of life, functional capacity, and participation. Additionally, nurse-led care may be highly cost-effective. Finally, this project may form the basis for a sustainable implementation of nurse-led care in standard rheumatology care in Germany. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00015526. Registered on 11 January 2019.

Day-patient treatment after short inpatient care versus continued inpatient treatment in adolescents with anorexia nervosa (ANDI): a multicentre, randomised, open-label, non-inferiority trial.

BACKGROUND: In-patient treatment (IP) is the treatment setting of choice for moderately-to-severely ill adolescents with anorexia nervosa, but it is costly, and the risks of relapse and readmissions are high. Day patient treatment (DP) is less expensive and might avoid problems of relapse and readmission by easing the transition from hospital to home. We investigated the safety and efficacy of DP after short inpatient care compared with continued IP. METHODS: For this multicentre, randomised, open-label, non-inferiority trial, we enrolled female patients (aged 11-18 years) with anorexia nervosa from six centres in Germany. Patients were eligible if they had a body-mass index (BMI) below the tenth percentile and it was their first admission to hospital for anorexia nervosa. We used a computer-generated randomisation sequence to randomly assign patients to continued IP or DP after 3 weeks of inpatient care (1:1; stratified for age and BMI at admission). The treatment programme and treatment intensity in both study groups were identical. The primary outcome was the increase in BMI between the time of admission and a 12-month follow-up adjusted for age and duration of illness (non-inferiority margin of 0·75 kg/m(2)). Analysis was done by modified intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number Register, number ISRCTN67783402, and the Deutsches Register Klinischer Studien, number DRKS00000101. FINDINGS: Between Feb 2, 2007, to April 27, 2010, we screened 660 patients for eligibility, 172 of whom we randomly allocated to treatment: 85 to IP and 87 to DP. DP was non-inferior to IP with respect to the primary outcome, BMI at the 12-month follow-up (mean difference 0·46 kg/m(2) in favour of DP (95% CI, -0·11 to 1·02; pnon-inferiority<0·0001). The number of treatment-related serious adverse events was similar in both study groups (eight in the IP group, seven in the DP group). Three serious adverse events in the IP group and two in the DP group were related to suicidal ideation; one patient in the DP attempted suicide 3 months after she was discharged. INTERPRETATION: DP after short inpatient care in adolescent patients with non-chronic anorexia nervosa seems no less effective than IP for weight restoration and maintenance during the first year after admission. Thus, DP might be a safe and less costly alternative to IP. Our results justify the broad implementation of this approach. FUNDING: German Ministry for Education and Research.

Objective assessment, repeatability, and agreement of shoulder ROM with a 3D gyroscope.

BACKGROUND: Assessment of shoulder mobility is essential for diagnosis and clinical follow-up of shoulder diseases. Only a few highly sophisticated instruments for objective measurements of shoulder mobility are available. The recently introduced DynaPort MiniMod TriGyro ShoulderTest-System (DP) was validated earlier in laboratory trials. We aimed to assess the precision (repeatability) and agreement of this instrument in human subjects, as compared to the conventional goniometer. METHODS: The DP is a small, light-weight, three-dimensional gyroscope that can be fixed on the distal upper arm, recording shoulder abduction, flexion, and rotation. Twenty-one subjects (42 shoulders) were included for analysis. Two subsequent assessments of the same subject with a 30-minute delay in testing of each shoulder were performed with the DP in two directions (flexion and abduction), and simultaneously correlated with the measurements of a conventional goniometer. All assessments were performed by one observer. Repeatability for each method was determined and compared as the statistical variance between two repeated measurements. Agreement was illustrated by Bland-Altman-Plots with 95% limits of agreement. Statistical analysis was performed with a linear mixed regression model. Variance for repeated measurements by the same method was also estimated and compared with the likelihood-ratio test. RESULTS: Evaluation of abduction showed significantly better repeatability for the DP compared to the conventional goniometer (error variance: DP = 0.89, goniometer = 8.58, p = 0.025). No significant differences were found for flexion (DP = 1.52, goniometer = 5.94, p = 0.09). Agreement assessment was performed for flexion for mean differences of 0.27° with 95% limit of agreement ranging from -7.97° to 8.51°. For abduction, the mean differences were 1.19° with a 95% limit of agreement ranging from -9.07° to 11.46°. CONCLUSION: In summary, DP demonstrated a high precision even higher than the conventional goniometer. Agreement between both methods is acceptable, with possible deviations of up to greater than 10°. Therefore, static measurements with DP are more precise than conventional goniometer measurements. These results are promising for routine clinical use of the DP.

Objective assessment of shoulder mobility with a new 3D gyroscope--a validation study.

BACKGROUND: Assessment of shoulder mobility is essential for clinical follow-up of shoulder treatment. Only a few high sophisticated instruments for objective measurements of shoulder mobility are available. The interobserver dependency of conventional goniometer measurements is high. In the 1990s an isokinetic measuring system of BIODEX Inc. was introduced, which is a very complex but valid instrument. Since 2008 a new user-friendly system called DynaPort MiniMod TriGyro ShoulderTest-System (DP) is available. Aim of this study is the validation of this measuring instrument using the BIODEX-System. METHODS: The BIODEX is a computerized robotic dynamometer used for isokinetic testing and training of athletes. Because of its size the system needs to be installed in a separated room. The DP is a small, light-weighted three-dimensional gyroscope that is fixed on the distal upper patient arm, recording abduction, flexion and rotation. For direct comparison we fixed the DP on the lever arm of the BIODEX. The accuracy of measurement was determined at different positions, angles and distances from the centre of rotation (COR) as well as different velocities in a radius between 0° - 180° in steps of 20°. All measurements were repeated 10 times. As satisfactory accuracy a difference between both systems below 5° was defined. The statistical analysis was performed with a linear regression model. RESULTS: The evaluation shows very high accuracy of measurements. The maximum average deviation is below 2.1°. For a small range of motion the DP is slightly underestimating comparing the BIODEX, whereas for higher angles increasing positive differences are observed. The distance to the COR as well as the position of the DP on the lever arm have no significant influence. Concerning different motion speeds significant but not relevant influence is detected. Unfortunately device related effects are observed, leading to differences between repeated measurements with any two different devices up to 8° at maximal range of motion (180°). CONCLUSIONS: In summary the results shows high correlation and good reproducibility of measurements. All deviations are inside the tolerance interval of 5°, if one device is used. An unlikely systematic device effect is detected. These laboratory trials are promising for the validation of this system in humans. The challenge for both systems will be the changing of the COR in the shoulder joint at elevations higher than 90°.