The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial.

BACKGROUND: eHealth approaches show promising results for smoking cessation (SC). They can improve quit rates, but rigorous research is sparse regarding their effectiveness and the effects of their interactivity, tailoring, and use intensity. OBJECTIVE: We examined the effectiveness of Techniker Krankenkasse Smoking Cessation Coaching (TK-SCC), an internet-based, tailored, and interactive SC intervention. Our hypotheses were as follows: hypothesis 1, in the intervention group (IG; access to TK-SCC), a clinically relevant number of participants will be abstinent at the 12-month follow-up (T3); hypothesis 2, the number of abstinent participants will be significantly greater in the IG than the control group (CG) at T3; and hypothesis 3, in the IG, more intense use of TK-SCC will be positively associated with abstinence. METHODS: Individuals who smoke were randomized into the IG (563/1115, 50.49%) or CG (552/1115, 49.51%), which received a noninteractive, nontailored, and information-only web-based intervention. Data were collected before the intervention, at the postintervention time point (T1), at the 4-month follow-up (T2), and at T3. We tested hypothesis 1 through equivalence tests between the IG's success rate and success rates of comparable effective interventions reported in 2 current meta-analyses. For hypothesis 2, we conducted binary logistic regressions. For hypothesis 3, we assigned the IG participants to 1 of 4 user types and used binary logistic regressions with user types as the independent variable and smoking abstinence as the dependent variable. RESULTS: In the IG, 11.5% (65/563) and 11.9% (67/563) of participants were smoke free at T1 and T3, respectively. These values were statistically equivalent to the effects in the 2 meta-analyses, which reported 9% (z score=0.64, P=.74) and 10.9% (z score=-0.71, P=.24) success rates, respectively. In the CG, 6.2% (34/552) of the participants were smoke free at T1, which increased up to 8.2% (45/552) at T3. The difference between the IG and CG was statistically significant only at T1 (odds ratio [OR] 2.0, 99% CI 1.1 to 3.6; P=.002), whereas the effect was nonsignificant following α error corrections at T3 (OR 1.6, 99% CI 0.9 to 2.7; P=.02). In the IG, constant users of the program became smoke free significantly more often than rare users of the program (T1: OR 15.0, 99% CI 6.1 to 36.9; P<.001; T3: OR 6.5, 99% CI 2.8 to 15.5; P<.001). CONCLUSIONS: TK-SCC is effective for SC. However, its superiority compared with a minimal SC intervention could not be confirmed in the long term. Insufficient implementation of the techniques used and cotreatment bias could explain this outcome. Higher use intensity of TK-SCC was positively related to abstinence. Therefore, additional efforts to motivate users to adhere to intervention use as intended could improve the intervention's effectiveness. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020249, Universal Trial Number U1111-1245-0273; https://drks.de/search/de/trial/DRKS00020249. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-021-05470-8.

Effects of a Web-Based Lifestyle Intervention on Weight Loss and Cardiometabolic Risk Factors in Adults With Overweight and Obesity: Randomized Controlled Clinical Trial.

BACKGROUND: The high proportion of people with overweight and obesity has become a worldwide problem in recent decades, mainly due to health consequences, such as cardiovascular diseases, neoplasia, and type 2 diabetes mellitus. Regarding effective countermeasures, the digitization of health services offers numerous potentials, which, however, have not yet been sufficiently evaluated. Web-based health programs are becoming increasingly interactive and can provide individuals with effective long-term weight management support. OBJECTIVE: The purpose of this randomized controlled clinical trial was to evaluate the effectiveness of an interactive web-based weight loss program on anthropometric, cardiometabolic, and behavioral variables and to compare it with a noninteractive web-based weight loss program. METHODS: The randomized controlled trial included people who were aged between 18 and 65 years (mean 48.92, SD 11.17 years) and had a BMI of 27.5 to 34.9 kg/m2 (mean 30.71, SD 2.13 kg/m2). Participants (n=153) were assigned to either (1) an interactive and fully automated web-based health program (intervention) or (2) a noninteractive web-based health program (control). The intervention program focused on dietary energy density and allowed for dietary documentation with appropriate feedback on energy density and nutrients. The control group only received information on weight loss and energy density, but the website did not contain interactive content. Examinations were performed at baseline (t0), at the end of the 12-week intervention (t1), and at 6 months (t2) and 12 months (t3) thereafter. The primary outcome was body weight. The secondary outcomes were cardiometabolic variables as well as dietary and physical activity behaviors. Robust linear mixed models were used to evaluate the primary and secondary outcomes. RESULTS: The intervention group showed significant improvements in anthropometric variables, such as body weight (P=.004), waist circumference (P=.002), and fat mass (P=.02), compared with the control group over the course of the study. The mean weight loss after the 12-month follow-up was 4.18 kg (4.7%) in the intervention group versus 1.29 kg (1.5%) in the control group compared with the initial weight. The results of the nutritional analysis showed that the energy density concept was significantly better implemented in the intervention group. Significant differences in cardiometabolic variables were not detected between the 2 groups. CONCLUSIONS: The interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3390/ijerph19031393.

Costs of a structured early detection program for advanced liver fibrosis and cirrhosis: insights on the "plus" of Check-up 35.

BACKGROUND: The implementation of an early detection program for liver cirrhosis in a general population has been discussed for some time. Recently, the effectiveness of a structured screening procedure, called SEAL (Structured Early detection of Asymptomatic Liver cirrhosis), using liver function tests (AST and ALT) and APRI to early detect advanced fibrosis and cirrhosis in participants of the German "Check-up 35" was investigated. METHODS: This study identifies the expected diagnostic costs of SEAL in routine care and their drivers and reports on prevailing CLD etiologies in this check-up population. The analysis is based on theoretical unit costs, as well as on the empirical billing and diagnostic data of SEAL participants. RESULTS: Screening costs are mainly driven by liver biopsies, which are performed in a final step in some patients. Depending on the assumed biopsy rates and the diagnostic procedure, the average diagnostic costs are between EUR 5.99 and 13.74 per Check-up 35 participant and between EUR 1,577.06 and 3,620.52 per patient diagnosed with fibrosis/cirrhosis (F3/F4). The prevailing underlying etiology in 60% of cases is non-alcoholic fatty liver disease. DISCUSSION: A liver screening following the SEAL algorithm could be performed at moderate costs. Screening costs in routine care depend on actual biopsy rates and procedures, attendance rates at liver specialists, and the prevalence of fibrosis in the Check-up 35 population. The test for viral hepatitis newly introduced to Check-up 35 as once-in-a-lifetime part of Check-up 35 is no alternative to SEAL.

Evaluation of an Interactive Web-Based Health Program for Weight Loss-A Randomized Controlled Trial.

Personal behavior patterns, such as unhealthy diet and lack of physical activity, lead to the development of overweight and obesity. These are associated with other comorbidities, reduced quality of life, premature frailty and increased mortality. Personalized web-based interventions are promising in inducing behavioral change leading to effective reductions in body weight at relatively low costs. However, the long-term effects have not been thoroughly investigated. This work evaluates the effectiveness of web-based interactive weight loss coaching and compares it to a non-interactive web-based health program. Therefore, a randomized controlled trial (RCT) was implemented, measuring primary and secondary outcomes at four time points (program start; end of the 12-week-program; 6 months after program end, 12 months after program end). The net sample covered 1499 subjects in the intervention group and 1492 in the control group. On average, the IG was 43 years old (±13.6), 80.1% male, and had 86.4 kg body weight (±16.1) at baseline. The CG was 42.7 years old (±13.9), 79.5% male and had a mean body weight of 86.1 (±15.7). Multilevel analyses with fixed effects were carried out both from the perspective of an intention-to-treat (ITT) and a complete cases approach (CCA). In sum, our adjusted models suggest a weight loss of 0.4 kg per time point. At the end of the program, significant differences in weight loss in % to baseline (delta M = 1.8 in the CCA) were observed in favor of the intervention group. From a long-term perspective, no superiority of the intervention group in comparison to the control group could be found. More intensive use of the program was not statistically associated with higher weight loss.

A nationwide registry for recurrent urolithiasis in the upper urinary tract - The RECUR study protocol.

BACKGROUND: Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research in this area seem to lag far behind cardiovascular diseases or cancer. This may be due to the lack of an immediate deadly threat from the disease and therefore less public and professional interest. However, the patients suffer from recurring, sometimes intense pain and often must be treated in hospital. Long-term morbidity includes doubled rates of chronic kidney disease and arterial hypertension after at least one stone-related event. Observational studies, more specifically, registries and other electronic data sets have been proposed as a means of filling critical gaps in evidence. We propose a nationwide digital and fully automated registry as part of the German Ministry for Education and Research (BMBF) call for the "establishment of model registries". METHODS: RECUR builds on the technical infrastructure of Germany's Medical Informatics Initiative. Local data integration centres (DIC) of participating medical universities will collect pseudonymized and harmonized data from respective hospital information systems. In addition to their clinical data, participants will provide patient reported outcomes using a mobile patient app. Scientific data exploration includes queries and analysis of federated data from DICs of eleven participating sites. All primary patient data will remain at the participating sites at all times. With comprehensive data from this longitudinal registry, we will be able to describe the disease burden, to determine and validate risk factors, and to evaluate treatments. Implementation and operation of the RECUR registry will be funded by the BMBF for five years. Subsequently, the registry is to be continued by the German Society of Urology without significant costs for study personnel. DISCUSSION: The proposed registry will substantially improve the structural and procedural framework for patients with recurrent urolithiasis. This includes advanced diagnostic algorithms and treatment pathways. The registry will help us identify those patients who will most benefit from specific interventions to prevent recurrences. The RECUR study protocol and the registry's technical architecture including full digitalization and automation of almost all registry-associated proceedings can be transferred to future registries. TRIAL REGISTRATION: This study is registered at the German Clinical Trial Register (Deutsches Register Klinischer Studien), DRKS-ID DRKS00026923 , date of registration January, 11th 2022.

Effects of a Web-Based Weight Loss Program on the Healthy Eating Index-NVS in Adults with Overweight or Obesity and the Association with Dietary, Anthropometric and Cardiometabolic Variables: A Randomized Controlled Clinical Trial.

This randomized, controlled clinical trial examined the impact of a web-based weight loss intervention on diet quality. Furthermore, it was investigated whether corresponding changes in diet quality were associated with changes in measures of cardiovascular risk profile. Individuals with a body mass index (BMI) of 27.5 to 34.9 kg/m2 and an age of 18 to 65 y were assigned to either an interactive and fully automated web-based weight loss program focusing on dietary energy density (intervention) or a non-interactive web-based weight loss program (control). Examinations were performed at baseline (t0), after the 12-week web-based intervention (t1), and after an additional 6 (t2) and 12 months (t3). Based on a dietary record, the Healthy Eating Index-NVS (HEI-NVS) was calculated and analyzed using a robust linear mixed model. In addition, bootstrapped correlations were performed independently of study group to examine associations between change in HEI-NVS and change in dietary, anthropometric, and cardiometabolic variables. A total of n = 153 participants with a mean BMI of 30.71 kg/m2 (SD 2.13) and an average age of 48.92 y (SD 11.17) were included in the study. HEI-NVS improved significantly in the intervention group from baseline (t0) to t2 (p = 0.003) and to t3 (p = 0.037), whereby the course was significantly different up to t2 (p = 0.013) and not significantly different up to t3 (p = 0.054) compared to the control group. Independent of study group, there was a significant negative association between change in HEI-NVS and dietary energy density. A higher total score in HEI-NVS did not correlate with improvements in cardiovascular risk profile. The interactive and fully automated web-based weight loss program improved diet quality. Independent of study group, changes in HEI-NVS correlated with changes in energy density, but there was no association between improvements in HEI-NVS and improvements in cardiovascular risk profile.

[RECUR - Establishment of An Automated Digital Registry for Patients with Recurrent Stones in the Upper Urinary Tract]. / RECUR ­ Aufbau eines automatisierten digitalen Registers für Patient*innen mit rezidivierenden Steinen des oberen Harntraktes.

Kidney stones, like cardiovascular diseases and diabetes mellitus, affect a large number of people. Patients suffer from acute pain, repeated hospitalizations and associated secondary diseases, such as arterial hypertension and renal insufficiency. This results in considerable costs for the society and its health care system. The recurrence rate is as high as 50%. The registry for RECurrent URolithiasis (RECUR) aims to fill existing evidence gaps. The prospective and longitudinal RECUR registry is funded by the German Ministry of Education and Science (BMBF). It is based on the digital infrastructure of the German Medical Informatics Initiative (MII). RECUR aims to include patients that have suffered from more than one stone occurrence and treated at any one of the ten participating university hospitals of the MIRACUM consortium. The intention is to obtain new information on risk factors and to evaluate different diagnosis and treatment algorithms. Along with the data form the patient's Electronic Health Records (EHR), the RECUR project will also collect Patient Reported Outcomes data from patients with recurrent kidney stones. These data will be collected at participating sites using digital questionnaires via a smartphone app. These data will be merged with medical data from the hospital information systems and saved in the MII research data repositories. The RECUR registry has a model character due to its fully federated, digital approach. This allows the recruitment of many patients, the collection of a wide range of data and their processing with low administrative and personnel costs.

Psychometric properties of the German version of the Leicester Cough Questionnaire in sarcoidosis.

BACKGROUND: Cough is one of the most common symptoms in general and pulmonary medicine with profound negative impact on health-related quality of life (HRQL). The Leicester Cough Questionnaire (LCQ) is a validated HRQL questionnaire, yet a validated German version of the LCQ is not available and it has never been tested in a cohort with sarcoidosis. OBJECTIVES: To translate the LCQ into German and determine its psychometric properties. METHODS: The LCQ was translated in a forward-backward approach. Structured interviews in sarcoidosis patients were performed. Subsequently, sarcoidosis patients were asked to answer the German LCQ and comparative questionnaires. Distribution properties, item difficulty, concurrent validity, Rasch model fit and internal consistency of the German LCQ were determined. RESULTS: 200 patients with sarcoidosis were included. We provide evidence for reliability, unidimensionality and internal consistency. However, only a moderate correlation with general and respiratory-specific HRQL questionnaires, no Rasch model fit could be shown. Skewed responses caused by floor effects were detected. CONCLUSION: We demonstrate that the German LCQ is valid and reliable and its psychometric properties fulfil the standards required for its use in clinical settings as well as in interventional trials.