@misc{VoellerBindlNagelsetal.2017,
  author    = {V{\"o}ller, Heinz and Bindl, Dominik and Nagels, Klaus and Hofmann, Reiner and Vettorazzi, Eik and Wegscheider, Karl and Fleck, Eckart and Nagel, Eckhard},
  title     = {Remote telemonitoring in chronic heart failure does not reduce healthcare cost but improves quality of life},
  series = {Journal of the American College of Cardiology},
  volume    = {69},
  journal   = {Journal of the American College of Cardiology},
  number    = {11 Supplement},
  publisher = {Elsevier},
  address   = {New York},
  issn      = {0735-1097},
  pages     = {672 -- 672},
  year      = {2017},
  abstract  = {Background: Evidence that home telemonitoring (HTM) for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Therefore the CardioBBEAT trial was designed to prospectively assess the health economic impact of a dedicated home monitoring system for patients with CHF based on actual costs directly obtained from patients' health care providers. Methods: Between January 2010 and June 2013, 621 patients (mean age 63,0 ± 11,5 years, 88 \% male) with a confirmed diagnosis of CHF (LVEF ≤ 40 \%) were enrolled and randomly assigned to two study groups comprising usual care with and without an interactive bi-directional HTM (Motiva®). The primary endpoint was the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow up of 12 months. Secondary outcome measures were total mortality and health related quality of life (SF-36, WHO-5 and KCCQ). Results: In the intention-to-treat analysis, total mortality (HR 0.81; 95\% CI 0.45 - 1.45) and days alive and not in hospital (343.3 ± 55.4 vs. 347.2 ± 43.9; p = 0.909) were not significantly different between HTM and usual care. While the resulting primary endpoint ICER was not positive (-181.9; 95\% CI -1626.2 ± 1628.9), quality of life assessed by SF-36, WHO-5 and KCCQ as a secondary endpoint was significantly higher in the HTW group at 6 and 12 months of follow-up. Conclusions: The first simultaneous assessment of clinical and economic outcome of HTM in patients with CHF did not demonstrate superior incremental cost effectiveness compared to usual care. On the other hand, quality of life was improved. It remains open whether the tested HTM solution represents a useful innovative approach in the recent health care setting.},
  language  = {en}
}
@article{HofmannVoellerNagelsetal.2015,
  author    = {Hofmann, Reiner and V{\"o}ller, Heinz and Nagels, Klaus and Bindl, Dominik and Vettorazzi, Eik and Dittmar, Ronny and Wohlgemuth, Walter and Neumann, Till and St{\"o}rk, Stefan and Bruder, Oliver and Wegscheider, Karl and Nagel, Eckhard and Fleck, Eckart},
  title     = {First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT},
  series = {Trials},
  volume    = {16},
  journal   = {Trials},
  publisher = {BioMed Central},
  address   = {London},
  organization    = {CardioBBEAT Investigators},
  issn      = {1745-6215},
  doi       = {10.1186/s13063-015-0886-8},
  pages     = {12},
  year      = {2015},
  abstract  = {Background: Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Methods: Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva (R)). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. Results: A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. Conclusions: CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System.},
  language  = {en}
}