title: Health services research in heart failure patients treated with a remote monitoring device in Germany-a retrospective database analysis in evaluating resource use.
abstract: OBJECTIVE
  Heart failure is an increasing burden for all healthcare systems with prevalence reaching over 20 million patients worldwide and direct costs of disease requiring ∼1% of healthcare budget expenditures. Beyond traditional pharmaceutical treatment, medical devices and remote monitoring tools were introduced to ensure a closely managed control of patients. In this context, a decision-maker needs to know whether the new technology provides clinical benefit towards patients and what resource use is attached to them.
  
  
  METHODS
  Health services research is a complementary approach to clinical trials providing results to the impact of the technology in real life settings. As an example this study reports of a secondary data analysis of one of the largest health insurance companies in Germany, comparing resource use of heart failure patients receiving a cardiac resynchronization therapy (CRT) device coupled with a fluid status monitoring and alert function with patients receiving conventional CRT, ICD (implantable cardioverter defibrillator), or no intervention.
  
  
  RESULTS
  Disease-associated expenses can be attributed to far more than 50% to heart failure. Although implementation of the CRT device with alert function was most expensive (31,794 Euros compared to 27,659 Euros in the conventional CRT group, 24,128 Euros in the ICD group, and 3735 Euros in the no intervention group) in the first year after implementation, the least costs have been caused in this group (7000 Euros compared to more than 11,000 Euros in all other groups).
  
  
  CONCLUSIONS
  This article highlights potential health services research approaches focusing on the example of a CRT device coupled with a pulmonary diagnostic and alert function. Although this retrospective analysis holds a number of limitations (e.g., small number of patients in intervention group, cost calculations only from the payer perspective), and despite the need for randomized controlled trials, it was shown that secondary data research in this field is a valuable approach.
authors.affiliation: Steinbeis University, Berlin, Germany. bernd.brueggenjuergen@stw.de
authors.forename: Bernd
authors.initials: B
authors.lastname: Brüggenjürgen
authors.forename: Carsten W
authors.initials: CW
authors.lastname: Israel
authors.forename: Armin A
authors.initials: AA
authors.lastname: Klesius
authors.forename: Nadja
authors.initials: N
authors.lastname: Ezzat
authors.forename: Stefan N
authors.initials: SN
authors.lastname: Willich
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058406:Cardiac Resynchronization Therapy / Q000191:economics* / Q000379:methods; D002648:Child; D016208:Databases, Factual; D017147:Defibrillators, Implantable; D005260:Female; D005858:Germany; D017048:Health Care Costs / Q000639:trends; D006295:Health Resources / Q000706:statistics & numerical data*; D006302:Health Services Research; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012189:Retrospective Studies; D013686:Telemetry / Q000191:economics* / Q000295:instrumentation; D055815:Young Adult