Background Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort. Methods and results Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (− 0.4 vs. − 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM. Conclusion The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.
There are high expectations from digitalization of health care, ehealth and telemedicine. Nevertheless, the diffusion of these services falls short of expectations. This study analyses the strength and weaknesses of the German digital health economy. Thereby, we specially focus on small and medium-sized enterprises (SME). The study is based on a literature review, interviews of experts and a workshop. The digital health economy is influenced by a heterogeneous environment with both promotive and obstructive factors. One of the largest weaknesses results from a lack of business models. There is a lack of possibilities of reimbursement by the Statutory Health Insurance (SHI). In addition, private users only have a small willingness to pay for digital services. The large number of regulations makes the implementation even harder, especially for SMEs. Thus, the current environment hampers fast diffusion of digital services in the German health care market.
the treatment of asthma were not accepted due to comments about population and model input, lack of statistical calculations and size of the incremental effects. Ranibizumab's results for age-related macular degeneration were not accepted because of a wrong comparator, lack of long term data, assumptions on risks and mortality, and uncertainties around health care costs and ICER sensitivity. Finally, ZiNL considered the appropriate use of alglucosidase alfa for Pompe's disease to be unsubstantiated because of the population choice for the ICER calculation and the use of a higher dose than the registered dose which was not supported by scientific data. The outcome results of alglucosidase alfa for cost-effectiveness were accepted, however. ConClusions: Although at T= 0 ZiNL provided feedback regarding the design of the outcome research study, most of ZiNL's comments were on the final methodology used. The outcome research studies were considered to be of mixed quality and the results could often not substantiate the claim of cost-effectiveness and appropriate use.objeCtives: In the UK, when a technology is recommended by the National Institute for Health and Care Excellence (NICE), the NHS is mandated to provide the funding to accommodate it within three months. Explicit in NICE's approach to health technology assessment (HTA) is the assumption that the approval of a new, cost-increasing technology will result in the displacement of an existing, less cost-effective health care programme from elsewhere in the NHS. The objective of this study is to identify the actual opportunity costs of specific NICE decisions by documenting how in practice local commissioners in Wales accommodated financial shocks arising from technology appraisals (TAs). Methods: Interviews were conducted with Finance and Medical Directors from all seven Local Health Boards (LHBs) in NHS Wales. These interviews covered prioritisation processes, as well as methods of financing NICE TAs and other financial "shocks" at each LHB. We then undertook a systematic identification of themes and topics from the information recorded. Results: The financial impact of NICE TAs is generally planned for in advance and the majority of LHBs have contingency funds available for this purpose. Efficiency savings (defined as reductions in costs with no assumed reductions in quality) were a major source of funds for all cost pressures. Service displacements were not linkable to particular TAs and there appears to be a general lack of explicit prioritisation activities. The Welsh Government has, on occasion, acted as the funder of last resort. ConClusions: The assumption that newly recommended technologies will displace existing NHS services does not appear to hold true in practice. As the additional cost pressures represented by new NICE TAs are likely to be accommodated by greater efficiency and increased expenditure, the true opportunity cost of HTA decisions is extremely difficult to quantify and may even lie outside the NHS.
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