[Ten years of hypoglossal nerve stimulation in obstructive sleep apnea: a systematic literature review]. / Zehn Jahre Hypoglossusnerv-Stimulation bei obstruktiver Schlafapnoe ­ ein systematischer Literaturreview.

OBJECTIVE: To show the importance of hypoglossal nerve stimulation (HGNS) as a treatment method for obstructive sleep apnea (OSA) in the German healthcare context and to better assess the way patients who do not receive adequate care could benefit from HGNS. METHODS: A systematic literature review in the Medline and Cochrane Library literature database was conducted, including publications using different stimulation technologies for HGNS. The efficacy of HGNS was assessed based on patient-relevant outcomes (daytime sleepiness, quality of life), treatment adherence and the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI). The safety of the treatment method was assessed based on adverse events (AEs). RESULTS: Inclusion and analysis of 33 publications: 2 randomized controlled trials (RCTs, level Ib), 1 level IIb trial (n = 1) and 30 level IV trials with a study duration of up to 60 months. The RCTs showed better values for daytime sleepiness and quality of life when using HGNS than in the control group. AHI and ODI showed a deterioration under placebo stimulation or therapy withdrawal in the RCTs. Consistently high adherence was also reported in the long-term course. Severe AEs under HGNS were rare and could usually be resolved by repositioning electrodes or replacing device components. Other AEs were mostly transient or could be resolved by non-invasive measures. All investigated parameters showed similar results in the evaluated studies. The results of different stimulation systems are comparable in type and extent. CONCLUSION: The comprehensive review of the literature shows consistent data that highlight the importance of HGNS as an effective and safe treatment for OSA after unsuccessful CPAP treatment. The evaluation also shows that the different stimulation systems make it possible to better tailor the therapy to the patient's individual requirements. A future systematic evaluation of real-world data on the use of HGNS would help gain additional insights into the relevance of the method in routine clinical practice.

DiGA - A Chance for the German Healthcare System.

A DiGA is a safe and data-protected interoperable medical device (officially called a "digital health application") of a low-risk class, which has the potential to improve the healthcare system in Germany for patients - with or without the involvement of a physician. It therefore already represents the first component of the envisaged future digitalised healthcare. In order not to promote the emergence of parallel healthcare markets (3rd Healthcare Market), a rapid rethinking is necessary, above all among physicians requiring more expertise and competence regarding digitalisation. Continuing Medical Education (CME) can accompany and accelerate this process and thus contribute to the success of digital healthcare, which offers solutions to current challenges for the benefit of patients.

How Many Cases of Spine Surgery Are Performed in Germany? Method of Counting the Number of Cases of Spine Surgery in Germany.

Objective The number of cases of spinal DRGs (German Diagnosis-Related Groups) is calculated on the basis of the data released by the German DRG-Institute. The data thus obtained were subsequently compared with the previously publicly debated data of cases, which were based on the counting of OPS (German Procedure Classification) codes. Methods Specific and Nonspecific Spinal DRGs are identified according to the German Coding Guidelines and the OPS catalogs. Those are verified in a multistage process, including the formation of test cases, to ensure that those DRGs consistently contain spinal cases. The verified DRGs are filtered out of the G-DRG § 21 KHEntgG Browser, including the years from 2005 to 2012 to calculate the respective number of cases. For a better overview, the DRGs are divided into groups according to Specific and Nonspecific Spinal DRGs. Both groups are summarized under the title Surgical Spine DRGs to be able to compare the results with the data already published. Two datasets are used for comparison: one from a publication in the German Ärzteblatt, which is based on the data collected by the German insurance company AOK, and the other from data published by the German Federal Office of Statistics. Results As a result, the number of cases which is presented here shows a significant variance compared with the figures that have been published. The Specific Spinal DRGs show a growth of 75% from 2005 to 2011. The case numbers of the Nonspecific Spinal DRGs show an increased rate of 51% between 2005 and 2006. In addition, the Surgical Spine DRGs rose by 69% between 2005 and 2011. This contrasts with the German government-proposed increase of 125% in the area of spinal surgery over the same period. Conclusion To summarize, the significant gap between the case numbers presented here and the existing ones gives reason to question the benefit of using OPS codes to calculate the actual number of cases in the field of spinal surgery, and it suggests the advantage of using DRG-based calculations.

Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data.

STUDY DESIGN: Observational study. OBJECTIVE: Examine the overall survival and treatment costs from a third-party-payer perspective for patients with osteoporotic vertebral compression fractures (OVCFs) treated by vertebral augmentation or conservative treatment in Germany. SUMMARY OF BACKGROUND DATA: OVCFs are associated with increased morbidity, mortality and thus reduced quality of life. Vertebral augmentation has been shown to be effective in these fractures. The association between treatment and survivorship as well as cost per life year gained for balloon kyphoplasty (BKP) and percutaneous vertebroplasty (PVP) was analyzed in the Medicare population. Replication of these analyses is warranted for confidence in findings. METHODS: Claims data from a major health insurance fund were used. Mortality risk differences between operated (BKP, PVP) and nonoperated cohorts were assessed by Cox regression. Operated patient groups were established by propensity score matching adjusting for covariates. For the matched operated patients with OVCF, (2006-2010) survival was estimated by Kaplan-Meier method. RESULTS: A total of 598 newly diagnosed patients with OVCF were operated of 3607 patients with OVCF. The operated cohort was 43% less likely to die than the nonoperated one in the 5-year study period (hazard ratio = 0.57; P < 0.001). Patients who received BKP had higher 60-month adjusted survival rate (66.7%) than those who received PVP (58.7%) (P = 0.68). Cumulative 4-year mean overall costs after first diagnosis were lower for the BKP cohort (PVP: €42,510 vs. BKP: €39,014). Initial upfront higher costs driven by surgical treatment for patients who received BKP are offset by considerable pharmacy costs in patients who received PVP. There were differences between the values of painkiller consumption (PVP: €3321 vs. BKP: €2224). CONCLUSION: Results suggest a higher overall survival rate for operated than nonoperated patients with OVCF and indicate a potential survival benefit for patients who received BKP compared with patients who received PVP. The reasons merit further investigation. Total costs were lower after 4 years for patients who received BKP versus PVP due to less consumption of pharmaceuticals. LEVEL OF EVIDENCE: 3.