Improved follow-up by peripheral arterial tonometry in CPAP-treated patients with obstructive sleep apnea and persistent excessive daytime sleepiness.

BACKGROUND: OSA-patients with persistent excessive daytime sleepiness (EDS) despite CPAP treatment are challenging in daily clinical life. To rule out residual sleep-disordered breathing (SDB), CPAP device-derived data are used in outpatient setting. In case of no pathological finding, a more intensive work-up with is necessary. 6-channel portable monitoring (6Ch-PM) is frequently used to exclude residual SDB. Peripheral arterial tonometry (PAT), as embodied in the WatchPAT device, represents an alternative technique for detecting SDB based on changes in autonomic tone. We wanted to investigate whether PAT might be a useful tool to improve diagnostic work-up in this specific patient group by better identifying residual SDB due to insufficient CPAP-adjustment. METHODS: Forty-nine OSA patients (39 male, 10 female) with sufficient CPAP treatment according to device-derived data were consecutively recruited. EDS was assessed by Epworth Sleepiness Scale (ESS). All patients underwent home-based CPAP therapy control by 6Ch-PM and portable monitoring using PAT technology on two consecutive nights. A sequence of both types of monitoring was randomized to prevent possible first night effect bias. RESULTS: Twelve out of 49 patients showed persistent EDS according to ESS (ESS > 10 points). 6Ch-PM showed a residually increased AHI under CPAP-treatment in 2 of those 12 subjects (positive predictive value, PPV = 16.7%). PAT-PM revealed 5 patients of those 12 with residual SDB (PPV = 41.7%). CONCLUSION: PAT could detect significantly more residual SDB under CPAP treatment than 6Ch-PM. Diagnostic work-up of CPAP-treated OSA patients with persistent EDS might be optimized, as insufficient pressure level adjustments could be recognized more precisely in time, possibly preventing more resource-consuming procedures, and potentially increased morbidity. CLINICAL TRIAL REGISTRATION: DRKS00007705.

Budget impact of the Oncotype DX® test compared to other gene expression tests in patients with early breast cancer in Germany.

PURPOSE: Gene expression tests can inform decisions on whether to recommend chemotherapy for patients with HR+, HER2- early breast cancer. The goal of this analysis was to compare treatment costs by an expanded budget impact model of reimbursed gene expression tests in Germany. METHODS: A cost comparison was constructed as an expanded budget impact model to calculate average total costs per patient covered by public health insurance. Based on the strong clinical evidence from the prospective randomized controlled trial TAILORx including more than 10,000 patients with HR+ and node negative breast cancer, the assumption was made that the Oncotype DX® test accurately predicts chemotherapy benefit and clinical outcomes. For the further reimbursed tests (EndoPredict®, MammaPrint®, Prosigna®), results from comparative studies - aligned with prognosis studies - as analyzed in IQWiG Rapid Report D19-01 were applied. RESULTS: The use of the Oncotype DX test led to estimated average savings per patient of 2,500 € vs. EndoPredict, 1,936 € vs. MammaPrint, and 649 € vs. Prosigna. Savings were achieved by reduction of unnecessary chemotherapy use, a consequence of false-positive test results (EndoPredict 73%, MammaPrint 42%, Prosigna 20%). False-negative test results (EndoPredict 5%, MammaPrint 22%, Prosigna 49%) reduced necessary chemotherapies, which initially results in cost savings, but may lead to increased long-term costs associated with management of progressive disease. CONCLUSION: The results from this model suggest that the use of the Oncotype DX test reduces the cost of health care in Germany making it the most cost effective test compared to the further tests.