TY - JOUR A1 - Sánchez, Alba A1 - Thomas, Christine A1 - Deeken, Friederike A1 - Wagner, Sören A1 - Klöppel, Stefan A1 - Kentischer, Felix A1 - von Arnim, Chrstine A. F. A1 - Denkinger, Michael A1 - Conzelmann, Lars O. A1 - Biermann-Stallwitz, Janine A1 - Joos, Stefanie A1 - Sturm, Heidrun A1 - Metz, Brigitte A1 - Auer, Ramona A1 - Skrobik, Yoanna A1 - Eschweiler, Gerhard W. A1 - Rapp, Michael Armin T1 - Patient safety, cost-effectiveness, and quality of life BT - reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults—study protocol for a stepped-wedge cluster randomized trial (PAWEL Study) JF - Trials N2 - Background Postoperative delirium is a common disorder in older adults that is associated with higher morbidity and mortality, prolonged cognitive impairment, development of dementia, higher institutionalization rates, and rising healthcare costs. The probability of delirium after surgery increases with patients’ age, with pre-existing cognitive impairment, and with comorbidities, and its diagnosis and treatment is dependent on the knowledge of diagnostic criteria, risk factors, and treatment options of the medical staff. In this study, we will investigate whether a cross-sectoral and multimodal intervention for preventing delirium can reduce the prevalence of delirium and postoperative cognitive decline (POCD) in patients older than 70 years undergoing elective surgery. Additionally, we will analyze whether the intervention is cost-effective. Methods The study will be conducted at five medical centers (with two or three surgical departments each) in the southwest of Germany. The study employs a stepped-wedge design with cluster randomization of the medical centers. Measurements are performed at six consecutive points: preadmission, preoperative, and postoperative with daily delirium screening up to day 7 and POCD evaluations at 2, 6, and 12 months after surgery. Recruitment goals are to enroll 1500 patients older than 70 years undergoing elective operative procedures (cardiac, thoracic, vascular, proximal big joints and spine, genitourinary, gastrointestinal, and general elective surgery procedures. Discussion Results of the trial should form the basis of future standards for preventing delirium and POCD in surgical wards. Key aims are the improvement of patient safety and quality of life, as well as the reduction of the long-term risk of conversion to dementia. Furthermore, from an economic perspective, we expect benefits and decreased costs for hospitals, patients, and healthcare insurances. Trial registration German Clinical Trials Register, DRKS00013311. Registered on 10 November 2017. KW - Cross-sectoral care KW - Delirium prevention KW - Postoperative cognitive dysfunction KW - Dementia KW - Older patients KW - Elective surgery KW - Quality of life KW - Cost-effectiveness Y1 - 2019 U6 - https://doi.org/10.1186/s13063-018-3148-8 SN - 1468-6694 SN - 1745-6215 SN - 1468-6708 VL - 20 IS - 71 PB - BioMed Central CY - London ER - TY - JOUR A1 - Dorenkamp, Marc A1 - Bonaventura, Klaus A1 - Leber, Alexander W. A1 - Boldt, Julia A1 - Sohns, Christian A1 - Boldt, Leif-Hendrik A1 - Haverkamp, Wilhelm A1 - Frei, Ulrich A1 - Roser, Mattias T1 - Potential lifetime cost-effectiveness of catheter-based renal sympathetic denervation in patients with resistant hypertension JF - European heart journal N2 - Aims Recent studies have demonstrated the safety and efficacy of catheter-based renal sympathetic denervation (RDN) for the treatment of resistant hypertension. We aimed to determine the cost-effectiveness of this approach separately for men and women of different ages. Methods and results A Markov state-transition model accounting for costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness was developed to compare RDN with best medical therapy (BMT) in patients with resistant hypertension. The model ran from age 30 to 100 years or death, with a cycle length of 1 year. The efficacy of RDN was modelled as a reduction in the risk of hypertension-related disease events and death. Analyses were conducted from a payer's perspective. Costs and QALYs were discounted at 3% annually. Both deterministic and probabilistic sensitivity analyses were performed. When compared with BMT, RDN gained 0.98 QALYs in men and 0.88 QALYs in women 60 years of age at an additional cost of (sic)2589 and (sic)2044, respectively. As the incremental cost-effectiveness ratios increased with patient age, RDN consistently yielded more QALYs at lower costs in lower age groups. Considering a willingness-to-pay threshold of (sic)35 000/QALY, there was a 95% probability that RDN would remain cost-effective up to an age of 78 and 76 years in men and women, respectively. Cost-effectiveness was influenced mostly by the magnitude of effect of RDN on systolic blood pressure, the rate of RDN non-responders, and the procedure costs of RDN. Conclusion Renal sympathetic denervation is a cost-effective intervention for patients with resistant hypertension. Earlier treatment produces better cost-effectiveness ratios. KW - Cost-effectiveness KW - Resistant hypertension KW - Renal sympathetic denervation KW - Prevention KW - Cardiovascular disease Y1 - 2013 U6 - https://doi.org/10.1093/eurheartj/ehs355 SN - 0195-668X VL - 34 IS - 6 SP - 451 EP - + PB - Oxford Univ. Press CY - Oxford ER - TY - JOUR A1 - Bonaventura, Klaus A1 - Leber, Alexander W. A1 - Sohns, Christian A1 - Roser, Mattias A1 - Boldt, Leif-Hendrik A1 - Kleber, Franz X. A1 - Haverkamp, Wilhelm A1 - Dorenkamp, Marc T1 - Cost-effectiveness of paclitaxel-coated balloon angioplasty and paclitaxel-eluting stent implantation for treatment of coronary in-stent restenosis in patients with stable coronary artery disease JF - Clinical research in cardiology : official journal of the German Cardiac Society. N2 - Recent studies have demonstrated the safety and efficacy of drug-coated balloon (DCB) angioplasty for the treatment of coronary in-stent restenosis (ISR). The cost-effectiveness of this practice is unknown. A Markov state-transition decision analytic model accounting for varying procedural efficacy rates, complication rates, and cost estimates was developed to compare DCB angioplasty with drug-eluting stent (DES) placement in patients with bare-metal stent (BMS)-ISR. Data on procedural outcomes associated with both treatment strategies were derived from the literature, and the cost analysis was conducted from a health care payer perspective. Effectiveness was expressed as life-years gained. In the base-case analysis, initial procedure costs amounted to a,not sign3,604.14 for DCB angioplasty and to a,not sign3,309.66 for DES implantation. Over a 12-month time horizon, the DCB strategy was found to be less costly (a,not sign4,130.38 vs. a,not sign5,305.30) and slightly more effective in terms of life expectancy (0.983 vs. 0.976 years) than the DES strategy. Extensive sensitivity analyses indicated that, in comparison with DES implantation, the cost advantage of the DCB strategy was robust to clinically plausible variations in the values of key model input parameters. The variables with the greatest impact on base-case results were the duration of dual antiplatelet therapy with acetylsalicylic acid and clopidogrel after DCB angioplasty, the use of generic clopidogrel, and variations in the costs associated with the DCB device. DCB angioplasty is a cost-effective treatment option for coronary BMS-ISR. The higher initial costs of DCB are more than offset by later cost-savings, predominantly as a result of reduced medication costs. KW - Cost-effectiveness KW - Drug-coated balloon KW - Drug-eluting stent KW - Restenosis KW - Revascularization Y1 - 2012 U6 - https://doi.org/10.1007/s00392-012-0428-2 SN - 1861-0684 VL - 101 IS - 7 SP - 573 EP - 584 PB - Springer CY - Heidelberg ER - TY - JOUR A1 - Boldt, Julia A1 - Leber, Alexander W. A1 - Bonaventura, Klaus A1 - Sohns, Christian A1 - Stula, Martin A1 - Huppertz, Alexander A1 - Haverkamp, Wilhelm A1 - Dorenkamp, Marc T1 - Cost-effectiveness of cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary artery disease in Germany JF - Journal of cardiovascular magnetic resonance N2 - Background: Recent studies have demonstrated a superior diagnostic accuracy of cardiovascular magnetic resonance (CMR) for the detection of coronary artery disease (CAD). We aimed to determine the comparative cost-effectiveness of CMR versus single-photon emission computed tomography (SPECT). Methods: Based on Bayes' theorem, a mathematical model was developed to compare the cost-effectiveness and utility of CMR with SPECT in patients with suspected CAD. Invasive coronary angiography served as the standard of reference. Effectiveness was defined as the accurate detection of CAD, and utility as the number of quality-adjusted life-years (QALYs) gained. Model input parameters were derived from the literature, and the cost analysis was conducted from a German health care payer's perspective. Extensive sensitivity analyses were performed. Results: Reimbursement fees represented only a minor fraction of the total costs incurred by a diagnostic strategy. Increases in the prevalence of CAD were generally associated with improved cost-effectiveness and decreased costs per utility unit (Delta QALY). By comparison, CMR was consistently more cost-effective than SPECT, and showed lower costs per QALY gained. Given a CAD prevalence of 0.50, CMR was associated with total costs of (sic)6,120 for one patient correctly diagnosed as having CAD and with (sic)2,246 per Delta QALY gained versus (sic)7,065 and (sic)2,931 for SPECT, respectively. Above a threshold value of CAD prevalence of 0.60, proceeding directly to invasive angiography was the most cost-effective approach. Conclusions: In patients with low to intermediate CAD probabilities, CMR is more cost-effective than SPECT. Moreover, lower costs per utility unit indicate a superior clinical utility of CMR. KW - Cost-effectiveness KW - Cardiovascular magnetic resonance KW - Scintigraphy KW - Coronary angiography KW - Coronary artery disease Y1 - 2013 U6 - https://doi.org/10.1186/1532-429X-15-30 SN - 1097-6647 VL - 15 IS - 30 PB - BioMed Central CY - London ER -