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Background
The metabolic syndrome (MetS) is a risk cluster for a number of secondary diseases. The implementation of prevention programs requires early detection of individuals at risk. However, access to health care providers is limited in structurally weak regions. Brandenburg, a rural federal state in Germany, has an especially high MetS prevalence and disease burden. This study aims to validate and test the feasibility of a setup for mobile diagnostics of MetS and its secondary diseases, to evaluate the MetS prevalence and its association with moderating factors in Brandenburg and to identify new ways of early prevention, while establishing a “Mobile Brandenburg Cohort” to reveal new causes and risk factors for MetS.
Methods
In a pilot study, setups for mobile diagnostics of MetS and secondary diseases will be developed and validated. A van will be equipped as an examination room using point-of-care blood analyzers and by mobilizing standard methods. In study part A, these mobile diagnostic units will be placed at different locations in Brandenburg to locally recruit 5000 participants aged 40-70 years. They will be examined for MetS and advice on nutrition and physical activity will be provided. Questionnaires will be used to evaluate sociodemographics, stress perception, and physical activity. In study part B, participants with MetS, but without known secondary diseases, will receive a detailed mobile medical examination, including MetS diagnostics, medical history, clinical examinations, and instrumental diagnostics for internal, cardiovascular, musculoskeletal, and cognitive disorders. Participants will receive advice on nutrition and an exercise program will be demonstrated on site. People unable to participate in these mobile examinations will be interviewed by telephone. If necessary, participants will be referred to general practitioners for further diagnosis.
Discussion
The mobile diagnostics approach enables early detection of individuals at risk, and their targeted referral to local health care providers. Evaluation of the MetS prevalence, its relation to risk-increasing factors, and the “Mobile Brandenburg Cohort” create a unique database for further longitudinal studies on the implementation of home-based prevention programs to reduce mortality, especially in rural regions.
Trial registration
German Clinical Trials Register, DRKS00022764; registered 07 October 2020—retrospectively registered.
Background
The metabolic syndrome (MetS) is a risk cluster for a number of secondary diseases. The implementation of prevention programs requires early detection of individuals at risk. However, access to health care providers is limited in structurally weak regions. Brandenburg, a rural federal state in Germany, has an especially high MetS prevalence and disease burden. This study aims to validate and test the feasibility of a setup for mobile diagnostics of MetS and its secondary diseases, to evaluate the MetS prevalence and its association with moderating factors in Brandenburg and to identify new ways of early prevention, while establishing a “Mobile Brandenburg Cohort” to reveal new causes and risk factors for MetS.
Methods
In a pilot study, setups for mobile diagnostics of MetS and secondary diseases will be developed and validated. A van will be equipped as an examination room using point-of-care blood analyzers and by mobilizing standard methods. In study part A, these mobile diagnostic units will be placed at different locations in Brandenburg to locally recruit 5000 participants aged 40-70 years. They will be examined for MetS and advice on nutrition and physical activity will be provided. Questionnaires will be used to evaluate sociodemographics, stress perception, and physical activity. In study part B, participants with MetS, but without known secondary diseases, will receive a detailed mobile medical examination, including MetS diagnostics, medical history, clinical examinations, and instrumental diagnostics for internal, cardiovascular, musculoskeletal, and cognitive disorders. Participants will receive advice on nutrition and an exercise program will be demonstrated on site. People unable to participate in these mobile examinations will be interviewed by telephone. If necessary, participants will be referred to general practitioners for further diagnosis.
Discussion
The mobile diagnostics approach enables early detection of individuals at risk, and their targeted referral to local health care providers. Evaluation of the MetS prevalence, its relation to risk-increasing factors, and the “Mobile Brandenburg Cohort” create a unique database for further longitudinal studies on the implementation of home-based prevention programs to reduce mortality, especially in rural regions.
Trial registration
German Clinical Trials Register, DRKS00022764; registered 07 October 2020—retrospectively registered.
Hintergrund In den letzten Jahrzehnten führte die leitliniengerechte Therapie des akuten Myokardinfarktes (MI) zu einer Mortalitätsreduktion in Deutschland, wobei zwischen einzelnen Bundesländern erhebliche Unterschiede beschrieben werden. Ziel war es daher, die aktuelle Versorgungssituation von Patienten mit MI in der Region Nordost-Deutschland (Berlin, Brandenburg [BRB] und Mecklenburg-Vorpommern [MV]) zu untersuchen und Prädiktoren der 1-Jahresmortalität unter Berücksichtigung der regionalen Zuordnung zu identifizieren.
Methode Auf Basis pseudonymisierter Abrechnungsdaten einer gesetzlichen Krankenversicherung wurden für das Jahr 2012 anhand des ICD 10-Codes I21 und I22 von 1 387 084 Versicherten insgesamt 6733 Patienten mit stationärer Aufnahme bei MI gefiltert. Neben der Krankenhaus- und 1-Jahresmortalität wurden potenzielle Prognoseprädiktoren unter Berücksichtigung von Komorbiditäten, periinfarziellen Prozeduren und sekundärpräventiver Pharmakotherapie erfasst und im Ländervergleich analysiert.
Ergebnisse Sowohl die Krankenhaus- als auch die 1-Jahresmortalitätsrate der einzelnen Länder (Berlin 13,6 resp. 27,5 %, BRB 13,9 resp. 27,9 %, MV 14,4 resp. 29,0 %) war vergleichbar zur Gesamtrate (13,9 % resp. 28,0 %) und im Ländervergleich weitgehend identisch. Die multiple Analyse der Einflussfaktoren auf die 1-Jahresmortalität identifizierte vor allem die Koronarangiografie (OR 0,42, 95 % KI 0,35 – 0,51, p < 0,001) und die Umsetzung der pharmakologischen Leitlinienempfehlungen (OR 0,14, 95 % KI 0,12 – 0,17, p < 0,001) als wesentliche Maßnahmen zur Risikoreduktion. Bei beiden Einflussfaktoren lagen univariat keine statistischen Unterschiede zwischen den drei Bundesländern vor.
Schlussfolgerung Die vorliegenden Daten lassen auf eine vergleichbare stationäre und poststationäre Versorgung und 1-Jahresprognose von Patienten mit akutem MI in den Bundesländern Berlin, Brandenburg und Mecklenburg-Vorpommern in der untersuchten Population schließen, wobei insbesondere der Durchführung einer Koronarangiografie und der adäquaten Umsetzung einer leitliniengerechten Pharmakotherapie prognostische Bedeutung zukommt.
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.
Potential cost-effectiveness of therapeutic drug monitoring in patients with resistant hypertension
(2014)
Background: Nonadherence to drug therapy poses a significant problem in the treatment of patients with presumed resistant hypertension. It has been shown that therapeutic drug monitoring (TDM) is a useful tool for detecting nonadherence and identifying barriers to treatment adherence, leading to effective blood pressure (BP) control. However, the cost-effectiveness of TDM in the management of resistant hypertension has not been investigated.
Results: In the age group of 60-year olds, TDM gained 1.07 QALYs in men and 0.97 QALYs in women at additional costs of (sic)3854 and (sic)3922, respectively. Given a willingness-to-pay threshold of (sic)35 000 per QALY gained, the probability of TDM being cost-effective was 95% or more in all age groups from 30 to 90 years. Results were influenced mostly by the frequency of TDM testing, the rate of nonresponders to TDM, and the magnitude of effect of TDM on BP.
Conclusion: Therapeutic drug monitoring presents a potential cost-effective healthcare intervention in patients diagnosed with resistant hypertension. Importantly, this finding is valid for a wide range of patients, independent of sex and age.
Antiplatelet therapy in the era of percutaneous coronary intervention with drug-eluting balloons
(2011)
The high rate of restenosis associated with percutaneous coronary intervention (PCI) procedures can be reduced with the implantation of metallic stents into the stenotic vessels. The knowledge that neointimal formation can result in restenosis after stent implantation led to the development of drug-eluting stents (DES) which require long lasting antiplatelet therapy to avoid thrombotic complications. In the last years, the drug-eluting balloon (DEB) technology has emerged as an alternative option for the treatment of coronary and peripheral arteries. Clinical studies demonstrated the safety and effectiveness of DEB in various clinical scenarios and support the use of paclitaxel-eluting balloons for the treatment of in-stent restenosis, of small coronary arteries and bifurcations lesions. The protocols of DEB studies suggest that the dual antiplatelet therapy with aspirin and clopidogrel of four weeks after DEB is safe and effective.
Background Preparticipation examinations (PPE) are frequently used to evaluate eligibility for competitive sports in adolescent athletes. Nevertheless, the effectiveness of these examinations is under debate since costs are high and its validity is discussed controversial.
Purpose To analyse medical findings and consequences in adolescent athletes prior to admission to a sports school.
Methods In 733 adolescent athletes (318 girls, 415 boys, age 12.3+/-0.4, 16 sports disciplines), history and clinical examination (musculoskeletal, cardiovascular, general medicine) was performed to evaluate eligibility. PPE was completed by determination of blood parameters, ECG at rest and during ergometry, echocardiography and x-rays and ultrasonography if indicated. Eligibility was either approved or rated with restriction. Recommendations for therapy and/or prevention were given to the athletes and their parents.
Results Historical (h) and clinical (c) findings (eg, pain, verified pathologies) were more frequent regarding the musculoskeletal system (h: 120, 16.4%; c: 247, 33.7%) compared to cardiovascular (h: 9, 1.2%; c: 23, 3.1%) or general medicine findings (h: 116, 15.8%; c: 71, 9.7%). ECG at rest was moderately abnormal in 46 (6.3%) and severely abnormal in 25 athletes (3.4%). Exercise ECG was suspicious in 25 athletes (3.4%). Relevant echocardiographic abnormalities were found in 17 athletes (2.3%). In 52 of 358 cases (14.5%), x-rays led to diagnosis (eg, Spondylolisthesis). Eligibility was temporarily restricted in 41 athletes (5.6%). Three athletes (0.4%) had to be excluded from competitive sports. Therapy (eg, physiotherapy, medication) and/or prevention (sensorimotor training, vaccination) recommendations were deduced due to musculoskeletal (t:n = 76,10.3%; p:n = 71,9.8%) and general medicine findings (t:n = 80, 10.9%; p:n = 104, 14.1%).
Conclusion Eligibility for competitive sports is restricted in only 5.5% of adolescent athletes at age 12. Eligibility refusals are rare. However, recommendations for therapy and prevention are frequent, mainly regarding the musculoskeletal system. In spite of time and cost consumption, adolescent preparticipation before entering a career in high-performance sports is supported.
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.