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Publications (8)10.92 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Ziel dieser offenen, randomisierten Multizenterstudie ist es, Nutzen und Wirtschaftlichkeit des Selbstmanagements der oralen Antikoagulation bei Patienten mit Vorhofflimmern (SMAAF-Studie) im Vergleich zur herkömmlichen beim Haus- oder Facharzt betreuten Patientengruppe zu untersuchen. Liegt eine Eignung zur Selbstkontrolle vor, werden 2000 Patienten randomisiert entweder dem Selbstmanagement oder der Kontrollgruppe zugeteilt. Als primäre Endpunkte während des zweijährigen Beobachtungszeitraums werden die Anzahl behandlungsbedürftiger thromboembolischer bzw. hämorrhagischer Komplikationen ermittelt. Sekundäre Zielparameter sind die Einhaltung der INR-Werte im individuellen Zielbereich, die INR-Varianz, der Zeitverlauf der Komplikation sowie die Kosteneffizienz des Selbstmanagements im Vergleich zum routinemäßigen Verfahren. Letztere schließt die durchgeführten diagnostischen und/oder therapeutischen Maßnahmen, die Krankenhausliegedauer sowie auch die sozialen Folgen mit ein (Anschlußheilbehandlung, Berufsunfähigkeit, Berentung). Die Fallzahlschätzung ergibt sich aus der Annahme, daß während dauerhafter Antikoagulation bei Patienten mit chronischem nichtvalvulärem Vorhofflimern im Rahmen der Primär- und Sekundärprävention vier schwere thromboembolische bzw. hämorrhagische Komplikationen pro 100 Patientenjahre auftreten. Da sich diese Rate durch das Selbstmanagement halbieren läßt, ist bei einer Power von 80% und einem Signifikanzniveau von 5% bei einem einseitigen χ2-Test zur Absicherung eine Stichprobengröße von n = 997 Patienten pro Gruppe erforderlich. Die Ergebnisse der SMAAF-Studie werden den sozio-ökonomischen Nutzen des Selbstmanagements bei Patienten mit chronischem nichtvalvulärem Vorhofflimmern ermitteln. The objective of this open, randomized, multicenter study is to investigate the benefits and economic efficiency of self-management of oral anticoagulation in patients with atrial fibrillation (SMAAF study) in comparison with a group of patients given conventional care by a general practitioner or specialist. Two thousand patients suitable for self-management will be assigned at random to either the self-management group or the control group. The numbers of thromboembolic and hemorrhagic complications requiring treatment during the 2-year follow-up period will be recorded as the primary end point. The secondary endpoint variables will be maintenance of the INR value in the individual target range, INR variance, the course of complications over time, and the cost efficiency of self-management compared with the routine procedures. The last of these parameters will include the diagnostic and/or therapeutic measures carried out, the duration of inpatient hospital treatment, and the social consequences (subsequent rehabilitation treatment, inability to work, forced rentirement). The estimate of the required number of patients was based on the assumption that during long-term anticoagulant therapy within the framework of primary and secondary prevention 4% of patients with chronic non-valvular atrial fibrillation would have severe thromboembolic of hemorrhagic complications each year. Since this rate can be halved by self-management, a one-tailed χ2-test of 80% power and a 5% significance threshold would require n = 997 patients per group. The results of the SMAAF study will establish the socioeconomic benefits of selfmanagement in patients with non-valvular atrial fibrillation. Schlüsselwörter Antikoagulation – Selbstmanagement – VorhofflimmernKey words Anticoagulation – self-management – atrial fibrillation
    Zeitschrift für Kardiologie 04/2012; 89(4):284-288. · 0.97 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Most patients with atrial fibrillation are at risk of suffering thromboembolic events. This risk can be reduced by twothirds by efficient anticoagulation. This prospective multi-center trial investigated whether the quality of treatment can be improved by self-management in patients with atrial fibrillations (SMAAF Study) compared to conventional patient management by the family doctor. Two thousand patients suitable for self-management were to be randomized into the two arms of the study. In the period of investigation from December 1999 to July 2001, only 202 patients (64.3+/-9.2 years, 69.3% men) consented to participate. The study was discontinued prematurely since the number of patients was too low. As a consequence, the group comparison is confined to the evaluation of the INR values measured using the two-tailed t test. Of the 202 patients included, 101 were assigned to the self-management group (64.6+/-9.6 years, 71.4% men) and 101 (64.1+/-8.9 years, 61.4% men, n.s.) were assigned to the group managed by the family doctor. The total number of INR measurements was 2 865. This comprised 2 072 measurements in patients under self-management and 793 in the family doctor group. The values were within the target range significantly more frequently (p=0.0061) in patients under self-management (67.8%) as compared to the family doctor group (58.5%). There was a trend with regard to the time within target range, but the difference was not significant (178.8+/-126 days as compared to 155.9+/-118.4 days). In the self-management group, there were two severe hemorrhages, and there was one thromboembolic event in the family doctor group. Management of oral anticoagulation by INR self-management in patients with atrial fibrillation is not inferior to conventional care.
    Zeitschrift für Kardiologie 04/2005; 94(3):182-6. · 0.97 Impact Factor
  • Zeitschrift Fur Kardiologie - Z KARDIOL. 01/2005; 94(3):182-186.
  • A Bernardo, H Völler
    DMW - Deutsche Medizinische Wochenschrift 04/2001; 126(12):346-51. · 0.65 Impact Factor
  • A Bernardo, H Völler
    Deutsche Medizinische Wochenschrift - DEUT MED WOCHENSCHR. 01/2001; 126(12):346-351.
  • Thrombosis Research 06/2000; 98(4):287-93. · 3.13 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The objective of this open, randomized, multicenter study is to investigate the benefits and economic efficiency of self-management of oral anticoagulation in patients with atrial fibrillation (SMAAF study) in comparison with a group of patients given conventional care by a general practitioner or specialist. Two thousand patients suitable for self-management will be assigned at random to either the self-management group or the control group. The numbers of thromboembolic and hemorrhagic complications requiring treatment during the 2-year follow-up period will be recorded as the primary end point. The secondary endpoint variables will be maintenance of the INR value in the individual target range, INR variance, the course of complications over time, and the cost efficiency of self-management compared with the routine procedures. The last of these parameters will include the diagnostic and/or therapeutic measures carried out, the duration of inpatient hospital treatment, and the social consequences (subsequent rehabilitation treatment, inability to work, forced retirement). The estimate of the required number of patients was based on the assumption that during long-term anticoagulant therapy within the framework of primary and secondary prevention 4% of patients with chronic non-valvular atrial fibrillation would have severe thromboembolic of hemorrhagic complications each year. Since this rate can be halved by self-management, a one-tailed chi 2-test of 80% power and a 5% significance threshold would require n = 997 patients per group. The results of the SMAAF study will establish the socioeconomic benefits of self-management in patients with non-valvular atrial fibrillation.
    Zeitschrift für Kardiologie 05/2000; 89(4):284-8. · 0.97 Impact Factor
  • U Taborski, F J Wittstamm, A Bernardo
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    ABSTRACT: In this study, the cost-effectiveness of anticoagulation self-management--which is now established in Germany--was compared with the conventional method of monitoring oral anticoagulant therapy by the patient's family physician or by a specialist. Costs were determined based on the usual conditions in Germany such as frequency of testing and control testing, scope of the tests, and diagnostic and therapeutic standards for thromboembolic or bleeding complications. In addition to direct monitoring costs, we determined the costs for treating minor and serious complications and used them to calculate overall therapy costs. The incidence of complications was estimated based on the results of more recent studies. The only costs considered in this study were those covered by the primary cost carrier--the government-controlled health insurance funds--and included outpatient visits and, in cases of serious complications, acute inpatient treatment and rehabilitation. It was shown that the costs to treat minor complications only slightly affected annual, overall treatment costs. The potential reduction in incidences of serious bleeding and thromboembolic complications due to anticoagulation self-management--which is independent of the indication for oral anticoagulation--reduced overall therapy costs from DM 2,061.48/patient-year for conventional therapeutic methods to DM 1,342.46/patient-year for patients under self-management of anticoagulation.
    Seminars in Thrombosis and Hemostasis 02/1999; 25(1):103-7. · 4.22 Impact Factor