Entwicklung einer evidenzbasierten Leitlinie zur kardiologischen Rehabilitation - Phase 1: Bewertende Literaturanalyse

 

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Zusammenfassung

Hintergrund: Leitlinien sind ein Instrument zur Umsetzung evidenzbasierter Medizin in die Praxis auch für die Rehabilitation. Ein 1998 von der BfA gefördertes Projekt zur kardiologischen Rehabilitation kommt zu dem Ergebnis, dass die 1995 von der Agency for Health Care Policy and Research (AHCPR) publizierte Leitlinie als Rahmenleitlinie für die kardiale Rehabilitation koronarer Patienten von der BfA übernommen werden sollte. Die Wirksamkeit der kardialen Rehabilitation kann zwar auf der Basis dieser und anderer systematischer Übersichtsarbeiten als belegt angesehen werden, allerdings werden keine dezidierten Aussagen zu Struktur- und Prozessvorgaben einer mehrdimensionalen, umfassenden kardialen Rehabilitation gemacht. Vor diesem Hintergrund wurden therapeutische Interventionen in Studien, die eine Effektivität der kardialen Rehabilitation belegen, näher analysiert, um die für eine effektive kardiale Rehabilitation zentralen Elemente zu charakterisieren und für eine evidenzbasierte Leitlinie zu konkretisieren. Methodik: Grundlage bilden die in der AHCPR-Leitlinie zitierten wissenschaftlichen Arbeiten, die ergänzt wurden um nach Erscheinen der Leitlinie publizierte (randomisierte) kontrollierte Studien. Nach Anwendung a priori definierter Kriterien wurde ein Drittel (n = 53) der 159 mittels systematischer Recherche identifizierten Studien zur Leitlinienkonkretisierung herangezogen. Charakteristika des Studiendesigns, der Intervention und der erzielten Outcomes wurden in ein standardisiertes Datenextraktionsblatt übertragen. Um die Vergleichbarkeit zu erleichtern, wurden die vorliegenden Studien nach Interventionen und untersuchten Zielgruppen geordnet. Aus Gründen der Übersichtlichkeit können nicht alle Ergebnisse dargestellt werden, so dass sich die Publikation auf wesentliche, das Vorgehen illustrierende Aspekte konzentriert. Ergebnisse: 32 der 53 berücksichtigten Studien wurden zur Indikation „Myokardinfarkt” (MI) durchgeführt. In diesen 32 Studien wurden insgesamt 40 Interventionen an 2912 Patienten untersucht. 28 der 40 Interventionen befassen sich mit Ausdauertraining bzw. Ausdauertraining und weiteren Bewegungselementen (z. B. Krafttraining), 7 Interventionen beinhalten nur Beratungselemente und 5 Interventionen umfassen sowohl Bewegungs- als auch Beratungselemente. Mit einem Ausdauertraining wird in der Regel 3 - 4 Wochen nach MI begonnen. Überwiegend wird etwa 30 - 60 Minuten drei- bis 5mal pro Woche trainiert. Die Trainingsintensität beträgt entweder 65 - 85 % der im Belastungstest ermittelten maximalen Herzfrequenz oder ca. 70 % der ermittelten maximalen Sauerstoffaufnahme. Alle Interventionen erhöhen die Belastungstoleranz. Der Netto-Zugewinn im Vergleich zu unbehandelten Kontrollgruppen liegt dabei zwischen + 11 % und + 30 %. Je höher die Trainingsintensität, desto größer die Trainingseffekte. Ergebnisparameter wie psychisches Wohlbefinden, Wiedereingliederung in den Beruf oder die Modifikation von Risikofaktoren werden in der Mehrzahl der Studien zur Evaluation eines Ausdauertrainings nach MI nicht erhoben. Diskussion: Trotz mitunter verbesserungsfähiger Reportqualität und methodischer Limitationen der vorliegenden Studien lassen sich aus der detaillierten Analyse der Interventionen konkrete Hinweise auf die optimale Gestaltung kardialer Rehabilitation ableiten. Für die zentralen Elemente können relevante Charakteristika quantifiziert und in „Behandlungskorridore” übersetzt werden. Dabei wird Kompatibilität mit der KTL (Klassifikation therapeutischer Leistungen in der medizinischen Rehabilitation) angestrebt, um in einem nächsten Schritt anhand der KTL-Statistiken die Bereiche zu identifizieren, in denen sich statistisch gesicherte Unterschiede zwischen den definierten Vorgaben und den in der Rehabilitationspraxis erbrachten Leistungen zeigen. Als weiterer Schritt zu einer evidenzbasierten, empirisch abgesicherten, praktikablen und akzeptablen Leitlinie ist geplant, die Ergebnisse des Projektes mit Experten aus Klinik und Wissenschaft zu konsentieren.

Abstract

Background: Guidelines are a means to support effective clinical practice and can be used to implement evidence-based medicine in rehabilitative practice. In 1998 a study on cardiac rehabilitation, funded by Bundesversicherungsanstalt für Angestellte, BfA, concluded that the AHCPR's Guideline on Cardiac Rehabilitation published in 1995 could be used as a reference guideline for the rehabilitation of coronary patients. The AHCPR Guideline and other systematic reviews showed cardiac rehabilitation to be an effective means in coronary care. However, no detailed information is given with regard to the structural and processual details that are required for a multidimensional and comprehensive cardiac rehabilitation scheme. To define those central characteristics, therapeutic interventions that had been proven to be effective for cardiac rehabilitation were analysed. The information derived from these analyses will then be used to develop a more detailed evidence-based guideline. Methods: The analysis was based on the research cited in the AHCPR Guideline. Additionally, a systematic search of the literature identified (randomised) controlled studies published after 1995 for the analysis. Using criteria that had been developed prior to our review, one third (n = 53) of the 159 studies identified were considered suitable for further analysis. Characteristics of the study design, the interventions and the outcomes reported were extracted on a standardised data sheet. In order to facilitate comparisons, studies were arranged according to main intervention and target groups. As it is not possible to present the results in their entirety, this publication focuses on the main aspects which illustrate the method applied. Results: 32 of the 53 studies included dealt with patients after myocardial infarction (MI). In these 32 studies a total of 40 interventions (in 2,912 patients) were investigated. 28 of these interventions dealt with exercise training or exercise training combined with other physical training (i. e. strength training). 7 interventions dealt with counselling only, and 5 interventions had exercise training and counselling as integral parts. Exercise training starts mainly three to four weeks after MI, for 30 - 60 minutes three to 5 times a week. Usually, training intensity is set at 65 - 80 % of the maximum heart rate (or 70 % of the maximum oxygen consumption) reached in standardised exercise testing. All interventions lead to gains in exercise tolerance. Compared to untreated control groups the net benefit ranges from + 11 % to + 30 %. The higher the intensity of the training, the larger the net benefit. The majority of the studies on the effectiveness of exercise training after MI do not report outcomes like psychological well-being, return to work or modification of risk factors. Discussion: Despite limitations in report quality and methodology in some of the studies included, a detailed analysis of the interventions investigated can be used to substantiate optimal cardiac rehabilitation. It is possible to quantify important characteristics of the main elements and to define lower and upper limits of treatment. While formulating these limits, it is intended to maintain compatibility with the BfA Classification of therapeutic measures in medical rehabilitation (KTL). As a next step the data from the KTL statistics will be used to assess the scope of German rehabilitative care to define areas which do not comply with the limits defined in the guideline. The results will be consented with experts from science and clinical practice in order to develop an evidence-based, empirically founded, practicable and acceptable guideline for cardiac rehabilitation.

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Dr. med. Eva Maria BitzerM.P.H. 

ISEG - Institut für Sozialmedizin, Epidemiologie und Gesundheitssystemforschung

Lavesstr. 80

30159 Hannover

Email: bitzer@iseg.org