Zusammenfassung
Hintergrund
Lediglich auf Basis randomisierter, prospektiver klinischer Studien kann die Therapie von Patienten mit lebensgefährlichen Verletzungen oder Erkrankungen verbessert werden. Beobachtungen aus England und Nordamerika zeigten allerdings einen deutlichen Rückgang solcher Studien. Untersucht wurde der Beitrag deutschsprachiger Länder an Publikationen von klinischen randomisierten, prospektiven Studien in der Notfallmedizin der letzten 22 Jahre.
Methoden
Für den Zeitraum 01.01.1990 bis 31.12.2012 wurde eine Internetrecherche in der Onlinedatenbank Medline mit den (Tracer-)Diagnosen „Herz-Kreislauf-Stillstand“, „kardiopulmonale Reanimation“, „Polytrauma“, „hämorrhagischer Schock“, „Schädel-Hirn-Trauma“, „Schlaganfall“ oder „Herzinfarkt“ durchgeführt. Nur prospektive, randomisierte und kontrollierte Arbeiten aus Deutschland, Österreich und der Schweiz wurden aufgenommen.
Ergebnisse
Von 474 Studien aus deutschsprachigen Ländern erfüllten 25 (5,3 %) die Einschlusskriterien. Von 1990 bis Ende 2012 wurde gleichbleibend ca. eine prospektive, randomisierte, kontrollierte Studie pro Jahr aus Deutschland, Österreich und der Schweiz zu den genannten Diagnosen publiziert. Die Patientenzahl betrug im Median bei 159 (Minimum 16, Maximum 1219). Die meisten Studien (80 %) hatten ihren Ursprung in Deutschland und wurden überwiegend im Fachbereich der Anästhesiologie (68 %) durchgeführt. In 68 % der Studien war der „Herz-Kreislauf-Stillstand“ das untersuchte Thema. Etwa die Hälfte der Studien bekam finanzielle Unterstützung von der Industrie.
Schlussfolgerung
In dieser retrospektiven Studie konnte keine eindeutige Zu- oder Abnahme an prospektiven, randomisierten, kontrollierten Studien in der deutschsprachigen Notfallmedizin der letzten 22 Jahre festgestellt werden, obwohl insgesamt die Zahl an notfallmedizinischen Studien zugenommen hat. Pro Jahr kommt durchschnittlich nur eine prospektive, randomisierte, klinische Studie mit notfallmedizinischen (Tracer-)Kerndiagnosen aus Deutschland, Österreich oder der Schweiz.
Abstract
Background
Only randomized clinical trials can improve the outcome of life-threatening injuries or diseases but observations from England and North America suggest that the number of such randomized clinical trials is decreasing. In this study contributions from German speaking countries with regards to randomized clinical trials in emergency medicine over the last 22 years were investigated.
Methods
The Medline database was searched from January 1990 to December 2012 for prospective randomized clinical trials in the prehospital setting using the criteria “cardiac arrest”, “cardiopulmonary resuscitation”, “multiple trauma”, “hemorrhagic shock”, “head trauma”, “stroke” as well as myocardial infarction and emergency medical service. Only studies originating from Germany, Austria or Switzerland were included.
Results
A total of 474 studies were found and 25 studies (5.3 %) fulfilled the inclusion criteria. In the last 22 years German speaking countries have published approximately one prospective, randomized, clinical trial per year on prehospital emergency medicine. The median number of patients included in the trials was 159 (minimum 16, maximum 1,219). Most (80 %) studies originated from Germany and most (64 %) studies were conducted by anesthesiology departments. Cardiac arrest was the most frequent subject of the investigated studies. Approximately 50 % of the studies had financial support from industrial companies.
Conclusion
A significant increase or decrease in the number of prospective randomized clinical trials in the out-of-hospital setting could not be found in German speaking countries despite the fact that the absolute numbers of studies had increased. Only about one prospective, randomized clinical trial with an emergency medicine core tracer diagnosis originated from Germany, Austria and Switzerland per year.
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Interessenkonflikt. J. Ausserer, T. Abt, K.H. Stadlbauer, P. Paal, J. Kreutziger, K.H. Lindner, V. Wenzel geben an, dass kein Interessenkonflikt besteht. Der Beitrag enthält keine Studien an Menschen oder Tieren.
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Diese Arbeit beruht auf der Diplomarbeit von T. Abt.
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Ausserer, J., Abt, T., Stadlbauer, K. et al. Außerklinische Notfallmedizin in Deutschland, Österreich und der Schweiz. Anaesthesist 63, 54–61 (2014). https://doi.org/10.1007/s00101-013-2259-6
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DOI: https://doi.org/10.1007/s00101-013-2259-6