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Randomisierte kontrollierte und kontrollierte klinische Studien in der Zeitschrift „Der Chirurg“

Randomized and nonrandomized controlled clinical trials in a German surgical journal

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Zusammenfassung

Hintergrund

Die Zusammenfassung randomisierter kontrollierter und kontrollierter klinischer Studien (englisch: RCT und CCT) in systematischen Übersichtsarbeiten setzt die vollständige Erfassung aller Studien zu einer Fragestellung voraus. Ziel dieser Arbeit war die quantitative und qualitative Darstellung aller RCTs und CCTs in der Zeitschrift „Der Chirurg“.

Methoden

Es erfolgte eine Handdurchsuchung mit quantitativer und qualitativer Merkmalserfassung der Studien in „Der Chirurg“ von 1948 bis 2005 und ein Vergleich der Publikationshäufigkeiten (RCTs) mit führenden chirurgischen Zeitschriften.

Ergebnisse

Es wurden 112 (90 RCTs, 22 CCTs) Studien identifiziert. Eine Fallzahlberechnung wurde in 12 (13%), eine Beschreibung der Randomisierungstechnik in 44 (49%) und eine Analyse nach „intention to treat“ in 5 (6%) RCTs angegeben. Ab dem Jahr 2000 nehmen die RCTs in „Der Chirurg“ im Gegensatz zum internationalen Trend ab.

Schlussfolgerung

Verbesserte Rahmenbedingungen für Studien in der Chirurgie, die Umsetzung internationaler Standards (CONSORT Statement) und eine Änderung der Publikationsstrategie könnten die Quantität und Qualität deutschsprachiger RCTs und CCTs in „Der Chirurg“ steigern.

Abstract

Background

Comprehensive identification of relevant literature is mandatory for valid assessment of the effectiveness of surgical interventions. Thus, electronic database searches are often complemented by handsearching of relevant surgical journals. The aim of this study was to assess the quantity and quality of randomized controlled (RCTs) and controlled clinical trials (CCTs) in the German surgical journal Der Chirurg.

Methods

Quantitative and qualitative assessment was made after handsearching of studies published from 1948 to 2005 in Der Chirurg. Systematic database search (MEDLINE) was used for comparison of RCTs published in Der Chirurg and international surgical journals.

Results

Overall, 112 controlled clinical trials (90 RCTs, 22 CCTs) were identified by handsearching. The implementation of sample size calculation was reported in 12 of 90 (13%) RCTs. Forty-six (51%) did not specify the randomization process, and five (6%) incorporated the “intention to treat” principle in their analyses. After 2000, RCTs were published in declining frequency in Der Chirurg, whereas international surgical journals printed stable quantities of these studies.

Conclusion

Improving the prerequisites of patient-centered clinical research in surgery, rigorous implementation of principles of the CONSORT statement, and modified publication strategies may improve the quality and quantity of reports on clinical studies in Germany.

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Diener, M.K., Blümle, A., Szakallas, V. et al. Randomisierte kontrollierte und kontrollierte klinische Studien in der Zeitschrift „Der Chirurg“. Chirurg 77, 837–843 (2006). https://doi.org/10.1007/s00104-006-1211-6

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