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[Randomized and nonrandomized controlled clinical trials in a German surgical journal]
M K Diener1, A Blümle, V Szakallas
1Deutsches Cochrane Zentrumsklinikum, Institut für Medizinische Biometrie und Medizinische Informatik, Universitätsklinikum Freiburg.
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.
