M N Wente1, W Schwenk, C M Seiler. 1. Studienzentrum der Deutschen Gesellschaft für Chirurgie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg. moritz.wente@med.uni-heidelberg.de
Abstract
BACKGROUND: Information about multicenter randomized controlled trials (mRCT) comparing surgical procedures that are open for patient recruitment is hardly available for potentially interested surgeons. On the other hand many mRCT fail because of poor recruitment of participating surgeons, not just of patients. MATERIAL AND METHOD: The available items in the International Clinical Trials Registry Platform (ICTRP) of the World Health Organisation were analyzed for their relevance to surgeons, and a basic data set was extracted by two surgeons in a consensus procedure. RESULTS: Of 20 items in the ICTRP, seven were identified as relevant to the surgeon in practice: study acronym with register number, principal investigator, patients, surgical procedures, status of the study (randomized patients and sample size), financing and case money, and contact information. DISCUSSION: In a new column introduced into the German surgical journal"Der Chirurg", a regularly updated list of recruiting mRCT will be printed. The trials must be registered internationally and provide basic information for interested surgeons. CONCLUSION: Through this new heading, improvements are expected in communication between surgeons performing trial studies, patient recruitment, and in planning, conducting, and analyzing mRCT.
BACKGROUND: Information about multicenter randomized controlled trials (mRCT) comparing surgical procedures that are open for patient recruitment is hardly available for potentially interested surgeons. On the other hand many mRCT fail because of poor recruitment of participating surgeons, not just of patients. MATERIAL AND METHOD: The available items in the International Clinical Trials Registry Platform (ICTRP) of the World Health Organisation were analyzed for their relevance to surgeons, and a basic data set was extracted by two surgeons in a consensus procedure. RESULTS: Of 20 items in the ICTRP, seven were identified as relevant to the surgeon in practice: study acronym with register number, principal investigator, patients, surgical procedures, status of the study (randomized patients and sample size), financing and case money, and contact information. DISCUSSION: In a new column introduced into the German surgical journal"Der Chirurg", a regularly updated list of recruiting mRCT will be printed. The trials must be registered internationally and provide basic information for interested surgeons. CONCLUSION: Through this new heading, improvements are expected in communication between surgeons performing trial studies, patient recruitment, and in planning, conducting, and analyzing mRCT.
Authors: Catherine D DeAngelis; Jeffrey M Drazen; Frank A Frizelle; Charlotte Haug; John Hoey; Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A John P M Overbeke; Torben V Schroeder; Hal C Sox; Martin B Van Der Weyden Journal: JAMA Date: 2004-09-08 Impact factor: 56.272
Authors: Hanns-Peter Knaebel; Markus K Diener; Moritz N Wente; Hartwig Bauer; Markus W Büchler; Matthias Rothmund; Christoph M Seiler Journal: Langenbecks Arch Surg Date: 2005-02-22 Impact factor: 3.445
Authors: Alison M McDonald; Rosemary C Knight; Marion K Campbell; Vikki A Entwistle; Adrian M Grant; Jonathan A Cook; Diana R Elbourne; David Francis; Jo Garcia; Ian Roberts; Claire Snowdon Journal: Trials Date: 2006-04-07 Impact factor: 2.279