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[外科手术临床试验的影响]

[Impact of clinical trials for surgery].

作者信息

Seiler C M, Diener M K, Schuhmacher C

机构信息

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 110, Heidelberg, Germany.

出版信息

Chirurg. 2010 Apr;81(4):334-40. doi: 10.1007/s00104-009-1838-1.

DOI:10.1007/s00104-009-1838-1
PMID:20306010
Abstract

Clinical trials play a key role in patient care, academic education and research in surgery. Without valid studies the practice of evidence-based medicine is limited. Surgery is supported through funding by the German Ministry of Education and Research to establish an infrastructure for clinical trials. So far seven universities have worked together in a network since 2007 and successfully obtained funding for six large randomized trials from a program existing since 2004. Until now 2,249 patients have been randomized within 11 trials and 910 patients have been treated at local hospitals without academic responsibilities. An increase in the interest in clinical trials in daily practice has resulted through the certification of hospitals for special treatment that specifies that at least 5% of all patients are included in clinical trials.

摘要

临床试验在外科患者护理、学术教育及研究中发挥着关键作用。没有有效的研究,循证医学的实践就会受到限制。德国教育与研究部提供资金支持外科建立临床试验基础设施。自2007年以来,已有七所大学联合组成一个网络,并从2004年起实施的一个项目中成功获得了六项大型随机试验的资金。到目前为止,已有2249名患者在11项试验中被随机分组,另有910名患者在当地医院接受治疗,但这些医院没有学术任务。通过对特殊治疗医院进行认证,规定所有患者中至少5%要纳入临床试验,这使得日常实践中对临床试验的兴趣有所增加。

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引用本文的文献

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[Why nurses fly and surgeons rotate. The surgical study network CHIR-Net].[护士为何飞行而外科医生为何轮岗。外科研究网络CHIR-Net]
Chirurg. 2013 Jul;84(7):580-6. doi: 10.1007/s00104-013-2500-5.
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Surgical evaluation and knowledge transfer--methods of clinical research in surgery.外科评估和知识转移——外科临床研究方法。
Langenbecks Arch Surg. 2012 Dec;397(8):1193-9. doi: 10.1007/s00423-011-0775-x. Epub 2011 Mar 22.

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Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer.直肠前切除术后吻合口漏的定义和分级:直肠癌国际研究组的建议。
Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
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No surgical innovation without evaluation: the IDEAL recommendations.未经评估,不得进行手术创新:IDEAL 建议
Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.
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Challenges in evaluating surgical innovation.
评估手术创新的挑战。
Lancet. 2009 Sep 26;374(9695):1097-104. doi: 10.1016/S0140-6736(09)61086-2.
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Evaluation and stages of surgical innovations.外科创新的评估与阶段
Lancet. 2009 Sep 26;374(9695):1089-96. doi: 10.1016/S0140-6736(09)61083-7.
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Surgical research: the reality and the IDEAL.
Lancet. 2009 Sep 26;374(9695):1037. doi: 10.1016/S0140-6736(09)61678-0.
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Coordinating a national clinical trials center: the German experience.协调国家临床试验中心:德国的经验。
Surgery. 2009 Jun;145(6):590-7. doi: 10.1016/j.surg.2009.03.001. Epub 2009 Apr 19.
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[Clinical trials beyond the German Drug Law. Clinical trials in surgery].[德国药品法之外的临床试验。外科手术中的临床试验]
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2009 Apr;52(4):433-8. doi: 10.1007/s00103-009-0827-3.
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Four years of teaching principles in clinical trials--a continuous evaluation of the postgraduate workshop for surgical investigators at the study center of the German Surgical Society.四年的临床试验教学原则——对德国外科学会研究中心外科研究者研究生研讨会的持续评估
J Surg Educ. 2009 Jan-Feb;66(1):15-9. doi: 10.1016/j.jsurg.2008.08.003.
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Early metabolic response evaluation by fluorine-18 fluorodeoxyglucose positron emission tomography allows in vivo testing of chemosensitivity in gastric cancer: long-term results of a prospective study.
Clin Cancer Res. 2008 Apr 1;14(7):2012-8. doi: 10.1158/1078-0432.CCR-07-0934.
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Chirurg. 2007 Oct;78(10):938-44. doi: 10.1007/s00104-007-1404-7.