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创伤外科临床试验设计:克服研究障碍。

Designing clinical trials in trauma surgery: overcoming research barriers.

机构信息

University of Warwick, Warwick MedicalSchool, Clinical Sciences Research Laboratories, Clifford BridgeRoad, Coventry, CV2 2DX, UK.

出版信息

Bone Joint Res. 2014 Apr 24;3(4):123-9. doi: 10.1302/2046-3758.34.2000283. Print 2014.

DOI:10.1302/2046-3758.34.2000283
PMID:24764547
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4036301/
Abstract

The surgical community is plagued with a reputation for both failing to engage and to deliver on clinical research. This is in part due to the absence of a strong research culture, however it is also due to a multitude of barriers encountered in clinical research; particularly those involving surgical interventions. 'Trauma' amplifies these barriers, owing to the unplanned nature of care, unpredictable work patterns, the emergent nature of treatment and complexities in the consent process. This review discusses the barriers to clinical research in surgery, with a particular emphasis on trauma. It considers how barriers may be overcome, with the aim to facilitate future successful clinical research. Cite this article: Bone Joint Res 2014;3:123-9.

摘要

外科领域一直面临着未能参与和开展临床研究的声誉问题。这部分是由于缺乏强烈的研究文化,但也是由于在临床研究中遇到了许多障碍;特别是那些涉及外科干预的障碍。由于护理的计划性、工作模式的不可预测性、治疗的紧急性和同意过程的复杂性,“创伤”放大了这些障碍。本文讨论了外科临床研究中的障碍,特别是创伤。它考虑了如何克服障碍,旨在促进未来成功的临床研究。引用本文:Bone Joint Res 2014;3:123-9.

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Designing clinical trials in trauma surgery: overcoming research barriers.创伤外科临床试验设计:克服研究障碍。
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本文引用的文献

1
World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言:涉及人类受试者的医学研究伦理原则》
J Am Coll Dent. 2014 Summer;81(3):14-8.
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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言:涉及人类受试者的医学研究伦理原则》
JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053.
3
The Warwick Hip Trauma Evaluation Two -an abridged protocol for the WHiTE Two Study: An embedded randomised trial comparing the Dual-Mobility withpolyethylene cups in hip arthroplasty for fracture.沃里克髋关节创伤评估 2:WHiTE 2 研究的简化方案:一项嵌入式随机试验,比较双动与聚乙烯杯在髋部骨折置换术中的应用。
Bone Joint Res. 2013 Oct 2;2(10):210-3. doi: 10.1302/2046-3758.210.2000186. Print 2013.
4
The Warwick Hip Trauma Evaluation One -an abridged protocol for the WHiTE One Study: An embedded randomised trial comparing the X-bolt with slidinghip screw fixation in extracapsular hip fractures.沃里克髋关节创伤评估一 - WHiTE One 研究的简化方案:一项嵌入式随机试验,比较 X-bolt 与滑动髋螺钉固定在髋关节囊外骨折中的应用。
Bone Joint Res. 2013 Oct 2;2(10):206-9. doi: 10.1302/2046-3758.210.2000183. Print 2013.
5
Proposed revisions to the EU clinical trials directive--comments from the European Resuscitation Council.欧盟临床试验指令的拟议修订——欧洲复苏委员会的意见
Resuscitation. 2013 Mar;84(3):263-4. doi: 10.1016/j.resuscitation.2013.01.018.
6
Understanding surgical interventions in RCTs: the need for better methodology.理解随机对照试验中的外科干预措施:对更好方法学的需求。
Lancet. 2013 Jan 5;381(9860):27-8. doi: 10.1016/S0140-6736(13)60015-X.
7
UK DRAFFT - a randomised controlled trial of percutaneous fixation with kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius.英国草案——一项经皮克氏针固定与掌侧锁定钢板固定治疗桡骨远端背侧移位骨折的成年患者的随机对照试验。
BMC Musculoskelet Disord. 2011 Sep 13;12:201. doi: 10.1186/1471-2474-12-201.
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Successful recruitment to trials: a phased approach to opening gates and building bridges.成功招募试验参与者:分阶段的方法,打开大门并架起桥梁。
BMC Med Res Methodol. 2011 May 19;11:73. doi: 10.1186/1471-2288-11-73.
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The successful integration of research and care: how pediatric oncology became the subspecialty in which research defines the standard of care.研究与医疗的成功融合:儿科肿瘤学如何成为以研究定义医疗标准的亚专科。
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Strategies for increasing recruitment to randomised controlled trials: systematic review.增加随机对照试验招募的策略:系统评价。
PLoS Med. 2010 Nov 9;7(11):e1000368. doi: 10.1371/journal.pmed.1000368.