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正确报告随机对照临床试验(randomized controlled trial,RCT)是严格评价试验结果真实性与有效性的必要前提。含22项条目清单和流程图的CONSORT(Consolidated Standards of Reporting Trials)声明旨在通过改进RCT的报告来解决这一问题。然而,《CONSORT声明》中没有专门论及那些适用于非药物治疗(如手术、技术干预、仪器设备、康复理疗、心理治疗和行为干预等)临床试验的具体问题。此外,相当多的证据表明非药物临床试验的报告仍然需要改进,因此CONSORT小组针对评估非药物治疗的临床INFORMATION FOR AUTHORS试验制定了《CONSORT扩展声明》。为制定《CONSORT扩展声明》以规范非药物临床试验的报告,33名专家于2006年2月在法国巴黎组织召开了讨论会议,并就此达成了共识。与会者扩充了原有《CONSORT声明》中的11项条目,新增了1项条目,修改并重新制定了报告流程图。为便于充分理解和执行《CONSORT扩展声明》,CONSORT小组通过对文献的回顾编制了这一说明与详述文本,旨在为正确报告非药物临床试验提供范例。本扩展声明,连同《CONSORT声明》以及《CONSORT声明》的其他扩展本,将有助于改进非药物治疗领域RCT的报告。
Correct reporting of randomized controlled trials (RCTs) is a necessary prerequisite for a rigorous assessment of the authenticity and validity of the test results. The CONSORT (Consolidated Standards of Reporting Trials) statement, which contains a list of 22 entries and flowcharts, is intended to address this issue by improving the RCT’s report. However, the CONSORT Statement does not specifically address specific issues that are relevant for clinical trials of non-medical treatments such as surgery, technical interventions, equipment, rehabilitation physiotherapy, psychotherapy and behavioral interventions. In addition, there is considerable evidence that reporting of non-drug clinical trials still needs improvement, so the CONSORT team has developed the CONSORT Statement of Extensions for the clinical INFORMATION FOR AUTHORS trial to evaluate non-drug therapies. In order to develop the “CONSORT Statement of Expansion” to standardize the report on non-drug clinical trials, 33 experts organized a discussion meeting in February 2006 in Paris, France, and reached a consensus on this. Participants expanded 11 of the original CONSORT Statement, added an entry, revised and re-established the flow chart of the report. To facilitate a full understanding and implementation of the CONSORT Statement of Expansion, the CONSORT Group has prepared this note and the detailed text through a review of the literature, aiming to provide an example for the proper reporting of non-drug clinical trials. This Statement of Extensions, together with the CONSORT Statement and other extensions to the CONSORT Statement, will help improve the RCT’s report in the area of non-drug treatment.