精心设计和报告临床研究.doc

精心设计和报告临床研究 -- 解读CONSORT 方积乾 (中山大学公共卫生学院) 前言 推荐一篇文章 The CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration 作者：Altman, Schulz, Moher, Egger, Davidoff, Elbourne, G?tzsche and Lang for the CONSORT Group. 杂志: Annals of Internal Medicine，Volume 134 ? Number 8 66317 April 2001. 什么是 CONSORT Statement? Consolidated Standards of Reporting Trials : CONSORT statement (JAMA, 1996) DerSimonian and colleagues (N Engl J Med, 1982) 建议“编辑向作者提供一份他们希望认真报告的项目清单将会大大改善临床试验报告的质量” 。 早在1990年代，两组杂志编辑、试验人员和方法学专家独立地发表了关于试验报告的建议 (JAMA, 1994)。 接着，Rennie (JAMA, 1995) 强烈要求这两个小组会面，并发展一套共同的建议; 其成果就是 CONSORT statement。 此后，CONSORT statement的修改始于1999年。 2001年， The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials 同时发表于ANN Intern Med. , JAMA 和 Lancet 三个杂志，作者是The CONSORT Group。 CONSORT statement (Consolidated Standards of Reporting Trials): (1) 医学报告基本项目的清单(checklist) (2) 医学试验的病人流程图 (Flow Chart) 许多杂志，如 The Lancet, British Medical Journal, Journal of the AmericanMedical Association, Annals of Internal Medicine, Journal of Hand Surgery, Journal of Pediatric Psychology … 和越来越多的生物医学编辑部，如 The International Committee of Medical Journals Editors (Vancouver Group) 和 The Council of Science Editors 都正式支持CONSORT. 当人们必须做观察时，总是可能有偏倚。 良好设计的随机对照试验(RCT)是干预效果的最佳证据; 但方法学不当会夸大疗效； 粗糙设计和报告的试验会误导医疗卫生决策. Table 2. Checklist of Items To Include When Reporting a Randomized Trial? Paper Section and Topic Item Number Descriptor Title and abstract 1 How participants were allocated to interventions (e.g., “random allocation,” “randomized” or “randomly assigned”). Introduction Background 2 Scientific background and explanation of rationale. Methods Participants 3 Eligibility criteria for participants and the settings and locations where the data were collected. Interventions 4 Precise details of the interventions intended for each group and how and when they were actually administered. Objec