（优质课件）医学研究报告规范——CONSORT声明.ppt

方法（Methods） 7b：如有，需解释中间分析和停止原则 Many trials recruit participants over a long period. If an intervention is working particularly well or badly, the study may need to be ended early for ethical reasons. This concern can be addressed by examining results as the data accumulate, preferably by an independent data monitoring committee. * 方法（Methods） 8a 随机分组序列的产生方式 8b 随机化的方式；任何限制性详细情况（如分层和区组大小） 9 如何来完成随机系列分配，如用数字产生器还是中心电话数字，数字安排是否随机隐藏，干预分配方案是否隐藏。 10 谁产生随机分配实验，谁登记参与者，谁分配参与者接受干预 11a 干预分配后谁是对分配情况不知道的（如参加者、护理者、结局评估者），如何评价盲法的成功性 11b 如有可能，描述干预措施的相似性 * 方法（Methods） * 12a 比较 主要结果和次要结果的统计方法分析 12b 附加的统计方法，例如对亚组的分析及矫正分析 方法（Methods） * 结果（Results） 13a 对每个组来说，随机分配各组的人数、接受预期处理、和主要结局分析的人数 13b 对每个组来说，随机化分组后参与者的丢失和排除，及理由 * CONSORT 2010 Flow Diagram Assessed for eligibility (n= ) Excluded (n= ) ¨? Not meeting inclusion criteria (n= ) ¨? Declined to participate (n= ) ¨? Other reasons (n= ) Analysed (n= )¨?Excluded from analysis (give reasons) (n= ) Lost to follow-up (give reasons) (n= ) Discontinued intervention (give reasons) (n= ) Lost to follow-up (give reasons) (n= ) Discontinued intervention (give reasons) (n= ) Analysed (n= )¨?Excluded from analysis (give reasons) (n= ) Analysis Follow-Up Randomized (n= ) Enrollment Allocated to intervention (n= ) ¨?Received allocated intervention (n= ) ¨?Did not receive allocated intervention (give reasons) (n= ) Allocated to intervention (n= ) ¨?Received allocated intervention (n= ) ¨?Did not receive allocated intervention (give reasons) (n= ) Allocation * CONSORT 2010 Flow Diagram * 结果（Results） 14a 决定病人入选标准和随访的时间 14b 为什么试验结束或停止 15 各组人口统计学和临床特征的基线资料表格 16 每组参加人数(分母)包括每次分析时及是否按最初分配进行分析均被包括进去，是否按最初分组分析 * 结果（Results） *