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Journal of Chinese Integrative Medicine ›› 2009, Vol. 7 ›› Issue (4): 392-397.

• Biomedical Publication • Previous Articles     Next Articles

Improving the reporting of pragmatic trials: An extension of the CONSORT statement

Zwarenstein Ma,b,c,Treweek Sd,e,Gagnier JJf,Altman DGg,Tunis Sh,Haynes Bi,Oxman ADe,Moher Dj,k   

  1. a Health Services Sciences, Sunnybrook Hospital, Toronto, Ontario, Canada
    b Institute for Clinical Evaluative Sciences, Toronto Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
    c Division of International Health (IHCAR), Karolinska Institute, Stockholm, Sweden
    d Clinical and Population Sciences and Education, University of Dundee, Dundee, United Kingdom
    e Norwegian Knowledge Centre for the Health Services, Oslo, Norway
    f Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
    g Centre for Statistics in Medicine, University of Oxford，Oxford，United Kingdom
    h Center for Medical Technology Policy, Baltimore, Maryland, USA
    i Department of Clinical Epidemiology and Biostatistics and Department of Medicine, McMaster University Faculty of Health Sciences，Hamilton, Ontario, Canada
    j Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Canada
    k Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada
  • Online:2009-04-20 Published:2009-04-15

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解释性试验 实效性试验
问题 效力（efficacy）——该干预措施是否有效? 效果（effectiveness）——在现实环境中,该干预措施是否有效?
试验实施场所 具有充分资源配置的“理想”场所 现实环境
研究对象 严格选择。依从性低的患者和那些具有可能减弱干预效果情况的患者常常被排除 排除标准很低或者没有超出临床实际
干预 严格实施,严格监控患者依从性 运用灵活,与临床实际相似
结局 常常是替代指标或是过程测量 与研究对象、出资者、社区和保健人员直接相关
与实践的相关性 间接关联——试验设计未充分满足那些决定选择何种治疗方案的人所需要的实施干预措施的现实临床场所 直接关联——试验设计满足那些决定选择何种治疗方案的人所需要的实施干预措施的场所

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以解释为主的试验 以实效性为主的试验
问题 70%~99％具有颈动脉狭窄症状的患者实施颈动脉内膜切除术合用最佳药物治疗与单用最佳药物治疗比较,前者是否能降低两年严重卒中发作或者死亡率? 合格针灸师实施短期针灸疗法能否减少患有长期非特异性腰痛患者的疼痛?
试验实施场所 美国和加拿大自愿参加研究的学术型医院和专科医院,拥有神经和神经外科多学科队伍和详尽的操作手册,死亡率低 英国全科医疗和私人针灸门诊
研究对象 根据患者颈动脉狭窄症状的严重程度分层,颈动脉狭窄严重组（高风险组）被认为颈动脉内膜切除术最有可能对其有效,保证其基本利益。排除标准包括智力障碍和其他可能导致5年内死亡的疾病。如果患者有7种疾病中的任何一种病,在病情不稳定时也暂时被视为不合格对象（比如,高血压或糖尿病未得到控制者） 18~65岁（无性别限制）,非特异性腰痛4~52周,被其全科医生判定符合研究受试人群标准。患脊柱疾病者排除
干预 必须实施颈动脉内膜切除术（不使用支架或者其他术式）,不过,外科医生有选择如何行此术的权利。外科医生由专家组指定,必须在过去的24个月内至少做过颈动脉内膜切除术50次,且术后并发症（30 d内中风或死亡）发生率低于6％。是否依从研究治疗方案由中心监控,在监控缺乏时研究主管到现场巡视 针灸师根据患者的需要决定治疗方法和治疗次数
结局 主要结局指标：再次发生同侧中风的时间,结局可能主要受到颈动脉内膜切除术的影响。次要结局指标：各类型卒中、严重卒中和死亡 主要结局指标：用36条目简明量表（SF-36）测量疼痛。次要结局指标：服用止疼药和患者的满意度
与实践的相关性 间接——患者和临床医生都经过严格选择,结论实用范围不清楚 直接——全科医生和患者能立即利用试验结果做出治疗决策

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项目 条目 《CONSORT声明》标准说明 实效性试验补充
标题和摘要 1 患者如何被分配（如随机分配）
引言
背景 2 科学背景与原理解释 说明干预措施所针对的卫生或卫生服务问题或其他通常用以解决这一问题的干预措施
方法
研究对象 3 纳入标准;试验数据采集场所 纳入标准应该清楚明白,以显示纳入研究的典型研究对象的界限;如果可能的话,还应交待典型干预实施者（如护士）、机构（如医院）、社区或居住区（如城镇）和场所（如不同的卫生福利体系）
干预 4 明确各组干预措施的细节、干预时间和干预地点 说明完成干预所添加的或减少的措施。指出是否将干预措施标准化,或者是否允许不同的研究对象、实施者或研究地点采取不同的干预措施和途径
同等细化描述对照组
目的 5 明确的目标和假设
结局 6 明确定义主要结局和次要结局,如果可行,交待任何能够提高测量质量的方法（如多次观察和评估员培训） 解释为何选择结局及随访期的长短（如相关的话）,这些对于使用试验结果的人来说十分重要
样本量 7 样本量如何计算;如果可行,交待任何期间分析（interim analyses）和终止规则（如有的话） 针对目标决策者的需要考虑的重要最小差异,以此计算样本量（最低重要差异）,需报告该差异的依据如何获得
随机分配序列
产生		 8 用以产生随机分配序列的方法,包括任何限制性条件的细节（如区组、分层）
随机分配隐藏 9 实施随机的方法（如抽签或中心电话分配）,明确在实施干预之前分配是否隐藏
随机化实施 10 谁生成随机分配序列,谁招募研究对象,谁将研究对象分组
盲法（遮蔽） 11 是否对研究对象、干预措施实施者以及结局评估者实施了盲法 如果没有实施盲法,或者无法实施,解释其原因
统计学方法 12 主要结局指标组间比较统计方法;补充分析方法,如亚组分析和校正分析
结果
研究对象流程图 13 每一阶段研究对象的流程（强烈推荐用图表描述）,特别是每组随机分组的例数、接受干预措施的例数、研究方案的完成过程以及主要结局分析,说明偏离原研究方案之处及其原因 参加试验的研究对象或单位的数目、合格的研究对象数目以及未参与试验对象的原因都应报告
招募 14 招募和随访的日期
基线资料 15 人口统计学基线资料和每组临床特征
分析的例数 16 每项分析中每组研究对象人数（分母）,注明是否采用了意向性分析;如果可能,应该采用绝对数报告结果（例如10/20,而非50%）
结局与判断 17 对于每一项主要结局和次要结局,概括报告每组的结果、判断效果及其精确度（如95％可信区间）
辅助分析 18 是否采用多因素分析报告所有其他已执行的分析,包括亚组分析和校正分析,指出哪些是事先设定的,哪些是探索性的
不良事件 19 接受干预措施的所有组发生的所有重要的不良反应或副作用事件
讨论
解释 20 解释结果,要考虑研究假设、潜在的偏倚或不严密之处,以及与多因素分析和结局评价相关的危险
实用性 21 试验结论的外部真实性 描述决定试验结果的关键研究场所信息。讨论在其他场景下的临床传统习惯、卫生服务机构、服务人员或资源与本试验可能存在的区别之处
当前所有证据 22 关于当前证据结论的综合解释
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