继续解读：观察性研究报告规范STROBE声明

前一期，我们已对STROBE声明的方法部分做了详细解析，相信大家已了解观察性研究报告的研究设计、研究设置、变量、数据来源、样本大小及统计方法等各方面的规范，本期，我们继续解读STROBE声明的结果部分。

STROBE清单的“结果部分”清单详见下表，主要包括：研究对象、描述性资料、结局资料、主要结果和其他分析等条目。下面，我们就对每个条目做详细解析。

STROBE清单的“结果部分”

Item 13  研究对象

1)          报告研究各个阶段研究对象的数量，要尽量详细。

Ø   因为进入研究的人可能不同于研究结果适用的目标人群，导致患病率或发病率的估计值不能反映目标人群的水平；

Ø   例如：母亲生育年龄小和后代患白血病之间的关联，部分原因是有健康孩子的年轻母亲会比有不健康孩子的年轻母亲更少参加这种调查研究。

2)          描述各阶段研究对象未能参与的原因，以便读者判断研究人群是否代表目标人群，是否会产生偏倚，例如：

Ø   横断面调查中，所选对象由于与健康无关的原因而不参加研究(如征集信函由于错误的地址而没有邮寄到)会影响估计的精度，但却可能不会产生偏倚。

3)          建议使用流程图，例如：

Item 14  描述性资料

Ø   描述研究对象的特征(如人口学、临床和社会特征)以及关于暴露和潜在混杂因素的信息以及关于暴露和潜在混杂因子的信息；

Ø   指出每个关心的变量有缺失值的研究对象数目、暴露、潜在混杂因子和患者的其他重要特征，不同程度和原因的失访；

Ø   队列研究总结随访时间，报告随访期限的最大值和最小值或总体分布的百分位数，总随访人年，所获得潜在数据的一些比例指标。

Item 15  结局资料

1)          报告发生结局事件（队列研究、横断面研究）或暴露类别（病例-对照研究）的数量；

2)          或根据时间总结发生结局事件的数量。

Item 16  主要结果

1)          给出未校正的和校正的混杂因素的关联强度估计值、精确度(如95％CI)；

Ø   阐明根据哪些混杂因素进行了调整以及选择这些因素的原因；

2)          当对连续性变量分组时，报告分组界值；

3)          如有关联，可将有意义时期内的相对危险度转化成绝对危险度。

Item 17  其他分析

1)          亚组分析：

Ø   分辨几个合适分类的亚组分别分析的关联与总体关联是否一致；

Ø   介绍在数据分析过程中出现的感兴趣的亚组，需报告准备进行哪些分析，没有准备的哪些分析；

2)          交互作用分析：

Ø   应同时报告每种暴露各自的效果和他们之间的联合作用及置信区间；

3)          敏感性分析：

Ø   有助于估计在缺失数据或可能的偏倚下得到的研究结果是否可靠；

Ø   如果所分析的问题很受关注，或者效应估计值变化很大时需要详细说明。

 

第二篇：STROBE声明：评价观察性研究报道质量的有效工具

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