Sex and Gender Differences Research Design for Basic, Clinical, and Population Studies: Essentials for Investigators.
Sex and Gender Differences Research Design for Basic, Clinical, and Population Studies: Essentials for Investigators.
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DOI：
10.1210/er.2017-00246
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发表时间：
2018-08-01
影响因子：
20.3
通讯作者：
Goldstein JM
中科院分区：
文献类型：
--
作者：
Rich-Edwards JW;Kaiser UB;Chen GL;Manson JE;Goldstein JM
性别和性别知情的观点增加了严谨性，促进了发现，并扩大了生物医学研究的相关性。在当前对男性和女性数据负责的时代，深思熟虑的方法可以改善性别和性别差异研究的研究设计和推断。我们讨论了动机、受试者选择、样本量、数据收集、分析和解释等问题，并考虑了对基础、临床和人口研究的影响。我们特别关注测试性别/性别差异的方法，作为影响修改或相互作用，并讨论为什么从性别分层数据中得出的一些推论应该谨慎看待。如果没有仔细的方法，尽管有资助机构的授权，但对性别差异研究的追求将导致矛盾的文献。然而，鉴于历史上对性别差异缺乏关注，没有性别差异的证据并不一定是没有性别差异的证据。为了推动所有性别和性别的科学和治疗发现，需要深思熟虑地构思和实施性别和性别差异研究。综述了基础、临床和人口研究中性别和性别差异研究的研究动机、主题选择、样本量、数据收集、分析和解释。
A sex- and gender-informed perspective increases rigor, promotes discovery, and expands the relevance of biomedical research. In the current era of accountability to present data for males and females, thoughtful and deliberate methodology can improve study design and inference in sex and gender differences research. We address issues of motivation, subject selection, sample size, data collection, analysis, and interpretation, considering implications for basic, clinical, and population research. In particular, we focus on methods to test sex/gender differences as effect modification or interaction, and discuss why some inferences from sex-stratified data should be viewed with caution. Without careful methodology, the pursuit of sex difference research, despite a mandate from funding agencies, will result in a literature of contradiction. However, given the historic lack of attention to sex differences, the absence of evidence for sex differences is not necessarily evidence of the absence of sex differences. Thoughtfully conceived and conducted sex and gender differences research is needed to drive scientific and therapeutic discovery for all sexes and genders. A review of study motivation, subject selection, sample size, data collection, analysis, and interpretation in sex and gender differences research for basic, clinical, and population studies is provided.
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