Doubly blind: a systematic review of gender in randomised controlled trials.
Doubly blind: a systematic review of gender in randomised controlled trials.
复制标题
DOI：
10.3402/gha.v9.29597
复制
发表时间：
2016
影响因子：
2.6
通讯作者：
Hamberg K
中科院分区：
文献类型：
--
作者：
Phillips SP;Hamberg K
尽管观察数据显示性别或社会经济地位等社会特征是健康的强有力预测因素，但在随机对照研究（RCTs）中很少研究它们的影响。使用随机抽样的最近随机对照试验从高影响力的期刊，我们研究了如何最经常记录的社会特征，性别/性别，是考虑在设计，分析和解释。从2008年9月至2013年12月31日发表在《内科学年鉴》、《英国医学杂志》、《柳叶刀》、《加拿大医学协会杂志》或《新英格兰医学杂志》上的712项RCT中，我们随机选择了57项，分析了资金、方法、中心数量、社会环境文件、纳入/排除标准、女性/男性比例、并在分析和讨论中报告性/性别问题。大多数研究记录了参与者的性别（52/57）。39%的人中男女比例大致相等。在43%没有明确排除妇女的研究中，男子人数过多，这表明选择过程受到了干扰。少数分析了性别/性别差异的研究（22%）没有讨论或反思这些问题，或者忽视了重要的发现。两项研究强化了关于女性角色的传统观念，发现母乳喂养对婴儿健康没有影响，但报告了可能的好处。值得怀疑的方法，如在研究中改变方案，不确定的排除标准，允许当地研究人员将参与者从研究中删除，以及在没有发现的情况下提出可能的益处，特别是在行业资助的研究中。性别等社会特征在RCT的分析和解释中仍然是隐藏的，从设计到解释的过程中沿着伴随着信息的丢失和错误的嵌入，因此，在临床实践中也是如此。我们的研究结果表明，为了扩大外部效度，特别是，需要更精细的试验设计和分析，考虑性别/性别和其他社会特征。
Although observational data show social characteristics such as gender or socio-economic status to be strong predictors of health, their impact is seldom investigated in randomised controlled studies (RCTs). Using a random sample of recent RCTs from high-impact journals, we examined how the most often recorded social characteristic, sex/gender, is considered in design, analysis, and interpretation. Of 712 RCTs published from September 2008 to 31 December 2013 in the Annals of Internal Medicine, British Medical Journal, Lancet, Canadian Medical Association Journal, or New England Journal of Medicine, we randomly selected 57 to analyse funding, methods, number of centres, documentation of social circumstances, inclusion/exclusion criteria, proportions of women/men, and reporting about sex/gender in analyses and discussion. Participants’ sex was recorded in most studies (52/57). Thirty-nine percent included men and women approximately equally. Overrepresentation of men in 43% of studies without explicit exclusions for women suggested interference in selection processes. The minority of studies that did analyse sex/gender differences (22%) did not discuss or reflect upon these, or dismissed significant findings. Two studies reinforced traditional beliefs about women's roles, finding no impact of breastfeeding on infant health but nevertheless reporting possible benefits. Questionable methods such as changing protocols mid-study, having undefined exclusion criteria, allowing local researchers to remove participants from studies, and suggesting possible benefit where none was found were evident, particularly in industry-funded research. Social characteristics like sex/gender remain hidden from analyses and interpretation in RCTs, with loss of information and embedding of error all along the path from design to interpretation, and therefore, to uptake in clinical practice. Our results suggest that to broaden external validity, in particular, more refined trial designs and analyses that account for sex/gender and other social characteristics are needed.