Representation of elderly persons and women in published randomized trials of acute coronary syndromes
Representation of elderly persons and women in published randomized trials of acute coronary syndromes
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DOI：
10.1001/jama.286.6.708
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发表时间：
2001-08-08
影响因子：
120.7
通讯作者：
Peterson, ED
中科院分区：
文献类型：
--
作者：
Lee, PY;Alexander, KP;Peterson, ED
背景1990年以前的随机对照试验（RCT）中老年人和女性的代表性不足。从那时起，人们一直在努力纠正这些偏见，但其效果尚不清楚。目的确定老年人和妇女在急性冠状动脉综合征临床试验中的比例是否增加，以及这种招募与疾病患病率的比较。数据来源MEDLINE和科克伦数据库中检索1966年1月至2000年3月期间有关心肌梗死的英文文章，不稳定型心绞痛或急性冠状动脉综合征。其他数据来源包括荟萃分析、综述文章和心脏病学教科书。社区心肌梗死发生率的估计来自国家心肌梗死登记处和Worcester心脏研究。研究选择已发表的急性冠脉综合征患者随机对照试验被纳入，入选50例或更少患者的试验、无临床终点的试验、以英语以外的语言发表的论文和未发表的手稿被排除。在7645项研究中，选择了593项随机对照试验进行综述。数据提取随机对照试验由2位作者按出版年份、支持来源进行提取（即资金）、药物治疗、研究分期、研究中心数量、试验地点、患者数量、研究人群的平均年龄，资料综合已发表的明确排除年龄的随机对照试验的数量从1966-1990年的58%下降到1991年的40%，2000.在1966-1990年期间发表的研究中，75岁或以上患者的试验入组率从2%增加到1991-2000年期间的9%，但仍远低于美国所有心肌梗死患者（37%）的比例。入选的女性从1966-1990年发表的研究的20%上升到1991-2000年的25%，但仍远低于其在美国所有心肌梗死患者中的比例（43%）。因此，在已发表的试验文献中，相对于妇女和老年人的患病率，妇女和老年人的代表性仍然不足。由于安全性和有效性可能因性别和年龄而异，这些招募偏倚破坏了为所有心脏病患者提供循证护理的努力。
Context Elderly persons and women were underrepresented in randomized controlled trials (RCTs) prior to 1990. Since then, efforts have been made to correct these biases, but their effect is unclear.Objective To determine whether the percentage of elderly persons and women in published clinical trials of acute coronary syndromes has increased and how this enrollment compared with disease prevalence.Data Sources The MEDLINE and Cochrane databases were searched for English-language articles from January 1966 to March 2000 regarding myocardial infarction, unstable angina, or acute coronary syndromes. Additional data sources included meta-analyses, review articles, and cardiology textbooks. Estimates of community-based myocardial infarction rates came from the National Registry of Myocardial Infarction and the Worcester Heart Study.Study Selection Published RCTs of acute coronary syndrome patients were included and trials enrolling 50 patients or fewer, those without clinical end points, papers published in a language other than English, and unpublished manuscripts were excluded. Of 7645 studies identified, 593 RCTs were selected for review.Data Extraction The RCTs were abstracted by 2 of the authors for year of publication, source of support (ie, funding), pharmacotherapy, study phase, number of study sites, trial location, number of patients, mean age of the study population, and any age exclusion criteria for enrollment.Data Synthesis The number of published RCTs with explicit age exclusions has declined from 58% during 1966-1990 to 40% during 1991-2000. Trial enrollment of patients aged 75 years or older increased from 2% for studies published during 1966-1990 to 9% during 1991-2000, but remains well below their representation among all patients with myocardial infarction (37%) in the United States. Enrollment of women has risen from 20% for studies published between 1966-1990 to 25% during 1991-2000, but remains well below their proportion of all patients with myocardial infarction (43%) in the United States.Conclusions Attempts at making cardiovascular RCTs more inclusive appear to have had limited success; thus, women and elderly persons remain underrepresented in published trial literature relative to their disease prevalence. Because safety and efficacy can vary as a function of sex and age, these enrollment biases undermine efforts to provide evidence-based care to all cardiac patients.