Exclusion of Older Adults and Women from Recent Trials of Acute Coronary Syndromes
Exclusion of Older Adults and Women from Recent Trials of Acute Coronary Syndromes
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DOI：
10.1111/j.1532-5415.2010.03305.x
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发表时间：
2011-03-01
影响因子：
6.3
通讯作者：
Gurwitz, Jerry H.
中科院分区：
文献类型：
--
作者：
Dodd, Katherine S.;Saczynski, Jane S.;Gurwitz, Jerry H.
为了确定老年人和女性参与已发表的临床试验是否在近年来有所增加，对2007年5月至2009年5月发表的急性冠状动脉综合征（ACS）临床试验进行了系统回顾。如果试验招募的参与者少于50人，是以前发表的试验的子研究，或在急性心脏事件后超过3周开始治疗，则排除试验。SETTINGA搜索MEDLINE和科克伦对照试验中心注册。参与者80项试验的68016名参与者。测量试验参与者的年龄，女性参与者的百分比，从所有纳入的试验中提取是否有基于年龄的特定排除标准，其中23项试验（29.7%）有明确的基于年龄的排除标准。只有13.8%的研究参与者年龄在75岁及以上，27.7%是女性。这些百分比低于近年来所有75岁及以上（41.9%）或女性（41.5%）经历ACS的美国成年人的代表性。所有研究参与者的平均年龄为61.6 +/- 3.8。有一个显着的关联之间的平均年龄的研究人群和妇女的比例参加了trial. CONCLUSION老年人和妇女仍然代表性不足，在最近的临床试验的人住院ACS。这些排除可能会阻碍在这些高危人群中为循证临床决策提供信息的努力。
OBJECTIVESTo determine whether the participation of older adults and women in published clinical trials has increased during recent years.DESIGNSystematic review to identify clinical trials of acute coronary syndromes (ACSs) published from May 2007 to May 2009. Trials were excluded if they enrolled fewer than 50 participants, were substudies of previously published trials, or initiated treatment more than 3 weeks after the acute cardiac event.SETTINGA search of MEDLINE and the Cochrane Central Register of Controlled Trials.PARTICIPANTSSixty-eight thousand sixteen participants of 80 trials.MEASUREMENTSInformation on the age of trial participants, percentage of participants who were female, and whether there were specific exclusions based on age were abstracted from all included trials.RESULTSTwenty-three trials (29.7%) had explicit exclusion criteria based on age. Only 13.8% of study participants were aged 75 and older, and 27.7% were women. These percentages are below the representation of all U.S. adults experiencing an ACS in recent years who were aged 75 and older (41.9%) or female (41.5%). The average age of all study participants was 61.6 +/- 3.8. There was a significant association between the mean age of a study population and the proportion of women enrolled in the trial.CONCLUSIONOlder adults and women remain underrepresented in recent clinical trials of people hospitalized with an ACS. These exclusions may hinder efforts to inform evidence-based clinical decision-making in these high-risk populations.