Birth Rates Among Hispanics and Non-Hispanics and their Representation in Contemporary Obstetric Clinical Trials
Birth Rates Among Hispanics and Non-Hispanics and their Representation in Contemporary Obstetric Clinical Trials
复制标题
西班牙裔和非西班牙裔的出生率及其在当代产科临床试验中的表现
DOI：
10.1055/s-0036-1584543
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发表时间：
2016
影响因子：
2
通讯作者：
Aagaard KM
中科院分区：
文献类型：
--
作者：
Kahr MK;De La Torre R;Racusin DA;Suter MA;Ramin SM;Clark SL;Dildy GA;Belfort MA;Aagaard KM
目的我们的研究目的是确定参加当前产科临床试验的受试者是否按比例反映了美国西班牙裔种族及其出生率的当代代表性。方法使用美国疾病控制和预防中心 (CDC) 在规定时间间隔（2011 年 1 月至 2015 年 9 月）按种族划分的出生率的综合源数据，我们评估了按种族划分的比例，然后分析了观察到的与预期的登记受试者相对比率。女性对美国的出生人数做出了重大贡献（占所有出生人数的 23%）。对 90 项已发表的产科临床试验的系统分析显示，西班牙裔孕妇的纳入与相应州的出生率之间存在相关性 (r = 0.501，p< 0.001)。虽然平均值密切相关，但相对于其区域人口而言，个别临床试验可能存在相对过度入组（n= 31 或 34%）或入组不足（n= 33 或 37%）的情况。在 48% 的产科临床试验中，没有报告研究人群中西班牙裔的比例。 结论 西班牙裔孕妇代表了当代美国新生儿的很大一部分，并且通常在临床试验中充分代表了产科受试者。然而，这取决于试验，相对于该地区出生人口，西班牙裔受试者的入组人数明显不足和过多。
ObjectiveOur study aims were to establish whether subjects enrolled in current obstetric clinical trials proportionately reflects the contemporary representation of Hispanic ethnicities and their birth rates in the United States.MethodsUsing comprehensive source data over a defined interval (January 2011–September 2015) on birth rates by ethnicity from the Centers for Disease Control and Prevention (CDC), we evaluated the proportional rate by ethnicity, then analyzed the observed to expected relative ratio of enrolled subjects.ResultsHispanic women comprise a significant contribution to births in the United States (23% of all births). Systematic analysis of 90 published obstetric clinical trials showed a correlation between inclusion of Hispanic gravidae and the corresponding state's birth rates (r = 0.501,p< 0.001). While the mean was strongly correlated, individual clinical trials may have relatively over-enrolled (n= 31, or 34%) or under-enrolled (n= 33, or 37%) relative to their regional population. In 48% of obstetric clinical trials the Hispanic proportion of the study population was not reported.ConclusionHispanic gravidae represent a significant number of contemporary U.S. births, and are generally adequately represented as obstetric subjects in clinical trials. However, this is trial-dependent, with significant trial-specific under- and over-enrollment of Hispanic subjects relative to the regional birth population.
影响因子：
9.8
作者：
Bryant AS;Worjoloh A;Caughey AB;Washington AE
通讯作者：
Washington AE