Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease.
Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease.
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DOI：
10.1111/jgs.14833
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发表时间：
2017-11
影响因子：
6.3
通讯作者：
Ioannidis JPA
中科院分区：
文献类型：
--
作者：
Bourgeois FT;Orenstein L;Ballakur S;Mandl KD;Ioannidis JPA
老年人缺血性心脏病的循证和以患者为中心的护理需要临床试验，研究临床医生在实践中看到的患者群体。我们的目的是测量老年人被排除在研究缺血性心脏病药物干预的随机试验之外，并描述这些试验的特征。研究药物干预缺血性心脏病的干预性临床试验开始于2006年及之后，在ClinicalTrials.gov上得到确认。根据研究特征提取数据，包括基于年龄的纳入标准。参与者及其年龄分布的数据收集自试验出版物、研究者询问和ClinicalTrials.gov上的结果数据。根据年龄、试验参与者的平均年龄以及≥65岁和≥75岁的入组参与者的比例排除患者的试验比例。在839项确定的试验中，446项（53%）明确排除了老年人。最常见的年龄上限为80岁（n=164）和75岁（n=114），中位年龄上限为80岁（IQR 75,80）。年龄上限排除的试验往往较小（参与者中位数为100 vs 201， p<0.001），并且更有可能主要由非行业来源资助（78.3% vs 70.0%, p=0.006）。试验参与者的总体平均年龄为62.7岁，平均最高年龄为74岁。年龄≥65岁的估计比例为42.5%，年龄≥75岁的估计比例为12.3%。尽管缺血性心脏病在老年患者中的负担很高，但大多数药物试验没有招募反映年龄相关疾病患病率的参与者。
Evidence-based and patient-centered care of elderly adults with ischemic heart disease requires clinical trials that study the patient population seen by clinicians in practice. We aimed to measure the exclusion of elderly persons from randomized trials studying drug interventions for ischemic heart disease and describe the characteristics of these trials. Interventional clinical trials studying a drug intervention for ischemic heart disease and started 2006 and after were identified in ClinicalTrials.gov. Data were extracted on study features, including age-based inclusion criteria. Data on participants and their age distribution were collected from trial publications, investigator inquiry, and result data in ClinicalTrials.gov. Proportion of trials excluding patients based on age, mean age of trial participants, and proportion of enrolled participants who were ≥65 years and ≥75 years. Of 839 identified trials, 446 (53%) explicitly excluded elderly persons. The most frequent upper age limits were 80 (n=164) and 75 (n=114) with a median upper age limit of 80 (IQR 75, 80). Trials with upper age limit exclusions tended to be smaller (median number of participants 100 vs 201, p<0.001) and were more likely to be funded primarily by non-industry sources (78.3% vs 70.0%, p=0.006). The overall mean age of trial participants was 62.7 years with a mean maximum age of 74 years. The estimated proportion of participants that was ≥65 years was 42.5% and the estimated proportion that was ≥75 years was 12.3%. Despite the high burden of ischemic heart disease among elderly patients, the majority of drug trials do not enroll participants reflective of age-related prevalence of the disease.
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影响因子：
4
作者：
Hozo SP;Djulbegovic B;Hozo I
通讯作者：
Hozo I
影响因子：
18.2
作者：
Gabet, Amelie;Juilliere, Yves;Olie, Valerie
通讯作者：
Olie, Valerie
影响因子：
6.3
作者：
Cruz-Jentoft, Alfonso J.;Carpena-Ruiz, Marina;Sanchez-Garcia, Elisabet
通讯作者：
Sanchez-Garcia, Elisabet
影响因子：
5
作者：
Gerber, Yariv;Weston, Susan A.;Roger, Veronique L.
通讯作者：
Roger, Veronique L.
影响因子：
45.3
作者：
Crivellari, D;Bonetti, M;Goldhirsch, A
通讯作者：
Goldhirsch, A