Exclusion of Older Adults from Ongoing Clinical Trials About Type 2 Diabetes Mellitus
Exclusion of Older Adults from Ongoing Clinical Trials About Type 2 Diabetes Mellitus
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DOI：
10.1111/jgs.12215
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发表时间：
2013-05-01
影响因子：
6.3
通讯作者：
Sanchez-Garcia, Elisabet
中科院分区：
文献类型：
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作者：
Cruz-Jentoft, Alfonso J.;Carpena-Ruiz, Marina;Sanchez-Garcia, Elisabet
目的评估老年人被排除在正在进行的2型糖尿病临床试验之外的程度。设计队列研究。建立世界卫生组织临床试验注册平台。参与者使用老年人参与临床试验的方法，2011年7月31日从平台中提取了正在进行的2型糖尿病临床试验的数据。使用任意年龄上限或其他排除标准排除可能间接导致老年人招募有限的个人的试验比例。排除标准分为合理或不合理。结果在440项研究2型糖尿病治疗的试验中，289项（65.7%）排除了使用任意年龄上限的个体。这种排除在计算样本量小于100例受试者的试验中更为常见（73.6% vs 59.5%; P= 0.002）。338项试验（76.8%）排除了合并症; 236项试验（53.6%）的排除理由不充分。排除多种药物（29.5%的试验），认知障碍（18.4%），预期寿命短（8.9%），以及其他可能限制老年人入选的理由不充分的排除标准也存在。只有6项试验（1.4%）是专门为老年人设计的。结论尽管国际监管机构的建议，排除老年人从正在进行的试验中2型糖尿病是freedenthighter比其他年龄相关疾病的报道。这种排除限制了临床医生在治疗年老、虚弱、复杂的糖尿病患者时使用的证据的价值。
Objective To assess the extent of exclusion of older individuals from ongoing clinical trials regarding type 2 diabetes mellitus. Design Cohort study. Setting World Health Organization Clinical Trials Registry Platform. Participants Using the Participation of the Elderly in Clinical Trials methodology, data from ongoing clinical trials on type 2 diabetes mellitus were extracted from the platform on July 31, 2011. Measurements Proportion of trials excluding individuals using an arbitrary upper age limit or other exclusion criteria that might indirectly cause limited recruitment of older individuals. Exclusion criteria were classified as justified or poorly justified. Results Of 440 trials investigating treatments for type 2 diabetes mellitus, 289 (65.7%) excluded individuals using an arbitrary upper age limit. Such exclusion was significantly more common in trials with calculated sample sizes of less than 100 subjects (73.6% vs 59.5%; P=.002). Exclusion for comorbidity was present in 338 trials (76.8%); this exclusion was poorly justified in 236 trials (53.6%). Exclusion for polypharmacy (29.5% of trials), cognitive impairment (18.4%), short life expectancy (8.9%), and other poorly justified exclusion criteria that could limit the inclusion of older individuals was also present. Only six trials (1.4%) were designed specifically to study older adults. Conclusion Despite the recommendations of international regulatory agencies, exclusion of older individuals from ongoing trials regarding type 2 diabetes mellitus is frequenthigher than reported for other age-related diseases. This exclusion limits the value of the evidence that clinicians use when treating old, frail, complex patients with diabetes mellitus.