The Robert Wood Johnson Foundation Clinical Scholars Program, University of Michigan, 6312 Medical Science Building I, 1150 W Medical Center Drive, Ann Arbor, MI 48109-5604, USA.
J Gen Intern Med. 2011 Jul;26(7):783-90. doi: 10.1007/s11606-010-1629-x. Epub 2011 Feb 1.
Due to a shortage of studies focusing on older adults, clinicians and policy makers frequently rely on clinical trials of the general population to provide supportive evidence for treating complex, older patients.
To examine the inclusion and analysis of complex, older adults in randomized controlled trials.
A PubMed search identified phase III or IV randomized controlled trials published in 2007 in JAMA, NEJM, Lancet, Circulation, and BMJ. Therapeutic interventions that assessed major morbidity or mortality in adults were included. For each study, age eligibility, average age of study population, primary and secondary outcomes, exclusion criteria, and the frequency, characteristics, and methodology of age-specific subgroup analyses were reviewed.
Of the 109 clinical trials reviewed in full, 22 (20.2%) excluded patients above a specified age. Almost half (45.6%) of the remaining trials excluded individuals using criteria that could disproportionately impact older adults. Only one in four trials (26.6%) examined outcomes that are considered highly relevant to older adults, such as health status or quality of life. Of the 42 (38.5%) trials that performed an age-specific subgroup analysis, fewer than half examined potential confounders of differential treatment effects by age, such as comorbidities or risk of primary outcome. Trials with age-specific subgroup analyses were more likely than those without to be multicenter trials (97.6% vs. 79.1%, p < 0.01) and funded by industry (83.3% vs. 62.7%, p < 0.05). Differential benefit by age was found in seven trials (16.7%).
Clinical trial evidence guiding treatment of complex, older adults could be improved by eliminating upper age limits for study inclusion, by reducing the use of eligibility criteria that disproportionately affect multimorbid older patients, by evaluating outcomes that are highly relevant to older individuals, and by encouraging adherence to recommended analytic methods for evaluating differential treatment effects by age.
由于缺乏针对老年人的研究，临床医生和政策制定者经常依赖一般人群的临床试验来提供支持治疗复杂老年患者的证据。
检查随机对照试验中复杂老年患者的纳入和分析情况。
通过 PubMed 搜索，确定了 2007 年在 JAMA、NEJM、Lancet、Circulation 和 BMJ 上发表的 III 期或 IV 期随机对照试验。纳入评估成年人主要发病率或死亡率的治疗干预措施。对每项研究的年龄资格、研究人群的平均年龄、主要和次要结局、排除标准以及年龄特异性亚组分析的频率、特征和方法进行了审查。
在全面审查的 109 项临床试验中，有 22 项（20.2%）排除了特定年龄以上的患者。其余试验中近一半（45.6%）排除了可能不成比例地影响老年人的标准。只有四分之一的试验（26.6%）检查了被认为与老年人高度相关的结局，如健康状况或生活质量。在进行年龄特异性亚组分析的 42 项试验中（38.5%），不到一半的试验检查了年龄对治疗效果差异的潜在混杂因素，如合并症或主要结局的风险。进行年龄特异性亚组分析的试验比没有进行亚组分析的试验更有可能是多中心试验（97.6% vs. 79.1%，p < 0.01）和由行业资助（83.3% vs. 62.7%，p < 0.05）。在 7 项试验（16.7%）中发现了年龄相关的疗效差异。
通过消除研究纳入的年龄上限、减少不成比例地影响多病老年患者的资格标准、评估与老年人高度相关的结局以及鼓励采用推荐的分析方法来评估年龄对治疗效果的差异，可以改善指导治疗复杂老年患者的临床试验证据。
