背景:体弱的老年人占老年人口的很大一部分。然而,虚弱患者通常被排除在随机对照试验之外.这种代表性不足限制了试验结果可以推广到该人群的程度。我们比较了来自加拿大5C随机对照试验的样本,该试验调查了老年肿瘤学环境中的综合老年评估(CGA),以将患者转诊到老年癌症诊所(OACC),以确定该试验样本是否代表正常的老年肿瘤学实践。
方法:在玛格丽特公主癌症中心(PM)看到的5C试验参与者的基线CGA数据,与5C试验期间(2018年4月至2020年4月)观察到的符合5C纳入标准的OACC患者的数据进行比较.为了评估样本的脆弱性,性别,年龄,疾病部位,合并症水平,医疗优化,社会支持,功能状态,跌倒风险,营养,认知,使用Fisher精确和独立样本t检验比较5C参与者和OACC患者的情绪。
结果:纳入115个5C参与者和205个OACC患者的样本。5C参与者和OACC患者的平均年龄为75.4岁和81.6岁,分别(p<0.001)。疾病部位的分布在样本之间显着不同(p<0.001),与5C参与者的合并症相比,OACC患者的受损程度也明显更高(23.4%对10.4%高合并症)(p=0.001),IADL依赖性(55.1%对42.6%)(p=0.036),身体功能受损(70.6%对31.3%)(p<0.001),跌倒风险(67.8%对27%)(p<0.001),营养受损(55.6%对40.9%)(p=0.014),和认知(47.2%对10%)(p<0.001)。性别没有差异,药物优化,可怜的社会支持,样本之间的情绪受损。
结论:5C样本比在老年肿瘤诊所看到的患者更脆弱和年轻。寻找解决纳入脆弱老年人的障碍的策略对于增加他们在未来试验中的代表性非常重要,以便将研究结果推广到这一弱势群体。
背景:Clinicaltrials.gov#NCT03154671。
Frail older adults make up a substantial portion of the older adult population. However, frail patients are often excluded from randomized controlled trials. This underrepresentation restricts the extent to which trial findings can be generalized to this population. We compared a sample from the Canadian 5C Randomized Controlled Trial investigating comprehensive geriatric assessment (CGA) in the geriatric oncology setting in terms of frailty to patients referred to the Older Adults with Cancer Clinic (OACC) to determine if the trial sample was representative of the normal geriatric oncology practice.
Baseline CGA data of 5C Trial participants seen at the Princess Margaret Cancer Centre (PM), were compared to data from OACC patients that were seen during the duration of the 5C trial (between April 2018 and April 2020) and that satisfied the 5C inclusion criteria. To assess the frailty of samples, sex, age, disease site, comorbidity level, medical optimization, social supports, functional status, falls risk, nutrition, cognition, and mood were compared between 5C participants and OACC patients using Fisher\'s exact and independent samples t-test.
A sample of 115 5C participants and 205 OACC patients were included. The mean age of 5C participants and OACC patients was 75.4 and 81.6 years, respectively (p < 0.001). The distribution of disease sites was significantly different between the samples (p < 0.001) and OACC patients were also significantly more impaired compared to 5C participants in comorbidity (23.4% versus 10.4% high comorbidity) (p = 0.001), IADL dependence (55.1% versus 42.6%) (p = 0.036), impaired physical function (70.6% versus 31.3%) (p < 0.001), falls risk (67.8% versus 27%) (p < 0.001), impaired nutrition (55.6% versus 40.9%) (p = 0.014), and cognition (47.2% versus 10%) (p < 0.001). There were no differences in sex, medication optimization, poor social supports, and impaired mood between the samples.
The 5C sample was less frail and younger than patients seen in the geriatric oncology clinic. Finding strategies to address barriers to the inclusion of frailer older adults is important to increase their representation in future trials to allow findings to be generalized to this vulnerable population.
Clinicaltrials.gov # NCT03154671.