How representative are participants in geriatric oncology clinical trials? The case of the 5C RCT in geriatric oncology: A cross-sectional comparison to a geriatric oncology clinic.

INTRODUCTION: 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. MATERIALS AND METHODS: 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. RESULTS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov # NCT03154671.

Nontraditional risk factors of coronary artery disease among Palestinians: A case-control study.

BACKGROUND: Coronary Artery Disease (CAD) is one of the most common causes of death in Palestine. This study aimed to assess the nontraditional risk factors among CAD patients underwent invasive coronary angiography in Gaza-Palestine. METHODS: Unmatched one-to-one case-control study was conducted among 200 participants. Cases were recruited from newly discovered CAD patients after a confirmed diagnosis of CAD by interventional cardiologist post catheterization "coronary angiography" in Al-Shifa Cardiovascular Catheterization Center. Controls were enrolled from individuals with no history of CAD. An interview-based questionnaire was used to assess patient's characteristic data and medical history; anthropometric, and the Ankle Brachial Index(ABI) was measured and calculated. Furthermore, biochemical analysis of high sensitivity C-reactive protein (hs-CRP) level and Random blood glucose level (RBG) and Leukocyte count (WBCs)were investigated. All required ethical approvals were obtained. Data were managed and analyzed by STATA version 14. Correlation analysis by multivariate logistic regression was done. RESULTS: hs-CRP, RBG, and WBCs remained significant predictors for CAD adjusted for age, education level, employment status, and monthly income. As, the odds of CAD increased by 3% for each unit increased in hs-CRP (Odd Ratio (OR)=1.03; 95% confidence interval (CI):1.01, 1.06; P = 0.020); and the odds of CAD was augmented by 30% for each unit increased in WBCs (OR= 1.30; 95% CI: 1.07, 1.67; P = 0.010); While the odds of CAD was 5 times more for each unit increased in RBG (OR=5.04; 95% CI: 1.17, 14.88; P = 0.003). Still, age remained a significant risk factor as the odds of CAD was 19% more for each increased year in age (OR=1.19; 95%CI: 1.13, 1.26; P<0.001). CONCLUSION: Nontraditional factors (hs-CRP, RBG, and WBCs) are significant predictors of CAD, and should be considered in adult patients coming with attacks of angina pain.