Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial.
Ontology highlight
ABSTRACT: Background
Cancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population.Methods
At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n = 16,703; U.S., n = 2411). Eligible participants were healthy, free of major diseases and expected to survive 5 years.Results
Nearly 20% of enrolling ASPREE participants reported a prior cancer diagnosis; 18% of women and 22% of men, with women diagnosed younger (16% vs 6% of diagnoses <50 years). Cancer prevalence increased with age. Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants. Cancer history prevalence was not associated with contemporary common risk factors nor previous aspirin use, but was associated with poor health ratings in men. Blood and breast cancer history were more common with past aspirin use.Conclusions
Personal cancer history in healthy older ASPREE participants was as expected for the most common cancer types in the respective populations, but was not necessarily aligned with known risk factors. We attribute this to survivor bias, likely driven by entry criteria.Trial registration
International Standard Randomised Controlled Trial Number Register (ISRCTN83772183) and clinicaltrials.gov (NCT01038583).
SUBMITTER: Orchard SG
PROVIDER: S-EPMC8009087 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThere is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.DesignData were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010-2017 ('ASPirin in Reducing Events in the Elderly (ASPREE)', n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.ResultsOver a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.ConclusionAspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.Trial registration numberASPREE. NCT01038583.
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Project description:BACKGROUND:Large-scale studies risk generating inaccurate and missing data due to the complexity of data collection. Technology has the potential to improve data quality by providing operational support to data collectors. However, this potential is under-explored in community-based trials. The Aspirin in reducing events in the elderly (ASPREE) trial developed a data suite that was specifically designed to support data collectors: the ASPREE Web Accessible Relational Database (AWARD). This paper describes AWARD and the impact of system design on data quality. METHODS:AWARD's operational requirements, conceptual design, key challenges and design solutions for data quality are presented. Impact of design features is assessed through comparison of baseline data collected prior to implementation of key functionality (n?=?1000) with data collected post implementation (n?=?18,114). Overall data quality is assessed according to data category. RESULTS:At baseline, implementation of user-driven functionality reduced staff error (from 0.3% to 0.01%), out-of-range data entry (from 0.14% to 0.04%) and protocol deviations (from 0.4% to 0.08%). In the longitudinal data set, which contained more than 39 million data values collected within AWARD, 96.6% of data values were entered within specified query range or found to be accurate upon querying. The remaining data were missing (3.4%). Participant non-attendance at scheduled study activity was the most common cause of missing data. Costs associated with cleaning data in ASPREE were lower than expected compared with reports from other trials. CONCLUSIONS:Clinical trials undertake complex operational activity in order to collect data, but technology rarely provides sufficient support. We find the AWARD suite provides proof of principle that designing technology to support data collectors can mitigate known causes of poor data quality and produce higher-quality data. Health information technology (IT) products that support the conduct of scheduled activity in addition to traditional data entry will enhance community-based clinical trials. A standardised framework for reporting data quality would aid comparisons across clinical trials. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number Register, ISRCTN83772183. Registered on 3 March 2005.
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Project description:ObjectivesIdentifying risk factors of depression can provide a better understanding of the disorder in older people. However, to minimize bias due to the influence of confounders and to detect reverse influence, a focus on longitudinal studies using multivariate analysis is required.DesignA systematic literature search was conducted by searching the databases MEDLINE, Cochrane, PsycINFO and Web of Science for all relevant articles published from January 2000 to the end of March 2020. The following inclusion criteria were used: prospective design, nationally or regionally representative sample, published in English or German, analyzed risk factors for depression of individuals 65+ identified by multivariate analysis, and provided validity of diagnostic instrument. All results of multivariate analysis were reported and summarized.ResultsThirty articles were identified. Heterogeneous results were found for education, female gender, self-rated health, cognitive impairment and older age, although significant in several studies. Findings hinted at a protective quality of physical activity. In terms of physical health, chronic disease and difficulty initiating sleep homogeneously increased risk of depression. Mobility impairment resulted as a risk factor in three studies. IADL impairment and vision impairment were mostly identified as significant risk factors. Alcohol consumption and smoking behavior yielded heterogenous results. Psychosocial factors were assessed similarly in multiple studies and yielded heterogenous results.LimitationsResearch was limited to articles published in English or German. Length of follow up was not considered for the presentation of results. Adjustments for and inclusion of different variables in the studies may distort results.ConclusionOur findings demonstrate the necessity of refined, more comparable assessment tools for evaluating potential risk factors.
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Project description:INTRODUCTION:Cigarette smoking is associated with many adverse health effects and is an important public health concern. Increased understanding of smokers' behavior is central to developing effective interventions. Cigarette scavenging, a behavior that involves smoking shared or previously used cigarettes has thus far only been shown to be prevalent among homeless or incarcerated populations. The current study examines whether cigarette scavenging is prevalent in a more general population of adult smokers enrolling in a smoking cessation clinical trial, and whether engagement in this behavior is associated with demographic or smoking-related psychosocial factors. METHODS:Baseline data was obtained from adult smokers (N=227) enrolling in a randomized clinical trial for smoking cessation. Cigarette scavenging was assessed using three items: a) sharing a cigarette with a stranger; b) smoking a "found" cigarette and c) smoking a previously used cigarette "butt". Participants who endorsed engaging in at least one of these three behaviors were categorized as a scavenger. RESULTS:Approximately 32% of participants endorsed at least one cigarette scavenging behavior. A multiple logistic regression analysis found that scavengers were more likely to be: men (p<0.001), of younger age at smoking onset (p=0.012), unemployed (p=0.003), more likely to have used marijuana in the past 30days (p=0.005), single or living alone (p=0.003), and to have experienced higher withdrawal symptoms during previous quit attempts (p=0.044) as compared to non-scavengers. CONCLUSIONS:Scavenging is common among adult smokers. Interventions that address cigarette scavenging behaviors may better meet the needs of this unique smoking subgroup.
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Project description:BackgroundEfforts to minimize medication risks among older adults include avoidance of potentially inappropriate medications. Contemporary analysis of medication use in community-dwelling older people compared with the general population is lacking.ParticipantsA total of 19,114 community-dwelling adults in Australia and the United States aged 70 years or older (65 years or older for U.S. minorities) without histories of major cardiovascular disease, cognitive impairment, or disability participated in a randomized, placebo-controlled trial of aspirin: ASPirin in Reducing Events in the Elderly study. Measurements Prescribed baseline medications obtained by self-report and medical record review were grouped by World Health Organization Anatomic and Therapeutic Chemical category. Potentially inappropriate medications were defined using a modified American Geriatrics Society Beers Criteria. Polypharmacy was defined as 5 or more medications, and hyperpolypharmacy defined as 10 or more medications. Cross-sectional descriptive statistics and adjusted odds ratios were computed.ResultsThe median number of prescription medications per participant was three, regardless of age. Women had a higher medication prevalence. Cardiovascular drugs (primarily antihypertensives) were the most commonly reported (64%). Overall, 39% of the cohort reported taking at least one potentially inappropriate medication, with proton-pump inhibitors being the most commonly reported (21.2% of cohort). Of the cohort, 27% had polypharmacy, and 2% hyperpolypharmacy. Age 75 years or older, less than 12 years of education, hypertension, diabetes mellitus, chronic kidney disease, frailty, gastrointestinal complaint, and depressive symptoms were associated with an increased likelihood of potentially inappropriate medications and polypharmacy. For almost all medication classes, prevalence was equivalent or lower than the general older population.ConclusionOverall medication burden and polypharmacy are low in older adults free of major cardiovascular disease, disability, and cognitive impairment. The prevalence of potentially inappropriate medications is higher than previously reported and similar to more vulnerable populations as a result of the introduction of proton-pump inhibitors to the American Geriatrics Society Beers Criteria. Longitudinal follow-up is required to further understand the balance of benefits and risks for potentially inappropriate medications and polypharmacy in community-dwelling older people.
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Project description:Background Previous studies demonstrated that lower outdoor temperatures increase the levels of established cardiovascular disease risk factors, such as blood pressure and lipids. Whether or not low temperatures increase novel cardiovascular disease risk factors levels is not well studied. The aim was to investigate associations of outdoor temperature with a comprehensive range of established and novel cardiovascular disease risk factors in two large Northern European studies of older adults, in whom cardiovascular disease risk is increased. Design and methods Data came from the British Regional Heart Study (4252 men aged 60-79 years) and the Prospective Study of Pravastatin in the Elderly at Risk (5804 men and women aged 70-82 years). Associations between outdoor temperature and cardiovascular disease risk factors were quantified in each study and then pooled using a random effects model. Results With a 5? lower mean temperature, total cholesterol was 0.04?mmol/l (95% confidence interval (CI) 0.02-0.07) higher, low density lipoprotein cholesterol was 0.02?mmol/l (95% CI 0.01-0.05) higher and SBP was 1.12?mm Hg (95% CI 0.60-1.64) higher. Among novel cardiovascular disease risk factors, C-reactive protein was 3.3% (95% CI 1.0-5.6%) higher, interleukin-6 was 2.7% (95% CI 1.1-4.3%) higher, and vitamin D was 11.2% (95% CI 1.0-20.4%) lower. Conclusions Lower outdoor temperature was associated with adverse effects on cholesterol, blood pressure, circulating inflammatory markers, and vitamin D in two older populations. Public health approaches to protect the elderly against low temperatures could help in reducing the levels of several cardiovascular disease risk factors.
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Project description:Aims/hypothesisThe aim of this work was to assess the role of well-established cardiovascular risk factors in the late-life cognitive decline of patients with type 2 diabetes.MethodsData from 831 participants (aged 60-75 years) attending the 4 year follow-up of the Edinburgh Type 2 Diabetes Study (ET2DS) were used. Smoking history (pack-years), BP, HbA1c, plasma glucose and cholesterol were determined at baseline clinics (single time measurements) and/or from serial data recorded on a clinical management database from diagnosis until recruitment ('historical' data). Principal component analysis derived a factor, g, of general ability from seven cognitive tests. Linear regression models of follow-up g were adjusted for baseline g to represent 4 year cognitive change. 'Accelerated late-life cognitive decline' was defined as scoring in the lowest tertile of '4 year cognitive change' regression scores. Analyses controlled for age and sex.ResultsA baseline history of moderate/heavy smoking (? 10 pack-years) and a 1% increased historical HbA1c (equivalent to an increase by 11 mmol/mol) predicted a 64% (OR 1.64; 95% CI 1.14, 2.34; p = 0.007) and 21% (OR 1.21; 95% CI 1.00, 1.45; p = 0.046) increased risk of accelerated cognitive decline, respectively. When treated as continuous measures, higher pack-years, historical HbA1c and historical BP emerged as significant independent predictors of 4 year decline in g (standardised ? range -0.07 to -0.14; all p ? 0.05).Conclusions/interpretationIncreased smoking and poorer glycaemic control (with relatively weaker findings for BP) during the life-course were independently associated with accelerated late-life cognitive decline. Where possible, evaluation is warranted of these risk factors as targets for intervention to reduce the burden of cognitive impairment in diabetes.
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Project description:BACKGROUND:A significant recent innovation is the development of internet-based psychological treatments for suicidal thinking. However, we know very little about individuals experiencing suicidal ideation who seek help through Web-based services and, in particular, their previous health service use patterns. OBJECTIVE:We aimed to examine service use history and its correlates among adults experiencing suicidal ideation who enrolled in a Web-based suicidal ideation treatment trial. METHODS:We used baseline data of 418 individuals seeking Web-based treatment for their suicidal ideation recruited into a randomized controlled trial of a 6-week Web-based self-help program. Participants at preintervention reported demographic information, clinical characteristics, and health service use over the previous 6 months. RESULTS:Participants had a high rate of service use in the 6 months before enrolling in the treatment trial (404/418, 96.7% of participants had contact with services). The two most common contact points were general practitioners (385/418, 92.1% of participants) and mental health professionals (295/418, 70.6% of participants). Notably, those with a previous single suicide attempt had lower odds of contact with any service than those with no attempt (odds ratio [OR] 0.21, 95% CI 0.05-0.86; P=.03). Those living in rural or remote areas had lower odds of contacting general practitioners (OR 0.35, 95% CI 0.13-0.91; P=.03) or mental health professionals (OR 0.44, 95% CI 0.23-0.83; P=.01) than those living in metropolitan areas. CONCLUSIONS:Individuals enrolling in an electronic health intervention trial have often received treatment from general practitioners or mental health professionals. These services can therefore play an important role in preventing the escalation of suicidal thinking. Enrollment in our Web-based treatment trial suggested, though, that face-to-face health services may not be enough. Our study also highlighted the need to improve the provision of coordinated and assertive care after a suicide attempt, as well as health service availability and utilization for those living in rural and remote areas. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12613000410752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364016 (Archived by WebCite at http://www.webcitation.org/6vK5FvQXy); Universal Trial Number U1111-1141-6595.
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Project description:BackgroundThe older population has been especially affected by the severe acute respiratory syndrome coronavirus 2 pandemic (COVID-19).ObjectiveThe aim of the study was to explore the incidence, severity, mortality rate, clinical features, and risk factors of symptoms of COVID-19 in home-dwelling older people, and its association with type of residence, cognitive deterioration, and neurodegenerative diseases.MethodsData about symptoms of COVID-19 were collected through a telephone survey in the cohort of 913 older volunteers of the Vallecas Project, aged 75-90 years, most of them (902) home-dwelling, in Madrid, Spain. The association of demographic and anthropometric measures, genetic polymorphisms, comorbidities, life habits, type of residence, and frailty surrogates were explored as potential risk factors for the incidence, severity, and mortality of COVID-19 in the older population.FindingsSixty-two cases reported symptoms compatible with COVID-19; 6 of them had died, 4 in their home and 2 in the nursing home. Moderate/severe cases were significantly older and more frequently males. The APOE ?4 allele was associated with the presence of symptoms of COVID-19. Higher systolic blood pressure, more intense smoking habit, more alcohol intake, lower consumption of coffee and tea, and cognitive impairment were associated with disease severity.ConclusionsThe estimated incidence of symptomatic COVID-19 in this older cohort of Madrid was 6.8%, with an overall mortality rate of 0.7% (18.2% in those living in a nursing home) and a fatality rate of 9.9%. Our exploratory study indicates that life habits, other clinical conditions and, the ?4 variant of the APOE gene are associated with the presence and clinical severity of coronavirus infection.
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Project description:Context: The effect of L-arginine on risk factors of cardiovascular diseases (CVD) has mostly focused on western countries. Since cardiovascular diseases is the second cause of death in Iran and, as far as we are aware, there have been no studies about the effect of L-arginine on CVD risk factors, the aim of this trial was to assess the effects of L-arginine supplementation on CVD risk factors in healthy men. Objective: The purpose of this study was to evaluate the effect of low-dose L-arginine supplementation on CVD risk factors (lipid profile, blood sugar and blood pressure) in Iranian healthy men. Design, setting, participants: We conducted a double-blind randomized controlled trial in 56 patients selected from sport clubs at the Isfahan University of Medical Science between November 2013 and December 2013. Interventions: Healthy men received L-arginine supplementation (2000 mg daily) in the intervention group or placebo (2000 mg maltodextrin daily) in the control group for 45 days. Main outcome measure: The primary outcome measures were we measured the levels of fasting blood sugar, blood pressure and lipid profile including triglyceride (TG), cholesterol, LDL and HDL in healthy subjects. It was hypothesized that these measures would be significantly improved in those receiving L-arginine supplementation. at the beginning and end of the study. Results: In this trial, we had complete data for 52 healthy participants with mean age of 20.85±4.29 years. At the end of study, fasting blood sugar (P=0.001) and lipid profile (triglycerideTG (P<0.001), cholesterol (P<0.001), LDL (P=0.04), HDL (P=0.015)) decreased in the L-arginine group but we found no significant change in the placebo group. In addition, the reduction of fasting blood sugar and lipid profile in L-arginine was significant compared with placebo group. No significant changes were found about systolic (P=0.81) and diastolic blood pressure either in L-arginine or placebo group. (P=0.532). Conclusion: The use of L-arginine significantly improved outcomes compared to placebo.
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