METHODS: This phase 3, randomised, double-blind, placebo-controlled trial was conducted at 66 centres across 11 countries and territories (ten in Asia-Pacific; one in the Middle East). The trial included patients aged 18 years and older with Dukes' C or high-risk Dukes' B colon cancer or Dukes' B or C rectal cancer who had undergone resection and had completed standard adjuvant therapy (at least 3 months of chemotherapy). Patients with contraindications to aspirin, familial syndromes of colorectal cancer, recent other cancers, and clinically significant history of cardiovascular disease or stroke were excluded. Patients were randomly assigned (1:1) to aspirin 200 mg daily or placebo for 3 years, and were followed up for 5 years. Randomisation was stratified by study centre, tumour site and stage, and inclusion of oxaliplatin in adjuvant chemotherapy. The patients, study team, and sponsor were masked to treatment assignment. The primary endpoint was disease-free survival. The primary analysis used a stratified Cox model in those commencing study treatment (modified intention-to-treat population), analysing all events to March 31, 2023. Safety was analysed in the same population. This trial is registered at ClinicalTrials.gov (NCT00565708). The primary analysis has been completed, but translational studies of putative aspirin sensitivity biomarkers are ongoing.
FINDINGS: Between Feb 25, 2009, and June 30, 2021, 1587 patients underwent randomisation, of whom 1550 were included in the modified intention-to-treat analysis: 791 (51%) in the aspirin group and 759 (49%) in the placebo group. Of these patients, the median age was 57 years (IQR 48-65); 897 (58%) were male and 653 (42%) female; 271 (17%) had Dukes' B colon cancer, 770 (50%) Dukes' C colon cancer, and 509 (33%) rectal cancer. Median follow-up at data cutoff was 59·2 months (IQR 36·7-60·0). 5-year disease-free survival was 77·0% (95% CI 73·6-80·0) in the aspirin group and 74·8% (71·3-77·9) in the placebo group (hazard ratio of 0·91 [95% CI 0·73-1·13]; p=0·38). Any-grade adverse events were reported in 390 (49%) of 791 patients in the aspirin group versus 386 (51%) of 759 in the placebo group. Serious adverse events were reported in 95 (12%) patients in the aspirin group versus 107 (14%) in the placebo group. There were no treatment-related deaths in either group. Among adverse events of special interest, there were no cases of acute myocardial infarction in the aspirin group versus two in the placebo group; no ischaemic cerebrovascular events in the aspirin group versus two in the placebo group; and three major gastrointestinal bleeds in the aspirin group versus one in the placebo group.
INTERPRETATION: In patients with colorectal cancer, aspirin 200 mg daily for 3 years after completion of standard adjuvant therapy was well tolerated but did not significantly improve disease-free survival.
FUNDING: SingHealth Foundation, National Medical Research Council Singapore, National Cancer Centre Research Fund, Rising Tide Foundation, Lee Foundation, Lee Kim Tah Foundation, Duke-NUS Khoo Bridge Funding Award, Terry-Fox Run, Silent Foundation, Cancer Australia, Bowel Cancer Australia, and Cancer Council NSW.
METHODS: A multicenter cross-sectional survey was conducted. Participants were recruited by a multi-stage stratified cluster-sampling procedure from a mountainous region in Lishui City, Zhejiang Province, China. A validated questionnaire of Healthy Aging Instruments (HAI), Basic Psychological Needs Satisfaction (BPNS), Patient Health Questionnaire (PHQ-9), Ascertain Dementia 8 questionnaire (AD8), Family Adaption Scale (FAS), Community-Based Health Promotion Activity Questionnaires (HPAQ), Social Function Questionnaire for Chinese Older Adults (SFQCOA), Adult Health Self-Management Skills (ability) Rating Scale (AHSMSRS) was incorporated. The questionnaire also captured sociodemographic characteristics, lifestyle behaviors, and Self-Perceived Healthy Ageing (SPHA). Multivariate stepwise linear regression analysis was performed.
RESULTS: The mean score of the Healthy Aging index was 136.5 (18.22). The majority of the participants have a high level of healthy aging (65.5%). Regression analysis showed 12 predictors of healthy aging: self-perceived economic independence, lifestyle-related behaviors, subjective physical health, psychological health, better competence of BPNS, frequency of community-based HPA participation, lower HPA-perceived barriers, social support, social engagement, and Health Self-Management (HSM) ability with two dimensions HSM-Consciousness and HSM-Behavior, as well as SPHA (P
METHODS: Monthly Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS (RPBS) Item Reports of ADHD prescriptions and Australian ADHD-related Google Trends (GT) data (2004-2023) were sourced. We modelled the lagged effect of GT on ADHD medication prescriptions, using an autoregressive moving average model with autoregressive conditional heteroskedasticity, adjusting for COVID-19 lockdown effects. Results were compared to a model of GT for pain-related searches and PBS/RPBS opioid prescriptions, and counterfactual alternatives: (1) ADHD-related GT and opioid prescriptions and (2) pain-related GT and ADHD prescriptions. We descriptively analysed additional ADHD-related online news data.
RESULTS: Annual prescriptions doubled from 1,424,904 in 2020 to 3,112,072 in 2023. ADHD medication prescriptions and ADHD-related GT considerably increased since the COVID-19 pandemic. GT had a statistically significant positive lagged association with ADHD prescriptions. Comparator models did not show statistically significant associations between GT and prescriptions. Online news data supported recently increased public interest in ADHD.
CONCLUSIONS: ADHD-related online interest predicts increased ADHD prescriptions, which was accentuated during the pandemic. Studies are needed to evaluate causal pathways, health information quality and sociodemographic determinants.
AIM: This study aimed to identify the range of clinical pharmacy activities in ambulatory care, assess the suitability of the existing ward-based tool for capturing these activities, and recommend modifications.
METHOD: Non-participant direct observations were conducted to record pharmacists' clinical activities in ambulatory clinics and multidisciplinary meetings. These observations were compared to the existing ward-based tool to identify discrepancies. Semi-structured interviews with eight ambulatory pharmacists were transcribed verbatim and thematically analysed inductively to explore the tool's representativeness of their routine clinical activities.
RESULTS: Twenty-nine clinical pharmacy activities were observed in ambulatory services. Only fifteen were captured by the existing tool, with therapy monitoring and recommending therapeutic changes not accurately captured. Pharmacists agreed that the tool was not fully representative and included irrelevant activities. Four common uncaptured activities were multidisciplinary meeting-specific activities, arranging laboratory tests, monitoring patient outcomes, and liaising with community healthcare professionals. This study identified 33 candidate ambulatory clinical pharmacy activities.
CONCLUSION: The existing ward-based tool does not fully capture the full range of ambulatory care clinical pharmacy activities, highlighting the need for an improved tool. Pharmacists recommended including the uncaptured activities. The candidate activities provide a foundation for standardised measurement of relevant ambulatory care activities to enable effective workforce deployment and improve patient outcomes.
METHODS: A survey questionnaire was administered online and as hard copy using purposive sampling to 32 healthcare facilities providing cancer services and the Formulary Management Branch in the Ministry of Health. Respondents reported whether a criterion "will be considered" and weighted its relative importance on a 5-point scale. The choice of safety and efficacy/effectiveness outcomes were ranked from 1 to 5, and the minimum value of benefit for the efficacy/effectiveness outcome ranked 1 was provided. Trade-offs between survival and quality of life were also explored. Inferential statistics were used to explore difference in responses.
RESULTS: A total of 316 healthcare professionals responded to the survey. The most important criteria for value assessment of cancer drug were safety and effectiveness. Other criteria deemed important were quality of evidence, disease severity, and patient-reported outcomes. There was no difference in the criteria preference and weights across the various respondent groups. Overall survival was the most preferred clinical benefit outcome. Overall, willingness to pay was higher for life-prolonging treatment than treatment that improved quality of life.
CONCLUSIONS: This study revealed that a wide range of criteria beyond the traditional decision-making criteria of efficacy, safety, and cost-effectiveness are important for value assessment of cancer drugs for the purpose of formulary decisions.