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1.
J Clin Oncol ; 42(13): 1466-1471, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38350047

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.POUT was a phase III, randomized, open-label trial, including 261 patients with muscle-invasive or lymph node-positive, nonmetastatic upper tract urothelial cancer (UTUC) randomly assigned after radical nephroureterectomy to platinum-based chemotherapy (132) or surveillance (129). Primary outcome analysis demonstrated that chemotherapy improved disease-free survival (DFS). At that time, the planned secondary outcome analysis of overall survival (OS) was immature. By February 2022, 50 and 67 DFS events had occurred in the chemotherapy and surveillance groups, respectively, at a median follow-up of 65 months. The 5-year DFS was 62% versus 45%, univariable hazard ratio (HR), 0.55 (95% CI, 0.38 to 0.80, P = .001). The restricted mean survival time (RMST) was 18 months longer (95% CI, 6 to 30) in the chemotherapy arm. There were 46 and 60 deaths in the chemotherapy and control arms, respectively. The 5-year OS was 66% versus 57%, with univariable HR, 0.68 (95% CI, 0.46 to 1.00, P = .049) and RMST difference 11 months (95% CI, 1 to 21). Treatment effects were consistent across chemotherapy regimens (carboplatin or cisplatin) and disease stage. Toxicities were similar to those previously reported, and there were no clinically relevant differences in quality of life between arms. In summary, although OS was not the primary outcome measure, the updated results add further support for the use of adjuvant chemotherapy in patients with UTUC, suggesting long-term benefits.


Subject(s)
Nephroureterectomy , Humans , Nephroureterectomy/methods , Chemotherapy, Adjuvant , Female , Disease-Free Survival , Male , Aged , Middle Aged , Carcinoma, Transitional Cell/drug therapy , Carcinoma, Transitional Cell/mortality , Carcinoma, Transitional Cell/surgery , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Urologic Neoplasms/drug therapy , Urologic Neoplasms/mortality , Urologic Neoplasms/surgery , Urologic Neoplasms/pathology , Ureteral Neoplasms/drug therapy , Ureteral Neoplasms/mortality , Ureteral Neoplasms/surgery , Ureteral Neoplasms/pathology , Kidney Neoplasms/drug therapy , Kidney Neoplasms/mortality , Kidney Neoplasms/surgery , Kidney Neoplasms/pathology
2.
Article in English | MEDLINE | ID: mdl-36231891

ABSTRACT

BACKGROUND: Hypertension comorbid with metabolic syndrome could increase the development of adverse cardiovascular events. Educational interventions were effective to improve outcomes in patients. METHODS: This was a secondary data analysis of participants with hypertension. The original randomized controlled trial aimed to examine the effect of app and booklet versus control among individuals diagnosed with metabolic syndrome living in the community. A 30-min health education was provided to each participant. In addition to the education, the app group received a mobile app while the booklet group received a booklet. Data were collected at baseline, week 4, week 12, and week 24. Intention-to-treat principle was followed, and generalized estimating equations was employed for data analysis. RESULTS: A total of 118 participants with hypertension and metabolic syndrome were extracted from the three-arm trial data. The sample size was 36, 42, and 40 in the app group, booklet group, and control group, respectively. Compared to the control group, the app group showed a significant reduction on body weight and waist circumference at week 24, while the total exercise and self-efficacy for exercise were increased at week 12 and week 24 but no significant findings were observed in the booklet group. CONCLUSIONS: The educational intervention supported with app was superior to the booklet support on the outcomes of body weight, waist circumference, total exercise, and self-efficacy for exercise among patients with hypertension and metabolic syndrome in the community.


Subject(s)
Hypertension , Metabolic Syndrome , Mobile Applications , Body Weight , Data Analysis , Humans , Hypertension/epidemiology , Hypertension/therapy , Metabolic Syndrome/therapy , Pamphlets
3.
Risk Manag Healthc Policy ; 15: 597-610, 2022.
Article in English | MEDLINE | ID: mdl-35422666

ABSTRACT

Purpose: Coronary heart disease (CHD) is the leading cause of morbidity and mortality globally. This study aimed to examine the preliminary effect of a nurse-led support programme using a mobile application versus nursing telephone advice on patients at risk of CHD living in the community. Patients and Methods: A prospective randomized controlled trial was adopted. Sixty eligible CHD participants were randomized into the app group (App) or the nursing telephone advice (NTA) group to support their own health care and exercise. Data were collected at baseline (T0), 1 month (T1), and 3 months (T2). Outcomes were total amount of exercise, self-efficacy of chronic disease management, total time of exercise, blood pressure, and lipid concentrations. Data were analyzed using the generalized estimating equation models. Results: Ninety-two individuals were screened for eligibility and 60 were randomized into the app group (n = 30) or NTA group (n = 30). The mean age of the participants was 60.92. The total attrition rate at T2 was 1.66%. The app group showed a moderate effect (Cohen's d =0.43) in significant increase in exercise amount, and reduction of lipid concentration (total cholesterol d=-0.43, triglyceride d=-0.39) respectively. Other outcomes showed improvement trend but non-significant between group. Conclusion: The CHD app is effective to motivate CHD patients for maintaining exercise amount which will be beneficial to their lipid control.

4.
Tob Induc Dis ; 15: 44, 2017.
Article in English | MEDLINE | ID: mdl-29162997

ABSTRACT

BACKGROUND: Workplace smoking cessation (SC) intervention is effective in increasing quit rate but little was known about the factors associated with voluntary SC promotion. Comprehensive smoke-free legislation, including banning smoking in all indoor area of workplaces, has been enforced in Hong Kong. This survey investigated the prevalence of company's compliance with smoke-free legislation and examined the relation between voluntary SC promotion in workplace and employer's knowledge of and attitude towards smoking and SC. METHODS: Half (50.3%, n = 292) of a convenience sample of companies completed a self-administered questionnaire on company's voluntary SC promotion in the workplace. Factors investigated included company's characteristics (size, type, and number of smoking employees); employers' knowledge of smoking, second-hand smoke and SC effects on health; perceived responsibility in assisting employees to quit smoking and smoking prohibition in workplace (smoke free policy). Logistic regression yielded adjusted odds ratio (aOR) for voluntary SC promotion. RESULTS: A notable proportion of companies (14.7%) showed non-compliance with the smoke free workplace ordinance and only 10% voluntarily promoted SC. Perceived greater negative impact of smoking on the company (adjusted odds ratio[aOR] 1.94, 95% confidence interval [CI] 1.18-3.20) and better knowledge of smoking (aOR 1.40, 95%CI 1.00-1.94) were associated with voluntary SC promotion. Positive but non-significant associations were observed between perceived responsibility of assisting employees to quit, workplace smoke free policy and voluntary SC promotion. Company characteristics were generally not associated with voluntary SC promotion except white collar companies were less likely to promote SC (aOR 0.26, 95% CI 0.08-0.85). CONCLUSIONS: This is the first survey on company's SC promotion in the Chinese population. A notable proportion of companies was not compliant with the smoke-free workplace ordinance. Employers with a higher level of knowledge and perceived impact of smoking on companies and from blue-collar companies were more likely to promote SC in workplace. The findings inform future workplace intervention design and policy. TRIAL REGISTRATION: The study was retrospectively registered at ClinicalTrials.gov (NCT02179424) dated 27 June 2014.

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