scholarly journals Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol

2020 ◽  
Vol 98 ◽  
pp. 106152
Author(s):  
John P. Pierce ◽  
David R. Strong ◽  
Matthew D. Stone ◽  
Adriana Villaseñor ◽  
Claudiu V. Dimofte ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Real World ◽  
Trial Protocol ◽  
Warning Labels ◽  
Graphic Warning

scholarly journals Achieving blood pressure control targets in hypertensive patients of rural China – A pilot randomized trial

2020 ◽  
Author(s):  
Xiao Huang ◽  
Lishun Liu ◽  
Yun Song ◽  
Lan Gao ◽  
Min Zhao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Trial ◽  
Real World ◽  
Large Scale ◽  
Rural China ◽  
Standard Group ◽  
Open Label ◽  
Target Groups ◽  
Serious Adverse Events ◽  
Hypertensive Patients

Abstract Background This study aimed to test the feasibility and titration methods to achieve specific BP control targets in hypertensive patients of rural China. Methods A randomized, controlled, open-label trial was conducted in Rongcheng, China. We enrolled 105 hypertensive participants aged over 60 years, and who had no history of stroke and cardiovascular disease. The patients were randomly assigned to one of three systolic BP target groups: standard: 140 - < 150mmHg; moderately intensive: 130 - < 140mmHg; and intensive: <130mmHg. Patients were followed for 6 months. Discussion The optimal target for SBP lowering is still uncertain worldwide and such information is critically needed, especially in China. However, in China the rates of awareness, treatment and control are only 46.9%, 40.7% and 15.3%, respectively. It is challenging to achieve BP control in the real world and it is very important to develop population-specific BP control protocols that fully consider the population’s characteristics, such as age, sex, socio-economic status, compliance, education level and lifestyle. This randomized trial showed feasibility and safety of the titration protocol to achieve desirable SBP targets (<150, <140, and <130mmHg) in a sample of rural Chinese hypertensive patients. The three BP target groups had similar baseline characteristics. After 6 months of treatment, the mean SBP measured at an office visit was 137.2mmHg, 131.1mmHg, and 124.2mmHg in the three groups. Home BP and central aortic BP measurements were also obtained. At 6 months, home BP measurements (2 hours after drug administration) showed a mean SBP of 130.9 mmHg in the standard group, 124.9 mmHg in the moderately intense group, and 119.7 mmHg in the intensive group. No serious adverse events were recorded over the 6-month study period. Rates of adverse events including dry cough, palpitations, and arthralgia were low and showed no significant differences between the three groups. This trial gained real world experience and laid the foundation for a future large-scale BP target study.

scholarly journals The estimated effect of graphic warning labels on smoker’s intention to quit in Shanghai, China: a cross-sectional study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ruiping Wang ◽  
Yan Qiang ◽  
Yan Zhu ◽  
Xiangjin Gao ◽  
Qiong Yang ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Logistic Regression ◽  
Control Measures ◽  
Intention To Quit ◽  
Lower Percentage ◽  
Warning Labels ◽  
Cross Sectional ◽  
Smoking Intensity ◽  
Graphic Warning ◽  
Cigarette Packs

Abstract Background Tobacco consumption is the leading cause of death worldwide. Overwhelming studies demonstrate graphic warning labels (GWLs) on cigarette packs are effective in eliciting negative response to tobacco smoking, modifying beliefs about tobacco dangers, and increasing reported intention to quit, but the estimated effect of GWLs on smoking cessation intention among smokers is still limited in China. In this study, we aim to understand the smoking intensity, smoking duration and smoking cessation intention among current smokers, and to explore how their smoking cessation intention would be influenced by the GWLs in Shanghai. Methods From January to June 2021, we totally recruited 1104 current smokers in Songjiang district and Fengxian district of Shanghai by multistage sampling design. We used Android pad assisted electronic questionnaire for data collection, and then implemented logistic regression for odds ratio (OR) and 95% confidence interval (CI) calculation to explore how smoking cessation intention would be influenced by the GWLs among current smokers. Results One thousand one hundred four current smokers included 914 males (82.79%), with an average age of 43.61 years. 58.06% of current smokers reported smoking cessation intention due to GWLs. Logistic regression indicated a higher percentage of smoking cessation intention due to GWLs was among female smokers [OR = 2.41, 95% CI (1.61–3.59)], smokers with smoking intensity < 20 cigarette/day [OR = 1.92, 95% CI (1.44–2.55)], smokers with tobacco burden < 20% [OR = 1.94, 95% CI (1.35–2.79)], and among smokers had plan to quit in a year [OR = 6.58, 95% CI (4.71–9.18). Smokers with higher individual monthly income had lower percentage of smoking cessation intention (OR were 0.35, 0.46 and 0.41). Meanwhile, among 642 current smokers without plan to quit in a year, approximately 40% of them reported smoking cessation intention due to GWLs. Conclusions Smoking cessation intention due to the assumed GWLs on cigarette packs is high among current smokers in Shanghai, especially in female smokers, smokers with light tobacco burden and mild nicotine dependence. Incorporating smoking intensity as well as smoking burden into the implementation of GWLs as tobacco control measures would discourage smoking in China.

scholarly journals Should Graphic Warning Labels Proposed for Cigarette Packages Sold in the United States Mention the Food and Drug Administration?

2020 ◽  
Author(s):  
Mia Jovanova ◽  
Chris Skurka ◽  
Sahara Byrne ◽  
Motasem Kalaji ◽  
Amelia Greiner Safi ◽  
...  
Keyword(s):  
Middle School ◽  
Tobacco Control ◽  
Drug Administration ◽  
Source Credibility ◽  
Food And Drug Administration ◽  
The United States ◽  
Smoking Prevention ◽  
Warning Labels ◽  
The Us ◽  
Graphic Warning

Abstract Introduction Under the US Family Smoking Prevention and Tobacco Control Act, the US Food and Drug Administration (FDA) has the authority to implement graphic warning labels (GWLs) on cigarette packages. Neither the original labels proposed by the FDA nor the revised labels include a source to indicate sponsorship of the warnings. This study tests the potential impact of adding a sponsor to the content of GWLs. Methods We recruited adult smokers (N = 245) and middle-school youth (N = 242) from low-income areas in the Northeastern US. We randomly assigned participants to view one of three versions of the original FDA–proposed warning labels in a between-subjects experiment: no sponsor, “US Food and Drug Administration,” or “American Cancer Society” sponsor. We tested the effect of varying sponsorship on source attribution and source credibility. Results Compared to unsponsored labels, FDA sponsorship increased source attributions that the FDA sponsored the labels among both middle-school, largely nonsmoking youth and adult smokers. However, sponsorship had no effect on source credibility among either population. Conclusions We found no evidence that adding FDA as the source is likely to boost source credibility judgments, at least in the short term; though doing so would not appear to have adverse effects on credibility judgments. As such, our data are largely consistent with the Tobacco Control Act’s provisions that allow, but do not require, FDA sponsorship on the labels. Implications This study addresses the FDA’s regulatory efforts by informing the possible design and content of future cigarette warning labels. Our results do not offer compelling evidence that adding the FDA name on GWLs will directly increase source credibility. Future work may test more explicit FDA source labeling and continue to examine the credibility of tobacco message content among high–priority populations.

scholarly journals Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic, feasibility, online randomized trial protocol

2020 ◽  
Vol 98 ◽  
pp. 106142
Author(s):  
Tzeyu L. Michaud ◽  
Paul A. Estabrooks ◽  
Wen You ◽  
Todd J. McGuire ◽  
Fabio Almeida ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Trial ◽  
Financial Incentives ◽  
Trial Protocol ◽  
Weight Loss Intervention

scholarly journals Emotional Impact and Perceived Effectiveness of Text-Only versus Graphic Health Warning Tobacco Labels on Adolescents

2019 ◽  
Vol 22 ◽  
Author(s):  
Pedro Margalhos ◽  
Francisco Esteves ◽  
Jaime Vila ◽  
Patrícia Arriaga
Keyword(s):  
Smoking Status ◽  
Cross Sectional Study ◽  
Emotional Impact ◽  
Negative Consequences ◽  
Perceived Effectiveness ◽  
Warning Labels ◽  
Health Warnings ◽  
Cross Sectional ◽  
Graphic Warning ◽  
Valence And Arousal

AbstractThe study of smoking in adolescence is of major importance as nicotine dependence often begins in younger groups. Tobacco health warnings have been introduced to inform people of the negative consequences of smoking. This study assessed the emotions and perceived effectiveness of two formats of tobacco warnings on adolescents: Text-only versus graphic warning labels. In addition, we analyzed how emotions predicted their perceived effectiveness. In a cross-sectional study, 413 adolescents (131 smokers, 282 non-smokers) between 13–20 years of age rated their emotions (valence and arousal) and perceived effectiveness towards a set of tobacco warnings. Results showed that graphic warnings evoked higher arousal than text-only warning labels (p = .038). Most of the warning labels also evoked unpleasantness with smokers reporting higher unpleasantness regarding text-only warnings compared to non-smokers (p = .002). In contrast, perceived effectiveness of the warnings was lower in smokers than in non-smokers (p = .029). Finally, high arousal and being a non-smoker explained 14% of the variance of perceiving the warnings more effective. Given the role that warnings may play in increasing health awareness, these findings highlight how smoking status and emotions are important predictors of the way adolescents consider tobacco health labels to be effective.

Retrospective comparison of neoadjuvant chemoradiation (nCRT) +/- surgery using the CROSS trial regimen and definitive chemoradiation (dCRT) with carboplatin (C) and paclitaxel (P) in esophageal (EC), and gastroesophageal junction cancer (GEJC) in Canada.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 313-313
Author(s):  
Sidra Khalid ◽  
Wilma M. Hopman ◽  
Kiran Virik
Keyword(s):  
Real World ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Outcome Data ◽  
World Population ◽  
Trial Protocol ◽  
Real World Data ◽  
Eligibility Criteria ◽  
Trimodality Therapy ◽  
The Cross

313 Background: Trimodality therapy using the CROSS trial protocol is an accepted standard of care for locally advanced EC and GEJC. For medically inoperable patients (pts), CRT has been a standard. CRT with C and P is an option in the definitive setting. This single institution review aims to assess the application and outcomes of the CROSS trial protocol in our real world population. Methods: From June 2012 until June 2018, a retrospective review was undertaken of 83 pts who underwent CRT with C and P with trimodaility or upfront definitive intent. 65 pts underwent nCRT; 40 proceeded to surgery. 18 had upfront dCRT. Pt demographics, clinical, pathological, treatment and surgical characteristics were assessed. These factors and outcomes were analyzed in exploratory analyses. Results: Of the 83 pts: median (m) age was 69 yrs (range 48-82), 34% were ≥ 75 yrs, 80% were male, 21% had CAD, 43% GERD, 23% Barrett’s, 77% adenocarcinoma, m tumor length was 5 cm, 36% had BMI > 30 and 80% were Siewert I tumors. The m RT dose was 50.4 Gy, m chemo doses were 5, m time to CRT was 69 days and m time from CRT to surgery was 66 days. 23% nCRT pts and 72% dCRT pts were ≥ 75 yrs and 49% and 33% of these respectively had no interruptions to CRT. Pts who underwent surgery were younger (p = 0.04) and weighed more (p = 0.05). Pts ≥75 yrs were likely to have dCRT (p = 0.001). For nCRT and surgery, nCRT only and dCRT respectively, median overall survival (mOS) was 35.5, 12.1 and 17.1 months (M) (log rank p = 0.08), PFS was 32.2, 10 and 9.6M (log rank p = 0.01). Compared to the other 2 groups, pts who underwent surgery had: no COPD (p = 0.004), less CAD (p = 0.003), less renal impairment (p = 0.023) and had lower esophageal tumors (p = 0.027). mOS for pts who had nCRT was 28.9M and 17.1M for dCRT (log rank p = 0.70). Further correlative outcome data will be presented. Conclusions: Despite the broadening of CROSS trial eligibility criteria in our real world data, there appears to be a survival benefit with trimodality therapy. The use of C and P in dCRT may be of value especially in the elderly, and requires further study.

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