A cross-sectional analysis of how young adults perceive tobacco brands: implications for FCTC signatories

BACKGROUND: The Framework Convention on Tobacco Control calls for the elimination of tobacco advertising, promotion and sponsorship. To test whether tobacco packaging functions as advertising by communicating attractive and distinctive brand attributes, we explored how young adult smokers and non-smokers interpreted familiar and unfamiliar tobacco brands. METHODS: We conducted an on-line survey of 1035 young adult smokers and non-smokers aged 18–30. Participants evaluated eight tobacco brands using ten attributes based on brand personality scales. We used factor analysis and ANOVA to examine patterns in brand-attribute associations. RESULTS: Young adults distinguished between brands on the basis of their packaging alone, associated each brand with specific attributes, and were equally able to interpret familiar and unfamiliar brands. Contrary to our expectations, non-smokers made more favourable brand-attribute associations than smokers, but both groups described Basic, a near generic brand, as ‘plain’ or ‘budget’. There were no significant gender or ethnicity differences. CONCLUSIONS: Tobacco packaging uses logos, colours and imagery to create desirable connotations that promote and reinforce smoking. By functioning in the same way as advertising, on-pack branding breaches Article 13 of the FCTC and refutes tobacco companies’ claims that pack livery serves only as an indentifying device that simplifies smokers’ decision-making. Given this evidence, signatories should see plain packaging policies as a priority consistent with their FCTC obligations to eliminate all tobacco advertising and promotion

The response of young adult smokers and nonsmokers in the United Kingdom to dissuasive cigarettes: An online survey

Introduction  The cigarette stick is an important communications tool as well as the object of consumption. We explored young adults’ responses to cigarettes designed to be dissuasive.  Methods  Data come from a cross-sectional online survey, conducted in September 2015, with 16-24 year old smokers and non-smokers (N=997) in the United Kingdom. Participants were shown images of a standard cigarette (white cigarette paper with imitation cork filter), a standard cigarette displaying the warning ‘Smoking kills’ on the cigarette paper, and an unattractively coloured cigarette (green cigarette paper and filter). They were asked to rate each of the three cigarettes, shown individually, on eight perception items, and to rate the three cigarettes, shown together, on how likely they would be to try them. Ordering of the cigarettes and questions, with the exception of the question on trial, was randomised.  Results  The eight perceptions items were combined to form a composite measure of cigarette perceptions. For smokers and non-smokers, the two dissuasive cigarettes (cigarette with warning, green cigarette) were rated significantly less favourably than the standard cigarette, and less likely to encourage trial. For cigarette perceptions no significant interaction was detected between cigarette style and smoking status or susceptibility to smoke among never smokers. A significant interaction was found for likelihood of trying the cigarettes, with dissuasive cigarettes having a greater impact with smokers than non-smokers.  Conclusions  This study suggests that dissuasive cigarettes may help to reduce the desirability of cigarettes.  Implications The cigarette stick is the object of tobacco consumption, which is seen every time a cigarette is smoked. It is also an increasingly important promotional tool for tobacco companies. In this study, young adults rated two dissuasive cigarettes (a green coloured cigarette and a cigarette displaying a health warning) more negatively than a standard cigarette, and considered them less likely to encourage product trial. Our findings suggest that it may be possible to reduce the desirability of cigarette sticks by altering their design, e.g. with the addition of a warning or use of an unattractive colour

Butting out:An analysis of support for measures to address tobacco product waste

Background: Cigarette butts are ubiquitous litter items, causing major environmental damage and imposing significant clean-up costs. Tobacco companies frame smokers as both the cause of this problem and the source of its solution. However, an extended producer responsibility perspective challenges this view and holds tobacco companies to account for the full life cycle costs of tobacco product waste (TPW). Methods: Using an online cross-sectional survey of 396 New Zealand smokers and 414 non-smokers, we estimated awareness of TPW, attribution of responsibility for TPW and support for interventions to reduce TPW. Descriptive analyses and logistic regression models examined associations between demographic attributes and smoking behaviours, and perceptions of TPW and potential solutions to this problem. Results: Most respondents saw butt litter as toxic to the environment and held smokers primarily responsible for creating TPW. However, when knowledge of butt non-biodegradability increased, so too did the proportion holding tobacco companies responsible for TPW. Changes to product design, fines for littering and expanded smoke-free spaces were considered most likely to reduce TPW. Smokers and non-smokers held different views on measures to address TPW, with smokers favouring more educative approaches and non-smokers more restrictive policies. Conclusions: Strategies to increase awareness of tobacco companies' role in creating TPW could foster political support for producer responsibility measures that require the industry to manage TPW. Nevertheless, policy measures should continue to foster smoking cessation and decrease uptake, as reducing smoking prevalence presents the best long-term solution to addressing TPW.</p

The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol

Background: Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved analgesic regimens yet lidocaine patches are untested as an early intervention in the Emergency Department (ED). The aim of this trial is to investigate uncertainties around trial design and conduct, to establish whether a definitive randomised trial of topical lidocaine patches in older patients with rib fractures is feasible. Methods: RELIEF is an open label, multicentre, parallel group, individually randomised, feasibility randomised controlled trial with economic scoping and nested qualitative study. Patients aged ≥ 65 years presenting to the ED with traumatic rib fracture(s) requiring admission will be randomised 1:1 to lidocaine patches (intervention), in addition to standard clinical management, or standard clinical management alone. Lidocaine patches will be applied immediately after diagnosis in ED and continued daily for 72 hours or until discharge. Feasibility outcomes will focus on recruitment, adherence and follow-up data with a total sample size of 100. Clinical outcomes, such as 30-day pulmonary complications, and resource use will be collected to understand feasibility of data collection. Qualitative interviews will explore details of the trial design, trial acceptability and recruitment processes. An evaluation of the feasibility of measuring health economics outcomes data will be completed. Discussion: Interventions to improve outcomes in elderly patients with rib fractures are urgently required. This feasibility trial will test a novel early intervention which has the potential of fulfilling this unmet need. The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF) feasibility trial will determine whether a definitive trial is feasible. ISRCTN Registration: ISRCTN14813929 (22/04/2021)

The RELIEF feasibility trial: Topical lidocaine patches in older adults with rib fractures

Background: Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible. Methods: This was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes. Results: Between October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74–88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures. Conclusion: Recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial. Trial registration number: ISRCTN14813929

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570