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Tobacco Control Dec 2019Blu's 'Something Better' advertising campaign ran in popular print magazines in 2017. The campaign included advertisements with fake warnings conveying positive... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Blu's 'Something Better' advertising campaign ran in popular print magazines in 2017. The campaign included advertisements with fake warnings conveying positive messages, which mimicked the Food and Drug Administration (FDA)'s warning requirements for electronic cigarette (e-cigarette) advertisements that took effect in 2018. We report adolescent males' recall of these fake warnings and how exposure to fake warnings affected recall of other advertisement components, including the actual warning or health risks, brand and product.
METHODS
Ohio males ages 12-19 years (N = 775; 73.8 % white non-Hispanic) were randomly assigned to view an e-cigarette advertisement with or without a fake warning. Afterward, they were asked what they remembered most about the advertisement. Responses were qualitatively coded. Statistical analyses included survey-weighted descriptive statistics and logistic regression.
RESULTS
Of participants who viewed an e-cigarette advertisement with a fake warning, 27.0 % reported the fake warning was what they remembered most, and 18.8 % repeated the fake warning message. Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements.
CONCLUSIONS
Adolescents viewing an advertisement with a fake warning were less likely to recall the advertisement's actual warning or health risks. Although e-cigarette advertisements now carry large FDA-mandated warnings, this tactic could be used for cigarette advertisements that continue to carry small warnings in the USA. Findings underscore the necessity of tobacco advertisement surveillance and study of advertisements' effects on adolescents.
Topics: Adolescent; Advertising; Child; Electronic Nicotine Delivery Systems; Humans; Male; Mental Recall; Ohio; Product Labeling; United States; United States Food and Drug Administration; Young Adult
PubMed: 30772827
DOI: 10.1136/tobaccocontrol-2018-054805 -
British Journal of Haematology Nov 2013Evidence regarding the efficacy of gemtuzumab ozogamicin (GO) addition to standard induction chemotherapy in newly diagnosed acute myeloid leukaemia (AML) is... (Meta-Analysis)
Meta-Analysis Review
Evidence regarding the efficacy of gemtuzumab ozogamicin (GO) addition to standard induction chemotherapy in newly diagnosed acute myeloid leukaemia (AML) is conflicting. This systematic review aimed to identify and summarize all evidence regarding the benefits and harms of adding GO to conventional chemotherapy for induction treatment of AML. A comprehensive literature search of two databases (PUBMED and Cochrane) from inception up to November 22, 2012, and 4 years of proceedings from four major haematology/oncology conferences was undertaken. Endpoints included benefits (complete remission, relapse-free, event-free, and overall survival), and harms (early mortality and incidence of hepatic veno-occlusive disease/sinusoidal obstructive syndrome). Seven trials (3942 patients) met all inclusion criteria. Addition of GO showed improved relapse-free [Hazard Ratio (HR) = 0·84 (95% confidence interval (CI) 0·71-0·99)] and event-free survival [HR = 0·59 (95%CI 0·48-0·74)] but not overall survival [HR = 0·95 (95%CI 0·83-1·08)]. Addition of GO resulted in higher rate of early mortality [Risk Ratio = 1·60 (95%CI 1·07-2·39)]. Improved overall survival was observed in studies using a lower cumulative GO dose (<6 mg/m(2) ) [HR = 0·89 (95%CI 0·81-0·99)]. Addition of GO to conventional chemotherapy as induction therapy may improve relapse-free and event-free survival, but does not impact overall survival and significantly increases early mortality in AML.
Topics: Aminoglycosides; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Disease-Free Survival; Evidence-Based Medicine; Gemtuzumab; Hepatic Veno-Occlusive Disease; Humans; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Randomized Controlled Trials as Topic; Remission Induction; Safety-Based Drug Withdrawals; Survival Analysis; Treatment Outcome; United States; United States Food and Drug Administration
PubMed: 24033280
DOI: 10.1111/bjh.12528 -
JAMA Network Open May 2021The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval...
IMPORTANCE
The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices and relies on benchtop (nonclinical and biomechanical) and descriptive data. Existing literature suggests that the clinical trials required by PMA are associated with reduced risk of recall compared with devices granted 510(k) clearance. Several investigators have found weaknesses in pivotal PMA trials, raising safety concerns. Furthermore, methodological factors may have led to a previous underestimation of recall risk for devices with PMA.
OBJECTIVES
To compare risk of recall and high-risk recall between devices that received 510(k) clearance and those that received PMA and to compare the risk of recall between devices for medical specialties.
DESIGN, SETTING, AND PARTICIPANTS
This cohort study compared devices with 510(k) clearance vs those with PMA that reached the market between January 1, 2008, and December 31, 2017. Two- to 12-year follow-up was obtained from the FDA's 510(k) and PMA medical device database. Orthopedic surgery was chosen arbitrarily as the reference category for analysis between specialties because no baseline exists. Statistical analysis was performed from February 1 to November 1, 2020.
MAIN OUTCOMES AND MEASURES
The FDA issues recalls for safety concerns. These recalls are stratified into class I, II, and III, with class I representing high-risk issues for serious harm or death. The main outcome was the hazard ratio of any recall and class I recall between devices with PMA and those with 510(k) clearance. The secondary outcome was the recall hazard ratio between specialties with respect to the reference category. A single Cox proportional hazards regression model evaluating the association of medical specialty and FDA approval pathway with the risk of recall was performed.
RESULTS
During the study period, 28 246 devices received 510(k) clearance and 310 devices (10.7%) received PMA; 3012 devices (10.7%) with 510(k) clearance and 84 devices (27.1%) with PMA were recalled. A total of 216 devices (0.8%) with 510(k) clearance and 16 devices (5.2%) with PMA had class I recalls. Devices with PMA compared with those with 510(k) clearance had a hazard ratio for recall of 2.74 (95% CI, 2.19-3.44; P < .001) and a hazard ratio for high-risk recall of 7.30 (95% CI, 4.39-12.13; P < .001). Only radiologic devices were associated with an increased risk of recall (hazard ratio, 1.57; 95% CI, 1.32-1.87; P < .001), whereas 6 specialties were assocated with a decreased risk compared with the orthopedic reference category: general and plastic surgery, otolaryngology, obstetrics and gynecology, physical medicine, hematology, and general hospital.
CONCLUSIONS AND RELEVANCE
This study suggests that high-risk medical devices approved via PMA are associated with a greater risk of recall than previously reported. Most recalls are for devices with 510(k) clearance, also raising safety concerns. Strengthening postmarketing surveillance strategies and pivotal trials may improve device safety.
Topics: Cohort Studies; Device Approval; Humans; Proportional Hazards Models; Risk Factors; Safety-Based Medical Device Withdrawals; United States; United States Food and Drug Administration
PubMed: 33956132
DOI: 10.1001/jamanetworkopen.2021.7274 -
Tobacco Regulatory Science May 2018In the U.S., print advertisements for smokeless tobacco (SLT) feature a large black-and-white text warning covering 20% of the advertisement space. Cigarette and...
OBJECTIVES
In the U.S., print advertisements for smokeless tobacco (SLT) feature a large black-and-white text warning covering 20% of the advertisement space. Cigarette and e-cigarette advertisements feature a small warning covering approximately 4% of advertisement space. We explored how warning size affects adolescent boys' spontaneous recollection of the warning, brand-relevant advertisement features, and product risks.
METHODS
1,220 adolescent males (ages 11-16) viewed SLT, cigarette, and e-cigarette advertisements. After each advertisement, boys were asked to recall what they remembered most. Coders identified recalls of the warning label, brand-relevant advertisement features, and risks associated with the product in responses.
RESULTS
Participants were less likely to recall warnings in the cigarette vs. SLT (OR=0.30, p<0.001) and e-cigarette vs. SLT (OR=0.15, p<0.001) ads. Separate GEEs revealed that boys who recalled warnings were less likely to mention brand-relevant advertisement features (OR's<0.32, p's<0.001). Logistic regressions revealed that boys who recalled the warnings were more likely to mention risks associated with the products (OR's>3.50, p's<0.001).
CONCLUSIONS
Youth are more likely to recall large SLT warnings than small cigarette and e-cigarette warnings. Warning recall is associated with lower likelihood of recalling brand-relevant advertisement features and greater likelihood of mentioning product risks.
PubMed: 30009217
DOI: 10.18001/TRS.4.3.7 -
Frontiers in Neuroscience 2020Odors can be powerful stimulants. It is well-established that odors provide strong cues for recall of locations, people and events. The effects of specific scents on...
Odors can be powerful stimulants. It is well-established that odors provide strong cues for recall of locations, people and events. The effects of specific scents on other cognitive functions are less well-established. We hypothesized that scents with different odor qualities will have a different effect on attention. To assess attention, we used Inter-Subject Correlation of the EEG because this metric is strongly modulated by attentional engagement with natural audiovisual stimuli. We predicted that scents known to be "energizing" would increase Inter-Subject Correlation during watching of videos as compared to "calming" scents. In a first experiment, we confirmed this for eucalyptol and linalool while participants watched animated autobiographical narratives. The result was replicated in a second experiment, but did not generalize to limonene, also considered an "energizing" odorant. In a third, double-blind experiment, we tested a battery of scents including single molecules, as well as mixtures, as participants watched various short video clips. We found a varying effect of odor on Inter-Subject Correlation across the various scents. This study provides a basis for reliably and reproducibly assessing effects of odors on brain activity. Future research is needed to further explore the effect of scent-based up-modulation in engagement on learning and memory performance. Educators, product developers and fragrance brands might also benefit from such objective neurophysiological measures.
PubMed: 32754012
DOI: 10.3389/fnins.2020.00702 -
Journal of Clinical Sleep Medicine :... Feb 2022As more patients depend upon mechanical or electronic technologies for treatment, medical device recalls-like the recent recall of common positive airway pressure...
UNLABELLED
As more patients depend upon mechanical or electronic technologies for treatment, medical device recalls-like the recent recall of common positive airway pressure treatment devices-impact millions of patients, often causing significant anxiety, extra costs, and interruption of care for patients. When recalls require health care and/durable medical equipment providers to be part of the solution, the burden on practices and businesses can be significant, creating strains on access for new patients and on limited medical supplies. We have observed that having an established and well-organized medical device recall plan in place allows for a rapid response, decreased practice burden, and reduced provider stress. Coupling the organized response with proactive, empathic, and clear communication with patients reduces their anxiety, provides clear directions for how to address the issue constructively, and reduces reactive communications. We share what we believe are key components of a medical device and produce recall procedure as we describe our institutions response in hopes that others can build on these basics as they design their own response plans.
CITATION
Morgenthaler TI, Linginfelter EA, Gay PC, et al. Rapid response to medical device recalls: an organized patient-centered team effort. 2022;18(2):663-667.
Topics: Humans; Medical Device Recalls; Patient-Centered Care; United States; United States Food and Drug Administration
PubMed: 34705629
DOI: 10.5664/jcsm.9748 -
International Journal of Environmental... Nov 2020This study aimed to assess consumers' implicit and explicit recall, understanding and perceptions of products with a nutrition claim and a symbol depicting 'health,' and...
This study aimed to assess consumers' implicit and explicit recall, understanding and perceptions of products with a nutrition claim and a symbol depicting 'health,' and to determine whether these perceptions differed among Nutrition Facts table (NFt) users vs. nonusers. In an online survey, participants (n = 1997) were randomized to one of eight conditions in a 2 × 2 × 2 factorial design, consisting of a label with a claim (present/absent) a heart-shaped symbol depicting 'health' (present/absent) for a healthier or less healthy soup. Participants were shown a label for 10 s and asked whether they recalled seeing a claim. If participants answered yes, they were then asked to describe their response using open-ended questions. Participants also rated the product's perceived nutritional quality and purchase intentions using seven-point Likert scales. In the claim condition, most participants (75%) were able to recall the presence of a claim, while 12% incorrectly mentioned the presence of a claim when there was none. Claims likely attracted consumers' attention and increased perceived nutritional quality, although with limited influence among NFt users (23%). The symbol depicting 'health' did not enhance perceived nutritional quality or purchase intentions. Although most participants (77%) made their decisions implicitly using the front of labels, those who used the NFt had a better understanding of the nutritional quality of products.
Topics: Child; Choice Behavior; Consumer Behavior; Female; Food Labeling; Food Preferences; Humans; Male; Nutritive Value; Perception; Surveys and Questionnaires
PubMed: 33172128
DOI: 10.3390/ijerph17218213 -
Nicotine & Tobacco Research : Official... Jul 2018While research has documented associations between recall of point-of-sale (POS) tobacco marketing and youth tobacco use, much of the research is cross-sectional and...
INTRODUCTION
While research has documented associations between recall of point-of-sale (POS) tobacco marketing and youth tobacco use, much of the research is cross-sectional and focused on cigarettes. The present longitudinal study examined recall of tobacco marketing at the POS and multiple types of tobacco use 6 months later.
METHODS
The Texas Adolescent Tobacco Advertising and Marketing Surveillance System (TATAMS) is a large-scale, representative study of 6th, 8th, and 10th graders in 79 middle and high schools in five counties in Texas. Weighted logistic regression examined associations between recall of tobacco advertisements and products on display at baseline and ever use, current use, and susceptibility to use for cigarette, e-cigarette, cigar, and smokeless products 6 months later.
RESULTS
Students' recall of signs marketing e-cigarettes at baseline predicted ever e-cigarette use and increased susceptibility to use e-cigarettes at follow-up, across all store types. Recall of e-cigarette displays only predicted susceptibility to use e-cigarettes at follow-up, across all store types. Both recall of signs marketing cigars and cigar product displays predicted current and ever cigar smoking and increased susceptibility to smoking cigars at follow-up, across all store types. Recall of cigarette and smokeless product marketing and displays was not associated with tobacco use measures.
CONCLUSION
The POS environment continues to be an important influence on youth tobacco use. Restrictions on POS marketing, particularly around schools, are warranted.
IMPLICATIONS
Cross-sectional studies have shown that exposure to POS cigarette marketing is associated with use of cigarettes among youth, though longitudinal evidence of the same is sparse and mixed. Cross-sectional studies have found that recall of cigars, smokeless product, and e-cigarette tobacco marketing at POS is associated with curiosity about tobacco use or intentions to use tobacco among youth, but limited longitudinal research has been conducted. Findings from the present longitudinal study suggest that recall of tobacco marketing at retail POS predicts ever use of e-cigarettes and cigars, current use of cigars, and susceptibility to cigar and e-cigarette use among youth.
Topics: Adolescent; Adolescent Behavior; Cross-Sectional Studies; Electronic Nicotine Delivery Systems; Female; Follow-Up Studies; Forecasting; Humans; Longitudinal Studies; Male; Marketing; Product Recalls and Withdrawals; Smoking; Students; Texas; Tobacco Products; Vaping
PubMed: 29069425
DOI: 10.1093/ntr/ntx237 -
Nicotine & Tobacco Research : Official... May 2021In October 2019, a heated tobacco product (HTP) IQOS debuted in the United States. This study examined young adults' attention and cognitions in response to an IQOS ad...
INTRODUCTION
In October 2019, a heated tobacco product (HTP) IQOS debuted in the United States. This study examined young adults' attention and cognitions in response to an IQOS ad that carried two mandated textual health warnings (Surgeon General's warning and nicotine warning), and how their vaping and smoking status may interact with attention patterns to affect attitude and intention to use IQOS.
METHODS
In November 2019, college students (N = 164) viewed IQOS' first U.S. magazine ad and two distractor ads. Viewing patterns were recorded with eye-tracking. Masked recall and aided recognition, attitude and intention towards IQOS use were later assessed with self-report. Ordinary Least Squares (OLS) regressions and moderated mediation analyses examined the associations between visual attention and viewers' cognitions about IQOS use.
RESULTS
Promotional content attracted significantly more attention compared to the warnings. Attention to the Surgeon General's warning but not to the nicotine warning was associated with recall and recognition of the warning's content. For ever-vapers, greater attention allocation to the promotional content in the IQOS ad was associated with more favorable attitude toward IQOS use, which was in turn positively associated with intention to use IQOS. Attention allocation to the warnings did not affect attitude or intentions, regardless of tobacco use status.
CONCLUSIONS
The results revealed the effects of IQOS promotional content overshadowed the two health warnings in influencing young people's attitude and intention to use IQOS. Young adults who vaped were more vulnerable to HTP advertising with respect to future use and vaping may be a gateway to HTP use.
IMPLICATIONS
This is the first eye-tracking study examining attention and cognitions associated with the new IQOS ad exposure among young adults. Promotional content in the ad attracted significantly more attention than the two warnings combined. Attention to the Surgeon General's warning but not to the nicotine warning was associated with recall and recognition of the warning's content. Greater attention allocation to the promotional content led to a more favorable attitude toward IQOS use which was associated with increased intention to use IQOS for ever-vapers. However, greater attention allocation to the warnings did not affect attitude or intentions to use IQOS.
Topics: Adolescent; Adult; Advertising; Attention; Attitude; Cognition; Consumer Behavior; Eye-Tracking Technology; Female; Health Behavior; Humans; Intention; Male; Mental Recall; Nicotine; Product Labeling; Reading; Smokers; Nicotiana; Tobacco Products; Tobacco Smoking; United States; Vaping; Young Adult
PubMed: 33245339
DOI: 10.1093/ntr/ntaa243 -
Nicotine & Tobacco Research : Official... Aug 2021Advertisement warnings are often overlooked, which reduces the opportunity for risk communication. (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Advertisement warnings are often overlooked, which reduces the opportunity for risk communication.
METHODS
We used Prolific to survey 1131 young adults (18-35) who currently used e-cigarettes or tobacco products. We randomized participants to one of four warning conditions: black text on white background (BW), white on black (WB), black on yellow (BY), and yellow on black (YB). We examined associations between condition and attention, recall, ad appeal, perceived message effectiveness (PME), and intentions to use e-cigarettes using chi-square and analysis of variance (ANOVA) where appropriate. We conducted logistic regressions by condition for attention and recall controlling for demographics and tobacco use.
RESULTS
The warning was selected as the most attention-capturing area of the advertisement more often by those exposed to yellow warnings than white (59.9% vs. 46.8%), even after controlling for demographics and tobacco use (p < .05). Recall was greater among those exposed to yellow warnings than white (44.2% vs. 37.3%), which held in controlled models. There were no significant differences between yellow and white warnings for ad appeals, PME, or intentions to use. In subanalyses, WB warnings generated higher PME (10.1 vs. 9.5) and lower intentions to use e-cigarettes (3.0 vs. 3.3) than black on white (BW) (each p < .05).
CONCLUSIONS
Yellow warning color increases attention and recall of the warning, but this increase in attention did not translate to differences in downstream effects. Among currently mandated warning variations, the white text on black background warning appears more effective than the BW. Future research should examine whether differences translate to behavior change.
IMPLICATIONS
We tested color variations of the FDA-mandated nicotine text warning on e-cigarette advertisements. Yellow variations (yellow text on black background and BY) better-captured attention and increased warning recall compared to the mandated black and white warnings. Among the FDA-mandated BW and WB warnings, the WB variation appears more effective, generating higher perceived message effectiveness and lower intentions to use e-cigarettes. Given the difficulty in implementing pictorial warnings in the United States, color might represent an alternative to improve warning effectiveness. Findings may also be applicable to those designing tobacco-related health communications.
Topics: Advertising; Electronic Nicotine Delivery Systems; Humans; Nicotine; Product Labeling; Tobacco Products; United States; Young Adult
PubMed: 33713411
DOI: 10.1093/ntr/ntab043