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Preventive Medicine Reports Jan 2024Cannabis legalization provides an opportunity to communicate with consumers through mandated health warnings on cannabis packaging. However, research on cannabis health... (Review)
Review
BACKGROUND
Cannabis legalization provides an opportunity to communicate with consumers through mandated health warnings on cannabis packaging. However, research on cannabis health warnings is a nascent field. Therefore, a review is needed to synthesize cannabis health warning research and inform ongoing policy discussions.
METHODS
This paper used systematic review guidelines to search online databases, including PubMed Central, Scopus, Web of Science, Jstor, Communication and Mass Media Complete, Medline, PsycINFO, and Google Scholar. Search strings combined the terms "cannabis" or "marijuana" with "health warning" or "health warning message" or "warning label" or "health warning label" or "health information label." Results were synthesized narratively.
RESULTS
The search identified 90 research articles. After screening, 17 studies on the impact of cannabis health warnings were retained. Retained studies focused on the hypothetical effects of cannabis health warnings ( = 11; 64.7 %) and "real world" effects of implementing warnings post-legalization ( = 6; 35.3 %). Evidence indicated mandated cannabis health warnings improved noticing and recall of health warning content. Cannabis health warnings describing risks of addiction were consistently rated the least effective. Pictorial cannabis health warnings generally outperformed text-only warnings when displayed on their own, while experiments with warnings on products had mixed results. Cannabis health warnings decreased product appeal, mainly when package branding was minimized.
CONCLUSIONS
Health warnings on cannabis packaging are an important strategy to communicate risk to consumers. Mandating warnings increased notice, recall, and health knowledge. Warnings with pictures and describing specific risks were most effective, as was showing warnings without product branding.
PubMed: 38222305
DOI: 10.1016/j.pmedr.2023.102573 -
Journal of Medical Internet Research Sep 2023The innovative method of sentiment analysis based on an emotional lexicon shows prominent advantages in capturing emotional information, such as individual attitudes,...
BACKGROUND
The innovative method of sentiment analysis based on an emotional lexicon shows prominent advantages in capturing emotional information, such as individual attitudes, experiences, and needs, which provides a new perspective and method for emotion recognition and management for patients with breast cancer (BC). However, at present, sentiment analysis in the field of BC is limited, and there is no emotional lexicon for this field. Therefore, it is necessary to construct an emotional lexicon that conforms to the characteristics of patients with BC so as to provide a new tool for accurate identification and analysis of the patients' emotions and a new method for their personalized emotion management.
OBJECTIVE
This study aimed to construct an emotional lexicon of patients with BC.
METHODS
Emotional words were obtained by merging the words in 2 general sentiment lexicons, the Chinese Linguistic Inquiry and Word Count (C-LIWC) and HowNet, and the words in text corpora acquired from patients with BC via Weibo, semistructured interviews, and expressive writing. The lexicon was constructed using manual annotation and classification under the guidance of Russell's valence-arousal space. Ekman's basic emotional categories, Lazarus' cognitive appraisal theory of emotion, and a qualitative text analysis based on the text corpora of patients with BC were combined to determine the fine-grained emotional categories of the lexicon we constructed. Precision, recall, and the F1-score were used to evaluate the lexicon's performance.
RESULTS
The text corpora collected from patients in different stages of BC included 150 written materials, 17 interviews, and 6689 original posts and comments from Weibo, with a total of 1,923,593 Chinese characters. The emotional lexicon of patients with BC contained 9357 words and covered 8 fine-grained emotional categories: joy, anger, sadness, fear, disgust, surprise, somatic symptoms, and BC terminology. Experimental results showed that precision, recall, and the F1-score of positive emotional words were 98.42%, 99.73%, and 99.07%, respectively, and those of negative emotional words were 99.73%, 98.38%, and 99.05%, respectively, which all significantly outperformed the C-LIWC and HowNet.
CONCLUSIONS
The emotional lexicon with fine-grained emotional categories conforms to the characteristics of patients with BC. Its performance related to identifying and classifying domain-specific emotional words in BC is better compared to the C-LIWC and HowNet. This lexicon not only provides a new tool for sentiment analysis in the field of BC but also provides a new perspective for recognizing the specific emotional state and needs of patients with BC and formulating tailored emotional management plans.
Topics: Humans; Female; Breast Neoplasms; Sentiment Analysis; Emotions; Fear; Sadness
PubMed: 37698914
DOI: 10.2196/44897 -
Expert Review of Clinical Pharmacology 2023Preclinical and experimental research have provided promising evidence that medicinal cannabis may be efficacious in the treatment of posttraumatic stress disorder... (Review)
Review
INTRODUCTION
Preclinical and experimental research have provided promising evidence that medicinal cannabis may be efficacious in the treatment of posttraumatic stress disorder (PTSD). However, implementation of medicinal cannabis into routine clinical therapies may not be straightforward.
AREAS COVERED
In this review, we describe some of the clinical, practical, and safety challenges that must be addressed for cannabis-based treatment of PTSD to be feasible in a real-world setting. These issues are especially prevalent if medicinal cannabis is to be combined with trauma-focused psychotherapy.
EXPERT OPINION
Future consideration of the clinical and practical considerations of cannabis use in PTSD therapy will be essential to both the efficacy and safety of the treatment protocols that are being developed. These issues include dose timing and titration, potential for addiction, product formulation, windows of intervention, and route of administration. In particular, exposure therapy for PTSD involves recall of intense emotions, and the interaction between cannabis use and reliving of trauma memories must be explored in terms of patient safety and impact on therapeutic outcomes.
Topics: Humans; Stress Disorders, Post-Traumatic; Medical Marijuana; Australia; Psychotherapy; Cannabis; Hallucinogens
PubMed: 37885234
DOI: 10.1080/17512433.2023.2276309 -
Nutrition (Burbank, Los Angeles County,... Aug 2023Diet plays an important role in cognitive health, but the long-term association of diet early in life with cognitive function in adulthood has not, to our knowledge,...
OBJECTIVES
Diet plays an important role in cognitive health, but the long-term association of diet early in life with cognitive function in adulthood has not, to our knowledge, been rigorously studied. The aim of this study was to examine the association of youth, adulthood, and long-term dietary patterns from youth to adulthood with cognitive function in midlife.
METHODS
This was a population-based cohort study that assessed dietary intake in 1980 (baseline, participants 3-18 y of age), 1986, 2001, 2007, and 2011 and cognitive function in 2011. Six dietary patterns were derived from 48-h food recall or food frequency questionnaires using factor analysis. The dietary patterns were traditional Finnish, high-carbohydrate, vegetables and dairy products, traditional Finnish and high-carbohydrate, red meat, and healthy. Scores of long-term dietary patterns were calculated as the average between youth and adulthood. Cognitive function outcomes assessed included episodic memory and associative learning, short-term working memory and problem solving, reaction and movement time, and visual processing and sustained attention. Standardized z-scores of exposures and outcomes were used for analyses.
RESULTS
Participants (n = 790, mean age 11.2 y) were followed up for 31 y. Multivariable models showed that both youth and long-term vegetable and dairy products and healthy patterns were positively associated with episodic memory and associative learning scores (β = 0.080-0.111, P < 0.05 for all). Both youth and long-term traditional Finnish patterns were negatively associated with spatial working memory and problem solving (β = -0.085 and -0.097, respectively; P < 0.05 for both). Long-term high-carbohydrate and traditional Finnish and high-carbohydrate patterns were inversely associated with visual processing and sustained attention, whereas the vegetable and dairy products pattern was positively associated with this cognitive domain (β = -0.117 to 0.073, P < 0.05 for all). Adulthood high-carbohydrate and traditional Finnish and high-carbohydrate patterns were inversely associated with all cognitive domains except for reaction and movement time (β = -0.072 to -0.161, P < 0.05 for all). Both long-term and adulthood red meat pattern were positively associated with visual processing and sustained attention (β = 0.079 and 0.104, respectively; P < 0.05 for both). These effect sizes correspond to approximately 1.6 to 16.1 y of cognitive aging on these cognitive domains.
CONCLUSIONS
Higher adherence to traditional Finnish, high-carbohydrate, and traditional Finnish and high-carbohydrate patterns across the early life course was associated with poorer cognitive function in midlife, whereas higher adherence to healthy and vegetable and dairy product patterns was associated with better cognitive function. The findings, if causative, highlight the importance of maintaining a healthy dietary pattern from early life to adulthood in an attempt to promote cognitive health.
Topics: Humans; Adolescent; Child; Finland; Cohort Studies; Cardiovascular Diseases; Risk Factors; Cognition; Vegetables; Heart Disease Risk Factors; Carbohydrates
PubMed: 37269718
DOI: 10.1016/j.nut.2023.112063 -
Statistics in Medicine Sep 2023Unmeasured confounding is a major obstacle to reliable causal inference based on observational studies. Instrumented difference-in-differences (iDiD), a novel idea...
Unmeasured confounding is a major obstacle to reliable causal inference based on observational studies. Instrumented difference-in-differences (iDiD), a novel idea connecting instrumental variable and standard DiD, ameliorates the above issue by explicitly leveraging exogenous randomness in an exposure trend. In this article, we utilize the above idea of iDiD, and propose a novel group sequential testing method that provides valid inference even in the presence of unmeasured confounders. At each time point, we estimate the average or conditional average treatment effect under iDiD setting using the data accumulated up to that time point, and test the significance of the treatment effect. We derive the joint distribution of the test statistics under the null using the asymptotic properties of M-estimation, and the group sequential boundaries are obtained using the -spending functions. The performance of our proposed approach is evaluated on both synthetic data and Clinformatics Data Mart Database (OptumInsight, Eden Prairie, MN) to examine the association between rofecoxib and acute myocardial infarction, and our method detects significant adverse effect of rofecoxib much earlier than the time when it was finally withdrawn from the market.
Topics: Humans; Bias; Myocardial Infarction; Safety-Based Drug Withdrawals; Statistics as Topic
PubMed: 37345519
DOI: 10.1002/sim.9836 -
Critical Reviews in Toxicology Jun 2024Over the past several decades, there have been many epidemiology studies on talc and cancer published in the scientific literature, and several reviews and meta-analyses... (Review)
Review
Over the past several decades, there have been many epidemiology studies on talc and cancer published in the scientific literature, and several reviews and meta-analyses of talc and respiratory, female reproductive, and stomach cancers, specifically. To help provide a resource for the evaluation of talc as a potential human carcinogen, we applied a consistent set of examination methods and criteria for all epidemiology studies that examined the association between talc exposure (by various routes) and cancers (of various types). We identified 30 cohort, 35 case-control, and 12 pooled studies that evaluated occupational, medicinal, and personal-care product talc exposure and cancers of the respiratory system, the female reproductive tract, the gastrointestinal tract, the urinary system, the lymphohematopoietic system, the prostate, male genital organs, and the central nervous system, as well as skin, eye, bone, connective tissue, peritoneal, and breast cancers. We tabulated study characteristics, quality, and results in a systematic manner, and evaluated all cancer types for which studies of at least three unique populations were available in a narrative review. We focused on study quality aspects most likely to impact the interpretation of results. We found that only one study, of medicinal talc use, evaluated direct exposure measurements for any individuals, though some used semi-quantitative exposure metrics, and few studies adequately assessed potential confounders. The only consistent associations were with ovarian cancer in case-control studies and these associations were likely impacted by recall and potentially other biases. This systematic review indicates that epidemiology studies do not support a causal association between occupational, medicinal, or personal talc exposure and any cancer in humans.
PubMed: 38868996
DOI: 10.1080/10408444.2024.2351081 -
Environmental Research Sep 2023European Union (EU) law regulates the manufacture, presentation, and sale of tobacco and related products in all member states. This study examined whether legislation... (Observational Study)
Observational Study
BACKGROUND
European Union (EU) law regulates the manufacture, presentation, and sale of tobacco and related products in all member states. This study examined whether legislation non-compliant tobacco products and electronic cigarettes were available for sale in the European market.
METHODS
We queried the EU Rapid Information System for dangerous non-food products, covering 28 current and former EU member states and 3 associated countries, also known as Rapex, for non-compliant tobacco and related products reported between 2005 and 2022.
FINDINGS
During the operation of the Rapex system, 183 violations were reported (six on tobacco, three on traditional cigarettes, and 174 on e-cigarettes). Insufficient product safety information was found in 86% of the reports on e-cigarettes and 74% of the refills. Violations regarding the volume of the liquid container were observed in 26% of the e-cigarette reports and 20% of the refill reports. Approximately 15% of the reported e-cigarettes and 17% of refill liquids exceeded permissible nicotine levels. More serious standard violations were recorded for refills than for e-cigarettes. Approximately one-third of Rapex system countries submitted no notifications.
INTERPRETATION
E-cigarettes were the most frequently reported items in the European market of tobacco and non-tobacco nicotine products. The most common concerns were inadequate product safety information, incorrect liquid container volume, and excessive nicotine concentration. Identifying the most recognized legal infringements did not require laboratory tests and was based only on packaging and the manufacturer's declaration analysis. Further studies are necessary to corroborate whether products available in countries where no violations have been reported meet EU safety standards.
Topics: Nicotine; Electronic Nicotine Delivery Systems; Tobacco Products; Europe
PubMed: 37329947
DOI: 10.1016/j.envres.2023.116429 -
Patient Education and Counseling Jun 2024The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to... (Review)
Review
OBJECTIVES
The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to manufacturing problems, flawed designs, or new and unexpected risks, which in some cases require devices to be recalled. In 2021, the FDA's Patient Engagement Advisory Committee (PEAC) recommended that the FDA consider changes to the communication approach used for medical device recalls to make them more patient-focused, timely, and action-oriented.
METHODS
To support this recommendation, we conducted a rapid review of literature published from 2008-2022 to capture and examine information on risk communication approaches, methods, and best practices for recall-related communications about medical products.
RESULTS
We identified 23 articles to include in our review.
CONCLUSION
Our review found a lack of research-based studies as well as gaps in understanding about consumer perspectives, comprehension, and communication preferences related to recalls. Despite these limitations, we identified current communication approaches, numerous challenges, and recommendations for communicating medical products recall information to consumers.
PRACTICE IMPLICATIONS
Further research is needed to assess consumer attitudes, understanding, and preferences and to reach consensus on best practices for effectively communicating recall information to consumers of medical products.
Topics: United States; Humans; Medical Device Recalls; United States Food and Drug Administration; Consensus; Patient Participation
PubMed: 38484598
DOI: 10.1016/j.pec.2024.108244 -
Pharmaceutical Research Sep 2023The goal of pharmacovigilance (PV) is to prevent adverse events (AEs) associated with drugs and vaccines. Current PV programs are of a reactive nature and rest entirely...
The goal of pharmacovigilance (PV) is to prevent adverse events (AEs) associated with drugs and vaccines. Current PV programs are of a reactive nature and rest entirely on data science, i.e., detecting and analyzing AE data from provider/patient reports, health records and even social media. The ensuing preventive actions are too late for people who have experienced AEs and often overly broad, as responses include entire product withdrawals, batch recalls, or contraindications of subpopulations. To prevent AEs in a timely and precise manner, it is necessary to go beyond data science and incorporate measurement science into PV efforts through person-level patient screening and dose-level product surveillance. Measurement-based PV may be called 'preventive pharmacovigilance', the goal of which is to identify susceptible individuals and defective doses to prevent AEs. A comprehensive PV program should contain both reactive and preventive components by integrating data science and measurement science.
Topics: Humans; Pharmacovigilance; Vaccines
PubMed: 37349651
DOI: 10.1007/s11095-023-03548-3 -
Spine Jan 2024Observational epidemiological study.
STUDY DESIGN
Observational epidemiological study.
OBJECTIVE
This study's primary objective was to examine the risk of recall for novel spine devices over time. Secondarily, we sought to analyze interbody fusion and vertebral body replacement (VBR) devices (corpectomy cages) as a risk factor for recall.
SUMMARY OF BACKGROUND DATA
The recall risk of a novel spine device over time has not been reported. Additionally, FDA regulations were lowered for interbody fusion devices to enter the market in 2007. As well, VBR implants were recently approved by the FDA for use in the cervical spine in 2015.
METHODS
Spine devices cleared between January 1, 2008 and December 31, 2018 were identified from the FDA's 510(k) database. All recall data was collected from the database in January of 2021 to provide a 2-year minimum follow-up for a recall to occur. Product labels were used to classify interbody fusion and VBR devices. Cumulative incidence function was conducted to compare the overall risk of recall for FDA cleared spine devices, and the hazard ratio determined for VBR and all other devices vs interbody implants during the study period.
RESULTS
2,384 spine devices were cleared via 510(k) in the study period. The hazard of recall at 5 years was 5.3% (95% CI: 4.4%-6.2%) and 6.5% (95% CI: 5.4-7.7%) at 10 years. No significant difference in recall risk was identified for interbody fusion and VBR devices.
CONCLUSION
The risk of recall at 5 and 10 years of a novel spine device is about half the 12% rate reported for orthopedic devices in general. Despite lowered FDA regulations for interbody fusion devices and recent approval for VBR device use in the cervical spine, no increased risk of recall was detected. Further research is necessary to explain the reason for the lower risk of recall with spine devices.
LEVEL OF EVIDENCE
V.
PubMed: 38273730
DOI: 10.1097/BRS.0000000000004939