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1.
Nicotine Tob Res ; 25(Suppl_1): S5-S15, 2023 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-37506243

RESUMO

INTRODUCTION: Understanding the characteristics of premium cigar use patterns is essential for minimizing public health harms. Typically, premium cigars are handmade, larger, more expensive, and without the characterizing flavors that are present in other cigar types: Nonpremium traditional cigars, cigarillos, and filtered cigars. AIMS AND METHODS: Self-reported brand and price data were used from Wave 6 of the Population Assessment of Tobacco and Health (PATH) Study to define and estimate premium versus nonpremium cigar use among U.S. adults, as well as to explore cigar smoking patterns, purchasing behavior, and reasons for use by cigar type. RESULTS: In 2021, 0.9% (95% CI = 0.7-1.0) of adults were premium cigar users, compared to 0.4% of nonpremium traditional cigar users (95% CI = 0.3-0.5), 1.1% of cigarillo users (95% CI = 1.0-1.2), and 0.6% filtered cigar users (95% CI = 0.5-0.7). Premium cigar users were overwhelmingly male (97.7%), and 35.8% were aged ≥55 years. The average premium cigar price/stick was $8.67, $5.50-7.00 more than other cigar types. Compared to other cigar types, significantly fewer premium cigar users had a regular brand with a flavor other than tobacco (~15% vs. 38%-53%). Though flavors remained the top reason for premium cigar use, they were less likely to endorse flavors as a reason for use than other cigar users (~40% vs. 68-74%). Premium cigar users had a lower prevalence (aRR: 0.37, 95% CI = 0.25-0.55) of dual use of cigars and cigarettes. CONCLUSIONS: Although <1% of U.S. adults use premium cigars, their use and purchasing characteristics continue to differ from other cigar types, highlighting the importance of capturing data specific to premium cigar use. IMPLICATIONS: This manuscript extends previous research from the National Academies of Science, Engineering, and Medicine report, "Premium cigars: Patterns of use, marketing, and health effects" by utilizing the most recent PATH Study data (Wave 6) to examine patterns of cigar use, including purchasing behavior and reasons for use, by cigar type (eg, premium traditional cigars, nonpremium traditional cigars, cigarillos, and filtered cigars). The findings support continued research on patterns of premium cigar use, which differ from use patterns of other cigar types.


Assuntos
Fumar Charutos , Produtos do Tabaco , Adulto , Humanos , Masculino , Fumar Charutos/epidemiologia , Autorrelato , Fumar/epidemiologia , Estados Unidos/epidemiologia , Feminino , Adolescente , Adulto Jovem , Pessoa de Meia-Idade
2.
J Pediatr Hematol Oncol ; 42(2): e121-e124, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-30830033

RESUMO

Studies have been conducted on adults prescribed with methadone to determine the necessary frequency of QTc monitoring but no consensus has been reached and no similar research has been conducted in the pediatric population. The objective of this retrospective study was to determine the occurrence rate of QTc interval prolongation associated with methadone use in a pediatric oncologic population. In total, 18% of patients developed QTc interval prolongation. These patients had longer baseline QTc intervals and were on more QTc interval-prolonging medications. Our data suggest that these variables may be able to risk stratify patients who require more frequent monitoring.


Assuntos
Analgésicos Opioides/efeitos adversos , Dor do Câncer/tratamento farmacológico , Síndrome do QT Longo/epidemiologia , Metadona/efeitos adversos , Neoplasias/complicações , Adolescente , Adulto , Dor do Câncer/etiologia , Dor do Câncer/patologia , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Incidência , Lactente , Síndrome do QT Longo/induzido quimicamente , Síndrome do QT Longo/patologia , Masculino , New York/epidemiologia , Prognóstico , Estudos Retrospectivos , Adulto Jovem
3.
Tob Control ; 29(Suppl 3): s139-s146, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321847

RESUMO

OBJECTIVE: Cigarettes are the most harmful and most prevalent tobacco product in the USA. This study examines cross-sectional prevalence and longitudinal pathways of cigarette use among US youth (12-17 years), young adults (18-24 years) and adults 25+ (25 years and older). DESIGN: Data were drawn from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US adults and youth. Respondents with data at all three waves (youth, N=11 046; young adults, N=6478; adults 25+, N=17 188) were included in longitudinal analyses. RESULTS: Among Wave 1 (W1) any past 30-day (P30D) cigarette users, more than 60%, persistently used cigarettes across three waves in all age groups. Exclusive cigarette use was more common among adult 25+ W1 P30D cigarette users (62.6%), while cigarette polytobacco use was more common among youth (57.1%) and young adults (65.2%). Persistent exclusive cigarette use was the most common pathway among adults 25+ and young adults; transitioning from exclusive cigarette use to cigarette polytobacco use was most common among youth W1 exclusive cigarette users. For W1 youth and young adult cigarette polytobacco users, the most common pattern of use was persistent cigarette polytobacco use. CONCLUSIONS: Cigarette use remains persistent across time, regardless of age, with most W1 P30D smokers continuing to smoke at all three waves. Policy efforts need to continue focusing on cigarettes, in addition to products such as electronic nicotine delivery systems that are becoming more prevalent.


Assuntos
Fumar Cigarros/epidemiologia , Produtos do Tabaco/estatística & dados numéricos , Uso de Tabaco/epidemiologia , Adolescente , Adulto , Fatores Etários , Criança , Estudos de Coortes , Estudos Transversais , Humanos , Estudos Longitudinais , Prevalência , Fumantes/estatística & dados numéricos , Fatores de Tempo , Estados Unidos/epidemiologia , Adulto Jovem
4.
Tob Control ; 29(Suppl 3): s147-s154, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321848

RESUMO

OBJECTIVE: Electronic nicotine delivery systems (ENDS; including e-cigarettes) are rapidly evolving in the US marketplace. This study reports cross-sectional prevalence and longitudinal pathways of ENDS use across 3 years, among US youth (12-17 years), young adults (18-24 years) and adults 25+ (25 years and older). DESIGN: Data were from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth and adults. Respondents with data at all three waves (youth, n=11 046; young adults, n=6478; adults 25+, n=17 188) were included in longitudinal analyses. RESULTS: Weighted cross-sectional ever use of ENDS increased at each wave. Across all three waves, young adults had the highest percentages of past 12-month, past 30-day (P30D) and daily P30D ENDS use compared with youth and adults 25+. Only about a quarter of users had persistent P30D ENDS use at each wave. Most ENDS users were polytobacco users. Exclusive Wave 1 ENDS users had a higher proportion of subsequent discontinued any tobacco use compared with polytobacco ENDS users who also used cigarettes. CONCLUSIONS: ENDS use is most common among young adults compared with youth and adults 25+. However, continued use of ENDS over 2 years is not common for any age group. Health education efforts to reduce the appeal and availability of ENDS products might focus on reducing ENDS experimentation, and on reaching the smaller subgroups of daily ENDS users to better understand their reasons for use.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Produtos do Tabaco/estatística & dados numéricos , Uso de Tabaco/epidemiologia , Vaping/epidemiologia , Adolescente , Adulto , Fatores Etários , Criança , Estudos de Coortes , Estudos Transversais , Humanos , Estudos Longitudinais , Prevalência , Fatores de Tempo , Estados Unidos/epidemiologia , Adulto Jovem
5.
Tob Control ; 29(Suppl 3): s155-s162, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321849

RESUMO

OBJECTIVE: The goal of this study is to examine cross-sectional rates of use and longitudinal pathways of hookah use among US youth (ages 12-17), young adults (ages 18-24), and adults 25+ (ages 25 and older). DESIGN: Data were drawn from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US adults and youth. Respondents with data at all three waves (youth, n=11 046; young adults, n=6478; adults 25+, n=17 188) were included in longitudinal analyses. RESULTS: Young adults had higher ever, past 12-month (P12M) and past 30-day cross-sectional prevalence of hookah use at each wave than youth or adults 25+. The majority of Wave 1 (W1) hookah users were P12M users of other tobacco products (youth: 73.9%, young adults: 80.5%, adults 25+: 83.2%). Most youth and adult W1 P12M hookah users discontinued use in Wave 2 or Wave 3 (youth: 58.0%, young adults: 47.5%, adults 25+: 63.4%). Most W1 P12M hookah polytobacco users used cigarettes (youth: 49.4%, young adults: 59.4%, adults 25+: 63.2%) and had lower rates of quitting all tobacco than exclusive hookah users or hookah polytobacco users who did not use cigarettes. CONCLUSIONS: Hookah use is more common among young adults than among youth or adults 25+. Discontinuing hookah use is the most common pathway among exclusive or polytobacco hookah users. Understanding longitudinal transitions in hookah use is important in understanding behavioural outcomes at the population level.


Assuntos
Cachimbos de Água , Uso de Tabaco/epidemiologia , Tabaco para Cachimbos de Água/estatística & dados numéricos , Fumar Cachimbo de Água/epidemiologia , Adolescente , Adulto , Fatores Etários , Criança , Estudos Transversais , Humanos , Estudos Longitudinais , Abandono do Hábito de Fumar/estatística & dados numéricos , Fatores de Tempo , Produtos do Tabaco/estatística & dados numéricos , Estados Unidos/epidemiologia , Adulto Jovem
6.
Tob Control ; 29(Suppl 3): s163-s169, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321850

RESUMO

OBJECTIVE: The goal of this study is to examine the cross-sectional prevalence of use and 3-year longitudinal pathways of cigar use in US youth (12-17 years), young adults (18-24 years), and adults 25+ (25 years or older). DESIGN: Data were drawn from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth and adults. Respondents with data at all three waves (youth, n=11 046; young adults, n=6478; adults 25+, n=17 188) were included in longitudinal analyses. RESULTS: Weighted cross-sectional prevalence of past 30-day (P30D) use was stable for adults 25+ (~6%), but decreased in youth (Wave 1 (W1) to Wave 3 (W3)=2.5% to 1.2%) and young adults (W1 to W3=15.7% to 14.0%). Among W1 P30D cigar users, over 50% discontinued cigar use (irrespective of other tobacco use) by Wave 2 (W2) or W3. Across age groups, over 70% of W1 P30D cigar users also indicated P30D use of another tobacco product, predominantly cigar polytobacco use with cigarettes. Discontinuing all tobacco use by W2 or W3 was greater in adult exclusive P30D cigar users compared with polytobacco cigar users. CONCLUSIONS: Although the majority of P30D cigar users discontinued use by W3, adult polytobacco users of cigars were less likely to discontinue all tobacco use than were exclusive cigar users. Tracking patterns of cigar use will allow further assessment of the population health impact of cigars.


Assuntos
Abandono do Hábito de Fumar/estatística & dados numéricos , Produtos do Tabaco/estatística & dados numéricos , Uso de Tabaco/epidemiologia , Adolescente , Adulto , Fatores Etários , Criança , Estudos de Coortes , Estudos Transversais , Humanos , Estudos Longitudinais , Prevalência , Estados Unidos/epidemiologia , Adulto Jovem
7.
Tob Control ; 29(Suppl 3): s170-s177, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321851

RESUMO

OBJECTIVE: Use of smokeless tobacco (SLT) with other tobacco products is growing, yet gaps in understanding transitions among SLT and other product use remain. The aim of this study is to examine cross-sectional prevalence and longitudinal pathways of SLT use among US youth (12-17 years), young adults (18-24 years) and adults 25+ (25 years and older). DESIGN: Data were drawn from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth and adults. Respondents with data at all three waves (youth, n=11 046; young adults, n=6478; adults 25+, n=17 188) were included in longitudinal analyses. RESULTS: Young adults had the highest current SLT use compared with other age groups. Among Wave 1 (W1) past 30-day youth and young adult SLT users, most were SLT and cigarette polytobacco users compared with adults 25+, who more often used SLT exclusively. Among W1 exclusive SLT users, persistent exclusive use across all three waves was more common among adults 25+, while transitioning from exclusive SLT use to SLT polytobacco use at Wave 2 or Wave 3 was more common among youth and young adults. Among W1 SLT and cigarette polytobacco users, a common pathway was discontinuing SLT use but continuing other tobacco use. CONCLUSIONS: Our results showed distinct longitudinal transitions among exclusive and SLT polytobacco users. Deeper understanding of these critical product transitions will allow for further assessment of population health impact of these products.


Assuntos
Produtos do Tabaco/estatística & dados numéricos , Uso de Tabaco/epidemiologia , Tabaco sem Fumaça , Adolescente , Adulto , Fatores Etários , Criança , Estudos de Coortes , Estudos Transversais , Feminino , Humanos , Estudos Longitudinais , Masculino , Prevalência , Estados Unidos/epidemiologia , Adulto Jovem
8.
Tob Control ; 29(Suppl 3): s178-s190, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321852

RESUMO

OBJECTIVE: This study reports weighted cross-sectional prevalence of never use of tobacco, and longitudinal past 12-month (P12M), past 30-day (P30D) and frequent P30D any tobacco or specific tobacco product initiation across three 1-year waves. Longitudinal three-wave pathways are examined to outline pathways of exclusive and polytobacco initiation, as well as pathways of new initiators of electronic nicotine delivery systems (ENDS) or cigarettes. DESIGN: Data were drawn from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth and adults. Respondents with data at all three waves (youth, N = 11 046; young adults, N = 6478; adults 25+, N = 17 188) were included in longitudinal analyses. RESULTS: Across the three age groups, weighted cross-sectional analyses revealed never any tobacco use decreased each year from 2013 to 2016, reflecting overall increases in tobacco initiation in the population during this time. Compared with cigarettes, cigars, hookah and smokeless tobacco, ENDS had the highest proportion of P12M initiation from Wave 1 to Wave 3 (W3) for each age group. Among youth Wave 2 P30D initiators of exclusive ENDS or cigarettes, the most common W3 outcome was not using any tobacco (ENDS: 59.0% (95% CI 48.4 to 68.8); cigarettes: 40.3% (95% CI 28.7 to 53.1)). CONCLUSIONS: Initiation rates of ENDS among youth and young adults have increased the number of ever tobacco users in the US prevention strategies across the spectrum of tobacco products which can address youth initiation of tobacco products.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina/estatística & dados numéricos , Produtos do Tabaco/estatística & dados numéricos , Uso de Tabaco/epidemiologia , Vaping/epidemiologia , Adolescente , Adulto , Fatores Etários , Criança , Estudos de Coortes , Estudos Transversais , Humanos , Estudos Longitudinais , Prevalência , Estados Unidos/epidemiologia , Adulto Jovem
9.
Tob Control ; 29(Suppl 3): s203-s215, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321854

RESUMO

OBJECTIVE: To report on demographic and tobacco use correlates of cessation behaviours across tobacco products (cigarettes, electronic nicotine delivery systems (ENDS), cigars, hookah and smokeless tobacco) among the US population. DESIGN: Data were drawn from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth (ages 12-17) and adults (ages 18+) . Past 30-day (P30D) tobacco users at Wave 1 (W1) or Wave 2 (W2) were included (n=1374 youth; n=14 389 adults). Generalised estimating equations were used to evaluate the association between demographic and tobacco use characteristics at baseline, with cessation behaviours at follow-up (discontinuing use, attempting to quit, quitting), over two 1-year periods (W1-W2, W2-Wave 3). RESULTS: Among adult users of each type of tobacco product, frequency of use was negatively associated with discontinuing use. Among adult cigarette smokers, non-Hispanic white smokers, those with lower educational attainment and those with lower household income were less likely to discontinue cigarette use; ENDS use was positively associated with making quit attempts but was not associated with cigarette quitting among attempters; smokeless tobacco use was positively associated with quitting among attempters; tobacco dependence was negatively associated with quitting among attempters. Among youth cigarette smokers, tobacco dependence was negatively associated with making quit attempts. DISCUSSION: Demographic correlates of tobacco cessation behaviours underscore tobacco use disparities in the USA. Use of ENDS and use of smokeless tobacco products are positively associated with some adult cigarette cessation behaviours.


Assuntos
Produtos do Tabaco/estatística & dados numéricos , Abandono do Uso de Tabaco/estatística & dados numéricos , Tabagismo/epidemiologia , Adolescente , Adulto , Fatores Etários , Criança , Estudos de Coortes , Sistemas Eletrônicos de Liberação de Nicotina/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Adulto Jovem
10.
Tob Control ; 29(Suppl 3): s191-s202, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321853

RESUMO

OBJECTIVE: To report on demographic and tobacco product use correlates of tobacco product initiation (cigarettes, electronic nicotine delivery systems (ENDS), cigars, hookah and smokeless tobacco) among the US population. DESIGN: Data were from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth (aged 12-17 years) and adults (aged 18+ years). Never users of at least one type of tobacco product at Wave 1 (W1, 2013/14) or Wave 2 (W2, 2014/15) were included (n=12 987 youth; n=25 116 adults). Generalised estimating equations were used to evaluate the association between demographic and tobacco product use characteristics at baseline, and tobacco product initiation at follow-up (ever, past 30 day (P30D), frequent (use on 20 or more of thepast 30 days)) over two 1-year periods (W1-W2 and W2-Wave 3). RESULTS: Youth aged 15-17 years were more likely than youth aged 12-14 years and adults aged 18-24 years were more likely than older adults to initiate P30D tobacco use across products; non-heterosexuals were more likely than heterosexuals to initiate P30D cigarette and ENDS use. Older adults were more likely than young adults, and males were more likely than females, to be frequent users of ENDS on initiation. Ever use of another tobacco product predicted P30D initiation of each tobacco product. DISCUSSION: Other tobacco product use and age predict P30D tobacco initiation across products whereas associations with other demographic characteristics vary by product. Continued contemporary evaluation of initiation rates within the changing tobacco product marketplace is important.


Assuntos
Heterossexualidade/estatística & dados numéricos , Minorias Sexuais e de Gênero/estatística & dados numéricos , Produtos do Tabaco/estatística & dados numéricos , Uso de Tabaco/epidemiologia , Adolescente , Adulto , Fatores Etários , Criança , Estudos de Coortes , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Fumar/epidemiologia , Fatores de Tempo , Estados Unidos/epidemiologia , Vaping/epidemiologia , Adulto Jovem
11.
Tob Control ; 29(Suppl 3): s134-s138, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32321846

RESUMO

The Family Smoking Prevention and Tobacco Control Act provided the US Food and Drug Administration authority to regulate tobacco products using a population health standard. Models have been developed to estimate the population health impacts of tobacco initiation, cessation and relapse transitions. Models should be informed by high-quality, longitudinal data to estimate these constructs. Simulation studies have generated data to predict the impact of various tobacco control interventions, including the influence of regulations on tobacco use behaviours and health. The purpose of this paper is to provide a high-level conceptual overview for understanding tobacco transition behaviours and correlates of these behaviours using data from the Population Assessment of Tobacco and Health (PATH) Study, a US nationally representative longitudinal tobacco study of about 46 000 persons aged 12+ years. The papers that follow in this journal issue build and expand on this conceptual overview using data from the first three waves of the PATH Study. These papers describe use patterns of different tobacco products and their correlates, and can serve as foundations for more in-depth papers that will help the research community better understand the population health impacts and drivers of different tobacco use patterns.


Assuntos
Prevenção do Hábito de Fumar/métodos , Produtos do Tabaco , Uso de Tabaco/epidemiologia , Adolescente , Adulto , Criança , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Modelos Teóricos , Saúde da População , Projetos de Pesquisa , Abandono do Hábito de Fumar/métodos , Uso de Tabaco/prevenção & controle , Estados Unidos/epidemiologia , United States Food and Drug Administration , Adulto Jovem
12.
J Pediatr Gastroenterol Nutr ; 66(2): 286-288, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28742719

RESUMO

The risk of venous thromboembolism (VTE) is significantly increased in patients with inflammatory bowel disease (IBD). For the adult population, prophylaxis guidelines exist to help guide physicians in their management of high-risk IBD patients. Although it is known that children with IBD also experience increased rates of VTE, there is no clear consensus on how best to prevent these unwanted complications. We sought to better understand practicing pediatric gastroenterologists' awareness of this issue and practices surrounding prevention of VTE in their pediatric patients. We found that pediatric gastroenterologists are well aware of the increased risk for VTE in children with IBD, that anticoagulant prophylaxis is infrequently used for pediatric patients, and that the most commonly cited reason for not providing prophylaxis is the lack of available guidelines in the literature.


Assuntos
Anticoagulantes/administração & dosagem , Doenças Inflamatórias Intestinais/complicações , Padrões de Prática Médica/estatística & dados numéricos , Tromboembolia Venosa/prevenção & controle , Criança , Gastroenterologistas/estatística & dados numéricos , Humanos , Inquéritos e Questionários , Tromboembolia Venosa/etiologia
13.
Dig Dis Sci ; 63(9): 2439-2444, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29761252

RESUMO

BACKGROUND: Common mechanisms against small intestinal bacterial overgrowth (SIBO), including an intact ileocecal valve, gastric acid secretion, intestinal motility, and an intact immune system, are compromised in inflammatory bowel disease (IBD), and therefore, a relatively high incidence of SIBO has been reported in this population. AIMS: We aimed to determine whether an improvement in IBD clinical activity scores is seen after testing and treating SIBO. METHODS: A retrospective cohort study of 147 patients with inflammatory bowel disease who were referred for SIBO breath testing from 1/2012 to 5/2016 was performed. Characteristics of SIBO positive and treated patients were compared to SIBO negative patients, including the changes in Partial Mayo Score or Harvey Bradshaw Index (HBI), using Student's t test for continuous variables and Chi-squared or Fisher's exact test for categorical variables. RESULTS: 61.9% were SIBO positive and treated, and 38.1% were SIBO negative. In Crohn's disease, the median HBI decreased from 5 to 3 and 5 to 4, in the SIBO positive and negative groups, respectively (p = 0.005). In ulcerative colitis, the Partial Mayo Score decreased from 2 to 1.5 and 2 to 1, respectively (p = 0.607). CONCLUSIONS: This study examines the clinical effect of testing and treating for SIBO in an IBD population. We see a significant reduction in HBI after testing for and treating SIBO. Future prospective studies are necessary to further investigate the role of SIBO in the evaluation and management of IBD.


Assuntos
Síndrome da Alça Cega/diagnóstico , Síndrome da Alça Cega/epidemiologia , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/epidemiologia , Adulto , Síndrome da Alça Cega/terapia , Testes Respiratórios/métodos , Estudos de Coortes , Feminino , Humanos , Doenças Inflamatórias Intestinais/terapia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
14.
Pharmacoepidemiol Drug Saf ; 26(2): 208-214, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-28028914

RESUMO

PURPOSE: Our study sought to systematically evaluate protocol-specified study methodology in prospective pregnancy exposure registries including pre-specified pregnancy outcomes, power calculations for sample size, and comparator group selection. METHODS: U.S. pregnancy exposure registries designed to evaluate safety of drugs or biologics were identified from www.clinicaltrials.gov, the FDA's Office of Women's Health website, and the FDA's list of postmarketing studies. Protocols or similar documentation were obtained. RESULTS: We identified 35 U.S. registries for drugs or biologic use during pregnancy. All registries assessed risk for overall major congenital malformations. Pre-specified target enrollment was stated for 18 (51%) registries, and ranged from 150 to 500 exposed pregnancies (median 300). Thirty-two (91%) registries identified at least one comparison group, but only nine (26%) planned to use an internal comparator. The most common external comparator group (n = 24, 69%) was the Metropolitan Atlanta Congenital Defects Program (MACDP). CONCLUSIONS: No registries were designed to have sufficient power to assess specific malformations, despite the plausibility that most teratogens cause specific defects. Only half of the registries included a power analysis. Despite their common use, external comparators, including MACDP, have important limitations. In the absence of randomized controlled trial data in pregnant women, pregnancy registries remain an important tool as part of a comprehensive pregnancy surveillance program; however, pregnancy registries alone may not be sufficient to obtain adequate data regarding risks of specific malformations. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.


Assuntos
Anormalidades Induzidas por Medicamentos/epidemiologia , Complicações na Gravidez/epidemiologia , Resultado da Gravidez/epidemiologia , Feminino , Humanos , Gravidez , Sistema de Registros , Projetos de Pesquisa , Tamanho da Amostra , Revisões Sistemáticas como Assunto , Teratogênicos/toxicidade , Estados Unidos , United States Food and Drug Administration
15.
BMC Nephrol ; 18(1): 181, 2017 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-28558814

RESUMO

BACKGROUND: Growth impairment remains common in children with chronic kidney disease (CKD). Available literature indicates low level of recombinant human growth hormone (rhGH) utilization in short children with CKD. Despite efforts at consensus guidelines, lack of high-level evidence continues to complicate rhGH therapy decision-making and the level of practice variability in rhGH treatment by pediatric nephrologists is unknown. METHODS: Cross-sectional online survey electronically distributed to pediatric nephrologists through the Midwest Pediatric Nephrology Consortium and American Society of Pediatric Nephrology. RESULTS: Seventy three pediatric nephrologists completed the survey. While the majority (52.1%) rarely involve endocrinology in rhGH management, 26.8% reported that endocrinology managed most aspects of rhGH treatment in their centers. The majority of centers (68.5%) have a dedicated renal dietitian, but 20.6% reported the nephrologist as the primary source of nutritional support for children with CKD. Children with growth failure did not receive rhGH most commonly because of family refusal. Differences in initial work-up for rhGH therapy include variable use of bone age (95%), thyroid function (58%), insulin-like growth factor-1 (40%), hip/knee X-ray (36%), and ophthalmologic evaluation (7%). Most pediatric nephrologists (95%) believe that rhGH treatment improves quality of life, but only 24% believe that it improves physical function; 44% indicated that rhGH improves lean body mass. CONCLUSIONS: There is substantial variation in pediatric nephrology practice in addressing short stature and rhGH utilization in children with CKD. Hence, there may be opportunities to standardize care to study and improve growth outcomes in short children with CKD.


Assuntos
Transtornos do Crescimento/tratamento farmacológico , Hormônio do Crescimento Humano/uso terapêutico , Nefrologia , Pediatria , Proteínas Recombinantes/uso terapêutico , Insuficiência Renal Crônica/complicações , Determinação da Idade pelo Esqueleto , Atitude do Pessoal de Saúde , Criança , Estudos Transversais , Endocrinologia , Transtornos do Crescimento/diagnóstico , Transtornos do Crescimento/etiologia , Quadril/diagnóstico por imagem , Humanos , Fator de Crescimento Insulin-Like I/metabolismo , Joelho/diagnóstico por imagem , América do Norte , Equipe de Assistência ao Paciente , Padrões de Prática Médica , Inquéritos e Questionários , Testes de Função Tireóidea
16.
HIV Clin Trials ; 17(2): 55-62, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27077672

RESUMO

BACKGROUND/OBJECTIVE: In a previous report of HIV-infected patients with fat redistribution, we found that recombinant human growth hormone (rhGH) therapy reduced visceral adipose tissue (VAT) but increased insulin resistance, and that the addition of rosiglitazone reversed the negative effects of rhGH on insulin sensitivity. In this study, we sought to determine the effects of rhGH and rosiglitazone therapy on an array of inflammatory and fibrinolytic markers. METHODS: 72 patients with HIV-associated abdominal obesity and insulin resistance were randomized to treatment with rhGH, rosiglitazone, the combination of rhGH and rosiglitazone, or placebo for 12 weeks. Subjects with plasma and serum samples available at weeks 0 (n=63) and 12 (n=46-48) were assessed for adiponectin, C-reactive protein, homocysteine, interleukin-1, interleukin-6, tumor necrosis factor alpha, interferon gamma, fibrinogen, plasminogen activator inhibitor-1 antigen, and tissue plasminogen activator antigen. RESULTS: Treatment with both rosiglitazone alone and the combination of rosiglitazone and rhGH for 12 weeks resulted in significant increases in adiponectin levels from baseline. Adiponectin levels did not change significantly in the rhGH arm alone . There were no significant changes in the other biomarkers among the different treatment groups. DISCUSSION: In this study of HIV-infected patients with altered fat distribution, treatment with rosiglitazone had beneficial effects on adiponectin concentrations, an effect that was also seen with a combination of rosiglitazone and rhGH. RhGH administration alone, however, did not demonstrate any significant impact on adiponectin levels despite reductions in VAT.


Assuntos
Gordura Abdominal/metabolismo , Adiponectina/sangue , Infecções por HIV/complicações , Hormônio do Crescimento Humano/administração & dosagem , Hipoglicemiantes/administração & dosagem , Obesidade/tratamento farmacológico , Tiazolidinedionas/administração & dosagem , Gordura Abdominal/efeitos dos fármacos , Adulto , Idoso , Biomarcadores/sangue , Glicemia/metabolismo , Proteína C-Reativa/metabolismo , Quimioterapia Combinada , Feminino , Infecções por HIV/imunologia , Infecções por HIV/metabolismo , Humanos , Interleucina-6/sangue , Masculino , Pessoa de Meia-Idade , Obesidade/etiologia , Obesidade/imunologia , Obesidade/metabolismo , Rosiglitazona , Adulto Jovem
17.
Artigo em Inglês | MEDLINE | ID: mdl-35409819

RESUMO

BACKGROUND: Prior studies have not clearly established risk of cardiovascular disease (CVD) among smokers who switch to exclusive use of electronic nicotine delivery systems (ENDS). We compared cardiovascular disease incidence in combustible-tobacco users, those who transitioned to ENDS use, and those who quit tobacco with never tobacco users. METHODS: This prospective cohort study analyzes five waves of Population Assessment of Tobacco and Health (PATH) Study data, Wave 1 (2013-2014) through Wave 5 (2018-2019). Cardiovascular disease (CVD) incidence was captured over three intervals (Waves 1 to 3, Waves 2 to 4, and Waves 3 to 5). Participants were adults (40+ years old) without a history of CVD for the first two waves of any interval. Change in tobacco use status, from exclusive past 30 day use of any combustible-tobacco product to either exclusive past 30 day ENDS use, dual past 30 day use of ENDS and combustible-tobacco, or no past 30 day use of any tobacco, between the first two waves of an interval was used to predict onset of CVD between the second and third waves in the interval. CVD incidence was defined as a new self-report of being told by a health professional that they had congestive heart failure, stroke, or a myocardial infarction. Generalized estimating equation (GEE) analyses combined 10,548 observations across intervals from 7820 eligible respondents. RESULTS: Overall, there were 191 observations of CVD among 10,548 total observations (1.7%, standard error (SE) = 0.2), with 40 among 3014 never users of tobacco (1.5%, SE = 0.3). In multivariable models, CVD incidence was not significantly different for any tobacco user groups compared to never users. There were 126 observations of CVD among 6263 continuing exclusive combustible-tobacco users (adjusted odds ratio [AOR] = 1.44; 95% confidence interval (CI) 0.87-2.39), 15 observations of CVD among 565 who transitioned to dual use (AOR = 1.85; 0.78-4.37), and 10 observations of CVD among 654 who quit using tobacco (AOR = 1.18; 0.33-4.26). There were no observations of CVD among 53 who transitioned to exclusive ENDS use. CONCLUSIONS: This study found no difference in CVD incidence by tobacco status over three 3 year intervals, even for tobacco quitters. It is possible that additional waves of PATH Study data, combined with information from other large longitudinal cohorts with careful tracking of ENDS use patterns may help to further clarify this relationship.


Assuntos
Doenças Cardiovasculares , Sistemas Eletrônicos de Liberação de Nicotina , Produtos do Tabaco , Adulto , Doenças Cardiovasculares/epidemiologia , Humanos , Estudos Prospectivos , Nicotiana
18.
Artigo em Inglês | MEDLINE | ID: mdl-35162490

RESUMO

Limited data are available for how biomarkers of tobacco exposure (BOE) change when cigarette smokers transition to using electronic nicotine delivery systems (ENDS). Using biomarker data from Waves 1 (2013-2014) and 2 (2014-2015) of the PATH Study, we examined how mean BOE concentrations, including metabolites of nicotine, tobacco-specific nitrosamines (TSNA), polycyclic aromatic hydrocarbons (PAH), and volatile organic compounds (VOC) and metals, changed when 2475 adult smokers transitioned to using ENDS or quit tobacco products. Exclusive smokers who transitioned to dual use had a significant decrease in NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), but not nicotine metabolites, most PAHs, metals, or VOCs. Exclusive smokers who became dual users had significant reductions in total nicotine equivalents, NNAL, and 2CyEMA (acrylonitrile metabolite), but only in those who reduced cigarettes per day (CPD) by >=50%. Smokers who transitioned to exclusive ENDS use had significant reductions in most TSNAs, PAHs, and VOCs; however, nicotine metabolites did not decrease in dual users who became exclusive ENDS users. Smokers who quit tobacco use had significant decreases in nicotine metabolites, all TSNAs, most PAHs, and most VOCs. Cigarette smokers who became dual users did not experience significant reductions in most BOEs. Reductions were impacted by changes in CPD. However, transitioning from smoking to no tobacco or exclusive ENDS use was associated with reduced exposure to most BOEs measured. Future analyses could incorporate additional waves of PATH data and examine changes in biomarker exposure by ENDS device type and CPD.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Produtos do Tabaco , Adulto , Biomarcadores/análise , Humanos , Fumantes , Nicotiana , Uso de Tabaco
19.
J Adolesc Health ; 68(3): 612-614, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32753342

RESUMO

PURPOSE: This study examined U.S. middle and high school student observations of electronic nicotine product (ENP) use in and around the school building and students' normative perceptions of use among peers. METHODS: Adolescents and young adult participants enrolled in middle (n = 672) or high school (n = 962) were recruited from an online nationally representative panel and surveyed from November 2 to 15, 2018. They answered questions on observed ENP use in and around the school building as well as perceptions of use among peers. RESULTS: Nearly one in five U.S. middle and high school students believed that at least half of their peers used ENPs. Confirming anecdotal reports, nearly six in 10 reported ever seeing someone use ENPs in or around their school, most often outside the school building and in bathrooms or locker rooms. CONCLUSIONS: The findings of this study underscore the importance of targeted prevention strategies and education efforts to prevent and combat adolescent ENP use in and around schools.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Nicotina , Adolescente , Eletrônica , Humanos , Percepção , Instituições Acadêmicas , Estudantes , Adulto Jovem
20.
Cancer Epidemiol Biomarkers Prev ; 30(7): 1320-1327, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33947655

RESUMO

BACKGROUND: While smokeless tobacco (ST) causes oral cancer and is associated with cardiovascular diseases, less is known about how its effects differ from other tobacco use. Biomarkers of potential harm (BOPH) can measure short-term health effects such as inflammation and oxidative stress. METHODS: We compared BOPH concentrations [IL6, high-sensitivity C-reactive protein, fibrinogen, soluble intercellular adhesion molecule-1 (sICAM-1), and F2-isoprostane] across 3,460 adults in wave 1 of the Population Assessment of Tobacco and Health study (2013-2014) by tobacco use groups: primary ST users (current exclusive ST use among never smokers), secondary ST users (current exclusive ST use among former smokers), exclusive cigarette smokers, dual users of ST and cigarettes, former smokers, and never tobacco users. We estimated geometric mean ratios using never tobacco users, cigarette smokers, and former smokers as referents, adjusting for demographic and health conditions, creatinine (for F2-isoprostane), and pack-years in smoker referent models. RESULTS: BOPH levels among primary ST users were similar to both never tobacco users and former smokers. Most BOPH levels were lower among ST users compared with current smokers. Compared with never tobacco users, dual users had significantly higher sICAM-1, IL6, and F2-isoprostane. However, compared with smokers, dual users had similar biomarker levels. Former smokers and secondary ST users had similar levels of all five biomarkers. CONCLUSIONS: ST users have lower levels of inflammatory and oxidative stress biomarkers than smokers. IMPACT: ST use alone and in combination with smoking may result in different levels of inflammatory and oxidative stress levels.


Assuntos
Fumar Cigarros/efeitos adversos , Neoplasias/prevenção & controle , Tabaco sem Fumaça/efeitos adversos , Adolescente , Adulto , Biomarcadores/análise , Fumar Cigarros/epidemiologia , Fumar Cigarros/imunologia , Estudos Transversais , Ex-Fumantes/estatística & dados numéricos , Humanos , Inflamação/diagnóstico , Inflamação/epidemiologia , Inflamação/imunologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Neoplasias/etiologia , não Fumantes/estatística & dados numéricos , Estresse Oxidativo , Fumantes/estatística & dados numéricos , Tabaco sem Fumaça/estatística & dados numéricos , Estados Unidos/epidemiologia , Adulto Jovem
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