A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation.


BACKGROUND:This study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs) using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT) with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used. METHODS:Participants (N = 520) will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. DISCUSSION:Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations. TRIAL REGISTRATION:TRN: NCT02342795 , registered December 16, 2014.


BMC Public Health


BMC public health


Lopez AA,Cobb CO,Yingst JM,Veldheer S,Hrabovsky S,Yen MS,Foulds J,Eissenberg T




Has Abstract


2016-03-03 00:00:00










  • The prevalence of hyperuricemia in China: a meta-analysis.

    abstract:BACKGROUND:The prevalence of hyperuricemia varied in different populations and it appeared to be increasing in the past decades. Recent studies suggest that hyperuricemia is an independent risk factor for cardiovascular disease. However, there has not yet been a systematic analysis of the prevalence of hyperuricemia in...

    journal_title:BMC public health

    pub_type: 杂志文章,meta分析


    authors: B L,T W,Hn Z,Ww Y,Hp Y,Cx L,J Y,Ry J,Hw N

    更新日期:2011-10-27 00:00:00

  • Cultural tailoring for the promotion of hepatitis B screening in Turkish Dutch: a protocol for a randomized controlled trial.

    abstract:BACKGROUND:Chronic hepatitis B virus infection (HBV) is an important health problem in the Turkish community in the Netherlands, and promotion of screening for HBV in this risk group is necessary. An individually tailored intervention and a culturally tailored intervention have been developed to promote screening in fi...

    journal_title:BMC public health

    pub_type: 杂志文章,随机对照试验


    authors: van der Veen YJ,de Zwart O,Mackenbach J,Richardus JH

    更新日期:2010-11-05 00:00:00

  • Stigma and intersectionality: a systematic review of systematic reviews across HIV/AIDS, mental illness, and physical disability.

    abstract:BACKGROUND:Stigma across HIV/AIDS, mental illness, and physical disability can be co-occurring and may interact with other forms of stigma related to social identities like race, gender, and sexuality. Stigma is especially problematic for people living with these conditions because it can create barriers to accessing n...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Jackson-Best F,Edwards N

    更新日期:2018-07-27 00:00:00

  • Associations between psychological distress and the most concerning present personal problems among working-age men in Japan.

    abstract:BACKGROUND:Personal problems are known to influence mental health among workers. The current study investigated the most concerning present personal problems which have the greatest impact on psychological distress among working-age Japanese men, rather than issues relating to work tasks or duties. METHODS:We obtained...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Wada K,Eguchi H,Yoneoka D,Okahisa J,Smith DR

    更新日期:2015-03-31 00:00:00

  • An examination of Australian newspaper coverage of the link between alcohol and cancer 2005 to 2013.

    abstract:BACKGROUND:Alcohol is a Class-1 carcinogen but public awareness of the link between alcohol and cancer is low. The news media is a popular, readily-accessible source of health information and plays a key role in shaping public opinion and influencing policy-makers. Examination of how the link between alcohol and cancer...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Eliott J,Forster AJ,McDonough J,Bowd K,Crabb S

    更新日期:2017-07-24 00:00:00

  • Risk behaviors and sports facilities do not explain socioeconomic differences in childhood obesity: a cross-sectional study.

    abstract:BACKGROUND:To assess whether the relationship between neighborhood socioeconomic context of residence and childhood obesity is explained by family socioeconomic position, risk behaviors and availability of sports facilities. METHODS:Based on the income and educational level of residents in the neighborhoods of the cit...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Albaladejo R,Villanueva R,Navalpotro L,Ortega P,Astasio P,Regidor E

    更新日期:2014-11-19 00:00:00

  • Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).

    abstract:BACKGROUND:Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral thera...

    journal_title:BMC public health

    pub_type: 杂志文章,随机对照试验


    authors: Labhardt ND,Ringera I,Lejone TI,Masethothi P,Thaanyane T,Kamele M,Gupta RS,Thin K,Cerutti B,Klimkait T,Fritz C,Glass TR

    更新日期:2016-04-14 00:00:00

  • Predictors of young people's use of sexual and reproductive health services in Nigeria: a mixed-method approach.

    abstract:BACKGROUND:Sexual and Reproductive health Services (SRHS) are essential for the prevention and control of SRH problems among young people and the achievement of sustainable development goal 3. These services may be available but certain factors interfere with their access and utilization by the young people. This study...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Odo AN,Ofuebe JI,Anike AI,Samuel ES

    更新日期:2021-01-06 00:00:00

  • Disease-specific health literacy, disease knowledge, and adherence behavior among patients with type 2 diabetes in Taiwan.

    abstract:BACKGROUND:To examine the association between health literacy, level of disease knowledge, and adherence behavior among patients with type 2 diabetes. METHODS:A cross-sectional survey study of 1059 Mandarin- and Taiwanese-speaking patients aged 20 years or older with type 2 diabetes was conducted. The demographic prof...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Yeh JZ,Wei CJ,Weng SF,Tsai CY,Shih JH,Shih CL,Chiu CH

    更新日期:2018-08-24 00:00:00

  • Efficacy of a church-based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members: a randomized controlled trial in Pretoria, South Africa.

    abstract:BACKGROUND:In persons 15 years and above in South Africa the prevalence of pre-diabetes and diabetes has been estimated at 9.1% and 9.6%, respectively, and the prevalence of systolic prehypertension and hypertension, 38.2% and 24.6%, respectively. Elevated blood glucose and elevated blood pressure are prototype of prev...

    journal_title:BMC public health

    pub_type: 杂志文章,随机对照试验


    authors: Pengpid S,Peltzer K,Skaal L

    更新日期:2014-06-06 00:00:00

  • Faith leaders' messaging is essential to enhance HIV prevention among black Americans: results from the 2016 National Survey on HIV in the black community (NSHBC).

    abstract:BACKGROUND:To investigate whether religious service attendance and faith leaders' messages about HIV and same-sex relationships are associated with acceptance of HIV prevention strategies. METHODS:Multivariable Poisson regression assessed whether attending religious services, faith leaders' messages about HIV and same...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Ransome Y,Bogart LM,Nunn AS,Mayer KH,Sadler KR,Ojikutu BO

    更新日期:2018-12-19 00:00:00

  • Work situation and self-perceived economic situation as predictors of change in burnout--a prospective general population-based cohort study.

    abstract:BACKGROUND:Sick leave rates due to mental and behavioural disorders have increased in Sweden during the last decades. The aim of this prospective study was to investigate changes in the level of burnout in a working subset of the general population and to identify how such changes relate to changes in work situation an...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Norlund S,Reuterwall C,Höög J,Janlert U,Slunga Järvholm L

    更新日期:2015-04-03 00:00:00

  • Midlife women, bone health, vegetables, herbs and fruit study. The Scarborough Fair study protocol.

    abstract:BACKGROUND:Bone loss is accelerated in middle aged women but increased fruit/vegetable intake positively affects bone health by provision of micronutrients essential for bone formation, buffer precursors which reduce acid load and phytochemicals affecting inflammation and oxidative stress. Animal studies demonstrated b...

    journal_title:BMC public health

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Gunn CA,Weber JL,Kruger MC

    更新日期:2013-01-10 00:00:00

  • Mortality in Western Australian seniors with chronic respiratory diseases: a cohort study.

    abstract:BACKGROUND:Relatively few studies have examined survival by pharmacotherapy level and the effects of patient characteristics on mortality by pharmacotherapy level in older chronic respiratory disease (CRD) patients. This study aimed to investigate these issues in older (> or = 65) CRD patients in Western Australia. ME...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Einarsdóttir K,Preen DB,Sanfilippo FM,Reeve R,Emery JD,Holman CD

    更新日期:2010-07-01 00:00:00

  • Higher blood pressure control rate in a real life management program provided by the community health service center in China.

    abstract:BACKGROUND:Community health service center (CHSC) in China is always regarded as a good facility of primary care, which plays an important role in chronic non-communicable disease management. This study aimed to investigate the blood pressure (BP) control rate in a real life CHSC-based management program and its determ...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Chen XJ,Gao XL,You GY,Jiang J,Sun XL,Li X,Chen YC,Liang YJ,Zhang Q,Zeng Z

    更新日期:2014-08-07 00:00:00

  • A knowledge management tool for public health: health-evidence.ca.

    abstract:BACKGROUND:The ultimate goal of knowledge translation and exchange (KTE) activities is to facilitate incorporation of research knowledge into program and policy development decision making. Evidence-informed decision making involves translation of the best available evidence from a systematically collected, appraised, ...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Dobbins M,DeCorby K,Robeson P,Husson H,Tirilis D,Greco L

    更新日期:2010-08-18 00:00:00

  • The quality of life of Croatian women after mastectomy: a cross-sectional single-center study.

    abstract:BACKGROUND:Measuring the quality of life (QoL) of women with breast cancer is an important aspect of measuring treatment success. In Croatia, no QoL studies have been carried out with a focus on patients after mastectomy. The aim of this study was to examine QoL 1 month and 1 year after mastectomy. METHODS:This cross-...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Pačarić S,Kristek J,Mirat J,Kondža G,Turk T,Farčić N,Orkić Ž,Nemčić A

    更新日期:2018-08-10 00:00:00

  • Estimation of salt intake by 24-hour urinary sodium excretion: a cross-sectional study in Yantai, China.

    abstract:BACKGROUND:High levels of dietary sodium are associated with raised blood pressure and adverse cardiovascular health. To determine baseline salt intake, we investigated the average dietary salt intake from 24-hour urinary sodium excretion with a small sample of Yantai adults in the Shandong province of China. METHODS:...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Xu J,Wang M,Chen Y,Zhen B,Li J,Luan W,Ning F,Liu H,Ma J,Ma G

    更新日期:2014-02-08 00:00:00

  • Who will increase their physical activity? Predictors of change in objectively measured physical activity over 12 months in the ProActive cohort.

    abstract:BACKGROUND:The aim was to identify predictors of change in objectively measured physical activity over 12 months in the ProActive cohort to improve understanding of factors influencing change in physical activity. METHODS:ProActive is a physical activity promotion trial that took place in Eastern England (1999-2004). ...

    journal_title:BMC public health

    pub_type: 杂志文章,随机对照试验


    authors: Simmons RK,van Sluijs EM,Hardeman W,Sutton S,Griffin SJ,ProActive project team.

    更新日期:2010-04-30 00:00:00

  • Trends in poverty risks among people with and without limiting-longstanding illness by employment status in Sweden, Denmark, and the United Kingdom during the current economic recession--a comparative study.

    abstract:BACKGROUND:Previous studies have found higher employment rates and lower risk of relative poverty among people with chronic illness in the Nordic countries than in the rest of Europe. However, Nordic countries have not been immune to the general rise in poverty in many welfare states in recent decades. This study analy...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Falk J,Bruce D,Burström B,Thielen K,Whitehead M,Nylén L

    更新日期:2013-10-04 00:00:00

  • Impact of video-led educational intervention on the uptake of influenza vaccine among adults aged 60 years and above in China: a study protocol for a randomized controlled trial.

    abstract:BACKGROUND:Influenza is a global health threat to older adults, and the influenza vaccine is the most effective approach to prevent influenza infection. However, influenza vaccination coverage among Chinese older adults is far less than in developed countries such as the United States (4.0% vs. 64.9%). This study aims ...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Li P,Hayat K,Jiang M,Pu Z,Yao X,Zou Y,Lambojon K,Huang Y,Hua J,Xiao H,Du F,Shi L,Zhai P,Ji W,Feng Z,Gong Y,Fang Y

    更新日期:2021-01-27 00:00:00

  • A cross-sectional study of the prevalence of intensity of infection with Schistosoma japonicum in 50 irrigated and rain-fed villages in Samar Province, the Philippines.

    abstract:BACKGROUND:Few studies have described heterogeneity in Schistosoma japonicum infection intensity, and none were done in Philippines. The purpose of this report is to describe the village-to-village variation in the prevalence of two levels of infection intensity across 50 villages of Samar Province, the Philippines. M...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Tarafder MR,Balolong E Jr,Carabin H,Bélisle P,Tallo V,Joseph L,Alday P,Gonzales RO,Riley S,Olveda R,McGarvey ST

    更新日期:2006-03-09 00:00:00

  • Children's sedentary behaviour: descriptive epidemiology and associations with objectively-measured sedentary time.

    abstract:BACKGROUND:Little is known regarding the patterning and socio-demographic distribution of multiple sedentary behaviours in children. The aims of this study were to: 1) describe the leisure-time sedentary behaviour of 9-10 year old British children, and 2) establish associations with objectively-measured sedentary time....

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Klitsie T,Corder K,Visscher TL,Atkin AJ,Jones AP,van Sluijs EM

    更新日期:2013-11-25 00:00:00

  • The measurement scale of resilience among family caregivers of children with cancer: a psychometric evaluation.

    abstract:BACKGROUND:Resilience to disease is a process of positive adaptation despite the loss of health, it involves the development of vitality and skills to overcome the negative effects of adversity, risks, and vulnerability caused by disease. In Mexico, cancer is the leading cause of death in children. Both the diagnosis a...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Toledano-Toledano F,Moral de la Rubia J,Broche-Pérez Y,Domínguez-Guedea MT,Granados-García V

    更新日期:2019-08-27 00:00:00

  • The impact of children's sex composition on parents' mortality.

    abstract:BACKGROUND:This study explores the relationship between children's sex composition and parents' mortality in a contemporary western society. It improves on earlier research by using a larger and more representative dataset - constructed from registers and encompassing the entire Norwegian population. METHODS:The analy...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Christiansen SG

    更新日期:2014-09-23 00:00:00

  • The provision of non-needle/syringe drug injecting paraphernalia in the primary prevention of HCV among IDU: a systematic review.

    abstract:BACKGROUND:Sharing drug injecting paraphernalia other than needles and syringes (N/S) has been implicated in the transmission of Hepatitis C virus (HCV) among injecting drug users (IDU). We aimed to determine whether the provision of sterile non-N/S injecting paraphernalia reduces injecting risk behaviours or HCV trans...

    journal_title:BMC public health

    pub_type: 杂志文章,评审


    authors: Gillies M,Palmateer N,Hutchinson S,Ahmed S,Taylor A,Goldberg D

    更新日期:2010-11-23 00:00:00

  • Sexual behavior and vulnerability to HIV infection among seasonal migrant laborers in Metema district, northwest Ethiopia: a cross-sectional study.

    abstract:BACKGROUND:Poor socio-economic conditions fuel seasonal migration of adult males from Northwestern Ethiopia, but behavioral and other migration-related changes increase their vulnerability to HIV/AIDS. This study examined risky sexual behaviors and associated factors that may lead to increased HIV infection vulnerabili...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Tiruneh K,Wasie B,Gonzalez H

    更新日期:2015-02-11 00:00:00

  • Body mass index had different effects on premenopausal and postmenopausal breast cancer risks: a dose-response meta-analysis with 3,318,796 subjects from 31 cohort studies.

    abstract:BACKGROUND:There is sufficient evidence supporting a relationship between increased body mass index (BMI) and an increased risk for breast cancer among postmenopausal women. However, most studies have found a decreased risk for premenopausal breast cancer. This study was conducted to find out the different effects of B...

    journal_title:BMC public health

    pub_type: 杂志文章,meta分析


    authors: Chen Y,Liu L,Zhou Q,Imam MU,Cai J,Wang Y,Qi M,Sun P,Ping Z,Fu X

    更新日期:2017-12-08 00:00:00

  • Weight misperception amongst youth of a developing country: Pakistan -a cross-sectional study.

    abstract:BACKGROUND:Weight misperception is the discordance between an individual's actual weight status and the perception of his/her weight. It is a common problem in the youth population as enumerated by many international studies. However data from Pakistan in this area is deficient. METHODS:A multi-center cross-sectional ...

    journal_title:BMC public health

    pub_type: 杂志文章,多中心研究


    authors: Saleem MD,Ahmed G,Mulla J,Haider SS,Abbas M

    更新日期:2013-08-02 00:00:00

  • Age differences in demographic, social and health-related factors associated with loneliness across the adult life span (19-65 years): a cross-sectional study in the Netherlands.

    abstract:BACKGROUND:Recognition of loneliness as a health concern among adults stresses the need to understand the factors associated with loneliness. Research into factors of influence in the various phases of the adult life span (19-65 years) is scarce. Therefore, the associations between demographic, social and health-relate...

    journal_title:BMC public health

    pub_type: 杂志文章


    authors: Franssen T,Stijnen M,Hamers F,Schneider F

    更新日期:2020-08-06 00:00:00