A Framework for the Next Generation of Risk Science

Objectives: In 2011, the U.S. Environmental Protection Agency initiated the NexGen project to develop a new paradigm for the next generation of risk science.Methods: The NexGen framework was built on three cornerstones: the availability of new data on toxicity pathways made possible by fundamental advances in basic biology and toxicological science, the incorporation of a population health perspective that recognizes that most adverse health outcomes involve multiple determinants, and a renewed focus on new risk assessment methodologies designed to better inform risk management decision making.Results: The NexGen framework has three phases. Phase I (objectives) focuses on problem formulation and scoping, taking into account the risk context and the range of available risk management decision-making options. Phase II (risk assessment) seeks to identify critical toxicity pathway perturbations using new toxicity testing tools and technologies, and to better characterize risks and uncertainties using advanced risk assessment methodologies. Phase III (risk management) involves the development of evidence-based population health risk management strategies of a regulatory, economic, advisory, community-based, or technological nature, using sound principles of risk management decision making.Conclusions: Analysis of a series of case study prototypes indicated that many aspects of the NexGen framework are already beginning to be adopted in practice.Citation: Krewski D, Westphal M, Andersen ME, Paoli GM, Chiu WA, Al-Zoughool M, Croteau MC, Burgoon LD, Cote I. 2014. A framework for the next generation of risk science. Environ Health Perspect 122:796–805; http://dx.doi.org/10.1289/ehp.1307260     

Socioeconomic Disparities in Telephone-Based Treatment of Tobacco Dependence

Objectives. We examined socioeconomic disparities in tobacco dependence treatment outcomes from a free, proactive telephone counseling quitline.Methods. We delivered cognitive–behavioral treatment and nicotine patches to 6626 smokers and examined socioeconomic differences in demographic, clinical, environmental, and treatment use factors. We used logistic regressions and generalized estimating equations (GEE) to model abstinence and account for socioeconomic differences in the models.Results. The odds of achieving long-term abstinence differed by socioeconomic status (SES). In the GEE model, the odds of abstinence for the highest SES participants were 1.75 times those of the lowest SES participants. Logistic regression models revealed no treatment outcome disparity at the end of treatment, but significant disparities 3 and 6 months after treatment.Conclusions. Although quitlines often increase access to treatment for some lower SES smokers, significant socioeconomic disparities in treatment outcomes raise questions about whether current approaches are contributing to tobacco-related socioeconomic health disparities. Strategies to improve treatment outcomes for lower SES smokers might include novel methods to address multiple factors associated with socioeconomic disparities.In the United States, the prevalence of daily smoking among lower socioeconomic status (SES) groups is 3 to 4 times higher than that of higher SES groups and a leading contributor to socioeconomic health disparities.1–5 Comprehensive tobacco control programs can reduce these disparities by providing all smokers with effective treatment for tobacco dependence; however, significant socioeconomic disparities in treatment outcomes are observed in many treatment settings, raising concerns about contributing to or at least maintaining existing disparities with these approaches.6–14 Treatment delivered through telephone quitlines has become widely available in the United States and the United Kingdom.15 Proactive quitlines attract a large proportion of lower SES smokers16–18 and smokers with different demographic and clinical characteristics than in-person, community-based treatments.16,19,20 Because of their ubiquitous nature and because they appear to be especially accessible and attractive to lower SES smokers,16,17,18 quitlines have the potential to attenuate tobacco-related disparities; however, if quitlines also demonstrate socioeconomic disparities in treatment outcomes, then this would strengthen concerns about current approaches contributing to or maintaining these disparities.SES ideally incorporates the social and economic factors that influence what position individuals or groups hold in a societal structure.21,22 In health research, SES is a broad construct describing relative access to basic resources required to achieve or maintain good health.23,24 Consistent with leading conceptual models of health disparities,23–26 SES is empirically related to smoking cessation through complex reciprocal relations among clinical, environmental, and treatment utilization factors including stress, coping resources, psychological factors, exposure to other smokers, and use of treatment resources.6,27–32Cognitive–behavioral treatment (CBT) provided through proactive quitlines is a practical innovation that attracts a promising number of lower SES smokers.15–17,33 Although not targeted to or tailored for lower SES groups, CBT, when delivered appropriately, addresses individuals’ treatment-related clinical characteristics (e.g., stress, coping, dependence level, motivation, self-efficacy, environmental challenges). Nonetheless, significant disparities have been found in CBT treatment outcomes in many tobacco treatment settings.6–14 Quitlines treat smokers with different characteristics than in-person treatment,16,19,20 however, and thus might not demonstrate the same disparities as in-person CBT treatment.6–13We investigated socioeconomic disparities in tobacco dependence treatment outcomes using data from a proactive quitline in Arkansas in operation from 2005 to 2008. We used statistical modeling of abstinence at the end of treatment (EOT) and 3 and 6 months after treatment to examine the independent contribution of SES to treatment outcomes controlling for other factors. Consistent with findings from community-based treatment, we hypothesized that after accounting for demographic, clinical, environmental, and treatment utilization factors, the lowest SES participants would be least likely to achieve long-term abstinence.     

Adolescent Substance Abuse and Mental Health: Problem Co-Occurrence and Access to Services

The purpose of this study is to identify factors associated with adolescent alcohol or drug (AOD) abuse/dependence, mental health and co-occurring problems, as well as factors associated with access to treatment. This is a secondary analysis of data from the National Survey on Drug Use and Health (NSDUH) 2000. The 12-month prevalence rate of adolescents with only mental health problems was 10.8%, 5.1% had AOD abuse/dependence only, and 2.7% had co-occurring problems. Approximately 15% of youths reported receiving behavioral health treatment in the past 12 months. Several factors associated with having behavioral health problems and receiving treatment are presented.     

Client incentives versus contracting and staff incentives: How care continuity interventions in substance abuse treatment can improve residential to outpatient transition

Interventions for improving transition from short-term residential to outpatient treatment were examined. Usual care (UC; n = 114) was referral to a preferred outpatient program with advance appointment optional. Client incentive (CI; n = 97) offered up to $100 in gift cards for intake and attendance during the first 30 days of treatment. Contracting with staff incentives (CSI; n = 49) consisted of meeting with an outpatient counselor prior to residential discharge, signing an attendance contract, receiving an appointment and payment to staff if clients attended. CSI significantly improved rates of successful transition (84%) and admission (74%) compared to UC (64% contact; 49% admitted). CI did not result in significantly improved outcomes (74%; 60%). CSI was likely mediated by the reliability (92 versus 52% in UC) and immediacy (1.0 versus 3.9 days) of appointment scheduling. This study supports use of CSI for improving rates of transition between residential and outpatient continuing care treatment.     

Listening to the rural health workers in Papua New Guinea - the social factors that influence their motivation to work

Despite rural health services being situated and integrated within communities in which people work and live, the complex interaction of the social environment on health worker motivation and performance in Low Middle Income Countries has been neglected in research. In this article we investigate how social factors impact on health worker motivation and performance in rural health services in Papua New Guinea (PNG). Face-to-face in-depth interviews were conducted with 33 health workers from three provinces (Central, Madang, and Milne Bay) in PNG between August and November 2009. They included health extension officers, community health workers and nursing officers, some of whom were in charge of the health centres. The health centres were a selection across church based, government and private enterprise health facilities. Qualitative analysis identified the key social factors impacting on health worker motivation and performance to be the local community context, gender roles and family related issues, safety and security and health beliefs and attitudes of patients and community members. Our study identified the importance of strong supportive communities on health worker motivation. These findings have implications for developing sustainable strategies for motivation and performance enhancement of rural health workers in resource poor settings.     

Self-management among patients living with diabetes in the United States Virgin Islands

The United States Virgin Islands (USVI) is facing a diabetes epidemic similar to the one on the U.S. mainland, yet little is known regarding the cultural context relevant to self-management in this U.S. territory. We conducted in-home interviews (n=53) supplemented by self-administered questionnaire and A1c testing with U.S. Virgin Islanders to characterize self-management knowledge, attitudes, and behaviors among patients living with diabetes. The mean glycosylated hemoglobin (A1c) was 7.63 (Range=5-13); a composite score of traditional self-management behaviors was not associated with A1c. Several recurrent themes emerged from qualitative analysis including: 1) cultural nuances shaped perspectives on self-management, 2) culturally-specific challenges were barriers to effective self-management, 3) medical homes were rarely viewed as the primary source of education and support, and 4) fear largely motivated or stalled self-management practices. This study highlights the need for culturally-tailored measures and interventions to address the specific needs within this population.     

A preliminary investigation of rapid smoking as a lapse-responsive treatment for tobacco dependence

Lapses within the first 2 weeks of a smoking cessation attempt are strongly associated with a return to regular smoking (S. L. Kenford et al., 1994). Unfortunately, little is known about how to prevent an initial lapse from progressing to a full relapse, and presently there are no validated lapse-responsive therapeutic interventions. The present study tested the efficacy and feasibility of rapid smoking plus counseling as a novel lapse-responsive intervention. Sixty-seven participants enrolled in a smoking treatment program involving brief counseling and a 9-week course of bupropion. Beginning on the quit day, participants' smoking behavior was tracked daily for 14 days. Once an early smoking lapse was identified, participants were randomly assigned to receive either 3 sessions of rapid smoking plus counseling or no intervention (usual care). Consistent with previous research, participants who smoked during the first 2 weeks of the quit attempt had significantly poorer 6-month outcomes (3% abstinent) than did those who did not smoke (64% abstinent). Compared with early abstainers, early lapsers were more nicotine dependent and reported greater cravings and lower confidence in their ability to abstain from smoking during the first 48 hours of abstinence. As expected, rapid smoking produced a variety of aversive effects, including increased nausea, dizziness, and vomiting as well as sharply decreased cravings to smoke. However, rapid smoking did not improve abstinence outcomes relative to usual care. Although rapid smoking has been shown to be an effective treatment for initial smoking cessation, in this preliminary study the authors failed to demonstrate its effectiveness as a lapse-responsive treatment.     

Gender-based wage differentials among registered dietitians

The debate on compensation equity is broad-based, addressing many organizational, personal, and outcome factors. Central to compensation philosophy is the issue of gender equity. Health care, like many other industries, remains fraught with gender inequity in compensation. This inequity is partially explained by choice of practice area. However, much remains unexplained. Health care is a female-dominated industry with most of the women working in the allied health professions (eg, nurses, dietitians, etc). Registered dietitians (RD) may experience wage discrimination, similar to registered nurses, but prior to the present study, the assumption was not tested. Using data from the first comprehensive study of RD compensation, we examined gender equity in total cash compensation to RDs. Data were collected on total cash compensation, and questions focused on career progression and work outcomes. For purposes of our study, we analyzed data on 5,477 full-time RDs. Ninety-six percent were women, the median age was 43, and median total cash compensation for RDs employed in the position for at least 1 year was $45,500.00. Women earned $45,285.00 and men earned $50,250.00. A median wage gap of $4,965.00 between women and men was observed. Variability in total cash compensation to women was best explained by size of budget, years of experience, work setting, and educational level. Variability for men was explained by size of budget, years of experience, educational level, and employer status. Conclusions suggest that given the wage discrimination that female RDs experience, work organizations should evaluate their pay plans to monitor pay equity. Factors that women can manage to receive compensation that is equal to that of the men include size of budgets they manage, years of experience in the field, employer status, work setting, and educational level attained. Findings are useful for career advisers, human resource specialists, compensation specialists, supervisors, RDs, and compensation researchers.     

Effects of adolescent fluoxetine treatment on fear-, anxiety-or stress-related behaviors in C57BL/6J or BALB/cJ mice

Rationale  5-Hydroxytryptamine (5-HT, serotonin) plays a major role in brain ontogeny. Disruption of 5-HT during early postnatal development produces lasting changes in rodent ‘emotion-related’ behaviors. Adverse effects of treatment with serotonin reuptake inhibitor (SRI) antidepressants have been reported in human adolescents. However, the long-term effects of chronic SRI treatment during adolescence in rodents remain unclear. Objectives  The objectives of the study are to assess the effects of fluoxetine treatment throughout the adolescent period in measures of fear-, anxiety- and stress-related endpoints in drug-free adults and to examine these effects in two genetic strains of mice differing in baseline stress- and anxiety-related behaviors and sensitivity to SRIs. Materials and methods  C57BL/6J and BALB/cJ mice received one of two fluoxetine doses for 4 weeks during adolescence (3–7 weeks old). A separate group of C57BL/6J and BALB/cJ mice received fluoxetine for 4 weeks during adulthood (8–12 weeks old). After a 3-week washout period, mice were tested for anxiety-like behaviors (novel open field, elevated plus-maze), fear conditioning and extinction, and stress-related responses to forced swim, as well as serotonin brain levels. Results  Adolescent fluoxetine treatment did not increase adult measures of anxiety-, fear- or stress-related behaviors, or brain serotonin levels. The same duration of treatment in adulthood also had no effects on these measures when tested after a 3-week washout period. Conclusions  In clear contrast with emotion-related abnormalities caused by preadolescent fluoxetine treatment or genetic inactivation of fluoxetine’s pharmacological target, the 5-HT transporter, fluoxetine treatment throughout mouse adolescence did not produce detectable, lasting abnormalities in either “high” or “low anxiety” inbred mouse strains. Maxine Norcross and Poonam Mathur contributed equally to this work. An erratum to this article can be found at     

Subjective effects of the nicotine lozenge: assessment of abuse liability

Rationale. A nicotine lozenge was developed as a novel smoking cessation aid. Abuse liability, which in this context refers to use by novices not addicted to tobacco, may be expected to be low for the lozenge due to the relatively slow route of nicotine absorption. However, its resemblance to commercially marketed lozenges and its palatability, intended to increase medication compliance, may increase its abuse liability, especially among younger individuals. Objectives. The present study evaluated the abuse liability of the nicotine lozenge. Effects of the lozenge on cigarette craving were also measured. Methods. Subjective and physiological effects of the nicotine lozenge were tested in healthy adult smokers (n=12, 22–55 years old); a group of younger subjects (n=12, 18–21 years) was also included to allow for assessment of abuse liability of the lozenge in young adults specifically. Amphetamine and a confectionery lozenge were included in the study conditions as positive controls for abuse liability and palatability, respectively, and nicotine gum was included to allow for comparison with a marketed oral nicotine replacement product with low abuse liability. Results. The nicotine lozenge did not increase ratings of traditional abuse liability predictors (good effect, like effect, MBG scale of the ARCI), while amphetamine significantly increased ratings on these measures. The lozenge dose dependently decreased craving for cigarettes after 70 min of abstinence, but only in the older group. Palatability of the lozenge was rated lower than a confectionery lozenge, but not lower than nicotine mint gum. Conclusions. Results suggest that the nicotine lozenge has low abuse liability, both in adults and young adults. The lozenge reduces craving to smoke, although craving reduction may not apply to young adults (18–21 years). Subjective effects of the lozenge are consistent with utility as a smoking cessation aid and are comparable to those of nicotine gum. Electronic Publication