Estimating the Population Health Impact of Recently Introduced Modified Risk Tobacco Products: A Comparison of Different Approaches.

INTRODUCTION: Various approaches have been used to estimate the population health impact of introducing a Modified Risk Tobacco Product (MRTP). AIMS AND METHODS: We aimed to compare and contrast aspects of models considering effects on mortality that were known to experts attending a meeting on models in 2018. RESULTS: Thirteen models are described, some focussing on e-cigarettes, others more general. Most models are cohort-based, comparing results with or without MRTP introduction. They typically start with a population with known smoking habits and then use transition probabilities either to update smoking habits in the "null scenario" or joint smoking and MRTP habits in an "alternative scenario". The models vary in the tobacco groups and transition probabilities considered. Based on aspects of the tobacco history developed, the models compare mortality risks, and sometimes life-years lost and health costs, between scenarios. Estimating effects on population health depends on frequency of use of the MRTP and smoking, and the extent to which the products expose users to harmful constituents. Strengths and weaknesses of the approaches are summarized. CONCLUSIONS: Despite methodological differences, most modellers have assumed the increase in risk of mortality from MRTP use, relative to that from cigarette smoking, to be very low and have concluded that MRTP introduction is likely to have a beneficial impact. Further model development, supplemented by preliminary results from well-designed epidemiological studies, should enable more precise prediction of the anticipated effects of MRTP introduction. IMPLICATIONS: There is a need to estimate the population health impact of introducing modified risk nicotine-containing products for smokers unwilling or unable to quit. This paper reviews a variety of modeling methodologies proposed to do this, and discusses the implications of the different approaches. It should assist modelers in refining and improving their models, and help toward providing authorities with more reliable estimates.

Assessing the Likelihood and Magnitude of a Population Health Benefit Following the Market Introduction of a Modified-Risk Tobacco Product: Enhancements to the Dynamic Population Modeler, DPM(+1).

Researchers and those responsible for evaluating and implementing policies intended to reduce population harm must assess the potential for both intended and unintended consequences associated with those policies. Such assessments should be based on the combined dimensions of magnitude, and thus likelihood, of shifts in exposure patterns needed to produce a population benefit or harm, and magnitude of the expected population benefit or harm. In response to this assessment need, we provide a conceptual description of the dynamic population modeler, DPM(+1), as well as illustrative analyses that estimate the effects on all-cause mortality, life expectancy, and quality of life-adjusted life expectancy if exposure patterns in the population shift from a higher risk product (e.g., cigarettes) to a lower, or modified, risk tobacco product (MRTP) in specified ways. Estimates from these analyses indicate that, within a single birth cohort, switching completely from cigarette smoking to MRTP use is more likely to lead to a population-level survival benefit than initiating tobacco use with an MRTP instead of cigarettes. This is because tobacco initiation rarely occurs beyond young adulthood, whereas continuing smokers exist in all subsequent age categories, leading to a greater cumulative effect. In addition, complete switching to MRTP use among a small proportion of smokers in each age category offsets the survival deficit caused by unintended shifts in exposure patterns, such as MRTP initiation among never tobacco users followed by transitioning to cigarette smoking and/or cigarette smokers switching to MRTP use instead of quitting.

Stroke risk among menthol versus non-menthol cigarette smokers in the United States: Analysis of the National Health and Nutrition Examination Survey (NHANES).

Though available evidence is relatively consistent in showing no additional health effects among smokers due to menthol in cigarettes, two studies reported conflicting results for stroke risk using different subsets of NHANES data. We investigated reasons for the differences in these reports by analyzing NHANES cycles conducted between 1999 and 2012, combined and in subsets. Adjusted odds ratios (AOR) and 95% confidence intervals (CI) from three different survey logistic regression models compare risk of reported stroke diagnoses among menthol and non-menthol cigarette smokers. Depending on timeframe, about 1150 to 8000 U.S. adults (aged ≥ 20 years) who smoked on ≥ 1 of the last 30 days had complete data for cigarette type and all covariates included in each model. Results were not much affected by which covariates were included in the models, but depended strongly on the NHANES cycles included in the analysis. Using NHANES 1999-2012 data combined, AORs and 95% CIs for stroke comparing menthol with non-menthol cigarette smokers were 0.95 (95% CI: 0.65, 1.37), 0.85 (95% CI: 0.59, 1.23) or 0.86 (95% CI: 0.59, 1.25). Collectively, findings illustrate the need for fully reporting research and analytical methods, especially when analyses are meant to develop evidence intended for regulatory decision-making.

Injury during U.S. Army basic combat training: a systematic review of risk factor studies.

CONTEXT: Approximately one quarter of men and half of women in U.S. Army basic combat training experience an injury. Preventing basic combat training-related injuries would reduce associated human and economic costs and discharges from the Army. Identification of risk factors for such injuries is a crucial step toward their prevention. Although some research has begun to address this need, prior studies of risk factors for training-related injury have not been reviewed systematically. This study systematically reviews the literature on risk factors for injury during U.S. Army basic combat training. EVIDENCE ACQUISITION: Original studies of risk factors for injury during U.S. Army basic combat training published since 1990 in peer-reviewed journals were identified using PubMed and manual searches of reference lists. This search was last performed in May 2013. Nineteen studies met the inclusion criteria. EVIDENCE SYNTHESIS: Methodologic quality and potential for bias were assessed. The findings of 11 studies deemed to be of high or medium quality were synthesized to determine the level of evidence supporting the association between each risk factor studied and risk of injury during basic combat training. Quality assessment and evidence synthesis were performed from June to September 2013. CONCLUSIONS: There is strong or moderate evidence supporting association of older age, history of smoking, and self-rated low physical activity level prior to basic combat training with increased risk of training-related injury among male trainees. There is limited, mixed, or insufficient evidence to identify risk factors for injury among female trainees.

Measures of initiation and progression to increased smoking among current menthol compared to non-menthol cigarette smokers based on data from four U.S. government surveys.

There are no large-scale, carefully designed cohort studies that provide evidence on whether menthol cigarette use is associated with a differential risk of initiating and/or progressing to increased smoking. However, questions of whether current menthol cigarette smokers initiated smoking at a younger age or are more likely to have transitioned from non-daily to daily cigarette use compared to non-menthol smokers can be addressed using cross-sectional data from U.S. government surveys. Analyses of nationally representative samples of adult and youth smokers indicate that current menthol cigarette use is not associated with an earlier age of having initiated smoking or greater likelihood of being a daily versus non-daily smoker. Some surveys likewise provide information on cigarette type preference (menthol versus non-menthol) among youth at different stages or trajectories of smoking, based on number of days smoked during the past month and/or cigarettes smoked per day. Prevalence of menthol cigarette use does not appear to differ among new, less experienced youth smokers compared to established youth smokers. While there are limitations with regard to inferences that can be drawn from cross-sectional analyses, these data do not suggest any adverse effects for menthol cigarettes on measures of initiation and progression to increased smoking.

Patterns of menthol cigarette use among current smokers, overall and within demographic strata, based on data from four U.S. government surveys.

The National Health and Nutrition Examination Survey, National Survey on Drug Use and Health, National Health Interview Survey and Tobacco Use Supplement to the Current Population Survey provide estimates of the proportions of U.S. smokers who currently use menthol cigarettes, overall and within demographic strata. Among adult past-month, regular and daily smokers, menthol cigarette use ranges from 26% to 30%, with statistically higher proportions of female versus male smokers (8-11 percentage points higher) currently using menthol cigarettes. Compared to adult smokers overall, statistically higher proportions of non-Hispanic Black smokers (72-79%) and statistically lower proportions of non-Hispanic White smokers (19-22%) currently use menthol cigarettes, with no differences among smokers of other race/ethnicity groups (18-20% to 28-30%, depending on the survey). Higher proportions of younger adult past-month, regular and daily smokers (aged 18-25years) currently use menthol cigarettes compared to older adult smokers (aged 26-29years and/or ⩾30years); however, differences are small in magnitude, with the vast majority of adult smokers (70-75%) who currently use menthol cigarettes being aged ⩾30years. Comparisons between youth and adult smokers are provided, although data for youth smokers are less available and provide less consistent patterns of menthol cigarette use.

Evaluating the association between menthol cigarette use and the likelihood of being a former versus current smoker.

Menthol in cigarettes has been examined for its potential to affect smoking dependence, measured primarily as number of cigarettes smoked per day and time to first cigarette after waking; the ability to quit smoking constitutes an additional measure of dependence. Successful quitting among menthol compared to non-menthol cigarette smokers is difficult to determine from the literature, due in part to the various definitions of quitting used by researchers. Nevertheless, intervention and follow-up studies of smoking cessation treatments generally indicate no differences in quitting success among menthol compared to non-menthol smokers, while cross-sectional studies suggest some differences within race/ethnicity groups. The association between menthol cigarette use and likelihood of being a former versus current smoker was examined based on data from the National Health Interview Survey and Tobacco Use Supplement to the Current Population Survey. Analyses stratified by race/ethnicity and limited to smokers who had quit at least one year prior to survey participation provided inconsistent results with regard to menthol cigarette use and quitting, both within surveys (i.e., comparing race/ethnicity groups) and between surveys (i.e., same race/ethnicity group across surveys). Evidence suggesting the existence or direction of an association between menthol in cigarettes and quitting depended on the data source.

Primary measures of dependence among menthol compared to non-menthol cigarette smokers in the United States.

Previously published studies provide somewhat inconsistent evidence on whether menthol in cigarettes is associated with increased dependence. The National Health and Nutrition Examination Survey, National Survey on Drug Use and Health, National Health Interview Survey, and Tobacco Use Supplement to the Current Population Survey collect data on current cigarette type preference and primary measures of dependence, and thus allow examination of whether menthol smokers are more dependent than non-menthol smokers. Analyses based on combined data from multiple administrations of each of these four nationally representative surveys, using three definitions for current smokers (i.e., smoked ⩾1day, ⩾10days and daily during the past month), consistently demonstrate that menthol smokers do not report smoking more cigarettes per day than non-menthol smokers. Moreover, two of the three surveys that provide data on time to first cigarette after waking indicate no difference in urgency to smoke among menthol compared to non-menthol smokers, while the third suggests menthol smokers may experience a greater urgency to smoke; estimates from all three surveys indicate that menthol versus non-menthol smokers do not report a higher Heaviness of Smoking Index. Collectively, these findings indicate no difference in dependence among U.S. smokers who use menthol compared to non-menthol cigarettes.

A dynamic population model for estimating all-cause mortality due to lifetime exposure history.

We developed a comprehensive, flexible dynamic model that estimates all-cause mortality for a hypothetical cohort. All model input is user-specified. In the base case, members of the cohort may be exposed to a high risk product as they age. The counterfactual scenario includes exposure to both a high risk and a lower risk product. The model sorts the population into age and exposure categories, and applies the appropriate mortality rates to each category. The model tracks individual exposure histories, and estimates, at the end of each modeled age category, the number of survivors in the two exposure scenarios (base case and counterfactual), and the difference between them. Markov Chain Monte Carlo techniques are used to estimate the variability of the results. Model output was compared against US and Swedish life tables using population-specific tobacco exposure transition probabilities derived from the literature, and it produced similar survival estimates.

A review of health effects of carbon disulfide in viscose industry and a proposal for an occupational exposure limit.

Occupational exposure limits (OELs) for carbon disulfide vary between 1 and 10 ppm worldwide. They are generally based on health effects observed in viscose industry. Publications after the mid-1970s are reviewed to determine whether there is a scientific justification for an OEL below 10 ppm. The exposure situation in viscose industry is governed by long exposure durations, high exposures in past decades, high peak exposures, former analytical procedures underestimating exposure, and shift work. Three approaches were used to define an OEL based on workplace data: (1) Division of a cumulative exposure index by lifetime exposure duration. This approach ignores the possible existence of a threshold and fails to differentiate between brief high and sustained low exposures. (2) Defining the NOEL/LOEL by mean exposure levels. With a wide range of exposures, effects observed at the mean are driven by high exposures underestimating the true NOEL. (3) Assessment of effects observed at workplaces complying with a predefined exposure limit. Without adverse effects at such a limit this should be the starting point to define the OEL. The most important health effects for carbon disulfide are coronary heart disease, coronary risk factors, retinal angiopathy, color discrimination, effects on peripheral nerves, psychophysiological effects, morphological and other central nervous system (CNS) effects, and fertility and hormonal effects. The data generally support an OEL of 10 ppm. Some uncertainties exist for effects on electrocardiogram (ECG), heart rate, retinal microaneurysms (in Japanese workers), peripheral nerve conduction velocities, some psychophysiological parameters, brain magnetic resonance imaging (MRI; hyperintensive spots), and hearing function. Further investigations on workers under defined long-term exposure conditions might help to come to a final conclusion. Finally, the reproductive capacity of female workers may not be adequately protected at exposures around 10 ppm.

Cause-specific mortality among Kelly Air Force Base civilian employees, 1981-2001.

In response to concerns about occupational and environmental exposures, and a perceived cluster of amyotrophic lateral sclerosis (ALS) in the community, the mortality experience among 31,811 civilian employees who worked for at least 1 year between 1981 and 2000 at Kelly Air Force Base, Texas was ascertained. A total of 3264 deaths occurred through October 31, 2001. Overall, significant deficits in mortality were observed for all causes of death and all cancers combined. An excess of breast cancer [standardized mortality ratio (SMR) = 216; 95% confidence interval (CI) = 128-341] among blue-collar women was identified, and remained elevated after adjusting for race and ethnicity [rate ratio (RR) = 2.83; 95% CI = 1.50-5.34]. Mortality from motor neuron disease, which includes ALS deaths, was not increased overall (SMR = 0.98; 95% CI = 0.52-1.68), and was lower among blue-collar employees and higher among white-collar employees than expected, based on small numbers. Overall, mortality patterns indicated a healthy worker population and no large increased mortality associated with employment at Kelly Air Force Base.