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"Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world."--Publisher's description

In discussing Waller's paper, we build on his review of medical conditions and the risk of motor vehicle accidents (MVAs) using principles derived from geriatrics, gerontology, and health services research. Three approaches are suggested. The medical model uses discrete diseases as risk factors, but despite its utility and appeal, this model does not sufficiently characterize health and functional status to be the sole approach, and future investigative efforts should at least consider severity of illness concepts. The functional status model emphasizes a functional and physiological approach to health status, but despite its successful application in geriatric assessment and its investigative promise, functional status can be difficult to measure and has not been validated in relation to MVA risk. Finally we consider a behavioral model and within that framework discuss the relation of depressive and other emotional illnesses as well as social vitality to driving patterns and MVA occurrence.

The human menstrual cycle is characterized by a series of dynamic hormonal relationships that result in the regular maturation of ovarian follicles, ovulation and corpus luteum formation. As methodology has changed and improved, it has become possible to examine these events in greater detail. The simple analysis of menstrual cycle length, when done with care in a large number of women over long time spans, has revealed much about the fundamental biological rhythm of the menstrual cycle. Of particular interest are the predictable changes in cycle length and variability that occur at different stages of reproductive life (Treloar et al., 1967; Vollman, 1977). Basal body temperature records add another dimension to the analyses of menstrual cycle length because they permit estimation of the length of the pre- and post-ovulatory phases of the menstrual cycle and provide some index of the integrity of corpus luteum function.

BACKGROUND: Low back pain (LBP) is common among military veterans seeking treatment in Department of Veterans Affairs (VA) healthcare facilities. As chiropractic services within VA expand, well-designed pragmatic trials and implementation studies are needed to assess clinical effectiveness and program uptake. This study evaluated veteran stakeholder perceptions of the feasibility and acceptability of care delivery and research processes in a pilot trial of multimodal chiropractic care for chronic LBP. METHODS: The qualitative study was completed within a mixed-method, single-arm, pragmatic, pilot clinical trial of chiropractic care for LBP conducted in VA chiropractic clinics. Study coordinators completed semi-structured, in person or telephone interviews with veterans near the end of the 10-week trial. Interviews were audiorecorded and transcribed verbatim. Qualitative content analysis using a directed approach explored salient themes related to trial implementation and delivery of chiropractic services. RESULTS: Of 40 participants, 24 completed interviews (60% response; 67% male gender; mean age 51.7 years). Overall, participants considered the trial protocol and procedures feasible and reported that the chiropractic care and recruitment methods were acceptable. Findings were organized into 4 domains, 10 themes, and 21 subthemes. Chiropractic service delivery domain encompassed 3 themes/8 subthemes: scheduling process (limited clinic hours, scheduling future appointments, attendance barriers); treatment frequency (treatment sufficient for LBP complaint, more/less frequent treatments); and chiropractic clinic considerations (hire more chiropractors, including female chiropractors; chiropractic clinic environment; patient-centered treatment visits). Outcome measures domain comprised 3 themes/4 subthemes: questionnaire burden (low burden vs. time-consuming or repetitive); relevance (items relevant for LBP study); and timing and individualization of measures (questionnaire timing relative to symptoms, personalized ...

IMPORTANCE: Millions of Americans use electronic cigarettes (e-cigarettes). A growing number of state and local governments have started to draft and implement laws regarding the sale, marketing, and use of e-cigarettes. The association of US state regulations regarding e-cigarettes with e-cigarette use remains unknown. OBJECTIVE: To examine the association of US state regulations regarding e-cigarettes with current e-cigarette use among adults in the United States. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included adults aged 18 years or older from the 2016 and 2017 Behavioral Risk Factor Surveillance System, which is a nationwide, telephone-administered survey that collects state-representative data on health-related risk behaviors, chronic health conditions, and use of preventive services. Data analysis was performed from February 1, 2019, to April 31, 2019. EXPOSURES: United States state laws regulating e-cigarette use, including prohibiting e-cigarette use in indoor areas of private workplaces, restaurants, and bars; requiring retailers to purchase a license to sell e-cigarettes; prohibiting self-service displays of e-cigarettes; prohibiting sales of tobacco products, including e-cigarettes, to persons younger than 21 years; and e-cigarette taxes. MAIN OUTCOMES AND MEASURES: Current use of e-cigarettes. RESULTS: Among 894 997 participants aged 18 years or older (503 688 women [51.3%], 679 443 non-Hispanic white [62.6%], 71 730 non-Hispanic black [16.3%], 69 823 Hispanic [11.4%], and 74 001 non-Hispanic other races [9.8%]), 28 907 (weighted prevalence, 4.4%) were currently using e-cigarettes. The age-standardized weighted prevalence of current e-cigarette use varied across US states and territories, from 1.0% in Puerto Rico to 6.2% in Guam. After adjustment for demographic, socioeconomic, and lifestyle factors, including conventional cigarette use, the odds ratios of current e-cigarette use were 0.90 (95% CI, 0.83-0.98) for state laws prohibiting e-cigarette use in indoor areas of ...

"Tobacco consumption continues to be the leading cause of preventable disease and death in the United States. The Food and Drug Administration (FDA) regulates the manufacture, distribution, and marketing of tobacco products - specifically cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco - to protect public health and reduce tobacco use in the United States. Given the strong social component inherent to tobacco use onset, cessation, and relapse, and given the heterogeneity of those social interactions, agent-based models have the potential to be an essential tool in assessing the effects of policies to control tobacco. Assessing the Use of Agent-Based Models for Tobacco Regulation describes the complex tobacco environment; discusses the usefulness of agent-based models to inform tobacco policy and regulation; presents an evaluation framework for policy-relevant agent-based models; examines the role and type of data needed to develop agent-based models for tobacco regulation; provides an assessment of the agent-based model developed for FDA; and offers strategies for using agent-based models to inform decision making in the future."--Publisher's description

Abstract

Background
Multimorbidity, defined as the presence of 2 or more chronic health conditions, is increasingly common among older adults. The combination of lifestyle characteristics such as diet quality, smoking status, alcohol intake, physical activity (PA), sleep duration, and body fat as assessed by body mass index (BMI) or waist circumference, and risk of multimorbidity are not well understood.


Objectives
We investigated the association between the healthy lifestyle index (HLI), generated by combining indicators of diet quality, smoking, alcohol, PA, sleep amount, and BMI, and risk of multimorbidity, a composite outcome that included cardiovascular disease (CVD), diabetes, cancer, and fracture.


Methods
We studied 62 037 postmenopausal women aged 50–79 years at enrollment in the Women's Health Initiative, with no reported history of CVD, diabetes, cancer, or fracture at baseline. Lifestyle characteristics measured at baseline were categorized and a score (0–4) was assigned to each category. The combined HLI (0–24) was grouped into quintiles, with higher quintiles indicating a healthier lifestyle. Multivariable adjusted estimates of hazard ratios (HRs) and 95% confidence intervals (95% CIs) for the risk of developing multimorbidity were obtained using Cox proportional hazard models.


Results
Over an average follow-up period of 16.3 years, 5 656 women developed multimorbidity. There was an inverse association between the HLI levels and risk of multimorbidity (compared to the HLI_1st quintile: HR_2nd quintile = 0.81 95% CI 0.74–0.83, HR_3rd quintile = 0.77 95% CI 0.71–0.83, HR_4th quintile = 0.70 95% CI 0.64–0.76, and HR_5th quintile = 0.60 95% CI 0.54–0.66; p trend < .001). Similar associations were observed after stratification by age or BMI categories.


Conclusions
Among postmenopausal women, higher levels of the HLI were associated with a reduced risk of developing multimorbidity.

BACKGROUND: Low-risk limits recommended for alcohol consumption vary substantially across different national guidelines. To define thresholds associated with lowest risk for all-cause mortality and cardiovascular disease, we studied individual-participant data from 599 912 current drinkers without previous cardiovascular disease. METHODS: We did a combined analysis of individual-participant data from three large-scale data sources in 19 high-income countries (the Emerging Risk Factors Collaboration, EPIC-CVD, and the UK Biobank). We characterised dose-response associations and calculated hazard ratios (HRs) per 100 g per week of alcohol (12·5 units per week) across 83 prospective studies, adjusting at least for study or centre, age, sex, smoking, and diabetes. To be eligible for the analysis, participants had to have information recorded about their alcohol consumption amount and status (ie, non-drinker vs current drinker), plus age, sex, history of diabetes and smoking status, at least 1 year of follow-up after baseline, and no baseline history of cardiovascular disease. The main analyses focused on current drinkers, whose baseline alcohol consumption was categorised into eight predefined groups according to the amount in grams consumed per week. We assessed alcohol consumption in relation to all-cause mortality, total cardiovascular disease, and several cardiovascular disease subtypes. We corrected HRs for estimated long-term variability in alcohol consumption using 152 640 serial alcohol assessments obtained some years apart (median interval 5·6 years [5th-95th percentile 1·04-13·5]) from 71 011 participants from 37 studies. FINDINGS: In the 599 912 current drinkers included in the analysis, we recorded 40 310 deaths and 39 018 incident cardiovascular disease events during 5·4 million person-years of follow-up. For all-cause mortality, we recorded a positive and curvilinear association with the level of alcohol consumption, with the minimum mortality risk around or below 100 g per week. Alcohol consumption was roughly linearly associated with a higher risk of stroke (HR per 100 g per week higher consumption 1·14, 95% CI, 1·10-1·17), coronary disease excluding myocardial infarction (1·06, 1·00-1·11), heart failure (1·09, 1·03-1·15), fatal hypertensive disease (1·24, 1·15-1·33); and fatal aortic aneurysm (1·15, 1·03-1·28). By contrast, increased alcohol consumption was log-linearly associated with a lower risk of myocardial infarction (HR 0·94, 0·91-0·97). In comparison to those who reported drinking >0-≤100 g per week, those who reported drinking >100-≤200 g per week, >200-≤350 g per week, or >350 g per week had lower life expectancy at age 40 years of approximately 6 months, 1-2 years, or 4-5 years, respectively. INTERPRETATION: In current drinkers of alcohol in high-income countries, the threshold for lowest risk of all-cause mortality was about 100 g/week. For cardiovascular disease subtypes other than myocardial infarction, there were no clear risk thresholds below which lower alcohol consumption stopped being associated with lower disease risk. These data support limits for alcohol consumption that are lower than those recommended in most current guidelines. FUNDING: UK Medical Research Council, British Heart Foundation, National Institute for Health Research, European Union Framework 7, and European Research Council.