Introduction The 2009 Family Smoking Prevention and Tobacco Control Act banned characterizing flavors other than menthol in cigarettes but did not restrict their use in other forms of tobacco (e.g., ...smokeless, cigars, hookah, e-cigarettes). Methods A cross-sectional analysis of Wave 1 data from 45,971 U.S. adults and youth, aged ≥12 years in the Population Assessment of Tobacco and Health (PATH) Study collected in 2013–2014, was conducted in 2016. This study examined (1) the prevalence and reasons for use of flavored tobacco products; (2) the proportion of ever tobacco users reporting that their first product was flavored; and (3) correlates of current flavored tobacco product use. Results Current flavored (including menthol) tobacco product use was highest in youth (80%, aged 12–17 years); and young adult tobacco users (73%, aged 18–24 years); and lowest in older adult tobacco users aged ≥65 years (29%). Flavor was a primary reason for using a given tobacco product, particularly among youth. Eighty-one percent of youth and 86% of young adult ever tobacco users reported that their first product was flavored versus 54% of adults aged ≥25 years. In multivariable models, reporting that one’s first tobacco product was flavored was associated with a 13% higher prevalence of current tobacco use among youth ever tobacco users and a 32% higher prevalence of current tobacco use among adult ever users. Conclusions These results add to the evidence base that flavored tobacco products may attract young users and serve as starter products to regular tobacco use.
Context Rapid developments in e-cigarettes, or electronic nicotine delivery systems (ENDS), and the evolution of the overall tobacco product marketplace warrant frequent evaluation of the published ...literature. The purpose of this article is to report updated findings from a comprehensive review of the published scientific literature on ENDS. Evidence acquisition The authors conducted a systematic review of published empirical research literature on ENDS through May 31, 2016, using a detailed search strategy in the PubMed electronic database, expert review, and additional targeted searches. Included studies presented empirical findings and were coded to at least one of nine topics: (1) Product Features; (2) Health Effects; (3) Consumer Perceptions; (4) Patterns of Use; (5) Potential to Induce Dependence; (6) Smoking Cessation; (7) Marketing and Communication; (8) Sales; and (9) Policies; reviews and commentaries were excluded. Data from included studies were extracted by multiple coders (October 2015 to August 2016) into a standardized form and synthesized qualitatively by topic. Evidence synthesis There were 687 articles included in this systematic review. The majority of studies assessed patterns of ENDS use and consumer perceptions of ENDS, followed by studies examining health effects of vaping and product features. Conclusions Studies indicate that ENDS are increasing in use, particularly among current smokers, pose substantially less harm to smokers than cigarettes, are being used to reduce/quit smoking, and are widely available. More longitudinal studies and controlled trials are needed to evaluate the impact of ENDS on population-level tobacco use and determine the health effects of longer-term vaping.
Objective The purpose of this study was to model outcomes in laparoscopic hysterectomy with morcellation compared with abdominal hysterectomy for the presumed fibroid uterus and to examine short- and ...long-term complications and death. Study Design A decision tree was constructed to compare outcomes for a hypothetical cohort of 100,000 premenopausal women who underwent hysterectomy for presumed fibroid tumors over a 5-year time horizon. Parameter and quality-of-life utility estimates were determined from published literature for postoperative complications, leiomyosarcoma incidence, death related to leiomyosarcoma, and procedure-related death. Results The decision-tree analysis predicted fewer overall deaths with laparoscopic hysterectomy compared with abdominal hysterectomy (98 vs 103 per 100,000). Although there were more deaths from leiomyosarcoma after laparoscopic hysterectomy (86 vs 71 per 100,000), there were more hysterectomy-related deaths with abdominal hysterectomy (32 vs 12 per 100,000). The laparoscopic group had lower rates of transfusion (2400 vs 4700 per 100,000), wound infection (1500 vs 6300 per 100,000), venous thromboembolism (690 vs 840 per 100,000) and incisional hernia (710 vs 8800 per 100,000), but a higher rate of vaginal cuff dehiscence (640 vs 290 per 100,000). Laparoscopic hysterectomy resulted in more quality-adjusted life years (499,171 vs 490,711 over 5 years). Conclusion The risk of leiomyosarcoma morcellation is balanced by procedure-related complications that are associated with laparotomy, including death. This analysis provides patients and surgeons with estimates of risk and benefit on which patient-centered decisions can be made.
Background Cardiovascular disease, including aortic root dilation, dissection, and rupture, is the leading cause of mortality in patients with Marfan syndrome (MFS). The maximal aortic root diameter ...at the sinuses of Valsalva is considered the best predictor of adverse cardiovascular outcome. Although advances in therapy have improved life expectancy, affected individuals continue to suffer cardiovascular morbidity and mortality. Recent studies in an FBN1 -targeted mouse model of MFS with aortic disease similar to that seen in humans showed that treatment with losartan normalized aortic root growth and aortic wall architecture. Methods The Pediatric Heart Network designed a randomized clinical trial to compare aortic root growth and other short-term cardiovascular outcomes in subjects with MFS receiving atenolol or losartan. Individuals 6 months to 25 years of age with a body surface area–adjusted aortic root z score >3.0 will be eligible for inclusion. The primary aim is to compare the effect of atenolol therapy with that of losartan therapy on the rate of aortic root growth over 3 years. Secondary end points include progression of aortic regurgitation; incidence of aortic dissection, aortic root surgery, and death; progression of mitral regurgitation; left ventricular size and function; echocardiographically derived measures of central aortic stiffness; skeletal and somatic growth; and incidence of adverse drug reactions. Conclusion This randomized trial should make a substantial contribution to the management of individuals with MFS and expand our understanding of the mechanisms responsible for the aortic manifestations of this disorder.
Hysterectomy for presumed leiomyomata is 1 of the most common surgical procedures performed in nonpregnant women in the United States. Laparoscopic hysterectomy (LH) with morcellation is an appealing ...alternative to abdominal hysterectomy (AH) but may result in dissemination of malignant cells and worse outcomes in the setting of an occult leiomyosarcoma (LMS). We sought to evaluate the cost-effectiveness of LH versus AH.
Decision-analytic model of 100 000 women in the United States assessing the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life-year (QALY) gained (Canadian Task Force classification III).
U.S. hospitals.
Adult premenopausal women undergoing LH or AH for presumed benign leiomyomata.
We developed a decision-analytic model from a provider perspective across 5 years, comparing the cost-effectiveness of LH to AH in terms of dollar (2014 US dollars) per QALY gained. The model included average total direct medical costs and utilities associated with the procedures, complications, and clinical outcomes. Baseline estimates and ranges for cost and probability data were drawn from the existing literature.
Estimated overall deaths were lower in LH versus AH (98 vs 103). Death due to LMS was more common in LH versus AH (86 vs 71). Base-case assumptions estimated that average per person costs were lower in LH versus AH, with a savings of $2193 ($24 181 vs $26 374). Over 5 years, women in the LH group experienced 4.99 QALY versus women in the AH group with 4.91 QALY (incremental gain of .085 QALYs). LH dominated AH in base-case estimates: LH was both less expensive and yielded greater QALY gains. The ICER was sensitive to operative costs for LH and AH. Varying operative costs of AH yielded an ICER of $87 651/QALY gained (minimum) to AH being dominated (maximum). Probabilistic sensitivity analyses, in which all input parameters and costs were varied simultaneously, demonstrated a relatively robust model. The AH approach was dominated 68.9% of the time; 17.4% of simulations fell above the willingness-to-pay threshold of $50 000/QALY gained.
When considering total direct hospital costs, complications, and morbidity, LH was less costly and yielded more QALYs gained versus AH. Driven by the rarity of occult LMS and the reduced incidence of intra- and postoperative complications, LH with morcellation may be a more cost-effective and less invasive alternative to AH and should remain an option for women needing hysterectomy for leiomyomata.
Intensive statin therapy (IST) has been shown to decrease cardiovascular events in patients with acute coronary syndrome (ACS). Numerous studies have described statin use for secondary prevention; ...however, few data have highlighted IST use after ACS. The objective of the present study was to describe IST use in an ACS population before hospitalization, on discharge, and during early follow-up after discharge. A retrospective chart review was conducted of randomly selected patients admitted to a tertiary care center from November 1, 2007 to October 31, 2008. Eligible patients included adults admitted to cardiology with a most responsible diagnosis of ACS ( International Classification of Diseases code 20-25). The exclusion criteria included transfer to another hospital or cardiovascular surgery ward and in-hospital death. Phase 1 included an inpatient chart review. Phase 2 was a follow-up cardiologist clinic letter review that included only patients who started IST in-hospital. Of 234 charts reviewed, 111 (47%) patients met the inclusion criteria (mean age 65 ± 11.7 years, 76% men). Most patients (93%) were discharged with a statin. However, although 72% of the study population were eligible for IST, only 52% had IST during hospitalization. Of the patients who started IST with clinic letters available (n = 31), 68% continued IST (mean interval to follow-up 85 days, range 33 to 208). In conclusion, although statin use is good, IST use after ACS is suboptimal. Additionally, newly initiated IST demonstrates poor persistence after discharge.
Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health–National Heart, Lung, and Blood Institute ...(NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators.
Background To reduce the incidence of phlebotomy-related percutaneous injuries (PIs), factors that contribute to these injuries must be identified. This study examined institutional phlebotomy ...practices, policies, perceptions, and culture to identify facilitators and barriers that appear to have the greatest impact in preventing injuries. Methods During site visits at study hospitals, observational data were collected during the performance of phlebotomy. In addition, interviews and focus groups were conducted with hospital personnel involved in phlebotomy procedures. Results Nine hospitals participated in the study. A total of 126 phlebotomy procedures were observed. Health care personnel chose devices with safety features for the majority of observed procedures (n = 122, 97%). Recommended phlebotomy practices for handling needles after use were observed in 42% to 92% of procedures. Adherence varied by type of device, occupation, and facility PI rate. In the 23 interviews and 9 focus groups, participants identified factors that facilitated PI prevention such as the availability and use of devices with safety mechanisms, adherence to recommended safe needle-handling practices, and institutional phlebotomy training. Conclusion The quantitative and qualitative data indicate that a wide array of factors can affect phlebotomy-related practices and perceptions. Prevention of PIs may require comprehensive, multifaceted intervention efforts to improve the safety culture and reduce PIs and exposure to bloodborne pathogens in health care facilities.
ABSTRACT
Individuals diagnosed with impaired glucose tolerance (i.e., prediabetes) are at increased risk for developing diabetes. We proposed a clinical trial with a novel adaptive randomization ...designed to examine the impact of a home-based physical activity (PA) counseling intervention on metabolic risk in prediabetic elders. This manuscript details the lessons learned relative to recruitment, study design, and implementation of a 12-month randomized controlled PA counseling trial. A detailed discussion on how we responded to unforeseen challenges is provided. A total of 302 older patients with prediabetes were randomly assigned to either PA counseling or usual care. A novel adaptive design that reallocated counseling intensity based on self-report of adherence to PA was initiated but revised when rates of non-response were lower than projected. This study presents baseline participant characteristics and discusses unwelcome adaptations to a highly innovative study design to increase PA and enhance glucose metabolism when the best-laid plans went awry.
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