Douglas E. Levy

Survival after the onset of congestive heart failure in Framingham Heart Study subjects.

BackgroundRelatively limited epidemiological data are available regarding the prognosis of congestive heart failure (CHF) and temporal changes in survival after its onset in a population-based setting. Methods and ResultsProportional hazards models were used to evaluate the effects of selected clinical variables on survival after the onset of CHF among 652 members of the Framingham Heart Study (51% men; mean age, 70.0 ± 10.8 years) who developed CHF between 1948 and 1988. Subjects were older at the diagnosis of heart failure in the later decades of this study (mean age at heart failure diagnosis, 57.3 ± 7.6 years in the 1950s, 65.9 ± 7.9 years in the 1960s, 71.6 ± 9.4 years in the 1970s, and 76.4 ± 10.0 years in the 1980s; p<0.001). Median survival after the onset of heart failure was 1.7 years in men and 3.2 years in women. Overall, 1-year and 5-year survival rates were 57% and 25% in men and 64% and 38% in women, respectively. Survival was better in women than in men (age-adjusted hazards ratio for mortality, 0.64; 95% CI, 0.54-0.77). Mortality increased with advancing age in both sexes (hazards ratio for men, 1.27 per decade of age; 95% CI, 1.09-1.47; hazards ratio for women, 1.61 per decade of age; 95% CI, 1.37-1.90). Adjusting for age, there was no significant temporal change in the prognosis of CHF during the 40 years of observation (hazards ratio for men for mortality, 1.08 per calendar decade; 95% CI, 0.92-1.27; hazards ratio for women for mortality, 1.02 per calendar decade; 95% CI, 0.83-1.26). ConclusionCHF remains highly lethal, with better prognosis in women and in younger individuals. Advances in the treatment of hypertension, myocardial ischemia, and valvular heart disease during the four decades of observation did not translate into appreciable improvements in overall survival after the onset of CHF in this large, unselected population.

Left Ventricular Dilatation and the Risk of Congestive Heart Failure in People without Myocardial Infarction

BACKGROUND Left ventricular dilatation is a well-recognized precursor of ventricular dysfunction and congestive heart failure after myocardial infarction. The effect of left ventricular dilatation on the risk of heart failure in people initially free of myocardial infarction is not known. METHODS We examined the relation of the left ventricular end-diastolic and end-systolic internal dimensions, as measured by M-mode echocardiography, to the risk of congestive heart failure in 4744 subjects (2083 men and 2661 women) who had not sustained a myocardial infarction and who were free of congestive heart failure. We used sex-stratified proportional-hazards regression to assess the association between base-line left ventricular internal dimensions and the subsequent risk of congestive heart failure, after adjusting for age, blood pressure, hypertension treatment, body-mass index, diabetes, valve disease, and interim myocardial infarction. RESULTS Over an 11-year follow-up period, congestive heart failure developed in 74 subjects (38 men and 36 women). The risk-factor-adjusted hazard ratio for congestive heart failure was 1.47 (95 percent confidence interval, 1.25 to 1.73) for an increment of 1 SD in the left ventricular end-diastolic dimension, indexed for height. We obtained similar results using the left ventricular end-systolic dimension (hazard ratio, 1.43; 95 percent confidence interval, 1.24 to 1.65). CONCLUSIONS An increase in left ventricular internal dimension is a risk factor for congestive heart failure in men and women who have not had a myocardial infarction. Knowledge of the left ventricular dimension improves predictions of the risk of congestive heart failure made on the basis of traditional risk factors, perhaps by aiding in the identification of subjects with subclinical left ventricular dysfunction.

A 2-Phase Labeling and Choice Architecture Intervention to Improve Healthy Food and Beverage Choices

OBJECTIVES We assessed whether a 2-phase labeling and choice architecture intervention would increase sales of healthy food and beverages in a large hospital cafeteria. METHODS Phase 1 was a 3-month color-coded labeling intervention (red = unhealthy, yellow = less healthy, green = healthy). Phase 2 added a 3-month choice architecture intervention that increased the visibility and convenience of some green items. We compared relative changes in 3-month sales from baseline to phase 1 and from phase 1 to phase 2. RESULTS At baseline (977,793 items, including 199,513 beverages), 24.9% of sales were red and 42.2% were green. Sales of red items decreased in both phases (P < .001), and green items increased in phase 1 (P < .001). The largest changes occurred among beverages. Red beverages decreased 16.5% during phase 1 (P < .001) and further decreased 11.4% in phase 2 (P < .001). Green beverages increased 9.6% in phase 1 (P < .001) and further increased 4.0% in phase 2 (P < .001). Bottled water increased 25.8% during phase 2 (P < .001) but did not increase at 2 on-site comparison cafeterias (P < .001). CONCLUSIONS A color-coded labeling intervention improved sales of healthy items and was enhanced by a choice architecture intervention.

Underutilization of BRCA1/2 testing to guide breast cancer treatment: black and Hispanic women particularly at risk.

Purpose: Women with early-onset (age ≤40 years) breast cancer are at high risk of carrying deleterious mutations in the BRCA1/2 genes; genetic assessment is thus recommended. Knowledge of BRCA1/2 mutation status is useful in guiding treatment decisions. To date, there has been no national study of BRCA1/2 testing among newly diagnosed women.Methods: We used administrative data (2004–2007) from a national sample of 14.4 million commercially insured patients to identify newly diagnosed, early-onset breast cancer cases among women aged 20–40 years (n = 1474). Cox models assessed BRCA1/2 testing, adjusting for covariates and differential lengths of follow-up.Results: Overall, 30% of women aged 40 years or younger received BRCA1/2 testing. In adjusted analyses, women of Jewish ethnicity were significantly more likely to be tested (hazard ratio = 2.83, 95% confidence interval: 1.52–5.28), whereas black women (hazard ratio = 0.34, 95% 0.18–0.64) and Hispanic women (hazard ratio = 0.52, 95% confidence interval: 0.33–0.81) were significantly less likely to be tested than non-Jewish white women. Those enrolled in a health maintenance organization (hazard ratio = 0.73, 95% confidence interval: 0.54–0.99) were significantly less likely to receive BRCA1/2 testing than those point of service insurance plans. Testing rates increased sharply for women diagnosed in 2007 compared with 2004.Conclusions: In this national sample of patients with newly diagnosed breast cancer at high risk for BRCA1/2 mutations, genetic assessment was low, with marked racial differences in testing.

Traffic-Light Labels and Choice Architecture Promoting Healthy Food Choices

BACKGROUND Preventing obesity requires maintenance of healthy eating behaviors over time. Food labels and strategies that increase visibility and convenience of healthy foods (choice architecture) promote healthier choices, but long-term effectiveness is unknown. PURPOSE Assess effectiveness of traffic-light labeling and choice architecture cafeteria intervention over 24 months. DESIGN Longitudinal pre-post cohort follow-up study between December 2009 and February 2012. Data were analyzed in 2012. SETTING/PARTICIPANTS Large hospital cafeteria with a mean of 6511 transactions daily. Cafeteria sales were analyzed for (1) all cafeteria customers and (2) a longitudinal cohort of 2285 hospital employees who used the cafeteria regularly. INTERVENTION After a 3-month baseline period, cafeteria items were labeled green (healthy); yellow (less healthy); or red (unhealthy) and rearranged to make healthy items more accessible. MAIN OUTCOME MEASURES Proportion of cafeteria sales that were green or red during each 3-month period from baseline to 24 months. Changes in 12- and 24-month sales were compared to baseline for all transactions and transactions by the employee cohort. RESULTS The proportion of sales of red items decreased from 24% at baseline to 20% at 24 months (p<0.001), and green sales increased from 41% to 46% (p<0.001). Red beverages decreased from 26% of beverage sales at baseline to 17% at 24 months (p<0.001); green beverages increased from 52% to 60% (p<0.001). Similar patterns were observed for the cohort of employees, with the largest change for red beverages (23%-14%, p<0.001). CONCLUSIONS A traffic-light and choice architecture cafeteria intervention resulted in sustained healthier choices over 2 years, suggesting that food environment interventions can promote long-term changes in population eating behaviors.

Capturing quality of life in pediatric orthopaedics: two recent measures compared.

There is a clear need for standardized measures to assess health status that are valid and appropriate to the needs of children with orthopaedic problems. The Child Health Questionnaire and the American Academy of Orthopaedic Surgeons Pediatric Outcomes Data Collection Instrument, two new pediatric health status measures, were assessed for their ability to detect differences in health states in a pediatric orthopaedic population. The instruments have a range of scales designed to measure various aspects of physical and psychosocial health. Two hundred forty-two patients with wide-ranging diagnoses were enrolled in this cross-sectional study. The instruments exhibited ceiling effects in some domains but generally performed as they were intended in this large cohort. Using secondary factor analysis, it was shown that the domains of the instruments appropriately distinguish physical and psychosocial health. Several domains from each instrument discriminated between diagnosis groups and patients with varying numbers of comorbidities. Both of these measures show significant promise and have an important role in helping define the outcomes of children with orthopaedic problems.

Assessment of quality of life in adolescent patients with orthopaedic problems : Are adult measures appropriate?

New pressures of accountability brought on by a rapidly evolving system of health care financing have underscored the need for standardized, valid measures of patient outcome that reflect the effect of clinical intervention on all aspects of quality of life. In response, there has been a burgeoning interest in the area of outcomes assessment and measurement of quality of life after orthopaedic intervention in adults, but less attention has been focused on the assessment of broadly defined outcomes in children. In an effort to borrow from the broader adult experience in this area, the authors sought to examine whether the Medical Outcomes Study Short Form 36 (SF-36) or the EuroQol questionnaire, widely accepted adult health status measures, would be valid in this setting. These two measures were administered to 196 adolescent patients (10–18 years old) seeking orthopaedic evaluation. Tests of scale properties and construct validity show that these properties are maintained in this population, but neither instrument reflected known differences in health status among this cohort. Most importantly, both the SF-36 and the EuroQol exhibited serious ceiling effects (most respondents scored at the top of their scales), despite evidence indicating those patients often had suboptimal health status. Thus, neither the SF-36 nor the EuroQol is valid for use in this population. The assessment of pediatric health status demands outcomes measures specifically designed to reflect the unique needs of this population.

Sustained Care Intervention and Postdischarge Smoking Cessation Among Hospitalized Adults: A Randomized Clinical Trial

IMPORTANCE Health care systems need effective models to manage chronic diseases like tobacco dependence across transitions in care. Hospitalizations provide opportunities for smokers to quit, but research suggests that hospital-delivered interventions are effective only if treatment continues after discharge. OBJECTIVE To determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial compared sustained care (a postdischarge tobacco cessation intervention) with standard care among 397 hospitalized daily smokers (mean age, 53 years; 48% were males; 81% were non-Hispanic whites) who wanted to quit smoking after discharge and received a tobacco dependence intervention in the hospital; 92% of eligible patients and 44% of screened patients enrolled. The study was conducted from August 2010 through November 2012 at Massachusetts General Hospital. INTERVENTIONS Sustained care participants received automated interactive voice response telephone calls and their choice of free smoking cessation medication (any type approved by the US Food and Drug Administration) for up to 90 days. The automated telephone calls promoted cessation, provided medication management, and triaged smokers for additional counseling. Standard care participants received recommendations for postdischarge pharmacotherapy and counseling. MAIN OUTCOMES AND MEASURES The primary outcome was biochemically confirmed past 7-day tobacco abstinence at 6-month follow-up after discharge from the hospital; secondary outcomes included self-reported tobacco abstinence. RESULTS Smokers randomly assigned to sustained care (n = 198) used more counseling and more pharmacotherapy at each follow-up assessment than those assigned to standard care (n = 199). Biochemically validated 7-day tobacco abstinence at 6 months was higher with sustained care (26%) than with standard care (15%) (relative risk [RR], 1.71 [95% CI, 1.14-2.56], P = .009; number needed to treat, 9.4 [95% CI, 5.4-35.5]). Using multiple imputation for missing outcomes, the RR for 7-day tobacco abstinence was 1.55 (95% CI, 1.03-2.21; P = .04). Sustained care also resulted in higher self-reported continuous abstinence rates for 6 months after discharge (27% vs 16% for standard care; RR, 1.70 [95% CI, 1.15-2.51]; P = .007). CONCLUSIONS AND RELEVANCE Among hospitalized adult smokers who wanted to quit smoking, a postdischarge intervention providing automated telephone calls and free medication resulted in higher rates of smoking cessation at 6 months compared with a standard recommendation to use counseling and medication after discharge. These findings, if replicated, suggest an approach to help achieve sustained smoking cessation after a hospital stay. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01177176.

Guidelines for genetic risk assessment of hereditary breast and ovarian cancer: early disagreements and low utilization.

ABSTRACTBACKGROUNDBRCA1/2 testing is one of the most well-established genetic tests to predict cancer risk. Guidelines are available to help clinicians determine who will benefit most from testing.OBJECTIVETo identify women at high risk of hereditary breast and ovarian cancer and estimate their awareness of and experience with genetic testing for cancer risk.DESIGNAnalyses of the 2000 and 2005 National Health Interview Surveys.PARTICIPANTSWomen with no personal history of breast or ovarian cancer (n = 35,116).MEASUREMENTSRisk of hereditary breast or ovarian cancer based on self-reported family history of cancer and national guidelines; self-reported awareness of genetic testing for cancer risk; discussion of genetic testing for cancer risk with a health professional; having undergone genetic testing for breast/ovarian cancer risk.RESULTSUsing guideline criteria, 0.96% of women were identified as being at high risk of hereditary breast and ovarian cancer. Among high-risk women, 54.04% were aware of genetic testing for cancer risk, 10.39% had discussed genetic testing with a health professional, and 1.41% had undergone testing for breast/ovarian cancer risk. Adjusting for survey year, high-risk women were more likely than average-risk women to have heard of genetic testing for cancer risk (RR, 1.3, 95% CI 1.2-1.4), to have discussed genetic testing with a health professional (RR 5.2, 95% CI 3.6-7.4), and to have undergone genetic testing for breast/ovarian cancer risk (RR 6.8, 95% CI 2.6-18.0).CONCLUSIONSWe find low provision of guideline-recommended advice to women for whom testing may be appropriate and of significant clinical benefit.

A Longitudinal Study of Medicaid Coverage for Tobacco Dependence Treatments in Massachusetts and Associated Decreases in Hospitalizations for Cardiovascular Disease

Thomas Land and colleagues show that among Massachusetts Medicaid subscribers, use of a comprehensive tobacco cessation pharmacotherapy benefit was followed by a substantial decrease in claims for hospitalizations for acute myocardial infarction and acute coronary heart disease.