National Media Coverage of the Veterans Affairs Waitlist Scandal: Effects on Veterans' Distrust of the VA Health Care System.

BACKGROUND: On April 23, 2014, US media outlets broadcast reports of excessive wait times and "secret" waitlists at some Veterans Affairs (VA) hospitals, precipitating legislation to increase Veterans' access to private sector health care. OBJECTIVE: The aims were to assess changes in Veterans' distrust in the VA health care system before and after the media coverage and explore sex and racial/ethnic differences in the temporal patterns. METHODS: Veterans completed semistructured interviews on health care satisfaction from June 2013 to January 2015, including a validated scale of health system distrust (range: 1-5). We used linear splines with knots at 90-day intervals to assess changes in distrust before and after April 23, 2014 ("day 0") in linear mixed models. To explore sex and racial/ethnic differences in temporal patterns, we stratified models by sex and tested for interactions of race/ethnicity with time. RESULTS: For women (n=600), distrust scores (mean=2.09) increased by 0.45 in days 0-90 (P<0.01), then decreased by 0.45 in days 90-180 (P<0.01). Among men (n=575), distrust scores (mean=2.05) increased by 0.18 in days 0-90 (P=0.059). Distrust levels were significantly higher for Black versus White women (time adjusted mean difference=0.21) and for Black and Hispanic versus White men (differences=0.26 and 0.18). However, the temporal patterns did not vary by race/ethnicity for women or men (interaction P=0.85 and 0.21, respectively). CONCLUSIONS: Health system distrust increased in women following media coverage of VA access problems and was higher in Black/Hispanic versus White Veterans at all time periods. Such perceptions could influence Veteran decisions to seek health care in the community rather than VA.

Veteran Satisfaction with Early Experiences of Health Care Through the Veterans Choice Program: a Concurrent Mixed Methods Study.

BACKGROUND: The 2014 Veterans Access, Choice and Accountability Act (i.e., "Choice") allows eligible Veterans to receive covered health care outside the Veterans Affairs (VA) Healthcare System. The initial implementation of Choice was challenging, and use was limited in the first year. OBJECTIVE: To assess satisfaction with Choice, and identify reasons for satisfaction and dissatisfaction during its early implementation. DESIGN AND PARTICIPANTS: Semi-structured telephone interviews from July to September 2015 with Choice-eligible Veterans from 25 VA facilities across the USA. MAIN MEASURES: Satisfaction was assessed with 5-point Likert scales and open-ended questions. We compared ratings of satisfaction with Choice and VA health care, and identified reasons for satisfaction/dissatisfaction with Choice in a thematic analysis of open-ended qualitative data. RESULTS: Of 195 participants, 35 had not attempted to use Choice; 43 attempted but had not received Choice care (i.e., attempted only); and 117 attempted and received Choice care. Among those who attempted only, a smaller percentage were somewhat/very satisfied with Choice than with VA health care (17.9% and 71.8%, p < 0.001); among participants who received Choice, similar percentages were somewhat/very satisfied with Choice and VA health care (66.6% and 71.1%, p = 0.45). When asked what contributed to Choice ratings, participants who attempted but did not receive Choice care reported poor access (50%), scheduling problems (20%), and care coordination issues (10%); participants who received Choice care reported improved access (27%), good quality of care (19%), and good distance to Choice provider (16%). Regardless of receipt of Choice care, most participants expressed interest in using Choice in the future (70-82%). CONCLUSIONS: Access and scheduling barriers contributed to dissatisfaction for Veterans unsuccessfully attempting to use Choice during its initial implementation, whereas improved access and good care contributed to satisfaction for those receiving Choice care. With Veterans' continued interest in using services outside VA facilities, subsequent policy changes should address Veterans' barriers to care.

Racial, Ethnic, and Gender Equity in Veteran Satisfaction with Health Care in the Veterans Affairs Health Care System.

BACKGROUND: Patient satisfaction is an important dimension of health care quality. The Veterans Health Administration (VA) is committed to providing high-quality care to an increasingly diverse patient population. OBJECTIVE: To assess Veteran satisfaction with VA health care by race/ethnicity and gender. DESIGN AND PARTICIPANTS: We conducted semi-structured telephone interviews with gender-specific stratified samples of black, white, and Hispanic Veterans from 25 predominantly minority-serving VA Medical Centers from June 2013 to January 2015. MAIN MEASURES: Satisfaction with health care was assessed in 16 domains using five-point Likert scales. We compared the proportions of Veterans who were very satisfied, somewhat satisfied, and less than satisfied (i.e., neither satisfied nor dissatisfied, somewhat dissatisfied, or very dissatisfied) in each domain, and used random-effects multinomial regression to estimate racial/ethnic differences by gender and gender differences by race/ethnicity. KEY RESULTS: Interviews were completed for 1222 of the 1929 Veterans known to be eligible for the interview (63.3%), including 421 white, 389 black, and 396 Hispanic Veterans, 616 of whom were female. Veterans were less likely to be somewhat satisfied or less than satisfied versus very satisfied with care in each of the 16 domains. The highest satisfaction ratings were reported for costs, outpatient facilities, and pharmacy (74-76% very satisfied); the lowest ratings were reported for access, pain management, and mental health care (21-24% less than satisfied). None of the joint tests of racial/ethnic or gender differences in satisfaction (simultaneously comparing all three satisfaction levels) was statistically significant (p > 0.05). Pairwise comparisons of specific levels of satisfaction revealed racial/ethnic differences by gender in three domains and gender differences by race/ethnicity in five domains, with no consistent directionality across demographic subgroups. CONCLUSIONS: Our multisite interviews of a diverse sample of Veterans at primarily minority-serving sites showed generally high levels of health care satisfaction across 16 domains, with few quantitative differences by race/ethnicity or gender.

Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards.

BACKGROUND: Despite perceptions that institutional review boards (IRBs) delay research, little is known about how long it takes to secure IRB approval. We retrospectively quantified IRB review times at 10 large Veterans Affairs (VA) IRBs. METHODS: We collected IRB records pertaining to a stratified random sample of research protocols drawn from 10 of the 26 largest VA IRBs. Two independent analysts abstracted dates from the IRB records, from which we calculated overall and incremental review times. We used multivariable linear regression to assess variation in total and incremental review times by IRB and review level (i.e., exempt, expedited, or full board) and to identify potential targets for efforts to improve the efficiency and uniformity of the IRB review process. RESULTS: In a sample of 277 protocols, the mean review time was 112 d (95% confidence interval [CI]: 105-120). Compared with full-board reviews at IRB 1, average review times at IRBs 3, 8, 9, and 10 were 27 (95% CI: 6-48), 37 (95% CI: 11-63), 45 (95% CI: 20-69), and 24 (95% CI: 2-45) d shorter, and at IRB 6, times were 56 (95% CI: 28-84) d longer. Across all IRBs, expedited reviews were 44 (95% CI: 30-58) d shorter on average than were full-board reviews, with no significant difference between exempt and full-board reviews. However, after subtracting the time required for Research and Development Committee review, exempt reviews were 21 (95% CI: 1-41) d shorter on average than were full-board reviews. CONCLUSIONS: IRB review times differ significantly by IRB and review level. Few VA IRBs approach a consensus panel goal of 60 d for IRB review. The unexpectedly longer review times for exempt protocols in the VA can be attributed to time required for Research and Development Committee review. Prospective, routine collection of key time points in the IRB review process could inform IRB-specific initiatives for reducing VA IRB review times.

No Difference in Average Interdialytic Weight Gain Observed in a Randomized Trial With a Technology-Supported Behavioral Intervention to Reduce Dietary Sodium Intake in Adults Undergoing Maintenance Hemodialysis in the United States: Primary Outcomes of the BalanceWise Study.

OBJECTIVE: To evaluate the efficacy of behavioral counseling combined with technology-based self-monitoring for sodium restriction in hemodialysis (HD) patients. DESIGN: Randomized clinical trial. SUBJECTS: English literate adults undergoing outpatient, in-center intermittent HD for at least 3 months. INTERVENTIONS: Over a 16-week period, both the intervention and the attention control groups were shown 6 educational modules on the HD diet. The intervention group also received social cognitive theory-based behavioral counseling and monitored their diets daily using handheld computers. MAIN OUTCOME MEASURES: Average daily interdialytic weight gain (IDWGA) was calculated for every week of HD treatment over the observation period by subtracting the post-dialysis weight at the previous treatment time (t-1) from the pre-dialysis weight at the current treatment time (t), dividing by the number of days between treatments. Three 24-hour dietary recalls were obtained at baseline, 8 weeks, and 16 weeks and evaluated using the Nutrient Data System for Research. RESULTS: A total of 179 participants were randomized, and 160 (89.4%) completed final measurements. IDWGA did not differ significantly by treatment group at any time point considered (P > .79 for each). A significant differential change in dietary sodium intake observed at 8 weeks (-372 mg/day; P = .05) was not sustained at 16 weeks (-191 mg/day; P = .32). CONCLUSION: The BalanceWise Study intervention appeared to be feasible and acceptable to HD patients although IDWGA was unchanged and the desired behavioral changes observed at 8 weeks were not sustained. Unmeasured factors may have contributed to the mixed findings, and further research is needed to identify the appropriate patients for such interventions.

Adjuvant chemotherapy for stage III colon cancer: relative dose intensity and survival among veterans.

BACKGROUND: Given the paucity of information on dose intensity, the objective of this study is to describe the use of adjuvant chemotherapy for stage III colon cancer, focusing on relative dose intensity (RDI), overall survival (OS) and disease-free survival (DFS). METHODS: Retrospective cohort of 367 patients diagnosed with stage III colon cancer in 2003-2008 and treated at 19 VA medical centers. Kaplan-Meier curves summarize 5-year OS and 3-year DFS by chemotherapy regimen and RDI, and multivariable Cox proportional hazards regression was used to model these associations. RESULTS: 5-fluorouracil/leucovorin (FU/LV) was the most commonly initiated regimen in 2003 (94.4%) and 2004 (62.7%); in 2005-2008, a majority of patients (60%-74%) was started on an oxaliplatin-based regimen. Median RDI was 82.3%. Receipt of >70% RDI was associated with better 5-year OS (p < 0.001) and 3-year DFS (P = 0.009) than was receipt of ≤70% RDI, with 5-year OS rates of 66.3% and 50.5%, respectively and 3-year DFS rates of 66.1% and 52.7%, respectively. In the multivariable analysis of 5-year OS, oxaliplatin + 5-FU/LV (versus 5-FU/LV) (HR = 0.55; 95% CI = 0.34-0.91), >70% RDI at the first year (HR = 0.58; 95% CI = 0.37-0.89) and married status (HR = 0.66; 95% CI = 0.45-0.97) were associated with significantly decreased risk of death, while age ≥75 (versus 55-64) (HR = 2.06; 95% CI = 1.25-3.40), Charlson Comorbidity Index (HR = 1.17; 95% CI = 1.06-1.30), T4 tumor status (versus T1/T2) (HR = 5.88; 95% CI = 2.69-12.9), N2 node status (HR = 1.68; 95% CI = 1.12-2.50) and bowel obstruction (HR = 2.32, 95% CI = 1.36-3.95) were associated with significantly increased risk. Similar associations were observed for DFS. CONCLUSION: Patients with stage III colon cancer who received >70% RDI had improved 5-year OS. The association between RDI and survival needs to be examined in studies of adjuvant chemotherapy for colon cancer outside of the VA.

Potentially suboptimal prescribing for older veteran nursing home patients with dementia.

BACKGROUND: Nursing home patients with dementia may be more likely to suffer adverse drug events from suboptimal prescribing. Previous studies have not used national samples, nor have they examined multiple types of suboptimal prescribing by dementia severity. OBJECTIVE: To examine the prevalence of and factors associated with potentially suboptimal prescribing in older veteran nursing home patients with dementia. METHODS: This is a retrospective descriptive study of 1303 veterans 65 years or older admitted between January 1, 2004, and June 30, 2005, with dementia for long stays (90+ days) to 133 Veterans Affairs Community Living Centers. Dementia severity was determined by the Cognitive Performance Scale and functional status dependences. RESULTS: Overall, 70.2% with mild-moderate dementia (n = 1076) had underuse because they did not receive an acetylcholinesterase inhibitor (AChEI), and 27.2% had evidence of inappropriate use because of a drug-disease or drug-drug-disease interaction. Of the 227 with severe dementia, 36.1% had overuse by receiving an AChEI or lipid-lowering or other agents, and 25.1% had evidence of inappropriate use as a result of a drug-disease or drug-drug interaction. Multinomial logistic regression analyses among those with mild to moderate dementia identified that living in the South versus other regions was the single factor associated with all 3 types of suboptimal prescribing. In those with severe dementia, antipsychotic use was associated with all 3 suboptimal prescribing types. CONCLUSIONS: Potentially suboptimal prescribing was common in older veteran nursing home patients with dementia. Clinicians should develop a heightened awareness of these problems. Future studies should examine associations between potentially suboptimal prescribing and health outcomes in patients with dementia.

Survival outcomes in endometrial cancer patients are associated with CXCL12 and estrogen receptor expression.

CXCL12 is a chemotactic cytokine that has pro-metastatic functions in several malignancies through interactions with its receptor, CXCR4. CXCL12 is an estrogen-regulated gene, and notably, estrogen is a major risk factor for endometrial cancer (EC) development. As few studies examine concurrent CXCL12, CXCR4, and estrogen receptor (ER) expression in EC patients, we examined this pathway in 199 EC patients with data from the University of Pittsburgh Medical Center Cancer Registry. Immunohistochemistry (IHC) was used to detect CXCR4, CXCL12 and ER protein expression. As CXCR4 expression was positive in all cases, this investigation focused on associations between CXCL12 and ER expression, clinicopathologic factors and survival outcomes using chi-square tests, Kaplan-Meier graphs, and log-rank tests. CXCL12 expression was negative in 63 cases (32%) and positive in 136 cases (68%). Negative CXCL12 expression was borderline significantly associated with metastasis (χ(2) p = 0.07). ER expression was negative in 75 cases (38%) and positive in 124 cases (62%). Positive ER expression was significantly associated with low grade and early stage tumors (χ(2) p < 0.001). CXCL12 and ER were not significantly associated (χ(2) p = 0.11). Positive CXCL12 expression was associated with longer overall survival (OS) (log-rank p = 0.006) and longer recurrence-free survival (RFS) (log-rank p = 0.01) in ER negative patients, but not in ER positive patients. We identified a unique molecular signature associated with better OS and RFS in EC patients. In addition to pathological characteristics of the tumor, expression of CXCL12 and ER may be clinically useful for assigning adjuvant treatment to EC cases.

Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial.

BACKGROUND: Although practice guidelines recommend outpatient care for selected, haemodynamically stable patients with pulmonary embolism, most treatment is presently inpatient based. We aimed to assess non-inferiority of outpatient care compared with inpatient care. METHODS: We undertook an open-label, randomised non-inferiority trial at 19 emergency departments in Switzerland, France, Belgium, and the USA. We randomly assigned patients with acute, symptomatic pulmonary embolism and a low risk of death (pulmonary embolism severity index risk classes I or II) with a computer-generated randomisation sequence (blocks of 2-4) in a 1:1 ratio to initial outpatient (ie, discharged from hospital ≤24 h after randomisation) or inpatient treatment with subcutaneous enoxaparin (≥5 days) followed by oral anticoagulation (≥90 days). The primary outcome was symptomatic, recurrent venous thromboembolism within 90 days; safety outcomes included major bleeding within 14 or 90 days and mortality within 90 days. We used a non-inferiority margin of 4% for a difference between inpatient and outpatient groups. We included all enrolled patients in the primary analysis, excluding those lost to follow-up. This trial is registered with ClinicalTrials.gov, number NCT00425542. FINDINGS: Between February, 2007, and June, 2010, we enrolled 344 eligible patients. In the primary analysis, one (0·6%) of 171 outpatients developed recurrent venous thromboembolism within 90 days compared with none of 168 inpatients (95% upper confidence limit [UCL] 2·7%; p=0·011). Only one (0·6%) patient in each treatment group died within 90 days (95% UCL 2·1%; p=0·005), and two (1·2%) of 171 outpatients and no inpatients had major bleeding within 14 days (95% UCL 3·6%; p=0·031). By 90 days, three (1·8%) outpatients but no inpatients had developed major bleeding (95% UCL 4·5%; p=0·086). Mean length of stay was 0·5 days (SD 1·0) for outpatients and 3·9 days (SD 3·1) for inpatients. INTERPRETATION: In selected low-risk patients with pulmonary embolism, outpatient care can safely and effectively be used in place of inpatient care. FUNDING: Swiss National Science Foundation, Programme Hospitalier de Recherche Clinique, and the US National Heart, Lung, and Blood Institute. Sanofi-Aventis provided free drug supply in the participating European centres.

Impact of pharmacist-managed erythropoiesis-stimulating agents clinics for patients with non-dialysis-dependent CKD.

BACKGROUND: Erythropoiesis-stimulating agents (ESAs) are associated with serious adverse events, and maintaining hemoglobin levels within a narrow range can be difficult. We examined the quality of ESA prescribing and monitoring in pharmacist-managed ESA clinics versus usual care in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). STUDY DESIGN: Historical cohort. SETTING & PARTICIPANTS: Outpatients receiving ESAs for NDD-CKD at 10 Veterans Affairs Medical Centers with both pharmacist-managed ESA clinics (n = 314) and physician-based care (ie, usual care; n = 91) and 6 sites with usual care only (n = 167) on January 1, 2009, were followed up for 6 months. PREDICTOR: Type/site of care (ie, pharmacist-managed ESA clinic, usual care at ESA clinic site, usual-care site). OUTCOMES: Primary outcomes were proportion of hemoglobin values in the target range of 10-12 g/dL, ESA dose, and frequency of hemoglobin monitoring. Factors associated with hemoglobin values out of target range were identified using multinomial logistic regression. RESULTS: More hemoglobin values were in the target range in pharmacist-managed ESA clinics (71.1% vs 56.9% for usual-care sites; P < 0.001). The average 30-day dose of darbepoetin was 163 µg in pharmacist-managed ESA clinic patients versus 240 µg in usual-care site patients and 258 µg in usual-care patients at ESA clinic sites. For epoetin, corresponding average 30-day doses were 44,890 versus 47,141 and 57,436 IU. Veterans in pharmacist-managed ESA clinics had more hemoglobin measurements on average (5.8 vs 3.6 in usual-care sites and 3.8 in usual care at ESA clinic sites; P = 0.007). In the multinomial model, usual care was associated with hemoglobin levels out of target range, whereas heart failure and diabetes were associated with values in range. LIMITATIONS: We could not assess whether different hemoglobin targets were used by usual-care providers. CONCLUSIONS: Relative to usual care, pharmacist-managed clinics provided improved quality of ESA dosing and monitoring for patients with NDD-CKD.

Use of antipsychotics among older residents in VA nursing homes.

BACKGROUND: Antipsychotic medications are commonly prescribed to nursing home residents despite their well-established adverse event profiles. Because little is known about their use in Veterans Affairs (VA) nursing homes [ie, Community Living Centers (CLCs)], we assessed the prevalence and risk factors for antipsychotic use in older residents of VA CLCs. METHODS: This cross-sectional study included 3692 Veterans age 65 or older who were admitted between January 2004 and June 2005 to one of 133 VA CLCs and had a stay of ≥90 days. We used VA Pharmacy Benefits Management data to examine antipsychotic use and VA Medical SAS datasets and the Minimum Data Set to identify evidence-based indications for antipsychotic use (eg, schizophrenia, dementia with psychosis). We used multivariable logistic regression and generalized estimating equations to identify factors independently associated with antipsychotic receipt. RESULTS: Overall, 948/3692(25.7%) residents received an antipsychotic, of which 59.3% had an evidence-based indication for use. Residents with aggressive behavior [odds ratio (OR)=2.74, 95% confidence interval (CI), 2.04-3.67] and polypharmacy (9+ drugs; OR=1.84, 95% CI, 1.41-2.40) were more likely to receive antipsychotics, as were users of antidepressants (OR=1.37, 95% CI, 1.14-1.66), anxiolytic/hypnotics (OR=2.30, 95% CI, 1.64-3.23), or drugs for dementia (OR=1.52, 95% CI, 1.21-1.92). Those residing in Alzheimer/dementia special care units were also more likely to receive an antipsychotic (OR=1.66, 95% CI, 1.26-2.21). Veterans with dementia but no documented psychosis were as likely as those with an evidence-based indication to receive an antipsychotic (OR=1.10, 95% CI, 0.82-1.47). CONCLUSIONS: Antipsychotic use is common among VA nursing home residents aged 65 and older, including those without a documented evidence-based indication for use. Further quality improvement efforts are needed to reduce potentially inappropriate antipsychotic prescribing.

Group-based trajectory modeling of caregiver psychological distress over time.

BACKGROUND: Competing theories of adaptation and wear-and-tear describe psychological distress patterns among family caregivers. PURPOSE: This study seeks to characterize psychological distress patterns in family caregivers and identify predictors. METHODS: One hundred three caregivers of care recipients with primary malignant brain tumors were interviewed within 1, 4, 8, and 12 months post-diagnosis regarding psychological distress; care recipients were interviewed regarding clinical/functional characteristics. Group-based trajectory modeling identified longitudinal distress patterns, and weighted logistic/multinomial regression models identified predictors of distress trajectories. RESULTS: Group-based trajectory modeling identified high-decreasing (51.1 % of caregivers) and consistently low (48.9 %) depressive symptom trajectories, high-decreasing (75.5 %) and low-decreasing (24.5 %) anxiety trajectories, and high (37.5 %), moderate (40.9 %), and low-decreasing (21.6 %) caregiver burden trajectories. High depressive symptoms were associated with high trajectories for both anxiety and burden, lower caregivers age, income, and social support, and lower care recipient functioning. CONCLUSIONS: Our data support the adaptation hypothesis; interventions should target those at risk for persistent distress.

Ambient air pollution exposure and blood pressure changes during pregnancy.

BACKGROUND: Maternal exposure to ambient air pollution has been associated with adverse birth outcomes such as preterm delivery. However, only one study to date has linked air pollution to blood pressure changes during pregnancy, a period of dramatic cardiovascular function changes. OBJECTIVES: We examined whether maternal exposures to criteria air pollutants, including particles of less than 10 µm (PM(10)) or 2.5 µm diameter (PM(2.5)), carbon monoxide (CO), nitrogen dioxide (NO(2)), sulfur dioxide (SO(2)), and ozone (O(3)), in each trimester of pregnancy are associated with magnitude of rise of blood pressure between the first 20 weeks of gestation and late pregnancy in a prospectively followed cohort of 1684 pregnant women in Allegheny County, PA. METHODS: Air pollution measures for maternal ZIP code areas were derived using Kriging interpolation. Using logistic regression analysis, we evaluated the associations between air pollution exposures and blood pressure changes between the first 20 weeks of gestation and late pregnancy. RESULTS: First trimester PM(10) and ozone exposures were associated with blood pressure changes between the first 20 weeks of gestation and late pregnancy, most strongly in non-smokers. Per interquartile increases in first trimester PM(10) and O(3) concentrations were associated with mean increases in systolic blood pressure of 1.88 mm Hg (95% CI=0.84 to 2.93) and 1.84 (95% CI=1.05 to 4.63), respectively, and in diastolic blood pressure of 0.63 mm Hg (95% CI=-0.50 to 1.76) and 1.13 (95% CI=-0.46 to 2.71) in non-smokers. CONCLUSIONS: Our novel finding suggests that first trimester PM(10) and O(3) air pollution exposures increase blood pressure in the later stages of pregnancy. These changes may play a role in mediating the relationships between air pollution and adverse birth outcomes.

Body mass index and health status in the Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial (BARI 2D).

BACKGROUND: The longitudinal association between obesity, weight variability, and health status outcomes is important for patients with coronary disease and diabetes. METHODS: The BARI 2D was a multicenter randomized clinical trial designed to evaluate treatment strategies for patients with both documented stable ischemic heart disease and type 2 diabetes. We examined BARI 2D participants for 4 years to study how body mass index (BMI) was associated with health status outcomes. Health status was evaluated by the Duke Activity Status Index (DASI), RAND Energy/fatigue, Health Distress, and Self-rated Health. Body mass index was measured quarterly throughout follow-up years, and health status was assessed at each annual follow-up visit. Variation in BMI measures was separated into between-person and within-person change in longitudinal analysis. RESULTS: Higher mean BMI during follow-up years (the between-person BMI) was associated with poorer health status outcomes. Decreasing BMI (the within-person BMI change) was associated with better Self-rated health. The relationships between BMI variability and DASI or Energy appeared to be curvilinear and differed by baseline obesity status. Decreasing BMI was associated with better outcomes if patients were obese at baseline but was associated with poorer DASI and Energy outcomes if patients were nonobese at baseline. CONCLUSIONS: For patients with stable ischemic heart disease and diabetes, weight gain was associated with poorer health status outcomes, independent of obesity-related comorbidities. Weight reduction is associated with better functional capacity and perceived energy for obese patients but not for nonobese patients at baseline.

Comparison of survival outcomes between patients with malignant mixed mullerian tumors and high-grade endometrioid, clear cell, and papillary serous endometrial cancers.

INTRODUCTION: Malignant mixed mullerian tumors (MMMTs) are an aggressive subtype of endometrial cancer (EC). Previous studies compare survival between high-grade endometrioid (EM), clear cell (CC), and papillary serous (PS) ECs; yet few studies compare MMMTs to these aggressive subtypes. The goal of this study was to compare recurrence-free survival (RFS), disease-specific survival (DSS), and overall survival (OS) among EC subtypes. METHODS: We conducted a retrospective cohort study of EC cases treated at Magee-Women's Hospital between 1996 and 2008. Kaplan-Meier estimates of RFS, DSS, and OS as well as and log-rank tests were used to compare survival distributions between histologic subtypes. Cox regression was used to estimate hazard ratios for histologic subtypes, adjusted for other significant prognostic factors. Interactions between histologic subtype and prognostic factors were examined to assess effect modification. RESULTS: This cohort included 81 MMMT (15%), 254 high-grade EM (46%), 73 CC (13%), and 147 PS (26%) cases. Compared to high-grade EM (6%) and CC (7%) cases, relatively more MMMT (12%) and PS (12%) cases were nonwhite. Stage differed significantly among the subtypes, with 36%, 34%, 37%, and 51% of MMMT, high-grade EM, CC, and PS cases, respectively, diagnosed at advanced late stage (P<0.001). Kaplan-Meier curves and log-rank tests showed similar RFS, DSS, and OS between MMMT, high-grade EM, CC, and PS cases stratified by stage. In adjusted Cox regression models, RFS and DSS were not significantly different between MMMT and other subtypes. High-grade EM cases had a significantly better OS compared to MMMT cases (HR, 0.63; 95% confidence interval [CI], 0.41-0.98). CONCLUSIONS: This is the first retrospective study to suggest that certain survival outcomes are similar among MMMT, high-grade EM, CC, and PS subtypes. Other large-scale studies are needed to confirm these findings.

Personal digital assistant-based self-monitoring adherence rates in 2 dialysis dietary intervention pilot studies: BalanceWise-HD and BalanceWise-PD.

OBJECTIVE: The dialysis dietary regimen is complicated, and computer-based dietary self-monitoring may be useful for helping dialysis patients manage their dietary regimen. In this report, we describe dietary self-monitoring rates among study participants randomized to the intervention arms of 2 pilot studies. METHODS: Both studies tested similar interventions involving dietary counseling paired with personal digital assistant-based self-monitoring. One study was performed in hemodialysis (HD) and one in peritoneal dialysis (PD) patients. RESULTS: HD intervention participants entered an average of 244.9 meals (median = 288; interquartile range [IQR]: 186 to 342) over the 16-week intervention, 2.2 meals per day (median = 2.6; IQR: 1.7 to 3.1), and 73% of expected meals (median = 86; IQR: 55 to 102), assuming intake of 3 meals per day. At least some meals were entered in 87% of the observed weeks (median = 100%; IQR: 81 to 100). PD intervention participants entered an average of 212.1 meals (median = 203; IQR: 110 to 312) over the 16-week intervention, 1.9 meals per day (median = 1.8; IQR: 1 to 2.8), and 63% of expected meals (median = 60; IQR: 33 to 93), assuming 3 meals per day. At least some meals were entered in 80% of the observed weeks (median = 94; IQR: 50 to 100). CONCLUSION: These HD and PD patients demonstrated excellent rates of self-monitoring. Additional research with a larger sample is required to confirm these findings.

MicroRNA-137 promoter methylation in oral rinses from patients with squamous cell carcinoma of the head and neck is associated with gender and body mass index.

Head and neck cancer represents 3.3% of all new malignancies and 2.0% of cancer deaths in the USA, the majority of which are squamous in origin. The overall 5 year survival is 60% and worsens with increasing stage at diagnosis. Thus, novel biomarkers for early detection of squamous cell carcinoma of the head and neck (SCCHN) are needed. MicroRNA-137 (miR-137) plays a role in cell cycle control and seems to undergo promoter methylation in oral squamous cell carcinoma tissue. The main objectives of this study were to ascertain whether miR-137 promoter methylation is detectable in oral rinse samples, assess its association with SCCHN and identify potential risk factors for its occurrence. Oral rinse samples were collected from 99 SCCHN patients with no prior history of cancer and 99 cancer-free controls, frequency matched on gender; tumor tissue for 64 patients was also tested. Methylation of the miR-137 promoter, assessed using methylation-specific polymerase chain reaction, was detected in 21.2% oral rinses from SCCHN patients and 3.0% from controls [odds ratio (OR) = 4.80, 95% confidence interval (CI): 1.23-18.82]. Among cases, promoter methylation of miR-137 was associated with female gender (OR = 5.30, 95% CI: 1.20-23.44) and inversely associated with body mass index (BMI) (OR = 0.88, 95% CI: 0.77-0.99). Promoter methylation of miR-137 appears to be a relatively frequently detected event in oral rinse of SCCHN patients and may have future utility as a biomarker in DNA methylation panels. The observed associations with gender and BMI help to shed light on potential risk factors for an altered methylation state in SCCHN.

Differential effects of post-dilation after stent deployment in patients presenting with and without acute myocardial infarction.

BACKGROUND: In the practice of percutaneous coronary intervention, post-dilation often is performed after stent deployment to improve stent expansion. However, aggressive mechanical expansion is a risk factor of distal embolization and microvascular injury, especially for patients with acute myocardial infarction (AMI). Few studies have investigated the effects of post-dilation on medium-term clinical outcomes. METHODS AND RESULTS: Patients enrolled in the multicenter NHLBI Dynamic Registry between 2001 and 2006 were evaluated. Patients who were treated with ≥ 1 stent were studied. Patients with cardiogenic shock or history of coronary artery bypass graft surgery were excluded. Patients were followed up to 1 year. Because of the significant statistical interaction (P = .02) between post-dilation and AMI status on the hazard of death/myocardial infarction (MI), post-dilation effects were estimated separately for patients who did and did not present with an AMI. Among the 1,358 patients who presented with an AMI, post-dilation was associated with a significantly higher risk of death/MI (hazard ratio [HR] = 1.78, 95% CI 1.12-2.83, P = .01), not associated with the risk of repeat revascularization (HR = 1.15, 95% CI 0.81-1.62, P = .43). Among the 3,001 patients who did not present with AMI, post-dilation was not associated with risks of death/MI (HR = 1.08, 95% CI 0.77-1.50, P = .67) or repeat revascularization (HR = 1.17, 95% CI 0.93-1.47, P = .19). Similar effects were observed for the restricted analysis with additional adjustment for lesion characteristics among the 1,039 AMI patients and 2,179 non-AMI patients with a single lesion treated. CONCLUSIONS: Stent post-dilation is associated with an increased risk of death/MI in AMI patients but not in non-AMI patients. Further investigation is warranted.

Factors associated with Type I and Type II endometrial cancer.

OBJECTIVE: We investigated risk factors for Type II (n = 176) vs. Type I (n = 1,576) endometrial cancer (EC) in cases treated at Magee-Womens Hospital between 1996 and 2008. METHODS: Clinical data were available from the University of Pittsburgh Medical Center (UPMC) Network Cancer Registry. Logistic regression was used to estimate the adjusted odds of having Type II EC vs. Type I EC. Risk factors of interest in this analysis were age, race, body mass index (BMI), year of diagnosis, parity, menopausal status, and history of additional primary tumors. RESULTS: Relative to women with Type I EC, women with Type II EC were more likely to be older at diagnosis (OR: 1.03 per 1 year increase in age, 95% CI 1.01-1.05), of non-white race (OR: 2.95, 95% CI 1.66-5.27), have a history of additional primary tumors (OR: 1.56, 95% CI 1.05-2.32), and less likely to be obese (OR: 0.45, 95% CI 0.29-0.70). CONCLUSION: In this large retrospective cohort of patients with EC, the striking difference in risk factors associated with Type II vs. Type I tumors suggests that these subtypes represent different disease entities that require different treatment modalities. Currently, Type II cases have a significantly worse prognosis compared to Type I. Further characterization of risk factors associated with developing Type II tumors is needed to prevent this aggressive malignancy.

Provision of potentially teratogenic medications to female veterans of childbearing age.

BACKGROUND: Certain medications increase the risk of birth defects whether used during pregnancy or immediately preconception. OBJECTIVES: To describe dispensing of potentially teratogenic medications (Food and Drug Administration classes D or X) to female Veterans treated by the Veterans Affairs (VA) Healthcare System, and assess whether documented provision of family planning services is more common when potentially teratogenic medications are prescribed. RESEARCH DESIGN: We examined all 2,634,441 prescriptions filled in fiscal year 2007 or 2008 by 78,232 female Veterans, aged 18 to 45, who made >or=2 visits to VA clinics within the year prior to medication dispensing from VA pharmacies. MEASURES: : Medications dispensed, contraceptive counseling, and pregnancy testing. RESULTS: Prescriptions for potentially teratogenic medications were filled by 48.8% of female Veterans who received medications from a VA pharmacy. Women who filled prescriptions for potentially teratogenic medications were only slightly more likely to have documented family planning services (eg, contraception, contraceptive counseling, or pregnancy testing) than women who filled class C, but not class D or X, prescriptions (55.7% vs. 51.8%). Women filling only class A or B prescriptions were least likely to have documented family planning services (35.9%). Among women dispensed potentially teratogenic medications, family planning services were significantly more likely to be documented for women who were >or=25 years (odds ratio [OR], 2.82; 95% confidence interval [CI], 2.57-3.11), unmarried (OR, 1.30; 95% CI, 1.23-1.35), non-White (OR, 1.17; 95% CI, 1.09-1.26), seen at a women's clinic (OR, 1.96; 95% CI, 1.88-2.05), received a retinoid medication (OR, 7.72; 95% CI, 3.02-19.7), or had serious mental illness (OR, 1.26; 95% CI, 1.18-1.34). CONCLUSIONS: Medications that may cause birth defects if used during pregnancy are dispensed frequently to female Veterans by VA pharmacies without documented receipt of contraceptive counseling or pregnancy testing.