Search

BACKGROUND: The poor prognosis of esophageal adenocarcinoma (EAC) has focused efforts on early detection by serial endoscopic surveillance of Barrett’s esophagus (BE). Previously, we reported that receipt of endoscopy before EAC diagnosis was associated with improved survival. AIM: We aimed to refine our previous analysis, assessing surveillance as measured by performance of serial endoscopy before EAC diagnosis and evaluating its association with stage and survival. METHODS: A retrospective cohort study was performed using the Surveillance, Epidemiology and End Results (SEER)-Medicare database. Patients aged ≥ 70 years with EAC diagnosed 1998–2009 were identified. Diagnosis with BE and receipt of ≥ 2 upper endoscopic procedures within 5 years before cancer diagnosis were identified. We compared a reference group not receiving serial endoscopy to 3 patterns based on ≥ 2 endoscopy dates relative to a timepoint 2 years before cancer diagnosis: “remote,” “recent,” and “sustained.” RESULTS: Among 5,532 patients, 28% (n=1,575) had localized stage. Thirteen percent (n=703) received ≥ 2 endoscopic procedures before cancer diagnosis: 224, 298, and 181 in the “recent,” “remote,” and “sustained” groups. Serial endoscopy and prior BE were associated with localized stage (“sustained” group OR 2.95, 95% confidence interval [CI] 2.07, 4.19; prior BE OR 2.68, 95% CI 2.03, 3.56). Serial endoscopy was associated with improved survival even with adjustment for lead time bias (“sustained” group HR 0.45, 95% CI 0.37, 0.55) and length time bias. CONCLUSIONS: Sustained endoscopy was associated with earlier stage and improved survival. These results support the role of sustained surveillance in early detection of EAC.

BACKGROUND People with HIV (PWH) are at an increased risk of both heart and kidney disease, but the relationship between kidney disease and cardiac structure and function in this population has not been well studied. In particular, whether the relationship between kidney disease and cardiac structure and function is stronger for PWH compared with uninfected controls is unknown. METHODS One hundred PWH on antiretroviral therapy were compared with 100 age-matched and sex-matched controls without HIV in Uganda. Multivariable regression models were used to examine associations between creatinine-based and cystatin C-based estimated glomerular filtration rate (eGFR), albumin-creatinine ratio, and echocardiographic measures of cardiac structure and function. RESULTS PWH had lower eGFRcr (β -7.486, 95% confidence interval: -13.868 to -1.104, P = 0.022) and a higher rate of albumin-creatinine ratio ≥30 (odds ratio 2.146, 95% confidence interval: 1.027 to 4.484, P = 0.042) after adjustment for traditional risk factors. eGFR was inversely associated with both left ventricular mass index and diastolic dysfunction in adjusted models but not with systolic function. Albuminuria was associated with more diastolic dysfunction among PWH but not controls (P for interaction = 0.046). The association of HIV with a higher left ventricular mass index (P = 0.005) was not substantially affected by adjusting for eGFRcr. CONCLUSION Among Ugandans, eGFR is associated with elevated LV mass and diastolic dysfunction. The association between albuminuria and diastolic dysfunction is particularly strong for PWH.

To develop and assess the reliability of a measure of primary care using items from the Medical Expenditure Panel Survey (MEPS), a US representative survey of community-dwelling persons.On the basis of the domains from the literature on primary care characteristics, we identified relevant items within the 2013-2014 MEPS family of surveys. In a sample of primary survey respondents with at least 1 office-based physician visit in the last 12 months, we conducted exploratory factor analysis, retaining items with a factor loading of 0.30 and factors ≥3 items. Using a hold-out sample, internal consistency, reproducibility, and confirmatory factor analyses were performed.On the basis of 16 care domains, we found 32 candidate items in the MEPS. Factor analyses of data from 4549 persons meeting inclusion criteria (27.6% of the total sample), yielded 3 unique factors involving 24 items. We named these subscales Relationship, Comprehensiveness, and Health Promotion, displaying internal consistency reliability of 0.86, 0.78, and 0.69, respectively. Confirmatory factor analysis corroborated the stability of the exploratory findings in the hold out sample. Sensitivity analyses showed robustness to differences in underlying correlation structure, alternative approach to missing data, and extension to indirect survey respondents.The MEPS Primary Care measure with 3 subscales is reliable and may be useful in conducting primary care health services and outcomes research in the rich MEPS dataset. Further validation is needed, and is described in a companion paper.

Background: Clinical trials are a critical source of evidence for oncology care, yet very few patients participate. Among healthcare providers, nurses spend the most time with cancer patients and are the most highly trusted professionals. We developed and evaluated an educational program for oncology nurses targeting knowledge, attitudes, self-efficacy and perceived norms to facilitate discussion about clinical trials and support patient decision making. Methods: A nationwide sample of oncology nurses were randomly assigned to receive general clinical trials education delivered as text (attention control) vs. tailored video vignettes (intervention) in a web-based continuing education program. Participants completed a baseline assessment and follow up assessments immediately after the educational program and three months later. The primary outcome was intention to discuss clinical trials with patients. Secondary outcomes were knowledge and attitudes about clinical trials, self-efficacy, and perceived norms. Results: 1393 nurses enrolled and completed the educational program and post-intervention assessment (720 control, 673 video). Both text education and tailored video education increased intention to discuss clinical trials with patients, with a greater effect in the video group (p

BACKGROUND Behavioral intervention studies in older breast cancer survivors, particularly older African American (AA) and socioeconomic status-disadvantaged breast cancer survivors, are lacking. To inform future studies, the authors examined recruitment strategies in older breast cancer survivors who participated in an exercise intervention study. METHODS IMPROVE is a randomized trial designed to evaluate a group-based exercise intervention versus a support group (ClinicalTrials.gov identifier, NCT02763228). Participants were aged ≥65 years who had survived stage I through III breast cancer and were within 5 years of treatment completion. Participants were recruited through multiple approaches, including peripheral, linguistic, and constituent-involving strategies that incorporated the identification of potentially eligible patients from 3 local hospitals and from State of Ohio registries and through direct clinician and community organization referrals. RESULTS Between October 2016 and November 2019, 7487 patients were screened, 4790 were potentially eligible, and 213 were randomized into the study. The eligible:randomization rates were 4.4% overall and 84%, 8%, and 2% for recruitment using direct referrals, hospital registries, and state registries, respectively. The median age of the randomized cohort was 70 years (range, 65-88 years) and included 44% AA and 44% socioeconomic status-disadvantaged breast cancer survivors. Compared with all registry-eligible patients, directly referred-eligible patients were more likely to be AA versus Non-Hispanic White (41% vs 19%; P = .006), to be contacted successfully (100% vs 33%; P < .0001), and to accept study participation (88% vs 16%; P < .0001). CONCLUSIONS Direct referrals appeared to be the most efficient strategy for recruiting AA survivors. Behavioral intervention studies seeking to target older AA and socioeconomic status-disadvantaged breast cancer survivors should include strategies that foster direct referrals to study participation.

Background Inflammation has been associated with whole heart coronary artery calcification (CAC) among people with HIV (PWH) on antiretroviral therapy (ART); however, prior studies have not evaluated the distribution of calcium or separated mass versus volume scores, which are differentially associated with clinical events in the general population. Statins may also have a greater effect on CAC mass compared with volume. Methods 147 PWH were randomized 1:1 to rosuvastatin 10 mg or placebo and followed for 96 weeks. We re-analysed coronary calcium scans from 0, 48 and 96 weeks to determine mass and volume scores and measures of CAC diffusivity. Mixed effects models and generalized estimating equations were used to examine longitudinal associations of CAC with treatment and biomarkers. Results Median age at study entry was 46 years; 78% were male and 68% African American. Median CD4+ was 613 and half were on protease inhibitors. Randomization to statin therapy was not associated with a change in mass score, volume score, number of involved vessels or diffusivity index (all P>0.1). Soluble CD14 was associated with the presence of CAC ( P=0.05) and borderline associated with number of involved vessels ( P=0.07) across all three time points. Conclusions In PWH on ART, moderate intensity rosuvastatin does not appear to have a significant effect on volume, mass or regional distribution of CAC over 96 weeks. We extend previous cross-sectional observations to show that soluble CD14 is associated with whole heart CAC over time and independently of age and systolic blood pressure.

Objective To examine racial differences in physical performance among older women with newly diagnosed non-metastatic breast cancer and identify clinical, behavioral and biological factors that might contribute to such disparities. Methods This is a cross-sectional study of women aged ≥65 years with newly diagnosed stage I–III breast cancer recruited from ambulatory oncology clinics at an academic center, between September 2010 and August 2015. Participants completed a Comprehensive Geriatric Assessment and laboratory testing for biomarkers of inflammation [interleukin-6 (IL6)] prior to receiving systemic treatment for cancer. The primary outcome was poor physical performance, defined as scoring ≤7 on the Short Physical Performance Battery, Yes or No. Logistic regression analyses were undertaken. Results Among 135 women with mean age of 74.8 years (SD = 6.9), 31% were African-American (AA), and 33% had poor physical performance. Controlling for age, education, comorbidities and geriatric syndromes, participants with poor physical performance were more likely to be AA [versus (vs.) Non-Hispanic Whites (NHW)], odds ratio (OR) = 3.10, 95% confidence interval (CI) = 1.18–8.15. Controlling further for physical activity (PA) attenuated the racial disparity in physical performance (OR = 2.50, CI = 0.91–6.84). Lastly, controlling for IL6 further diminished the racial disparity in physical performance (OR = 1.93, CI = 0.67–5.56). In adjusted models, PA and IL6 explained 29% and 38%, respectively, of the racial disparity in poor physical performance. Conclusion Among older women with newly diagnosed non-metastatic breast cancer, poor physical performance was prevalent and AA were disproportionately affected. Less engagement in physical activity and subclinical inflammation partly contributed to this disparity.

Many longitudinal studies observe time to occurrence of a clinical event such as death, while also collecting serial measurements of one or more biomarkers that are predictive of the event, or are surrogate outcomes of interest. Joint modeling can be used to examine the relationship between the biomarker and the event, and also as a way of adjusting analyses of the biomarker for non-ignorable dropout. In settings such as registry studies, an additional complexity is caused when follow-up of subjects is delayed, referred to as left-truncation of follow-up in the survival analysis setting. If not adjusted for, this can cause bias in estimation of parameters of the survival distribution for the clinical event and in parameters of the longitudinal outcome such as the profile or rate of change over time because subjects may die or have the clinical event before follow-up starts. This paper illustrates how a broad class of shared parameter models can be used to jointly model a time to event outcome along with a longitudinal marker using available nonlinear mixed modeling software, when follow-up times are left truncated. Methods are applied to jointly model survival and decline in lung function in cystic fibrosis patients.

BACKGROUND As an organized screening program, the national Breast and Cervical Cancer Early Detection Program (BCCEDP) was launched in the early 1990s to improve breast cancer outcomes among underserved women. To analyze the impact of the BCCEDP on breast cancer outcomes in Ohio, this study compared cancer stages and mortality across BCCEDP participants, Medicaid beneficiaries, and “all others.” METHODS This study linked data across the Ohio Cancer Incidence Surveillance System, Medicaid, the BCCEDP database, death certificates, and the US Census and identified 26,426 women aged 40 to 64 years who had been diagnosed with incident invasive breast cancer during the years 2002-2008 (deaths through 2010). The study groups were as follows: BCCEDP participants (1-time or repeat users), Medicaid beneficiaries (women enrolled in Medicaid before their cancer diagnosis [Medicaid/prediagnosis] or around the time of their cancer diagnosis [Medicaid/peridiagnosis]), and all others (women identified as neither BCCEDP participants nor Medicaid beneficiaries). The outcomes included advanced-stage cancer at diagnosis and mortality. A multivariable logistic and survival analysis was conducted to examine the independent association between the BCCEDP and Medicaid status and the outcomes. RESULTS The percentage of women presenting with advanced-stage disease was highest among women in the Medicaid/peridiagnosis group (63.4%) and lowest among BCCEDP repeat users (38.6%). With adjustments for potential confounders and even in comparison with Medicaid/prediagnosis beneficiaries, those in the Medicaid/peridiagnosis group were twice as likely to be diagnosed with advanced-stage disease (adjusted odds ratio, 2.20; 95% confidence interval, 1.83-2.66). CONCLUSIONS Medicaid/peridiagnosis women are at particularly high risk to be diagnosed with advanced-stage disease. Efforts to reduce breast cancer disparities must target this group of women before they present to Medicaid. Cancer 2017. © 2017 American Cancer Society.

BACKGROUND Out-of-pocket expenditures are thought to be an important barrier to the receipt of cancer preventive services, especially for those of a lower socioeconomic status (SES). The Affordable Care Act (ACA) eliminated out-of-pocket expenditures for recommended services, including mammography and colonoscopy. The objective of this study was to determine changes in the uptake of mammography and colonoscopy among fee-for-service Medicare beneficiaries before and after ACA implementation. METHODS Using Medicare claims data, this study identified women who were 70 years old or older and had not undergone mammography in the previous 2 years and men and women who were 70 years old or older, were at increased risk for colorectal cancer, and had not undergone colonoscopy in the past 5 years. The receipt of procedures in the 2-year period before the ACA's implementation (2009-2010) and after its implementation (2011 to September 2012) was also identified. Multivariate generalized estimating equation models were used to determine the independent association and county-level quartile of median income and education with the receipt of testing. RESULTS For mammography, a lower SES quartile was associated with less uptake, but the post-ACA disparities were smaller than those in the pre-ACA period. In addition, mammography rates increased from the pre-ACA period to the post-ACA period in all SES quartiles. For colonoscopy, in both the pre- and post-ACA periods, there was an association between uptake and educational level and, to some extent, income. However, there were no appreciable changes in colonoscopy and SES after implementation of the ACA. CONCLUSIONS The removal of out-of-pocket expenditures may overcome a barrier to the receipt of recommended preventive services, but for colonoscopy, other procedural factors may remain as deterrents. Cancer 2017;123:1585–1589. © 2017 American Cancer Society.

BACKGROUND The purpose of this study was to determine the ability of the Vulnerable Elders Survey (VES-13) to predict the composite outcome of functional decline and death within 12 months of breast cancer treatment among women 65 years old or older with newly diagnosed stage I to III breast cancer. METHODS Two hundred and six participants were recruited from ambulatory oncology clinics at an academic center between April 2008 and April 2013. Participants competed the VES-13 at baseline just before neoadjuvant/adjuvant treatment. The primary outcome, functional decline/death, was defined as either a decrease of at least 1 point on the Activities of Daily Living scale and/or the Instrumental Activities of Daily Living scale or death between baseline and 12 months (yes or no). RESULTS One hundred and eighty four participants (89%) completed 12 months of follow-up. Twenty-two percent functionally declined (n = 34) or died (n = 7). Univariately, with increasing VES-13 scores, the estimated risk of functional decline/death rose from 23% for participants with a VES-13 score of 3 to 76% for participants with a VES-13 score of 10. In multivariate logistic regression analysis, VES-13 scores (adjusted odds ratio, 1.37; 95% confidence interval, 1.18-1.57) and having a high school education or less (adjusted odds ratio, 2.47; 95% confidence interval, 1.08-5.65) were independent predictors of functional decline/death (area under the receiver operator curve, 0.79). CONCLUSIONS Among older women with newly diagnosed nonmetastatic breast cancer, approximately 1 in 5 functionally declined and/or died within 12 months of breast cancer treatment initiation. Women with high school education or less were disproportionately affected. The VES-13 is a useful instrument for the early identification of those at risk for functional decline and/or death. Cancer 2016;122:2579–86. © 2016 American Cancer Society.

Purpose To investigate the effect of live and recorded perioperative music therapy on anesthesia requirements, anxiety levels, recovery time, and patient satisfaction in women experiencing surgery for diagnosis or treatment of breast cancer. Patients and Methods Between 2012 and 2014, 207 female patients undergoing surgery for potential or known breast cancer were randomly assigned to receive either patient-selected live music (LM) preoperatively with therapist-selected recorded music intraoperatively (n = 69), patient-selected recorded music (RM) preoperatively with therapist-selected recorded music intraoperatively (n = 70), or usual care (UC) preoperatively with noise-blocking earmuffs intraoperatively (n = 68). Results The LM and the RM groups did not differ significantly from the UC group in the amount of propofol required to reach moderate sedation. Compared with the UC group, both the LM and the RM groups had greater reductions (P < .001) in anxiety scores preoperatively (mean changes [and standard deviation: −30.9 [36.3], −26.8 [29.3], and 0.0 [22.7]), respectively. The LM and RM groups did not differ from the UC group with respect to recovery time; however, the LM group had a shorter recovery time compared with the RM group (a difference of 12.4 minutes; 95% CI, 2.2 to 22.5; P = .018). Satisfaction scores for the LM and RM groups did not differ from those of the UC group. Conclusion Including music therapy as a complementary modality with cancer surgery may help manage preoperative anxiety in a way that is safe, effective, time-efficient, and enjoyable.

Treated human immunodeficiency virus (HIV) infection is characterized by ectopic fat deposition, a persistent inflammatory state, and increased cardiometabolic risk. In this secondary analysis of a placebo controlled trial of rosuvastatin among 147 HIV+ subjects (median age 46; 78% men) on stable antiretroviral therapy, we aimed to evaluate longitudinal associations between computed tomography (CT) measures of pericardial fat (PCF) volume and density, insulin resistance, and inflammation. We measured PCF volume and density (mean attenuation in Hounsfield units) by noncontrast gated CT at baseline and week 96. Homeostatic model of insulin resistance was calculated from fasting insulin and glucose at entry, 24, 48, and 96 weeks. At baseline, insulin resistance correlated positively with PCF volume and negatively with density. Similarly divergent correlations of volume and density were observed with waist:hip ratio, nadir CD4+ count, and duration of antiretroviral therapy. In a linear mixed model, PCF density was associated with insulin resistance independent of PCF volume, body mass index, metabolic syndrome, and biomarkers of immune activation and systemic inflammation; however, baseline PCF measures were not associated with longitudinal changes in insulin resistance. Soluble CD163, a marker of monocyte activation, positively correlated with PCF volume and was associated with insulin resistance in linear models. Statin treatment assignment did not affect PCF volume or density change (both p > 0.8). In conclusion, the quantity and quality (i.e., radiodensity) of PCF are differentially related to insulin resistance and inflammation in patients with treated HIV infection.

Purpose To develop and evaluate an examination consisting of magnetic resonance (MR) fingerprinting-based T1, T2, and standard apparent diffusion coefficient (ADC) mapping for multiparametric characterization of prostate disease. Materials and Methods This institutional review board-approved, HIPAA-compliant retrospective study of prospectively collected data included 140 patients suspected of having prostate cancer. T1 and T2 mapping was performed with fast imaging with steady-state precession-based MR fingerprinting with ADC mapping. Regions of interest were drawn by two independent readers in peripheral zone lesions and normal-appearing peripheral zone (NPZ) tissue identified on clinical images. T1, T2, and ADC were recorded for each region. Histopathologic correlation was based on systematic transrectal biopsy or cognitively targeted biopsy results, if available. Generalized estimating equations logistic regression was used to assess T1, T2, and ADC in the differentiation of (a) cancer versus NPZ, (b) cancer versus prostatitis, (c) prostatitis versus NPZ, and (d) high- or intermediate-grade tumors versus low-grade tumors. Analysis was performed for all lesions and repeated in a targeted biopsy subset. Discriminating ability was evaluated by using the area under the receiver operating characteristic curve (AUC). Results In this study, 109 lesions were analyzed, including 39 with cognitively targeted sampling. T1, T2, and ADC from cancer (mean, 1628 msec ± 344, 73 msec ± 27, and 0.773 × 10

Background Obesity is a leading risk factor for endometrial cancer (EC), particularly Type I forms, which are increasing in the U.S. Although death rates from most cancers have been decreasing, overall mortality in EC is increasing in the U.S. EC survivors' poor fitness combined with their surgical treatments may make weight loss particularly challenging. High intensity exercise increases neurotrophins and neurological reward via altered striatal dopamine in animals, and, in humans, chronic high intensity exercise enhances meal-induced satiety and may reduce hedonic eating. “Assisted” exercise, a mode of exercise whereby a patient's voluntary exercise rate is augmented mechanically, may modulate brain dopamine levels in Parkinson's Disease patients but has not been previously evaluated as a treatment for obesity. Methods We describe the rationale and design of the REWARD trial, which has the overarching goal of randomizing 120 obese EC survivors to “assisted” or voluntary rate cycling to evaluate the efficacy of “assisted” exercise in enhancing and sustaining weight loss. Patients in both arms will receive 3 days/week of supervised exercise and 1 day/week of a group dietary behavioral intervention for 16 weeks and, then, will be followed for 6 months. Outcomes The primary outcome is weight loss. Secondary outcomes include measures for body composition, fitness, eating behavior, exercise motivation and, quality of life as well as cognition and food reward and motivation as assessed by functional magnetic resonance imaging (fMRI) tasks. Conclusions If successful, the REWARD program could be extended to help sustain weight loss in obese cancer and non-cancer patients.

The objective of this study was to demonstrate the feasibility of improving perceived acoustic comfort for a standard clinical magnetic resonance imaging protocol via gradient wave form optimization and validate parallel imaging as a means to achieve a further reduction of acoustic noise.The gradient wave forms of a standard T2 axial turbo spin-echo (TSE) sequence in head examinations were modified for acoustic performance while attempting to keep the total acquisition and inter-echo spacing the same. Parallel imaging was then used to double the inter-echo spacing and allow further wave form optimization. Along with comparative acoustic noise measurements, a statistical analysis of radiologist scoring was conducted on volumes from standard and modified sequences acquired from 10 patients after informed consent was obtained.Compared with TSE, significant improvement of acoustic comfort was measured for modified-sequences quiet TSE and quiet TSE with generalized autocalibrating partially parallel acquisitions (P = 0.0034 and P = 0.0003, respectively), and no statistically significant difference in diagnostic quality was observed without the use of parallel imaging.Standard clinical magnetic resonance imaging protocols can be made quieter through adequate gradient wave form optimization. In scans with high signal-to-noise ratio, parallel imaging can be used to further reduce acoustic noise.

BACKGROUND AND PURPOSE: MR imaging and PET/CT are integrated in the work-up of head and neck cancer patients. The hybrid imaging technology 18 F-FDG-PET/MR imaging combining morphological and functional information might be attractive in this patient population. The aim of the study was to compare whole-body 18 F-FDG-PET/MR imaging and 18 F-FDG-PET/CT in patients with head and neck cancer, both qualitatively in terms of lymph node and distant metastases detection and quantitatively in terms of standardized uptake values measured in 18 F-FDG-avid lesions. MATERIALS AND METHODS: Fourteen patients with head and neck cancer underwent both whole-body PET/CT and PET/MR imaging after a single injection of 18 F-FDG. Two groups of readers counted the number of lesions on PET/CT and PET/MR imaging scans. A consensus reading was performed in those cases in which the groups disagreed. Quantitative standardized uptake value measurements were performed by placing spheric ROIs over the lesions in 3 different planes. Weighted and unweighted κ statistics, correlation analysis, and the Wilcoxon signed rank test were used for statistical analysis. RESULTS: κ statistics for the number of head and neck lesion lesions counted (pooled across regions) revealed interreader agreement between groups 1 and 2 of 0.47 and 0.56, respectively. Intrareader agreement was 0.67 and 0.63. The consensus reading provided an intrareader agreement of 0.63. For the presence or absence of metastasis, interreader agreement was 0.85 and 0.70. The consensus reading provided an intrareader agreement of 0.72. The correlations between the maximum standardized uptake value in 18 F-FDG-PET/MR imaging and 18 F-FDG-PET/CT for primary tumors and lymph node and metastatic lesions were very high (Spearman r = 1.00, 0.93, and 0.92, respectively). CONCLUSIONS: In patients with head and neck cancer, 18 F-FDG-PET/MR imaging and 18 F-FDG-PET/CT provide comparable results in the detection of lymph node and distant metastases. Standardized uptake values derived from 18 F-FDG-PET/MR imaging can be used reliably in this patient population.

Treatment of pain in palliative care patients is challenging. Adjunctive methods of pain management are desirable. Music therapy offers a nonpharmacologic and safe alternative.To determine the efficacy of a single music therapy session to reduce pain in palliative care patients.Two hundred inpatients at University Hospitals Case Medical Center were enrolled in the study from 2009 to 2011. Patients were randomly assigned to one of two groups: standard care alone (medical and nursing care that included scheduled analgesics) or standard care with music therapy. A clinical nurse specialist administered pre- and post-tests to assess the level of pain using a numeric rating scale as the primary outcome, and the Face, Legs, Activity, Cry, Consolability Scale and the Functional Pain Scale as secondary outcomes. The intervention incorporated music therapist-guided autogenic relaxation and live music.A significantly greater decrease in numeric rating scale pain scores was seen in the music therapy group (difference in means [95% CI] -1.4 [-2.0, -0.8]; P0.0001). Mean changes in Face, Legs, Activity, Cry, Consolability scores did not differ between study groups (mean difference -0.3, [95% CI] -0.8, 0.1; P0.05). Mean change in Functional Pain Scale scores was significantly greater in the music therapy group (difference in means -0.5 [95% CI] -0.8, 0.3; P0.0001) [corrected]: A single music therapy intervention incorporating therapist-guided autogenic relaxation and live music was effective in lowering pain in palliative care patients.

The purpose of this study was to compare and correlate standardized uptake values (SUV) derived from magnetic resonance attenuation correction (MRAC) with those derived from computed tomography attenuation correction (CTAC) in an oncology patient population.The HIPAA-compliant study was approved by the Internal Review Board and all subjects gave written informed consent prior to inclusion in the study. Forty patients (mean age 61 ± 15.1; 20 male) referred for clinically indicated 2-deoxy-2-[(18)F]fluoro-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scans also underwent a PET/magnetic resonance imaging (MRI) examination. MRAC was performed using an automatic three-segment model. Regions of interest were drawn over eight normal structures in order to obtain SUVmax and SUVmean values. Spearman rank correlation coefficients (r) were calculated and two-tailed paired t tests were performed to compare the SUVmax and SUVmean values obtained from CTAC with those from MRAC.The mean time after FDG injection was 66 ± 7 min for PET/CT and 117 ± 15 min for PET/MRI examination. MRAC SUV values were significantly lower than the CTAC SUV values in mediastinal blood pool (p 0.001 for both SUVmax and SUVmean) and liver (p = 0.01 for SUVmean). The MRAC SUV values were significantly higher in bone marrow (p 0.001 for both SUVmax and SUVmean), psoas major muscle (p 0.001 for SUVmax), and left ventricular myocardium (p 0.001 for SUVmax and p = 0.01 for SUVmean). For the other normal structures, no significant difference was observed. When comparing SUV values generated from CTAC versus MRAC, high correlations between CTAC and MRAC were observed in myocardium (r = 0.96/0.97 for SUVmax/mean), liver (r = 0.68 for SUVmax), bone marrow (r = 0.80/0.83 for SUVmax/mean), lung tissue (r = 0.70 for SUVmax), and mediastinal blood pool (r = 0.0.68/.069 for SUVmax/mean). Moderate correlations were found in lung tissue (r = 0.67 for SUV mean), liver (r = 0.66 for SUVmean), fat (r = 0.48/0.53 for SUVmax/mean), psoas major muscle (r = 0.54/0.58 for SUVmax/mean), and iliacus muscle (r = 0.41 for SUVmax). Low correlation was found in iliacus muscle (r = 0.32 for SUVmean).Using the automatic three-segment model, our study showed high correlation for measurement of SUV values obtained from MRAC compared to those from CTAC, as the reference standard. Differences observed between MRAC and CTAC derived SUV values may be attributed to the time-delay between the PET/CT and PET/MRI scans or biologic clearance of radiotracer. Further studies are required to assess SUV measurements when performing different MR attenuation correction techniques.

BACKGROUND: Professional society guidelines recommend follow-up colonoscopy for patients with resected colonic adenomas. However, adherence to guideline recommendations in routine clinical practice has not been well characterized. METHODS: The authors used a population-based sample of Medicare beneficiaries to identify all patients aged ≥70 years who had a claim for colonoscopy with polypectomy or hot biopsy during the period from 2001 to 2004. Medicare claims through 2009 identified colonoscopy within the following 5 years as well as fecal occult blood testing, sigmoidoscopy, and barium enema. RESULTS: In total, 12,771 patients were included. At 5 years, 45.7% of patients underwent another colonoscopy, and 32.3% of procedures included a polypectomy. The rates of fecal occult blood testing, flexible sigmoidoscopy, and barium enema at 5 years were 54%, 3.8%, and 2.9%, respectively. There was a marked decrease in repeat colonoscopy at 1 year, 3 years, and 5 years with more recent years of index procedures. Other predictors of undergoing repeat colonoscopy were younger age, African American race, and a colonoscopy before the index examination. There was no association with physician specialty. The decreasing use of colonoscopy with time was maintained in a multivariable analysis. CONCLUSIONS: In a sample of elderly Medicare beneficiaries, there was under use of follow-up colonoscopy at 5 years after polypectomy, and

Background Mohs micrographic surgery examines all margins of the resected sample and has a 99% cure rate. However, many nonmelanoma skin cancers (NMSCs) are not readily amenable to Mohs micrographic surgery. This defines an unmet clinical need to assess the completeness of non-Mohs micrographic surgery resections during surgery to prevent re-excision/recurrence. Objective We sought to examine the utility of quenched activity-based probe imaging to discriminate cancerous versus normal-appearing skin tissue. Methods The quenched activity-based probe GB119 was applied to NMSC excised from 68 patients. We validated activation of the probe for hematoxylin-eosin–confirmed cancerous tissue versus normal-appearing skin tissue. Results Topical application of the probe differentiated basal cell carcinoma and squamous cell carcinoma from normal-appearing skin with overall estimated sensitivity and specificity of 0.989 (95% confidence interval 0.940-1.00) and 0.894 (95% confidence interval 0.769-0.965), respectively. Probe activation accurately defined peripheral margins of NMSC as compared with conventional hematoxylin-eosin–based pathology. Limitations This study only examined NMSC debulking excision specimens. The sensitivity and specificity for this approach using final NMSC excision margins will be clinically important. Conclusions These findings merit further studies to determine whether quenched activity-based probe technology may enable cost-effective increased cure rates for patients with NMSC by reducing re-excision and recurrence rates with a rapid and easily interpretable technological advance.

Objective Most prior studies on aggressive end-of-life care in older patients with cancer have accounted for social determinants of health (e.g., race, income, and education), but rarely for multimoribidity (MM). In this study, we examine the association between end-of-life care and each of the social determinants of health and MM, hypothesizing that higher MM is associated with less aggressive care. Methods From the linked 1991–2008 Health and Retirement Study, Medicare data, and the National Death Index, we identified fee-for-service patients age ≥66years who died from cancer ( n =835). MM was defined as the occurrence or co-occurrence of chronic conditions, functional limitations, and/or geriatric syndromes. Aggressive care was based on claims-derived measures of receipt of cancer-directed treatment in the last two weeks of life; admission to the hospital and/or emergency department (ED) within the last month; and in-hospital death. We also identified patients enrolled in hospice. In multivariable logistic regression models, we analyzed the associations of interest, adjusting for potential confounders. Results While 61.2% of the patients enrolled in hospice, 24.6% underwent cancer-directed treatment; 55.1% were admitted to the hospital and/or ED; and 21.7% died in the hospital. We observed a U-shaped distribution between income and in-hospital death. Chronic conditions and geriatric syndromes were associated with some outcomes, but not with others. Conclusions To improve quality end-of-life care and curtail costs incurred by dying patients, relevant interventions need to account for social determinants of health and MM in a nuanced fashion.

Aim: To assess academic achievement, rates of learning disabilities (LD) and special education in extremely low birth weight (ELBW

Background: Despite the American Society of Echocardiography recommendation to use left atrial volume indexed for body surface area (LAVI) for quantification of left atrial size, a variety of methods are used in clinical practice. Our objectives were to evaluate the accuracy of M-mode and two-dimensional (2D) echocardiographic LA size estimates to LAVI and to determine their ability to predict left ventricular diastolic dysfunction. Methods: In 150 consecutive patients, LA diameter (LAD), LA diameter indexed for body surface area (LADI), LA area in the apical two- and four-chamber views (LAA 2c and LAA 4c), biplane area–length LA volume (LAV), and LAVI were obtained. The accuracy of these methods to quantify LA enlargement by LAVI, correlation with clinical parameters, and ability to act as a surrogate for diastolic dysfunction were determined using Pearson correlation coefficients along with univariate and multiple logistic analysis. Results: The true degree of LA size (with LAVI as standard) was identified by LAD in 45%, LADI in 42%, LAA 4c in 43%, and LAA 2c in 41%. All methods showed positive correlation with age, E/E′, mitral regurgitation, and right atrial size and negative correlation with ejection fraction. LAVI was the strongest method to predict any (c = 0.655, P = 0.012) or moderate–severe (P = 0.856 and P < 0.001) diastolic dysfunction. All methods have greater capacity to identify moderate or severe diastolic dysfunction than any degree of diastolic dysfunction alone. Conclusions: One-dimensional and 2D methods inaccurately quantify LA size and are inferior to LAVI to predict diastolic dysfunction. (Echocardiography 2012;29:379-384)

Background Following a colonoscopy that is negative for cancer, a subset of patients may be diagnosed with colorectal cancer, also termed interval cancer. The frequency and predictors have not been well studied in a population-based U.S. cohort.

BackgroundEsophagectomy for esophageal cancer carries high morbidity and mortality, particularly in older patients. Transthoracic esophagectomy allows formal lymphadenectomy, but leads to greater perioperative morbidity and pain than transhiatal esophagectomy. Epidural analgesia may attenuate the stress response and be less immunosuppressive than opioids, potentially affecting long-term outcomes. These potential benefits may be more pronounced for transthoracic esophagectomy due to its greater physiologic impact. We evaluated the impact of epidural analgesia on survival and recurrence after transthoracic versus transhiatal esophagectomy.MethodsA retrospective cohort study was performed using the linked Surveillance, Epidemiology and End Results (SEER)-Medicare database. Patients aged ≥66 years with locoregional esophageal cancer diagnosed 1994-2009 who underwent esophagectomy were identified, with follow-up through December 31, 2013. Epidural receipt and surgical approach were identified from Medicare claims. Survival analyses adjusting for hospital esophagectomy volume, surgical approach, and epidural use were performed. A subgroup analysis restricted to esophageal adenocarcinoma patients was performed.ResultsAmong 1,921 patients, 38% underwent transhiatal esophagectomy (n = 730) and 62% underwent transthoracic esophagectomy (n = 1,191). 61% (n = 1,169) received epidurals and 39% (n = 752) did not. Epidural analgesia was associated with transthoracic approach and higher volume hospitals. Patients with epidural analgesia had better 90-day survival. Five-year survival was higher with transhiatal esophagectomy (37.2%) than transthoracic esophagectomy (31.0%, p = 0.006). Among transthoracic esophagectomy patients, epidural analgesia was associated with improved 5-year survival (33.5% epidural versus 26.5% non-epidural, p = 0.012; hazard ratio 0.81, 95% confidence interval [0.70, 0.93]). Among the subgroup of esophageal adenocarcinoma patients undergoing transthoracic esophagectomy, epidural analgesia remained associated with improved 5-year survival (hazard ratio 0.81, 95% confidence interval [0.67, 0.96]); this survival benefit persisted in sensitivity analyses adjusting for propensity to receive an epidural.ConclusionAmong patients undergoing transthoracic esophagectomy, including a subgroup restricted to esophageal adenocarcinoma, epidural analgesia was associated with improved survival even after adjusting for other factors.

Objective Retinopathy of prematurity (ROP), a vasoproliferative disorder of the retina in preterm infants, is associated with multiple factors, including oxygenation level. We explored whether the common intermittent hypoxemic events in preterm infants are associated with the development of ROP. Study design Oxygen desaturation events were quantified in 79 preterm infants (gestational age, 24 to 27-6/7 weeks) during the first 8 weeks of life. Infants were classified as requiring laser treatment for ROP versus having less severe or no ROP. A linear mixed model was used to study the association between the incidence of intermittent hypoxia and laser treatment of ROP, controlling for gestational age, sex, race, multiple births, and initial severity of illness. Results For all infants, hypoxemic events increased with postnatal age ( P .001). Controlling for all covariates, a higher incidence of oxygen desaturation events was found in the infants undergoing laser therapy for ROP ( P .001), males ( P .02), and infants of younger gestational age ( P .003). Conclusions The incidence of hypoxemic events was higher in infants with ROP requiring laser therapy. Therapeutic strategies to optimize oxygenation in preterm infants should include minimization of desaturation episodes, which may in turn decrease serious morbidity in this high-risk population.

Objectives/Hypothesis: To evaluate the efficacy of photodynamic therapy (PDT) with the phthalocyanine photosensitizer Pc 4 for treating an animal model of recurrent respiratory papillomatosis (RRP). Methods: Rabbit skin was grafted onto the dorsum of severe combined immunodeficient mice, two xenografts per animal. After the graft healed, it was inoculated with cottontail rabbit papillomavirus (CRPV). When papillomas developed, Pc 4 (0.6 or 1.0 mg/kg) was administered systemically, and 48 hours later, one papilloma of the two on each animal was exposed to 675-nm photoactivating light at either 100 or 150 J/cm 2 . In addition to the contralateral tumors, which received Pc 4 but no light, other controls included animals receiving light only or neither agent. Response was assessed by measuring papilloma size with a caliper. Some papillomas and residual skin were harvested for histological assessment. Results: For the lower-dose PDT regimens, papilloma growth rates were not significantly different from the controls. In contrast, 13 of 15 papillomas receiving the higher Pc 4 dose (1.0 mg/kg) and the higher light fluence (150 J/cm 2 ) regressed completely and did not regrow within the observation period of up to 79 days. The response of these papillomas was significantly different from the controls (P < .001). Histological analysis confirmed the absence of residual tumor following complete response and replacement with near-normal epithelium. Conclusions: Pc 4-PDT is highly effective in treating virally induced (CRPV) papillomas in a murine model of RRP, and thus warrants further study as a treatment for HPV-induced papillomas.

High rates of asthma treatment nonadherence have been reported, particularly in economically disadvantaged African American youth. The relationship between adherence to combined medication treatment and asthma outcomes has potential clinical significance but is not well understood. Using electronic monitoring, we describe the pattern of adherence to daily corticosteroid (fluticasone) and leukotriene receptor antagonist (montelukast) medication over the course of 1 year in a population of African American youth with moderate to severe asthma. On average, adherence to montelukast was higher than adherence to fluticasone (p0.01); however, for both medications, adherence rates significantly declined over the course of the study. After 1 year, participants took only 31% of prescribed doses of montelukast and 23% of prescribed doses of fluticasone. The decline in adherence to both fluticasone (p0.05) and montelukast (p0.001) was related to increased healthcare utilization. Furthermore, asthma symptom ratings were related montelukast (p0.001), but not fluticasone adherence. These results suggest that adherence promotion intervention strategies are warranted to improve health-related outcomes in families who are at-risk for treatment nonadherence.

Bryostatin 1, isolated from a marine bryozoan, enhances the efficacy of cytotoxic agents through modulation of the protein kinase C pathway and is active in combination with vincristine for diffuse large B-cell lymphoma. Further, the apoptotic frequency of peripheral blood T lymphocytes as determined by flow cytometry may predict which patients will respond to this combination. We tested the efficacy and safety of bryostatin 1 50 microg/m(2) given over 24 hr and vincristine 1.4 mg/m(2) on days 1 and 15 every 28 days in aggressive B-cell non-Hodgkin lymphoma (NHL) relapsing after autologous stem cell transplantation. End points included tumor response, toxicity, and survival. Responses were correlated with an increase in apoptotic frequency of CD5+ cells by flow cytometry using annexin V staining. Fourteen patients were enrolled with 13 being evaluable for a response. The overall response rate was 31% with two patients achieving a complete response. The most common toxicities were Grade 3 lymphopenia (seven patients), Grade 3 to 4 neutropenia (two patients), and Grade 3 hypophosphatemia (two patients). Median progression-free and overall survivals for all patients were 5.7 and 21.4 months, respectively. One patient demonstrated an increase in T-cell apoptotic frequency, also achieving a complete response. Bryostatin 1 and vincristine have efficacy in select patients with aggressive NHL. Future investigations of agents targeting the protein kinase C pathway may benefit from early response assessment using flow cytometry to evaluate T-cell apoptosis.

To describe the prevalence of behavioral problems and symptomatology suggestive of Autism and Asperger's disorders at age 8 years among extremely low birth weight (ELBW,1 kg) children, born 1992 through 1995.Parent reports of the behavior of 219 ELBW (mean birth weight, 810 g; gestational age 26 weeks) were compared with 176 normal birth weight children of similar maternal sociodemographic status, sex, and age. Behavior was assessed via the Child Symptom Inventory that includes both Symptom Severity Scores and scores meeting DSM-IV criteria for disorders.ELBW compared with normal birth weight children had significantly higher mean Symptom Severity Scores for the inattentive, hyperactive, and combined types of attention-deficit hyperactivity disorder (all p.001) as well as higher scores for Generalized Anxiety (p.01) and Autistic (p.001) and Asperger's (p.01) disorders. When DSM-IV criteria were considered, ELBW children also had significantly higher rates of attention-deficit hyperactivity disorder of the inattentive (10% vs 3%, p.01) and combined (5% vs 0.6%, p.05) types.Attention-deficit hyperactivity disorder, mainly the inattentive type is prevalent among ELBW children. Our findings of an increase in symptoms pertaining to Autistic and Asperger's disorders at school age agree with recent reports of others during early childhood. Early identification and intervention for these problems might improve child functioning and ameliorate parent and child distress.

Objective: The objective of this study was to demonstrate the reliability of cardiac-gated computerized tomography (CGCT) in diagnosing aortic atheroma in patients with ischemic stroke. Materials and Methods: Two radiologists each read 32 CGCT studies and estimated aortic atheroma and interreliability/intrareliability measures. Results: The intraobserver intraclass correlation coefficients (ICCs) were 0.95 and 0.87 for the diagnosis of aortic atheroma with CGCT. The interrater ICC was 0.93. Conclusion: This prospective study demonstrated that CGCT is a reliable imaging modality with good interreader and intrareader reproducibilities.

Objective We sought to determine the prevalence of unsuspected, pre-existing valvular regurgitation in a large, heterogeneous population of patients referred for an echocardiogram. Methods The echocardiograms of 6851 consecutive individuals without suspected valve disease were reviewed. Regurgitant severity was graded using a clinical composite of published methods and multiple logistic analyses were used to model various clinical variables. Results The overall prevalence of moderate or greater mitral regurgitation (MR) was 11.7% in male patients and 12.5% in female patients. For mild or greater aortic insufficiency (AI), the prevalence was 18.9% in male patients and 19.7% in female patients. Both MR and AI increased exponentially as a function of age. Female sex predicted MR, but AI was sex neutral. Regurgitant severity increased with decreasing ejection fraction and body mass index, a history of hypertension, the presence of left ventricular hypertrophy, and valvular abnormalities. Conclusions The prevalence of unsuspected MR and AI is substantial, increases exponentially with age, and is predicted by commonly used clinical variables.

OBJECTIVE. The goal was to evaluate whether changes in neonatal intensive care have improved outcomes for children with bronchopulmonary dysplasia (oxygen dependence at corrected age of 36 weeks).METHODS. We compared outcomes of extremely low birth weight (RESULTS. For both groups, significant practice changes between period I and period II included increased prenatal and decreased postnatal steroid therapy and increased surfactant therapy, indomethacin therapy, and patent ductus arteriosus ligation. Significant morbidity changes included decreased rates of severe cranial ultrasound abnormalities and increased rates of ventilator dependence. Rates of bronchopulmonary dysplasia did not change (52% vs 53%). Follow-up evaluation revealed significantly lower rates of neurosensory abnormalities during period II (extremely low birth weight: 29% vs 16%; extremely low gestational age: 31% vs 16%). There were no changes in rates of Mental Developmental Index scores of CONCLUSIONS. Neurosensory outcomes of infants with bronchopulmonary dysplasia improved during 2000 to 2003 but overall neurodevelopmental outcomes did not change.

High-dose ibuprofen in a 4-year controlled trial slowed FEV(1) decline in young subjects with cystic fibrosis, but the effectiveness of ibuprofen has not been assessed in a large group of patients treated clinically with this therapy.To assess the effect of ibuprofen therapy on FEV(1) decline in children and adolescents with cystic fibrosis, using observational data from the Cystic Fibrosis Foundation Patient Registry.The rate of decline in FEV(1) percent predicted over 2-7 years among patients age 6-17 years with FEV(1)60% predicted, and who were treated with ibuprofen (1,365), was compared with patients of similar age and disease severity who were not treated with this therapy (8,960). Multilevel repeated-measures mixed-regression models were used to estimate rates of decline, adjusting for characteristics and therapies that influenced FEV(1) decline. Adverse effects were compared among those treated versus not treated with ibuprofen.FEV(1) declined less rapidly among patients treated with ibuprofen (difference, 0.60% predicted per year; 95% confidence interval, 0.31 to 0.89; P0.0001); a 29% reduction in slope based on an average decline of 2.08% predicted per year for patients not treated. Those treated with ibuprofen were more likely to have an episode of gastrointestinal bleeding requiring hospitalization, but the occurrence was rare in both groups (annual incidence, 0.37 vs. 0.14%; relative risk, 2.72; P0.001).Slower rates of FEV(1) decline are seen in children and adolescents with cystic fibrosis who are treated with ibuprofen. The apparent benefits of ibuprofen therapy outweigh the small risk of gastrointestinal bleeding.

To examine parent protection and its correlates among 8-year-old ELBW children compared with normal birth weight (NBW) controls.The population included 217 eight-year-old ELBW children born 1992-1995 (92% of the surviving birth cohort; mean birth weight, 811 g; mean gestational age, 26.4 weeks) and 176 NBW controls. The primary outcome measure, the Parent Protection Scale (PPS), included a total score and four domains including Supervision, Separation, Dependence, and Control. Multivariate analyses were performed to examine the predictors of parental protection and overprotection.After adjusting for socioeconomic status (SES), race, sex, and age of the child, parents of ELBW children reported significantly higher mean total Parent Protection Scale scores (31.1 vs 29.7, p = .03) than parents of NBW children and higher scores on the subscale of Parent Control (8.0 vs 7.5, p = .04). These differences were not significant when the 36 children with neurosensory impairments were excluded. Parents of ELBW children also reported higher rates of overprotection than controls (10% vs 2%, p = .001), findings that remained significant even after excluding children with neurosensory impairments (8% vs 2%, p = .011). Multivariate analyses revealed lower SES to be associated with higher total Parent Protection Scale scores in both the ELBW (p.001) and NBW (p.05) groups. Additional correlates included neurosensory impairment (p.05) and functional limitations (p.001) in the ELBW group and black race (p.05) and maternal depression (p.01) in the NBW group. Lower child IQ was significantly associated with higher PPS scores only in the neurosensory impaired subgroup of ELBW children.Longer term follow-up will be necessary to examine the effects of the increased parent protection on the development of autonomy and interpersonal relationships as the children enter adolescence.

Purpose Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. Patients and Methods A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient’s barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Results Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. Conclusion These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers.

Purpose The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials. Methods We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): “How much of a burden on you is the cost of your medical care?,” “I'm afraid that my health insurance won't pay for a clinical trial,” and “I’m worried that I wouldn’t be able to afford the costs of treatment on a clinical trial.” Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics. Results One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models). Conclusion Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients’ financial needs and concerns may reduce distress and improve patient decision making.

BACKGROUND The Affordable Care Act (ACA) removed copayments for screening mammography and colonoscopy in Medicare beneficiaries, but its clinical impact is unknown. METHODS Using a 5% random sample of Medicare claims from 2009 through 2012 in individuals age 70 years or older who were due for screening, we examined claims for screening mammography and screening or surveillance colonoscopy for two years prior to ACA (2009-2010) and two years post-ACA (2011-2012). Receipt of the procedures at the patient level was compared across years using generalized estimating equations. Statistical tests were two-sided. RESULTS Compared with 2009, we found an increase in mammography uptake during the ACA coverage period, with multivariable odds ratios (MOR) of 1.22 (95% confidence interval [CI] = 1.20 to 1.25, P < .001) for 2011 and 1.17 (95% CI = 1.15 to 1.20, P < .001) for 2012 and less change in 2010 (OR = 1.03, 95% CI = 1.01 to 1.05, P = .01). In contrast to mammography, uptake of screening or surveillance colonoscopy decreased in 2012 (MOR = 0.95, 95% CI = 0.92 to 0.98, P = .002) compared with 2009, with no change in 2010 (MOR = 1.01, 95% CI = 0.99 to 1.04, P = .47) or 2011 (MOR = 1.01, 95% CI = 0.99 to 1.04, P = .34). Other factors associated with procedure receipt included younger age and prior preventive health visits. In an analysis restricted to patients age 70 to 74 years, colonoscopy use increased slightly in 2011 but was unchanged in 2012, and the findings by year for mammography were consistent with the main analysis. CONCLUSIONS Following ACA implementation with concomitant reduction in out-of-pocket expenditures, there was a statistically significant increment in mammography uptake but not colonoscopy. This suggests that affordability is a necessary but not sufficient facilitator of preventive services.

Magnetic resonance fingerprinting (MRF) is an imaging tool that produces multiple magnetic resonance imaging parametric maps from a single scan. Herein we describe the normal range and progression of MRF-derived relaxometry values with age in healthy individuals. In total, 56 normal volunteers (24 men and 32 women) aged 11–71 years were scanned. Regions of interest were drawn on T1 and T2 maps in 38 areas, including lobar and deep white matter (WM), deep gray nuclei, thalami, and posterior fossa structures. Relaxometry differences were assessed using a forward stepwise selection of a baseline model that included either sex, age, or both, where variables were included if they contributed significantly (p &lt, 0.05). In addition, differences in regional anatomy, including comparisons between hemispheres and between anatomical subcomponents, were assessed by paired t tests. MRF-derived T1 and T2 in frontal WM regions increased with age, whereas occipital and temporal regions remained relatively stable. Deep gray nuclei such as substantia nigra, were found to have agerelated decreases in relaxometry. Differences in sex were observed in T1 and T2 of temporal regions, the cerebellum, and pons. Men were found to have more rapid age-related changes in frontal and parietal WM. Regional differences were identified between hemispheres, between the genu and splenium of the corpus callosum, and between posteromedial and anterolateral thalami. In conclusion, MRF quantification measures relaxometry trends in healthy individuals that are in agreement with the current understanding of neurobiology and has the ability to uncover additional patterns that have not yet been explored.

Introduction The National Breast and Cervical Cancer Early Detection Program (BCCP) in Ohio provides screening and treatment services for uninsured low-income women aged 40 to 64. Because participation in the BCCP might engender greater self-efficacy for cancer screening, we hypothesized that breast cancer and survival outcomes would be better in BCCP participants who become age-eligible to transition to Medicare than in their low-income non-BCCP counterparts. Methods Linking data from the 2000 through 2009 Ohio Cancer Incidence Surveillance System with the BCCP database, Medicare files, Ohio death certificates (through 2010), and the US Census, we identified Medicare beneficiaries who were aged 66 to 74 and diagnosed with incident invasive breast cancer. We compared the following outcomes between BCCP women (n = 93) and low-income non-BCCP women (n = 420): receipt of screening mammography in previous year, advanced-stage disease at diagnosis, timely and standard care, all-cause survival, and cancer survival. We conducted multivariable logistic regression and survival analysis to examine the association between BCCP status and each of the outcomes, adjusting for patient covariates. Results Women who participated in the BCCP were nearly twice as likely as low-income non-BCCP women to have undergone screening mammography in the previous year (adjusted odds ratio, 1.77; 95% confidence interval, 1.01–3.09). No significant differences were detected in any other outcomes. Conclusion With the exception of screening mammography, the differences in outcomes were not significant, possibly because of the small size of the study population. Future analysis should be directed toward identifying the factors that explain these findings.

Purpose To evaluate the tolerability of escalating doses of stereotactic body radiotherapy (SBRT) for primary treatment of localized renal cell carcinoma (RCC) in poor surgical candidates. Patients and methods Eligible patients included those with clinically staged radiographic and or pathologically confirmed RCC who had not undergone previous abdominal or pelvic radiotherapy. All patients had comorbid medical conditions which precluded surgery. Median (range) patient age was 77.6years (range 59–89) years and all patients had Karnofsky Performance Status of ⩾60. Median tumor volume was 57.9cm 3 (range 13.8–174.7cm 3 ). Dose-limiting toxicity (DLT) was defined as grade 3 or worse gastrointestinal/genitourinary toxicity by Common Terminology Criteria of Adverse Events (version 4). Tumor response was assessed by imaging results using Response Evaluation Criteria In Solid Tumors (RECIST) measurement and percutaneous biopsy. Results A total of 19 patients (13 men and 6 women) were treated on protocol from June 2006 through August 2011. Groups of 3–6 patients received 24, 32, 40, and 48Gy in 4 fractions. Median (range) follow-up was 13. 7months (5.9–34.7months). For possibly treatment-related acute toxicities, one patient developed grade 2 fatigue and one developed grade 4 duodenal ulcer. For possibly treatment-related late toxicities, 2 patients experienced grade 3 renal toxicity (worsening chronic kidney disease), one reported grade 2 urinary incontinence and one developed grade 4 duodenal ulcer. Among the 15 patients with evaluable response, 3 and 12 had partial response and stable disease, respectively, utilizing RECIST criteria. Among the 11 patients who had post-SBRT biopsy, only one (9%) was negative on first biopsy and an additional one (9%) turned negative without further therapy on second biopsy. Conclusions Dose escalation to 48Gy in 4 fractions has been achieved successfully without dose-limiting toxicities. A planned extension of this phase I trial is currently underway treating patients to 60Gy in 3 fractions to further evaluate this experimental therapy.

Background Lipidized dermatofibromas represent a rare variant of dermatofibroma that has been regarded as an incidental finding with no particular clinical significance. Objective The goal of this study was to investigate the relationship between lipidized dermatofibromas and patient age, anatomic location, and serum total cholesterol. Methods A retrospective case control format was used with an experimental group containing patients with biopsy-proven lipidized dermatofibromas and a control group containing patients with nonlipidized dermatofibromas. Results Ages in the experimental group ranged from 35 to 75 years with a mean value of 53 years whereas ages in the control group ranged from 27 to 72 years with a mean value of 48 years. A comparison between the mean of the ages between the two groups using the t test method showed no statistically significant difference ( P = .09). Lesion location on the body was grouped into 4 sites: leg, thigh, trunk, and upper extremity. Of the 23 patients in the experimental group, 10 had lesions on the legs, 5 had lesions on the thighs, 2 had lesions on the trunk, and 5 had lesions on the upper extremities. Of the 41 patients in the control group, 15 had lesions on the legs, 7 had lesions on the thighs, 9 had lesions on the trunk, and 10 had lesions on the upper extremities. A comparison between the two groups showed no statistically significant difference ( P = .60). In all, 16 of the 23 patients in the experimental group and 24 of the 41 patients in the control group were considered to have high cholesterol. A comparison showed no statistically significant difference between the cholesterol levels of the two groups ( P = .38). Limitations Limitations that we encountered during the study included the relative infrequency of lipidized dermatofibromas, limiting the number of patients in the study. In addition, medication histories and lipid levels on patients were not always available. In addition, we formed a control group from people who had their cholesterol checked often, which may cause them to have a higher average cholesterol than that of the general population. Conclusions Our data show that lipidized dermatofibromas do not differ clinically from nonlipidized dermatofibromas in age distribution of patients, tumor location, or underlying serum lipid levels.

Cystic fibrosis is caused by defects in the cystic fibrosis transmembrane conductance regulator gene, which codes for a chloride channel, but the role of this chloride channel in inflammation induced by lung infection with Pseudomonas aeruginosa remains to be defined.We tested the hypothesis that loss of this chloride channel alone is sufficient to cause excessive inflammation in response to inflammatory stimuli.We investigated the response of cystic fibrosis and wild-type mice to mucoid P. aeruginosa administered by insufflation.The host responses measured included survival, weight change, lung morphometry, bacterial clearance, and inflammatory mediators, and cell counts were assessed in bronchoalveolar lavage fluid.Depending on the dose administered and frequency of dosing, cystic fibrosis mice experienced significantly higher mortality rates, greater weight loss, higher lung pathology scores, and higher inflammatory mediator and neutrophil levels compared with wild-type mice, even after the bacteria had been cleared. Surprisingly, bacteria were cleared just as rapidly in cystic fibrosis mice as in wild-type mice, and sepsis was not observed. Chronic lung infections could not be established with mucoid P. aeruginosa in either cystic fibrosis or wild-type mice.Absence of this chloride channel alone appears sufficient for exaggerated inflammation and excess mortality compared with wild-type controls in the face of mucoid P. aeruginosa lung infection. To establish chronic infection, additional factors such as bacterial trapping or poor clearance may be required.

Atopic dermatitis (AD) patients with predominantly head and neck involvement react to patch tests of the yeast Malassezia sympodialis (Ms). Protein patch testing methods and interpretation are controversial, but subgroups of AD patients may have unique triggers for disease activity. The aim of the study was to identify clinical characteristics of patients who are patch test-positive to Dermatophagoides farinae/pteronyssinus (Df) and Ms and characterize cutaneous cytokine profiles of the atopy patch tests (APTs). 25 AD patients and 27 control dermatitis patients were patch tested with Ms and Df. Qualitative analysis of Th-1 and Th-2 cytokines by RT-PCR mRNA was obtained from positive APTs. Atopic dermatitis patients with a textile pattern or head and neck involvement demonstrated more positive APTs to Ms than control patients. Early positive APTs (

Polymorphisms in genes other than the cystic fibrosis transmembrane conductance regulator (CFTR) gene may modify the severity of pulmonary disease in patients with cystic fibrosis.We performed two studies with different patient samples. We first tested 808 patients who were homozygous for the DeltaF508 mutation and were classified as having either severe or mild lung disease, as defined by the lowest or highest quartile of forced expiratory volume in one second (FEV1), respectively, for age. We genotyped 16 polymorphisms in 10 genes reported by others as modifiers of disease severity in cystic fibrosis and tested for an association in patients with severe disease (263 patients) or mild disease (545). In the replication (second) study, we tested 498 patients, with various CFTR genotypes and a range of FEV1 values, for an association of the TGFbeta1 codon 10 CC genotype with low FEV1.In the initial study, significant allelic and genotypic associations with phenotype were seen only for TGFbeta1 (the gene encoding transforming growth factor beta1), particularly the -509 and codon 10 polymorphisms (with P values obtained with the use of Fisher's exact test and logistic regression ranging from 0.006 to 0.0002). The odds ratio was about 2.2 for the highest-risk TGFbeta1 genotype (codon 10 CC) in association with the phenotype for severe lung disease. The replication study confirmed the association of the TGFbeta1 codon 10 CC genotype with more severe lung disease in comparisons with the use of dichotomized FEV1 for severity status (P=0.0002) and FEV1 values directly (P=0.02).Genetic variation in the 5' end of TGFbeta1 or a nearby upstream region modifies disease severity in cystic fibrosis.

Our objective was to compare the blood pressure of 20-y-old very low birth weight (VLBW;1.5 kg) individuals with that of normal birth weight (NBW) control individuals. The population included 195 VLBW (92 female and 103 male) and 208 NBW (107 female and 101 male) individuals who were born between 1977 and 1979. Independent effects of birth weight status (VLBW versus NBW) and within the VLBW cohort of intrauterine growth (birth weight z score) were examined via multiple regression analyses. VLBW individuals had a higher mean systolic blood pressure (SBP) than NBW control individuals (114 +/- 11 versus 112 +/- 13 mm Hg). SBP for VLBW female infants was 110 +/- 9 versus NBW 107 +/- 12 and for VLBW male individuals was 118 +/- 11 versus NBW 117 +/- 11 mm Hg. After adjustment for gender, race, and maternal education, the difference in SBP between VLBW and NBW individuals was 1.9 mm Hg but was 3.5 mm after also adjustment for later size (20-y weight and height z scores), which reflects catch-up growth. For female individuals, the difference in SBP between VLBW and NBW individuals was significant both unadjusted and adjusted for later size, whereas for male individuals, the difference was significant only after adjustment for later size. Intrauterine growth did not have a significant effect on SBP within the VLBW group, even after adjustment for later size. VLBW individuals, specifically female individuals, have a higher SBP than NBW control individuals. This is not explained by intrauterine growth failure.

Objective To examine the longitudinal relationship between depressive symptoms at study entry (T1) on pain intensity (PI) and functional disability over a 1-year period among children with either sickle cell disease (SCD) or juvenile idiopathic arthritis (JIA). Methods 119 children, ages 8-17 years, completed measures of depression at T1 as well as pain and functional disability at T1, 6-month (T2), and 12-month (T3) follow-ups. Caregivers also rated their child's pain and disability at each time point. General linear mixed modeling was employed to examine longitudinal relationships between study variables. Results For children with JIA, T1 pain significantly moderated the effects of T1-depressive symptoms on T2 and T3 pain where T1-depressive symptoms predicted future child-reported pain only when T1 pain was relatively mild. Similarly, T1-depressive symptoms predicted future child-reported disability only when initial reports of disability were relatively low. Only family income significantly predicted T2 and T3 pain in children with SCD. Conclusions Study findings suggest that T1-depressive symptoms play a role in the longitudinal course of pain symptoms in children with JIA but not in children with SCD.

Although transesophageal echocardiography (TEE) is a well-established tool in delineating the cardiac and aortic sources of emboli in stroke patients, its reproducibility in detecting aortic atherosclerosis (AA) that may lead to stroke is not well documented. The aim of this study is to demonstrate the inter- and intra-observer agreement in diagnosing AA based on the TEE study. During the study period, 2 echocardiographers read 32 TEE studies performed on a group of stroke patients. The AA was estimated by measuring the largest atheroma thickness in millimeters (mm). The intra-observers and intraclass correlation coefficients (ICC) were 0.97 and 0.85, respectively, for the 2 TEE observers. The inter-rater ICC coefficient between TEE readers was 0.91. In conclusion, TEE detected AA and defined high proportions of the morphological characteristics of atheroma with good reproducibility among inter and intra-observers.