Publications by authors named "Seunghee Margevicius"

38 Publications

Randomized trial of a web-based nurse education intervention to increase discussion of clinical trials.

Contemp Clin Trials Commun 2021 Jun 4;22:100789. Epub 2021 Jun 4.

Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.

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 < .0001). Likewise, knowledge, attitudes, perceived behavioral control, and perceived norms were all improved with education in both groups, and the magnitude of benefit was greater (p < .001) for the video group in all outcomes except knowledge.

Conclusion: A one-time online educational program for oncology nurses improves knowledge, attitudes, self-efficacy and intention to engage patients in discussions about clinical trials. A tailored video format was associated with a greater effect than standard text only material.
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http://dx.doi.org/10.1016/j.conctc.2021.100789DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8209078PMC
June 2021

Circadian characteristics of the rest-activity rhythm, executive function, and glucose fluctuations in young adults with type 1 diabetes.

Chronobiol Int 2021 Jun 15:1-11. Epub 2021 Jun 15.

Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio, USA.

Circadian alignment is an important element in individual health, and one behavioral marker, rest-activity rhythm, could influence self-management in young adults with type 1 diabetes (T1D). Little is known about the rest-activity rhythms, executive function, and glycemia among young adults with type 1 diabetes (T1D). The purpose of this study was to evaluate parametric and nonparametric circadian characteristics of the rest-activity rhythm and the associations between these variables, sleep-wake behavior, executive function, and glycemia among young adults with T1D. Young adults with T1D, recruited from diabetes clinics, wore wrist actigraphs and a continuous glucose monitor (CGM) concurrently for 6-14 days. Participants completed a 3-minute Trail Making Test on paper and electronic questionnaires - 8-item PROMIS v1.0 Emotional Distress Scale, 17-item Diabetes Distress Scale, including twice-daily Pittsburgh sleep diaries. Cosinor and nonparametric analyses were used to compute the rest-activity rhythm parameters, and linear regression modeling procedures were performed to determine the associations among the study variables. The sample included 46 young adults (mean age 22.3 ± 3.2; 32.6% male; 84.8% non-Hispanic White, HbA1c mean 7.2 ± 1.1%, BMI mean 27.0 ± 4.4 kg/m). A number of parametric associations were observed between a stronger rhythm, better objective sleep-wake characteristics, and less daytime sleepiness. Nonparametric circadian parameters were significantly associated with several outcomes: a stronger rhythm adherence (higher inter-daily stability) with better objective sleep-wake characteristics, better executive function, lower diabetes distress, less hyperglycemia risk, and more time spent in hypoglycemia/hypoglycemia risk; and a more robust rhythm (higher relative amplitude) with better objective sleep-wake characteristics and more time spent in hypoglycemia/higher hypoglycemia risk. Future work should be directed at designs that test causality, such as interventions directed at the strength and stability of rest-activity rhythms, for the potential to improve glucoregulation and other diabetes outcomes.
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http://dx.doi.org/10.1080/07420528.2021.1932987DOI Listing
June 2021

Sex, HIV Status, and Measures of Cardiac Stress and Fibrosis in Uganda.

J Am Heart Assoc 2021 Jun 15;10(11):e018767. Epub 2021 May 15.

Case Western Reserve University School of Medicine Cleveland OH.

Background Biomarkers of myocardial stress and fibrosis are elevated in people living with HIV and are associated with cardiac dysfunction. It is unknown whether sex influences these markers of heart failure risk in sub-Saharan Africa, where HIV burden is high and where the vast majority of women with HIV live. Methods and Results Echocardiograms and 6 plasma biomarkers (suppression of tumorigenicity-2, growth differentiation factor 15, galectin 3, soluble fms-like tyrosine kinase-1, NT-proBNP [N-terminal pro-B-type natriuretic peptide], and cystatin C) were obtained from 100 people living with HIV on antiretroviral therapy and 100 HIV-negative controls in Uganda. All participants were ≥45 years old with ≥1 major cardiovascular risk factor. Multivariable linear and logistic regression models were used to assess associations between biomarkers, echocardiographic variables, HIV status, and sex, and to assess whether sex modified these associations. Overall, mean age was 56 years and 62% were women. Suppression of tumorigenicity-2 was higher in men versus women (<0.001), and growth differentiation factor 15 was higher in people living with HIV versus controls (<0.001). Sex modified the HIV effect on cystatin C and NT-proBNP (both for interaction <0.025). Women had more diastolic dysfunction than men (0.02), but there was no evidence of sex-modifying HIV effects on cardiac structure and function. Cardiac biomarkers were more strongly associated with left ventricular mass index in men compared with women. Conclusions There are prominent differences in biomarkers of cardiac fibrosis and stress by sex and HIV status in Uganda. The predictive value of cardiac biomarkers for heart failure in people living with HIV in sub-Saharan Africa should be examined, and novel risk markers for women should be further explored.
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http://dx.doi.org/10.1161/JAHA.120.018767DOI Listing
June 2021

Statin effect on coronary calcium distribution, mass and volume scores and associations with immune activation among HIV+ persons on antiretroviral therapy.

Antivir Ther 2020 ;25(8):419-427

School of Medicine, Case Western Reserve University, Cleveland, OH, USA.

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.
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http://dx.doi.org/10.3851/IMP3389DOI Listing
January 2020

Receipt of Serial Endoscopy Procedures Prior to Esophageal Adenocarcinoma Diagnosis Is Associated with Better Survival.

Dig Dis Sci 2021 Apr 21. Epub 2021 Apr 21.

Division of Gastroenterology and Liver Disease, Department of Medicine, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue Mailstop 5066, Cleveland, OH, 44106-5066, USA.

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-Medicare database. Patients aged ≥ 70 years with EAC diagnosed during 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 5532 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.
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http://dx.doi.org/10.1007/s10620-021-06927-1DOI Listing
April 2021

IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and Non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Recruitment strategies and baseline characteristics.

Cancer 2021 Jun 4;127(11):1836-1846. Epub 2021 Feb 4.

Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio.

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.
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http://dx.doi.org/10.1002/cncr.33430DOI Listing
June 2021

A Community and Technology-Based Approach for Hypertension Self-Management (COACHMAN) to Improve Blood Pressure Control in African Americans: Results from a Pilot Study.

Patient Prefer Adherence 2020 23;14:2301-2313. Epub 2020 Nov 23.

Department of Internal Medicine, School of Medicine, Case Western Reserve University, Cleveland, OH, USA.

Purpose: Adoption of technology has increased to support self-managing chronic diseases. However, behavioral interventions evaluating such technology have been understudied in African Americans with hypertension. The aim of this study was to explore a community and technology-based intervention for hypertension self-management (COACHMAN) intervention on blood pressure (BP) control and health-related quality of life (HRQoL) in African Americans with hypertension.

Methods: Sixty African Americans (mean age 60; 75% females) who were prescribed antihypertensive medications and owning a smartphone were randomized to the COACHMAN (n = 30) or enhanced usual care (n = 30) group for 12 weeks. COACHMAN is comprised of four components: web-based education, home BP monitoring, medication management application, and nurse counseling. Hypertension knowledge, self-efficacy, technology adoption/use, medication adherence, BP, and HRQoL scores were assessed.

Results: Mean systolic and diastolic BP at baseline was 150.49 (SD 13.89) and 86.80 (SD = 13.39), respectively. After completing the 3-month intervention to improve hypertension self-management, the groups did not significantly differ in BP control and HRQoL. Clinically relevant BP reduction was observed in the intervention group. Paired -test showed that mean medication-taking adherence scores significantly improved in the intervention group ( = 0.023) compared to the control group ( = 0.075).

Conclusion: Using technology may have a positive impact on supporting hypertension self-management, particularly in medication-taking adherence. Further research is warranted in a larger sample and should include standardization of medication management to isolate the effects of behavioral interventions on changes in BP.

Clinicaltrialsgov Identifier: NCT03722667.
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http://dx.doi.org/10.2147/PPA.S283086DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7695598PMC
November 2020

Association of Kidney Disease With Abnormal Cardiac Structure and Function Among Ugandans With HIV Infection.

J Acquir Immune Defic Syndr 2021 01;86(1):104-109

Department of Internal Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH.

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.
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http://dx.doi.org/10.1097/QAI.0000000000002529DOI Listing
January 2021

The nonlinear relationship between speed of sound and compression in articular cartilage: Measurements and modeling.

J Mech Behav Biomed Mater 2020 10 19;110. Epub 2020 Jun 19.

Case Center for Multimodal Evaluation of Engineered Cartilage, Case Western Reserve University, Cleveland, OH, USA.

We measured speed of sound in bovine articular cartilage as a function of compressive strain. Using techniques we developed, it was possible to apply strain starting from the unstrained, full height of a sample. Our measurements showed that speed of sound was not a monotonic function of strain as reported in earlier investigations. Speed increased with increasing strain over a range of lower strains. It reached a maximum, and then decreased as the strain increased further. These results were corroborated using a model of wave propagation in deformable porous materials. Using this model, we also established conditions under which a maximum in the speed would exist for samples in compression. Our measurements and analysis resolve the conflicting results reported in previous studies.
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http://dx.doi.org/10.1016/j.jmbbm.2020.103923DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7493830PMC
October 2020

Simultaneous Mapping of T and T Using Cardiac Magnetic Resonance Fingerprinting in a Cohort of Healthy Subjects at 1.5T.

J Magn Reson Imaging 2020 10 28;52(4):1044-1052. Epub 2020 Mar 28.

Department of Radiology, University of Michigan, Ann Arbor, Michigan, USA.

Background: Cardiac MR fingerprinting (cMRF) is a novel technique for simultaneous T and T mapping.

Purpose: To compare T /T measurements, repeatability, and map quality between cMRF and standard mapping techniques in healthy subjects.

Study Type: Prospective.

Population: In all, 58 subjects (ages 18-60). FIELD STRENGTH/SEQUENCE: cMRF, modified Look-Locker inversion recovery (MOLLI), and T -prepared balanced steady-state free precession (bSSFP) at 1.5T.

Assessment: T /T values were measured in 16 myocardial segments at apical, medial, and basal slice positions. Test-retest and intrareader repeatability were assessed for the medial slice. cMRF and conventional mapping sequences were compared using ordinal and two alternative forced choice (2AFC) ratings.

Statistical Tests: Paired t-tests, Bland-Altman analyses, intraclass correlation coefficient (ICC), linear regression, one-way analysis of variance (ANOVA), and binomial tests.

Results: Average T measurements were: basal 1007.4±96.5 msec (cMRF), 990.0±45.3 msec (MOLLI); medial 995.0±101.7 msec (cMRF), 995.6±59.7 msec (MOLLI); apical 1006.6±111.2 msec (cMRF); and 981.6±87.6 msec (MOLLI). Average T measurements were: basal 40.9±7.0 msec (cMRF), 46.1±3.5 msec (bSSFP); medial 41.0±6.4 msec (cMRF), 47.4±4.1 msec (bSSFP); apical 43.5±6.7 msec (cMRF), 48.0±4.0 msec (bSSFP). A statistically significant bias (cMRF T larger than MOLLI T ) was observed in basal (17.4 msec) and apical (25.0 msec) slices. For T , a statistically significant bias (cMRF lower than bSSFP) was observed for basal (-5.2 msec), medial (-6.3 msec), and apical (-4.5 msec) slices. Precision was lower for cMRF-the average of the standard deviation measured within each slice was 102 msec for cMRF vs. 61 msec for MOLLI T , and 6.4 msec for cMRF vs. 4.0 msec for bSSFP T . cMRF and conventional techniques had similar test-retest repeatability as quantified by ICC (0.87 cMRF vs. 0.84 MOLLI for T ; 0.85 cMRF vs. 0.85 bSSFP for T ). In the ordinal image quality comparison, cMRF maps scored higher than conventional sequences for both T (all five features) and T (four features).

Data Conclusion: This work reports on myocardial T /T measurements in healthy subjects using cMRF and standard mapping sequences. cMRF had slightly lower precision, similar test-retest and intrareader repeatability, and higher scores for map quality.

Evidence Level: 2 TECHNICAL EFFICACY: Stage 1 J. Magn. Reson. Imaging 2020;52:1044-1052.
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http://dx.doi.org/10.1002/jmri.27155DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772954PMC
October 2020

Recruitment Strategies for Nurse Enrollment in an Online Study.

Nurs Res 2020 Jan/Feb;69(1):69-73

Jessica Surdam, MPH, is Research Project Director, Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio. Barbara Daly, PhD, RN, FAAN, is Professor, School of Medicine, Case Western Reserve University, Cleveland, Ohio. Sarah Fulton, MA, is Research Operations Manager, Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio. Seunghee Margevicius, PhD, is Research Associate, Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio. Mark Schluchter, PhD, is Professor, Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio. Susan Flocke, PhD, is Professor of Family Medicine, School of Medicine, Oregon Health & Science University, Portland, Ohio. Sharon Manne, PhD, is Professor, Robert Wood Johnson Medical School, Rutgers, State University of New Jersey, New Brunswick. Neal J. Meropol, MD, is Vice President, Research Oncology, Flatiron Health, New York, New York, and Adjunct Professor, Case Comprehensive Cancer Center, School of Medicine, Case Western Reserve University, Cleveland, Ohio.

Background: Although there is a great deal of literature regarding effective recruitment and challenges of recruiting specific patient populations, there is less known about best practices for recruitment of nurses as study subjects.

Objectives: The purpose of this article is to report our experience with recruitment and retention for a randomized trial of an online educational program to prepare oncology nurses to discuss oncology clinical trials with patients.

Methods: The study population included currently employed oncology nurses with direct patient interaction. There were three phases of this study: (1) qualitative interviews, (2) a pilot test, and (3) the randomized trial. Phase 3 was rolled out in five waves of recruitment. The distinct phases of the study-and the gradual roll out of recruitment during Phase 3-allowed us to test and refine our recruitment and retention methods for the randomized trial. Upon analysis of our response rate and attrition after the first wave of recruitment in Phase 3, we made several changes to improve recruitment and retention, including adding incentives, shortening the survey, and increasing the number of reminders to complete the program.

Results: The response rate was higher when we used both e-mail and U.S. postal mail solicitations. After the first wave of recruitment in the final phase, changes in our strategies did not increase our overall response rate significantly; however, the rate of attrition following baseline declined.

Discussion: Recruitment planning is an important component of successful clinical research. The use of the Internet for both recruitment of subjects and testing of interventions remains a cost-effective and potentially high yield methodology. Our research demonstrated several successful approaches to yield increased participation and retention of subjects, including seeking formal relationships with professional organizations as sponsors or supporters, providing meaningful incentives to participants, keeping surveys or questionnaires as short as possible, and planning multiple follow-up contacts from the outset.
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http://dx.doi.org/10.1097/NNR.0000000000000393DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6911026PMC
April 2020

MR Fingerprinting and ADC Mapping for Characterization of Lesions in the Transition Zone of the Prostate Gland.

Radiology 2019 09 23;292(3):685-694. Epub 2019 Jul 23.

From the Department of Radiology, Mayo Clinic, Rochester, Minn (A.P.); Department of Diagnostic, Interventional and Pediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (V.C.O.); Departments of Biomedical Engineering (W.C.L., M.A.G.), Epidemiology and Biostatistics (S.M., M.S.), and Radiology (Y.J., C.B., M.A.G., V.G.), Case Western Reserve University, Cleveland, Ohio; Department of Radiology, University of Michigan, UH B1 G503, 1500 E. Medical Center Drive, SPC 5030, Ann Arbor, MI 48109-5030 (Y.J., V.G.); Department of Radiology, Mayo Clinic, Phoenix, Az (I.J.P.); Departments of Radiology (I.J.P., D.N., C.B., M.A.G.) and Urology (I.J., L.E.P.), University Hospitals Cleveland Medical Center, Cleveland, Ohio.

BackgroundPreliminary studies have shown that MR fingerprinting-based relaxometry combined with apparent diffusion coefficient (ADC) mapping can be used to differentiate normal peripheral zone from prostate cancer and prostatitis. The utility of relaxometry and ADC mapping for the transition zone (TZ) is unknown.PurposeTo evaluate the utility of MR fingerprinting combined with ADC mapping for characterizing TZ lesions.Materials and MethodsTZ lesions that were suspicious for cancer in men who underwent MRI with T2-weighted imaging and ADC mapping ( values, 50-1400 sec/mm), MR fingerprinting with steady-state free precession, and targeted biopsy (60 in-gantry and 15 cognitive targeting) between September 2014 and August 2018 in a single university hospital were retrospectively analyzed. Two radiologists blinded to Prostate Imaging Reporting and Data System (PI-RADS) scores and pathologic diagnosis drew regions of interest on cancer-suspicious lesions and contralateral visually normal TZs (NTZs) on MR fingerprinting and ADC maps. Linear mixed models compared two-reader means of T1, T2, and ADC. Generalized estimating equations logistic regression analysis was used to evaluate both MR fingerprinting and ADC in differentiating NTZ, cancers and noncancers, clinically significant (Gleason score ≥ 7) cancers from clinically insignificant lesions (noncancers and Gleason 6 cancers), and characterizing PI-RADS version 2 category 3 lesions.ResultsIn 67 men (mean age, 66 years ± 8 [standard deviation]) with 75 lesions, targeted biopsy revealed 37 cancers (six PI-RADS category 3 cancers and 31 PI-RADS category 4 or 5 cancers) and 38 noncancers (31 PI-RADS category 3 lesions and seven PI-RADS category 4 or 5 lesions). The T1, T2, and ADC of NTZ (1800 msec ± 150, 65 msec ± 22, and [1.13 ± 0.19] × 10 mm/sec, respectively) were higher than those in cancers (1450 msec ± 110, 36 msec ± 11, and [0.57 ± 0.13] × 10 mm/sec, respectively; < .001 for all). The T1, T2, and ADC in cancers were lower than those in noncancers (1620 msec ± 120, 47 msec ± 16, and [0.82 ± 0.13] × 10 mm/sec, respectively; = .001 for T1 and ADC and = .03 for T2). The area under the receiver operating characteristic curve (AUC) for T1 plus ADC was 0.94 for separation. T1 and ADC in clinically significant cancers (1440 msec ± 140 and [0.58 ± 0.14] × 10 mm/sec, respectively) were lower than those in clinically insignificant lesions (1580 msec ± 120 and [0.75 ± 0.17] × 10 mm/sec, respectively; = .001 for all). The AUC for T1 plus ADC was 0.81 for separation. Within PI-RADS category 3 lesions, T1 and ADC of cancers (1430 msec ± 220 and [0.60 ± 0.17] × 10 mm/sec, respectively) were lower than those of noncancers (1630 msec ± 120 and [0.81 ± 0.13] × 10 mm/sec, respectively; = .006 for T1 and = .004 for ADC). The AUC for T1 was 0.79 for differentiating category 3 lesions.ConclusionMR fingerprinting-based relaxometry combined with apparent diffusion coefficient mapping may improve transition zone lesion characterization.© RSNA, 2019
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http://dx.doi.org/10.1148/radiol.2019181705DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6716564PMC
September 2019

Targeted Biopsy Validation of Peripheral Zone Prostate Cancer Characterization With Magnetic Resonance Fingerprinting and Diffusion Mapping.

Invest Radiol 2019 08;54(8):485-493

Case Western University School of Medicine, Departments of.

Objective: This study aims for targeted biopsy validation of magnetic resonance fingerprinting (MRF) and diffusion mapping for characterizing peripheral zone (PZ) prostate cancer and noncancers.

Materials And Methods: One hundred four PZ lesions in 85 patients who underwent magnetic resonance imaging were retrospectively analyzed with apparent diffusion coefficient (ADC) mapping, MRF, and targeted biopsy (cognitive or in-gantry). A radiologist blinded to pathology drew regions of interest on targeted lesions and visually normal peripheral zone on MRF and ADC maps. Mean T1, T2, and ADC were analyzed using linear mixed models. Generalized estimating equations logistic regression analyses were used to evaluate T1 and T2 relaxometry combined with ADC in differentiating pathologic groups.

Results: Targeted biopsy revealed 63 cancers (low-grade cancer/Gleason score 6 = 10, clinically significant cancer/Gleason score ≥7 = 53), 15 prostatitis, and 26 negative biopsies. Prostate cancer T1, T2, and ADC (mean ± SD, 1660 ± 270 milliseconds, 56 ± 20 milliseconds, 0.70 × 10 ± 0.24 × 10 mm/s) were significantly lower than prostatitis (mean ± SD, 1730 ± 350 milliseconds, 77 ± 36 milliseconds, 1.00 × 10 ± 0.30 × 10 mm/s) and negative biopsies (mean ± SD, 1810 ± 250 milliseconds, 71 ± 37 milliseconds, 1.00 × 10 ± 0.33 × 10 mm/s). For cancer versus prostatitis, ADC was sensitive and T2 specific with comparable area under curve (AUC; (AUCT2 = 0.71, AUCADC = 0.79, difference between AUCs not significant P = 0.37). T1 + ADC (AUCT1 + ADC = 0.83) provided the best separation between cancer and negative biopsies. Low-grade cancer T2 and ADC (mean ± SD, 75 ± 29 milliseconds, 0.96 × 10 ± 0.34 × 10 mm/s) were significantly higher than clinically significant cancers (mean ± SD, 52 ± 16 milliseconds, 0.65 ± 0.18 × 10 mm/s), and T2 + ADC (AUCT2 + ADC = 0.91) provided the best separation.

Conclusions: T1 and T2 relaxometry combined with ADC mapping may be useful for quantitative characterization of prostate cancer grades and differentiating cancer from noncancers for PZ lesions seen on T2-weighted images.
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http://dx.doi.org/10.1097/RLI.0000000000000569DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6602844PMC
August 2019

A National Study of Oncology Nurses Discussing Cancer Clinical Trials With Patients.

West J Nurs Res 2019 12 19;41(12):1747-1760. Epub 2019 Feb 19.

Case Western Reserve University, Cleveland, OH, USA.

In the United States less than 10% of cancer patients engage in clinical trials. Although most oncology nurses have multiple opportunities to discuss clinical trials with patients, barriers including attitudes and social norms may impede these discussions. Guided by the Theory of Planned Behavior, we developed and evaluated measures for attitudes, subjective norms, and perceived behavioral control of nurses for discussing clinical trials with cancer patients. Of the 18,000 Oncology Nurse Society members invited, 1,964 completed the survey. Structural equation modeling and internal consistency reliability were used to evaluate items and constructs. We found that overall model fit and reliability was good: Confirmatory Fit Index (CFI) = 0.91, Root Mean Square Error of Approximation (RMSEA) = 0.05; attitudes, 21 items, alpha = 0.84; perceived behavioral control, 10 items, alpha = 0.85; and subjective norms, 9 items, alpha = 0.89. These measures of attitudes, subjective norms, and perceived behavioral control show good reliability and initial evidence of validity.
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http://dx.doi.org/10.1177/0193945919829145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6699918PMC
December 2019

Surgical approach and the impact of epidural analgesia on survival after esophagectomy for cancer: A population-based retrospective cohort study.

PLoS One 2019 22;14(1):e0211125. Epub 2019 Jan 22.

Case Comprehensive Cancer Center, Cleveland, Ohio, United States of America.

Background: Esophagectomy 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.

Methods: A 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.

Results: Among 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.

Conclusion: Among patients undergoing transthoracic esophagectomy, including a subgroup restricted to esophageal adenocarcinoma, epidural analgesia was associated with improved survival even after adjusting for other factors.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0211125PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6342325PMC
October 2019

Human and Rat Bone Marrow-Derived Mesenchymal Stem Cells Differ in Their Response to Fibroblast Growth Factor and Platelet-Derived Growth Factor.

Tissue Eng Part A 2018 12 22;24(23-24):1831-1843. Epub 2018 Aug 22.

1 Department of Biology, Skeletal Research Center, Case Western Reserve University, Cleveland, Ohio.

Tissue engineering requires large numbers of cells with enhanced differentiation properties. Thus, the effect of expansion conditions must be explored. Human and rat marrow-derived mesenchymal stem cells (hMSCs and rMSCs, respectively) were comparatively culture expanded through seven passages in the presence of either fibroblast growth factor-2 (FGF-2) or platelet-derived growth factor BB (PDGF-BB). Proliferation of both hMSCs and rMSCs was enhanced by FGF-2 and PDGF-BB. Population doubling times for hMSCs were 2.4 days for control and 1.75 and 2.0 days for FGF-2 and PDGF-BB, respectively, and 3.25, 3.06, and 2.95 days for rMSCs. Supplementation with FGF-2 during cell expansion resulted in significantly greater in vivo bone formation for hMSCs. Use of PDGF-BB resulted in greater bone formation than that observed for control conditions, but the differences were only significant for P1. For rMSCs, significant increases in bone formation were noted in either FGF-2 or PDGF-BB expanded cells implanted at P4 or P7, but not for P1. Under in vitro osteogenic stimulation, calcium content was elevated and bone matrix deposition was enhanced for P1 and P7 rMSCs expanded with FGF-2. Although culture conditions, including FBS, were held constant, these observations suggest that medium must be optimized separately for each species of MSCs.
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http://dx.doi.org/10.1089/ten.TEA.2018.0126DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6302675PMC
December 2018

The Effects of a Single Electronic Music Improvisation Session on the Pain of Adults with Sickle Cell Disease: A Mixed Methods Pilot Study.

J Music Ther 2018 Jun;55(2):156-185

Department of Medicine- Hematology, Case Western Reserve University, University Hospitals Seidman Cancer Center, Cleveland, OH, USA.

Background: Adults with sickle cell disease (SCD) experience acute pain that is multidimensional. Despite recent improvements in treatment, pain management remains a significant challenge for these individuals. Music therapy interventions have the potential to address several dimensions of SCD pain, but they require systematic investigation.

Objective: This study investigated feasibility and preliminary efficacy of a single-session electronic music improvisation with a music therapist to diminish pain intensity and improve pain relief and mood in adults with SCD.

Methods: Using a three-group mixed methods intervention design, we randomized 60 adults with SCD to standard care plus one of three 20-minute study conditions: 1) electronic music improvisation with a music therapist (MT); 2) recorded music listening (ML); or 3) no intervention (control). Measures of pain intensity (VASPI), pain relief (VASPR), and mood (VASMOOD) were assessed before and after the study conditions, with a subset of MT and ML participants interviewed after measure completion.

Results: Compared to control, MT produced significant improvements in VASPI (odds ratio (OR) = 5.12, P = 0.035) and VASMOOD (OR = 11.60, P = 0.005). ML produced significant improvements in VASMOOD compared to control (OR = 5.76, P = 0.040). Qualitatively, there were two prominent themes directly related to music: 1) ML and MT offered many positive and few negative effects; and 2) music therapists provided comfort beyond the music.

Conclusions: Preliminary findings were promising and support the need for additional studies evaluating improvisational music therapy interventions for acute pain management in adults with SCD.
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http://dx.doi.org/10.1093/jmt/thy004DOI Listing
June 2018

Ser-486/491 phosphorylation and inhibition of AMPKα activity is positively associated with Gleason score, metastasis, and castration-resistance in prostate cancer: A retrospective clinical study.

Prostate 2018 07 26;78(10):714-723. Epub 2018 Mar 26.

The James and Eilleen Dicke Laboratory, Department of Urology, Case Western Reserve University, Cleveland, Ohio.

Background: We previously demonstrated that adenosine monophosphate-activated protein kinase (AMPKα) activity is significantly inhibited by Ser-486/491 phosphorylation in cell culture and in vivo models of metastatic and castration-resistant prostate cancer, and hypothesized these findings may translate to clinical specimens.

Methods: In this retrospective, single-institution pilot study, 45 metastatic prostate cancer cases were identified within the University Hospitals Cleveland Medical Center Pathology Archive with both metastasis and matched primary prostate tumor specimens in formalin-fixed, paraffin-embedded blocks, and complete electronic medical records. Thirty non-metastatic, hormone-dependent prostate cancer controls, who were progression-free as defined by undetectable prostate specific antigen for at least 79.6 months (range 79.6-136.0 months), and matched metastatic cases based on age, race, and year of diagnosis. All specimens were collected from 1991 to 2014; primary tumor specimens were obtained via diagnostic biopsy or prostatectomy, and metastasis specimens obtained via surgery or perimortem. 5-μ sequential slides were processed for phospho-Ser-486/491 AMPKα /α , phospho-Thr-172 AMPKα, AMPKα /α , phospho-Ser-792 Raptor, phospho-Ser-79 acetyl-CoA carboxylase, and phospho-Ser-872, 3-hydroxy-3-methylglutaryl-CoA reductase immunohistochemistry to determine expression, phosphorylation pattern, and activity of AMPKα.

Results: Increased inhibitory Ser-486/491 AMPKα /α phosphorylation, increased AMPKα protein expression, decreased AMPKα activity, and loss of nuclear AMPKα and p-AMPKα are associated with prostate cancer progression to metastasis. Increased p-Ser-486/491 AMPKα /α was also positively correlated with higher Gleason grade and progression to castration-resistance.

Conclusions: p-Ser-486/491 AMPKα /α is a novel marker of prostate cancer metastasis and castration-resistance. Ser-486/491 phosphokinases should be pursued as targets for metastatic and castration-resistant prostate cancer chemotherapy.
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http://dx.doi.org/10.1002/pros.23515DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6591712PMC
July 2018

Effect of Pericardial Fat Volume and Density on Markers of Insulin Resistance and Inflammation in Patients With Human Immunodeficiency Virus Infection.

Am J Cardiol 2017 Oct 24;120(8):1427-1433. Epub 2017 Jul 24.

Case Western Reserve University School of Medicine, Cleveland, Ohio; University Hospitals Cleveland Medical Center, Cleveland, Ohio.

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.
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http://dx.doi.org/10.1016/j.amjcard.2017.07.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5614847PMC
October 2017

The effects of music therapy on transition outcomes in adolescents and young adults with sickle cell disease.

Int J Adolesc Med Health 2017 Aug 5;31(3). Epub 2017 Aug 5.

Department of Medicine-Hematology, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.

Background The Build, Educate, Advance, Transition, in Sickle cell disease (BEATS) music therapy program was developed to address health challenges faced by adolescents/young adults (AYA) with sickle cell disease (SCD) during the transition to adult medical care. Objective The purpose of this study was to investigate the effects of BEATS on self-efficacy, trust, knowledge about SCD, and adherence in adolescents/young adults (AYA) with SCD. Subjects Thirty AYA with SCD, 18-23 years old, recruited from an adult SCD clinic agreed to participate in four BEATS sessions over 1 year. Methods Self-efficacy, trust and SCD knowledge were measured prospectively at baseline and months 3, 6, 9, and 12. Adherence to clinic appointments and healthcare utilization were measured retrospectively from medical records. A repeated measures linear mixed-effect model with compound symmetry covariance structure was used to fit the data. Results BEATS participants demonstrated a significant improvement in SCD knowledge (p = 0.0002) compared to baseline, an increase in acute care clinic, but not emergency department, utilization (p = 0.0056), and a non-significant improvement in clinic attendance (p = 0.1933). Participants' subjective evaluations revealed a positive response to BEATS. There were no significant changes in self-efficacy, trust, hospital admissions, or blood transfusion adherence. Conclusion Culturally tailored, developmentally appropriate music therapy transition interventions can concretely improve SCD knowledge and may improve transition for AYA with SCD.
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http://dx.doi.org/10.1515/ijamh-2017-0004DOI Listing
August 2017

Short Physical Performance Battery, usual gait speed, grip strength and Vulnerable Elders Survey each predict functional decline among older women with breast cancer.

J Geriatr Oncol 2017 Sep 22;8(5):356-362. Epub 2017 Jul 22.

Division of Hematology/Oncology, Department of Medicine, Case Western Reserve School of Medicine, United States; Case Comprehensive Cancer Center, Cleveland, OH, United States.

Objective: To determine the ability of three performance-based measures [Short Physical Performance Battery (SPPB), gait speed, and Grip Strength] and a self-report measure [Vulnerable Elders Survey (VES-13)] to predict functional decline among older women with breast cancer.

Patients And Methods: Longitudinal data from a study of women ≥65years, with newly diagnosed stages I-III breast cancer, recruited from ambulatory oncology clinics between July 2010 and April 2014, was used. The primary outcome was functional decline, Yes or No, defined as a decrease in ≥1-point from baseline to 12months, on Activities of Daily Living Scales. Multivariable logistic regression and receiver operator curve analyses were conducted.

Results: Among 123 participants 18 (15%) developed functional decline. The predictive abilities for measures were: SPPB [Adjusted odds ratio (AOR)=1.65 per unit decrease in scores, 95% confidence interval (CI)=1.33-2.05; area under the receiver operator curve (AUC)=0.93; sensitivity=94%, specificity=80%]; gait speed (AOR=1.76 per unit increase in usual walking time, CI=1.29-2.41; AUC=0.93; sensitivity=87%, specificity=79%); VES-13 (AOR=1.64 per unit increase in scores, CI=1.31-2.05; AUC=0.87; sensitivity=83%, specificity=84%); and grip strength: (AOR=1.18 per unit decrease in grip strength, CI=1.06-1.30; AUC=0.80; sensitivity=67%, specificity=77%).

Conclusion: SPPB, gait speed, grip strength and VES-13 all demonstrated excellent predictive abilities for functional decline. Larger studies are warranted to confirm the utility of these measures for identifying older adults with cancer at increased risk for functional decline, who may then be targeted for studies to explore the effects of interventions to improve function.
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http://dx.doi.org/10.1016/j.jgo.2017.07.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5747299PMC
September 2017

Development of a Combined MR Fingerprinting and Diffusion Examination for Prostate Cancer.

Radiology 2017 06 10;283(3):729-738. Epub 2017 Feb 10.

From the School of Medicine (A.C.Y., M.R.), Department of Radiology (C.B., S.P., S.D., M.A.G., V.G.), Department of Urology (L.E.P., W.T., R.A., V.G.), Department of Biomedical Engineering (Y.J., M.A.G., V.G.), Department of Epidemiology and Biostatistics (S.M., M.S.), and Department of Mathematics (D.M.), Case Western Reserve University, 11100 Euclid Ave, Cleveland, OH 44106.

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 mm/sec ± 0.331, respectively) were significantly lower than those from NPZ (mean, 2247 msec ± 450, 169 msec ± 61, and 1.711 × 10 mm/sec ± 0.269) (P < .0001 for each) and together produced the best separation between these groups (AUC = 0.99). ADC and T2 together produced the highest AUC of 0.83 for separating high- or intermediate-grade tumors from low-grade cancers. T1, T2, and ADC in prostatitis (mean, 1707 msec ± 377, 79 msec ± 37, and 0.911 × 10 mm/sec ± 0.239) were significantly lower than those in NPZ (P < .0005 for each). Interreader agreement was excellent, with an intraclass correlation coefficient greater than 0.75 for both T1 and T2 measurements. Conclusion This study describes the development of a rapid MR fingerprinting- and diffusion-based examination for quantitative characterization of prostatic tissue. RSNA, 2017 Online supplemental material is available for this article.
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http://dx.doi.org/10.1148/radiol.2017161599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5452885PMC
June 2017

Vulnerable elders survey and socioeconomic status predict functional decline and death among older women with newly diagnosed nonmetastatic breast cancer.

Cancer 2016 08 27;122(16):2579-86. Epub 2016 Jun 27.

Division of Hematology/Oncology, Department of Medicine, Case Western Reserve School of Medicine, Cleveland, Ohio.

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.
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http://dx.doi.org/10.1002/cncr.30046DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5027843PMC
August 2016

Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.

J Clin Oncol 2016 Feb 23;34(5):469-78. Epub 2015 Dec 23.

Neal J. Meropol, University Hospitals Case Medical Center Seidman Cancer Center; Neal J. Meropol, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller, and Mark D. Schluchter, Case Comprehensive Cancer Center, Case Western Reserve University; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Yu-Ning Wong, Suzanne M. Miller, Michael Collins, Brian Egleston, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania Health System, Philadelphia, PA; Terrance Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Sharon Manne, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz, International Myeloma Foundation, North Hollywood, CA; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA.

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.
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http://dx.doi.org/10.1200/JCO.2015.63.2257DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872012PMC
February 2016

Financial Concerns About Participation in Clinical Trials Among Patients With Cancer.

J Clin Oncol 2016 Feb 23;34(5):479-87. Epub 2015 Dec 23.

Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA.

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.
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http://dx.doi.org/10.1200/JCO.2015.63.2463DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872013PMC
February 2016

Peptide-Targeted Gold Nanoparticles for Photodynamic Therapy of Brain Cancer.

Part Part Syst Charact 2015 Apr;32(4):448-457

Departments of Biomedical Engineering and Radiology, NFCR Center for Molecular Imaging, Case Western Reserve University, 11100 Euclid Ave., Cleveland, OH 44106, USA.

Targeted drug delivery using epidermal growth factor peptide-targeted gold nanoparticles (EGF-Au NPs) is investigated as a novel approach for delivery of photodynamic therapy (PDT) agents, specifically Pc 4, to cancer. In vitro studies of PDT show that EGF-Au NP-Pc 4 is twofold better at killing tumor cells than free Pc 4 after increasing localization in early endosomes. In vivo studies show that targeting with EGF-Au NP-Pc 4 improves accumulation of fluorescence of Pc 4 in subcutaneous tumors by greater than threefold compared with untargeted Au NPs. Targeted drug delivery and treatment success can be imaged via the intrinsic fluorescence of the PDT drug Pc 4. Using Pc 4 fluorescence, it is demonstrated in vivo that EGF-Au NP-Pc 4 impacts biodistribution of the NPs by decreasing the initial uptake by the reticuloendothelial system (RES) and by increasing the amount of Au NPs circulating in the blood 4 h after IV injection. Interestingly, in vivo PDT with EGF-Au NP-Pc 4 results in interrupted tumor growth when compared with EGF-Au NP control mice when selectively activated with light. These data demonstrate that EGF-Au NP-Pc 4 utilizes cancer-specific biomarkers to improve drug delivery and therapeutic efficacy over untargeted drug delivery.
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http://dx.doi.org/10.1002/ppsc.201400119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4437573PMC
April 2015

Persisting behavior problems in extremely low birth weight adolescents.

J Dev Behav Pediatr 2015 Apr;36(3):178-87

*Department of Pediatrics, Case Western Reserve University and Rainbow Babies & Children's Hospital, University Hospitals Case Medical Center, Cleveland, OH; †Department of Epidemiology and Biostatistics, Case Western Reserve University, Cleveland, OH.

Objective: To describe behavior problems in extremely low birth weight (ELBW, <1000 g) adolescents born 1992 through 1995 based on parent ratings and adolescent self-ratings at age 14 years and to examine changes in parent ratings from ages 8-14.

Method: Parent ratings of behavior problems and adolescent self-ratings were obtained for 169 ELBW adolescents (mean birth weight 815 g, gestational age 26 wk) and 115 normal birth weight (NBW) controls at 14 years. Parent ratings of behavior at age 8 years were also available. Behavior outcomes were assessed using symptom severity scores and rates of scores above DSM-IV symptom cutoffs for clinical disorder.

Results: The ELBW group had higher symptom severity scores on parent ratings at age 14 years than NBW controls for inattentive attention-deficit hyperactivity disorder (ADHD), anxiety, and social problems (all p's < .01). Rates of parent ratings meeting DSM-IV symptom criteria for inattentive ADHD were also higher for the ELBW group (12% vs. 1%, p < .01). In contrast, the ELBW group had lower symptom severity scores on self-ratings than controls for several scales. Group differences in parent ratings decreased over time for ADHD, especially among females, but were stable for anxiety and social problems.

Conclusions: Extremely low birth weight adolescents continue to have behavior problems similar to those evident at a younger age, but these problems are not evident in behavioral self-ratings. The findings suggest that parent ratings provide contrasting perspectives on behavior problems in ELBW youth and support the need to identify and treat these problems early in childhood.
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http://dx.doi.org/10.1097/DBP.0000000000000139DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4382381PMC
April 2015

Trajectory and correlates of growth of extremely-low-birth-weight adolescents.

Pediatr Res 2014 Feb 11;75(2):358-66. Epub 2013 Nov 11.

Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio.

Background: Catch-up growth may predispose to obesity and metabolic sequelae. We sought to examine the trajectory and correlates of growth and catch up among extremely-low-birth-weight (ELBW) (<1 kg) adolescents.

Methods: A cohort study of 148 neurologically normal ELBW children and 115 normal-birth-weight (NBW) controls born during the period 1992-1995 was conducted. Longitudinal measures of gender-specific growth of ELBW children from birth, in addition to growth and measures of obesity of ELBW and NBW children at 14 y, were evaluated.

Results: Following neonatal growth failure, ELBW children had accelerated growth, but at 8 y, they still had lower weight and height z scores than NBW children. By 14 y, ELBW boys had caught up in growth to their NBW controls, but ELBW girls remained significantly smaller. ELBW children, however, did not differ from their controls in measures of obesity. In hierarchical multiple regression analyses, only maternal BMI and weight gain during infancy and childhood predicted the ELBW children's 14-y weight z scores, BMI z scores, and abdominal circumference. Perinatal risk factors, including intrauterine growth, only predicted growth up to 20 mo.

Conclusion: Maternal BMI and rate of growth, rather than perinatal factors, predict 14-y obesity among neurologically normal ELBW adolescents.
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http://dx.doi.org/10.1038/pr.2013.209DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3992255PMC
February 2014

Bullying of extremely low birth weight children: associated risk factors during adolescence.

Early Hum Dev 2013 May 27;89(5):333-8. Epub 2012 Dec 27.

Department of Pediatrics, Case Western Reserve University, Cleveland, OH 44106-6010, USA.

Background: Preterm children have many risk factors which may increase their susceptibility to being bullied.

Aims: To examine the prevalence of bullying among extremely low birth weight (ELBW, <1 kg) and normal birth weight (NBW) adolescents and the associated sociodemographic, physical, and psychosocial risk factors and correlates among the ELBW children.

Methods: Cohort study of self-reports of bullying among 172 ELBW adolescents born 1992-1995 compared to 115 NBW adolescents of similar age, sex and sociodemographic status. Reports of being bullied were documented using the KIDSCREEN-52 Questionnaire which includes three Likert type questions concerning social acceptance and bullying. Multiple linear regression analyses adjusting for sociodemographic factors were used to examine the correlates of bullying among the ELBW children.

Results: Group differences revealed a non-significant trend of higher mean bullying scores among ELBW vs. NBW children (1.56 vs. 1.16, p=0.057). ELBW boys had significantly higher bullying scores than NBW boys (1.94 vs. 0.91, p<0.01), whereas ELBW and NBW girls did not differ (1.34 vs. 1.30, p=0.58). Bullying of ELBW children was significantly associated with subnormal IQ, functional limitations, anxiety and ADHD, poor school connectedness, less peer connectedness, less satisfaction with health and comfort, and less risk avoidance.

Conclusion: ELBW boys, but not girls, are more likely to be victims of bullying than NBW boys. School and health professionals need to be aware of the risk of bullying among ELBW male adolescents.
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http://dx.doi.org/10.1016/j.earlhumdev.2012.11.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3625459PMC
May 2013

Music therapy reduces pain in palliative care patients: a randomized controlled trial.

J Pain Symptom Manage 2013 May 24;45(5):822-31. Epub 2012 Sep 24.

Music Therapy Department, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA.

Context: Treatment of pain in palliative care patients is challenging. Adjunctive methods of pain management are desirable. Music therapy offers a nonpharmacologic and safe alternative.

Objectives: To determine the efficacy of a single music therapy session to reduce pain in palliative care patients.

Methods: 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.

Results: 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]; P<0.0001). 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; P>0.05). 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; P<0.0001) [corrected]: A single music therapy intervention incorporating therapist-guided autogenic relaxation and live music was effective in lowering pain in palliative care patients.
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http://dx.doi.org/10.1016/j.jpainsymman.2012.05.008DOI Listing
May 2013
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