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Raz D.J.,City of Hope | Ruel N.,Biostatistics Core | Chang W.,City of Hope | Erhunmwunsee L.,City of Hope | And 4 more authors.
Clinical Lung Cancer | Year: 2017

Background: The purpose of this study was to evaluate the feasibility and acceptability of a multimedia self-management (MSM) intervention to prepare patients and family caregivers for lung surgery. Patients and Methods: This is a quasi-experimental, 2-group, sequential enrollment pilot study of a 4-session multimedia intervention (audio/visual + print) to enhance self-management and quality of life (QOL) for patients and family caregivers. The intervention, Preparing for Lung Surgery, begins before surgery, and continues through hospitalization and discharge, with 2 telephone support sessions after discharge. Outcomes were assessed before surgery (preintervention), at discharge, and 2 to 4 weeks postdischarge (postintervention). Patient outcomes were assessed using the Functional Assessment of Cancer Therapy-General (QOL), MD Anderson Symptom Inventory and Functional Assessment of Cancer Therapy-Pulmonary Symptom Index (symptoms), self-efficacy, surgery-related knowledge, and patient activation. Family caregiver outcomes included City of Hope-QOL-Family (QOL), Caregiver Burden Scale, and knowledge. Paired t tests were used for exploratory evaluations of score changes from pre- to postintervention. Results: Sixty participants (38 patients, 22 family caregivers) enrolled in the study (70% accrual). Postintervention scores were significantly improved for patients' emotional QOL (P = .001). Trends for improvements were observed for patient self-efficacy, surgery-related knowledge, and activation. Family caregivers' surgery-related knowledge was significantly improved (P = .02). Overall, participants were highly satisfied with the acceptability/usability of the intervention (3.6-3.7 of 4.0). Conclusion: A standardized MSM intervention was feasible and acceptable in supporting readiness and preparedness for lung surgery and postoperative recovery. A larger randomized trial is needed to verify the impact of the MSM intervention on patient/family caregiver outcomes and health care resource use. © 2017 Elsevier Inc.


Yiu A.J.,151 Research Service | Kalejaiye A.,151 Research Service | Kalejaiye A.,The Surgical Center | Amdur R.L.,Biostatistics Core | And 2 more authors.
International Journal of Oral and Maxillofacial Surgery | Year: 2016

To further define potential factors that may contribute to stone formation in salivary glands (sialolithiasis), a retrospective chart review was performed of patients diagnosed with sialolithiasis between March 1, 1998 and February 29, 2012. Information on salivary gland stone number, location and size, medical history, medications, and serum electrolyte levels were collected. Associations between electrolyte levels and stone characteristics (such as stone number and size) were examined. Fifty-nine patients were identified; their median age was 58 years (range 25-89 years) and most were male (95%). Salivary stones were most commonly located in the submandibular glands (83%). Thirty-five patients (59%) had a smoking history, with 16 (27%) reported as current smokers. There was a significant association between current smoker status and stone size (mean largest stone size 12.4 ± 8.8 mm vs. 7.5 ± 4.8 mm in current smokers vs. non-smokers; P = 0.03). Serum sodium levels (r = 0.32, P = 0.014) and serum potassium levels (r = 0.31, P = 0.017) showed significant positive correlations with stone size. While the aetiology of sialolithiasis remains unclear, smoking (which can contribute to reduced saliva flow) and higher serum sodium levels (which can reflect volume depletion) are associated with larger salivary stones. © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.


Ragin C.,Fox Chase Cancer CenterTemple HealthPhiladelphia | Kim S.,Biostatistics and Bioinformatics Research CenterCedars Sinai Medical CenterLos Angeles | Chen Z.,Biostatistics Core | Belani C.P.,Penn State Hershey Cancer InstituteHershey
Cancer | Year: 2015

BACKGROUND: The last 3 decades have witnessed limited therapeutic advances in small cell lung cancer (SCLC) management. This study evaluated real-world trends in the use of systemic therapies and the impact on patient outcomes in the United States. METHODS: The Surveillance, Epidemiology, and End Results-Medicare database was used to find patients diagnosed with SCLC between 1985 and 2005. The 1985-1990 period served as the baseline for a temporal analysis conducted at 5-year intervals (1985-1990, 1991-1995, 1996-2000, and 2001-2005). Cox proportional models were used to estimate the effect of chemotherapy on survival. Results were validated with a propensity-matched analysis. RESULTS: There were 47,351 eligible patients: 52% were male; the median age was 71 years; and 87% were white, 7% were black, and 1.4% were Asian. The proportion of patients treated with chemotherapy was low but increased over time (38%, 55%, 50%, and 53%; P < .001). Race, diagnosis period, age, stage, and location of residence significantly predicted chemotherapy use. Females (51%), Asians (53%), and rural residents (60%) were more likely to receive chemotherapy. The median overall survival with and without chemotherapy was 9.6 and 3.6 months, respectively. Linear trend analyses showed a modest reduction in the impact of chemotherapy on survival for patients treated with chemotherapy versus untreated patients (hazard ratios [HRs], 0.59, 0.61, 0.64, and 0.62; P < .001) but an overall trend of improved survival for treated (HRs, 1.0, 1.03, 1.00, and 0.96; P = .005) and untreated patients (HRs, 1.0, 0.99, 0.94, and 0.92; P < .001). There was no survival difference between patients treated with carboplatin and patients treated with cisplatin (HR, 0.99; confidence interval [CI], 0.81-1.19; P = .875). Additional therapy beyond platinum-based chemotherapy was associated with a survival benefit (HR, 0.78; CI, 0.75-0.81; P < .001). CONCLUSIONS: Chemotherapy use was associated with a survival benefit in Medicare patients with SCLC treated in a real-world setting. © 2015 American Cancer Society.


Soldan A.,Johns Hopkins University | Pettigrew C.,Johns Hopkins University | Selnes O.,Johns Hopkins University | Albert M.,Johns Hopkins University | And 37 more authors.
Human Brain Mapping | Year: 2015

This study evaluated the utility of baseline and longitudinal magnetic resonance imaging (MRI) measures of medial temporal lobe brain regions collected when participants were cognitively normal and largely in middle age (mean age 57 years) to predict the time to onset of clinical symptoms associated with mild cognitive impairment (MCI). Furthermore, we examined whether the relationship between MRI measures and clinical symptom onset was modified by apolipoprotein E (ApoE) genotype and level of cognitive reserve (CR). MRI scans and measures of CR were obtained at baseline from 245 participants who had been followed for up to 18 years (mean follow-up 11 years). A composite score based on reading, vocabulary, and years of education was used as an index of CR. Cox regression models showed that lower baseline volume of the right hippocampus and smaller baseline thickness of the right entorhinal cortex predicted the time to symptom onset independently of CR and ApoE-e{open}4 genotype, which also predicted the onset of symptoms. The atrophy rates of bilateral entorhinal cortex and amygdala volumes were also associated with time to symptom onset, independent of CR, ApoE genotype, and baseline volume. Only one measure, the left entorhinal cortex baseline volume, interacted with CR, such that smaller volumes predicted symptom onset only in individuals with lower CR. These results suggest that MRI measures of medial temporal atrophy, ApoE-e{open}4 genotype, and the protective effects of higher CR all predict the time to onset of symptoms associated with MCI in a largely independent, additive manner during the preclinical phase of Alzheimer's disease. Hum Brain Mapp 36:2826-2841, 2015. © 2015 Wiley Periodicals, Inc.


PubMed | Translational Research Core, Biostatistics Core and H. Lee Moffitt Cancer Center and Research Institute
Type: Clinical Trial, Phase I | Journal: EBioMedicine | Year: 2016

Vitamin E -tocotrienol (VEDT), a natural vitamin E from plants, has shown anti-neoplastic and chemoprevention activity in preclinical models of pancreatic cancer. Here, we investigated VEDT in patients with pancreatic ductal neoplasia in a window-of-opportunity preoperative clinical trial to assess its safety, tolerability, pharmacokinetics, and apoptotic activity.Patients received oral VEDT at escalating doses (from 200 to 3200 mg) daily for 13 days before surgery and one dose on the day of surgery. Dose escalation followed a three-plus-three trial design. Our primary endpoints were safety, VEDT pharmacokinetics, and monitoring of VEDT-induced neoplastic cell apoptosis (ClinicalTrials.gov number NCT00985777).In 25 treated patients, no dose-limiting toxicity was encountered; thus no maximum-tolerated dose was reached. One patient had a drug-related adverse event (diarrhea) at a 3200-mg daily dose level. The effective half-life of VEDT was ~ 4 h. VEDT concentrations in plasma and exposure profiles were quite variable but reached levels that are bioactive in preclinical models. Biological activity, defined as significant induction of apoptosis in neoplastic cells as measured by increased cleaved caspase-3 levels, was seen in the majority of patients at the 400-mg to 1600-mg daily dose levels.VEDT from 200 to 1600 mg daily taken orally for 2 weeks before pancreatic surgery was well tolerated, reached bioactive levels in blood, and significantly induced apoptosis in the neoplastic cells of patients with pancreatic ductal neoplasia. These promising results warrant further clinical investigation of VEDT for chemoprevention and/or therapy of pancreatic cancer.


News Article | December 2, 2016
Site: www.eurekalert.org

New research demonstrates that a novel imaging agent can quickly and accurately detect metastasis of prostate cancer, even in areas where detection has previously been difficult. Published in the December issue of The Journal of Nuclear Medicine, the Phase 1 dose-escalation study of Zr-89-desferrioxamine-IAB2M (Zr-89-Df-IAB2M), an anti-PSMA (prostate-specific membrane antigen) minibody, in patients with metastatic prostate cancer shows its effectiveness in targeting both bone and soft tissue lesions. "This agent is imaged faster than other PSMA-targeting imaging antibodies due to its small size and has been shown to be safe for patients," explains Neeta Pandit-Taskar, MD, of the Memorial Sloan Kettering Cancer Center in New York City. "The radiotracer combines a small amount of the radioactive material zirconium-89 with a fragment of an antibody called a minibody. This minibody has anti-PSMA qualities and attaches to overexpression of the enzyme on the exterior of prostate cancer cells, wherever they may have traveled in the body. Particles emitted from the site are then detected by positron emission tomography (PET). The resulting scan highlights 'hot spots' of PSMA overexpression." She adds, "Using this agent, we can detect the prostate cancer cells that have metastasized to bone--one of the most difficult areas to evaluate using standard methods." For the study, 18 patients were imaged with the new agent using PET/CT as well as a variety of conventional imaging modalities, including computed tomography (CT), magnetic resonance imaging (MRI), molecular bone scan (SI), and PET with fluorodeoxyglucose (FDG-PET). Suspected disease sites were then selected and biopsied. Both skeletal and nodal lesions were detected with Zr-89-Df-IAB2M; scans were positive in 17 of the 18 patients, with bone lesions targeted in 9 and soft tissue disease seen in 14. In comparison, bone scans with more traditional agents (Tc-99m-methylene diphosphonate and FDG) were positive for bone lesions in 9 and 6 patients, respectively; for nodal/soft tissue disease, CT and FDG scans were positive in 14 and 10 patients, respectively. In two patients, a single site of disease per patient was identified only by the minibody. In total, Zr-89-Df-IAB2M imaging detected 147 bone and 82 soft-tissue or nodal lesions. "Results of imaging with this Zr-89 radiolabeled minibody have shown that we are able to detect more disease sites in patients than with conventional imaging," Pandit-Taskar states. "We hope that with further development this technology will help us in earlier and more accurate assessment of disease and assist in clinical decision-making." She points out, "With further validation, this agent could potentially be used for targeted biopsies, which could lead to more appropriate, timely treatment for prostate cancer patients. It may also have potential use in targeted radiotherapy." According to the National Cancer Institute, in 2013 nearly 3 million men in the U.S. were living with prostate cancer. In 2016, more than 180,000 men in the U.S. are expected to be diagnosed with prostate cancer, and more than 26,000 are likely to die from the disease. Authors of the article "First-in-Human Imaging with 89Zr-Df-IAB2M Anti-PSMA Minibody in Patients with Metastatic Prostate Cancer: Pharmacokinetics, Biodistribution, Dosimetry, and Lesion Uptake" include Neeta Pandit-Taskar, Jorge A. Carrasquillo, Jason S. Lewis, Steven M. Larson, Wolfgang A. Weber, Howard I. Scher, and Michael J. Morris, Memorial Sloan Kettering Cancer Center (MSK) and Weill Cornell Medical College (WCMC), New York, New York; Joseph A. O'Donoghue, Shutian Ruan, Serge K. Lyashchenko, Glenn Heller, Danny F. Martinez, Sarah M. Cheal, and Martin Fleisher, MSK; and Jennifer S. Keppler, Robert E. Reiter, and Anna M. Wu, ImaginAb, Inc., Inglewood, California. This work was funded by ImaginAb, Inc.; DOD Clinical Consortium (#PC071610); and MSK's Radiochemistry & Molecular Imaging Probe Core and Biostatistics Core (CCSG P30 CA008748). Please visit the SNMMI Media Center to view the PDF of the study, including images, and more information about molecular imaging and personalized medicine. To schedule an interview with the researchers, please contact Laurie Callahan at (703) 652-6773 or lcallahan@snmmi.org. Current and past issues of The Journal of Nuclear Medicine can be found online at http://jnm. . About the Society of Nuclear Medicine and Molecular Imaging The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international scientific and medical organization dedicated to raising public awareness about nuclear medicine and molecular imaging, a vital element of today's medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated and helping provide patients with the best health care possible. SNMMI's more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit http://www. .


PubMed | University of Hawaii at Manoa, Biostatistics Core and Louisiana State University Health Sciences Center
Type: | Journal: SpringerPlus | Year: 2015

Empirical evidence regarding cancer screening and health literacy is mixed. Cancer is the leading cause of death in Asian Americans, yet screening rates are notably low. Using a population-based sample, we determined if health literacy: (1) was associated with breast and cervical cancer screening, and (2) helped to explain Asian cancer screening disparities.We analyzed the 2007 California Health Interview Survey for Asian (Japanese, Chinese, Filipino, Korean, Vietnamese, other Asian) and white women within age groups relevant to US Preventive Services Task Force (USPSTF) screening guidelines: cervical: ages 21-65 (n=15,210) and breast: ages 50-74 (n=11,163). Multilevel logistic regression models predicted meeting USPSTF screening guidelines both with and without self-reported health literacy controlling for individual-level and contextual-level factors.Low health literacy significantly (p<0.05) predicted lower cancer screening in final models for both cancer types. In unadjusted models, Asians were significantly less likely than whites to receive both screening types and significantly more likely to report low health literacy. However, in multivariable models, the addition of the low health literacy variable did not diminish Asian vs. white cancer screening disparities.Self-reported health literacy predicted cervical and breast cancer screening, but was not able to explain Asian cancer screening disparities. We provide new evidence to support a relationship between health literacy and cancer screening. Health literacy is likely a useful focus for interventions to improve cancer screening and ultimately reduce the burden of cancer. To specifically reduce Asian cancer disparities, additional areas of focus should be considered.


Guo M.W.,University of Hawaii at Manoa | Ahn H.J.,Biostatistics Core | Juarez D.T.,University of Hawaii at Hilo | Miyamura J.,Hawaii Health Information Corporation | Sentell T.L.,University of Hawaii at Manoa
Preventing Chronic Disease | Year: 2015

Introduction The objective of this study was to compare in-hospital deaths and length of stays for diabetes-related preventable hospitalizations (D-RPHs) in Hawai'i for Asian American, Pacific Islander, and white Medicare recipients aged 65 years or older. Methods We considered all hospitalizations of older (>65 years) Japanese, Chinese, Native Hawaiians, Filipinos, and whites living in Hawai'i with Medicare as the primary insurer from December 2006 through December 2010 (n = 127,079). We used International Classification of Diseases - 9th Revision (ICD-9) codes to identify D-RPHs as defined by the Agency for Healthcare Research and Quality. Length of stays and deaths during hospitalization were compared for Asian American and Pacific Islander versus whites in multivariable regression models, adjusting for age, sex, location of residence (Oahu, y/n), and comorbidity. Results Among the group studied, 1,700 hospitalizations of 1,424 patients were D-RPHs. Native Hawaiians were significantly more likely to die during a D-RPH (odds ratio [OR], 3.92; 95% confidence interval [CI], 1.42-10.87) than whites. Filipinos had a significantly shorter length of stay (relative risk [RR], 0.77; 95% CI, 0.62-0.95) for D-RPH than whites. Among Native Hawaiians with a D-RPH, 59% were in the youngest age group (65-75 y) whereas only 6.3% were in the oldest (≥85 y). By contrast, 23.2% of Japanese were in the youngest age group, and 32.2% were in the oldest. Conclusion This statewide study found significant differences in the clinical characteristics and outcomes of D-RPHs for Asian American and Pacific Islanders in Hawai'i. Native Hawaiians were more likely to die during a D-RPH and were hospitalized at a younger age for a D-RPH than other studied racial/ethnic groups. Focused interventions targeting Native Hawaiians are needed to avoid these outcomes.


PubMed | University of Hawaii at Manoa, Biostatistics Core, University of Hawaii at Hilo and Hawaii Health Information Corporation
Type: | Journal: Preventing chronic disease | Year: 2015

The objective of this study was to compare in-hospital deaths and length of stays for diabetes-related preventable hospitalizations (D-RPHs) in Hawaii for Asian American, Pacific Islander, and white Medicare recipients aged 65 years or older.We considered all hospitalizations of older (>65 years) Japanese, Chinese, Native Hawaiians, Filipinos, and whites living in Hawaii with Medicare as the primary insurer from December 2006 through December 2010 (n = 127,079). We used International Classification of Diseases - 9th Revision (ICD-9) codes to identify D-RPHs as defined by the Agency for Healthcare Research and Quality. Length of stays and deaths during hospitalization were compared for Asian American and Pacific Islander versus whites in multivariable regression models, adjusting for age, sex, location of residence (Oahu, y/n), and comorbidity.Among the group studied, 1,700 hospitalizations of 1,424 patients were D-RPHs. Native Hawaiians were significantly more likely to die during a D-RPH (odds ratio [OR], 3.92; 95% confidence interval [CI], 1.42-10.87) than whites. Filipinos had a significantly shorter length of stay (relative risk [RR], 0.77; 95% CI, 0.62-0.95) for D-RPH than whites. Among Native Hawaiians with a D-RPH, 59% were in the youngest age group (65-75 y) whereas only 6.3% were in the oldest (85 y). By contrast, 23.2% of Japanese were in the youngest age group, and 32.2% were in the oldest.This statewide study found significant differences in the clinical characteristics and outcomes of D-RPHs for Asian American and Pacific Islanders in Hawaii. Native Hawaiians were more likely to die during a D-RPH and were hospitalized at a younger age for a D-RPH than other studied racial/ethnic groups. Focused interventions targeting Native Hawaiians are needed to avoid these outcomes.


Juarez D.T.,University of Hawaii at Hilo | Ma C.,University of Hawaii at Hilo | Kumasaka A.,University of Hawaii at Hilo | Shimada R.,University of Hawaii at Manoa | Davis J.,Biostatistics Core
Population Health Management | Year: 2014

The objectives of this study were to describe patient characteristics and types of medications taken by those with poor glycemic control (A1c>7%) despite being adherent to antidiabetic medications. This is a retrospective analysis of administrative data from adult patients with diabetes enrolled in a large health plan in Hawaii (n=21,267 observations for 11,013 individuals) and adherent to their antidiabetic medications. Multivariable logistic regressions were estimated to determine characteristics and types of medications associated with poor glycemic control. Separate models were estimated to examine category of medication (insulin only, 1 oral medication, multiple oral medications, both oral medications and insulin) and specific therapeutic class of oral antidiabetic medications. Despite being adherent to their medications, 56.1% of patients had poor glycemic control. Compared to patients taking combination sulfonylureas, patients had a higher odds of having A1c>7% for all other oral diabetic medications, with odds ratios ranging from OR=2.07 for sulfonylureas alone to OR=1.33 for combination DPP-4 inhibitors. More than half of patients in this study had poor A1c control despite being adherent to their medications. This suggests that physicians, pharmacists, and other providers may need to monitor treatment regimens more carefully, encourage healthy behaviors, and intensify pharmacological treatment as needed. (Population Health Management 2014;17:218-223) © Copyright 2014, Mary Ann Liebert, Inc. 2014.

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