Can mHealth Improve Risk Assessment in Underserved Populations? Acceptability of a Breast Health Questionnaire App in Ethnically Diverse, Older, Low-Income Women.

Background: Use of mobile health (mHealth) tools has expanded rapidly but little research has been done on its acceptability by low-income, diverse, older patient populations. Objective: To assess the attitudes of a diverse group of underserved women on the acceptability and usability of mHealth tools in a clinical setting using a breast health questionnaire application (app) at a public hospital mammography clinic. Methods: Semi-structured interviews were conducted in a breast-imaging center of an urban safety net institution from July-August 2012. Interviews included pre- and post-questions. Women completed the Athena breast health questionnaire app on an iPad and were asked about their experience and ways to improve the tool. Results: Fifteen women age 45-75 years from diverse ethnic and educational backgrounds were interviewed. The majority of women, 11 of 15, preferred the Athena app over a paper version and all the women thought the app was easy to use. Two Spanish-speaking Latinas preferred paper; and two women, with limited mobile phone use, did not have a preference. Many women indicated that it would be necessary to have staff available for instruction and assistance if the app were to be implemented. Conclusions: mHealth tools are an acceptable, if not preferred, method of collecting health information for diverse, older, low-income women. Further studies are required to evaluate the reliability and accuracy of data collection using mHealth tools in underserved populations. mHealth tools should be explored as a novel way to engage diverse populations to improve clinical care and bridge gaps in health disparities

Latinos and Cancer Information: Perspectives of Patients, Health Professionals and Telephone Cancer Information Specialists

Semi-structured interviews were conducted with 16 Latino cancer patients diagnosed in California; 10 health professionals from the San Francisco Bay Area and Fresno, California; and 10 Cancer Information Services (CIS) information specialists from the regional offices handling calls from Spanish-speakers. Interview guides were designed by the investigators to answer three main research questions: 1) How do Latinos obtain information about cancer and what types of information do they access?; 2) What sources of cancer information do they seek out and find credible?; and 3) What are the barriers and facilitators to Latinos obtaining cancer information? Stakeholders generally viewed health professionals as the most credible source of cancer information. All groups regarded family and friends as important sources of information. Patients and health professionals tended to differ on the value of print materials. Although patients found them generally useful, health professionals tended to view them as inadequate for meeting the informational needs of their Latino patients due to the challenge of low health literacy. Health professionals also tended to undervalue internet resources compared to patients and CIS specialists. All stakeholders viewed language, ethnic discordance and the impact on patients of the initial diagnosis as barriers to effective communication of cancer information. Health professionals and CIS specialists, but not patients, mentioned low literacy as a barrier. Our findings underscore the importance of the physician-patient relationship as a point of intervention to address the unmet informational and psychosocial needs of Latino cancer patients

Health literate organizations: Are clinical trial sites equipped to recruit minority and limited health literacy patients?

Background. Racial/ethnic minority patients are less likely than non-Latino white patients to participate in cancer clinical trials. A key barrier to participation is limited health literacy which is more common among minorities. At the organizational level, it is important that clinical trials sites become better equipped to recruit minority patients by expanding their organizational health literacy including language competency and outreach efforts. We explored the characteristics of clinical trial sites that are associated with these health literate behaviors. Methods. We identified 353 breast clinical trials recruiting participants in 2006 from four states (California, Florida, Illinois, and New York) through the National Cancer Institute Physician Data Query system. From October 2008 to November 2009, we contacted one research team member (RTM) from each site for a telephone survey to assess the site’s health literate characteristics. Results. Of 233 RTMs who responded, 93% were female and 89% were US-born. Overall, 48% of sites offered supplementary trial information, 80% offered materials to assist with patient navigation and 45% reported outreach efforts. Lower percentages offered information in other languages while 65% offered professional interpretation services. Sites with \u3e10% limited English proficiency (LEP) patients were more likely than their counterparts to offer consent forms (OR=3.13, 1.36-7.19) and supplementary information about trials in other languages (OR=2.52, 1.15-5.52). Sites with diverse patient populations (\u3e10% Latino) were also more likely than less diverse sites to engage in outreach (OR=1.97, 1.07-3.60), to offer consent forms (OR=2.72, 1.38-5.36), supplementary information about trials (OR=2.58, 1.24-5.36), and materials to improve patient navigation (OR=2.50, 1.22-5.13) in other languages. Conclusions. Efforts to recruit diverse participants were limited. Practice type and diversity of patient population were associated with sites’ efforts to accommodate these characteristics, suggesting that sites were responsive to the needs of their patients when diversity was prevalent

Application of Photovoice with Focus Groups to Explore Dietary Behaviors of Older Filipino Adults with Cardiovascular Disease

Filipino Americans have high rates of cardiovascular diseases (CVD). This study explored the dietary behaviors, a modifiable risk factor, of Filipinos with CVD. Filipinos with CVD were recruited and trained to do Photovoice. Participants took photos to depict their “food experience,” defined as their daily dietary activities. Participants then shared their photos during focus groups. Focus group transcripts were analyzed using an iterative, grounded theory approach. Among 38 Filipino participants, the mean age was 70 years old and all were foreign-born. Major themes included efforts to retain connection to Filipino culture through food, and dietary habits shaped by cultural health beliefs. Many believed that traditional dietary practices increased CVD risk. Receiving a CVD diagnosis and clinician advice changed their dietary behaviors. Household members, the physical environment, and economic constraints also influenced dietary behaviors. Photovoice is feasible among older Filipinos and may enhance understanding of drivers of dietary behaviors

IND-Enabling Studies for a Clinical Trial to Genetically Program a Persistent Cancer-Targeted Immune System

PURPOSE: To improve persistence of adoptively transferred T-cell receptor (TCR)-engineered T cells and durable clinical responses, we designed a clinical trial to transplant genetically-modified hematopoietic stem cells (HSCs) together with adoptive cell transfer of T cells both engineered to express an NY-ESO-1 TCR. Here, we report the preclinical studies performed to enable an investigational new drug (IND) application. EXPERIMENTAL DESIGN: HSCs transduced with a lentiviral vector expressing NY-ESO-1 TCR and the PET reporter/suicide gene HSV1-sr39TK and T cells transduced with a retroviral vector expressing NY-ESO-1 TCR were coadministered to myelodepleted HLA-A2/Kb mice within a formal Good Laboratory Practice (GLP)-compliant study to demonstrate safety, persistence, and HSC differentiation into all blood lineages. Non-GLP experiments included assessment of transgene immunogenicity and in vitro viral insertion safety studies. Furthermore, Good Manufacturing Practice (GMP)-compliant cell production qualification runs were performed to establish the manufacturing protocols for clinical use. RESULTS: TCR genetically modified and ex vivo-cultured HSCs differentiated into all blood subsets in vivo after HSC transplantation, and coadministration of TCR-transduced T cells did not result in increased toxicity. The expression of NY-ESO-1 TCR and sr39TK transgenes did not have a detrimental effect on gene-modified HSC's differentiation to all blood cell lineages. There was no evidence of genotoxicity induced by the lentiviral vector. GMP batches of clinical-grade transgenic cells produced during qualification runs had adequate stability and functionality. CONCLUSIONS: Coadministration of HSCs and T cells expressing an NY-ESO-1 TCR is safe in preclinical models. The results presented in this article led to the FDA approval of IND 17471

New genetic loci link adipose and insulin biology to body fat distribution.

Body fat distribution is a heritable trait and a well-established predictor of adverse metabolic outcomes, independent of overall adiposity. To increase our understanding of the genetic basis of body fat distribution and its molecular links to cardiometabolic traits, here we conduct genome-wide association meta-analyses of traits related to waist and hip circumferences in up to 224,459 individuals. We identify 49 loci (33 new) associated with waist-to-hip ratio adjusted for body mass index (BMI), and an additional 19 loci newly associated with related waist and hip circumference measures (P < 5 × 10(-8)). In total, 20 of the 49 waist-to-hip ratio adjusted for BMI loci show significant sexual dimorphism, 19 of which display a stronger effect in women. The identified loci were enriched for genes expressed in adipose tissue and for putative regulatory elements in adipocytes. Pathway analyses implicated adipogenesis, angiogenesis, transcriptional regulation and insulin resistance as processes affecting fat distribution, providing insight into potential pathophysiological mechanisms

Significant benefits of AIP testing and clinical screening in familial isolated and young-onset pituitary tumors

Context Germline mutations in the aryl hydrocarbon receptor-interacting protein (AIP) gene are responsible for a subset of familial isolated pituitary adenoma (FIPA) cases and sporadic pituitary neuroendocrine tumors (PitNETs). Objective To compare prospectively diagnosed AIP mutation-positive (AIPmut) PitNET patients with clinically presenting patients and to compare the clinical characteristics of AIPmut and AIPneg PitNET patients. Design 12-year prospective, observational study. Participants & Setting We studied probands and family members of FIPA kindreds and sporadic patients with disease onset ≤18 years or macroadenomas with onset ≤30 years (n = 1477). This was a collaborative study conducted at referral centers for pituitary diseases. Interventions & Outcome AIP testing and clinical screening for pituitary disease. Comparison of characteristics of prospectively diagnosed (n = 22) vs clinically presenting AIPmut PitNET patients (n = 145), and AIPmut (n = 167) vs AIPneg PitNET patients (n = 1310). Results Prospectively diagnosed AIPmut PitNET patients had smaller lesions with less suprasellar extension or cavernous sinus invasion and required fewer treatments with fewer operations and no radiotherapy compared with clinically presenting cases; there were fewer cases with active disease and hypopituitarism at last follow-up. When comparing AIPmut and AIPneg cases, AIPmut patients were more often males, younger, more often had GH excess, pituitary apoplexy, suprasellar extension, and more patients required multimodal therapy, including radiotherapy. AIPmut patients (n = 136) with GH excess were taller than AIPneg counterparts (n = 650). Conclusions Prospectively diagnosed AIPmut patients show better outcomes than clinically presenting cases, demonstrating the benefits of genetic and clinical screening. AIP-related pituitary disease has a wide spectrum ranging from aggressively growing lesions to stable or indolent disease course