Citations

Abstract Background: African immigrants in the US have substantially higher prevalences of viral hepatitis and hepatocellular carcinoma than the general population. In Minnesota, which has the third largest state population of African immigrants in the US, the incidence and mortality for hepatocellular carcinoma among Blacks is 3 times higher than Caucasians (The 2012 Minnesota Department of Health Cancer Report). Most African immigrants are unaware of their risk for hepatocellular carcinoma which contributes to substantial liver health disparities. Limited research exists on the burden of viral hepatitis and hepatocellular carcinoma among African immigrants. Thus, we conducted a pilot study to evaluate the knowledge, attitudes, and behaviors (KAB) of African immigrants related to liver disease. Methods: The study used a community-engaged research framework. The research team consisted of stakeholders from an academic medical center and Ethiopian, Liberian, and Kenyan community-based organizations and faith-based centers. A semi-structured focus group guide was developed using a KAB approach with open-ended questions. Content analysis was used to thematically code the transcribed data. Qualitative analysis software (ATLAS.TI) was used to organize codes and highlight major themes contributing to liver health disparities. Results: We enrolled 63 participants and conducted 9 focus groups (1 in Amharic, 2 in Oromo, and 6 in English) in Rochester and Minneapolis, Minnesota. The mean age was 47±19; 32 participants (51%) were male; the median years lived in the US was 12 years. General knowledge of the modes of transmission of viral hepatitis and of the prevention and development of liver cancer was minimal. Themes related to barriers to viral hepatitis screening and vaccination included perceived cultural stigma and use of traditional remedies. Common sources of general health information included internet, pamphlets, friends, family, spiritual leaders and healthcare professionals. Healthcare professionals are the source for information on screening, prevention, transmission and treatment of viral hepatitis and liver cancer. Most participants sought healthcare at reputable medical institutions. Media sources and community-based events at faith-centers were preferred modes of information dissemination on viral hepatitis and liver cancer screening and prevention. Conclusions: Participants identified several factors contributing to the increased burden of hepatocellular carcinoma in Minnesota including lack of knowledge of disease transmission and progression, cultural stigma/taboos, and lack of preventive care. Culturally and linguistically appropriate interventions are needed to increase awareness, prevention, early detection, and treatment of viral hepatitis and liver cancer among African immigrants in Minnesota. Citation Format: Essa A. Mohamed, Nasra H. Giama, Hassan M. Shaleh, Linda M. Kerandi, Abdul M. Oseini, Hager F. Ahmed Mohammed, Henry M. Kerandi, Dekermue Togbah, Abdiwahab O. Ali, Ibrahim A. Waaeys, Hamdi A. Ali, Safra A. Mohamed, Hawa M. Ali, Joyce E. Balls-Berry, Lewis R. Roberts. Evaluating knowledge, attitudes, and behaviors about viral hepatitis and hepatocellular carcinoma among recent African immigrants in Minnesota: A community-engaged qualitative study. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr C01.

Abstract Background: The rising incidence of hepatocellular carcinoma in the US is partly due to increased immigration from sub-Saharan Africa. Viral hepatitis is prevalent in sub-Saharan Africa, resulting in ~20% of all hepatocellular carcinoma cases worldwide. Community-based education and screening efforts aimed at identifying viral hepatitis cases among African immigrants will likely reduce the burden of hepatocellular carcinoma. Aim: To determine the knowledge, attitudes and behaviors (KAB) of Liberian and Kenyan immigrants residing in Minnesota about hepatitis B virus and hepatitis C virus screening, vaccination, acquisition, and disease management. Methods: A community-engaged research framework was used for the development of this cross-sectional study. The team created a survey using validated items designed to assess the KAB of viral hepatitis measured on a 1 to 20 scale with 1 being low and 20 being high. Using community-engaged methodology, participants who were ≥18 years of age and self-identified either as Liberian and Kenyan were recruited from churches, community centers, and community events. The survey was administered between June 2014 and February 2015. Spearman's rho correlation was used to identify associations among scores while the Mann-Whitney U-test was used for comparisons between Liberians and Kenyans. Results: Of 80 distributed surveys, 73 were returned, achieving a response rate of 91%. Respondents were 50 (64%) Liberians and 23 (29%) Kenyans; 42 (54%) were female; the mean age was 42 years (range 18-90); most were college educated (57%) and had health insurance (83%). 55% reported previous screening for hepatitis B, 51% had completed hepatitis B vaccination and 38% reported being screened for hepatitis C. Mean scores ± SD were 4.6±2.8 for knowledge, 4.7±1.0 for attitude, and 4.2±1.9 for behavior, resulting in poor knowledge and adequate attitude and behavioral levels. Significant and positive linear correlation was observed between attitude and behavior (r=.385, p<.001), while there were no significant correlations between knowledge and attitude (r=-.115, p=.33) or knowledge and behavior (r=-.11, p=.36). When Liberians and Kenyans were compared, knowledge was higher in Liberians (6.2±1.9 vs1.5±1.0; p<.001); there were no significant differences observed in attitude or behavior scores (p>.05 for both). Conclusions: There is lack of awareness among African immigrants of the health risks associated with viral hepatitis which contributes to disparities in healthcare seeking behaviors. It is important to implement comprehensive education and screening programs on viral hepatitis in these communities in order to reduce the burden of viral hepatitis and hepatocellular carcinoma development. Citation Format: Hassan M. Shaleh, Nasra H. Giama, Essa A. Mohamed, Hager F. Ahmed Mohammed, Linda M. Kerandi, Abdul M. Oseini, Abdiwahab O. Ali, Ibrahim A. Waaeys, Jonggi Choi, Henry M. Kerandi, Safra A. Mohamed, Hamdi A. Ali, Hawa M. Ali, Joyce E. Balls-Berry, Lewis R. Roberts. A cross-sectional assessment of knowledge, attitudes, and behaviors about viral hepatitis and hepatocellular carcinoma among Kenyan and Liberian immigrants living in Minnesota. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr A46.

Abstract Background: The need remains for novel agents that prolong survival and/or improve QOL in women with aBC. EP is a long-acting topoisomerase 1 inhibitor engineered to produce sustained exposure to irinotecan and its active metabolite SN38. Given previous efficacy seen in an earlier phase II trial in MBC, EP 145 mg/m2 every 3 weeks was compared to TPC (one of 7 single-agent regimens) in the randomized phase 3 BEACON study (NCT01492101). As reported at ASCO 2015 (abstract 1001), EP prolonged median overall survival by 2.1 months, although this did not reach statistical significance (12.4 vs 10.3 months; HR 0.87, p=0.08). Grade ≥ 3 adverse events were significantly less common with EP (48% vs 63% with TPC, p<0.001). We now present results of the QOL analyses. Methods: Patients completed validated health-related QoL (HRQoL) questionnaires, EORTC QLQ-C30 (version 3.0) and breast cancer-specific QLQ-BR23, pretreatment and every 8 weeks until progression, death or withdrawal of consent. Questionnaires were scored according to the EORTC manual. For each scale, raw scores were standardized via a linear transformation to a range from 0 to 100. Absolute scores and changes from baseline were analyzed longitudinally and categorically using a 5-point difference calculated by treatment group. Comparisons between treatment groups were conducted to evaluate the differences in global health status, functional scores and symptoms over time. Results: The majority of patients who were randomized (total: 733/852 [86%], EP: 378/429 [88%], TPC: 355/423 [84%]) completed at least one post-baseline HRQoL questionnaire. In the EORTC QLQ-C30, grade ≥ 3 AEs significantly impacted HRQoL measured by global health status and 5 additional functional domains. Of the six domains, compared to TPC in a longitudinal analysis, EP was statistically superior in the mean treatment effect through Week 32 in global health status p=0.02 and physical functioning scale p=0.01. EP was also numerically superior in all other scales. In EORTC QLQ-C30 and BR-23, a total of 13 symptoms were measured and categorically analyzed. There were no treatment differences in 7 of 13 symptom scales. EP was associated with worsening of 3 symptom scales: appetite loss, nausea/vomiting, and diarrhea. TPC was associated with worsening of 2 symptom scales: dyspnea and systemic side effects. Conclusions: In the phase 3 BEACON trial comparing EP to TPC, the more favorable toxicity profile of EP resulted in an improvement in global health status and physical function (results of the symptom scales confirmed the different toxicities of the two arms). EP remains a promising investigational therapy for aBC. Citation Format: Cortes J, Awada A, Perez EA, Rugo HS, Twelves C, Im S-A, Zhao C, Hoch U, Ney J, Hannah AL, O'Shaughnessy J. Impact of treatment on quality of life (QOL) in the BEACON study, a randomized phase III trial of etirinotecan pegol (EP) versus treatment of physician's choice (TPC) in patients (pts) with advanced breast cancer (aBC) whose disease has progressed following anthracycline (A), taxane (T) and capecitabine (C). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-11-08.

Minorities have historically been underrepresented in health-related research. Several strategies have been recommended to increase the participation of minorities in health-related research. However, most of the recommendations and guidelines apply to research in clinical or laboratory contexts. One of the more prominent methods to enhance minority participation in health-related research that has recently come to the fore is the use of community-engaged strategies. The purpose of this article is to summarize community-engaged outreach efforts that can be translated into useable strategies for health education research teams seeking to diversify the pool of research participants. Also, we provide a succinct overview of the various components of a research endeavor that may influence minority participation in health-related research. Finally, we analyze how health education specialists and SOPHE (Society of Public Health Education) can play a leading role in helping enhance minority participation in health-related research.

AbstractBackgroundOveruse of computed tomography (CT) for minor head injury continues despite developed and rigorously validated clinical decision rules like the Canadian CT Head Rule (CCHR). Adherence to this sensitive and specific rule could decrease the number of CT scans performed in minor head injury by 35%. But in practice, the CCHR has failed to reduce testing, despite its accurate performance.ObjectivesThe objective was to identify nonclinical, human factors that promote or inhibit the appropriate use of CT in patients presenting to the emergency department (ED) with minor head injury.MethodsThis was a qualitative study in three phases, each with interview guides developed by a multidisciplinary team. Subjects were recruited from patients treated and released with minor head injuries and providers in an urban academic ED and a satellite community ED. Focus groups of patients (four groups, 22 subjects total) and providers (three groups, 22 subjects total) were conducted until thematic saturation was reached. The findings from the focus groups were triangulated with a cognitive task analysis, including direct observation in the ED (>150 hours), and individual semistructured interviews using the critical decision method with four senior physician subject matter experts. These experts are recognized by their peers for their skill in safely minimizing testing while maintaining patient safety and engagement. Focus groups and interviews were audio recorded and notes were taken by two independent note takers. Notes were entered into ATLAS.ti and analyzed using the constant comparative method of grounded theory, an iterative coding process to determine themes. Data were double‐coded and examined for discrepancies to establish consensus.ResultsFive core domains emerged from the analysis: establishing trust, anxiety (patient and provider), constraints related to ED practice, the influence of others, and patient expectations. Key themes within these domains included patient engagement, provider confidence and experience, ability to identify and manage patient anxiety, time constraints, concussion knowledge gap, influence of health care providers, and patient expectations to get a CT.ConclusionsDespite high‐quality evidence informing use of CT in minor head injury, multiple factors influence the decision to obtain CT in practice. Identifying and disseminating approaches and designing systems that help clinicians establish trust and manage uncertainty within the ED context could optimize CT use in minor head injury.

SUMMARYThis comprehensive review outlines the impact of military-relevant respiratory infections, with special attention to recruit training environments, influenza pandemics in 1918 to 1919 and 2009 to 2010, and peacetime operations and conflicts in the past 25 years. Outbreaks and epidemiologic investigations of viral and bacterial infections among high-risk groups are presented, including (i) experience by recruits at training centers, (ii) impact on advanced trainees in special settings, (iii) morbidity sustained by shipboard personnel at sea, and (iv) experience of deployed personnel. Utilizing a pathogen-by-pathogen approach, we examine (i) epidemiology, (ii) impact in terms of morbidity and operational readiness, (iii) clinical presentation and outbreak potential, (iv) diagnostic modalities, (v) treatment approaches, and (vi) vaccine and other control measures. We also outline military-specific initiatives in (i) surveillance, (ii) vaccine development and policy, (iii) novel influenza and coronavirus diagnostic test development and surveillance methods, (iv) influenza virus transmission and severity prediction modeling efforts, and (v) evaluation and implementation of nonvaccine, nonpharmacologic interventions.

Abstract Background: Etirinotecan pegol (EP) is the first long-acting topoisomerase 1-inhibitor providing sustained level of active metabolite that concentrate in the tumor for an entire chemotherapy cycle. In a Phase 2 study (Lancet Oncology 2013), EP demonstrated a 29% overall response rate in patients with metastatic breast cancer, leading to the Phase 3 global BEACON study in this population. Detection of circulating tumor cells (CTCs) using immunomagnetic EpCAM-based methods have been conceptually accepted as a "liquid tumor biopsy". To circumvent the limited recovery of CTCs these methods provide for molecular profiling applications, we isolated CTCs based on an antibody-independent, continuous flow dielectrophoresis (DEP) technology (ApoStream®). We developed quantitative multiplex immunofluorescent assays for target-specific pharmacodynamics (PD) biomarkers for EP in CTCs isolated pre- and post-treatment. Here we present the distribution of the PD biomarkers in CTC samples collected from BEACON patients. Methods: Donation of blood samples for CTC analysis was voluntary. BEACON patients participating in the substudy had serial (pre-dose, Cycle 2 Day 1, Cycle 4 Day 1, End of Treatment) 7.5-mL whole blood samples drawn in EDTA tubes and shipped ambient to ApoCell (Houston, TX) within 96 hrs for processing. PBMCs were separated by Ficoll® gradient, and CTCs were isolated using ApoStream® technology. Isolated cells were deposited on three slides and stained for DAPI, CD45, and cytokeratin markers, as well as 2-3 of the seven PD markers, and analyzed by iCys® laser scanning cytometer equipped with image analysis software. CTC count, mean fluorescence intensity (MFI) of PD biomarkers, and % marker-positive cells were analyzed for their distribution. Results: 75% of the 852 BEACON patients participated in the CTC substudy, yielding 649 pre-treatment CTC samples. As of Mar14, 538 Cycle 2 Day 1, 281 Cycle 4 Day 1, and 394 End of Treatment samples were collected. 98% of pre-treatment blood samples were successfully processed. 97% had detectable CTCs, with a median of 504 CTCs (interquartile range: 128-1432). PD markers could be analyzed in 83-92% of samples after implementing a minimum requirement of 10 CTCs analyzed. Staining was positive for Top1, Top2, μH2Ax, Rad51, ABCG2, Ki67, and TUNEL in 82%, 71%, 14%, 30%, 20%, 56%, and 94% of samples, respectively. Percent of marker-positive cells varied from 0.2-69%, with 6- to 37-fold interquartile ranges. Median MFI in these cells varied between 25x103 and 100x103, with 1.2- to 1.6-fold interquartile ranges. Conclusions: CTC collection was successfully incorporated into the BEACON study, with 75% patient participation. CTC detection rate using ApoStream® was high, permitting evaluation of biomarkers at baseline and over time. EP target-specific PD biomarkers can be measured in CTCs isolated from patients participating in BEACON and will be assessed for their potential to predict clinical response. Final BEACON efficacy and safety results are expected in early 2015, which will allow further analysis of CTCs with patient outcome (response, PFS, OS) and change in CTCs at time of progression. Citation Format: Edith A Perez, Katie Caygill, Alison L Hannah, Javier Cortes, Ahmad Awada, Joyce O'Shaughnessy, Christopher Twelves, Hope Rugo, Seock-Ah Im, Kenna Anderes, Darren W Davis, Ute Hoch. Etirinotecan pegol target-specific pharmacodynamic biomarkers in circulating tumor cells from patients with metastatic breast cancer in the phase 3 BEACON study [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-10-03.