The Prospect of Lactoferrin Use as Adjunctive Agent in Management of SARS-CoV-2 Patients: A Randomized Pilot Study.

Background and Objectives: Preventive, adjunctive and curative properties of lactoferrin have been evaluated since the first wave of severe acute respiratory syndrome coronavirus (SARS-CoV), a viral respiratory disease, emerged 18 years ago. Despite the discovery of new vaccine candidates, there is currently no widely approved treatment for SARS-CoV-2 (COVID-19). Strict adherence to infection prevention and control procedures, as well as vaccines, can, however, prevent the spread of SARS-CoV-2. This study aimed to evaluate the efficacy of lactoferrin treatment in improving clinical symptoms and laboratory indices among individuals with mild to moderate coronavirus disease-19 (COVID-19). Materials and Method: A randomized, prospective, interventional pilot study conducted between 8 July and 18 September 2020 used a hospital-based sample of 54 laboratory-confirmed participants with mild to moderate symptoms of COVID-19. Randomization into a control and two treatment groups ensured all groups received the approved Egyptian COVID-19 management protocol; only treatment group participants received lactoferrin at different doses for seven days. Clinical symptoms and laboratory indices were assessed on Days 0, 2 and 7 after starting treatments. Mean values with standard deviation and one-way analysis of variance with least significant difference of demographic and laboratory data between control and treatment groups were calculated. Results: Our study showed no statistically significant difference among studied groups regarding recovery of symptoms or laboratory improvement. Conclusions: Further research into therapeutic properties particularly related to dosage, duration and follow-up after treatment with lactoferrin in individuals with COVID-19 is required.

Attitudes toward molecular testing for personalized cancer therapy.

BACKGROUND: This study assessed attitudes of breast cancer patients toward molecular testing for personalized therapy and research. METHODS: A questionnaire was given to female breast cancer patients presenting to a cancer center. Associations between demographic and clinical variables and attitudes toward molecular testing were evaluated. RESULTS: Three hundred eight patients were approached, and 100 completed the questionnaire (a 32% response rate). Most participants were willing to undergo molecular testing to assist in the selection of approved drugs (81%) and experimental therapy (59%) if testing was covered by insurance. Most participants were white (71%). Even if testing was financially covered, nonwhite participants were less willing to undergo molecular testing for the selection of approved drugs (54% of nonwhites vs 90% of whites, odds ratio [OR] = 0.13, P = .0004) or experimental drugs (35% vs 68%, OR = 0.26, P = .0072). Most participants (75%) were willing to undergo a biopsy to guide therapy, and 46% were willing to undergo research biopsies. Nonwhite participants were less willing to undergo research biopsies (17% vs 55%, OR = 0.17, P = .0033). Most participants wanted to be informed when research results had implications for treatment (91%), new cancer risk (90%), and other preventable/treatable diseases (87%). CONCLUSIONS: Most patients were willing to undergo molecular testing and minimally invasive procedures to guide approved or experimental therapy. There were significant differences in attitudes toward molecular testing between racial groups; nonwhites were less willing to undergo testing even if the results would guide their own therapy. Novel approaches are needed to prevent disparities in the delivery of genomically informed care and to increase minority participation in biomarker-driven trials. Cancer 2015;121:243-50. © 2014 American Cancer Society.

Applying implementation science in the field of transplant and cellular therapy.

Implementation science (IS) is a systematic way to approach the broader adoption of evidence-based practices and has as its goal to understand and address the gap between research and practice, ensuring that research findings are effectively translated into practice and policy to improve health outcomes and service. We describe the various facets of IS and their relevance to the field of hematopoietic cell transplantation and cellular therapy (HCT/CT) with an emphasis on health equity, community engagement, and systems approach. We also review the similarities and differences among clinical research, quality improvement, and implementation science. Additionally, we describe how CIBMTR applies IS across various phases: dissemination, analyzing current practices, and developing implementation intervention strategies. This includes designing studies and evaluation, scaling up operations, and ensuring sustainability. Lastly, we discuss further applications of IS in HCT/CT including the application to prospective research studies, collaboration across the field, and standardization and adoption of best practices. The application of IS in HCT/CT is pivotal to bringing research benefits directly to all patients. Through partnership, open-mindedness, and a commitment to evidence-based practice, we can collectively ensure the greatest impact of research on improving patient outcomes following HCT/CT.

Cumulative incidence estimates for solid tumors after HCT in the CIBMTR and California Cancer Registry.

Compared with the general population, hematopoietic cell transplantation (HCT) survivors are at elevated risk for developing solid subsequent neoplasms (SNs). The Center for International Blood and Marrow Transplant Research (CIBMTR) is a key resource for quantifying solid SN incidence following HCT, but the completeness of SN ascertainment is uncertain. Within a cohort of 18,450 CIBMTR patients linked to the California Cancer Registry (CCR), we evaluated the completeness of solid SN data reported to the CIBMTR during 1991-2018 to understand the implications of using CIBMTR data alone or combined with CCR data to quantify the burden of solid SNs post-HCT. We estimated the cumulative incidence of developing a solid SN, accounting for the competing risk of death. Within the cohort, solid SNs were reported among 724 patients; 15.6% of these patients had an SN reported by CIBMTR-only, 36.9% by CCR-only, and 47.5% by both. The corresponding cumulative incidence of developing a solid SN at 10 years following a first HCT was 4.0% (95% CI=3.5% to 4.4%) based on CIBMTR data only, 5.3% (95% CI=4.9% to 5.9%) based on CCR data only, and 6.3% (95% CI=5.7% to 6.8%) based on both sources combined. The patterns were similar for allogeneic and autologous HCT recipients. Linking detailed HCT information from CIBMTR with comprehensive SN data from cancer registries provides an opportunity to optimize SN ascertainment for informing follow-up care practices and evaluating risk factors in the growing population of HCT survivors.

Current trends and outcomes in cellular therapy activity in the United States, including prospective Patient Reported Outcomes data collection within the CIBMTR registry.

BACKGROUND: Center for International Blood and Marrow Transplant Research (CIBMTR) prepares an annual set of summary slides to detail the trends in transplantation and cellular therapies. For the first time in the 2023 summary slides, CIBMTR incorporates data for patients receiving chimeric antigen receptor T-cell (CAR-T) infusions. In addition, the data on patient-reported outcomes (PROs) is also included. OBJECTIVES: This report aims to update the annual trends in US HCT activity and incorporate data on the use of CAR-T therapies. Here we also aim to present and describe the development, implementation, and current status of the PRO data collection. STUDY DESIGN: In August 2020, CIBMTR launched the Protocol for Collection of Patient Reported Outcomes Data (CIBMTR PRO Protocol). The CIBMTR PRO Protocol operates under a centralized infrastructure to reduce burden to centers. Specifically, PRO data is collected from a prospective convenience sample of adult HCT and CAR-T patients who received treatment at contributing centers and consented for research. Data are merged and stored with the clinical data and used under the governance of the CIBMTR Research Database Protocol. Participants answer a series of surveys developed by the Patient Reported Outcomes Measurement Information System© (PROMIS) focusing on physical, social and emotional, and others measures assessing financial well-being, occupational functioning, and social determinants of health. To complement traditionally measured clinical outcomes, the surveys are administered at the same timepoints that clinical data is routinely collected. RESULTS: As of September 2023, PRO data from 993 patients across 25 different centers has been collected. With the goal of incorporating these important patient perspectives into standard clinical care, CIBMTR has added the PRO data to Data Back to Centers (DBtC). Through expanding the data types represented in the registry, CIBMTR aims to support holistic research accounting for the patient perspective in improving patient outcomes. CONCLUSION: PRO data at CIBMTR aims to provide the foundation for future large scale, population-level evaluations to determine areas for improvement, emerging disparities in access and health outcomes (eg, by age, race, and ethnicity), and new therapies that may impact current treatment guidelines. Continuing to collect and grow the PRO data is critical for understanding these changes and identifying methods for improving patient quality of life.

Assessing Medicaid Coverage for Hematopoietic Cell Transplantation and Chimeric Antigen Receptor T Cell Therapy: A Project from the American Society for Transplantation and Cellular Therapy and the National Marrow Donor Program ACCESS Initiative.

The American Society for Transplantation and Cellular Therapy (ASTCT) and the National Marrow Donor Program (NMDP) formed the ACCESS Initiative to address and reduce barriers to hematopoietic cell transplantation (HCT) and cellular therapy (CT) to ensure equal access and outcomes for all patients in need. The 3 committees, addressing awareness, poverty, and racial and ethnic inequity, defined pilot projects focusing on addressing relevant barriers to HCT/CT. Because many socioeconomically disadvantaged HCT/CT recipients receive care through state Medicaid programs, the Poverty Committee conducted a Medicaid scan of all 50 US states with the following objectives: to define beneficiary coverage for allogeneic and autologous HCT and chimeric antigen receptor (CAR) T cell therapy; to define support for travel, temporary lodging, and meals for both beneficiaries and caregivers; and to determine search and cell acquisition payment procedures. Here we summarize the results of the Medicaid scan and highlight significant variations and gaps in coverage for HCT/CT recipients. We also provide an initial roadmap for addressing gaps in Medicaid support for HCT and CAR-T therapy recipients.

Reducing barriers of access and care related to hematopoietic cell transplantation and cellular therapy: The mission-driven role of the national marrow donor program.

The treatment of malignant and nonmalignant hematologic disorders continues to benefit from significant scientific advancement and progress in the use of hematopoietic cell transplantation and cellular therapies. However, barriers associated with receiving these lifesaving treatments and care remain, which necessitate innovative approaches to overcome, so all persons in need can receive these therapies. This article reviews barriers to receiving hematopoietic cell transplantation and cellular therapies, and highlights novel approaches taken by the National Marrow Donor Program in reducing barriers for all patients in need.

Proceedings of the 2023 Second Annual ASTCT-NMDP ACCESS Initiative Workshop.

Here the proceedings from the Second Annual American Society for Transplantation and Cellular Therapy (ASTCT) and National Marrow Donor Program (NMDP) ACCESS Initiative are reviewed to inform the hematopoietic cell transplantation (HCT) and cellular therapy (CT) ecosystem about progress and direction of the collaborative. Highlights from the meeting, including updates on the progress of projects from the Awareness, Poverty, and Racial Inequity Committees, are presented. The ACCESS Initiative continues to evolve and will remain dependent on the HCT/CT ecosystem's continued dedication to reduce barriers and improve outcome disparities for all patients in need of HCT/CT.

Real-World Data Showing Trends and Outcomes by Race and Ethnicity in Allogeneic Hematopoietic Cell Transplantation: A Report from the Center for International Blood and Marrow Transplant Research.

The use of HLA-mismatched donors could enable more patients with ethnically diverse backgrounds to receive allogeneic hematopoietic cell transplantation (HCT) in the United States. However, real-world trends and outcomes following mismatched donor HCT for diverse patients remain largely undefined. We conducted this study to determine whether the use of mismatched donor platforms have increased the access to allogeneic HCT for ethnically diverse patients, particularly through the application of novel graft-versus-host disease (GVHD) prophylaxis regimens, and whether outcomes for diverse patients are comparable to those of non-Hispanic White patients. This observational cross-sectional study used real-world data from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry. All patients receiving their first allogeneic HCT in the United States between 2009 and 2020 were included, with a focus on transplantations performed in 2020. Data from patients undergoing allogeneic HCT using bone marrow, peripheral blood, or cord blood from HLA-matched or mismatched related and unrelated donors were analyzed. Specifically, relative proportion of allogeneic HCT was generated as percentage of total for donor type and for patient age, disease indication, GVHD prophylaxis, and race and ethnicity. Causes of death were summarized using frequencies, and the Kaplan-Meier estimator was used for estimating overall survival. Compared to matched related donor and matched unrelated donor HCT, more ethnically diverse patients received mismatched unrelated donor, haploidentical donor, and cord blood HCT. Although matched unrelated donor remains the most common donor type, the use of haploidentical donors has increased significantly over the last 5 years. Paralleling this increase in haploidentical HCT is the increased use of post-transplantation cyclophosphamide (PTCy) as GVHD prophylaxis. Relative to previous transplantation eras, the most contemporary era is associated with the highest survival rates following allogeneic HCT irrespective of patient race and ethnicity. Nonetheless, disease relapse remains the primary cause of death for both adult and pediatric allogeneic HCT recipients by donor type and across all patient racial/ethnic groups. Ethnically diverse patients are undergoing allogeneic HCT at higher rates, largely through the use of alternative donor platforms incorporating PTCy. Maintaining access to potential life-saving allogeneic HCT using alternative donors and novel GVHD prophylaxis strategies and improving HCT outcomes, particularly disease relapse, remain urgent clinical needs.

The burden of oral health problems in children with mental health disorders in the United States.

OBJECTIVES: Mental health disorders (MHDs) are major public health concerns with increasing risk of morbidity and mortality among children. Oral health problems (OHPs) are receiving attention as associated comorbidities. This study assessed the burden of oral health problems in children aged 3-17 years with MHD in the United States. METHODS: Cross sectional analyses was performed using the National Survey of Children's Health database 2016-2017 containing information of 60,655,439 children. Weighted survey binomial logistic regression generating odds ratio for association between MHD and OHP were calculated. Weighted dose-response models captured incremental effects of MHD severity on oral health conditions. Population attributable risk (PAR) to quantify proportions of potentially avertable OHP as a result of intervention targeted at different levels of MHD severity were estimated. RESULTS: Prevalence of OHP among those with any MHD was 22.5 percent. Children with MHD were more likely to be non-Hispanic White, living in poorer households, and having private health insurance P < 0.001. Dose-response analyses showed children with mild MHD were 85 percent more likely [OR = 1.85 (95% CI: 1.47-2.32)], and those with moderate/severe MHD 93 percent more likely (OR = 1.93, 95% CI: 1.50-2.49) to experience OHP, compared to children without MHD. Population attributable risk (PAR) revealed that if mild and moderate/severe MHD were improved by 75 percent, OHP would be averted in 152,206 children with mild and 255,851 with moderate/severe MHD, respectively. CONCLUSION: Our results suggest that disparities persist among the pediatric population with MHD who suffer OHP in the United States.

Development of a Quality Assurance Score for the Nigeria AIDS Indicator and Impact Survey (NAIIS) Database: Validation Study.

BACKGROUND: In 2018, Nigeria implemented the world's largest HIV survey, the Nigeria AIDS Indicator and Impact Survey (NAIIS), with the overarching goal of obtaining more reliable metrics regarding the national scope of HIV epidemic control in Nigeria. OBJECTIVE: This study aimed to (1) describe the processes involved in the development of a new database evaluation tool (Database Quality Assurance Score [dQAS]) and (2) assess the application of the dQAS in the evaluation and validation of the NAIIS database. METHODS: The dQAS tool was created using an online, electronic Delphi (e-Delphi) methodology with the assistance of expert review panelists. Thematic categories were developed to form superordinate categories that grouped themes together. Subordinate categories were then created that decomposed themes for more specificity. A validation score using dQAS was employed to assess the technical performance of the NAIIS database. RESULTS: The finalized dQAS tool was composed of 34 items, with a total score of 81. The tool had 2 sections: validation item section, which contains 5 subsections, and quality assessment score section, with a score of "1" for "Yes" to indicate that the performance measure item was present and "0" for "No" to indicate that the measure was absent. There were also additional scaling scores ranging from "0" to a maximum of "4" depending on the measure. The NAIIS database achieved 78 out of the maximum total score of 81, yielding an overall technical performance score of 96.3%, which placed it in the highest category denoted as "Exceptional." CONCLUSIONS: This study showed the feasibility of remote internet-based collaboration for the development of dQAS-a tool to assess the validity of a locally created database infrastructure for a resource-limited setting. Using dQAS, the NAIIS database was found to be valid, reliable, and a valuable source of data for future population-based, HIV-related studies.

The Burden of HIV, Hepatitis B and Hepatitis C by Armed Conflict Setting: The Nigeria AIDS Indicator and Impact Survey, 2018.

Background: Against a background of security challenges, Nigeria conducted recently the largest population-based HIV survey in the world to ascertain the burden of the HIV disease in the country. Objective: We evaluated the main outcomes of the survey and the level of success using participation/response indicators. Methods: The survey was conducted from July-December 2018 by over 6,000 field staff across Nigeria in six consecutive webs, using two-stage cluster sampling. We estimated the prevalence of HIV, hepatitis B and hepatitis C in the entire country and by conflict zone status. Adjusted odds ratios (OR) and 95% confidence intervals (CI) from survey logistic regression models were used to compare the likelihood of test positivity for the three infections between zones. Findings: A total of 186,405 adults were interviewed from 97,250 households in 3,848 census enumeration areas. The overall HIV, hepatitis B and hepatitis C positivity rates were 1.55%, 7.63% and 1.73%, respectively. The prevalence of HIV, hepatitis B and C infection was significantly greater in conflict than non-conflict zones (HIV: 1.75% versus 1.0%; hepatitis B: 9.9% versus 7.3%; and hepatitis C: 3.2% versus 0.3%; p < 0.01 in all cases). Individuals living in conflict zones were about three times as likely to test positive for HIV (OR = 2.80, 95% CI = 2.08, 3.60) and nearly six times as likely to test positive for hepatitis C (OR = 5.90, 95% CI = 2.17, 16.67). Conclusion: Large population-based surveys are feasible, even in armed conflict settings. The burden of HIV, hepatitis B and hepatitis C was significantly higher in areas of conflict in Nigeria, highlighting the need for reinforced public health control measures in these settings in order to attain UNAIDS' 95-95-95 targets of controlling the HIV epidemic in sub-Saharan Africa by 2030.

Health Insurance Status of Pregnant Women and the Likelihood of Receipt of Antenatal Screening for HIV in Sub-Saharan Africa.

BACKGROUND: We investigated if initiating preventive care against HIV vertical transmission by antenatal HIV screening is independent of the patients' source of financial reimbursement for the care received in sub-Saharan Africa (SSA). METHODS: Using information from the WHO's Global Health Expenditure Database and the Demographic Health Surveys Database for 27 sub-Saharan countries, we used Spearman's correlation and adjusted survey logistic regression to determine the potential relationship between enrollment in health insurance and the likelihood that expectant mothers would be offered antenatal HIV screening. RESULTS: We found that expectant mothers covered by health insurance were more than twice as likely to be offered antenatal screening for HIV compared to the uninsured. The likelihood differed by the type of insurance plan the expectant mother carried. DISCUSSION: Health insurance is more of a financial tool that this study finds to be necessary to boost the uptake of preventive and therapeutic HIV care in SSA. CONCLUSION: The ensuing disparity in receiving proper care could hinder the goals of 90-90-90 and the forthcoming 95-95-95 plan in SSA.

Association between Intimate Partner Violence, Knowledge and Use of Contraception in Africa: Comparative Analysis across Five African Regions.

BACKGROUND OR OBJECTIVES: Intimate partner violence (IPV) against women is common globally, and is associated with several adverse consequences. This study provides a comparative analysis of potential regional differences in the association between IPV and knowledge and use of contraceptives within Africa. METHODS: A multi-country cross-sectional study was conducted using data on women of reproductive age 15-49 years from the Demographic and Health Surveys covering five African regions. Exposure and outcome variables were IPV and reproductive literacy (comprising modern contraception knowledge and contraception usage) respectively. We used survey log-binomial regression models to generate prevalence ratios that estimated the association between IPV versus knowledge and usage of modern contraception. RESULTS: Overall IPV prevalence in Africa was 30.8% with notable regional differences. Demographic, socioeconomic, and reproductive history markers of IPV were more pronounced in younger women, rural residents, women of low socioeconomic status and those with copious knowledge but poor usage of modern contraception. The level of knowledge of contraception was 84% greater among African women who were victims of IPV compared to their counterparts who were not victims of IPV (p < 0.0001). IPV was not associated with actual usage of modern contraception (p = 0.21). CONCLUSION AND GLOBAL HEALTH IMPLICATIONS: IPV against women in Africa may incentivize knowledge seeking of modern contraception as protective mechanisms. Regional variations notwithstanding, understanding the existing and new characteristics predictive of IPV may inform policy development, resource allocation and prevention of IPV globally.

Oral Health Problems among Children with Neurodevelopmental Disorders in the United States.

Children with neurodevelopmental disabilities (NDD) suffer poor oral health problems (OHP) leading to adverse health outcomes. We examined the association between NDD and OHP among children in the United States (US) ages 3-17 years using data from the National Survey of Children's Health (NSCH) 2016-17. The prevalence of OHP was 19.1%. Children with NDD had about 40% greater likelihood of poor oral health compared to their non-NDD counterparts (p <0.0001). Living at or above 200%-300% of the federal poverty level (FPL), private insurance coverage, and living with a least a college educated adult were found to be protective factors against poor oral health among children.

Social Determinants of Overweight and Obesity Among Children in the United States.

BACKGROUND: Childhood obesity is one of the foremost threats to population health in the United States (U.S.) leading to the emergence of co-morbidities and increased healthcare cost. We explore the influence of selected social determinants of health (SDOH) on overweight and obesity among U.S. children. METHODS: We utilized the National Survey of Children's Health (NSCH) 2016-17 dataset for this analysis. Overweight was defined as Body Mass Index (BMI) ≥ 85th to<95th, while obesity was defined as BMI ≥95th percentile for age and sex. Based on the literature and pathway plausibility, we examined several SDOH variables as predictors of childhood overweight or obesity in the US. Survey log-binomial regression models were built to generate prevalence ratio (PR) estimates to capture the associations between SDOH and overweight or obesity. RESULTS: About 30.6 million children were surveyed of which 9.5 million (31.0%) were either overweight or obese. The likelihood of obesity was elevated among non-Hispanic Black and Hispanic children (PR = 1.53; 95% CI = 1.01-2.31) and (PR = 1.50; 95% CI = 1.18-1.90) respectively. Overweight was more frequent in younger children, children of single parents, and children who lived in a neighborhood with no amenities. Parental attainment of college education, health insurance coverage, female gender, and language spoken in home other than Spanish were protective against overweight or obesity. CONCLUSIONS AND GLOBAL HEALTH IMPLICATIONS: SDOH represent markers of overweight or obesity in children. We recommend the development of innovative interventions using SDOH risk and protective pathways as guide to address the current epidemic of childhood overweight and obesity.

Engaging vulnerable populations in parent-led support groups: Testing a recruitment strategy.

Despite the proven benefits of parenting interventions, parent engagement in such interventions remains low and is particularly challenging among vulnerable populations. This theoretically grounded study tested the effectiveness of a recruitment strategy - a simulated parent-led support group (PSG) - to increase intentions to attend a PSG in a predominantly low income, minority sample. The study also examined sociodemographic characteristics that may influence the effectiveness of the recruitment strategy and engagement in PSGs. Surveys assessing intentions to attend a PSG were administered before and after the simulation, and a 2-month follow-up survey assessed subsequent PSG attendance. A total of 95 participants were included in this study. Results indicate that participants' intentions to attend a PSG significantly increased following the PSG simulation (Cohen's d = 1.15), especially among Hispanics. However, PSG attendance in the 2 months following the PSG simulation was relatively low, with only 13% of parents attending a PSG or a planning meeting to start a new PSG. Nevertheless, this recruitment strategy may serve as an important component of a larger engagement effort, especially given the substantial challenges of engaging vulnerable populations in PSGs and other parenting interventions to reduce educational and health disparities.

Strategies of High-Performing Teaching Hospitals.

Teaching hospitals are large and complex, and under constant financial pressure. In this study, we examine the financial performance of 80 large teaching hospitals in the 20 largest cities in the U.S. over the last five years, to identify which strategic and operational management factors separate high-performing hospitals from lower-performing ones. Results suggest that growth strategies should continue to be sought for improving long-term financial condition. Operational efficiency was less important than market share, economic status of surrounding community, hospital size, and teaching intensity. This study's findings should help guide strategic planning for teaching hospitals.

Patient knowledge and information-seeking about personalized cancer therapy.

BACKGROUND: Understanding patients' knowledge and prior information-seeking regarding personalized cancer therapy (PCT) may inform future patient information systems, consent for molecular testing and PCT protocols. We evaluated breast cancer patients' knowledge and information-seeking behaviors regarding PCT. METHODS: Newly registered female breast cancer patients (n=100) at a comprehensive cancer center completed a self-administered questionnaire prior to their first clinic visit. RESULTS: Knowledge regarding cancer genetics and PCT was moderate (mean 8.7±3.8 questions correct out of 16). A minority of patients (27%) indicated that they had sought information regarding PCT. Higher education (p=0.009) and income levels (p=0.04) were associated with higher knowledge scores and with seeking PCT information (p=0.04). Knowledge was not associated with willingness to participate in PCT research. CONCLUSION: Educational background and financial status impact patient knowledge as well as information-seeking behavior. For most patients, clinicians are likely to be patients' initial source of information about PCT. Understanding patients' knowledge deficits at presentation may help inform patient education efforts.

Attitudes regarding privacy of genomic information in personalized cancer therapy.

OBJECTIVE: To evaluate attitudes regarding privacy of genomic data in a sample of patients with breast cancer. METHODS: Female patients with breast cancer (n=100) completed a questionnaire assessing attitudes regarding concerns about privacy of genomic data. RESULTS: Most patients (83%) indicated that genomic data should be protected. However, only 13% had significant concerns regarding privacy of such data. Patients expressed more concern about insurance discrimination than employment discrimination (43% vs 28%, p<0.001). They expressed less concern about research institutions protecting the security of their molecular data than government agencies or drug companies (20% vs 38% vs 44%; p<0.001). Most did not express concern regarding the association of their genomic data with their name and personal identity (49% concerned), billing and insurance information (44% concerned), or clinical data (27% concerned). Significantly fewer patients were concerned about the association with clinical data than other data types (p<0.001). In the absence of direct benefit, patients were more willing to consent to sharing of deidentified than identified data with researchers not involved in their care (76% vs 60%; p<0.001). Most (85%) patients were willing to consent to DNA banking. DISCUSSION: While patients are opposed to indiscriminate release of genomic data, privacy does not appear to be their primary concern. Furthermore, we did not find any specific predictors of privacy concerns. CONCLUSIONS: Patients generally expressed low levels of concern regarding privacy of genomic data, and many expressed willingness to consent to sharing their genomic data with researchers.