integrating Data for Analysis, Anonymization, and SHaring
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1 integrating Data for Analysis, Anonymization, and SHaring Informed Consent for Biospecimen Collection and Data Sharing among Low-income, Uninsured and Underinsured Women: Is it a Matter of Trust? Maria Elena Martinez, PhD Ian Komenaka, MD
2 Outline Background and Rationale Goal and Specific Aims Methods Progress Report Future Directions 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 2
3 Background Obtaining informed consent for collection, storage, and future research of biospecimen is challenging and complex. Even more challenging is the informed consent process involving vulnerable and underserved populations. Perception that individuals from underserved populations will be less likely to share their biospecimens than other groups. 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 3
4 Biospecimen Sharing Published reports:» Knowledge and understanding about specimen sharing» Use of existing/stored biological specimens» Some data exist on individual s willingness to provide biospecimens but less is known about actual provision of these. 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 4
5 Willingness to Provide Biospecimens Loffredo et al., 2013 Factors associated with knowledge about and intention to provide biospecimens for research purposes. 331 foreign-born Latinos from Central and South America attending safety-net clinics in the Washington, DC area. Results:» 47 % knew what biospecimens were» 67 % said that they would provide a specimen after being given information about what this involved» Individuals with higher education level were more likely to say they would provide biospecimens.» Medical mistrust was not related to provision. 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 5
6 Awareness and Interest in Biospecimen Donation for Cancer Research in Latino community (Rodriguez et al., 2013) Key informant interviews with Latino community leaders (N=6). Focus groups with members of the Latino community (N=22). Implications Issues that need to be addressed:» Educational materials/programs that explain the purpose of community participation in biospecimen donation» Explanation of potential risks and benefits of participation in biobanking research is needed» Clear statement of what, if any, information will or will not be returned to participants 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 6
7 Rationale Need for biospecimen repositories to include samples from individuals from traditionally under-represented groups. Perceived barriers related to biospecimen donation:» lack of information or knowledge» fear» mistrust 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 7
8 DBP Overview Conduct a pilot study to compare physician vs. non-physician delivery of informed consent for biospecimen and data sharing among underserved women in a safety-net health care setting. Ian Komenaka, MD 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 8
9 Specific Aims To compare informed consent for biospecimen collection and data sharing for research obtained by a physician vs. consent obtained by a research assistant, both electronically via a tablet (i.e., ipad). To explore differences in informed consent delivery by the following factors:» Age» Race/ethnicity» Health literacy» Cancer risk perception» Language» Breast cancer vs. non-cancer diagnosis» Trust 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 9
10 Methods: Patient Population MIHS serves a racially and ethnically diverse population, many of whom face major challenges to accessing health care. Breast Center serves ~900 patients per year; 9-10 new breast cancers are diagnosed each month. 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 10
11 Maricopa Integrated Health System Patient Characteristics Maricopa Integrated Health System (MIHS) is the health care safety-net provider for residents of Maricopa County. Socioeconomic status:» 46% have less than H.S. education» 33% unemployed» Mean household income is $1,071/month» 90% uninsured or on Medicaid; 3.5% on Medicare. Race/ethnicity:» 67% Hispanic/Latino» 20% NHW» 9% Black/African-American 53% non-english speaking 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 11
12 Methods Recruit 140 women; randomize 70 to each arm. Eligibility criteria:» 18 years or older» English or Spanish speaking» Undergoing breast biopsy for any reason Patients will be shown a short video about the benefits of consenting to biospecimen and data sharing for research (TAKEN OUT). Outcome measures:» Participation rate by randomization arm.» Differences in informed consent according to age, race/ethnicity, health literacy, cancer risk perception, language use, and breast cancer vs. noncancer diagnosis. Tissue collected: FFPE tumor tissue and saliva sample. 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 12
13 Methods: Data Collection Sociodemographics Cancer Risk Perception (Diefenbach et al.). Health literacy using Newest Vital Signs (NVS) instrument (Weiss et al.). Trust survey (Wells et al.). Satisfaction survey. Marcia Bouton, PA Ian Komenaka, MD 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 13
14 Progress Report Accomplishments Electronic consent IRB approval Staff training IT support Collection and transfer of saliva samples Few refusals so recruitment is fast Challenges/Hurdles Subcontract award Ordering saliva kits Hiring research assistant Permission to purchase ipads Low accrual Acquiring tumor tissue 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 14
15 Accrual Goal: 2-3/week for 15 months. 140 by end of December Began June 19 th Recruiting 2-3 per week (only one day per week). As of September 4 th, randomized 22 participants. Need to recruit 118 patients (~8 per month). 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 15
16 Next Steps Hiring a second research assistant and add one more day of recruitment per week to meet timeline: 100 by end of No shortage of patients. Given the already high consent rate, do not plan to use the video. Continue to send saliva samples to UCSD.? Tumor tissue samples 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 16
17 Recruitment Timeline July, 2013 (n=100) August, 2014 (n=60) December, 2014 (n=100) April, 2015 (n=140) 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 17
18 Unsolicited Participant Comments 40 y.o. female being seen for follow-up. After giving her sputum sample she said, Even though I will not benefit from this [research] it makes me feel good that I will be helping other people. 59 y.o. female. Paget s disease in 1999 then probable recurrence in Now left breast cancer in Consented for this study, Myriad testing, and City of Hope registry. When she handed Dr. Komenaka her sputum sample, he dropped it! He tried to tell her forget it, we ll do it next time but she said No I ll do it now. This is important. AND she had 2 of her adopted kids with her and they also were totally supportive of her participation in the research. 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 18
19 Acknowledgements Maricopa Ian Komenaka Marcia Bouton UCSD Elena Martinez Jesse Nodora Olivier Harismendy Richard Schwab idash team Kristen Wells (SDSU) 9/25/2014 Supported by the NIH Grant U54 HL to the University of California, San Diego 19
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