An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study.

BACKGROUND: Obtaining explicit consent from patients to use their remnant biological samples and deidentified clinical data for research is essential for advancing precision medicine. OBJECTIVE: We aimed to describe the operational implementation and scalability of an electronic universal consent process that was used to power an institutional precision health biobank across a large academic health system. METHODS: The University of California, Los Angeles, implemented the use of innovative electronic consent videos as the primary recruitment tool for precision health research. The consent videos targeted patients aged ≥18 years across ambulatory clinical laboratories, perioperative settings, and hospital settings. Each of these major areas had slightly different workflows and patient populations. Sociodemographic information, comorbidity data, health utilization data (ambulatory visits, emergency room visits, and hospital admissions), and consent decision data were collected. RESULTS: The consenting approach proved scalable across 22 clinical sites (hospital and ambulatory settings). Over 40,000 participants completed the consent process at a rate of 800 to 1000 patients per week over a 2-year time period. Participants were representative of the adult University of California, Los Angeles, Health population. The opt-in rates in the perioperative (16,500/22,519, 73.3%) and ambulatory clinics (2308/3390, 68.1%) were higher than those in clinical laboratories (7506/14,235, 52.7%; P<.001). Patients with higher medical acuity were more likely to opt in. The multivariate analyses showed that African American (odds ratio [OR] 0.53, 95% CI 0.49-0.58; P<.001), Asian (OR 0.72, 95% CI 0.68-0.77; P<.001), and multiple-race populations (OR 0.73, 95% CI 0.69-0.77; P<.001) were less likely to participate than White individuals. CONCLUSIONS: This is one of the few large-scale, electronic video-based consent implementation programs that reports a 65.5% (26,314/40,144) average overall opt-in rate across a large academic health system. This rate is higher than those previously reported for email (3.6%) and electronic biobank (50%) informed consent rates. This study demonstrates a scalable recruitment approach for population health research.

Risk estimation, anxiety, and breast cancer worry in women at risk for breast cancer: A single-arm trial of personalized risk communication.

OBJECTIVE: Elevated anxiety and breast cancer worry can impede mammographic screening and early breast cancer detection. Genetic advances and risk models make personalized breast cancer risk assessment and communication feasible, but it is unknown whether such communication of risk affects anxiety and disease-specific worry. We studied the effect of a personalized breast cancer screening intervention on risk perception, anxiety, and breast cancer worry. METHODS: Women with a normal mammogram but elevated risk for breast cancer (N = 122) enrolled in the Athena Breast Health risk communication program were surveyed before and after receiving a letter conveying their breast cancer risk and a breast health genetic counselor consultation. We compared breast cancer risk estimation, anxiety, and breast cancer worry before and after risk communication and evaluated the relationship of anxiety and breast cancer worry to risk estimation accuracy. RESULTS: Women substantially overestimated their lifetime breast cancer risk, and risk communication somewhat mitigated this overestimation (49% pre-intervention, 42% post-intervention, 13% Gail model risk estimate, P < .001). Both general anxiety and breast cancer worry declined significantly after risk communication in women with high baseline anxiety. Baseline anxiety and breast cancer worry were essentially unrelated to risk estimation accuracy, but risk communication increased alignment of worry with accuracy of risk assessment. CONCLUSIONS: Personalized communication about breast cancer risk was associated with modestly improved risk estimation accuracy in women with relatively low anxiety and less anxiety and breast cancer worry in women with higher anxiety. We detected no negative consequences of informing women about elevated breast cancer risk.

Electronic Video Consent to Power Precision Health Research: A Pilot Cohort Study.

BACKGROUND: Developing innovative, efficient, and institutionally scalable biospecimen consent for remnant tissue that meets the National Institutes of Health consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer. OBJECTIVE: This study aims to pilot-test an electronic video consent that individuals could complete largely on their own. METHODS: The University of California, Los Angeles developed a video consenting approach designed to be comprehensive yet fast (around 5 minutes) for providing universal consent for remnant biospecimen collection for research. The approach was piloted in 175 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. The pilot yielded 164 completed postconsent surveys. The pilot assessed the usefulness, ease, and trustworthiness of the video consent. In addition, we explored drivers for opting in or opting out. RESULTS: The pilot demonstrated that the electronic video consent was well received by patients, with high scores for usefulness, ease, and trustworthiness even among patients that opted out of participation. The revised more animated video pilot test in phase 2 was better received in terms of ease of use (P=.005) and the ability to understand the information (P<.001). There were significant differences between those who opted in and opted out in their beliefs concerning the usefulness of tissue, trusting researchers, the importance of contributing to science, and privacy risk (P<.001). The results showed that "I trust researchers to use leftover biological specimens to promote the public's health" and "Sharing a biological sample for research is safe because of the privacy protections in place" discriminated opt-in statuses were the strongest predictors (both areas under the curve were 0.88). Privacy concerns seemed universal in individuals who opted out. CONCLUSIONS: Efforts to better educate the community may be needed to help overcome some of the barriers in engaging individuals to participate in precision health initiatives.

Correction: Electronic Video Consent to Power Precision Health Research: A Pilot Cohort Study.

[This corrects the article DOI: 10.2196/29123.].

Implementing a Population-Based Breast Cancer Risk Assessment Program.

BACKGROUND: Personalized breast cancer risk assessment is important in identifying and managing women at increased risk for breast cancer. However, there has been little evaluation of the practical aspects of implementing a population-based program that identifies and refers high-risk patients for further evaluation. PATIENTS AND METHODS: We implemented a semiautomated approach to collect personal and family history to identify women at high risk of breast cancer. On the basis of the survey, women identified as elevated risk received letters inviting them to telephone consultations with licensed breast health genetic counselors (BHGCs). High-risk women's history was verified and counseling and referrals provided, as appropriate. RESULTS: Among 20,558 women screened, 2000 (9.7%) women were identified as high risk on the basis of patient initial report. However, most (1,580) were excluded from receiving risk communication after BHGC review of risk information with the woman or because of previous attention to breast cancer risk or an abnormal mammogram. Among 420 subjects who received risk letters, 225 received a BHGC consultation. Of these 225 women, 63 were reclassified as average risk, 158 were referred to high-risk clinics, and 5 consultations were incomplete after determining that further information was needed. Of the 158 women referred to high-risk breast clinics, 51 attended an appointment. CONCLUSION: This study highlights the complex nature of a population-based breast cancer screening program in a clinical setting and shows the substantial effort needed to identify newly discovered women at high risk for breast cancer and refer them to appropriate services.