McCormick, Jennifer Blair

As applications of genomic sequencing have expanded, offering genetic counseling support to all patients is arguably no longer practical. Additionally, whether individuals desire and value genetic counseling services for genomic screening is unclear. We offered elective genetic counseling to 5110 individuals prior to undergoing sequencing and 2310 participants who received neutral results to assess demand. A total of 0.2% of the study participants accessed genetic counseling services prior to sequencing, and 0.3% reached out after receiving neutral results. We later conducted 50 interviews with participants to understand why they did not access these services. Many interviewees did not recall the availability of genetic counseling and were unfamiliar with the profession. Interviewees described not needing counseling before sequencing because they understood the study and felt that they could cope with any result. Counseling was considered equally unnecessary after learning neutral results. Although the participants had questions about their results, they did not feel that speaking with a genetic counselor would be helpful. Genomic screening efforts that employ opt-in models of genetic counseling may need to clarify the potential value of genetic counseling support from the outset and feature genetic counseling services more prominently in program materials.

e20608 Background: The American Society of Clinical Oncology recommends that physicians (MDs) assess the treatment goals and preferences of patients (pts) with advanced stage cancer. Available data, however, shows that pts’ values are not always well prioritized when making a treatment plan. Therefore, we iteratively developed a values tool containing 16 belief domains to inform MDs during conversations with their pts about the pts’ current priorities as they plan the next step in care. The purpose of this study was to determine the feasibility of using this values tool (defined as half of the tools having at least one value checked and half of the MDs discussing at least one value) in a phase I clinic setting. Methods: We audio-taped initial MD-pt conversations about potential enrollment in a phase I clinical trial at two academic medical centers (Emory and Mayo). The pts completed the values tool by selecting the 4 most important considerations for their next stage of care and were instructed to give the completed tool to the MD. The MDs were informed through the consent process but not specifically coached on use of the tool. The recorded conversations were coded using standard qualitative methodology to determine if a value from the tool was discussed. Results: There were 23 recorded encounters. All of the completed tools had at least one value checked and 19 of 23 (83%) completed tools were delivered to the MDs by the pts, as instructed. Of those who received the tool, 12 (63%) MDs discussed one or more of the values. The average satisfaction scores on a 5-point Likert scale were 3.9, 4.0, and 4.0, respectively, for tool clarity, ease of understanding, and benefit for pts who are offered a phase 1 trial (22/23 pts completed the evaluation). Average satisfaction scores from the 19 MDs who completed evaluations were 4.2 and 4.6, respectively, for influence of the tool on their treatment recommendation and accurate reflection of pts’ desires. Conclusions: The study met the predefined feasibility threshold and provides a strong rationale for future efficacy testing, including coaching of MDs. The tool was well accepted by both MDs and pts, and failure to deliver the completed tool by the pt was identified as a potential barrier to its effectiveness.

Background: DNA biobanks frequently obtain broad permissions from sample donors, who agree to allow their biospecimens to be used for a variety of future purposes. A limitation of this approach is that it may not be possible to discuss or anticipate all potential uses of biospecimens at the time patient consent is obtained. We surveyed biobank participants to clarify their views regarding the need to be informed about research involving whole genome sequencing (WGS). Methods: We invited 1200 participants in the Mayo Clinic Biobank to complete a survey inquiring about their support for WGS; their interest in being recontacted before WGS of their biospecimens; whether they would consent to WGS if asked; and the acceptability of proceeding with WGS if sample donors could not be reached. Results: Six hundred eighty-seven biobank participants returned completed surveys (57% response). More than 96% of biobank participants were supportive of WGS and would give permission for WGS of their sample, if asked. Nonetheless, 61% of biobank participants felt they should be recontacted before WGS was done. Participants were divided regarding the permissibility of conducting WGS if efforts to recontact sample donors were unsuccessful. Discussion: Our findings highlight a potential discrepancy between the broad permissions granted by biobank participants at the time they donated biospecimens and their views about the application of WGS to their samples. Biobank participants appear to value the ability to confirm their commitment to genetic research when the studies in question involve WGS, a technological capacity they may not have anticipated at the time they donated their biospecimens. Efforts to reevaluate biobank participants' views about the acceptability of new technologies may help to ensure alignment of participants' current beliefs and research applications that would have been difficult to anticipate at the time biospecimens were collected.

Abstract Objective We describe a stratified sampling design that combines electronic health records (EHRs) and United States Census (USC) data to construct the sampling frame and an algorithm to enrich the sample with individuals belonging to rarer strata. Materials and Methods This design was developed for a multi-site survey that sought to examine patient concerns about and barriers to participating in research studies, especially among under-studied populations (eg, minorities, low educational attainment). We defined sampling strata by cross-tabulating several socio-demographic variables obtained from EHR and augmented with census-block-level USC data. We oversampled rarer and historically underrepresented subpopulations. Results The sampling strategy, which included USC-supplemented EHR data, led to a far more diverse sample than would have been expected under random sampling (eg, 3-, 8-, 7-, and 12-fold increase in African Americans, Asians, Hispanics and those with less than a high school degree, respectively). We observed that our EHR data tended to misclassify minority races more often than majority races, and that non-majority races, Latino ethnicity, younger adult age, lower education, and urban/suburban living were each associated with lower response rates to the mailed surveys. Discussion We observed substantial enrichment from rarer subpopulations. The magnitude of the enrichment depends on the accuracy of the variables that define the sampling strata and the overall response rate. Conclusion EHR and USC data may be used to define sampling strata that in turn may be used to enrich the final study sample. This design may be of particular interest for studies of rarer and understudied populations.

Introduction: Lack of health equity ultimately leads to unequal treatment of diverse patients and contributes to the growing disparities seen in national health. Academic medical centers should consider providing health care providers and biomedical researchers training on how to identify and address health disparities. Methods: The authors led an introductory health disparities course for graduate students and research and clinical fellows at an academic medical center in the Midwest. We compared pre/postcourse assessments to determine changes in learners’ perceptions and knowledge of health disparities using an unpaired analysis to permit inclusion of responses provided only at baseline. Results: Sixty-two learners completed preassessment, with 56 completing the postassessment (90%). In the postcourse assessment, learners reported an increase in knowledge of disparities and had changes in their perceptions of health disparities linked to treatment of different patient groups based on demographic characteristics. There was a statistically significant difference in learners’ perceptions of how patients are treated based on gender identity (P=0.02) and sexual orientation (P=0.04). Conclusions: The results detail how an academic medical center can provide training on health disparities for diverse learners. This study underscores the influence of health disparities from the perspective of learners who conduct biomedical research and patient care. This course serves a model for introductory-level health disparities courses.

AbstractClinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.