Managing the Unimaginable: Biobank Participant Views on Reconsent for Whole Genome Sequencing of Stored Biospecimens.

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.

Comparison of audio vs. audio + video for the rating of shared decision making in oncology using the observer OPTION5 instrument: an exploratory analysis.

BACKGROUND: How non-verbal data may influence observer-administered ratings of shared decision making is unknown. Our objective for this exploratory analysis was to determine the effect of mode of data collection (audio+video vs. audio only) on the scoring of the OPTION5 instrument, an observer rated measure of shared decision making. METHODS: We analyzed recordings of 15 encounters between cancer patients and clinicians in which a clinical decision was made. Audio+video or audio only recordings of the encounters were randomly assigned to four trained raters, who reviewed them independently. We compared the adjusted mean scores of audio+video and audio only. RESULTS: Forty-one unique decisions were identified within the 15 encounters. The mean OPTION5 score for audio+video was 17.5 (95% CI 13.5, 21.6) and for audio only was 21.8 (95% CI 17.2, 26.4) with a mean difference of 4.28 (95% CI = 0.36, 8.21; p = 0.032). CONCLUSION: A rigorous and well established measure of shared decision making performs differently when the data source is audio only. Data source may influence rating of observer administered measures of shared decision making. This potential bias needs to be confirmed as video recording to examine communication behaviors becomes more common.

Genomic data in the electronic medical record: perspectives from a biobank community advisory board.

A proof of principle pharmacogenomic translational study was used as a case example to explore Biobank Community Advisory Board (CAB) member views about placing genomic information into the medical record and to establish how CAB input could affect research design. CAB members expressed enthusiasm for the potential benefit of the research discussed, yet voiced concerns regarding the recruitment and consent materials. They discussed the value of genomic research and its clinical utility; the risk of genetic discrimination; and personal ownership of genomic data. Members distinguished between indirect benefits to future generations and individual risk to research participants. Feedback was used to revise the recruitment and consent materials. Results highlight tensions reported between the public's support for genomic research and concerns with genomic information in the medical record and its use in medical decision-making.

The experience of addiction as told by the addicted: incorporating biological understandings into self-story.

How do the addicted view addiction against the framework of formal theories that attempt to explain the condition? In this empirical paper, we report on the lived experience of addiction based on 63 semi-structured, open-ended interviews with individuals in treatment for alcohol and nicotine abuse at five sites in Minnesota. Using qualitative analysis, we identified four themes that provide insights into understanding how people who are addicted view their addiction, with particular emphasis on the biological model. More than half of our sample articulated a biological understanding of addiction as a disease. Themes did not cluster by addictive substance used; however, biological understandings of addiction did cluster by treatment center. Biological understandings have the potential to become dominant narratives of addiction in the current era. Though the desire for a "unified theory" of addiction seems curiously seductive to scholars, it lacks utility. Conceptual "disarray" may actually reflect a more accurate representation of the illness as told by those who live with it. For practitioners in the field of addiction, we suggest the practice of narrative medicine with its ethic of negative capability as a useful approach for interpreting and relating to diverse experiences of disease and illness.

Shared decision making in cancer screening and treatment decisions for American Indian and Alaska native communities: can we ethically calibrate interventions to patients' values?

Shared decision making has been advocated as a key ethical strategy to improve quality of care and cancer control, especially in relation to screening and treatment decisions at various stages of the cancer continuum. Recent research on cancer in American Indian/Alaska Native (AI/AN) communities has highlighted significant disparities, raising questions about how best to implement prevention and screening programs in often fragmented and underfunded Indian health, tribal and urban systems. Incorporating shared decision making initiatives routinely may provide opportunities to address the complex choices AI/AN patients face.

Factors influencing cancer risk perception in high risk populations: a systematic review.

BACKGROUND: Patients at higher than average risk of heritable cancer may process risk information differently than the general population. However, little is known about clinical, demographic, or psychosocial predictors that may impact risk perception in these groups. The objective of this study was to characterize factors associated with perceived risk of developing cancer in groups at high risk for cancer based on genetics or family history. METHODS: We searched Ovid MEDLINE, Ovid Embase, Ovid PsycInfo, and Scopus from inception through April 2009 for English-language, original investigations in humans using core concepts of "risk" and "cancer." We abstracted key information and then further restricted articles dealing with perceived risk of developing cancer due to inherited risk. RESULTS: Of 1028 titles identified, 53 articles met our criteria. Most (92%) used an observational design and focused on women (70%) with a family history of or contemplating genetic testing for breast cancer. Of the 53 studies, 36 focused on patients who had not had genetic testing for cancer risk, 17 included studies of patients who had undergone genetic testing for cancer risk. Family history of cancer, previous prophylactic tests and treatments, and younger age were associated with cancer risk perception. In addition, beliefs about the preventability and severity of cancer, personality factors such as "monitoring" personality, the ability to process numerical information, as well as distress/worry also were associated with cancer risk perception. Few studies addressed non-breast cancer or risk perception in specific demographic groups (e.g. elderly or minority groups) and few employed theory-driven analytic strategies to decipher interrelationships of factors. CONCLUSIONS: Several factors influence cancer risk perception in patients at elevated risk for cancer. The science of characterizing and improving risk perception in cancer for high risk groups, although evolving, is still relatively undeveloped in several key topic areas including cancers other than breast and in specific populations. Future rigorous risk perception research using experimental designs and focused on cancers other than breast would advance the field.