Parents Reported Likelihood of Sharing Actionable Vs. Non- Actionable Genetic Results
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1 Parents Reported Likelihood of Sharing Actionable Vs. Non- Actionable Genetic Results Carrie A. Weaver, MA Melanie Myers, PhD, MS, LGC Matt Veerkamp, BA And Cynthia A. Prows, MSN, CNS, FAAN
2 Arguments against Returning Research Results 1. Rests on a mistaken interpretation of autonomy Decision lies in informed consent 2. Poses an unsustainable burden on research infrastructure Money, time 3. Harmful consequences Psychological, physical [1, 4, 6]
3 Arguments for Returning Research Results 1. Beneficence Increase physical, psychological well being 2. Autonomy Choice to be given results 3. Reciprocity Results as compensation 4. Disclosure improves public understanding of genetics [1, 4, 6]
4 Present Study Sample: 117 parents of children with extra biological samples for future research stored at Cincinnati Children s Hospital Case: participant s child exposed to opioids (n= 55, 47.01%) Control: participant s child without previous exposure to opioids (n= 62, 52.99%) Samples genotyped for CYP2D6 to determine predisposition for codeine response. Results given to parents over the phone
5 Methods Return of emerge research results survey Adapted from Haga et al. (2012) Similarities: telephone interviews concerning genomic results Differences: hypothetical testing vs. actual pharmacogenetic testing and returning of results Adults answering questions about their own hypothetical results vs. parents answering questions about their child s actual result Survey administered immediately following result disclosure If not possible then within 1 week of return of results 10 to 20 minutes to complete
6 Actionability Classification Actionable 1 CYP2D6 gene that does not make enzyme and 1 CYP2D6 gene that makes an enzyme that does not work as well as expected 2 CYP2D6 genes that do not work at least 3 CYP2D6 genes that work well Potentially actionable 1 CYP2D6 gene that makes normal amount of enzyme and one gene that makes enzyme that does not work as well as expected. 1 CYP2D6 gene that makes normal amount of enzyme and one gene that does not. 2 CYP2D6 genes that make enzyme that does not work as well as expected Not actionable 2 CYP2D6 genes that make normal amounts of enzyme
7 Hypotheses Child s previous opioid exposure will influence parents likelihood of sharing results with health care providers Parents who receive actionable results will be more inclined to share results with health care providers
8 Analyses Data analyzed with PSPP and JMP Descriptive statistics Frequencies Pair-wise comparisons Wilcoxon Rank Sum
9 Demographics Demographic Frequency (%) Education Some High School 2 (1.71%) HS grad/ged 19 (16.24%) Some college/2year 27 (23.08%) 4 year college 48 (41.03%) 4 year + 21 (17.95%) Income Less than $25,000 9 (7.69%) $25,000 to $49, (10.26%) $50,000 to $74, (20.51%) $75,000 to $99, (22.22%) More than $100, (30.77%) Refused 8 (6.84%) Don t know 1 (0.85%)
10 Race (N=117)
11 Demographics Demographic Frequency (%) Worked in Health Care Yes 56 (47.86%) No 61 (52.14%) Has Health Insurance Yes 116 (99.15%) No 1 (0.85%) Actionability Actionable 7 (5.98%) Potentially 69 (58.97%) Not Actionable 41 (35.04%)
12 My child s doctor can use this CYP2D6 research test result when providing care to him/her. Would you say you Metabolizer type Strongly agree Somewhat agree Somewhat Disagree Strongly disagree Total Actionable (5.98%) Potentially actionable Not actionable (58.97%) (35.04%) Total [n (%)] 98 (83.76) 19 (16.24) N= % Potentially Actionable vs. Not Actionable: p=.0041
13 How likely are you to share (your child s) CYP2D6 research test result with his/her doctor? Metabolizer type Extremely likely Somewhat likely Not very likely Not at all likely N (%) Actionable (5.98) Potentially actionable Not actionable (58.97) (35.04) 117 Total [n (%)] 85 (72.65) 30 (25.64) 2 (1.71) (100.00) Not actionable vs. Actionable: p=.0220 Potentially Actionable vs. Not Actionable: p= %
14 How likely are you to share your child s CYP2D6 research test result with his/her pharmacist? Metabolizer type Extremely likely Somewhat likely Not very likely Not at all likely N (%) Actionable (6.03) Potentially actionable Not actionable (58.62) (35.34) Total [n (%)] 31 (26.72) 48 (41.38) 26 (22.41) 11 (9.48) 116 (100.00) Not significant %
15 Discussion Actionability confers clinical utility. Clinical utility: a result is clinically useful when it leads to an improved health outcome [1] Results, regardless of category, have personal utility Personal utility: a result is personally useful when the outcome has value to the individual Replication of literature suggesting individuals want to receive results [2,5,6]
16 Acknowledgments John B. Harley, M.D., Ph.D. Andrea Murad, B.A. Brooke McLaughlin, M.S. Lisa Martin, Ph.D. Cincinnati Children s Research Foundation Cincinnati Genomic Control Cohort
17 References 1. Bredenoord, A. L., Kroes, H. Y., Cuppen, E., Parker, M., & van Delden, J. J. M. (2011). Disclosure of individual genetic data to research participants: the debate reconsidered. Trends in Genetics, 27 (2): doi: /j.tig Fullerton, S. M., Wolf, W. A., Brothers., K. B., et al. (2012). Return of individual research results from genome-wide association studies: Experience of the electronic medical records & genomics (emerge) network. Genetic Medicine, 14 (4): doi: /gim Haga, S. B., O Daniel, J. M., Tindall, G. M., Lipkus, I. R., Agans, R. (2012). Survey of US public attitudes toward pharmacogenetic testing. Pharmacogenomics, 12 (3): doi: /tpj Hens, K., Nys, H., Cassiman, J., Dierickx, K. (2011). The reutrn of invidiual research findings in paediatric genetic research. Journal of Medical Ethics, 37: doi: /jme Jarvik, G. P., Amendola, L. M., Berg, J. S., et al. (2014). Return of genomic results to research participants: the floor, the ceiling, and the choices in between. The American Journal of Human Genetics, 94: doi: /j.ajhg Kleiderman, E., Knoppers, B. M., Fernandez, C. V. et al. (2014). Returning incidental findings from genetic research to chidren: views of partents of children affected by rare diseases. Journal of Medical Ethics, 40: doi: /medethics
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