Exome sequencing study in a clinical research setting finds general acceptance of study returning secondary genomic findings with little decisional conflict.
| Title: | Exome sequencing study in a clinical research setting finds general acceptance of study returning secondary genomic findings with little decisional conflict. |
|---|---|
| Authors: | Similuk MN; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.; Yan J; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.; Medical Science and Computing, LLC, Rockville, MD, USA.; Setzer MR; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.; Medical Science and Computing, LLC, Rockville, MD, USA.; Jamal L; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.; Medical Science and Computing, LLC, Rockville, MD, USA.; Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, MD, USA.; Littel P; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.; Lenardo M; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.; Su HC; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA. |
| Source: | Journal of genetic counseling [J Genet Couns] 2021 Jun; Vol. 30 (3), pp. 766-773. Date of Electronic Publication: 2020 Dec 15. |
| Publication Type: | Journal Article; Research Support, N.I.H., Intramural |
| Language: | English |
| Journal Info: | Publisher: Wiley Country of Publication: United States NLM ID: 9206865 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-3599 (Electronic) Linking ISSN: 10597700 NLM ISO Abbreviation: J Genet Couns Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2019- : [Hoboken, NJ] : Wiley; Original Publication: New York, N.Y. : Human Sciences Press, c1992- |
| MeSH Terms: | Decision Making* ; Exome*; Adult ; Cross-Sectional Studies ; Genomics ; Humans ; Surveys and Questionnaires |
| Abstract: | The most appropriate strategies for managing secondary genomic findings (SF) in clinical research are being developed and evaluated. We surveyed patients at the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate decisional conflict regarding enrolling in a study that returns SF. Responses were collected using a cross-sectional survey after informed consent but before return of SF. Sixty-six adults of 116 eligible participants responded. No participant explicitly declined because they did not want to possibly receive a SF. Sixty-five of 66 (98%) participants thought it was appropriate to return SFs in research; one participant was unsure. Decisional conflict regarding enrolling in a study returning SF was low overall with 68% of participants reporting a score of less than 10 on a 100-point decisional conflict scale, implying that they felt informed, clear on what they wanted, and supported. Lower genetic literacy was weakly associated with higher decisional conflict (Spearman's rho = -0.297, p = .015). Six participants reported confusion related to the choices about SFs. Our data suggest that participants in our study feel it is appropriate to receive SF and have little decisional conflict about potentially receiving such information; however, some participants may need further education and counseling.; (© 2020 National Society of Genetic Counselors.) |
| References: | J Gen Intern Med. 2013 Jan;28(1):121-6. (PMID: 22782275); Am J Med Genet C Semin Med Genet. 2006 Nov 15;142C(4):209-20. (PMID: 16941666); Soc Sci Med. 1998 Oct;47(7):865-75. (PMID: 9722107); Int J Epidemiol. 2005 Apr;34(2):346-52. (PMID: 15737971); J Clin Immunol. 2018 Nov;38(8):836-843. (PMID: 30386947); Am J Hum Genet. 2014 Jun 5;94(6):818-26. (PMID: 24814192); J Allergy Clin Immunol. 2018 Sep;142(3):993-997.e3. (PMID: 29803798); J Clin Immunol. 2019 Aug;39(6):577-591. (PMID: 31250335); J Nurs Scholarsh. 2014 Nov;46(6):423-31. (PMID: 25130209); Arch Intern Med. 1998 Jan 26;158(2):166-72. (PMID: 9448555); Am J Med Genet A. 2008 Jan 15;146A(2):174-81. (PMID: 18076116); Soc Sci Med. 2007 Oct;65(7):1442-57. (PMID: 17614177); Genet Med. 2017 Feb;19(2):249-255. (PMID: 27854360); Inflamm Bowel Dis. 2014 May;20(5):901-8. (PMID: 24691112); J Genet Couns. 2015 Oct;24(5):833-41. (PMID: 25592144); Patient Educ Couns. 2012 Feb;86(2):239-51. (PMID: 21684708); Genet Med. 2013 Jul;15(7):565-74. (PMID: 23788249); Med Decis Making. 2015 May;35(4):539-57. (PMID: 25145577); Med Decis Making. 1995 Jan-Mar;15(1):25-30. (PMID: 7898294); J Law Med Ethics. 2015 Fall;43(3):486-501. (PMID: 26479558); JAMA. 2004 Oct 6;292(13):1593-601. (PMID: 15467062); Am J Health Behav. 2013 May;37(3):351-9. (PMID: 23985182); Psychooncology. 2008 Aug;17(8):822-30. (PMID: 18157792); Am J Health Promot. 1996 Nov-Dec;11(2):87-98. (PMID: 10163601); Health Psychol. 2018 Apr;37(4):394-398. (PMID: 29389156); Dialogues Clin Neurosci. 2012 Mar;14(1):77-89. (PMID: 22577307); Psychooncology. 2012 Jan;21(1):29-42. (PMID: 21072753); Psychosoc Med. 2013;10:Doc01. (PMID: 23429426); Genet Med. 2008 Jan;10(1):19-32. (PMID: 18197053); Science. 2020 Jul 10;369(6500):202-207. (PMID: 32647003); Eur J Hum Genet. 2013 Mar;21(3):261-5. (PMID: 22892536); Genet Med. 2015 May;17(5):405-24. (PMID: 25741868); Psychosom Med. 2008 Sep;70(7):741-56. (PMID: 18725425); Psychooncology. 2015 Jan;24(1):33-9. (PMID: 24839250); Am J Hum Genet. 2018 Sep 6;103(3):358-366. (PMID: 30122538); J Clin Invest. 2018 May 1;128(5):1793-1806. (PMID: 29408806); Clin Genet. 2011 Mar;79(3):207-18. (PMID: 21114486); Genet Med. 2005 May-Jun;7(5):332-8. (PMID: 15915085); Genet Med. 2018 Sep;20(9):1069-1076. (PMID: 29300387); Genet Med. 2016 Dec;18(12):1218-1225. (PMID: 27101135); J Health Commun. 2018;23(10-11):967-976. (PMID: 30526402); Per Med. 2016 Jan 1;13(1):13-20. (PMID: 27019659) |
| Grant Information: | Z99 AI999999 United States ImNIH Intramural NIH HHS |
| Contributed Indexing: | Keywords: clinical research; decision-making; exome sequencing; genetic counseling; literacy; secondary findings |
| Entry Date(s): | Date Created: 20201215 Date Completed: 20211015 Latest Revision: 20250530 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC10478172 |
| DOI: | 10.1002/jgc4.1367 |
| PMID: | 33320394 |
| Database: | MEDLINE |
Journal Article; Research Support, N.I.H., Intramural