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Randomized Controlled Trial
. 2022 Aug;24(8):1664-1674.
doi: 10.1016/j.gim.2022.04.008. Epub 2022 May 6.

ORCA, a values-based decision aid for selecting additional findings from genomic sequencing in adults: Efficacy results from a randomized trial

Elizabeth G Liles  1 , Michael C Leo  2 , Amanda S Freed  3 , Kathryn M Porter  4 , Jamilyn M Zepp  5 , Tia L Kauffman  2 , Erin Keast  2 , Carmit K McMullen  2 , Inga Gruß  2 , Barbara B Biesecker  6 , Kristin R Muessig  5 , Donna J Eubanks  2 , Laura M Amendola  3 , Michael O Dorschner  3 , Bradley A Rolf  3 , Gail P Jarvik  3 , Katrina A B Goddard  5 , Benjamin S Wilfond  7
Affiliations
Randomized Controlled Trial

ORCA, a values-based decision aid for selecting additional findings from genomic sequencing in adults: Efficacy results from a randomized trial

Elizabeth G Liles et al. Genet Med. 2022 Aug.

Abstract

Purpose: Individuals having genomic sequencing can choose to be notified about pathogenic variants in genes unrelated to the testing indication. A decision aid can facilitate weighing one's values before making a choice about these additional results.

Methods: We conducted a randomized trial (N = 231) comparing informed values-choice congruence among adults at risk for a hereditary cancer syndrome who viewed either the Optional Results Choice Aid (ORCA) or web-based additional findings information alone. ORCA is values-focused with a low-literacy design.

Results: Individuals in both arms had informed values-choice congruence (75% and 73% in the decision aid and web-based groups, respectively; odds ratio [OR] = 1.10, 95% CI = 0.58-2.08). Most participants had adequate knowledge (79% and 76% in the decision aid and web-based groups, respectively; OR = 1.20, 95% CI = 0.61-2.34), with no significant difference between groups. Most had information-seeking values (97% and 98% in the decision aid and web-based groups, respectively; OR = 0.59, 95% CI = 0.10-3.61) and chose to receive additional findings.

Conclusion: The ORCA decision aid did not significantly improve informed values-choice congruence over web-based information in this cohort of adults deciding about genomic results. Both web-based approaches may be effective for adults to decide about receiving medically actionable additional results.

Keywords: Decision aid; Genomic sequencing; Incidental results; Informed consent; Secondary findings.

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Conflict of interest statement

Conflict of Interest All authors declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
Flowchart of CHARM study design and embedded randomized trial of a decision aid about receiving additional findings.
Figure 2.
Figure 2.
CONSORT flow diagram of study enrollment, allocation, baseline data, follow-up data and analysis.
Figure 3.
Figure 3.
Schematic diagram of results relevant to components of the primary outcome, informed values-choice congruence.
See this image and copyright information in PMC

References

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