Dataset Information

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

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.

SUBMITTER: Liles EG

PROVIDER: S-EPMC9586129 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Liles Elizabeth G EG Leo Michael C MC Freed Amanda S AS Porter Kathryn M KM Zepp Jamilyn M JM Kauffman Tia L TL Keast Erin E McMullen Carmit K CK Gruß Inga I Biesecker Barbara B BB Muessig Kristin R KR Eubanks Donna J DJ Amendola Laura M LM Dorschner Michael O MO Rolf Bradley A BA Jarvik Gail P GP Goddard Katrina A B KAB Wilfond Benjamin S BS

Genetics in medicine : official journal of the American College of Medical Genetics 20220506 8

<h4>Purpose</h4>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.<h4>Methods</h4>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 findi ...[more]

PMID: 35522237

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Project description:IntroductionGenome sequencing, a novel genetic diagnostic technology that analyses the billions of base pairs of DNA, promises to optimise healthcare through personalised diagnosis and treatment. However, implementation of genome sequencing faces challenges including the lack of consensus on disclosure of incidental results, gene changes unrelated to the disease under investigation, but of potential clinical significance to the patient and their provider. Current recommendations encourage clinicians to return medically actionable incidental results and stress the importance of education and informed consent. Given the shortage of genetics professionals and genomics expertise among healthcare providers, decision aids (DAs) can help fill a critical gap in the clinical delivery of genome sequencing. We aim to assess the effectiveness of an interactive DA developed for selection of incidental results.Methods and analysisWe will compare the DA in combination with a brief Q&A session with a genetic counsellor to genetic counselling alone in a mixed-methods randomised controlled trial. Patients who received negative standard cancer genetic results for their personal and family history of cancer and are thus eligible for sequencing will be recruited from cancer genetics clinics in Toronto. Our primary outcome is decisional conflict. Secondary outcomes are knowledge, satisfaction, preparation for decision-making, anxiety and length of session with the genetic counsellor. A subset of participants will complete a qualitative interview about preferences for incidental results.Ethics and disseminationThis study has been approved by research ethics boards of St. Michael's Hospital, Mount Sinai Hospital and Sunnybrook Health Sciences Centre. This research poses no significant risk to participants. This study evaluates the effectiveness of a novel patient-centred tool to support clinical delivery of incidental results. Results will be shared through national and international conferences, and at a stakeholder workshop to develop a consensus statement to optimise implementation of the DA in practice.Trial registration numberNCT03244202; Pre-results.

Project description:INTRODUCTION:Failure to intensify treatment for type 2 diabetes mellitus (T2DM) when indicated, or clinical inertia, is a major obstacle to achieving optimal glucose control. This study investigates the impact of a values-focused patient decision aid (PDA) for T2DM antihyperglycemic agent intensification on patient values related to domains important in decision-making and preferred treatments. METHODS:Patients with poorly controlled T2DM who were taking a metformin-containing regimen were recruited through physicians to access a PDA presenting evidence-based information on T2DM and antihyperglycemic agent class options. Participants' preferences for treatment, decision-making, and the relative importance they placed on various values related to treatment options (e.g., dosing, weight gain, side effects) were assessed before and after interacting with the PDA. Changes from baseline were calculated (post-PDA minus pre-PDA difference) and assessed in univariate generalized linear models exploring associations with patients' personal values. RESULTS:Analyses included 114 diverse patients from 27 clinics across the US. The importance of avoiding injections, concern about hypoglycemia, and taking medications only once a day significantly decreased after interacting with the PDA [- 1.1 (p = 0.002), - 1.3 (p < 0.001), - 1.1 (p = 0.004), respectively], while the importance of taking medications that avoided weight gain increased [0.8 (p = 0.004)]. Prior to viewing the PDA, most patients (58.8%) had not begun thinking about the decision of adding a medication, and few (12.3%) indicated that they had already made a decision. Post-PDA, 46.5% could state a medication preference. CONCLUSION:The values-focused PDA for T2DM medication intensification prepared patients to make a shared decision with their clinician and changed patients' values regarding what was important in making that decision. Helping patients understand their options and underlying values can promote shared decision-making and may reduce clinical inertia delaying treatment intensification. FUNDING:Janssen Scientific Affairs, LLC.

Project description:BackgroundEvidence is lacking on the most effective values clarification methods (VCMs) in patient decision aids (PtDAs). We tested the effects of an adaptive conjoint analysis (ACA)-based VCM compared with a ranking-based VCM and no VCM on several decision-related outcomes, with the decisional conflict and its subscale "perceived values clarity" as primary outcomes.DesignOnline experimental study with 3 conditions: no VCM versus ranking-based VCM versus ACA-based VCM (N = 282; Mage = 63.11 y, s = 12.12), with the latter 2 conditions including attributes important for a lung cancer treatment decision. We assessed 1) decisional conflict, 2) perceived values clarity (decisional conflict subscale), 3) perceived cognitive load, 4) anticipated regret, 5) ambivalence, 6) preparedness for decision making, 7) hypothetical treatment preference, and 8) values congruence (proxy). We performed analysis of covariance and linear regression. Age and level of deliberation were included as potential moderators, and we controlled for subjective numeracy (covariate). We exploratively tested the moderating effects of subjective numeracy and health literacy (without covariates).ResultsWe found no significant effect of type of VCM on overall decisional conflict or perceived values clarity. Age had a moderating effect: in younger participants, no VCM (v. ranking-based VCM) led to more values clarity, while in older participants, a ranking-based VCM (v. no VCM) led to more values clarity. Completing the ACA-based VCM, compared with no VCM, resulted in more values congruence.LimitationsThe hypothetical choice situation might have induced lower levels of cognitive/affective involvement in the decision.ConclusionsThis study found mixed effects of an ACA-based VCM. It did not decrease decisional conflict or increase perceived values clarity, yet it did improve values congruence.ImplicationsCompletion of an ACA-based VCM in a PtDA may increase values congruence.HighlightsAn adaptive conjoint analysis or a ranking-based values clarification method did not decrease analog patients' decisional conflict nor did it increase their perceived values clarity.In younger participants, no VCM (v. ranking-based VCM) led to more values clarity, while in older participants, a ranking-based VCM (v. no VCM) led to more values clarity.An adaptive conjoint analysis task for values clarification resulted in more values congruence.

Dataset Information

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

Purpose

Methods

Results

Conclusion

Publications

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

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