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Protocol - Clinician Confidence in Returning Genetic Test Results

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Description

The healthcare provider is asked about his or her knowledge of genetic results without seeking information from other sources. A scale with responses from “not at all confident” to “very confident” is used to measure the provider’s confidence. A second set of items refers to the usefulness of the genetic test results with a scale that ranges from strongly disagree to strongly agree.

Specific Instructions

The following instructions appear at the top of the Clinical Sequencing Evidence-Generating Research Consortium (CSER) questionnaire.

Timeframe: within 0–6 weeks of Return of Results (RoR) visit.

Audience: Providers of participants receiving all types of results (positive, negative, variance of unknown sequence [VUS], secondary). Necessary to include providers receiving positive results, VUS results, and secondary results. Number of providers receiving negative results should be at least equal to the number of positive results—or more, if budget and time allow.

Target: The provider who will be primarily responsible for managing the results and making medical recommendations, the patient’s current medical home for the reason the testing was performed. This may or may not be the same provider that disclosed the results as part of the study. It could be a primary or specialty care provider.

Protocol

Have you had a medical encounter with your patient since you received the genomic result?

[ ] Yes

[ ] No

1. Before looking at resources other than those provided with the result, when you received the genomic result, how confident did you feel in your…

Knowledge about the condition caused by this gene?

[ ] Not at all confident

[ ] A little confident

[ ] Somewhat confident

[ ] Very confident

Ability to explain the result to your patient?

[ ] Not at all confident

[ ] A little confident

[ ] Somewhat confident

[ ] Very confident

Ability to answer your patient’s questions about the results?

[ ] Not at all confident

[ ] A little confident

[ ] Somewhat confident

[ ] Very confident

Ability to personally manage the patient’s care based on the result?

[ ] Not at all confident

[ ] A little confident

[ ] Somewhat confident

[ ] Very confident

2. To what extent do you agree with the following statements about receiving this unsolicited genomic result?

The result was informative

[ ] Strongly disagree

[ ] Somewhat disagree

[ ] Somewhat agree

[ ] Strongly agree

The result was confusing

[ ] Strongly disagree

[ ] Somewhat disagree

[ ] Somewhat agree

[ ] Strongly agree

The result was helpful

[ ] Strongly disagree

[ ] Somewhat disagree

[ ] Somewhat agree

[ ] Strongly agree

The result was useless

[ ] Strongly disagree

[ ] Somewhat disagree

[ ] Somewhat agree

[ ] Strongly agree

Protocol Name from Source

Clinical Sequencing Evidence-Generating Research Consortium (CSER) Provider Measures - Post-Return of Results Follow-up #1 & Electronic Medical Records and Genomics (eMERGE) Post-Return of Results Provider Follow-up Questionnaire

Availability

Available

Personnel and Training Required

The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews. The interviewer should be trained to prompt respondents further if a “don’t know” response is provided.

Note: Also administered as an online questionnaire.

Equipment Needs

The PhenX Working Group acknowledges these questions can be administered in a computerized or noncomputerized format (i.e., paper-and-pencil instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Self-administered or interviewer-administered questionnaire

Life Stage

Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Participants

Healthcare providers after sharing the genetic results with the patient.

Selection Rationale

These items are from a questionnaire recommended by a consortium of genomic experts and they are low burden. 

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Genomic Medicine Implementation Clinician Genetic Testing Confidence Assessment Text 7408774 CDE Browser
Derived Variables

None

Process and Review

Not applicable

Source

Clinical Sequencing Evidence-Generating Research Consortium (CSER) Provider Measures – Post-Return of Results Follow-up #1

Electronic Medical Records and Genomics (eMERGE) Post–Return of Results Provider Follow-up Questionnaire

General References

Manuscripts are in progress.

Protocol ID

310501

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
Genomic Medicine Implementation
Measure Name

Clinician Confidence in Returning Genetic Test Results

Release Date

September 10, 2020

Definition

A series of questions to assess a healthcare provider’s knowledge and understanding of the genetic test results and the usefulness of the results related to the care of a patient. 

Purpose

To assess healthcare providers’ understanding of genetic test results and the health and care implications for each patient.

Keywords

Test results, genetic testing, genomic medicine, Clinical Sequencing Evidence-Generating Research Consortium, CSER, Electronic Medical Records and Genomics, eMERGE, return of results, RoR, provider