Clinical Implem of PGx

In the General Steps in Clinical Implementation of Pharmacogenomics for the Preparation for implementation, we need to create a plan of what data would be useful to collect and should have key performance indicators for such as:

•Service process

•Service utilization

•Patients and provider satisfaction

AND •Develop a plan for workflow

• True

• False

In the General Steps in Clinical Implementation of Pharmacogenomics for the Preparation for implementation, we need to create a plan which

•Need to have administrative approval

•Develop clinical decision support system (CDS) that includes:

•Notifications to clinicians that genotyping is available if a specific drug is selected in the electronic health record (EHR) for drugs that there is evidence from pharmacogenomic data

•Notification to PGx service and personnel when a genotype is ordered

• True

• False

In the General Steps in Clinical Implementation of Pharmacogenomics for the Preparation for implementation, we need to create a plan including:

•Develop clinical decision support system (CDS) that includes:

•Provide guidance for clinicians what tests to order and when the results are available what are the prescribing implications (e.g. does the dose of a drug need to be decreased based on the genotype)

•Starting implementation

•Communication with stakeholder

•Cost analysis

• True

• False

Evidence Needed to Support Clinical Implementation of Pharmacogenomics

The Evaluation of genetic and genomic tests include:

• All of the above

• Analytic validity

• Clinical utility

• Clinical validity

•Measures of accuracy that apply to genetic tests:

•Analytic validity

•Clinical validity

WHILE

•Measure of the quality of a genetic test (usefulness of a genetic test)

•Clinical utility

• True

• False

Analytic validity:

•How well test calculates/predicts presence or absence of a particular gene or genetic change

AND

•Can the test accurately identify/detect whether a specific genetic variant is present or absent

• True

• False

•Clinical validity:

•How well the genetic variant which is being analyzed is related to the presence, absence, or is a risk of a specific disease

•If used for diagnostic purposes: measures the precision with which test identifies person with clinical condition

• True

• False

•Clinical validity is described with:

• Sensitivity

• Negative predictive value

• Positive predictive value

• Specificity

• All of the above

Clinical validity:

Sensitivity

•Proportion of people who have positive test results among people with a specific condition

WHILE

•Specificity

•Proportion of people who have negative test results among people who do not have a specific condition

• True

• False

Clinical validity:

Positive Predictive Value:

•Proportion of people who have condition among people with positive test results

WHILE

Negative Predictive Value:

•Proportion of people who do not have condition among people with negative test results

• True

• False