Form No number No number Policy Survey

Attachment D4 - Policy Survey

This survey is intended for organizations that develop or advocate policy regarding the validity, utility and appropriate use of genetic tests. These include medical professional (e.g., American Academy of Family Physicians, American College of Medical Genetics) and other organizations (e.g., Secretary’s Advisory Committee on Genetics, Health and Society, Genetics and Public Policy Center, public health) that develop clinical guidelines/recommendations.

Note: Skip patterns will be programmed into the online form, making a streamlined survey for respondents.

Objectives - Types of information to be collected include:

1. Identify general descriptive characteristics of respondents (e.g., position in organization, role).

2. Understand respondents’ awareness of EGAPP and EGAPP products (e.g., evidence reports, EGAPP Working Group recommendations)

3. Determine if the respondent has read any products (e.g., published or web-posted evidence reports, published EGAPP recommendations).

4. Get feedback on whether specific products may have impact on policy decisions and/or decisions to develop guidelines.

Form Approved

OMB No.: 0920-0751

Exp. Date: 8/31/2010

Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Survey

Introduction to the EGAPP Survey

Evaluation of Genomic Applications in Practice and Prevention (EGAPP) is an initiative launched in 2004 by the National Office of Public Health Genomics (NOPHG) at the Centers for Disease Control and Prevention (CDC). The efforts of EGAPP are focused around an independent, non-federal, multidisciplinary EGAPP Working Group. The goal of EGAPP is to establish a systematic, evidence-based process to assess the effectiveness of selected genetic tests that are in transition from research to clinical and public health practice.

Products of the EGAPP project include evidence reports on selected genetic tests and published EGAPP Working Group recommendations on the appropriate use of the tests based on the evidence collected. Some evidence reports sponsored by the EGAPP project are conducted and released by Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers.

To evaluate the value and impact of the EGAPP products, an independent consultant has been contracted to survey key stakeholder groups, including healthcare providers, healthcare payers and purchasers, certain policy organizations, targeted consumer groups, and website visitors. Response to these surveys is very important to inform the EGAPP Working Group and CDC about the best methods and approaches for future review of the effectiveness of emerging genetic tests, and about the potential impact of accurate and timely information on genetic tests on current healthcare practices.

Your feedback will provide important information about the relevance of EGAPP products to your practice. The questions relate only to EGAPP-supported evidence reports and EGAPP Working Group Recommendations. Thank you for your time and assistance.

Public reporting burden of this collection of information is estimated to range between 5 and 10 minutes with an average of 8 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0751).

Please note: While taking the survey, please do not use your browser's back and/or forward buttons; please only use the next and previous buttons within the survey. Thank you.

1. Which best describes your group? (Please check only one)

___ Medical professional organization involved in policy/guideline development

___ Advisory panel to the government

___ Public health program

___ Accreditation organization

(Checking one of alternative choices below redirects to Policy/Payer Survey)

___ Health plan

___ Health insurer

___ Staff-model HMO

___ Government agency

___ Organization of health insurance plans

(Checking one of alternative choices below redirects to Purchaser Survey)

___ Small business that purchases healthcare packages/policies for employees

___ Large company that purchases healthcare packages/policies for employees

___ Federal purchaser of healthcare

___ Group purchasing organization

___ I am not affiliated with any group listed.  Exit survey. SUBMIT

___ Other organization developing or advocating policy: (please describe) ____________

2. Within your group, in which of the following activities are you involved? (please check all that apply)

___ Developing policy statements

___ Research or data collection to support development of policy

___ Developing practice guidelines or recommendations

___ Using evidence-based information to make programmatic decisions

___Other (please describe ) _________________________________________

3. Prior to this survey, had you read or heard about EGAPP?

___ yes

___ no Skip to question 5a (first survey distribution) or 6a (second survey distribution)

___unsure Skip to question 5a (first survey distribution) or 6a (second survey distribution)

4. Where have you read or heard about EGAPP activities? (please check all that apply)

____ I read about EGAPP on the CDC or www.egappreviews.org website.

____ I heard about EGAPP through a professional journal/newsletter.

____ A colleague told me about EGAPP.

____ I learned about EGAPP at a meeting.

____ Other (please describe) ________________________________________

If you checked the "I heard about EGAPP through a professional journal/newsletter" response above, please specify that journal/newsletter title here:

If you checked the "I learned about EGAPP at a meeting" response above, please specify that meeting here:

If this is the second survey distribution, respondents will be skipped to question 6a.

Following is a set of questions about a genetic test for which EGAPP has completed an evidence report and a recommendation. The test is described briefly before the questions.

Cytochrome P450 (CYP450) genotyping is a genetic test proposed for use in patients treated for depression with selective serotonin reuptake inhibitors (SSRIs) to help in selection of drug and dosage.

5a. Are you aware of the CYP450 genetic test?

___ yes

___ no Skip to question 8

___ unsure Skip to question 8

5b. From what source(s) have you heard about the CYP450 genetic test? (check all that apply)

___ An EGAPP-sponsored evidence report or published summary

___ An EGAPP Working Group recommendation

___ Primary research/review article

___ Professional organization

___ Colleague

___ Meeting/conference

___ News media

___ Other (please specify)

The following questions refer specifically to the evidence report/published summary and EGAPP Working Group recommendation on CYP450 testing

5c. Have you read the EGAPP-sponsored evidence report on CYP450 testing, or the published summary of the evidence report?

____ yes ____ no ____unsure

If no or unsure, respondent skips to item 5f

5d. How understandable did you find the evidence report/published summary to be?

___very understandable ____somewhat understandable ___not understandable

5e. Will the evidence on CYP450 testing influence the way your organization makes policy decisions or develops guidelines on the use of the CYP450 test in patients with depression treated with SSRIs? ___ yes ___ no ___ unsure

If yes, please explain: _____________________________________

5f. Have you read the EGAPP Working Group recommendation about the use of

CYP450 testing in patients with depression treated with SSRIs?

___ yes ___ no ___unsure

If no or unsure, respondent skips to item 5k

5g. How understandable did you find the EGAPP recommendation to be?

___very understandable ____somewhat understandable ___not understandable

5h. Will the EGAPP recommendation influence the way your organization makes policy decisions or develops guidelines on the use of the CYP450 test in patients with depression treated with SSRIs?

___yes ___no ___unsure

If yes, please explain: _____________________________________

5i. Which will be more useful to your organization? (Please check one)

___Evidence report/published summary ___EGAPP recommendation ___Not applicable

5k. Does your organization have a policy in place or guidelines developed on the use of CYP450 testing for patients with depression treated with SSRIs?

___ yes ___ no ___ unsure

5j. Please provide any comments about the evidence report/published summary or EGAPP recommendation on the use of CYP450 testing for patients with depression treated with SSRIs that you feel would improve the information for policy makers.

Comment box here

If this is the first survey distribution, respondents will be skipped to question 8a.

Testing for Hereditary Non-Polyposis Colorectal Cancer (HNPCC or Lynch Syndrome) in newly diagnosed colorectal cancer patients and their families may be offered to a selected subset of high risk patients to detect a heritable form of colorectal cancer.

6a. Are you aware of genetic testing for HNPCC (Lynch Syndrome) in patients newly diagnosed with colorectal cancer?

___ yes

___ no Skip to question 7a

___ unsure Skip to question 7a

6b. From what source(s) have you heard about genetic testing for HNPCC (Lynch Syndrome)? (Please check all that apply)

___ An EGAPP-sponsored evidence report or published summary

___ An EGAPP Working Group recommendation

___ Primary research/review article

___ Professional organization

___ Colleague

___ Meeting/conference

___ News media

___ Other (please specify)

The following questions refer specifically to the evidence report/published summary and EGAPP recommendation on HNPCC (Lynch Syndrome) testing

6c. Have you read the EGAPP-sponsored evidence report on genetic testing for HNPCC (Lynch Syndrome), or a published summary of the evidence report?

____ yes ____ no ____unsure

If no or unsure, respondent skips to item 6f

6d. How understandable did you find the evidence report/published summary to be?

___very understandable ____ somewhat understandable ___ not understandable

6e. Will this information on genetic testing for HNPCC (Lynch Syndrome) influence the way your organization makes policy decisions or develops guidelines on the use of this test for patients newly diagnosed with colorectal cancer?

___ yes ___ no ___unsure

If yes, please explain: ____________________________________

6f. Have you read the EGAPP Working Group recommendation on the use of genetic testing for HNPCC (Lynch Syndrome) in newly diagnosed patients with colorectal cancer?

___ yes ___ no ___unsure

If no or unsure, respondent skips to item 6j

6g. How understandable did you find the EGAPP recommendation to be?

___very understandable ____ somewhat understandable ___ not understandable

6h. Will this recommendation on the use of genetic testing for HNPCC (Lynch Syndrome) influence the way your organization makes policy decisions or develops guidelines on the use of the test?

____ yes ____ no ___ unsure

If yes, please explain: _________________________

6i. Which will be more useful to your organization? (Please check one.)

___evidence report or published summary of evidence ___recommendations ____ Not applicable

6j. Does your organization have a policy in place or guidelines developed on the use HNPCC (Lynch Syndrome) testing in patients with newly diagnosed colorectal cancer?

___ yes ___ yes, but only patients with a family history of CRC

___ no ___ unsure

6k. Please provide any comments about the evidence report/published summary or EGAPP recommendation on the use of HNPCC (Lynch Syndrome) testing in patients with newly diagnosed colorectal cancer that you feel would improve the information for policy makers.

Comment box here

UGT1A1 testing is a pharmacogenetic test for colorectal cancer that may be offered to patients treated with irinotecan.

7a. Are you aware of genetic testing for UGT1A1 for colorectal cancer patients treated with irinotecan?

___ yes

___ no Skip to question 8

___ unsure Skip to question 8

7b. From what source(s) have you heard about genetic testing for UGT1A1? (Please check all that apply)

___ An EGAPP-sponsored evidence report or published summary

___ An EGAPP Working Group recommendation

___ Primary research/review article

___ Professional organization

___ Colleague

___ Meeting/conference

___ News media

___ Other (please specify)

The following questions refer specifically to the evidence report/published summary and EGAPP recommendation on UGT1A1 testing

7c. Have you read the EGAPP-sponsored evidence report on genetic testing for HNPCC, or a published summary of the evidence report?

____ yes ____ no ____unsure

If no or unsure, respondent skips to item 7f

7d. How understandable did you find the evidence report/published summary to be?

___very understandable ____ somewhat understandable ___ not understandable

7e. Will this information on genetic testing for UGT1A1 influence the way your organization makes policy decisions or develops guidelines on the use of this test for colorectal cancer patients treated with irinotecan?

___ yes ___ no ___unsure

If yes, please explain: ____________________________________

7f. Have you read the EGAPP Working Group recommendation on the use of genetic testing for UGT1A1 for colorectal cancer patients treated with irinotecan?

___ yes ___ no ___unsure

If no or unsure, respondent skips to item 7j

7g. How understandable did you find the EGAPP recommendation to be?

___very understandable ____ somewhat understandable ___ not understandable

7h. Will this recommendation on the use of genetic testing for UGT1A1 influence the way your organization makes policy decisions or develops guidelines on the use of the test?

____ yes ____ no ___ unsure

If yes, please explain: _________________________

7i. Which will be more useful to your organization? (Please check one.)

___evidence report or published summary of evidence ___recommendations ____ Not applicable

7j. Does your organization have a policy in place or guidelines developed on the use UGT1A1 testing for colorectal cancer patients treated with irinotecan?

___ yes

___ no ___ unsure

7k. Please provide any comments about the evidence report/published summary or EGAPP recommendation on the use of UGT1A1 testing in patients with newly diagnosed colorectal cancer that you feel would improve the information for policy makers.

Comment box here

8. Have you read any EGAPP sponsored evidence reports/published summaries or EGAPP recommendations other than the one mentioned in question in this survey?

___ yes ___ no ___unsure

Respondent directed to 9 if no or unsure to:

5a and 8 (first survey distribution)

6a and 7a and 8 (second survey distribution)

Respondent directed to question 10 if yes to 8 (first and second survey distribution)

9. If an evidence-based report on a specific test and a recommendation from a credible expert panel were available, please indicate your response to the statements below based on the scale given:

.

Evidence-based information/guidelines on genetic tests are useful in my practice to:

1. understand what uses of the test are supported by

evidence.

2. identify the population or individuals for

whom the test may be appropriate.

3. provide expectations for laboratory performance

and the estimated clinical validity of the test.

4. know what actions or interventions may be

suggested based on test results.

5. understand what is known about the balance

of benefits and harms related to use of the test.

6. appreciate the ethical, legal, and social

implications related to testing.

Respondents answering Question 9 skip to Question 12

Question 10 will only be asked of those respondents who have read at least one EGAPP-sponsored evidence review/summary or recommendations

10. Based on your experience with EGAPP sponsored evidence reports and/or Working Group recommendations, please indicate your response to the statements below based on the scale given:

Evidence-based information/guidelines on genetic tests are useful in my practice to:

1. understand what uses of the test are supported by

evidence.

2. identify the population or individuals for

whom the test may be appropriate.

3. provide expectations for laboratory performance

and the estimated clinical validity of the test.

4. know what actions or interventions may be

suggested based on test results.

5. understand what is known about the balance

of benefits and harms related to use of the test.

6. appreciate the ethical, legal, and social

implications related to testing.

11. In general, how well does the EGAPP process for evidence review and development of recommendations by the independent EGAPP Working Group meet standards that your organization requires for setting policy or developing guidelines?

___ Exceeds standards ___ Meets standards

___ Does not meet/Falls below standards ___ Unsure ____Not applicable

12. Have you visited the EGAPP website: www.egappreviews.org?

___ yes

___ no Skip to question 14

13. How useful did you find the EGAPP website?

___very useful ____ somewhat useful ___ not useful

14. If you have other comments you would like to make please do so in the box below.

COMMENT BOX HERE

This is the end of the survey, thank you for your feedback! Click the "Submit" button below to submit your responses. --------→ SUBMIT

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