Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

Can screening and survellance for colorectal cancer (CRC) using fecal DNA analysis improve health outcomes?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Primary screening and survellance for colorectal cancer using fecal DNA analysis versus fecal occult blood testing (FOBT).

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Asymptomatic (for CRC) adults aged >/= 50 years

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Interested in improved survival, reduction in CRC morbidity and mortality.

Describe any health-related risks, side effects, or harms that you are concerned about.

Potential for harms associated with false-positives could include psychological distress and incurrence of unnecessary risks associated with follow-up colonoscopy and/or other resultant procedures. With false-negative results, concern is primarily with the possibility of increased CRC-related mortality resulting from delayed diagnosis and treatment.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cancer

AHRQ Priority Populations

• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

This topic is under consideration by EGAPP, and the EGAPP Working Group may use an evidence review on this topic to develop a recommendation statement (evidence-based guideline). Previous evidence-based assessments have been published on fecal DNA analysis in the context of CRC, however, modifications to commercially available (and DTC marketed) tests have been made, and new testing strategies have become available, since their completion.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

See response above

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

Although an evidence-based guideline (http://www.guideline.gov/content.aspx?id=14346) addresses fecal DNA analysis, no appropriate screening interval was determined for those with negative test results.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

EGAPP Working Group may develop evidence-based guidelines based on the results of this systematic review.

Describe the timeframe in which an answer to your question is needed.

Ideally within 1 year.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

EGAPP Working Group may develop evidence-based guidelines based on the results of this systematic review.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program