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

What are effective methods for prevention and early detection of skin cancers among Caucasians, African-Americans, and Hispanics? How can new cancerous tumors on the skin be effectively diagnosed in skin cancer survivors, particularly in ways that can avoid unnecessary skin biopsies? What is the comparative effectiveness of new, noninvasive techniques for diagnosing and preventing skin cancer? (These techniques include epidermal genetic tape stripping, confocal microscopy, diagnosis by "scent"/"odor", full-body photography, and ultraviolet photography.) How effective are topical sunscreens, special protective clothing, and vitamin d in preventing skin cancer for people who have never had skin cancer as well as people who have been treated for skin cancer? In addition, what are the balance of harms and benefits of different sunscreen formulations in preventing (or promoting) the development of skin cancer, particularly those containing oxybenzone.

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:

Methods for prevention and early detection of skin cancer, including comparative effectiveness of new, non-invasive technologies. Similiarly, information about the harms and benefits of sun screens which contain different ingredients which have limited evidence about their long-term effects.

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.)

Please consider age differences. Screening and detection methods may be different for 20-44 year olds as compared to elderly individuals over 65. Please also consider differences between skin cancer survivors as compared to people who have never had a skin cancer as approaches may be different.

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

Please consider racial differences and methods for skin cancer survivors. For racial differences, Caucausians are generally considered at higher risk but African Americans and Hispanics are diagnosed at a later stage of illness leading to decreased life expectance in minorities. For skin cancer survivors, it is difficult to distinguish whether new atypical lesions and lentigo's are cancerous or non-cancerous (without biopsy, which can be disfiguring and potentially misleading at early stages.)

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

Improvements in the prevention, detection, screening, diagnosis of skin cancer.

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

Disfiguring biopsies, misdiagnoses, side effects from diagnostic tests, costs associated with screening and unnecessary screening. I am also concerned about sunscreens, which are generally thought to be safe but few controlled studies have been done and ingredients vary widely in different preparations. One ingredient, oxybenzone, has raised several consumer concerns about its safety. Safety information from FDA on sunscreens is incomplete.

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)

None

AHRQ Priority Populations

None

Federal Health Care Program

None

Importance

Describe why this topic is important.

AHRQ's USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of using a whole-body skin examination by a primary care clinician or patient skin self-examination for the early detection of skin cancer. http://www.ahrq.gov/clinic/uspstf/uspsskca.htm

Other similar organizations have reached similar conclusions over the past decade (e.g., Canadian Task Force on Preventive), yet few new research studies have been completed over the decade to fill this evidence gap. Nonetheless, mortality from skin cancer, particular melanomas, continue to rise in the United States. Likewise, new diagnostic tests are being developed as are new, expensive treatments for late stage melanoma.

Finally, there is little evidence to inform skin cancer survivors and their doctors about how to prevent new skin cancers or other cancers from developing.

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.)

1. USPSTF statement of incomplete evidence on skin cancer screening in Annals of Internal Medicine (Ann Intern Med 2009;150:188-93).

2. High costs of care preventing cancer survivors from receiving care. See Kathryn E. Weaver, Ph.D., cancer prevention fellow, Office of Cancer Survivorship, U.S. National Cancer Institute, Bethesda, Md.; Steffie Woolhandler, M.D., associate professor, medicine, Harvard Medical School, Boston; abstract, conference on Science of Health Care Disparities, Feb. 3-6, 2009, American Association for Cancer Research, Carefree, Ariz.

3. Hu S, Soza-Vento RM, Parker DF, Kirsner RS. Comparison of Stage at Diagnosis of Melanoma Among Hispanic, Black, and White Patients in Miami-Dade County, Florida

Arch Dermatol. 2006;142:704-708.

4. Family history of skin cancer 'almost doubles risk of Parkinson's (see study by Dr. Xiang Gao from Harvard School of Public Health to be released at American Academy of Neurology's annual meeting: http://health.usnews.com/articles/health/healthday/2009/02/16/family-history-of-melanoma-doubles-parkinsons-risk.html)

5. 2007 Sunscreen Proposed Rule

The U.S. Food and Drug Administration has proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

http://www.fda.gov/cder/drug/infopage/sunscreen/default.htm

6. New York Times Article, "Sunscreen Safety Is Called Into Question"

http://www.nytimes.com/2008/07/22/health/22well.html

7. According to a release from the Environmental Working Group (EWG), a new study from the Centers for Disease Control (CDC) indicates that the bodies of nearly all Americans are contaminated with a sunscreen chemical that has been linked to allergies, hormone disruption, and cell damage.

CDC study, "CDC: Americans Carry ‘Body Burden’ of Toxic Sunscreen Chemical"

http://www.ewg.org/node/26217

Antonia M. Calafat, Lee-Yang Wong, Xiaoyun Ye, John A. Reidy, and Larry L. Needham (2008). "Concentrations of the Sunscreen Agent, Benzophenone-3, in Residents of the United States: National Health and Nutrition Examination Survey 2003–2004" (in press). Environmental Health Perspectives. doi:10.1289/ehp.11269.

9. New national interest in prevention and comparative effectiveness research. This includes potential collaborations between AHRQ and NIH and other government agencies.

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:

See previous answers, particularly USPSTF statements.

Potential Impact

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

Improve patient care and reduced mortality due to cancer.

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

No specific timeframe, but suggest that research be initiated due to rising number of skin cancers and lack of evidence.

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

Hu S, Soza-Vento RM, Parker DF, Kirsner RS. Comparison of Stage at Diagnosis of Melanoma Among Hispanic, Black, and White Patients in Miami-Dade County, Florida

Arch Dermatol. 2006;142:704-708.

Military personnel stationed in areas with high sun exposure may also be affected.

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)

Improve patient care and reduced mortality due to cancer.

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

Individual

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

None