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Final Research Plan

Skin Cancer: Screening

July 17, 2014

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from May 15 until June 11, 2014 at 5:00 p.m., ET.

Text Description.

Figure 1 is the analytic framework, which depicts the 6 key questions for the systematic review of screening for skin cancer in adolescents and adults. Key question 1 addresses the effectiveness of skin cancer screening in reducing mortality and morbidity from skin cancer. Key question 2 addresses the potential harms of skin cancer screening and subsequent diagnostic followup. Key question 3 addresses the accuracy of screening for skin lesions by primary care providers and dermatologists. Key question 4 addresses whether skin cancer screening leads to earlier detection of skin cancer tumors, specifically either an earlier stage tumor or one with less thickness. Key question 5 addresses whether earlier detection of skin lesions leads to decreased skin cancer morbidity and mortality. Finally, key question 6 addresses the harms that are associated with the treatment of skin cancer by surgical excision.

  1. What is the direct evidence that visual screening for skin cancer by a primary care provider or dermatologist reduces skin cancer morbidity and mortality and all-cause mortality?
  2. What are the harms of screening for skin cancer and diagnostic followup?
  3. What are the test characteristics of visual screening for skin cancer when performed by primary care providers versus dermatologists?
  4. Does visual screening for skin cancer lead to earlier detection of skin cancer compared with usual care?
  5. What is the association between earlier detection of skin cancer and skin cancer morbidity and mortality and all-cause mortality?
  6. What are the harms of surgical treatment of skin cancer?

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. Are there identifiable high-risk groups (e.g., via developed algorithms or various phenotypic features) who would have a more favorable balance of benefits and harms from screening for skin cancer compared with the general population?
  2. What proportion of skin biopsies are excised completely (i.e., past the margin)?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Include Exclude
Population Asymptomatic adolescents and adults age 15 years and older
  • Persons younger than age 15 years
  • Persons who are already under surveillance for skin cancer because of previous skin or other cancer
Settings Primary care–relevant, countries categorized as “High” on the Human Development Index (as defined by the World Health Organization)  
Screening tests Total or partial visual skin examination conducted by primary care providers or dermatologists with or without tools to aid examination (e.g., dermatoscopy, whole body photography)
  • Diagnostic skin examinations in response to patient concern
  • Skin self-screening by individuals or partners
  • Physician counseling for self-screening
Comparison KQs 1, 2: No visual skin examination

KQ 3: Biopsy

KQ 4: Usual care

KQ 5: Stage at detection

  
Outcomes KQs 1, 5: Morbidity associated with any skin cancer (including melanoma in situ, dysplastic nevi, actinic keratosis), including quality of life; skin cancer mortality; all-cause mortality

KQ 2: Any harm from screening, biopsy, or excision, including overdiagnosis, psychosocial harms, or procedure-related adverse events

KQ 3: Sensitivity, specificity, positive predictive value, false-positive results, false-negative results, cancer detection rates

KQ 4: Lesion thickness or stage at diagnosis

KQ 6: Any harm from lymph node dissection or complete dissection
  • Locations other than skin
  • Intermediate or health outcomes relating clinician skin examination to other risk behaviors (e.g., self-screening, sun protective behaviors) or measures of doctor-patient relationship quality
Study design
  • Fair- to good-quality studies published between January 1, 1995 and March 31, 2015
  • Systematic reviews (of included study designs); randomized, controlled trials; selected well-designed controlled clinical trials; observational studies, including cohort and case-control studies; ecologic studies

KQs 2, 6: Same as above, as well as case series on the harms of screening

 Poor-quality studies with a fatal flaw; studies outside of the publication window; case reports and case series (except as noted for KQs 2 and 6); decision analyses

 

The draft Research Plan for this topic was posted for public comment from May 15 to June 11, 2014. Public response was largely favorable toward the proposed research approach. In response to specific comments, the USPSTF revised the inclusion and exclusion criteria to include adolescents (age 15 years and older) and clarified that the review will include alternative screening approaches in addition to a basic visual examination (such as whole body photography and dermatoscopy). The USPSTF also refined the search window to include studies published between January 1, 1995 and March 31, 2015.