Final Research Plan
Skin Cancer: Screening
March 25, 2021
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.
*Previously referred to as nonmelanoma skin cancer; includes basal cell carcinoma and squamous cell carcinoma.
Note: For all Key Questions and Contextual Questions, “skin cancer” refers to melanoma and keratinocyte carcinomas (basal cell carcinoma and squamous cell carcinoma).
- What is the effectiveness of routine skin cancer screening with visual skin examination by clinicians in reducing skin cancer morbidity and mortality or all-cause mortality?
- Does the effectiveness of screening vary by subgroups (e.g., age, sex, skin type, race/ethnicity, socioeconomic status, or ultraviolet [UV] exposure)?
- Does routine skin cancer screening lead to higher rates of detection of precancerous lesions or earlier stage skin cancer compared to usual care (e.g., lesion-directed skin examination)?
- Do rates of earlier skin cancer detection vary by subgroups (e.g., age, sex, skin type, race/ethnicity, socioeconomic status, or UV exposure)?
- What are the harms of skin cancer screening and diagnostic followup?
- Do the harms of screening vary by subgroups (e.g., age, sex, skin type, race/ethnicity, socioeconomic status, or UV exposure)?
- What is the association between detection of precancerous lesions or earlier stage skin cancer and morbidity and mortality due to skin cancer or all-cause mortality?
- Does this association vary by subgroups (e.g., age, sex, skin type, race/ethnicity, socioeconomic status, or UV exposure)?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What validated risk assessment tools are available for assessing skin cancer risk in primary care?
- What is the potential for overdiagnosis and overtreatment associated with skin cancer screening?
- What is the test performance of routine skin cancer screening in a primary care or dermatology setting?
- What are the serious harms of treatment of skin cancer?
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).
Proposed inclusion and exclusion criteria are generally consistent with the 2016 review. However, outcomes for KQ 2 now are focused on stage or lesion thickness at detection of skin cancer or precancerous lesion, rather than on the diagnostic accuracy of screening by primary care clinicians compared to screening by dermatologists.
|Population||KQs 1–3: Asymptomatic adolescents and adults age 15 years and older with or without a family history of melanoma
KQ 4: Adolescents and adults age 15 years and older diagnosed with skin cancer
|Individuals younger than age 15 years
KQs 1–3: Individuals under surveillance for skin cancer (e.g., previous skin cancer; genetic syndromes associated with increased skin cancer risk; conditions associated with an immunosuppressed state)
||KQs 1, 2: Studies conducted exclusively in specialty care settings (e.g., dermatology/plastic surgery)|
|Screening tests||Total or partial visual skin examination conducted by a clinician with or without tools to aid examination (including but not limited to, dermatoscopy, whole body photography)||
KQ1: Lesion-directed diagnostic skin examination (e.g., in response to patient concern)
KQs 1–4: Skin self-examination or behavioral counseling by clinician for self-examination*
|Comparison||KQs 1, 2: No visual skin examination
KQ 2: Usual care, (e.g. lesion-directed examination)
KQ 4: Stage at detection (precancerous lesions or skin cancer)
|Outcomes||KQs 1, 4: Morbidity associated with skin cancer, including quality of life; skin cancer mortality; all-cause mortality
KQ 2: Stage or lesion thickness at detection of skin cancer or precancerous lesion
KQ 3: Any persistent harm (beyond 30 days) from screening, biopsy, or excision, including psychosocial harms and procedure-related adverse events
|KQs 1, 2, 4:
|Study design||All KQs: Fair- and good-quality studies
KQs 1, 2, 4: Randomized, controlled trials; controlled clinical trials; observational or nonrandomized studies with a contemporaneous controlKQ 3: Randomized, controlled trials; controlled clinical trials; large screening registry or database; observational studies; cohort studies; and systematically selected case series
|All KQs: Poor-quality studies
KQs 1, 2: Decision analysesKQ 3: Case studies
* Covered in 2018 evidence review on behavioral counseling for skin cancer prevention.1
The draft Research Plan was posted on the USPSTF website for public comment from January 7, 2021, to February 3, 2021. In response to public comment, the USPSTF clarified the wording of KQs 2 and 4 to more clearly delineate precancerous lesions from early-stage skin cancer, clarified that the exclusion of “lesion-directed diagnostic skin examination (e.g., in response to patient concern)” applies to KQ 1 only, added race/ethnicity and socioeconomic status as additional examples of subpopulations that will be examined for each KQ, and added KQ 4a to assess whether the association varies by subgroups. The USPSTF made no other substantive changes that altered the scope of the review.