Final Research Plan
Skin Cancer Prevention: Behavioral Counseling
June 30, 2016
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.
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 March 17 until April 13, 2016 at 8:00 p.m., ET.
The analytic framework depicts the five Key Questions (KQs) described in the research plan. Specifically, it illustrates the following questions: whether counseling patients in skin cancer prevention improves intermediate outcomes (sunburn or precursor lesions) or skin cancer outcomes (melanoma, squamous or basal cell carcinoma incidence, morbidity, or mortality) (KQ1); whether primary care–relevant counseling interventions improve skin cancer prevention behaviors (reduced sun exposure, sunscreen use, protective clothing use, and skin self-examination) and avoidance of indoor tanning (KQ2); the harms of counseling interventions for skin cancer prevention (increased time in the sun, reduced physical activity, vitamin D deficiency, and anxiety) (KQ3); the association between skin self-examination and skin cancer outcomes (melanoma, squamous or basal cell carcinoma incidence, morbidity, or mortality) (KQ4); and the harms of skin self-examination (KQ5).
- Does counseling patients in skin cancer prevention improve a) intermediate outcomes (sunburn or precursor lesions) or b) skin cancer outcomes (melanoma, squamous cell, or basal cell carcinoma incidence, morbidity, or mortality)?
- Do primary care–relevant counseling interventions improve skin cancer prevention behaviors (e.g., reduced sun exposure, sunscreen use, protective clothing use, avoidance of indoor tanning, and skin self-examination)?
- What are the harms of counseling interventions for skin cancer prevention (e.g., increased time in the sun, reduced physical activity, vitamin D deficiency, and anxiety)?
- What is the association between skin self-examination and skin cancer outcomes (melanoma, squamous cell, or basal cell carcinoma incidence, morbidity, or mortality)?
- What are the harms of skin self-examination?
*Key questions (KQs) 4 and 5 will only be addressed systematically if there is sufficient evidence from KQs 1–3 that behavioral counseling increases skin self-examination behavior.
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the association between sun exposure, sun protection behaviors, indoor tanning, skin self-examination, and a) skin cancer incidence, morbidity, or mortality or b) other health outcomes?
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 KQs.
||Persons with prior history of skin cancer or who are otherwise under surveillance for skin cancer because of known increased risk|
||Settings not affiliated with primary care, such as community, worksite, child care, school, or recreational/tourism settings|
|Comparison||Usual care, no intervention, waitlist, or minimal intervention||Another skin cancer counseling intervention|
|Outcomes||KQs 1, 4: Skin cancer outcomes: melanoma, basal cell, or squamous cell carcinoma incidence, morbidity, or mortality; intermediate outcomes: sunburn, nevi, and actinic keratosis
KQ 2: Behavioral outcomes: sunscreen use; time spent in the sun; shade-seeking; avoiding midday sun; avoiding indoor tanning; use of protective clothing, hats, or sunglasses; composite measures of sun protection behavior; skin self-examination behavior
KQ 3: Any harm of behavioral counseling interventions, such as anxiety, increased time spent in the sun, reduced physical activity, or vitamin D deficiency
KQ 5: Any harm of skin self-examination, including overdiagnosis and cosmetic or psychosocial harms
|All KQs: Skin cancer metastasis or progression
KQs 1, 2, 4: Outcomes with less than 3 months followup after baseline assessment
|Study design||KQs 1, 2: Randomized and controlled clinical trials
KQs 3–5: Randomized and controlled clinical trials; prospective cohort studies
|Case-control studies, cross-sectional designs, case series, case reports, narrative reviews, commentaries, editorials, and theses; qualitative studies; ecologic studies|
|Timing||2009 to present*|
|Quality||Fair or good (according to design-specific USPSTF criteria)||Poor (according to design-specific USPSTF criteria)|
* The USPSTF will continue to consider and use evidence that was included in its prior systematic reviews. For skin self-examination, the search period will begin with August 2005, the search date of the last USPSTF review on this topic.
The draft Research Plan was posted for public comment on the USPSTF Web site from March 17 to April 13, 2016. In response to public comment, the USPSTF made a few minor changes. In the analytic framework, the USPSTF added “avoidance of indoor tanning” to the behavioral outcomes to emphasize the inclusion of this sun protection behavior. In the contextual question, the USPSTF replaced “sunscreen use” with “sun protection behaviors.” The USPSTF changed the included study designs from observational studies to case-control studies and cross-sectional designs. Finally, the USPSTF removed hospitals from the included settings.