Page 54 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers

Appendix B. Inclusion and Exclusion Criteria

Table B-1. Literature abstract screening (PICO) criteria
Inclusion criteria Exclusion criteria
Population (P) - History of past or current skin cancer: - All other skin cancers
melanoma, basal cell carcinoma, squamous - Kaposi’s sarcoma
cell carcinoma - Merkel cell carcinoma
- Patients with new or recurrent pigmented or - Mycosis fungoides
suspicious skin lesions, including facial skin - Skin lymphoma
cancers, basal cell nevus syndrome, and - Sezary syndrome
Gorlin’s Syndrome - Choroidal melanoma
- Included all age, race, sex, and countries - Subungal, ocular, and visceral
lesions
- Head and neck cancers
- Metastases
Diagnostic device of - General - Spectrophotometric intracutaneous
interest (I) - Full body photography Analysis (SIAscopy)
- Digital photography - Spectrophotometry
- Dermoscopy - Photoacoustic microscopy
- Limited Use - Photodynamic therapy (PDT)
- Confocal microscopy - Colorimetry
- Ultrasound, including laser Doppler, color - 18 F-FDG positron emission
mapping tomography (PET)
- Photodynamic diagnosis - Computer tomography (CT)
- Investigational - Single photon emission computed
- Multiphoton laser scanning microscopy tomography (SPECT)
- Multispectral imaging with computer-analysis - Lymphoscintigraphy
- Optical coherence tomography - Fluorescent in situ hybridization
- Epidermal genetic tape stripping - Therapeutic interventions
- Bio-electrical impedance - Pre-surgical planning
- Thermography
Comparator (C) - Biopsy
- Any intervention and device listed above
- Clinical exam/assessment
Outcomes (O) - Any clinical outcomes reported (including - Metastases detection
skin cancer survival and overall survival) - Prognosis prediction
- Quality of life measures
- Intermediate outcomes, e.g., changes in size
and number of lesions
- Lesion characterizations
- Adverse events, harms, or safety data
- FDA clearance/approval status (if applicable)
- Process measures, e.g., time to specialty
referral, hospital wait times, healthcare
utilization
- Diagnostic test accuracy, e.g., sensitivity,
specificity, positive predictive value, negative
predictive value
Study design - Systematic reviews
- Narrative reviews
- Trials
- Comparative cohorts
- Case series
- Case reports
- Diagnostic tests

B-1