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









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