Title: A programme of systematic reviews to determine the accuracy of tests for the diagnosis and staging of skin cancer
Funder: Department of Health (England)

Abstract: BackgroundSkin cancer is the most common human cancer ranging from relatively slow growing and locallydestructive basal cell carcinoma (rodent ulcer or BCC) through squamous cell carcinoma (SCC) tomelanoma skin cancer which is often fatal when the disease has spread into the bloodstream. Accurate timely diagnosis and staging is important to ensure best outcomes of treatment. Aims and objectivesOur aim is to systematically review the evidence for the accuracy of all tests used in clinical practice or research settings for melanoma diagnosis and staging and for diagnosis of BCC and SCC to identify the most accurate test(s) and to provide clinicians policy-makers and patients with robust evidence on which to base diagnostic and staging decisions.The reviews cover six main areas: 1) diagnosis of melanoma in the general population; 2) diagnosis of melanoma in high risk groups; 3) diagnosis of basal cell carcinoma; 4) diagnosis of squamous cell carcinoma; 5) staging of melanoma and; 6) the effectiveness of training interventions on diagnostic efficiency for diagnosis of melanomaMethodsReview of each test for each condition will be undertaken according to the Cochrane Diagnostic Test Accuracy Handbook methodology; tests will then be compared and reported in Cochrane DTA Overviews. Generic protocols for topics 1) to 5) will be prepared detailing eligibility criteria and core common methods. Test–specific protocols will detail relevant test specific background and methodological detail. A standard intervention review protocol will be prepared for 6) the review of training interventions. All protocols will be peer reviewed by the Cochrane Skin Group and DTA Editorial Team.A comprehensive search will cover MEDLINE MEDLINE In Process EMBASE Cochrane Library CINAHL and Science Citation Index using search terms for the target conditions combined with search terms for the index tests of interest. Eligibility criteria for full-text papers quality assessment and data extraction forms will be designed and piloted. Quality assessment will be undertaken using the QUADAS-2 tool. Each of the main stages of the reviews will be carried out independently by two reviewers with referral to a third reviewer where necessary. Hierarchical models will be used for meta-analysis. The form of the analysis will be chosen to appropriately accommodate the thresholds that each test is reported at. Average sensitivity and specificities will be reported where possible. Comparisons between tests settings and by thickness will be made using bivariate meta-regression models. Results will be reported in an accessible way as standardised frequencies of false positive and false negative rates and presented using Summary of Findings tables.ConclusionBy identifying the most appropriate tests and settings for diagnosis and staging of melanoma andother skin cancers the output from the project will provide the basis for more appropriate identification of patients requiring triage or particular treatments. Evidence-based diagnosis is becoming increasingly important in an era of rising treatment costs.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS