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. 2018 Dec 4;2018(12):CD011902. doi: 10.1002/14651858.CD011902.pub2
Criterion Inclusion Exclusion
Study design For diagnostic and staging reviews
  • Any study for which a 2×2 contingency table can be extracted, e.g.

    • diagnostic case‐control studies

    • 'cross‐sectional' test accuracy study with retrospective or prospective data collection

    • studies where estimation of test accuracy was not the primary objective but test results for both index and reference standard were available

    • RCTs of tests or testing strategies where participants were randomised between index tests and all undergo a reference standard (i.e. accuracy RCTs)

  • < 5 melanoma cases (diagnosis reviews)

  • < 10 participants (staging reviews)

  • Studies developing new criteria for diagnosis unless a separate 'test set' of images were used to evaluate the criteria (mainly digital dermoscopy)

  • Studies using 'normal' skin as controls

  • Letters, editorials, comment papers, narrative reviews

  • Insufficient data to construct a 2×2 table

Target condition
  • Melanoma

  • Keratinocyte skin cancer (or non‐melanoma skin cancer)

    • BCC or epithelioma

    • cSCC

  • Studies exclusively conducted in children

  • Studies of non‐cutaneous melanoma or SCC

Population For diagnostic reviews
  • Adults with a skin lesion suspicious for melanoma, BCC, or cSCC (other terms include PSL/naevi, melanocytic, keratinocyte, etc.)

  • Adults at high risk of developing melanoma skin cancer, BCC, or cSCC


For staging reviews
  • Adults with a diagnosis of melanoma or cSCC undergoing tests for staging of lymph nodes or distant metastases or both

  • People suspected of other forms of skin cancer

  • Studies conducted exclusively in children

Index tests For diagnosis
  • Visual inspection/clinical examination

  • Dermoscopy/dermatoscopy

  • Teledermoscpoy

  • Smartphone/mobile phone applications

  • Digital dermoscopy/artificial intelligence

  • Confocal microscopy

  • Ocular coherence tomography

  • Exfoliative cytology

  • High‐frequency ultrasound

  • Canine odour detection

  • DNA expression analysis/gene chip analysis

  • Other


For staging
  • CT

  • PET

  • PET‐CT

  • MRI

  • Ultrasound +/fine needle aspiration cytology FNAC

  • SLNB +/high‐frequency ultrasound

  • Other


Any test combination and in any order
Any test positivity threshold
Any variation in testing procedure (e.g. radioisotope used)
  • Sentinel lymph biopsy for therapeutic rather than staging purposes

  • Tests to determine melanoma thickness

  • Tests to determine surgical margins/lesion borders

  • Tests to improve histopathology diagnose

  • LND

Reference standard For diagnostic studies
  • Histopathology of the excised lesion

  • Clinical follow‐up of non‐excised/benign appearing lesions with later histopathology if suspicious

  • Expert diagnosis (studies should not be included if expert diagnosis is the sole reference standard)


For studies of imaging tests for staging
  • Histopathology (via LND or SLMB)

  • Clinical/radiological follow‐up

  • A combination of the above


For studies of SLNB accuracy for staging
  • LND of both SLN+ and SLn participants to identify all diseased nodes

  • LND of SLN+ participants and follow‐up of SLN participants to identify a subsequent nodal recurrence in a previously investigated nodal basin

For diagnostic studies
  • Exclude if any disease positive participants have diagnosis unconfirmed by histology

  • Exclude if > 50% of disease‐negative participants have diagnosis confirmed by expert opinion with no histology or follow‐up

  • Exclude studies of referral accuracy, i.e. comparing referral decision with expert diagnosis, unless evaluations of teledermatology or mobile phone applications

BCC: basal cell carcinoma; cSCC: cutaneous squamous cell carcinoma; CT: computed tomography; FNAC: fine needle aspiration cytology; lND: lymph node dissection; MRI: magnetic resonance imaging; PET: positron emission tomography; PET‐CT: positron emission tomography computed tomography; RCT: randomised controlled trial; SCC: squamous cell carcinoma; SLN+: positive sentinel lymph node; SLn: negative sentinel lymph node; SLNB: sentinel lymph node biopsy.