Applied Evidence

Diagnosing skin malignancy: Assessment of predictive clinical criteria and risk factors

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Conversely, if one of the criteria is met, there is nearly a 1.5% (positive predictive value) probability it is melanoma. Excisional biopsy of the lesion is indicated if good clinical judgment is used and it cannot be identified with certainty as a typical benign lesion (SOR: A). This test thus guides clinicians when making a decision to biopsy, as well as in choosing a biopsy technique.

The ABCDE criteria establish a risk of malignancy if the lesion is 6 mm in diameter or greater. Some evidence, however, suggests that this value should not be used as an absolute cutoff for diagnosing malignant melanoma. A large retrospective study performed in Australia found that 31% of biopsy-confirmed melanomas were less than 6 mm in diameter (LOE: 2b).20

Revised 7-point checklist. Another potentially useful diagnostic test is the revised 7-point checklist developed in the United Kingdom ( Table 5). This test was found to have a high sensitivity, but low specificity ( Table 4) . Therefore, it has a low false-negative rate, and is useful for ruling out the diagnosis of melanoma when negative. However, the test yields a significant number of false positive results, leading to possibly unnecessary biopsies and increased patient anxiety (SOR: B).16,21,22

Note: the described sensitivities and specificities for both tests apply only to malignant melanomas, and their accuracy decreases when including basal cell and squamous cell carcinomas. Also, the 2 tests were scored differently in some of the validation studies, making attempts to generalize problematic.

Studies of physicians’ global assessments to detect melanomas ( Table 4) vary widely for sensitivity (50% to 97%) but are consistent for specificity (96% to 99%) (SOR: B).23-28 Additionally, some studies have shown higher percentages of correct diagnosis of malignant melanoma among dermatologists compared with nondermatologists, but all these studies (except for a small subset of patients in one) used lesion images rather than patient examinations (SOR: B).23,29-33

More importantly, when the choice of correct treatment was evaluated, no statistically significant difference was found between the two groups. Further prospective cohort trials using patient examinations are needed to evaluate dermatologist performance versus nondermatologist performance.

TABLE 3
American Cancer Society's ABCDE criteria

The test is considered positive if a lesion exhibits 1 or more of the 5 criteria
Assymetry—one half of the lesion not identical to the other
Border irregularity—lesion has an uneven or ragged border
Color variegation—lesion has more than one color (ie, black, blue, pink, red, or white)
Diameter—lesion has a diameter greater than 6 mm
Elevation or Enlargement—elevation of lesion above skin surface or enlargement by patient report

TABLE 4
Clinical prediction tests for skin malignancies

Diagnostic testStudy quality (SOR)*Sensitivity % (average)Specificity % (average)LR+ (1% pretest)LR–PV+PV–
ABCDE criteria (1 criterion positive)16-19A92–97 (93)13–63 (37)1.50.21.5%99.8%
Revised 7-point checklist16,21,22B79–100 (90)30–37 (34)1.40.31.4%99.7%
Physician global assessments23-28B50–97 (74)96–99 (98)370.327.2%99.7%
*See page 239 for a description of strength of recommendation
Note: These calculations are based on simple averages. Statistical homogeneity could not be fully evaluated due to study data limitations.
SOR, strength of recommendation; LR+, positive likelihood ratio; LR–, negative likelihood ratio; PV+, positive predictive value; PV–, negative predictive value

TABLE 5
Revised 7-point checklist for assessing risk of melanoma

Suspect melanoma if there are 1 or more major signs:
  1. Change in size
  2. Change in shape
  3. Change in color
3 or 4 minor signs without a major sign can also indicate a need to biopsy suspicious moles:
  1. Inflammation
  2. Crusting or bleeding
  3. Sensory change
  4. Diameter (≥7 mm)

No validated tool for diagnosis of nonmelanoma skin cancers

A useful diagnostic tool has not yet been validated for nonmelanoma skin cancers. Over 60% of non-melanoma skin cancers occur on the face and neck, and these areas bear careful inspection. Lesions behind the ear, at the medial canthus, and within the nasolabial folds are most easily missed.

How to proceed in assessing lesions

When evaluating skin lesions, remember the gold standard for diagnosis of skin malignancies is a tissue biopsy. If you or your patient has any doubt about the diagnosis, a biopsy should be performed.

To review: Good evidence supports the use the ABCDE criteria or the revised 7-point checklist in determining whether lesions are likely to be malignant melanomas. No similar diagnostic rules exist for basal cell and squamous cell carcinomas. The decision to biopsy these lesions must be based on global assessment and typical characteristics.

Based on this information, we developed an algorithm for evaluating patients at risk for skin malignancies ( Figure) . The first step is to apply the ABCDE criteria and the revised 7-point checklist to identify or rule out possible malignant melanomas. An excisional biopsy should be performed if either test is positive (and the lesion is not clinically benign), or if you or your patient has any doubt.

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