Nachbar 1994.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: prospective Period of data collection: November 1991‐July 1992 Country: NR (authors' institutions Germany and USA) |
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Patient characteristics and setting |
Inclusion criteria: pigmented melanocytic skin lesions consecutively excised Setting: secondary (general dermatology) Prior testing: selected for excision (no further detail) Setting for prior testing: NR Exclusion criteria: unequivocal appearance/diagnosis criteria used to exclude non‐melanocytic described in detail in Table 1 Sample size (participants): NR Sample size (lesions): number included: 194 Participant characteristics: none reported Lesion characteristics: thickness, 35/69 MM ≤ 0.75 mm (50.7%) |
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Index tests |
Dermoscopy: ABCD Method of diagnosis: in‐person diagnosis Prior test data: clinical examination and/or case notes Diagnostic threshold: > 5.45 (determined based on retrospective analysis of the data) For the calculation of ABCD score the criteria of asymmetry (A), abrupt cutoff of the pigment pattern at the border (B), different colours (C), and different structural components (D) were assessed to yield a semiquantitative score (all described in detail). "The results of the retrospective study showed that melanocytic pigmented skin lesions could be differentiated into two diagnostic groups as follows: melanocytic naevi (MN) if the final score was less than 5.45 and MM if the score was higher than 5.45. Retrospective analysis showed an early melanoma could not be completely excluded in all lesions with an ABCD score between 4.75 and 5.45.Therefore these lesions were excised. All lesions were examined by two independent dermatopathologists." Diagnosis based on: unclear (n = NR) Observer qualifications: NR; presumably dermatologists; "colleagues in our department" Experience in practice: high experience or ‘Expert’ Experience with dermoscopy: high experience /‘Expert’ users Study also presents 2x2 data for VI; excluded from review as clinicians 'mostly' also used dermoscope for diagnosis. From text: "In comparing the clinical with the dermatoscopic diagnosis with the ABCD rule it must be noted that all our colleagues in this department referring patients for the study were experienced and in most cases used the dermatoscope without applying the new ABCD rule. Thus clinical diagnosis in our study was expected to be already biased by the dermatoscopic feature and therefore to be more accurate than by the naked eye" |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone 194 (not further described)
Disease‐positive: 69; disease‐negative: 125 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 69 BCC: 3 Sebhorrheic keratosis: 19 'Benign' diagnoses: 103 melanocytic naevus |
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Flow and timing |
Time interval to reference test: NR Time interval between index test(s): appears consecutive |
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Comparative | |||
Notes | ‐ | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Are the included patients and chosen study setting appropriate? | No | ||
Did the study avoid including participants with multiple lesions? | Unclear | ||
Low | High | ||
DOMAIN 2: Index Test Dermoscopy ‐ in‐person | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
If a threshold was used, was it pre‐specified? | No | ||
For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others? | |||
Was the test applied and interpreted in a clinically applicable manner? | No | ||
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? | Yes | ||
Was the test interpretation carried out by an experienced examiner? | Yes | ||
High | High | ||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
Expert opinion (with no histological confirmation) was not used as a reference standard | Yes | ||
Was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist? | Yes | ||
Low | Low | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
If the reference standard includes clinical follow‐up of borderline/benign appearing lesions, was there a minimum follow‐up following application of index test(s) of at least: 3 months for melanoma or cSCC or 6 months for BCC? | |||
If more than one algorithm was evaluated for the same test, was the interval between application of the different algorithms 1 month or less? | |||
Unclear |