Unlu 2014.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: January 2008‐January 2010 Country: Turkey |
||
Patient characteristics and setting |
Inclusion criteria: melanocytic lesions excised at Ankara University Department of Dermatology Pigmented Lesion Clinic Setting: specialist unit; Ankara University Department of Dermatology Pigmented Lesion Clinic Prior testing: selected for excision (no further detail) Setting for prior testing: specialist unit (skin cancer/PLC) Exclusion criteria: location/site of lesion facial, nail and volar acral lesions were excluded; non‐melanocytic appearance Sample size (participants): number included: 115 Sample size (lesions): number included: 115 Participant characteristics: mean age: 38.72 years (+/‐ 18.46 years). Male: 56 (49%) Lesion characteristics: lesion site: 100% trunk and limbs. Melanoma thickness: 10 (41.7%) < 0.75 mm; 14 (58.3%) ≥ 0.75 mm |
||
Index tests |
VI: no algorithm; appears to be original clinical diagnosis at time of lesion presentation Method of diagnosis: in‐person diagnosis. Appears to be diagnosis on presentation Prior test data: N/A; in‐person diagnosis Other test data: dermoscopic images presented to different observers Diagnostic threshold: NR Diagnosis based on: unclear; for VI appears to be single examiner at time of clinic diagnosis (n = NR); dermoscopic images "scored by three other experienced dermatoscopists" Observer qualifications: NR; assumed dermatologists; described as experienced dermatoscopists Experience in practice: unclear for clinic diagnosis; dermatoscopists described as "experienced" Experience with index test: described as "experienced" Dermoscopy 3‐point rule; 7PCL; ABCD; CASH algorithm Method of diagnosis: dermoscopic images Prior test data: no further information used; clinical image evaluation appears to be separate from dermoscopy interpretation Diagnostic threshold: ABCD score ≥ 5.45 highly suggestive for melanoma; 7‐point score ≥ 3; 3‐point score 2 or 3 criteria present; CASH algorithm ≥ 8 Observers: as described for Visual Inspection above |
||
Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Disease‐positive: 24; disease‐negative: 91 Target condition (final diagnoses) Melanoma (in situ and invasive, or NR): 24 'Benign' diagnoses: 91 melanocytic benign lesions; 37 (32.2%) dermal naevi; 15 (13%) Clark's naevi; 14 (12.2%) compound naevi; 13 (11.3%) blue naevi; 6 (5.2%) SN; 4 (3.5%) congenital melanocytic naevi; 2 (1.7%) junctional naevi |
||
Flow and timing |
Excluded participants: none reported Time interval to reference test: NR |
||
Comparative |
Blinding between tests: used in‐person clinical diagnosis; clinical image evaluation appears to be separate from dermoscopy interpretation Time interval between index test(s): appear to be consecutively applied but not described |
||
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? | Yes | ||
Low | High | ||
DOMAIN 2: Index Test Visual Inspection ‐ 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? | Unclear | ||
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? | Yes | ||
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? | No | ||
Was the test interpretation carried out by an experienced examiner? | Unclear | ||
Unclear | High | ||
DOMAIN 2: Index Test Dermoscopy ‐ image‐based | |||
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? | Yes | ||
For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others? | Unclear | ||
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 | ||
Low | 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 | |||
DOMAIN 5: Comparative | |||
Was each index test result interpreted without knowledge of the results of other index tests or testing strategies? | Yes | ||
Was the interval between application of the index tests less than one month? | Unclear | ||
Were all tests applied and interpreted in a clinically applicable manner? | No | ||
Unclear | High |