Piccolo 2014.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective image selection/prospective interpretation Period of data collection: September 2010‐October 2013 Country: Italy |
||
Patient characteristics and setting |
Inclusion criteria: dermoscopically atypical PSLs selected from the archives of the Dermatology Department at the University of L’Aquila, Italy; described as "a panel of ... retrospectively selected PSLs" Setting: secondary (general dermatology) Prior testing: NR Setting for prior testing: NR Exclusion criteria: location/site of lesion ‐ acral sites and the face Sample size (participants): number included: 165 Sample size (lesions): number included: 165 Participant characteristics: mean age 43.5 years (range 12‐84 years); male: 59.4% Lesion characteristics: lesion site; upper extremities 18 (11%); lower extremities 53 (31%); 62 (37.5%) on the back; 32 (19.4%) on the chest. Melanoma thickness 87.9% (29/33) < 0.75 mm; 11% (4/33) > 1.5 mm |
||
Index tests |
Dermoscopy: ABCD Method of diagnosis: dermoscopic images Prior test data: no further information used Diagnostic threshold: total dermoscopic score > 4.75 and > 5.45 Diagnosis based on: single observer (n = 4) Observer qualifications: 3 dermatologists and 1 GP with different degrees of dermoscopic experience Experience in practice: mixed Experience with dermoscopy: high (observer 1 ‐ dermatologist); moderate (observers 2 and 3 ‐ dermatologists); low (observer 4 ‐ GP; underwent dermoscopic training by studying an interactive atlas of dermoscopy between time periods T0 and T1) Any other detail: experience was scored based on number of years specialising in dermoscopy; number of PSLs assessed by dermoscopy on a daily basis; number of relevant workshops/seminars attended; and the number of authored publications on dermoscopy. |
||
Target condition and reference standard(s) |
Reference standard: histological diagnosis alone (not further described) Target condition (final diagnoses) Melanoma (invasive): 23; melanoma (in situ): 10 Benign naevus: 105 Clark naevi; 19 Spitz/Reed naevi; 5 blue naevi; 3 dermal naevi |
||
Flow and timing |
Excluded participants: none reported Time interval to reference test: not described |
||
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? | Unclear | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | No | ||
Are the included patients and chosen study setting appropriate? | No | ||
Did the study avoid including participants with multiple lesions? | Yes | ||
High | 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? | |||
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? | Unclear | ||
Low | Unclear | ||
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 |