Curchin 2011.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: prospective Period of data collection: January 2010 to May 2010 Country: Australia |
||
Patient characteristics and setting |
Inclusion criteria: people from Dermatology Department's minor excision booking list; not further described Setting: secondary (general dermatology) Prior testing: selected for excision (no further detail) Setting for prior testing: unspecified Exclusion criteria: none reported Sample size (participants): number included: 42 Sample size (lesions): number included: 50 Participant characteristics: none reported Lesion characteristics: none reported |
||
Index tests |
RCM: Vivascope 1500; RCM score (Pellacani 2007) and LM score for suspected LM of the face (Guitera 2010) Method of diagnosis: in‐person diagnosis Prior test data: dermoscopy "dermoscopic and RCM images were aligned over the top of each other so that correlation between the two could be made." Diagnostic threshold: for melanoma – RCM score: ≥ 3; threshold for LM score for suspected LM of the face was not described (Guitera 2010). Observer diagnosis for SCC/BCC; RCM features listed Diagnosis based on: single observer; (n = 1?) Observer qualifications: NR Experience in practice: not described Experience with index test: low experience/novice users; analysis was performed by a novice to RCM analysis after completing an RCM analysis course in Modena, Italy. |
||
Target condition and reference standard(s) |
Type of reference standard: histological diagnosis alone Details: no further details provided Disease positive: 21; disease negative: 29 Target condition (final diagnoses): melanoma (invasive): 12; melanoma (in situ): 1; BCC: 9; cSCC: 6 (included SK or AK, or both); 'benign' diagnoses: 23 |
||
Flow and timing | Time interval to reference test: NR | ||
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 participants and chosen study setting appropriate? | Unclear | ||
Did the study avoid including participants with multiple lesions? | No | ||
Low | High | ||
DOMAIN 2: Index Test Reflectance confocal microscopy | |||
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? | Yes | ||
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? | Yes | ||
Was the test interpretation carried out by an experienced examiner? | No | ||
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 | ||
Were the reference standard results interpreted without knowledge of the referral diagnosis? | Unclear | ||
Unclear | Unclear | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Was the minimum clinical follow‐up after application of index test(s) adequate? | |||
If more than one algorithm evaluated for the same test, was the interval between application of the different algorithms 1 month or less? | |||
Low |