Incel 2015.

Study characteristics
Patient sampling	Study design: case series Data collection: prospective (assumed); "Written consent was obtained from all participants before enrolment." Period of data collection: NR Country: Turkey
Patient characteristics and setting	Inclusion criteria: people with non‐pigmented suspected tumoral lesions or proliferative skin lesions and with a vascular structure on dermoscopic examination Setting: secondary (not further described) Istanbul Training and Research Hospital Prior testing: clinical or dermatoscopic suspicion, or both – all participants underwent clinical evaluations "following guidelines of the visual inspection and diagnosis of nonpigmented skin tumor;" those with a vascular structure on dermoscopic examination underwent RCM Setting for prior testing: secondary (general dermatology); specialist unit (skin cancer/pigmented lesions clinic) Exclusion criteria: prominent hyperkeratosis; history of significant other skin disease, kidney, liver, heart disease, surgery, or invasive procedure on the localisation of tumour in the last 6 months, sunbathing or indoor tanning in the last 3 months, and people receiving therapy that has angiogenic effects such as systemic/topical steroids Sample size (participants): number included: 114 Sample size (lesions): number included: 122 Participant characteristics: median age 61 years, range 18‐87 years; male: 57% Lesion characteristics: site – head and neck: 76.2%; extremities: 10.2%; back, abdomen, and chest: 13.6%
Index tests	RCM: characteristics from previous studies selected to assist correct diagnosis of different lesion types; also assessed vascularity of lesions using RCM but this did not inform diagnosis. Vivascope 3000 Method of diagnosis: unclear; images of first 60 lesions subjected to blinded evaluation by 2 observers to identify vascular morphology; unclear whether overall diagnoses reported were based on images or in‐person assessments Prior test data: unclear Diagnostic threshold: characteristics listed for BCC included: dark silhouettes in dermis, bright tumour islands at DEJ and in the dermis; cleft‐like dark areas; dendritic cells, bright rond cells, canalicular vessels. Characteristics listed for SCC included: refractile squam/crust in stratum corneum and nucleated cells with dark centre (parakeratotic) cells; atypical honeycomb pattern, disarranged pattern at stratum granulosum layer; large, round, nucleated cells at the granular layer (dyskeratotic cells); dendritic cells at the granular layer and small edged papillae at DEJ; dendritic cells (referenced to Ahlgrimm‐Siess 2010; Ahlgrimm‐Siess 2011; Eichert 2010; Malvehy 2012; Röwert‐Huber 2007) Derivation aspect to study: study assessed vascularity of lesions with RCM but diagnoses of each lesion type reportedly based on above characteristics. Diagnosis based on: NR Observer qualifications: NR Experience in practice: NR Experience with index test: NR
Target condition and reference standard(s)	Type of reference standard: histological diagnosis alone Details: clinically, dermoscopically, and confocally suspected malignant lesions, recurrent, and therapy resistant lesions were excised; benign appearing but suspected lesions were punch biopsied. Formalin fixed paraffin embedded tissue sections were stained with haematoxylin–eosin. Histopathological examination was conventionally operated by light microscopy Target condition (final diagnoses): BCC: 56; cSCC: 9; keratoacanthoma 3; SK 11; AK 8; Bowen's disease 7; and 24 other non‐pigmented tumours that included sebaceous hyperplasia 4, eccrine poroma 4, pyogenic granuloma 3, amelanotic melanoma 2, sebaceous adenoma 2, trichilemmoma 2, warty dyskeratoma 1, pilomatrixoma 1, kaposi sarcoma 1, fibrohistiocytic tumour 1, eccrine spiradenoma 1, and eccrine porocarcinoma 1
Flow and timing	Index to reference interval: appears consecutive "Biopsy was taken for routine histology from selected patients, and was examined with RCM." No exclusions reported
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?	Yes
Are the included participants and chosen study setting appropriate?	Unclear
Did the study avoid including participants with multiple lesions?	No
		Unclear	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?	Unclear
Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication?	Yes
Was the test interpretation carried out by an experienced examiner?	Unclear
		Low	Unclear
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