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. 2018 Dec 4;2018(12):CD013193. doi: 10.1002/14651858.CD013193

Oliveira 2002.

Study characteristics
Patient sampling Study design: case series
Data collection: unclear but appeared prospective
Period of data collection: NR
Country: Brazil
Patient characteristics and setting Inclusion criteria: participants with suspect dermatological identified by an assistant nurse who had undergone training to identify potentially malignant skin lesions. Only those who attended for FTF assessment were included.
Setting: primary care; Centro de Saúde Escola Geraldo de Paula Souza (primary care public health service)
Prior testing: none
Setting for prior testing: N/A
Exclusion criteria: none reported
Sample size (participants): 103 eligible; 90 included
Sample size (lesions): 90
Participant characteristics: NR
Lesion characteristics: NR
Index tests TD
Acquisition and transmission of images: lesions photographed in primary care by an assistant nurse using a Kodak DC265 Zoom digital camera. 2 hours' training in the use of the camera was provided and included instruction on the installation of the camera's software and transferring the images to the computer. Images were sent by nurse with an electronic case report form and included her diagnostic impression whether the lesion was non‐malignant or malignant.
Nature of images used: clinical
Any additional participant information provided: participant record
Diagnosis based on: single observer
Number of examiners: 1
Observer qualifications (remote diagnosis): dermatologist from the Department of Dermatology of the Faculty of Medicine of the University of São Paulo
Method of diagnosis: not clearly described. All cases were assessed remotely by a dermatologist prior to the in‐person evaluation
Management options: malignant or benign; malignant diagnosis indicated biopsy needed
Target condition and reference standard(s) Reference standard: expert diagnosis (referral accuracy)
Details: within 1 week the same dermatologist saw the participant in‐person. Participants were referred for biopsy when skin cancer was the suspected diagnosis. The in‐person assessments by the dermatologist (and the biopsy results in a few cases) were used as reference.
Target condition (FTF diagnoses)
Malignant: 8
Benign: 82
Flow and timing Excluded participants: 2 lesions without a TD diagnosis
Time interval to reference test: 1 week from photographs being taken
Time interval between index test(s): N/A
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? Yes    
Did the study avoid including participants with multiple lesions? Yes    
    Low Low
DOMAIN 2: Index Test Teledermatology
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    
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? Unclear    
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? No    
Were the reference standard results interpreted without knowledge of the results of the index tests? No    
For studies comparing TD/FTF clinical diagnosis to histology, was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist?      
For studies comparing TD to FTF diagnosis, was the clinical diagnosis carried out by an experienced observer? Unclear    
    High 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? No    
If the reference standard includes clinical FU of borderline/benign appearing lesions, was there a minimum FU following application of index test(s) of at least: 3 months for melanoma or cSCC or 6 months for BCC?      
    High