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

Borve 2015.

Study characteristics
Patient sampling Study design: case series
Data collection: prospective
Period of data collection: January 2011 to December 2012
Country: Sweden
Patient characteristics and setting Inclusion criteria: adults > 18 years of age with ≥ 1 skin lesions of concern requiring referral to a dermatologist using the TD referral system
Setting: primary (20 primary healthcare centres in western Sweden)
Prior testing: N/A
Setting for prior testing: N/A
Exclusion criteria: did not attend FTF visit(s), did not comply or skin lesions were located on a body part that could not be photographed.
Sample size (participants): number eligible: 902; number included: 816
Participant characteristics:
Age: mean 54; range: 18–93 years
Gender: 474 (61.3%) women
Lesion characteristics: NR
Index tests TD
Acquisition and transmission of images: GPs used the smartphone TD referral system. The GP took 1 clinical and 1 dermoscopic image using an iPhone 4 with a FotoFinder Handyscope app, and completed a standardised query form including all the relevant clinical information. This was then sent through a secure web‐based TD platform (Tele‐Dermis) with a secure socket layer encryption. Simultaneously the participating dermatologists received an email that a new referral was ready for assessment.
Nature of images used: clinical photographs and dermoscopic images
Any additional participant information provided: clinical information
Diagnosis based on: single; number of examiners: 4
Observer qualifications (remote diagnosis): 3 specialists in dermatology and 1 resident in dermatology
Method of diagnosis: dermatologists logged onto the Tele‐Dermis platform to review the referrals on a 17‐ or 19‐inch liquid crystal display monitor. They chose from standardised triage responses including an assessment of the nature of the lesion (benign, malignant or unclear), ≥ 1 possible diagnoses, the priority given (high, within 2 weeks; medium, within 4 weeks or low, within 8–12 weeks), suggested management (none, medical therapy, destructive therapy or surgery) and, finally, a dermoscopic description.
Target condition and reference standard(s) Histological plus expert diagnosis
Histology: 551
Details: All MMs and SCCs (keratoacanthomas were classified as SCCs) were confirmed histopathologically. Final diagnosis confirmed histopathologically in 292 TD referrals (36%) and 259 paper referrals (35%)
Expert diagnosis (FTF diagnosis at dermatology clinic): 265
Method of diagnosis: dermatologists used dermoscopy to evaluate the study lesions and carried out full body skin examination
Prior test data: all relevant clinical information (FTF visits were not blinded to the results of the teledermoscopists)
Diagnostic threshold: NR
Diagnosis based on: single
Number of examiners: NR
Observer qualifications: dermatologists (specialists in dermoscopy)
Experience in practice: high
Experience with index test: high
Target condition (final diagnoses)
Malignant: MM: 19 (2.3%); MiS: 16 (2.0%); SCC: 17 (2.1%); SCC in situ: 7 (0.9%); BCC: 109 (13.4%); AK: 61 (7.5%); other malignant: 0
Benign: dysplastic nevi: 89 (10.9%); BN: 236 (28.9%); SK: 125 (15.3%); other benign: 137 (16.8%)
Flow and timing
  • Excluded participants: none reported

  • Time interval to reference test: all participants were called to attend an FTF visit at the corresponding department of dermatology. A suspicion of MM or SCC was triaged within 2 weeks. After the triage process, all participants were managed according to standard protocols at the hospitals independently of the referral method.

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? Unclear    
    Low Unclear
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? Yes    
    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? Unclear    
For studies comparing TD/FTF clinical diagnosis to histology, was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist? Unclear    
For studies comparing TD to FTF diagnosis, was the clinical diagnosis carried out by an experienced observer?      
    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? No    
Were all patients included in the analysis? Yes    
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? Yes    
    High