Borve 2015.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: prospective Period of data collection: January 2011 to December 2012 Country: Sweden |
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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 |
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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. |
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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%) |
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Flow and timing |
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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 |