Shapiro 2004.

Study characteristics
Patient sampling	Study design: case series Data collection: prospective Period of data collection: 10 July 1998 to 4 August 2000 Country: USA
Patient characteristics and setting	Inclusion criteria: PCP referred only those people with skin growths that posed a true diagnostic challenge. Setting: primary, recruitment of study participants from PCP (estimated 50% of PCP participants had dermatological lesions that were encountered during routine evaluation and 3% present exclusively for dermatological reasons). Private (FTF consultation with the local dermatologist in private practice). Secondary care (images sent from PCP to academic dermatologist for SAF dermatological consultation) Prior testing: a network community PCP‐recruited participants whom he judged to require dermatological consultation for evaluation of a cutaneous growth. Setting for prior testing: primary Exclusion criteria: people who underwent previous evaluation by a dermatologist Sample size (participants): number eligible: 61; number included: 49 Sample size (lesions): NR Participant characteristics: NR Lesion characteristics: NR
Index tests	TD Acquisition and transmission of images: images were acquired by the PCP using an Olympus D‐600L digital camera. The first image captured the head and upper trunk. This was followed by an image of the affected body part. The image and a clinical history were downloaded to a personal computer using a serial port interface and accompanying software. The image transmission was performed via e‐mail using HUPNet, a private encrypted University of Pennsylvania Health System area network Nature of images used: clinical photographs Any additional participant information provided: clinical history Observer qualifications (remote diagnosis): dermatologist (1) (academic dermatologist with over 20 years' experience in clinical dermatology) Diagnosis based on: single observer Number of observers: 1 Method of diagnosis: the images were reviewed by the PCP immediately before they were sent to a board certified academic dermatologist for teledermatological consultation. After assessing the case, the teledermatologist notified the PCP of the diagnosis or differential diagnosis and indicate on a standard data collection sheet whether a sampling biopsy was necessary. The reason for recommending biopsy was specified as well. Management options: asked to choose a management plan from 15 entries including 3 biopsy plans (to rule out malignancy, to establish a diagnosis or to remove a benign lesion for cosmetic purposes)
Target condition and reference standard(s)	FTF diagnosis as reference standard Method of diagnosis: the participants were simultaneously scheduled for an FTF visit with the local dermatologist, who is in private practice, within 1 month. The FTF dermatologist completed a standardised consultation form notifying the PCP of his decision regarding the diagnosis, differential diagnosis and whether a biopsy was indicated. A biopsy was performed at that visit by the FTF dermatologist if the FTF dermatologist or the SAF teledermatologist favoured biopsy of the lesion. Prior test data: the telediagnosis triage decision was contained in a sealed envelope which was opened by the FTF dermatologist after making his decision. Biopsy was then carried out by the FTF dermatologists if recommended by either dermatologist. Diagnostic threshold: not described Diagnosis based on: single Number of examiners: 1 Observer qualifications: dermatologist Experience in practice: > 20 years of experience in clinical dermatology Experience with index test: high Target condition (for 26 lesions undergoing biopsy; 23 on dermatologist recommendation and 3 at participant request) Malignant: BCC: 5; cSCC: 4 Benign: benign neoplasms: 17 Assumed benign (no biopsy): 23 (including 1 participant who refused biopsy)
Flow and timing	Excluded participants: 11 breached the study protocol and were not included in the analysis. Of the latter 11, 4 failed to present to the FTF dermatologist, 4 saw a different FTF dermatologist, 1 died of unrelated causes before seeing the FTF dermatologist, and 2 underwent evaluation of different lesions by the SAF teledermatologist and FTF dermatologist. Time interval to reference test: participants were simultaneously scheduled for an FTF visit with the local dermatologist, who was in private practice, within 1 month. 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?	Unclear
Are the included patients and chosen study setting appropriate?	Yes
Did the study avoid including participants with multiple lesions?	Unclear
		Unclear	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?	Yes
For studies comparing TD/FTF clinical diagnosis to histology, was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist?	Yes
For studies comparing TD to FTF diagnosis, was the clinical diagnosis carried out by an experienced observer?	Yes
		High	Low
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