Jolliffe 2001a.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: prospective Period of data collection: NR Country: UK |
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Patient characteristics and setting |
Inclusion criteria: people referred by their GP for dermatological assessment of a pigmented lesion at the PLC Setting: specialist unit (skin cancer/pigmented lesions clinic) Prior testing: not explicitly mention but most likely clinical examination Setting for prior testing: primary Sample size (participants): number eligible: 138; number included: 138 Sample size (lesions): number eligible: 144; number included: 144; clinical diagnosis 140; teledermoscopy Participant characteristics: Age: range 15–94 years Gender: male: 48 (34%); female 90 (66%) Lesion characteristics: NR |
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Index tests |
In‐person FTF clinical assessment Method of diagnosis: at the PLC a clinical diagnosis (± the use of dermoscopy) based upon information in the referral letter and examination findings was made and recorded by the examining doctor Prior test data: clinical examination or case notes (or both) Diagnostic threshold: NR Diagnosis based on: single Number of examiners: 1 Observer qualifications: dermatologist Experience in practice: unclear Experience with index test: unclear TD Acquisition and transmission of images: the examining doctor using a single chip video camera, obtained an image of the pigmented lesion. The image was then archived using proprietary software and images were transmitted through a Fast Screen Machine 2 video overlay card and viewed on a 15 inch monitor. Nature of images used: clinical Any additional participant information provided: clinical examination or case notes (or both) Observer qualifications (remote diagnosis): dermatologist Diagnosis based on: single observer Number of observers: 1 Method of diagnosis: the anonymous video images and the GP's referral letter were then viewed several months later by the same doctor who performed the in‐person assessment and a diagnosis made. Management options: NR |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis alone Lesions had been excised either to confirm or refute clinical suspicion of malignancy or atypia. No participant had a lesion removed on account of the study Target condition (final diagnoses) Malignant: melanoma (in situ and invasive, or NR): 2; Lentigo maligna: 2; BCC: 9. Benign diagnoses: atypical naevus: 5; benign melanocytic naevus: 89; SK: 9; solar lentigo: 7; blue naevus: 4; freckle: 2; SN: 2; dermoid cyst: 2; pyogenic granuloma: 2; congenital naevus: 1; naevus sebaceous: 1; DF: 1; haemangioma: 1; abscess: 1; nodular hidradenoma: 1; non‐caseating granuloma: 1; apocrine hidrocystoma: 1; angiokeratoma circumscriptum: 1 |
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Flow and timing |
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Comparative | The anonymous video images and the GP's referral letter were then viewed several months later by the same doctor and a diagnosis made. The same doctor who performed the clinical examination viewed the images. The doctor's potential memory of a lesion may, therefore, be perceived to be a source of bias. In reality, > 800 pigmented lesions had been seen by this doctor between the in‐person and video examinations, making memory of a specific lesion less likely. | ||
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? | Unclear | ||
Are the included patients and chosen study setting appropriate? | No | ||
Did the study avoid including participants with multiple lesions? | Yes | ||
Unclear | High | ||
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? | No | ||
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 | High | ||
DOMAIN 2: Index Test FTF diagnosis | |||
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? | Unclear | ||
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 | ||
Unclear | 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 | ||
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? | |||
Low | Unclear | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
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 | |||
DOMAIN 5: Comparative | |||
Was each index test result interpreted without knowledge of the results of other index tests or testing strategies? | Unclear | ||
Was the interval between application of the index tests less than 1 month? | No | ||
Were all tests applied and interpreted in a clinically applicable manner? | No | ||
High | High |