Moreno Ramirez 2005.
Study characteristics | |||
Patient sampling |
Study design: case series Data collection: retrospective Period of data collection: January to April 2004 Country: Spain |
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Patient characteristics and setting |
Inclusion criteria: people with pigmented, circumscribed lesions fulfilling ≥ 1 of the following criteria: changing lesion ('ABCD changes'), recent lesion (< 3‐year history), multiple lesions (> 20 MN counted by the GP), symptomatic lesion (pain, itching, bleeding) or concerned about moles. Accuracy data reported only for those subsequently referred to the PLC and for whom pathology results were available. Setting: specialist unit (skin cancer/pigmented lesions clinic) Prior testing: most likely clinical examination (the reasons for teleconsultation were listed as concern about moles; recent pigmented lesion; changing lesions; symptoms; multiple lesions) Setting for prior testing: unspecified Exclusion criteria: Excluded difficult to diagnose Sample size (participants): number eligible: 219; number included: 108 referred to PLC, 57 participants included in the final analysis Participant characteristics: Age: mean: 43; range: 2–84 years Gender: male: 77 (35%); female 142 (65%) Lesion characteristics: NR |
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Index tests |
TD Acquisition and transmission of images: 2 digital pictures were taken by the GP using a digital camera at a resolution of 1600×1200 pixels (Coolpix 4300, Nikon). A panoramic view of the lesion area and a close up of the lesion were taken. Images were inserted into a word document with relevant clinical information. This was transmitted via the intranet to an email account at the PLC. Nature of images used: clinical photographs Any additional participant information provided: clinical examination or case notes (or both) Diagnosis based on: unclear how many remote observers Number of examiners: NR Observer qualifications (remote diagnosis): dermatologist Method of diagnosis: at the teleconsultation, observers classified the lesions as being, "benign melanocytic naevus, multiple MN (>20 naevi as seen on teleconsultation), atypical naevus,7 congenital naevus, blue naevus, solar lentigo, lentigo maligna, melanoma, special melanocytic lesion (genital naevus, acral naevus, recurrent naevus), seborrhoeic keratoses, basal cell carcinoma (BCC), DF, vascular lesion, non‐pigmented lesion, or a 'difficult to diagnose' lesion." After evaluation of the pictures and clinical information, a report was returned to the GP at the primary care centre, with suggestions regarding the diagnosis and management of the case. Management options: limited to 'referral' or 'non‐referral' of the participant to the FTF clinic. Participants who had readily identifiable benign lesions such as benign melanocytic naevus, solar lentigo, SK, DF, vascular lesions and non‐pigmented lesions were not referred to the PLC. All other remaining categories were routinely referred to the PLC for FTF assessment. |
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Target condition and reference standard(s) |
Reference standard: histological diagnosis Details: at the PLC, physical and dermoscopic examinations were carried out, as well as excisional biopsy in suspicious or malignant cases, and FU of participants with risk factors for melanoma (16/25 benign underwent histology) Target condition (final diagnoses) Melanoma (in situ): 1, BCC: 23; lentigo maligna: 3; dysplastic nevi: 16, common: nevi 8; blue nevi: 4 |
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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? | Unclear | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | No | ||
Are the included patients and chosen study setting appropriate? | No | ||
Did the study avoid including participants with multiple lesions? | Unclear | ||
High | 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? | 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? | Unclear | ||
High | 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? | No | ||
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 |