Accuracy of mobile digital teledermoscopy for skin self-examinations in adults at high risk of skin cancer: an open-label, randomised controlled trial.
Journal
The Lancet. Digital health
ISSN: 2589-7500
Titre abrégé: Lancet Digit Health
Pays: England
ID NLM: 101751302
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
28
10
2019
revised:
16
12
2019
accepted:
08
01
2020
entrez:
18
12
2020
pubmed:
19
12
2020
medline:
28
1
2021
Statut:
ppublish
Résumé
Skin self-examinations supplemented with mobile teledermoscopy might improve early detection of skin cancers compared with naked-eye skin self-examinations. We aimed to assess whether mobile teledermoscopy-enhanced skin self-examination can improve sensitivity and specificity of self-detection of skin cancers when compared with naked-eye skin self-examination. This randomised, controlled trial was done in Brisbane (QLD, Australia). Eligible participants (aged ≥18 years) had at least two skin cancer risk factors as self-reported in the eligibility survey and had to own or have access to an iPhone compatible with a dermatoscope attachment (iPhone versions 5-8). Participants were randomly assigned (1:1), via a computer-generated randomisation procedure, to the intervention group (mobile dermoscopy-enhanced self-skin examination) or the control group (naked-eye skin self-examination). Control group and intervention group participants received web-based instructions on how to complete a whole body skin self-examination. All participants completed skin examinations at baseline, 1 month, and 2 months; intervention group participants submitted photographs of suspicious lesions to a dermatologist for telediagnosis after each skin examination and control group participants noted lesions on a body chart that was sent to the research team after each skin examination. All participants had an in-person whole-body clinical skin examination within 3 months of their last skin self-examination. Primary outcomes were sensitivity and specificity of skin self-examination, patient selection of clinically atypical lesions suspicious for melanoma or keratinocyte skin cancers (body sites examined, number of lesions photographed, types of lesions, and lesions missed), and diagnostic concordance of telediagnosis versus in-person whole-body clinical skin examination diagnosis. All primary outcomes were analysed in the modified intention-to-treat population, which included all patients who had a clinical skin examination within 3 months of their last skin self-examination. This trial was registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12616000989448. Between March 6, 2017, and June 7, 2018, 234 participants consented to enrol in the study, of whom 116 (50%) were assigned to the intervention group and 118 (50%) were assigned to the control group. 199 participants (98 participants in the intervention group and 101 participants in the control group) attended the clinical skin examination and thus were eligible for analyses. Participants in the intervention group submitted 615 lesions (median 6·0 per person; range 1-24) for telediagnosis and participants in the control group identified and recorded 673 lesions (median 6·0 per person; range 1-16). At the lesion level, sensitivity for lesions clinically suspicious for skin cancer was 75% (95% CI 63-84) in the intervention group and 88% (95% CI 80-91) in the control group (p=0·04). Specificity was 87% (95% CI 85-90) in the intervention group and 89% (95% CI 87-91) in the control group (p=0·42). At the individual level, the intervention group had a sensitivity of 87% (95% CI 76-99) compared with 97% (95% CI 91-100) in the control group (p=0·26), and a specificity of 95% (95% CI 90-100) compared with 96% (95% CI 91-100) in the control group. The overall diagnostic concordance between the telediagnosis and in-person clinical skin examination was 88%. The use of mobile teledermoscopy did not increase sensitivity for the detection of skin cancers compared with naked-eye skin self-examination; thus, further evidence is necessary for inclusion of skin self-examination technology for public health benefit. National Health and Medical Research Council (Australia).
Sections du résumé
BACKGROUND
Skin self-examinations supplemented with mobile teledermoscopy might improve early detection of skin cancers compared with naked-eye skin self-examinations. We aimed to assess whether mobile teledermoscopy-enhanced skin self-examination can improve sensitivity and specificity of self-detection of skin cancers when compared with naked-eye skin self-examination.
METHODS
This randomised, controlled trial was done in Brisbane (QLD, Australia). Eligible participants (aged ≥18 years) had at least two skin cancer risk factors as self-reported in the eligibility survey and had to own or have access to an iPhone compatible with a dermatoscope attachment (iPhone versions 5-8). Participants were randomly assigned (1:1), via a computer-generated randomisation procedure, to the intervention group (mobile dermoscopy-enhanced self-skin examination) or the control group (naked-eye skin self-examination). Control group and intervention group participants received web-based instructions on how to complete a whole body skin self-examination. All participants completed skin examinations at baseline, 1 month, and 2 months; intervention group participants submitted photographs of suspicious lesions to a dermatologist for telediagnosis after each skin examination and control group participants noted lesions on a body chart that was sent to the research team after each skin examination. All participants had an in-person whole-body clinical skin examination within 3 months of their last skin self-examination. Primary outcomes were sensitivity and specificity of skin self-examination, patient selection of clinically atypical lesions suspicious for melanoma or keratinocyte skin cancers (body sites examined, number of lesions photographed, types of lesions, and lesions missed), and diagnostic concordance of telediagnosis versus in-person whole-body clinical skin examination diagnosis. All primary outcomes were analysed in the modified intention-to-treat population, which included all patients who had a clinical skin examination within 3 months of their last skin self-examination. This trial was registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12616000989448.
FINDINGS
Between March 6, 2017, and June 7, 2018, 234 participants consented to enrol in the study, of whom 116 (50%) were assigned to the intervention group and 118 (50%) were assigned to the control group. 199 participants (98 participants in the intervention group and 101 participants in the control group) attended the clinical skin examination and thus were eligible for analyses. Participants in the intervention group submitted 615 lesions (median 6·0 per person; range 1-24) for telediagnosis and participants in the control group identified and recorded 673 lesions (median 6·0 per person; range 1-16). At the lesion level, sensitivity for lesions clinically suspicious for skin cancer was 75% (95% CI 63-84) in the intervention group and 88% (95% CI 80-91) in the control group (p=0·04). Specificity was 87% (95% CI 85-90) in the intervention group and 89% (95% CI 87-91) in the control group (p=0·42). At the individual level, the intervention group had a sensitivity of 87% (95% CI 76-99) compared with 97% (95% CI 91-100) in the control group (p=0·26), and a specificity of 95% (95% CI 90-100) compared with 96% (95% CI 91-100) in the control group. The overall diagnostic concordance between the telediagnosis and in-person clinical skin examination was 88%.
INTERPRETATION
The use of mobile teledermoscopy did not increase sensitivity for the detection of skin cancers compared with naked-eye skin self-examination; thus, further evidence is necessary for inclusion of skin self-examination technology for public health benefit.
FUNDING
National Health and Medical Research Council (Australia).
Identifiants
pubmed: 33334577
pii: S2589-7500(20)30001-7
doi: 10.1016/S2589-7500(20)30001-7
pii:
doi:
Banques de données
ANZCTR
['ACTRN12616000989448']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e129-e137Subventions
Organisme : Department of Health
Pays : United Kingdom
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.