Evidence map›Paper›PMID 38020164›Full record

ArticleFrontiers in medicine2023

Real-world post-deployment performance of a novel machine learning-based digital health technology for skin lesion assessment and suggestions for post-market surveillance.

Lucy Thomas, Chris Hyde, Dan Mullarkey, Jack Greenhalgh, Dilraj Kalsi, Justin Ko

Abstract read
In one paragraph

Article in Frontiers in medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Lucy ThomasChelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom.
Chris HydeExeter Test Group, Department of Health and Community Sciences, University of Exeter Medical School, Exeter, United Kingdom.
Dan MullarkeySkin Analytics Ltd., London, United Kingdom.
Jack GreenhalghSkin Analytics Ltd., London, United Kingdom.
Dilraj KalsiSkin Analytics Ltd., London, United Kingdom.
Justin KoDepartment of Dermatology, Stanford Medicine, Stanford, CA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Deep Ensemble for Recognition of Malignancy (DERM) is an artificial intelligence as a medical device (AIaMD) tool for skin lesion assessment. Methods: We report prospective real-world performance from its deployment within skin cancer pathways at two National Health Service hospitals (UK) between July 2021 and October 2022. Results: A total of 14,500 cases were seen, including patients 18-100 years old with Fitzpatrick skin types I-VI represented. Based on 8,571 lesions assessed by DERM with confirmed outcomes, versions A and B demonstrated very high sensitivity for detecting melanoma (95.0-100.0%) or malignancy (96.0-100.0%). Benign lesion specificity was 40.7-49.4% (DERM-vA) and 70.1-73.4% (DERM-vB). DERM identified 15.0-31.0% of cases as eligible for discharge. Discussion: We show DERM performance in-line with sensitivity targets and pre-marketing authorisation research, and it reduced the caseload for hospital specialists in two pathways. Based on our experience we offer suggestions on key elements of post-market surveillance for AIaMDs.

Indexed as

AI as a medical deviceAI for skin cancerartificial intelligencedeep ensemble for the recognition of malignancyDERMSkin Analyticsskin cancer

Identifiers

PMID38020164
PMCPMC10645139

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.