FDA Updates – August 2023
August 1, 2023CUE1®
August 1, 2023Development and Assessment of an Artificial Intelligence Based Tool for Skin Condition Diagnosis by Primary Care Physicians and Nurse Practitioners in Teledermatology Practices
Artificial Intelligence might help clinicians diagnose skin conditions more accurately in primary care practices...
Importance
Most dermatologic cases are initially evaluated by nondermatologists such as primary care physicians (PCPs) or nurse practitioners (NPs).
Objectives
Design, Setting and Participants
This multiple-reader, multiple-case diagnostic study developed an AI-based tool and evaluated its utility. Primary care physicians and NPs retrospectively reviewed an enriched set of cases representing 120 different skin conditions. Randomization was used to ensure each clinician reviewed each case with or without AI assistance; each clinician alternated between batches of 50 cases in each modality. The reviews occurred from February 21 to April 28, 2020. Data were analyzed from May 26, 2020, to January 27, 2021.
The AI assistant shows as many as 5 top predictions of skin conditions, with the confidence in each prediction shown as colored dots and additional information (e.g., sample images from an atlas) available with a click. The study was designed as a multiple-reader, multiple-case (MRMC) study comprising 1048 cases. Two groups of clinicians (primary care physicians [PCPs] and nurse practitioners [NPs]) reviewed each case with or without AI assistance. The modality alternated every 50 cases. For every case, each clinician was instructed to rank as many as three differential diagnoses using a search-as-you-type interface and selecting matching skin conditions from a list of 3961 conditions. If their desired skin condition was not present, clinicians could provide free-text entries. All skin conditions were mapped to a list of 419 conditions. SCC indicates squamous cell carcinoma; SCCIS, SCC in situ.
Exposure
An AI-based assistive tool for interpreting clinical images and associated medical history
Main Outcomes and Measures:
The primary analysis evaluated agreement with reference diagnoses provided by a panel of 3 dermatologists for PCPs and NPs. Secondary analyses included diagnostic accuracy for biopsy-confirmed cases, biopsy and referral rates, review time, and diagnostic confidence.
Results
Forty board-certified clinicians, including 20 PCPs (14 women [70.0%]; mean experience, 11.3 [range, 2-32] years) and 20 NPs (18 women [90.0%]; mean experience, 13.1 [range, 2-34] years) reviewed 1048 retrospective cases (672 female [64.2%]; median age, 43 [interquartile range, 30-56] years; 41 920 total reviews) from a teledermatology practice serving 11 sites and provided 0 to 5 differential diagnoses per case (mean [SD], 1.6 [0.7]). The PCPs were located across 12 states, and the NPs practiced in primary care without physician supervision across 9 states. The NPs had a mean of 13.1 (range, 2-34) years of experience and practiced in primary care without physician supervision across 9 states. Artificial intelligence assistance was significantly associated with higher agreement with reference diagnoses. For PCPs, the increase in diagnostic agreement was 10% (95% CI, 8%-11%; P < .001), from 48% to 58%; for NPs, the increase was 12% (95% CI, 10%-14%; P < .001), from 46% to 58%. In secondary analyses, agreement with biopsy-obtained diagnosis categories of malignant, precancerous, or benign increased by 3% (95% CI, −1% to 7%) for PCPs and by 8% (95% CI, 3%-13%) for NPs. Rates of desire for biopsies decreased by 1% (95% CI, 0-3%) for PCPs and 2% (95% CI, 1%-3%) for NPs; the rate of desire for referrals decreased by 3% (95% CI, 1%-4%) for PCPs and NPs. Diagnostic agreement on cases not indicated for a dermatologist referral increased by 10% (95% CI, 8%-12%) for PCPs and 12% (95% CI, 10%-14%) for NPs, and median review time increased slightly by 5 (95% CI, 0-8) seconds for PCPs and 7 (95% CI, 5-10) seconds for NPs per case.
A, Confidence of the primary care physicians (PCPs) and nurse practitioners (NPs) as a stacked bar plot. NA indicates cases for which the clinician could not provide a diagnosis. B, Comparison of the differences in case review time for the full set of 1048 cases as a box plot. The box edges represent quartiles, whereas the whiskers extend to the last observed points that fall within 1.5 times the interquartile range from the quartiles. Outliers beyond the whiskers are indicated with dots; a total of 182 (0.4% of the reads) outliers beyond 900 seconds are excluded from the 4 box plots for ease of visualization. The median time for diagnosis increased from 89 to 94 seconds for PCPs and from 77 to 84 seconds for NPs.
Conclusions and Relevance
Artificial intelligence assistance was associated with improved diagnoses by PCPs and NPs for 1 in every 8 to 10 cases, indicating potential for improving the quality of dermatologic care.
Relevance to Healthcare Field
According to the American Academy of Dermatology Association, approximately 9500 people in the US are diagnosed with skin cancer daily. This article showed that Artificial Intelligence might help clinicians diagnose skin conditions more accurately in primary care practices, where most skin diseases are initially evaluated, allowing to get a diagnosis and management of skin conditions, especially when a dermatologist is out of reach. There were some limitations with skin types I and V (Fitzpatrick skin type scale), requiring more studies to include a more representative sample. However, this AI method will provide a time and cost-effective approach, especially for patients.