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BACKGROUND Many dermatologic cases are first evaluated by primary care physicians or nurse practitioners. OBJECTIVE This study aimed to evaluate an artificial intelligence (AI)-based tool that assists with interpreting dermatologic conditions. METHODS We developed an AI-based tool and conducted a randomized multi-reader, multi-case study (20 primary care physicians, 20 nurse practitioners, and 1047 retrospective teledermatology cases) to evaluate its utility. Cases were enriched and comprised 120 skin conditions. Readers were recruited to optimize for geographical diversity; the primary care physicians practiced across 12 states (2-32 years of experience, mean 11.3 years), and the nurse practitioners practiced across 9 states (2-34 years of experience, mean 13.1 years). To avoid memory effects from incomplete washout, each case was read once by each clinician either with or without AI assistance, with the assignment randomized. The primary analyses evaluated the top-1 agreement, defined as the agreement rate of the clinicians’ primary diagnosis with the reference diagnoses provided by a panel of dermatologists (per case: 3 dermatologists from a pool of 12, practicing across 8 states, with 5-13 years of experience, mean 7.2 years of experience). We additionally conducted subgroup analyses stratified by cases’ self-reported race and ethnicity and measured the performance spread: the maximum performance subtracted by the minimum across subgroups. RESULTS The AI’s standalone top-1 agreement was 63%, and AI assistance was significantly associated with higher agreement with reference diagnoses. For primary care physicians, the increase in diagnostic agreement was 10% (PP CONCLUSIONS AI assistance was associated with significantly improved diagnostic agreement with dermatologists. Across race and ethnicity subgroups, for both primary care physicians and nurse practitioners, the effect of AI assistance remained high at 8%-15%, and the performance spread was similar at 5%-7%.

The brightfield microscope is instrumental in the visual examination of both biological and physical samples at sub-millimeter scales. One key clinical application has been in cancer histopathology, where the microscopic assessment of the tissue samples is used for the diagnosis and staging of cancer and thus guides clinical therapy. However, the interpretation of these samples is inherently subjective, resulting in significant diagnostic variability. Moreover, in many regions of the world, access to pathologists is severely limited due to lack of trained personnel. In this regard, Artificial Intelligence (AI) based tools promise to improve the access and quality of healthcare. However, despite significant advances in AI research, integration of these tools into real-world cancer diagnosis workflows remains challenging because of the costs of image digitization and difficulties in deploying AI solutions. Here we propose a cost-effective solution to the integration of AI: the Augmented Reality Microscope (ARM). The ARM overlays AI-based information onto the current view of the sample through the optical pathway in real-time, enabling seamless integration of AI into the regular microscopy workflow. We demonstrate the utility of ARM in the detection of lymph node metastases in breast cancer and the identification of prostate cancer with a latency that supports real-time workflows. We anticipate that ARM will remove barriers towards the use of AI in microscopic analysis and thus improve the accuracy and efficiency of cancer diagnosis. This approach is applicable to other microscopy tasks and AI algorithms in the life sciences and beyond.

Gleason grading of prostate cancer is an important prognostic factor, but suffers from poor reproducibility, particularly among non-subspecialist pathologists. Although artificial intelligence (A.I.) tools have demonstrated Gleason grading on-par with expert pathologists, it remains an open question whether and to what extent A.I. grading translates to better prognostication. In this study, we developed a system to predict prostate cancer-specific mortality via A.I.-based Gleason grading and subsequently evaluated its ability to risk-stratify patients on an independent retrospective cohort of 2807 prostatectomy cases from a single European center with 5–25 years of follow-up (median: 13, interquartile range 9–17). Here, we show that the A.I.’s risk scores produced a C-index of 0.84 (95% CI 0.80–0.87) for prostate cancer-specific mortality. Upon discretizing these risk scores into risk groups analogous to pathologist Grade Groups (GG), the A.I. has a C-index of 0.82 (95% CI 0.78–0.85). On the subset of cases with a GG provided in the original pathology report (n = 1517), the A.I.’s C-indices are 0.87 and 0.85 for continuous and discrete grading, respectively, compared to 0.79 (95% CI 0.71–0.86) for GG obtained from the reports. These represent improvements of 0.08 (95% CI 0.01–0.15) and 0.07 (95% CI 0.00–0.14), respectively. Our results suggest that A.I.-based Gleason grading can lead to effective risk stratification, and warrants further evaluation for improving disease management. Gleason grading is the process by which pathologists assess the morphology of prostate tumors. The assigned Grade Group tells us about the likely clinical course of people with prostate cancer and helps doctors to make decisions on treatment. The process is complex and subjective, with frequent disagreement amongst pathologists. In this study, we develop and evaluate an approach to Gleason grading based on artificial intelligence, rather than pathologists’ assessment, to predict risk of dying of prostate cancer. Looking back at tumors and data from 2,807 people diagnosed with prostate cancer, we find that our approach is better at predicting outcomes compared to grading by pathologists alone. These findings suggest that artificial intelligence might help doctors to accurately determine the probable clinical course of people with prostate cancer, which, in turn, will guide treatment. Wulczyn et al. utilise a deep learning-based Gleason grading model to predict prostate cancer-specific mortality in a retrospective cohort of radical prostatectomy patients. Their model enables improved risk stratification compared to pathologists’ grading and demonstrates the potential for computational pathology in the management of prostate cancer.

IMPORTANCE: Most dermatologic cases are initially evaluated by nondermatologists such as primary care physicians (PCPs) or nurse practitioners (NPs). OBJECTIVE: To evaluate an artificial intelligence (AI)–based tool that assists with diagnoses of dermatologic conditions. 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 either 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. EXPOSURES: 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

Background Many dermatologic cases are first evaluated by primary care physicians or nurse practitioners. Objective This study aimed to evaluate an artificial intelligence (AI)-based tool that assists with interpreting dermatologic conditions. Methods We developed an AI-based tool and conducted a randomized multi-reader, multi-case study (20 primary care physicians, 20 nurse practitioners, and 1047 retrospective teledermatology cases) to evaluate its utility. Cases were enriched and comprised 120 skin conditions. Readers were recruited to optimize for geographical diversity; the primary care physicians practiced across 12 states (2-32 years of experience, mean 11.3 years), and the nurse practitioners practiced across 9 states (2-34 years of experience, mean 13.1 years). To avoid memory effects from incomplete washout, each case was read once by each clinician either with or without AI assistance, with the assignment randomized. The primary analyses evaluated the top-1 agreement, defined as the agreement rate of the clinicians’ primary diagnosis with the reference diagnoses provided by a panel of dermatologists (per case: 3 dermatologists from a pool of 12, practicing across 8 states, with 5-13 years of experience, mean 7.2 years of experience). We additionally conducted subgroup analyses stratified by cases’ self-reported race and ethnicity and measured the performance spread: the maximum performance subtracted by the minimum across subgroups. Results The AI’s standalone top-1 agreement was 63%, and AI assistance was significantly associated with higher agreement with reference diagnoses. For primary care physicians, the increase in diagnostic agreement was 10% (P Conclusions AI assistance was associated with significantly improved diagnostic agreement with dermatologists. Across race and ethnicity subgroups, for both primary care physicians and nurse practitioners, the effect of AI assistance remained high at 8%-15%, and the performance spread was similar at 5%-7%. Acknowledgments This work was funded by Google LLC. Conflicts of Interest AJ, DW, VG, YG, GOM, JH, RS, CE, KN, KBD, GSC, LP, DRW, RCD, DC, Yun Liu, PB, and Yuan Liu are/were employees at Google and own Alphabet stocks.

Importance Expert-level artificial intelligence (AI) algorithms for prostate biopsy grading have recently been developed. However, the potential impact of integrating such algorithms into pathologist workflows remains largely unexplored. Objective To evaluate an expert-level AI-based assistive tool when used by pathologists for the grading of prostate biopsies. Design, Setting, and Participants This diagnostic study used a fully crossed multiple-reader, multiple-case design to evaluate an AI-based assistive tool for prostate biopsy grading. Retrospective grading of prostate core needle biopsies from 2 independent medical laboratories in the US was performed between October 2019 and January 2020. A total of 20 general pathologists reviewed 240 prostate core needle biopsies from 240 patients. Each pathologist was randomized to 1 of 2 study cohorts. The 2 cohorts reviewed every case in the opposite modality (with AI assistance vs without AI assistance) to each other, with the modality switching after every 10 cases. After a minimum 4-week washout period for each batch, the pathologists reviewed the cases for a second time using the opposite modality. The pathologist-provided grade group for each biopsy was compared with the majority opinion of urologic pathology subspecialists. Exposure An AI-based assistive tool for Gleason grading of prostate biopsies. Main Outcomes and Measures Agreement between pathologists and subspecialists with and without the use of an AI-based assistive tool for the grading of all prostate biopsies and Gleason grade group 1 biopsies. Results Biopsies from 240 patients (median age, 67 years; range, 39-91 years) with a median prostate-specific antigen level of 6.5 ng/mL (range, 0.6-97.0 ng/mL) were included in the analyses. Artificial intelligence–assisted review by pathologists was associated with a 5.6% increase (95% CI, 3.2%-7.9%;P Conclusions and Relevance In this study, the use of an AI-based assistive tool for the review of prostate biopsies was associated with improvements in the quality, efficiency, and consistency of cancer detection and grading.

Quantifying the clearance of extractables and leachables (E/L) throughout ultrafiltration/diafiltration (UFDF) operations allows for greater flexibility in the implementation of single-use technologies in steps upstream of the UFDF process. A proof-of-concept study was completed in which the clearance of 7 E/L from single-use technologies (trimethylsilanol, hexanoic acid, butyrolactone, t-butyl alcohol, caprolactam, acetonitrile, and benzyl alcohol) in four representative proteins were measured and monitored during the UFDF process using quantitative NMR. This study demonstrated that the defined E/L spiked into a variety of protein solutions can be cleared to1 ppm by 9 diavolumes from a maximum initial load concentration of 1,000 ppm. However, in some cases a rebound effect was observed in the recovered pool to1 ppm, which is explained in detail. The overall clearance trend observed for both buffer control and protein-containing solutions resembled the ideal clearance trend where no apparent interactions were observed between E/L with the protein, UFDF system, or with other defined E/L which may be present in the system. Additionally, the UFDF system is capable of clearing these potential E/L from single-use technologies below 1 ppm irrespective of initial concentrations in the load (1,000 or 100 ppm), independently from the type of protein. In general, mass recoveries were within ±15% of each spiked compound in protein solutions and their respective buffer controls, suggesting spiked E/L do not interact strongly with protein. By demonstrating the product independent clearance trends of the spiked E/L across UFDF, these results will contribute to the simplification of the E/L toxicology assessment and allow modular manufacturing approach for single-use technologies in biopharmaceutical manufacturing. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:718-724, 2016.