Current Status and Future Directions: The Application of Artificial Intelligence/Machine Learning for Precision Medicine.

Technological innovations, such as artificial intelligence (AI) and machine learning (ML), have the potential to expedite the goal of precision medicine, especially when combined with increased capacity for voluminous data from multiple sources and expanded therapeutic modalities; however, they also present several challenges. In this communication, we first discuss the goals of precision medicine, and contextualize the use of AI in precision medicine by showcasing innovative applications (e.g., prediction of tumor growth and overall survival, biomarker identification using biomedical images, and identification of patient population for clinical practice) which were presented during the February 2023 virtual public workshop entitled "Application of Artificial Intelligence and Machine Learning for Precision Medicine," hosted by the US Food and Drug Administration (FDA) and University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). Next, we put forward challenges brought about by the multidisciplinary nature of AI, particularly highlighting the need for AI to be trustworthy. To address such challenges, we subsequently note practical approaches, viz., differential privacy, synthetic data generation, and federated learning. The proposed strategies - some of which are highlighted presentations from the workshop - are for the protection of personal information and intellectual property. In addition, methods such as the risk-based management approach and the need for an agile regulatory ecosystem are discussed. Finally, we lay out a call for action that includes sharing of data and algorithms, development of regulatory guidance documents, and pooling of expertise from a broad-spectrum of stakeholders to enhance the application of AI in precision medicine.

Effect of Passing Plays on Injury Rates in the National Football League.

ABSTRACT: Burke, J, Geller, JS, Perez, JR, Naik, K, Vidal, AF, Baraga, MG, and Kaplan, LD. The effect of passing plays on injury rates in the national football league. J Strength Cond Res 35(12S): S1-S4, 2021-The National Football League (NFL) has one of the highest all-cause injury rates in sports, yet our understanding of extrinsic injury risk factors is limited. The objective of this study was to assess the effect of play type on injury incidence in the NFL. We obtained data for every regular season game played during the 2013-2016 seasons from the official NFL game books. There were 2,721 in-game injuries during the 4 seasons examined, with an overall rate of 1.33 injuries per team per game. For statistical analysis, p < 0.05 was considered significant. Passing plays conferred significantly higher odds of injury than running plays (odds ratio [OR] 1.4, 95% confidence interval [CI]: 1.3-1.5, p < 0.0001). This primarily stems from increased risks in quarterbacks (OR 6.9, 95% CI: 3.6-13.3, p < 0.0001), receivers (OR 5.0, 95% CI: 3.7-6.6, p < 0.0001), and defensive backs (OR 2.3, 95% CI: 1.9-2.7, p < 0.0001). Our study suggests that passing plays confer a greater risk of overall injuries in the NFL when compared with running plays, specifically regarding concussions and core or trunk injuries.

Social media use by shoulder and elbow surgeons increases the number of ratings on physician review websites.

BACKGROUND: The use of physician review websites by patients is increasingly frequent. One potential way for shoulder and elbow surgeons to enhance their online reputation and attract patients is via social media, yet its impact is unknown. This study sought to analyze the effect of social media use on the number of online ratings and overall rating of shoulder and elbow surgeons. We secondarily studied variables affecting social media use. METHODS: The American Shoulder and Elbow Surgeons directory was probed to identify practicing surgeons. Surgeon evaluation data, including ratings, comments, and reviews, were compiled from 3 physician review websites (Google, Healthgrades, and Vitals). Google was queried to assess for a professional Facebook, Twitter, or Instagram account, as well as obtain information on surgeon training, practice location, and other demographic variables. RESULTS: A total of 646 surgeons met the inclusion criteria (93.8% male and 6.2% female surgeons). Overall, 37% had a professional social media account (Facebook, 23.1%; Twitter, 24.1%; and Instagram, 9.4%). Linear regression analysis showed that Facebook use correlated with an average increase of 48.6 in the number of ratings. No social media platform correlated with physician rating. The surgeons more likely to use social media were those who graduated residency in 2000 or later (40.8% vs. 29.2%), those who practiced in cities with higher populations (mean, 1188.9 vs. 708.4 [per 1000]), and those with more surgeons practicing in the same city (mean, 7.0 vs. 5.0). CONCLUSION: The majority of shoulder and elbow surgeons do not have a professional social media account. Those using this platform are younger and located in more populous cities with more competition. Having a professional social media profile was not correlated with ratings, but there was a positive association with the number of online ratings, and Facebook had the strongest association. Surgeon ratings are overwhelmingly positive with minimal variability; therefore, a high number of ratings confirms a surgeon's exceptional reputation. The residency graduation year, city population, and number of nearby surgeons affected ratings, although the absolute differences were minimal. For shoulder and elbow surgeons, a professional social media account correlates with an increase in the number of online physician ratings. Recent graduates practicing in competitive locations may feel increased pressure to leverage this in an attempt to build their practices.

FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.

The pharmaceutical industry is actively applying quantitative systems pharmacology (QSP) to make internal decisions and guide drug development. To facilitate the eventual development of a common framework for assessing the credibility of QSP models for clinical drug development, scientists from US Food and Drug Administration and the pharmaceutical industry organized a full-day virtual Scientific Exchange on July 1, 2020. An assessment form was used to ensure consistency in the evaluation process. Among the cases presented, QSP was applied to various therapeutic areas. Applications mostly focused on phase 2 dose selection. Model transparency, including details on expert knowledge and data used for model development, was identified as a major factor for robust model assessment. The case studies demonstrated some commonalities in the workflow of QSP model development, calibration, and validation but differ in the size, scope, and complexity of QSP models, in the acceptance criteria for model calibration and validation, and in the algorithms/approaches used for creating virtual patient populations. Though efforts are being made to build the credibility of QSP models and the confidence is increasing in applying QSP for internal decisions at the clinical stages of drug development, there are still many challenges facing QSP application to late stage drug development. The QSP community needs a strategic plan that includes the ability and flexibility to Adapt, to establish Common expectations for model Credibility needed to inform drug Labeling and patient care, and to AIM to achieve the goal (ACCLAIM).

Potential Lack of Association Between Three Vestigial Muscles in Humans: A Willed Body Donor Study.

PURPOSE: Anatomical agenesis within a population is not well understood, with variations including but not limited to complete absence, unilateral presence, or bilateral presence. Agenesis of human vestigial muscles including the palmaris longus (PL), fibularis tertius (FT), and psoas minor (PM) has been studied; however, the relationship between their presence and absence has not been examined. The purpose of this study is to analyze the prevalence of the PL, FT, and PM muscles, investigate any relationship of prevalence based on sex or race, and investigate any correlation between the presence or absence of each muscle within individual donors. METHODS: Twenty-three willed body donors were comprehensively dissected by medical students, and the presence or absence of the PL, FT, and PM muscles was recorded. RESULTS: The PL was present bilaterally in 87% of donors and absent bilaterally in 13%. The FT was present bilaterally in 96% of donors, and present unilaterally in 4% of donors. There was no evidence of total agenesis of the FT within our sample. The PM was present bilaterally in 39% of donors, and absent bilaterally in 61% of donors. No statistically significant relationship was indicated between muscle presence and the sex or race of the donors. No correlation between the presence or absence of each of the muscles was found. CONCLUSION: In this sample of willed body donors, there was no relationship between muscular agenesis of the vestigial muscles. This suggests that muscle agenesis is a local genetic developmental event at each muscle, and that there is not a single developmental event that leads to agenesis of multiple vestigial muscles. Further understanding of the agenesis of vestigial structures within populations and subpopulations can aid in physician diagnosis and understanding of the anatomical makeup of individuals.