Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study.

BACKGROUND: Bivalent RSV prefusion F subunit vaccine (RSVpreF), comprised of equal quantities of stabilized prefusion F antigens from the major circulating subgroups (RSV A, RSV B), is licensed for prevention of RSV-associated lower respiratory tract illness (LRTI) in older adults and for maternal vaccination for prevention of RSV-associated LRTI in infants. To support licensure and large-scale manufacturing, this lot consistency study was conducted to demonstrate equivalence in immunogenicity across 3 RSVpreF lots. METHODS: This phase 3, multicenter, parallel-group, placebo-controlled, randomized (1:1:1:1), double-blind study evaluated immunogenicity, safety, and tolerability of RSVpreF in healthy 18-49-year-old adults. Participants received a single 120-µg injection of 1 of 3RSVpreF lots or placebo. Geometric mean ratio (GMR) of RSV serum 50 % neutralizing geometric mean titers obtained 1 month after vaccination were compared between each vaccine lot for RSV A and RSV B, separately. Equivalence between lots was defined using a 1.5-fold criterion (GMR 95 % CIs for every lot pair within the 0.667-1.5 interval). Safety and tolerability were assessed. RESULTS: Of 992participants vaccinated, 948 were included in the evaluable immunogenicity population. All 3 RSVpreF lots elicited strong immune responses, meeting the 1.5-fold equivalence criterion for all between-lot comparisons for both RSV A and RSV B. Across the 3 lots, RSV A and RSV B 50 % neutralizing geometric mean titers substantially increased from baseline (RSV A, 1671-1795; RSV B 1358-1429) to 1 month after RSVpreF vaccination (RSV A, 24,131-25,238; RSV B, 19,238-21,702), corresponding to ≥14-fold increases in 50 % neutralizing titers for both RSV A and RSV B from before to 1 month after vaccination. Single doses of RSVpreF were safe and well tolerated, with similar safety profiles across the 3 RSVpreF lots. CONCLUSIONS: These findings support the reproducibility of RSVpreF vaccine manufacturing with similar safety and reactogenicity profiles (NCT05096208).

Serum Troponin I Assessments in 5- to 30-Year-Olds After BNT162b2 Vaccination.

INTRODUCTION: Rare myocarditis and pericarditis cases have occurred in coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccine recipients. Troponin levels, a potential marker of myocardial injury, were assessed in healthy participants before and after BNT162b2 vaccination. METHODS: Vaccine-experienced 12- to 30-year-olds in phase 3 crossover C4591031 Substudy B (NCT04955626) who had two or three prior BNT162b2 30-µg doses were randomized to receive BNT162b2 30 µg followed by placebo, or placebo followed by BNT162b2 30 µg, 1 month apart. A participant subset, previously unvaccinated against COVID-19, in the phase 3 C4591007 study (NCT04816643) received up to three vaccinations (BNT162b2 10 µg or placebo [5- to 11-year-olds]) or open-label BNT162b2 30 µg (12- to 15-year-olds). Blood samples collected pre-vaccination, 4 days post-vaccination, and 1-month post-vaccination (C4591031 Substudy B only) were analyzed. Frequencies of elevated troponin I levels (male, > 35 ng/l; female, > 17 ng/l) were assessed. RESULTS: Percentages of 12- to 30-year-olds (n = 1485) in C4591031 Substudy B with elevated troponin levels following BNT162b2 or placebo receipt were 0.5% and 0.8% before vaccination, 0.7% and 1.0% at day 4, and 0.7% and 0.5% at 1 month, respectively. In Study C4591007 (n = 1265), elevated troponin I levels were observed in 0.2, 0.4, and 0.2% of 5- to 11-year-old BNT162b2 recipients at baseline and 4 days post-dose 2 and 3, respectively; corresponding values in 12- to 15-year-olds were 0.4, 0.4, and 0.7%. No 5- to 11-year-old placebo recipients had elevated troponin levels. No myocarditis or pericarditis cases or deaths were reported. CONCLUSIONS: Among 5- to < 30-year-olds in both studies, troponin levels were rarely elevated (≤ 1.0%) and similar before and post-vaccination; troponin levels were also similar between BNT162b2 and placebo in 12- to 30-year-old and 5- to 11-year-old recipients in the respective studies. No myocarditis or pericarditis cases were reported. These findings did not provide evidence that BNT162b2 causes troponin elevations. No utility of routine measurement of troponin levels in asymptomatic BNT162b2 recipients was identified.

Exploring Racial Disparities in the 1918 Influenza Pandemic: A Case Study of Durham, North Carolina.

The paradox of excess mortality among White Americans during the 1918 influenza pandemic has long puzzled historians and scientists. Recent scholarship has suggested that this disparity was not true for the country as a whole, but rather regional variation was observed. The factors influencing these disparities remain speculative. A case study was conducted of Durham, North Carolina, a city known nationally for the achievements of its Black middle class, to further explore these themes relying on numerous sources including newspapers and death certificates. Though Durham's overall mortality was lower than many places in North Carolina, the White mortality rate greatly exceeded that of the Black population. Previously described theories, including Alfred Crosby's exposure hypothesis and segregation, were explored. The most notable difference between Durham's pandemic narrative and other comparable towns was the robust healthcare response, which was made possible by the excellence of the Black nursing force from Lincoln Hospital. Nursing care was the best treatment available for the 1918 influenza, but most of the nation experienced severe nursing shortages due to the war effort. This study thus provides an example of how the Black health community has proven an active agent in countering the structural forces driving racial disparities.

Forgotten Pediatrics: 8 Disturbing Windows on the Past.

The 75 years since Pediatrics was first published has witnessed an explosion of the scientific knowledge base informing child health. Yet, the path leading to the present has not been linear. We examine several articles that illustrate some of the unexpected twists and turns that have characterized our specialty's history. We hope that it will provide a reminder of the ever-changing nature of scientific knowledge and the need to continually re-evaluate how our own cultural assumptions shape medical practice.

Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.

BACKGROUND: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain. METHODS: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 µg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth. A lower boundary of the confidence interval for vaccine efficacy (99.5% confidence interval [CI] at 90 days; 97.58% CI at later intervals) greater than 20% was considered to meet the success criterion for vaccine efficacy with respect to the primary end points. RESULTS: At this prespecified interim analysis, the success criterion for vaccine efficacy was met with respect to one primary end point. Overall, 3682 maternal participants received vaccine and 3676 received placebo; 3570 and 3558 infants, respectively, were evaluated. Medically attended severe lower respiratory tract illness occurred within 90 days after birth in 6 infants of women in the vaccine group and 33 infants of women in the placebo group (vaccine efficacy, 81.8%; 99.5% CI, 40.6 to 96.3); 19 cases and 62 cases, respectively, occurred within 180 days after birth (vaccine efficacy, 69.4%; 97.58% CI, 44.3 to 84.1). Medically attended RSV-associated lower respiratory tract illness occurred within 90 days after birth in 24 infants of women in the vaccine group and 56 infants of women in the placebo group (vaccine efficacy, 57.1%; 99.5% CI, 14.7 to 79.8); these results did not meet the statistical success criterion. No safety signals were detected in maternal participants or in infants and toddlers up to 24 months of age. The incidences of adverse events reported within 1 month after injection or within 1 month after birth were similar in the vaccine group (13.8% of women and 37.1% of infants) and the placebo group (13.1% and 34.5%, respectively). CONCLUSIONS: RSVpreF vaccine administered during pregnancy was effective against medically attended severe RSV-associated lower respiratory tract illness in infants, and no safety concerns were identified. (Funded by Pfizer; MATISSE ClinicalTrials.gov number, NCT04424316.).

History of Medicine in the Clerkships: A Novel Model for Integrating Medicine and History.

The history of medicine has only unevenly been integrated into medical education. Previous attempts to incorporate the subject have focused either on the first year, with its already over-subscribed curriculum, or the fourth year in the form of electives that reach a small minority of students. Duke University provides an alternative model for other universities to consider. At our institution we have overcome many of the curricular limitations by including history during the mandatory third year clerkships. Reaching 100% of the medical school class, these sessions align with clinical disciplines, providing students a longitudinal perspective on what they are seeing and doing on the hospital wards. They are taught in conjunction with a medical history librarian and rely heavily on the utilization and interpretation of physical artifacts and archival manuscripts. The surgery, obstetrics/gynecology, and pediatrics rotations now feature successful and popular history of medicine sessions. Describing our lesson plans and featuring a list of both physical and online resources, we provide a model others can implement to increase the use, the framing, and the accessibility of history in their medical schools.

Fall, Crush, Kick: Mechanisms and Outcomes in a Cohort of Equine-Related Injuries.

INTRODUCTION: The potential for significant traumatic injury to individuals who interact with horses remains high due to animal size, forces applied, and unpredictability. Despite an estimated 30 million riders in the United States annually, few recent publications have addressed this patient population. OBJECTIVES: This study describes characteristics of patients injured in interactions with horses, focusing on mechanism of injury and use of protective equipment. METHODS: We queried our institution's trauma registry for all patients admitted for equine-related injuries (ERI) between January 1, 2013 and December 31, 2017. We categorized by specific mechanism of injury (fall, crush, kick, fall + crush, and fall + kick) and presence or absence of protective devices. RESULTS: We discovered 143 patients admitted for injuries in equine-related accidents. Patients averaged 49.2 years old, and 62.2% were female. Crush injuries resulted in a high rate of rib fractures. Riders who were kicked had an increased chance of solid organ and facial injuries and falls most commonly led to rib fractures and extremity trauma. Despite lack of documentation on most subjects, protective devices were associated with less severe injuries in those with data (n = 36). CONCLUSIONS: In this relatively large series of patients with ERI, we found mechanism differences within injury groups. Providers should more carefully document specific circumstances of ERIs. All individuals working with or around horses should exercise prudence and consider using protective equipment.

Are Radiographs Associated With Patient Satisfaction After Scarf Bunionectomy?

There are over 350,000 bunion surgeries performed in the USA annually, making it one of the most common elective forefoot surgeries. Studies have suggested that as many as 10% of patients remain dissatisfied after bunion surgery. The purpose of this study is to evaluate if radiographic variables are associated with patient satisfaction at 1 year postoperatively. We performed a secondary analysis of prospectively collected data on 69 consecutive adult patients (mean age 45 ± 14 years, 91% female [63/69]) who underwent isolated hallux valgus surgery from January 2016 to January 2017. Subjects completed a standardized 4-item survey inquiring about their satisfaction with regards to pain relief, overall operative result, cosmetic appearance, and ability to wear desired shoe gear. Conventional radiographic indices for hallux valgus were examined preoperatively and 3 months postoperatively. An association model using backward stepwise logistic regression was utilized to determine which variables, if any, are most important in explaining patient satisfaction after surgery. Sixty-nine subjects completed the 4-item satisfaction survey with 53.6% (37/69) of subjects answering they were fully satisfied on all aspects of the survey at 12 months postoperatively. In the final regression model, no radiographic or demographic variables were associated with patient satisfaction including shoe gear, cosmetic appearance, pain relief, and overall operative result. Radiographic variables did not appear to be associated with patient satisfaction at one year postoperatively in our study. Factors such as quality of life, anxiety levels, fear of surgery, and/or preoperative expectations may offer more insight into satisfaction; however, further research should be performed to examine this further.

The Statistical Fragility of Foot and Ankle Surgery Randomized Controlled Trials.

Fragility index (FI) is a metric used to interpret the results of randomized controlled trials (RCTs), and describes the number of subjects that would need to be switched from event to non-event for a result to no longer be significant. Studies that analyze FI of RCTs in various orthopedic subspecialties have shown the RCTs to be largely underpowered and highly fragile. However, FI has not been assessed in foot and ankle RCTs. The MEDLINE and Embase online databases were searched from 1/1/2011 through 11/19/2021 for RCTs involving foot and ankle conditions. FI, fragility quotient (FQ), and difference between the FI and number of subjects lost to follow-up was calculated. Spearman correlation was performed to determine the relationship between sample size and FI. Overall, 1262 studies were identified of which 18 were included in the final analysis. The median sample size was 65 (interquartile range [IQR] 57-95.5), the median FI was 2 (IQR 1-2.5), and the median FQ was 0.026 (IQR 0.012-0.033). Ten of 15 (67%) studies with non-zero FI values had FI values less than the number of subjects lost to follow-up. There was linear association between FI and sample size (R2 = 0.495, p-value: .031). This study demonstrates that RCTs in the field of foot and ankle surgery are highly fragile, similar to other orthopedic subspecialties.

Biomanufacturing readiness levels [BRL]-A shared vocabulary for biopharmaceutical technology development and commercialization.

The Manufacturing Readiness Levels (MRLs) developed by the Department of Defense are well-established tools for describing the maturity of new technologies resulting from government-sponsored Research and Development programs, from the concept phase to commercial deployment. While MRLs are generally applicable to a wide range of industries and technologies, there is significant value in offering an industry-specific view on how the basic principles may be applied to biomanufacturing. This paper describes Biomanufacturing Readiness Levels (BRLs) developed by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a public/private partnership that is part of the Manufacturing USA network. NIIMBL brings together private, federal, nonprofit, and academic stakeholders to accelerate the deployment of innovative technologies for biopharmaceutical production and to educate and train a world-leading biomanufacturing workforce. We anticipate that these BRLs will lay the groundwork for a shared vocabulary for assessment of technology maturity and readiness for commercial biomanufacturing that effectively meets the needs of this critical, specialized, and highly regulated industry.

Recommendation Reversals in Gastroenterology Clinical Practice Guidelines.

Background: Recommendations in clinical practice guidelines (CPGs) may be reversed when evidence emerges to show they are futile or unsafe. In this study, we identified and characterized recommendation reversals in gastroenterology CPGs. Methods: We searched CPGs published by 20 gastroenterology societies from January 1990 to December 2019. We included guidelines which had at least two iterations of the same topic. We defined reversals as when (a) the more recent iteration of a CPG recommends against a specific practice that was previously recommend in an earlier iteration of a CPG from the same body, and (b) the recommendation in the previous iteration of the CPG is not replaced by a new diagnostic or therapeutic recommendation in the more recent iteration of the CPG. The primary outcome was the number of recommendation reversals. Secondary outcomes included the strength of recommendations and quality of evidence cited for reversals. Results: Twenty societies published 1022 CPGs from 1990 to 2019. Our sample for analysis included 129 unique CPGs. There were 11 recommendation reversals from 10 guidelines. New evidence was presented for 10 recommendation reversals. Meta-analyses were cited for two reversals, and randomized controlled trials (RCTs) for seven reversals. Recommendations were stronger after the reversal for three cases, weaker in two cases, and of similar strength in three cases. We were unable to compare recommendation strengths for three reversals. Conclusion: Recommendation reversals in gastroenterology CPGs are uncommon but highlight low value or harmful practices.

Treatment of Lesser Metatarsophalangeal Joint Instability With Plantar Plate Repair: A Systematic Review and Meta-Analysis.

Recognition of metatarsophalangeal joint plantar plate injuries has improved over time as the condition has become more widely understood and identified. With the diagnosis of a plantar plate injury as a subset of metatarsalgia becoming more common place, there are multiple surgical options that have been utilized to address the condition. Direct repair of the plantar plate has emerged as the treatment of choice for foot surgeons with a tendency to favor a direct dorsal approach for the repair. We performed a systematic review and meta-analysis using preferred reporting items for systematic reviews and meta-analysis guidelines, to determine the magnitude of change that can be expected in visual analog scale pain and American Orthopedic Foot and Ankle Society scores postoperatively. A total of 12 studies involving 537 plantar plate tears were included who underwent direct repair of the plantar plate through either a dorsal (10 articles) or plantar approach (2 articles). Summary estimates were calculated which revealed improvement in visual analog scale pain (pooled mean change of -5.01 [95%CI -5.36, -4.66] pre-to postoperative) and improvement in American Orthopedic Foot and Ankle Society scores (pooled postoperative mean improvement 40.44 [95%CI 37.90, 42.97]) of patients within the included studies. Random effects models were used for summary estimates. I2 statistic was used to assess for heterogeneity. We concluded there is a predictable level of improvement in pain and function in patients undergoing a direct dorsal approach plantar plate repair with follow-up out to 2 years.

Phonosurgery: A review of current methodologies.

Cold-steel has served as the gold standard modality of phonosurgery for most of its history. Surgical laser technology has revolutionized this field with its wide use of applications. Additional modalities have also been introduced such as coagulative lasers, photodynamic therapy, and cryotherapy. This review will compare the surgical modalities of cold steel, surgical lasers, phototherapy and cryotherapy. The mechanism of action, tissue effects and typical uses will be addressed for each modality.

Computational Methods to Measure Patterns of Gaze in Toddlers With Autism Spectrum Disorder.

Importance: Atypical eye gaze is an early-emerging symptom of autism spectrum disorder (ASD) and holds promise for autism screening. Current eye-tracking methods are expensive and require special equipment and calibration. There is a need for scalable, feasible methods for measuring eye gaze. Objective: Using computational methods based on computer vision analysis, we evaluated whether an app deployed on an iPhone or iPad that displayed strategically designed brief movies could elicit and quantify differences in eye-gaze patterns of toddlers with ASD vs typical development. Design, Setting, and Participants: A prospective study in pediatric primary care clinics was conducted from December 2018 to March 2020, comparing toddlers with and without ASD. Caregivers of 1564 toddlers were invited to participate during a well-child visit. A total of 993 toddlers (63%) completed study measures. Enrollment criteria were aged 16 to 38 months, healthy, English- or Spanish-speaking caregiver, and toddler able to sit and view the app. Participants were screened with the Modified Checklist for Autism in Toddlers-Revised With Follow-up during routine care. Children were referred by their pediatrician for diagnostic evaluation based on results of the checklist or if the caregiver or pediatrician was concerned. Forty toddlers subsequently were diagnosed with ASD. Exposures: A mobile app displayed on a smartphone or tablet. Main Outcomes and Measures: Computer vision analysis quantified eye-gaze patterns elicited by the app, which were compared between toddlers with ASD vs typical development. Results: Mean age of the sample was 21.1 months (range, 17.1-36.9 months), and 50.6% were boys, 59.8% White individuals, 16.5% Black individuals, 23.7% other race, and 16.9% Hispanic/Latino individuals. Distinctive eye-gaze patterns were detected in toddlers with ASD, characterized by reduced gaze to social stimuli and to salient social moments during the movies, and previously unknown deficits in coordination of gaze with speech sounds. The area under the receiver operating characteristic curve discriminating ASD vs non-ASD using multiple gaze features was 0.90 (95% CI, 0.82-0.97). Conclusions and Relevance: The app reliably measured both known and new gaze biomarkers that distinguished toddlers with ASD vs typical development. These novel results may have potential for developing scalable autism screening tools, exportable to natural settings, and enabling data sets amenable to machine learning.

Factors Associated with Poor Quality of Life in a Canadian Cohort of Patients with Inflammatory Bowel Disease: A Cross-sectional Study.

BACKGROUND: Health-related quality of life (QoL) is often adversely affected in patients with inflammatory bowel disease (IBD). We aimed to identify factors associated with poor QoL among Canadian patients with IBD in clinical remission. METHODS: We enrolled patients at a single academic tertiary care center with inactive IBD. All eligible patients completed a series of questionnaires that included questions on demographics, disease activity, anxiety, depression and the presence of irritable bowel syndrome (IBS) symptoms. Stool sample for fecal calprotectin (FC) was also collected to assess for subclinical inflammation. The primary outcome measure was QoL assessed by the short inflammatory bowel disease questionnaire (SIBDQ), with planned subgroup comparisons for fatigue, anxiety, depression and IBS symptoms. RESULTS: Ninety-three patients were eligible for inclusion in this study. The median SIBDQ scores were lower in patients with anxiety (P < 0.001), depression (P = 0.004), IBS symptoms (P < 0.001) and fatigue (P = 0.018). Elevated FC in patients in clinical remission did not impact QoL. These findings were consistent on multivariate linear regression. CONCLUSIONS: Anxiety, depression, fatigue and IBS symptoms are all independently associated with lower QoL in patients with inactive IBD. Clinicians are encouraged to screen for these important factors as they may detrimentally impact QoL in IBD patients even in clinical remission.

A scalable computational approach to assessing response to name in toddlers with autism.

BACKGROUND: This study is part of a larger research program focused on developing objective, scalable tools for digital behavioral phenotyping. We evaluated whether a digital app delivered on a smartphone or tablet using computer vision analysis (CVA) can elicit and accurately measure one of the most common early autism symptoms, namely failure to respond to a name call. METHODS: During a pediatric primary care well-child visit, 910 toddlers, 17-37 months old, were administered an app on an iPhone or iPad consisting of brief movies during which the child's name was called three times by an examiner standing behind them. Thirty-seven toddlers were subsequently diagnosed with autism spectrum disorder (ASD). Name calls and children's behavior were recorded by the camera embedded in the device, and children's head turns were coded by both CVA and a human. RESULTS: CVA coding of response to name was found to be comparable to human coding. Based on CVA, children with ASD responded to their name significantly less frequently than children without ASD. CVA also revealed that children with ASD who did orient to their name exhibited a longer latency before turning their head. Combining information about both the frequency and the delay in response to name improved the ability to distinguish toddlers with and without ASD. CONCLUSIONS: A digital app delivered on an iPhone or iPad in real-world settings using computer vision analysis to quantify behavior can reliably detect a key early autism symptom-failure to respond to name. Moreover, the higher resolution offered by CVA identified a delay in head turn in toddlers with ASD who did respond to their name. Digital phenotyping is a promising methodology for early assessment of ASD symptoms.

End-to-end collaboration to transform biopharmaceutical development and manufacturing.

An ambitious 10-year collaborative program is described to invent, design, demonstrate, and support commercialization of integrated biopharmaceutical manufacturing technology intended to transform the industry. Our goal is to enable improved control, robustness, and security of supply, dramatically reduced capital and operating cost, flexibility to supply an extremely diverse and changing portfolio of products in the face of uncertainty and changing demand, and faster product development and supply chain velocity, with sustainable raw materials, components, and energy use. The program is organized into workstreams focused on end-to-end control strategy, equipment flexibility, next generation technology, sustainability, and a physical test bed to evaluate and demonstrate the technologies that are developed. The elements of the program are synergistic. For example, process intensification results in cost reduction as well as increased sustainability. Improved robustness leads to less inventory, which improves costs and supply chain velocity. Flexibility allows more products to be consolidated into fewer factories, reduces the need for new facilities, simplifies the acquisition of additional capacity if needed, and reduces changeover time, which improves cost and velocity. The program incorporates both drug substance and drug product manufacturing, but this paper will focus on the drug substance elements of the program.

Computer Vision Analysis for Quantification of Autism Risk Behaviors.

Observational behavior analysis plays a key role for the discovery and evaluation of risk markers for many neurodevelopmental disorders. Research on autism spectrum disorder (ASD) suggests that behavioral risk markers can be observed at 12 months of age or earlier, with diagnosis possible at 18 months. To date, these studies and evaluations involving observational analysis tend to rely heavily on clinical practitioners and specialists who have undergone intensive training to be able to reliably administer carefully designed behavioural-eliciting tasks, code the resulting behaviors, and interpret such behaviors. These methods are therefore extremely expensive, time-intensive, and are not easily scalable for large population or longitudinal observational analysis. We developed a self-contained, closed-loop, mobile application with movie stimuli designed to engage the child's attention and elicit specific behavioral and social responses, which are recorded with a mobile device camera and then analyzed via computer vision algorithms. Here, in addition to presenting this paradigm, we validate the system to measure engagement, name-call responses, and emotional responses of toddlers with and without ASD who were presented with the application. Additionally, we show examples of how the proposed framework can further risk marker research with fine-grained quantification of behaviors. The results suggest these objective and automatic methods can be considered to aid behavioral analysis, and can be suited for objective automatic analysis for future studies.

Digital Behavioral Phenotyping Detects Atypical Pattern of Facial Expression in Toddlers with Autism.

Commonly used screening tools for autism spectrum disorder (ASD) generally rely on subjective caregiver questionnaires. While behavioral observation is more objective, it is also expensive, time-consuming, and requires significant expertise to perform. As such, there remains a critical need to develop feasible, scalable, and reliable tools that can characterize ASD risk behaviors. This study assessed the utility of a tablet-based behavioral assessment for eliciting and detecting one type of risk behavior, namely, patterns of facial expression, in 104 toddlers (ASD N = 22) and evaluated whether such patterns differentiated toddlers with and without ASD. The assessment consisted of the child sitting on his/her caregiver's lap and watching brief movies shown on a smart tablet while the embedded camera recorded the child's facial expressions. Computer vision analysis (CVA) automatically detected and tracked facial landmarks, which were used to estimate head position and facial expressions (Positive, Neutral, All Other). Using CVA, specific points throughout the movies were identified that reliably differentiate between children with and without ASD based on their patterns of facial movement and expressions (area under the curves for individual movies ranging from 0.62 to 0.73). During these instances, children with ASD more frequently displayed Neutral expressions compared to children without ASD, who had more All Other expressions. The frequency of All Other expressions was driven by non-ASD children more often displaying raised eyebrows and an open mouth, characteristic of engagement/interest. Preliminary results suggest computational coding of facial movements and expressions via a tablet-based assessment can detect differences in affective expression, one of the early, core features of ASD. LAY SUMMARY: This study tested the use of a tablet in the behavioral assessment of young children with autism. Children watched a series of developmentally appropriate movies and their facial expressions were recorded using the camera embedded in the tablet. Results suggest that computational assessments of facial expressions may be useful in early detection of symptoms of autism.