Artificial intelligence and real-world data for drug and food safety - A regulatory science perspective

In 2013, the Global Coalition for Regulatory Science Research (GCRSR) was established with members from over ten countries (www.gcrsr.net). One of the main objectives of GCRSR is to facilitate communication among global regulators on the rise of new technologies with regulatory applications through the annual conference Global Summit on Regulatory Science (GSRS). The 11th annual GSRS conference (GSRS21) focused on "Regulatory Sciences for Food/Drug Safety with Real-World Data (RWD) and Artificial Intelligence (AI)." The conference discussed current advancements in both AI and RWD approaches with a specific emphasis on how they impact regulatory sciences and how regulatory agencies across the globe are pursuing the adaptation and oversight of these technologies. There were presentations from Brazil, Canada, India, Italy, Japan, Germany, Switzerland, Singapore, the United Kingdom, and the United States. These presentations highlighted how various agencies are moving forward with these technologies by either improving the agencies' operation and/or preparing regulatory mechanisms to approve the products containing these innovations. To increase the content and discussion, the GSRS21 hosted two debate sessions on the question of "Is Regulatory Science Ready for AI?" and a workshop to showcase the analytical data tools that global regulatory agencies have been using and/or plan to apply to regulatory science. Several key topics were highlighted and discussed during the conference, such as the capabilities of AI and RWD to assist regulatory science policies for drug and food safety, the readiness of AI and data science to provide solutions for regulatory science. Discussions highlighted the need for a constant effort to evaluate emerging technologies for fit-for-purpose regulatory applications. The annual GSRS conferences offer a unique platform to facilitate discussion and collaboration across regulatory agencies, modernizing regulatory approaches, and harmonizing efforts

The development and validation of a scoring tool to predict the operative duration of elective laparoscopic cholecystectomy

Background: The ability to accurately predict operative duration has the potential to optimise theatre efficiency and utilisation, thus reducing costs and increasing staff and patient satisfaction. With laparoscopic cholecystectomy being one of the most commonly performed procedures worldwide, a tool to predict operative duration could be extremely beneficial to healthcare organisations. Methods: Data collected from the CholeS study on patients undergoing cholecystectomy in UK and Irish hospitals between 04/2014 and 05/2014 were used to study operative duration. A multivariable binary logistic regression model was produced in order to identify significant independent predictors of long (> 90 min) operations. The resulting model was converted to a risk score, which was subsequently validated on second cohort of patients using ROC curves. Results: After exclusions, data were available for 7227 patients in the derivation (CholeS) cohort. The median operative duration was 60 min (interquartile range 45–85), with 17.7% of operations lasting longer than 90 min. Ten factors were found to be significant independent predictors of operative durations > 90 min, including ASA, age, previous surgical admissions, BMI, gallbladder wall thickness and CBD diameter. A risk score was then produced from these factors, and applied to a cohort of 2405 patients from a tertiary centre for external validation. This returned an area under the ROC curve of 0.708 (SE = 0.013, p  90 min increasing more than eightfold from 5.1 to 41.8% in the extremes of the score. Conclusion: The scoring tool produced in this study was found to be significantly predictive of long operative durations on validation in an external cohort. As such, the tool may have the potential to enable organisations to better organise theatre lists and deliver greater efficiencies in care

Analysis comparing the recovery of airway reflexes and cognitive ability after sevoflurane with desflurane anesthesia

Introduction: Although sevoflurane and desflurane have nearly identical blood-gas solubilities, current research suggests that airway reflexes recover more quickly with desflurane than sevoflurane; however, cognitive function recovery varies substantially. The current study was piloted to appraise the lengths of time needed to recover from anesthesia following desflurane and sevoflurane anesthesia. Materials and Methods: A prospective clinical trial was piloted among 70 adult non-obese subjects who underwent elective surgery and were classified I–II by the “American Association of Anesthesiologists (ASA)”. Sevoflurane and desflurane were tested among the subjects who were equally distributed. These agents were used in accordance with a normal general anaesthesia procedure. After they were extubated, tests for regaining cognitive function and airway reflexes were carried out, and different time intervals were recorded. The observations were calculated and P < 0.05 was used to conduct the statistical analysis. Results: The average amount of time that passed between the patient's first vocal response and their first successful completion of the swallowing test was analogous between the two groups (T2) with 5.25 ± 3.11 vs 5.01 ± 2.12 in sevoflurane and desflurane, respectively. There was no significant variance at T2. For all the other time intervals of T1, T3, and T4, there was evidence of the significant variance.(P = 0.003; 0.0013; <0.001, respectively). Conclusion: Desflurane causes patients to recover more quickly than sevoflurane does after laparoscopic cholecystectomy under controlled circumstances

Effect of staining beverages on color stability of composite: A spectrophotometric study

Objective: This study used spectrophotometry to examine how staining beverages affect the color stability of three commercial composite materials (nanohybrid composite (A), bulk fill composite (B), and flowable composite (C)) over time. Materials and Methods: Composite discs were randomly divided into groups. The specimens were kept in coffee, tea, red wine, and cola for 14 days at 37°C in the dark. At baseline, 7 days, and 14 days, spectrophotometers measured color. Calculated and analyzed color differences (E). Results: Staining beverages changed the color of all composites. Composite material A had the best color stability, whereas material C stained beverages the most. Red wine and coffee discolored composites most. Discoloration increased over the 14-day immersion period. Conclusion: Composite materials with better color stability were material A. Red wine and coffee discolored composites most. When choosing restorative materials, dentists should consider composite materials' color stability for long-lasting, visually acceptable results

Outcomes and Predictors of Mortality in Hospitalized Frail Patients Undergoing Percutaneous Coronary Intervention

Objective To study the impact of frailty on inpatient outcomes among patients undergoing percutaneous coronary intervention (PCI). Methods The National Inpatient Sample data of all PCI-related hospitalizations throughout the United States (US) from 2010 through 2014 was utilized. Patients were divided into two groups: frailty and no-frailty. International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes were used to stratify groups and outcomes. In order to address the substantial difference in the total number of valid observations between the two groups, a propensity-matched analysis was performed at a 1:1 ratio and caliper width of 0.01. Results A total of 2,612,661 PCI-related hospitalizations throughout the US from 2010 through 2014 were identified, out of which 16,517 admissions (0.6%) had coexisting frailty. Only 1:1 propensity-matched data was utilized for the study. Propensity-matched frailty group (n=14,717) as compared to no-frailty (n=14,755) was frequently older, white, and Medicare enrollee (p\u3c0.05). The frailty group had significantly higher rates of comorbidities and complications (p\u3c 0.05). All-cause in-hospital mortality was higher in the no-frailty group (p\u3c 0.05). Age, white race, non-elective admission, urban hospitals, and comorbidities predicted in-hospital mortality in frailty group (p\u3c 0.05). Rheumatoid arthritis, depression, hypertension, obesity, dyslipidemia, and history of previous PCI decreased odds of in-hospital mortality in frailty group (p\u3c 0.05). Frailty group had prolonged hospital stay and higher hospital charges (p\u3c 0.05). Conclusions Frailty has a significant effect on PCI-related outcomes. We present a previously unknown protective effect of cardiovascular disease risk factors and other health risk factors on frail patients undergoing PCI. Frailty\u27s inclusion in risk stratification will help in predicting the post-procedure complications and improve resource utilization

Imaging advances in oral cavity cancer and perspectives from a population in need: Consensus from the UK-India oral cancer imaging group

Oral squamous cell carcinoma (OSCC) accounts for a third of the cancer burden in India, with a correspondingly high cancer-specific mortality. Although treatment of OSCC in India mirrors that of high-income nations, extreme burden of disease, late presentation, and the associated advanced stage of disease pose unique challenges in a resource-constrained environment. Despite a multimodal treatment paradigm, survival rates are low. Often the cause for late presentation is the delayed diagnosis, inappropriate investigation and referral, and compromised or incorrect treatment, leading to poor patient outcomes and costs to the health-care provider. To address these issues, the first UK-India Symposium on Advances in Oral Cancer Imaging Symposium was organized in Bangalore, India, in April 2019; participants included radiologists, imaging scientists, clinicians, and data scientists from the United Kingdom, India, Singapore, and the United States. Following the discussions held during this meeting, in this manuscript, we present evidence-based guidance for the role of imaging in OSCC, recommendations for service development, and details of future potential for evolution in head and neck imaging