Regional Interests Research Articles

Regulatory compliance of taurine containing food products marketed in India using a validated method: A pilot study

Taurine is an important functional food ingredient found in infant food, nutritional supplements and energy drinks. Concerns about the safety and quality of these products have prompted enhanced regulatory interest and enforcement. This study aimed to investigate regulatory compliance of taurine, in selected food products available in the Indian market. To assess compliance, a liquid chromatography method based on post-column derivatization with ninhydrin for the determination of taurine was validated for selectivity, accuracy, precision, linearity range, limit of detection, recovery and analysis of certified reference material. Excellent sensitivity, reproducibility and selectivity were achieved. The limit of detection and limit of quantification for the method was 0.0014 mg/100 mL and 0.0044 mg/100 mL, respectively. The overall percentage recoveries ranged from 95 % to 98 %. A total of 26 different products were analysed for their taurine content and compared with the label claim. Box-plots revealed wide variation in the taurine content. The determined concentrations of taurine ranged from 21.69 to 36.80 mg/100 g for infant foods with 7 out of the 9 samples analysed in the permitted tolerance limit of 20 % of the stated claim. Taurine content varied from 195.7 to 445.8 mg/100 mL for energy drinks with the percentage difference between obtained and declared values ranging from 4.15 to 11.46. All the 9 dietary supplements analyzed were found to contain taurine (20.48–68.62 mg/100 g), even though it was not listed as an ingredient. Our results confirm the efficacy of the proposed method in ensuring compliance with taurine in food products, underlining its importance for risk assessors and regulators.

Competing with the platform: Complementor positioning and cross‐platform response to entry

AbstractResearch SummaryThis study contrasts traditional entry dynamics with platform owner entry into a complementor market and examines cross‐platform complementor response to competition with the platform. Generalists experience low repositioning cost and are more likely to shift effort away, while specialists focus their effort on the focal platform. We examine Apple's “Files” app entry and find support for our hypotheses: generalists shift effort toward the competing platform, while specialists double down on the focal platform. Moreover, empirically comparing Apple's entry with that of other large firms, we find that only the platform owner elicits a strong complementor response. This article contributes to the competitive and corporate strategy literatures, underscoring how complementor heterogeneity affects cross‐platform allocation of effort when the platform owner becomes a competitor in complementor spaces.Managerial SummaryGiven the growing managerial and regulatory interest in competitive arenas on digital platforms, we analyze how firms respond to competition with the platform owner. We hypothesize that platform‐enabled firms (complementors) with an outside option—those who also operate on a different platform—reposition, while firms only focused on a single platform double down. Examining the case of the “Files” app on Apple's App Store, we find support for these predictions. We also study other large firm entries on App Store (by Microsoft and SanDisk), but do not observe a meaningful response by complementors. We describe how market entry by the platform owner differs from traditional entry and argue stakeholders may benefit from a deeper understanding of the unique nature of competing with a platform.

Assessing the genotoxicity of N-nitrosodiethylamine with three in vivo endpoints in male Big Blue® transgenic and wild-type C57BL/6N mice.

The detection of N-nitrosamines in drug products has raised global regulatory interest in recent years due to the carcinogenic potential of some nitrosamines in animals and a need to identify a testing strategy has emerged. Ideally, methods used would allow for the use of quantitative analysis of dose-response data from in vivo genotoxicity assays to determine a compound-specific acceptable intake for novel nitrosamines without sufficient carcinogenicity data. In a previous study we compared the dose-response relationships of N-nitrosodiethylamine (NDEA) in three in vivo genotoxicity endpoints in rats. Here we report a comparison of NDEA's genotoxicity profile in mice. Big Blue® mice were administered NDEA at doses of 0.001, 0.01, 0.1, 1 and 3 mg/kg/day by oral gavage for 28 days followed by 3 days of expression. Statistically significant increases in the NDEA induced mutations were detected by both the transgenic rodent mutation assay (TGR) using the cII endpoint and by duplex sequencing in the liver but not bone marrow of mice. In addition, administration of NDEA for two consecutive days in male C57BL/6N mice caused elevated DNA damage levels in the liver as measured by % tail DNA in comet assay. The benchmark dose (BMD) analysis shows a BMDL50 of 0.03, 0.04 and 0.72 mg/kg/day for TGR, duplex sequencing and comet endpoints, respectively. Overall, this study demonstrated a similar genotoxicity profile of NDEA between mice and rats and provides a reference that can be used to compare the potential potency of other novel nitrosamines for the induction of gene mutations.

Current Approaches in Traffic Lane Detection: a minireview

The continuous development and importance of the field of road transport these days make it necessary to design, develop and implement technological solutions that reduce (eliminate as much as possible) the risk of road accidents. Such a technological solution is also represented by advanced driver assistance systems (ADAS), systems that assist drivers in various ways, such as collision avoidance, automatic parking, adaptive cruise control, attention and lane departure warnings. Over the next ten years, there will likely be a rise in the need for ADAS system deployment in automobile construction, driven by consumer and regulatory interest in safety applications that protect drivers and lower accident rates. At the moment, autonomous emergency braking and forward collision warning systems are mandated for all cars in the US and the EU. Additionally, advanced driver assistance systems (ADAS) may soon distinguish automobile brands and have a significant impact on consumer preference. The present work aims to provide a general picture related to the current research and development of ADAS systems that refer to the detection of the traffic lane and lane markings. The approaches are presented regarding: the current development directions of ADAS systems, current traffic lane detection techniques, traffic lane detection methods and the use of artificial intelligence techniques in this field. The general conclusion is that further research is needed in the field, research to increase the performance of traffic lane detective systems by using advanced algorithms and easy-to-implement methods that do not require large hardware resources.

Everything, everywhere, all at once: The impossible mission of compliance officers

This paper explores how the increasing interconnectivity of risks and regulatory interests create new compliance challenges. The paper explains how this causes new challenges for effective compliance risk management, particularly with regard to the definition of compliance risk, which keeps on expanding, and to the growing complexity of determining compliance roles and responsibilities across the organisation. It also offers insights on how AI and technology are actively disrupting compliance operations. As a matter of illustration, the paper considers how non-financial risks such as conduct and environmental, social and governance create cross-enterprise complexities that may be shifting the compliance risk management paradigm. Finally, the conclusion gives practical advice on how the modern compliance officer can stay relevant in a changing world.

Exploring practices, challenges, and priorities for human health and ecological risk assessments in Indigenous communities in Canada.

Indigenous peoples in Canada are disproportionately exposed to environmental contaminants and may face elevated health risks related to their unique cultural, spiritual, and economic relationships with the land, including the use of traditional food systems. However, to date, institutionalized approaches to assess risks to human and ecological health from contaminants have not been well developed or implemented with Indigenous community contexts in mind. There is regulatory interest in developing new approach methods for risk assessment, and thus an opportunity to increase their relevance to Indigenous communities in which they will be ultimately applied. Therefore, we conducted an anonymous mixed-methods survey of those involved with risk assessment in Indigenous communities in Canada to: (1) understand risk assessment practice in Indigenous communities, (2) explore challenges with conventional assessment methods and compare these across sectors, and (3) gather perspectives on the development of new approaches. In all, 38 completed survey responses were received (14% response rate). Respondents were from Indigenous community environment and health offices (21% of respondents), Indigenous governments (8%), federal and provincial governments (21%), and academia (45%). Risk communication was seen as the most challenging part of risk assessment (71% responded "difficult"), and nearly all respondents agreed that time (86%), cost (76%), and resource availability (86%) were "moderate" to "serious" problems. Few respondents (16%) had heard of "new approach methods" for risk assessment, and 76% of respondents (and 100% of community-based respondents) agreed on the need to develop improved risk assessment approaches. To modernize risk assessment, respondents recommended advancing cumulative risk assessment methods, improving risk communication, and promoting Indigenous leadership and Traditional Knowledge in assessment activities. Integr Environ Assess Manag 2024;20:1677-1692. © 2024 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Development of a Phthalate Environmental Reproductive Health Literacy (PERHL) Scale.

Substantial evidence exists linking phthalate exposure to adverse reproductive health outcomes. Current US federal regulations of consumer product chemicals place the onus on individuals to mitigate their exposure to phthalates, with assumptions of sufficient environmental health literacy (EHL). Few validated scales for people of reproductive age exist to evaluate phthalate-specific EHL. Our objective is to develop a multidimensional scale characterizing latent factors of phthalate knowledge, risk perception, and self-efficacy to inform individual-level interventions for reducing phthalate exposure. We distributed a survey with 31 items to 117 participants in the Environmental Reproductive and Glucose Outcomes (ERGO) cohort who gave birth within the last 5 years. Exploratory factor analysis (EFA) was used to identify underlying latent factors. Internal reliability was assessed via omega hierarchical coefficient. Average sum scores for each latent factor and the overall Phthalate Environmental Reproductive Health Literacy (PERHL) score were calculated. Associations between latent factors, overall PERHL score, and sociodemographic characteristics were explored using linear models. Six latent factors were identified as follows: "Awareness of Phthalate Reproductive Health Impacts," "Uncertainty," "Protective Behavior/Risk Control," "Regulatory Interest," "Awareness of Phthalate Exposure Pathways," and "General Phthalate Knowledge." Each factor demonstrated acceptable to strong internal reliability, with coefficients ranging between 0.63 and 0.93. Non-white participants had lower scores for the "Awareness of Phthalate Reproductive Health Impacts" [: , 95% confidence interval (CI): , ], "Awareness of Phthalate Exposure Pathways" (: , 95% CI: , ), and "General Phthalate Knowledge" (: , 95% CI: , ), but no significant difference in scores on "Uncertainty" (: 0.17, 95% CI: , 0.50), "Protective Behavior/Risk Control" (: , 95% CI: , 0.28), or "Regulatory Interest" (: , 95% CI: , 0.09). No associations were seen for age or educational attainment and latent or sum factors. Six latent factors were identified for the PERHL scale. Non-white race and ethnicity was associated with lower scores for knowledge-related scale factors. https://doi.org/10.1289/EHP13128.

Caught in the web: Pitfalls of electronic communications

This paper explores the regulatory interest in and examination focus on electronic messaging at financial institutions. The regulatory landscape for recordkeeping at broker-dealers and registered investment advisers is discussed in the context of enforcement actions for alleged recordkeeping failures. Practical considerations are offered to enable compliance professionals to monitor and supervise electronic messaging.

The social-ecological landscape of herding on the high mountain commons of Larrau in the western Pyrenees (France)

IntroductionMuch has been written about herding, pastoralism and the ethos of the commons that persists in Soule and the valley republics of the western Pyrenees. However, more has been written about the idealized norms of the practice than the social dynamics of alliance formation on which cooperation in herding on the high mountain commons in Soule has depended for centuries. We use empirical evidence from the parish-commune of Larrau to analyze the emergence, social alliance, and landscape placement of Cayolar, a syndicate of herders associated with a named inholding within the high mountain commons, to inform our understanding of the process of settling down in the western Pyrenees.MethodsWe abstract the institutional features of herding in the Soule Valley then proceed with a (1) Bayesian analysis of calibrated radiocarbon dates from herding sites across the commons, (2) a Bayesian social network analysis of herders and other alliance-relevant information, and (3) a landscape analysis of the placement of Cayolar inholdings.ResultsA syndicate of herders organized as a Cayolar succeed by following mutually agreed upon rules, making credible commitments to each other, and monitoring members' conformance to the rules. The organizational performance of a Cayolar depends on the articulation of herders to the members of the Soule community of interest through nested levels of institutional decision-making. Archaeological, historical and ethnographic results provide direct evidence for use of Cayolar structures and inholdings by c. 1000 CE and the institutional and organizational aspects of decision-making by c. 1100 CE.DiscussionThe Cayolar is an enduring place-based organization with an average use-span of c. 850 years. Members have a regulatory interest in enforcing the collaboration of others in collective herding and little incentive to defect since unlike Hardin's herders, Cayolar members share a past and expect to share a future as members of the Soule community of interest. Íñigo Arista established the Basque kingdom of Navarra in 824 CE, and his donations contributed to the founding of the Benedictine monastery of Leyre that established a pastoral enterprise at Betzula within the Soule Valley. Other monastic orders soon turned their attention to the western Pyrenees responding to attempts by the Catholic Church to counter civil unrest in southern France. The real turning point for collective herding on the high mountain commons was the introduction of primordial fueros on the Iberian side of the Pyrenees. These direct royal agreements with freemen encouraged resettlement and repopulation of the western Pyrenees and provided the means for local communities of interest to coalesce and develop institutions to organize the collective effort of individuals for the benefit of a group.

ТРАНСФОРМАЦІЯ СТРУКТУРИ СИСТЕМИ ВАЛЮТНОГО КОНТРОЛЮ В ЦИФРОВІЙ ЕКОНОМІЦІ АЗЕРБАЙДЖАНУ

Digital transformation in the banking and financial services sector largely involves a shift towards online and digital services from top-down branch banking, integrating digital systems, customer service platforms, applications and infrastructure. The purpose of the article is characterise the transformation of the structure of the currency control system in the digital economy of Azerbaijan. The subject of the study is processes of transformation of the currency control system structure in the digital economy of Azerbaijan. The methodological basis and information base of the research are current scientific and applied research, statistical information. The article uses a number of methods, including analysis, synthesis, comparison and generalization. The main hypothesis of the study was the assumption that the efficiency of economic management and the financial condition of the public sector depend on the quality of budget forecasting and planning, because they are the key to the sustainable development of socio-economic processes. Presenting main material. Technologies being implemented include blockchain, artificial intelligence (AI), cloud computing, machine learning, and customer data collection, management and analysis. With increasing adoption of FinTech (innovative technology supporting banking and financial services) disrupting the sector, it is attracting regulatory interest and prompting stricter regulatory standards.The originality and practical significance of the research.Systemic reforms of the payment ecosystem not only affect the development of financial markets and the country’s economy as a whole, but also ensure safe and efficient payments between business entities. Conclusions. Deepening digital transformation in the banking system and expanding the use of innovative payment solutions makes electronic payments an integral part of our daily lives and at the same time increases the competitiveness of the banking system as a whole

A Review on Dissolution Method Development for Drug Products: Current Regulations and Prospects

Dissolution (in vitro release) testing has been the subject of intense scientific and regulatory interest over the past several decades. As an analytical methodology, in vitro dissolution testing measures drug release into the dissolution media. The U. S. Food and Drug Administration (USFDA) Dissolution Database was reviewed and screened regarding the type of dosage forms, apparatus type, agitation speed, media volume, and recommended time points for the dissolution profile. The dissolution method requires special laboratory equipment, following a well-defined protocol. Basic information is available in the United States Pharmacopeia general chapters<711> Dissolution, <724> Drug Release, and <1092> The Dissolution Procedure – Development and Validation and these chapters were used as a starting point for this revision. The article describes current regulatory expectations for establishing a suitable dissolution method for implementing quality control tools, a way to maintain lot quality and consistency between development batches and post-approval commercial batches. Dissolution methods draw offers some advantages as a possible surrogate for extensive clinical studies in certain cases required after scale-up and post-approval changes in the product's life cycle and serves as an essential tool for establishing waivers for filing of lower strengths of the drug product. The step-by-step dissolution method development plan as per current regulatory perspectives and the factors to be considered are explained with examples. Scientist requires detailed insights on the selection of media and volumes, physicochemical properties of active substance, sink condition, type of enzymes, selection of apparatus, deaeration, sinkers, agitation speed, and time point’s measures. The advanced dissolution method is evaluated against its discriminatory power by intentionally varying formulation and process variables

Understanding Delayed Graft Function to Improve Organ Utilization and Patient Outcomes: Report of a Scientific Workshop Sponsored by the National Kidney Foundation

Delayed graft function (DGF) is a common complication after kidney transplant. Despite extensive literature on the topic, the extant definition of DGF has not been conducive to advancing the scientific understanding of the influences and mechanisms contributing to its onset, duration, resolution, or long-term prognostic implications. In 2022, the National Kidney Foundation sponsored a multidisciplinary scientific workshop to comprehensively review the current state of knowledge about the diagnosis, therapy, and management of DGF and conducted a survey of relevant stakeholders on topics of clinical and regulatory interest. In this Special Report, we propose and defend a novel taxonomy for the clinical and research definitions of DGF, address key regulatory and clinical practice issues surrounding DGF, review the current state of therapies to reduce and/or attenuate DGF, offer considerations for clinical practice related to the outpatient management of DGF, and outline a prospective research and policy agenda.

Assessing the effectiveness of artificial neural networks (ANN) and multiple linear regressions (MLR) in forcasting AQI and PM10 and evaluating health impacts through AirQ+ (case study: Tehran)

Air pollution is one of the major concerns for the population and the environment due to its hazardous effects. PM10 has affected significant scientific and regulatory interest because of its strong correlation with chronic health such as respiratory illnesses, lung cancer, and asthma. Forcasting air quality and assessing the health impacts of the air pollutants like particulate matter is crucial for protecting public health.This study incorporated weather, traffic, green space information, and time parameters, to forcst the AQI and PM10. Traffic data plays a critical role in predicting air pollution, as it significantly influences them. Therefore, including traffic data in the ANN model is necessary and valuable. Green spaces also affect air quality, and their inclusion in neural network models can improve predictive accuracy. The key factors influencing the AQI are the two-day lag time, the proximity of a park to the AQI monitoring station, the average distance between each park and AQI monitoring stations, and the air temperature. In addition, the average distance between each park, the number of parks, seasonal variations, and the total number of vehicles are the primary determinants affecting PM10.The straightforward effective Multilayer Perceptron Artificial Neural Network (MLP-ANN) demonstrated correlation coefficients (R) of 0.82 and 0.93 when forcasting AQI and PM10, respectively. This study also used the forcasted PM10 values from the ANN model to assess the health effects of elevated air pollution. The results indicate that elevated levels of PM10 can increase the likelihood of respiratory symptoms. Among children, there is a higher prevalence of bronchitis, while among adults, the incidence of chronic bronchitis is higher. It was estimated that the attributable proportions for children and adults were 6.87% and 9.72%, respectively. These results underscore the importance of monitoring air quality and taking action to reduce pollution to safeguard public health.

Auditor sustainability focus and client sustainability reporting

We examine the relationship between auditors' sustainability focus and their clients' sustainability reporting. Sustainability reporting is of increasing social and regulatory interest following SEC guidance on the provision of sustainability disclosures. Auditors can bridge the gap between a myriad of technical guidance and their clients. Positive assortative matching could occur between clients who plan to increase their sustainability reporting and auditors who have a greater sustainability focus, with sustainability alignment comprising part of client strategy for credibly reporting sustainability information. Specifically, we examine auditor-client sustainability alignment through the association between relative auditor sustainability focus and their clients' sustainability disclosures and activities. We measure auditors' sustainability focus by examining the sustainability focus in auditors’ tweets. We find that auditor sustainability focus is positively associated with client sustainability reporting, through both sustainability disclosures and social and governance sustainability activities. Our study provides a greater understanding of auditor involvement in sustainability reporting.

P09.03.A DEVELOPMENT OF A CORE OUTCOME SET FOR USE IN ADULT PRIMARY GLIOMA PHASE III INTERVENTIONAL TRIALS - A MIXED METHODS STUDY

Abstract BACKGROUND Glioma patients’ high symptom burden and the poor prognosis of high grade glioma has emphasised quality of survival and overall health-related quality of life (HRQOL) throughout the disease trajectory in clinical trials. Patient-reported outcomes (PROs) allow insight into how investigative treatment affects patients’ perceived functioning, complementing other outcome data (e.g. survival, radiological response) in clinical decision-making. Creating robust evidence requires effective data synthesis and meta-analyses across trials, underpinned by consistent trial outcome measurement, analysis and reporting. However, a standard ontology is lacking in cancer clinical trials, and brain tumours specifically, and selective outcome reporting is common. Core outcome set (COS) development is one means to improve data synthesis. The COBra project aimed to develop a COS for use in glioma phase III trials in support of those goals. Given stakeholder interest in PROs and prioritising the patient perspective, we also undertook initial exploration of which items could be patient reportable. MATERIAL AND METHODS A COS for adult primary glioma phase III interventional trials was developed through: (1) trial registry review and systematic review of qualitative studies; (2) interviews with glioma patients and caregivers; (3) outcome list de-duplication; (4) two-round Delphi process and outcome list rating; (5) a consensus meeting to finalise the COS. Patient-reportable COS outcomes were identified by cross-referencing the final COS outcomes with outcomes and PRO measures (PROMs) reported in the trial registry review. Activities were guided by UK Patient and Public Involvement standards and public contributors were core research team members. RESULTS A COS consisting of 19 outcomes grouped into seven outcome domains (Survival, Adverse Events, Activities of Daily Living, HRQOL, Seizure Activity, Cognitive Function and Physical Function) was finalised for use in glioma trials using this structured approach. Mapping PROMs identified in the registry review suggests that sub-domains of 6/7 outcome domains in the final COS can be patient-reported (adverse events, activities of daily living, HRQOL, seizure activity, neurocognitive function, physical function). Other currently unidentified instruments may also be suitable. Further research will identify appropriate measurement tools, promote accessible PRO delivery, and validate this COS for wider use. CONCLUSION A COS for glioma trials was developed, comprising seven outcome domains. Development of this COS coincides with growing regulatory interest in patient-reported data. To optimise data synthesis and prioritise the patient perspective, opportunities to collect data in this way should be promoted and taken. As such, this COS could be considered for use in registrational trials after further validation.

Relationship Between Regulatory Interest and Market Interest Rates in Vietnam: Quantitative Analysis Perspective

The article studies the relationship between regulatory interest and market interest rates in Vietnam from 2015 – 2022. This relationship has been mentioned in many theories and empirical studies in different countries and in different periods. In order to explain it, the research team collected data on the refinancing rate – which represents the regulatory interest rates and lending rates – representing the market interest rates from 2005 to 2022. The data is collected quarterly and analyzed using Eviews8 software to build a linear regression model showing the relationship between regulatory interest rates and market interest rates during the research period. In this article, the research team divides the research period into three phases: 2005Q1 – 2011Q4, 2012Q1 – 2016Q4, 2017Q1 – 2022Q4. The results of the linear regression model show that for the period 2005Q1 – 2011Q4, when the regulatory interest rate increases by 1%, the market interest rate increases by 1%, the market interest rate increases by 0.7326%; for the period 2012Q1 – 2016Q4, when the regulatory interest rate increases by 1%, the market interest rate increases by 0.5943%; for the period 2017Q1-2022Q4, when the regulatory interest rate increases by 1%, the market interest rate increases by 0.2269%. This shows a positive relationship of regulatory interest rate and market interest rate. In addition, for the period 2012Q1-2016Q4, the research team added trend variables and for the period 2017Q1-2022Q4 the research team added trend variables and dummy variables to the regression model. It also proves that the market interest rate in the research period is governed by the trend and volatility of the economy. From the research results, the research team made several exchanges and discussions to improve the effectiveness of the interest rate management policy in order to achieve the goal of stabilizing the macro economy and supporting economic growth.

Evaluating the validity of regulatory interest rate risk measures – a simulation approach

This paper assesses the validity of changes in the economic value of equity (EVE) and the net interest incom (NII) as regulatory risk measures for a bank’s interest rate risk in the banking book. We develop a novel simulation approach and evaluate the measures retrospectively from the time of a bank’s default as a consequence of stressed market interest rates. Our results show that both measures significantly indicate inherent interest rate risk. We find the EVE to be a robust and conclusive risk measure, whereby the results concerning the NII measure are against the economic intuition, less robust, and might depend on the prevailing level of interest rates. Further, we derive critical values of quarterly changes in risk measures serving as indicators for substantial risk levels. Our findings validate the EVE and contribute to a thorough understanding of the risk measures.

Evaluation of streamflow as a covariate in models for predicting daily pesticide concentrations

AbstractSeveral models have been developed with streamflow as a covariate for predicting daily pesticide concentrations in surface water systems. Among these models, the SEAWAVE‐QEX model has been proposed by the United States Environmental Protection Agency for regulatory assessments. In this paper, the model was modified to include alternative transformations of streamflow data, and to include no streamflow covariates. The predictive performance of the modified models was evaluated and compared with the original SEAWAVE‐QEX model using a high frequency sampling dataset that includes 9 sites with 10 years of data from the Atrazine Ecological Monitoring Program. Streamflow transformations evaluated included those in the SEAWAVE‐QEX model (short‐term and mid‐term flow anomalies), reduced models with only short‐term flow anomaly or without any flow covariates, normalized Box‐Cox transformation of flow, and combinations of normalized Box‐Cox and flow anomalies. Loglinear interpolation was also evaluated. The normalized Box‐Cox transformation provided best predictive performance and significantly better predictive performance than that of the SEAWAVE‐QEX model for a target quantity of regulatory interest, such as the maximum 1‐day rolling average (similarly for the maximum 60‐day rolling average, but not significantly so). The no‐flow covariate model was only slightly worse than Box‐Cox. Significant differences in predictive performance of the SEAWAVE‐QEX model were detected across sites.

PCR16 Patient-Reported Outcomes in Opioid Use Disorder (PR-OUD): Recommendations and Barriers in Clinical Trials and Studies

Based on regulatory interest in utilizing patient-centric outcomes in clinical trials for treatments of opioid use disorder (OUD), a review of the published literature was conducted to understand current use of patient-reported outcomes (PROs) in clinical trials and non-interventional studies. Additionally, patient barriers to providing transparent PRO data were investigated.

Implementing a health-system–wide antibiotic stewardship program in ambulatory surgery centers

Background: In 2016, the CDC released the Core Elements of Outpatient Antibiotic Stewardship, which extended the requirements previously released for hospital facilities and nursing homes to the outpatient setting. Several regulatory agencies focused on outpatient antimicrobial use. However, The Joint Commission and the Ambulatory Surgery Center (ASC) Leapfrog Group excluded ambulatory surgery centers from their medication management standards and questions. Due to the public health and patient safety benefits of implementing an antimicrobial stewardship program (ASP) and increasing regulatory interest in the matter, the Hospital Corporation of America (HCA) Ambulatory Surgery Division formally launched a nationwide ASP for its ambulatory surgery centers in March 2021. Methods: HCA is a large healthcare system with 146 ASCs in 16 states in 2021. The structure of the ASCs are local surgery centers with a medical director, a nurse responsible for infection prevention, and a pharmacist at a regional level. The types of surgeries vary based on location and ASC site. In 2019, a multidisciplinary team formed the corporate planning committee. The program was modeled after the CDC Core Elements and The Joint Commission’s requirements for an ASP. Each ASC was asked to build a local ASP team, led by a local physician and a regionally based pharmacist. In addition, a stewardship goal was established to update all preoperative antibiotic surgical-site infection prophylaxis order sets. The corporate committee provided educational resources, including evidence-based guidelines for appropriate antibiotic selection for surgical-site infections. They collected antibiotic cost per case as a baseline metric to track and analyze. Pediatric, ophthalmic, and gastrointestinal endoscopic procedures were excluded from the program. Results: From January 1, 2020, through December 31, 2021, including only centers that were operational during this period and excluding single specialty endoscopy centers, antibiotic cost per case decreased annually from $2.38 to $1.84 (t = 4.157; P < .005), and the postoperative infection rate also declined from 0.370 to 0.304 (t = 2.079; P = .040). Conclusions: Our findings suggest that implementing a health-system–wide outpatient antibiotic stewardship program in the ambulatory surgery center setting is feasible and may contribute to decreased antibiotic cost per case and improved postoperative surgical site infection rates.Disclosures: None