Regulatory Definition Research Articles

The concept and structural elements of the system of personal empowerment rights of employees

The article considers the problem of defining the system of personal non-property rights of an employee, as a set of its individual structural basic elements in the system of personal non-property benefits of an individual, and in the general system of human rights. The essence and content of any social, legal phenomena, which are the personal non-property rights of employees, as relevant legal values, can be fully revealed only thanks to the study of objective signs characteristic of these rights. When studying the current issues of employees’ personal rights, it is extremely important to determine their structure as a certain systemic formation and a separate group in the general system of labour rights which would reflect and ensure their internal differentiation and external unity. Due to the fact that the personal rights of a person are a separate type of subjective rights (they belong to the category of intangible goods), their features are the absence of direct property content and an inseparable connection with the personality of their bearer. At the same time, in an objective sense, personal non-property rights are undeniably a complex legal institution that forms the norms of various branches of public and private law (constitutional, criminal, administrative, environmental, civil, family, housing, labor, etc.). Based on the analysis of the provisions of national and prospective legislation, as well as the achievements of scientific thought, the article provides a legal description of the concept of the system, structure and elements of the system of personal non-property rights of an employee in connection with the performance of his/her employment duties. The issue of the possibility of regulatory definition and consolidation of the system and classification of personal non-property rights of employees in the course of their employment functions has been investigated. The scientific novelty of the publication is that the issue of systematization and/or classification of the employee's personal non-property rights has been comprehensively researched, taking into account the classes (types) of their types, in accordance with the requirements of national civil and labor legislation and according to scientific research.

Feeding Next-Generation Nanomedicines to Europe: Regulatory and Quality Challenges.

New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" generally identifies medicinal products that use nanotechnology in their design or production. Due to the intrinsic high structural complexity of these products, the scientific and regulatory communities are reflecting on how to revise the regulatory framework to provide a more appropriate benefit/risk balance to authorize them on the market, considering the impact of their peculiar physicochemical features in the evaluation of efficacy and safety patterns. Herein, a critical perspective is provided on the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued. Strengthening the multilevel alliance among academic institutions, industrial stakeholders, and regulatory authorities seems strategic to support innovation by standard approaches (e.g., qualification, characterization, risk assessment), and to expand current knowledge, also benefiting from the new opportunities offered by artificial intelligence and digitization in predictive modelling of the impact of nanomedicine characteristics on their fate in vivo.

Use of Real-World Evidence in Neuroscience-Related New Drug and Biologics License Applications for Novel Therapeutics.

The US Food and Drug Administration (FDA) is evaluating the potential use of real-world evidence (RWE) in regulatory decision making. Some groups have evaluated the use of RWE in regulatory submissions in the United States and abroad, reporting that reliance on RWE to support new product approvals is relatively common. Confusion regarding the use of RWE in drug-approval decisions may arise, however, based on different application of the terms real-world data (RWD) and RWE. We evaluated RWE in new drug applications (NDAs) and biologics license applications (BLAs) from January 2019 to June 2021 for novel drugs and biologics approved by the FDA with indications related to psychiatry, neurology, pain, or sedation (here, termed neuroscience-related). We sought to determine whether the submissions included RWE and to describe the types of data and study designs used. Thirty neuroscience-related NDAs or BLAs were identified for novel drugs and biologics approved during the time-period of interest. Among these approvals, three applications (10%) were adjudicated as containing RWE, one of which included RWE as primary evidence of effectiveness. Our findings highlight how different operational definitions of the terms RWD and RWE can result in demonstrably different reporting of the use of RWE in regulatory decision making for neuroscience-related novel drugs and biologics. A better understanding of this topic, along with awareness of regulatory definitions of RWE, are important factors to promote accurate tracking and reporting of regulatory submissions involving RWE. These factors can also improve awareness among the stakeholder community regarding the role of RWD and RWE in regulatory decision making.

САМОВРЯДНА ПАРАДИГМА У ФОРМУВАННІ ТА ФУНКЦІОНУВАННІ ДЕМОКРАТИЧНОЇ ПРАВОВОЇ ДЕРЖАВНОСТІ: ДО ВИЗНАЧЕННЯ ЗМІСТУ, РОЛІ ТА ЗНАЧЕННЯ

The article is devoted to the scientific and theoretical substantiation of the problem of determining the content, role and significance of the self-governing paradigm in the formation and functioning of a democratic legal statehood. In domestic jurisprudence, this topic is practically not studied. The authors connect the appearance of this problem with the factors of formation, development and improvement of the phenomenology of democratic legal statehood, when it is in these conditions that permanent para-democratic, meta-democratic processes of a tactical and strategic nature arise and intensify, as well as purely democratic tendencies are formed, determined by these processes, which permanently stimulate as a phenomenology of statehood, emphasizing its potential promising opportunities, as well as new forms of communicative interaction and rather productive cooperation of actors. At the same time, it is noted that the above processes are stimulated not only at the level of intrastate relations: a) the state, b) its public authorities, including local selfgovernment bodies, c) citizens who are simultaneously residents of certain territories of the state, i.e. residents-members relevant territorial communities; d) other natural persons with different legal status (foreigners, stateless persons, refugees, etc.), who are legally on the territory of a specific state and permanently residing within its borders, are also residents and members of the relevant communities, who are in subordinate, coordination and reorientational subordination among themselves within the limits of national constitutional and administrative law in the understanding of communication of subjects of public authority. They are quite clearly and sensibly manifested at the level of actors of international legal relations: a) sovereign states; b) international intergovernmental and intergovernmental organizations, which enter on the basis of the sovereignty and equality of their patrimonial and other states in a complex and multifactorial inter-subject interaction within intergovernmental structures on the basis of the fundamental principles and norms of general international law. It is noted that the self-governing paradigm is based on the managerial humanisticself-governing paradigm "human rights - municipal human rights - municipal person", which, firstly, acts as its content, and, secondly, acts as a strategic and basic direction in the formation and the functioning of a democratic legal state, because it is within the limits of the Ministry of Internal Affairs that a person: a) carries out his life cycle; b) realizes all his life aspirations, needs and interests, which are transformed into human rights; c) the constitutional and legal status of a person and a citizen is realized in the sphere of the Ministry of Internal Affairs. It is noted that the paradigm "human rights - municipal human rights - municipal person" has a clear and understandable management character, has a number of identifying features: A) subject-object composition, B) structural organization, C) national and international regulatory legal support and provision, which, in turn, endows it with: a) a theoretical basis; b) doctrinal justification; c) praxeological realization; d) value-methodological orientation; d') existential essence and objective-existential potential; e) regulatory definition; e) ascertaining the existence of managerial impulses; g) objectification of management actions; g) connotational content; h) communicative coordinate system; i) strategic narrative content.

Classification system for nanotechnology-enabled health products with both scientific and regulatory application.

The lack of specific regulatory guidelines for nanotechnology-enabled health products (NHPs) is hampering development and patient access to these innovative technologies. Namely, there is an urgent need for harmonized regulatory definitions and classification systems that allow establishing a standardized framework for NHPs regulatory assessment. In this work, a novel classification system for NHPs is proposed. This classification can be applied for sorting nano-based innovations and regulatory guidelines according to the type of NHPs they address. Said methodology combines scientific and regulatory principles and it is based on the following criteria: principal mode of action, chemical composition, medical purpose and nanomanufacturing approach. This classification system could serve as a useful tool to sensor the state of the art of NHPs which is particularly useful for regulators to support strategy development of regulatory guidelines. Additionally, this tool would also allow manufacturers of NHPs to align their development plans with their applicable guidelines and standards and thus fulfill regulators expectations.

Judicial reform in Ukraine: the certainty of a categorical apparatus

The article highlights normative-legal and theoretical-methodological approaches to understanding the legal categories and concepts of judicial reform in Ukraine.
 It is established that the judicial reform, first of all, needs appropriate scientific support, in particular with regard to the clear definition of its subject and the development of a conceptual and categorical apparatus, given the lack of a clear regulatory and legal definition of a number of important terms, primarily such as «judicial system», «judicial authority», «justice system», «judiciary», which are repeatedly used in the development of relevant reformation provisions.
 The purpose of the article is to establish the concept of the relationship of legal categories relevant to the judicial reform through the prism of legal analysis of normative-legal and theoretical-methodological approaches to their understanding and their further development.
 It is also established that the current legislation of Ukraine does not contain a normative legal definition of such definitions as «judiciary», «judicial authority», «judicial system», «justice», «justice system», even though it actively uses them, carrying out legal regulation of relations in the field of the judiciary and the status of judges. In scientific legal literature, these terms are sometimes used without specifying their definition, given the close connection between them and meaningful interdependence, forming a synonymous line from them. Simultaneously, to comply with the subject of reformation provisions to such criteria as logic, rationality and non-contradiction, the need to distinguish between these terms has been proven, having identified the appropriate criteria for such a distinction.
 According to the results of the legal analysis of legislative and doctrinal approaches to solving this problem, the expediency of recognizing the category «justice system» as a comprehensive legal category, which will include the judicial system and the systems of other legal institutions related to the judicial authority (Public prosecutor’s office, Bar, enforcement of decisions), which functionally ensure its implementation, is substantiated. It is proposed to rename Chapter VIII of the Constitution of Ukraine to the «Justice System», given that the administration of justice requires the proper organization of judicial power, its implementation by courts and ensure by specially authorized bodies and institutions, which in their totality and interrelationships constitute the justice system, which includes institutional, functional elements and organizational aspects.

Review of Restricted Experiment Requests, Division of Select Agents and Toxins, US Centers for Disease Control and Prevention, 2014-2021.

The US Centers for Disease Control and Prevention Division of Select Agents and Toxins (DSAT) regulates laboratories that possess, use, or transfer select agents and toxins within United States as part of the Federal Select Agent Program. DSAT also mitigates biosafety risks through the review of "restricted experiments," which under the select agent regulations are experiments that pose heightened biosafety risks. In a previous study, we evaluated restricted experimental requests submitted to DSAT for review between 2006 and 2013. The purpose of this study is to provide an updated analysis of requests to conduct potential restricted experiments submitted to DSAT between 2014 and 2021. This article describes the trends and characteristics of the data associated with restricted experimental requests involving select agents and toxins that have an impact on public health and safety (US Department of Health and Human Services agents only) or both public health and safety and animal health or products (overlap agents). From January 2014 to December 2021, DSAT received 113 requests to conduct potential restricted experiments; however, 82% (n=93) of those requests were determined not to meet the regulatory definition of a restricted experiment. Of the 20 requests that met the definition of a restricted experiment, 8 were denied because the experiments had the potential to compromise disease control in humans. DSAT continues to encourage entities to practice due diligence and request a review of research that could potentially meet the regulatory definition of a restricted experiment out of an abundance of caution to protect public health and safety and prevent any potential compliance action.

Digital technologies: Innovations that transform the face of drug development.

Recently, digital health technologies (DHTs) and digital biomarkers have gained a lot of traction in clinical investigations, motivating sponsors, investigators, and regulators to discuss and implement integrated approaches for deploying DHTs. These new tools present new and unique challenges for optimal technology integration in clinical trial processes, including operational, ethical, and regulatory issues. In this paper, we gathered different perspectives to discuss challenges and perspectives from three different stakeholders: industry, US regulators, and a public-private partnership consortium. The complexities of DHT implementation, which include regulatory definitions, defining the scope of validation experiments, and the need for partnerships between BioPharma and the technology sectors, are highlighted. Most of these challenges are related to translation of DHT-derived measures into endpoints that are meaningful to clinicians and patients, participant safety, training, and retention and privacy of data. The example of the Wearable Assessments in the Clinic and Home in PD (WATCH-PD) study is discussed as an example that demonstrated the advantages of pre-competitive collaborations, which include early regulatory feedback, data sharing, and multistakeholder alignment. Future advances in DHTs are expected to spur device-agnostic measured development and incorporate patient reported outcomes in drug development. More efforts are needed to define validation experiments for a defined context of use, incentivize data sharing and development of data standards. Multistakeholder collaborations via precompetitive consortia will help facilitate broad acceptance of DHT-enabled measures in drug development.

Hard Exterior, Soft Interior: Skill Regulation and Employer Control over Migrant Worker Selection Policy in Australia

Abstract This paper utilises a regulatory analysis of skilled visas and insights from labour law scholarship to examine how Australian immigration law regulates ‘skill’ and the implications for migrant workers’ employment relationships. While qualifications or ‘hard skills’ act as the formal basis for selection under Australian immigration law, interpersonal attributes associated with ‘soft skills’ often decide who employers recruit. Immigration regulations that allow employers discretion to recruit based on soft skills widen scope for employer misuse and migrant worker exploitation, including for those on high-skilled visas, and for diversity bias against women and ethnic minorities. Our major theoretical contribution is to highlight how immigration laws that give employers discretion over the criteria used in skilled immigration selection intensify power imbalances within the contract of employment. The regulatory definitions of skill constructed by immigration law can thus serve as an additional lever of employer control. The findings indicate that precise regulation of skill is necessary to limit the potential for employers to exert undue control over migrants in worker selection processes.

US Policies ThatDefine Foods for Junk Food Taxes, 1991-2021.

Suboptimal diet is a substantial contributor to weight gain, cardiometabolic diseases, and certain cancers. Junk food taxes can raise the price of the taxed product to reduce consumption and the revenue can be used to invest in low-resource communities. Taxes on junk food are administratively and legally feasible but no definition of "junk food" has been established. To identify legislative and regulatory definitions characterizing food for tax and other related purposes, this research used Lexis+ and the NOURISHING policy database to identify federal, state, territorial, and Washington DC statutes, regulations, and bills (collectively denoted as "policies") defining and characterizing food for tax and related policies, 1991-2021. This research identified and evaluated 47 unique laws and bills that defined food through one or more of the following criteria: Product Category (20 definitions), Processing (4 definitions), Product intertwined with Processing (19 definitions), Place (12 definitions), Nutrients (9 definitions), and Serving Size (7 definitions). Of the 47 policies, 26 used more than one criterion to define food categories, especially those with nutrition-related goals. Policy goals included taxing foods (snack, healthy, unhealthy, or processed foods), exempting foods from taxation (snack, healthy, unhealthy, or unprocessed foods), exempting homemade or farm-made foods from state and local retail regulations, and supporting federal nutrition assistance objectives. Policies based on Product Categories alone differentiated between necessity/staple foods on the one hand and nonnecessity/nonstaple foods on the other. In order to specifically identify unhealthy food, policies commonly included a combination of Product Category, Processing, and/or Nutrient criteria. Explanations for repealed state sales tax laws on snack foods identified retailers' difficulty pinpointing which specific foods were subject to the tax as a barrier to implementation. An excise tax assessed on manufacturers or distributors of junk food is a method to overcome this barrier and may be warranted.

International legal support of fishing in the conditions of the exclusive economic maritime zone

The use of the oceans requires the study of its various zones, in particular, economic (fishing) zones, which will allow to increase the level of Ukraine's economy and strengthen environmental protection.
 Ecology in the general sense is the science of the interrelationships of flora and fauna with each other and the environment, the general laws and relationships between nature and society. In this sense, environmental law and order is the relationship established by regulations that allows for the preservation of a favorable environment for humans and other living beings and the safety of life. Environmental safety is the conditions that ensure a favorable life, preservation and development of nature and society in their interconnection with the Ukrainian economy, as well as improvement of environmental protection.
 Ukrainian legislation is actualizing the problem of environmental protection, creating conditions for the inviolability of law enforcement, and a set of rules from various branches of law.
 Maritime economic zones, including fishing zones, have a special purpose.
 Thus, laws have been adopted in Ukraine: On the Exclusive Economic Maritime Zone of Ukraine, the Regulation on the Protection of Ukraine's Sovereign Rights in its Exclusive Economic Maritime Zone. [1] These regulatory acts contain the defining rules for ensuring the safety of navigation in the exclusive economic maritime zone of Ukraine. In the field of combating economic offenses, domestic legislation should be based on the experience of other states when concluding agreements to prevent offenses. Achieving this goal requires a regulatory definition of the object and subject of such legal relations. The reference of the law of Ukraine to the classification of illegal fishing, hunting and other aquatic extraction as an offense does not indicate the definition of these concepts. It may be provided in a Note to the relevant article, thus having the character of an authentic interpretation of the law, as well as through judicial interpretation in the resolutions of the Plenum of the Supreme Court of Ukraine.
 The analysis of the scientific study of the problem shows that it is imperfect and requires further development. In the blanket disposition of Articles 249 and 250 of the Criminal Code, the Ukrainian legislator defines liability for illegal fishing, hunting or other aquatic extraction and blasting in violation of the rules for the protection of fish stocks. [2] Such a general reference to specific offenses does not contribute to a clear application of these articles. This is especially true of the wording regarding the definition of animal and other aquatic fishing.
 It is the indication in the Code that criminal law has as its task the legal support of environmental protection (Article 1 of the Criminal Code of Ukraine) [2] that emphasizes its environmentalization and active preventive nature. This also corresponds to the current significance of the problems of environmental protection efficiency and contributes to ensuring unity in approaches to the criminalization of offenses in the sphere of animal and other aquatic fishing.
 It is the indication in the Code that criminal law has as its task the legal support of environmental protection (Article 1 of the Criminal Code of Ukraine) [2] that emphasizes its environmentalization and active preventive nature. This also corresponds to the current significance of the problems of environmental protection efficiency and contributes to ensuring unity in approaches to the criminalization of environmental offenses.

General principles of coercive medical measure application: concepts and basic criteria

The article is devoted to the study of the general principles of coercive medical measure application and formulation of the author's own generalized conclusions on this basis, aimed at further development of the scientific idea of such coercive measures of criminal law impact personalization and improvement of their practice implementation through compliance of law enforcement entities with certain rules or criteria. It has been noted that one of the shortcomings of the general principles regulatory certainty of coercive medical measures application is that the current criminal legislation of Ukraine does not have an article that would separately enshrine such general principles or rules. In this regard, the author has proposed own definition of general principles of coercive medical measures application concept and a variant of its regulatory definition in a separate article of the current criminal legislation of Ukraine.

Remnant Blood Quantification: Informing the Definition of Minimal Risk in Clinical Research.

Guidelines from the Office for Human Research Protections regarding categories of research that institutional review boards (IRBs) may review through expedited procedures limit the volume of blood that can be obtained from research participants for minimal risk research purposes. As defined by the Common Rule, minimal risk research is research in which the probability and magnitude of harm or discomfort anticipated are not greater than the probability and magnitude of harm or discomfort encountered from routine clinical tests. For this study, we considered the volume of remnant blood following routine clinical tests in light of the current definition of minimal risk in research. Conducted at a single institution, this was a prospective cross-sectional study that evaluated blood draws from 122 patients. The median daily remnant blood volume was 11.6 (interquartile range [IQR]: 12.3, 15.2) ml for all patients and 12.9 (IQR: 13.1, 16.9) ml for patients admitted to the intensive care unit. Our findings regarding daily remnant blood volume suggest that the currently allowable blood-volume limits to qualify for expedited review or to qualify as not more than minimal risk research involving blood draws from nonhealthy adults are less than what patients experience in routine medical testing. These findings support permitting an increase in the allowable blood-volume limits to meet the regulatory definition of minimal risk research for obtaining expedited IRB review of studies in which blood samples will be collected.

P151 Assessing comprehensive remission for Ulcerative Colitis in clinical practice: International consensus recommendations

Abstract Background Real-world treatment of ulcerative colitis (UC) requires a patient-centric, holistic definition of ‘comprehensive remission' that goes beyond standard regulatory definitions. In an international initiative, we reviewed aspects of UC that affect patients and attempted to achieve consensus on which aspects should be considered in a definition of ‘comprehensive remission’, using a modified Delphi process. This initiative summarized expert consensus recommendations on aspects of UC that are important to patients and that affect their lives, how to measure and score these aspects, and objective markers of mucosal inflammation that are relevant to evaluate in remission, such as endoscopic and histological activity and inflammatory biomarkers. Methods The Delphi consensus panel comprised 10 physicians with expertise in UC and one patient advocate, and two additional physicians chaired the process. To inform the Delphi statements, we asked 18 patients about their experiences of living with UC in remission, asked panel members about their experience of treating patients and systematically reviewed associations between outcome measures in UC. Panel members voted on a 6-point Likert scale in three rounds of anonymous voting, the final round of which was preceded by a live discussion. Consensus was met if ≥ 67% of the panel agreed with the statement (4–6 on the 6-point Likert scale). Statements not meeting consensus in voting rounds 1 and 2 were revised and any not meeting consensus by the end of voting round 3 were discarded (Figure 1). Results The panel agreed that a definition of comprehensive remission should include aspects of UC that are currently measured in clinical trials (blood in stools, stool frequency, disease-related quality of life [QoL], endoscopic remission, histological inflammatory activity, inflammatory biomarkers and discontinuation of corticosteroids), but also additional patient-reported symptoms should be added. These were bowel urgency, abdominal pain, extra-intestinal manifestations, fatigue and sleep disturbance (Table 1). Suggestions for how the severity could be measured and thresholds for remission were agreed for each aspect, with the exception of extra-intestinal manifestations. Disease activity evaluated using ultrasound was voted as important to consider but was not recommended to be included in a measure of comprehensive remission at this stage. Conclusion We used a robust methodology to reach agreement and provide recommendations on the aspects of UC that can be used to define comprehensive remission and assessed in clinical practice. We plan to develop this as a combined measure which may also have applicability in clinical trials.

Federal Statutory and Regulatory Definitions of 'Indian'

Federal Statutory and Regulatory Definitions of 'Indian'

A Regulamentação da Nova Lei de Licitações: Definição da Lógica Institucional Prevalente em um Campo

ABSTRACT Objective: the present research analyzes how regulatory definitions occur in a field, in which participants defend multiple logics in the public procurement of large-scale engineering works and services, with a focus on the requisition of guarantee insurance. It also discusses a take-back clause and the percentage of the contract value to be insured. Theoretical approach: this work is part of the discussion about how an institutional logic is constituted, given the competition between multiple logics in a field. Method: the research is focused on discussions relevant to the field. Data collection was carried out through a documentary survey of the analysis of speeches in Congress, as well as interviews with relevant actors in the field using a semi-structured script. Results: the conflicts between logics are resolved through combinations with elements from other field logics. They emphasize the power of actors’ coalitions to define regulatory issues. The study, thus, pointed out how the participants managed to reduce the influence of the logic defended by the insurance market, in favor of the interest of construction companies in the drafting of the project, showing that different market logics can contradict one another. Finally, elements exogenous to the logic under construction are fundamental in its formulation. Conclusions: the theoretical contribution of the study indicates that the institutional logic that becomes prevalent in a complex field is the result of the imposition of a coalition of actors combining elements from distinct logics. However, the coalitions may be different for each of the questions examined.

Schrodinger’s Gat: A Paradox of Regulatory Definitions in Which Pistols Can Be Rifles, and a Piece of Raw Material Can Be a Receiver

Schrodinger’s Gat: A Paradox of Regulatory Definitions in Which Pistols Can Be Rifles, and a Piece of Raw Material Can Be a Receiver

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis.

Objective: To investigate the safety and effectiveness of medical cannabis (MC) in the real-world clinical practice setting. Design: A 4-year prospective noncomparative registry of adult patients who initiated MC for a variety of indications. This paper reports on patients followed for up to 12 months, with interim visits at 3, 6, and 9 months after enrollment. Setting: Public or private outpatient clinics certified to authorize MC in the province of Quebec, Canada. Participants: Overall, 2991 adult (age ≥18 years) patients (mean age 51 years; 50.2% women) were enrolled between May 2015 and October 2018, with the last follow-up ending in May 2019. Interventions/Exposures: Cannabis products (dried, oil, or other) purchased from a Canadian licensed cannabis producer as authorized by physicians. Main Outcome Measures: The primary outcomes were self-reported pain severity, interference and relief (Brief Pain Inventory [BPI]), symptoms using the Revised Edmonton Symptom Assessment System (ESAS-r) and health-related quality of life dimensions (EQ-5D-5L) at baseline and each follow-up visit. The secondary outcomes were self-reported adverse events (AEs) and characteristics of cannabis treatment. Results: All patient-reported outcomes (BPI, ESAS-r, and EQ-5D-5L) showed a statistically significant improvement at 3 months (all p<0.01), which was maintained or further improved (for pain interference, tiredness, and well-being) over the remainder of the 12-month follow-up. Results also revealed clinically significant improvements in pain interference and tiredness, anxiety, and well-being from baseline. There were 79 AE reports (77 patients), 16 met the regulatory definition of seriousness, in which only 8 AEs were certainly or probably related to MC. Conclusions: MC directed by physicians appears to be safe and effective within 3 months of initiation for a variety of medical indications.

Combining Environmental, Multispectral, and LiDAR Data Improves Forest Type Classification: A Case Study on Mapping Cool Temperate Rainforests and Mixed Forests

Predictive vegetation mapping is an essential tool for managing and conserving high conservation-value forests. Cool temperate rainforests (Rainforest) and cool temperate mixed forests (Mixed Forest, i.e., rainforest spp. overtopped by large remnant Eucalyptus trees) are threatened forest types in the Central Highlands of Victoria. Logging of these forest types is prohibited; however, the surrounding native Eucalyptus forests can be logged in some areas of the landscape. This requires accurate mapping and delineation of these vegetation types. In this study, we combine niche modelling, multispectral imagery, and LiDAR data to improve predictive vegetation mapping of these two threatened ecosystems in southeast Australia. We used a dataset of 1586 plots partitioned into four distinct forest types that occur in close proximity in the Central Highlands: Eucalyptus, Tree fern, Mixed Forest, and Rainforest. We calibrated our model on a training dataset and validated it on a spatially distinct testing dataset. To avoid overfitting, we used Bayesian regularized multinomial regression to relate predictors to our four forest types. We found that multispectral predictors were able to distinguish Rainforest from Eucalyptus forests due to differences in their spectral signatures. LiDAR-derived predictors were effective at discriminating Mixed Forest from Rainforest based on forest structure, particularly LiDAR predictors based on existing domain knowledge of the system. For example, the best predictor of Mixed Forest was the presence of Rainforest-type understorey overtopped by large Eucalyptus crowns, which is effectively aligned with the regulatory definition of Mixed Forest. Environmental predictors improved model performance marginally, but helped discriminate riparian forests from Rainforest. However, the best model for classifying forest types was the model that included all three classes of predictors (i.e., spectral, structural, and environmental). Using multiple data sources with differing strengths improved classification accuracy and successfully predicted the identity of 88% of the plots. Our study demonstrated that multi-source methods are important for capturing different properties of the data that discriminate ecosystems. In addition, the multi-source approach facilitated adding custom metrics based on domain knowledge which in turn improved the mapping of high conservation-value forest.

2243. Patient Perceptions of Treatment Success in Uncomplicated Urinary Tract Infection

Abstract Background Regulatory guidance for developing uncomplicated urinary tract infection (uUTI) treatments requires endpoints assessing uUTI symptom resolution present at trial entry. The meaningfulness of this endpoint and definition of treatment success is rarely explored with patient-experience data (PED), and there is a paucity of PED in the literature. Methods This cross-sectional interview study included English- and Spanish-speaking women aged ≥ 12 years with confirmed uUTI diagnosis within 14 days of screening. Interviews were recorded, transcribed and analyzed using qualitative methods. Participants were asked questions to elicit spontaneous and probed reports of uUTI symptoms and how these impacted health-related quality of life. Participants provided descriptions of symptom resolution, treatment success and evaluated a 4-point scale assessing dysuria, urinary frequency, urinary urgency and suprapubic pain. They were asked if the scale contents captured their uUTI experience, including assessing meaningful treatment effect. Results Overall, 30 participants were included, mean age 40 (range: 12–61) years. Urgency was the most common symptom reported (n=29, Table 1), and nearly all (n=29) participants reported their recent uUTI affected mood/emotions (Table 2). Participants reported the relevance of symptoms and the meaning of the points on the scale (Table 3). At interview, 24 participants scored each symptom as “none” and reported this was meaningful/important. Most participants (n=27) said they would not consider treatment successful if they still experienced ≥ 1 symptom by the end of the treatment period; however, almost half (n=14) agreed that with severe symptoms, the smallest meaningful improvement would be moving from severe to moderate. A limitation of this study is that participants were not asked about underlying symptoms between episodes of uUTI. Table 1.Patient-reported uUTI symptoms (N=30)*The symptom was not probed during the interview but was spontaneously reported by the participant(s). Abbreviation: uUTI, uncomplicated urinary tract infection.Table 2.Patient-reported impacts of uUTI (N=30)*The impact was not systematically probed during the interview but was spontaneously reported by the participant; †daily activities included cleaning, shopping, caring for children, exercising, or playing sports; ‡physical activities included walking, hiking, playing sports, exercising, and going to the gym; §adolescents (n=5) were not asked about intimate relationships.Abbreviation: uUTI, uncomplicated urinary tract infection.Table 3.Sample of quotations from patient interviewsAbbreviations: UTI, urinary tract infection; uUTI, uncomplicated urinary tract infection. Conclusion Participants reported numerous impacts of uUTI. Definitions of symptom resolution and treatment success should be established with PED, with complete symptom resolution considered the most valued. The regulatory definition relevance of symptom resolution for uUTI and the content validity of a scale to assess symptom resolution was confirmed by participants. Disclosures Claire L. Trennery, MSc, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370 Susan Martin, MSPH, GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370|RTI Health Solutions: Employee of RTI Health Solutions which received funding from GlaxoSmithKline plc. to conduct this study Katherine Kosa, MSc, GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370|RTI Health Solutions: Employee of RTI Health Solutions which received funding from GlaxoSmithKline plc. to conduct this study Lydia Demetriou, MSc, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370 Ashish V. Joshi, PhD, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study.