Expert Committee Research Articles

Dietary exposure from food colours by Brazilian adolescents using the ERICA 2013–2014 food consumption database

Colouring food additives are added for the purpose of restoring, intensifying or imparting colour. Although food colours exposure estimates are available in Brazil, no comprehensive assessments were found covering all food colours allowed in the country and no study considered consumption data from ERICA (Study of Cardiovascular Risks in Adolescents), which covers data from more than 70,000 Brazilian students from 12 to 17 years old. This study estimated dietary exposure to 33 food colours authorized in Brazil and for which numerical safety values have been established, followed by risk characterization. Consumption data were obtained from two days dietary recalls applied to students in public and private schools from Brazilian cities with more than 100,000 residents. Exposure estimates were performed in two scenarios: mean and high exposures levels, undertaking conservative assumptions. Estimates were compared with the Acceptable Daily Intake (ADI) values established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Prioritization for future risk assessment was made based on ADI exceedance, with 14 colours as a low priority, 10 as a medium and 9 as a high priority. For high priority food colours, refined estimates are encouraged to evaluate more precisely real exposures and the need of implementation of management actions to reduce exposure.

An Environmental Scan of Tools That Help Individuals Living With Mild Cognitive Impairment or Neurocognitive Disorders Achieve Their Preferred Health or Well-Being.

Older adults experiencing neurocognitive disease (NCD) contend with complex care often characterized by high emotional strain. Mitigating complex care with decision support tools can clarify options. When used in conjunction with the practice of shared decision making (SDM), these tools can improve satisfaction and confidence in treatment. The use of these tools for cognitive health has increased, but more is needed to understand how these tools incorporate social needs into treatment plans. We conducted an environmental scan using a MEDLINE-informed search strategy and feedback from an expert steering committee to characterize current tools and approaches for engaging older adults experiencing NCD. We assessed their application and development, incorporation of social determinants, goals or preferences, and inclusion of caregivers in their design. We identified 11 articles, 7 of which show that SDM helps guide tool development and that mostcenter on clinical decision making. Types of tools varied by clinical site and those differences reflected patient need. A collective value across tools was their use to forge meaningful conversations. Most tools appeared designed without the explicit goal to elicit patient social needs or incorporate nonclinical strategies into treatment plans. Several challenges and opportunities exist thatcenter on strategies to engage patients in the design and testing of tools that support conversations with clinicians about cognitive health. Future work should focus on building and testing adaptable tools that support patient and family social care needs beyond clinical care settings.

Assessment and validation of the pet-owner relationship scale for Brazil.

This study aimed to perform a cross-cultural adaptation of the cat-owner/dog-owner relationship scales. The method involved several stages: conceptual, item, semantic, operational, measurement, and functional equivalence. Procedures included translation, synthesis of translations, back-translation, consensus on the English versions, external evaluation by the original authors, expert committee evaluation, and pre-tests. The study surveyed 234 pet owners across Brazil using a 20-item questionnaire. Data analysis utilized confirmatory factor analysis, covariance-based modeling, and multigroup analysis. The study confirmed the content and construct validity of the model, demonstrating good convergent validity. Hypotheses testing revealed significant inverse relationships between Perceived Cost and Perceived Emotional Closeness, and between Perceived Cost and Pet-Owner Interactions. A positive correlation was found between Perceived Emotional Closeness and Pet-Owner Interactions, with Perceived Emotional Closeness also mediating the relationship between Perceived Cost and Pet-Owner Interactions. No significant differences were found across different pet owner groups, indicating the scale's invariance and reliability across various demographics. The study significantly expands understanding of the complex dynamics in pet-owner relationships and emphasizes the interplay between emotional and practical factors. It offers valuable insights for future research and practices in animal and human welfare.

Evaluating the Malay version of NIOSH WellBQ: A study on reliability and construct validity for enhanced workplace well-being assessment

This study aimed to validate the Worker Well-Being Questionnaire, originally developed by the US National Institute for Occupational Safety and Health, in the Malay language. The translation process involved an initial independent translation by a professional translator, followed by a comparison of translations to synthesize a unified version, which was subsequently back-translated. The back-translations were then reviewed by an expert committee to create a finalized questionnaire version. The results of this validation study indicate a high level of satisfaction, demonstrating an excellent fit with confirmatory factor analysis (CFI and TLI values ranging from 0.96 to 0.99) and a low root mean square error of approximation (RMSEA values ranging from 0.03 to 0.07). Moreover, the questionnaire exhibits sound internal consistency, with Cronbach’s alpha values exceeding 0.7, and the factor structures align with theoretical expectations. In conclusion, the Malay version of the questionnaire faithfully reproduces the original instrument, enabling a robust and efficient assessment of workers’ well.

EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results

BackgroundThe new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established process of Notified Body reviews. These experts provide a review and opinion that ultimately is taken into consideration alongside the information reviewed by the Notified Body during the review process. Four expert committees (General and Plastic Surgery and Dentistry; Orthopaedics, Traumatology, Rehabilitation, Rheumatology; Circulatory System; and Neurology) have published at least one Scientific Opinion (SO) under the Clinical Evaluation Consultation Procedure (CECP) in 2021–2022.MethodsThe four expert committees with published CECP opinions were reviewed to assess the academic backgrounds and professional expertise of each member with respect to clinical, technical, and biological domains on a 0–2 scale for each domain. A content review was conducted on the 10 CECP opinions published by these committees to assess their consistency with the goals and outcome expectations set by the MDR. The extent of content related to each of the clinical, technical, and biological domains was also assessed on a 0–2 scale.ResultsAll committees were composed primarily by members with strong clinical expertise, but only a few had strong technical and biological expertise. Across committees, the average scores of members related to academic background and professional expertise both ranged from 1.64 to 2.00 in the clinical domain, but only 0–0.15 and 0.15–0.69, respectively, in the biological domain, and 0.12–0.55 and 0.23–0.73, respectively, in the technical domain. A content review for the 10 SOs showed that all opinions focused exclusively or primarily on the clinical evidence. Three contained a modest amount of additional text directed at technical/engineering issues and five at biological issues.ConclusionExpert committees are composed predominantly of expert clinical reviewers but have many fewer members with significant technical or biological expertise. This may limit the ability of the committees to evaluate the significant technical and biological risks that are often best understood by preclinical testing. Broadening the expertise across the committees may improve the depth of their benefit/risk critiques.

The Swedish Stroke Self-Efficacy Questionnaire: translation and cross-cultural adaptation

ObjectiveTo translate and cross-culturally adapt the Stroke Self-Efficacy Questionnaire (SSEQ) from English to Swedish and to evaluate psychometric properties of the questionnaire.MethodsA cross-sectional study design, where the translation followed a process including initial translation, synthesis, backward translation, expert committee, and pretest. Content validity was assessed using Content validity index (CVI). Psychometric assessments included floor-ceiling effects and internal consistency.ResultsLanguage and cultural congruence were achieved, and content validity index scores were high (0.923-1). The psychometric evaluations provided acceptable outcomes concerning internal consistency, with Cronbach’s alpha scores for the total scale (0.902), the activities subscale (0.861) and the self-management subscale (0.818) respectively. Ceiling effects were evident, but no floor effects.ConclusionThis study found the Swedish version of the SSEQ promising as a tool for assessment of self-efficacy in a Swedish stroke care setting, although further psychometric assessments are recommended in future studies.

Influence of 21-day antiortostatic hypokinesia on the functional state of the musculoskeletal system of human

The influence of antiorthostatic hypokinesia with an inclination angle relative to the horizon of -6 degrees for 21 days was used as a ground model of the physiological effects of weightlessness. 10 practically healthy male volunteers (30.7 ± 5.4 years, 78.0 ± 8.5 kg, 179.7 ± 5.3 cm) took part in the experimental study, who successfully passed the medical expert commission of the SSC RF-IMBP RAS, familiarized with the study program and signed a voluntary informed consent to participate in the study. The state of the musculoskeletal system was assessed according to the results of speed-strength testing on an isokinetic dynamometer before hypokinesia and on the 3rd day after its completion. Staying in conditions of 21-day anti-orthostatic hypokinesia with a body inclination angle of –6° relative to the horizon, as a model of the physiological effects of weightlessness, leads to changes in the functional state of the musculoskeletal lower limbs which manifests itself during speed-strength testing after hypokinesia by a decrease in maximum voluntary force (MPF) of the knee joint extensor muscles from 9 to 15% compared with the base level. The decrease in MPF did not depend on a change in the force gradient, which reflects the ability to exert greater force in the shortest possible time. This indicated that the decrease in the MPF level after hypokinesia was mainly due to a change in the activity of slow motor units. At the same time, we assume that exposure to hypokinesia did not cause a significant change in the activity of fast motor units. This is confirmed by the results of the analysis of the electromyographic activity of the extensor muscles of the knee joint during testing on an isokinetic dynamometer. Also, after hypokinesia, the possibility of using muscle potential significantly decreased - the physiological cost of work increased with a decrease in strength indicators.

Comparative effectiveness of linvoseltamab versus standard-of-care (SOC) treatment (tx) in real-world patients (pts) in the United States (US) with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM).

7561 Background: Pts with TCE RRMM have poor outcomes and a high unmet need, with no established SOC tx. LINKER-MM1 (NCT03761108) is a single-arm, Phase 1/2 study investigating linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody, in pts with RRMM who were previously treated with a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody, or were triple-class refractory (TCR) to these tx. The aim of this study was to contextualize LINKER-MM1 by comparing outcomes with linvoseltamab vs a real-world (RW) external control arm (ECA). Methods: A RW ECA was derived from 2 US electronic health record databases (COTA, Guardian Research Network) of pts who started a new line of therapy (LOT) after classification as TCE or TCR and met key eligibility criteria for LINKER-MM1. Eligibility was assessed at the initiation of each new LOT, and all eligible LOTs were included in the ECA. Data in Phase 2 pts who received linvoseltamab 200 mg in LINKER-MM1 were included (data cutoff: Sep 8, 2023). Inverse probability of tx weighting (IPTW) was used to reduce imbalances between the RW and LINKER-MM1 cohorts. Key prognostic factors were identified using a systematic review and rank ordered by an international committee of MM experts (Kumar et al., 2023). Outcomes included overall response rate (ORR), progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS). An independent committee of epidemiology and oncology experts reviewed the comparability of the cohorts and endpoint assessments prior to conducting comparative analyses. Results: Comparative analyses were performed in 105 pts in the linvoseltamab cohort and 101 RW pts (137 LOTs). Following IPTW, the distribution of cytogenetic risk, age, TCR status, Eastern Cooperative Oncology Group Performance Status, and platelet count were balanced between the 2 cohorts (absolute standardized mean difference <0.10). After adjustment, pts receiving linvoseltamab had significantly improved ORR, PFS, TTNT, and OS vs the RW ECA (see table). Conclusions: Linvoseltamab significantly improved outcomes vs RW SOC in the US, highlighting its potential as a highly effective tx in pts with TCE RRMM. [Table: see text]

Pediatric Asthma Therapy Assessment Questionnaire for the Brazilian population: Cross-cultural adaptation and measurement properties.

To cross-culturally adapt the Pediatric Asthma Therapy Assessment Questionnaire (ATAQ) into Brazilian Portuguese and analyze its measurement properties. This exploratory methodological study included eight experts and 30 caregivers in the translation and cross-cultural adaptation steps. Thereafter, 118 caregivers of pediatric patients with asthma aged between 5 and 17 years were involved in the analysis of measurement properties. We analyzed the content, structural (exploratory and confirmatory factorial), construct (convergent and discriminant), and known-groups validities; floor and ceiling effects; and determined the cut-off point (receiver operator characteristic curve) to identify pediatric patients with uncontrolled asthma. Intraclass correlation coefficient (ICC) analyzed test-retest reliability with 54 caregivers, whereas Cronbach's α and composite reliability verified the internal consistency of the items. The committee of experts and caregivers found the instructions and response options relevant, understandable, and clear (K > 0.75). During the cross-cultural adaptation, three items (2, 4, and 12) were slightly modified by including terms to facilitate understanding. A two-factor structure (asthma control and patient-provider communication) was identified. Internal consistency (α > .67; composite reliability > 0.73) and test-retest reliability (ICC > 0.80) were acceptable. For construct and know-groups validities, 85.71% of the hypothesis were confirmed. A cut-off point of >3 for the control domain was considered adequate to identify pediatric patients with uncontrolled asthma (sensitivity: 86.21%; specificity: 80.90%). The Pediatric ATAQ was adequately adapted for Brazilian pediatric patients with asthma and produced valid and reliable measures for assessing asthma control. Therefore, it may be considered an adequate instrument for monitoring asthma control in the Brazilian pediatric population.

Evaluating perceived barriers to optimal care in head and neck cancer: A mixed-methods study.

6079 Background: Head and neck cancer (HNC) is a complex disease that requires multidisciplinary care and poses significant challenges for patients and healthcare providers. Despite the availability of evidence-based guidelines, achieving optimal HNC care faces many barriers. This mixed-methods study explores the perceived barriers by patients and clinicians to optimal HNC care. Methods: The Association of Cancer Care Centers (ACCC) collaborated with the Head and Neck Cancer Alliance and the American Society for Radiation Oncology (ASTRO), along with an expert steering committee of multidisciplinary roles representing diverse cancer care centers, to evaluate the current landscape of HNC care delivery. Using an explanatory sequential design, ACCC conducted patient (n= 247) and provider (n=206) surveys and four focus groups which included patients with HNC and clinicians to capture barriers to optimal HNC care. Results: Barriers were classified as patient-related, provider-related, and system-related factors. Survey highlights include: 32% of patients received multimodal treatment including surgery, radiation, and medications; 50% of clinicians were at centers that utilized multidisciplinary clinics for HNC; 60% of patients “strongly agreed” they were satisfied with their care; 48% of patients felt members of their treatment team communicated and coordinated care “very well”; and 56% of patients “strongly agreed” clinicians explained their diagnosis comprehensibly. Clinicians and patients differed in their perspectives on how care was delivered in a few areas: 52% of clinicians vs. 40% of patients agreed that side effects of treatment were explained in ways that patients could understand; 29% of clinicians vs. 21% of patients felt that emotional concerns and mental health needs were addressed. Clinicians identified key areas that needed improvement to provide more effective care: financial resources (62%), dedicated navigation (45%), and coordination across members of the care team (45%). Qualitative analysis of focus group responses identified travel logistics to care centers, inadequate health insurance coverage, and lack of dental insurance delaying care as major systems-related barriers to optimal HNC care. Conclusions: This study revealed insights into the delivery of optimal care in HNC in the US, including being a high-volume center, having dedicated HNC nurse navigators, and multidisciplinary meetings for care coordination. Multifactorial barriers to optimal HNC care were also identified and will be used to inform future educational programming and the development of interventions to improve care.

Questionnaire survey and analysis of drug clinical research implementation capabilities of breast cancer treatment departments in Chinese hospitals.

e23257 Background: Clinical research competence determines the quality of clinical research and the reliability of research findings and is vital in the development of new antitumor drugs and the diagnosis and treatment of breast cancer. Our study aimed to explore the clinical research implementation capabilities of breast cancer treatment departments in China and to analyze the differences among regions, departments and different hospital classifications. Methods: This was a department-based cross-sectional study conducted in the form of electronic questionnaires in China from 7th August to 31st August 2023; this study was initiated by the breast cancer expert committee of the National Cancer Center (NCC). The questionnaire was designed on the Wenjuanxing platform. Our study was conducted among the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers, which includes 200 hospitals selected by the NCC on the basis of the level of breast cancer diagnosis and treatment, surgery volume and other factors. The centers cover 30 provinces, and all of them are tertiary-level general hospitals or cancer hospitals. Results: A total of 127 questionnaires from 122 hospitals were ultimately included in the analysis. Medical personnel involved in the clinical research of 118 (92.9%) departments received good clinical practice (GCP) training. A total of 89.3% (109/122) underwent centralized institutional review board (IRB) review. The steps of the approval process from research initiation to completion lasted 2-4 weeks or longer. The majority of departments initiated or participated in 2 or fewer clinical research projects over the past year. Among the differences between different departments, the Department of Medical Oncology had a better qualification profile and process and greater number of initiated and participated clinical studies than did the Department of Surgical Oncology. There were more patients enrolled in registered clinical trials in specialized cancer hospitals than in general hospitals (50 and below, 50-200, and more than 200 patients from specialized cancer hospitals vs. general hospitals: 39.1%, 52.2%, and 8.7% vs. 76.9%, 16.4%, and 6.7%, respectively; p = 0.001). For needs and problems, most of the departments were strongly willing to undertake clinical research and receive professional training; the most common problem in the process of conducting studies was patient recruitment. Conclusions: Most departments generally exhibited complete capabilities for implementing clinical research. Improvements in implementation efficiency, quality and quantity of research and patient recruitment are still needed. Professional training and communication, as well as the recommendation and implementation of clinical research, are required in future development.

Current status of PD-(L)1 inhibitor usage in advanced or metastatic non-small cell lung cancer: A national survey of oncologists in China.

e20559 Background: The aim of the present study conducted by Chinese Society of Clinical Oncology Expert Committee on Immunotherapy was to obtain real-world information on the use of PD-(L)1 inhibitors for non-small cell lung cancer (NSCLC) in different regions of China via a national questionnaire survey for oncologists. Methods: This survey was distributed online to cancer-related medical departments in 202 first-tier to fourth-tier cities of China between March to April 2023. The national survey consisted of four sections regarding oncologists’ concerns about immunotherapy as follows: treatment choice, response assessment, treatment duration, and management of immune-related adverse events (irAEs). Results: A total of 2,018 oncologists completed this survey. For advanced squamous (SQ) and non-squamous (NSQ) NSCLC without targetable genetic alterations, PD-(L)1 inhibitor-based regimens were the most widely used first-line treatment regimen (SQ: 52%, NSQ: 46%), followed by chemotherapy alone (SQ: 37%, NSQ: 37%) and other regimens (SQ: 11%, NSQ: 17%). The average treatment duration of 1L PD-(L)1 inhibitor-based regimens in SQ NSCLC and NSQ NSCLC were 6.4 and 6.2 cycles, respectively. 67% of oncologists may discontinue immunotherapy or change regimens when the first radiographic tumor assessment was SD per RECIST 1.1. Other reasons for early discontinuation of PD-(L)1 inhibitors before PD or unacceptable toxicity included economic reasons (78%) and patients’ low willingness to continue immunotherapy even they reached CR/PR (62%). Oncologists in the second-tier cities and below were more likely to discontinue immunotherapy when the tumors were stable, with shorter treatment duration of 5.7 cycles versus 7.1 cycles in the first-tier cities. The most common irAEs included dermatologic, endocrine, pulmonary, gastrointestinal, and hepatic toxicities. Conclusions: PD-(L)1 inhibitor-based regimens have become the priority choice for advanced NSCLC in China, however, the status of standardized continuous use of immunotherapy is obviously insufficient. There is a gap between clinical practice and clinical trials regarding PD-(L)1 inhibitor usage, which need more attention. [Table: see text]

PECULIARITIES OF THE ACTIVITIES OF THE UNITED NATIONS COMMITTEE OF EXPERTS ON GLOBAL GEOSPATIAL INFORMATION MANAGEMENT (UN-GGIM): UKRAINE'S EXPERIENCE

This article examines the activities of the United Nations Committee of Experts on Global Geospatial Information Management (UN-GGIM), namely: the structure of the organisation, programmes and areas of work; resolutions adopted by the Committee and strategies for the development of geospatial information. The aim of this paper is to research the peculiarities of the UN Committee of Experts on Global Geospatial Information Management (UN-GGIM) and analyse the results of the active participation of Ukrainian scientists and civil servants in this organisation. It analysed what role Ukraine plays by actively participating in the projects of the UN-GGIM Committee, and how the results obtained affect the topographic, geodetic and mapping activities and the sphere of the National Geospatial Data Infrastructure of Ukraine (hereinafter referred to as NGDI). 11 programmes of the UN-GGIM Committee were separately analysed for the participation of the Ukrainian side in the working groups. The results obtained allowed us to conclude that Ukraine, represented by the State Service of Ukraine for Geodesy, Cartography and Cadastre, continues to overcome the path of NSDI development and creation of high-quality, reliable, up-to-date, interoperable geospatial data that will meet the current level of development of geographic information systems and global trends of the Fourth Industrial Revolution. It should be noted that in most programmes of the UN-GGIM Committee, the Ukrainian side is not represented as a team member, although it implements these topics at the national level in terms of research and development.

Korean Translation and Cross-Cultural Adaptation of the Sport Concussion Assessment Tool 6th Edition (SCAT6): Reliability and Validity

PURPOSE: This study aimed to establish a contemporary, standardized Korean version of the Sports Concussion Assessment Tool 6th edition, characterized by superior face validity and reliability.METHODS: Translation and cultural adaptation involved seven stages, namely initial translation, integration of translation, back translation, validation with five expert committees, pre-testing with 12 rugby athletes, finalization, and a test-retest with 30 rugby and American-football athletes. Alternative tests were conducted for the Months In Reverse Order Test due to the naming differences between English and Korean.RESULTS: The English Months In Reverse Order Test took 11.00 ± 2.69 seconds with a difficulty of 2.27 ± 0.98 points, while the Korean Months In Reverse Order Test took 5.69 ± 1.35 seconds with a difficulty of 1.50 ± 0.73 points (p < .001). The Adding Serial 3s Test and Days of the Week Backward Test were evaluated for completion time, difficulty, and accuracy in 30 English and 30 Korean participants. The results of the Korean Adding Serial 3s Test were poor (time 10.50 ± 3.55 seconds; difficulty 2.97 ± 1.25 points), while The Korean Days of the Week Backward Test was fast and easily replaced Months In Reverse Order Test (time 3.46 ± 0.72 seconds; difficulty 1.5 ± 0.82 points). An attempt with Korean Months In Reverse Order Test and Days of the Week Backward Test, where participants were asked to recite all at once, yielded acceptable results (time 10.62 ± 2.04 seconds; difficulty 1.90 ± 0.99 points) compared to English Months In Reverse Order Test (p > .05). The face validity was adequate and reliability was mostly high (Cronbach alpha = 0.79).CONCLUSIONS: The results indicate that The Korean Sports Concussion Assessment Tool 6th edition was well translated and exhibited adequate face validity and reliability.

Alemtuzumab, Cladribine, Fingolimod, Natalizumab, and Rituximab as First-Line Treatments in Adults With Highly Active Relapsing-Remitting Multiple Sclerosis

What Is the Problem? Relapsing-remitting multiple sclerosis (RRMS), the most common disease course of multiple sclerosis (MS), is a chronic immune-mediated disease with clearly defined episodes of new or increasing neurologic symptoms followed by periods of relative stability. In contrast, the highly active, aggressive disease course leads to rapid disability, and these patients face an unmet need. The principal goal of MS treatment is to delay and prevent the accumulation of disability by reducing the frequency of relapses. Currently reimbursed first-line drugs fail to prevent the consequences of irreversible damage to the nervous system. There has been a paradigm shift in clinical practice toward the use of a high-efficacy treatment strategy as early as possible during the inflammatory process to provide optimal clinical benefits in preserving neurologic function in patients with highly active RRMS. What Did We Do? A systematic review of the clinical effectiveness and safety of alemtuzumab, natalizumab, cladribine, fingolimod, and rituximab relative to current first-line drugs in adults with highly active RRMS was conducted; it identified post hoc subgroup analyses from 5 randomized controlled trials (RCTs) and 1 prospective comparative cohort study. What Did We Find? Evidence was uncertain and conclusions were limited by risk of bias and small sample sizes; conclusions for some outcome comparisons were also limited by imprecision and incomplete reporting. Compared to placebo, cladribine and natalizumab may result in a clinically important reduction in relapses, disability, and key MRI lesions. Alemtuzumab may result in a clinically important reduction in relapses compared to interferon, while fingolimod may result in a clinically important reduction in relapses compared to placebo. The clinical evidence was insufficient to determine the effect of fingolimod on relapses when compared with interferon. Harms outcomes, when reported, appeared consistent with the known harms profile of the drugs. Assessment of the effectiveness and safety of rituximab could not be performed due to the lack of evidence. Evidence was also lacking for many important outcomes such as health-related quality of life (HRQoL), instrumental activities of daily living, symptoms, and cognitive outcomes. No evidence could be identified to inform on treatment sequencing. Two pragmatic RCTs (the TREAT-MS and DELIVER-MS trials) are currently ongoing, aiming to compare an early, high-efficacy treatment strategy versus a traditional escalation treatment strategy, which may inform treatment sequencing. Further research is needed to compensate for clinical data gaps to inform an appropriate and relevant economic evaluation. What Does This Mean? Jurisdictions may reconsider the current reimbursement criteria for drugs used in the first-line setting specifically for adults demonstrating highly active RRMS; however, caution should be taken given the gaps and uncertainty in evidence. Upon request from public drug plans, this review may inform a future implementation advice panel or expert committee recommendation.

Posner-Schlossman Syndrome European Study Group: study protocol and baseline patients characteristics of a multicentre study

BackgroundThe aim of the Posner-Schlossman Syndrome European Study Group (PSS-ESG) is to acquire a comprehensive dataset of European patients with PSS. Here, we present the first report on the study...

Chinese expert consensus on surgical continuous quality improvement goals in esophageal cancer and esophagogastric junction cancer (2024 edition)

Improving the quality and efficiency of surgical diagnosis and treatment guarantees the outcome for most patients with esophageal cancer and esophagogastric junction cancer, and the continuous quality improvement mechanism oriented to the "textbook outcome" is the best choice. To ensure the successful implementation of the "Quality Control Indicators for Standardized Diagnosis and Treatment of Esophageal Cancer in China (2022 Version)" aligning with it more effectively is crucial. The Expert Committee on Quality Control of Esophageal Cancer at the National Cancer Center leads work teams comprised of multidisciplinary experts, particularly those in thoracic surgery, to establish a consensus. The current consensus comprises eight "textbook outcomes" to standardize, promote, and consolidate surgical quality management and continuously improve the surgical quality of esophageal cancer and esophagogastric junction cancer.

P.058 Neuromuscular neurologists’ experience in recognizing, diagnosing, and treating Long-chain fatty acid disorders (LC-FAOD): a national survey

Background: LC-FAOD may be missed in neuromuscular (NM) clinics due to its rarity and absence from common NM genetic panels. The Canadian Neuromuscular Disease Registry (CNDR) collects real-world patient data and includes a network of clinician-investigators. Our objective was to inform future registry work by evaluating diagnosis pathways for LC-FAOD patients and estimating the number followed at Canadian NM clinics. Methods: A questionnaire was developed with an expert committee and circulated to 111 CNDR-affiliated NM neurologists. Results: 12 neurologists in 5 provinces, primarily adult-treating (n=8) completed the survey (10.8% response rate). Eleven (91.7%) practiced for >10 years. Agreement trends existed between definition of, and tests to evaluate, rhabdomyolysis. Four clinics routinely follow LC-FAOD patients. In the last 1-2 years, respondents diagnosed approximately 91 patients with LC-FAOD (mean=7.5 per clinic). 83.3% never received continuing education on LC-FAOD, though 75% indicated interest in expert-led webinars. Further data will be presented. Conclusions: Low sample size limits conclusions about LC-FAOD clinical trends. Results suggest LC-FAOD may be under-diagnosed or not routinely followed by NM specialists, limiting viability of an LC-FAOD registry. Practitioners may be interested in LC-FAOD-specific education. Future work could include collaboration with metabolic geneticists on education initiatives to raise awareness and improve care for these patients.

Embodiment of Pharmacist Intervention in Palliative Care and Augmentation of a Curriculum for its Assessment

Background Palliative care is the care of patients who have progressive, life-threatening illnesses and who are facing death in the foreseeable future. Since there is a growing need for pharmacist’s intervention in palliative care and there is a gap in the education of palliative care for pharmacy students, this study aims to identify roles and services that have to be performed by palliative care pharmacists in medication-related areas and also to formulate an add-on course to train pharmacy graduates. Materials and Methods A prospective interventional study was done in the palliative care centre in Perinthalmanna, Kerala, India. Relevant data were pooled and analysed for drug-related problems. Necessary interventions were made. Results were interpreted and an add-on course for the training of pharmacy graduates was formulated. Results A total of 88 patients were included in the study. The most prevalent conditions in our palliative setting were kidney disease, liver disease, cancer and stroke. Notably, 38 and 10 cases were found to have drug interactions and drug duplications, respectively. Four patients required dosage adjustments. Fifty cases involved pharmacist intervention which improved the outcome by 80%. At the end of the study, a curriculum was formulated to implement a 3-month add-on course entitled ‘PALLIATIVE PHARMACY’ under the guidance of an Expert committee for training pharmacists and pharmacy students. Conclusion The study identified that there are various roles a pharmacist must undertake in a palliative setup. The involvement of pharmacists in patients’ treatment helps to prevent drug-related problems to a greater extent. The addition of an integrated course for the management of palliative care patients will help to improve the learning as well as practical skills of pharmacists. Incorporating basic and clinical sciences in the therapeutic course is an effective learning plan.

#2389 Enhancing immunoglobulin A nephropathy management: insights from the IGAN-MIC project

Abstract Background and Aims Immunoglobulin A nephropathy (IgAN) comprises a substantial proportion of primary glomerulonephritis cases in China, yet comprehensive nationwide data regarding its diagnosis and treatment are lacking. The Immunoglobulin A Nephropathy Management Quality Improvement Initiative Project in China (IGAN-MIC) seeks to establish an IgAN cohort collaboration network to comprehend real-world IgAN management practices in China. Method The IGAN-MIC project convened 15 Chinese experts from 14 regions to form an expert committee to develop a registry of IgAN patients to evaluate regional differences in IgAN management from 2015 to 2024. The registry will involve comprehensive data collection from electronic medical records, encompassing key aspects including demographic and clinical characteristics, renal biopsies, diagnoses, comorbidities, laboratory findings, and treatment modalities, facilitating a detailed analysis of disease progression and changes in treatment strategies from initial diagnosis through subsequent follow-up periods. Results The IGAN-MIC project has garnered applications from 78 healthcare institutions, with 7 of them already incorporated into the initiative and initiated data collection. As of January 1, 2024, the project has enrolled 543 pathologically confirmed IgAN patients diagnosed between 2015 and 2023 from these 7 centers. At the time of diagnosis, the median (IQR) of age was 38.00 (30.00, 48.00) years; 54.51% were females; the median (IQR) of eGFR was 75.41 (51.93, 104.09) mL/min/1.73 m2 and the median (IQR) 24-hour urinary protein was 1263.50 (645.30, 2362.64) mg/day. For these patients, the utilization rates of RAS inhibitors (RASi), SGLT2 inhibitors (SGLT2i) and glucocorticoids at initial treatment were 53.41%, 3.51%, and 42.73% respectively. The utilization rate of SGLT2i from 2022 to 2023 was 9.90%, as the first indication for SGLT2i in CKD was approved in China in September 2022. A detailed outline of patient baseline characteristics is presented in Table 1 below. Conclusion These initial findings in the registry showed that the Chinese IgAN patients were young, had mildly reduced renal function, and with massive proteinuria at the time of initial diagnosis. For initial treatment, only half of the patients received RASi, and only one tenth received SGLT2i. More education needs to be focused on promoting guideline-directed medical therapies in the future. Given that nationwide data on Chinese IgAN patients are limited, the IGAN-MIC project is anticipated to broaden its registry to include more healthcare institutions and Chinese IgAN patients in the future, with the aim of providing a more in-depth understanding of the changing clinical presentations and ongoing follow-up scenarios among IgAN patients, contributing crucial insights to the clinical management of IgAN.