Vascular Complications in Children and Young People with Type 1 Diabetes: A Worldwide Assessment of Diabetologists' Adherence to International Recommendations.

INTRODUCTION: This global survey evaluated the practices and adherence to international Clinical Practice Consensus Guidelines (CPCG) of physicians involved in pediatric diabetes care regarding screening, prevention and treatment of vascular complications of type 1 diabetes (T1D). METHOD: A web-based survey gathering data about respondents' background, practices related to screening, prevention, and treatment of diabetic nephropathy, retinopathy, neuropathy, and macrovascular diseases and a self-assessment of physicians' knowledge based on the ISPAD CPCG 2018 were shared by ISPAD. RESULTS: We received 175 responses from 62 countries (60% female, median age 42.3 years, 72.0% ISPAD members). Two-thirds of respondents initiated nephropathy and retinopathy screening per CPCG recommendations. Only half of them adhered to recommendations for neuropathy and macrovascular disease risk factors (RFs). Over 85% of respondents used the recommended screening method for nephropathy, retinopathy and macrovascular disease RFs, and only 59% for neuropathy. Lack of access to neuropathy and macrovascular diseases RF screening methods was reported by 22.2% and 11.8% of respondents, respectively. Adherence to recommended screening frequency varied: 92% for nephropathy, around two-thirds for neuropathy and macrovascular disease RFs, and only 17.7% for retinopathy. Most participants aligned their practices for treating T1D complications with CPCG recommendations, except for nephropathy. Significant differences in adherence to CPCG and individuals' financial contributions reflected countries' income levels. Around 50% of the respondents were very familiar with the ISPAD CPCG content. CONCLUSION: Our study highlights global variation in adherence to CPCG for T1D vascular complications, which is influenced by country income and healthcare disparities. It also revealed knowledge gaps among physicians on this critical topic.

The Impact of Prior Authorization on Clinical Practice and Patient Care Outcomes: A Work Group Report of the AAAAI Prior Authorization Task Force.

The Prior Authorization Task Force of the American Academy of Allergy, Asthma & Immunology (AAAAI), a presidential initiative of David Khan, MD, FAAAI, was established to develop an AAAAI position statement outlining ways to improve health care for our patients, to support legislation that advocates for prior authorization (PA) reform and identify the impact PA has on its membership using a questionnaire survey. This article describes the results of this survey. An electronic anonymous survey questionnaire was developed to assess the impact and burden of PA on AAAAI members and their staff and patients. Surveys were sent to randomly selected members and fellows of the AAAAI in the United States. Descriptive statistics were used to analyze the results by the Information Services team of the AAAAI and the authors of this work group report. The questionnaire responses from allergy immunology specialists demographically reflected the AAAAI membership and indicate that PAs can significantly affect patient care delivery and increase administrative burden to clinical practices, leading to serious adverse events in some circumstances. Differential responses regarding PAs for various medication classes likely reflect the physician's patient population, which can shift prescribing patterns. Prior authorization is a serious health care problem that is wasting financial resources and needlessly placing patients in danger when they are unable to access medications or medical services required for clinical management. The results of this questionnaire study support the recommendations made in the recent AAAAI position statement on PA.

Assessment of the knowledge, attitude and practices of the informed consent process in oral healthcare among dental students in Makerere University Dental Hospital, Uganda.

INTRODUCTION: Informed consent is an ethical and legal component of healthcare. It ensures patient autonomy and allows patients to make decisions regarding their treatment. In dental care, informed consent is particularly important because most dental procedures are invasive. Since dental students are future dentists, they need to learn about their ethical obligations and accountability through the informed consent process as this is critical to patients' well-being. This study aimed to determine dental students' knowledge, attitudes, and practices of the informed consent process for oral health care in Makerere University Dental Hospital, Uganda. STUDY METHODOLOGY: This was a descriptive cross-sectional study using quantitative methods. It was carried out at Makerere University Dental Hospital and third, fourth, and fifth-year students (n = 102) pursuing a Bachelor of Dental Surgery program took part in the survey. A self-administered structured questionnaire was used to assess their knowledge, attitudes, and practices of informed consent for oral health care. Collected data were entered into Epi-data version 3.1, where it was cleaned, coded, and imported to STATA version 14 software for statistical analysis. RESULTS: About two-thirds 67 (65.7%) of the participants were males. The mean age was 25 (SD = 3.21) years. The majority (90%) of the students had a high level of knowledge of the informed consent process. About (80%) had a positive attitude towards informed consent and (85%) most often practiced the informed consent process. Based on bi-variate analysis, training on informed consent, year of study, age, and sex were significantly associated with the informed consent process. However, there was no significant risk factor associated with informed consent in multiple logistic regression analysis. CONCLUSION: The study findings highlighted high levels of knowledge, positive attitude, and practice of the informed consent process among the clinical dental students. Continuous training is necessary to remind dental students about the importance of informed consent in healthcare, not only for complex procedures.

French national survey on breast cancer care: caregiver and patient views.

PURPOSE: To improve the quality of care for patients with breast cancer, an analysis of the health-care pathway, considering feedback from both health-care practitioners (HCPs) and patients, is needed. METHODS: Between 2020 and 2022, we conducted a survey at French breast cancer centers and analyzed information from questionnaires completed by HCPs and patients. We collected information on center organization, diagnostic processes, treatment decisions and modalities, supportive care, patient advocacy groups, and work issues. RESULTS: Twenty-three breast cancer centers were included and questionnaires completed by 247 HCPs and 249 patients were analyzed. The centers closely followed the legal French framework for cancer treatments, which includes formal diagnostic announcements, multidisciplinary tumor boards, personalized treatment summaries, and supportive care access. HCPs and patients were satisfied with the time to diagnosis (≤ 2 weeks as evaluated by 75% of patients), time to surgery (mean 61 days), time between surgery and chemotherapy (mean 47 days), and time between surgery and radiotherapy (mean 81 days). Fertility preservation counseling for women under 40 years of age was systematically offered by 67% of the HCPs. The majority (67%) of the patients indicated that they had received a personalized treatment summary; the topics discussed included treatments (92%), tumor characteristics (84%), care pathways (79%), supportive care (52%), and breast reconstruction (33%). Among HCPs, 44% stated that reconstructive surgery was offered to all eligible patients and 57% and 45% indicated coordination between centers and primary care physicians for adverse effects management and access to supportive care should be improved, for chemotherapy and radiotherapy, respectively. Regarding patient advocacy groups, 34% of HCPs did not know whether patients had contact and only 23% of patients declared that they had such contact. For one-third of working patients, work issues were not discussed. Twenty-eight percent of patients claimed that they had faced difficulties for supportive care access. Among HCPs, 13% stated that a formal personalized survivorship treatment program was administered to almost all patients and 37% almost never introduced the program to their patients. Compliance to oral treatments was considered very good for 75-100% of patients by 62% of HCPs. CONCLUSIONS: This study provides an updated analysis of breast cancer care pathways in France. Overall, the initial processes of diagnosis, announcement, and treatment were swift and were in agreement with the best care standards. No barriers to accessing care were identified. Based on the study findings, we proposed several strategies to improve the quality of care for patients in supportive care, coordination with primary care physicians, reconstructive surgery, and fertility preservation access.

Diagnostic Performance of Deep Learning in Video-Based Ultrasonography for Breast Cancer: A Retrospective Multicentre Study.

OBJECTIVE: Although ultrasound is a common tool for breast cancer screening, its accuracy is often operator-dependent. In this study, we proposed a new automated deep-learning framework that extracts video-based ultrasound data for breast cancer screening. METHODS: Our framework incorporates DenseNet121, MobileNet, and Xception as backbones for both video- and image-based models. We used data from 3907 patients to train and evaluate the models, which were tested using video- and image-based methods, as well as reader studies with human experts. RESULTS: This study evaluated 3907 female patients aged 22 to 86 years. The results indicated that the MobileNet video model achieved an AUROC of 0.961 in prospective data testing, surpassing the DenseNet121 video model. In real-world data testing, it demonstrated an accuracy of 92.59%, outperforming both the DenseNet121 and Xception video models, and exceeding the 76.00% to 85.60% accuracy range of human experts. Additionally, the MobileNet video model exceeded the performance of image models and other video models across all evaluation metrics, including accuracy, sensitivity, specificity, F1 score, and AUC. Its exceptional performance, particularly suitable for resource-limited clinical settings, demonstrates its potential for clinical application in breast cancer screening. CONCLUSIONS: The level of expertise reached by the video models was greater than that achieved by image-based models. We have developed an artificial intelligence framework based on videos that may be able to aid breast cancer diagnosis and alleviate the shortage of experienced experts.

eHealth in the Management of Depressive Episodes in Catalonia's Primary Care From 2017 to 2022: Retrospective Observational Study.

BACKGROUND: The reasons for mental health consultations are becoming increasingly relevant in primary care. The Catalan health care system is undergoing a process of digital transformation, where eHealth is becoming increasingly relevant in routine clinical practice. OBJECTIVE: This study aimed to analyze the approach to depressive episodes and the role of eHealth in the Catalan health care system from 2017 to 2022. METHODS: A retrospective observational study was conducted on diagnostic codes related to depressive episodes and mood disorders between 2017 and 2022 using data from the Catalan Institute of Health. The sociodemographic evolution and prevalence of depression and mood disorders in Catalonia were analyzed between 2017 and 2022. Sociodemographic variables were analyzed using absolute frequency and percentage. The prevalence of depressive episodes was calculated, highlighting the year-to-year changes. The use of eHealth for related consultations was assessed by comparing the percentages of eHealth and face-to-face consultations. A comparison of sociodemographic variables based on attendance type was conducted. Additionally, a logistic regression model was used to explore factors influencing face-to-face attendance. The analysis used R software (version 4.2.1), with all differences examined using 95% CIs. RESULTS: From 2017 to 2022, there was an 86.6% increase in the prevalence of depression and mood disorders, with women consistently more affected (20,950/31,197, 67.2% in 2017 and 22,078/33,169, 66.6% in 2022). In 2022, a significant rise in depression diagnoses was observed in rural areas (difference 0.71%, 95% CI 0.04%-1.43%), contrasting with a significant decrease in urban settings (difference -0.7%, 95% CI -1.35% to -0.05%). There was a significant increase in antidepressant use in 2022 compared to 2017 (difference 2.4%, 95% CI 1.87%-3.06%) and the proportion of eHealth visits rose from 4.34% (1240/28,561) in 2017 to 26.3% (8501/32,267) in 2022. Logistic regression analysis indicated that men (odds ratio [OR] 1.06, 95% CI 1.04-1.09) and younger individuals had a higher likelihood of eHealth consultations in 2022. Furthermore, individuals using eHealth consultations were more likely to use antidepressants (OR 1.54, 95% CI 1.50-1.57) and anxiolytics (OR 1.06, 95% CI 1.03-1.09). CONCLUSIONS: The prevalence of depression in Catalonia has significantly increased in the last 6 years, likely influenced by the COVID-19 pandemic. Despite ongoing digital transformation since 2011, eHealth usage remained limited as of 2017. During the lockdown period, eHealth accounted for nearly half of all health care consultations, representing a quarter of consultations by 2022. In the immediate aftermath of the COVID-19 pandemic, emerging evidence suggests a significant role of eHealth in managing depression-related consultations, along with an apparent likelihood of patients being prescribed antidepressants and anxiolytics. Further research is needed to understand the long-term impact of eHealth on diagnostic practices and medication use.

Clinical practices and adherence to guidelines for eosinophilic esophagitis: A European survey.

BACKGROUND: We aimed to assess the clinical practices and adherence to guidelines for adult Eosinophilic Esophagitis (EoE) patients in Europe. METHODS: A cross-sectional web survey containing 23 questions was distributed to members of the European Consortium for Eosinophilic Diseases of the Gastrointestinal Tract (EUREOS) and the Italian Association of Hospital Gastroenterologists and digestive endoscopists (AIGO). We conducted a subgroup analysis to assess the impact of EoE expertise and practice setting on clinical practices. RESULTS: 228 physicians from 18 European countries participated. Adherence to guidelines varied from 72% to 98.6%. 83.4% of total respondents obtained ≥ 6 esophageal biopsies in suspected EoE. 42% of total respondents, 82.5% of EoE experts (vs. non-experts 33%; P < 0.0001), and 55% of academics (vs. 29.1 non-academics; P < 0.0001) routinely used the EREFS score. Regarding first-line therapy, 82.9% of total respondents prescribed proton pump inhibitors, 41.6% topical steroids, 20.6% elimination diets, and 9.2% combination therapies. Only 72% of respondents used symptoms and endoscopy with <15 Eosinophils/HPF to define treatment response. 21.5% of all respondents did not prescribe maintenance therapies and 12.7% discontinued therapy before response evaluation endoscopy. CONCLUSION: Our findings revealed significant heterogeneity in practice patterns and suboptimal adherence to EoE guidelines across Europe. Expertise in EoE and working in an academic hospital positively influenced clinical practices and adherence to guidelines.

Controlled human infection trials: Legitimacy and conditions of implementation in France.

This round table is the result of an observation. The observation being that controlled human infection clinical trials (also called "infectious challenge" trials or "Controlled Human Infection Models", "CHIM") recommended or even encouraged in the context of vaccine developments in particular, are not carried out in France. However, there are no formal prohibitions within regulations or ethical principles, which point to the prior assessment of risks and benefits for individuals and for society. The participants in this Round Table thus wished to examine, through the prism of their respective disciplines, the scientific and medical relevance of conducting such trials in France and, if possible, to imagine the conditions under which they would be carried out, thus resulting in recommendations on (1) the advisability of their conduct in France (2), the conditions under which they would be implemented in terms of logistics and regulations, and (3) their social acceptability. The recommendations on which the participants of the Round Table came to an agreement are presented as the analysis progresses.

Shoulder Spasticity Treatment With Botulinum Toxin: A Nationwide Cross-Sectional Survey of Clinical Practices.

INTRODUCTION: Upper limb spasticity can be responsible for several complications (e.g., pain, spasms, contractures, deformity, decreased or lost motor control), which can have a negative impact on functional independence and the quality of life of patients. Chemodenervation with botulinum toxin type A (BoNT-A) is a first-line treatment of focal spasticity in the upper limb (UL). However, shoulder muscles were not included in the classical pivotal BoNT-A studies, leaving a knowledge gap regarding the application of intra-muscular BoNT-A in the spasticity management of this anatomical area compared with the arm and forearm. MATERIALS AND METHODS: We conducted a descriptive cross-sectional nationwide online survey of the current Portuguese clinical practices for BoNT-A injections treating shoulder spasticity. Data were collected regarding the patient's spasticity cause, shoulder muscles treated, BoNT-A doses, guidance methods used, primary goal domains, treatment effectiveness, adverse effects, and recommendation of adjuvant therapy. RESULTS: A total of 33 physical medicine and rehabilitation physicians were surveyed. Most of the surveyed doctors (90.91%; n = 30) identified post-stroke spasticity as the major condition for the use of BoNT-A injections in their clinical practice. The most frequently injected muscles for patterns that included shoulder adduction and internal rotation were the pectoralis major (100%; n = 33), subscapularis (93.94%; n = 31), latissimus dorsi (54.55%; n = 18), and teres major (24.24%; n = 8). In patterns including shoulder extension, the posterior deltoid (75.76%; n = 25), the long head of the triceps brachii (66.67%; n = 22), and the latissimus dorsi (48.48%; n = 16) were the most frequently targeted muscles. The primary goals of treatments were improvements in passive function (96.97%; n = 32), pain (84.85%; n = 28), active function (45.45%; n = 15), and range of motion (39.39%; n = 13). The overall impression of therapeutic efficacy was "good" (60.61%; n = 20), and adverse drug reactions were considered "very rare" (84.85%; n = 28) and "mild" (93.94%; n = 31). Ultrasound was used "always" and "most times" in 66.67% (n = 22) of cases. The maximum BoNT-A doses per muscle were lower than those in previously reported studies. Conventional kinesiotherapy was "always" recommended as adjuvant therapy after BoNT-A by 66.67% (n = 22) of physiatrists. CONCLUSIONS: This study provides the first nationwide Portuguese description of "real-life" clinical practices concerning the use of BoNT-A for shoulder spasticity. The selection of goal domains aligned with international results, and the targeted muscles were relatively similar. The use of ultrasound was high, and the maximum BoNT-A doses per muscle were lower than those in other reported clinical practices. The providers reviewed indicated high safety satisfaction with using BoNT-A for shoulder spasticity. Further development of clinical guidelines to standardize practices may be useful.

Application of Quantitative MRI in Thyroid Eye Disease: Imaging Techniques and Clinical Practices.

Thyroid eye disease (TED) is a complex autoimmune disorder that impairs various orbital structures, leading to cosmetic damage and vision loss. Magnetic resonance imaging (MRI) is a fundamental diagnostic tool utilized in clinical settings of TED, for its accurate demonstration of orbital lesions and indication of disease conditions. The application of quantitative MRI has brought a new prospect to the management and research of TED, offering more detailed information on morphological and functional changes in the orbit. Therefore, many researchers concentrated on the implementation of different quantitative MRI techniques on TED for the exploration of clinical practices. Despite the abundance of studies utilizing quantitative MRI in TED, there remain considerable barriers and disputes on the best exploitation of this tool. This could possibly be attributed to the complexity of TED and the fast development of MRI techniques. It is necessary that clinical and radiological aspects of quantitative MRI in TED be better integrated into comprehensive insights. Hence, this review traces back 30 years of publications regarding quantitative MRI utilized in TED and elucidates this promising application in the facets of imaging techniques and clinical practices. We believe that a deeper understanding of the application of quantitative MRI in TED will enhance the efficacy of the multidisciplinary management of TED. LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY: Stage 3.

Current Practice Trends in Knee Arthroplasty in India Among ISHKS Members: ISHKS Annual Meeting 2019.

Aim: To assess the current practice trends in knee arthroplasty in India among ISHKS members. Methods: Literature review on 12 areas of key interest in total knee arthroplasty was conducted. Twenty-eight questions pertaining to these key areas in total knee arthroplasty surgery were presented to the delegates for a physical voting with audience response system (ARS) at ISHKS meeting, Bangalore, 2019. The members who could not attend the meeting voted by an online monkey survey. All questions were given three responses: a. Agree, b. Disagree, and c. Abstain. Results: 310 delegates participated and 295 voted in the physical meeting and 110 voted online. Consensus was reached for 28 statements representing five domains on the best practices. Overall, 92% of statements reached unanimous or strong consensus. The statements that achieved strong majority (> 90%) were the factors on pre-operative skin preparations, administration of antibiotics 30 min prior skin incision, and current practices of bilateral TKR. Furthermore, there was strong consensus approval on the role of aspirin for prophylaxis of DVT, lack of benefit on use of drain, considerations for pre-emptive analgesia, and neuraxial anesthesia. Finally, there were disparate views and weak consensus on use of laminar airflow theaters and use of surgical space suits, length of antibiotic administration postoperatively, and linking of DVT with PE and death. Conclusion: This study gives the surgeon practice preferences in knee arthroplasty in India and assists in clinical decision-making for all healthcare professionals.

Heterogeneity in Clinical Practices for Post-Cardiotomy Extracorporeal Life Support: a Pilot Survey from the PELS-1 Multicenter Study.

BACKGROUND: High-quality evidence for post-cardiotomy extracorporeal life support (PC-ECLS) management is lacking. This study investigated the real-world PC-ECLS clinical practices. METHODS: This cross-sectional, multi-institutional, international pilot survey explored center organization, anticoagulation management, left ventricular unloading, distal limb perfusion, PC-ECLS monitoring and transfusions practices. Twenty-nine questions were distributed among 34 hospitals participating in the Post-cardiotomy Extra-Corporeal Life Support Study. RESULTS: Of the 32 centers [16 low-volume (50%); 16 high-volume (50%)] that responded, 16 (50%) had dedicated ECLS specialists. Twenty-six centers (81.3%) reported using additional mechanical circulatory supports. Anticoagulation practices were highly heterogeneous: 24 hospitals (75%) reported using patient's bleeding status as a guide, without a specific threshold in 54.2% of cases. Transfusion targets ranged 7-10 g/dL. Most centers used cardiac venting on a case-by-case basis (78.1%) and regular distal limb perfusion (84.4%). Nineteen (54.9%) centers reported dedicated monitoring protocols including daily echocardiography (87.5%), Swan-Ganz catheterization (40.6%), cerebral near-infrared spectroscopy (53.1%) and multimodal assessment of limb ischemia. Inspection of the circuit (71.9%), oxygenator pressure drop (68.8%), plasma free hemoglobin (75%), d-dimer (59.4%), lactate dehydrogenase (56.3%) and fibrinogen (46.9%) are used to diagnose hemolysis and thrombosis. CONCLUSIONS: This study shows remarkable heterogeneity in clinical practices for PC-ECLS management. More standardized protocols and better implementation of available evidence are recommended.

Italian good practice recommendations on management of persons with Long-COVID.

A significant number of people, following acute SARS-CoV-2 infection, report persistent symptoms or new symptoms that are sustained over time, often affecting different body systems. This condition, commonly referred to as Long-COVID, requires a complex clinical management. In Italy new health facilities specifically dedicated to the diagnosis and care of Long-COVID were implemented. However, the activity of these clinical centers is highly heterogeneous, with wide variation in the type of services provided, specialistic expertise and, ultimately, in the clinical care provided. Recommendations for a uniform management of Long-COVID were therefore needed. Professionals from different disciplines (including general practitioners, specialists in respiratory diseases, infectious diseases, internal medicine, geriatrics, cardiology, neurology, pediatrics, and odontostomatology) were invited to participate, together with a patient representative, in a multidisciplinary Panel appointed to draft Good Practices on clinical management of Long-COVID. The Panel, after extensive literature review, issued recommendations on 3 thematic areas: access to Long-COVID services, clinical evaluation, and organization of the services. The Panel highlighted the importance of providing integrated multidisciplinary care in the management of patients after SARS-CoV-2 infection, and agreed that a multidisciplinary service, one-stop clinic approach could avoid multiple referrals and reduce the number of appointments. In areas where multidisciplinary services are not available, services may be provided through integrated and coordinated primary, community, rehabilitation and mental health services. Management should be adapted according to the patient's needs and should promptly address possible life-threatening complications. The present recommendations could provide guidance and support in standardizing the care provided to Long-COVID patients.

Systematic review of clinical practice guidelines for traumatic dental injuries.

BACKGROUND/AIMS: Traumatic dental injuries (TDI) are considered a public health problem due to their high prevalence and associated physical, economic, psychological and social consequences. Hence, good Clinical Practice Guidelines are essential to achieving a favourable prognosis. The aim of this review was to appraise the existing Clinical Practice Guidelines (CPGs) on TDI using AGREE II and AGREE-REX. MATERIALS AND METHODS: A systematic search for existing guidelines on TDI was performed on PubMed, EMBASE, CINAHL, Cochrane Library, ProQuest, National Institute for Health Care Excellence, BMJ Best Practice, Trip database, Guideline International Network, Scottish Intercollegiate Guidelines Network, World Health Organisation, Web of Science and 'Ministry of Health worldwide' databases. Four appraisers independently appraised the included CPGs. The AGREE II tool was applied to assess the methodological quality, while AGREE REX assessed the quality of recommendations of the included guidelines. RESULTS: Of the 7736 titles screened, three guidelines, namely the International Association of Dental Traumatology Guidelines (IADT), and the Italian and Malaysian guidelines, were included for the final analysis. These guidelines were published between 2019 and 2020. The AGREE II analysis demonstrated scores above 80% for the IADT and Italian guidelines for the scope and purpose domain. Overall, the Malaysian guidelines achieved the highest score for all domains. The AGREE REX analysis indicated variability in implementation across the nine items, with five that scored above the midpoint of 4.0 on the response scale. Both the Italian and the IADT guidelines had a similar score for the values and preference domains (36.36%). CONCLUSIONS: Several deficiencies exist in the methodological quality of existing CPGs on TDI. Future guidelines should consider improvements for domains such as 'rigour of development', 'stakeholder involvement' and 'applicability' to overcome the existing limitations.

Drawbacks of Artificial Intelligence and Their Potential Solutions in the Healthcare Sector.

Artificial intelligence (AI) has the potential to make substantial progress toward the goal of making healthcare more personalized, predictive, preventative, and interactive. We believe AI will continue its present path and ultimately become a mature and effective tool for the healthcare sector. Besides this AI-based systems raise concerns regarding data security and privacy. Because health records are important and vulnerable, hackers often target them during data breaches. The absence of standard guidelines for the moral use of AI and ML in healthcare has only served to worsen the situation. There is debate about how far artificial intelligence (AI) may be utilized ethically in healthcare settings since there are no universal guidelines for its use. Therefore, maintaining the confidentiality of medical records is crucial. This study enlightens the possible drawbacks of AI in the implementation of healthcare sector and their solutions to overcome these situations.

[Déterminants du succès d'une démarche provinciale d'usage optimal des antipsychotiques chez les résidents en soins de longue durée selon les acteurs clés impliqués dans l'implantation].

Le Québec présente le taux de prescriptions d'antipsychotiques le plus élevé chez les personnes âgées de 65 ans et plus au Canada. La démarche « Optimiser les pratiques, les usages, les soins et les services - antipsychotiques ¼ (OPUS-AP) vise à pallier cet enjeu. Étant donné ses premiers résultats prometteurs, notre étude visait à identifier les déterminants de son succès. Elle repose sur un devis d'étude de cas regroupant une analyse documentaire et 21 entrevues auprès d'acteurs clés impliqués dans l'implantation. Les résultats mettent en lumière cinq déterminants centraux : 1) une démarche intégrée, collaborative et probante; 2) des communications et des réseaux au service de la démarche; 3) un climat d'implantation favorable aux changements; 4) un engagement et une implication des parties prenantes; et 5) une stratégie d'application des connaissances intégrée et appuyée. Des défis et recommandations pour assurer la pérennisation et la mise à l'échelle d'OPUS-AP et inspirer des démarches similaires sont identifiés.

Assessments of Aphasia: Practices and Challenges faced by Malaysian SpeechLanguage Therapists (Penilaian Aphasia: Amalan dan Cabaran yang dihadapi oleh Jurupulih Pertuturan-Bahasa Malaysia) / Jurnal Sains Kesihatan Malaysia

@#Aphasia assessment is crucial in diagnosing aphasia, determining the extent of language impairment, and identifying factors that may support or restrict aphasia recovery to design an appropriate plan of care for people with aphasia. Speech-language therapists (SLTs) play a major role in conducting aphasia assessments. Little is known about the practices of SLTs in assessing aphasia in low-resource regions. The present study aims to identify aphasia assessment practices among Malaysian SLTs and related challenges, as well as strategies for improving aphasia assessments from SLTs’ perspectives. A total of 32 SLT participants who have been practicing in Malaysia completed an online survey to gather their background information, data pertaining to practices and challenges in conducting aphasia assessments, and suggestions for improving aphasia assessments. Descriptive analyses were conducted for all numerical data. Suggestions for improving aphasia assessment practices were analysed qualitatively using the thematic content analysis approach. SLT practices in aphasia assessment were found to be consistent in certain aspects, but not all. Two major challenges were identified: (a) linguistic barriers between clinicians and clients/caregivers, and (b) a lack of standardized assessment tools for aphasia evaluations. Participants suggested “Internal Strategies” and “External Strategies” for improving aphasia assessment practices.

Elaboration of guideline for monitoring in relative bioavailability / pharmaceutical bioequivalence study by the sponsor / Elaboração de diretriz para monitoramento em biodisponibilidade relativa / estudo de bioequivalência farmacêutica pelo patrocinador / Elaboración de la directriz para el seguimiento en la biodisponibilidad relativa / estudio de bioequivalencia farmacéutica por parte del promotor

For registration of generic and similar drugs, it is necessary to carry out pharmaceutical equivalence (PE) tests and pharmaceutical bioequivalence (PB). To carry out these tests, duly qualified research centers are contracted, which need to be monitored by the sponsor who is legally responsible for the activities. To this end, it is the recommendation of the Document of the Americas, periodic monitoring to verify compliance with quality requirements, Standard Operating Procedures, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), of the applicable regulatory framework, as well as of compliance with the study protocol. Thus, monitoring is a methodical and documented process to evaluate the degree of adhesion of the center to the planned design for the evaluation of the formulations. To this end, the implementation of a standardized and easily completed guideline is a very important tool to guarantee a consistent evaluation and maintain the organizational memory of the evaluated items by monitors designated by the sponsor, contributing to the constant improvement of the contracted centers and supporting traceability of the studies. This work provided a systemic view of the evidence process related mainly to pharmaceutical bioequivalence, with the monitoring guideline summarizing the items of greatest relevance to be verified.

Para registro de medicamentos genéricos e similares, é necessária a realização de testes de equivalência farmacêutica (EF) e bioequivalência farmacêutica (BF). Para a realização desses testes, são contratados centros de pesquisa devidamente habilitados, que precisam ser monitorados pelo patrocinador legalmente responsável pelas atividades. Há também a recomendação do Documento das Américas de realizar monitoramentos periódicos para verificar o cumprimento dos requisitos de qualidade, Procedimentos Operacionais Padrão, Boas Práticas Clínicas (BPC), Boas Práticas de Laboratório (BPL), de marco regulatório aplicável, bem como de cumprimento do protocolo do estudo. Assim, o monitoramento é um processo metódico e documentado para avaliar o grau de adesão do centro ao desenho planejado para a avaliação das formulações. Para tanto, a implantação de uma diretriz padronizada e de fácil preenchimento é uma ferramenta muito importante para garantir uma avaliação consistente e manter a memória organizacional dos itens avaliados por monitores designados pelo patrocinador, contribuindo para a melhoria constante dos centros contratados e apoiando rastreabilidade dos estudos. Este artigo forneceu uma visão sistêmica do processo de evidência relacionado principalmente à bioequivalência farmacêutica, com a diretriz de monitoramento resumindo os itens de maior relevância a serem verificados.

Para el registro de medicamentos genéricos y similares, es necesario realizar pruebas de equivalencia farmacéutica (EP) y de bioequivalencia farmacéutica (PB). Para llevar a cabo estas pruebas se contratan centros de investigación debidamente cualificados, que deben ser supervisados por el promotor, que es el responsable legal de las actividades. Para ello, es la recomendación del Documento de las Américas, el monitoreo periódico para verificar el cumplimiento de los requisitos de calidad, los Procedimientos Operativos Estándar, las Buenas Prácticas Clínicas (BPC), las Buenas Prácticas de Laboratorio (BPL), del marco regulatorio aplicable, así como del cumplimiento del protocolo del estudio. Así, la monitorización es un proceso metódico y documentado para evaluar el grado de adhesión del centro al diseño previsto para la evaluación de las formulaciones. Para ello, la implantación de una pauta estandarizada y de fácil cumplimentación es una herramienta muy importante para garantizar una evaluación consistente y mantener la memoria organizativa de los elementos evaluados por parte de los monitores designados por el promotor, contribuyendo a la mejora constante de los centros contratados y apoyando la trazabilidad de los estudios. Este trabajo proporcionó una visión sistémica del proceso de evidencia relacionado principalmente con la bioequivalencia farmacéutica, con la pauta de monitoreo que resume los ítems de mayor relevancia a ser verificados.

Assessment of total annual effective doses to representative person, for authorised and accidental releases from the Nuclear Medicine Department at Cattinara Hospital (Trieste, Italy).

PURPOSE: Clinical procedures in a Nuclear Medicine Department produce radioactive liquid and solid waste. Regarding waste release into the environment from an authorised hospital, it is mandatory to verify the compliance with European Directive 2013/59/EURATOM, adopted by the Italian Government via the Legislative Decree 101/2020. METHODS: Different activity release pathways into the environment from Trieste Nuclear Medicine Department have been analysed: liquid waste from patients' excreta discharged by sewage treatment system into the sea, and atmospheric releases following solid waste incineration. Reference models, provided by NCRP and IAEA guidelines, have been implemented to assess the impact of the discharged radioactivity for coastal waters and atmospheric transport conditions. Finally, an accidental fire event occurring in Radiopharmacy Laboratories has been simulated by HotSpot software. RESULTS: Advanced screening models give an effective dose to population of 5.3 · 10-3 µSv/y and 1.4 · 10-4 µSv/y for introduction by sewage system into coastal waters and atmospheric releases by the incinerator, respectively. Workers involved in the maintenance of the sewage treatment plant receive a total annual effective dose of 3.8 µSv/y, while for incinerator staff the total annual exposure is 5.9 · 10-8 µSv/y. For the accidental fire event the maximum total effective dose to an individual results 3.8 · 10-8 Sv with mild wind, and 4.1 · 10-7 Sv with strong wind. CONCLUSIONS: The total annual effective doses estimated to representative person, due to both Nuclear Medicine authorised clinical practices and in case of an accidental fire event, are in compliance with regulatory stipulations provided by Directives.