Consideraciones bioéticas en el manejo de la esclerosis lateral amiotrófica: Una aproximación al quehacer fonoaudiológico

Introducción: La esclerosis lateral amiotrófica (ELA) es la forma más común de enfermedad degenerativa de motoneurona en la edad adulta y es considerada una enfermedad terminal. Por lo mismo, el accionar del fonoaudiólogo debe considerar el respeto a los principios bioéticos básicos para garantizar una asistencia adecuada. Objetivo: Conocer aquellas consideraciones bioéticas relacionadas al manejo y estudio de personas con ELA para luego brindar una aproximación hacia el quehacer fonoaudiológico. Método: Se efectuó una búsqueda bibliográfica en las bases de datos PubMed, Scopus y SciELO. Se filtraron artículos publicados desde 2000 hasta junio de 2023 y fueron seleccionados aquellos que abordaban algún componente bioético en población con ELA. Resultados: Aspectos relacionados al uso del consentimiento informado y a la toma de decisiones compartidas destacaron como elementos esenciales para apoyar la autonomía de las personas. Conclusión: Una correcta comunicación y una toma de decisiones compartida son claves para respetar la autonomía de las personas. A su vez, la estandarización de procedimientos mediante la investigación clínica permitirá aportar al cumplimiento de los principios bioéticos de beneficencia y no maleficencia, indispensables para la práctica profesional.

Introduction: Amyotrophic lateral sclerosis (ALS) is the most common form of degenerative motor neuron disease in adulthood and is considered a terminal disease. For this reason, the actions of the speech therapist must consider respect for basic bioethical principles to guarantee adequate assistance. Objective: To know those bioethical considerations related to the management and study of people with ALS to then provide an approach to speech therapy. Methodology: A bibliographic search was carried out in the PubMed, Scopus, and SciELO databases. Articles published from 2000 to June 2023 were filtered and those that addressed a bioethical component in the population with ALS were selected. Results: Aspects related to the use of informed consent and shared decision-making stood out as essential elements to support people's autonomy. Conclusion: Proper communication and shared decision-making are key to respecting people's autonomy. In turn, the standardization of procedures through clinical research will contribute to compliance with the bioethical principles of beneficence and non-maleficence, essential for professional practice.

Outcomes of a Community of Practice on Quebec Speech Language Pathologists' Voice Assessment Practices and Professional Identity

In a context where different protocols for recommended practices in clinical voice assessment exist, while there are gaps in the literature regarding the evidence base supporting assessment procedures and measures, clinicians from regions where a strong community holding expertise in clinical and scientific voice practices lack can struggle to confidently develop their voice assessment practices. In an effort to improve voice assessment practices and strengthen professional identity among speech-language pathologists in Quebec, Canada, a community of practice (CoP) was established, with the aim of promoting knowledge sharing, implementing change in clinical practice, and improving professional identity. Thirty-nine participants took part in the CoP activities conducted over a four-month period, including virtual meetings and in-person workshops. Participants had a high rate of attendance (> 74% participation rate in virtual meetings), and were highly satisfied with their participation and intended to remain involved after the project's end. Statistically significant changes in voice assessment practices were observed post-CoP, regarding probability of performing assessments (p < .001), and perceived importance of assessment for evaluative purposes (p <.001), as well as improvements in assessment specific confidence, specifically for procedure of auditory-perceptual assessment (p < .001) and purpose of aerodynamic assessment (p = .05). Moreover, there was an increase in professional identity post-CoP (p < .001) and participants felt they made significant learnings. The present study highlighted the need to involve SLPs in future research to identify assessments that are relevant to the specific evaluative objectives of SLPs working with voice, and suggests CoPs are an efficient tool for that purpose.

En un contexto en el que existen diferentes protocolos para las prácticas recomendadas en la evaluación vocal clínica, y en el que se presentan vacíos en la literatura respecto a la base de evidencia que respalda los procedimientos y medidas de evaluación, los profesionales de regiones donde no hay una comunidad sólida con experiencia en prácticas vocales clínicas y científicas pueden enfrentar dificultades para desarrollar con confianza sus prácticas de evaluación vocal. Con el propósito de mejorar las prácticas de evaluación vocal y fortalecer la identidad profesional entre los logopedas de Quebec, Canadá, se estableció una comunidad de práctica (CdP). Esta tenía como objetivo fomentar el intercambio de conocimientos, implementar cambios en la práctica clínica y mejorar la identidad profesional. Un total de treinta y nueve participantes se involucraron en las actividades de la CdP, llevadas a cabo durante un período de cuatro meses, que incluyeron reuniones virtuales y talleres presenciales. Los participantes tuvieron una alta tasa de asistencia (> 74% de participación en las reuniones virtuales) y expresaron un alto grado de satisfacción con su participación, manifestando su intención de continuar involucrados después de la finalización del proyecto. Se observaron cambios estadísticamente significativos en las prácticas de evaluación vocal posterior a la CdP, en lo que respecta a la probabilidad de llevar a cabo evaluaciones (p < .001) y la percepción de la importancia de la evaluación con fines evaluativos (p < .001), así como mejoras en la confianza específica en la evaluación, particularmente en el procedimiento de evaluación auditivo-perceptual (p < .001) y el propósito de la evaluación aerodinámica (p = .05). Además, se registró un aumento en la identidad profesional posterior a la CdP (p < .001) y los participantes sintieron que obtuvieron aprendizajes significativos. El presente estudio destacó la necesidad de involucrar a los logopedas en investigaciones futuras, para identificar evaluaciones pertinentes a los objetivos evaluativos específicos de los logopedas que trabajan con la voz, y sugiere que las CdP son una herramienta eficiente con ese propósito.

Informing evidence-based policy during the COVID-19 pandemic and recovery period: learning from a national evidence centre.

BACKGROUND: The COVID-19 pandemic demonstrated the vital need for research to inform policy decision-making and save lives. The Wales COVID-19 Evidence Centre (WCEC) was established in March 2021 and funded for two years, to make evidence about the impact of the pandemic and ongoing research priorities for Wales available and actionable to policy decision-makers, service leads and the public. OBJECTIVES: We describe the approaches we developed and our experiences, challenges and future vision. PROGRAM IMPLEMENTATION: The centre operated with a core team, including a public partnership group, and six experienced research groups as collaborating partners. Our rapid evidence delivery process had five stages: 1. Stakeholder engagement (continued throughout all stages); 2. Research question prioritisation; 3. Bespoke rapid evidence review methodology in a phased approach; 4. Rapid primary research; and 5. Knowledge Mobilisation to ensure the evidence was available for decision-makers. MAIN ACHIEVEMENTS: Between March 2021-23 we engaged with 44 stakeholder groups, completed 35 Rapid Evidence Reviews, six Rapid Evidence Maps and 10 Rapid Evidence Summaries. We completed four primary research studies, with three published in peer reviewed journals, and seven ongoing. Our evidence informed policy decision-making and was cited in 19 Welsh Government papers. These included pandemic infection control measures, the Action Plan to tackle gender inequalities, and Education Renew and Reform policy. We conducted 24 Welsh Government evidence briefings and three public facing symposia. POLICY IMPLICATIONS: Strong engagement with stakeholder groups, a phased rapid evidence review approach, and primary research to address key gaps in current knowledge enabled high-quality efficient, evidence outputs to be delivered to help inform Welsh policy decision-making during the pandemic. We learn from these processes to continue to deliver evidence from March 2023 as the Health and Care Research Wales Evidence Centre, with a broader remit of health and social care, to help inform policy and practice decisions during the recovery phase and beyond.

Re-Imagining Child Welfare to Support Children and Families.

Children and adolescents in foster care include many of the most severely traumatized victims of child abuse and neglect. They deserve the best possible care and treatment, yet their outcomes remain poor. The persistence of poor outcomes for youth in foster care reflects challenges of psychiatric diagnostic formulation and of service system design/access, both areas in which child and adolescent psychiatrists have a key role to improve care and outcomes.

Progress on the health-related Sustainable Development Goals and targets in the Eastern Mediterranean Region, 2023: 2nd progress report

The 2030 Agenda for Sustainable Development includes a vision of healthy lives and well-being for all at all ages. This major report provides an update on progress towards the health-related Sustainable Development Goals (SDGs) in the WHO Eastern Mediterranean Region. It presents regional trends between 2010 and 2022 for 50 health-related SDG indicators using available data from WHO and estimates from other United Nations agencies. The report reveals some successes at the country level amid a marked slowdown regionally with setbacks across indicators on health health risks and determinants and access to services. We are at the halfway point for the 2030 Agenda for Sustainable Development: to reverse current trends and ensure the health and well-being of our population we must take bold steps now.

Hipodermóclise como tecnologia integrativa ao processo infusional em crianças / Hypodermoclysis as an integrative technology for the infusion process in children / Hipodermoclisis como tecnología integradora para el proceso de infusión en niños

Objetivo: Identificar as evidências científicas acerca da efetividade e da segurança da hipodermóclise em comparação à via intravenosa, no processo de infusão de fluidos, para reidratação de crianças até 10 de idade, com leve a moderada desidratação, nos contextos hospitalares e domiciliares. Métodos: Revisão sistemática conduzida conforme as recomendações do Instituto Joanna Briggs®, com protocolo publicado e registrado. A busca foi realizada em cinco recursos informacionais diferentes (bases de dados, literatura cinzenta, referências dos estudos). Todo o processo de seleção foi conduzido por revisores independentes. Resultados: Foram identificados 1410 estudos e dois foram incluídos na análise. Devido a heterogeneidade dos estudos não foi possível a realização da meta-análise. Os desfechos analisados foram volume total de líquido infundido, alteração da desidratação conforme escala de Gorelick e peso, número de tentativas para inserção do cateter, e eventos adversos. Conclusão: Demonstra-se benefícios do uso da hipodermóclise como prática integrativa ao processo de infusão de fluidos em crianças, porém com baixo nível de evidência. Novas pesquisas com alta qualidade metodológica serão promissoras para sua implementação no cuidado ao paciente pediátrico. (AU)

Objective: To identify scientific evidence about the effectiveness and safety of hypodermoclysis compared to the intravenous route, in the fluid infusion process, for rehydration of children up to 10 years of age, with mild to moderate dehydration, in hospital and home settings. Methods: Systematic review conducted according to the recommendations of the Joanna Briggs® Institute, with a published and registered protocol. The search was performed in six databases, five gray literature databases, and references of the included studies. The entire selection process was conducted by independent reviewers. Results: 1410 studies were identified and two were included in the analysis. Due to the heterogeneity of the studies, it was not possible to carry out the meta-analysis. The outcomes analyzed were total volume of fluid infused, change in dehydration according to the Gorelick scale and weight, number of attempts to insert the catheter, and adverse events. Conclusion: Benefits of the use of hypodermoclysis as an integrative practice in the fluid infusion process in children are demonstrated, but with a low level of evidence. New research with high methodological quality will be promising for its implementation in pediatric patient care. (AU)

Objetivo: Identificar evidencia científica sobre la efectividad y seguridad de la hipodermoclisis en comparación con la vía intravenosa, en el proceso de infusión de líquidos, para la rehidratación de niños hasta los 10 años de edad, con deshidratación leve a moderada, en el ámbito hospitalario y domiciliario. Métodos: Revisión sistemática realizada de acuerdo con las recomendaciones del Instituto Joanna Briggs®, con protocolo publicado y registrado. La búsqueda se realizó en seis bases de datos, cinco bases de datos de literatura gris y referencias de los estudios incluidos. Todo el proceso de selección fue realizado por revisores independientes. Resultados: Se identificaron 1410 estudios y se incluyeron dos en el análisis. Debido a la heterogeneidad de los estudios, no fue posible realizar el metanálisis. Los resultados analizados fueron el volumen total de líquido infundido, el cambio en la deshidratación según la escala y el peso de Gorelick, el número de intentos de insertar el catéter y los eventos adversos. Conclusión: Se demuestran los beneficios del uso de la hipodermoclisis como práctica integradora en el proceso de infusión de líquidos en niños, pero con un bajo nivel de evidencia. Nuevas investigaciones con alta calidad metodológica serán prometedoras para su implementación en la atención del paciente pediátrico. (AU)

A framework for integrating evidence to assess hazards and risk.

To accurately characterize human health hazards, human, animal, and mechanistic data must be integrated and the relevance to the research question of all three lines of evidence must be considered. Mechanistic data are often critical to the full integration of animal and human data and to characterizing relevance and uncertainty. This novel evidence integration framework (EIF) provides a method for synthesizing data from comprehensive, systematic, quality-based assessments of the epidemiological and toxicological literature, including in vivo and in vitro mechanistic studies. It organizes data according to both the observed human health effects and the mechanism of action of the chemical, providing a method to support evidence synthesis. The disease-based component uses the evidence of human health outcomes studied in the best quality epidemiological literature to organize the toxicological data according to authors' stated purpose, with the pathophysiology of the disease determining the potential relevance of the toxicological data. The mechanism-based component organizes the data based on the proposed mechanisms of effect and data supporting events leading to each endpoint, with the epidemiological data potentially providing corroborating information. The EIF includes a method to cross-classify and describe the concordance of the data, and to characterize its uncertainty. At times, the two methods of organizing the data may lead to different conclusions. This facilitates identification of knowledge gaps and shows the impact of uncertainties on the strength of causal inference.

Narrative Review of Brivaracetam: Preclinical Profile and Clinical Benefits in the Treatment of Patients with Epilepsy.

One third of patients with epilepsy will continue to have uncontrolled seizures despite treatment with antiseizure medications (ASMs). There is therefore a need to develop novel ASMs. Brivaracetam (BRV) is an ASM that was developed in a major drug discovery program aimed at identifying selective, high-affinity synaptic vesicle protein 2A (SV2A) ligands, the target molecule of levetiracetam. BRV binds to SV2A with 15- to 30-fold higher affinity and greater selectivity than levetiracetam. BRV has broad-spectrum antiseizure activity in animal models of epilepsy, a favorable pharmacokinetic profile, few clinically relevant drug-drug interactions, and rapid brain penetration. BRV is available in oral and intravenous formulations and can be initiated at target dose without titration. Efficacy and safety of adjunctive BRV (50-200 mg/day) treatment of focal-onset seizures was demonstrated in three pivotal phase III trials (NCT00490035/NCT00464269/NCT01261325), including in patients who had previously failed levetiracetam. Efficacy and safety of adjunctive BRV were also demonstrated in adult Asian patients with focal-onset seizures (NCT03083665). In several open-label trials (NCT00150800/NCT00175916/NCT01339559), long-term safety and tolerability of adjunctive BRV was established, with efficacy maintained for up to 14 years, with high retention rates. Evidence from daily clinical practice highlights BRV effectiveness and tolerability in specific epilepsy patient populations with high unmet needs: the elderly (≥ 65 years of age), children (< 16 years of age), patients with cognitive impairment, patients with psychiatric comorbid conditions, and patients with acquired epilepsy of specific etiologies (post-stroke epilepsy/brain tumor related epilepsy/traumatic brain injury-related epilepsy). Here, we review the preclinical profile and clinical benefits of BRV from pivotal trials and recently published evidence from daily clinical practice.

One in three people with epilepsy continue to have seizures despite treatment. Brivaracetam is a medicine used to treat seizures in people with epilepsy. It binds to a protein in the brain (synaptic vesicle protein 2A) and is effective in many different animal models of epilepsy. Brivaracetam enters the brain quickly. It has few interactions with other medicines, which is important because people with epilepsy may be taking additional medicines for epilepsy or other conditions. Brivaracetam is available as tablets, oral solution, and solution for intravenous injection, can be started at the recommended target dose, and is easy to use. In three phase III trials, people with uncontrolled focal-onset seizures taking brivaracetam 50­200 mg each day had fewer seizures than people taking a placebo. Brivaracetam was tolerated well. It also worked well in many people who had previously not responded to antiseizure medications. The efficacy of brivaracetam treatment is maintained for up to 14 years. Brivaracetam treatment reduces seizures in the elderly (≥ 65 years old), in children (< 16 years old), in people with cognitive or learning disabilities, in people with additional psychiatric conditions, and in people with different causes of epilepsy (post-stroke epilepsy, brain-tumor related epilepsy, and traumatic brain injury-related epilepsy). Here, we review brivaracetam characteristics and the results when people with epilepsy received brivaracetam in key clinical trials and real-world studies in daily clinical practice.

Utility of the Endoscopic Healing Index in Identifying Active Inflammation in Patients with Crohn's Disease: Real World Data from a Tertiary Center.

BACKGROUND: The Endoscopic Healing Index (EHI) analyzes biomarkers in a patient's peripheral blood to assess mucosal healing. We aimed to characterize the effectiveness of the EHI as a predictor of disease activity in a real world clinical setting. METHODS: This retrospective study looked at patients treated and followed up at the University of Chicago Medicine IBD center who had EHI tests done as part of routine clinical care. The results of the EHI were compared with radiological imaging or endoscopy performed within 3 months of the EHI in order to determine accuracy at diagnosing active inflammation. RESULTS: Fifty-five patients with CD and with an available EHI were included in this study. Four (50%) patients with an EHI of < 20 (n = 8) had evidence of objective inflammation. A cutoff of ≤ 20 had a sensitivity of 89% and specificity of 23.5% for predicting no evidence of any objective inflammation with an AUROC of 0.69. This score had a negative predictive value (NPV) of 50% and positive predictive value (PPV) of 72.3%. A cutoff EHI of 30 tended to classify patients as either having objective evidence of inflammation or not more often than FCAL (Correctly classifying inflammation: 89% vs 64%, respectively; p = 0.32). CONCLUSION: In this real world analysis, the EHI showed poor predictive value for the absence of active inflammation as assessed by imaging or endoscopy, has limited utility in confirming deep remission and should be used with another objective modality.

What should I eat today? Evidence, guidelines, dietary patterns and consumer's behavior.

Over the past century, dietary recommendations emphasizing food patterns as means to deliver essential nutrients have garnered widespread acceptance. The necessity for foods supplying vital nutrients and energy throughout various life stages requires the involvement of local resources and cultural practices to prevent nutrient deficiency diseases. Since the 1980s, dietary guidelines aimed at adverting chronic diseases have relied on epidemiological research to predict which dietary patterns correlate with reduced risk of chronic disease or links to health outcomes. Dietary guidelines have been broad, typically recommending avoiding excess or deficiency of single nutrients. Efforts to fine-tune these recommendations face challenges due to a scarcity of robust scientific data supporting more specific guidance across the life cycle. Consumers have become skeptical of dietary guidelines, because media coverage of new studies is often in conflict with accepted nutrition dogma. Indications to align individual and planet's health have been issued supporting the concept of sustainable dietary patterns. Whether we really have a science-based databank to support dietary guidelines is still a matter of ongoing debate, as presented in this paper.

Antidiabetic Potential of Tea and Its Active Compounds: From Molecular Mechanism to Clinical Evidence.

Diabetes mellitus (DM) is a chronic endocrine disorder that poses a long-term risk to human health accompanied by serious complications. Common antidiabetic drugs are usually accompanied by side effects such as hepatotoxicity and nephrotoxicity. There is an urgent need for natural dietary alternatives for diabetic treatment. Tea (Camellia sinensis) consumption has been widely investigated to lower the risk of diabetes and its complications through restoring glucose metabolism homeostasis, safeguarding pancreatic ß-cells, ameliorating insulin resistance, ameliorating oxidative stresses, inhibiting inflammatory response, and regulating intestinal microbiota. It is indispensable to develop effective strategies to improve the absorption of tea active compounds and exert combinational effects with other natural compounds to broaden its hypoglycemic potential. The advances in clinical trials and population-based investigations are also discussed. This review primarily delves into the antidiabetic potential and underlying mechanisms of tea active compounds, providing a theoretical basis for the practical application of tea and its active compounds against diabetes.

A retrospective analysis of perioperative medications for opioid-use disorder and tapering additional postsurgical opioids via a transitional pain service.

AIMS: To investigate perioperative opioid requirements in patients on methadone or buprenorphine as medication for opioid-use disorder (MOUD) who attended a transitional pain clinic (Personalized Pain Program, PPP). METHODS: This retrospective cohort study assessed adults on MOUD with surgery and attendance at the Johns Hopkins PPP between 2017 and 2022. Daily non-MOUD opioid use over 6 time-points was evaluated with regression models controlling for days since surgery. The time to complete non-MOUD opioid taper was analysed by accelerated failure time and Kaplan-Meier models. RESULTS: Fifty patients (28 on methadone, 22 on buprenorphine) were included with a median age of 44.3 years, 54% male, 62% Caucasian and 54% unemployed. MOUD inpatient administration occurred in 92.8% of patients on preoperative methadone but only in 36.3% of patients on preoperative buprenorphine. Non-MOUD opioid use decreased over time postoperatively (ß = -0.54, P < .001) with a median decrease of 90 mg morphine equivalents (MME) between the first and last PPP visit, resulting in 46% tapered off by PPP completion. Older age and duration in PPP were associated with lower MME, while mental health conditions, longer hospital stays and higher discharge opioid prescriptions were associated with higher MME. The average time to non-MOUD opioid taper was 1.79× longer in patients on buprenorphine (P = .026), 2.75× in males (P = .023), 4.66× with mental health conditions (P < .001), 2.37× with chronic pain (P = .031) and 3.51× if on preoperative non-MOUD opioids; however, higher initial MOUD level decreased time to taper (P = .001). CONCLUSIONS: Postoperative opioid tapering utilizing a transitional pain service is possible in patients on MOUD.

Real-world effectiveness of palbociclib in HR+/HER2- metastatic breast cancer: a literature review.

Approximately 70% of newly diagnosed breast cancers are of the HR+/HER2- subtype. For the treatment of patients with HR+/HER2- metastatic breast cancer, current guidelines recommend the use of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in combination with endocrine therapy. In this review we assess existing literature concerning real-world effectiveness of palbociclib. Survival outcomes in terms of progression-free survival and overall survival are discussed and compared among the included real-world studies and in relation to the phase III PALOMA trials.

About 70% of newly diagnosed breast cancers belong to a specific subgroup called hormone receptor positive (HR+)/Human epidermal growth factor receptor 2 negative (HER2-). In cases with metastatic disease, doctors recommend a treatment approach combining drugs such as palbociclib along with hormonal therapy. Our review evaluates how palbociclib performs in patients in real-world practice situations, beyond clinical trial settings. We looked at two key measures: how long the cancer stays controlled (progression-free survival) and overall survival. The results from these real-world studies are discussed and compared to findings in clinical trials.

Dollar store policy opportunities in Baltimore City: community member and policy maker perspectives.

Introduction: There are currently over 50 dollar stores in Baltimore City, Maryland. Community perceptions of over-saturation and resulting neighborhood impacts have garnered recent attention. A Maryland State Senate Bill required further study of dollar stores in Baltimore City to inform future policy. Therefore, the over-arching goal of this study was to generate community-informed policy recommendations for the Baltimore City Council. Methods: Three methods of data collection were used: (1) in-depth interviews with community members, retail staff/owners, dollar store staff, and policy makers; (2) an online survey of Baltimore City residents; and (3) workshop with community members and one with policy makers. Triangulation across data sources, discussion amongst the research team, and member checking were used to generate the top four policy options: a conditional use ordinance, a community benefits agreements, a dispersal ordinance, and a staple foods ordinance. Results: There was strong support for policies that encourage dollar stores to better align with community priorities (e.g., improving store cleanliness and appearance, increasing availability of healthy foods), as opposed to closing or banning dollar stores entirely. There was also strong support for policies that would empower communities to participate in determining the role of dollar stores in their neighborhoods, for example through a conditional use ordinance or community benefits agreement. Key concerns included policy enforcement, given the additional funding required, and current limited capacity at the city government level. Strategies to address such challenges were generated including implementing business licenses at the city level, linking new ordinances to dollar store leases and permits, and encouraging dollar store participation in federal and local programs to more feasibly stock healthier food items (e.g., fresh produce). Dissatisfaction was expressed regarding a lack of policy options to address the existing dollar stores, not just new dollar stores entering the City. Discussion: This study is the first of its kind to assess community support for dollar store policies at the local level, and serves to inform policies that improve dollar stores. A report of these findings was provided to Baltimore City Council to inform new, community-supported dollar store policies.

OHDSI-compliance: a set of document templates facilitating the implementation and operation of a software stack for real-world evidence generation.

Introduction: The open-source software offered by the Observational Health Data Science and Informatics (OHDSI) collective, including the OMOP-CDM, serves as a major backbone for many real-world evidence networks and distributed health data analytics platforms. While container technology has significantly simplified deployments from a technical perspective, regulatory compliance can remain a major hurdle for the setup and operation of such platforms. In this paper, we present OHDSI-Compliance, a comprehensive set of document templates designed to streamline the data protection and information security-related documentation and coordination efforts required to establish OHDSI installations. Methods: To decide on a set of relevant document templates, we first analyzed the legal requirements and associated guidelines with a focus on the General Data Protection Regulation (GDPR). Moreover, we analyzed the software architecture of a typical OHDSI stack and related its components to the different general types of concepts and documentation identified. Then, we created those documents for a prototypical OHDSI installation, based on the so-called Broadsea package, following relevant guidelines from Germany. Finally, we generalized the documents by introducing placeholders and options at places where individual institution-specific content will be needed. Results: We present four documents: (1) a record of processing activities, (2) an information security concept, (3) an authorization concept, as well as (4) an operational concept covering the technical details of maintaining the stack. The documents are publicly available under a permissive license. Discussion: To the best of our knowledge, there are no other publicly available sets of documents designed to simplify the compliance process for OHDSI deployments. While our documents provide a comprehensive starting point, local specifics need to be added, and, due to the heterogeneity of legal requirements in different countries, further adoptions might be necessary.

Heterogeneous risk tolerance, in-groups, and epidemic waves.

There is a growing interest in the joint modeling of the dynamics of disease and health-related beliefs and attitudes, but coupling mechanisms are yet to be understood. We introduce a model where risk information, which can be delayed, comes in two flavors, including historical risk derived from perceived incidence data and predicted risk information. Our model also includes an interpretation domain where the behavioral response to risk information is subject to in-group pressure. We then simulate how the strength of behavioral reaction impacts epidemic severity as measured by epidemic peak size, number of waves, and final size. Simulated behavioral response is not effective when the level of protection that prophylactic behavior provides is as small as 50% or lower. At a higher level of 75% or more, we see the emergence of multiple epidemic waves. In addition, simulations show that different behavioral response profiles can lead to various epidemic outcomes that are non-monotonic with the strength of reaction to risk information. We also modeled heterogeneity in the response profile of a population and find they can lead to less severe epidemic outcome in terms of peak size.

Real-world setting comparison of bridging therapy versus direct mechanical thrombectomy for acute ischemic stroke: A meta-analysis.

BACKGROUND AND PURPOSE: Intravenous Thrombolysis (IVT) prior to Mechanical Thrombectomy (MT) for Acute Ischaemic Stroke (AIS) due to Large-Vessel Occlusion (LVO) remains controversial. Therefore, the authors performed a meta-analysis of the available real-world evidence focusing on the efficacy and safety of Bridging Therapy (BT) compared with direct MT in patients with AIS due to LVO. METHODS: Four databases were searched until 01 February 2023. Retrospective and prospective studies from nationwide or health organization registry databases that compared the clinical outcomes of BT and direct MT were included. Odds Ratios (ORs) and 95 % Confidence Intervals (CIs) for efficacy and safety outcomes were pooled using a random-effects model. RESULTS: Of the 12 studies, 86,695 patients were included. In patients with AIS due to LVO, BT group was associated with higher odds of achieving excellent functional outcome (modified Rankin Scale score 0-1) at 90 days (OR = 1.48, 95 % CI 1.25-1.75), favorable discharge disposition (to the home with or without services) (OR = 1.33, 95 % CI 1.29-1.38), and decreased mortality at 90 days (OR = 0.62, 95 % CI 0.56-0.70), as compared with the direct MT group. In addition, the risk of symptomatic intracranial hemorrhage did not increase significantly in the BT group. CONCLUSION: The present meta-analysis indicates that BT was associated with favorable outcomes in patients with AIS due to LVO. These findings support the current practice in a real-world setting and strengthen their validity. For patients eligible for both IVT and MT, BT remains the standard treatment until more data are available.

Empowering nursing council implementation science: An appeal to action.

BACKGROUND: In most hospitals, nursing councils are responsible for EBP implementation and evaluation. To enhance the perceived value of council participation by frontline nurses, administrators must promote the impact of council projects on healthcare outcomes. PURPOSE: The purposes of this appeal to action are to describe the role of nursing councils in promoting IS and EBP, and to provide recommendations that enhance the value of IS and/or EBP councils to frontline nurses, thereby incentivizing participation on these councils. METHODS: Nurse researchers from three metropolitan hospitals partnered with a medical librarian to recommend six strategies aimed at enhancing the perceived value of council participation. An argumentative review was conducted to support these strategies. DISCUSSION: Recommendations are inclusion of methods experts on councils; support from nursing administrators in the development, implementation, and evaluation of projects; formation of partnerships with nursing academic departments; expansion of publication opportunities and availability; and connection of projects to measurable quality indicators. CONCLUSION: Enhancing the perceived value of nursing councils by providing tools that optimize time and resource management can result in greater council participation and broader dissemination of IS evidence.

The expansion of the medical Cannabis market in Brazil and regulatory gaps

Expenditures with public provision of Cannabis products in Brazil are rising and have reached over 150 million reais. Growing interest in these products is the result of initiatives by various manufacturers, which are authorized to produce and sell, and by importers, that enable entry of more than 500 different products, from several countries. The present scenario is of increase in demand and of insufficient regulation, compounded by low quality of evidence for possible indications. Regulatory voids open pathways for market practices that may be unaligned with public health interests. The result is an ever-greater number of companies striving to operate in this lucrative and flexible market niche. Anvisa has created alternatives for patient access to Cannabis-containing products, which are not recognized as medicines, and which therefore have not been assessed as to effectiveness, safety or quality. This amounts to a serious regulatory breach, since these products that are supplied through the SUS do not comply to legal health standards. Anvisa is expected to take a firm stance in relation to Cannabis products regulation, regarding indications, acknowledged scientific evidence and availability of those authorized for sale and importation in the country.

Expenditures with public provision of Cannabis products in Brazil are rising and have reached over 150 million reais. Growing interest in these products is the result of initiatives by various manufacturers, which are authorized to produce and sell, and by importers, that enable entry of more than 500 different products, from several countries. The present scenario is of increase in demand and of insufficient regulation, compounded by low quality of evidence for possible indications. Regulatory voids open pathways for market practices that may be unaligned with public health interests. The result is an ever-greater number of companies striving to operate in this lucrative and flexible market niche. Anvisa has created alternatives for patient access to Cannabis-containing products, which are not recognized as medicines, and which therefore have not been assessed as to effectiveness, safety or quality. This amounts to a serious regulatory breach, since these products that are supplied through the SUS do not comply to legal health standards. Anvisa is expected to take a firm stance in relation to Cannabis products regulation, regarding indications, acknowledged scientific evidence and availability of those authorized for sale and importation in the country.