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1.
Can Vet J ; 65(4): 325-333, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38562985

RESUMEN

Background: Access to veterinary care has been identified as the largest animal welfare issue in contemporary society. Access to veterinary care is complicated by several factors, including the cost of care, potential language differences between providers and clients, the number of care providers, and distance to a care provider. Each of these factors alone can impact an individual's ability to seek adequate veterinary medical care for their companion animal, with an additional burden when multiple factors are present. Procedure: A veterinary care accessibility score (VCAS) was created, consisting of key variables for Canada, that measured these factors and scored them in relation to the rest of the country at the census division level. Results: In this study, nearly 2 million households in Quebec and 700 000 in Ontario were in the lowest VCAS ranking. Further, nearly 75% of households in New Brunswick were in low-access census divisions. The ratios of care providers to the estimated numbers of pet-owning households and households were also derived. An estimated veterinary clinic employee shortage was calculated at a minimum of 6803 to simply bring every census division up to a weighted mean, although the actual shortage is likely higher. Conclusion: This research could be used by policymakers, funders, and the animal welfare community to prioritize investment and design targeted solutions.


Cartographie des soins vétérinaires au Canada : Un indice d'accessibilité aux soins. Mise en contexte: L'accès aux soins vétérinaires a été identifié comme le plus grand problème de bien-être animal dans la société contemporaine. L'accès aux soins vétérinaires est compliqué par plusieurs facteurs, notamment le coût des soins, les différences linguistiques potentielles entre les prestataires et les clients, le nombre de prestataires de soins et la distance par rapport à un prestataire de soins. Chacun de ces facteurs à lui seul peut avoir un impact sur la capacité d'un individu à rechercher des soins médicaux vétérinaires adéquats pour son animal de compagnie, avec un fardeau supplémentaire lorsque plusieurs facteurs sont présents. Procédure: Un score d'accessibilité aux soins vétérinaires (VCAS) a été créé, composé de variables clés pour le Canada, qui mesurait ces facteurs et les notait par rapport au reste du pays au niveau des divisions de recensement. Résultats: Dans cette étude, près de 2 millions de ménages au Québec et 700 000 en Ontario se retrouvaient au bas du classement VCAS. De plus, près de 75 % des ménages du Nouveau-Brunswick se trouvaient dans des divisions de recensement à faible accès. Les ratios de prestataires de soins par rapport au nombre estimé de ménages possédant des animaux de compagnie et de ménages ont également été calculés. Une pénurie estimée d'employés de cliniques vétérinaires a été calculée à un minimum de 6803 pour simplement ramener chaque division de recensement à une moyenne pondérée, bien que la pénurie réelle soit probablement plus élevée. Conclusion: Cette recherche pourrait être utilisée par les décideurs politiques, les bailleurs de fonds et la communauté du bienêtre animal pour prioriser les investissements et concevoir des solutions ciblées.(Traduit par Dr Serge Messier).


Asunto(s)
Bienestar del Animal , Animales , Ontario , Quebec
2.
Digit Health ; 10: 20552076241238075, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38465291

RESUMEN

Objective: Mentoring and coaching practices have supported the career and skill development of healthcare professionals (HCPs); however, their role in digital technology adoption and implementation for HCPs is unknown. The objective of this scoping review was to summarize information on healthcare education programs that have integrated mentoring or coaching as a key component. Methods: The search strategy and keyword searches were developed by the project team and a research librarian. A two-stage screening process consisting of a title/abstract scan and a full-text review was conducted by two independent reviewers to determine study eligibility. Articles were included if they: (1) discussed the mentoring and/or coaching of HCPs on digital technology, including artificial intelligence, (2) described a population of HCPs at any stage of their career, and (3) were published in English. Results: A total of 9473 unique citations were screened, identifying 19 eligible articles. 11 articles described mentoring and/or coaching programs for digital technology adoption, while eigth described mentoring and/or coaching for digital technology implementation. Program participants represented a diverse range of industries (i.e., clinical, academic, education, business, and information technology). Digital technologies taught within programs included electronic health records (EHRs), ultrasound imaging, digital health informatics, and computer skills. Conclusions: This review provided a summary of the role of mentoring and/or coaching practices within digital technology education for HCPs. Future training initiatives for HCPs should consider appropriate resources, program design, mentor-learner relationship, security concerns and setting clear expectations for program participants. Future research could explore mentor/coach characteristics that would facilitate successful skill transfer.

3.
BMC Emerg Med ; 24(1): 29, 2024 Feb 16.
Artículo en Inglés | MEDLINE | ID: mdl-38360571

RESUMEN

BACKGROUND: Workplace violence (WPV) in healthcare is a growing challenge posing significant risks to patient care and employee well-being. Existing metrics to measure WPV in healthcare settings often fail to provide decision-makers with an adequate reflection of WPV due to the complexity of the issue. This increases the difficulty for decision-makers to evaluate WPV in healthcare settings and implement interventions that can produce sustained improvements. OBJECTIVE: This study aims to identify and compile a list of quality indicators that have previously been utilized to measure WPV in healthcare settings. The identified quality indicators serve as tools, providing leadership with the necessary information on the state of WPV within their organization or the impact of WPV prevention interventions. This information provides leadership with a foundation for planning and decision making related to addressing WPV. METHODS: Ovid databases were used to identify articles relevant to violence in healthcare settings, from which 43 publications were included for data extraction. Data extraction produced a total of 229 quality indicators that were sorted into three indicator categories using the Donabedian model: structure, process, and outcome. RESULTS: A majority of the articles (93%) contained at least 1 quality indicator that possessed the potential to be operationalized at an organizational level. In addition, several articles (40%) contained valuable questionnaires or survey instruments for measuring WPV. In total, the rapid review process identified 84 structural quality indicators, 121 process quality indicators, 24 outcome quality indicators, 57 survey-type questions and 17 survey instruments. CONCLUSIONS: This study provides a foundation for healthcare organizations to address WPV through systematic approaches informed by quality indicators. The utilization of indicators showed promise for characterizing WPV and measuring the efficacy of interventions. Caution must be exercised to ensure indicators are not discriminatory and are suited to specific organizational needs. While the findings of this review are promising, further investigation is needed to rigorously evaluate existing literature to expand the list of quality indicators for WPV.


Asunto(s)
Violencia Laboral , Humanos , Violencia Laboral/prevención & control , Indicadores de Calidad de la Atención de Salud , Servicio de Urgencia en Hospital , Instituciones de Salud , Encuestas y Cuestionarios , Atención a la Salud
4.
BMJ Open ; 14(1): e081006, 2024 01 22.
Artículo en Inglés | MEDLINE | ID: mdl-38262651

RESUMEN

OBJECTIVE: We aimed to understand how, why and in what context upskilling programmes for unregulated care providers (UCPs) to provide foot screening for systematically marginalised groups living with diabetes were implemented. DESIGN: We used realist synthesis based on Realist And Meta-narrative Evidence Syntheses: Evolving Standards guidance. DATA SOURCES: We searched the Medline, Embase, PsycINFO, CINAHL, ERIC, Web of Science Core Collection, and Scopus databases and the grey literature (Google Scholar, ProQuest Dissertations and Theses) up to November 2022. ELIGIBILITY CRITERIA: We included experimental and non-experimental articles in English that either described mechanisms or discussed expected outcomes for educational interventions for patients and family caregivers or healthcare providers, both regulated and unregulated. We also included articles that evaluated the impact of foot care programmes if the UCPs' training was described. DATA EXTRACTION AND SYNTHESIS: The lead author extracted, annotated and coded uploaded relevant data to identify contexts, mechanisms and outcome configurations using MAXQDA (a qualitative data analysis software). We used deductive and inductive coding to structure the process. Our team members double-reviewed and appraised a random sample of 20% of articles at all stages to ensure consistency. RESULTS: Our search identified 52 articles. Evidence suggested the necessity of developing upskilling foot screening programmes within the context of preventive care programmes that also provide education in diabetes, and early referrals for appropriate interventions. Multidisciplinary programmes created an ideal context facilitating coordination between UCPs and their regulated counterparts. Engaging patients and community partners, using a competency-based model, and incorporating cultural competencies were determinants of success for these programmes. CONCLUSION: This review provides a realistic programme theory for the mechanisms used, the context in which these programmes were developed, and the expected outcomes to train UCPs to provide preventive foot care for systematically marginalised populations. PROSPERO REGISTRATION NUMBER: CRD42022369208.


Asunto(s)
Diabetes Mellitus , Pie Diabético , Humanos , Pie , Escolaridad , Extremidad Inferior , Competencia Cultural
5.
Ann Neurol ; 2023 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-37714824

RESUMEN

OBJECTIVE: We sought to better understand the workflow, outcomes, and complications of deep brain stimulation (DBS) for pediatric status dystonicus (SD). We present a systematic review, alongside a multicenter case series of pediatric patients with SD treated with DBS. METHODS: We collected individual data regarding treatment, stimulation parameters, and dystonia severity for a multicenter case series (n = 8) and all previously published cases (n = 77). Data for case series were used to create probabilistic voxelwise maps of stimulated tissue associated with dystonia improvement. RESULTS: In our institutional series, DBS was implanted a mean of 25 days after SD onset. Programming began a mean of 1.6 days after surgery. All 8 patients in our case series and 73 of 74 reported patients in the systematic review had resolution of their SD with DBS, most within 2 to 4 weeks of surgery. Mean follow-up for patients in the case series was 16 months. DBS target for all patients in the case series and 68 of 77 in our systematic review was the globus pallidus pars interna (GPi). In our case series, stimulation of the posterior-ventrolateral GPi was associated with improved dystonia. Mean dystonia improvement was 32% and 51% in our institutional series and systematic review, respectively. Mortality was 4% in the review, which is lower than reported for treatment with pharmacotherapy alone (10-12.5%). INTERPRETATION: DBS is a feasible intervention with potential to reverse refractory pediatric SD and improve survival. More work is needed to increase awareness of DBS in this setting, so that it can be implemented in a timely manner. ANN NEUROL 2023.

6.
BMJ Open ; 13(8): e072570, 2023 08 23.
Artículo en Inglés | MEDLINE | ID: mdl-37612108

RESUMEN

INTRODUCTION: Foot ulcers are one of the most devastating complications of diabetes mellitus leading to leg amputations. In Canada, systematically marginalised and racialised populations are more prone to developing foot ulcers and at higher risk of limb amputations. Shortages of regulated healthcare have hindered efforts to provide foot care. Upskilling unregulated care providers (UCPs) to deliver foot screening seems a reasonable solution to reduce limb loss. UCPs can advocate for health equity and deliver appropriate care. There is a need, however, to understand how and why an educational intervention for UCPs providing foot screening for these high-risk groups may or may not work. METHODS AND ANALYSIS: This realist review will follow the Realist And Meta-narrative Evidence Syntheses: Evolving Standards standards. First, we will develop an initial programme theory (PrT) based on exploratory searches and discussions with experts and stakeholders. Then, we will search MEDLINE, Embase, PsycINFO, ERIC, CINAHL and Scopus databases along with relevant sources of grey literature. The retrieved articles will be screened for studies focusing on planned educational interventions for UCPs related to diabetic foot assessment. Data regarding contexts, mechanisms and outcomes will be extracted and analysed using a realist analysis through an iterative process that includes data reviewing and consultation with our team. Finally, we will use these results to modify the initial PrT. ETHICS AND DISSEMINATION: Ethical approval is not required for this review. The main output of this research will be an evidence-based PrT for upskilling programmes for UCPs. We will share our final PrT using text, tables and infographics to summarise our results and draw insights across papers/reports. For academic, clinical, social care and educational audiences, we will produce peer-reviewed journal articles, including those detailing the process and findings of the realist review and establishing our suggestions for effective upskilling programmes. PROSPERO REGISTRATION NUMBER: CRD42022369208.


Asunto(s)
Pie Diabético , Equidad en Salud , Humanos , Pie Diabético/prevención & control , Pie , Amputación Quirúrgica , Canadá , Literatura de Revisión como Asunto
7.
RMD Open ; 9(2)2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-37349123

RESUMEN

OBJECTIVES: To identify criteria and descriptors used to measure response to treatment and change in disease activity in giant cell arteritis (GCA). METHODS: A systematic literature review (SLR) to retrieve randomised controlled trials (RCTs) and longitudinal observational studies (LOS). Criteria and descriptors of active disease, remission, response, improvement, worsening and relapse were extracted. RCTs, LOS with >20 subjects, and qualitative research studies were included. RESULTS: 10 593 studies were retrieved, of which 116 were included (11 RCTs, 104 LOS, 1 qualitative study). No unified definition of response to therapy was found. Most RCTs used composite endpoints to assess treatment outcomes. Active disease was described in all RCTs and 19% of LOS; and was largely defined by a combination of clinical and laboratory components. Remission was reported in 73% of RCTs and 42% of LOS; It was predominantly defined as the combination of clinical and laboratory components. One LOS reported response with a definition resembling the definition of remission from other studies. Improvement was rarely used as an endpoint and it was mostly a surrogate of remission. No study specifically defined worsening. Relapse was reported in all RCTs and 86% of LOS. It was predominantly defined as the combination of clinical, laboratory and treatment components. CONCLUSIONS: The results of this SLR demonstrate that definitions of response used in clinical studies of GCA are scant and heterogeneous. RCTs and LOS mainly used remission and relapse as treatment outcomes. The descriptors identified will inform the development of the future European Alliance of Associations for Rheumatology-American College of Rheumatology response criteria for GCA.


Asunto(s)
Arteritis de Células Gigantes , Humanos , Estados Unidos , Arteritis de Células Gigantes/diagnóstico , Arteritis de Células Gigantes/tratamiento farmacológico , Evaluación de Resultado en la Atención de Salud , Resultado del Tratamiento , Inducción de Remisión , Recurrencia
8.
BMC Psychiatry ; 23(1): 327, 2023 05 10.
Artículo en Inglés | MEDLINE | ID: mdl-37165333

RESUMEN

BACKGROUND: Electroconvulsive therapy (ECT) is a procedural treatment that is potentially life-saving for some patients with severe psychiatric illness. At the start of the global coronavirus disease 2019 (COVID-19) pandemic, ECT practice was remarkably disrupted, putting vulnerable individuals at increased risk of symptom exacerbation and death by suicide. This study aimed to capture the self-reported experiences of psychiatrists based at healthcare facilities across Canadian provinces who were delivering ECT treatments during the first phase of the COVID-19 pandemic (i.e., from mid-March 2020 to mid-May 2020). METHODS: A multidisciplinary team of experts developed a survey focusing on five domains: ECT unit operations, decision-making, hospital resources, ECT procedure, and mitigating patient impact. Responses were collected from psychiatrists providing ECT at 67 ECT centres in Canada, grouped by four geographical regions (Ontario, Quebec, Atlantic Canada, and Western Canada). RESULTS: Clinical operations of ECT programs were disrupted across all four regions - however, centres in Atlantic Canada were able to best preserve outpatient and maintenance care, while centres in Western Canada were able to best preserve inpatient and acute care. Similarly, Atlantic and Western Canada demonstrated the best decision-making practices of involving the ECT team and clinical ethicists in the development of pandemic-related guidelines. Across all four regions, ECT practice was affected by the redeployment of professionals, the shortage of personal protective equipment, and the need to enforce social distancing. Attempts to introduce modifications to the ECT delivery room and minimize bag-valve-mask ventilation were consistently reported. All four regions developed a new patient prioritization framework, and Western Canada, notably, aimed to provide ECT to only the most severe cases. CONCLUSIONS: The results suggest that ECT provision was disproportionately affected across different parts of Canada. Possible factors that could explain these interregional differences include population, distribution of urban vs. rural areas, pre-pandemic barriers in access to ECT, number of cases, ability to control the spread of infection, and the general reduction in physicians' activities across different areas of health care. Studying these factors in the future will inform how medical centres should respond to public health emergencies and pandemic-related circumstances in the context of procedural treatments.


Asunto(s)
COVID-19 , Terapia Electroconvulsiva , Trastornos Mentales , Humanos , COVID-19/epidemiología , Pandemias/prevención & control , Terapia Electroconvulsiva/métodos , Trastornos Mentales/terapia , Ontario
9.
Vet Clin Pathol ; 52(2): 295-298, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36931892

RESUMEN

A 4-year-old female spayed Australian cattle dog was presented to the Emergency Service at the University of Missouri Veterinary Health Center Small Animal Hospital for generalized pain and lethargy. At presentation, the dog showed severe cervical spinal pain and thoracic limb deficits consistent with a multifocal neuroanatomic localization. Magnetic resonance imaging of the cervical spine revealed T2 and T1 postcontrast intense signal extending from the level of the medulla through C5 most marked in the caudal brainstem and cranial cervical spinal cord. The suspected diagnosis was severe meningoencephalomyelitis and secondary edema. Analysis of cerebrospinal fluid (CSF) collected from the cerebellomedullary cistern revealed a marked mixed pleocytosis with intralesional structures morphologically consistent with Mycobacterium sp. Standard DNA PCR assay performed on the CSF yielded the presence of Mycobacterium haemophilum. To the authors' knowledge, this is the first reported case of CNS mycobacteriosis diagnosed on CSF analysis in a dog.


Asunto(s)
Enfermedades de los Bovinos , Enfermedades de los Perros , Mycobacterium haemophilum , Femenino , Bovinos , Perros , Animales , Australia , Médula Espinal/diagnóstico por imagen , Imagen por Resonancia Magnética/veterinaria , Leucocitosis/veterinaria , Enfermedades de los Perros/diagnóstico , Enfermedades de los Perros/líquido cefalorraquídeo , Líquido Cefalorraquídeo
10.
JMIR Res Protoc ; 11(11): e42681, 2022 Nov 09.
Artículo en Inglés | MEDLINE | ID: mdl-36350706

RESUMEN

BACKGROUND: Web-based instruction plays an essential role in health professions education (HPE) by facilitating learners' interactions with educational content, teachers, peers, and patients when they would not be feasible in person. Within the unsupervised settings where web-based instruction is often delivered, learners must effectively self-regulate their learning to be successful. Effective self-regulation places heavy demands on learners' motivation, so effective web-based instruction must be designed to instigate and maintain learners' motivation to learn. Models of motivational design integrate theories of motivation with design strategies intended to create the conditions for motivated engagement. Teachers can use such models to develop their procedural and conceptual knowledge in ways that help them design motivating instruction in messy real-world contexts. Studies such as randomized controlled trials (RCTs) and other quasi-experimental designs that compare different motivational design strategies play a critical role in advancing models of motivational design. Synthesizing the evidence from those studies can identify effective strategies and help teachers and researchers understand the mechanisms governing why strategies work, for whom, and under what circumstances. OBJECTIVE: The planned review aims to analyze how studies comparing motivational design strategies for web-based instruction in HPE support and advance models of motivational design by (1) controlling for established risks to internal validity, (2) leveraging authentic educational contexts to afford ecological validity, (3) drawing on established theories of motivation, (4) investigating a wide breadth of motivational constructs, and (5) analyzing mediators and moderators of strategy effects. METHODS: The planned review will use database searching, registry searching, and hand searching to identify studies comparing motivational design strategies for web-based instruction, delivered to learners in HPE. Studies will be considered from 1990 onward. Two team members will independently screen studies and extract data from the included studies. During extraction, we will record information on the design characteristics of the studies, the theories of motivation they are informed by, the motivational constructs they target, and the mediators and moderators they consider. RESULTS: We have executed our database and registry searches and have begun screening titles and abstracts. CONCLUSIONS: By appraising the characteristics of studies that have focused on the motivational design of web-based instruction in HPE, the planned review will produce recommendations that will ensure impactful programs of future research in this crucial educational space. TRIAL REGISTRATION: PROSPERO CRD42022359521; https://tinyurl.com/57chuzf6. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42681.

11.
Clin Transl Sci ; 15(12): 2785-2795, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36129129

RESUMEN

Advances in the technologies to enable patient-centric sampling (PCS) have the potential to improve blood sample collection by enabling clinical trial participants to collect samples via self-collection or with the help of a caregiver in their home. Typically, blood samples to assess pharmacokinetics and pharmacodynamics of a drug during clinical development are collected at a clinical site via venous blood draw. In this position paper by the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), the potential value PCS can bring to patients, to the clinical datasets generated, and to clinical trial sponsors is discussed, along with considerations for program decision making, bioanalytical feasibility, operations, and regulatory implications. With an understanding of the value of PCS and considerations when implementing during clinical drug development, we can bring the promise of PCS closer to reality and enable decentralized clinical trials.


Asunto(s)
Desarrollo de Medicamentos , Atención Dirigida al Paciente , Humanos
12.
HIV Res Clin Pract ; 23(1): 76-90, 2022 08 02.
Artículo en Inglés | MEDLINE | ID: mdl-35968737

RESUMEN

Background: HIV cure-directed clinical trials using analytical treatment interruptions (ATIs) require participants to adhere to frequent monitoring visits for viral load tests. Novel viral load monitoring strategies are needed to decrease participant burden during ATIs.Objective: To examine acceptability of a novel home-based blood collection device for viral load testing in the context of two ongoing ATI trials in Philadelphia, PA, United States.Methods: From January 2021 to February 2022, participants completed three in-depth interviews via teleconference during their participation in an ATI: (1) within two weeks of enrollment in the device study, (2) approximately four weeks after beginning to use the device, and (3) within two weeks of the end of the ATI when ART was re-initiated. We used conventional content analysis to analyze the data.Results: We recruited 17 participants: 15 were cisgender males, 1 cisgender female, and 1 transgender woman. We observed an overall 87% success rate in drawing blood with the device from home collection and found overall high acceptance of the device. A mean of 91.5 devices per participant were used for home-based blood collection. Most PWH viewed the device as relatively convenient, painless, easy to use, and a simple solution to frequent blood draws. The main challenge encountered was the inability to completely fill up devices with blood in some cases. Most participants reported positive experiences with mailing blood samples and could see themselves using the device on a regular basis outside of ATIs.Conclusions: Our study showed participant valued the novel home-based peripheral blood collection for viral load testing in the context of ATI trials. More research will be necessary to optimize implementation of the device and to assess whether blood collected can reliably measure viral loads in the context of ATI trials.


Asunto(s)
Infecciones por VIH , Femenino , Infecciones por VIH/tratamiento farmacológico , Humanos , Estudios Longitudinales , Masculino , Pruebas Serológicas , Estados Unidos , Carga Viral , Privación de Tratamiento
13.
AAPS J ; 24(3): 53, 2022 04 06.
Artículo en Inglés | MEDLINE | ID: mdl-35384522

RESUMEN

In-clinic venous dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer's disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a potential alternative to plasma PK sampling. Initially, plasma and DBS PK samples were collected concurrently to better understand the DBS-plasma verubecestat concentration relationship, with the intention of discontinuing DBS or plasma sampling following interim analysis. Following initial analyses and comparison of results with prespecified selection criteria, plasma PK sampling was discontinued; however, a stability issue resulting in generally lower DBS verubecestat concentrations with longer collection-to-assay times was subsequently discovered (associated with non-compliance in DBS sample handling), prompting reintroduction of plasma sampling. To enable inclusion of DBS data in population PK analyses, a conversion algorithm for calculating plasma-equivalent concentrations (accounting for DBS sample instability) was developed using paired (time-matched) plasma and DBS data from the EPOCH study. Verubecestat population PK models developed from pooled phase 1/1b and EPOCH data using either (1) plasma-only data or (2) plasma and plasma-equivalent concentrations (calculated from non-paired DBS samples) yielded similar results. The algorithm robustness was demonstrated using DBS data from paired samples from the APECS study and comparison between plasma and plasma-equivalent concentrations. The population PK model was updated with APECS data (both plasma and, if no plasma sample available, plasma equivalents). The results demonstrated similar PK in the two phase 3 populations and exposures consistent with expectations from phase 1 data. This case study illustrates challenges with employing new sampling techniques in large, global trials and describes lessons learned.


Asunto(s)
Enfermedad de Alzheimer , Tiadiazinas , Enfermedad de Alzheimer/tratamiento farmacológico , Óxidos S-Cíclicos , Pruebas con Sangre Seca/métodos , Humanos
14.
AAPS J ; 24(3): 52, 2022 04 06.
Artículo en Inglés | MEDLINE | ID: mdl-35384529

RESUMEN

In-clinic dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer's disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a potential alternative to plasma PK sampling for improved logistical feasibility and decreased blood volume burden. However, an interim PK analysis revealed verubecestat concentrations in DBS samples declined with time to assay in both trials. An investigation revealed wide variation in implementation practices for DBS sample handling procedures resulting in insufficient desiccation which caused verubecestat instability. High-resolution mass spectrometry evaluations of stressed and aged verubecestat DBS samples revealed the presence of two hydrolysis degradants. To minimize instability, new DBS handling procedures were implemented that provided additional desiccant and minimized the time to analysis. Both verubecestat hydrolysis products were previously discovered and synthesized during active pharmaceutical ingredient stability characterization. A liquid chromatography-mass spectrometry assay to quantitate the dominant verubecestat degradant in DBS samples was developed and validated. The application of this method to stressed and aged verubecestat DBS samples confirmed that degradant concentrations accounted for the observed decreases in the verubecestat concentration. Furthermore, after increasing desiccant amounts, degradant concentrations accounted for approximately 7% of the verubecestat concentration in DBS clinical samples, indicating that issues with sample handling were minimized with new storage and shipping conditions. This case study illustrates the challenges with employing new sampling techniques in large, global trials, and the importance of anticipating and mitigating implementation risks.


Asunto(s)
Pruebas con Sangre Seca , Espectrometría de Masas en Tándem , Óxidos S-Cíclicos , Pruebas con Sangre Seca/métodos , Higroscópicos , Manejo de Especímenes , Espectrometría de Masas en Tándem/métodos , Tiadiazinas
15.
HIV Res Clin Pract ; 23(1): 120-135, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-35348047

RESUMEN

BACKGROUND: People with HIV (PWH) and community members have advocated for the development of a home-based viral load test device that could make analytical treatment interruptions (ATIs) less burdensome. OBJECTIVE: We assessed community acceptability of a novel home-based viral load test device. METHODS: In 2021, we conducted 15 interviews and 3 virtual focus groups with PWH involved in HIV cure research. We used conventional thematic analysis to analyze the data. RESULTS: PWH viewed the home-based viral load test device as a critical adjunct in ongoing HIV cure trials with ATIs. The ability to test for viral load at home on demand would alleviate anxiety around being off ART. Participants drew parallels with glucometers used for diabetes. A preference was expressed for the home-based test to clearly indicate whether one was detectable or undetectable for HIV to mitigate risk of HIV transmission to partners. Perceived advantages of the device included convenience, sense of control, and no puncturing of veins. Perceived concerns were possible physical marks, user errors and navigating the logistics of mailing samples to a laboratory and receiving test results. Participants expressed mixed effects on stigma, such as helping normalize HIV, but increased potential for inadvertent disclosure of HIV status or ATI participation. Increasing pluri-potency of the device beyond viral load testing (e.g., CD4+ count test) would increase its utility. Participants suggested pairing the device with telemedicine and mobile health technologies. CONCLUSIONS: If proven effective, the home-based viral load test device will become a critical adjunct in HIV cure research and HIV care.


Asunto(s)
Infecciones por VIH , Humanos , Estados Unidos , Carga Viral , Recuento de Linfocito CD4 , Punciones
16.
Vet Clin Pathol ; 51(3): 422-425, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-35288963

RESUMEN

A 12-year-old female spayed, Silken Windhound dog was presented with a 3-month history of lethargy and cervical and lumbosacral spinal pain. No significant abnormalities were noted on CBC or serum biochemical assays. Magnetic resonance imaging of the spine demonstrated a soft tissue mass within the ventral and right epidural space at the level of the L7 vertebra. During surgery, a pale brown mass was identified within the epidural fat. Cytologic and histopathologic examinations demonstrated that the mass was composed of adipose tissue and hematopoietic elements, consistent with a myelolipoma. The lumbosacral spinal pain resolved after surgery. Epidural myelolipomas are rarely reported in the human and veterinary literature.


Asunto(s)
Neoplasias de las Glándulas Suprarrenales , Enfermedades de los Perros , Mielolipoma , Neoplasias de las Glándulas Suprarrenales/patología , Neoplasias de las Glándulas Suprarrenales/cirugía , Neoplasias de las Glándulas Suprarrenales/veterinaria , Animales , Enfermedades de los Perros/diagnóstico por imagen , Enfermedades de los Perros/cirugía , Perros , Espacio Epidural/patología , Femenino , Humanos , Imagen por Resonancia Magnética/veterinaria , Mielolipoma/diagnóstico , Mielolipoma/cirugía , Mielolipoma/veterinaria , Dolor/veterinaria , Seda
17.
J Pers Med ; 12(2)2022 Feb 07.
Artículo en Inglés | MEDLINE | ID: mdl-35207719

RESUMEN

Frequent viral load testing is necessary during analytical treatment interruptions (ATIs) in HIV cure-directed clinical trials, though such may be burdensome and inconvenient to trial participants. We implemented a national, cross-sectional survey in the United States to examine the acceptability of a novel home-based peripheral blood collection device for HIV viral load testing. Between June and August 2021, we distributed an online survey to people with HIV (PWH) and community members, biomedical HIV cure researchers and HIV care providers. We performed descriptive analyses to summarize the results. We received 73 survey responses, with 51 from community members, 12 from biomedical HIV cure researchers and 10 from HIV care providers. Of those, 51 (70%) were cisgender men and 50 (68%) reported living with HIV. Most (>80% overall) indicated that the device would be helpful during ATI trials and they would feel comfortable using it themselves or recommending it to their patients/participants. Of the 50 PWH, 42 (84%) indicated they would use the device if they were participating in an ATI trial and 27 (54%) also expressed a willingness to use the device outside of HIV cure studies. Increasing sensitivity of viral load tests and pluri-potency of the device (CD4 count, chemistries) would augment acceptability. Survey findings provide evidence that viral load home testing would be an important adjunct to ongoing HIV cure-directed trials involving ATIs. Survey findings may help inform successful implementation and uptake of the device in the context of personalized HIV care.

18.
J Pharm Biomed Anal ; 212: 114639, 2022 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-35176654

RESUMEN

For pharmacokinetics characterization of a therapeutic insulin dimer, an ultrasensitive plasma method was required due to the expected low circulating levels in humans. A bioanalytical strategy combining immunoprecipitation enrichment with liquid chromatography - tandem mass spectrometry (LC-MS/MS) analysis of the intact protein offers the opportunity to resolve the analyte from endogenous and exogenous insulin and insulin analogs. Nonetheless, interference from complex background matrix was observed limiting reliable measurements at the low concentration range. A sample preparation approach incorporating protein precipitation and immunoprecipitation was developed and optimized to further reduce sample complexity prior to LC-MS/MS analysis. This approach enabled a deeper level of selectivity and presented a cleaner mass spectrometric detection that may otherwise be confounded. Sample preparation was automated to allow high throughput analysis. The method reached a limit of quantitation at 0.3 ng/mL (25 pM), and a linear dynamic range from 0.3 to 300 ng/mL. Results were highly reproducible, with intra-day and inter-day precision and bias below 11%. Furthermore, the organic solvent treatment involved in protein precipitation is expected to improve assay resistance to the bias introduced by endogenous protein binding such as that exerted by anti-drug antibodies. The method was successfully applied to support clinical pharmacokinetics studies. This approach may potentially be adapted to bioanalysis of low abundance proteins.


Asunto(s)
Insulina , Espectrometría de Masas en Tándem , Cromatografía Liquida/métodos , Humanos , Proteínas , Reproducibilidad de los Resultados , Espectrometría de Masas en Tándem/métodos
19.
J ECT ; 38(1): 52-59, 2022 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-34519681

RESUMEN

OBJECTIVES: The COVID-19 pandemic has disrupted the provision of essential and potentially life-saving procedural treatments such as electroconvulsive therapy (ECT). We surveyed ECT providers across Canada to understand how the first wave of the pandemic affected ECT delivery between mid-March 2020 and mid-May 2020. METHODS: The survey was administered to ECT team members and decision makers at 107 Canadian health care centers with a focus on 5 domains: operations, decision-making, hospital resources, ECT procedure, and patient impact. Responses were obtained from 72 institutions, and collected answers were used to derive representative responses reflecting the situation at each ECT center. For specific domains, responses were split into 2 databases representing the perspective of psychiatrists (n = 67 centers) and anesthesiologists (n = 24 centers). RESULTS: Provision of ECT decreased in 64% centers and was completely suspended in 27% of centers after the onset of the pandemic. Outpatient and maintenance ECT were more affected than inpatient and acute ECT. Programs reported a high level of collaboration between psychiatry and hospital leadership (59%) but a limited input from clinical ethicists (18%). Decisions were mostly made ad hoc leading to variability across institutions in adopted resource allocation, physical location of ECT delivery, and triaging frameworks. The majority of centers considered ECT to be aerosol-generating and incorporated changes to airway management. CONCLUSIONS: Electroconvulsive therapy services in Canada were markedly disrupted by the COVID-19 pandemic. The variability in decision-making across centers warrants the development of a rational approach toward offering ECT in pandemic contexts.


Asunto(s)
COVID-19 , Terapia Electroconvulsiva , Canadá , Terapia Electroconvulsiva/métodos , Humanos , Pandemias , SARS-CoV-2 , Encuestas y Cuestionarios
20.
J Contin Educ Health Prof ; 42(1): 66-69, 2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34009838

RESUMEN

INTRODUCTION: The field of Continuing Professional Development (CPD) has a role to play in supporting health care professionals as they respond to the COVID-19 pandemic. However, the evolving science of COVID-19, the need for quick action, and the disruption of conventional knowledge networks pose challenges to existing CPD practices. To meet these emergent and rapidly evolving needs, what is required is an approach to CPD that draws insights from the domain of knowledge mobilization (KMb). METHODS: This short report describes a research protocol for exploring rapid KMb responses to COVID-19 at one Canadian academic teaching hospital. The proposed research will proceed as a case study using a mixed methods design collecting quantitative (surveys and Web site use metrics) and qualitative data (interviews) from individuals involved in developing, using, and supporting the KMb resources. Analysis will proceed in two phases: descriptive analysis of data to share insights and integrative analysis of data to build theory. RESULTS: Results from this study will inform the immediate KMb and CPD contribution to the COVID-19 response. DISCUSSION: Findings from this study will also make a broader contribution to the field of CPD, theoretically informing intersections between KMb and CPD and therefore contributing to an integrated science of CPD.


Asunto(s)
COVID-19 , COVID-19/epidemiología , Canadá , Humanos , Conocimiento , Pandemias , SARS-CoV-2
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