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2.
Transfusion ; 64(5): 775-783, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38516758

RESUMO

BACKGROUND: Immunoglobulin (IG) therapy is widely used to treat primary and secondary immune deficiencies and as immunomodulatory agent for various disorders. There is great concern that shortages of IG may rise, potentially affecting medical treatment options. STUDY DESIGN AND METHODS: An international survey was developed to study how intravenous immunoglobulins (IVIGs) are used and managed within hospitals in case of shortages. Study data were collected and managed using REDCap electronic data capture tools hosted by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. The survey was directed to hospital pharmacists and blood bank transfusion professionals and disseminated through members of the BEST Collaborative network. RESULTS: Survey respondents from institutions in the USA, Canada, Europe, Japan, and Australia (n = 13) confirmed that the primary specialties utilizing IG are neurology, hematology, and immunology. More than 60% of respondents reported IG supply shortages, but mitigation strategies were not well developed. DISCUSSION: As IG is the leading driver in plasma demand, more studies are needed to understand current and future demand for IG from the clinical perspective. Necessity lies in establishing clinical guidance to address shortages.


Assuntos
Imunoglobulinas Intravenosas , Humanos , Inquéritos e Questionários , Imunoglobulinas Intravenosas/uso terapêutico , Austrália , Canadá , Hospitais/estatística & dados numéricos , Japão , Estados Unidos , Bancos de Sangue/provisão & distribuição , Bancos de Sangue/estatística & dados numéricos
3.
Transfusion ; 64(5): 839-845, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38534065

RESUMO

BACKGROUND: Current Association for the Advancement of Blood & Biotherapies (AABB) standards require transfusion services to have a policy on Rh immune globulin (RhIG) immunoprophylaxis for when RhD-negative patients are exposed to RhD-positive red cells. This is a survey of AABB-accredited transfusion services in the United States (US) regarding institutional policies and practices on RhIG immunoprophylaxis after RhD-negative patients receive RhD-positive (i.e., RhD-incompatible) packed red blood cell (pRBC) and platelet transfusions. RESULTS: Approximately half of the respondents (50.4%, 116/230) have policies on RhIG administration after RhD-incompatible pRBC and platelet transfusions, while others had policies for only pRBC (13.5%, 31/230) or only platelet (17.8%, 41/230) transfusions, but not both. In contrast, 18.3% (42/230) report that their institution has no written policies on RhIG immunoprophylaxis after RhD-incompatible transfusions. Most institutions (70.2%, 99/141) do not have policies addressing safety parameters to mitigate the risk of hemolysis associated with the high dose of RhIG required to prevent RhD alloimmunization after RhD-incompatible pRBC transfusions. DISCUSSION: With approximately half of US AABB-accredited institutions report having policies on RhIG immunoprophylaxis after both RhD-incompatible pRBC and platelet transfusions, some institutions may not be in compliance with AABB standards. Further, most with policies on RhIG immunoprophylaxis after RhD-incompatible pRBC transfusion do not have written safeguards to mitigate the risk of hemolysis associated with the high dose of RhIG required. CONCLUSION: This survey underscores the diverse and inadequate institutional policies on RhIG immunoprophylaxis after RhD exposure in Rh-negative patients via transfusion. This observation identifies an opportunity to improve transfusion safety.


Assuntos
Transfusão de Plaquetas , Sistema do Grupo Sanguíneo Rh-Hr , Imunoglobulina rho(D) , Humanos , Imunoglobulina rho(D)/uso terapêutico , Sistema do Grupo Sanguíneo Rh-Hr/imunologia , Transfusão de Plaquetas/efeitos adversos , Isoimunização Rh/prevenção & controle , Transfusão de Eritrócitos , Estados Unidos , Eritrócitos/imunologia , Inquéritos e Questionários
4.
Chest ; 2024 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-38447639

RESUMO

BACKGROUND: Albumin is used commonly across a wide range of clinical settings to improve hemodynamics, to facilitate fluid removal, and to manage complications of cirrhosis. The International Collaboration for Transfusion Medicine Guidelines developed guidelines for the use of albumin in patients requiring critical care, undergoing cardiovascular surgery, undergoing kidney replacement therapy, or experiencing complications of cirrhosis. METHODS: Cochairs oversaw the guideline development process and the panel included researchers, clinicians, methodologists, and a patient representative. The evidence informing this guideline arises from a systematic review of randomized clinical trials and systematic reviews, in which multiple databases were searched (inception through November 23, 2022). The panel reviewed the data and formulated the guideline recommendations using Grading of Recommendations Assessment, Development and Evaluation methodology. The guidelines were revised after public consultation. RESULTS: The panel made 14 recommendations on albumin use in adult critical care (three recommendations), pediatric critical care (one recommendation), neonatal critical care (two recommendations), cardiovascular surgery (two recommendations), kidney replacement therapy (one recommendation), and complications of cirrhosis (five recommendations). Of the 14 recommendations, two recommendations had moderate certainty of evidence, five recommendations had low certainty of evidence, and seven recommendations had very low certainty of evidence. Two of the 14 recommendations suggested conditional use of albumin for patients with cirrhosis undergoing large-volume paracentesis or with spontaneous bacterial peritonitis. Twelve of 14 recommendations did not suggest albumin use in a wide variety of clinical situations where albumin commonly is transfused. CONCLUSIONS: Currently, few evidence-based indications support the routine use of albumin in clinical practice to improve patient outcomes. These guidelines provide clinicians with actionable recommendations on the use of albumin.

6.
Transfusion ; 64(4): 590-596, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38400777

RESUMO

BACKGROUND: Correct classification of transfusion reactions is important not only for effective patient care and donor management but also for accurate tracking of events in hemovigilance systems. We compared the ability of a generative artificial intelligence (AI) system to correctly diagnose hypothetical clinical situations as transfusion reactions in comparison to previous studies reporting the accuracy of transfusion medicine (TM) specialists in assessing these cases. METHODS: An AI system was requested to assess 36 case scenarios to provide a diagnosis, severity, and imputability of the transfusion reactions using the CDC National Healthcare Safety Network (NHSN) criteria. Responses were compared to an expert panel's classifications and to the published responses of a panel of TM specialists. Additionally, the AI's responses were compared to the TM specialists' prior attempts to use the TrDDx web-based algorithm for the five most challenging cases. RESULTS: The AI's classification accuracy varied widely depending on the NHSN category. The AI accurately classified all transfusion-associated circulatory overload and transfusion-related acute lung injury cases, exceeding TM specialists' assessments. Conversely, it did not correctly identify any cases in select NHSN categories such as DSTR. Overall accuracy among all diagnostic categories was 48.7% for AI responses versus 72.1% for prior TM specialist responses (p = 0.005). AI-generated responses included non-standard terminology, limited severity assessments, and no imputability determinations. DISCUSSION: A generative AI system may have a role in helping healthcare providers to consider transfusion reaction categories that might be missed, but caution is advised in applying the AI's output to transfusion reaction classification at present.


Assuntos
Inteligência Artificial , Reação Transfusional , Humanos , Algoritmos , Instalações de Saúde , Pessoal de Saúde
7.
Fam Pract ; 41(2): 155-160, 2024 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-37950458

RESUMO

PURPOSE: Antibiotic use and misuse are common in pregnant women and young children. Few studies have assessed real-world discussions of antibiotics in these populations. Using social media posts of pregnant women and parents, our goal was to identify key themes about facilitators and barriers to appropriate antibiotic usage. METHODS: A purposive sample of public posts and comments relevant to antibiotic use was collected from the BabyCenter United States social media site. Using a directed content analysis, themes related to facilitators and barriers to appropriate antibiotic use were identified. RESULTS: Seven hundred and twenty-six posts and 5227 comments were analysed. Themes centred around individual factors, interpersonal factors, and structural factors. Individual factors included knowledge and beliefs. Though misinformation was present, most parents were aware of appropriate antibiotic usage and perceived antibiotics as safe and effective. Some hesitance around using antibiotics led to recommendations for home remedies or over-the-counter treatments. Interpersonal factors focused on a lack of available offline peer support, the expertise of providers, as well as a potential lack of attention from those providers. Structural factors, including access to care, also impacted parents' antibiotic use and misuse. CONCLUSION: Though most parents demonstrated appropriate knowledge about antibiotics and a willingness to follow guidelines, negative experiences with their providers, a lack of support from peers, and structural factors presented as potential barriers to appropriate antibiotic use. Implementing avenues for peer support for parents, allowing more time for providers to address parents' concerns, and improving access to providers could improve appropriate antibiotic use in parents.


Assuntos
Poder Familiar , Pais , Criança , Humanos , Feminino , Gravidez , Pré-Escolar , Gestantes , Aconselhamento , Antibacterianos/uso terapêutico
8.
Arch Pathol Lab Med ; 148(2): 149-154, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-37134231

RESUMO

CONTEXT.­: Ankylosing spondylitis (AS) is an autoimmune disorder with a strong genetic risk, especially with HLA-B27. Clinical testing for HLA-B27 has been used to help diagnose patients with signs and symptoms of AS. Testing methods used by clinical laboratories for HLA-B27 fall into the broad categories of serologic/antibody- or molecular-based methods and have evolved over time. The College of American Pathologists (CAP) offers a proficiency testing survey for HLA-B27. OBJECTIVE.­: To analyze HLA-B27 testing trends and their performance in the past decade, using the proficiency testing survey data submitted to CAP. DESIGN.­: We analyzed the HLA-B27 CAP proficiency testing data from 2010 to 2020 for the method used, participant concordance, and error rates. Results from case scenarios to understand evolving scientific data around HLA-B27 risk alleles were also analyzed. RESULTS.­: Antibody-based flow cytometry is the most common method, though it has decreased from 60% in 2010 to 52% in 2020, with a corresponding increase in molecular methods. Among the molecular methods, real-time polymerase chain reaction has increased from 2% to 15%. Flow cytometry had the highest error rate (5.33%), and sequence-specific oligonucleotide (0%) is the most accurate (0%). Results of case scenarios demonstrated that most participants understood that allele-level HLA-B27 typing results inform clinical interpretation, for example HLA-B*27:06 is not associated with AS. CONCLUSIONS.­: These data demonstrated the changing trends for HLA-B27 testing during the past decade. HLA-B27 allelic typing provides a better understanding of AS association. This is possible by testing for the second field with methods like next-generation sequencing.


Assuntos
Antígeno HLA-B27 , Espondilite Anquilosante , Humanos , Antígeno HLA-B27/genética , Alelos , Patologistas , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/genética , Reação em Cadeia da Polimerase em Tempo Real
9.
Acad Pathol ; 10(4): 100096, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37964769

RESUMO

Health literacy has been defined and studied as an important component of a patient's ability to understand and obtain appropriate healthcare. However, a laboratory component of health literacy, as it pertains to the understanding of laboratory tests and their results, has not been previously defined. An analysis of readily available health literacy tools was conducted to determine laboratory testing-specific content representation. One hundred and four health literacy tools from a publicly available database were analyzed. Many of the health literacy tools were found to be lacking items related to laboratory testing. Of the health literacy tools that did contain a laboratory component, they were categorized pertaining to the laboratory test/testing content. Emerging from this process, eight competencies were identified that encompassed the entire range of laboratory-related aspects of health literacy. We propose that these eight competencies form the basis of a set of competencies needed for one to access, interpret, and act on laboratory results-a capacity we are referring to as "laboratory literacy."

10.
Transfus Med Rev ; 37(3): 150757, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37741794

RESUMO

Ensuring patient informed consent is a key tenet of modern medicine. Although transfusion of blood products is among the most common medical procedures performed in hospitalized patients, there is evidence that informed consent for transfusion is at times incomplete, poorly understood, hurried, and/or inaccurate. This study aimed to develop a narrative that can be used as a framework for practicing physicians and for educational purposes to optimize the process for obtaining informed consent for blood transfusion. The narrative was developed using a modified Delphi approach with 5 Rounds that included feedback from transfusion medicine (TM) experts, transfusion-provider physicians, and lay people. The surveys collected qualitative and quantitative data analyzed using thematic content analysis and descriptive statistics, respectively. Results from Rounds 1 and 2 generated a draft narrative and Rounds 3 to 5 informed further modifications. Round 1 included draft narrative scripts from 28 TM experts; thematic coding generated 97 topics. In round 2, 22/28 of the initial experts rated items identified from Round 1. Those with a content validity index (CVI) ≥ 0.8 were used by the authors to develop a narrative. In Round 3, 20/24 participants from Round 2 reviewed the narrative with 100% agreeing on the items included and 90% agreeing the flow was logical. In Round 4, 23 transfusion prescribers (non-TM physicians) reviewed the narrative for flow, manner, length, and usability; there was 83% agreement with the nonexclusion of important topics; 91% felt it would be effective for teaching trainees. Round 5 included 24 nonmedical laypeople of different demographics. Most participants (92%) thought that the script was appropriate in length and there were opportunities to ask questions. Participants could also identify the adverse transfusion reactions and understand that they could refuse the transfusion. A narrative for obtaining informed consent for blood transfusion was created through multiple rigorous iterations of review and feedback with both transfusion providers and the lay public. The narrative, developed for a specific clinical scenario, was well-received by medical and nonmedical participants and can be used, and modified, to help ensure patients understand the risks and benefits of blood transfusion.

11.
Arch Pathol Lab Med ; 2023 Aug 23.
Artigo em Inglês | MEDLINE | ID: mdl-37610100

RESUMO

CONTEXT.­: Gene editing-based therapies are currently in development in the areas of oncology, inherited disease, and infectious disease. These potentially life-altering therapies are derived from decades of research in both academic and industry settings that developed technologies rooted in principles and products of nature. However, with such technologic developments come many important considerations, including adverse risks, high cost, and ethical questions. OBJECTIVE.­: To educate pathologists about gene editing technologies, inform them of potential indications and risks, outline regulatory and practical issues that could affect hospital-based practice and laboratory testing, and advocate that pathologists need to be present at discussions among industry and regulators pertaining to gene editing-based therapies. DESIGN.­: A Gene Editing Workgroup, facilitated by the College of American Pathologists Personalized Health Care Committee and consisting of pathologists of various backgrounds, was convened to develop an educational paper to serve as a stimulus to increase pathologist involvement and inquiry in gene editing therapeutic and diagnostic implementation. RESULTS.­: Through multiple discussions and literature review, the workgroup identified potential gaps in pathologists' knowledge of gene editing. Additional topics that could impact pathology and laboratory medicine were also identified and summarized in order to facilitate pathologists as stakeholders in gene editing therapy administration and monitoring and potential use in diagnostics. CONCLUSIONS.­: Gene editing therapy is a complex but potentially transformative area of medicine. This article serves as an introduction to pathologists to assist them in future discussions with colleagues and potentially identify and alter pathology practices that relate to gene editing.

12.
Arch Pathol Lab Med ; 2023 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-37603682

RESUMO

CONTEXT­: Gene editing-based therapies are currently in development in the areas of oncology, inherited disease, and infectious disease. These potentially life-altering therapies are derived from decades of research in both academic and industry settings that developed technologies rooted in principles and products of nature. However, with such technologic developments come many important considerations, including adverse risks, high cost, and ethical questions. OBJECTIVE­: To educate pathologists about gene editing technologies, inform them of potential indications and risks, outline regulatory and practical issues that could affect hospital-based practice and laboratory testing, and advocate that pathologists need to be present at discussions among industry and regulators pertaining to gene editing-based therapies. DESIGN­: A Gene Editing Workgroup, facilitated by the College of American Pathologists Personalized Health Care Committee and consisting of pathologists of various backgrounds, was convened to develop an educational paper to serve as a stimulus to increase pathologist involvement and inquiry in gene editing therapeutic and diagnostic implementation. RESULTS­: Through multiple discussions and literature review, the workgroup identified potential gaps in pathologists' knowledge of gene editing. Additional topics that could impact pathology and laboratory medicine were also identified and summarized in order to facilitate pathologists as stakeholders in gene editing therapy administration and monitoring and potential use in diagnostics. CONCLUSIONS­: Gene editing therapy is a complex but potentially transformative area of medicine. This article serves as an introduction to pathologists to assist them in future discussions with colleagues and potentially identify and alter pathology practices that relate to gene editing.

14.
Transfusion ; 62(3): 540-545, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35044688

RESUMO

BACKGROUND: Under-transfusion is an underreported entity within most hospitals and hemovigilance systems. While critical blood shortages are being reported more frequently, without incident codes to document instances of under-transfusion due to lack of inventory, estimating its impact on patient care as it relates to hemotherapy (HT) has hampered our ability to assess and inform strategic initiatives to combat inventory issues as well as prepare for future blood supply threats. STUDY DESIGN AND METHOD: An 11-member working group of the AABB (Association for the Advancement of Blood and Biotherapies) Hemovigilance Committee was formed in October 2020 to study the topic of under-transfusion including its potential causes and clinical expressions. The group was also charged with proposing simple definition/incident codes to be used by hemovigilance systems to document such instances. RESULTS: The working group proposed four simple incident codes under the new process code-No Blood (NB)-that can be used by hemovigilance systems to appropriately document instances of under-transfusion due to lack of inventory. The codes were described as: (1) NB 01-Inventory less than usual level due to supplier shortage; (2) NB 02-Demand for blood product exceeding usual inventory levels; (3) NB 03-Substitution with incompatible/inappropriate units; and (4) NB 04-Suboptimal dose/no transfusion given. CONCLUSION: The adoption of these codes within hemovigilance systems globally would assist in recognition and reporting instances of under-transfusion due to inventory, thus supporting development of better collection strategies, inventory management techniques as well as effective policies to improve blood safety and availability.


Assuntos
Segurança do Sangue , Reação Transfusional , Transfusão de Sangue , Humanos
15.
J Immunol Methods ; 499: 113157, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34597620

RESUMO

OBJECTIVE: Our goal was to develop a simpler and less expensive method of obtaining human clinical-grade WBCs using an alternative method to continuous leukapheresis. Our purpose for the WBCs is to arm them with rabbit anticancer antibodies for a phase I clinical trial. METHODS: Using leukocyte reduction filters (LRFs) discarded from the blood bank, we evaluated multiple variables to maximize recovery of WBCs with the lowest contamination of RBCs. Using an optimized protocol, full-scale runs according to FDA current Good Manufacturing Practice (cGMP) standards were completed with immediate filtration of blood obtained from donors participating in our study. RESULTS: Forward flushing of the filter removed 85% to 95% of residual RBCs and platelets. When backward flushed with 800 mL, 95% of the WBCs recovered were contained in the first 400 mL. The number of recovered WBCs was in the range of 166-211 million/100 mL filtered blood. Subpopulations of WBCs recovered from the LRFs were in the same proportion as the donors' whole blood. Viability of recovered WBCs was 96-99%. Exogenous rabbit antibodies bound well to the recovered WBCs and were retained for at least 5 h without significant reduction. Three full scale runs of WBCs recovered from donor blood filtered through the LRF met all FDA specification of sterility, endotoxin levels, viability and stability. CONCLUSION: Using LRFs, high quality clinical grade WBCs are readily obtained in quantities of 0.2 to 1.2 billion cells from 100 mL to 450 mL (1 unit) of whole blood.


Assuntos
Filtração , Leucócitos/citologia , Humanos
16.
Transfusion ; 61(9): 2668-2676, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34227689

RESUMO

BACKGROUND: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context. STUDY DESIGN AND METHODS: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. RESULTS: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. CONCLUSION: The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.


Assuntos
Doadores de Sangue , Segurança do Sangue , COVID-19/sangue , COVID-19/imunologia , SARS-CoV-2/imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/diagnóstico , COVID-19/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Vigilância em Saúde Pública , Estudos Retrospectivos , Índice de Gravidade de Doença , Estados Unidos/epidemiologia , Adulto Jovem
17.
Acad Pathol ; 8: 23742895211011928, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34027053

RESUMO

Testing during the COVID-19 pandemic has been crucial to public health surveillance and clinical care. Supply chain constraints-spanning limitations in testing kits, reagents, pipet tips, and swabs availability-have challenged the ability to scale COVID-19 testing. During the early months, sample collection kits shortages constrained planned testing expansions. In response, the University of Vermont Medical Center, University of Vermont College of Medicine, Vermont Department of Health Laboratory, Aspenti Health, and providers across Vermont including 16 area hospitals partnered to surmount these barriers. The primary objectives were to increase supply availability and manage utilization. Within the first month of Vermont's stay-at-home order, the University of Vermont Medical Center laboratory partnered with College of Medicine to create in-house collection kits, producing 5000 per week. University of Vermont Medical Center reassigned 4 phlebotomists, laboratory educators, and other laboratory staff, who had reduced workloads, to participate (requiring a total of 5.3-7.6 full-time equivalent (FTE) during the period of study). By August, automation at a local commercial laboratory produced 22,000 vials of media in one week (reducing the required personnel by 1.2 FTE). A multisite, cross-institutional approach was used to manage specimen collection kit utilization across Vermont. Hospital laboratory directors, managers, and providers agreed to order only as needed to avoid supply stockpiles and supported operational constraints through ongoing validations and kit assembly. Throughout this pandemic, Vermont has ranked highly in number of tests per million people, demonstrating the value of local collaboration to surmount obstacles during disease outbreaks and the importance of creative allocation of resources to address statewide needs.

18.
Transfusion ; 61(8): 2487-2495, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33969906

RESUMO

BACKGROUND: Transfusions are a common intervention within pediatrics and require unique considerations to optimize patient care. Poor knowledge of evidence-based transfusion practice can lead to misuse of transfusion therapy and harm. While there have been assessments of transfusion medicine knowledge of physicians caring for adult patients, there is little data regarding pediatricians. STUDY DESIGN AND METHODS: Using a published transfusion medicine knowledge exam for internal medicine physicians as a backbone, pediatric transfusion medicine experts, using an iterative process, developed a pediatric-specific examination. Pilot testing and Rasch analysis, a method used in high-stakes testing, was used to validate the exam. The exam and a previously validated survey on transfusion medicine training, attitudes, and perceived ability were administered to pediatric residents. Analysis consisted of descriptive statistics as well as comparisons of exam scores based on survey responses. RESULTS: 330 pediatric residents from 19 sites in 6 countries participated in the study. The vast majority (91%) of residents had obtained blood product consent. The mean exam score was 37.1% (range 9.5%-71.4%) with no statistical differences based on amount or perceived quality of transfusion medicine education or perceived ability. DISCUSSION: A rigorously validated exam has now been developed that can be used to assess pediatric transfusion medicine knowledge. A large international group of pediatric residents performed poorly on the exam demonstrating a pressing need for improved transfusion medicine education to ensure safe and appropriate administration of blood components to infants and children.


Assuntos
Pediatria/educação , Medicina Transfusional/educação , Adulto , Criança , Competência Clínica , Humanos , Internato e Residência , Avaliação das Necessidades , Adulto Jovem
19.
Arch Pathol Lab Med ; 145(6): 704-716, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-33237994

RESUMO

CONTEXT.­: Chimeric antigen receptor T-cell (CAR-T) technology has shown great promise in both clinical and preclinical models in mediating potent and specific antitumor activity. With the advent of US Food and Drug Administration-approved CAR-T therapies for B-cell lymphoblastic leukemia and B-cell non-Hodgkin lymphomas, CAR-T therapy is poised to become part of mainstream clinical practice. OBJECTIVE.­: To educate pathologists on CAR-T and chimeric antigen receptor-derived cellular therapy, provide a better understanding of their role in this process, explain important regulatory aspects of CAR-T therapy, and advocate for pathologist involvement in the delivery and monitoring of chimeric antigen receptor-based treatments. Much of the focus of this article addresses US Food and Drug Administration-approved therapies; however, more general issues and future perspectives are considered for therapies in development. DESIGN.­: A CAR-T workgroup, facilitated by the College of American Pathologists Personalized Health Care Committee and consisting of pathologists of various backgrounds, was convened to develop a summary guidance paper for the College of American Pathologists Council on Scientific Affairs. RESULTS.­: The workgroup identified gaps in pathologists' knowledge of CAR-T therapy, including uncertainty in the role of the clinical laboratory in supporting CAR-T therapy. The workgroup considered these issues and summarized the findings to assist pathologists to become stakeholders in CAR-T therapy administration. CONCLUSIONS.­: This manuscript serves to both educate pathologists on CAR-T therapy and serve as a point of initial discussions in areas of CAR-T science, clinical therapy, and regulatory issues as CAR-T therapies continue to be introduced into clinical practice.


Assuntos
Imunoterapia Adotiva/métodos , Linfoma de Células B/terapia , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Receptores de Antígenos de Linfócitos T/imunologia , Receptores de Antígenos Quiméricos/imunologia , Linfócitos T/imunologia , Educação Médica Continuada/métodos , Humanos , Linfoma de Células B/imunologia , Patologistas/educação , Leucemia-Linfoma Linfoblástico de Células Precursoras/imunologia , Linfócitos T/metabolismo , Estados Unidos , United States Food and Drug Administration
20.
Acad Pathol ; 7: 2374289520953557, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32989424

RESUMO

Patients with substance use disorders (SUD) are at increased risk of both coronavirus disease-19 complications as well as exacerbations of their current conditions due to social distancing and isolation. Innovations that provide increased access to support substance use disorder patients may mitigate long-term sequelae associated with continued or renewed drug use. To improve patient access during the coronavirus disease-19 pandemic, we deployed a mobile unit to enable access to urine drug testing where needed for patients suffering from substance use disorder. Over a 3-week pilot program, 54 patients received urine drug testing across 5 providers and 8 zip codes. The mobile unit was cost-effective, demonstrating a volume-dependent 19% lower cost compared to pre-coronavirus disease-19 patient service centers in a similar geographic region. The mobile unit was well-received by patients and providers with an average of 9 out of 10 satisfaction scores and allowed for access to urine drug testing for 67% patients who would not have received testing during this time frame. No statistically significant differences were found in substance use positivity rates in comparison to pre-coronavirus disease findings; however, some shifts in use included higher rates of fentanyl and opioid positivity and reductions in tetrahydrocannabinol and cocaine use in the mobile collections setting. Deployment of mobile collection services during the coronavirus disease-19 pandemic has shown to be an effective mechanism for supporting patients suffering from substance use disorder, allowing for access to care of this often stigmatized, vulnerable population.

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