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1.
Arch Pathol Lab Med ; 148(1): 117-127, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-37014974

RESUMO

CONTEXT.­: Pathologists have produced a substantial body of literature on graduate medical education (GME). However, this body of literature is diverse and has not yet been characterized. OBJECTIVE.­: To chart the concepts, research methods, and publication patterns of studies on GME in pathology. DATA SOURCES.­: This was a systematic scoping review covering all literature produced since 1980 in the PubMed and Embase databases. CONCLUSIONS.­: Research on GME in pathology is evenly dispersed across educational topics. This body of literature would benefit from research based on theory, stronger study designs, and studies that can provide evidence to support decisions on educational policies.


Assuntos
Educação de Pós-Graduação em Medicina , Internato e Residência , Humanos , Educação de Pós-Graduação em Medicina/métodos , Patologistas , Projetos de Pesquisa
2.
Transfusion ; 64(2): 289-300, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38116828

RESUMO

BACKGROUND: Transfusion-related acute lung injury (TRALI) is a leading cause of transfusion-related mortality. A concern with passive surveillance to detect transfusion reactions is underreporting. Our aim was to obtain evidence-based estimates of TRALI incidence using meta-analysis of active surveillance studies and to compare these estimates with passive surveillance. STUDY DESIGN AND METHODS: We performed a systematic review and meta-analysis of studies reporting TRALI rates. A search of Medline and Embase by a research librarian identified studies published between January 1, 1991 and January 20, 2023. Prospective and retrospective observational studies reporting TRALI by blood component (red blood cells [RBCs], platelets, or plasma) were identified and all inpatient and outpatient settings were eligible. Adult and pediatric, as well as general and specific clinical populations, were included. Platelets and plasma must have used at least one modern TRALI donor risk mitigation strategy. A random effects model estimated TRALI incidence by blood component for active and passive surveillance studies and heterogeneity was examined using meta-regression. RESULTS: Eighty studies were included with approximately 176-million blood components transfused. RBCs had the highest number of studies (n = 66) included, followed by platelets (n = 35) and plasma (n = 34). Pooled TRALI estimates for active surveillance studies were 0.17/10,000 (95% confidence intervals [CI]: 0.03-0.43; I2 = 79%) for RBCs, 0.31/10,000 (95% CI: 0.22-0.42; I2 = <1%) for platelets, and 3.19/10,000 (95% CI: 0.09-10.66; I2 = 86%) for plasma. Studies using passive surveillance ranged from 0.02 to 0.10/10,000 among the various blood components. DISCUSSION: In summary, these estimates may improve a quantitative understanding of TRALI risk, which is important for clinical decision-making weighing the risks and benefits of transfusion.


Assuntos
Lesão Pulmonar Aguda , Lesão Pulmonar Aguda Relacionada à Transfusão , Adulto , Humanos , Criança , Lesão Pulmonar Aguda Relacionada à Transfusão/etiologia , Lesão Pulmonar Aguda Relacionada à Transfusão/complicações , Estudos Retrospectivos , Incidência , Estudos Prospectivos , Conduta Expectante , Lesão Pulmonar Aguda/epidemiologia , Lesão Pulmonar Aguda/etiologia , Doadores de Sangue
3.
Transfusion ; 63(9): 1719-1727, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37589199

RESUMO

BACKGROUND: The relative safety of bacterial risk control strategies for platelets that include culture with or without rapid testing has been compared using simulation analysis. A wide range of bacterial lag and doubling times were included. However, published data on growth rates are available and these data have not been synthesized. We conducted a systematic review and meta-analysis to estimate growth rates and used these estimates to refine a comparative safety analysis of bacterial risk control strategies in the FDA guidance STUDY DESIGN AND METHODS: Data were extracted from published studies on bacterial growth rates in platelet components during storage. These data were used to estimate the practical range of growth rates. This refined the inputs for a simulation model comparing the safety of the testing strategies. RESULTS: In total, 108 growth curves for 11 different aerobic organisms were obtained. Doubling times ranged from 0.8 to 12 h, but the lower 90% range was approximately 1-5 h. The revised comparative safety simulation using the narrower 1-5-h range showed similar rankings to the prior simulation, with 48-h large-volume delayed sampling with 7-day expiration (48C-7) demonstrating the lowest-ranking relative performance at the 103 and 105 colony forming unit (CFU)/mL exposure thresholds. DISCUSSION: This was a two-step study. First, meta-analysis of published data on aerobic bacterial growth rates in stored platelets showed the vast majority of doubling times were 1-5 h. Next, an updated comparative safety simulation yielded similar results to a prior study, with 48C-7 showing the least favorable relative safety performance.


Assuntos
Plaquetas , Comportamentos Relacionados com a Saúde , Humanos , Simulação por Computador
4.
Transfusion ; 63(1): 104-116, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36420793

RESUMO

BACKGROUND: The purpose of this scoping review was to identify available sources of evidence on the epidemiology of transfusion-related acute lung injury (TRALI) and whether meta-analysis on the incidence of TRALI is feasible. TRALI is a serious complication and the second leading cause of death related to blood transfusion. Estimates of the incidence of TRALI would provide a useful benchmark for research to reduce TRALI. STUDY DESIGN AND METHODS: We searched the Medline, EMBASE, and PubMed databases for publications related to the incidence of TRALI and hemovigilance. We included all studies irrespective of language or country. Both full-text articles and conference abstracts were included. Participants of the studies must all have received a blood transfusion. Reviews and case studies were excluded. RESULTS: We identified 427 articles or abstracts to include for review. More than half were abstracts, and the majority were published after 2010. Reported TRALI definitions varied, but only 27.2% of studies reported any definition for TRALI. TRALI rates were reported using different denominators, such as per blood unit (54.1%), patient (34.4%), and transfusion episode (14.8%). Study populations and contexts were mostly general (75.6% and 80.3%, respectively). There was also variation in study design with most being observational (90.6%) and only 13.1% of all studies used modern donor restriction policies. DISCUSSION: There was substantial variation in reporting in studies on TRALI incidence. Meta-analysis of TRALI rates may be feasible in specific circumstances where reporting is clear. Future studies should clearly report key items, such as a TRALI definition.


Assuntos
Lesão Pulmonar Aguda Relacionada à Transfusão , Humanos , Transfusão de Sangue , Lesão Pulmonar Aguda Relacionada à Transfusão/epidemiologia , Metanálise como Assunto
5.
Transfusion ; 63(1): 182-192, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36371753

RESUMO

BACKGROUND: Non-pathogen reduction platelet bacterial risk control strategies in the US FDA guidance include at least one culture. Almost all of these strategies have a culture hold time of ≥12 h. Studies have reported time to detection (TTD) of bacterial cultures inoculated with bacteria from contaminated platelets, but these data and estimates of risk associated with detection failures have not been synthesized. METHODS: We performed a literature search to identify studies reporting TTD for samples obtained from spiked platelet components. Using extracted data, regression analysis was used to estimate TTD for culture bottles at different inoculum sizes. Detection failures were defined as events in which contaminated components are transfused to a patient. We then used published data on time of transfusion (ToT) to estimate the risk of detection failures in practice. RESULTS: The search identified 1427 studies, of which 16 were included for analysis. TTD data were available for 16 different organisms, including 14 in aerobic cultures and 11 in anaerobic cultures. For inocula of 1 colony forming unit (CFU), the average TTD for aerobic organisms was 19.2 h while it was 24.9 h in anaerobic organisms, but there was substantial overall variation. A hold time of 12 versus 24 h had minimal effect for most organisms. CONCLUSION: TTD variation occurs between bacterial species and within a particular species. Under typical inventory management, the relative contribution of culture detection failures is much smaller than the residual risk from sampling failures. Increasing the hold period beyond 12 h has limited value.


Assuntos
Bactérias , Plaquetas , Humanos , Plaquetas/microbiologia , Fatores de Tempo , Transfusão de Plaquetas
6.
Autoimmun Rev ; 21(6): 103100, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35452854

RESUMO

OBJECTIVE: To determine the impact of myeloperoxidase (MPO) and proteinase 3 (PR3) antigen-specific immunoassays in the stratification of patients at-risk for anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitides (AAV) at diagnosis. METHODS: A Medline search was conducted to identify diagnostic accuracy studies using PR3-ANCA or MPO-ANCA for the evaluation of granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). Studies estimates were pooled using the bivariate method. RESULTS: Diagnostic accuracy varied by analyte and AAV subtype. PR3-ANCA had greater sensitivity than MPO-ANCA for GPA (74% vs 11%, p < 0.001) and MPO-ANCA greater sensitivity for MPA (73% vs 7%, p < 0.001). Specificities of both MPO-ANCA and PR3-ANCA were consistently high (mean 97%, range: 93-99%) for both AAV subtypes. There was insufficient data to perform meta-analysis for the diagnostic accuracy of EPGA. CONCLUSION: These results validate the use of high quality MPO-ANCA and PR3-ANCA immunoassays to screen patients at-risk for AAV as well as to categorize disease as GPA or MPA subtype. However, caution must be exercised in doing so, since some assays may not have optimal performance. Each laboratory should validate appropriate algorithms based on the tests used and testing population.


Assuntos
Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos , Síndrome de Churg-Strauss , Granulomatose com Poliangiite , Poliangiite Microscópica , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/diagnóstico , Anticorpos Anticitoplasma de Neutrófilos , Síndrome de Churg-Strauss/diagnóstico , Granulomatose com Poliangiite/diagnóstico , Humanos , Imunoensaio , Mieloblastina , Peroxidase
7.
Transfus Med Rev ; 35(3): 44-52, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34158212

RESUMO

Septic reactions from platelet transfusions are one of the leading causes of transfusion-associated mortality. The FDA guidance for platelet bacterial risk control includes bacterial culture using both aerobic and anaerobic bottles. Several studies have reported false positive rates (FPR) of culture, but these data have not been summarized or influencing factors analyzed. A systematic review and meta-analysis was performed according to published guidelines to assess the false positive rate and influencing factors. Eighteen studies were included for analysis. The combined aerobic/anaerobic FPR was 2.4 events per thousand (EPT) with a prediction interval of 0.5 to 5.7, while the aerobic FPR rate was 1.0 EPT (prediction interval: 0.2-2.2) and the anaerobic rate was 1.8 EPT. Estimates were based on a total of almost 5 million units tested. The rate of false positives due to instrument error was between 0.5-1.7 EPT, while it was between 0.3-1.0 EPT for sampling contamination based on whether only aerobic, anaerobic, or aerobic/anaerobic cultures were performed. The FPR is approximately 2 to 5 times higher than the literature reported true positive rate of 0.5 EPT.


Assuntos
Plaquetas , Transfusão de Plaquetas , Anaerobiose , Bactérias , Humanos , Controle de Qualidade
8.
Vox Sang ; 116(4): 397-404, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32996621

RESUMO

BACKGROUND AND OBJECTIVES: Septic transfusion reactions are a principal cause of transfusion-related mortality. The frequency of detectable bacterial contamination is greater in platelets compared to other blood components because platelets are stored at room temperature. Most strategies outlined in the September 2019 FDA guidance require both aerobic culture (AC) and anaerobic culture (AnC) testing. We performed a systematic review and meta-analysis in an effort to provide the best available estimate of the effectiveness of AnC. MATERIALS AND METHODS: Our analysis was performed according to published guidelines. Broad and context-specific meta-analyses of bacterial detection rates in platelets by AnC were performed to assess the practical effectiveness of AnC as a risk control measure. RESULTS: Seven studies with a total of 1 767 014 tested platelet components were included for analysis. With exclusion of positives due to Cutibacterium/Propionibacterium species and redundancy due to AC results, AnC detected 0·06 contamination events per thousand (EPT) components tested, twofold lower than the AC (0·12 EPT). CONCLUSION: Excluding Cutibacterium/Propionibacterium species, AnC detects occasional bacterial contamination events that are not detected by AC (~1 in 17 000 platelet components).


Assuntos
Bactérias/metabolismo , Técnicas Bacteriológicas/métodos , Plaquetas/microbiologia , Contaminação de Medicamentos/prevenção & controle , Transfusão de Plaquetas/métodos , Reação Transfusional/microbiologia , Anaerobiose , Segurança do Sangue , Humanos , Transfusão de Plaquetas/efeitos adversos , Reação Transfusional/prevenção & controle
9.
Transfusion ; 60(9): 2029-2037, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32757411

RESUMO

BACKGROUND: Primary culture alone was a bacterial risk control strategy intended to facilitate interdiction of contaminated platelets (PLTs). A September 2019 FDA guidance includes secondary testing options to enhance safety. Our objective was to use meta-analysis to determine residual contamination risk after primary culture using secondary culture and rapid testing. STUDY DESIGN AND METHODS: A December 2019 literature search identified articles on PLT bacterial detection rates using primary culture and a secondary testing method. We used meta-analysis to estimate secondary testing detection rates after a negative primary culture. We evaluated collection method, sample volume, sample time, and study date as potential sources of heterogeneity. RESULTS: The search identified 6102 articles; 16 were included for meta-analysis. Of these, 12 used culture and five used rapid testing as a secondary testing method. Meta-analysis was based on a total of 103 968 components tested by secondary culture and 114 697 by rapid testing. The residual detection rate using secondary culture (DRSC ) was 0.93 (95% CI, 0.24-0.6) per 1000 components, while residual detection rate using rapid testing (DRRT ) was 0.09 (95% CI, 0.01-0.25) per 1000 components. Primary culture detection rate was the only statistically significant source of heterogeneity. CONCLUSION: We evaluated bacterial detection rates after primary culture using rapid testing and secondary culture. These results provide a lower and upper bound on real-world residual clinical risk because these methods are designed to detect high-level exposures or any level of exposure, respectively. Rapid testing may miss some harmful exposures and secondary culture may identify some clinically insignificant exposures.


Assuntos
Bactérias/crescimento & desenvolvimento , Técnicas Bacteriológicas , Hemocultura , Plaquetas/microbiologia , Transfusão de Plaquetas/efeitos adversos , Sepse , Reação Transfusional , Bactérias/classificação , Feminino , Humanos , Masculino , Sepse/etiologia , Sepse/microbiologia , Reação Transfusional/etiologia , Reação Transfusional/microbiologia
10.
Cochrane Database Syst Rev ; 7: CD009833, 2020 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-32693433

RESUMO

BACKGROUND: Invasive fungal infections (IFIs) are life-threatening opportunistic infections that occur in immunocompromised or critically ill people. Early detection and treatment of IFIs is essential to reduce morbidity and mortality in these populations. (1→3)-ß-D-glucan (BDG) is a component of the fungal cell wall that can be detected in the serum of infected individuals. The serum BDG test is a way to quickly detect these infections and initiate treatment before they become life-threatening. Five different versions of the BDG test are commercially available: Fungitell, Glucatell, Wako, Fungitec-G, and Dynamiker Fungus. OBJECTIVES: To compare the diagnostic accuracy of commercially available tests for serum BDG to detect selected invasive fungal infections (IFIs) among immunocompromised or critically ill people. SEARCH METHODS: We searched MEDLINE (via Ovid) and Embase (via Ovid) up to 26 June 2019. We used SCOPUS to perform a forward and backward citation search of relevant articles. We placed no restriction on language or study design. SELECTION CRITERIA: We included all references published on or after 1995, which is when the first commercial BDG assays became available. We considered published, peer-reviewed studies on the diagnostic test accuracy of BDG for diagnosis of fungal infections in immunocompromised people or people in intensive care that used the European Organization for Research and Treatment of Cancer (EORTC) criteria or equivalent as a reference standard. We considered all study designs (case-control, prospective consecutive cohort, and retrospective cohort studies). We excluded case studies and studies with fewer than ten participants. We also excluded animal and laboratory studies. We excluded meeting abstracts because they provided insufficient information. DATA COLLECTION AND ANALYSIS: We followed the standard procedures outlined in the Cochrane Handbook for Diagnostic Test Accuracy Reviews. Two review authors independently screened studies, extracted data, and performed a quality assessment for each study. For each study, we created a 2 × 2 matrix and calculated sensitivity and specificity, as well as a 95% confidence interval (CI). We evaluated the quality of included studies using the Quality Assessment of Studies of Diagnostic Accuracy-Revised (QUADAS-2). We were unable to perform a meta-analysis due to considerable variation between studies, with the exception of Candida, so we have provided descriptive statistics such as receiver operating characteristics (ROCs) and forest plots by test brand to show variation in study results. MAIN RESULTS: We included in the review 49 studies with a total of 6244 participants. About half of these studies (24/49; 49%) were conducted with people who had cancer or hematologic malignancies. Most studies (36/49; 73%) focused on the Fungitell BDG test. This was followed by Glucatell (5 studies; 10%), Wako (3 studies; 6%), Fungitec-G (3 studies; 6%), and Dynamiker (2 studies; 4%). About three-quarters of studies (79%) utilized either a prospective or a retrospective consecutive study design; the remainder used a case-control design. Based on the manufacturer's recommended cut-off levels for the Fungitell test, sensitivity ranged from 27% to 100%, and specificity from 0% to 100%. For the Glucatell assay, sensitivity ranged from 50% to 92%, and specificity ranged from 41% to 94%. Limited studies have used the Dynamiker, Wako, and Fungitec-G assays, but individual sensitivities and specificities ranged from 50% to 88%, and from 60% to 100%, respectively. Results show considerable differences between studies, even by manufacturer, which prevented a formal meta-analysis. Most studies (32/49; 65%) had no reported high risk of bias in any of the QUADAS-2 domains. The QUADAS-2 domains that had higher risk of bias included participant selection and flow and timing. AUTHORS' CONCLUSIONS: We noted considerable heterogeneity between studies, and these differences precluded a formal meta-analysis. Because of wide variation in the results, it is not possible to estimate the diagnostic accuracy of the BDG test in specific settings. Future studies estimating the accuracy of BDG tests should be linked to the way the test is used in clinical practice and should clearly describe the sampling protocol and the relationship of time of testing to time of diagnosis.


Assuntos
Estado Terminal , Hospedeiro Imunocomprometido , Infecções Fúngicas Invasivas/diagnóstico , beta-Glucanas/sangue , Aspergilose/diagnóstico , Biomarcadores/sangue , Candidíase Invasiva/diagnóstico , Estudos de Casos e Controles , Humanos , Infecções por Pneumocystis/diagnóstico , Pneumocystis carinii , Estudos Prospectivos , Curva ROC , Estudos Retrospectivos , Sensibilidade e Especificidade
11.
Clin Chim Acta ; 510: 191-195, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32673669

RESUMO

BACKGROUND: Lactoferrin and calprotectin are frequently ordered stool tests used to screen patients for inflammatory bowel disease versus functional bowel disease. Current guidelines recommend using either one to screen for inflammation in the GI tract; however, little information is available on how these 2 assays compare and their use in different clinical specialties. METHODS: We compared order patterns for lactoferrin and calprotectin using data from a large reference laboratory over a 10-y period (2009-2019). We also studied the concordance of lactoferrin and calprotectin in cases where both tests were ordered concurrently. Finally, we reviewed the records at a university hospital to determine which clinicians ordered each test and the indications associated with orders. RESULTS: Orders for calprotectin are increasing relative to lactoferrin. The relative proportion of calprotectin orders have increased from 60% to nearly 90% over the past decade. Results for lactoferrin and calprotectin show concordance (90%). Calprotectin and lactoferrin are ordered by different clinical specialties for different indications. Calprotectin is most often ordered by gastroenterologists in the context of abdominal pain. Lactoferrin is most often ordered by primary care providers in the context of acute diarrhea. CONCLUSION: Lactoferrin and calprotectin are not treated as equivalent tests by clinicians.


Assuntos
Doenças Inflamatórias Intestinais , Complexo Antígeno L1 Leucocitário , Biomarcadores , Fezes , Humanos , Doenças Inflamatórias Intestinais/diagnóstico , Lactoferrina , Sangue Oculto
12.
Transfusion ; 60(8): 1723-1731, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32632927

RESUMO

BACKGROUND: Bacterial contamination of platelets is a problem that can lead to harmful septic transfusion reactions. The US Food and Drug Administration published a guidance in September 2019 detailing several permissible risk control strategies. Our objective was to compare the safety of each bacterial testing strategy for apheresis platelets. STUDY DESIGN AND METHODS: We used simulation to compare safety of the nine risk control strategies involving apheresis platelet testing. The primary outcome was the risk of exposure. An exposure event occurred if a patient received platelets exceeding a specific contamination threshold (>0, 103 , and 105 colony-forming units (CFU/mL). We generated a range of bacterial contamination scenarios (inoculum size, doubling time, lag time) and compared risk of exposure for each policy in each contamination scenario. We then computed the average risk difference over all scenarios. RESULTS: At the 0 CFU/mL exposure threshold, two-step policies that used secondary culture ranked best (all top three), while single-step 24-hour culture with 3-day expiration ranked last (ninth). This latter policy performed well (median rank of 1) at both the 103 and 105 CFU/mL thresholds, but 48-hour culture with 7-day expiration performed relatively poorly. At these higher thresholds, median ranks of two-step policies that used secondary culture were again top three. Two-step policies that used rapid testing improved at the higher (105 CFU/mL) harm threshold, with median rankings between 1 and 5. CONCLUSION: Two-step policies that used secondary culture were generally safer than single-step policies. Performance of two-step policies that used rapid testing depended on the CFU per milliter threshold of exposure used.


Assuntos
Infecções Bacterianas , Plaquetas/microbiologia , Segurança do Sangue , Modelos Biológicos , Transfusão de Plaquetas , Plaquetoferese , Infecções Bacterianas/sangue , Infecções Bacterianas/etiologia , Política de Saúde , Humanos , Fatores de Risco
13.
J Occup Environ Med ; 62(6): 412-419, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32510907

RESUMO

OBJECTIVE: The aim of this study was to compare spirometry results in microwave popcorn and flavoring manufacturing workers. METHODS: We used NIOSH data on current and former microwave popcorn workers (MPWs) and surveillance data on flavoring manufacturing workers (FMWs). RESULTS: Former MPW had higher prevalence of mixed and high severity abnormalities, some had excessive lung function drops. Current MPW had lowest occurrence of excessive lung function drops. FMW with excessive drops and spirometric abnormalities at last test had developed a restrictive pattern. Spirometric abnormalities and excessive drops were associated with work-related factors. CONCLUSION: There was evidence of a healthy worker survivor effect in MPW. Importantly, removal from exposure did not always stabilize lung function decline indicating a need for continued monitoring. The development of a restrictive pattern should raise the level of suspicion for possible work-related disease in flavoring-exposed workers.


Assuntos
Indústria Alimentícia , Pulmão/fisiopatologia , Doenças Profissionais , Exposição Ocupacional , Aromatizantes , Humanos , Doenças Profissionais/epidemiologia , Espirometria
14.
Transfusion ; 60(5): 986-996, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32181889

RESUMO

BACKGROUND: Platelets have the highest bacterial contamination risk of all blood components, and septic transfusion reactions remain a problem. A good estimate of contamination rates could provide information about residual risk and inform optimal testing strategies. We performed a systematic review and meta-analysis of platelet contamination rates by primary culture. STUDY DESIGN AND METHODS: A literature search in December 2019 identified articles on platelet contamination rates using primary culture. We used meta-analysis to estimate the overall rate of contamination and meta-regression to identify heterogeneity. We studied the following sources of heterogeneity: collection method, sample volume, positivity criteria, and study date. Contamination rate estimates were obtained for apheresis (AP), platelet rich plasma (PRP), and buffy coat (BC) collection methods. RESULTS: The search identified 6102 studies, and 22 were included for meta-analysis. Among these 22 studies, there were 21 AP cohorts (4,072,022 components), 4 PRP cohorts (138,869 components), and 15 BC cohorts (1,474,679 components). The overall mean contamination rate per 1000 components was 0.51 (95% CI: 0.38-0.67) including AP (0.23, 95% CI: 0.18-0.28), PRP, (0.38, 95% CI: 0.15-0.70), and BC (1.12, 95% CI: 0.51-1.96). There was considerable variability within each collection method. Sample volume, positivity criteria, and publication year were significant sources of heterogeneity. CONCLUSION: The bacterial contamination rate of platelets by primary culture is 1 in 1961. AP and PRP components showed a lower contamination rate than BC components. There is clinically significant between-study variability for each method. Larger sample volumes increased sensitivity, and bacterial contamination rates have decreased over time.


Assuntos
Infecções Bacterianas/sangue , Remoção de Componentes Sanguíneos/estatística & dados numéricos , Plaquetas/microbiologia , Contaminação de Medicamentos/estatística & dados numéricos , Transfusão de Plaquetas/estatística & dados numéricos , Cultura Primária de Células/estatística & dados numéricos , Infecções Bacterianas/epidemiologia , Infecções Bacterianas/transmissão , Técnicas Bacteriológicas , Remoção de Componentes Sanguíneos/efeitos adversos , Transfusão de Componentes Sanguíneos/efeitos adversos , Transfusão de Componentes Sanguíneos/estatística & dados numéricos , Plaquetas/citologia , Células Cultivadas , Humanos , Transfusão de Plaquetas/efeitos adversos , Plasma Rico em Plaquetas/microbiologia , Cultura Primária de Células/métodos , Cultura Primária de Células/normas , Reação Transfusional/epidemiologia , Reação Transfusional/microbiologia
15.
J Appl Lab Med ; 5(1): 136-141, 2020 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-31811070

RESUMO

BACKGROUND: Our national reference laboratory sought to improve stewardship for multiple sclerosis (MS) testing, which included orders for myelin basic protein (MBP) and oligoclonal bands (OCB). From 2011 to 2012, we performed 2 interventions for MS testing: one gentle-strength intervention of a publication designed to educate others about the lack of utility for MBP results and a second medium-strength intervention that included removal of MBP from the panel of MS tests. The ordering trends and practice variation were examined for OCB and MBP to retrospectively observe the effect of the interventions. METHODS: Data from clients within academic and community hospitals were examined (n = 1710 clients). Ordering patterns for OCB and MBP were investigated from 2008 to 2018 by calculating the %OCB: %OCB = (OCB)/(OCB + MBP). Practice variation was examined by comparing the distribution of clients with different %OCB statistics before and after the interventions in 5-year blocks (2008-2012 vs 2014-2018). RESULTS: From 2000 to 2011, the %OCB was approximately 50%, but gradually increased to 67% in 2018. For practice variation, analysis of the distribution of clients by %OCB also demonstrated a shift toward clients favoring OCB alone vs OCB + MBP for MS testing for the later time period of 2014-2018. CONCLUSION: Our 2 interventions had a measurable, beneficial effect on ordering trends for MS testing over a 10-year period at a single reference laboratory. However, given that MBP has questionable clinical utility, stronger interventions are likely needed to bring about larger changes in ordering behavior.


Assuntos
Esclerose Múltipla , Proteína Básica da Mielina/análise , Bandas Oligoclonais/análise , Utilização de Procedimentos e Técnicas/tendências , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Testes Diagnósticos de Rotina/tendências , Humanos , Esclerose Múltipla/sangue , Esclerose Múltipla/líquido cefalorraquidiano , Esclerose Múltipla/diagnóstico , Padrões de Prática Médica , Garantia da Qualidade dos Cuidados de Saúde , Reprodutibilidade dos Testes , Estados Unidos
16.
Am J Clin Pathol ; 152(5): 638-646, 2019 10 07.
Artigo em Inglês | MEDLINE | ID: mdl-31305881

RESUMO

OBJECTIVES: Anti-ß2 glycoprotein I domain I (anti-domain I) and anti-phosphatidylserine/prothrombin (aPS/PT) antibodies are present in patients with antiphospholipid syndrome (APS); however, their use in evaluation remains unclear. METHODS: Diagnostic attributes of lupus anticoagulant (LAC), anti-domain I IgG, anti-cardiolipin, anti-ß2 glycoprotein I (anti-ß2GPI), and aPS/PT IgG and IgM antibodies were assessed in 216 patients evaluated for APS. RESULTS: LAC had the best odds ratio (OR, 14.2) while that for anti-domain 1 IgG was comparable to anti-ß2GPI IgG (OR, 8.3 vs 9.4) but higher than all others. Significant correlations were observed for thrombosis (P = .03) and pregnancy-related morbidity (P = .001) with anti-domain IgG and for any thrombosis with aPS/PT IgG (P = .006). Use of noncriteria antiphospholipid with or without criteria markers did not significantly increase the probability to diagnose APS. CONCLUSIONS: Noncriteria tests can contribute to diagnosis and stratification of APS but do not improve diagnostic yield. Optimal strategies for implementation require prospective investigation.


Assuntos
Anticorpos Antifosfolipídeos/sangue , Síndrome Antifosfolipídica/diagnóstico , Autoanticorpos/sangue , Adulto , Síndrome Antifosfolipídica/classificação , Síndrome Antifosfolipídica/imunologia , Cardiolipinas/imunologia , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Inibidor de Coagulação do Lúpus/sangue , Masculino , Pessoa de Meia-Idade , Razão de Chances , Fosfatidilserinas/imunologia , Gravidez , Complicações na Gravidez/imunologia , Protrombina/imunologia , Estudos Retrospectivos , beta 2-Glicoproteína I/imunologia
17.
Transfusion ; 59(7): 2316-2323, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31106447

RESUMO

BACKGROUND: Risk-adjusted benchmarking could be useful to compare blood utilization between hospitals or individual groups, such as physicians, while accounting for differences in patient complexity. The aim of this study was to analyze the association of red blood cell (RBC) use and diagnosis-related group (DRG) weights across all inpatient hospital stays to determine the suitability of using DRGs for between-hospital risk-adjusted benchmarking. Specific hierarchical organizational units (surgical vs. nonsurgical patients, departments, and physicians) were also evaluated. STUDY DESIGN AND METHODS: We studied blood use among all adult inpatients, and within organizational units, over 4 years (May 2014 to March 2018) at an academic center. Number of RBCs transfused, all patient refined (APR)-DRGs, and other variables were captured over entire hospital stays. We used multilevel generalized linear modeling (zero-inflated negative binomial) to study the relationship between RBC utilization and APR-DRG. RESULTS: A total of 97,955 hospital stays were evaluated and the median APR-DRG weight was 1.2. The association of RBCs transfused and APR-DRG weight was statistically significant at all hierarchical levels (incidence rate ratio = 1.22; p < 0.001). The impact of APR-DRG on blood use, measured by the incidence rate ratio, demonstrated an association at the all-patient and surgical levels, at several department and physician levels, but not at the medical patient level. The relationship between RBCs transfused and APR-DRG varied across organizational units. CONCLUSION: Number of RBCs transfused was associated with APR-DRG weight at multiple hierarchical levels and could be used for risk-adjusted benchmarking in those contexts. The relationship between RBC use and APR-DRG varied across organizational units.


Assuntos
Benchmarking , Transfusão de Sangue , Grupos Diagnósticos Relacionados , Pacientes Internados , Tempo de Internação , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco
18.
Lab Med ; 50(3): e50-e55, 2019 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-30953076

RESUMO

BACKGROUND: Point of care (POC) testing is rapidly evolving. POC testing is often managed by POC coordinators (POCC), but this role is relatively new and has not been characterized. OBJECTIVES: To characterize the background, responsibilities, and job satisfaction of POCCs. METHODS: Structured interviews were conducted with 15 POCCs. On the basis of these interviews, a 38-item questionnaire was developed and administered as a web-based survey. RESULTS: The respondents (N = 98) were mostly female (87%) and had a bachelor's degree (79%). About half the respondents were older than 55 years and were in supervisory positions. Overall, respondents indicated high job satisfaction, but women were significantly less satisfied than men. POCCs were infrequently involved in decisions regarding the implementation of new tests. The number of tests managed by each POCC varied widely (median, 6.0; range, 1-30). CONCLUSIONS: The POCC role is in flux. There is consensus regarding some aspects of the job, but there are significant differences in the way that hospitals organize the POCC function.


Assuntos
Atitude do Pessoal de Saúde , Testes Imediatos/organização & administração , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Entrevistas como Assunto , Descrição de Cargo , Satisfação no Emprego , Masculino , Pessoa de Meia-Idade
19.
Am J Clin Pathol ; 151(3): 275-285, 2019 02 04.
Artigo em Inglês | MEDLINE | ID: mdl-30307463

RESUMO

Objectives: To determine the accuracy of Fungitell, a ß-d-glucan (BDG) test, for the diagnosis of invasive fungal infection (IFI) among cancer patients. Methods: For this meta-analysis, MEDLINE and EMBASE were searched for references related to BDG testing. Study quality was evaluated using QUADAS-2. Statistical analysis was performed using Stata 14. Results: We screened 12,426 references and identified 189 studies for full-text review. Nineteen studies were included in the final meta-analysis. There was moderate heterogeneity between studies. Nine studies had a high risk of bias, which significantly elevated the overall specificity estimate. Restricting to only low-bias studies, the sensitivity and specificity were 80% and 63%, respectively. Conclusions: The overall sensitivity and specificity of Fungitell as a diagnostic test for IFI is moderate, and there is substantial heterogeneity between studies. Limiting studies to only low-bias risk reduced heterogeneity but also lowered the overall specificity estimate.


Assuntos
Glucanos/análise , Neoplasias Hematológicas/complicações , Infecções Fúngicas Invasivas/diagnóstico , Testes Diagnósticos de Rotina , Humanos , Hospedeiro Imunocomprometido , Infecções Fúngicas Invasivas/complicações , Infecções Fúngicas Invasivas/microbiologia , Sensibilidade e Especificidade
20.
Arch Pathol Lab Med ; 143(5): 628-633, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30576239

RESUMO

CONTEXT.­: Molecular analysis of lung adenocarcinoma for therapeutically important genes is standard of practice, with multiple professional organizations recommending testing of all adenocarcinomas for mutations in EGFR, ALK, and ROS1. Some organizations recommend analyzing these genes in association with a panel. Few data exist as to optimal testing method or optimal sequence of testing from a cost perspective. OBJECTIVE.­: To determine which order of gene testing was least costly and whether sequential, small panel, or next-generation sequencing (NGS) was cheapest. DESIGN.­: Recent recommendations propose a set of essential molecular tests (EGFR, ALK, and ROS1) and an optional set of molecular tests that may be useful for selection of clinical trials. We compared the costs of different testing sequencing strategies for both the 3 essential genes and for 5 optimal genes. Testing costs were determined by a survey of prices from large laboratories. The strategy most frequently rated as the lowest cost strategy was designated the optimal testing strategy. RESULTS.­: Sequential testing of the essential genes in the order EGFR-ROS1-ALK was optimal from a cost perspective. The expected cost of sequential testing was $2227 (95% CI, $1733-$2794). The cost of NGS was $2500. The expected cost per positive result was $11,362 using this strategy. CONCLUSIONS.­: Molecular testing of lung adenocarcinomas for the set of 3 essential genes and 5 optional genes can be performed by a variety of methods and in a variety of sequences. From a cost perspective, sequential testing in the order EGFR, ROS1, then ALK is optimal. NGS would be competitive if the price was less than $2200. NGS is optimal if testing for the 3 essential genes will be followed by testing for the 5 optional genes. NGS testing is optimal if the clinician plans to test both essential and optional genes.


Assuntos
Adenocarcinoma de Pulmão/genética , Técnicas Genéticas/economia , Testes Genéticos/economia , Neoplasias Pulmonares/genética , Custos e Análise de Custo , Humanos
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