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1.
Proc Natl Acad Sci U S A ; 121(12): e2314813121, 2024 Mar 19.
Artículo en Inglés | MEDLINE | ID: mdl-38470917

RESUMEN

Potential Mycobacterium tuberculosis (Mtb) transmission during different pulmonary tuberculosis (TB) disease states is poorly understood. We quantified viable aerosolized Mtb from TB clinic attendees following diagnosis and through six months' follow-up thereafter. Presumptive TB patients (n=102) were classified by laboratory, radiological, and clinical features into Group A: Sputum-Xpert Ultra-positive TB (n=52), Group B: Sputum-Xpert Ultra-negative TB (n=20), or Group C: TB undiagnosed (n=30). All groups were assessed for Mtb bioaerosol release at baseline, and subsequently at 2 wk, 2 mo, and 6 mo. Groups A and B were notified to the national TB program and received standard anti-TB chemotherapy; Mtb was isolated from 92% and 90% at presentation, 87% and 74% at 2 wk, 54% and 44% at 2 mo and 32% and 20% at 6 mo, respectively. Surprisingly, similar numbers were detected in Group C not initiating TB treatment: 93%, 70%, 48% and 22% at the same timepoints. A temporal association was observed between Mtb bioaerosol release and TB symptoms in all three groups. Persistence of Mtb bioaerosol positivity was observed in ~30% of participants irrespective of TB chemotherapy. Captured Mtb bacilli were predominantly acid-fast stain-negative and poorly culturable; however, three bioaerosol samples yielded sufficient biomass following culture for whole-genome sequencing, revealing two different Mtb lineages. Detection of viable aerosolized Mtb in clinic attendees, independent of TB diagnosis, suggests that unidentified Mtb transmitters might contribute a significant attributable proportion of community exposure. Additional longitudinal studies with sputum culture-positive and -negative control participants are required to investigate this possibility.


Asunto(s)
Bacillus , Mycobacterium tuberculosis , Tuberculosis Pulmonar , Tuberculosis , Humanos , Esputo/microbiología , Tuberculosis Pulmonar/diagnóstico , Tuberculosis/microbiología , Firmicutes , Sensibilidad y Especificidad
2.
PLoS Pathog ; 17(2): e1009262, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33524021

RESUMEN

Interrupting transmission is an attractive anti-tuberculosis (TB) strategy but it remains underexplored owing to our poor understanding of the events surrounding transfer of Mycobacterium tuberculosis (Mtb) between hosts. Determining when live, infectious Mtb bacilli are released and by whom has proven especially challenging. Consequently, transmission chains are inferred only retrospectively, when new cases are diagnosed. This process, which relies on molecular analyses of Mtb isolates for epidemiological fingerprinting, is confounded by the prolonged infectious period of TB and the potential for transmission from transient exposures. We developed a Respiratory Aerosol Sampling Chamber (RASC) equipped with high-efficiency filtration and sampling technologies for liquid-capture of all particulate matter (including Mtb) released during respiration and non-induced cough. Combining the mycobacterial cell wall probe, DMN-trehalose, with fluorescence microscopy of RASC-captured bioaerosols, we detected and quantified putative live Mtb bacilli in bioaerosol samples arrayed in nanowell devices. The RASC enabled non-invasive capture and isolation of viable Mtb from bioaerosol within 24 hours of collection. A median 14 live Mtb bacilli (range 0-36) were isolated in single-cell format from 90% of confirmed TB patients following 60 minutes bioaerosol sampling. This represented a significant increase over previous estimates of transmission potential, implying that many more organisms might be released daily than commonly assumed. Moreover, variations in DMN-trehalose incorporation profiles suggested metabolic heterogeneity in aerosolized Mtb. Finally, preliminary analyses indicated the capacity for serial image capture and analysis of nanowell-arrayed bacilli for periods extending into weeks. These observations support the application of this technology to longstanding questions in TB transmission including the propensity for asymptomatic transmission, the impact of TB treatment on Mtb bioaerosol release, and the physiological state of aerosolized bacilli.


Asunto(s)
Pruebas Respiratorias , Tos/microbiología , Mycobacterium tuberculosis/aislamiento & purificación , Tuberculosis Pulmonar/microbiología , Adulto , Estudios de Cohortes , Humanos , Microscopía Fluorescente , Nanotecnología/instrumentación
3.
Am J Respir Crit Care Med ; 206(2): 206-216, 2022 07 15.
Artículo en Inglés | MEDLINE | ID: mdl-35584342

RESUMEN

Rationale: Interrupting tuberculosis (TB) transmission requires an improved understanding of how and when the causative organism, Mycobacterium tuberculosis (Mtb), is aerosolized. Although cough is commonly assumed to be the dominant source of Mtb aerosols, recent evidence of cough-independent Mtb release implies the contribution of alternative mechanisms. Objectives: To compare the aerosolization of Mtb bacilli and total particulate matter from patients with TB during three separate respiratory maneuvers: tidal breathing (TiBr), FVC, and cough. Methods: Bioaerosol sampling and Mtb enumeration by live-cell, fluorescence microscopy were combined with real-time measurement of CO2 concentration and total particle counts from 38 patients with GeneXpert-positive TB before treatment initiation. Measurements and Main Results: For all maneuvers, the proportions of particles detected across five size categories were similar, with most particles falling between 0.5-5 µm. Although total particle counts were 4.8-fold greater in cough samples than either TiBr or FVC, all three maneuvers returned similar rates of positivity for Mtb. No correlation was observed between total particle production and Mtb count. Instead, for total Mtb counts, the variability between individuals was greater than the variability between sampling maneuvers. Finally, when modelled using 24-hour breath and cough frequencies, our data indicate that TiBr might contribute more than 90% of the daily aerosolized Mtb among symptomatic patients with TB. Conclusions: Assuming the number of viable Mtb organisms released offers a reliable proxy of patient infectiousness, our observations imply that TiBr and interindividual variability in Mtb release might be significant contributors to TB transmission among active cases.


Asunto(s)
Mycobacterium tuberculosis , Tuberculosis , Aerosoles , Tos/microbiología , Humanos , Sistema Respiratorio , Sensibilidad y Especificidad , Esputo/microbiología
4.
BMC Med Inform Decis Mak ; 21(1): 160, 2021 05 17.
Artículo en Inglés | MEDLINE | ID: mdl-34001121

RESUMEN

BACKGROUND: The variety of medical documentation often leads to incompatible data elements that impede data integration between institutions. A common approach to standardize and distribute metadata definitions are ISO/IEC 11179 norm-compliant metadata repositories with top-down standardization. To the best of our knowledge, however, it is not yet common practice to reuse the content of publicly accessible metadata repositories for creation of case report forms or routine documentation. We suggest an alternative concept called pragmatic metadata repository, which enables a community-driven bottom-up approach for agreeing on data collection models. A pragmatic metadata repository collects real-world documentation and considers frequent metadata definitions as high quality with potential for reuse. METHODS: We implemented a pragmatic metadata repository proof of concept application and filled it with medical forms from the Portal of Medical Data Models. We applied this prototype in two use cases to demonstrate its capabilities for reusing metadata: first, integration into a study editor for the suggestion of data elements and, second, metadata synchronization between two institutions. Moreover, we evaluated the emergence of bottom-up standards in the prototype and two medical data managers assessed their quality for 24 medical concepts. RESULTS: The resulting prototype contained 466,569 unique metadata definitions. Integration into the study editor led to a reuse of 1836 items and item groups. During the metadata synchronization, semantic codes of 4608 data elements were transferred. Our evaluation revealed that for less complex medical concepts weak bottom-up standards could be established. However, more diverse disease-related concepts showed no convergence of data elements due to an enormous heterogeneity of metadata. The survey showed fair agreement (Kalpha = 0.50, 95% CI 0.43-0.56) for good item quality of bottom-up standards. CONCLUSIONS: We demonstrated the feasibility of the pragmatic metadata repository concept for medical documentation. Applications of the prototype in two use cases suggest that it facilitates the reuse of data elements. Our evaluation showed that bottom-up standardization based on a large collection of real-world metadata can yield useful results. The proposed concept shall not replace existing top-down approaches, rather it complements them by showing what is commonly used in the community to guide other researchers.


Asunto(s)
Documentación , Metadatos , Humanos , Estándares de Referencia , Semántica
5.
BMC Infect Dis ; 20(1): 624, 2020 Aug 24.
Artículo en Inglés | MEDLINE | ID: mdl-32838751

RESUMEN

An amendment to this paper has been published and can be accessed via the original article.

6.
BMC Infect Dis ; 20(1): 587, 2020 Aug 08.
Artículo en Inglés | MEDLINE | ID: mdl-32770954

RESUMEN

BACKGROUND: Tuberculosis (TB) is transmitted in bioaerosols containing Mycobacterium tuberculosis (Mtb). Despite being central to ongoing TB transmission, no routine diagnostic assay exists to measure Mtb in bioaerosols. Furthermore, published studies of Mtb in bioaerosol samples have been limited to individuals with sputum-positive pulmonary TB. Notably, TB diagnosis is based on clinical symptoms and sputum laboratory findings. This is despite the fact that approximately half of all patients commencing TB treatment are sputum-negative, resulting in a high proportion of presumptive treatments. Here, we propose to use a sensitive air sampling protocol to investigate the prevalence of Mtb-containing bioaerosols in both sputum-positive and sputum-negative TB suspects, at the same time evaluating the potential to identify unrecognized transmitters of TB. METHODS: Our parallel-group design will identify viable Mtb in bioaerosols produced by individuals attending a TB clinic in South Africa. Sampling will be performed on eligible individuals presenting with symptoms indicative of TB and repeated at 14 days if initially positive. Participants will be prospectively classified into three distinct groups based on National TB Control Program (NTBCP) criteria: Group A, TB notification with sputum-based laboratory confirmation; Group B, TB notification with empiric diagnosis; and Group C, individuals not notified. Group C individuals with detectable Mtb bioaerosol will be monitored until resolution of clinical and laboratory status. Collection of bioaerosol specimens will be via two consecutive sampling modalities: (1) direct sampling following a specific respiratory manoeuvre; and (2) indirect sampling during passive respiratory activity. Bioaerosol specimens will be analyzed for viable Mtb using DMN-trehalose staining and live-cell fluorescence microscopy. Mtb genomes and mycobacterial and host lipids will be detected using droplet digital PCR and mass spectrometry analyses, respectively. The primary objective is to determine the prevalence of Mtb bioaerosols in all TB clinic attendees and in each of the groups. Secondary objectives are to investigate differences in prevalence of Mtb bioaerosol by HIV status and current isoniazid preventive therapy (IPT) use; we will also determine the impact of anti-TB chemotherapy on Mtb-containing bioaerosol production. DISCUSSION: Respiratory bioaerosol has a potential role in non-invasive TB diagnosis, infectivity measurement and treatment monitoring. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04241809 . Date of Registration: 27/1/2020.


Asunto(s)
Aerosoles/análisis , Manejo de Especímenes/métodos , Tuberculosis Pulmonar/diagnóstico , Adulto , ADN Bacteriano/química , ADN Bacteriano/metabolismo , Femenino , Humanos , Masculino , Espectrometría de Masas , Persona de Mediana Edad , Mycobacterium tuberculosis/genética , Mycobacterium tuberculosis/aislamiento & purificación , Reacción en Cadena de la Polimerasa , Sudáfrica , Esputo/microbiología
7.
medRxiv ; 2024 Apr 03.
Artículo en Inglés | MEDLINE | ID: mdl-38633787

RESUMEN

Pioneering studies linking symptomatic disease and cough-mediated release of Mycobacterium tuberculosis (Mtb) established the infectious origin of tuberculosis (TB), simultaneously informing the pervasive notion that pathology is a prerequisite for Mtb transmission. Our prior work has challenged this assumption: by sampling TB clinic attendees, we detected equivalent release of Mtb-containing bioaerosols by confirmed TB patients and individuals not receiving a TB diagnosis, and we demonstrated a time-dependent reduction in Mtb bioaerosol positivity during six-months' follow-up, irrespective of anti-TB chemotherapy. Now, by extending bioaerosol sampling to a randomly selected community cohort, we show that Mtb release is common in a TB-endemic setting: of 89 participants, 79.8% (71/89) produced Mtb bioaerosols independently of QuantiFERON-TB Gold status, a standard test for Mtb infection; moreover, during two-months' longitudinal sampling, only 2% (1/50) were serially Mtb bioaerosol negative. These results necessitate a reframing of the prevailing paradigm of Mtb transmission and infection, and may explain the current inability to elucidate Mtb transmission networks in TB-endemic regions.

8.
iScience ; 27(9): 110731, 2024 Sep 20.
Artículo en Inglés | MEDLINE | ID: mdl-39310776

RESUMEN

Pioneering studies linking symptomatic disease and cough-mediated Mycobacterium tuberculosis (Mtb) release established the infectious origin of tuberculosis (TB), simultaneously informing the notion that pathology is a prerequisite for Mtb transmission. Our recent work has challenged this assumption: by sampling TB clinic attendees, we detected equivalent release of Mtb-containing bioaerosols by confirmed TB patients and individuals not receiving a TB diagnosis and observed time-dependent reduction in Mtb bioaerosol positivity during 6-month follow-up of both cohorts, irrespective of anti-TB chemotherapy. Now, we report widespread Mtb release in our TB-endemic setting: of 89 randomly recruited community members, 79.8% (71/89) produced Mtb-containing bioaerosols independently of QuantiFERON status, a standard test for Mtb exposure. Moreover, during 2-month longitudinal sampling, only 2% (1/50) were serially Mtb bioaerosol negative. These results necessitate a reframing of the prevailing paradigm of Mtb transmission and TB etiology, perhaps explaining the historical inability to elucidate Mtb transmission networks in TB-endemic regions.

9.
bioRxiv ; 2023 Mar 28.
Artículo en Inglés | MEDLINE | ID: mdl-37034714

RESUMEN

The mycobacterial mutasome - minimally comprising ImuA', ImuB, and DnaE2 proteins - has been implicated in DNA damage-induced mutagenesis in Mycobacterium tuberculosis. ImuB, predicted to enable mutasome function via its interaction with the ß clamp, is a catalytically inactive member of the Y-family of DNA polymerases. Like other members of the Y family, ImuB features a recently identified amino acid motif with homology to the RecA-N-terminus (RecA-NT). In RecA, the motif mediates oligomerization of RecA monomers into RecA filaments. Given the role of ImuB in the mycobacterial mutasome, we hypothesized that the ImuB RecA-NT motif might mediate its interaction with ImuA', a RecA homolog of unknown function. To investigate this possibility, we constructed a panel of imuB alleles in which RecA-NT was removed, or mutated. Results from microbiological and biochemical assays indicate that RecA-NT is critical for the interaction of ImuB with ImuA'. A region downstream of RecA-NT (ImuB-C) also appears to stabilize the ImuB-ImuA' interaction, but its removal does not prevent complex formation. In contrast, replacing two key hydrophobic residues of RecA-NT, L378 and V383, is sufficient to disrupt ImuA'-ImuB interaction. To our knowledge, this constitutes the first experimental evidence showing the role of the RecA-NT motif in mediating the interaction between a Y-family member and a RecA homolog.

10.
Elife ; 122023 08 02.
Artículo en Inglés | MEDLINE | ID: mdl-37530405

RESUMEN

A DNA damage-inducible mutagenic gene cassette has been implicated in the emergence of drug resistance in Mycobacterium tuberculosis during anti-tuberculosis (TB) chemotherapy. However, the molecular composition and operation of the encoded 'mycobacterial mutasome' - minimally comprising DnaE2 polymerase and ImuA' and ImuB accessory proteins - remain elusive. Following exposure of mycobacteria to DNA damaging agents, we observe that DnaE2 and ImuB co-localize with the DNA polymerase III ß subunit (ß clamp) in distinct intracellular foci. Notably, genetic inactivation of the mutasome in an imuBAAAAGG mutant containing a disrupted ß clamp-binding motif abolishes ImuB-ß clamp focus formation, a phenotype recapitulated pharmacologically by treating bacilli with griselimycin and in biochemical assays in which this ß clamp-binding antibiotic collapses pre-formed ImuB-ß clamp complexes. These observations establish the essentiality of the ImuB-ß clamp interaction for mutagenic DNA repair in mycobacteria, identifying the mutasome as target for adjunctive therapeutics designed to protect anti-TB drugs against emerging resistance.


Asunto(s)
Proteínas Bacterianas , Mycobacterium tuberculosis , Proteínas Bacterianas/química , Mycobacterium tuberculosis/genética , Mutagénesis , Reparación del ADN , Antituberculosos/farmacología
11.
Sci Rep ; 12(1): 7919, 2022 05 13.
Artículo en Inglés | MEDLINE | ID: mdl-35562381

RESUMEN

Human breath contains trace amounts of non-volatile organic compounds (NOCs) which might provide non-invasive methods for evaluating individual health. In previous work, we demonstrated that lipids detected in exhaled breath aerosol (EBA) could be used as markers of active tuberculosis (TB). Here, we advanced our analytical platform for characterizing small metabolites and lipids in EBA samples collected from participants enrolled in clinical trials designed to identify molecular signatures of active TB. EBA samples from 26 participants with active TB and 73 healthy participants were processed using a dual-phase extraction method, and metabolites and lipids were identified via mass spectrometry database matching. In total, 13 metabolite and 9 lipid markers were identified with statistically different optimized relative standard deviation values between individuals diagnosed with active TB and the healthy controls. Importantly, EBA lipid profiles can be used to separate the two sample types, indicating the diagnostic potential of the identified molecules. A feature ranking algorithm reduced this number to 10 molecules, with the membrane glycerophospholipid, phosphatidylinositol 24:4, emerging as the top driver of segregation between the two groups. These results support the use of this approach to identify consistent NOC signatures from EBA samples in active TB cases. This suggests the potential to apply this method to other human diseases which alter respiratory NOC release.


Asunto(s)
Líquidos Corporales , Tuberculosis , Compuestos Orgánicos Volátiles , Aerosoles/análisis , Biomarcadores/análisis , Líquidos Corporales/química , Pruebas Respiratorias/métodos , Espiración , Humanos , Lípidos/análisis , Tuberculosis/diagnóstico , Compuestos Orgánicos Volátiles/análisis
12.
Tuberculosis (Edinb) ; 126: 102038, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33316737

RESUMEN

BACKGROUND: Symptoms of infectious respiratory illnesses are often assumed to drive transmission. However, production and release of Mycobacterium tuberculosis (Mtb) bioaerosols is poorly understood. We report quantitation of Mtb exhaled during specific respiratory manoeuvres. METHODS: Direct capture of nascent bioaerosol particles and indirect collection of aged particles was performed in 10 healthy subjects. Indirect and direct capture of exhaled viable Mtb bacilli was compared in 38 PTB patients and directly captured viable Mtb during cough and bronchiole-burst manoeuvres in 27 of the PTB patients. RESULTS: Direct sampling of healthy subjects captured larger bioaerosol volumes with higher proportions of 2-5 µm particles than indirect sampling. Indirect sampling identified viable Mtb in 92.1% (35 of 38) of PTB patients during 60-min relaxed breathing, median bacillary count 7.5 (IQR: 3.25-19). Direct sampling for 10-min identified Mtb in 97.4% (37 of 38) of PTB patients with higher bacilli counts (p < 0.001), median 24.5 (IQR:11.25-37.5). A short 5-min sampling regimen of 10 coughs or 10 bronchiole-burst manoeuvres yielded a median of 11 (IQR: 4-17) and 11 (IQR: 7-17.5) Mtb bacilli, respectively (p = 0.53). CONCLUSIONS: Peripheral lung bioaerosol released through deep exhalations alone contained viable Mtb suggesting non-cough transmission is possible in PTB.


Asunto(s)
Aerosoles/análisis , Tos/microbiología , Pulmón/microbiología , Mycobacterium tuberculosis/aislamiento & purificación , Tuberculosis Pulmonar/microbiología , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Manejo de Especímenes , Tuberculosis Pulmonar/transmisión
13.
PLoS One ; 15(9): e0238193, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32881875

RESUMEN

INTRODUCTION: Detection of Mycobacterium tuberculosis (Mtb) in patient-derived bioaerosol is a potential tool to measure source case infectiousness. However, current bioaerosol sampling approaches have reported low detection yields in sputum-positive TB cases. To increase the utility of bioaerosol sampling, we present advances in bioaerosol collection and Mtb identification that improve detection yields. METHODS: A previously described Respiratory Aerosol Sampling Chamber (RASC) protocol, or "RASC-1", was modified to incorporate liquid collection of bioaerosol using a high-flow wet-walled cyclone (RASC-2). Individuals with GeneXpert-positive pulmonary TB were sampled pre-treatment over 60-minutes. Putative Mtb bacilli were detected in collected fluid by fluorescence microscopy utilising DMN-Trehalose. Exhaled air and bioaerosol volumes were estimated using continuous CO2 monitoring and airborne particle counting, respectively. Mtb capture was calculated per exhaled air volume sampled and bioaerosol volume for RASC-1 (n = 35) and for RASC-2 (n = 21). Empty chamber samples were collected between patients as controls. RESULTS: The optimised RASC-2 protocol sampled a median of 258.4L (IQR: 226.9-273.6) of exhaled air per patient compared with 27.5L (IQR: 23.6-30.3) for RASC-1 (p<0.0001). Bioaerosol volume collection was estimated at 2.3nL (IQR: 1.1-3.6) for RASC-2 compared with 0.08nL (IQR: 0.05-0.10) for RASC-1 (p<0.0001). The detection yield of viable Mtb improved from 43% (median 2 CFU, range: 1-14) to 95% (median 20.5 DMN-Trehalose positive bacilli, range: 2-155). These improvements represent a lowering of the limit of detection in the RASC-2 platform to 0.9 Mtb bacilli per 100L of exhaled air from 3.3 Mtb bacilli per 100L (RASC-1). CONCLUSION: This study demonstrates that technical improvements in particle collection together with sensitive detection enable rapid quantitation of viable Mtb in bioaerosols of sputum positive TB cases. Increased sampling sensitivity may allow future TB transmission studies to be extended to sputum-negative and subclinical individuals, and suggests the potential utility of bioaerosol measurement for rapid intervention in other airborne infectious diseases.


Asunto(s)
Aerosoles/análisis , Manejo de Especímenes/métodos , Tuberculosis/diagnóstico , Adulto , Dióxido de Carbono/química , Espiración , Femenino , Humanos , Masculino , Mycobacterium tuberculosis/aislamiento & purificación , Tuberculosis/microbiología
14.
J Neurol ; 266(7): 1789-1795, 2019 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-31069528

RESUMEN

BACKGROUND: Seizures and epilepsy may substantially add to the burden of disease in multiple sclerosis (MS), whereas the exact prevalence and prognosis of seizures and epilepsy in patients with MS remains largely unknown. OBJECTIVES: We aimed to investigate the epidemiology and prognosis of seizures and epilepsy in MS. METHODS: We retrospectively analyzed a cohort of 4078 MS patients from a single tertiary referral clinic. RESULTS: After excluding 37 patients with unconfirmed MS and alternative seizure etiologies, we found seizures attributable to MS in 1.5% and epilepsy in 0.9% of patients. 40.4% of patients with a follow-up of at least twelve months experienced only a single seizure and 59.6% had recurring seizures. 39% of patients with recurrent seizures were considered drug-resistant, with 9.7% experiencing status epilepticus. Seizure recurrence after a first seizure depended significantly on the MS subtype and was seen more often if the first seizure occurred simultaneously with a MS relapse than in the absence of a relapse. CONCLUSION: Our study shows a lower number of seizures and epilepsy in MS than previously reported. While a single seizure in MS usually has a good prognosis, relapse-associated seizures and established epilepsy in MS may not be as benign as previously assumed.


Asunto(s)
Epilepsia/diagnóstico , Epilepsia/epidemiología , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/epidemiología , Convulsiones/diagnóstico , Convulsiones/epidemiología , Adulto , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Pronóstico , Estudios Retrospectivos , Centros de Atención Terciaria/tendencias
15.
Stud Health Technol Inform ; 253: 35-39, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30147036

RESUMEN

Annotation with semantic codes helps to overcome interoperability issues for electronic documentation in medicine. However, the manual annotation process is laborious and semantic codes are ambiguous. We developed a publicly accessible web service to alleviate these drawbacks with a sophisticated and fast search mechanism based on more than 330,000 semantic code suggestions. These suggestions are derived from semantically annotated data elements contained in the Portal of Medical Data Models manually curated by medical professionals. Integrating this suggestion service can support the manual annotation process and strengthen uniform coding. Integration is demonstrated for two separate data model editors. Usage statistics show over 5,500 suggestion requests per month for semantic annotation of items. The web service may also prove helpful for automatic semantic coding.


Asunto(s)
Curaduría de Datos , Registros Electrónicos de Salud , Semántica , Documentación
16.
J Am Med Inform Assoc ; 25(5): 593-602, 2018 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-29036406

RESUMEN

Objectives: To systematically classify the clinical impact of computerized clinical decision support systems (CDSSs) in inpatient care. Materials and Methods: Medline, Cochrane Trials, and Cochrane Reviews were searched for CDSS studies that assessed patient outcomes in inpatient settings. For each study, 2 physicians independently mapped patient outcome effects to a predefined medical effect score to assess the clinical impact of reported outcome effects. Disagreements were measured by using weighted kappa and solved by consensus. An example set of promising disease entities was generated based on medical effect scores and risk of bias assessment. To summarize technical characteristics of the systems, reported input variables and algorithm types were extracted as well. Results: Seventy studies were included. Five (7%) reported reduced mortality, 16 (23%) reduced life-threatening events, and 28 (40%) reduced non-life-threatening events, 20 (29%) had no significant impact on patient outcomes, and 1 showed a negative effect (weighted κ: 0.72, P < .001). Six of 24 disease entity settings showed high effect scores with medium or low risk of bias: blood glucose management, blood transfusion management, physiologic deterioration prevention, pressure ulcer prevention, acute kidney injury prevention, and venous thromboembolism prophylaxis. Most of the implemented algorithms (72%) were rule-based. Reported input variables are shared as standardized models on a metadata repository. Discussion and Conclusion: Most of the included CDSS studies were associated with positive patient outcomes effects but with substantial differences regarding the clinical impact. A subset of 6 disease entities could be filtered in which CDSS should be given special consideration at sites where computer-assisted decision-making is deemed to be underutilized. Registration number on PROSPERO: CRD42016049946.


Asunto(s)
Toma de Decisiones Asistida por Computador , Sistemas de Apoyo a Decisiones Clínicas , Resultado del Tratamiento , Algoritmos , Mortalidad Hospitalaria , Humanos , Pacientes Internos , Sistemas de Entrada de Órdenes Médicas
17.
Stud Health Technol Inform ; 247: 231-235, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29677957

RESUMEN

CDISC's Operational Data Model (ODM) is a flexible standard for exchanging and archiving metadata and subject clinical data in clinical trials. The Portal of Medical Data Models (MDM-Portal) uses ODM to store more than 15000 medical forms. As not every electronic health system accepts ODM as input format, there is a need for conversion between ODM and other data standards and formats. This research proposes a standardised template-based process to develop ODM converters. So far, ten converters have been developed and integrated in the MDM-Portal following this process and new ones should be included soon. The template, programming utilities and an ODM test suite have been made online available and can be used to easily develop new converters.


Asunto(s)
Investigación Biomédica , Metadatos , Archivos , Modelos Teóricos
18.
Stud Health Technol Inform ; 245: 225-229, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-29295087

RESUMEN

The increasing use of electronic health information systems brings up an unresolved issue: the lack of interoperability between these systems. The Clinical Data Interchange Standards Consortium's Operational Data Model (ODM) is an xml based standard for the exchange of clinical data and metadata. The University of Münster has been using ODM to store medical forms in a web based metadata registry called Portal of Medical Data Models, which includes a complete set of tools to transform ODM forms into other formats. One kind of medical form is the Patient Reported Outcome, a trending type due to its easy integration with mobile data capture systems. ResearchKit is a development framework that allows the easy creation of these for iOS devices; unfortunately its current interoperability is limited. This research proposes a mapping between ODM and ResearchKit and presents the successful implementation of a converter for ODM into JSON based ResearchKit readable files.


Asunto(s)
Investigación Biomédica , Sistemas de Información en Salud , Metadatos , Humanos , Modelos Anatómicos , Medición de Resultados Informados por el Paciente , Sistema de Registros
19.
Stud Health Technol Inform ; 243: 95-99, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28883178

RESUMEN

Due to the increasing use of electronic data capture systems for clinical research, the interest in saving resources by automatically generating and reusing case report forms in clinical studies is growing. OpenClinica, an open-source electronic data capture system enables the reuse of metadata in its own Excel import template, hampering the reuse of metadata defined in other standard formats. One of these standard formats is the Operational Data Model for metadata, administrative and clinical data in clinical studies. This work suggests a mapping from Operational Data Model to OpenClinica and describes the implementation of a converter to automatically generate OpenClinica conform case report forms based upon metadata in the Operational Data Model.


Asunto(s)
Automatización , Investigación Biomédica , Registros Médicos , Humanos , Difusión de la Información , Metadatos
20.
Stud Health Technol Inform ; 245: 1175-1179, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-29295288

RESUMEN

Computerized Clinical Decision Support Systems (CDSS) are implemented in hospitals to improve prevention of Venous Thromboembolisms (VTE). A physician-driven review was conducted to assess extent of patient outcome effects of recently published CDSS studies. To facilitate future re-implementations within existing hospital information systems, input variables of included systems were extracted, standardized and annotated with semantic codes. Item category coverages of the different systems were then compared. 73% of studies showed positive medical effect. Of these, 53% showed strong positive medical effect by reducing incidence of deep vein thromboses and pulmonary embolisms. Outcome-improving systems tend to cover more item categories. A broad set of clinically relevant input variables should be taken into account or reused from the electronic health record if considering CDSS implementation. Input data models are provided for download in different standardized formats. Site-specific organizational factors that determine how systems are introduced, implemented and tested are also crucial for success.


Asunto(s)
Sistemas de Apoyo a Decisiones Clínicas , Tromboembolia Venosa/prevención & control , Anticoagulantes , Humanos , Incidencia , Trombosis de la Vena
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