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1.
J Nurs Adm ; 51(3): 162-167, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33570374

RESUMO

A focused effort is needed to capture the utility and usability of the electronic health record for providing usable and reusable data while reducing documentation burden. A collaborative effort of nurse leaders and experts was able to generate national consensus recommendations on documentation elements related to admission history. The process used in this effort is summarized in a framework that can be used by other groups to develop content that reduces documentation burden while maximizing the creation of usable and reusable data.


Assuntos
Gerenciamento de Dados/normas , Documentação/normas , Registros Eletrônicos de Saúde/normas , Colaboração Intersetorial , Objetivos Organizacionais , Guias de Prática Clínica como Assunto/normas , Humanos , Estados Unidos
2.
Mutat Res ; 854-855: 503199, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32660827

RESUMO

The bacterial reverse mutation test (Ames test) is the most commonly used genotoxicity test; it is a primary component of the chemical safety assessment data required by regulatory agencies worldwide. Within the current accepted in vitro genotoxicity test battery, it is considered capable of revealing DNA reactivity, and identifying substances that can produce gene mutations via different mechanisms. The previously published consolidated EURL ECVAM Genotoxicity and Carcinogenicity Database, which includes substances that elicited a positive response in the Ames test, constitutes a collection of data that serves as a reference for a number of regulatory activities in the area of genotoxicity testing. Consequently, we considered it important to expand the database to include substances that fail to elicit a positive response in the Ames test, i.e., Ames negative substances. Here, we describe a curated collection of 211 Ames negative substances, with a summary of complementary data available for other genotoxicity endpoints in vitro and in vivo, plus available carcinogenicity data. A descriptive analysis of the data is presented. This includes a representation of the chemical space formed by the Ames-negative database with respect to other substances (e.g. REACH registered substances, approved drugs, pesticides, etc.) and a description of the organic functional groups found in the database. We also provide some suggestions on further analyses that could be made.


Assuntos
Testes de Carcinogenicidade/normas , Carcinógenos/toxicidade , Bases de Dados Factuais/normas , Testes de Mutagenicidade/normas , Mutagênicos/toxicidade , Resultados Negativos/normas , Animais , Dano ao DNA/efeitos dos fármacos , Dano ao DNA/genética , Gerenciamento de Dados/normas , Humanos
5.
PLoS One ; 15(4): e0230722, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32271788

RESUMO

With the rapid development of informatization, an increasing number of industries and organizations outsource their data to cloud servers, to avoid the cost of local data management and to share data. For example, industrial Internet of things systems and mobile healthcare systems rely on cloud computing's powerful data storage and processing capabilities to address the storage, provision, and maintenance of massive amounts of industrial and medical data. One of the major challenges facing cloud-based storage environments is how to ensure the confidentiality and security of outsourced sensitive data. To mitigate these issues, He et al. and Ma et al. have recently independently proposed two certificateless public key searchable encryption schemes. In this paper, we analyze the security of these two schemes and show that the reduction proof of He et al.'s CLPAEKS scheme is incorrect, and that Ma et al.'s CLPEKS scheme is not secure against keyword guessing attacks. We then propose a channel-free certificateless searchable public key authenticated encryption (dCLPAEKS) scheme and prove that it is secure against inside keyword guessing attacks under the enhanced security model. Compared with other certificateless public key searchable encryption schemes, this scheme has higher security and comparable efficiency.


Assuntos
Computação em Nuvem/normas , Segurança Computacional/normas , Armazenamento e Recuperação da Informação , Internet das Coisas , Setor Público , Algoritmos , Confidencialidade , Gerenciamento de Dados/métodos , Gerenciamento de Dados/organização & administração , Gerenciamento de Dados/normas , Eficiência Organizacional , Registros Eletrônicos de Saúde/organização & administração , Registros Eletrônicos de Saúde/normas , Troca de Informação em Saúde/normas , Humanos , Armazenamento e Recuperação da Informação/métodos , Armazenamento e Recuperação da Informação/normas , Internet das Coisas/organização & administração , Internet das Coisas/normas , Serviços Terceirizados/organização & administração , Serviços Terceirizados/normas , Setor Público/organização & administração , Setor Público/normas , Tecnologia sem Fio/organização & administração , Tecnologia sem Fio/normas
6.
JCO Clin Cancer Inform ; 4: 184-200, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32134684

RESUMO

Big data for health care is one of the potential solutions to deal with the numerous challenges of health care, such as rising cost, aging population, precision medicine, universal health coverage, and the increase of noncommunicable diseases. However, data centralization for big data raises privacy and regulatory concerns.Covered topics include (1) an introduction to privacy of patient data and distributed learning as a potential solution to preserving these data, a description of the legal context for patient data research, and a definition of machine/deep learning concepts; (2) a presentation of the adopted review protocol; (3) a presentation of the search results; and (4) a discussion of the findings, limitations of the review, and future perspectives.Distributed learning from federated databases makes data centralization unnecessary. Distributed algorithms iteratively analyze separate databases, essentially sharing research questions and answers between databases instead of sharing the data. In other words, one can learn from separate and isolated datasets without patient data ever leaving the individual clinical institutes.Distributed learning promises great potential to facilitate big data for medical application, in particular for international consortiums. Our purpose is to review the major implementations of distributed learning in health care.


Assuntos
Algoritmos , Gerenciamento de Dados/normas , Mineração de Dados/ética , Assistência à Saúde/ética , Registros Eletrônicos de Saúde/ética , Aprendizado de Máquina , Privacidade , Mineração de Dados/métodos , Bases de Dados Factuais/estatística & dados numéricos , Assistência à Saúde/métodos , Humanos , Medicina de Precisão/métodos
7.
Clin Pharmacol Ther ; 107(4): 915-925, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31956997

RESUMO

Exploring and combining results from more than one real-world data (RWD) source might be necessary in order to explore variability and demonstrate generalizability of the results or for regulatory requirements. However, the heterogeneous nature of RWD poses challenges when working with more than one source, some of which can be solved by analyzing databases converted into a common data model (CDM). The main objective of the study was to evaluate the implementation of the Observational Medical Outcome Partnership (OMOP) CDM on IQVIA Medical Research Data (IMRD)-UK data. A drug utilization study describing the prescribing of codeine for pain in children was used as a case study to be replicated in IMRD-UK and its corresponding OMOP CDM transformation. Differences between IMRD-UK source and OMOP CDM were identified and investigated. In IMRD-UK updated to May 2017, results were similar between source and transformed data with few discrepancies. These were the result of different conventions applied during the transformation regarding the date of birth for children younger than 15 years and the start of the observation period, and of a misclassification of two drug treatments. After the initial analysis and feedback provided, a rerun of the analysis in IMRD-UK updated to September 2018 showed almost identical results for all the measures analyzed. For this study, the conversion to OMOP CDM was adequate. Although some decisions and mapping could be improved, these impacted on the absolute results but not on the study inferences. This validation study supports six recommendations for good practice in transforming to CDMs.


Assuntos
Analgésicos Opioides/normas , Pesquisa Biomédica/normas , Codeína/normas , Gerenciamento de Dados/normas , Bases de Dados Factuais/normas , Prescrições de Medicamentos/normas , Analgésicos Opioides/administração & dosagem , Pesquisa Biomédica/estatística & dados numéricos , Criança , Pré-Escolar , Gerenciamento de Dados/estatística & dados numéricos , Bases de Dados Factuais/estatística & dados numéricos , Prescrições de Medicamentos/estatística & dados numéricos , Registros Eletrônicos de Saúde/normas , Registros Eletrônicos de Saúde/estatística & dados numéricos , Feminino , Humanos , Masculino , Estudos Retrospectivos , Resultado do Tratamento , Reino Unido/epidemiologia
8.
Artigo em Inglês | MEDLINE | ID: mdl-31389322

RESUMO

BACKGROUND: The knowledge of the pathophysiology of Lysosomal Storage Disorders has gradually increased, but information on their incidence is still scarce. The objective of this study was to evaluate the status and use of resources of these disorders in Spain from 1997 to 2015. METHODS: Records from 4,999 patients diagnosed with a Lysosomal Storage Disorder were extracted from a Spanish database containing data from public and private hospitals from 1997 to 2015. RESULTS: The database registered 2,441 patients with an LSD in Spain during the study period. Leukodystrophy, Krabbe disease, Pelizaeus-Merzbacher disease and sulfatide lipidosis represented, as a group, the most common combination of diseases in Spain, affecting 26% of total patients. The average age of diagnosis of these disorders was 16.7 years. A sex bias was observed in most of the groups, with a proportion of male/female of 60 to 40%. The direct medical cost of Lysosomal Storage Diseases was €5,686 per patient with an average cost per hospital admission of €4,923. Global costs displayed a growing tendency. CONCLUSION: Contrary to worldwide disease incidence estimations, the group with Krabbe disease registered the highest number of patients in the study period, which makes evident the need for accurate regional disease incidence and patient demographic studies. Altogether, data suggest the need to improve LSDs diagnostic protocols, and support the inclusion of these disorders in standard newborn screening programs.


Assuntos
Gerenciamento de Dados/métodos , Bases de Dados Factuais , Recursos em Saúde , Doenças por Armazenamento dos Lisossomos/diagnóstico , Doenças por Armazenamento dos Lisossomos/epidemiologia , Adolescente , Adulto , Criança , Pré-Escolar , Gerenciamento de Dados/normas , Bases de Dados Factuais/normas , Feminino , Recursos em Saúde/normas , Humanos , Lactente , Recém-Nascido , Masculino , Triagem Neonatal/métodos , Triagem Neonatal/normas , Espanha/epidemiologia , Adulto Jovem
9.
Neurosurgery ; 86(1): 46-60, 2020 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-31225602

RESUMO

BACKGROUND: Use of large databases such as the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) has become increasingly common in neurosurgical research. OBJECTIVE: To perform a critical appraisal and evaluation of the methodological reporting for studies in neurosurgical literature that utilize the ACS-NSQIP database. METHODS: We queried Ovid MEDLINE, EMBASE, and PubMed databases for all neurosurgical studies utilizing the ACS-NSQIP. We assessed each study according to number of criteria fulfilled with respect to Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement, REporting of studies Conducted using Observational Routinely-collected Health Data (RECORD) Statement, and Journal of American Medical Association-Surgical Section (JAMA-Surgery) Checklist. A separate analysis was conducted among papers published in core and noncore journals in neurosurgery according to Bradford's law. RESULTS: A total of 117 studies were included. Median (interquartile range [IQR]) scores for number of fulfilled criteria for STROBE Statement, RECORD Statement, and JAMA-Surgery Checklist were 20 (IQR:19-21), 9 (IQR:8-9), and 6 (IQR:5-6), respectively. For STROBE Statement, RECORD Statement, and JAMA-Surgery Checklist, item 9 (potential sources of bias), item 13 (supplemental information), and item 9 (missing data/sensitivity analysis) had the highest number of studies with no fulfillment among all studies (56, 68, 50%), respectively. When comparing core journals vs noncore journals, no significant difference was found (STROBE, P = .94; RECORD, P = .24; JAMA-Surgery checklist, P = .60). CONCLUSION: While we observed an overall satisfactory reporting of methodology, most studies lacked mention of potential sources of bias, data cleaning methods, supplemental information, and external validity. Given the pervasive role of national databases and registries for research and health care policy, the surgical community needs to ensure the credibility and quality of such studies that ultimately aim to improve the value of surgical care delivery to patients.


Assuntos
Lista de Checagem/normas , Gerenciamento de Dados/normas , Procedimentos Neurocirúrgicos/normas , Melhoria de Qualidade/normas , Cirurgiões/normas , Lista de Checagem/métodos , Bases de Dados Factuais/normas , Humanos , Procedimentos Neurocirúrgicos/métodos , Estudos Observacionais como Assunto/métodos , Estudos Observacionais como Assunto/normas , Guias de Prática Clínica como Assunto/normas , Sistema de Registros , Estados Unidos
10.
Future Oncol ; 16(3): 4455-4460, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31820657

RESUMO

Aim: We assessed the extent to which chemotherapy cycles recorded in Hospital Episode Statistics (HES) Admitted Patient Care (APC) were captured in National Cancer Registration & Analysis Service Systemic Anti-Cancer Therapy (SACT) for a cohort of lung cancer patients. Methods: All chemotherapy cycles recorded for linkage eligible lung cancer patients with a National Cancer Registration & Analysis Service diagnosis between 2012 and 2015 were identified in HES APC and SACT. Results: Among a population of 4070 lung cancer patients, 6076 chemotherapy cycles were observed in HES APC data. A total of 61% of cycles were recorded in SACT on the same day, 8% on a different day and 31% were not recorded in SACT. Conclusion: Our results suggest that SACT may not capture all chemotherapy cycles administered to a patient between 2012 and 2016; however, administrative changes mean data after this period may be more complete.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Gerenciamento de Dados/estatística & dados numéricos , Bases de Dados Factuais/estatística & dados numéricos , Neoplasias Pulmonares/tratamento farmacológico , Sistema de Registros/estatística & dados numéricos , Estudos de Coortes , Gerenciamento de Dados/normas , Bases de Dados Factuais/normas , Conjuntos de Dados como Assunto , Esquema de Medicação , Inglaterra , Hospitalização/estatística & dados numéricos , Humanos , Sistema de Registros/normas , Medicina Estatal/estatística & dados numéricos
11.
Med Sci (Paris) ; 35(8-9): 689-692, 2019.
Artigo em Francês | MEDLINE | ID: mdl-31532382

RESUMO

Methodological reproducibility refers to the ability to reproduce exactly the same results by reproducing the same study protocol on the same data. The aim of this study was to assess the methodological reproducibility of studies published in the Revue d'Epidémiologie et de Santé Publique between 2008 and 2017 and using data from the national health data system. Our results suggest that only 49% of the studies could be replicated without the help of the authors. The results may reveal a lack of concern about the purpose of public health research. It is difficult to attribute responsibility for this default of reproducibility solely to researchers, so we hypothesize an instituted ethical misconduct.


Assuntos
Demandas Administrativas em Assistência à Saúde/estatística & dados numéricos , Bases de Dados como Assunto , Projetos de Pesquisa Epidemiológica , Sistemas Computadorizados de Registros Médicos/estatística & dados numéricos , Sistemas Computadorizados de Registros Médicos/normas , Academias e Institutos/ética , Academias e Institutos/normas , Academias e Institutos/estatística & dados numéricos , Gerenciamento de Dados/ética , Gerenciamento de Dados/organização & administração , Gerenciamento de Dados/normas , Bases de Dados como Assunto/normas , Bases de Dados como Assunto/estatística & dados numéricos , Humanos , Disseminação de Informação/ética , Disseminação de Informação/métodos , Princípios Morais , Saúde Pública/normas , Saúde Pública/estatística & dados numéricos , Reprodutibilidade dos Testes , Má Conduta Científica/estatística & dados numéricos
12.
Br J Clin Pharmacol ; 85(12): 2784-2792, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31471967

RESUMO

AIMS: Monitoring risk-based approaches in clinical trials are encouraged by regulatory guidance. However, the impact of a targeted source data verification (SDV) on data-management (DM) workload and on final data quality needs to be addressed. METHODS: MONITORING was a prospective study aiming at comparing full SDV (100% of data verified for all patients) and targeted SDV (only key data verified for all patients) followed by the same DM program (detecting missing data and checking consistency) on final data quality, global workload and staffing costs. RESULTS: In all, 137 008 data including 18 124 key data were collected for 126 patients from 6 clinical trials. Compared to the final database obtained using the full SDV monitoring process, the final database obtained using the targeted SDV monitoring process had a residual error rate of 1.47% (95% confidence interval, 1.41-1.53%) on overall data and 0.78% (95% confidence interval, 0.65-0.91%) on key data. There were nearly 4 times more queries per study with targeted SDV than with full SDV (mean ± standard deviation: 132 ± 101 vs 34 ± 26; P = .03). For a handling time of 15 minutes per query, the global workload of the targeted SDV monitoring strategy remained below that of the full SDV monitoring strategy. From 25 minutes per query it was above, increasing progressively to represent a 50% increase for 45 minutes per query. CONCLUSION: Targeted SDV monitoring is accompanied by increased workload for DM, which allows to obtain a small proportion of remaining errors on key data (<1%), but may substantially increase trial costs.


Assuntos
Confiabilidade dos Dados , Coleta de Dados/normas , Gerenciamento de Dados/normas , Bases de Dados Factuais/normas , Registros Eletrônicos de Saúde/normas , Controle de Formulários e Registros/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Carga de Trabalho/normas , Análise Custo-Benefício , Controle de Formulários e Registros/economia , Controle de Formulários e Registros/normas , Humanos , Estudos Prospectivos
13.
Anesth Analg ; 129(3): 726-734, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31425213

RESUMO

The convergence of multiple recent developments in health care information technology and monitoring devices has made possible the creation of remote patient surveillance systems that increase the timeliness and quality of patient care. More convenient, less invasive monitoring devices, including patches, wearables, and biosensors, now allow for continuous physiological data to be gleaned from patients in a variety of care settings across the perioperative experience. These data can be bound into a single data repository, creating so-called data lakes. The high volume and diversity of data in these repositories must be processed into standard formats that can be queried in real time. These data can then be used by sophisticated prediction algorithms currently under development, enabling the early recognition of patterns of clinical deterioration otherwise undetectable to humans. Improved predictions can reduce alarm fatigue. In addition, data are now automatically queriable on a real-time basis such that they can be fed back to clinicians in a time frame that allows for meaningful intervention. These advancements are key components of successful remote surveillance systems. Anesthesiologists have the opportunity to be at the forefront of remote surveillance in the care they provide in the operating room, postanesthesia care unit, and intensive care unit, while also expanding their scope to include high-risk preoperative and postoperative patients on the general care wards. These systems hold the promise of enabling anesthesiologists to detect and intervene upon changes in the clinical status of the patient before adverse events have occurred. Importantly, however, significant barriers still exist to the effective deployment of these technologies and their study in impacting patient outcomes. Studies demonstrating the impact of remote surveillance on patient outcomes are limited. Critical to the impact of the technology are strategies of implementation, including who should receive and respond to alerts and how they should respond. Moreover, the lack of cost-effectiveness data and the uncertainty of whether clinical activities surrounding these technologies will be financially reimbursed remain significant challenges to future scale and sustainability. This narrative review will discuss the evolving technical components of remote surveillance systems, the clinical use cases relevant to the anesthesiologist's practice, the existing evidence for their impact on patients, the barriers that exist to their effective implementation and study, and important considerations regarding sustainability and cost-effectiveness.


Assuntos
Anestesiologia/métodos , Gerenciamento de Dados/métodos , Informática Médica/métodos , Qualidade da Assistência à Saúde , Tecnologia de Sensoriamento Remoto/métodos , Anestesiologia/economia , Anestesiologia/normas , Análise Custo-Benefício/métodos , Análise Custo-Benefício/normas , Gerenciamento de Dados/economia , Gerenciamento de Dados/normas , Humanos , Informática Médica/economia , Informática Médica/normas , Qualidade da Assistência à Saúde/economia , Qualidade da Assistência à Saúde/normas , Tecnologia de Sensoriamento Remoto/economia , Tecnologia de Sensoriamento Remoto/normas , Fatores de Tempo
14.
J Med Genet ; 56(11): 734-740, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31300549

RESUMO

INTRODUCTION: Between 0.02% and 0.04% of articles are retracted. We aim to: (a) describe the reasons for retraction of genetics articles and the time elapsed between the publication of an article and that of the retraction notice because of research misconduct (ie, fabrication, falsification, plagiarism); and (b) compare all these variables between retracted medical genetics (MG) and non-medical genetics (NMG) articles. METHODS: All retracted genetics articles published between 1970 and 2018 were retrieved from the Retraction Watch database. The reasons for retraction were fabrication/falsification, plagiarism, duplication, unreliability, and authorship issues. Articles subject to investigation by company/institution, journal, US Office for Research Integrity or third party were also retrieved. RESULTS: 1582 retracted genetics articles (MG, n=690; NMG, n=892) were identified . Research misconduct and duplication were involved in 33% and 24% of retracted papers, respectively; 37% were subject to investigation. Only 0.8% of articles involved both fabrication/falsification and plagiarism. In this century the incidence of both plagiarism and duplication increased statistically significantly in genetics retracted articles; conversely, fabrication/falsification was significantly reduced. Time to retraction due to scientific misconduct was statistically significantly shorter in the period 2006-2018 compared with 1970-2000. Fabrication/falsification was statistically significantly more common in NMG (28%) than in MG (19%) articles. MG articles were significantly more frequently investigated (45%) than NMG articles (31%). Time to retraction of articles due to fabrication/falsification was significantly shorter for MG (mean 4.7 years) than for NMG (mean 6.4 years) articles; no differences for plagiarism (mean 2.3 years) were found. The USA (mainly NMG articles) and China (mainly MG articles) accounted for the largest number of retracted articles. CONCLUSION: Genetics is a discipline with a high article retraction rate (estimated retraction rate 0.15%). Fabrication/falsification and plagiarism were almost mutually exclusive reasons for article retraction. Retracted MG articles were more frequently subject to investigation than NMG articles. Retracted articles due to fabrication/falsification required 2.0-2.8 times longer to retract than when plagiarism was involved.


Assuntos
Pesquisa Biomédica/normas , Má Conduta Científica/estatística & dados numéricos , China , Gerenciamento de Dados/normas , Bases de Dados Factuais , Humanos , Retratação de Publicação como Assunto
15.
J Clin Epidemiol ; 112: 59-66, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31051247

RESUMO

OBJECTIVE: PubMed is one of the most commonly used search tools in biomedical and life sciences. Existing studies of database coverage generally conclude that searching PubMed may not be sufficient although some find that the contributions from other databases are modest at best. However, generalizability of the studies of the coverage of PubMed is typically restricted. The objective of this study is to analyze the coverage of PubMed across specialties and over time. STUDY DESIGN AND SETTING: We use the more than 50,000 included studies in all Cochrane reviews published from 2012 to 2016 as our population and examine if the studies and resulting publications can be identified in PubMed. RESULTS: The results show that PubMed has a coverage of 70.9, 95% confidence interval (CI) (68.40, 73.30) of all the included publications and 82.8%, 95% CI (80.9, 84.7) of the included studies. There are huge differences in coverage across and within specialties. In addition, coverage varies within groups over time. CONCLUSION: Databases used for searching topics within the groups with highly varying or low coverage should be chosen with care as PubMed may have a relatively low coverage.


Assuntos
Pesquisa Biomédica/estatística & dados numéricos , Gerenciamento de Dados , Armazenamento e Recuperação da Informação/métodos , PubMed , Intervalos de Confiança , Gerenciamento de Dados/métodos , Gerenciamento de Dados/normas , Bases de Dados Bibliográficas/normas , Bases de Dados Bibliográficas/estatística & dados numéricos , Humanos , PubMed/normas , PubMed/estatística & dados numéricos , Publicações/estatística & dados numéricos , Revisões Sistemáticas como Assunto
16.
Heart Lung Circ ; 28(10): 1459-1462, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30962063

RESUMO

Over two decades, the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) cardiac surgery database program has evolved from a single state-based database to a national clinical quality registry program and is now the most comprehensive cardiac surgical registry in Australia. We report the current structure and governance of the program and its key activities.


Assuntos
Gerenciamento de Dados/normas , Garantia da Qualidade dos Cuidados de Saúde/estatística & dados numéricos , Sistema de Registros , Sociedades Médicas , Cirurgia Torácica/estatística & dados numéricos , Procedimentos Cirúrgicos Torácicos/normas , Austrália , Humanos , Nova Zelândia
17.
Trials ; 20(1): 227, 2019 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-30995932

RESUMO

BACKGROUND: Triggered monitoring in clinical trials is a risk-based monitoring approach where triggers (centrally monitored, predefined key risk and performance indicators) drive the extent, timing, and frequency of monitoring visits. The TEMPER study used a prospective, matched-pair design to evaluate the use of a triggered monitoring strategy, comparing findings from triggered monitoring visits with those from matched control sites. To facilitate this study, we developed a bespoke risk-based monitoring system: the TEMPER Management System. METHODS: The TEMPER Management System comprises a web application (the front end), an SQL server database (the back end) to store the data generated for TEMPER, and a reporting function to aid users in study processes such as the selection of triggered sites. Triggers based on current practice were specified for three clinical trials and were implemented in the system. Trigger data were generated in the system using data extracted from the trial databases to inform the selection of triggered sites to visit. Matching of the chosen triggered sites with untriggered control sites was also performed in the system, while data entry screens facilitated the collection and management of the data from findings gathered at monitoring visits. RESULTS: There were 38 triggers specified for the participating trials. Using these, 42 triggered sites were chosen and matched with control sites. Monitoring visits were carried out to all sites, and visit findings were entered into the TEMPER Management System. Finally, data extracted from the system were used for analysis. CONCLUSIONS: The TEMPER Management System made possible the completion of the TEMPER study. It implemented an approach of standardising the automation of current-practice triggers, and the generation of trigger data to inform the selection of triggered sites to visit. It also implemented a matching algorithm informing the selection of matched control sites. We hope that by publishing this paper it encourages other trialists to share their approaches to, and experiences of, triggered monitoring and other risk-based monitoring systems.


Assuntos
Coleta de Dados/normas , Gerenciamento de Dados/normas , Estudos Multicêntricos como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Algoritmos , Comitês de Monitoramento de Dados de Ensaios Clínicos/normas , Confiabilidade dos Dados , Humanos , Medição de Risco , Fatores de Risco , Fatores de Tempo
18.
J Am Med Inform Assoc ; 26(5): 447-456, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30848796

RESUMO

OBJECTIVE: This study evaluated the degree to which recommendations for demographic data standardization improve patient matching accuracy using real-world datasets. MATERIALS AND METHODS: We used 4 manually reviewed datasets, containing a random selection of matches and nonmatches. Matching datasets included health information exchange (HIE) records, public health registry records, Social Security Death Master File records, and newborn screening records. Standardized fields including last name, telephone number, social security number, date of birth, and address. Matching performance was evaluated using 4 metrics: sensitivity, specificity, positive predictive value, and accuracy. RESULTS: Standardizing address was independently associated with improved matching sensitivities for both the public health and HIE datasets of approximately 0.6% and 4.5%. Overall accuracy was unchanged for both datasets due to reduced match specificity. We observed no similar impact for address standardization in the death master file dataset. Standardizing last name yielded improved matching sensitivity of 0.6% for the HIE dataset, while overall accuracy remained the same due to a decrease in match specificity. We noted no similar impact for other datasets. Standardizing other individual fields (telephone, date of birth, or social security number) showed no matching improvements. As standardizing address and last name improved matching sensitivity, we examined the combined effect of address and last name standardization, which showed that standardization improved sensitivity from 81.3% to 91.6% for the HIE dataset. CONCLUSIONS: Data standardization can improve match rates, thus ensuring that patients and clinicians have better data on which to make decisions to enhance care quality and safety.


Assuntos
Conjuntos de Dados como Assunto/normas , Interoperabilidade da Informação em Saúde , Gerenciamento de Dados/normas , Demografia , Troca de Informação em Saúde , Humanos , Recém-Nascido , Triagem Neonatal , Saúde Pública , Sistema de Registros , Previdência Social , Estados Unidos
19.
AMIA Annu Symp Proc ; 2019: 681-690, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-32308863

RESUMO

Developing promising treatments in biomedicine often requires aggregation and analysis of data from disparate sources across the healthcare and research spectrum. To facilitate these approaches, there is a growing focus on supporting interoperation of datasets by standardizing data-capture and reporting requirements. Common Data Elements (CDEs)-precise specifications of questions and the set of allowable answers to each question-are increasingly being adopted to help meet these standardization goals. While CDEs can provide a strong conceptual foundation for interoperation, there are no widely recognized serialization or interchange formats to describe and exchange their definitions. As a result, CDEs defined in one system cannot be easily be reused by other systems. An additional problem is that current CDE-based systems tend to be rather heavyweight and cannot be easily adopted and used by third-parties. To address these problems, we developed extensions to a metadata management system called the CEDAR Workbench to provide a platform to simplify the creation, exchange, and use of CDEs. We show how the resulting system allows users to quickly define and share CDEs and to immediately use these CDEs to build and deploy Web-based forms to acquire conforming metadata. We also show how we incorporated a large CDE library from the National Cancer Institute's caDSR system and made these CDEs publicly available for general use.


Assuntos
Pesquisa Biomédica , Elementos de Dados Comuns , Coleta de Dados/normas , Gerenciamento de Dados/métodos , Elementos de Dados Comuns/normas , Gerenciamento de Dados/normas , Humanos , Internet , Metadados , National Institutes of Health (U.S.) , Sistema de Registros , Estados Unidos , Interface Usuário-Computador
20.
AMIA Annu Symp Proc ; 2019: 1157-1166, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-32308913

RESUMO

Availability of an accurate and complete health facility list is fundamental in producing quality and timely data that is sufficient to aid evidence-based decision, resource allocation and planning within the healthcare ecosystem. This study aimed at examining the approaches used in Uganda to manage data about health facilities and the challenges they are facing. We conducted a qualitative study involving 32 interviews with participants from Ministry of Health, government regulatory organizations, district local government, general public, academia, implementing partners and healthcare providers. Our analysis identified four divergent approaches that had five common challenges, namely; lack of a health facility unique identifier, non-standardized, incomplete, inaccurate data, difficulty accessing and using data. Establishing a national central health facility registry to manage the national health facility list would improve patient referrals, facility look-ups, health information exchange, data curation and access and health information system integration.


Assuntos
Gerenciamento de Dados/normas , Administração de Instituições de Saúde , Troca de Informação em Saúde/normas , Gerenciamento de Dados/métodos , Instalações de Saúde , Pessoal de Saúde , Entrevistas como Assunto , Sistemas Computadorizados de Registros Médicos , Pesquisa Qualitativa , Sistema de Registros/normas , Uganda
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