scholarly journals A Standardized SOA for Clinical Data Sharing to Support Acute Care, Telemedicine and Clinical Trials

Author(s):  
Roberta Gazzarata ◽  
Mauro Giacomini
2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.


2019 ◽  
Vol 14 (1) ◽  
pp. 10-23 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran

Background:A clinical data management system is a software supporting the data management process in clinical trials. In this system, the effective support of clinical data management dimensions leads to the increased accuracy of results and prevention of diversion in clinical trials. The aim of this review article was to investigate the dimensions of data management in clinical data management systems.Methods:This study was conducted in 2017. The used databases included Web of Science, Scopus, Science Direct, ProQuest, Ovid Medline and PubMed. The search was conducted over a period of 10 years from 2007 to 2017. The initial number of studies was 101 reaching 19 in the final stage. The final studies were described and compared in terms of the year, country and dimensions of the clinical data management process in clinical trials.Results:The research findings indicated that none of the systems completely supported the data management dimensions in clinical trials. Although these systems were developed for supporting the clinical data management process, they were similar to electronic data capture systems in many cases. The most significant dimensions of data management in such systems were data collection or entry, report, validation, and security maintenance.Conclusion:Seemingly, not sufficient attention has been paid to automate all dimensions of the clinical data management process in clinical trials. However, these systems could take positive steps towards changing the manual processes of clinical data management to electronic processes.


BMJ ◽  
2017 ◽  
pp. j2372 ◽  
Author(s):  
Darren B Taichman ◽  
Peush Sahni ◽  
Anja Pinborg ◽  
Larry Peiperl ◽  
Christine Laine ◽  
...  
Keyword(s):  

2021 ◽  
Author(s):  
Abhijit Duggal ◽  
Rachel kast ◽  
Emily Van Ark ◽  
Lucas Bulgarelli ◽  
Matthew Siuba ◽  
...  

Rationale: The acute respiratory distress syndrome (ARDS) is a heterogenous condition, and identification of subphenotypes may help in better risk stratification. Objectives: Identify ARDS subphenotypes using new simpler methodology and readily available clinical variables. Design: Retrospective Cohort Study of ARDS trials. Setting: Data from the U.S. ARDSNet trials and from the international ART trial. Participants: 3763 patients from ARDSNet datasets and 1010 patients from the ART dataset. Primary and secondary outcome measures: The primary outcome was 60-day or 28-day mortality, depending on what was reported in the original trial. K-means cluster analysis was performed to identify subgroups. For feature selection, sets. Sets of candidate variables were tested to assess their ability to produce different probabilities for mortality in each cluster. Clusters were compared to biomarker data, allowing identification of subphenotypes. Results: Data from 4,773 patients was analyzed. Two subphenotypes (A and B) resulted in optimal separation in the final model, which included nine routinely collected clinical variables, namely: heart rate, mean arterial pressure, respiratory rate, bilirubin, bicarbonate, creatinine, PaO2, arterial pH, and FiO2. Participants in subphenotype B showed increased levels of pro-inflammatory markers, had consistently higher mortality, lower number of ventilator-free days at day 28, and longer duration of ventilation compared to patients in the subphenotype A. Conclusions: Routinely available clinical data can successfully identify two distinct subphenotypes in adult ARDS patients. This work may facilitate implementation of precision therapy in ARDS clinical trials.


2021 ◽  
Author(s):  
Timothy Coetzee ◽  
Mad Price Ball ◽  
Marc Boutin ◽  
Abby Bronson ◽  
David T Dexter ◽  
...  
Keyword(s):  

UNSTRUCTURED REMOVE


2011 ◽  
Vol 22 (1) ◽  
pp. 7-13 ◽  
Author(s):  
J Marc Overhage ◽  
Lauren M Overhage

Observational data sets offer many potential advantages for medical research including their low cost, large size and generalisability. Because they are collected for clinical care and health care operations purposes, observational data sets have some limitations that must be considered in order to perform useful analyses. Sensible use of observational data sets can yield valuable insights, particularly when clinical trials are impractical.


2018 ◽  
Vol 23 (3) ◽  
pp. 403-409 ◽  
Author(s):  
Takuya Kawahara ◽  
Musashi Fukuda ◽  
Koji Oba ◽  
Junichi Sakamoto ◽  
Marc Buyse

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Sallyanne Duncan ◽  
Jennifer Mc Gaughey ◽  
Richard Fallis ◽  
Daniel F. McAuley ◽  
Margaret Walshe ◽  
...  

Abstract Background Oropharyngeal dysphagia or swallowing difficulties are common in acute care and critical care, affecting 47% of hospitalised frail elderly, 50% of acute stroke patients and approximately 62% of critically ill patients who have been intubated and mechanically ventilated for prolonged periods. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, increased length of hospital stay and re-admission to hospital. To date, most dysphagia interventions in acute care have been tested with acute stroke populations. While intervention studies in critical care have been emerging since 2015, they are limited and so there is much to learn about the type, the delivery and the intensity of treatments in this setting to inform future clinical trials. The aim of this systematic review is to summarise the evidence regarding the relationship between dysphagia interventions and clinically important patient outcomes in acute and critical care settings. Methods We will search MEDLINE, EMBASE, CENTRAL, Web of Science, CINAHL and clinical trial registries from inception to the present. We will include studies conducted with adults in acute care settings such as acute hospital wards or units or intensive care units and critical care settings. Studies will be restricted to randomised controlled trials and quasi-randomised controlled trials comparing a new dysphagia intervention with usual care or another intervention. The main outcomes that will be collected include length of time taken to return to oral intake, change in incidence of aspiration and pneumonia, nutritional status, length of hospital stay and quality of life. Key intervention components such as delivery, intensity, acceptability, fidelity and adverse events associated with such interventions will be collected to inform future clinical trials. Two independent reviewers will assess articles for eligibility, data extraction and quality appraisal. A meta-analysis will be conducted as appropriate. Discussion No systematic review has attempted to summarise the evidence for oropharyngeal dysphagia interventions in acute and critical care. Results of the proposed systematic review will inform practice and the design of future clinical trials. Systematic review registration PROSPERO CRD 42018116849 (http://www.crd.york.ac.uk/PROSPERO/)


Sign in / Sign up

Export Citation Format

Share Document