Showing papers on "Electronic data capture published in 2006"

DADOS-Prospective: an open source application for Web-based prospective data collection

Abstract: Randomized, prospective trials involving multi-institutional collaboration have become a central part of clinical and translational research. However, data management and coordination of multi-center studies is a complex process that involves developing systems for data collection and quality control, tracking data queries and resolutions, as well as developing communication procedures. We describe DADOS-Prospective, an open-source Web-based application for collecting and managing prospective data on human subjects for clinical and translational trials. DADOS-Prospective not only permits users to create new clinical research forms (CRF) and supports electronic signatures, but also offers the advantage of containing, in a single environment, raw research data in downloadable spreadsheet format, source documentation and regulatory files stored in PDF format, and audit trails. Feedback from formal and field usability tests was used to guide the design and development of DADOS-Prospective. To date, DADOS-Prospective has been implemented in five prospective clinical studies at our institution. Four of these studies are still in the CRF creation phase and one study has been entirely launched. DADOS-Prospective has significant advantages over existing Web-based data collecting programs. At our institution, it has been demonstrated to be an efficient tool for prospective clinical studies.

Evolving paradigms in pharmacovigilance.

Abstract: All medicines have adverse effects as well as benefits. The aim of pharmacovigilance is to protect public health by monitoring medicines to identify and evaluate issues and ensure that the overall benefits outweigh the potential risks. The tools and processes used in pharmacovigilance are continually evolving. Increasingly sophisticated tools are being designed to evaluate safety data from clinical trials to enhance the likelihood of detecting safety signals ahead of product registration. Methods include integration of safety data throughout development, meta-analytical techniques, quantitative and qualitative methods for evaluation of adverse event data and graphical tools to explore laboratory and biometric data. Electronic data capture facilitates monitoring of ongoing studies so that it is possible to promptly identify potential issues and manage patient safety. In addition, GSK employs a number of proactive methods for post-marketing signal detection and knowledge management using state-of-the-art statistical and analytical tools. Using these tools, together with safety data collected through pharmacoepidemiologic studies, literature and spontaneous reporting, potential adverse drug reactions can be better identified in marketed products. In summary, the information outlined in this paper provides a valuable benchmark for risk management and pharmacovigilance in pharmaceutical development.

Tailoring Cardiovascular Risk Management Educational Interventions: A Synergy of SCORE Risk Assessment and Behaviour Change Model

Abstract: Quality and timely patient education can reduce cardiovascular risk. The PULSE (Personalization Using Linkages of SCORE and behaviour change readiness to webbased Education) project objectives are to generate and evaluate a web-based personalized educational intervention for the management of cardiovascular risk. The program is based on a patient profile generated by combining: (a) an electronic data capture template (DCT); (b) the Systematic COronary Risk Evaluation (SCORE) algorithm for ten-year risk assessment for fatal cardiovascular disease; and (c) a Stage determination model for behavioural change readiness. The DCT inherently contains a set of evidence-based parameters for patient description and disease evaluation. The SCORE estimation directs the selection of clinical guideline target values for risk factors. The patient’s Stage of behaviour Change determines messages consistent with the individual’s change processes, decisional balance, and selfefficacy. The interventions are designed to address both medical and psychosocial aspects of risk management and, as such, we combine staged lifestyle modification materials and non-staged messages based on Canadian clinical guidelines to motivate personal risk management. The personalization decision logic is represented in Medical Logic Modules implemented in Java. The PULSE educational process is initiated by a healthcare professional in a primary care setting. An intelligent interactive system generates the personally relevant educational materials and delivers them to the patient via the Web. An evaluation study will be conducted to determine whether web-based personalized educational strategies that incorporate behavioural change readiness can exert favourable influence on patient's interest, knowledge, and perceived compliance to the suggested lifestyle modifications.

CTMS Procurement: The Seven Deadly Sins

Abstract: Clinical trials are becoming larger, more expensive and increasingly complex. Numerous factors conspire to drive this increase in size, cost and complexity including increased regulatory scrutiny; submissions in greater numbers of markets; a greater proportion of investigational drugs targeted at chronic diseases; and, in some therapeutic areas at least, competition for patients and investigators. Effective management of clinical trials is, therefore, critical for pharmaceutical and biotechnology companies worldwide. In response, vendors have produced a number of IT solutions allowing sponsors, Clinical Research Organisations (CROs) and investigators to run clinical trials more effectively and efficiently. Many clinical trials now employ clinical data management systems (CDMS), clinical trial management systems (CTMS), electronic data capture (EDC), drug supply management (DSM), and interactive voice response systems (IVRS).

Electronic Diaries: Exploring Cross-Cultural Preferences and Acceptability

Abstract: The literature supports the use of electronic diaries (e-diaries) in a variety of populations, including different disease and age groups. However, there has been little discussion of cross-cultural preferences. The aim of this study was to compare acceptability of paper and electronic diaries to collect symptom data from patients with benign prostatic hyperplasia (BPH) in the United States and Slovakia. Participants were 28 US and 20 Slovak men aged 49–83 years with moderate-to-severe BPH. All were randomly assigned to complete a paper or electronic urinary symptom diary for 7 consecutive days, then complete the alternate version for another 7 days. Participants’ experiences with the diaries were assessed via ease of use and preference questions and patient interview. Site issues were assessed via tracking of technical problems and investigator feedback. The US men preferred the electronic version, whereas men in Slovakia had equal preference between the formats. Most men in both countries felt they could continue using the e-diary for another 2 weeks and still provide accurate information. Technical issues at the Slovakian site included incompatibility with power supplies, loss of battery power, and problems downloading data. The use of e-diaries is feasible with BPH populations, although this may vary by country. When including in clinical trials patients who are less familiar with technology, careful consideration should be given to diary design, training, and technical issues in that country that may have an impact on the data collection process.

Development of clinical data management system: current status home and abroad

Abstract: Clinical data management,a critical part of clinical trials,plays a decisive role in assuring the accuracy and reliability of the trail results.This article discusses the quality standards of clinical data,introduces the important rules and principles for standardized clinical data management,and reviews the development and current status of clinical data management home and abroad.It is proposed that we should learn the advanced clinical data management modes from international partners and introduce standardized clinical management software from abroad,so as to improve the clinical data management in China.

Using metadata to generate web-based Electronic Data Capture Forms.

Abstract: Generation of web-based Electronic Data Capture Forms (EDCF) from XML-encoded metadata is an efficient and reliable way to support research data collection. Using metadata-driven development we improved efficiency, maximized reuse and consistency. We describe why we developed our EDCF generator in this manner, our design goals and highlight two representative studies that made use of this approach.