DADOS-Prospective: an open source application for Web-based prospective data collection
© Nguyen et al; licensee BioMed Central Ltd. 2006
Received: 21 July 2006
Accepted: 13 November 2006
Published: 13 November 2006
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.
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, to name a few. Such cumbersome processes have deemed traditional, paper-based data collection and management systems increasingly less efficient. More recently, the Internet has arisen as an efficient and secure tool for collecting and managing information in single-site and multi-site prospective clinical trials and observational studies involving registries .
Advances in Web-based data collection have allowed for remote data entry through clinical research forms (CRF) that can be accessed on the Internet from anywhere. Since information can be collected from different locations and stored into a secure central database, the Internet facilitates the onerous task of data quality control involved in multi-institutional studies, allowing for real-time centralized data monitoring and auditing. Furthermore, compared to the traditional paper-based method, Web-based data entry offers the advantage of faster availability of data for sharing, processing and analysis, and, importantly, greater security for data storage and archiving .
Commercial products have greatly evolved over the years to maximize efficiency of Web-based data collection in studies involving multiple centers and large data registries. However, some of these commercial tools can be expensive, difficult to use, and may require considerable customization in order to implement . In this article, we describe DADOS-Prospective, an open-source Web-based application for collecting and managing data on human subjects for clinical and translational trials. DADOS-Prospective not only permits users to securely archive and download data and to create new CRFs, but also offers the advantage of containing, in a single environment, CRFs, raw research data in regular spreadsheet format, source documentation and regulatory files stored in PDF format, and audit trails. The combination of these factors in a single location greatly streamlines the research process, allowing for efficient data collection and study management. We outline below the design objectives, software architecture, implementation, usability, and future directions for DADOS-Prospective.
Support electronic signatures.
Have a trail record for changes made to the data entry once the form has been signed
Be maintained in a secure protocol such as HTTPS
Allow for storage of source documentation in PDF (portable document format) attached to each subject record in order to facilitate audits performed remotely.
The application should be able to create clinical research forms (CRFs) based on a templating system that takes previous CRFs as their model.
CRFs should allow for any type of fields (dates, pictures, text, etc) and these fields should be arranged in any table format.
The application should be able to contain non-traditional fields such as upload of electronic fields and image files with immediate display (for clinical images such as x-rays, computerized tomography, etc)
CRFs should be easy to modify once created, but CRFs should not be modified once data have been entered. The latter feature preserves data integrity.
Data extraction should be simple and easy to use, providing all the data required by data analysts in a spreadsheet format.
DADOS-Prospective should serve as a study management system, containing the capability to support future interview scheduling, and the ability to add/update patient information and participating users in a simple process.
Contain, in a single location, the audit trail, data in a regular spreadsheet format, and source documentation in PDF (portable document format). The combination of these three factors allows for easy auditing of the application.
The technology should be user-friendly so that users can create and modify CRFs and enter data directly on the interface, reducing the number of pop-up windows and the number of clicks needed to navigate through the application and save information.
There are three different levels of access to DADOS-Prospective: administrator, coordinator, and interviewer. The administrator, typically a Webmaster, has total access to all projects enrolled in the application, including the ability to modify the content of any study that has not been launched. The administrator has exclusive rights to extract research data for analysis at any time. Coordinators may create new studies, access and modify forms for only those studies that belong to them. As in the case of administrator access, coordinators may not modify the content of a study for which data entry has been initiated; this feature serves to protect data integrity. Interviewer access is strictly limited to data entry.
Navigation toolbar. Functions for each of the menu items found on the DADOS-Prospective navigation toolbar.
Return to the list of all existing projects to which user is allowed access
Study: (name of study)
View a list of all subjects enrolled in the selected study, or search for subjects enrolled in the selected study by "Name," "MRN," or "DOS."
Create/modify encounters and their associated baseline and CRFs
Enroll a new or an existing subject into the selected study, or delete a subject from the study. Add new subjects to the database without enrolling them into the selected study, or delete them from the database.
Add/upload or delete any reference documentations pertinent to the study (i.e. rating scales, codes)
Add to or delete from the study personnel with data entry access only.
Upload or delete regulatory files related to the study
Download the study's data in Excel spreadsheet format
Add new users who may access the study as a coordinator or interviewer
When creating a new study, the coordinator may utilize the navigation toolbar described in Table 1 to setup the study's content. Choosing the tab labeled "modify encounter," the coordinator may create the different encounters (i.e. Eligibility, Test Results, Treatment 1) for the study. Once all encounters are created, they may be arranged in a desired sequence by using the up/down arrows next to each encounter to move them up or down the list [see Figure 2]. Note, the software defines "baseline" as the day of the first encounter with a patient, thus the encounter on top of the list is automatically defined as the baseline encounter [see Figure 2]. For subsequent encounters, all numerical values entered into the boxes underneath baseline will be interpreted as the number of weeks until the next encounter is to be executed, counting from the date on which the baseline encounter (the very first encounter on the list) is completed. With this feature, the program calculates the exact date on which an encounter is to take place, giving the users easy access to all future interview scheduling. Simply clicking on a patient's name will display all previously defined encounters and the date when each encounter will occur.
As data is entered onto the forms, it is automatically stored in password-protected, encrypted servers at the host institution. At any time during the data collection process, only an administrator can extract the data for analysis by using the tab labeled "Data extraction" in the navigation toolbar. The program stores data in a spreadsheet format, making it readily available for analysis upon extraction.
To date, DADOS-Prospective has been implemented in five different studies conducted by various departments within the Duke University Health System. Four of these studies are still in the form creation phase, and one study has been officially launched. Our initial experiences have indicated that DADOS-Prospective has been used with relative ease by the investigators and the software has streamlined their study creation and management processes.
Formal usability. Results from formal usability tests.
DADOS-Prospective speed is excellent.
DADOS-Prospective is extremely easy to learn
DADOS-Prospective is extremely easy to use
It is very easy to understand all functionality available within DADOS-Prospective
The navigation in DADOS-Prospective is highly intuitive
The first three months of field usability measurement were focused primarily on fixing minor software problems related to coding, including buttons that were not working appropriately, navigational issues related to users being taken to the wrong page after completing a task, and the implementation of a consistent interface across all pages of the application. After initial field testing was completed, the system was tested with actual CRFs from various departments and tested with mock patient data. Additional navigational problems were identified and several features were requested to improve usability. Requested features included: navigational issues, additional form creation functions, addition of a function for "subject search," and additional data extraction methods.
The DADOS-Prospective application is currently being used in five different studies. Four of these studies are still in the CRF creation phase and one study has been entirely launched. The active study in DADOS-Prospective replaced a pre-existing database process. The database is a registry for subjects who will undergo outpatient surgery (approximately 40 subjects per day), and houses the database that is used for retrospective studies for the Department of Anesthesiology. Implementation for this project included creating special plug-ins for the CRF which would allow for surgical procedures to be added to a list on the data collection form. This enables alternatives to be added and/or updated on the CRF when the plug-in is used for the purposes of form creation, even after the study has gone live, thus maintaining the integrity of the data collection and recognizing the ever-changing possibilities for surgical procedures and techniques. Feedback from data entry specialists indicates that they prefer the new database using DADOS-Prospective compared to the old database, adding that it is much easier to use and their process has been significantly streamlined.
Numerous programs have emerged to take advantage of the Internet as a primary means for collecting data in randomized, prospective clinical trials [1, 7–11]. However, many of them are expensive, difficult to use, or they are only tailored to specific study designs. For example, commercial Windows-based software applications are limited in their ability to centralize data for file sharing in multi-institutional studies, to comply with HIPAA regulations in order to support electronic signatures, and to maintain an audit trail of use . While commercial products do not permit modification of source code, we are confident that the modifiable source code of DADOS-Prospective will encourage users to utilize and improve upon the features in this release. Furthermore, unlike DADOS-Prospective, many existing open-source applications either do not have the flexibility to allow users to simultaneously customize study designs and CRFs for multiple clinical studies covering different medical subspecialties within the same software, or do not support user autonomy that allows individual users to create future studies at anytime (Web-based Electronic Patient Record System, Berlin, Germany; CARE Application, Hershey, PA; WARG study, Stockholm, Sweden; Delphi Method, New Heaven, CT).
We developed DADOS-Prospective as an open-source program that not only addresses the limitations of existing commercial platforms, but also possesses the versatility to create and manage any type of prospective clinical study. As such, the program is fully customizable by the institutional user. In addition to achieving full compliance with HIPAA regulations, the ability of the program to create virtually any CRF format allows investigators to use DADOS-Prospective to develop studies in any medical specialty. Furthermore, by possessing the capability to support future interview scheduling as well as a patient database monitoring system, DADOS-Prospective steps beyond the task of data collection and management and acts as a complete study management system. Most notably, the program contains in one single location source documents, regulatory files, raw data in spreadsheet format, audit trails, interview scheduling, patient database, and CRFs. This feature greatly enhances the visibility of the two crucial aspects of coordination and management of studies and data, thereby making DADOS-Prospective an ideal tool in conducting prospective clinical trials. More crucially, due to the fact that it was designed to work under slow Internet data transfer speeds, DADOS-Prospective is especially suitable for multicenter prospective international studies, thus taking advantage of a large population base. One limitation we have discovered is the lack of communication channels between users within the software application; this is a function that we feel would greatly enhance the management of the multicenter studies. We are currently developing potential solutions for this issue.
Whereas previous Web-based prospective clinical studies may have taken up to nine months to develop using existing tools, our initial experiences have demonstrated that complex studies were developed within 3–4 months using DADOS-Prospective. The program's user-friendly interface makes DADOS-Prospective quite easy to use and does not require much training. Although several studies launched at our own institution had few minor issues with some features (saving follow-up dates, updating patient registration information, minor difficulties editing CRFs with certain versions of Microsoft Internet Explorer), these problems were quickly addressed and corrected. We have also recognized the need to constantly increase the security of our software and are currently seeking new ways to do this.
We have demonstrated that the current version of DADOS-Prospective has significant advantages over existing Web-based data collecting programs. The program's ease of use, enhanced visibility for data auditing, versatility of CRF creation, simple data query mechanisms, and full compliance with HIPAA regulations make DADOS-Prospective an ideal tool for creating and managing prospective clinical trials.
Availability and requirements
Project name: DADOS-Prospective
Project home page: http://www.ceso.duke.edu/ (click link for "Free software")
Operating systems: Linux and Windows
Programming language: Java
Other requirements: Tomcat 5.x
License: GNU General Public License. This license ensures that the source code can be freely distributed, modified, or even sold, as long as the source code is provided with every copy of the application. The source code for the application is available at no charge.
Any restrictions to use by non-academics: None.
Clinical research form
Health Insurance Portability and Accountability Act
We would like to acknowledge Erika Nielsen for administrative assistance.
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