The NDB Project
FORWARD has major interests in the treatment aspects of illness, social medicine, work disability, and the social consequences of illness. It collaborates with researchers worldwide and makes its data available to qualified investigators (students, residents, rheumatologists/physicians, allied health professionals) without charge. For other qualified investigators or companies, there is a charge depending on what FORWARD is providing, i.e. raw data, statistical analysis, reporting, safety registry managment, etc.
Some key variables in the FORWARD data bank include: socio-demographics, clinical and disease activity through patient self-report, treatments and treatment response, physical function scores (e.g., HAQ and HAQ-II), health-related quality of life (e.g., Euroqol, SF-36), direct medical costs, indirect productivity costs including disability and work participation, comorbidities, hospitalizations, mortality status and many others. FORWARD is also capable of adding questions to the 6-month questionnaires or provide 1-time special questionnaires for research projects.
The following article provides information about the NDB project and the content of the data:
If you are interested in doing research with FORWARD or interested in what the NDB project may be able to provide for your research, please fill out the form on this page.
- Outcomes and Clinical Research Study Design, Development & Implementation
- Data Acquisition & Storage Services
- Outcomes and Clinical Research Project Management Services
- Form Design, Development & Distribution
- Database Design, Development & Implementation
- Database & Form Programming
- Adverse Event Tracking & Reporting
- Data Analysis & Publication
- Research Study Consulting & FDA Meeting Review
FORWARD-The National Databank for Rheumatic Disease was founded in 1998 by Dr. Frederick Wolfe. Dr. Wolfe began computerized data collection in 1974 in his own rheumatology practice using programs he developed and wrote. In 1981, clinic visit data were complemented by detailed survey questionnaires mailed to patients at 6 month intervals. This data bank, called the “Wichita Data Bank” is the largest and longest clinical rheumatology data base in existence any where in the world, and has been the source of many important studies relating to the course and outcome of RA, OA and Fibromyalgia. In 1988, the Wichita Data Bank became a component data bank of the larger NDB project.
FORWARD was founded with the idea of having a representative US sample that represented the practices of hundred of rheumatologists. SF-36 and other standard instruments were to be used; psychosocial questions added; and the data bank was to be expanded to approximately 10,000 patients such that the sample size would be adequate to test hypotheses at the individual drug level that reflected current treatment patterns. In 1997, FORWARD made contact with US rheumatologists and asked them to enroll patients who they would see during a 30-day period. 13,486 patients were contributed, including all diagnoses. Since then on-going recruitment projects have continued to add patients to the NDB project.
Summary of Operations
Data Management Center (DMC)
The activities of the DMC include:
- Data Acquisition
- Data Quality Control and Checking
- Data Storage
- Data Back-up Facilities
- Data Reporting
The Data Management Center has primary responsibility in the following major areas:
- Forms Design and Preparation
- Data Acquisition
- Data Processing
- Data Validation
- Quality Control
- Data Security
- Acquisition of Radiographic data
- Acquisition of Serum and Blood Specimens
- Statistical Preparation and Reporting
- Research Project Management
Data are stored primarily in a SQL Server database that has been optimized for longitudinal data collection in rheumatology. Backup of the database to tape is performed nightly, and off site storage of the backup tapes occurs routinely. There are three servers each with 128 virtual cores and 256GB RAM and a 30TB file server that make up the core of FORWARD’s compute facilities. These servers host virtual machines that each have dedicated tasks assigned to them such as web hosting, statistical processing, and bioinformatic computing.
Eight dedicated rotating telephone lines are used to access a dedicated fax server (Castelle version 6.2). The Castelle fax server is integrated with the Teleform software.
The primary method of data acquisition is through scanned forms working in a dedicated Teleform network. Teleform software (www.opentext.com) replaces manual data entry with the automated processing of forms and documents. Teleform is a scalable network-based system designed for high-volume data and document capture. Teleform network components — Designers, Readers, Verifiers and Scan Stations – are main components used to process the NDB project data.
A second major activity of data processing at the NDB project involves follow-up with patients to correct data, and also to validate patient replies. All patient reports of hospitalizations or malignancies require that medical records be obtained so that the diagnoses can be verified and DRGs obtained.
WebQuest: Direct entry of patient data on the Web
FORWARD has developed software for direct entry of patient data via the Internet. Employing program quality control checks and branching logic, the NDB project WebQuest automates high-quality multi-lingual, multi-questionnaire data entry. Data are published to the NDB project SQL servers. You can find the WebQuest portal at https://wq.forwarddatabank.org
Additional software and facilities
Internet data submission from physician sites
We also have an add-in Teleform module for Designer PDF+Forms, which was designed with the form filler in mind. By providing paper-to-electronic hybridization, form fillers have the ability to:
- Submit forms electronically
- Submit forms via e-mail
- Partially fill a form, save, fill at a later time, then submit online or via e-mail
- Print the form, fill by hand, fax or mail
- Partially fill the form, print, complete form by hand, fax or mail
These software modules may be particularly useful in electronic rather than fax acquisition of data in physician offices.
Statistical conversion and reporting
The SQL database has been deliberately designed and organized to allow optimum data acquisition and retrieval. It is not, however, suitable for complex data analysis because of the SQL organizational structure. To perform data analyses, a series of conversion programs are employed. First, using StatTransfer (www.stattransfer.com), data are converted to Stata statistical package format (www.stata.com). Data are then decoded (e.g., drug, adverse events, etc), indexes calculated (e.g., SF-36, HAQ), and other data manipulations performed. Variable labels and value labels are attached. A certification script is run that certifies there are no errors present. The data are then available for use. With transformation software (e.g., Stat/Transfer) the data can be converted to SAS, SPSS, and S-Plus formats without difficulty.
Quality control is a central activity of the data processing unit, and is integrated into each step of the data processing.
- Forms design. At the forms designer step, software coding is designed into each form to trap incomplete and erroneous data.
- Forms verification. Software and operators work together to identify and/or correct data errors.
- Patient follow-up. Direct telephone or mail contact is made with patients to obtain additional data or to verify and correct data.
- Hospitalization and outpatient surgery records. Obtained to document and validate patients self-report.
- Coding checks. A series of data items require FORWARD staff interpretation and coding of data. These interpretations include coding for hospitalizations, infections, malignancies, adverse reactions, and so on. Each month, multiple records are randomly selected and evaluated blindly for coding errors. The data are evaluated at the level of individual coders, and efforts are made to identify systematic or individual coding problems. Results of these efforts are communicated formally to the staff, and adjustments in methods are promulgated as necessary.
- SQL level error check. A full series of range and missing data check are also implemented as part of the SQL level data check. These are designed to identify data problems that not corrected or identified in previous stages of the data processing procedure.
- Statistical data set error checking. Each day data from the SQL database are converted into a statistical package readable format where they then undergo extensive checking. Data (for example, treatment and adverse reaction data) are decoded and converted to usual clinical variables. Indexes such as SF-36 and HAQ scores are similarly computed. Each variable is then examined individually of the presence of range errors, outliers, and improper distributions among categorical data. Comprehensive logic checks that include comparisons between visits are performed. Formal reports are generated. The data bank is only ready for use if all of the checks are passed.
Other data resources
Serum and blood databank
FORWARD, in conjunction with the University of Nebraska Medical Center (UNMC), has laboratory facilities for the processing of specimens, and freezers for the storage of blood and serum specimens. These specimens are linked to the SQL database for easy identification and retrieval.
All x-ray films received at the NDB are scanned into a dedicated workstation using a Lumisys LS-75 scanner and DI-2000 software. Radiographs are digitized and stored at a pixel size no smaller than 100 microns. Data are available on CD-ROMS and tape, and are directly linked to the SQL database.
Bar-coded labels are available and can be used for acquisition of patient IDs, mailing information, specimen and x-ray labeling.