About the NDB

The NDB is a non-profit research data bank whose purposes include publication of rheumatic disease research data in peer-reviewed forums and publications. The NDB has a strong track record of important research publications. The NDB 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 the NDB is providing, i.e. raw data, statistical analysis, reporting, safety registry managment, etc.

Some key variables in the NDB 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. The NDB 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 and the content of the data in the NDB:

http://www.arthritis-research.org/sites/default/files/NDB Registry Review - Rheumatology.pdf

http://www.arthritis-research.org/sites/default/files/The content of the NDB.doc

If you are interested in doing research with the NDB or interested in what the NDB may be able to provide for your research, please click on the link below, complete the Research Request form and we will get back to you after reviewing the request.

http://www.arthritis-research.org/research/research-request-form

 

Our Mission

The National Data Bank for Rheumatic Diseases (NDB) performs unique clinical research in rheumatoid arthritis, osteoarthritis, fibromyalgia and other rheumatic diseases, designed to improve the treatment and outcomes of these conditions.

Research: The NDB is a non-profit research databank whose major goal is to perform rheumatic disease research for publication in peer-reviewed journals.

Education: The NDB served as the research educational base of the CHORD rheumatology fellowship program. In 2002-2004, a total of 28 rheumatology trainees participated nationally.

Service: The NDB provides the rheumatology community with data collection tools and individualized database support for the purposes of research.

 

Services Available

  • 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

 

How to contact us

Director- Fred Wolfe, MD

Co-Director- Kaleb Michaud, PhD

Executive Director- Rebecca Schumacher

 

Arthritis Research Center Foundation, Inc.

1035 North Emporia, Suite 288

Wichita, Kansas 67214

316-263-2125 ext 0

316-263-0761 FAX

www.ndb.org

 

Historical information

The National Data Bank for Rheumatic Disease (NDB) 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.

 

The NDB 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, NDB 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.

 

Staff

The Medical and research director of the NDB is Dr. Frederick Wolfe. The Co-Director is Kaleb Michaud, PhD.  The Executive Director is Rebecca Schumacher. They are supported by a staff of 2 programmers and 16 others, who direct or work in the areas specific to forms design, data acquisition, quality control, and patient-physician contact

 

Summary of Operations

DataManagement 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

 

Computer Facilities

Data are stored primarily in a Microsoft SQL server databank that has been optimized for longitudinal data collection in rheumatology. A Sun Fire X4600 runs 8 Dual Core Opteron 885 processors at 2.61 GHz (16 total cores). The server is equipped with 32 GB of RAM. Redundant hard disk and power supply ensure stability. Backup of the databank to tape is performed nightly, and off site storage of the backup tapes occurs routinely. There are three other servers that make up the entire NDB network system. These include a Web Server, Email Server, and File Sever. Currently there are 27 workstations attached to the NDB network, and Internet access is via dedicated fiber optic line.

Fax server

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 fax server is also integrated with Exchange Server and Microsoft Office, adding the flexibility to send faxes from within these applications.

 

Data acquisition

The primary method of data acquisition is through scanned forms working in a dedicated Teleform network. Teleform software (www.cardiff.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 NDB data. 

A second major activity of data processing at the NDB 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

The NDB has developed software for direct entry of patient data via the Internet. Employing program quality control checks and branching logic, the NDB WebQuest automates high-quality multi-lingual, multi-questionnaire data entry. Data are published to the NDB SQL servers.

 

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 data bank 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., DBMSCOPY) the Databank can be converted to SAS, SPSS, and S-Plus formats without difficulty.

Quality control

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 NDB 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  data bank 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 data bank

The NDB, 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.

X-Ray Databank

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 major SQL databank.

Bar-coding

Bar-coded labels are available and can be used for acquisition of patient IDs, mailing information, specimen and x-ray labeling.