MEDICAL INFORMATION MANAGEMENT PROGRAM

The Medical Information Management Program provides support for clinical research at Fox Chase and Fox Chase Network hospitals. Applications were developed for maintenance of detailed information on active clinical research studies as well as data on individual patients that participate in those studies. Each application is centered around a relational database and uses a web-based graphical interface for data entry and retrieval. Linking the database to the web provides flexibility to the user community in terms of hardware, software, and route of access. Together with the Protocol Office and Research Review Committee, these database resources support our Clinical Protocol Scientific Review and Monitoring System (CPSRMS) that has been approved by the National Cancer Institute.

Approximately 150 studies are open for patient accrual at any one time while an additional 150 studies must remain active for monitoring of previously enrolled patients. Development of a web-based protocol management system was triggered by the need to disseminate reliable information to affiliated hospitals and staff and collect data in a timely and accurate fashion. Database tools were also required to streamline routine procedures such as annual safety and scientific review, document distribution, amendment logging, and data analysis. For an on-line protocol management system to be effective in the long term, it remains an important goal to minimize the amount of additional work for Protocol Office staff. This was accomplished by integrating data management with routine office procedures to avoid duplicate effort. Security and confidentiality of information was also considered for each application. Finally, relational database technology and dynamic web documents were used whenever possible to limit the amount of hypertext markup language (html) programming and simplify overall support. The entire site can be explored from the medical information management homepage at <http://www.protonet.fccc.edu>.

The Protocol Information Management System (PIMS) is a secure site that provides basic protocol information to all users without password authentication. More detailed information and advanced management options are provided for exclusive use by protocol support staff at Fox Chase. Approximately 900 protocols are organized by primary disease site and treatment category. Protocol information is viewed in progressive detail through a series of screens that retrieve requested material directly from the database. A variety of summary reports can also be generated from the database, including a master list of all active studies sorted by disease and treatment categories. More specialized features include the automatic generation of reports for individual studies as they become due for annual review, including objectives, toxicity, and patient accrual data with demographics. The protocol database also includes general information on cancer staging and links to other disease-specific resources such as the National Cancer Institute Physician Data Query (PDQ) system.

The Patient Tracking System (PTS) is a companion to PIMS and provides detailed information about each of the 8000 patients enrolled on clinical trials through Fox Chase and affiliated hospitals over the last ten years. Access is restricted, and the data is encrypted to protect patient confidentiality. PTS is optimized for data entry and generation of reports that include patient accrual, demographics, hospital site, disease site, survival and other data. Development continues within PTS on individual patient flowsheets that are optimized for web-based graphical presentation of laboratory, treatment, and toxicity data, including XY plots of clinical data over time. Modules have also been implemented for generation and tracking of chemotherapy orders for patients on clinical protocols and recording of toxicity in compliance with newly revised criteria from the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute.

We currently allow remote data entry from Fox Chase Network hospitals into the protocol and patient databases. This process will continue to expand as our Network affiliates acquire better internet access. The Network Hospital Information System (NHIS) provides a map of these important affiliated sites, who together contribute approximately 350 patients annually toward common clinical research goals. A staff directory and directions to each institution are maintained in the database to facilitate patient referral.

We are eager to collaborate with other academic cancer centers to improve our information systems. In this regard, we have implemented changes within the software and database to allow multiple primary institutions to store their own protocol and patient data in a distinct environment with appropriate security and confidentiality.

In collaboration with the National Comprehensive Cancer Network (NCCN) and our departments of nursing and social work, we are participating in a pilot study to monitor outcomes and compliance with NCCN treatment guidelines. Detailed clinical data on our breast cancer patients are retrieved and abstracted from clinical records and transferred via web-based forms to a centralized multi-institutional database maintained at the City of Hope National Medical Center in Duarte, California.

We have also collaborated with our tumor registry at Fox Chase to develop web-based forms that can be used to query the tumor registry for aggregate statistics based on tumor site, stage, histology, age, sex, race, and other factors. The rapid availability of aggregate statistics has proven valuable for the design and critical review of treatment protocols and grant applications. More detailed reports that include patient identifiers can be generated by tumor registry staff with proper authorization and security.

Additional online educational resources include the Antiemetic Ladder developed by the Pharmacy and Therapeutics Committee, which provides guidelines and cost information regarding antiemetic therapy. A chemotherapy database was developed in collaboration with Ginny Martin (clinic nursing) and Rich Needleman (pharmacy) to provide practical information about drug toxicity suitable for distribution to patients. We also provided the capability to search a regional database of 13,000 community physicians maintained by Fox Chase Physician Services, which provides rapid access to address and phone numbers for ongoing correspondence between healthcare professionals.

The rapid evolution of web technology continues to provide an exciting and challenging environment for development of information management applications for clinical research. As we adapt to these changes, we also strive to maintain continuity with other information resources at Fox Chase. Sharing of diverse healthcare data will help provide a robust infrastructure and tools for outcomes research.

Illustrations or unpublished data in these reports should not be used without permission of the author.

Fox Chase Cancer Center

Scientific Report 1998