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Web-based protocol information management

By Michael A. Bookman, M.D.

Fox Chase Cancer Center maintains a large number of clinical research studies for patients with cancer. This is an important component of our mission as a National Cancer Institute (NCI) designated Comprehensive Cancer Center. These studies include new approaches for cancer prevention as well as innovative strategies for cancer treatment. Approximately 150 studies are active for accrual of new patients at any one time. An additional 150 studies must remain active for monitoring of previously enrolled patients. One third of these studies represent original collaborative research by Fox Chase investigators. The remainder are sponsored by nationwide clinical trials organizations, including the Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG); or the pharmaceutical industry.

Development of a web-based protocol management system was triggered by the need to disseminate reliable protocol information to affiliated community hospitals and staff as well as the need to collect data in a timely and accurate fashion. In addition, the responsibilities of our Protocol Office have become more demanding from both a regulatory and operational perspective, including frequent audits, reports, and annual reviews. Database tools were needed to streamline routine procedures such as annual safety and scientific reviews, document distribution, amendment logging, and data analysis.

Many web sites are quick to be established without careful attention to maintenance and ongoing support. For example, our team conducted an informal online survey of other cancer centers and found isolated examples of incorrect protocol information that was more than 2 years out of date. Outdated cancer treatment information is not only unhelpful, but potentially dangerous. For the online protocol management system to be effective in the long term, it was very important that the amount of additional work be kept to an absolute minimum for staff in the Protocol Office. This was best accomplished by integrating data management with routine office procedures to avoid duplicate effort. It was also important to consider appropriate security and confidentiality for all data entry and retrieval. Finally, database technology and dynamic web documents were extensively used to limit the amount of actual html programming which further simplifies overall support.

The system was established using a secure web server (Netscape Commerce Server) linked to a relational database (Sybase). Tools for database access are rapidly expanding, and currently include modular “scripts” or programs written using cgi, perl, and java. Programming for the Fox Chase system was developed by Andy Wolfenden, Lorna McLaughlin, and Shirley Burgess in collaboration with the Protocol Office and user community under my guidance. An unrestricted educational grant from Bristol-Myers Squibb was essential in providing initial project support.

Each major component is described below, together with appropriate links to the site, which is best viewed with either Netscape v2.0 (or greater) or Microsoft Internet Explorer v2.0 (or greater). Some areas require data encryption, user passwords, or other security features for protection of confidential information as noted. Users that wish more information on these secure components can contact me directly via electronic mail (ma_bookman@fccc.edu) or telephone (215-728-2987). The homepage for the Medical Information Management Program at Fox Chase <http://www.protonet.fccc.edu> can be used as a starting point for exploration.

The first component to be developed was the Network Hospital Information System (NHIS) <http://www.protonet.fccc.edu/nhis>. This provides a map of all community hospitals in the Delaware Valley that collaborate on clinical trials with Fox Chase Cancer Center. Together, approximately 350 patients are enrolled annually on cancer protocols through these community hospitals. For each hospital, there is a general description, detailed map, written directions, and directory of pertinent staff maintained in a database format. This material can be printed during clinic and given to patients that are being referred to community treatment centers closer to their home.

The Protocol Information Management System (PIMS) <https://www.protonet.fccc.edu/fccc/pims> is a secure site that provides basic protocol information without password authentication. More detailed information and management options are restricted for use by protocol staff located at Fox Chase. The site begins with a map of the body that can be used to query a database of more than 600 studies organized by major body site. Queries can be refined by treatment categories and text word matching. For example, selecting “All Sites” and typing in “paclitaxel” will retrieve all protocols that use the drug paclitaxel, regardless of disease site. Protocols can be viewed in progressive detail, including title, activation status, contact personnel, summaries, and informed consent documents. Although full text of these studies are not currently maintained online, there is a useful summary of eligibility and treatment parameters that can facilitate the rapid selection of active studies for specific patients in clinic. As each of the cooperative groups move toward electronic document distribution, this material will be expanded in the future.

A variety of summary reports can be generated from the protocol database. For example, clicking on “FCCC” within the “Master Protocol Listings” heading under the body map image will immediately query the database and generate a master list of all 150 active studies sorted by primary tumor site and treatment category. As the 20-page list is generated “on the fly” from the database, it is always up to date, and does not require any additional maintenance beyond information that is already included in the system. Fox Chase was the first cancer center to develop a comprehensive protocol database that can be maintained and queried using these live web-based tools. More extensive customized reports are also available to Fox Chase staff, including an automated listing of all protocols that are due for annual review during a particular month. Reports remain linked to the primary data, and one report can then trigger subreports. For example, individualized annual reviews for a specific protocol can be automatically generated from the annual review list. These detailed reports include protocol specific objectives, toxicity reporting, and actual patient accrual data with demographics.

Finally, the protocol database also includes general information on cancer staging, such as the American Joint Commission on Cancer (AJCC) guidelines and limited links to other disease-specific information through the NCI PDQ program. Individual TNM staging grids are included for each major tumor type, and the AJCC summary stage is calculated after the user enters the appropriate TNM values.

The online Patient Tracking System (PTS) is not available to staff outside of Fox Chase, as it includes detailed and confidential information on each of the 5000 patients enrolled on clinical trials. However, this is a valuable resource that is optimized for data entry and report generation, allowing for the automatic preparation of complex reports that include patient accrual, demographics, hospital location, disease sites, survival, and other information. PTS also provides individual patient “flowsheets” that are optimized for web-based graphical presentation of laboratory data, including XY plots. The flowsheets are in the process of being expanded to include treatment records and toxicity grading. As the scope of online data management continues to grow, it is planned to begin remote data entry from our community hospitals that participate in the Fox Chase Network.

Another online resource is the Physician Referral Database, which is also not available to staff outside of Fox Chase. This includes an updated and verified listing of more than 15,000 physicians in the Delaware Valley that can be queried by state, county, city, zip code, or last name. This is valuable during clinic to facilitate written and telephone correspondence with referring physicians regarding particular patients.

Educational material has also been included on the site as it is developed, such as the Anti-Emetic Ladder <http://www.protonet.fccc.edu/emetic>, which describes cost and recommendations for standard antiemetic regimens. A new resource, Chemotherapy Drug Information, describes common chemotherapy drug toxicity in a format that can be used for patient education under the direction of nursing staff. After selection of one or more chemotherapy agents, the program will assemble general toxicity information from a database and print a customized information sheet for a particular patient. At the current time, this resource is only available to staff at Fox Chase.

The rapid evolution of web technology is exciting, but can also cause some anxiety, particularly in the context of institutional database design and support. While the Medical Information Management team at Fox Chase continues their efforts to integrate clinical data with the world wide web, it is reassuring that the core of the database is maintained using a standard commercial product (Sybase) that lends itself to many different platforms. Consistent use of a common database at Fox Chase has facilitated sharing of clinical information among different departments.

The team would appreciate any questions or comments regarding the site, or the content of this article. Like many web resources, online protocol management remains a dynamic but rewarding challenge.

Michael A. Bookman, M.D. is Director of Medical Gynecologic Oncology and Director of Medical Information Management at Fox Chase Cancer Center. His email address is ma_bookman@fccc.edu.

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