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Protocol advisor knowledge-based system
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Abstracts Protocol Advisor Knowledge-Based System O. Dalesio, N.J.I. Mars, A. M a r t h e r u s , a n d S. R o d e n h u i s
The Netherlands Cancer Institute and University of Twente, Amsterdam, The Netherlands (P54) When 100 protocols are permanently active, the choice of the appropriate protocol for a particular patient requires a very efficient organization. During patient consultation, a physician needs to recall the outline of a pertinent trial and check the eligibility criteria before informing the patient of the possibility of joining the study. Trial information bulletins are an imperfect solution to this problem and require frequent reediting with updated information. A knowledge-based system, "trial matching program," is being developed to tackle this problem in a more efficient way. The first prototype is already available for extensive testing in three strategic locations in the hospital and in the Trial Office. The trial information database is stored in a central computer (Trial Office) accessible through networking by AT3 personal computers. Special emphasis has been put on the user-friendliness of the program. Through a series of questions on the characteristics of the patient and the tumor, the appropriate protocol(s) is selected. The questions posed are based on the protocols available in the database, and thus deletion or addition of a study modifies the questioning session, avoiding irrelevant questions. It is expected that this facility will have a positive impact on the accrual of patients in prospective clinical trials.
Development of N e w Clinical Measures for a Randomized Trial M a u r e e n G. M a g u i r e , for the M a c u l a r P h o t o c o a g u l a t i o n S t u d y G r o u p The Johns Hopkins Medical Institutions, Baltimore, Maryland (P55) Clinical trials may need new measures of harm or benefit for appropriate evaluation of new treatments. The development of measuring devices that are suitable for clinical use, yet having sufficient accuracy and precision, is a multistep process that can be both exciting and frustrating. Initially, the exact function or quantity to be measured must be identified. Measuring devices currently available must be obtained and evaluated for use in the trial. If no particular instrument is suitable, a new device must be designed. Potential manufacturers must be engaged and prototypes pilot tested. Finally, the device must be mass produced and distributed. The above development process is exemplified by tests of vision designed for the Macular Photocoagulation Study. Considerations common to all fields are emphasized. Suggestions for improving the process are provided and solicited.
Procedures for Handling Allocation Irregularities in a Transplantation Trial N a n c y E. Fink, M a u r e e n G. M a g u i r e , Walter J. Stark, a n d the C C T S Research Group The Johns Hopkins Medical Institutions, Baltimore, Maryland (P56) The Collaborative Corneal Transplantation Studies (CCTS) are double-masked multicenter clinical trials designed to investigate the value of donor-recipient histocompatibility matching by pooling high-risk recipients and donor tissue via a nationwide network for donor selection and tissue distribution. Given the short time between donor death and deterioration of the donor cornea, the CCTS developed a highly structured system for tissue allocation aimed at preventing patients from not receiving the cornea assigned. This system was subjected to a series of field tests before patient enrollment was initiated; however, 20% of corneas allocated are not transplanted into the assigned recipients. Data system and policy procedures have been built into the CCTS to identify, prevent, and accommodate allocation irregularities. Centrally managed status codes prevent the selection of patients when they or their surgeons are unavailable. Alternates are assigned whenever possible and only easily reversible data management actions are taken until surgery is verified. Despite elaborate preventative measures, some irregularities will occur and corrective measures must be available. These measures are discussed and generalized for other clinical trials.
Abstracts Protocol Advisor Knowledge-Based System O. Dalesio, N.J.I. Mars, A. M a r t h e r u s , a n d S. R o d e n h u i s
The Netherlands Cancer Institute and University of Twente, Amsterdam, The Netherlands (P54) When 100 protocols are permanently active, the choice of the appropriate protocol for a particular patient requires a very efficient organization. During patient consultation, a physician needs to recall the outline of a pertinent trial and check the eligibility criteria before informing the patient of the possibility of joining the study. Trial information bulletins are an imperfect solution to this problem and require frequent reediting with updated information. A knowledge-based system, "trial matching program," is being developed to tackle this problem in a more efficient way. The first prototype is already available for extensive testing in three strategic locations in the hospital and in the Trial Office. The trial information database is stored in a central computer (Trial Office) accessible through networking by AT3 personal computers. Special emphasis has been put on the user-friendliness of the program. Through a series of questions on the characteristics of the patient and the tumor, the appropriate protocol(s) is selected. The questions posed are based on the protocols available in the database, and thus deletion or addition of a study modifies the questioning session, avoiding irrelevant questions. It is expected that this facility will have a positive impact on the accrual of patients in prospective clinical trials.
Development of N e w Clinical Measures for a Randomized Trial M a u r e e n G. M a g u i r e , for the M a c u l a r P h o t o c o a g u l a t i o n S t u d y G r o u p The Johns Hopkins Medical Institutions, Baltimore, Maryland (P55) Clinical trials may need new measures of harm or benefit for appropriate evaluation of new treatments. The development of measuring devices that are suitable for clinical use, yet having sufficient accuracy and precision, is a multistep process that can be both exciting and frustrating. Initially, the exact function or quantity to be measured must be identified. Measuring devices currently available must be obtained and evaluated for use in the trial. If no particular instrument is suitable, a new device must be designed. Potential manufacturers must be engaged and prototypes pilot tested. Finally, the device must be mass produced and distributed. The above development process is exemplified by tests of vision designed for the Macular Photocoagulation Study. Considerations common to all fields are emphasized. Suggestions for improving the process are provided and solicited.
Procedures for Handling Allocation Irregularities in a Transplantation Trial N a n c y E. Fink, M a u r e e n G. M a g u i r e , Walter J. Stark, a n d the C C T S Research Group The Johns Hopkins Medical Institutions, Baltimore, Maryland (P56) The Collaborative Corneal Transplantation Studies (CCTS) are double-masked multicenter clinical trials designed to investigate the value of donor-recipient histocompatibility matching by pooling high-risk recipients and donor tissue via a nationwide network for donor selection and tissue distribution. Given the short time between donor death and deterioration of the donor cornea, the CCTS developed a highly structured system for tissue allocation aimed at preventing patients from not receiving the cornea assigned. This system was subjected to a series of field tests before patient enrollment was initiated; however, 20% of corneas allocated are not transplanted into the assigned recipients. Data system and policy procedures have been built into the CCTS to identify, prevent, and accommodate allocation irregularities. Centrally managed status codes prevent the selection of patients when they or their surgeons are unavailable. Alternates are assigned whenever possible and only easily reversible data management actions are taken until surgery is verified. Despite elaborate preventative measures, some irregularities will occur and corrective measures must be available. These measures are discussed and generalized for other clinical trials.