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Drug supply system for the post CABG studies clinical trial
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Abstracts 1480 ANALYZING EDIT QUERIES TO IDENTIFY PROBLEMS IN DATA COLLECTION, EDITS, AND MANAGEMENT Brett A. Hoover and Paul B. Connor
The Johns Hopkins University Baltimore, Maryland An analysis of edit queries from the Collaborative Ocular Melanoma Study (COMS) was used to identify problems with data collection, edits, and management. The COMS is a set of two multicenter randomized clinical trials to evaluate radiation versus enucleation treatment of choroidal melanoma. A complex data editing system which allows the specification of custom-written logical conditions and messages is implemented to ensure data integrity for the COMS. For each edit query resolved, information about its source and cause is stored. As of June 30, 1990, 24,132 forms had been edited and generated 6,836 edit queries. Of the edit queries generated, 3,918 (57%) resulted from invalid data values originating at COMS centers and were resolved by making changes to the database. Thirty-one percent (2,084) of the edit queries were confirmed as correct and no modifications to the data were made. Incorrect formulation of edit query logic accounted for 513 (8%) of the edit queries. The remaining 321 (5%) edit queries resulted from data entry errors (corresponding to an error rate of 0.07% per keyed item). After accounting for clinic workloads, clinics showed similar edit frequencies. Regression and residual analyses identified clinics with extreme performances. An identical analysis by form type revealed similar frequencies for forms and identified those with extreme frequencies. Weighted edit frequencies were used for further analyses to identify extreme performances of certified personnel and to analyze the distribution of errors over time for clinics, forms, and personnel. Results of these analyses have prompted changes in COMS editing system, forms design, and personnel training to insure complete and accurate data. A$1 DRUG SUPPLY SYSTEM FOR THE POST CABG STUDIES CLINICAL TRIAL Norma Lynn Fox, Frances LoPrestl, Evelyn Mlrenzl and Joan Staggers?
Maryland Medical Research Institute Baltimore, Maryland The POST CABG Studies Clinical Tdal has a 2 x 2 factorial design of intensive versus moderate lipidlowering therapy, and low dose warfarin versus placebo. Study medications include Iovastatin in 2.5 and 40 mg tablets, cholestyramine or placebo, and warfarin or placebo. The doses of Iovastatin and warfarin (or placebo) are individually titrated so the required quantity of each drug differs among patients. Not all patients are prescdbed cholestyramine (or placebo). In developing the drug supply system, consideration was given to the following: shipping in standard quantities in order to avoid =customized" ordering; allowing for a supply "buffer" in the Clinics, as well as the limitations of storage space and shelf life of drugs; and taking into account that not all patients are prescribed cholestyremine (or placebo). Two systems were developed and the rationale and application of each will be discussed. First, the Iovastatin and warfarin supply system is based on review of each patient's appointment calendar to identify patients scheduled for particular Follow-up Visits within a given time period. Second, the cholestyremine system is based on review of the length of time since cholestyramine (or placebo) was first recommended. Lists of the medication numbers to be resupplied are transmitted electronically to the Drug Distribution Center on a monthly basis.
?Merck Sharp & Dohme Research Laboratories, West Point, Pennsylvania
Abstracts 1480 ANALYZING EDIT QUERIES TO IDENTIFY PROBLEMS IN DATA COLLECTION, EDITS, AND MANAGEMENT Brett A. Hoover and Paul B. Connor
The Johns Hopkins University Baltimore, Maryland An analysis of edit queries from the Collaborative Ocular Melanoma Study (COMS) was used to identify problems with data collection, edits, and management. The COMS is a set of two multicenter randomized clinical trials to evaluate radiation versus enucleation treatment of choroidal melanoma. A complex data editing system which allows the specification of custom-written logical conditions and messages is implemented to ensure data integrity for the COMS. For each edit query resolved, information about its source and cause is stored. As of June 30, 1990, 24,132 forms had been edited and generated 6,836 edit queries. Of the edit queries generated, 3,918 (57%) resulted from invalid data values originating at COMS centers and were resolved by making changes to the database. Thirty-one percent (2,084) of the edit queries were confirmed as correct and no modifications to the data were made. Incorrect formulation of edit query logic accounted for 513 (8%) of the edit queries. The remaining 321 (5%) edit queries resulted from data entry errors (corresponding to an error rate of 0.07% per keyed item). After accounting for clinic workloads, clinics showed similar edit frequencies. Regression and residual analyses identified clinics with extreme performances. An identical analysis by form type revealed similar frequencies for forms and identified those with extreme frequencies. Weighted edit frequencies were used for further analyses to identify extreme performances of certified personnel and to analyze the distribution of errors over time for clinics, forms, and personnel. Results of these analyses have prompted changes in COMS editing system, forms design, and personnel training to insure complete and accurate data. A$1 DRUG SUPPLY SYSTEM FOR THE POST CABG STUDIES CLINICAL TRIAL Norma Lynn Fox, Frances LoPrestl, Evelyn Mlrenzl and Joan Staggers?
Maryland Medical Research Institute Baltimore, Maryland The POST CABG Studies Clinical Tdal has a 2 x 2 factorial design of intensive versus moderate lipidlowering therapy, and low dose warfarin versus placebo. Study medications include Iovastatin in 2.5 and 40 mg tablets, cholestyramine or placebo, and warfarin or placebo. The doses of Iovastatin and warfarin (or placebo) are individually titrated so the required quantity of each drug differs among patients. Not all patients are prescdbed cholestyramine (or placebo). In developing the drug supply system, consideration was given to the following: shipping in standard quantities in order to avoid =customized" ordering; allowing for a supply "buffer" in the Clinics, as well as the limitations of storage space and shelf life of drugs; and taking into account that not all patients are prescribed cholestyremine (or placebo). Two systems were developed and the rationale and application of each will be discussed. First, the Iovastatin and warfarin supply system is based on review of each patient's appointment calendar to identify patients scheduled for particular Follow-up Visits within a given time period. Second, the cholestyremine system is based on review of the length of time since cholestyramine (or placebo) was first recommended. Lists of the medication numbers to be resupplied are transmitted electronically to the Drug Distribution Center on a monthly basis.
?Merck Sharp & Dohme Research Laboratories, West Point, Pennsylvania