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Longitudinal measures of compliance in the elderly
Abstracts
313
Distributed Data Processing as a Clinical M a n a g e m e n t Tool i n Collaborative Trials: T h e SHEP S t u d y T. Remijas, K. Molvig, A. Bagniewska, D. Black, D. Feigal, C. Fox University of California, San Francisco, CA (P78) We have previously reported on the use of distributed data processing in multicenter clinical trials as an on-site data entry and verification system. In addition to its usefulness for data entry, the clinic computer can be integrated into other aspects of the study, including data form generation, protocol monitoring, and clinical management. In the Systolic Hypertension in the Elderly Program (SHEP) distributed system, the clinic computer provides appointment schedules and patient status reports used to prepare the clinic visits. A computer-generated worksheet data form is used by clinicians as a guide to the drug treatment protocol and as a data collection instrument. Other reports and lists are prepared by the computer for use by clerical staff, clinicians, pharmacists and principal investigators. The clinic study computer thus improves clinical efficiency and, thereby, the trial itself. This poster includes workflow diagrams to illustrate the relationship between various clinical procedures and the study computer. A terminal on-line to a SHEP clinic is used to demonstrate the potential of this technology. Ascertainment System for Morbidity and Mortality Follow-Up of SHEP Participants S. Harvey, A. Bagniewska, D. Feigal, S. Hulley, L. Kuller, a n d H.M. Perry University of California, San Francisco, CA (P79) The Systolic Hypertension in the Elderly Project (SHEP) endpoint ascertainment system is designed to collect relevant information on all deaths, on all hospitalizations, and on nonhospitalized morbid events related to hypertension or atherosclerosis. Within 48 hours of a suspected event, a brief form initiates a system that assures that complete data are collected and reviewed by the Morbidity and Mortality Committee. The effectiveness of this morbidity surveillance has been good, judging by a validation at annual visit. Morbidity and mortality follow-up is continued on all participants, including those no longer willing to come to clinic. By requiring a contact with questions on disease events at least every 6 months, follow-up on the 551 participants has been 100% complete. The most recent contact took place by clinic visit (89%), telephone to participant (8%) or to a friend (1%), home visit (1%), or letter (1%). Morbidity and mortality follow-up rates of 100% are an achievable objective in studies of this sort.
Longitudinal Measures of Compliance in the Elderly M e r w y n Greenlick, G l e n n H u g h e s , Jackie Smith, a n d D e n n i s Black Kaiser Foundation Hospital, Portland, OR (P80) This paper reviews the development and validation of longitudinal summary measures of compliance in the Systolic Hypertension in the Elderly Project (SHEP). Various individual measures are presented and the relationship between baseline attitudinal measures and compliance is investigated. The compliance measures used are scores of self-reported pill taking, scores based on whether medication was returned at each visit, and the summary pill count at each visit. Longitudinal data produce a single score on each variable for each participant. These measures are compared across individuals and a summary measure is produced. To investigate the determinants of compliance the measures are used as dependent variables in an analysis using baseline data as the independent variables. Baseline data include measures on attitudes concerning the study and researach generally, and on health beliefs, social support systems, and attitudes towards medications and drug taking. A System to Check Eligibility in a Randomized Clinical Trial with Complicated
Admission Criteria J.G.P. Tijssen, H.J.J. K e r k k a m p , a n d J. L u b s e n
Netherlands Interuniversity Cardiology Institute and Thoraxcenter, Rotterdam, The Netherlands (P81) A randomized clinical trial to study the efficacy of nifedipine and metoprolol in cooling off patients admitted to a coronary care unit because of unstable angina, is performed in the Netherlands.
313
Distributed Data Processing as a Clinical M a n a g e m e n t Tool i n Collaborative Trials: T h e SHEP S t u d y T. Remijas, K. Molvig, A. Bagniewska, D. Black, D. Feigal, C. Fox University of California, San Francisco, CA (P78) We have previously reported on the use of distributed data processing in multicenter clinical trials as an on-site data entry and verification system. In addition to its usefulness for data entry, the clinic computer can be integrated into other aspects of the study, including data form generation, protocol monitoring, and clinical management. In the Systolic Hypertension in the Elderly Program (SHEP) distributed system, the clinic computer provides appointment schedules and patient status reports used to prepare the clinic visits. A computer-generated worksheet data form is used by clinicians as a guide to the drug treatment protocol and as a data collection instrument. Other reports and lists are prepared by the computer for use by clerical staff, clinicians, pharmacists and principal investigators. The clinic study computer thus improves clinical efficiency and, thereby, the trial itself. This poster includes workflow diagrams to illustrate the relationship between various clinical procedures and the study computer. A terminal on-line to a SHEP clinic is used to demonstrate the potential of this technology. Ascertainment System for Morbidity and Mortality Follow-Up of SHEP Participants S. Harvey, A. Bagniewska, D. Feigal, S. Hulley, L. Kuller, a n d H.M. Perry University of California, San Francisco, CA (P79) The Systolic Hypertension in the Elderly Project (SHEP) endpoint ascertainment system is designed to collect relevant information on all deaths, on all hospitalizations, and on nonhospitalized morbid events related to hypertension or atherosclerosis. Within 48 hours of a suspected event, a brief form initiates a system that assures that complete data are collected and reviewed by the Morbidity and Mortality Committee. The effectiveness of this morbidity surveillance has been good, judging by a validation at annual visit. Morbidity and mortality follow-up is continued on all participants, including those no longer willing to come to clinic. By requiring a contact with questions on disease events at least every 6 months, follow-up on the 551 participants has been 100% complete. The most recent contact took place by clinic visit (89%), telephone to participant (8%) or to a friend (1%), home visit (1%), or letter (1%). Morbidity and mortality follow-up rates of 100% are an achievable objective in studies of this sort.
Longitudinal Measures of Compliance in the Elderly M e r w y n Greenlick, G l e n n H u g h e s , Jackie Smith, a n d D e n n i s Black Kaiser Foundation Hospital, Portland, OR (P80) This paper reviews the development and validation of longitudinal summary measures of compliance in the Systolic Hypertension in the Elderly Project (SHEP). Various individual measures are presented and the relationship between baseline attitudinal measures and compliance is investigated. The compliance measures used are scores of self-reported pill taking, scores based on whether medication was returned at each visit, and the summary pill count at each visit. Longitudinal data produce a single score on each variable for each participant. These measures are compared across individuals and a summary measure is produced. To investigate the determinants of compliance the measures are used as dependent variables in an analysis using baseline data as the independent variables. Baseline data include measures on attitudes concerning the study and researach generally, and on health beliefs, social support systems, and attitudes towards medications and drug taking. A System to Check Eligibility in a Randomized Clinical Trial with Complicated
Admission Criteria J.G.P. Tijssen, H.J.J. K e r k k a m p , a n d J. L u b s e n
Netherlands Interuniversity Cardiology Institute and Thoraxcenter, Rotterdam, The Netherlands (P81) A randomized clinical trial to study the efficacy of nifedipine and metoprolol in cooling off patients admitted to a coronary care unit because of unstable angina, is performed in the Netherlands.