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Compliance measures in the Cholesterol Lowering Atherosclerosis Study (CLAS)
155
Abstracts
the course of the trial, cannot investigate the differences in response times of patients to different treatments. Response data are collected periodically in the course of an arthritis trial at "evaluation" visits. Hence, an alternative procedure of analysis is to construct a dichotomized measure of improvement using weighted sums of response variables and define those individuals as "improved" who satisfy the criteria of this measure at any evaluation visit. Time to "improvement" or cessation of observation can then be compared for several treatments using the usual methodology of survival analysis. Survival analysis is already used in such trials to study time to toxicity in the various drug groups. The contribution of survival analysis to the study of efficacy will be compared to the usual methods for data from three arthritis clinical trials.
Developing Simulated Patients for Training and Evaluating THai Staff in Adherence Counseling Michael L. Russell, K e n n e t h Ghee, Jeffrey L. Probstfield, a n d William Insull, Jr.,
The Baylor-Methodist Lipid Research Clinic (LRC), Houston, TX (68) The evaluation and training of clinical trial staff who counsel patients in lifestyle changes for disease prevention is greatly aided by a review of interviews conducted with a simulated patient (SP). This report describes the Inventory for Simulated Patient Characteristics (ISPC), a listing of 33 generic parameters for developing an SP for use in staff training and evaluation in counseling. Use of the ISPC creates a complete person in all critical aspects of counseling for lifestyle change (e.g., daily routines, family, job). The ISPC was used in the LRC's Coronary Primary Prevention Trial (CPPT) to examine trial staff's skills in counseling for regimen adherence. In 1979, 96 staff interviewed two SPs developed using ISPC and rated the portrayals as highly realistic (4.4 on a 5-point scale). In 1980, two different SPs developed using ISPC were rated as 4.2 by 72 staff. The ISPC also verified that all SPs' portrayals were >90% faithful to their characterization. While SPs limited to specific clinical syndromes are used widely in medical education, no guidelines exist for their use in training trial staff in regimen counseling. The ISPC provides a simple template for creating SPs with broad characterizations that closely mimic actual trial patients.
Compliance Measures in the Cholesterol Lowering Atherosclerosis Study (CLAS) S h a r o n N e s s i m , S t a n l e y A z e n , R u t h J o h n s o n , a n d David Blanl
Abstracts
the course of the trial, cannot investigate the differences in response times of patients to different treatments. Response data are collected periodically in the course of an arthritis trial at "evaluation" visits. Hence, an alternative procedure of analysis is to construct a dichotomized measure of improvement using weighted sums of response variables and define those individuals as "improved" who satisfy the criteria of this measure at any evaluation visit. Time to "improvement" or cessation of observation can then be compared for several treatments using the usual methodology of survival analysis. Survival analysis is already used in such trials to study time to toxicity in the various drug groups. The contribution of survival analysis to the study of efficacy will be compared to the usual methods for data from three arthritis clinical trials.
Developing Simulated Patients for Training and Evaluating THai Staff in Adherence Counseling Michael L. Russell, K e n n e t h Ghee, Jeffrey L. Probstfield, a n d William Insull, Jr.,
The Baylor-Methodist Lipid Research Clinic (LRC), Houston, TX (68) The evaluation and training of clinical trial staff who counsel patients in lifestyle changes for disease prevention is greatly aided by a review of interviews conducted with a simulated patient (SP). This report describes the Inventory for Simulated Patient Characteristics (ISPC), a listing of 33 generic parameters for developing an SP for use in staff training and evaluation in counseling. Use of the ISPC creates a complete person in all critical aspects of counseling for lifestyle change (e.g., daily routines, family, job). The ISPC was used in the LRC's Coronary Primary Prevention Trial (CPPT) to examine trial staff's skills in counseling for regimen adherence. In 1979, 96 staff interviewed two SPs developed using ISPC and rated the portrayals as highly realistic (4.4 on a 5-point scale). In 1980, two different SPs developed using ISPC were rated as 4.2 by 72 staff. The ISPC also verified that all SPs' portrayals were >90% faithful to their characterization. While SPs limited to specific clinical syndromes are used widely in medical education, no guidelines exist for their use in training trial staff in regimen counseling. The ISPC provides a simple template for creating SPs with broad characterizations that closely mimic actual trial patients.
Compliance Measures in the Cholesterol Lowering Atherosclerosis Study (CLAS) S h a r o n N e s s i m , S t a n l e y A z e n , R u t h J o h n s o n , a n d David Blanl