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The role of computer assisted telephone interviewing in clinical research
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Abstracts A System for the Computerization of Individually Prescribed Medication Michael Thorn, Melvin Jackson, C.E. Davis, Kathy Roggenkamp, a n d Sherry Gates, Department of Biostatistics, UNC, Chapel Hill, NC (38) In a large-scale clinical trial, it is often difficult to monitor the use of nontrial prescription medications for the study of drug-drug interactions or the impact of these therapeutic agents on trial outcomes. A method for the numerical coding and computerization of prescription medication taken by Lipid Research Clinics Coronary Primary Prevention Trial participants is described. By making classifications easier, this method is useful for the rapid tabulation of pharmacologic classes of medication; additionally, the accessibility of individual medications is simplified. Advantages of as well as potential difficulties with this method will also be addressed. The Role of Computer Assisted Telephone Interviewing in Clinical Research Joseph A. Crawley, Kendall S. Krieger, a n d Richard A. Houchard, Medication Monitoring ProgramsM, The Upjohn Company, Kalamazoo, MI (39) A computer-assisted telephone interviewing system is currently being utilized by The Upjohn Company's Medication Monitoring Program for direct patient contact in Postmarketing Drug Surveillance (PMS). The system operates on a Hewlett-Packard (HP) 3000 series 30. All programming has been written in FORTRANand utilizes the HP V/3000 package. The system impacts upon interviewing activity in three major areas: (1) questionnaire scheduling, (2) the interview proper, and (3) postinterview data processing. Discussion focuses upon the impact computerassisted telephone interviewing has on personnel and data management in those three areas. This new extension of interviewing capabilities promises to significantly enhance a research team's ability to deal with interviewer consistency, validity of the data, and interviewing cost.
Reliability of Patient-Reported Health Events in an Outpatient Drug Monitoring S t u d y Jacqueline S. Gardner, Martin J. O'Connell, Joseph A. Crawley, a n d William S. Barry, Medication Monitoring Programs~, The Upjohn Company, Kalamazoo,
MI (40) In monitoring for drug effects in outpatients, the patient-reported health event could be a direct measure of adversity or benefit if it is reliable. A study was conducted using periodic interviews of users of nonsteroidal antiinflammatory drugs (NSAID). Hospitalizations reported by interview respondents were investigated by a field team that abstracted the medical records relating to the reported event. Analysis was made of the agreement between the health problems reported by respondents and the diagnoses confirmed by the field investigators. Data are presented showing 90% agreement between respondent report of events and confirmed diagnoses, which affirms that patient reports are a reliable information source in observational monitoring studies. This method may effectively screen health events for further investigation and may serve to identify transient medical problems not resulting in professional intervention.
Nursing Practice in a Clinical Trial Setting Jacqueline Brunell a n d Lorie Falvo-Gerard, University of California, San Francisco, CA (P-41) As clinical trials have moved beyond drug testing to focus on risk factors and behavioral interventions, the nursing role has become an important component. Nurses are ideally suited for the role of enhancing such scientific objectives as quality control, compliance, and quality of care. Their unique skills combine humanistic and scientific approaches to clinical research. This presentation describes the role of nurses in the Systolic Hypertension in the Elderly Program (SHEP), a multicenter, double-blind randomized pilot study of 500 participants, aged 60 years and up. Nurses in the SHEP have varied responsibilities including: primary care, clinic management, behavior assessment, health education, training, and quality control. They participate at every level of the SHEP and are included among the co-Principal Investigators and the Coordinating Center staff. Opportunities exist to contribute to ancillary studies, and other research.
Abstracts A System for the Computerization of Individually Prescribed Medication Michael Thorn, Melvin Jackson, C.E. Davis, Kathy Roggenkamp, a n d Sherry Gates, Department of Biostatistics, UNC, Chapel Hill, NC (38) In a large-scale clinical trial, it is often difficult to monitor the use of nontrial prescription medications for the study of drug-drug interactions or the impact of these therapeutic agents on trial outcomes. A method for the numerical coding and computerization of prescription medication taken by Lipid Research Clinics Coronary Primary Prevention Trial participants is described. By making classifications easier, this method is useful for the rapid tabulation of pharmacologic classes of medication; additionally, the accessibility of individual medications is simplified. Advantages of as well as potential difficulties with this method will also be addressed. The Role of Computer Assisted Telephone Interviewing in Clinical Research Joseph A. Crawley, Kendall S. Krieger, a n d Richard A. Houchard, Medication Monitoring ProgramsM, The Upjohn Company, Kalamazoo, MI (39) A computer-assisted telephone interviewing system is currently being utilized by The Upjohn Company's Medication Monitoring Program for direct patient contact in Postmarketing Drug Surveillance (PMS). The system operates on a Hewlett-Packard (HP) 3000 series 30. All programming has been written in FORTRANand utilizes the HP V/3000 package. The system impacts upon interviewing activity in three major areas: (1) questionnaire scheduling, (2) the interview proper, and (3) postinterview data processing. Discussion focuses upon the impact computerassisted telephone interviewing has on personnel and data management in those three areas. This new extension of interviewing capabilities promises to significantly enhance a research team's ability to deal with interviewer consistency, validity of the data, and interviewing cost.
Reliability of Patient-Reported Health Events in an Outpatient Drug Monitoring S t u d y Jacqueline S. Gardner, Martin J. O'Connell, Joseph A. Crawley, a n d William S. Barry, Medication Monitoring Programs~, The Upjohn Company, Kalamazoo,
MI (40) In monitoring for drug effects in outpatients, the patient-reported health event could be a direct measure of adversity or benefit if it is reliable. A study was conducted using periodic interviews of users of nonsteroidal antiinflammatory drugs (NSAID). Hospitalizations reported by interview respondents were investigated by a field team that abstracted the medical records relating to the reported event. Analysis was made of the agreement between the health problems reported by respondents and the diagnoses confirmed by the field investigators. Data are presented showing 90% agreement between respondent report of events and confirmed diagnoses, which affirms that patient reports are a reliable information source in observational monitoring studies. This method may effectively screen health events for further investigation and may serve to identify transient medical problems not resulting in professional intervention.
Nursing Practice in a Clinical Trial Setting Jacqueline Brunell a n d Lorie Falvo-Gerard, University of California, San Francisco, CA (P-41) As clinical trials have moved beyond drug testing to focus on risk factors and behavioral interventions, the nursing role has become an important component. Nurses are ideally suited for the role of enhancing such scientific objectives as quality control, compliance, and quality of care. Their unique skills combine humanistic and scientific approaches to clinical research. This presentation describes the role of nurses in the Systolic Hypertension in the Elderly Program (SHEP), a multicenter, double-blind randomized pilot study of 500 participants, aged 60 years and up. Nurses in the SHEP have varied responsibilities including: primary care, clinic management, behavior assessment, health education, training, and quality control. They participate at every level of the SHEP and are included among the co-Principal Investigators and the Coordinating Center staff. Opportunities exist to contribute to ancillary studies, and other research.