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Decreasing dropouts in long-term clinical trials
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Abstracts one for which technological advances based on videotex will facilitate coordination and data collection, and, for the sake of comparison, one that is based on current approach.
Comparisons of Cause of Death Verification Methods and Costs in the Lipid Research Clinics Program Follow-Up Study Shrikant Bangdiwala, Richard C o h n , Carol Hazard, C.E. Davis, a n d R o n Prineas University of North Carolina at Chapel Hill (P57) Classification of causes of death by a nosologist is standardized and relatively inexpensive, although the data recorded on death certificates are subject to questionable reliability and validity. A costly alternative is a classification by a panel of physicians reviewing additional clinical information. For deaths among the elderly (/> 65 years of age), determination of the underlying cause of death may be difficult using only the death certificate, especially as regards cardiovascular disease causes of death. Both classification methods are compared for 268 elderly deaths and 155 nonelderly deaths among males and females participating in the Lipid Research Clinics Program Follow-Up Study. The methods agreed better for the nonelderly deaths (75%) than for the elderly deaths (71%). However, the kappa statistics were not significantly different (p > 0.10). Thus, the agreement between the methods is not affected significantly by the age of the deaths being classified.
The Register of Randomized Controlled TriMs i n Perinatal Medicine Kay Dickersin, Virginia H e t h e r i n g t o n , a n d Iain C h a l m e r s
National Perinatal Epidemiology Unit, Radcliffe Infirmary, Oxford, England (P58) Since 1978, The National Perinatal Epidemiology Unit, with funding from WHO, has been compiling a Register of published randomized controlled trials in perinatal medicine. Over 3000 reports, dating from 1922 on, have been identified from 209 journals and 56 countries. For inclusion in the Register, a trial must involve (1) human mothers or infants during pregnancy or within 28 days of delivery and (2) assignment to treatment on a random or pseudo random basis. A detailed classification scheme denotes the stage of the perinatal period covered in each trial and the specific medical problems, interventions, and outcomes. Each trial also is classified by randomization method, number of treatment groups, and total number of subjects entered. This, along with publication information, is entered into a computer data tile. The full Register listing of all published perinatal trials through December 1983 will be available in early 1985. A major effort to expand the Register by the inclusion of unpublished and ongoing trials is planned.
Decreasing Dropouts in Long-Term Clinical Trials M. W e i n t r a u b , P.R. S u n d a r e s a n , G. Ginsberg, a n d L. Byrne Dept. of Prey. Med., University of Rochester, Rochester, NY (P59) Only 9 of 121 (7.4%) participants dropped out of a 34-week double-blind placebo-controlled weight control study. Reasons for this low rate include design features such as offering the placebo group active medication in subsequent study phases and effective, free ancillary therapy (dietitians and behavior modification support groups); study mechanics such as evening clinics where only participants and study staff are present, a newsletter containing data, articles, comments from participants, and schedule reminders, and personal attention wuch as supportive study staff and follow-up calls during clinic hours; and a study treatment that decreases ADRs while maintaining efficacy. At 72 weeks, only 19.8% of participants had left the study. However, intercurrent illness, life events, relocation, failure to improve, and fear of continuing therapy may result in further dropouts. Techniques used in this and in our other studies are applicable to many clinical trials involving chronic conditions studied for long periods.
Correlated Measures of Disease Outcome in Clinical Trials: Effects on T y p e I Errors M a r l e n e J. Egger
Cooperative Systematic Studies of Rheumatic Diseases, University of Utah School of Medicine, Salt Lake City, UT (P60) In clinical trials of chronic diseases, a constellation of intercorrelated clinical and laboratory response variables must be evaluated in order to decide whether a treatment is efficacious. When
Abstracts one for which technological advances based on videotex will facilitate coordination and data collection, and, for the sake of comparison, one that is based on current approach.
Comparisons of Cause of Death Verification Methods and Costs in the Lipid Research Clinics Program Follow-Up Study Shrikant Bangdiwala, Richard C o h n , Carol Hazard, C.E. Davis, a n d R o n Prineas University of North Carolina at Chapel Hill (P57) Classification of causes of death by a nosologist is standardized and relatively inexpensive, although the data recorded on death certificates are subject to questionable reliability and validity. A costly alternative is a classification by a panel of physicians reviewing additional clinical information. For deaths among the elderly (/> 65 years of age), determination of the underlying cause of death may be difficult using only the death certificate, especially as regards cardiovascular disease causes of death. Both classification methods are compared for 268 elderly deaths and 155 nonelderly deaths among males and females participating in the Lipid Research Clinics Program Follow-Up Study. The methods agreed better for the nonelderly deaths (75%) than for the elderly deaths (71%). However, the kappa statistics were not significantly different (p > 0.10). Thus, the agreement between the methods is not affected significantly by the age of the deaths being classified.
The Register of Randomized Controlled TriMs i n Perinatal Medicine Kay Dickersin, Virginia H e t h e r i n g t o n , a n d Iain C h a l m e r s
National Perinatal Epidemiology Unit, Radcliffe Infirmary, Oxford, England (P58) Since 1978, The National Perinatal Epidemiology Unit, with funding from WHO, has been compiling a Register of published randomized controlled trials in perinatal medicine. Over 3000 reports, dating from 1922 on, have been identified from 209 journals and 56 countries. For inclusion in the Register, a trial must involve (1) human mothers or infants during pregnancy or within 28 days of delivery and (2) assignment to treatment on a random or pseudo random basis. A detailed classification scheme denotes the stage of the perinatal period covered in each trial and the specific medical problems, interventions, and outcomes. Each trial also is classified by randomization method, number of treatment groups, and total number of subjects entered. This, along with publication information, is entered into a computer data tile. The full Register listing of all published perinatal trials through December 1983 will be available in early 1985. A major effort to expand the Register by the inclusion of unpublished and ongoing trials is planned.
Decreasing Dropouts in Long-Term Clinical Trials M. W e i n t r a u b , P.R. S u n d a r e s a n , G. Ginsberg, a n d L. Byrne Dept. of Prey. Med., University of Rochester, Rochester, NY (P59) Only 9 of 121 (7.4%) participants dropped out of a 34-week double-blind placebo-controlled weight control study. Reasons for this low rate include design features such as offering the placebo group active medication in subsequent study phases and effective, free ancillary therapy (dietitians and behavior modification support groups); study mechanics such as evening clinics where only participants and study staff are present, a newsletter containing data, articles, comments from participants, and schedule reminders, and personal attention wuch as supportive study staff and follow-up calls during clinic hours; and a study treatment that decreases ADRs while maintaining efficacy. At 72 weeks, only 19.8% of participants had left the study. However, intercurrent illness, life events, relocation, failure to improve, and fear of continuing therapy may result in further dropouts. Techniques used in this and in our other studies are applicable to many clinical trials involving chronic conditions studied for long periods.
Correlated Measures of Disease Outcome in Clinical Trials: Effects on T y p e I Errors M a r l e n e J. Egger
Cooperative Systematic Studies of Rheumatic Diseases, University of Utah School of Medicine, Salt Lake City, UT (P60) In clinical trials of chronic diseases, a constellation of intercorrelated clinical and laboratory response variables must be evaluated in order to decide whether a treatment is efficacious. When