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The trial coordinator's role in the diabetes control and complications trial (DCCT)
Abstracts
257
A Comparison of Form Design Elements Affecting Data Entry Quality: Results of Two Large Multicenter Trials Sue Pollizzi a n d C a r o l H a n d y
Maryland Medical Research Institute (P-31T) Data entry quality is related to form design elements that contribute to data entry errors. At MMRI forms are routinely double-keyed, adjudicated for discrepancies between keyings, and reentered completely should adjudication fail. Statistics are maintained on discrepancies and adjudications. These statistics are presented for two multicenter trials encompassing over 100 form/revision combinations. Form length ranged from 1 to 19 pages, data items ranged from 22 to 720, and keystrokes ranged from 47 to 1129. Form page layouts varied from one to nine columns of response. Data entry quality control statistics were evaluated in terms of the preceding characteristics, whether the responses to the items were precoded, numeric, or free-form, and whether there were dichotomous or multiple responses. If form design can be controlled to reduce data entry errors, study resources can be conserved for other uses.
Turnover Among Clinical Coordinators in Two Multicenter Clinical Trials D o n n a C. O p t i c a n , B a r b a r a S. H a w k i n s , a n d V i r g i n i a R e g a n
The Wilmer Opthalmological Institute, The Johns Hopkins University, Baltimore, Maryland and Michigan State University, Associated Reinal Consultants, Royal Oak, Michigan (P32T) During the first 5 years of clinic operations in the Macular Photocoagulation Study (MPS), 18 clinic coordinators resigned among a total of 34 current and former coordinators. During a similar time period in the Early Treatment Diabetic Retinopathy Study (ETDRS), 24 of 66 coordinators had resigned. We surveyed all present and former MPS and ETDRS coordinators. Our goal was to determine and compare features that characterized coordinators in the two studies and any that discriminated between coordinators who remained with each study and those who left. Factors investigated included age, sex, marital status, level of education, previous experience, salary, other professional responsibilities, career goals, and feedback and support systems. The two groups of coordinators were similar in many respects. Areas of concern among both groups of coordinators included training, interactions with the clinic investigators, and salary. Salary was the only factor identified that distinguished between current and former coordinators in both studies. Suggestions for reducing future coordinator turnover are offered. T h e Trial Coordinator's Role in the Diabetes Control and Complications Trial (DCCT) Davida Kruger The DCCT Research Group (P-33T) The DCCT is a multicenter clinical trial studying the effect of intensive therapy on vascular complications in insulin-dependent diabetic subjects. The DCCT currently includes more than 400 volunteers in 21 centers and will ultimately study 1400 subjects for 8-10 years. Trial coordinators play an essential and unique role in this complex trial. The trial coordinator's job has evolved to include recruitment, organizational, data collection, and patient management skills. At each clinic, the coordinator is responsible for quarterly collection of endpoint data and weekly collection of self-glucose monitoring results to adjust therapy in experimental group subjects. Subject adherence has been reinforced with group meetings, newsletters, and frequent, personal attention, which has served to bond subjects to the trial. On a trialwide basis, coordinators have created a Nurses Handbook and actively participated in the central committees that govern the trial. Part of the coordinator's job is specific to the DCCT, but much of it is generic and can serve as a model for other long-term interventional studies.
The Impact of the German ALL/AUL-Study on the Treatment of Acute Leukemia J o e r g H a s f o r d , G u d r u n Littig, D o r l e M e s s e r e r , a n d A l b r e c h t N e i s s
Biometric Centre for Therapeutic Studies (BZT), Munich, West Germany (~ 34T) As the diffusion of new medical knowledge can be remarkably slow, the BZT which runs several leukemia studies started a pilot study to investigate the state of the treatment of acute lympho-
257
A Comparison of Form Design Elements Affecting Data Entry Quality: Results of Two Large Multicenter Trials Sue Pollizzi a n d C a r o l H a n d y
Maryland Medical Research Institute (P-31T) Data entry quality is related to form design elements that contribute to data entry errors. At MMRI forms are routinely double-keyed, adjudicated for discrepancies between keyings, and reentered completely should adjudication fail. Statistics are maintained on discrepancies and adjudications. These statistics are presented for two multicenter trials encompassing over 100 form/revision combinations. Form length ranged from 1 to 19 pages, data items ranged from 22 to 720, and keystrokes ranged from 47 to 1129. Form page layouts varied from one to nine columns of response. Data entry quality control statistics were evaluated in terms of the preceding characteristics, whether the responses to the items were precoded, numeric, or free-form, and whether there were dichotomous or multiple responses. If form design can be controlled to reduce data entry errors, study resources can be conserved for other uses.
Turnover Among Clinical Coordinators in Two Multicenter Clinical Trials D o n n a C. O p t i c a n , B a r b a r a S. H a w k i n s , a n d V i r g i n i a R e g a n
The Wilmer Opthalmological Institute, The Johns Hopkins University, Baltimore, Maryland and Michigan State University, Associated Reinal Consultants, Royal Oak, Michigan (P32T) During the first 5 years of clinic operations in the Macular Photocoagulation Study (MPS), 18 clinic coordinators resigned among a total of 34 current and former coordinators. During a similar time period in the Early Treatment Diabetic Retinopathy Study (ETDRS), 24 of 66 coordinators had resigned. We surveyed all present and former MPS and ETDRS coordinators. Our goal was to determine and compare features that characterized coordinators in the two studies and any that discriminated between coordinators who remained with each study and those who left. Factors investigated included age, sex, marital status, level of education, previous experience, salary, other professional responsibilities, career goals, and feedback and support systems. The two groups of coordinators were similar in many respects. Areas of concern among both groups of coordinators included training, interactions with the clinic investigators, and salary. Salary was the only factor identified that distinguished between current and former coordinators in both studies. Suggestions for reducing future coordinator turnover are offered. T h e Trial Coordinator's Role in the Diabetes Control and Complications Trial (DCCT) Davida Kruger The DCCT Research Group (P-33T) The DCCT is a multicenter clinical trial studying the effect of intensive therapy on vascular complications in insulin-dependent diabetic subjects. The DCCT currently includes more than 400 volunteers in 21 centers and will ultimately study 1400 subjects for 8-10 years. Trial coordinators play an essential and unique role in this complex trial. The trial coordinator's job has evolved to include recruitment, organizational, data collection, and patient management skills. At each clinic, the coordinator is responsible for quarterly collection of endpoint data and weekly collection of self-glucose monitoring results to adjust therapy in experimental group subjects. Subject adherence has been reinforced with group meetings, newsletters, and frequent, personal attention, which has served to bond subjects to the trial. On a trialwide basis, coordinators have created a Nurses Handbook and actively participated in the central committees that govern the trial. Part of the coordinator's job is specific to the DCCT, but much of it is generic and can serve as a model for other long-term interventional studies.
The Impact of the German ALL/AUL-Study on the Treatment of Acute Leukemia J o e r g H a s f o r d , G u d r u n Littig, D o r l e M e s s e r e r , a n d A l b r e c h t N e i s s
Biometric Centre for Therapeutic Studies (BZT), Munich, West Germany (~ 34T) As the diffusion of new medical knowledge can be remarkably slow, the BZT which runs several leukemia studies started a pilot study to investigate the state of the treatment of acute lympho-