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An interactive data quality assurance program
81
Abstracts
m c o r p o r a t l o n of pre-surg.cal m o r b , d l W a n d m o r t a h t y m e v a l u a t i n g the effects of delayed surgery, (2) the u n i f o r m data collection from m o r e t h a n 70 n e u r o s u r g , c a l centers a n d , (3) t h e application of ep~dem~ologmcal m e t h o d s in the analys~s ot the results Th~s s t u d y d e s t g n offers a useful a l t e r n a t w e w h e n a r a n d o m i z e d cl.mcal trial Ls not feasible
Graphical Nonparametric Techniques for Exploring Hazard Functions with Time-Varying Covariates H T T h a l e r , Bwstatzstzcs Laboratory, Memorzal Sloan-Kettermg Cancer Center, New York, New York (P48) A great deal of m t e r e s t h a s b e e n g e n e r a t e d in the u s e ot Cox's p r o p o r h o n a l h a z a r d s m o d e l for s t u d y m g p r o g n o s t i c factors in d i s e a s e p o p u l a h o n s w h e n follow-up m f o r m a h o n on the e n d p o m t m a y be " c e n s o r e d '" M e t h o d s h a v e n o w been d e v e l o p e d for e s t , m a t m g a n d g r a p h m g h a z a r d f u n c t i o n s that m a y d e p e n d on a t l m e - v a r y m g c o v a n a t e , w i t h o u t a s s u m i n g a n y a p n o n m a t h e m a t i c a l form to t h e relationship T h e c o v a n a t e m a y be eRher discrete or c o n t m u o u s A specflLc a p p l , c a t l o n for a b , n a r y covarlate p r o v i d e s a m e t h o d for e v a l u a t m g the true c h m c a l b e n e h t to a c h i e v i n g a d e t m a b l e r e s p o n s e to t r e a t m e n t a n d avoids the h i d d e n bias r e s u l t m g from p l o t t m g s e p a r a t e survLval curves for r e s p o n d e r s a n d n o n r e s p o n d e r s Examples are g i v e n from s t u d i e s of p a t i e n t s on t r e a t m e n t protocols for h e m a t o p o l e h c t u m o r s
An Interactive Data Quality Assurance Program Wilham
D
Dupont
a n d R a n d a l l F W r i g h t , Vanderbtlt Umverstty, Nashwlle,
Tennessee (P49) We h a v e d e s i g n e d a package ot c o m p u t e r p r o g r a m s w h i c h enable chmcal trial m a n a g e r s to create data m a n a g e m e n t s y s t e m s that can be r u n by people lackmg c o m p u t e r skills Each s y s t e m ~s d e f i n e d b y m s t r u c t l o n s written Ln a s i m p l e control l a n g u a g e The s y s t e m g e n e r a t o r p r o g r a m reads t h e s e m s t r u c t i o n s a n d creates control tables that enable the p a c k a g e ' s utility p r o g r a m s to be c u s t o m i z e d to the m a n a g e r ' s n e e d s T h e data e n t r y utfl.ty is a m t e r a c t w e p r o g r a m that edits the data as it zs entered P r o m p t m g m e s s a g e s derived from the control tables g u l d e the u s e r t h r o u g h each d a t a t o r m T h l s m a k e s data e n t r y a n d e d l t . n g tasks easy to learn a n d p e r f o r m Entry errors can be detected a n d c o r r e c t e d t m m e d l a t e l v L t s t s u t r e m a i n i n g edit checks can be g e n e r a t e d for s u b s e q u e n t verlhcatlon a n d correction Data p o i n t s that are not e n t e r e d are automatically a s s i g n e d a m i s s i n g value code T h e u s e r m a y alter the order ot data e n t r y to skip m i s s i n g e n t r i e s or c h a n g e p r e w o u s l y e n t e r e d v a l u e s T h e p a c k a g e ts c o m p a t i b l e with BMDP, SPSS, etc It is currently i m p l e m e n t e d on a VAX 11:780 c o m p u t e r a n d wdl s o o n be written entirely in FORTRAN-77 to e n h a n c e its portability
Monitoring Late Effects of Therapy in Clinical Trials Jay Herson
a n d L o u i s e C S t r o n g , The Umverstty ot Texas System Cancer Center,
Houston, Texas (P50) A data b a s e s y s t e m h a s b e e n d e v e l o p e d to a s s e s s late effects ot t r e a t m e n t tor pediatric cancer c h m c a l trials p a t i e n t s Patients e n t e r a SIR p a t i e n t data b a s e on their hrst c h m c a l that registration A c h i e v e m e n t ot 5 year survival free of d i s e a s e m l t l a t e s e n t r y m t o a SIR long t~me s u r v i v o r data b a s e To date 700 p a t i e n t s h a v e b e e n entered Data e l e m e n t s , w h i c h are u p d a t e d annually, m c l u d e d e m o g r a p h i c factors, medical a n d f a i r l y h i s t o r y at d i a g n o s i s , chmcal course, detailed t r e a t m e n t record, a n d physical, mtellectual, d e v e l o p m e n t a l , reproductive a n d p r o g e n y status S t a n d a r d i z e d medical n o s o l o g y a n d p h a r m a c y codes are u~,ed This s y s t e m faclhtates cohort analysis of the risk of late effects by tlme, host a n d t r e a t m e n t tactors
Adjusting Treatment to Severity: Use of Prognostic Knowledge in the Design of Randomized Clinical Trials C Chastang,
A
Auquler,
B Asselam,
a n d F G r e m y , I N S E R M U 194, Par~s, France
(P51) For ethical reasons, p h y s i c i a n s w o u l d hke to d e / m e an o p h m a l t r e a t m e n t t o r a n y p a h e n t This a t t i t u d e raises i m p o r t a n t m e t h o d o l o g i c a l dlfhcultles We try to direct p h y s i c i a n s towards a r~gorous a d j u s t m e n t of t r e a t m e n t s to the predictable severity ot the d i s e a s e This l m p l , e s a p r o g n o s t i c k n o w l e d g e of the d . s e a s e b a s e d on criteria w h i c h are e a s d v d e f i e d , reproducible.
Abstracts
m c o r p o r a t l o n of pre-surg.cal m o r b , d l W a n d m o r t a h t y m e v a l u a t i n g the effects of delayed surgery, (2) the u n i f o r m data collection from m o r e t h a n 70 n e u r o s u r g , c a l centers a n d , (3) t h e application of ep~dem~ologmcal m e t h o d s in the analys~s ot the results Th~s s t u d y d e s t g n offers a useful a l t e r n a t w e w h e n a r a n d o m i z e d cl.mcal trial Ls not feasible
Graphical Nonparametric Techniques for Exploring Hazard Functions with Time-Varying Covariates H T T h a l e r , Bwstatzstzcs Laboratory, Memorzal Sloan-Kettermg Cancer Center, New York, New York (P48) A great deal of m t e r e s t h a s b e e n g e n e r a t e d in the u s e ot Cox's p r o p o r h o n a l h a z a r d s m o d e l for s t u d y m g p r o g n o s t i c factors in d i s e a s e p o p u l a h o n s w h e n follow-up m f o r m a h o n on the e n d p o m t m a y be " c e n s o r e d '" M e t h o d s h a v e n o w been d e v e l o p e d for e s t , m a t m g a n d g r a p h m g h a z a r d f u n c t i o n s that m a y d e p e n d on a t l m e - v a r y m g c o v a n a t e , w i t h o u t a s s u m i n g a n y a p n o n m a t h e m a t i c a l form to t h e relationship T h e c o v a n a t e m a y be eRher discrete or c o n t m u o u s A specflLc a p p l , c a t l o n for a b , n a r y covarlate p r o v i d e s a m e t h o d for e v a l u a t m g the true c h m c a l b e n e h t to a c h i e v i n g a d e t m a b l e r e s p o n s e to t r e a t m e n t a n d avoids the h i d d e n bias r e s u l t m g from p l o t t m g s e p a r a t e survLval curves for r e s p o n d e r s a n d n o n r e s p o n d e r s Examples are g i v e n from s t u d i e s of p a t i e n t s on t r e a t m e n t protocols for h e m a t o p o l e h c t u m o r s
An Interactive Data Quality Assurance Program Wilham
D
Dupont
a n d R a n d a l l F W r i g h t , Vanderbtlt Umverstty, Nashwlle,
Tennessee (P49) We h a v e d e s i g n e d a package ot c o m p u t e r p r o g r a m s w h i c h enable chmcal trial m a n a g e r s to create data m a n a g e m e n t s y s t e m s that can be r u n by people lackmg c o m p u t e r skills Each s y s t e m ~s d e f i n e d b y m s t r u c t l o n s written Ln a s i m p l e control l a n g u a g e The s y s t e m g e n e r a t o r p r o g r a m reads t h e s e m s t r u c t i o n s a n d creates control tables that enable the p a c k a g e ' s utility p r o g r a m s to be c u s t o m i z e d to the m a n a g e r ' s n e e d s T h e data e n t r y utfl.ty is a m t e r a c t w e p r o g r a m that edits the data as it zs entered P r o m p t m g m e s s a g e s derived from the control tables g u l d e the u s e r t h r o u g h each d a t a t o r m T h l s m a k e s data e n t r y a n d e d l t . n g tasks easy to learn a n d p e r f o r m Entry errors can be detected a n d c o r r e c t e d t m m e d l a t e l v L t s t s u t r e m a i n i n g edit checks can be g e n e r a t e d for s u b s e q u e n t verlhcatlon a n d correction Data p o i n t s that are not e n t e r e d are automatically a s s i g n e d a m i s s i n g value code T h e u s e r m a y alter the order ot data e n t r y to skip m i s s i n g e n t r i e s or c h a n g e p r e w o u s l y e n t e r e d v a l u e s T h e p a c k a g e ts c o m p a t i b l e with BMDP, SPSS, etc It is currently i m p l e m e n t e d on a VAX 11:780 c o m p u t e r a n d wdl s o o n be written entirely in FORTRAN-77 to e n h a n c e its portability
Monitoring Late Effects of Therapy in Clinical Trials Jay Herson
a n d L o u i s e C S t r o n g , The Umverstty ot Texas System Cancer Center,
Houston, Texas (P50) A data b a s e s y s t e m h a s b e e n d e v e l o p e d to a s s e s s late effects ot t r e a t m e n t tor pediatric cancer c h m c a l trials p a t i e n t s Patients e n t e r a SIR p a t i e n t data b a s e on their hrst c h m c a l that registration A c h i e v e m e n t ot 5 year survival free of d i s e a s e m l t l a t e s e n t r y m t o a SIR long t~me s u r v i v o r data b a s e To date 700 p a t i e n t s h a v e b e e n entered Data e l e m e n t s , w h i c h are u p d a t e d annually, m c l u d e d e m o g r a p h i c factors, medical a n d f a i r l y h i s t o r y at d i a g n o s i s , chmcal course, detailed t r e a t m e n t record, a n d physical, mtellectual, d e v e l o p m e n t a l , reproductive a n d p r o g e n y status S t a n d a r d i z e d medical n o s o l o g y a n d p h a r m a c y codes are u~,ed This s y s t e m faclhtates cohort analysis of the risk of late effects by tlme, host a n d t r e a t m e n t tactors
Adjusting Treatment to Severity: Use of Prognostic Knowledge in the Design of Randomized Clinical Trials C Chastang,
A
Auquler,
B Asselam,
a n d F G r e m y , I N S E R M U 194, Par~s, France
(P51) For ethical reasons, p h y s i c i a n s w o u l d hke to d e / m e an o p h m a l t r e a t m e n t t o r a n y p a h e n t This a t t i t u d e raises i m p o r t a n t m e t h o d o l o g i c a l dlfhcultles We try to direct p h y s i c i a n s towards a r~gorous a d j u s t m e n t of t r e a t m e n t s to the predictable severity ot the d i s e a s e This l m p l , e s a p r o g n o s t i c k n o w l e d g e of the d . s e a s e b a s e d on criteria w h i c h are e a s d v d e f i e d , reproducible.