A b s t r a c t s 77

Assessment of Intelligent Terminals for Data Entry: Experience in Three C l i n i c a l T r i a l s G e o r g e B o w d e n , F r a n L o P r e s h , S u s a n P o l h z z i , Maryland Medzcal Research, Baltimore, Maryland (34) The t r a n s c n p h o n of data from data collection forms to compu te r data files ideally requi res a m i n i m u m of data en t ry operator t ime for dec iphe r ing and keying, yields a m i n i m u m n u m b e r ot errors, and p rov ides records neces sa ry for ofhcial p l ann ing and m a n a g e m e n t ln te lhgent data en t ry te rminals are c o m m o n l y u sed for data en t ry The de s ign and imp lemen ta t i on ot a data en t ry sy s t em which uses intel l igent data en t ry te rminals will be descr ibed and d i s cus sed This sy s t em inc ludes suppor t p rog rams which (1) d isp lay a format s imilar to the actual form, (2) mteract ively edit cruc)al i t ems of form ident if icat ion th rough compar i son wzth prev ious ly en tered data from other forms, and (3) check r e sponses agains t pe rmiss ib le ranges for each ztem Evaluat ion of this sy s t em will cons ider p r o g r a m m e r coding , d e b u g g i n g , and tes t ing t ime, data en t ry operator t ime. a s s e s s m e n t of error rates for this sy s t em compared to a l ternat ive m e t h o d s of data en t ry , and the m a n a g e m e n t l n t o r m a h o n which can be obta ined from it

T h e Future of Statistical Computer Packages in Clinical Trial Analysis Bruce A B a r t o n , Maryland Medwal Research lnstttute, Baltzmore, Maryland (35) Wzth the prol i ferat ion of statistical compu te r packages , there s eems to be "a package for all s e a sons " Frequent ly, however , large chnlcal trial centers resort to wr l t .ng their own rout ines as the packages are (a) too costly to run , (b) too general to be useful , (c) not as reliable as preferred, and (d) m a y not have the "favor i te" stat ist ic of the center

This paper will compare i n - h o u s e statistical sof tware with centrally developed and d i s t n b - u ted s ta t lshcal compu t e r packages The efficiency of both types of sof tware, in te rms of compu te r t ime as well as staff t ime. will be addressed with specific examples The fu ture of both types ot sof tware in the analys is of clinical trials will be d i s cus sed

An Outcomes Monitoring System for Multicenter Cooperative Clinical Studies W K Poo le , T D. H a r t w e l l , A V R ao , B.K. H a s t i n g s , N . C Fox, a n d D A W h l t e h u r s t , Research Trtangle Institute, Research Trzangle Park, North Carohna (36) The d e s , g n of several m u l h c e n t e r clinical s tud ies specifies collection ot a large n u m b e r of data i tems at d i f terent po in t s in t ime on a n u m b e r of principal and seconda ry s t udy sublects l ' radlhonal or the more usua l m e t h o d s of data p rocess ing necessar i ly result in cons iderab le t ime delay be tween the receipt of data at the data center and the ava. labfl i ty of that data m a compu te r readable form S tudy overs igh t bodies such as the policy data m o m t o n n g panel requi re statistical reports based on ana lys i s of p r imary and s econda ry pat ient ou tcome var iables for mak i ng impor tan t dec i s ions conce rn ing the conduct ot the s t udy It is, therefore, essent ia l that these repor ts be based on the data on all pa t ien ts in the s t udy at the t ime of the report The data i t ems used for these pu rpose s are only a small fraction of the pat ient data collected

To meet the repor t ing r e q u i r e m e n t s of the s t udy overs ight commi t tees , the au tho r s have deve loped a pat ient ou t come mon i t o r i ng sy s t em The paper will descr ibe thzs sy s t em and il lustrate it with appl ica t ions to three cooperat ive clinical s tud ies

Clinical Trim Dropouts: Analysis of Demography and Reasons J L P r o b s t f i e l d , M L R u s s e l l a n d W Insu l l , Jr , Baylor-Methodtst Lzp~d Research Chmc, Houston, Texas (37) A successful p rogram to recover d ropou t s (DO) from a chmcal trial was repor ted (CCLTDH 1 168, 1980) Oblec twes of the current s t udy were to examine the na tu re of the p rob lems which characterize DO and to d e m o n s t r a t e the f r equency of di f ferences be tween the reasons mlha l l y stated and those uncovered du r i ng fol low-up D e m o g r a p h y of the Baylor-Methodls t (BM) cohort and of the DO s h o w s the fol lowing compar i sons , respechve ly m e a n age 46 1+6 6, 43 7+4 5, % marr ied 90, 92, % whi te collar workers 88, 7Z and % with college degree 58, 47 (All NS) The mlha l ly s tated reasons of 36 DO were characterized into three categories, s ide effects to the s t udy d rug (SE) 11%, medical p rob lems (M) 14°o, and behavioral dlff lculhes (B) 75°,o (p<0 01) In 1 l of 36 DO, the reason initially s tated evolved d u n n g two years of fol low-up to the c u r r e n t d l s t r l b u h o n o t S E 1 9 % , M 11%, B 69% (p<0 01) The entire cohort d e m o n s t r a t e d