280 Abstracts

P-07 INDUSTRY INVOLVEMENT IN COOPERATIVE GROUP TRIALS:

EFFECTS ON DATA MANAGEMENT

Nancy Paul Chmcal Trials Group

Nattonal Cancer Institute of Canada Kingston, Canada

The CTG coordinates large mult~center chn~cal tnals (CTs) ~n cancer therapy nationally and ~nternat~onally In recent years both the proportion of CTG CTs sponsored by pharmaceutical compames (PCs) and the ~ntens~ty of PC ~nvolvement has ~ncreased markedly For each CT, the CTG and the PC negotiate case report design and data flow, on-s~te monitoring by the PC may or may not be done The CTG d~stnbuted a survey to all 130 data managers (DMs) ~n participating centers w~thm Canada to (1) assess the ~mpact of PC ~nvolvement in CTs on data management (DMT) generally and CTG DMT specifically, and (2) sohc~t recommendations for the eventual formulation of administrative and procedural guidelines for CTG-PC collaboration Surveys completed numbered 89 (68%) Of responding DMs, 55% are nurses, 40% work full t~me on CTs DMT, 59% reported an ~ncrease ~n their ~nst~tut~ons of PC ~nvolvement ~n CTs Only 6% of DMs sa~d PC ~nvolvement affects data quahty negatively, many felt that on-s~te monitoring results ~n h~gher standards. However, 83% sa~d PC involvement affects data quantity, several commented that much of the data collected by PCs ~s ~rrelevant Regular ws~ts of PC monitors were sa~d to be useful by 82% of respondents, and yet 54% admitted the ws~ts are annoying For CTG-PC collaborative studies, data/query flow was reported by 64% of DMs as confusing at least some of the t~me When a PC sponsors/monitors a CTG CT, 93% sa~d 25%-50% more DMT t~me ~s required

P-08 AN ANALYSIS OF DATA COLLECTION MECHANISMS

Doris Tyrrell, Dorothy R. Cline, and Ronald G. Thomas VA Medlcal Center

Palo Alto, Cahforma

Mult~center chn~cal trials require the collection of data through various mechanisms The most common method ~s the use of data collection forms Typically, each trial requires the design, development, and creation of original forms during the early stages of study planning The method of choice for the creation of these forms is a topic of some debate. Selection of a procedure raises ~ssues of cost effectiveness, ease of use, ease of training, etc To our knowledge, no rewew has been conducted of the hardware and software options and their relaWe merits available to study planners. The Cooperative Studies Program Coordinating Center at the VA Medical Center ~n Palo Alto, Cahforn~a, conducted a survey among thirty national and ~nternat~onal chn~cal thai coordinating centers The primary goals of the survey were to determine the forms development strategy used at each of the centers and what ~ssues were ~nvolved ~n choosing that strategy We present the results and g~ve recommendations concerning the selection of a data collection forms design procedure

• P-09 USE OF AN EXTERNAL LOOKUP TABLE FOR

CODING TEXTUAL DATA

Harvey Nelson, Elizabeth Yetisir, and Michael Gent McMaster University and

Hamtlton Ctvtc Hospitals Research Centre Hamtlton, Ontario, Canada

Traditionally, the use of textual data ~n chn~cal studies has been restricted because of ~ts unsuitability for statistical analys~s Instead, text on data forms was coded ~nto analyzable categoncal variables Regulatory

Abstracts 281

agencies require submission of all data collected, thus, researchers include both categorical variables and test ~n data bases. Th~s requires manual coding for data entry, ~t slows down the data entry process, and ~t makes updates to data, and changes to codes, more d~ff~cult Ra~ms~o et al (1989) described a system that hnks hteral text stored ~n chn~cal data bases w~th codes maintained m a separate data base The conversion from text to codes ~s done at the point of data extraction rather than at entry Modifications to codes require s~mple updates ~n the external data base rather than changes to every relevant record ~n the clinical data base Our research group has d~verse ~nterests- thrombos~s, oncology, rheumatology Staff are often reallocated to other projects A common automated coding system that operates across these d~verse areas has the potential for reducing the cost of staff tra~mng, coding, and data entry t~me and ~mprowng job satisfaction A SIR DBMS ~mplementat~on of a system for coding adverse expenences ~s described The centrally ma~ntained lookup table can be accessed by several chn~cal data bases The system automatically codes text which matches ~tems ~n the lookup table and flags those which are not found for subsequent manual ~ntervent~on A lookup table for terms common to all studies ~s used ~n conjunction w~th a study-specific table containing exceptions or unusual terms Coding practices remain consistent across studies Several coding dictionaries can be apphed to the same data

P-10 COMPUTER-ASSISTED ELECTRORETINOGRAM GRADING

Anik Ganguly, Jim Baliker, and George Bresnick Umverslty of W~scons~n

Madison, W~sconsln

Electroret~nograms (ERGs) are recordings of the electrical response of the retina to hght stimulus. The Central Vein Occlusion Study ~s, for the first t~me, using ERGs ~n a mult~center chmcal trial Each chn~cal center uses a standardized ERG testing protocol and the grad~ngs are done at the ERG reading center using standardized rules for placing cursors Two ~ndependent grad~ngs for each ERG are compared and adjudicated ~f the d~fference ~s over the hm~t

We have developed a networked, m~crocomputer-based system to support th~s task The system allows the grader to ~nteract w~th a dynamic graphical d~splay of ERG and accurately mark the points of ~nterest. The system automatically performs the measurements, and stores the data ~n the study database The system then compares the ~ndependent grad~ngs and requests adjudication of ERG's on which the ~n~t~al graders d~ffer

We have ~ncorporated tools hke smoothing, d~g~tal subtraction and power spectrum d~splay to help the graders make consistent decisions The grading software ~s ~ntegrated w~th the data-management system, eliminating manual data entry and streamlining the comphcated logistics of a duphcate grading and adlud~cat~on system

P-11 PROBLEMS DEVELOPING A DISEASE-SPECIFIC QUALITY

OF LIFE MEASURE FOR MULTIPLE SCLEROSIS (MS)

I. Brownscombe, A. Laupacis, and J. Noseworthy University of Western Ontano

London, Ontario, Canada

A d~sease-specJfic quahty of hfe questionnaire (QLQ) was developed because generic instruments do not focus adequately on ~tems ~mportant to patients w~th MS F~fty randomly selected MS patients from a geographically based population were asked to ~dent~fy and rank the importance of 155 ~tems that affected their health using a 6-point (0-5) scale There were methodological d~ff~culties m developing the QLQ. Visual and sexual dysfunction, reported by only 33% and 20% of subjects, respectively, y~elded the h~ghest mean ~mportance, 4.69 and 4 44 Patients w~th severe d~sease m~n~m~zed the ~mportance of some problems (3 wheelchair-bound patients considered ~nab~hty to walk of 0 ~mportance). Some constructs ~dentified by factor analys~s d~d not make chn~cal sense The QLQ, which ~s demonstrated, ~ncludes 25 ~tems d~wded ~nto 5 d~mens~ons fatigue/weakness, mob~hty, emotional upset, control, and a patient-specific d~mens~on, physical complaints Methods of determ~ning rehabfl~ty, longitudinal construct vahd~ty and responsiveness ~n a relapsing-remitting d~sease with no treatment to slow d~sease progression are presented.