268 Abstracts

Issues ~n measunng the quahty of hfe of these patients ~nclude total number of assessments required, frequency of assessments, precise t~m~ng of assessments; maintaining comphance over a 20-week period, and the generahzabfl~ty of results Issues m operating as an ~ndependent ancillary study include consolidating the recruitment procedure, m~n~m~zmg the burden of s~multaneous participation ~n two studies, and communication procedures

Th~s paper describes the approaches taken to address the quahty-of-hfe measurement ~ssues and the ~mphcat~ons of operating as an ancillary study w~thm the framework of a larger thai

37 COST AND QUALITY OF LIFE OUTCOMES IN THE TAMI 5 TRIAL:

THE PRIMACY OF SECONDARY ENDPOINTS

James Melton, Lynn Harrelson-Woodlief, Hyla Cohen, Mark Hlatky, Joseph Lipscomb, Robert Califf, and

Daniel Mark Duke Umverslty Medical Center

Durham, North Carohna

The TAMI 5 study ~s a randomized thai of s~x d~fferent treatment strategies for acute myocardial ~nfarct~on three thrombolyt~c therapy regimens and two cardiac catheterization strategies F~ve hundred seventy five patients (patients) were entered ~n a factonal design. Each patient received a basehne and 6-month quahty-of- hfe (QOL) assessment ~nclud~ng general well-be~ng, functional, employment and psychological status Detaded hospital charges were collected on each patient from the 7 ma~n TAMI hospitals and the 25 satelhte hospitals Charges were converted to costs using Medicare cost-to-charge ratios Two approaches to cost effecWeness analys~s are being used A d~saggregated ("Consumer Reports") approach, and an aggregated quahty- adjusted hfe year approach

We d~scuss the role and ~mportance of cost and QOL endpo~nts ~n trials where primary endpo~nts, such as left ventncular function, ~ncreas~ngly show no treatment d~fferences

38 DESIGN OF AN RCT OF PREVENTION OF NON-A NON-B

POSTTRANSFUSION HEPATITIS WHEN INCIDENCE IS DECREASING

Shelley Bull, Mo Blajachman, and Victor Feinman Umverstty of Toronto

Toronto, Canada

Several factors have comphcated the design of a mult~center RCT planned to evaluate the efficacy of screening and w~thhold~ng donor blood w~th elevated levels of two surrogate markers These ~nclude (1) secular trend toward a reduction ~n the proportion of donor blood w~th elevated markers, (2) reduction ~n the number of patients rece~wng blood transfusions, (3) trend toward a reduction m the ~nc~dence of post- transfusion hepatitis ~n blood recipients, and (4) the ~ntroduct~on ~nto practice of a new wrus-spec~fic test for non-A, non-B hepatitis

Th~s article reviews the ~mpact of these trends on the sample s~ze requirements for the thai by companng the original sample size calculations w~th those based on more recent trends. Sample s~ze methods for a series of 2-by-2 tables w~th stratification by center and by t~me are used to ~ncorporate the secular changes and to investigate the sensitivity to assumptions about variation ~n incidence rates and about homogeneity of the effects of the ~ntervent~on Imphcat~ons for the t~m~ng of an ~ntenm analys~s are also considered.