256 Abstracts

• 07 LOWoTECH PROFILE WITH INDIVIDUALIZED

OPTIONS FOR A MULTINATIONAL SCREENING TRIAL

Sophie Alexander and Pierre Buekens REVE Co//aborattve Group

Schoo/ of Pub/ic Hea/th Unwersff~ L~bre de Bruxe//es

Bruxe//es, Be/g~urn

W=th=n EC Research and Development programs, a European collaboraWe RCT evaluating repeat vaginal exam=nat=on ~n antenatal care for prevent=on of preterm labor is ~n progress (REVE) Implementation raised vanous problems related to general d~fferences between EC countries

1 Patterns of care d=ffered so fundamentally that, desp=te adequate translation, some ~tems on the data collection form were totally irrelevant ~n certain countries

2 Levels and systems for medical records ranged from complex computer systems to absence of hnkage between antenatal and dehvery care

3 Telephone services were unrehable llq certain countries 4. Though EC ensures funding for coord~nat=on, each country had to finance local projects REVE has

been run ~n some countries on no money at all, wh~le other countries have had satisfactory funding Solut=ons to th~s unhomogenous background were sought, taking =nto account the local s~tuat~on They

occurred at recruitment, random=zat=on, data collection and analys~s level Quahty of ~mplementat~on was assessed ~n terms of (1) comphance to protocol (quahty of contrast), (2) percentage ehg~ble, (3) regularity of feedback and necessity to repeat field ws=ts, and (4) quahty of data collect=on and random allocation

08 PRERANDOMIZATION DRUG WITHDRAWAL-YIELD

AND PROCESS: THE SHEP TRIAL

Jacqueline Smith, Jan Davey, Nora Cosgrove, Judy Jensen, and Deanne Unger for the

SHEP Cooperative Group Medical Research Institute of San Francisco

San Francisco, Cahforma

Over 40% of screenees for the Systohc Hypertension ~n the Elderly Program (SHEP) were on ant~hypertens~ve medication On-med screenees were ehg~ble for Drug Evaluation V~s~ts (DEV) ~f Initial Contact (IC) SBP was 130-219 mm Hg and DBP <_ 84 mm Hg Because of the lengthy process for obtaining consents for drug w~thdrawal and h~gh number of DEVs to reach off-med BP eligibility of SBP > 160 at Basehne Ws~t 1 (BV1), SHEP chmc coordinators conducted a study of on-med randomization y~eld and the DEV process ~tself

DEV data on 476 screenees from March to December 1985 was manually collected from 13 SHEP centers to evaluate whether on-med screenees w~th lower SBPs at IC y~elded enough randomized participants to justify the t~me and effort ~nvolved. On-med IC SBPs between 130 and 149 mm Hg were analyzed for y~eld as well as number of DEVs prior to BV1, number of days from IC to BV1 and number of days between drug w~thdrawal and BV1 Type and dose of drug(s) w~thdrawn was also collected

Results showed a randomization y~eld of 34 6% for on-med screenees w~th SBPs < 150 mm Hg Th~s represented 11 4% of all randomizations at that point ~n recruitment The percent of on-med randomizations for each chmc varied from 5% to 33 3% Number of days from drug w~thdrawal to BV1 ranged from 0 to 183 w~th a mean of 28 days. It was concluded that the overall y~eld of 11 4% was a large enough contribution to warrant continuation of the DEV process despite the expense of t~me and effort ~nvolved These results prompted central collection of DEV data through end of recruitment (December 1986) and are ~ncluded ~n th~s presentation. Other ~mportant ~mphcat~ons about prerandom~zat~on drug w~thdrawal ws~ts such as protocol adherence, staffing, the need for clear w~thdrawal gu~dehnes, and withdrawing drugs ~n special populations such as the elderly are d~scussed