106s Abstracts

P58 RECRUITMENT SUCCESS BY TYPE OF SITE IN THE

ANTIHYPERTENSIVE AND LIPID LOWERING TREATMENT TO PREVENT HEART ATTACK TRIAL (ALLHAT) VANGUARD

Debra A. Egan, Sara Pressel and Barry Davis on Behalf of the ALLHAT Research Group Natinal Heart, Lung, and Blood Institute

Bethesda, h4arylmd

Traditional cIinicaI trials recruit primarily from academic centers. ALLHAT a large simple trial in patients 60 yrs and older with hypertension wiIl enroll 40,000 patients of which 55% wiII be African American (AA). 19 centers recruited 587 patients from a variety of settings ranging from office-based practices to university hospitals. We examined whether total number of patients recruited and in particular the percent of AA, varied according to type of site. Sites with less than 2 centers were not included in this analysis.

Site N sites % of goal %AA % Woman

VA 5 106 51 0

HMO 2 43 96 69

CHC 5 112 96 74

univ 4 57 69 62

Other 3 90 48 31

Overall, we achieved 98 % of our recruitment goal in the Vanguard phase and exceeded our goal for %AA by 15%. The top recruiter for number of patients and % AA was the Community Health Centers (CHC). The performance of each type of site was used as a guideline for additional site selection. Compliance to protocol by type of VANGUARD sites will also be discussed.

P59 INFORMED CONSENT VS. RANDOMIZED CONSENT: A

RANDOMIZED TRIAL WITH HEALTHY SUBJECTS

Ciro Gallo, Francesco Perrone, and Sabino DePlacido Universita Di Napoli

Naples, Italy

Randomized consent (RC) was proposed (Zelen, NEIJM 1979) to overcome problems Iinked to the informed consent (IC) for randomized cIinicaI trials. Recently the way as IC is applied by European oncologists has been criticized and a new debate is arising (Williams, EJk 1994). We invited healthy people visiting a scientific exhibition to simulate of being iII; 2,223 people aged 20 or more entered the trial and were assigned randomly to IC or RC; arms were well baIanced for age, sex and educational degree. Male sex, young age and high level school title were predominant. Subjects were given all commonly required information on the simulated disease and the hypothetical cIinicaI trial that they were invited to enter. Two different scenarios were simulated. In the first one, one-sided decision, surrogate patients refusing consent could only receive the best standard therapy and no consent was

Abstracts 107s

sought for standard therapy: 16.2% of subjects refused randomization after IC as compared with 12.1% of subjects who refused experimental treatment after RC (p = 0.0027). In the second scenario, two-sided decision, subjects refusing consent could choose the preferred treatment: refusal rates were 19.9 A after IC (70 1% preferring standard treatment and 12.8 % preferring experimental), 12.1% after RC to experimental therapy (preferring the standard one) and 49.2% after RC to standard therapy (preferring the experimental one) (p <O.OOOl). The perceived severity of the simulated disease affected the decision: the worse the prognosis the lower the refusal rate after IC or RC to experimental arm and the higher the refusal rate after RC to standard arm. In conclusion, RC is more efficient in one-sided decision. But, comparing “standard” with “experimental” treatment RC is less efficient than IC in two-sided decision. Other large-scale simulated trials are ongoing on relevant questions related to IC.

P60 PATIENT SATISFACTION WITH A DIETARY INTERVENTION:

THE MODIFICATION OF DIET IN RENAL DISEASE STUDY

Marian Olson, Terry Coyne, Arlene Caggiula, Patricia Gregory

University of Pittsburgh Pittsburgh, Pennsylvania

The MDRD Study assessed the acceptance of modified eating patterns in 840 participants who were randomized to either Usual Protein (UP) (1.3 gmlkglday) a Low Protein (LP) (0.60) or a Very Low Protein (VLP) (0.28) eating pattern based on their level of renal function. Adherence to protein goals was assessed using the average monthly urinary urea nitrogen excretion 24 hour urine samples. Dietary satisfaction was measured by questionnaire (DSQ) completed at baseline, at annual visits and at the 6naI visit. The DSQ gave participants an opportunity to summariz e their feelings about the modified eating pattern. Satisfaction was rated on a scale with 1 indicating a negative response (dislike extremely) and 5 representing a positive response (Iike very much). Satisfaction with the prescribed eating pattern changed Iiffle from baseline to the final visit in UP 3.7 & 1.1) to 3.8 & 1 .O) and LP groups 3.7 c+ 1 .O) to 3.6 b 1 .O) (p C .05) but decline in the VLP group 3.6 e 1 .O) to 3.1 & 0.9) (p < .Ol).

Satisfaction measured at the final visit was related to adherence to protein prescription in the LP and VLP groups. In the LP group, mean protein intake over follow-up was significantly lower (.72 gmlkglday) in participants who responded with positive ratings compared to those who were less satisfied (.79 gmlkglday) (p < .Ol). Greater decreases in protein intake from baseline were made in LP (-26% vs. -19 W) @ < .05) and VLP (-52% vs. -46 %) participants who Iiked the modified eating pattern compared to those who disliked it. We conclude that substantial changes (both increases and decreases) in dietary protein intake can be achieved with maintenance of dietary satisfaction.