Recruitment for a pediatric prevention trial

Craig, J. Hamilton, S.

Centre for Kidney Research, Royal Alexandra Hospital for Children, Westmead NSW, Australia

Background: The Prevention of Recurrent urinary tract Infection in children with Vesicoureteric reflux and Normal renal Tracts Trial (PRIVENT), is an NHMRC funded randomised trial that is designed to determine whether long-term antibiotics prevents urinary tract infection in children. Recruitment to PRIVENT has been difficult at times, a common problem among clinical trials, particularly prevention and placebo-controlled trials. After increasing the eligible pool and adding a second centre, the aim is to describe the effect of these changes on recruitment and consent rate. The recruitment target for PRIVENT is 16 patients per month, resulting in a total of 780 patients enrolled. In the first year of recruitment 17 eligible patients per month were referred with 3 per month enrolling, a consent rate of 18% (% enrolled/eligible).

Method: In January 2000 a research fellow was employed and the eligibility criteria was broadened. In September 2000 The Canberra Hospital joined PRIVENT. The effect of these changes have been measured using a before-after study design with the date of the change as the breakpoint, assuming no latency and tested using an unpaired t-test for differences in the mean monthly recruitment and consent rates.

Result: See table.

Table: Differences in the mean monthly recruitment and consent rates before and after Phase I and Phase II.

Conclusion: Broadening the eligibility criteria and including Canberra as another centre, resulted in an increase in both the number of patients enrolled and the consent rate.

Presented at the International Clinical Trials Symposium, Darling Harbour, Sydney NSW Australia 21-23 Oct 2002

Correspondence
Sana Hamilton
PRIVENT Trial Coordinator
Sanah@chw.edu.au