Results {Recruitment During the initial phase (the l2months originally planned for recruitment), 70 participants (61% of the goal) were recruited. The subsequent “extra effort” phase required employing additional efforts and another 6months to complete the recruitment of 114 patients. Figure 1 shows screening and recruitment of the PEDS-C patients compared to our goal. Initial recruitment focused on existing clinic patients. The principal investigators also sent out IRB-approved letters to
community physicians describing the study and encouraging referrals of patients and families that might be interested. Physician care, medication, laboratory evaluations, and supplies were provided free of charge. Other traditional resources for recruitment included the creation of a study Web site which families and referring physicians could access to gain more information about the trial. The study was also registered on the National Institute of Health (Web site at www.clinicaltn'als.gov). Our group of 11 pediatric hepatologists involved in the trial had originally estimated that we cared for approximately twice the number of children with CHC we needed to enroll in PEDS C. We therefore had not made special recruitment plans at the inception of the study.