Tozzi A E, Cofi Degli Atti M L, Panei P, Anemona A, Binkin N, Salmaso S, Luzi S, Greco D
Istituto Superiore di Sanità, Laboratorio di Epidemiologia e Biostatistica, Roma, Italie.
Rev Epidemiol Sante Publique. 1996 Oct;44(5):387-93.
To estimate the expected accrual rate in a double blinded controlled randomized trial of the absolute clinical efficacy of three anti-pertussis vaccines in infants, we performed a series of surveys among mothers and physicians in the areas to be considered for participation in the trial. In this paper, we compared the predicted enrollment with the actual enrollment achieved at the end of the recruitment phase of the trial. The predicted enrollment rate was 27%, while the observed rate was 26%. Results from the feasibility study were highly predictive of actual enrollment rate. In the local health units (USL) where such assessments were carried out, the accrual rate, was higher than those not participating in the feasibility phase.
为了估算在一项关于三种抗百日咳疫苗对婴儿绝对临床疗效的双盲对照随机试验中的预期入组率，我们在计划纳入该试验的地区的母亲和医生中开展了一系列调查。在本文中，我们将预测入组人数与试验招募阶段结束时的实际入组人数进行了比较。预测入组率为27%，而观察到的入组率为26%。可行性研究的结果对实际入组率具有高度预测性。在进行了此类评估的当地卫生单位（USL）中，入组率高于未参与可行性阶段的单位。
