ABSTRACT
The endpoint used for a phase 3 pneumococcal conjugate vaccine (PCV) trial in Bohol, Philippines was radiographic consolidation. Only one (Bohol Regional Hospital, BRH) of the four surveillance hospitals had a quality control/quality assurance program (QC/QA) prior to the trial. QC/QA was initiated in the three private hospitals. Radiologists from BRH evaluated radiographs from all hospitals based on recommended standards. Four thousand nine hundred and eighty nine films were analyzed. In 2000, the proportion of good quality films was 65% and 29% in BRH and private hospitals, respectively. By 2004, these increased to 92% and 79%, respectively. Poor film quality was commonly due to absence of collimation and poor contrast. The regular QC/QA implementation was necessary to improve film quality and was particularly important in our PCV trial that used X-ray proven consolidation as an endpoint.
