Radiology quality assurance in a developing country setting: the 11-valent pneumococcal conjugate vaccine trial, Bohol, Philippines

Vaccine. 2007 Mar 22;25(13):2528-32. doi: 10.1016/j.vaccine.2006.09.030. Epub 2006 Sep 20.

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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Developing Countries
  • Humans
  • Philippines
  • Pneumococcal Vaccines / therapeutic use*
  • Pneumonia, Pneumococcal / diagnostic imaging*
  • Quality Assurance, Health Care / methods
  • Radiography
  • Radiology / methods
  • Radiology / standards*

Substances

  • Pneumococcal Vaccines