PEDIATRICS Vol. 104 No. 4 October 1999, pp. 997
| The first 20% of the full text of this article appears below. |
To the Editor.
We wish to comment on the recently published
article1 that evaluates the impact of observer bias on the
estimate of clinical efficacy of one acellular pertussis vaccine. The
authors report that, in the Erlangen trial, the observed incidence in unblinded unvaccinated children (DT) was only 13%, compared with an
expected figure of approximately 40%. To determine potential observer
bias, the authors analyzed the trial physicians' cough referral rates
and used these rates to divide the physicians into three categories
indicating their compliance to the trial protocol, which required
referral of any cough lasting >7 days. Physicians who had reported an
at least 20% incidence of cough were classified as "highly
compliant." The authors then recalculated vaccine efficacy for each
compliance category and found that the estimated efficacy greatly
varied