To identify the occurrence and determinants of protocol-publication discrepancies in clinical drug trials.
According to the objectives of the study, we will analyse three end points (table 1): non-publication, discrepancies between the protocol and the publication as a proxy for selective publication and the direction of publication conclusions.
To assess publication rates, factors predicting publication, and discrepancies between conference abstracts and subsequent full-text publications of abstracts from the veterinary meetings of the American College of Veterinary Anesthesiologists and the Association of Veterinary Anaesthetists from 2003 to 2008.
In a study examining transition of scientific meeting abstracts to full-length journal article, 41% of publications exhibited significant discrepancies when compared to the original abstract data [16].
Although only 10% of the publications had major discrepancy between trial registry and publication, smaller changes are frequently made to the final presentation of the data that are not reflected in the registry of the trial.
To what extent a complete disclosure statement, including not only all potential or actual conflicts of interest but also detailed information on individual contributions to the study and publication, will increase discrepancies between guidelines and practice remains to be seen.
Therefore, among the trials with a randomised design, we will also assess the direction of publication conclusions and investigate whether the direction of publication conclusions is associated with discrepancies between protocol and publication.
If there are discrepancies between publications about a data item, we will use the data presented in the main trial publication (the publication that includes the results for the primary outcome) or the first chronological publication reporting that data item.
Discrepancies between publications and protocols Both the publications and the protocols for 34 trials described a sample size calculation.
24 25262728293031323334353637383940414243 38 39 40 41 42 43 We excluded the study by Yang et al 42 43 because discrepancies between publications meant that data interpretation was impossible.
