• Open Access

Quality of Reporting of Clinical Trials of Dogs and Cats and Associations with Treatment Effects

Authors


  • Preliminary results were presented at the Congress for Research Workers in Animal Diseases in December 2008 and at the 2009 ACVIM forum in June 2009.

Corresponding author: Jan M. Sargeant, Centre for Public Health and Zoonoses, Ontario Veterinary College, University of Guelph, 103 MacNabb House, Guelph, ON, Canada N1G 2W1; e-mail: sargeanj@uoguelph.ca.

Abstract

Background: To address concerns about the quality of reporting of randomized controlled trials, and the potential for biased treatment effects in poorly reported trials, medical journals have adopted a common set of reporting guidelines, the Consolidated Standards of Reporting Trials (CONSORT) statement, to improve the reporting of randomized controlled trials.

Hypothesis: The reporting of clinical trials involving dogs and cats might not be ideal, and this might be associated with biased treatment effects.

Animals: Dogs and cats used in 100 randomly selected reports of clinical trials.

Methods: Data related to methodological quality and completeness of reporting were extracted from each trial. Associations between reporting of trial features and the proportion of positive treatment effects within trials were evaluated by generalized linear models.

Results: There were substantive deficiencies in reporting of key trial features. An increased proportion of positive treatment effects within a trial was associated with not reporting: the method used to generate the random allocation sequence (P < .001), the use of double blinding (P < .001), the inclusion criteria for study subjects (P= .003), baseline differences between treatment groups (P= .006), the measurement used for all outcomes (P= .002), and possible study limitations (P= .03).

Conclusions and Clinical Importance: Many clinical trials involving dogs and cats in the literature do not report details related to methodological quality and aspects necessary to evaluate external validity. There is some evidence that these deficiencies are associated with treatment effects. There is a need to improve reporting of clinical trials, and guidelines, such as the CONSORT statement, can provide a valuable tool for meeting this need.

Ancillary