Purpose: To evaluate the quality of reporting of all the new randomized clinical trials published during 1999 in OPHTHALMOLOGY: using the CONSORT statement parameters.
Design: Descriptive series of published studies.
Studies included: Randomized clinical trials.
Methods: Eligible studies were all randomized clinical trials published in Volume 106 (1999) of OPHTHALMOLOGY: that reported the results of prospectively conducted studies in humans comparing two or more therapeutic options with regard to their effect on one or various outcomes, in which the authors stated that a process of randomization or quasi-randomization was performed before the interventions. Each study was evaluated by two independent observers establishing the specific report in the published manuscript of 57 CONSORT statement descriptors, and consensus was obtained between evaluators.
Main outcome measures: Overall presence of CONSORT statement descriptors in published reports.
Results: The mean number of positive CONSORT descriptors for the 24 eligible randomized clinical trials was 33.42 (standard error of the mean [SEM] 1.57) of 57 possible. This score was significantly different (P: < 0.001) from the score of 16.6 (standard error of the mean 0.6) reported for OPHTHALMOLOGY: in the 1991 to 1994 study by Scherer and Crawley. Of the nine descriptors measuring the quality of abstract reporting, a mean of 6.25 (SEM 0.3) was included in the 24 study abstracts evaluated, significantly different from the Scherer and Crawley score (5.2, SEM 0.2. P: < 0.001). Four and six descriptors increased and decreased, respectively, their reporting in more than 20%. Key descriptors such as hypothesis postulation, primary outcome determination, sample size calculations, and a discussion of the limitations of the study such as bias, imprecision, and internal validity are still reported in less than 42% of clinical trials.
Conclusions: This study describes for the first time after the adoption of the CONSORT statement recommendations the status on the quality of reporting of recently published randomized clinical trials in OPHTHALMOLOGY: Although not a direct measure of the intrinsic quality of a study, reporting quality provides the reader with useful tools for the evaluation of its validity. The quality of reporting of randomized clinical trials shows an overall improvement when compared with the period between 1991 and 1994. However, there is still significant room for improvement, especially in descriptors essential for the validation of clinical trial results that are still widely underreported.