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Reporting of radiographic methods in randomised controlled trials assessing structural outcomes in rheumatoid
Gabriel Baron1, Isabelle Boutron, Bruno Giraudeau
1Département d'Epidémiologie Biostatistique et Recherche Clinique, INSERM, U738, Groupe Hospitalier Bichat-Claude Bernard, 46 rue Henri Huchard, 75018 Paris, France. gabriel.baron@bch.aphp.fr
Background:
Because an increasing number of clinical trials evaluating disease-modifying antirheumatic drugs in rheumatoid arthritis (RA) emphasise radiographic outcomes as a primary outcome, using a reproducible radiographic measure should be placed at a premium.
Aim:
To evaluate the reporting of radiographic methods in randomised trials assessing radiographic outcomes in RA.
Methods:
Medline was searched for randomised controlled trials assessing radiographic outcomes published between January 1994 and December 2005 in general medical and specialty journals with a high impact factor. One reader extracted data (radiographic acquisition, assessment and reproducibility) using a standardised form.
Results:
A total of 46 reports were included in the analysis. The mean (SD) methodological quality scores on the Jadad scale (range 0-5) and the Delphi list (0-9) were 2.9 (1.2) and 6.4 (1.3), respectively. Use of a standardised procedure for the acquisition of the radiographs was reported in 2 (4.3%) articles. 2 (4.3%) reports indicated that the quality of the radiographs was evaluated. In 65.2% of the reports, > or = 2 radiographic scores were used. Reporting of radiographic assessment was well detailed for number of readers (91.3%), information on readers (71.7%), blinding (91.4%) and how films were viewed (74.0%). The reproducibility of the reading was reported in 39.1% of the articles.
Conclusion:
The reporting of results of randomised controlled trials of radiographic outcomes in RA shows great variability in radiographic scores used. Reporting of radiographic methods could be improved upon, especially the acquisition procedure and the reproducibility of the reading.
