Background: Careful design, conduct and analysis of a randomized
controlled trial minimizes bias so that any differences observed between
participants may, apart from random error, be attributed to the intervention.
The assessment of methodological quality of trials is intertwined with
the quality of reporting; inadequate reporting may reflect inadequate
methods but a well-conducted trial may just be badly reported or a biased
trial may be well reported. Recent guidelines on the reporting of trials
(CONSORT - Consolidated Standards of Reporting Trials) may have
improved quality. Objectives: To assess the methodological quality of
reporting of randomized trials in Iranian dental journals. Methods: Five
Iranian dental journals will be handsearched for reports of randomized
trials (RCTs) according to Cochrane criteria. The methodological quality of
the trials will be assessed for: randomized generation and concealment
of treatment allocation, blinding of outcome assessment and handling of
withdrawals. Where any of these dimensions are deemed ‘unclear’, we
intend to contact the trialists for clarification. The CONSORT checklist
(http://www.consort-statement.org/newene.htm#checklist) will be used to
determine the overall quality of reporting of these trials. Results: As of
March 2008, the initial pilot phase of this project has yielded results from
quality assessing 22 RCTs found by handsearching the Archives of Beheshti
University Dental Journal (2000 to January 2004). The randomization
method was either clearly described (ie in 4/22 studies), or ‘unclear’ (i.e., in
18/22). Only one study reported concealment of allocation. Blinding was
reported in 9/22 studies. In 9/22 studies patient withdrawals were
reported, but no appropriate ways described to handle these. Conclusions:
We intend to complete the full results of the quality assessment of
reports of randomized trials identified by handsearching Iranian dental
journals by October 2008.