Article type
Year
Abstract
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 healthcare journals.
Methods: Four Iranian healthcare 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 intention-to-treat analysis. 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 2006, the initial pilot phase of this project has yielded results from quality assessing 20 RCTs found by handsearching the Archives of Iranian Medicine (1998-Jan 2006). The randomization method was 'unclear' in 16/20 studies, and 'inadequate' in 2/20, only two studies had an appropriate description of the randomization method. No study reported an appropriate concealment of allocation. Blinding was reported in 7/20 studies. In 10/20 studies patient withdrawals were reported, but no appropriate ways described to handle these. In none of the studies intention-to-treat analysis was reported.
Conclusions: Full results of the quality assessment of reports of randomized trials identified by handsearching Iranian healthcare journals will be completed by October 2006.
Objectives: To assess the methodological quality of reporting of randomized trials in Iranian healthcare journals.
Methods: Four Iranian healthcare 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 intention-to-treat analysis. 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 2006, the initial pilot phase of this project has yielded results from quality assessing 20 RCTs found by handsearching the Archives of Iranian Medicine (1998-Jan 2006). The randomization method was 'unclear' in 16/20 studies, and 'inadequate' in 2/20, only two studies had an appropriate description of the randomization method. No study reported an appropriate concealment of allocation. Blinding was reported in 7/20 studies. In 10/20 studies patient withdrawals were reported, but no appropriate ways described to handle these. In none of the studies intention-to-treat analysis was reported.
Conclusions: Full results of the quality assessment of reports of randomized trials identified by handsearching Iranian healthcare journals will be completed by October 2006.