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Randomized Trials Lack Information to Assess Quality

Action needed to make authors aware of the need to improve reporting

THURSDAY, May 4 (HealthDay News) -- Most randomized controlled trials do not include information necessary to assess their quality based on criteria established a decade ago, according to an article in the May 3 issue of the Journal of the National Cancer Institute.

Thilo Kober, Ph.D., and colleagues at the University of Cologne in Germany, analyzed 242 published reports of randomized controlled trials on patients with Hodgkin lymphoma. The quality of the trials was assessed using a 14-item questionnaire based on the Consolidated Standards for Reporting Trials (CONSORT) checklist established in 1996. The studies occurred during two pre-CONSORT periods (1966-1988 and 1989-1995) and one post-CONSORT period (1996-2002).

During all three periods, only six of the 14 items were addressed in at least 75 percent of the studies. Less than 20 percent of the studies reported information necessary to evaluate the methodologic quality. Some information did improve with time, such as descriptions of statistical methods, methods of randomization and having performed intention-to-treat analysis.

"Reporting levels of CONSORT items in randomized controlled trials involving patients with Hodgkin lymphoma remain unsatisfactory," the authors conclude. "Further concerted action by journal editors, learned societies and medical schools is necessary to make authors even more aware of the need to improve the reporting of randomized controlled trials in medical journals to allow assessment of validity of published clinical research."

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