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BMC Pediatrics

, 2:2

First Online: 27 February 2002Received: 10 December 2001Accepted: 27 February 2002


ObjectiveTo evaluate the quality of reports of complementary and alternative medicine CAM randomized controlled trials RCTs in the pediatric population. We also examined whether there was a change in the quality of reporting over time.

MethodsWe used a systematic sample of 251 reports of RCTs that used a CAM intervention. The quality of each report was assessed using the number of CONSORT checklist items included, the frequency of unclear allocation concealment, and a 5-point quality assessment instrument.

ResultsNearly half 40% of the CONSORT checklist items were included in the reports, with an increase in the number of items included. The majority 81.3% of RCTs reported unclear allocation concealment with no significant change over time. The quality of reports achieved approximately 40% of their maximum possible total score as assessed with the Jadad scale with no change over time. Information regarding adverse events was reported in less than one quarter of the RCTs 22% and information regarding costs was mentioned in only a minority of reports 4%.

ConclusionsRCTs are an important tool for evidence based health care decisions. If these studies are to be relevant in the evaluation of CAM interventions it is important that they are conducted and reported with the highest possible standards. There is a need to redouble efforts to ensure that children and their families are participating in RCTs that are conducted and reported with minimal bias. Such studies will increase their usefulness to a board spectrum of interested stakeholders.

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Autor: David Moher - Margaret Sampson - Kaitryn Campbell - William Beckner - Leah Lepage - Isabelle Gaboury - Brian Berman


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