Assessing the quality of reports of randomized trials in pediatric complementary and alternative medicine.
OBJECTIVE
To 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.


METHODS
We 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.


RESULTS
Nearly 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%).


CONCLUSIONS
RCTs 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.
Moher
David
D
Thomas C. Chalmers Centre for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, Canada. dmoher@uottawa.ca
Sampson
Margaret
M
Campbell
Kaitryn
K
Beckner
William
W
Lepage
Leah
L
Gaboury
Isabelle
I
Berman
Brian
B
D002170:Canada; D002648:Child; D000529:Complementary Therapies / Q000706:statistics & numerical data*; D006801:Humans; D016247:Information Storage and Retrieval / Q000379:methods; D010372:Pediatrics / Q000706:statistics & numerical data*; D011159:Population Surveillance; D016730:Program Development / Q000706:statistics & numerical data; D011785:Quality Assurance, Health Care / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000592:standards*