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

被引:38
作者
Moher D. [1 ,2 ]
Sampson M. [1 ]
Campbell K. [3 ]
Beckner W. [4 ]
Lepage L. [1 ]
Gaboury I. [1 ]
Berman B. [4 ]
机构
[1] T. C. Chalmers Ctr. for Sys. Reviews, Children's Hospital, Eastern Ontario Research Institute, Ottawa, Ont.
[2] Department of Pediatrics, University of Ottawa, Ottawa, Ont.
[3] Faculty of Information/Media Studies, University of Western Ontario, London, Ont.
[4] University of Maryland, Complementary Medicine Program, Bethesda, MD
关键词
Allocation Concealment; Consort Statement; Checklist Item; National Population Health Survey; Jadad Scale;
D O I
10.1186/1471-2431-2-2
中图分类号
学科分类号
摘要
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. © 2002 Moher et al; licensee BioMed Central Ltd.
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共 23 条
[1]  
Spigelblatt L., Laine-Ammara G., Pless I.B., Guyver A., The use of alternative medicine by children, Pediatrics, 94, pp. 811-814, (1994)
[2]  
Ramsay S., In whose best interest is government-run health care?, (1997)
[3]  
Millar W.J., Use of Alternative Health Care Practitioners by Canadians, Canadian Journal of Public Health, 88, pp. 154-158, (1997)
[4]  
Berger E., Berger Population Health Monitor 21, (2000)
[5]  
Eisenberg D.M., Kessler R.C., Foster C., Norlock F.E., Calkins D.R., Delbanco T.L., Unconventional medicine in the United States: Prevalence, costs and pattern use, N. Engl. J. Med., 328, pp. 246-252, (1993)
[6]  
Eisenberg D.M., Davis R.B., Ettner S.L., Appel S., Wilkey S., van Rompay M., Et al., Trends in alternative medicine use in the United States, 1990-1997: Results of a follow-up national survey, JAMA, 280, pp. 1569-1575, (1998)
[7]  
Schulz K.F., Chalmers I., Grimes D.A., Altman D.G., Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals, JAMA, 272, pp. 125-128, (1994)
[8]  
Schulz K.F., Chalmers I., Hayes R.J., Altman D.G., Empirical evidence of bias: Dimensions of methodological quality associated with estimates of treatment effects in controlled trials, JAMA, 273, pp. 408-412, (1995)
[9]  
Moher D., Pham B., Jones A., Cook D.J., Jadad A.R., Moher M., Et al., Does the quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?, Lancet, 352, pp. 609-613, (1998)
[10]  
Kjaergad L.L., Villumsen J., Gluud C., Reported methodological quality and discrepancies between large and smaller randomized trials, BMJ, (2001)