Risk of bias assessment of clinical trials published in the Revista Colombiana de Anestesiología
Abstract
Introduction: Randomized clinical trials (RCT) are one of the most reliable methods of scientific investigation in health sciences. It is a corner stone of evidence based medicine and the backbone of high standard knowledge. Several types of errors can compromise the results and affect its validity.
Objectives: To assess the risk of bias of the clinical trials published in the Revista Colombiana de Anestesiología (RCA) medical journal by applying the «risk of bias detection» tool of the Cochrane Collaboration.
Methods: All the clinical trials in the RCA journal were found by carrying out a systematic research. These trials were randomly distributed among 6 evaluators trained in the use of the «risk of bias detection» tool of the Cochrane Collaboration. Results were presented descriptively, graphically and chronologically to each of the 6 parameters that conform the «risk of bias detection» tool.
Results: The RCA journal has published 40 volumes as of 1973. The searching process identified a total 75 RCT up until 2009. The frequency of RCT publication has risen with time. The cities with most publications were Bogotá DC and Medellín, and most trials were related to the management of acute and chronic pain. The greatest risk of bias (29% of all RCT) was found in the concealing of randomization sequences (parameter 2). 30% of the studies showed four or more parameter values of low risk of bias. A trend of decreasing proportion of high risk values was observed as time passed.
Conclusions: There is a sustained trend of improvement and risk reduction in RCTs' in the RCA journal.
References
2. Altman D. Better reporting of randomised controlled trials: the CONSORT statement. BMJ. 1996;313:570-1.
3. Glasziou P, Vandenbroucke J, Chalmers I. Assessing the quality of research. BMJ. 2004;328:39-41.
4. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [actualizado March 2011]. The Cochrane Collaboration; 2011. Disponible en: http://www.cochrane-handbook.org/
5. Chalmers T, Celano P, Sacks H, Smith HJ. Bias in treatment assignment in controlled clinical trials. N Engl J Med. 1983;309:1358-61.
6. Moher D, Pham B, Jones A, Cook D, Jadad A, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352:609-13.
7. Schulz K. Assessing allocation concealment and blinding in randomised controlled trials: why bother? Evid Based Nurs. 2001;4:4-6.
8. Schulz K, Chalmers I, Hayes R, Altman D. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408-12.
9. Jadad A, Moore R, Carroll D, Jenkinson C, Reynolds D, Gavaghan D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1-12.
10. Olivo S, Macedo L, Gadotti I, Fuentes J, Stanton T, Magee D. Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther. 2008;88:156-75.
11. Moher D, Jadad A, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials. 1995;16:62-73.
12. Chan A, Hróbjartsson A, Haahr M, G0tzsche P, Altman D. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457-65.
13. Higgins J, Altman D, Gotzsche P, Jüni P, Moher D, Oxman A, et al., The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;18:343.
14. Team RDC. R: A language and environment for statistical computing, reference index version 2.14.1. Vienna, Austria: R Foundation for Statistical Computing; 2005 [consultado 3 Feb 2011]. Disponible en: http://www.r-project.org
15. Rincoín-Valenzuela D. Jamais nos hemos resignado a ser simples artesanos de la Anestesia: pasado, presente y futuro de la Revista Colombiana de Anestesiologiia. Rev Colomb Anestesiol. 2012;40:6-7.
16. García-Alamino J, Parera A, Ollé G, Bonfill X. Características y calidad metodologica de los ensayos clínicos publicados en la Reuista Española de Anestesiología y Reanimación. Rev Esp Anestesiol Reanim. 2007;54:333-9.
17. Godlee F. Outcomes that matter to patients. BMJ. 2012;344:e318.
18. Yudkin J, Lipska K, Montori V. The idolatry of the surrogate. BMJ. 2011;343.
19. Liu Y, Yang S, Dai J, Xu Y, Zhang R, Jiang H, et al. Risk of bias tool in systematic reviews/meta-analyses of acupuncture in Chinese journals. PLoS One. 2011; 6:e28130.
20. Hartling L, Ospina M, Liang Y, Dryden D, Hooton N, Krebs Seida J, et al. Risk of bias versus quality assessment of randomised controlled trials: cross sectional study. BMJ.2009;339:b4012.
21. Armijo-Olivo S, Stiles C, Hagen N, Biondo P, Cummings G, Assessment of study quality for systematic reviews: a comparison of the Cochrane Collaboration Risk of Bias Tool and the Effective Public Health Practice Project Quality Assessment Tool: methodological research. J Eval Clin Pract. 2012;18:12-8.
22. Hartling L, Bond K, Vandermeer B, Seida J, Dryden D, Rowe B. Applying the risk of bias tool in a systematic review of combination long-acting beta-agonists and inhaled corticosteroids for persistent asthma. PLoS One. 2011;24:e17242.
23. Reyes G. Revista Colombiana de Anestesiologiia: auín en su volumen 40 sigue en busca de la excelencia como medio de la difusioin de nuestra produccioín cientiífica. Rev Colomb Anestesiol. 2012;40:4-5.
24. Miller D. Hacia una mayor transparencia y exactitud de los reportes cientiíficos en las revistas biomeidicas. Rev Colomb Anestesiol. 2012;40:1-3.
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