Some Methods to Maximize Extraction of Scientific Knowledge from Parallel Group Randomized Trials

Anders M. Galløe^*, Carsten T. Larsen

Department of Cardiology, Copenhagen University Hospital, Roskilde, Denmark.

DOI: 10.4236/wjcd.2015.51003                

Abstract

The amount of scientific knowledge from randomized parallel group trials have been improved by the CONSORT Guideline, but important intelligence with important clinical implications remains to be extracted. This may though be obtained if the conventional statistical significance testing is supplied by 1) Addition of an unbiased and reproducible quantification of the magnitude or size of the clinical significance/importance of a difference in treatment outcome; 2) Addition of a quantification of the credulity of statements on any possible effect size and finally; 3) Addition of a quantification of the risk of committing an error when the null hypothesis is either accepted or rejected. These matters are crucial to proper conversion of trial results into good usage in every-day clinical practice and may produce immediate therapeutic consequence in quite opposite direction to the usual ones. In our drug eluting stent trial “SORT OUT II”, the implementation of our suggestions would have led to immediate cessation of use of the paclitaxel-eluting stent, which the usual Consort like reporting did not lead to. Consequently harm to subsequent patients treated by this stent might have been avoided. Our suggestions are also useful in cancer treatment trials and in fact generally so in most randomized trial. Therefore increased scientific knowledge with immediate and potentially altered clinical consequence may be the result if hypothesis testing is made complete and the corresponding adjustments are added to the CONSORT Guideline—first of all— for the potential benefit of future patients.

Keywords

Parallel Group Randomized Trials

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	Moher, D., Hopewell, S., Schulz, K.F., et al. (2010) CONSORT 2010 Explanation and Elaboration: Updated Guidelines for Reporting Parallel Group Randomised Trials. British Medical Journal, 340, c869. http://dx.doi.org/10.1136/bmj.c869
[2]	Schulz, K.F., Altman, D.G. and Moher, D. (2010) CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. British Medical Journal, 340, c332. http://dx.doi.org/10.1136/bmj.c332
[3]	Moher, D., Schulz, K.F. and Altman, D.G. (2001) The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials. Journal of the American Medical Association, 285, 1987-1991. http://dx.doi.org/10.1001/jama.285.15.1987
[4]	Gliner, J.A., Leech, N.L. and Morgan, G.A. (2002) Problems with Null Hypothesis Testing (NHST): What Do the Textbooks Say? The Journal of Experimental Education, 71, 83-92. http://dx.doi.org/10.1080/00220970209602058
[5]	Galloe, A.M., Thuesen, L., Kelbaek, H., et al. (2008) Comparison of Paclitaxel- and Sirolimus-Eluting Stents in Everyday Clinical Practice: The SORT OUT II Randomized Trial. Journal of the American Medical Association, 299, 409-416. http://dx.doi.org/10.1001/jama.299.4.409
[6]	Bligaard, N., Thuesen, L., Saunamaki, K., et al. (2014) Similar Five-Year Outcome with Paclitaxel- and Sirolimus-Eluting Coronary Stents. Scandinavian Cardiovascular Journal, 48, 148-155. http://dx.doi.org/10.3109/14017431.2014.883461
[7]	Spiegel, M.R. (1980) Schaum’s Outline of Theory and Problems of Probability and Statistics. McGraw-Hill Book Company, New York.
[8]	Staguet, M.J., Rozenweig, M., Von Hoff, D.D., et al. (1979) The Delta and Epsilon Errors in Assessment of Cancer Clinical Trials. Cancer Treatment Reports, 63, 1917-1921.
[9]	Schomig, A., Dibra, A., Windecker, S., et al. (2007) A Meta Analysis of 16 Randomized Trials of Sirolimus-Eluting versus Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease. Journal of the American College of Cardiology, 50, 1173-1180. http://dx.doi.org/10.1016/j.jacc.2007.06.047