跳至主要内容

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

Read  full  paper  at:
http://www.scirp.org/journal/PaperInformation.aspx?PaperID=53462#.VMXpryzQrzE

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.
 
Cite this paper
Galløe, A. and Larsen, C. (2015) Some Methods to Maximize Extraction of Scientific Knowledge from Parallel Group Randomized Trials. World Journal of Cardiovascular Diseases, 5, 19-26. doi: 10.4236/wjcd.2015.51003.
 
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                                                              eww150126lx
标签：

评论

发表评论

此博客中的热门博文

Does Immigration Promote the Investment of the Monopolistic Firm?

In the present paper, we examine the effect of increasing uncertainty of immigrants’ growth on the optimal timing of investment of a firm that has a monopolistic power over the labor market. It is revealed that when the uncertainty of immigrants’ growth is more than a threshold level, increasing uncertainty of immigrants’ growth accelerates the optimal timing of firms’ investment and enhances the economic growth, even if the uncertainty of immigrants’ growth is formulated by the geometric Brownian motion, which is in sharp contrast to the standard result that an increase in the uncertainty postpones the optimal timing. With an increase in the immigrants over the past ten years, workforces in the host countries have been growing significantly to the extent that the immigrants represent 70% of the increase in the workforce in Europe, and 47% in the United States as OECD indicates. In the present paper, we attempted to investigate the effect of increased uncertainty caused by the growi...
发表评论
阅读全文

Education Policy Implementation: A Mechanism for Enhancing Primary Education Development in Zanzibar

Education is one of the fundamental rights of individuals; therefore, the government of a country needs to develop and strengthen educational policy and quality as well as to ensure that everyone has equal access to basic education. The improvement of access and quality of education in the world is becoming as an essential factor in development, whereas the basic education (primary school), is acknowledged as a foundation of the higher educational development for every country. To fulfill this goal, governments introduce several policies and procedures; however, it requires some reforms and participation from the politician, policymakers, and other stakeholders to re-examine educational policy so that it can lead to multiplication and betterment of the reforms. Educational reforms actually focus on accountability. A positive educational development and reform is very challenging and needs more effort and strategy on how to use and utilize the resources effectively as such it can achie...
发表评论
阅读全文