Some issues related to the reporting of statistics in clinical trials published in Indian medical journals: A survey

International Journal of Pharmacology

Volumn 6, Issue 4, 2010, Pages 484-489

  Jaykaran, J ^a   Yadav, P ^a   Chavda, N ^a   Kantharia, N D ^a  

^a GOVERNMENT MEDICAL COLLEGE   (India)

Author keywords

Baseline comparisons; Confidence interval; Inappropriate statistical tests; Intention to treat principle; Multiple endpoints; Sample size

Indexed keywords

ARTICLE; INDIA; MEDICAL LITERATURE; MEDICAL RESEARCH; PUBLICATION; QUALITY CONTROL; SAMPLE SIZE; STATISTICAL SIGNIFICANCE; STATISTICS; SYSTEMATIC ERROR;

EID: 77955612460     PISSN: 18117775     EISSN: 18125700     Source Type: Journal    
DOI: None     Document Type: Article

References (40)

1. Agha, R., D. Cooper and G. Muir, 2007. The reporting quality of randomized controlled trials in surgery: A systematic review. Int. J. Surg., 5: 413-422.
2. Altman, D.G., S.M. Gore, M.J. Gardner and S.J. Pocock, 1983. Statistical guidelines for contributors to medical journals. BMJ., 286: 1489-1493.
3. Altman, D.G. and C.J. Dore, 1990. Randomisation and baseline comparisons in clinical trials. Lancet, 335: 149-153.
4. Altman, D.G., 1991. Practical Statistics for Medical Research. Chapman and Hill, London.
5. Altman, D.G., 1998. Statistical reviewing for medical journals. Stat. Med., 17: 2661-2674.
6. Altman, D.G., K.F. Schulz and D. Moher, 2001. The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann. Int. Med., 134: 663-694.
7. Anttila, H., A. Malmivaara, R. Kunz, I. Utti-Ramo and M. Makela, 2006. Quality of reporting of randomized, controlled trials in cerebral palsy. Pediatrics, 117: 2222-2230.
8. Anturane Reinfarction Trial Research Group, 1978. Sulfinpyrazone in the prevention of cardiac death after myocardial infarction: The anturane reinfarction trial. New Engl. J. Med., 298: 289-295.
9. Anturane Reinfarction Trial Research Group, 1980. Sulfinpyrazone in the prevention of cardiac death after myocardial infarction. New Engl. J. Med., 302: 250-256.
10. Bailar, J.C. and F. Mosteller, 1988. Guidelines for statistical reporting in articles for medical journals. Ann. Intern. Med., 108: 266-273.
11. Cleophas, T J. and A.H. Zwinderman, 2006. Clinical trials are often false positive: A review of simple methods to control this problem. Curr. Clin. Pharmacol., 1: 1-4.
12. Gagnier, J.J., J. DeMelo, H. Boon and P. Rochon, 2006. Bombardier C. Quality of reporting of randomized controlled trials of herbal medicine interventions. Am. J. Med., 119: 800-811.
13. Gardner, M.J. and D. Altman, 1986. Confidence intervals rather than P values: Estimation rather than hypothesis testing. BMJ., 292: 746-750.
14. Goodman, N.W. and A.O. Hughes, 1992. Statistical awareness of research workers inbritish anaesthesia. Br. J. Anaesth., 68: 321-324.
15. Gore, S.M., G. Jones, S.G. Thompson, 1992. The Lancet's statistical review process: Areas for improvement by authors. Lancet, 340: 100-102.
16. Halpern, S.D., J.H. Karlawish and J.A. Berlin, 2002. The continuing unethical conduct of underpowered clinical trials. JAMA., 288: 358-362.
17. Hopewell, S., S. Dutton, L.M. Yu, A.W. Chan and D.G. Altman, 2010. The quality of reports of randomized trials in 2000 and 2006: Comparative study of articles indexed in PubMed. BMJ., 340: c723-c723.
18. Jaykaran, P. Yadav, P. Bhardwaj and J. Goyal, 2009. Problems in reporting of statistics: comparison between journal related to basic science with journal related to clinical practice. Internet J. Epidemiol., Vol. 7(1). http://www.ispub.com/journal/the_internet_journal_of_epidemiology/volume_7_number_l_24/article/problems-in-reporting-of-statistics-comparison-between-journal-related-to-basic-science-with-journal-related-to-clinical-practice.html
19. Jaykaran, M. Saurabh, P. Yadav, N. Chavda and P. Mody, 2010a. False positive clinical trials published in four Indian medical journals: A survey. J. Pharm. Res., 3: 822-823.
20. Jaykaran, M.K. Saurabh, S. Gohiya, V. Gohiya, G. Sharma and N. Chavda, 2010b. Reporting of power, sample size and confidence interval in negative clinical trials published in four Indian medical journals. J. Pharmacy Res., 3: 298-300.
21. Jaykaran, S. Gohiya,V. Gohiya, G. Sharma, M.K. Saurabh and P. Yadav, 2010c. Reporting of the methodological quality and ethical aspects in clinical trials published in Indian Journals: A survey. J. Pharm. Res., 3: 307-309.
22. Karan, J., N.D. Kantharia, P. Yadav and P. Bhardwaj, 2010. Reporting statistics in clinical trials published in Indian Journals: A survey. Pak. J. Med. Sci., 26: 212-216.
23. Lai, T.Y., V.W. Wong, R.F. Lam, A.C. Cheng, D.S. Lam and G.M. Leung, 2007. Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals. Ophthalmic Epidemiol., 14: 390-398.
24. Lang, T., 2004. Twenty statistical errors even you can find in biomedical research articles. Croat. Med. J., 45: 361-370.
25. May, G.S., D.L. DeMets and L.M. Friedman, 1981. The randomized clinical trial: Bias in analysis. Circulation, 64: 669-673.
26. McGuigan, S.M., 1995. The use of statistics in the British Journal of Psychiatry. Br. J. Psychol., 167: 683-688.
27. Mills, E. J., P. Wu, J. Gagnier and P.J. Devereaux, 2005. The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp. Clin. Trials, 26: 480-487.
28. Moreira, E.D., Z. Stein andE. Susser, 2001. Reporting on methods of subgroup analysis in clinical trials: A survey of four scientific journals. Brazilian J. Med. Biol. Res., 34: 1441-1446.
29. Murray, G.D., 1991. Statistical guidelines for the British Journal of Surgeiy. Br. J. Surg., 78: 782-784.
30. Nagele, P., 2003. Misuse of standard error of the mean (SEM) when reporting variability of a sample. A critical evaluation of four anaesthesia journals. Br. J. Anaesth., 90: 514-516.
31. Neuhauser, M., 2006. How to deal with multiple endpoints in clinical trials. Fundamental Clin. Pharmacol., 20: 515-523.
32. Pienaar, E.D., J. Volmink, M. Zwarenstein and G.H. Swingler, 2002. Randomised trials in the South African Medical Journal, 1948-1997. South Afr. Med. J., 92: 901-903.
33. Rios, L.P., A. Odueyungbo, M.O. Moitri, M.O. Rahman and L. Thabane, 2008. Quality of reporting of randomized controlled trials in general endocrinology literature. J. Clin. Endocrinol. Metab., 93: 3810-3816.
34. Saurabh, M.K. Jaykaran, N. Chavda, P. Yadav, N.D. Kantharia and L. Kumar, 2010a. Misuse of standard error of mean (SEM) when reporting variability of a sample: A critical appraisal of four Indian journals. J. Pharm. Res., 3: 277-279.
35. Saurabh, M.K., Jaykaran, P. Yadav, N. Chavda, R.V. Lokesh, S. Deodhare andM. Chaudhari, 2010b. Reporting of missing data in clinical trials published in four Indian journals: A survey. J. Pharm. Res., 3: 277-279.
36. Scales, Jr. C.D., R.D. Norris, G.M. Preminger, J. Vieweg, B.L. Peterson and P. Dahm, 2008. Evaluating the evidence: Statistical methods in randomized controlled trials in the urological literature. J. Urol., 180: 1463-1467.
37. Strasak, A.M., Q. Zaman, P.P. Karl, G. Göbel and H. Ulmer 2007. Statistical errors in medical research-a review of common pitfalls. Swiss MED Wkly., 137: 44-49.
38. Tyson, H., 2004. Ten categories of statistical errors: A guide for research in endocrinology and metabolism. Am. Physio. Endocrinol. Metab., 286: 495-501.
39. Wang, G., B. Mao, Z.Y. Xiong, T. Fan and X.D. Chen et al., 2007a. The quality of reporting of randomized controlled trials of traditional Chinese medicine: A survey of 13 randomly selected journals from mainland China. Clin. Ther., 29: 1456-1467.
40. Wang, R., S.W. Lagakos, J.H. Ware, D.J. Hunter and J.M. Drazen, 2007b. Statistics in medicine-reporting of subgroup analyses in clinical trials. N. Engl. J. Med., 21: 2189-2194.