Are surgical trials with negative results being interpreted correctly?

Journal of the American College of Surgeons

Volumn 216, Issue 1, 2013, Pages 158-166

  Brody, Baruch A ^a,b   Ashton, Carol M ^c   Liu, Dandan ^a   Xiong, Youxin ^a   Yao, Xuan ^a   Wray, Nelda P ^c  

^a RICE UNIVERSITY   (United States)

^b Center for Ethics Medicine and Public Policy   (United States)

^c HOUSTON METHODIST RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; AUTHOR; CALCULATION; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; HUMAN; PRIORITY JOURNAL; REFERENCE DATABASE; STATISTICAL ANALYSIS; TREATMENT OUTCOME; VALIDITY;

CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); RESEARCH DESIGN; SURGICAL PROCEDURES, OPERATIVE;

EID: 84871186922     PISSN: 10727515     EISSN: 18791190     Source Type: Journal    
DOI: 10.1016/j.jamcollsurg.2012.09.015     Document Type: Article

References (25)

1. D.M. Wenner, B.A. Brody, and A.F. Jarman Do surgical trials meet the ethical and scientific standards for clinical trials? J Am Coll Surg 215 2012 722 730
2. C.M. Ashton, N.P. Wray, and A.F. Jarman Ethics and methods in surgical trials J Med Ethics 35 2009 579 583
3. C.M. Ashton, N.P. Wray, and A.F. Jarman A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions J Med Ethics 37 2011 368 373
4. Y.D. Xu, Y.K. Ou, and Y.Q. Zheng The treatment for postirradiation otitis media with effusion: a study of three methods Laryngoscope 118 2008 2040 2043
5. D.J. Murphy, M. Macleod, and R. Bahl A randomized controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicenter pilot study BJOG 115 2008 1695 1702
6. T.J. Meretoja, K.A. von Smitten, and H.O. Kuokkanen Complications of skin-sparing mastectomy followed by immediate breast reconstruction Ann Plast Surg 60 2008 24 28
7. K.S. Lee, M.S. Choo, and Y.S. Lee Prospective comparison of the 'inside-out' and 'outside-in' transobturator-tape procedures for the treatment of female stress urinary incontinence Int Urogynecol J Pelvic Floor Dysfunct 19 2008 577 584
8. J. Kempfert, U.T. Opfermann, and M. Richter Twelve-month patency with the PAS-Port proximal connector device: a single center prospective randomized trial Ann Thorac Surg 85 2008 1579 1584
9. B. Alvarez, M. Ribo, and J. Maeso Transcervical carotid stenting with flow reversal is safe in octogenarians: a preliminary safety study J Vasc Surg 47 2008 96 100
10. C. Pearce, C. Torres, and S. Stallings Elective appendectomy at the time of cesarean delivery: a randomized controlled trial AJOG 199 2008 491
11. D. Glineur, C. Hanet, and A. Poncelet Comparison of bilateral internal thoracic artery revascularization using in situ or Y graft configurations Circulation 118 14 Suppl 2008 S216 S221
12. M.D. Barber, S. Kleeman, and M.M. Karram Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence Obstet Gynecol 111 2008 611 621
13. K. Rinne, E. Laurikainen, and A. Kivelä A randomized trial comparing TVT with TVT-O: 12-month results Int Urogynecol J Pelvic Floor Dysfunct 19 2008 1049 1054
14. H. Kelbaek, C.J. Terkelsen, and S. Helgvist Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarcation (DEDICATION) trial J Am Coll Cardiol 51 2008 899 905
15. B.O. Jensen, L.S. Rasmussen, and D.A. Steinbrüchel Cognitive outcomes in elderly high-risk patients 1 year after off-pump versus on-pump coronary artery bypass grafting. A randomized trial Eur J Cardiothorac Surg 34 2008 1016 1021
16. K.L. Ang, D. Chin, and F. Leyva Randomized, controlled trial of intramuscular or intracoronary injection of autologous bone marrow cells into scarred myocardium during CABG versus CABG alone Nat Clin Pract Cardiovasc Med 5 2008 663 670
17. J.E. Barbato, E. Dillavou, and M.B. Horowitz A randomized trial of carotid artery stenting with and without cerebral protection J Vasc Surg 47 2008 760 765
18. M. Ferenc, M. Gick, and R. Kienzle Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions Eur Heart J 29 2008 2859 2867
19. J. Freiman, T.C. Chalmers, H. Smith Jr., and R.R. Kuebler The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial: survey of 71 "negative" trials N Engl J Med 299 1978 690 694
20. S. Halpern, J. Karlawish, and J. Berlin The continuing unethical conduct of underpowered clinical trials JAMA 288 2002 358 362
21. K.F. Schultz, and D.A. Grimes Sample size calculations in randomized trials Lancet 365 2005 1348 1353
22. J.B. Dimick, M. Diener-West, and P.A. Lipsett Negative results of randomized clinical trials literature: equivalency or error? Arch Surg 136 2001 796 800
23. M.A. Maggard, J.B. O'Connell, and J.H. Liu Sample size calculations in surgery: are they correctly performed? Surgery 134 2003 275 279
24. P.L. Bedard, M.K. Krzyzanowska, M. Pintilie, and I. Tannock Statistical power of negative randomized controlled trials presented at American Society for Clinical Oncology annual meetings J Clin Oncol 25 2007 3482 3487
25. M.P. Lecoutre, and J. Poitevineau Even statisticians are not immune to misinterpretations of null hypothesis significance tests Int J Psychology 38 2003 37 45