The reporting quality of randomised controlled trials in surgery: A systematic review

作者: Riaz Agha , Derek Cooper , Gordon Muir

DOI: 10.1016/J.IJSU.2007.06.002

关键词:

摘要: Abstract Objectives In order to examine the reporting quality of urological RCTs, initial objectives this study were evaluate degree which RCTs involving surgical techniques (as intervention) published in years 2000–2003 complied with CONSORT statement, and assess trends patterns compliance. Following our findings urology, we extended methodology a number other specialties whether urology could be generalised disciplines. Methods The Royal Society Medicine (RSM) Library was commissioned search Medline Cochrane databases for compliance inclusion criteria below. Additional analyses five (non-urological trials: cardiovascular, gastrointestinal, hepatic, orthopaedic vascular) also made. For non-urological trials, 15 English language trials (from each specialty) randomly picked from blast conducted by RSM year 2003. given score out 22, reflecting how many 22 items (with item being equal weighting), termed "CONSORT score". Results Urology total 122 RCT abstracts identified met study. From these, 32 excluded as they follow-up studies, involved virtual procedure or cost analysis, leaving 90 across 35 different journals analysed (68.2%, 90/122). average 11.1 indicates that sample do not comply statement. No reported implemented their randomisation process. Only 46% stated had permission an ethics review board, 20% declared sources funding, 14% there any conflicts interest only 1.1% trial registry number. 11.2 obtained. Conclusion Clinical research teams conducting disciplines demonstrate poor We would recommend should registered at outset consider supporting statement have ‘hard-wired' into submission, editorial peer-review processes. Since it seems best researchers are unable produce results enable critically assessed, is need education about its importance all levels training. believe open debate needed on possible role designs, such tracker studies. Whether actually raises question appropriate techniques, leave reader.

参考文章(31)
Tom Schuller, The Future of Higher Education. SRHE and Open University Press, Celtic Court, 22 Ballmoor, Buckingham, England, United Kingdom MK18 1XW.. ,(1991)
David L. Sackett, Réal Préfontaine, The periodic health examination Canadian Medical Association Journal. ,vol. 122, pp. 748- 748 ,(1980)
Karin Huwiler-Müntener, Peter Jüni, Christoph Junker, Matthias Egger, Quality of reporting of randomized trials as a measure of methodologic quality. JAMA. ,vol. 287, pp. 2801- 2804 ,(2002) , 10.1001/JAMA.287.21.2801
KENNETH F. SCHULZ, Randomized controlled trials. Clinical Obstetrics and Gynecology. ,vol. 41, pp. 245- 256 ,(1998) , 10.1097/00003081-199806000-00005
Richard J Lilford, David A Braunholtz, Roger Greenhalgh, Sarah JL Edwards, Trials and fast changing technologies: the case for tracker studies BMJ. ,vol. 320, pp. 43- 46 ,(2000) , 10.1136/BMJ.320.7226.43
Stuart J. Pocock, Michael D. Hughes, Robert J. Lee, Statistical Problems in the Reporting of Clinical Trials New England Journal of Medicine. ,vol. 317, pp. 426- 432 ,(1987) , 10.1056/NEJM198708133170706
JOHN C. HALL, D. HILL, J. McK. Watts, Misuse of statistical methods in the Australasian surgical literature. Australian and New Zealand Journal of Surgery. ,vol. 52, pp. 541- 543 ,(1982) , 10.1111/J.1445-2197.1982.TB06050.X
Kenneth F Schulz, Iain Chalmers, Richard J Hayes, Douglas G Altman, Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials JAMA: The Journal of the American Medical Association. ,vol. 273, pp. 408- 412 ,(1995) , 10.1001/JAMA.273.5.408