The risk of false-positive results in orthopaedic surgical trials - PubMed (original) (raw)
The risk of false-positive results in orthopaedic surgical trials
Mohit Bhandari et al. Clin Orthop Relat Res. 2003 Aug.
Abstract
The risk of concluding that the results of a particular study are true, when, in fact, they really are attributable to chance (or random sampling error) is underappreciated by investigators. This erroneous false-positive conclusion is designated as a Type I or alpha error. The extent to which randomized trials in surgery risk Type I errors is unclear. The current authors hand-searched four orthopaedic journals, six general surgery journals, and five medical journals to identify recently published randomized trials (within the past 2 years). Information on outcomes and statistical adjustment for multiple outcomes was recorded for each study. The risk of a Type I error was calculated for each study that did not explicitly state a primary outcome measure for the main statistical comparison. One hundred fifty-nine studies met the inclusion criteria for the study: 60 studies from orthopaedic journals, 49 studies from nonorthopaedic surgical journals, and 50 studies from medical journals. Of the trials that did not state a primary outcome measure, the risk of Type I errors (false-positive results) in orthopaedic and nonorthopaedic surgery journals (mean 37.3% +/- 13.3% and 37.6% +/- 10.5%, respectively) were significantly greater than medical journals (10.1% +/- 1.9%). In the current review of randomized trials in surgery and medicine, the following is reported: (1) reporting of primary outcomes in trials was inadequate; (2) one in three trials in surgery and one in 10 trials in medicine risked false-positive results; and (3) few trials in surgery and medicine considered adjustment for multiple comparisons.
Similar articles
- Do orthopaedic journals provide high-quality evidence for clinical practice?
Kiter E, Karatosun V, Günal I. Kiter E, et al. Arch Orthop Trauma Surg. 2003 Apr;123(2-3):82-5. doi: 10.1007/s00402-003-0501-4. Epub 2003 Mar 22. Arch Orthop Trauma Surg. 2003. PMID: 12721685 - Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?
Poolman RW, Struijs PA, Krips R, Sierevelt IN, Lutz KH, Bhandari M. Poolman RW, et al. BMC Med Res Methodol. 2006 Sep 11;6:44. doi: 10.1186/1471-2288-6-44. BMC Med Res Methodol. 2006. PMID: 16965628 Free PMC article. - The handsearching of 2 medical journals of Bahrain for reports of randomized controlled trials.
Al-Hajeri AA, Fedorowicz Z, Amin FA, Eisinga A. Al-Hajeri AA, et al. Saudi Med J. 2006 Apr;27(4):526-30. Saudi Med J. 2006. PMID: 16598332 - Overview of studies of treatments for hand eczema-the EDEN hand eczema survey.
Van Coevorden AM, Coenraads PJ, Svensson A, Bavinck JN, Diepgen TL, Naldi L, Elsner P, Williams HC; European Dermato-Epidemiology Network (Eden). Van Coevorden AM, et al. Br J Dermatol. 2004 Aug;151(2):446-51. doi: 10.1111/j.1365-2133.2004.06040.x. Br J Dermatol. 2004. PMID: 15327553 Review. - Survival end point reporting in randomized cancer clinical trials: a review of major journals.
Mathoulin-Pelissier S, Gourgou-Bourgade S, Bonnetain F, Kramar A. Mathoulin-Pelissier S, et al. J Clin Oncol. 2008 Aug 1;26(22):3721-6. doi: 10.1200/JCO.2007.14.1192. J Clin Oncol. 2008. PMID: 18669458 Review.
Cited by
- PHENOME-WIDE INTERACTION STUDY (PheWIS) IN AIDS CLINICAL TRIALS GROUP DATA (ACTG).
Verma SS, Frase AT, Verma A, Pendergrass SA, Mahony S, Haas DW, Ritchie MD. Verma SS, et al. Pac Symp Biocomput. 2016;21:57-68. Pac Symp Biocomput. 2016. PMID: 26776173 Free PMC article. - Statistical fallacies in orthopedic research.
Indrayan A. Indrayan A. Indian J Orthop. 2007 Jan;41(1):37-46. doi: 10.4103/0019-5413.30524. Indian J Orthop. 2007. PMID: 21124681 Free PMC article. - Outcome instruments: rationale for their use.
Poolman RW, Swiontkowski MF, Fairbank JC, Schemitsch EH, Sprague S, de Vet HC. Poolman RW, et al. J Bone Joint Surg Am. 2009 May;91 Suppl 3(Suppl 3):41-9. doi: 10.2106/JBJS.H.01551. J Bone Joint Surg Am. 2009. PMID: 19411499 Free PMC article. - Analysis of variance: is there a difference in means and what does it mean?
Kao LS, Green CE. Kao LS, et al. J Surg Res. 2008 Jan;144(1):158-70. doi: 10.1016/j.jss.2007.02.053. Epub 2007 Oct 22. J Surg Res. 2008. PMID: 17936790 Free PMC article.
MeSH terms
LinkOut - more resources
Full Text Sources
Miscellaneous