Do Equivalence Trials Display Superiority Over the Traditional Comparative Study Methods in Orthopedic Surgery?
Journal
Clinical spine surgery
ISSN: 2380-0194
Titre abrégé: Clin Spine Surg
Pays: United States
ID NLM: 101675083
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
pubmed:
19
3
2020
medline:
28
9
2021
entrez:
19
3
2020
Statut:
ppublish
Résumé
Superiority and equivalence trials are 2 commonly encountered methods of designing randomized controlled trials. Traditionally, the goal of a randomized controlled trial is to show superiority. However, in more recent times, there has been a tendency to show equivalence in clinical randomized trials. These differing conclusions at first glance seem to be drawn on the basis of the results of the respective trials. However, to accurately reach these conclusions, there are stark contrasts in the methodologies of these different study types. This article provides a brief overview of superiority and equivalence trials, highlights the differences between the 2, and their relevance to orthopedic surgery.
Identifiants
pubmed: 32187079
doi: 10.1097/BSD.0000000000000978
pii: 01933606-202006000-00005
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
201-204Références
Akobeng AK. Understanding randomised controlled trials. Arch Dis Child. 2005;90:840–844.
Christensen E. Methodology of superiority vs. equivalence trials and non-inferiority trials. J Hepatol. 2007;46:947–954.
Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66:150–154.
Jones B, Jarvis P, Lewis JA, et al. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36–39.
Dorey FJ. In brief: statistics in brief: confidence intervals: what is the real result in the target population? Clin Orthop Relat Res. 2010;468:3137–3138.
Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Ann Int Med. 2000;133:455–463.
Garrett AD. Therapeutic equivalence: fallacies and falsification. Stat Med. 2003;22:741–762.
Blackwelder WC. Proving the null hypothesis in clinical trials. Control Clin Trials. 1982;3:345–353.
Dimick JB, Diener-West M, Lipsett PA. Negative results of randomized clinical trials published in the surgical literature: equivalency or error? Arch Surg. 2001;36:796–800.
Greene CJ, Morland LA, Durkalski VL, et al. Noninferiority and equivalence designs: issues and implications for mental health research. J Trauma Stress. 2008;21:433–439.
Jung SH. Design of phase II non-inferiority trials. Contemp Clin Trials Commun. 2017;7:23–27.
Turan FN, Senocak M. Evaluating “superiority”, “equivalence” and “non-inferiority” in clinical trials. Ann Saudi Med. 2007;27:284–288.
Jacobs WCH, Kruyt MC, Verbout AJ, et al. Spine surgery research: on and beyond current strategies. Spine J. 2012;12:706–713.
Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J Gen Intern Med. 2011;26:192–196.
Hung HM, Wang SJ, O’Neill R. A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials. Biom J. 2005;47:28–36.
Hung HM, Wang SJ, O’Neill R. Challenges and regulatory experiences with non-inferiority trial design without placebo arm. Biom J. 2009;51:324–334.
Vavken P. Rationale for and methods of superiority, noninferiority, or equivalence designs in orthopaedic, controlled trials. Clin Orthop Relat Res. 2011;469:2645–2653.
Greene WL, Concato J, Feinstein AR. Claims of equivalence in medical research: are they supported by the evidence? Ann Intern Med. 2000;132:715–722.
Patchell RA, Tibbs PA, Regine WF, et al. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Lancet. 2005;366:643–648.
Bilsky MH, Laufer I, Burch S. Shifting paradigms in the treatment of metastatic spine disease. Spine. 2009;34:S101–S107.
Rose PS, Buchowski JM. Metastatic disease in the thoracic and lumbar spine: evaluation and management. J Am Acad Orthop Surg. 2011;19:37–48.
Makela KT, Eskelinen A, Pulkkinen P, et al. Total hip arthroplasty for primary osteoarthritis in patients fifty-five years of age or older: an analysis of the Finnish arthroplasty registry. J Bone Joint Surg Am. 2008;90:2160–2170.
Busija L, Osborne RH, Nilsdotter A, et al. Magnitude and meaningfulness of change in SF-36 scores in four types of orthopedic surgery. Health Qual Life Outcomes. 2008;6:55.
Vavken P, Heinrich KM, Koppelhuber C, et al. The use of confidence intervals in reporting orthopaedic research findings. Clin Orthop Relat Res. 2009;467:3334–3339.
Vavken P, Culen G, Dorotka R. Clinical applicability of evidence-based orthopedics--a cross-sectional study of the quality of orthopedic evidence. Z Orthop Unfall. 2008;146:21–25.
Poolman RW, Struijs PA, Krips R, et al. Does a “level I evidence” rating imply high quality of reporting in orthopaedic randomised controlled trials? BMC Med Res Methodol. 2006;6:44.
Yu CC, Kadri O, Kadado A, et al. Intravenous and oral tranexamic acid are equivalent at reducing blood loss in thoracolumbar spinal fusion: a prospective randomized trial. Spine. 2019;44:755–761.
Bailey CS, Urquhart JC, Dvorak MF, et al. Orthosis versus no orthosis for the treatment of thoracolumbar burst fractures without neurologic injury: a multicenter prospective randomized equivalence trial. Spine J. 2014;14:2557–2564.
Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63:e1–e37.
Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation—The Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006;296:2441–2450.
Rajasekaran S, Thomas A, Kanna RM, et al. Lumbar spinous process splitting decompression provides equivalent outcomes to conventional midline decompression in degenerative lumbar canal stenosis. Spine. 2013;38:1737–1743.
Cohen D. Out of joint: the story of the ASR. BMJ. 2011;342:d2905.
Muirhead-Allwood SK. Lessons of a hip failure. BMJ. 1998;316:644.