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Reporting Of Noninferiority And Equivalence Randomized Trials: An Extension Of The CONSORT Statement.

G. Piaggio, D. Elbourne, D. Altman, S. Pocock, S. Evans
Published 2006 · Medicine

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The CONSORT (Consolidated Standards of Reporting Trials) Statement, including a checklist and a flow diagram, was developed to help authors improve their reporting of randomized controlled trials. Its primary focus was on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial designs. Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature. The quality of reporting of those that are published is often inadequate. In this article, we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.
This paper references
10.1001/ARCHSURG.136.7.796
Negative results of randomized clinical trials published in the surgical literature: equivalency or error?
J. Dimick (2001)
longed thromboprophylaxis with oral anticoagulants after total hip arthroplasty
P Prandoni (2000)
10.1016/s0140-6736(99)07403-6
Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial.
F. J. Van de Werf (1999)
10.1136/ebm.9.2.38
Superiority trials, non-inferiority trials, and prisoners of the 2-sided null hypothesis
D. Sackett (2004)
Points to Consider on the Choice of Noninferiority Margin
10.1002/SIM.1078
Use of the equivalence approach in reproductive health clinical trials.
G. Piaggio (2001)
10.1016/S0140-6736(02)11767-3
Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial
H. Hertzen (2002)
10.1016/S0140-6736(05)17906-9
Once versus three-times daily regimens of tobramycin treatment for pulmonary exacerbations of cystic fibrosis—the TOPIC study: a randomised controlled trial
A. Smyth (2005)
Harmonised Tripartite Guideline: Choice of Control Group and Related Issues in Clinical Trials (E10)
ICH Steering Committee (2006)
Note for Guidelines on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections. London
10.1002/9780471462422.eoct457
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
Ich Harmonised (2006)
10.1016/S0140-6736(02)12024-1
Ultrasonography in the diagnosis and management of developmental hip dysplasia (UK Hip Trial): clinical and economic results of a multicentre randomised controlled trial
D. Elbourne (2002)
10.1136/bmj.307.6912.1106
A randomised controlled trial to test equivalence between retinyl palmitate and beta carotene for vitamin A deficiency.
C. Carlier (1993)
10.1136/bmj.330.7488.385
Selective serotonin reuptake inhibitors (SSRIs) and suicide in adults: meta-analysis of drug company data from placebo controlled, randomised controlled trials submitted to the MHRA's safety review
D. Gunnell (2005)
Placebo mania. BMJ
KJ Rothman (1996)
10.1002/SIM.1425
Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics.
R. D'Agostino (2003)
Influence of galvanic phenomena on the occurrence of algic symptoms in the mouth.
H. Kučerová (2002)
10.7326/0003-4819-132-9-200005020-00006
Claims of Equivalence in Medical Research: Are They Supported by the Evidence?
W. L. Greene (2000)
10.1002/SIM.847
The effects of outcome misclassification and measurement error on the design and analysis of therapeutic equivalence trials.
M. Kim (2001)
10.1136/bmj.313.7048.36
Trials to assess equivalence: the importance of rigorous methods
B. Jones (1996)
10.1002/SIM.1934
A comparison of intent-to-treat and per-protocol results in antibiotic non-inferiority trials.
Erica Brittain (2005)
10.1001/ARCHINTE.1985.00360040141030
When was a "negative" clinical trial big enough? How many patients you needed depends on what you found.
A. Detsky (1985)
10.7326/0003-4819-141-10-200411160-00009
Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement
J. Ioannidis (2004)
CONSORT Group. Value of flow diagrams in reports of randomized controlled trials
M Egger (1999)
CONSORT Group. Use of the CONSORT statement and quality of reports of randomised trials: a comparative before-andafter evaluation
D Moher (1995)
10.1056/NEJM200103293441304
Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen.
F. Chan (2001)
10.1002/(SICI)1097-0258(19960830)15:16<1729::AID-SIM334>3.0.CO;2-M
An alternative to the use of two-sided tests in clinical trials.
C. Dunnett (1996)
Statistical Principles for Clinical Trials (E9)
ICH Steering Committee (2006)
10.7326/0003-4819-134-8-200104170-00012
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
D. Altman (2001)
10.1007/s00784-002-0188-x
The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
D. Moher (2003)
10.1056/NEJMOA032651
A comparison of laparoscopically assisted and open colectomy for colon cancer.
H. Nelson (2004)
10.1111/J.1600-0765.1992.TB01684.X
General design issues in efficacy, equivalency and superiority trials.
J. Fleiss (1992)
Safety and efficacy of vigabatrin and carbamazepine in newly diagnosed epilepsy : a multicentre randomised double - blind study
D Chadwick (1999)
10.1016/S0002-9343(01)00900-7
Active-control equivalence trials and antihypertensive agents.
F. McAlister (2001)
Vigabatrin European Monotherapy Study Group. Safety and efficacy of vigabatrin and carbamazepine in newly diagnosed epilepsy: a multicentre randomised double-blind study
D Chadwick (1999)
10.1002/SIM.1297
The European regulatory experience.
J. A. Lewis (2002)
10.1016/S0197-2456(02)00214-3
The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist.
P. Devereaux (2002)
10.1016/J.AHJ.2004.07.001
The Coronary Artery Revascularisation in Diabetes (CARDia) trial: background, aims, and design.
A. Kapur (2005)
10.1016/S0140-6736(00)04722-X
WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care
J. Villar (2001)
10.1016/S0140-6736(96)01201-9
Randomised trials, human nature, and reporting guidelines
K. Schulz (1996)
WHO mul - ticentre randomised trial of misoprostol in the management of the third stage of labour
AM Gülmezoglu (1999)
[Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization].
A. Albuquerque (2001)
10.1001/JAMA.285.15.1996
Value of flow diagrams in reports of randomized controlled trials.
M. Egger (2001)
10.1136/bmj.323.7303.42
Assessing the quality of controlled clinical trials
P. Jüni (2001)
10.1001/JAMA.285.15.1992
Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation.
D. Moher (2001)
Abacavirlamivudine-zidovudine vs indinavir-lamivudinezidovudine in antiretroviral-naı̈ve HIV-infected adults
S Staszewski (2001)
10.1001/JAMA.292.1.45
Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial.
J. Ferguson (2004)
10.1097/00006254-200103000-00010
Trial of Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of Human Immunodeficiency Virus Type 1
M. Lallemant (2001)
10.1197/J.AEM.2005.01.010
Advanced statistics: how to determine whether your intervention is different, at least as effective as, or equivalent: a basic introduction.
J. Tamayo-Sarver (2005)
The pros and cons of non-inferiority (equivalence) trials
S. Pocock (2002)
10.1198/tech.2003.s775
Testing Statistical Hypotheses of Equivalence
N. Lazar (2003)
10.1097/00006454-200208000-00011
Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children
D. Krysan (2002)
10.7326/0003-4819-105-3-445
Significance questing.
K. Rothman (1986)
ASSENT-2) Investigators. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial
(1999)
10.1016/S0002-9394(14)70422-2
Improving the quality of reporting of randomized controlled trials. The CONSORT statement.
C. Begg (1996)
10.1001/JAMA.1994.03520020048013
Statistical power, sample size, and their reporting in randomized controlled trials.
D. Moher (1994)
10.3171/JNS.2002.96.3.0527
Predictors of outcome in surgically managed patients with typical and atypical trigeminal neuralgia: comparison of results following microvascular decompression.
E. Tyler-Kabara (2002)
10.3310/HTA7010
How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study.
M. Egger (2003)
10.1002/SIM.1897
Design and analysis of non-inferiority mortality trials in oncology.
K. Carroll (2004)
Safety and efficacy of vigabatrin and carbamazepine in newly diagnosed epilepsy: a multicentre randomised double-blind study
(1999)
10.1136/bmj.325.7369.864
Oral pristinamycin versus standard penicillin regimen to treat erysipelas in adults: randomised, non-inferiority, open trial
P. Bernard (2002)
10.1136/bmj.328.7441.702
CONSORT statement: extension to cluster randomised trials
M. Campbell (2004)
10.1001/JAMA.289.7.853
Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial.
A. Lincoff (2003)
10.1016/S0140-6736(99)10327-1
Randomised trial of old and new antihypertensive drugs in elderly patients: cardiovascular mortality and morbidity the Swedish Trial in Old Patients with Hypertension-2 study
L. Hansson (1999)
10.1136/bmj.313.7048.3a
Placebo mania
K. Rothman (1996)
Abacavirlamivudine-zidovudine vs indinavir-lamivudinezidovudine in antiretroviral-naïve HIV-infected adults
S Staszewski (2001)
10.1016/S0197-2456(02)00232-5
The virtual colonoscopy study: a large multicenter clinical trial designed to compare two diagnostic screening procedures.
V. Durkalski (2002)
10.2307/2529457
Significance testing to establish equivalence between treatments, with special reference to data in the form of 2X2 tables.
C. Dunnett (1977)
10.1001/ARCHINTE.162.17.1966
Prolonged thromboprophylaxis with oral anticoagulants after total hip arthroplasty: a prospective controlled randomized study.
P. Prandoni (2002)
10.1002/9780470723586
Statistical Issues in Drug Development
S. Senn (1997)
WHO Collaborative Group to Evaluate Misoprostol in the Management of the Third Stage of Labour. WHO multicentre randomised trial of misoprostol in the management of the third stage of labour
AM Gülmezoglu (2001)
10.1016/S0197-2456(01)00196-9
Choosing an equivalence limit for noninferiority or equivalence studies.
B. Wiens (2002)
parison of two platelet glycoprotein IIb / IIIa inhibitors , tirobifan and abciximab , for the prevention of ischemic events with percutaneous coronary revascularization
EJ Topol (2001)
10.1056/NEJM200006293422619
The shocking tooth about trigeminal neuralgia.
W. Cheshire (2000)
10.1001/JAMA.285.9.1206
Scientific and ethical issues in equivalence trials.
B. Djulbegovic (2001)
10.1016/0197-2456(88)90101-8
Planning and monitoring of equivalence studies.
S. Durrleman (1990)
10.1016/J.CCT.2004.08.001
Negative results in cancer clinical trials--equivalence or poor accrual?
L. Costa (2004)



This paper is referenced by
10.3109/0284186X.2012.702924
Non-inferiority trials in breast and non-small cell lung cancer: Choice of non-inferiority margins and other statistical aspects
E. D. Saad (2012)
10.1097/EDE.0b013e3181577654
[The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies].
E. von Elm (2008)
10.14288/1.0379722
If journals embraced conditional equivalence testing, would research be better?
H. Campbell (2019)
10.1016/j.rgmx.2018.04.005
Helicobacter pylori eradication in Mexico with a levofloxacin-based scheme versus standard triple therapy: Results from an open-label, randomized, noninferiority phase iiib trial.
L. Ladrón-de-Guevara (2018)
10.1111/j.1610-0387.2007.06519_supp.x
Literaturbewertung mit Instrumenten der evidenzbasierten Medizin: eine Einführung anhand einer dermatologischen Therapiestudie
W. Boehncke (2007)
10.1161/CIRCULATIONAHA.111.026732
Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial.
S. Massberg (2011)
10.1089/tmj.2010.0007
Telepsychiatry assessments of child or adolescent behavior disorders: a review of evidence and issues.
J. Diamond (2010)
10.1016/j.jclinepi.2014.09.015
Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting.
O. Dekkers (2015)
10.3945/ajcn.114.085258
A systematic approach for establishing the range of recommended weight gain in pregnancy.
J. Hutcheon (2014)
10.1186/1471-2407-10-174
Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer
M. Kimman (2009)
10.1016/j.rmed.2011.08.008
Comparative effectiveness of radial probe endobronchial ultrasound versus CT-guided needle biopsy for evaluation of peripheral pulmonary lesions: a randomized pragmatic trial.
Daniel P Steinfort (2011)
10.3736/jintegrmed2013009
Extending the CONSORT Statement to moxibustion.
Chung-wah Cheng (2013)
10.1016/j.vaccine.2013.05.104
Intradermal fractional booster dose of inactivated poliomyelitis vaccine with a jet injector in healthy adults.
D. Soonawala (2013)
10.1007/s00192-010-1343-6
What patients think: patient-reported outcomes of retropubic versus trans-obturator mid-urethral slings for urodynamic stress incontinence—a multi-centre randomised controlled trial
R. Freeman (2010)
10.1111/j.1742-6723.2009.01183.x
Nebulized fentanyl versus intravenous morphine in children with suspected limb fractures in the emergency department: A randomized controlled trial
J. Furyk (2009)
10.24875/BMHIM.18000015
Early discharge of pediatric patients with cancer, fever, and neutropenia with low-risk of systemic infection.
M. Gil-Veloz (2018)
10.1213/ANE.0000000000004349
Comparison of Macintosh Laryngoscopy in Bed-up-Head–Elevated Position With GlideScope Laryngoscopy: A Randomized, Controlled, Noninferiority Trial
S. E. H. Tsan (2019)
10.1111/j.1600-6143.2008.02331.x
Design and Analysis of Clinical Trials in Transplantation: Principles and Pitfalls
J. Schold (2008)
10.1186/1471-2431-14-119
An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial
Alyssa C P Sawyer (2014)
10.1093/rheumatology/kes414
Ayurvedic medicine offers a good alternative to glucosamine and celecoxib in the treatment of symptomatic knee osteoarthritis: a randomized, double-blind, controlled equivalence drug trial.
A. Chopra (2013)
10.2196/jmir.1923
CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions
G. Eysenbach (2011)
10.1186/s13063-016-1434-x
A phase II trial comparing pazopanib with doxorubicin as first-line treatment in elderly patients with metastatic or advanced soft tissue sarcoma (EPAZ): study protocol for a randomized controlled trial
A. Karch (2016)
10.1371/journal.pone.0162679
Increasing Capacity for the Treatment of Common Musculoskeletal Problems: A Non-Inferiority RCT and Economic Analysis of Corticosteroid Injection for Shoulder Pain Comparing a Physiotherapist and Orthopaedic Surgeon
D. Marks (2016)
10.1186/1471-2288-6-46
Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance
J. Parienti (2006)
10.1186/s13063-020-04338-7
REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial
T. Kendrick (2020)
10.18725/OPARU-3424
Lungenfunktion nach offener Thorakotomie: Vergleich zwischen Interkostalblockade mit anschließender intravenöser Analgesie und Epiduralanästhesie - eine prospektive randomisierte klinische Studie
Eva Baltes (2014)
10.1542/peds.2011-2024
Breast Milk and Glucose for Pain Relief in Preterm Infants: A Noninferiority Randomized Controlled Trial
Mariana Bueno (2012)
10.3168/jds.2013-6713
Noninferiority trial comparing a first-generation cephalosporin with a third-generation cephalosporin in the treatment of nonsevere clinical mastitis in dairy cows.
Y. Schukken (2013)
10.1148/radiol.12120725
How to demonstrate similarity by using noninferiority and equivalence statistical testing in radiology research.
S. Ahn (2013)
10.1016/J.JHEP.2007.02.015
Methodology of superiority vs. equivalence trials and non-inferiority trials.
Erik Christensen (2007)
10.1016/S1470-2045(18)30566-7
Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials.
I. Vergote (2018)
10.1016/j.eururo.2018.06.026
Eighteen Months of Androgen Deprivation Therapy in Men with High-risk Prostate Cancer and the Risk of Death.
W. Xie (2018)
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