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Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting of noninferiority and equivalence randomized trials

Please note that the CONSORT website is currently unavailable. To access the checklist via the original published paper please follow the PubMed link below in the PubMed ID field.

Full bibliographic reference Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594-2604.
Language English
PubMed ID 23268518
Relevant more generic / specialised reporting guidelines
(i.e. main generic guideline or extension to a generic guideline)
CONSORT 2010 Statement: Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials.
Ann Int Med. 2010;152(11):726-732. PMID: 20335313
BMC Medicine. 2010;8:18. PMID: 20334633
BMJ. 2010;340:c332. PMID: 20332509
J Clin Epidemiol. 2010;63(8):834-840. PMID: 20346629
Lancet. 2010;375(9721):1136. supplementary webappendix
Obstet Gynecol. 2010;115(5):1063-1070. PMID: 20410783
Open Med. 2010;4(1):60-68.
PLoS Med. 2010;7(3):e1000251. PMID: 20352064
Trials. 2010;11:32. PMID: 20334632

CONSORT Harms: Junqueira DR, Zorzela L, Golder S, Loke Y, Gagnier JJ, Julious SA, Li T, Mayo-Wilson E, Pham B, Phillips R, Santaguida P, Scherer RW, Gøtzsche PC, Moher D, Ioannidis JPA, Vohra S; CONSORT Harms Group. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials.
BMJ. 2023;381:e073725. PMID: 37094878
J Clin Epidemiol. 2023:S0895-4356(23)00090-2. PMID: 37100738

CONSORT Cluster:  Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661. PMID: 22951546

CONSORT Herbal:  Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, for the CONSORT Group. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT Statement. Ann Intern Med. 2006;144(5):364-367. PMID: 16520478

CONSORT Non-pharmacological treatment interventions: Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40-47. PMID: 28630973

CONSORT Abstracts:  Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008; 5(1):e20. PMID: 18215107

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, the CONSORT Group. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371(9609):281-283. PMID: 18221781

CONSORT Pragmatic Trials: Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. PMID: 19001484

STRICTA Controlled trials of acupuncture:  MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261. PMID: 20543992

CONSORT PRO: Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814-822. PMID: 23443445

CONSORT-CENT: Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D; CENT group. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement.BMJ. 2015;350:h1738.  PMID: 25976398

CONSORT for orthodontic trials: Pandis N, Fleming PS, Hopewell S, Altman DG. The CONSORT Statement: Application within and adaptations for orthodontic trials. Am J Orthod Dentofacial Orthop. 2015;147(6):663-679. PMID: 26038070

TIDieR: Hoffmann T, Glasziou P, Boutron I, Milne R, Perera R, Moher D, Altman D, Barbour V, Macdonald H, Johnston M, Lamb S, Dixon-Woods M, McCulloch P, Wyatt J, Chan A, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. PMID: 24609605

Simulation Research: Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, Duval-Arnould J, Lin Y, Cook DA, Pusic M, Hui J, Moher D, Egger M, Auerbach M; International Network for Simulation-based Pediatric Innovation, Research, and Education (INSPIRE) Reporting Guidelines Investigators. Reporting Guidelines for Health Care Simulation Research: Extensions to the CONSORT and STROBE Statements. Simul Healthc. 2016;11(4):238-248. PMID: 27465839

CONSORT for pilot and feasibility trials: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; on behalf of the PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot and Feasibility Stud. 2016;2:64. PMID: 27965879

CONSORT-CHM formulas: Cheng C-W, Wu T-X, Shang H-C, Li Y-P, Altman DG, Moher D, Bian Z-X; for the CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. 2017. Ann Intern Med. Link to full-text.

CONSORT for within person randomised trials: Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ. 2017;357:j2835. PMID: 28667088

CONSORT Equity: Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P; CONSORT-Equity and Boston Equity Symposium. CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. BMJ. 2017;359:j5085. PMID: 29170161

CONSORT-SPI: Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, Moher D; on behalf of the CONSORT-SPI Group. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. Trials. 2018;19:407. PMID: 30060754

Stepped wedge cluster randomised trials: Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. PMID: 30413417

CONSORT for multi-arm parallel-group randomised trials: Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019;321(16):1610-1620. PMID: 31012939

CONSORT 2010 extension to randomised crossover trials: Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019;366:l4378. PMID: 31366597

CENT for TCM: Li J, Hu JY, Zhai JB, Niu JQ, Kwong JSW, Ge L, Li B, Wang Q, Wang XQ, Wei D, Tian JH, Ma B, Yang KH, Dai M, Tian GH, Shang HC; CENT for TCM Working Group. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): Recommendations, explanation and elaboration. Complement Ther Med. 2019;46:180-188. PMID: 31519276

STRICTOC: Zhang X, Tian R, Lam WC, Duan Y, Liu F, Zhao C, Wu T, Shang H, Tang X, Lyu A, Bian Z. Standards for reporting interventions in clinical trials of cupping (STRICTOC): extending the CONSORT statement. Chin Med. 2020;15:10. PMID: 32021646

ACE Statement: Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG; ACE Consensus Group. The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
BMJ. 2020;369:m115. PMID: 32554564
Trials. 2020;21(1):528. PMID: 32546273

CONSORT-AI: Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK; on behalf of the SPIRIT-AI and CONSORT-AI Working Group. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension.
BMJ 2020;370:m3164. PMID: 32909959
Nat Med. 2020:26(9):1364–1374. PMID: 32908283
Lancet Digital Health. 2020;2(10):e537-e548. PMID: 33328048

CONSORT-ROUTINE: Kwakkenbos L, Imran M, McCall SJ, McCord KA, Fröbert O, Hemkens LG, Zwarenstein M, Relton C, Rice DB, Langan SM, Benchimol EI, Thabane L, Campbell MK, Sampson M, Erlinge D, Verkooijen HM, Moher D, Boutron I, Ravaud P, Nicholl J, Uher R, Sauvé M, Fletcher J, Torgerson D, Gale C, Juszczak E, Thombs BD. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ. 2021;373:n857. PMID: 33926904

CONSORT-Outcomes: Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022;328(22):2252-2264. PMID: 36511921

CONSORT-DEFINE: Yap C, Solovyeva O, de Bono J, Rekowski J, Patel D, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Hopewell S, Ursino M, Rantell KR, Calvert M, Lee S, Kightley A, Ashby D, Chan AW, Garrett-Mayer E, Isaacs JD, Golub R, Kholmanskikh O, Richards D, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, Dimairo M, Weir CJ. Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance. BMJ. 2023;383:e076387. PMID: 37863501

CONSORT Factorial: Kahan BC, Hall SS, Beller EM, Birchenall M, Chan AW, Elbourne D, Little P, Fletcher J, Golub RM, Goulao B, Hopewell S, Islam N, Zwarenstein M, Juszczak E, Montgomery AA. Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2023;330(21):2106-2114. PMID: 38051324

Reporting guideline acronym CONSORT Non-inferiority
Study design Clinical trials, Experimental studies
Applies to the whole report or to individual sections of the report? Whole report
Previous versions of this guideline / Guideline history Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement replaces reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement published in 2006 (PMID: 16522836).

Record last updated on January 12, 2024


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