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CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting randomised pilot and feasibility trials conducted in advance of a future definitive randomised controlled trial.


CONSORT pilot and feasibility trials checklist (Word)

CONSORT pilot and feasibility trials flow diagram (Word)

CONSORT pilot and feasibility trials abstracts checklist (Word)

Full bibliographic reference 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.

This guideline was published simultaneously in 2 journals. You can read the guideline in either of these journals using the links below.

Pilot and Feasibility Studies. 2016;2:64. PMID: 27965879
BMJ. 2016;355:i5239. PMID: 27777223

Language English
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):726-32. PMID: 20335313
BMC Medicine. 2010;8:18. PMID: 20334633
BMJ. 2010;340:c332. PMID: 20332509
J Clin Epidemiol. 2010;63(8): 834-40. PMID: 20346629
Lancet. 2010;375(9721):1136 supplementary webappendix
Obstet Gynecol. 2010;115(5):1063-70. PMID: 20410783
Open Med. 2010;4(1):60-68.
PLoS Med. 2010;7(3): e1000251. PMID: 20352064
Trials. 2010;11:32. PMID: 20334632

CONSORT Non-inferiority:  Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): 2594-2604. PMID: 23268518

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):281-3. 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):814-22. 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

Stepped wedge cluster randomised trial: Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350:h391. PMID: 25662947

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-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

Study design Clinical trials, Experimental studies
Applies to the whole report or to individual sections of the report? Whole report
Additional information Read the reporting guideline development summary.

Read an article on the methods and processes for the development of this CONSORT extension for reporting pilot randomized controlled trials.

Read a related article in Nature Medicine.

Record last updated on August 1, 2017


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