The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Journal
BMJ (Clinical research ed.)
ISSN: 1756-1833
Titre abrégé: BMJ
Pays: England
ID NLM: 8900488
Informations de publication
Date de publication:
17 06 2020
17 06 2020
Historique:
entrez:
20
6
2020
pubmed:
20
6
2020
medline:
9
7
2020
Statut:
epublish
Résumé
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.
Identifiants
pubmed: 32554564
doi: 10.1136/bmj.m115
pmc: PMC7298567
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
m115Subventions
Organisme : Medical Research Council
ID : MC_UU_00002/6
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/L004933/2
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/N028171/1
Pays : United Kingdom
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.
Références
Stat Med. 2015 Jul 20;34(16):2476-80
pubmed: 26040434
Stat Med. 2017 Apr 30;36(9):1506-1518
pubmed: 28183155
Stat Med. 2013 Oct 15;32(23):3991-4005
pubmed: 23686358
Stat Med. 2009 May 1;28(10):1445-63
pubmed: 19266565
Clin Trials. 2012 Dec;9(6):714-20
pubmed: 22879573
J Biopharm Stat. 2006 May;16(3):275-83; discussion 285-91, 293-8, 311-2
pubmed: 16724485
Clin Infect Dis. 2020 May 6;70(10):2062-2072
pubmed: 31425580
Ther Innov Regul Sci. 2020 Jan;54(1):42-54
pubmed: 32008237
J Clin Oncol. 2003 May 1;21(9):1722-7
pubmed: 12721247
Lancet. 2009 Sep 5;374(9692):786
pubmed: 19733780
BMJ Open. 2017 Feb 17;7(2):e013537
pubmed: 28213598
Lancet. 2008 Jan 26;371(9609):281-3
pubmed: 18221781
Int J Behav Nutr Phys Act. 2015 Jan 24;12:4
pubmed: 25616598
Trials. 2014 Oct 02;15:383
pubmed: 25278265
Stat Methods Med Res. 2016 Apr;25(2):716-27
pubmed: 23242385
Ther Innov Regul Sci. 2017 Jan;51(1):77-88
pubmed: 30235997
Biometrics. 1999 Sep;55(3):853-7
pubmed: 11315017
Clin Trials. 2016 Dec;13(6):621-631
pubmed: 27271682
Contemp Clin Trials. 2018 Apr;67:31-36
pubmed: 29427757
Stat Med. 2010 Jan 15;29(1):1-13
pubmed: 19844944
Clin Trials. 2010 Oct;7(5):546-56
pubmed: 20571131
Chin Clin Oncol. 2015 Sep;4(3):33
pubmed: 26408300
Stat Med. 2016 Feb 10;35(3):325-47
pubmed: 25778935
Biom J. 2006 Aug;48(4):537-55
pubmed: 16972704
Clin Pharmacol Ther. 2009 Jul;86(1):97-100
pubmed: 19440188
J Heart Lung Transplant. 2016 Apr;35(4):528-36
pubmed: 27044532
Pharm Stat. 2014 Jul-Aug;13(4):229-37
pubmed: 24891148
BMJ Open. 2013 Jun 20;3(6):
pubmed: 23794538
Lancet Oncol. 2012 May;13(5):549-58
pubmed: 22452894
Stat Med. 2005 Sep 30;24(18):2747-64
pubmed: 16134130
Med Decis Making. 2017 Nov;37(8):894-904
pubmed: 28622083
Ther Innov Regul Sci. 2016 Nov;50(6):710-717
pubmed: 30231747
Stat Med. 2005 Jun 30;24(12):1783-90
pubmed: 15900586
Stat Med. 1995 May 15-30;14(9-10):1039-51; discussion 1053-5
pubmed: 7569499
Biometrics. 1979 Dec;35(4):775-83
pubmed: 526523
N Engl J Med. 2015 Feb 19;372(8):735-46
pubmed: 25693013
J Multidiscip Healthc. 2018 Sep 27;11:495-510
pubmed: 30310289
Stat Med. 2017 Jan 15;36(1):5-19
pubmed: 27435045
Br J Cancer. 2015 Sep 1;113(5):699-705
pubmed: 26263479
Stat Med. 2001 Dec 30;20(24):3861-73
pubmed: 11782039
Pharm Stat. 2011 Jul-Aug;10(4):347-56
pubmed: 22328327
J Biopharm Stat. 2012;22(4):853-67
pubmed: 22651119
Ann Am Thorac Soc. 2018 Feb;15(2):250-257
pubmed: 29388815
Clin Epidemiol. 2018 Mar 23;10:343-351
pubmed: 29606891
JAMA Netw Open. 2018 Dec 7;1(8):e186076
pubmed: 30646314
BMC Cardiovasc Disord. 2018 Nov 27;18(1):215
pubmed: 30482176
Med J Aust. 2006 Sep 4;185(5):263-7
pubmed: 16948622
Pharm Stat. 2009 Jan-Mar;8(1):1-4
pubmed: 18642402
Trials. 2016 Mar 19;17(1):150
pubmed: 26993469
Pain. 2017 Sep;158(9):1802-1812
pubmed: 28746076
Clin Trials. 2015 Feb;12(1):84-90
pubmed: 25278227
Clin Trials. 2016 Oct;13(5):484-92
pubmed: 27365011
Pharm Stat. 2014 Jan-Feb;13(1):71-80
pubmed: 24038922
JAMA. 2004 Jan 21;291(3):309-16
pubmed: 14734593
HIV Clin Trials. 2013 Nov-Dec;14(6):261-73
pubmed: 24334179
Stat Med. 2011 Jun 15;30(13):1541-54
pubmed: 21432887
JAMA. 2017 Dec 19;318(23):2301-2303
pubmed: 29260205
Value Health. 2019 Apr;22(4):391-398
pubmed: 30975389
Clin Trials. 2018 Oct;15(5):444-451
pubmed: 30084662
Pulm Pharmacol Ther. 2010 Jun;23(3):165-71
pubmed: 20080201
Comput Stat Data Anal. 2017 Sep;113:136-153
pubmed: 28630525
Biometrics. 1999 Dec;55(4):1286-90
pubmed: 11315085
Stat Med. 2009 Apr 15;28(8):1181-217
pubmed: 19206095
Stat Med. 2017 Jul 30;36(17):2643-2655
pubmed: 28470713
Clin Trials. 2009 Apr;6(2):119-25
pubmed: 19342463
Biometrics. 1989 Mar;45(1):317-23
pubmed: 2720057
Drug Discov Today. 2004 Apr 15;9(8):351-7
pubmed: 15081962
J Am Coll Cardiol. 2015 Dec 29;66(25):2886-2898
pubmed: 26718676
Stat Med. 2005 Dec 30;24(24):3697-714
pubmed: 16320264
Contemp Clin Trials. 2017 Nov;62:114-120
pubmed: 28866294
Stat Med. 1988 Dec;7(12):1231-42
pubmed: 3231947
BMC Med Res Methodol. 2017 Jul 18;17(1):108
pubmed: 28720094
J Biopharm Stat. 2005;15(4):575-91
pubmed: 16022164
Pharm Stat. 2009 Jan-Mar;8(1):62-72
pubmed: 18381595
Control Clin Trials. 1989 Dec;10(4 Suppl):209S-221S
pubmed: 2605969
Ann Intern Med. 2004 Nov 16;141(10):781-8
pubmed: 15545678
J Diabetes Sci Technol. 2012 Nov 01;6(6):1305-18
pubmed: 23294775
BMJ. 2011 Sep 26;343:d5886
pubmed: 21948873
Clin Trials. 2011 Apr;8(2):165-74
pubmed: 21478328
Ther Innov Regul Sci. 2016 Mar;50(2):195-203
pubmed: 30227002
Diabetes Obes Metab. 2011 May;13(5):426-33
pubmed: 21251178
J Trauma Acute Care Surg. 2017 Oct;83(4):736-741
pubmed: 28930965
JAMA. 2010 Mar 24;303(12):1180-7
pubmed: 20332404
Stat Med. 2014 Aug 30;33(19):3269-79
pubmed: 24825588
J Diabetes Sci Technol. 2012 Nov 01;6(6):1319-27
pubmed: 23294776
BMJ. 2018 Mar 8;360:k698
pubmed: 29519932
Stat Methods Med Res. 2017 Feb;26(1):508-524
pubmed: 25228636
Stat Med. 2012 Dec 30;31(30):4269-79
pubmed: 22826199
Expert Opin Drug Saf. 2010 Mar;9(2):289-300
pubmed: 20175698
J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1125-32
pubmed: 22791906
Stat Med. 2018 Dec 20;37(29):4335-4352
pubmed: 30088280
N Engl J Med. 1998 Dec 31;339(27):1979-84
pubmed: 9869669
PLoS One. 2016 Feb 24;11(2):e0149803
pubmed: 26910238
Trials. 2018 Nov 20;19(1):642
pubmed: 30454061
Stat Med. 1990 Dec;9(12):1439-45
pubmed: 2281231
J Biopharm Stat. 2014;24(5):976-93
pubmed: 24933121
Am Heart J. 2012 Dec;164(6):817-24.e13
pubmed: 23194481
Contemp Clin Trials. 2015 Jan;40:15-25
pubmed: 25460340
Clin Trials. 2009 Dec;6(6):565-73
pubmed: 19933716
Biom J. 2006 Aug;48(4):493-506
pubmed: 16972701
Biometrics. 1994 Dec;50(4):1029-41
pubmed: 7786985
Stat Med. 1999 Jul 30;18(14):1833-48
pubmed: 10407255
Clin Res Regul Aff. 2015 Oct 2;32(4):121-130
pubmed: 26622163
BMJ. 2010 Mar 23;340:c869
pubmed: 20332511
Trials. 2019 Feb 14;20(1):118
pubmed: 30760329
JAMA. 2012 Feb 15;307(7):674-84
pubmed: 22337679
Contemp Clin Trials. 2013 Nov;36(2):673-81
pubmed: 24076485
Stat Med. 2019 Jun 30;38(14):2524-2543
pubmed: 30887553
Pharm Stat. 2017 Jan;16(1):64-86
pubmed: 27730735
JAMA. 2013 Sep 18;310(11):1145-55
pubmed: 23995608
J Biopharm Stat. 2010 Nov;20(6):1090-7
pubmed: 21058104
Clin Trials. 2015 Dec;12(6):584-95
pubmed: 26195615
Stat Med. 2011 Dec 10;30(28):3267-84
pubmed: 22105690
Transl Psychiatry. 2017 Sep 12;7(9):e1232
pubmed: 28895941
Biometrics. 2009 Jun;65(2):539-46
pubmed: 18759843
Stat Med. 2006 Jan 15;25(1):23-36
pubmed: 16220517
PLoS Med. 2010 Feb 16;7(2):e1000217
pubmed: 20169112
Stat Methods Med Res. 2017 Jun;26(3):1078-1092
pubmed: 25586325
J Clin Pharm Ther. 2018 Feb;43(1):36-44
pubmed: 28749016
J Natl Cancer Inst. 2008 Sep 3;100(17):1204-14
pubmed: 18728279
BMJ. 2012 Sep 04;345:e5661
pubmed: 22951546
Clin Trials. 2012 Dec;9(6):671-80
pubmed: 23250942
Stat Med. 2010 Jan 30;29(2):210-8
pubmed: 19908261
J Biopharm Stat. 2013;23(5):1067-80
pubmed: 23957516
Stat Med. 1994 Sep 15;13(17):1715-26
pubmed: 7997705
Clin Infect Dis. 2018 Mar 19;66(7):1140-1146
pubmed: 29121202
Stat Med. 1995 Feb 15;14(3):231-46
pubmed: 7724909
PLoS One. 2015 Nov 03;10(11):e0141104
pubmed: 26528812
Stat Biosci. 2016 Jun;8(1):99-128
pubmed: 27617040
BMJ. 2018 Nov 5;363:k3750
pubmed: 30560792
Clin Trials. 2017 Feb;14(1):78-87
pubmed: 27729499
Stat Med. 2007 Dec 30;26(30):5422-33
pubmed: 17918195
Ann Emerg Med. 2015 Feb;65(2):214-5
pubmed: 25601251
Biometrics. 1986 Sep;42(3):461-71
pubmed: 3552069
N Engl J Med. 2018 Jan 4;378(1):11-21
pubmed: 29129157
Orphanet J Rare Dis. 2008 May 02;3:11
pubmed: 18454853
Stat Med. 2012 Nov 10;31(25):2973-84
pubmed: 22711298
Ther Innov Regul Sci. 2014 Jul;48(4):473-481
pubmed: 30235570
JAMA. 2001 Apr 18;285(15):1992-5
pubmed: 11308436
Clin Trials. 2017 Oct;14(5):451-461
pubmed: 28830236
Therapie. 2011 Jul-Aug;66(4):319-26, 309-17
pubmed: 21851793
BMJ Open. 2015 Oct 15;5(10):e009566
pubmed: 26474943
Cancer Discov. 2011 Jun;1(1):44-53
pubmed: 22586319
JAMA. 2012 Dec 26;308(24):2594-604
pubmed: 23268518
Biom J. 2014 Jul;56(4):614-30
pubmed: 24753160
Trials. 2016 Jul 29;17:373
pubmed: 27473126
J Biopharm Stat. 2016;26(1):99-119
pubmed: 26378339
BMC Med Res Methodol. 2014 Jun 30;14:84
pubmed: 24980283
Cancer Treat Rev. 2016 Feb;43:74-82
pubmed: 26827695
Clin Oncol (R Coll Radiol). 2017 Dec;29(12):778-786
pubmed: 29079227
PLoS One. 2008 Aug 28;3(8):e3081
pubmed: 18769481
Ther Innov Regul Sci. 2017 Jan;51(1):60-68
pubmed: 30235991
Stat Med. 2017 Nov 10;36(25):3935-3947
pubmed: 28783881
Mult Scler. 2011 Jan;17(1):81-8
pubmed: 20798135
Biom J. 2006 Aug;48(4):574-85
pubmed: 16972708
Stat Med. 2002 Sep 15;21(17):2449-63
pubmed: 12205692
Drugs R D. 2008;9(4):229-42
pubmed: 18588354
PLoS Med. 2008 Jan 22;5(1):e20
pubmed: 18215107
J Biopharm Stat. 2006 May;16(3):299-309; discussion 311-2
pubmed: 16724486
Clin Trials. 2010 Apr;7(2):167-73
pubmed: 20338900
Ther Innov Regul Sci. 2020 Jan;54(1):246-258
pubmed: 32008232
N Engl J Med. 2014 Sep 11;371(11):993-1004
pubmed: 25176015
BMC Med. 2018 Feb 28;16(1):29
pubmed: 29490655
Lancet. 2016 Mar 19;387(10024):1163-77
pubmed: 26719232
Stat Med. 2007 Dec 10;26(28):5047-80
pubmed: 17573678
Trials. 2012 Aug 23;13:145
pubmed: 22917111
BMC Med. 2018 Nov 16;16(1):210
pubmed: 30442137
Expert Rev Clin Pharmacol. 2017 Jul;10(7):727-736
pubmed: 28434375
Stat Med. 2018 Dec 30;37(30):4636-4651
pubmed: 30260533
Contemp Clin Trials. 2017 Dec;63:19-29
pubmed: 28522422
Trials. 2013 Jan 23;14:23
pubmed: 23343147
Stat Med. 2009 Feb 28;28(5):828-47
pubmed: 19061203
PLoS Negl Trop Dis. 2014 Jan 16;8(1):e2613
pubmed: 24454970
Clin Trials. 2017 Oct;14(5):441-450
pubmed: 28825324
Control Clin Trials. 1986 Mar;7(1):8-17
pubmed: 3956212
Biometrics. 1979 Sep;35(3):549-56
pubmed: 497341
Trials. 2015 Sep 28;16:430
pubmed: 26416387
Am J Nephrol. 2011;33(2):139-49
pubmed: 21242674
Orphanet J Rare Dis. 2011 Nov 30;6:79
pubmed: 22129361
J Clin Pharm Ther. 2018 Apr;43(2):170-180
pubmed: 28850685
Trials. 2012 Sep 15;13:168
pubmed: 22978443
Biometrics. 1995 Dec;51(4):1315-24
pubmed: 8589224
BMC Pediatr. 2009 Dec 13;9:77
pubmed: 20003383
Stat Med. 2008 May 10;27(10):1612-25
pubmed: 17876763
Stat Methods Med Res. 2019 Jun;28(6):1879-1892
pubmed: 29888651
Biometrics. 2017 Dec;73(4):1289-1299
pubmed: 28346823
Clin Trials. 2016 Jun;13(3):358-66
pubmed: 26908536
Control Clin Trials. 1992 Apr;13(2):106-21
pubmed: 1316826
BMJ. 2015 Mar 24;350:h809
pubmed: 25804210
Clin Trials. 2008;5(2):157-67
pubmed: 18375654
BMJ. 2019 Jul 31;366:l4378
pubmed: 31366597
Stat Med. 2012 Dec 30;31(30):4146-53
pubmed: 22736397
Trials. 2018 Oct 29;19(1):591
pubmed: 30373644
JAMA. 2015 Apr 28;313(16):1619-20
pubmed: 25799162
Pediatr Crit Care Med. 2014 Jul;15(6):511-22
pubmed: 24751788
Clin Infect Dis. 2014 Dec 15;59(12):e172-85
pubmed: 25115871
Eur J Cancer. 2013 Dec;49(18):3788-97
pubmed: 23890767
JAMA. 2017 Dec 19;318(23):2337-2343
pubmed: 29260229
Spinal Cord. 2018 Oct;56(10):919
pubmed: 30287888
BMJ Open. 2018 Feb 10;8(2):e018320
pubmed: 29440155
Stat Med. 2006 Oct 15;25(19):3366-81
pubmed: 16220489
Ann Intern Med. 2010 Jun 1;152(11):726-32
pubmed: 20335313
Pharm Stat. 2006 Jan-Mar;5(1):61-6
pubmed: 17080929
Trials. 2015 Dec 23;16:585
pubmed: 26700741
Stroke. 2017 Jul;48(7):2021-2025
pubmed: 28536178
Trials. 2018 Jan 29;19(1):80
pubmed: 29378640
Trials. 2015 Apr 22;16:179
pubmed: 25897686
Am J Respir Crit Care Med. 2010 Jul 15;182(2):155-62
pubmed: 20463178
Lancet. 2002 May 18;359(9319):1727-33
pubmed: 12049861
Trials. 2018 Nov 5;19(1):605
pubmed: 30396364
Eur J Cancer. 2017 Aug;81:183-190
pubmed: 28628843
Diabetes Obes Metab. 2014 Aug;16(8):748-56
pubmed: 24762094
Biom J. 2006 Aug;48(4):623-34
pubmed: 16972714
J Biopharm Stat. 2012;22(4):836-52
pubmed: 22651118
Stat Med. 2012 Feb 20;31(4):301-12
pubmed: 22139822
Ann Oncol. 2019 Jan 1;30(1):103-108
pubmed: 30357394
PLoS Clin Trials. 2007 Apr 13;2(4):e18
pubmed: 17443237
Stat Med. 2015 Dec 20;34(29):3793-810
pubmed: 26172385
JAMA. 2019 Apr 23;321(16):1610-1620
pubmed: 31012939
Annu Rev Public Health. 2009;30:1-25
pubmed: 19296774
Stat Med. 2017 Nov 20;36(26):4083-4093
pubmed: 28795420