Risk of harm in synthetic and biological intervention trials in patients with inflammatory arthritis: protocol for a metaepidemiological study focusing on contextual factors.
epidemiology
rheumatology
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
06 09 2021
06 09 2021
Historique:
entrez:
7
9
2021
pubmed:
8
9
2021
medline:
16
9
2021
Statut:
epublish
Résumé
Inflammatory arthritis (IA) conditions, including rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, are characterised by inflammatory infiltration of the joints. Biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively, reduce the effects of proinflammatory cytokines and immune cells to ameliorate disease. However, immunosuppression can be associated with high rates of serious adverse events (SAEs), including serious infections, and maybe an increased risk of malignancies and cardiovascular events. Currently, there is no empirical evidence on the extent to which contextual factors and risk of bias (RoB) domains may modify these harm signals in randomised trials. We will search MEDLINE (via PubMed) for systematic reviews published since April 2015 and all Cochrane reviews. From these reviews, randomised trials will be eligible if they include patients with an IA condition with at least one group randomly allocated to bDMARD and/or tsDMARD treatments. A predefined form will be used for extracting data on population characteristics (eg, baseline characteristics or eligibility criteria, such as medication background) and specific harm outcome measures, such as number of withdrawals, numbers of patients discontinuing due to adverse events and number of patients having SAEs. RoB in individual trials will be assessed using a modified Cochrane RoB tool. We will estimate the potentially causal harm effects related to the experimental intervention compared with control comparator as risk ratios, and heterogeneity across randomised comparisons will be assessed statistically and evaluated as inconsistency using the I Ethics approval is not required for this study. Results will be disseminated through publication in international peer-reviewed journals. CRD42020171124.
Identifiants
pubmed: 34489286
pii: bmjopen-2021-049850
doi: 10.1136/bmjopen-2021-049850
pmc: PMC8422485
doi:
Substances chimiques
Antirheumatic Agents
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e049850Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Rheumatology (Oxford). 2019 Feb 1;58(Suppl 1):i4-i16
pubmed: 30806710
J Rheumatol. 2019 Oct;46(10):1406-1408
pubmed: 30770514
Ann Rheum Dis. 2019 Mar;78(3):320-327
pubmed: 30612115
J Clin Epidemiol. 2014 Jul;67(7):745-53
pubmed: 24582946
Expert Rev Clin Pharmacol. 2016 Jun;9(6):747-9
pubmed: 26933755
Nat Rev Rheumatol. 2017 Apr;13(4):234-243
pubmed: 28250461
Autoimmun Rev. 2019 Jun;18(6):583-592
pubmed: 30959214
Rheumatology (Oxford). 2017 Mar 1;56(3):417-425
pubmed: 28013201
Cochrane Database Syst Rev. 2017 Mar 10;3:CD012591
pubmed: 28282491
Ann Rheum Dis. 2020 Oct;79(10):1269-1276
pubmed: 32606042
Epidemiol Health. 2014 Sep 25;36:e2014019
pubmed: 25266419
BMJ. 2015 Jan 02;350:g7647
pubmed: 25555855
Am J Epidemiol. 2006 Mar 15;163(6):493-501
pubmed: 16443796
Ann Rheum Dis. 2011 Sep;70(9):1631-40
pubmed: 21708910
N Engl J Med. 2011 Dec 8;365(23):2205-19
pubmed: 22150039
BMJ Open. 2020 Aug 13;10(8):e032552
pubmed: 32792421
Ann Intern Med. 2004 Nov 16;141(10):781-8
pubmed: 15545678
Expert Opin Drug Saf. 2016 Dec;15(sup1):11-34
pubmed: 27924643
Best Pract Res Clin Rheumatol. 2018 Jun;32(3):453-471
pubmed: 31171315
BMJ. 2010 Jul 16;341:c3515
pubmed: 20639294
J Rheumatol. 2017 Nov;44(11):1734-1739
pubmed: 28461648
Ann Intern Med. 2012 Sep 18;157(6):429-38
pubmed: 22945832
Stat Med. 2002 Jun 15;21(11):1559-73
pubmed: 12111920
Ann Rheum Dis. 2020 Nov;79(11):1400-1413
pubmed: 32759265
Ann Rheum Dis. 2014 May;73(5):871-82
pubmed: 23599436
J Clin Epidemiol. 2020 Jul;123:131-132
pubmed: 32247655
JAMA. 2006 May 17;295(19):2275-85
pubmed: 16705109
Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033
pubmed: 28207928
Ann Rheum Dis. 2015 Jun;74(6):963-9
pubmed: 24827533
Stat Med. 1999 Feb 15;18(3):321-59
pubmed: 10070677
Arthritis Res Ther. 2020 Jul 25;22(1):177
pubmed: 32711571
PLoS One. 2015 Sep 11;10(9):e0136982
pubmed: 26360583
J Clin Epidemiol. 2013 Feb;66(2):158-72
pubmed: 22609141
J Clin Epidemiol. 2018 Mar;95:128-136
pubmed: 29222059
Trials. 2018 Jan 25;19(1):67
pubmed: 29370811
Cochrane Database Syst Rev. 2017 May 08;5:CD012657
pubmed: 28481462
Ann Rheum Dis. 2020 Jun;79(6):760-770
pubmed: 32033941
Arthritis Care Res (Hoboken). 2018 Aug;70(8):1206-1217
pubmed: 29073353
Ann Intern Med. 2011 Jul 5;155(1):39-51
pubmed: 21727292
J Autoimmun. 2017 May;79:4-16
pubmed: 28209290
Cochrane Database Syst Rev. 2017 Jun 09;6:CD012095
pubmed: 28597983
BMJ. 2011 Oct 18;343:d5928
pubmed: 22008217
Ann Rheum Dis. 2021 Feb;80(2):242-249
pubmed: 33055082
BMJ. 2020 Jul 7;370:m2288
pubmed: 32636183
BMJ. 2017 Jul 27;358:j3248
pubmed: 28751303
Stat Med. 2002 Feb 15;21(3):371-87
pubmed: 11813224
Arthritis Care Res (Hoboken). 2021 Jun;73(6):861-872
pubmed: 32166872
Semin Immunol. 2017 Oct;33:52-57
pubmed: 29042029
Psychol Methods. 2004 Dec;9(4):426-45
pubmed: 15598097
Cochrane Database Syst Rev. 2016 Nov 17;11:CD012437
pubmed: 27855242
Ann Intern Med. 2001 Dec 4;135(11):982-9
pubmed: 11730399
Stat Med. 2004 May 15;23(9):1351-75
pubmed: 15116347
Lancet. 2015 Jul 18;386(9990):258-65
pubmed: 25975452
Psychol Methods. 2001 Sep;6(3):203-17
pubmed: 11570228
Stat Med. 2002 Feb 28;21(4):589-624
pubmed: 11836738
Lancet. 2005 Jan 22-28;365(9456):341-6
pubmed: 15664231
Stat Med. 2002 Jun 15;21(11):1513-24
pubmed: 12111917
Ann Rheum Dis. 2014 Feb;73(2):414-9
pubmed: 23355079
Ann Rheum Dis. 2015 Jun;74(6):1241-8
pubmed: 24718959
Cochrane Database Syst Rev. 2011 Feb 16;(2):CD008794
pubmed: 21328309
J Autoimmun. 2014 Feb-Mar;48-49:128-33
pubmed: 24534717
J Clin Epidemiol. 2016 Apr;72:66-74
pubmed: 26562052
BMJ. 2003 Sep 6;327(7414):557-60
pubmed: 12958120