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Guideline
. 2015 Jun;74(6):963-9.
doi: 10.1136/annrheumdis-2013-204948. Epub 2014 May 14.

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

Maya H Buch  1 , Lucia Silva-Fernandez  2 , Loreto Carmona  3 , Daniel Aletaha  4 , Robin Christensen  5 , Bernard Combe  6 , Paul Emery  1 , Gianfranco Ferraccioli  7 , Francis Guillemin  8 , Tore K Kvien  9 , Robert Landewe  10 , Karel Pavelka  11 , Kenneth Saag  12 , Josef S Smolen  13 , Deborah Symmons  14 , Désirée van der Heijde  15 , Joep Welling  16 , George Wells  17 , Rene Westhovens  18 , Angela Zink  19 , Maarten Boers  20 ; European League Against Rheumatism (EULAR)
Affiliations
Guideline

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

Maya H Buch et al. Ann Rheum Dis. 2015 Jun.

Abstract

Objectives: Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports.

Methods: We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A '0-10' agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance.

Results: Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations.

Conclusions: This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes.

Keywords: DMARDs (biologic); Epidemiology; Rheumatoid Arthritis.

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Figures

Figure 1
Figure 1
Schematic of flowcharts for inclusion in any trial extension study (TES) report following (A) a placebo-controlled randomised controlled trial (RCT) or (B) an active comparator trial. FU, follow-up; W, withdrawal. *And loss to follow-up number. The TES flowchart should detail the numbers from the start of the original RCT to the end of the TES. ‘W’ and the vertical dotted line shown between the RCT and TES phases denote those subjects who complete the RCT but opt not to proceed to the TES. During the RCT and TES, numbers of early withdrawals and patients subsequently lost to follow-up should also be included. (A) In the placebo-controlled RCT stage, subjects in the experimental arm who withdraw and proceed to standard of care, and in the placebo arm, subjects who withdraw and proceed to experimental or standard of care should be included. (B) Similarly, in the active comparator trial, subjects in the experimental arm who withdraw and proceed to standard of care, and in the active arm, subjects who withdraw and proceed to experimental or standard of care, should be included.
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References

    1. O'Dell JR, Leff R, Paulsen G, et al. Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: results of a two-year, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002;46:1164–70. - PubMed
    1. Boers M, Verhoeven AC, Markusse HM, et al. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet 1997;350:309–18. - PubMed
    1. Maini R, St Clair EW, Breedveld F, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999;354:1932–9. - PubMed
    1. Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999;340:253–9. - PubMed
    1. Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003;48:35–45. - PubMed

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