Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design

W.P. Maksymowych; O. Fitzgerald; G.A. Wells; D.D. Gladman; R. Landewe; Mikkel Østergaard; W.J. Taylor; R. Christensen; P.P. Tak; M. Boers; S.W. Syversen; J.M. Bathon; C.J. Ritchlin; P.J. Mease; V.P. Bykerk; P. Garnero; P. Geusens; H. El-Gabalawy; D. Aletaha; R.D. Inman; V.B. Kraus; T.K. Kvien; Heijde D. van der

Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design

W.P. Maksymowych, O. Fitzgerald, G.A. Wells, D.D. Gladman, R. Landewe, Mikkel Østergaard, W.J. Taylor, R. Christensen, P.P. Tak, M. Boers, S.W. Syversen, J.M. Bathon, C.J. Ritchlin, P.J. Mease, V.P. Bykerk, P. Garnero, P. Geusens, H. El-Gabalawy, D. Aletaha, R.D. InmanV.B. Kraus, T.K. Kvien, Heijde D. van der

30 Citations (Scopus)

Abstract

OBJECTIVE: At OMERACT 8 a framework for levels of evidence was proposed for the validation of biomarkers as surrogate outcome measures. We aimed to adapt this scheme in order to apply it in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). We also aimed to generate consensus on minimum standards for the design of longitudinal studies aimed at validating biomarkers. METHODS: Before the meeting, the Soluble Biomarker Working Group prepared a preliminary framework and discussed various models for association and prediction related to the statistical strength domain. In addition, 3 Delphi exercises addressing longitudinal study design for RA, PsA, and AS were conducted within the working group and members of the Assessments in SpondyloArthritis International Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). This formed the basis for discussions among OMERACT 9 participants. RESULTS: The proposed framework was accepted by consensus. In the study design domain a requirement for both prospective observational studies and randomized controlled trials (RCT) in different drug classes was noted. A template for determining the level of statistical strength was proposed. The addition of a new domain on biomarker assay performance was considered essential, and participants suggested that for any biomarker this domain should be addressed first, i.e., before starting clinical validation studies. Participants agreed on most elements of a longitudinal study design template. Where consensus was lacking the working group has drafted solutions that constitute a basis for prospective validation studies. CONCLUSION: The OMERACT 9 Soluble Biomarker Group has successfully formulated a levels of evidence scheme and a study design template that will provide guidance to conduct validation studies in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in RA, PsA, and AS
Udgivelsesdato: 2009/8

Original language	English
Journal	Journal of Rheumatology
Volume	36
Issue number	8
Pages (from-to)	1792-1799
Number of pages	8
ISSN	0315-162X
Publication status	Published - 2009

Cite this

Maksymowych, W. P., Fitzgerald, O., Wells, G. A., Gladman, D. D., Landewe, R., Østergaard, M., Taylor, W. J., Christensen, R., Tak, P. P., Boers, M., Syversen, S. W., Bathon, J. M., Ritchlin, C. J., Mease, P. J., Bykerk, V. P., Garnero, P., Geusens, P., El-Gabalawy, H., Aletaha, D., ... der, H. D. V. (2009). Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design. Journal of Rheumatology, 36(8), 1792-1799.

Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design. / Maksymowych, W.P.; Fitzgerald, O.; Wells, G.A. et al.

In: Journal of Rheumatology, Vol. 36, No. 8, 2009, p. 1792-1799.

Research output: Contribution to journal › Journal article › Research › peer-review

Maksymowych, WP, Fitzgerald, O, Wells, GA, Gladman, DD, Landewe, R, Østergaard, M, Taylor, WJ, Christensen, R, Tak, PP, Boers, M, Syversen, SW, Bathon, JM, Ritchlin, CJ, Mease, PJ, Bykerk, VP, Garnero, P, Geusens, P, El-Gabalawy, H, Aletaha, D, Inman, RD, Kraus, VB, Kvien, TK & der, HDV 2009, 'Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design', Journal of Rheumatology, vol. 36, no. 8, pp. 1792-1799.

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title = "Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design",

abstract = "OBJECTIVE: At OMERACT 8 a framework for levels of evidence was proposed for the validation of biomarkers as surrogate outcome measures. We aimed to adapt this scheme in order to apply it in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). We also aimed to generate consensus on minimum standards for the design of longitudinal studies aimed at validating biomarkers. METHODS: Before the meeting, the Soluble Biomarker Working Group prepared a preliminary framework and discussed various models for association and prediction related to the statistical strength domain. In addition, 3 Delphi exercises addressing longitudinal study design for RA, PsA, and AS were conducted within the working group and members of the Assessments in SpondyloArthritis International Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). This formed the basis for discussions among OMERACT 9 participants. RESULTS: The proposed framework was accepted by consensus. In the study design domain a requirement for both prospective observational studies and randomized controlled trials (RCT) in different drug classes was noted. A template for determining the level of statistical strength was proposed. The addition of a new domain on biomarker assay performance was considered essential, and participants suggested that for any biomarker this domain should be addressed first, i.e., before starting clinical validation studies. Participants agreed on most elements of a longitudinal study design template. Where consensus was lacking the working group has drafted solutions that constitute a basis for prospective validation studies. CONCLUSION: The OMERACT 9 Soluble Biomarker Group has successfully formulated a levels of evidence scheme and a study design template that will provide guidance to conduct validation studies in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in RA, PsA, and AS Udgivelsesdato: 2009/8",

author = "W.P. Maksymowych and O. Fitzgerald and G.A. Wells and D.D. Gladman and R. Landewe and Mikkel {\O}stergaard and W.J. Taylor and R. Christensen and P.P. Tak and M. Boers and S.W. Syversen and J.M. Bathon and C.J. Ritchlin and P.J. Mease and V.P. Bykerk and P. Garnero and P. Geusens and H. El-Gabalawy and D. Aletaha and R.D. Inman and V.B. Kraus and T.K. Kvien and der, {Heijde D. van}",

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volume = "36",

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T1 - Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design

AU - Maksymowych, W.P.

AU - Fitzgerald, O.

AU - Wells, G.A.

AU - Gladman, D.D.

AU - Landewe, R.

AU - Østergaard, Mikkel

AU - Taylor, W.J.

AU - Christensen, R.

AU - Tak, P.P.

AU - Boers, M.

AU - Syversen, S.W.

AU - Bathon, J.M.

AU - Ritchlin, C.J.

AU - Mease, P.J.

AU - Bykerk, V.P.

AU - Garnero, P.

AU - Geusens, P.

AU - El-Gabalawy, H.

AU - Aletaha, D.

AU - Inman, R.D.

AU - Kraus, V.B.

AU - Kvien, T.K.

AU - der, Heijde D. van

PY - 2009

Y1 - 2009

N2 - OBJECTIVE: At OMERACT 8 a framework for levels of evidence was proposed for the validation of biomarkers as surrogate outcome measures. We aimed to adapt this scheme in order to apply it in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). We also aimed to generate consensus on minimum standards for the design of longitudinal studies aimed at validating biomarkers. METHODS: Before the meeting, the Soluble Biomarker Working Group prepared a preliminary framework and discussed various models for association and prediction related to the statistical strength domain. In addition, 3 Delphi exercises addressing longitudinal study design for RA, PsA, and AS were conducted within the working group and members of the Assessments in SpondyloArthritis International Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). This formed the basis for discussions among OMERACT 9 participants. RESULTS: The proposed framework was accepted by consensus. In the study design domain a requirement for both prospective observational studies and randomized controlled trials (RCT) in different drug classes was noted. A template for determining the level of statistical strength was proposed. The addition of a new domain on biomarker assay performance was considered essential, and participants suggested that for any biomarker this domain should be addressed first, i.e., before starting clinical validation studies. Participants agreed on most elements of a longitudinal study design template. Where consensus was lacking the working group has drafted solutions that constitute a basis for prospective validation studies. CONCLUSION: The OMERACT 9 Soluble Biomarker Group has successfully formulated a levels of evidence scheme and a study design template that will provide guidance to conduct validation studies in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in RA, PsA, and AS Udgivelsesdato: 2009/8

AB - OBJECTIVE: At OMERACT 8 a framework for levels of evidence was proposed for the validation of biomarkers as surrogate outcome measures. We aimed to adapt this scheme in order to apply it in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). We also aimed to generate consensus on minimum standards for the design of longitudinal studies aimed at validating biomarkers. METHODS: Before the meeting, the Soluble Biomarker Working Group prepared a preliminary framework and discussed various models for association and prediction related to the statistical strength domain. In addition, 3 Delphi exercises addressing longitudinal study design for RA, PsA, and AS were conducted within the working group and members of the Assessments in SpondyloArthritis International Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). This formed the basis for discussions among OMERACT 9 participants. RESULTS: The proposed framework was accepted by consensus. In the study design domain a requirement for both prospective observational studies and randomized controlled trials (RCT) in different drug classes was noted. A template for determining the level of statistical strength was proposed. The addition of a new domain on biomarker assay performance was considered essential, and participants suggested that for any biomarker this domain should be addressed first, i.e., before starting clinical validation studies. Participants agreed on most elements of a longitudinal study design template. Where consensus was lacking the working group has drafted solutions that constitute a basis for prospective validation studies. CONCLUSION: The OMERACT 9 Soluble Biomarker Group has successfully formulated a levels of evidence scheme and a study design template that will provide guidance to conduct validation studies in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in RA, PsA, and AS Udgivelsesdato: 2009/8

M3 - Journal article

SN - 0315-162X

VL - 36

SP - 1792

EP - 1799

JO - Journal of Rheumatology

JF - Journal of Rheumatology

IS - 8

ER -