OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

S.M. Nielsen; M. Boers; M. de Wit; B. Shea; D.A. van der Windt; B.C. Reeves; D. Beaton; R. Alten; K.T. April; A. Boonen; R. Escorpizo; C. Flurey; D.E. Furst; F. Guillemin; A. Leong; C. Pohl; M.U. Rasmussen; J.A. Singh; J.S. Smolen; V. Strand; S.M.M. Verstappen; M. Voshaar; T.G. Woodworth; T. Ellingsen; L. March; G.A. Wells; P. Tugwell; R. Christensen

doi:10.1016/j.semarthrit.2021.03.013

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

S.M. Nielsen, M. Boers, M. de Wit, B. Shea, D.A. van der Windt, B.C. Reeves, D. Beaton, R. Alten, K.T. April, A. Boonen, R. Escorpizo, C. Flurey, D.E. Furst, F. Guillemin, A. Leong, C. Pohl, M.U. Rasmussen, J.A. Singh, J.S. Smolen, V. StrandS.M.M. Verstappen, M. Voshaar, T.G. Woodworth, T. Ellingsen, L. March, G.A. Wells, P. Tugwell, R. Christensen^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Objectives: To develop an operational definition of contextual factors (CF) [1].Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying-, Outcome Influencing -and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consen-sus (>70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

Original language	English
Pages (from-to)	601-606
Number of pages	6
Journal	Seminars in Arthritis and Rheumatism
Volume	51
Issue number	3
DOIs	https://doi.org/10.1016/j.semarthrit.2021.03.013
Publication status	Published - 1 Jun 2021

Keywords

OMERACT
Contextual factors
Delphi survey
Effect modifying contextual factors
Outcome explaining contextual factors
Measurement affecting contextual factors
ARTHRITIS

Access to Document

10.1016/j.semarthrit.2021.03.013Licence: CC BY

Cite this

Nielsen, S. M., Boers, M., de Wit, M., Shea, B., van der Windt, D. A., Reeves, B. C., Beaton, D., Alten, R., April, K. T., Boonen, A., Escorpizo, R., Flurey, C., Furst, D. E., Guillemin, F., Leong, A., Pohl, C., Rasmussen, M. U., Singh, J. A., Smolen, J. S., ... Christensen, R. (2021). OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study. Seminars in Arthritis and Rheumatism, 51(3), 601-606. https://doi.org/10.1016/j.semarthrit.2021.03.013

@article{637239f6faa440509ba365a5473399de,

title = "OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study",

abstract = "Objectives: To develop an operational definition of contextual factors (CF) [1].Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying-, Outcome Influencing -and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consen-sus (>70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)",

keywords = "OMERACT, Contextual factors, Delphi survey, Effect modifying contextual factors, Outcome explaining contextual factors, Measurement affecting contextual factors, ARTHRITIS",

author = "S.M. Nielsen and M. Boers and {de Wit}, M. and B. Shea and {van der Windt}, D.A. and B.C. Reeves and D. Beaton and R. Alten and K.T. April and A. Boonen and R. Escorpizo and C. Flurey and D.E. Furst and F. Guillemin and A. Leong and C. Pohl and M.U. Rasmussen and J.A. Singh and J.S. Smolen and V. Strand and S.M.M. Verstappen and M. Voshaar and T.G. Woodworth and T. Ellingsen and L. March and G.A. Wells and P. Tugwell and R. Christensen",

year = "2021",

month = jun,

day = "1",

doi = "10.1016/j.semarthrit.2021.03.013",

language = "English",

volume = "51",

pages = "601--606",

journal = "Seminars in Arthritis and Rheumatism",

issn = "0049-0172",

publisher = "W B Saunders Co-Elsevier Inc",

number = "3",

}

Nielsen, SM, Boers, M, de Wit, M, Shea, B, van der Windt, DA, Reeves, BC, Beaton, D, Alten, R, April, KT, Boonen, A, Escorpizo, R, Flurey, C, Furst, DE, Guillemin, F, Leong, A, Pohl, C, Rasmussen, MU, Singh, JA, Smolen, JS, Strand, V, Verstappen, SMM, Voshaar, M, Woodworth, TG, Ellingsen, T, March, L, Wells, GA, Tugwell, P & Christensen, R 2021, 'OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study', Seminars in Arthritis and Rheumatism, vol. 51, no. 3, pp. 601-606. https://doi.org/10.1016/j.semarthrit.2021.03.013

TY - JOUR

T1 - OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

AU - Nielsen, S.M.

AU - Boers, M.

AU - de Wit, M.

AU - Shea, B.

AU - van der Windt, D.A.

AU - Reeves, B.C.

AU - Beaton, D.

AU - Alten, R.

AU - April, K.T.

AU - Boonen, A.

AU - Escorpizo, R.

AU - Flurey, C.

AU - Furst, D.E.

AU - Guillemin, F.

AU - Leong, A.

AU - Pohl, C.

AU - Rasmussen, M.U.

AU - Singh, J.A.

AU - Smolen, J.S.

AU - Strand, V.

AU - Verstappen, S.M.M.

AU - Voshaar, M.

AU - Woodworth, T.G.

AU - Ellingsen, T.

AU - March, L.

AU - Wells, G.A.

AU - Tugwell, P.

AU - Christensen, R.

PY - 2021/6/1

Y1 - 2021/6/1

N2 - Objectives: To develop an operational definition of contextual factors (CF) [1].Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying-, Outcome Influencing -and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consen-sus (>70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

AB - Objectives: To develop an operational definition of contextual factors (CF) [1].Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying-, Outcome Influencing -and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consen-sus (>70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

KW - OMERACT

KW - Contextual factors

KW - Delphi survey

KW - Effect modifying contextual factors

KW - Outcome explaining contextual factors

KW - Measurement affecting contextual factors

KW - ARTHRITIS

U2 - 10.1016/j.semarthrit.2021.03.013

DO - 10.1016/j.semarthrit.2021.03.013

M3 - Article

C2 - 33875246

SN - 0049-0172

VL - 51

SP - 601

EP - 606

JO - Seminars in Arthritis and Rheumatism

JF - Seminars in Arthritis and Rheumatism

IS - 3

ER -