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

Sabrina Mai Nielsen; Maarten Boers; Maarten de Wit; Beverly Shea; Danielle A. van der Windt; Barnaby C. Reeves; Dorcas Beaton; Rieke Alten; Karine Toupin April; Annelies Boonen; Reuben Escorpizo; Caroline Flurey; Daniel E. Furst; Francis Guillemin; Amye Leong; Christoph Pohl; Marianne Uggen Rasmussen; Jasvinder A. Singh; Josef S. Smolen; Vibeke Strand; Suzanne M. M. Verstappen; Marieke Voshaar; Thasia G. Woodworth; Torkell Ellingsen; Lyn March; George A. Wells; Peter Tugwell; Robin 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

Sabrina Mai Nielsen, Maarten Boers, Maarten de Wit, Beverly Shea, Danielle A. van der Windt, Barnaby C. Reeves, Dorcas Beaton, Rieke Alten, Karine Toupin April, Annelies Boonen, Reuben Escorpizo, Caroline Flurey, Daniel E. Furst, Francis Guillemin, Amye Leong, Christoph Pohl, Marianne Uggen Rasmussen, Jasvinder A. Singh, Josef S. Smolen, Vibeke StrandSuzanne M. M. Verstappen, Marieke Voshaar, Thasia G. Woodworth, Torkell Ellingsen, Lyn March, George A. Wells, Peter Tugwell, Robin 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 consensus (≥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.

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

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Nielsen, S. M., Boers, M., de Wit, M., Shea, B., van der Windt, D. A., Reeves, B. C., Beaton, D., Alten, R., Toupin April, K., 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

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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 consensus (≥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.",

keywords = "Consensus, Humans, Outcome Assessment, Health Care, Research Design, Rheumatology, Surveys and Questionnaires",

author = "Nielsen, {Sabrina Mai} and Maarten Boers and {de Wit}, Maarten and Beverly Shea and {van der Windt}, {Danielle A.} and Reeves, {Barnaby C.} and Dorcas Beaton and Rieke Alten and {Toupin April}, Karine and Annelies Boonen and Reuben Escorpizo and Caroline Flurey and Furst, {Daniel E.} and Francis Guillemin and Amye Leong and Christoph Pohl and Rasmussen, {Marianne Uggen} and Singh, {Jasvinder A.} and Smolen, {Josef S.} and Vibeke Strand and Verstappen, {Suzanne M. M.} and Marieke Voshaar and Woodworth, {Thasia G.} and Torkell Ellingsen and Lyn March and Wells, {George A.} and Peter Tugwell and Robin 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 Ltd",

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Nielsen, SM, Boers, M, de Wit, M, Shea, B, van der Windt, DA, Reeves, BC, Beaton, D, Alten, R, Toupin April, K, 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

T2 - A mixed methods study

AU - Nielsen, Sabrina Mai

AU - Boers, Maarten

AU - de Wit, Maarten

AU - Shea, Beverly

AU - van der Windt, Danielle A.

AU - Reeves, Barnaby C.

AU - Beaton, Dorcas

AU - Alten, Rieke

AU - Toupin April, Karine

AU - Boonen, Annelies

AU - Escorpizo, Reuben

AU - Flurey, Caroline

AU - Furst, Daniel E.

AU - Guillemin, Francis

AU - Leong, Amye

AU - Pohl, Christoph

AU - Rasmussen, Marianne Uggen

AU - Singh, Jasvinder A.

AU - Smolen, Josef S.

AU - Strand, Vibeke

AU - Verstappen, Suzanne M. M.

AU - Voshaar, Marieke

AU - Woodworth, Thasia G.

AU - Ellingsen, Torkell

AU - March, Lyn

AU - Wells, George A.

AU - Tugwell, Peter

AU - Christensen, Robin

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 consensus (≥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.

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 consensus (≥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.

KW - Consensus

KW - Humans

KW - Outcome Assessment, Health Care

KW - Research Design

KW - Rheumatology

KW - Surveys and Questionnaires

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85104286090&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/33875246

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 -

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

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