OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Joanna C. Robson; Gunnar Tomasson; Nataliya Milman; Sue Ashdown; Annelies Boonen; George C. Casey; Peter F. Cronholm; David Cuthbertson; Jill Dawson; Haner Direskeneli; Ebony Easley; Tanaz A. Kermani; John T. Farrar; Don Gebhart; Georgia Lanier; Raashid A. Luqmani; Alfred Mahr; Carol A. McAlear; Jacqueline Peck; Beverley Shea; Judy A. Shea; Antoine G. Sreih; Peter S. Tugwell; Peter A. Merkel

doi:10.3899/jrheum.161139

OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Joanna C. Robson, Gunnar Tomasson, Nataliya Milman, Sue Ashdown, Annelies Boonen, George C. Casey, Peter F. Cronholm, David Cuthbertson, Jill Dawson, Haner Direskeneli, Ebony Easley, Tanaz A. Kermani, John T. Farrar, Don Gebhart, Georgia Lanier, Raashid A. Luqmani, Alfred Mahr, Carol A. McAlear, Jacqueline Peck, Beverley SheaJudy A. Shea, Antoine G. Sreih, Peter S. Tugwell, Peter A. Merkel^*

^*Corresponding author for this work

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

Abstract

Objective. The antineutrophil cytoplasmic antibody-associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016.

Methods. A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented.

Results. OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement).

Conclusion. The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial.

Original language	English
Pages (from-to)	1529-1535
Number of pages	7
Journal	Journal of Rheumatology
Volume	44
Issue number	10
DOIs	https://doi.org/10.3899/jrheum.161139
Publication status	Published - 1 Oct 2017

Keywords

ANCA-ASSOCIATED VASCULITIS
PATIENT-REPORTED OUTCOMES
PROMIS
ICF
OMERACT
QUALITY-OF-LIFE
WEGENERS-GRANULOMATOSIS
CLINICAL-TRIALS
CORE SET
INVOLVEMENT

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10.3899/jrheum.161139

Cite this

Robson, J. C., Tomasson, G., Milman, N., Ashdown, S., Boonen, A., Casey, G. C., Cronholm, P. F., Cuthbertson, D., Dawson, J., Direskeneli, H., Easley, E., Kermani, T. A., Farrar, J. T., Gebhart, D., Lanier, G., Luqmani, R. A., Mahr, A., McAlear, C. A., Peck, J., ... Merkel, P. A. (2017). OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody-associated Vasculitis. Journal of Rheumatology, 44(10), 1529-1535. https://doi.org/10.3899/jrheum.161139

@article{febf5ca302094b54a2b37c81bdb107b7,

title = "OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody-associated Vasculitis",

abstract = "Objective. The antineutrophil cytoplasmic antibody-associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016.Methods. A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented.Results. OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement).Conclusion. The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial.",

keywords = "ANCA-ASSOCIATED VASCULITIS, PATIENT-REPORTED OUTCOMES, PROMIS, ICF, OMERACT, QUALITY-OF-LIFE, WEGENERS-GRANULOMATOSIS, CLINICAL-TRIALS, CORE SET, INVOLVEMENT",

author = "Robson, {Joanna C.} and Gunnar Tomasson and Nataliya Milman and Sue Ashdown and Annelies Boonen and Casey, {George C.} and Cronholm, {Peter F.} and David Cuthbertson and Jill Dawson and Haner Direskeneli and Ebony Easley and Kermani, {Tanaz A.} and Farrar, {John T.} and Don Gebhart and Georgia Lanier and Luqmani, {Raashid A.} and Alfred Mahr and McAlear, {Carol A.} and Jacqueline Peck and Beverley Shea and Shea, {Judy A.} and Sreih, {Antoine G.} and Tugwell, {Peter S.} and Merkel, {Peter A.}",

year = "2017",

month = oct,

day = "1",

doi = "10.3899/jrheum.161139",

language = "English",

volume = "44",

pages = "1529--1535",

journal = "Journal of Rheumatology",

issn = "0315-162X",

publisher = "Journal of Rheumatology Publishing Co. Ltd.",

number = "10",

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Robson, JC, Tomasson, G, Milman, N, Ashdown, S, Boonen, A, Casey, GC, Cronholm, PF, Cuthbertson, D, Dawson, J, Direskeneli, H, Easley, E, Kermani, TA, Farrar, JT, Gebhart, D, Lanier, G, Luqmani, RA, Mahr, A, McAlear, CA, Peck, J, Shea, B, Shea, JA, Sreih, AG, Tugwell, PS & Merkel, PA 2017, 'OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody-associated Vasculitis', Journal of Rheumatology, vol. 44, no. 10, pp. 1529-1535. https://doi.org/10.3899/jrheum.161139

TY - JOUR

T1 - OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody-associated Vasculitis

AU - Robson, Joanna C.

AU - Tomasson, Gunnar

AU - Milman, Nataliya

AU - Ashdown, Sue

AU - Boonen, Annelies

AU - Casey, George C.

AU - Cronholm, Peter F.

AU - Cuthbertson, David

AU - Dawson, Jill

AU - Direskeneli, Haner

AU - Easley, Ebony

AU - Kermani, Tanaz A.

AU - Farrar, John T.

AU - Gebhart, Don

AU - Lanier, Georgia

AU - Luqmani, Raashid A.

AU - Mahr, Alfred

AU - McAlear, Carol A.

AU - Peck, Jacqueline

AU - Shea, Beverley

AU - Shea, Judy A.

AU - Sreih, Antoine G.

AU - Tugwell, Peter S.

AU - Merkel, Peter A.

PY - 2017/10/1

Y1 - 2017/10/1

N2 - Objective. The antineutrophil cytoplasmic antibody-associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016.Methods. A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented.Results. OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement).Conclusion. The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial.

AB - Objective. The antineutrophil cytoplasmic antibody-associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016.Methods. A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented.Results. OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement).Conclusion. The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial.

KW - ANCA-ASSOCIATED VASCULITIS

KW - PATIENT-REPORTED OUTCOMES

KW - PROMIS

KW - ICF

KW - OMERACT

KW - QUALITY-OF-LIFE

KW - WEGENERS-GRANULOMATOSIS

KW - CLINICAL-TRIALS

KW - CORE SET

KW - INVOLVEMENT

U2 - 10.3899/jrheum.161139

DO - 10.3899/jrheum.161139

M3 - Article

C2 - 28864650

SN - 0315-162X

VL - 44

SP - 1529

EP - 1535

JO - Journal of Rheumatology

JF - Journal of Rheumatology

IS - 10

ER -