PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

Ana-Maria Orbai*, Richard Holland, Ying Ying Leung, William Tillett, Niti Goel, Robin Christensen, Neil McHugh, Laure Gossec, Maarten de Wit, Pil Højgaard, Laura C Coates, Philip J Mease, Julie Birt, Lara Fallon, Oliver FitzGerald, Alexis Ogdie, Beverly Shea, Vibeke Strand, Kristina Callis Duffin, Peter Tugwell & 2 others Dorcas Beaton, Dafna D Gladman

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

OBJECTIVE: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL).

METHODS: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018).

RESULTS: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes."

CONCLUSION: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.

Original languageEnglish
JournalJournal of Rheumatology
Volume46
Issue number8
Pages (from-to)990-995
ISSN0315-162X
DOIs
Publication statusPublished - Aug 2019

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Psoriatic Arthritis
Quality of Life
Outcome Assessment (Health Care)
Clinical Trials
Amber
Longitudinal Studies
Randomized Controlled Trials
Research
Rheumatology
Psoriasis
Education

Cite this

Orbai, Ana-Maria ; Holland, Richard ; Leung, Ying Ying ; Tillett, William ; Goel, Niti ; Christensen, Robin ; McHugh, Neil ; Gossec, Laure ; de Wit, Maarten ; Højgaard, Pil ; Coates, Laura C ; Mease, Philip J ; Birt, Julie ; Fallon, Lara ; FitzGerald, Oliver ; Ogdie, Alexis ; Shea, Beverly ; Strand, Vibeke ; Callis Duffin, Kristina ; Tugwell, Peter ; Beaton, Dorcas ; Gladman, Dafna D. / PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials. In: Journal of Rheumatology. 2019 ; Vol. 46, No. 8. pp. 990-995.
@article{dafb57b6c21d449ca974a0bbde004383,
title = "PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials",
abstract = "OBJECTIVE: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL).METHODS: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018).RESULTS: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5{\%} (84) voted {"}yes{"} to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93{\%} of them (13) voted {"}yes{"}; 82 participants were not PRP and 87{\%} of them (71) voted {"}yes.{"}CONCLUSION: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.",
author = "Ana-Maria Orbai and Richard Holland and Leung, {Ying Ying} and William Tillett and Niti Goel and Robin Christensen and Neil McHugh and Laure Gossec and {de Wit}, Maarten and Pil H{\o}jgaard and Coates, {Laura C} and Mease, {Philip J} and Julie Birt and Lara Fallon and Oliver FitzGerald and Alexis Ogdie and Beverly Shea and Vibeke Strand and {Callis Duffin}, Kristina and Peter Tugwell and Dorcas Beaton and Gladman, {Dafna D}",
year = "2019",
month = "8",
doi = "10.3899/jrheum.181077",
language = "English",
volume = "46",
pages = "990--995",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology Publishing Co. Ltd.",
number = "8",

}

Orbai, A-M, Holland, R, Leung, YY, Tillett, W, Goel, N, Christensen, R, McHugh, N, Gossec, L, de Wit, M, Højgaard, P, Coates, LC, Mease, PJ, Birt, J, Fallon, L, FitzGerald, O, Ogdie, A, Shea, B, Strand, V, Callis Duffin, K, Tugwell, P, Beaton, D & Gladman, DD 2019, 'PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials', Journal of Rheumatology, vol. 46, no. 8, pp. 990-995. https://doi.org/10.3899/jrheum.181077

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials. / Orbai, Ana-Maria; Holland, Richard; Leung, Ying Ying; Tillett, William; Goel, Niti; Christensen, Robin; McHugh, Neil; Gossec, Laure; de Wit, Maarten; Højgaard, Pil; Coates, Laura C; Mease, Philip J; Birt, Julie; Fallon, Lara; FitzGerald, Oliver; Ogdie, Alexis; Shea, Beverly; Strand, Vibeke; Callis Duffin, Kristina; Tugwell, Peter; Beaton, Dorcas; Gladman, Dafna D.

In: Journal of Rheumatology, Vol. 46, No. 8, 08.2019, p. 990-995.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

AU - Orbai, Ana-Maria

AU - Holland, Richard

AU - Leung, Ying Ying

AU - Tillett, William

AU - Goel, Niti

AU - Christensen, Robin

AU - McHugh, Neil

AU - Gossec, Laure

AU - de Wit, Maarten

AU - Højgaard, Pil

AU - Coates, Laura C

AU - Mease, Philip J

AU - Birt, Julie

AU - Fallon, Lara

AU - FitzGerald, Oliver

AU - Ogdie, Alexis

AU - Shea, Beverly

AU - Strand, Vibeke

AU - Callis Duffin, Kristina

AU - Tugwell, Peter

AU - Beaton, Dorcas

AU - Gladman, Dafna D

PY - 2019/8

Y1 - 2019/8

N2 - OBJECTIVE: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL).METHODS: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018).RESULTS: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes."CONCLUSION: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.

AB - OBJECTIVE: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL).METHODS: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018).RESULTS: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes."CONCLUSION: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.

U2 - 10.3899/jrheum.181077

DO - 10.3899/jrheum.181077

M3 - Journal article

VL - 46

SP - 990

EP - 995

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 8

ER -