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

Research output: Contribution to journalArticle

1 Citation (Scopus)

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
Pages (from-to)990-995
Number of pages6
JournalThe Journal of Rheumatology
Volume46
Issue number1
Early online date15 Dec 2018
DOIs
Publication statusPublished - 1 Aug 2019

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

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: The Journal of Rheumatology, Vol. 46, No. 1, 01.08.2019, p. 990-995.

Research output: Contribution to journalArticle

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', The Journal of Rheumatology, vol. 46, no. 1, pp. 990-995. https://doi.org/10.3899/jrheum.181077
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: The Journal of Rheumatology. 2019 ; Vol. 46, No. 1. pp. 990-995.
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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.",
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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 - 2019/8/1

Y1 - 2019/8/1

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.

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