Literature DB >> 28213563

Development and validation of a patient-reported outcome instrument for skin involvement in patients with systemic sclerosis.

Ada Man1, Jeannette K Correa2, Jessica Ziemek3, Robert W Simms3, David T Felson3,4, Robert Lafyatis5.   

Abstract

OBJECTIVES: We developed a patient-reported outcome (PRO) instrument to assess the skin-related quality of life in patients with systemic sclerosis (SSc).
METHODS: Participants with SSc provided input on skin-related health effects through focus groups. We developed items for scleroderma skin PRO (SSPRO) to encompass these effects. Further consideration from cognitive interviews and an expert panel led to reduction and modification of items. A 22-item SSPRO was field tested. Psychometric analysis included test-retest reliability, internal consistency and exploratory factor analysis (EFA). Construct validity was assessed through correlation with other participant and physician-assessed measures.
RESULTS: 140 participants completed the SSPRO: mean age was 53.4 years, median disease duration was 5 years, 82.1% were female and 32.9% had diffuse cutaneous SSc. EFA supported four factors in SSPRO corresponding to hypothesised constructs: physical effects, physical limitations, emotional effects and social effects. Removal of 4/22 items resulted in acceptable goodness-of-fit statistics. Test-retest reliability (intraclass correlation coefficient=0.61-0.83) was moderate to high and internal consistency (Cronbach's α=0.89-0.96) was high. SSPRO correlated strongly with other participant-reported measures (r=0.59-0.88) suggesting construct validity, and less well with physician-assessed measures (r=0.31-0.40). SSPRO scores were significantly different for each level of participant-reported skin severity, and for limited versus diffuse cutaneous SSc.
CONCLUSIONS: SSPRO has been developed with extensive patient input and demonstrates evidence for reliability and validity. It is complementary to existing measures of SSc skin involvement with emphasis on the patient's experience. Further research is needed to assess its sensitivity to change. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Entities:  

Keywords:  Outcomes research; Patient perspective; Qualitative research; Systemic Sclerosis

Mesh:

Year:  2017        PMID: 28213563     DOI: 10.1136/annrheumdis-2016-210534

Source DB:  PubMed          Journal:  Ann Rheum Dis        ISSN: 0003-4967            Impact factor:   19.103


  8 in total

1.  Inhibition of β-Catenin Signaling in the Skin Rescues Cutaneous Adipogenesis in Systemic Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial of C-82.

Authors:  Robert Lafyatis; Julio C Mantero; Jessica Gordon; Nina Kishore; Mary Carns; Howard Dittrich; Robert Spiera; Robert W Simms; John Varga
Journal:  J Invest Dermatol       Date:  2017-08-12       Impact factor: 8.551

Review 2.  Endocannabinoid system and its modulation of brain, gut, joint and skin inflammation.

Authors:  Newman Osafo; Oduro K Yeboah; Aaron O Antwi
Journal:  Mol Biol Rep       Date:  2021-04-28       Impact factor: 2.316

Review 3.  Patient-reported outcome instruments in clinical trials of systemic sclerosis.

Authors:  John D Pauling; Joana Caetano; Corrado Campochiaro; Giacomo De Luca; Ana Maria Gheorghiu; Maria Grazia Lazzaroni; Dinesh Khanna
Journal:  J Scleroderma Relat Disord       Date:  2019-11-25

Review 4.  Assessment of disease outcome measures in systemic sclerosis.

Authors:  Robert Lafyatis; Eleanor Valenzi
Journal:  Nat Rev Rheumatol       Date:  2022-07-20       Impact factor: 32.286

Review 5.  Skin involvement in early diffuse cutaneous systemic sclerosis: an unmet clinical need.

Authors:  Ariane L Herrick; Shervin Assassi; Christopher P Denton
Journal:  Nat Rev Rheumatol       Date:  2022-03-15       Impact factor: 32.286

6.  Myofibroblast transcriptome indicates SFRP2hi fibroblast progenitors in systemic sclerosis skin.

Authors:  Tracy Tabib; Mengqi Huang; Nina Morse; Anna Papazoglou; Rithika Behera; Minxue Jia; Melissa Bulik; Daisy E Monier; Panayiotis V Benos; Wei Chen; Robyn Domsic; Robert Lafyatis
Journal:  Nat Commun       Date:  2021-07-19       Impact factor: 14.919

7.  Safety and Efficacy of Lenabasum in a Phase II, Randomized, Placebo-Controlled Trial in Adults With Systemic Sclerosis.

Authors:  Robert Spiera; Laura Hummers; Lorinda Chung; Tracy M Frech; Robyn Domsic; Vivien Hsu; Daniel E Furst; Jessica Gordon; Maureen Mayes; Robert Simms; Robert Lafyatis; Viktor Martyanov; Tammara Wood; Michael L Whitfield; Scott Constantine; Elizabeth Lee; Nancy Dgetluck; Barbara White
Journal:  Arthritis Rheumatol       Date:  2020-07-17       Impact factor: 10.995

8.  Clinical trial protocol: PRednisolone in early diffuse cutaneous Systemic Sclerosis (PRedSS).

Authors:  Ariane L Herrick; Deborah J Griffiths-Jones; W David Ryder; Justin C Mason; Christopher P Denton
Journal:  J Scleroderma Relat Disord       Date:  2020-09-17
  8 in total

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