Early development and qualitative evidence of content validity for the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure of psoriasis symptom severity

Martin, Mona L.; McCarrier, K.P.; Chiou, Chiun–Fang; Gordon, Kenneth B.; Kimball, Alexa B.; Voorhees, Abby S. Van; Gottlieb, Alice B.; Huang, Xingyue; Globe, Denise; Chau, Dina; Viswanathan, Hema N.; Kricorian, Greg

doi:10.3109/09546634.2012.759639

Cited by 37 publications

(48 citation statements)

References 13 publications

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“…16,18,20 The PSI captures patient experiences with psoriasis on eight items -itch, redness, scaling, burning, stinging, cracking, flaking and pain. A greater percentage of patients randomized to brodalumab compared with placebo reported no or mild severity on each item of the PSI.…”

Section: Discussionmentioning

confidence: 99%

“…The Psoriasis Symptom Inventory (PSI) is a validated eight-item psoriasis-specific patientreported outcome measure administered daily that rates the severity of signs and symptoms in the last 24 h from 0 to 4, for a total score from 0 (best) to 32 (worst). [16][17][18] The…”

Section: Clinical Assessmentsmentioning

confidence: 99%

“…Each item is scored from 0 to 3, for a total score from 0 to 21 each for the anxiety and depression scales. 19 HADS severity groups are categorized as 'normal' (score 0-7), 'mild' (8-10), 'moderate' (11)(12)(13)(14) and 'severe' (15)(16)(17)(18)(19)(20)(21). Gene expression and tissue concentrations of biomarkers in psoriatic lesional and nonlesional skin were analysed.…”

Section: Clinical Assessmentsmentioning

confidence: 99%

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A prospective phase III, randomized, double‐blind, placebo‐controlled study of brodalumab in patients with moderate‐to‐severe plaque psoriasis

et al. 2016

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SummaryBackground The interleukin-17 cytokine family plays a central role in psoriasis pathogenesis. Objectives To evaluate the efficacy and safety of brodalumab, a human anti-interleukin-17 receptor antibody, in treating patients with moderate-to-severe plaque psoriasis. Methods In this phase III, double-blind, placebo-controlled study (NCT01708590; AMAGINE-1), adult patients in the U.S.A., Canada and Europe were randomized to brodalumab (140 or 210 mg) or placebo every 2 weeks (Q2W), with an additional dose at week 1, for a 12-week induction phase. At week 12, patients receiving brodalumab who achieved static Physician's Global Assessment 0 or 1 (sPGA success) were rerandomized to the placebo or induction dose. After week 16, patients with sPGA ≥ 3 were re-treated with the induction dose. After ≥ 12 weeks of retreatment, patients with sPGA 2 for ≥ 4 weeks or sPGA ≥ 3 were rescued with brodalumab 210 mg Q2W. At week 12, patients randomized to brodalumab with sPGA ≥ 2 or placebo received brodalumab 210 mg Q2W. Coprimary end points were the percentage of patients with ≥ 75% improvement in Psoriasis Area and Severity Index score (PASI 75) and sPGA success at week 12. Results There were 661 patients randomized: 220 placebo, 219 brodalumab 140 mg and 222 brodalumab 210 mg. At week 12, 60% (140 mg) and 83% (210 mg) vs. 3% (placebo) achieved PASI 75, and 54% (140 mg) and 76% (210 mg) vs. 1% (placebo) achieved sPGA success. The safety profile was considered acceptable. Conclusions Brodalumab therapy resulted in significant clinical benefit and an acceptable safety profile in patients with moderate-to-severe plaque psoriasis.

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Section: Discussionmentioning

confidence: 99%

Section: Clinical Assessmentsmentioning

confidence: 99%

Section: Clinical Assessmentsmentioning

confidence: 99%

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A prospective phase III, randomized, double‐blind, placebo‐controlled study of brodalumab in patients with moderate‐to‐severe plaque psoriasis

et al. 2016

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“…[83][84][85][86] Nevertheless, our strategy ensures that the evidence obtained applies to patients with PsA as a whole.…”

Section: Discussionmentioning

confidence: 99%

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative

Højgaard

Klokker

Orbai

et al. 2018

Seminars in Arthritis and Rheumatism

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ReuseThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs (CC BY-NC-ND) licence. This licence only allows you to download this work and share it with others as long as you credit the authors, but you can't change the article in any way or use it commercially. More information and the full terms of the licence here: https://creativecommons.org/licenses/ Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing eprints@whiterose.ac.uk including the URL of the record and the reason for the withdrawal request. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. ABSTRACT Background: An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials

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“…There are separate distinct patient-reported psoriasis outcome measures: Self-Administered PASI (SAPASI), Visual Analog Scale (VAS), and Psoriasis Symptoms Inventory (PSI) [13][14][15][16][17]. Attempts to incorporate both the physician's and patient's assessments have led to the creation of composite severity scales, such as the National Psoriasis Foundation Score (NPF-PS), Salford Psoriasis Index (SPI), and Dermatology Index of Disease Severity (DIDS), all of which are not commonly utilized [18][19][20][21][22].…”

Section: Existing Psoriasis and Psoriatic Arthritis Outcome Measuresmentioning

confidence: 99%

Outcome Measures in Psoriasis and Psoriatic Arthritis

Kim

Gottlieb

2013

Curr Derm Rep

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The recent health policy imperatives in the United States have consequentially called to attention the absence of dermatologic evaluations in the health outcome and quality measures that will ultimately grade the success of providers. Psoriasis, in particular, represents a patient cohort with a chronic, complex and debilitating skin disorder commonly encountered in dermatology clinics that can have insufferable consequences from disease progression and comorbidities if it is not properly evaluated and managed. In order to have the appropriate compensation to the providers and the availabilities of the correct treatments to the patients, the presence of psoriasis-specific outcome measures are necessary. Incorporating the concepts employed by the rheumatology group, Outcome Measures for Rheumatoid Arthritis Clinical Trials (OMERACT), that created outcomes for several musculoskeletal diseases, initiatives in dermatology have already begun to create standardized, validated psoriasis outcome measures.

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Early development and qualitative evidence of content validity for the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure of psoriasis symptom severity

Abstract: The PSI is a short, low burden, patient-reported measure of psoriasis symptom severity with documented evidence of content validity.

Cited by 37 publications

References 13 publications

A prospective phase III, randomized, double‐blind, placebo‐controlled study of brodalumab in patients with moderate‐to‐severe plaque psoriasis

A prospective phase III, randomized, double‐blind, placebo‐controlled study of brodalumab in patients with moderate‐to‐severe plaque psoriasis

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative

Outcome Measures in Psoriasis and Psoriatic Arthritis

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