The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms: The Genital Psoriasis Symptoms Scale (GPSS)

Alice B. Gottlieb, Brian Kirby, Caitriona Ryan, April N. Naegeli, Russel Burge, Alison Potts Bleakman, Milena D. Anatchkova, Gil Yosipovitch

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Introduction: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. Methods: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs. Results: Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS. Conclusion: The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs. Funding: Eli Lilly & Company. Plain Language Summary: Plain language summary available for this article.

Original languageEnglish (US)
Pages (from-to)45-56
Number of pages12
JournalDermatology and Therapy
Volume8
Issue number1
DOIs
StatePublished - Mar 1 2018

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Psoriasis
Outcome Assessment (Health Care)
Symptom Assessment
Patient Reported Outcome Measures
Language
Clinical Trials
Interviews
Erythema
Cross-Sectional Studies

Keywords

  • Genital psoriasis
  • Health-related quality of life
  • Patient-reported outcomes
  • Psoriasis

ASJC Scopus subject areas

  • Dermatology

Cite this

The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms : The Genital Psoriasis Symptoms Scale (GPSS). / Gottlieb, Alice B.; Kirby, Brian; Ryan, Caitriona; Naegeli, April N.; Burge, Russel; Potts Bleakman, Alison; Anatchkova, Milena D.; Yosipovitch, Gil.

In: Dermatology and Therapy, Vol. 8, No. 1, 01.03.2018, p. 45-56.

Research output: Contribution to journalArticle

Gottlieb, Alice B. ; Kirby, Brian ; Ryan, Caitriona ; Naegeli, April N. ; Burge, Russel ; Potts Bleakman, Alison ; Anatchkova, Milena D. ; Yosipovitch, Gil. / The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms : The Genital Psoriasis Symptoms Scale (GPSS). In: Dermatology and Therapy. 2018 ; Vol. 8, No. 1. pp. 45-56.
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N2 - Introduction: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. Methods: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs. Results: Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS. Conclusion: The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs. Funding: Eli Lilly & Company. Plain Language Summary: Plain language summary available for this article.

AB - Introduction: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. Methods: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs. Results: Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS. Conclusion: The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs. Funding: Eli Lilly & Company. Plain Language Summary: Plain language summary available for this article.

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