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Monitoring disease activity

Development of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis: qualitative and quantitative analyses

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Pages 452-459 | Received 09 Jan 2019, Accepted 14 May 2019, Published online: 15 Jul 2019

References

  • Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70:512–516.
  • Michalek IM, Loring B, John SM. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol. 2017;31:205–212.
  • Furue M, Tsuji G, Chiba T, et al. Cardiovascular and metabolic diseases comorbid with psoriasis: beyond the skin. Intern Med. 2017;56:1613–1619.
  • Puig L. Cardiometabolic comorbidities in psoriasis and psoriatic arthritis. Int J Mol Sci. 2018;19:58.
  • Wu JJ, Feldman SR, Koo J, et al. Epidemiology of mental health comorbidity in psoriasis. J Dermatol Treat. 2018;29:487–495.
  • Li K, Armstrong AW. A review of health outcomes in patients with psoriasis. Dermatol Clin. 2012;30:61–72.
  • Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65–68.
  • Feldman SR, Fleischer AB, Jr., Reboussin DM, et al. The self-administered psoriasis area and severity index is valid and reliable. J Invest Dermatol. 1996;106:183–186.
  • Martin ML, McCarrier KP, Chiou CF, et al. Early development and qualitative evidence of content validity for the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure of psoriasis symptom severity. J Dermatol Treat. 2013;24:255–260.
  • Revicki DA, Jin Y, Wilson HD, et al. Reliability and validity of the psoriasis symptom inventory in patients with moderate-to-severe psoriasis. J Dermatolog Treat. 2014;25:8–14.
  • Armstrong A, Puig L, Langley R, et al. Validation of psychometric properties and development of response criteria for the Psoriasis Symptoms and Signs Diary (PSSD): results from a phase III clinical trial. J Dermatol Treat. 2019;30:27–34.
  • Mathias SD, Feldman SR, Crosby RD, et al. Measurement properties of a patient-reported outcome measure assessing psoriasis severity: the psoriasis symptoms and signs diary. J Dermatol Treat. 2016;27:322–327.
  • Naegeli AN, Flood E, Tucker J, et al. The Worst Itch Numeric Rating Scale for patients with moderate to severe plaque psoriasis or psoriatic arthritis. Int J Dermatol. 2015;54:715–722.
  • Kimball AB, Naegeli AN, Edson-Heredia E, et al. Psychometric properties of the Itch Numeric Rating Scale in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016;175:157–162.
  • Gottlieb AB, Kirby B, Ryan C, et al. The development of a patient-reported outcome measure for assessment of genital psoriasis symptoms: the Genital Psoriasis Symptoms Scale (GPSS). Dermatol Ther (Heidelb). 2018;8:45–56.
  • Bushnell DM, Martin ML, McCarrier K, et al. Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure to assess psoriasis symptom severity. J Dermatolog Treat. 2013;24:356–360.
  • Lebwohl M, Swensen AR, Nyirady J, et al. The Psoriasis Symptom Diary: development and content validity of a novel patient-reported outcome instrument. Int J Dermatol. 2014;53:714–722.
  • Feldman SR, Mathias SD, Schenkel B, et al. Development of a patient-reported outcome questionnaire for use in adults with moderate-to-severe plaque psoriasis: The Psoriasis Symptoms and Signs Diary. J Dermatol Dermatol Surg. 2016;20:19–26.
  • Chren MM, Lasek RJ, Quinn LM, et al. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol. 1996;107:707–713.
  • Brunelli C, Zecca E, Martini C, et al. Comparison of numerical and verbal rating scales to measure pain exacerbations in patients with chronic cancer pain. Health Qual Life Outcomes. 2010;8:42.
  • Food and Drug Administration. Public meeting on patient-focused drug development for psoriasis [transcript] [cited 2018 Mar 14]. 2016. Available from: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM513350.pdf.
  • Reich K, Rich P, Maari C, et al. Efficacy and safety of mirikizumab (LY3074828) in the treatment of moderate-to-severe plaque psoriasis: results from a Randomised Phase 2 Study. Br J Dermatol. 2019;181:88–95.
  • McHorney CA, Ware JE, Jr., Lu JF, et al. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994;32:40–66.
  • U.S. Department of Health and Human Services. Food and Drug Administration. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. December 2009; [cited 2018 Sep 28]. Available from: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf.
  • Hays RD, Revicki D. Reliability and validity (including responsiveness). In: Fayers P, Hays R, editors. Assessing quality of life in clinical trials: methods and practice. 2nd ed. New York (NY): Oxford University Press; 2005. p. 25–39.
  • Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159–174.
  • Basra MK, Salek MS, Camilleri L, et al. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology (Basel). 2015;230:27–33.
  • Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) – a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19:210–216.
  • Hongbo Y, Thomas CL, Harrison MA, et al. Translating the science of quality of life into practice: what do dermatology life quality index scores mean? J Invest Dermatol. 2005;125:659–664.
  • Ware JE, Kosinski M, Dewey JE. How to score Version 2 of the SF-36 Health Survey (Standard and Acute forms). 3rd ed. Lincoln (RI): QualityMetric; 2000.
  • Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483.
  • Cauli A, Gladman DD, Mathieu A, et al. Patient global assessment in psoriatic arthritis: a multicenter GRAPPA and OMERACT study. J Rheumatol. 2011;38:898–903.
  • Ashcroft DM, Wan Po AL, Williams HC, et al. Clinical measures of disease severity and outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol. 1999;141:185–191.
  • Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale (NJ): Lawrence Erlbaum Associates; 1988.
  • Rothman M, Burke L, Erickson P, et al. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health. 2009;12:1075–1083.
  • Strober B, Sigurgeirsson B, Popp G, et al. Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials. Int J Dermatol. 2016; 55:401–407.
  • Schäfer I, Hacker J, Rustenbach SJ, et al. Concordance of the Psoriasis Area and Severity Index (PASI) and patient-reported outcomes in psoriasis treatment. Eur J Dermatol. 2010;20:62–67.
  • Center for Drug Evaluation and Research. Application Number: 761061Orig1s000. [cited 2019 April 4]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761061Orig1s000OtherR.pdf.
  • Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica. 1978;157:238–244.
  • [EMA] European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. 2004. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf.
  • Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58:826–850.

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