The Psoriasis Symptom Diary: Development and content validity of a novel patient-reported outcome instrument

International Journal of Dermatology

Volumn 53, Issue 6, 2014, Pages 714-722

  Lebwohl, Mark ^a   Swensen, Andrine R ^a   Nyirady, Judit ^a   Kim, Edward ^a   Gwaltney, Chad J ^a   Strober, Bruce E ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; BURN; CLINICAL ARTICLE; CONTENT VALIDITY; FEMALE; HUMAN; INTERVIEW; LIMITED MOBILITY; MALE; OUTCOME ASSESSMENT; PERSONAL APPEARANCE; PRURITUS; PSORIASIS SYMPTOM DIARY; PSORIASIS VULGARIS; RECALL BIAS; SOCIAL BEHAVIOR; SWIMMING; SYMPTOM ASSESSMENT; ADAPTATION; ADAPTIVE BEHAVIOR; ADOLESCENT; AGE; COHORT ANALYSIS; MIDDLE AGED; OBSERVER VARIATION; PATHOPHYSIOLOGY; PSORIASIS; PSYCHOLOGY; PSYCHOMETRY; QUALITY OF LIFE; QUESTIONNAIRE; SELF REPORT; SEVERITY OF ILLNESS INDEX; SEX DIFFERENCE; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME; VALIDATION STUDY; YOUNG ADULT;

ADAPTATION, PHYSIOLOGICAL; ADAPTATION, PSYCHOLOGICAL; ADOLESCENT; ADULT; AGE FACTORS; AGED; COHORT STUDIES; FEMALE; HUMANS; MALE; MIDDLE AGED; OBSERVER VARIATION; PSORIASIS; PSYCHOMETRICS; QUALITY OF LIFE; QUESTIONNAIRES; SELF REPORT; SEVERITY OF ILLNESS INDEX; SEX FACTORS; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84900824464     PISSN: 00119059     EISSN: 13654632     Source Type: Journal    
DOI: 10.1111/j.1365-4632.2012.05798.x     Document Type: Article

References (19)

1. Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999; 41: 401-407.
2. Finlay AY, Coles EC. The effect of severe of psoriasis on the quality of life of 369 patients. Br J Dermatol 1995; 132: 236-244.
3. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol 2008; 58: 106-115.
4. Carlin SC, Feldman SR, Kreuger JG, et al. A 50% reduction in the psoriasis area and severity index (PASI 50) in a clinically significant endpoint in the assessment of psoriasis. J Am Acad Dermatol 2004; 50: 859-866.
5. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) - a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 210-216.
6. Chren MM, Lasek J, Flocke SA, et al. Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol 1997; 133: 1440-1443.
7. Feldman SR, Koo JY, Menter A, et al. Decision points for the initiation of systemic treatment for psoriasis. J Am Acad Dermatol 2005; 53: 101-107.
8. Lewis VJ, Finlay AY. Two decades' experience of the Psoriasis Disability Index. Dermatology 2005; 210: 261-268.
9. 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.
10. Jacobson CC, Kimball AB. Rethinking the psoriasis area and severity index: the impact of area should be increased. Br J Dermatol 2004; 151: 381-387.
11. Grob JJ. Why are quality of life instruments not recognized as reference measures in therapeutic trials of chronic skin disorders? J Invest Dermatol 2007; 127: 2315-2322.
12. Food and Drug Administration. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling. Silver Spring, MD: Food and Drug Administration, 2009.
13. Stone AA, Schwatz JE, Broderick JE, et al. Variability of momentary pain predicts recall of weekly pain: a consequence of the peak (or salience) memory. Pers Soc Psychol Bull 2005; 31: 1340-1346.
14. Dubertret L, Mrowietz U, Ranki A, et al. European patient perspectives on the impact of psoriasis: the EUROPSO patient membership survey. Br J Dermatol 2006; 155: 729-736.
15. Krueger G., Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: results from a 1998 National Psoriasis Foundation Patient-Membership Survey. Arch Dermatol 2001; 137: 280-284.
16. Ersser SJ, Surridge H, Wiles A. What criteria do patients use when judging the effectiveness of psoriasis management? J Eval Clin Pract 2002; 8: 367-376.
17. Patrick DL, Burke LB, Gwaltney CJ, et al. Establishing and reporting evidence of the content validity of newly-developed patient-reported outcome (PRO) instruments for medical product evaluation: good research practices. Part I: eliciting concepts for a new PRO instrument. Value Health 2011; 14: 967-977.
18. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain in clinical trials: IMMPACT recommendations. Pain 2005; 113: 9-19.
19. Patrick DL, Burke LB, Gwaltney CJ, et al. Establishing and reporting evidence of the content validity of newly-developed patient-reported outcome (PRO) instruments for medical product evaluation: good research practices. Part II: assessing respondent understanding. Value Health 2011; 14: 978-988.