Susan D Mathias1, Steven R Feldman2, Ross D Crosby1,3,4, Hilary H Colwell1, Kelly McQuarrie5, Chenglong Han5. 1. a Health Outcomes Solutions , Winter Park , FL , USA . 2. b Wake Forest University School of Medicine , Winston Salem , NC , USA . 3. c Neuropsychiatric Research Institute , Fargo , ND , USA . 4. d University of North Dakota School of Medicine and Health Sciences , Fargo , ND , USA , and. 5. e Janssen Global Services, LLC , Malvern , PA , USA.
Abstract
BACKGROUND: Collecting reliable and valid symptom information from patients is critical for assessing psoriasis severity in clinical research. OBJECTIVE: To evaluate measurement properties of a new patient-reported outcome (PRO), the Psoriasis Symptoms and Signs Diary (PSSD). METHODS: One hundred six US patients with moderate-to-severe plaque psoriasis completed two versions of the PSSD [a 24-hour recall (PSSD-24h) and 7-day recall (PSSD-7d)] using a 0-10 numerical rating scale. Reliability (test-retest and internal consistency), validity (convergent, divergent and known-groups), responsiveness, and version equivalence were evaluated. Minimally important difference was estimated. RESULTS: Based on exploratory factor analysis and clinical input, symptom, sign, and total severity scores were established. Internal consistency (Cronbach's alpha ≥ 0.944) and test-retest reliability (intraclass correlation coefficients ≥ 0.824) were acceptable. Correlations with Dermatology Life Quality Index (DLQI) (0.489 to 0.644) indicated convergent validity, while low correlations (< 0.30) with several Short Form (SF)-36 scales indicated divergent validity. PSSD scores differed when patients were categorized by Body Surface Area, DLQI, and Psoriasis Area Severity Index scores. PSSD-24h and PSSD-7d versions were equivalent (Pearson correlations ≥ 0.953). LIMITATIONS: PSSD responsiveness should be evaluated in patients receiving treatment. CONCLUSION: The PSSD is reliable and valid in measuring symptoms/signs of patients with moderate-to-severe plaque psoriasis.
BACKGROUND: Collecting reliable and valid symptom information from patients is critical for assessing psoriasis severity in clinical research. OBJECTIVE: To evaluate measurement properties of a new patient-reported outcome (PRO), the Psoriasis Symptoms and Signs Diary (PSSD). METHODS: One hundred six US patients with moderate-to-severe plaque psoriasis completed two versions of the PSSD [a 24-hour recall (PSSD-24h) and 7-day recall (PSSD-7d)] using a 0-10 numerical rating scale. Reliability (test-retest and internal consistency), validity (convergent, divergent and known-groups), responsiveness, and version equivalence were evaluated. Minimally important difference was estimated. RESULTS: Based on exploratory factor analysis and clinical input, symptom, sign, and total severity scores were established. Internal consistency (Cronbach's alpha ≥ 0.944) and test-retest reliability (intraclass correlation coefficients ≥ 0.824) were acceptable. Correlations with Dermatology Life Quality Index (DLQI) (0.489 to 0.644) indicated convergent validity, while low correlations (< 0.30) with several Short Form (SF)-36 scales indicated divergent validity. PSSD scores differed when patients were categorized by Body Surface Area, DLQI, and Psoriasis Area Severity Index scores. PSSD-24h and PSSD-7d versions were equivalent (Pearson correlations ≥ 0.953). LIMITATIONS: PSSD responsiveness should be evaluated in patients receiving treatment. CONCLUSION: The PSSD is reliable and valid in measuring symptoms/signs of patients with moderate-to-severe plaque psoriasis.
Entities:
Keywords:
Psoriasis; assessment tool; minimal important difference; questionnaire; reliability; validity
Authors: K A Papp; A Blauvelt; A B Kimball; C Han; B Randazzo; Y Wasfi; Y-K Shen; S Li; C E M Griffiths Journal: J Eur Acad Dermatol Venereol Date: 2018-04-10 Impact factor: 6.166