TY - JOUR
T1 - Generation and Validation of the Patient-Reported Outcome Measurement Information System Itch Questionnaire–Child (PIQ-C) to Measure the Impact of Itch on Life Quality
AU - Paller, Amy S.
AU - Lai, Jin Shei
AU - Jackson, Kathryn
AU - Rangel, Stephanie M.
AU - Nowinski, Cindy
AU - Silverberg, Jonathan I.
AU - Ustsinovich, Vitali
AU - Cella, David
N1 - Funding Information:
This work was supported by the National Institutes of Health grant U19069526. Patient-Reported Outcome Measurement Information System Itch Questionnaire–Child was developed as a new Patient-Reported Outcome Measurement Information System tool for assessing itch following Food and Drug Administrative guidelines for patient-reported outcome development ( United States Food and Drug Administration, 2009 ) and as a component of validation testing of Patient-Reported Outcome Measurement Information System tools through the Pediatric Patient-Reported Outcomes in Chronic Disease Consortium (NCT03051347). We thank the National Eczema Association, the Asthma and Allergy Network, the Foundation for Ichthyosis and Related Skin Types, and the Dystrophic Epidermolysis Bullosa Research Association for partnering with us to perform the calibration assessments through questionnaires. We acknowledge the input and support of members of the Pediatric Patient-Reported Outcomes in Chronic Diseases Consortium. Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences , grant number UL1TR001422. We are grateful to Divya Ramachandran, Neha Puar, Vidhi Patel, and Rachel Lefferdink for helping to gather data or present results. We greatly appreciate the assistance of Megan Reynolds, Peter Lio, Sarah Chamlin, and Anna Fishbein in helping with patient recruitment.
Funding Information:
Details on building and calibrating the PIQ-C item bank are presented in Supplementary Figure S1. Details on the construction of the conceptual themes that formed the basis for the initial 71-item pool have been published (Fang et al., 2021). The candidate item bank was field tested for calibration in children aged 8?17 years using a nationwide online internet panel maintained by Op4G (Portsmouth, NH) and national patient support organizations for AD (National Eczema Association, Asthma and Allergy Network), ichthyosis (Foundation for Ichthyosis and Related Skin Types), and epidermolysis bullosa (Dystrophic Epidermolysis Bullosa Research Association). Cut-off of age 8 years is standard, given that attempts to lower the reading level compromise the content and nuance needed for a representative item bank. A sample size of 500 (ours was 499) is sufficient when the IRT/graded response model is used to develop measures for which stable item parameters need to be established (Reise and Revicki, 2014).This work was supported by the National Institutes of Health grant U19069526. Patient-Reported Outcome Measurement Information System Itch Questionnaire?Child was developed as a new Patient-Reported Outcome Measurement Information System tool for assessing itch following Food and Drug Administrative guidelines for patient-reported outcome development (United States Food and Drug Administration, 2009) and as a component of validation testing of Patient-Reported Outcome Measurement Information System tools through the Pediatric Patient-Reported Outcomes in Chronic Disease Consortium (NCT03051347). We thank the National Eczema Association, the Asthma and Allergy Network, the Foundation for Ichthyosis and Related Skin Types, and the Dystrophic Epidermolysis Bullosa Research Association for partnering with us to perform the calibration assessments through questionnaires. We acknowledge the input and support of members of the Pediatric Patient-Reported Outcomes in Chronic Diseases Consortium. Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences, grant number UL1TR001422. We are grateful to Divya Ramachandran, Neha Puar, Vidhi Patel, and Rachel Lefferdink for helping to gather data or present results. We greatly appreciate the assistance of Megan Reynolds, Peter Lio, Sarah Chamlin, and Anna Fishbein in helping with patient recruitment. Concept and Design: ASP, DC, JSL; Funding Acquisition: ASP, JSL, DC; Data Curation: ASP, JSL, CN, VU, DC; Analysis and Interpretation of Data: ASP, JSL, KJ, CN, JS, DC; Drafting of the Manuscript: ASP; Critical Revision of the Manuscript for Important Intellectual Content: ASP, DC, JSL; Review of the Final Manuscript: All authors; Statistical Analysis: KJ, JSL; Administrative, Technical, or Material Support: All work done by the authors; Study Supervision: ASP, JSL. Drs Paller and Lai had full access to all data and take responsibility for data integrity and the accuracy of data and analysis, The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2021 The Authors
PY - 2022/5
Y1 - 2022/5
N2 - Itch compromises QOL, but most itch assessments focus only on itch intensity. We aimed to develop and validate a comprehensive Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measure for itch symptoms and itch impact, defined as the effect specifically of itch on physical, mental, and social health, all of which can affect life quality. After literature review, concept elicitation and cognitive interviews with parents and children with itch, and repeated content-expert review, an item pool was generated and refined. The pool was calibrated with data from 499 children with pruritus using exploratory and confirmatory factor analyses, item response theory, and item fit analysis. The resultant 45-item bank, PROMIS Itch Questionnaire–Child (PIQ-C), showed good convergent and discriminant validity in 181 children aged 8‒17 years, discriminating children with different levels of severity, and was responsive to change. Strong correlations (rho ≥ 0.60) were observed with pain and sleep measures, and moderate correlations were observed with other pediatric Patient-Reported Outcomes Measurement Information System measures. Patient-Reported Outcomes Measurement Information System Itch Questionnaire–Child comprehensively measures itch intensity and burden, providing an itch-specific alternative for assessing life quality. The independent calibration of each item/question allows for flexibility in generating short forms or computerized adaptive testing for efficient use in research and office practice.
AB - Itch compromises QOL, but most itch assessments focus only on itch intensity. We aimed to develop and validate a comprehensive Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measure for itch symptoms and itch impact, defined as the effect specifically of itch on physical, mental, and social health, all of which can affect life quality. After literature review, concept elicitation and cognitive interviews with parents and children with itch, and repeated content-expert review, an item pool was generated and refined. The pool was calibrated with data from 499 children with pruritus using exploratory and confirmatory factor analyses, item response theory, and item fit analysis. The resultant 45-item bank, PROMIS Itch Questionnaire–Child (PIQ-C), showed good convergent and discriminant validity in 181 children aged 8‒17 years, discriminating children with different levels of severity, and was responsive to change. Strong correlations (rho ≥ 0.60) were observed with pain and sleep measures, and moderate correlations were observed with other pediatric Patient-Reported Outcomes Measurement Information System measures. Patient-Reported Outcomes Measurement Information System Itch Questionnaire–Child comprehensively measures itch intensity and burden, providing an itch-specific alternative for assessing life quality. The independent calibration of each item/question allows for flexibility in generating short forms or computerized adaptive testing for efficient use in research and office practice.
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U2 - 10.1016/j.jid.2021.10.015
DO - 10.1016/j.jid.2021.10.015
M3 - Article
C2 - 34757070
AN - SCOPUS:85122329430
SN - 0022-202X
VL - 142
SP - 1309-1317.e1
JO - Journal of Investigative Dermatology
JF - Journal of Investigative Dermatology
IS - 5
ER -