TY - JOUR
T1 - Development and Preliminary Validation of a New Patient-Reported Outcome Measure for Chronic Rhinosinusitis (CRS-PRO)
AU - Ghadersohi, Saied
AU - Price, Caroline P.E.
AU - Jensen, Sally E.
AU - Beaumont, Jennifer L.
AU - Kern, Robert C.
AU - Conley, David B.
AU - Welch, Kevin C.
AU - Peters, Anju T.
AU - Grammer, Leslie C.
AU - Stevens, Whitney W.
AU - Calice, Alexis M.
AU - Stanton, Elizabeth
AU - VanderMeeden, Marisa K.
AU - Schleimer, Robert P.
AU - Tan, Bruce K.
N1 - Funding Information:
Conflicts of interest: R. C. Kern is a consultant of Lyra Therapeutics, Sanofi/Regeneron, GSK, and Genentech. A. T. Peters reports personal fees from Sanofi/Regeneron, grants and personal fees from Astrazeneca and Optinose, outside the submitted work. L. C. Grammer III has received grants from the National Institutes of Health and Bazley Foundation to support her research; has received grants for her institution from the National Institute of Health Food Allergy Network, AstraZeneca, and Sanofi Regeneron; serves as a consultant for Astellas Pharmaceuticals; and has received royalties and payment for lectures from the American Academy of Allergy, Asthma and Immunology (AAAAI), Mount Sinai, Lippincott, UpToDate, Elsevier, and Wolters Kluwer. W. W. Stevens has served on an advisory board for GlaxoSmithKline. R. P. Schleimer is a consultant for Intersect ENT, GlaxoSmithKline, Merck, Sanofi, AstraZeneca/Medimmune, Genentech, Otsuka, Actobio Therapeutics, Lyra Therapeutics, Astellas Pharm Inc, Genzyme/Sanofi Corp, and Celgene Corp; is also a consultant with stock/stock options that are not valued yet with Allakos, Aurasense, BioMarck, Exicure, and Aqualung Therapeutics Corp; has a patent with Allakos related to Siglec-8 and Siglec-8 ligand related products that have not been developed yet; and also received grants from the National Institutes of Health to support this and other research. B. K. Tan has received grants from the National Institutes of Health to support this research; and has served on advisory boards for Sanofi/Genzyme and Optinose. The rest of the authors declare that they have no relevant conflicts of interest.
Funding Information:
This study was supported by the National Institutes of Health Grants: U01 AI106683 - Chronic Rhinosinusitis Integrative Studies Program (CRISP), K23DC012067 , R01DC016645 ; the Ernest S. Bazley Foundation; and, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences , Grant Number UL1TR001422 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2020 American Academy of Allergy, Asthma & Immunology
PY - 2020/7/1
Y1 - 2020/7/1
N2 - Background: Patient-reported outcome (PRO) measures developed and validated on patients with the currently defined phenotypes of chronic rhinosinusitis (CRS) are needed to support clinical trials in CRS. Objective: This study developed and examined the initial reliability and validity of the CRS-PRO, a new PRO measure of CRS. Methods: Instrument development was performed through structured interviews and focus groups with clinical experts and 45 patients with CRS meeting current definitions of disease, 21 patients with CRS without nasal polyps (CRSsNP), and 24 patients with CRS with nasal polyps (CRSwNP) to identify items important to patients. Then another 50 patients (32 with CRSsNP and 18 with CRSwNP) with stable CRS symptoms were enrolled to evaluate the reliability of the instrument. Each patient completed the CRS-PRO, Sinonasal Outcome Test-22 (SNOT-22), and 4 Patient-Reported Outcome Measurement Information System short forms at the baseline visit and then at least 7 days later. Results: After the development process, 21 items were identified from the conceptual domains of physical symptoms, sensory impairment, psychosocial effects, and life impact. Using the responses of the 50 patients with CRS, 21 draft items were further refined to 12 items by eliminating conceptually similar or highly correlated items or those with low mean symptom severity. The 12-item questionnaire was shown to have excellent internal consistency (Cronbach α, 0.86) and test-retest reliability with a high intraclass correlation coefficient (0.89) and Pearson's correlation (r = 0.82, P <.0001). The 12-item CRS-PRO correlated highly with the longer SNOT-22 (r = 0.83, P <.0001) demonstrating its concurrent validity. We also demonstrated validity and reliability in a separate analysis for patients with CRSsNP and CRSwNP. Conclusion: The CRS-PRO is a concise, valid, and reliable measure that was developed with extensive input from patients with CRS with current disease definitions.
AB - Background: Patient-reported outcome (PRO) measures developed and validated on patients with the currently defined phenotypes of chronic rhinosinusitis (CRS) are needed to support clinical trials in CRS. Objective: This study developed and examined the initial reliability and validity of the CRS-PRO, a new PRO measure of CRS. Methods: Instrument development was performed through structured interviews and focus groups with clinical experts and 45 patients with CRS meeting current definitions of disease, 21 patients with CRS without nasal polyps (CRSsNP), and 24 patients with CRS with nasal polyps (CRSwNP) to identify items important to patients. Then another 50 patients (32 with CRSsNP and 18 with CRSwNP) with stable CRS symptoms were enrolled to evaluate the reliability of the instrument. Each patient completed the CRS-PRO, Sinonasal Outcome Test-22 (SNOT-22), and 4 Patient-Reported Outcome Measurement Information System short forms at the baseline visit and then at least 7 days later. Results: After the development process, 21 items were identified from the conceptual domains of physical symptoms, sensory impairment, psychosocial effects, and life impact. Using the responses of the 50 patients with CRS, 21 draft items were further refined to 12 items by eliminating conceptually similar or highly correlated items or those with low mean symptom severity. The 12-item questionnaire was shown to have excellent internal consistency (Cronbach α, 0.86) and test-retest reliability with a high intraclass correlation coefficient (0.89) and Pearson's correlation (r = 0.82, P <.0001). The 12-item CRS-PRO correlated highly with the longer SNOT-22 (r = 0.83, P <.0001) demonstrating its concurrent validity. We also demonstrated validity and reliability in a separate analysis for patients with CRSsNP and CRSwNP. Conclusion: The CRS-PRO is a concise, valid, and reliable measure that was developed with extensive input from patients with CRS with current disease definitions.
KW - CRS-PRO
KW - Chronic rhinosinusitis
KW - Nasal polyps
KW - Patient-reported outcome measure
KW - Reliability
KW - Validity
UR - http://www.scopus.com/inward/record.url?scp=85086050313&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85086050313&partnerID=8YFLogxK
U2 - 10.1016/j.jaip.2020.04.048
DO - 10.1016/j.jaip.2020.04.048
M3 - Article
C2 - 32376490
AN - SCOPUS:85086050313
SN - 2213-2198
VL - 8
SP - 2341-2350.e1
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 7
ER -