Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials
dc.contributor.author | Warren, Richard B.; email: Richard.Warren@manchester.ac.uk | |
dc.contributor.author | Gottlieb, Alice B. | |
dc.contributor.author | Merola, Joseph F. | |
dc.contributor.author | Garcia, Llenalia | |
dc.contributor.author | Cioffi, Christopher | |
dc.contributor.author | Peterson, Luke | |
dc.contributor.author | Pelligra, Christopher | |
dc.contributor.author | Ciaravino, Valerie | |
dc.date.accessioned | 2021-10-01T15:32:30Z | |
dc.date.available | 2021-10-01T15:32:30Z | |
dc.date.issued | 2021-07-14 | |
dc.date.submitted | 2021-05-27 | |
dc.identifier | https://chesterrep.openrepository.com/bitstream/handle/10034/626009/additional-files.zip?sequence=2 | |
dc.identifier | https://chesterrep.openrepository.com/bitstream/handle/10034/626009/13555_2021_Article_570_nlm.xml?sequence=3 | |
dc.identifier | https://chesterrep.openrepository.com/bitstream/handle/10034/626009/13555_2021_Article_570.pdf?sequence=4 | |
dc.identifier.citation | Dermatology and Therapy, volume 11, issue 5, page 1551-1569 | |
dc.identifier.uri | http://hdl.handle.net/10034/626009 | |
dc.description | From Springer Nature via Jisc Publications Router | |
dc.description | History: received 2021-05-27, registration 2021-06-16, accepted 2021-06-16, pub-electronic 2021-07-14, online 2021-07-14, pub-print 2021-10 | |
dc.description | Publication status: Published | |
dc.description | Funder: UCB Pharma | |
dc.description.abstract | Abstract: Introduction: Plaque psoriasis can significantly impact patients’ quality of life. We assessed psychometric properties of the Psoriasis Symptoms and Impacts Measure (P-SIM), developed to capture patients’ experiences of signs, symptoms and impacts of psoriasis. Methods: Pooled, blinded, 16-week data from 1002 patients in the BE VIVID and BE READY bimekizumab phase 3 trials were analysed. The suitability of the P-SIM missing score rule (weekly scores considered missing if ≥ 4 daily scores were missing) was assessed. Test–retest reliability was evaluated using intraclass correlation coefficients (ICCs). Convergent validity was assessed between P-SIM and relevant patient-reported outcome (PRO) (Dermatology Life Quality Index [DLQI], DLQI item 1 [skin symptoms], Patient Global Assessment of Psoriasis) and clinician-reported outcome (ClinRO) scores (Psoriasis Area and Severity Index [PASI], Investigator’s Global Assessment [IGA]) at baseline and week 16. Known-groups validity was assessed, comparing P-SIM scores between patient subgroups predefined using PASI/IGA scores. Sensitivity to change over 16 weeks was evaluated; responder definition (RD) thresholds were explored. Results: The missing score rule used did not impact P-SIM scores. Test–retest reliability analyses demonstrated excellent score reproducibility (ICC 0.91–0.98). Inter-item correlations at baseline and week 16 were strong (> 0.5), apart from “choice of clothing” with “skin pain” and “burning” at baseline (both 0.49). All P-SIM scores were moderately to strongly correlated with other outcomes, demonstrating convergent validity, apart from ClinROs (PASI, IGA) at baseline that had low variability. P-SIM scores discriminated known groups at week 16, confirming known-groups validity. Changes from baseline to week 16 in P-SIM and other clinically relevant outcomes were strongly correlated (> 0.5; weaker with ClinROs), establishing sensitivity to change. Anchor-based RD analyses determined a four-point P-SIM item score decrease as indicative of marked clinically meaningful improvement. Conclusion: P-SIM scores demonstrated good reliability, validity and sensitivity to change. A four-point RD threshold could be used to assess 16-week treatment effects. Trial Registration: BE VIVID: NCT03370133; BE READY: NCT03410992. | |
dc.language | en | |
dc.publisher | Springer Healthcare | |
dc.rights | Licence for this article: http://creativecommons.org/licenses/by-nc/4.0/ | |
dc.source | pissn: 2193-8210 | |
dc.source | eissn: 2190-9172 | |
dc.subject | Original Research | |
dc.subject | NCT03370133 and NCT03410992 | |
dc.subject | NCT | |
dc.subject | Bimekizumab | |
dc.subject | Patient-reported outcome | |
dc.subject | Plaque psoriasis | |
dc.subject | Psychometric validation | |
dc.subject | Responder definition | |
dc.title | Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials | |
dc.type | article | |
dc.date.updated | 2021-10-01T15:32:30Z | |
dc.date.accepted | 2021-06-16 |