Content validity of the ASQoL for use in a non-radiographic axial spondyloarthritis population: a qualitative study
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Content validity of the ASQoL for use in a non‑radiographic axial spondyloarthritis population: a qualitative study Mark C. Hwang1,6 · Mona Martin2 · Kristina Harris3 · Philip Geerdts4 · Jeffrey L. Stark5 · John Reveille1 Accepted: 8 June 2020 © The Author(s) 2020
Abstract Purpose The ankylosing spondylitis quality of life (ASQoL) instrument is widely used to assess health-related quality of life in patients with ankylosing spondylitis (AS). We assessed the relevance of the ASQoL items in patients with non-radiographic axial spondyloarthritis (nr-axSpA), a distinct subgroup within the axSpA disease spectrum. Methods This observational, cross-sectional, qualitative interview study recruited patients from clinic settings. Interviews from patients with axSpA who participated in a prior qualitative study were also used. Patients initially underwent a concept elicitation interview using open-ended questions to evaluate relevance of the concepts measured by the ASQoL. They then completed the ASQoL and underwent a cognitive interview to assess their understanding of the items, instructions and response options. Transcripts from patients who participated in the previous qualitative study (who did not complete the ASQoL or undergo cognitive interview) were evaluated to identify expressions of the concepts in the ASQoL. Results A total of 18 patients with nr-axSpA participated. The concept elicitation interview findings supported the relevance of the ASQoL items. Cognitive interviews determined that the ASQoL was easily understood; the 13 new patients chose a response for each item that matched their experience with nr-axSpA. Transcripts for the five previously interviewed patients confirmed the concepts presented in the ASQoL items were relevant and important to their experience of living with nr-axSpA. Conclusions Our results represent an important first step in confirming the relevance of the concepts in the ASQoL to patients with nr-axSpA, supporting quantitative assessment of ASQoL validity in this population. Keywords Ankylosing spondylitis quality of life · Content relevance · Health-related quality of life · Non-radiographic axial spondyloarthritis · Qualitative interviews
Introduction Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11136-020-02552-z) contains supplementary material, which is available to authorized users. * Mark C. Hwang [email protected] 1
McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA
2
Evidera PPD LLC, Bethesda, MD, USA
3
UCB Pharma, Hong Kong, China
4
UCB Pharma, Slough, UK
5
UCB Pharma, Smyrna, GA, USA
6
Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, 6431 Fannin, MSB 1.150, Houston, TX 77030, USA
Axial spondyloarthritis (axSpA) is a chronic inflammatory disease with a heterogeneous clinical phenotype that primarily affects the sacroiliac joints and spine. Patients with axSpA are classifie
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