The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research i
- PDF / 194,562 Bytes
- 9 Pages / 595.28 x 793.7 pts Page_size
- 8 Downloads / 133 Views
RESEARCH
Open Access
The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS) April N Naegeli1, Emuella Flood2, Jennifer Tucker2, Jennifer Devlen2 and Emily Edson-Heredia1*
Abstract Background: Ankylosing spondylitis (AS) is an autoimmune disorder characterized by inflammation of the spine and large joints. Fatigue is a common symptom that many AS patients find significantly impacts their health-related quality of life. The Worst Fatigue – Numeric Rating Scale (WF-NRS) assesses the severity of this symptom during the previous 24-hour period. The objective of this study was to perform qualitative research to support the development and content validity of the WF-NRS. Methods: Patients with AS were recruited from clinical sites in the U.S. for a qualitative study which first entailed concept elicitation interviews to gain understanding of the patients’ experience with AS and fatigue. Subsequently, cognitive debriefing interviews were undertaken to assess the understandability, clarity, and appropriateness from the patient’s perspective, of the content of a measure of fatigue severity. Results: Thirteen patients with AS participated in concept elicitation interviews and cognitive debriefing of the Brief Fatigue Inventory (BFI) fatigue severity subscale. The WF-NRS was developed from the worst fatigue item of the BFI as patients generally reported it to be understandable and covered an important concept, the completion instructions were modified, but the response scale remained as it was familiar and readily completed, and the recall period was appropriate. Conclusions: Patient responses resulted in the development of and supported the content validity of the WF-NRS. Further quantitative evaluation of the WF-NRS is warranted in order to assess its psychometric properties and confirm its usefulness as a clinical trial tool. Keywords: Ankylosing spondylitis, Concept elicitation, Content validity, Fatigue, Patient reported outcomes (PRO), Worst Fatigue Numeric Rating Scale (WF-NRS)
Background Ankylosing spondylitis (AS) is an autoimmune disorder characterized by inflammation of the spine and large joints. Prevalence rates for AS have been estimated to be 0.2 – 1.2% [1], and historically males have been found to be more predominantly affected than females [2,3]. However, this historical precedence may have contributed to gender biased research and under-diagnosis in women [4]. It is a chronic condition of young adults that * Correspondence: [email protected] 1 Eli Lilly and Co., Lilly, Corporate Center, Indianapolis, IN 46285, USA Full list of author information is available at the end of the article
commonly develops in the third decade of life [1]. Common symptoms include joint pain, fatigue, low-grade fever, loss of appetite, and eye inflammation [3]. There is wide inter-individual variability in bearing the burden of AS as some patients experience minor disabilities while others may have severe deformities o
Data Loading...
