Development and testing of candidate items for inclusion in a new rheumatoid arthritis stiffness patient-reported outcome measure

Abstract

Objective: To qualitatively develop and test a set of candidate items for a new RA stiffness patient-reported outcome measure (PROM) that capture the patient perspective. This is an essential first step in PROM development, prior to quantitative development, assessment and validation.Methods: Focus groups further examined the previously developed stiffness conceptual model and explored the patient perspective regarding stiffness assessment. Data were analysed using thematic analysis. An iterative process of item development was then performed by the expert study team of researchers, patients and clinicians, based on the two qualitative datasets and informed by measurement theory and guidelines. Finally, these candidate items were tested using formal cognitive interview methodology and subsequently refined.Results: Sixteen RA patients from the UK participated in focus groups. Data confirmed the conceptual model of the RA patient experience of stiffness and provided insight into stiffness assessment including suggestions regarding patient-relevant stiffness assessment categories such as impact, location, and timing. These data informed the development of 77 candidate stiffness PROM items, including multiple formats for some. Eleven RA patients participated in cognitive interviews. Minor changes were made to items to enhance understanding and 32 items were removed, resulting in 45 candidate PROM items. Conclusion:Rigorous qualitative methodology and considerable patient involvement has underpinned items for a new RA stiffness PROM with strong content validity. Crucially, patient involvement broadened assessment beyond 'early morning stiffness duration,' which may address existing PROM limitations. Items are now suitable for quantitative item reduction, structural development of the final PROM, and validation.

Musculoskeletal stiffness is common in healthy adults and increases with age

“…Musculoskeletal stiffness is a feature of rheumatological conditions of autoimmune, degenerative, and infectious origin, but there has been a lack of well‐tested instruments for quantifying or characterizing the impact of musculoskeletal stiffness (Halls et al, 2017; Van Tuyl, Lems, & Boers, 2014). This was the context for the development in RA of the questionnaire employed in the present survey (Halls et al, 2018). Severity of stiffness is sometimes reported using a visual analogue scale or numeric rating scale but with limited evidence of validity of any of the instruments used (Halls et al, 2018; Van Tuyl et al, 2014).…”

“…This was the context for the development in RA of the questionnaire employed in the present survey (Halls et al, 2018). Severity of stiffness is sometimes reported using a visual analogue scale or numeric rating scale but with limited evidence of validity of any of the instruments used (Halls et al, 2018; Van Tuyl et al, 2014). The WOMAC scale, which was originally developed for osteoarthritis (Bellamy, Buchanan, Goldsmith, Campbell, & Stitt, 1988), includes a stiffness subscale, but this is limited to two questions and has been reported to have a less than optimal test–retest reliability (McConnell, Kolopack, & Davis, 2001).…”

Tender and swollen joint counts are poorly associated with disability in chikungunya arthritis compared to rheumatoid arthritis

“…The specified 28-joint counts of tender and swollen joints used have been validated with respect to more comprehensive joint counts in RA and are now a widely used standard in this indication 20 – 22 . Symptoms were evaluated by the patient with a pain intensity visual analogue scale (0–100) and a 21-item musculoskeletal stiffness questionnaire (overall score expressed as a percentage) which incorporated several aspects of stiffness severity as well as the physical and psychological impacts of stiffness 9 , 23 . Functional disability was assessed with the modified Stanford Health Assessment Questionnaire (HAQ).…”

“…The rheumatologist has many different instruments at his disposal to evaluate the severity of disease in a patient with RA, instruments which have been extensively tested and proven to be of value. Tender and swollen joint counts are well established in RA as standard measures of joint involvement 7 , and recent work has addressed the comprehensive assessment of joint stiffness in RA, a previously understudied area 8 , 9 . These same measures and instruments have also been employed in CHIKV arthritis studies, but their usefulness in chikungunya disease is less clear 10 .…”

An Innovative Self-Feed Product For Elderly Arthritis With Hand Disability

“…Arthritis refers to joints inflammation; it can cause stiffness, pain, weak and deformity in joints (Merivale Hand Clinic, 2018). When arthritis affects the joints of the hands, it would rationalization stiffness and pain to the person (Halls et al, 2017). That pain can get worse whenever you use the hand a lot for repetitive tasks.…”