Abstract
Objective To investigate the construct validity, reliability (internal consistency and retest reliability), and feasibility of the patient-reported outcomes thermometer–5-item scale (5T-PROs), a new tool to measure overall health status in patients with painful chronic rheumatic diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axialSpA), and fibromyalgia (FM). Methods Consecutive patients have been involved in this study. The following analyses were performed to establish the validity of the 5T-PROs: (1) principal component factor analysis was used to identify the presence of a relatively small number of underlying latent factors than can be used to represent relations among sets of many variables; (2) Cronbach's alpha was calculated as an indicator of internal consistency; and (3) Pearson product-moment correlations were conducted to assess the convergent validity. The 5T-PROs was also administered a second time (two weeks after the initial administration) to a subset of sample (n = 426) to allow for calculation of test-retest reliability. We used the intraclass correlation coefficient (ICC) as an estimate of test-retest reliability. Additionally, discriminant validity was tested using analysis of variance (ANOVA) with Bonferroni post hoc multiple comparisons, in different disease conditions. Feasibility was analyzed by the time taken in completing the 5T-PROs and the proportion of patients able to complete the 5 item. Results 1,199 patients (572 with RA, 251 with axialSpA, 150 with PsA, and 226 with FM) were examined. The mean age was 55.7 (standard deviation: 13.1; range: 20 to 80) years. Factor analysis yielded two factors which accounted for 62.54% of the variance of the 5T-PROs. The first factor “Symptom Summary Score” (35.57% of the variance) revealed a good internal consistency (alpha = 0.88); the internal consistency of the second factor “Psychological Summary Score” (26.97% of the variance) was moderate (alpha = 0.69). The reliability of the whole instrument was good (alpha = 0.82). A very high correlation was obtained between Symptom Summary Score and SF-36 PCS and between pain thermometer intensity and SF-36 bodily pain. For all five items and summary scale scores of the SF-36, there was strong evidence that the mean rank of the scores differs significantly between the groups (Kruskal–Wallis tests, p < 0.001). Discriminant validity, assessed by comparing the 5T-PRO dimensions in patients with different states of disease activity, showed that the 5T-PROs show moderate association with the presence of comorbidities. It was also noted that it was inversely correlated (p=0.01) to years of formal education. Conclusion The 5T-PROs is easily administered, reliable and a valid instrument for evaluating the extensive multidimensional impact associated with chronic painful rheumatic conditions.
Highlights
Rheumatoid arthritis (RA), axial spondyloarthritis, and psoriatic arthritis (PsA) are common chronic painful rheumatic diseases characterized by systemic inflammation, joint destruction, and impairment in physical function and health-related quality of life (HRQoL)
Improvements in pain, fatigue, physical function, emotional well-being, and patient global ratings of health are often more important and meaningful in disease assessment than improvements in composite disease activity measures [14,15,16]. e relevance of patients preference is highlighted by the Outcome Measures in Rheumatology (OMERACT) [17, 18], by the American College of Rheumatology (ACR), by the European League Against Rheumatism recommendations (EULAR), by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) [19, 20], by the Assessment in Spondyloarthritis International Society (ASAS) [21], and in the US Food and Drug Administration guidance
Time constrains usually hinder the evaluation of HRQoL through long and difficult to compute instruments. us, we developed the Patient-Reported Outcomes ermometer–5-item scale (5T-patient-reported outcomes (PROs)), a simple tool made of 5 “thermometers” combining numerical rating scales (NRS) and verbal descriptor scales (VDS) (Figure 1), exploring the main domains of HRQoL, namely, pain, fatigue, physical function, depression, and general health status
Summary
Rheumatoid arthritis (RA), axial spondyloarthritis (axialSpA), and psoriatic arthritis (PsA) are common chronic painful rheumatic diseases characterized by systemic inflammation, joint destruction, and impairment in physical function and health-related quality of life (HRQoL). Improvements in pain, fatigue, physical function, emotional well-being, and patient global ratings of health are often more important and meaningful in disease assessment than improvements in composite disease activity measures [14,15,16]. E thermometer scales, a modified vertical VDS alongside a graphic thermometer, have been validated as a measure for pain in older adults and are recommended and commonly used in clinical practice in inflammatory arthritis [31]. Us, we developed the Patient-Reported Outcomes ermometer–5-item scale (5T-PROs), a simple tool made of 5 “thermometers” combining NRS and VDS (Figure 1), exploring the main domains of HRQoL, namely, pain, fatigue, physical function, depression, and general health status. E aims of this study were to investigate the construct validity, reliability (internal consistency and retest reliability), and feasibility of this new tool in patients suffering from chronic inflammatory joint diseases and FM
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