The State of Patient-Reported Outcome Measures in Rheumatology.

OBJECTIVE: We sought to evaluate the quality and timeliness of patient-reported outcome (PRO) measure reporting, which have not been previously studied. METHODS: Clinical trials that informed new US Food and Drug Administration (FDA) approvals for the first rheumatological indication between 1995 and 2021 were identified. Data were recorded to determine whether collected PROs were published, met minimum clinically important difference (MCID) or statistical significance (P < 0.05) thresholds, and were consistent with Consolidated Standards of Reporting Trials (CONSORT)-PRO standards. Hazard ratios and Kaplan-Meier estimate were used to assess the time from FDA approval to PRO publication. RESULTS: Thirty-one FDA approvals corresponded with 110 pivotal trials and 262 reported PROs. Of the 90 included studies, 1 (1.1%) met all 5 recommended items, 10 (11.1%) met 4 items, 17 (18.9%) met 3 items, 21 (23.3%) met 2 items, 26 (28.9%) met 1 item, and 15 (16.7%) met none of the reporting standards. Most PROs met MCID thresholds (149/262; 56.9%) and were statistically significant (223/262; 85.1%). Of our subset analysis, one-third of PROs were not published upfront (70/212; 33%) and 1 of 9 (22/212; 10.4%) remained unpublished ≥ 4 years after initial trial reporting. Publication rates were highest for the Health Assessment Questionnaire-Disability Index (97.4%) and lowest for the 36-item Short Form Health Survey (81.8%). Less than half of these published PROs met MCID and statistical significance thresholds (94/212; 44.3%). CONCLUSION: One in 9 PROs remained unpublished for ≥ 4 years after initial trial reporting, and compliance with CONSORT-PRO reporting guidelines was poor. Efforts should be made to ensure PROs are adequately reported and expeditiously published.

Skeletal muscle injury in COVID infection: Frequency and patterns.

INTRODUCTION/AIMS: Little is known about skeletal muscle injury with coronavirus disease 2019 (COVID-19). We estimate the frequency and explore the patterns of skeletal muscle injury in acute COVID-19. METHODS: A cohort of COVID patients with mild to moderate symptoms were evaluated in a COVID-designated hospital between May and December 2021 and followed for 2 weeks. Skeletal muscle injury was assessed according to creatine kinase (CK) levels, Manual Muscle Test-8 (MMT-8) score, and the Health Assessment Questionnaire (HAQ) score. Injury was defined as CK >200 IU/L with an MMT-8 score < 76. The association between such injury and severity and outcomes were evaluated using cross-tabulations. RESULTS: Two hundred fifty participants with a mean age of 50.2 years (SD: 17.2) were included. One hundred nine (43.6%) were women; 84 (34%) developed severe disease. Median CK levels were 91 IU/L (IQR 56-181). [Correction added on 17 November 2023, after first online publication: In the preceding sentence, the IQR was corrected from '56,181'.] Patients with weakness on the MMT-8 (n = 247, 98.8%) and disability on the HAQ (n = 107; 42.8%) were common. Neck flexor muscles were prominently affected. Skeletal muscle injury was seen in 22.4% (95% CI: 17.4-28.1). There was no significant association between skeletal muscle injury and maximal severity of illness or short-term outcomes. Disability increased over 14 days in most survivors (n = 172, 72.3%) and this was not seen in those with mild disease (OR: 0.4, 95% CI: 0.22-0.70). DISCUSSION: Skeletal muscle injury appears to be common in people presenting with mild to moderate COVID infection.

Association of disease activity using SDAI and DAS28, but not JADAS-27, with subsequent changes in physical function in adult patients with juvenile idiopathic arthritis.

OBJECTIVES: To investigate an optimal composite score for disease activity in adult JIA from the viewpoint of the subsequent changes in physical function. METHODS: Patients with JIA under the following conditions were enrolled: 1) disease onset < 18 years; 2) registered in the database by Tokyo Women's Medical University for the first time between 2000 and 2020; and 3) ≥18 years old at the time of registration. Patients were stratified according to mean disease activity scores in SDAI, DAS28, and JADAS-27 during the first year from baseline. Trends of estimated mean change in Japanese-HAQ score (ΔJ-HAQ) from baseline to 2 years later was examined across the stratified groups of each index. RESULTS: We included 294 eligible individuals (median age at onset, 14.0 years; RF positive in 64.7%). A significant increasing trend of the estimated mean ΔJ-HAQ at 2 years after baseline was observed along with an increase in the mean disease activity during the first year measured using DAS28 (p = 0.01) and SDAI (p = 0.018), but not using JADAS-27. CONCLUSIONS: Disease activity measured using SDAI and DAS28, but not using JADAS27, was significantly associated with subsequent changes in physical function in adult patients with JIA.

Predictors of poor function in RA based on two prospective UK inception cohorts. Do comorbidities matter?

OBJECTIVES: Evidence suggests that factors beyond disease activity associate with functional disability in RA. The primary study objective was to explore associations between comorbidities, sociodemographic factors and functional outcomes at five and 10 years. METHODS: RA patients from two UK prospective cohorts were grouped into low (<1.5) and high (≥1.5) five- and 10-year health assessment questionnaire (HAQ) score. Clinical variables (e.g. disease activity, rheumatoid nodules, erosions) and sociodemographic factors (e.g. ethnicity, deprivation) were recorded at baseline and yearly thereafter. Comorbidity was measured using the Rheumatic Diseases Comorbidity Index (RDCI). Binary logistic regression models were fitted using multiple imputation. RESULTS: In total, 2701 RA patients were recruited (mean age 56.1 years, 66.9% female). A total of 1718 (63.4%) had five-year and 820 (30.4%) 10-year follow-up data. In multivariable analysis, no association was found between RDCI and HAQ ≥ 1.5 at five or 10 years. Sociodemographic factors (increased age at disease onset, female gender, minority ethnicity) were associated with higher odds of HAQ ≥ 1.5 at five and 10 years, with worse deprivation additionally associated with HAQ ≥ 1.5 at 10 years (OR 0.79, 95% CI: 0.69, 0.90). CONCLUSION: Comorbidities at baseline have not been found to be associated with worse RA functional outcome in the long-term. On the other hand, sociodemographic factors, independently of disease measures, are associated with worse functional outcome in RA at five and 10 years, in models adjusting for comorbidity burden. Tailoring management interventions according to not only clinical disease parameters but also patient sociodemographic factors may improve long-term outcomes including functional disability.

Translation and validation of Modified Health Assessment Questionnaire score in local language Urdu in patients with rheumatoid arthritis presenting in a tertiary care center of Pakistan.

OBJECTIVE: To translate and validate the Modified Health Assessment Questionnaire from English to Urdu. METHODS: The validation study was conducted at the Rheumatology outpatient department of Fauji Foundation Hospital, Rawalpindi, Pakistan, from July 1 to September 30, 2019. Two translators were given the modified health assessment questionnaire for translation from English to Urdu. It was then back-translated by two independent translators. The translated version of the tool was applied to rheumatoid arthritis patients to check for reliability, test-retest and internal consistency. It was applied to another group of patients to check for criterion validity. Reliability analysis was checked by applying Cronbach alpha. Criterion validity was checked by assessing disease activity score-28 and its correlation with Modified Health Assessment Questionnaire. Data was analysed using SPSS 23. RESULTS: Of the 30 patients in the initial testing, 28(93%) were females and 2(6.6%) were males, with an overall mean age of 38±13.2 years. Of the 100 patients in the second group, 97(97%) were women and 3(3%) were men, with an overall mean age of 42±12.37 years. The mean disease duration of the cohort was 8.4±4.8 years. The Cronbach alpha value was 0.797 and interclass coefficient was 0.7, reflecting good reliability. A significantly high correlation between Modified Health Assessment Questionnaire and disease activity score-28 was noted along with pain, tenderness, swollen joints, patient global assessment, age and erythrocyte sedimentation rate (p<0.05), while poor correlation was found with gender, disease duration, rheumatoid arthritis factor and anti-cyclic citrullinated peptide antibody (p>0.05). CONCLUSIONS: The Urdu version of the Modified Health Assessment Questionnaire was found to be a reliable tool for the indigenous population.

Does exercise therapy improve patient-reported outcomes in rheumatoid arthritis? A systematic review and meta-analysis for the update of the 2020 JCR guidelines for the management of rheumatoid arthritis.

OBJECTIVES: This study aimed to evaluate the impact of exercise therapy on patient-reported outcomes (PROs) in rheumatoid arthritis (RA) as part of the process of updating the 2020 Japanese guidelines for the management of RA according to the Grading of Recommendations, Assessment, Development, and Evaluation system. METHODS: We searched PubMed, Japana Centra Revuo Medicina Web, and the Cochrane Library (from 2009 to 2018) to identify articles that evaluated PROs of exercise therapy and RA disease activity. RESULTS: A total of 662 articles were identified, including nine RCTs, and meta-analyses were performed on six RCTs on systemic exercise therapy and three RCTs on upper extremity exercise therapy. Analyzed exercise therapies were diverse, differing in target population, intervention method, and duration. Significant improvements were observed in the Health Assessment Questionnaire Disability Index (mean difference -0.35, 95% confidence interval (CI): -0.60 to -0.10), pain (standardized mean difference -2.04, 95% CI: -3.77 to -0.32), and SF-36. For upper extremity exercise therapy, significant improvements in PROs (Disabilities of the Arm, Shoulder, and Hand Questionnaire, Michigan Hand Outcome Questionnaire) were observed. CONCLUSION: Exercise therapy in RA treatment improves patient subjective assessment of pain, physical function, and quality of life.

Disease activity correlates and functionality in patients with rheumatoid arthritis - real-world experience from a South Asian country.

Introduction: There is a lack of data assessing disease activity in patients with rheumatoid arthritis from Pakistan. We sought to determine the correlation between Disease Activity Score 28 (DAS28) and disease activity parameters and the modified Health Assessment Questionnaire (mHAQ). Secondarily, we evaluated the concordance of acute phase reactants with disease activity. Material and methods: We prospectively studied 132 patients with rheumatoid arthritis (RA) as per the 2010 American College of Rheumatology/European League Against Rheumatism criteria, not in clinical remission. Based on the DAS28 score, the patients were divided into low, moderate, and high activity groups. The patients were also categorized according to the elevation of acute phase reactants to determine concordance and discordance with DAS28-ESR and DAS28-CRP. Descriptive statistics and Pearson's correlation were computed. Results: Complete demographics was available for 132 participants. The mean age was 46.2 ±12.8 years; there were 85.6% (n = 113) females. The mean disease duration was 5.7 ±6.4 years. The (Rephrase as mean ±SD) DAS28 and mHAQ scores were 3.4 ±1.8 and 0.77 ±0.68, respectively. A significant correlation was observed between DAS28 and tender and swollen joint count (r = 0.64; p < 0.001); DAS28 and mHAQ (r = 0.47; p-value < 0.001), DAS28 and patient's global assessment (PGA) (r = 0.45; p-value < 0.001). A weak correlation was observed between mHAQ and CRP and ESR, with r = 0.242 and 0.225, respectively, p-value < 0.001. In comparison, no correlation of DAS28 with the rheumatoid factor (r = -0.035) or ACPA antibody (r = -0.094) was noted. A positive concordance between ESR and CRP was observed in severely active RA. Conclusions: From an outpatient setting in a South Asian country, DAS28-ESR emerged as the preferred choice for an accurate assessment of disease severity in RA when combined with the mHAQ. Acute phase reactants increase positively in concordance with severely active RA, although discordant in low to moderately active disease.

Relationship between disease activity of rheumatoid arthritis and development of locomotive syndrome: A five-year longitudinal cohort study.

OBJECTIVE: This study aimed to longitudinally evaluate the association between rheumatoid arthritis (RA) and locomotive syndrome (LS) in RA patients using the 25-question Geriatric Locomotive Function Scale (GLFS-25). METHODS: Subjects were 58 RA patients (female, 48 (82.8%); mean age, 60.9 ± 10.9 years) who had GLFS-25 scores available for five consecutive years and who did not have LS at baseline (i.e. GLFS-25 < 16 points). Associations between DAS28-CRP and the development of LS were determined using linear regression analysis and receiver operating characteristic (ROC) curve analysis. RESULTS: Subjects were divided into the LS group (n = 15, GLFS-25 ≥ 16 points) and non-LS group (n = 43, GLFS-25 < 16 points) based on GLFS-25 scores at the 5th year of the study period. In the LS group, DAS28-CRP worsened every year. The linear regression model adjusted for age and sex revealed that ΔGLFS-25 increased by 3.80 (95% confidence interval: 1.81-5.79) each time ΔDAS28-CRP increased by 1 (p<.001). Among patients in remission (DAS28-CRP < 2.3), 13.5% had LS. ROC curve analysis yielded a five-year mean DAS28-CRP of 1.99 (sensitivity, 86.7%; specificity, 62.8%) as the cut-off point for the development of LS. CONCLUSION: Tight control of RA disease activity for deeper remission may be needed to prevent the development of LS.

Relationship between different anti-rheumatic drug therapies and complementary and alternative medicine in patients with rheumatoid arthritis: an interview based cross-sectional study.

OBJECTIVES: The use of complementary and alternative medicine (CAM) by patients with rheumatoid arthritis (RA) is highly prevalent. The relationship of these remedies with disease therapy are not fully studied. We aimed to explore the relationship between different anti-rheumatic drug therapy and CAM use in RA patients. METHODS: The study used an interview-based cross-sectional survey in two major referral centres in Riyadh, Saudi Arabia. Patients were adults with confirmed RA that attended rheumatology clinics. Information on the utilization of CAM, RA duration, drug therapy, and laboratory parameters were obtained. Descriptive statistics as well as adjusted odds ratio using bivariate logistic regression were used to explore the different factors related to CAM use, including drug therapy. RESULTS: A total of 438 adult patients with RA were included. The mean (±SD) age of the patients was 49 (±15.0) years. The majority were women 393 (89.7%). Two hundred and ninety-two patients (66.7%) had used CAM. The CAM users who had a longer disease duration (AOR 1.041 [95% CI: 1.011, 1.073]; p = 0.008) were more likely to be female (AOR 2.068 [95% CI: 1.098, 3.896]; p = 0.024), and use methotrexate (AOR 1.918 [95% CI: 1.249, 2.946]; p = 0.003) as opposed to celecoxib (AOR 0.509 [95% CI: 0.307, 0.844]; p = 0.009) and biologic monotherapy (AOR 0.443 [95% CI: 0.224, 0.876]; p = 0.019). Other factors related to CAM were meloxicam use (AOR 2.342 [95% CI: 1.341, 4.089]; p = 0.003) and traditional therapy (AOR 2.989 [95% CI: 1.647, 5.425]; p = 0.000). The remaining factors were not significant. CONCLUSION: CAM use is prevalent in patients with RA. Understanding patients and disease related factors associated with higher use of CAM is warranted to improve RA management and provide more rational use of these remedies.

Updated version of Japanese Childhood Health Assessment Questionnaire (CHAQ).

Objectives: The Childhood Health Assessment Questionnaire (CHAQ) is one of the most widely used self- report questionnaires to measure functional status in Juvenile idiopathic arthritis (JIA). The Japanese version of the CHAQ (JCHAQ) has been revised to meet requirements of clinical international trials which need the same number of questions in each functional area of the CHAQ.Methods: The original JCHAQ consisted of 36 items, measuring eight functional areas. This was changed to 30 items of questionnaire so that each functional area has same number of questions as the original US English version. The revised version was professionally translated from English to Japanese, reviewed, and validated with Japanese JIA patients.Results: A total of 42 JIA patients were enrolled in the validation: seven systemic, 30 polyarticular/oligoarticular and five enthesis related. Most patients were well controlled and the median disability index (DI) scores was 0.0 [0-0.03]; however, significant correlation was seen with visual analog scale (VAS) of pain, VAS overall well-being, physician VAS, DAS (Disease Activity Score) 28-ESR, and JADAS (Juvenile Arthritis Disease Activity Score)-27. In comparison of two groups of disease activity, remission or inactive/low disease activity vs. moderate/high disease activity, both DAS28-ESR and JADAS-27 showed significant correlation with DI.Conclusion: The updated JCHAQ was a reliable and valid tool for the functional assessment of children with JIA. It is more suitable for international and transitional comparison.

Spinal sagittal balance associated with age, vertebral fracture, and functional disability in patients with rheumatoid arthritis: A cross-sectional study.

Objectives: The purpose of this study was to assess the relationships between spinal sagittal balance and functional ability of Japanese patients with rheumatoid arthritis.Methods: A total of 491 patients with rheumatoid arthritis who underwent the measurement of sagittal vertical axis for the assessment of spinal sagittal balance were enrolled. Factors associated with sagittal vertical axis were analyzed by categorizing patients according to sagittal vertical axis (<4 cm, 4-9.5 cm, and >9.5 cm). In addition, univariate and multivariate regression analysis were performed to identify factors associated with Health Assessment Questionnaire Disability Index (HAQ-DI) in different age groups.Results: The percentage of patients with sagittal vertical axis <4 cm, 4-9.5 cm, and >9.5 cm was 61.1%, 32.4%, and 6.5%, respectively. Age, vertebral fracture, and gait speed were associated with sagittal vertical axis. Sagittal vertical axis was associated with HAQ-DI in the 80-90 years age group.Conclusion: Sagittal balance was associated with age, vertebral fracture, and gait speed. In super-aged patients with rheumatoid arthritis, HAQ-DI was affected by sagittal balance. Management of super-aged patients with rheumatoid arthritis should include evaluation of joints as well as spinal alignment.

Health outcomes and unmet needs in patients with long-standing rheumatoid arthritis attending tertiary care in Greece: a cohort study.

BACKGROUND: No previous studies have characterized a patient's experience of rheumatoid arthritis (RA) management in Greece and unmet needs may exist despite a broad range of available treatments. Therefore, we assessed quality of life (QoL), functional ability, and healthcare resource utilization in patients with established RA and receiving treatment in a tertiary care setting in Greece. METHODS: This was a prospective, observational cohort of patients aged ≥18 years, receiving any type of treatment for RA, and followed for 12 months at 7 rheumatology referral centers across mainland Greece (NCT01001182). Patient data were collected at the initial visit and 3, 6, and 9 months. QoL was evaluated using the Euro Quality of Life-5 dimensions questionnaire (EQ-5D) and functional ability was evaluated using the Health Assessment Questionnaire (HAQ). RESULTS: A total of 210 patients with RA were enrolled (76.7% women, mean ± standard deviation [SD] age: 59.1 ± 12.6 years, median [interquartile range] disease duration: 11.9 [5.0-16.0] years). Baseline mean ± SD EQ-5D and HAQ scores were 0.57 ± 0.32 and 0.75 ± 0.63, respectively, and remained largely unchanged throughout the study. Post-hoc comparison showed that patients receiving non-biologic disease-modifying antirheumatic drugs (non-bDMARDs) had significantly higher EQ-5D and lower HAQ-DI scores compared with those receiving biologic DMARDs. A majority of patients reported having difficulty doing housework or other duties (61.4 and 61.9%, respectively), and 55.2% reported needing external support for these tasks. Positive correlation was observed between QoL and functional ability. Hospitalization at least once during the study occurred in 9.5% of the patients, and 12.5% of these cases were due to exacerbation of RA. At baseline, 52.4% of the patients were retired, with 38.5% of retirees having retired early due to RA. Among the patients who were retired at baseline, the mean ± SD period from actual retirement to expected retirement age was 12.1 ± 8.1 years. CONCLUSION: QoL and functional ability were positively correlated in patients with long-standing RA, with a large proportion showing impairments in both. Timely, target-oriented treatment initiated as soon as possible after diagnosis may help to improve patient-reported outcomes and limit the burden of RA. TRIAL REGISTRATION: ClinicalTrials.gov NCT01001182 . Registered 23 October 2009.

Disability in idiopathic inflammatory myopathies: questionnaire-based study.

Idiopathic inflammatory myopathies (IIM) are progressive, debilitating diseases that can lead to severe impairment. The aim of the study was to evaluate the level of disability and compare it between different subtypes of IIM as well as to estimate clinical symptoms associated with greater risk of disability and distinguish the most troublesome activities in this group of patients. A online form concerning clinical symptoms, comorbidities and limitations in daily living was created and distributed to online support groups for patients with IIM. Health Assessment Questionnaire was used to estimate disability and physical limitations while visual analogue scales enabled to assess the intensity of clinical symptoms. 361 out of 377 responders were included for further evaluation. High prevalence of disability was observed in each subtype yet predominantly in patients with inclusion body myositis (IBM) as 51.43% of them fulfilled the criteria of severe to very severe disability. Level of disability correlated with muscle weakness, tolerance of physical activity and level of fatigue. 45.62% of responders in general required walking devices and 43.50% of participants declared using facilitating devices for maintaining hygiene. Patients with IIM encounter multitude physical limitations that can be partially compensated by usage of facilitating devices or aid of the caregivers. IBM seems to be the most disabling subtype.

Evaluation of factors associated with locomotive syndrome in Japanese elderly and younger patients with rheumatoid arthritis.

Objectives: We aimed to determine the prevalence of locomotive syndrome (LS) using the 25-question geriatric locomotive function scale (GLFS-25) and identify factors associated with LS in elderly and younger patients with rheumatoid arthritis (RA). Methods: Overall, 390 patients with RA who underwent GLFS-25 measurement, bone mineral density determination, and bioelectrical impedance analysis were enrolled. Factors associated with LS were analyzed by comparing patients with and without LS among both elderly and younger patients with RA. Results: The prevalence of LS was 41.5%, 47.7% and 32.3% in all patients, elderly patients, and younger patients with RA, respectively. Pain visual analog scale (VAS) and Health Assessment Questionnaire Disability Index (HAQ-DI) were associated with LS in both elderly and younger patients. Moreover, in younger patients with RA, disease activity score in 28 joints (DAS28), erythrocyte sedimentation rate (ESR), basal metabolic rate, and legs muscle mass were identified as being associated with LS. Conclusion: This study demonstrated that to prevent LS, we should aim to control pain and maintain a low HAQ-DI in elderly and younger patients with RA, and improve disease activity and maintain a higher basal metabolic rate, and legs muscle mass in younger patients with RA.

Prevalence of complementary and alternative medicine use among rheumatoid arthritis patients in Saudi Arabia.

BACKGROUND AND AIM: The use of complementary and alternative medicine (CAM) is unexplored among Saudi rheumatoid arthritis (RA) patients. The aim of this study was to estimate the prevalence and types of CAM used among patients with RA and factors associated with their use. EXPERIMENTAL PROCEDURE: A cross-sectional study was conducted at rheumatology clinics in two tertiary hospitals located in Riyadh, Saudi Arabia. The data was collected between May 2017 and February 2018. Unpaired Student's t-tests, Chi-square tests, and Pearson correlation tests were used to compare users vs nonusers. RESULTS: A total of 438 patients (mean age = 49, SD ±â€¯15 years; 89.7% females) were included in this study. Sixty seven percent of included patients had used CAM for their RA. The majority of CAM users were female (92.1%). The most frequently used CAM products were vitamin D (47%), calcium (37%), honey (15%), ginger (13%), turmeric (11%), black seeds (8%), and fenugreek (8%). One hundred ninety-six (45%) patients believe that CAM is safe, and 287 (96%) patients took it because they believed that CAM had "added benefits". Statistically significant differences were found for gender, RA duration, erythrocyte sedimentation rate (ESR) level, and seropositivity between CAM users and nonusers (P = 0.019, P = 0.011, P = 0.022, and P < 0.0001, respectively). A significant correlation was found between the Erythrocyte Sedimentation Rate (ESR) level, RA duration and CAM use (r = 0.110, P = 0.022 and r = 0.121, P = 0.012, respectively). These data indicated that patients who used CAM had higher ESR level and longer disease duration than patients didn't use CAM. CONCLUSION: There is a high prevalence of CAM use among RA patients. CAM use was perceived to add benefit and patients using it had higher ESR. Larger studies are needed to assess the use of CAM and its impact on RA and its management.

Psychometric properties of MDHAQ/RAPID3 in patients with systemic lupus erythematosus.

BACKGROUND: The Multidimensional Health Assessment Questionnaire (MDHAQ) is a patient-reported outcome (PRO) tool that includes the Routine Assessment of Patient Index Data 3 (RAPID3), an index that can be calculated at the point of care. The objective of this study was to perform psychometric analyses of MDHAQ/RAPID3 to study its measurement properties in systemic lupus erythematosus (SLE). METHODS: The MDHAQ was completed by 161 SLE patients in routine care, along with LupusPRO (a disease-specific PRO). The SLE disease-specific activity index (SELENA-SLEDAI) and damage (SDI) were assessed. Data from 70 patients with rheumatoid arthritis who had completed MDHAQ during their routine medical care were used as controls to compare the results of Physical Function (FN) domain exploratory factor analysis. Internal consistency reliability (ICR) for FN items was calculated using Cronbach's α. Validity of MDHAQ/RAPID3 was evaluated for content validity and construct validity. Responsiveness of the RAPID3 to changes in disease activity anchors was assessed. RESULTS: The ICR of the 10 physical function items on Cronbach's α was 0.88. Exploratory factor analysis revealed cross-loadings of three FN items. RAPID3 showed a strong correlation with LupusPRO health-related quality of life score (rho -0.68 (p < 0.001)), indicating convergent validity. RAPID3 scores did not correlate with disease activity indices or SDI. After adjustment for fibromyalgia status, a weak correlation with the Physician's Global Assessment (PGA) (rho = 0.31, p = 0.008) was noted. RAPID3 could differentiate between SLE patients based on flare status. RAPID3 was not responsive to changes in PGA, SELENA-SLEDAI or SELENA-Flare Index. CONCLUSIONS: MDHAQ/RAPID3 has fair reliability and validity in SLE.

The psychometric properties of the Childhood Health Assessment Questionnaire (CHAQ) in children with cerebral palsy.

BACKGROUND: The evaluation of children with cerebral palsy (CP) focuses on activity level measurement to examine the effect of health-care interventions on their physical functioning in the home, school, and community settings. This study aimed to identify the psychometric properties of the Korean version of the Childhood Health Assessment Questionnaire (CHAQ) by applying the Rasch model. The use of the Rasch model has an advantage in that item characteristic curve estimation is not affected by the characteristics of subject groups. METHODS: Data were collected from 65 children with CP aged 75-190 months using the Korean version of the CHAQ. Response data were analyzed according to the Rasch model, and item fitness and difficulty and the appropriateness and reliability of the rating scale were evaluated. RESULTS: Among the 30 items of the Korean version of the CHAQ, two items (nail-cutting and opening a bottle cap that was already opened) were shown to be misfit items with low fitness. The analysis results for item difficulty indicated the requirement for modification of item difficulty, pointing out the need for the addition of question items with both higher and lower difficulty. The use of 4-point rating scale in the evaluation questionnaire was shown to be appropriate. With respect to analysis outcomes, the subjects' separation reliability value and separation index were 0.97 and 5.92, respectively. In contrast, the separation reliability value and separation index for the question items were 0.95 and 4.51, respectively. CONCLUSIONS: The results of this study suggest the need for the modification of item fitness and difficulty. The psychometric properties of the Korean version of the CHAQ were identified using the item response theory-based Rasch analysis.

Rasch analysis suggests that health assessment questionnaire II is a generic measure of physical functioning for rheumatic diseases: a cross-sectional study.

BACKGROUND: Versions of the Health Assessment Questionnaire (HAQ) are commonly used to measure physical functioning across multiple rheumatic diseases but there has been no clear demonstration that any HAQ version is actually generic. This study aimed to show that the HAQ-II instrument is invariant across different rheumatic disease categories using the Rasch measurement model, which would confirm that the instrument is generic. METHODS: HAQ-II responses from 882 consecutive rheumatology clinic attendees were fitted to a Rasch model. Invariance across disease was assessed by analysis of variance of residuals implemented in RUMM2030. Rasch modeled HAQ-II scores across disease categories were compared and the mathematical relationship between raw HAQ-II scores and Rasch modeled scores was also determined. RESULTS: The HAQ-II responses fitted the Rasch model. There was no substantive evidence for lack of invariance by disease category except for a single item ("opening car doors"). Rasch modeled scores could be accurately obtained from raw scores with a cubic formula (R2 0.99). Patients with rheumatoid arthritis had more disability than patients with other kinds of inflammatory arthritis or autoimmune connective tissue disease. CONCLUSIONS: The HAQ-II can be used across different rheumatic diseases and scores can be similarly interpreted from patients with different diseases. Transforming raw scores to Rasch modeled scores enable a strictly linear, interval scale to be used. It remains to be seen how that would affect interpretation of change scores. TRIAL REGISTRATION: ANZCTR ACTRN12617001500347 . Registered 24th October 2017 (retrospectively registered).

Relationship between achievement of physical activity goal and characteristics of patients with rheumatoid arthritis.

OBJECTIVES: We aimed to identify the relationship between achievement of a physical activity goal and the characteristics of patients with rheumatoid arthritis (RA). METHODS: Overall, 137 patients with RA who performed physical activity were enrolled. Statistical analysis was performed to examine relationship between patient characteristics and achievement of physical activity goal by univariate analysis, multivariate logistic regression analysis and the receiver operating characteristic method. RESULTS: The significant factors considered for univariate analysis performed to compare RA patients with and without achievement in physical activity goal were age, disease duration, BMI, global VAS, pain VAS, CRP, DAS28-CRP, and HAQ-DI. The significant related factors by multivariate logistic regression analysis were age (OR: 0.926), BMI (OR: 1.180), pain VAS (OR: 0.969), and HAQ-DI (OR: 0.229). The cutoff values were 62.0 years for age (sensitivity 72.5%, specificity 59.6%), 19.7 for BMI (sensitivity 91.2%, specificity 36.2%), 20.0 for pain VAS (sensitivity 63.7%, specificity 71.9%), and 0.30 for HAQ-DI (sensitivity 48.8%, specificity 89.5%). CONCLUSION: We aim to preserve activities of daily living in patients with RA. To achieve physical activity goal, we should control pain VAS, and HAQ-DI. Further, the patients the value of HAQ-DI should be kept very low.

Points to consider for designing trials in systemic sclerosis patients with arthritic involvement.

Although musculoskeletal involvement is quite common in SSc (arthritic in particular), there have been few trials and even fewer controlled trials of therapeutic agents in arthritis in SSc. In addition, there have been only three outcome measures that have been validated for use in trials of SSc arthritis: the HAQ Disability Index, the Cochin Hand Function Scale and the Hand Mobility in SSc scale. The purpose of this article is to present evidence-based points to consider for the design of trials in SSc patients with musculoskeletal involvement (joints in particular). In addition, we make an argument for including outcome variables that can be validated within a given trial for use in future trials.