Health Assessment Questionnaire-II Research Articles

Association of Serum IL-17 and IL-23 Cytokines With Disease Activity and Various Parameters of Rheumatoid Arthritis in Indian Patients.

Introduction Interleukin-23/T helper 17 (IL-23/Th17) axis cytokine has been thought to be a critical pathway for rheumatoid arthritis (RA) disease development and its association with disease severity, joint erosion, and functional outcome. There is a paucity of data on the role of IL-23/Th17 axis cytokines in an Indian RA subset of patients. We aimed to determinethe association between serum cytokines (interleukin-17 [IL-17] and [IL-23]) and disease activityas well as with clinical and biochemical parameters of RA patients. Methods In this observational cross-sectional study, 84 consecutive RA cases were recruited after obtaining consent. Serum IL-17 and IL-23 levels were measured by the enzyme-linked immunosorbent assay (ELISA) method. Clinical and laboratory parameters, disease activity score 28-erythocyte sedimentation rate (DAS28-ESR), and Health Assessment Questionnaire-II (HAQ-II) were recorded. Correlation of cytokines with various clinical and biochemical parameters was elicited. Results Only C-reactive protein (CRP) correlated positively with IL-23 (rs = 0.26, p = 0.014)but not the ESR. Both IL-17 and IL-23 levels showed an insignificant, weak positive correlation with the disease activity DAS28 (rs = 0.18, p = 0.097; rs = 0.12, p = 0.259, respectively). Neither IL-17 nor IL-23 levels differed among the disease severity group (p = 0.13, p = 0.215). Only the IL-23 level positively correlated with functional status (HAQ-II) (rs = 0.28, p = 0.009). IL-17 level was higher in advanced RA as compared to early RA (p = 0.028). Both IL-17 and IL-23 levels did not vary within the different subgroups (age, obesity, disease-modifying drugs/steroid/biologics use, and serology status). Conclusion Females had higher IL-23 levels than males. Advanced RA had higher IL-17 levels than early RA. The cytokinelevels were not influenced by factors like age, duration of disease, serology status, or drugs. Neither of the cytokines correlated significantly with disease severity. Higher IL-17 levels may have a role in the progression of early non-erosive to chronic erosive arthritis. Higher IL-23 levels may signal a bad functional outcome.

Validation of a Spanish Version of the Health Assessment Questionnaire-II to Assess Mexican Patients' Physical Function with Rheumatoid Arthritis.

To evaluate the validity, reliability, and performance of the Health Assessment Questionnaire-II(HAQ-II) Spanish version questionnaire to measure physical function. A cross-sectional study of 496 patients with rheumatoid arthritis, distributed in 2 samples. The construct validity was evaluated employing the confirmatory factor analysis and the validity based on the relationship with other variables. Cronbach's alpha (α) and McDonald's omega (ω) coefficient were used to determine reliability. Item performance was analysed by fitting different models of item response theory. The one-factor model presented a poor fit in the confirmatory factor analysis; an exploratory factor analysis was carried out, which suggested a 2-factor structure. The confirmatory factor analysis in the second sample confirmed that the second-order model had a good fit to the data. The general factor explained more than 70% of the variance. The reliability indices showed adequate internal consistency (α=.92-.95; ω=.88-.93). Ninety-three percent of the contrasting hypotheses about the relationship of the HAQ-II scores with other variables were confirmed, demonstrating their convergent, divergent, and known group validity. The multidimensional graduated response model was the one that best predicted person's interaction with the items. The Spanish version of the HAQ-II presents adequate validity and reliability for measuring Mexican patients' physical function with rheumatoid arthritis.

Construct validity of a clinically correlated knee osteoarthritis ultrasonographic scale: a cross-sectional observational study

ObjectivesTo assess the validity of a novel ultrasonographic scale for knee osteoarthritis (KOA) and its relation with the degree of pain and clinical features.DesignA cross-sectional observational study including 245 patients...

Impact of ultrasonography detected quadriceps calcific tendinopathy on pain and function in patients with primary knee osteoarthritis.

Calcific tendinopathy is most commonly seen around the shoulder joint. Only a few cases of quadriceps calcific tendinopathy (QCT) were reported. This study compares pain, function, clinical examination results, and ultrasonographic findings among primary knee osteoarthritis (KOA) patients with or without ultrasonography-detected QCT. A cross-sectional study was conducted on 214 patients with knee OA. Ultrasonography (US) of knee joints was performed according to the EULAR guidelines. Kellgren-Lawrence radiographic grading was used to score OA. Pain and functional status were assessed using the visual analog scale (VAS), the Health Assessment Questionnaire-II (HAQ-II), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). QCT was detected in 50 out of 428 knees (11.6%), i.e. in 46 out of 214 patients (21.49%). Most cases of QCT were detected in the following sites: 36 in the vastus lateralis (72%), 10 in the vastus intermedius (20%), and only 4 in the vastus medialis (8%). QCT was found mainly in advanced KOA stages: 44 cases of QCT were found in patients with grade 4 KOA and 6 cases in grade 3 KOA. The presence of QCT showed a statistically significant association (p<0.05) with VAS, HAQ-II, WOMAC subscales, synovitis, and effusion detected by US. In knees with ultrasound-detected QCT, ultrasonographic features of CPPD were found in 31 knees (62%). QCT was found in cases with advanced KOA and mainly with ultrasonographic findings of CPPD disease. QCT could be considered an independent poor prognostic finding regarding pain, functional activity, and response to NSAIDs.

Validation of a Spanish version of the Health Assessment Questionnaire-II to assess Mexican patients’ physical function with rheumatoid arthritis

ObjectiveTo evaluate the validity, reliability, and performance of the Health Assessment Questionnaire-II (HAQ-II) Spanish version questionnaire to measure physical function. MethodsA cross-sectional study of 496 patients with rheumatoid arthritis (RA), distributed in 2 samples. The construct validity was evaluated employing the confirmatory factor analysis (CFA) and the validity based on the relationship with other variables. Cronbach's alpha (α) and McDonald’s omega (ω) coefficient were used to determine reliability. Item performance was analysed by fitting different models of item response theory (IRT). ResultsThe one-factor model presented a poor fit in the CFA; an exploratory factor analysis (AFE) was carried out, which suggested a 2-factor structure. The CFA in the second sample confirmed that the second-order model had a good fit to the data. The general factor explained more than 70% of the variance. The reliability indices showed adequate internal consistency (α = .92–.95; ω = .88–.93). Ninety-three percent of the contrasting hypotheses about the relationship of the HAQ-II scores with other variables were confirmed, demonstrating their convergent, divergent, and known group validity. The multidimensional graduated response model was the one that best predicted person's interaction with the items. ConclusionThe Spanish version of the HAQ-II presents adequate validity and reliability for measuring Mexican patients' physical function with RA.

Impact of ultrasonography-detected pes anserine bursitis on pain and function in patients with primary knee osteoarthritis

Background: Pes anserine bursitis (PAB) is one of the most common causes of knee pain. Hence, this study aimed to compare the pain and function among all primary knee osteoarthritis (KOA) patients with or without ultrasonic-detected PAB and the associated clinical and radiological findings.Methods: A single-center cross-sectional study was conducted on 245 patients with primary KOA. The more symptomatic knee examined with musculoskeletal ultrasound (MSUS), were then categorized into two groups according to the presence of PAB; PAB was graded from 0 to 2 on a semi-quantitative scale. Radiological grades of Kellgren–Lawrence were recorded. Pain and functional status was assessed by visual analog scale (VAS), Health Assessment Questionnaire-II (HAQ-II), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Results: A total of 110 (44.9%) patients were diagnosed with PAB where 91 (82.7%) of them had Grade 1 and only 19 (17.3%) had Grade 2. The presence of PAB was statistically significant related (P < 0.05*) with age, VAS, HAQ-II, WOMAC subscales, synovitis, and radiographic Grades 3 and 4. However, there was no statistically significant difference (P ≥ 0.05) between KOA patients without PAB and KOA patients with PAB, regarding sex, body mass index, Baker cyst, and effusion.Conclusion: The presence of PAB on MUS is associated with increased pain and disability in KOA. MSUS should be more widely used to establish the association between PAB and symptom severity and disability among KOA patients.

Abstract PD6-02: A randomized, controlled trial of high dose vs. standard dose vitamin D for aromatase inhibitor-induced arthralgia in breast cancer survivors

Abstract Background: Approximately half of women on aromatase inihbitor (AI) therapy develop AI-induced arthralgia (AIA), and many discontinue the medication because of this common side effect. While Vitamin D has been studied as a treatment for AIA, trial results have been conflicting thus far. Patients and Methods: All subjects were post menopausal women who were beginning adjuvant AI therapy for stage I-III hormone receptor positive breast cancer. Patients were randomized 1:1 to receive standard dose vitamin D3 (800 IU daily for 52 weeks) or high dose vitamin D3 (50,000 IU weekly for 12 weeks, followed by 2000 IU daily for 40 weeks). All patients also took oral calcium 600 mg daily. The primary endpoint was development of AIA, as defined by pre-specified changes in the Health Assessment Questionnaire II (HAQ-II). Secondary endpoints include compliance with AI therapy, and correlation between grip strength and development of AIA. Exploratory endpoint was measurement of inflammatory cytokine reduction in each arm. The trial was designed to enroll 184 patients, but this futility analysis was performed after 93 patients were enrolled. The futility boundary for stopping the trial early was calculated as p = 0.47. Results: All 93 patients (46 in the high dose arm, and 47 in the standard dose arm) enrolled in the study at the time of the interim analysis were evaluable. The HAQ-II was completed at 12 weeks in 76% on the high dose arm, and 68% in the standard dose arm. Subjects who did not complete the questionnaire were deemed as study failures (i.e. development of AIA was assumed). In the high dose arm, 25 patients (54%) developed AIA, compared to 27 patients (57%) in the standard dose arm. The one-tailed p value is 0.3818, and the Z-score is 0.3, yielding only a 38% conditional power that that study would find a significant difference between the two arms. Thus, the study was terminated early for futility. There was no significant difference between the two arms in adherence to AI therapy. The grip strength and inflammatory cytokine data are pending at this time. They will be ready by the time of the conference. Conclusions: There was no significant signal for benefit of high dose vitamin D supplementation, as compared to standard dose vitamin D, for AIA prevention in post menopausal women taking adjuvant AI therapy. These results further characterize the role of Vitamin D in AIA, and they inform future clinical trials in this arena. Further research is necessary, as this remains an important cause of non-adherence to this highly effective therapy. Citation Format: Niravath P, Wang T, Hilsenbeck SG, Lipscomb K, Pavlick A, Jiralerspong S, Nangia J, Ellis M, Ademuyiwa F, Cherian M, Frith A, Ma C, Park H, Rigden C, Suresh R, Osborne CK, Rimawi MF. A randomized, controlled trial of high dose vs. standard dose vitamin D for aromatase inhibitor-induced arthralgia in breast cancer survivors [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr PD6-02.

Predictors of activity limitation in people with gout: a prospective study.

The objective of the study was to determine clinical factors associated with activity limitation and predictors of a change in activity limitation after 1year in people with gout. Two hundred ninety-five participants with gout (disease duration < 10years) attended a baseline assessment which included medical and disease-specific history, pain visual analog score and plain radiographs scored for erosion and narrowing. Activity limitation was assessed using the Health Assessment Questionnaire-II (HAQ-II). After 1year, participants were invited to complete a further HAQ-II; follow-up questionnaires were available for 182 participants. Fully saturated and stepwise regression analyses were used to determine associations between baseline characteristics and HAQ-II at baseline and 1year, and to determine predictors of worsening HAQ-II in those with normal baseline scores. Median (range) baseline HAQ-II was 0.20 (0-2.50) and 0.20 (0-2.80) after 1year of follow-up. Pain score was the strongest independent predictor of baseline HAQ-II, followed by radiographic narrowing score, type 2 diabetes, swollen joint count, BMI, age and urate (model R2 = 0.51, P < 0.001). Baseline HAQ-II was the strongest predictor of change in HAQ-II at 1year, followed by tender joint count (model R2 = 0.19, P < 0.001). Of those with HAQ-II scores of 0 at baseline (n = 59, 32% of those with follow-up data), most did not progress (n = 52, 88%); however, baseline pain score, type 2 diabetes and flare frequency were significant predictors of worsening HAQ-II in this group (R2 = 0.34, P < 0.001). People with gout experience a wide range of activity limitation, and levels of activity limitation are, on average, stable over a 1-year period. Baseline pain scores are strongly associated with activity limitation and predict development of activity limitation in those with normal HAQ-II scores at baseline.

Abstract CT319: A randomized, controlled trial of high dose vs. standard dose vitamin D for aromatase inhibitor-induced arthralgia in breast cancer survivors

Abstract Aromatase inhibitors (AI's) are the most effective adjuvant anti-hormonal therapy for estrogen receptor positive (ER+) post-menopausal breast cancer patients, with superior disease free survival over tamoxifen. However, approximately half of the women who take this drug will develop significant joint pains, termed Aromatase Inhibitor-Induced Arthralgia (AIA). Though this medicine should be taken for 5 years, the joint pain can be so troublesome that 13-20% may prematurely discontinue it because of the arthralgia, thus sacrificing their best chance of disease free survival. Furthermore, daily quality of life is significantly affected by this chronic pain while taking AI therapy. Nonetheless, neither the etiology nor the treatment of AIA is well-understood within the medical community. It is known that low estrogen levels, as seen on AI therapy, decrease the amount of available, active vitamin D. Low Vitamin D is implicated in non-specific musculoskeletal pain in non-cancer patients, possibly mediated by higher levels of inflammatory cytokines IL-6 and TNF-alpha in a low vitamin D state. Vitamin D replacement has been shown to be helpful for AIA in some small clinical trials. We therefore propose to test the hypothesis that AIA can be effectively prevented by high dose Vitamin D supplementation, and that effective prophylaxis of the problem will lead to improved compliance with AI therapy. In this clinical trial, we will enroll 184 women who are beginning adjuvant AI therapy and randomize half of them to receive high dose vitamin D (50,000 IU Vitamin D3 per week for 12 weeks, followed by 2000 IU Vitamin D3 daily for 40 weeks), and the other half to receive standard dose vitamin D (800 IU Vitamin D3 daily for 52 weeks). We will assess each woman's baseline joint pains via a questionnaire (Health Assessment Questionnaire-II). We hypothesize that AIA can be effectively prevented with high dose vitamin D, and this will correlate to increased compliance in the high dose vitamin D arm.. The primary endpoint is development of AIA as measured by a defined change in HAQ-II score between baseline and 12 wks. This randomized Phase 2 study is powered to detect an improvement from an expected 33% incidence of AIA in the standard dose group to 18% or less in the high-dose group (alpha=10%, one-tailed). Finally, as an exploratory objective, we will determine whether those in the standard dose vitamin D arm have a correlation between higher levels of inflammatory cytokines and development of AIA. This study targets a very common cause of pain among breast cancer survivors and aims to offer an effective treatment strategy to alleviate pain and improve quality of life as well as medication compliance. Citation Format: Polly A. Niravath, Sue Hilsenbeck, Tao Wang, Mothaffar Rimawi. A randomized, controlled trial of high dose vs. standard dose vitamin D for aromatase inhibitor-induced arthralgia in breast cancer survivors. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr CT319. doi:10.1158/1538-7445.AM2014-CT319

Crosscultural Measurement Equivalence of the Health Assessment Questionnaire II

To evaluate the crosscultural measurement equivalence of the US and Dutch Health Assessment Questionnaire II (HAQ-II) in rheumatoid arthritis (RA). Item response theory (IRT) analyses were performed on US (n = 18,747) and Dutch (n = 1,022) HAQ-II data to evaluate the equivalence of crosscultural item performance. The observed inconsistencies were modeled by assigning country-specific item parameters to biased items. The impact of crosscultural item bias on the comparability of the Dutch and US total scores was analyzed by evaluating the agreement between physical function levels estimated from an IRT model with country-specific item parameters for biased items and physical function levels estimated from the original model that did not account for cultural bias. Two items showed significant crosscultural bias. However, the agreement in physical function estimates between the respecified and original models was very high, with an intraclass correlation coefficient >0.99 and Bland-Altman limits of agreement ranging from -0.08 to -0.01 on a latent scale with a mean of 0 and an SD of 1. This study suggests that the Dutch and US HAQ-II produce total scores that can be interpreted interchangeably across countries in RA studies, despite some minor bias at the item level.

Metabolic syndrome and insulin resistance comorbidity in systemic lupus erythematosus

The aim of the present study was to assess the effect of metabolic syndrome (MetS) and insulin resistance comorbidity on the carotid intima-media thickness (IMT) in systemic lupus erythematosus (SLE) patients and their relationship to clinical manifestations, disease activity, and damage. The study included 92 SLE patients (mean age 30.18 ± 8.27years) and 30 matched controls. Disease activity and damage were assessed by the SLEDAI and SLICC indices, respectively. The Health Assessment Questionnaire II (HAQII) and Quality of Life (QoL) index were evaluated in the patients. Levels of insulin, glucose, and creatinine and the lipid profile were measured in patients and controls. Insulin sensitivity was estimated using the homeostatic model assessment index (HOMA-B) for beta cell function and (HOMA-IR) for peripheral tissue insulin resistance. The carotid IMT was measured by ultrasonography. The SLE patients had high HOMA-IR and HOMA-B. The IMT was significantly increased (0.82± 0.29mm) compared to the controls (0.45± 0.2mm).The HOMA-IR, SLEDAI, SLICC, HAQII, and IMT were significantly higher and the QoL lower in those with MetS (n = 34) compared to those without (n = 58), while the HOMAB was comparable. There was a significant correlation between the IMT and the SLEDAI, SLICC, and WHR. Insulin sensitivity and IMT are altered in SLE patients, especially those with MetS comorbidity with an associated increase in disease activity and damage. Effective management of MetS would help control SLE activity, damage, and the future development of cardiovascular events especially in the absence of symptoms of cardiovascular disease.

Prescription and dosing of urate-lowering therapy, rather than patient behaviours, are the key modifiable factors associated with targeting serum urate in gout

BackgroundLong term serum urate (SU) lowering to a target of <0.36 mmol/l (6 mg/dl) is recommended for effective gout management. However, many studies have reported low achievement of SU targets. The aim of this cross-sectional study was to examine the clinical and psychological factors associated with SU targets in patients with gout.MethodsPatients with gout for <10 years were recruited from primary and secondary care settings. SU target was defined as SU concentration <0.36 mmol/L at the time of the study visit. Both clinical and psychological factors associated with SU target were analysed. The relationship between SU target and measures of gout activity such as flare frequency, tophi, work absences, and Health Assessment Questionnaire-II was also analysed.ResultsOf the 273 patients enrolled into the study, 89 (32.6%) had SU concentration <0.36 mmol/L. Urate-lowering therapy (ULT) use was strongly associated with SU target (p < 0.001). In those patients prescribed ULT (n = 181), allopurinol dose, patient confidence to keep SU under control, female sex, and ethnicity were independently associated with SU target. Other patient psychological measures and health-related behaviours, including adherence scores, were not independently associated with SU target in those taking ULT. Creatinine clearance, diuretic use, age, and body mass index were not associated with SU target. Patients at SU target reported lower gout flare frequency, compared with those not at target (p = 0.03).ConclusionsULT prescription and dosing are key modifiable factors associated with achieving SU target. These data support interventions focusing on improved use of ULT to optimise outcomes in patients with gout.

The Patient Activity Scale-II Is a Generic Indicator of Active Disease in Patients with Rheumatic Disorders

To determine whether the Patient Activity Scale-II (PAS-II) is a generic measure of disease activity by assessing whether the relationship of PAS-II with treatment decision (indicating disease activity) is invariant across disease. The Health Assessment Questionnaire-II (HAQ-II), a 10 cm visual analog scale for "pain," and another for "patient global assessment" were recorded from 1000 consecutive patients attending rheumatology outpatient clinics. Active disease was defined as treatment intensity increased and inactive disease was defined as treatment intensity unchanged or decreased. A logistic regression analysis was conducted with active disease as the dependent variable and the predictor variables were PAS-II, diagnostic category, and the interaction between diagnostic category and PAS-II. PAS-II had a weak but statistically significant association with active disease that was independent of diagnosis. An increase of 1 point in PAS-II increased the odds of being in the active disease state by 1.19 (95% CI 1.10 to 1.37). The relationship between active disease state and PAS was not affected by diagnostic category. PAS-II can be used as a generic self-report indicator of active disease across different rheumatic disorders, and not just in rheumatoid arthritis. The strength of the relationship with disease activity is weak and physician-derived indicators remain very important.

A computer-adaptive disability instrument for lower extremity osteoarthritis research demonstrated promising breadth, precision, and reliability

Objective To develop and evaluate a prototype measure (OA-DISABILITY-CAT) for osteoarthritis research using item response theory (IRT) and computer-adaptive test (CAT) methodologies. Study Design and Setting We constructed an item bank consisting of 33 activities commonly affected by lower extremity (LE) osteoarthritis. A sample of 323 adults with LE osteoarthritis reported their degree of limitation in performing everyday activities, and completed the Health Assessment Questionnaire-II (HAQ-II). We used confirmatory factor analyses to assess scale unidimensionality and IRT methods to calibrate the items and examine the fit of the data. Using CAT simulation analyses, we examined the performance of OA-DISABILITY-CATs of different lengths compared with the full-item bank and the HAQ-II. Results One distinct disability domain was identified. The 10-item OA-DISABILITY-CAT demonstrated a high degree of accuracy compared with the full-item bank ( r = 0.99). The item bank and the HAQ-II scales covered a similar estimated scoring range. In terms of reliability, 95% of OA-DISABILITY reliability estimates were over 0.83 vs. 0.60 for the HAQ-II. Except at the highest scores, the 10-item OA-DISABILITY-CAT demonstrated superior precision to the HAQ-II. Conclusion The prototype OA-DISABILITY-CAT demonstrated promising measurement properties compared with the HAQ-II, and is recommended for use in LE osteoarthritis research.