Gout Impact Scale Research Articles

Post-hoc analysis of two gout remission definitions in a two-year randomized controlled trial of nurse-led versus usual gout care

ObjectiveTo compare the performance of the 2016 preliminary gout remission definition and a simplified gout remission definition in a clinical trial of nurse-led gout care. MethodsData from a 2-year parallel arm, non-blinded, randomised controlled trial of 517 community-derived people with gout were analyzed. Participants were assigned 1:1 to receive nurse-led care or general practitioner usual care. Remission was defined using the 2016 preliminary gout remission definition and a simplified gout remission definition without patient reported outcomes. Binary logistic regression was used to compare intervention groups. General linear models were used to compare Gout Impact Scale (GIS) scores between those in remission and those not in remission using either definition. ResultsParticipants in the nurse-led care group were more likely to achieve remission using either definition; at Year 2 the odds ratio was 7.92 [95 % CI 4.86–12.92] using the 2016 preliminary definition and 11.88 [95 % CI 7.49–18.84] using the simplified definition. For all participants, the 2016 preliminary definition was fulfilled by 9.9 % at Year 1 and 28.4 % at Year 2, p < 0.001 and the simplified definition was fulfilled by 17.6 % at Year 1 and 42.7 % at Year 2, p < 0.001. People in remission using either definition had better gout outcomes assessed using the GIS, including greater control over their gout. ConclusionBoth definitions discriminated between the intervention groups and showed high construct validity. The simplified definition identified more people as being in gout remission at Year 1 and Year 2. The simplified definition is a feasible and valid option for defining gout remission.

High vegetable consumption and regular exercise are associated with better quality of life in patients with gout.

The Gout Impact Scale (GIS), a part of the Gout Assessment Questionnaire 2.0, is used to measure gout-specific health-related quality of life (HRQOL). Although several studies have been conducted on the factors affecting the HRQOL of patients with gout, few have focused on lifestyle factors. This study aimed to investigate the correlation between lifestyle habits and HRQOL using the GIS in patients with gout. We used data from the Urate-Lowering TheRApy in Gout (ULTRA) registry, a prospective cohort of Korean patients with gout treated at multiple centers nationwide. The patients were aged ≥18 years and met the 2015 American College of Rheumatology/European League Against Rheumatism gout classification criteria. They were asked to complete a GIS and questions regarding their lifestyle habits at enrollment. The study included 232 patients. 'Gout concern overall' scores in the GIS were significantly lower in patients who exercised more frequently and consumed soft drinks and meat less, and 'well-being during attack' scores were significantly lower in patients who consumed vegetables and exercised more frequently. The frequency of vegetable consumption had a negative linear relationship with the 'well-being during attack' and 'gout concern during attack' scores (p = 0.01, p = 0.001, respectively). The frequency of exercise had a negative linear relationship with the 'gout concern overall' and 'gout concern during attack' scores (p = 0.04 and p = 0.002, respectively). Patients with gout who frequently consumed vegetables and exercised regularly experienced less impact of gout, exhibiting a better GIS that represented HRQOL.

The Relationship Between Psychosocial Behavior and the Quality of Life of Male Gout Patients in Southwest China: A Cross-Sectional Study Based on an Information-Motivation-Behavioral Skills Model.

Gout is more severe in men, leading to a poor quality of life. Previous studies did not sufficiently pay attention to the quality of life and related factors in gout patients in Southwest China. This study aimed to investigate the quality of life of men with gout in Southwest China and explore the relationship between psychosocial factors and health-related quality of life from the perspective of an information-motivation-behavioral skill model. This was a cross-sectional study conducted in the West China Hospital of Sichuan University located in Southwest China. In total, 230 male patients with gout were enrolled. The health-related quality of life of patients was assessed using the gout impact scale. The gout knowledge questionnaire was used to assess patients' information. The positive psycap questionnaire was used to assess motivation. The gout patients' self-management assessment scale was used to assess behavioral skills. Multiple linear regression was used to identify the factors associated with the health-related quality of life of patients. The overall mean gout impact scale score was 52.7±15.3 (maximum possible = 100). Factors associated with the total gout impact scale score were tophi (β=0.138, P=0.050), pain (β=0.255, P<0.001), and resiliency (β=-0.282, P<0.001). In addition, demographic characteristics (educational level, smoking and marital status), clinical characteristics (tophi, pain, number of attacks over half a year, and number of affected joints) and psychosocial behavior variables (resiliency, hope, disease treatment management, diet management) were associated with several dimensions of the gout impact scale. The health-related quality of life of male patients with gout in Southwest China was at a medium level. We found that demographic characteristics, clinical characteristics, and psychosocial factors were associated with health-related quality of life of patients with gout. These findings can be used as a reference to improve health-related quality of life of patients with gout.

Reliability and Validity of the Korean Version of the Gout Impact Scale.

The Gout Impact Scale (GIS), part of the Gout Assessment Questionnaire 2.0, measures gout-specific health-related quality of life (HRQOL). This study aimed to translate the GIS into Korean and validate the Korean version (K-GIS) using generic HRQOL measures. The GIS was translated into Korean and back-translated into English. We asked patients aged 18 years or older who met the 2015 gout classification criteria to fill out the questionnaires (from January 2022 to June 2022); the K-GIS (5 scales [0-100 scores each]), along with the Korean version of Health Assessment Questionnaire (HAQ) and EuroQol-5 dimension (EQ-5D). We investigated the internal consistency, construct validity, and discriminative validity for gout characteristics of K-GIS. The K-GIS form was administrated to patients 4 weeks later to assess the test-retest reliability using the intraclass correlation coefficient (ICC). One hundred patients completed the questionnaire. The mean ± standard deviation age of the patients was 53.0 ± 15.1 years, and 99.0% of the patients were men. All scales had high degree of internal consistency (Cronbach's α = 0.59 to 0.96) and test-retest reliability (n = 18, ICC = 0.83 to 0.94, all P < 0.001), except for unmet gout treatment needs. Weak-to-moderate correlations were observed between the K-GIS scales and HAQ or EQ-5D (r = 0.21 to 0.46). The K-GIS scores were significantly higher in the presence of bone erosion, absence of urate-lowering therapy, serum urate levels > 6 mg/dL, frequent gout flares in the past year, and fewer comorbidities. In contrast, neither the HAQ nor the EQ-5D could discern these subsets of patients. The K-GIS is a reliable and valid HRQOL measure for patients with gout. Higher K-GIS scores were associated with clinical characteristics leading to unfavorable outcomes, which were not demonstrated by the HAQ and EQ-5D.

Factors associated with change in health-related quality of life in people with gout: a 3-year prospective cohort study in primary care.

To describe factors associated with change in health-related quality of life (HRQOL) in people living with gout in primary care. In a UK prospective cohort study, adults with a diagnosis of gout registered with 20 general practices completed the Gout Impact Scale (GIS; scale 0-100), 36-item Short Form Physical Function subscale (PF-10; 0-100) and HAQ Disability Index (HAQ-DI; 0-3) via postal questionnaires at baseline and 6, 12, 24 and 36 months. Linear mixed modelling was used to investigate factors associated with changes in HRQOL over 3 years. A total of 1184 participants responded at baseline (adjusted response 65.6%); 990 (83.6%) were male, with a mean age of 65.6 years (s.d. 12.5). A total of 818, 721, 696 and 605 responded at 6, 12, 24 and 36 months, respectively. Factors associated with worse disease-specific and generic HRQOL over 3 years were flare frequency (five or more flares; GIS subscales, PF-10), oligo/polyarticular flares (GIS subscales, PF-10, HAQ-DI), worse pain (GIS subscales, PF-10, HAQ-DI), body pain (GIS subscales, PF-10, HAQ-DI) and more severe depression (GIS subscales, PF-10, HAQ-DI) (P ≤ 0.05). More severe anxiety was associated with worse disease-specific HRQOL only (GIS subscales). Older age (PF-10), being female (PF-10, HAQ-DI) and BMI (HAQ-DI) were associated with worse generic HRQOL (P ≤ 0.05). Gout-specific, comorbid and sociodemographic factors were associated with change in HRQOL over a 3-year period, highlighting people at risk of worse outcomes who could be targeted for interventions.

Clinical Observation on Therapeutic Effect of Electroacupuncture Combined with Diclofenac Sodium in Treatment of Acute Gouty Arthritis: A Randomized Controlled Study.

Objective To observe the clinical effect of electroacupuncture (EA) combined with diclofenac sodium (DS) in the treatment of acute gouty arthritis (AGA). Methods Patients with AGA were randomly divided into three groups: the EA + DS treatment group (i.e., EA + DS group), the low-dose DS treatment group (i.e., low-dose DS group), and the conventional-dose DS treatment group (i. e., conventional DS group). Patients in the low-dose DS group took 50 mg of DS sustained-release capsules once a day. Patients in the conventional DS group took 100 mg of DS sustained-release capsules once a day. Patients in the EA + DS group were treated with EA three times in 7 days combined with 50 mg of DS sustained-release capsules once a day. For all the three groups, 7 days were regarded as a course of treatment. Outcome indicators included pain visual analog scale (VAS), joint tenderness, joint swelling and activity limitation, and levels of inflammatory indicators (C-reactive protein (CRP)/white blood cells (WBC)/percentage of neutrophils (NE%)), level of serum uric acid (SUA), gout impact scale (GIS), and frequency of adverse reactions). Results After a course of treatment, indicators regarding the VAS, joint tenderness, joint swelling, activity limitation, GIS, inflammatory indicators (CRP/WBC/NE%), and SUA were all improved (P < 0.05) with no adverse reactions in the EA + DS group. The EA + DS group performed better than the low-dose DS group in improving indicators regarding the VAS, joint tenderness, activity limitation, GIS, inflammatory markers (WBC/NE%), and SUA (P < 0.05). Similarly, the EA + DS group performed better than the conventional DS group in improving indicators regarding GIS, SUA, and adverse reactions (P < 0.05). Conclusion EA combined with DS can improve AGA patients' joint pain and functional status, thus improving their quality of life. Moreover, this combined treatment can reduce the levels of inflammatory markers and SUA, leading to fewer adverse reactions in AGA patients.

Translation, internal consistency, reliability and validity of the Thai version of Gout Assessment Questionnaire version 2.0 (GAQ 2.0).

To translate the Gout Assessment Questionnaire version 2.0(GAQ2.0) with Gout Impact (GI) Scale (GIS) into Thai and determine its psychometric property in gout patients with acute arthritis (acute arthritis group) and during the intercritical period (chronic gout group). Translation followed the ISPOR recommendations. Cronbach's α, intraclass correlation coefficient (ICC) and standardized response mean (SRM) were used to determine internal consistency, reliability and responsiveness to change, respectively. Correlations between GI subscales with generic health-related quality of life (HRQoL) questionnaires (SF-36, HAQ-DI and EQ-5D-5L) and gout clinical parameters were determined. The acute arthritis group and the chronic gout group comprised 27 and 92 patients, respectively. Internal consistency was sufficient for all GI subscales (Cronbach's α = 0.80-0.98), reliability was moderate to good in most GI subscales (ICC = 0.54-0.88) and responsiveness to change was moderate to large in most GI subscales (SRM = 0.43-0.98). The GI subscales correlated better with SF-36 than HAQ-DI and EQ-5D-5L. In the acute arthritis group, the unmet gout treatment needs subscale showed large and moderate negative correlation with tophi and serum uric acid, respectively. In the chronic gout group, the gout concern overall subscale had statistically significant, moderate correlation with overall gout severity rated by the patients and number of gout attacks over the past year, while the well-being during attack subscale and total GIS score had statistically significant, moderate correlation with overall gout severity rated by the patients. The Thai GAQ2.0 GIS showed acceptable internal consistency, reliability and responsiveness to change and correlated significantly with generic HRQoL questionnaires and clinical parameters. Key Points • The Thai GAQ2.0 GIS showed acceptable internal consistency, reliability and responsiveness to change in gout patients both during acute attack and during the intercritical period • The GI subscales showed significant correlation with SF-36 and HAQ questionnaires and gout clinical parameters in gout patients both during acute attack and during the intercritical period • The Thai GAQ2.0 GIS subscales should be used in conjunction with generic HRQoL for complete HRQoL assessment in gout patients.

Health-related quality of life assessed by Gout Impact Scale (GIS) in Chinese patients with gout

Objective The Gout Impact Scale (GIS) is a disease-specific health-related quality of life (HR-QoL) measurement for patients with gout. This study aimed to investigate the quality of life in Chinese patients with gout and potential risk factors for poorer HR-QoL by GIS. Methods Adults with gout from February 2017 to February 2019 were invited to complete a questionnaire containing the GIS, social demographic characteristics, clinical information and gout-specific questions. Pearson/Spearman correlation and linear regression were used to analyze the data. Results A total of 413 patients were included in the analysis (mean age, 51.85 years; 96.4% male). The mean (SD) score of GIS total was 56.79 ± 15.45. Worse gout-specific HR-QoL was associated with anxiety (p < .05), depression (p < .05) and fatigue (p < .05). The effectiveness and global satisfaction of Treatment Satisfaction Questionnaire for Medication (TSQM) were negatively related to each dimension of GIS. Age (B = −0.251, p = .013), fatigue (B = 1.850, p < .001) and depression (B = 9.068, p = .042) were independent predictors of GIS total score. Conclusion Gout-specific HR-QoL is impaired by social demographic and clinical characteristics, highlighting the importance of psychological factors (fatigue and depression) and patient-reported outcomes (patients’ satisfaction and confidence in gout treatment). These findings suggest that more studies should focus on disease-specific HR-QoL.

Use of the Gout Impact Scale to Evaluate Quality of Life in Chinese Subjects with Gout: A Cross-Sectional Study

BackgroundTo use a gout-specific quality of life (QoL) tool, the Gout Impact Scale (GIS), to evaluate characteristics of gout affecting QoL in subjects with gout.Material/MethodsIn this cross-sectional study, 169 individuals with gout completed the 24-item GIS and a general questionnaire regarding gout characteristics. The reliability and validity of the GIS were verified by Cronbach’s α and exploratory factor analysis, respectively. The impact of gout characteristics on the QoL of subjects with gout was assessed by stepwise multiple regression analysis.ResultsThe 169 subjects with gout included 149 (88.2%) men and 20 (11.8%) women, of median age 43 years. The reliability of the GIS was appropriate (0.84–0.90), except for Gout Medication Side Effects (0.69) and Unmet Gout Treatment Need (0.59). Exploratory factor analysis showed that construct validity was acceptable, with a cumulative variance contribution rate of 5 common factors of 70.09% and factor loading >0.5 between each pair of items of the GIS. Univariate analysis showed that male sex was positively correlated with Well-being During Attack (p<0.05), and that source of medical expenses, current cigarette use and drinking were significantly correlated with Unmet Gout Treatment Need (p<0.05 each). A family history of gout, gout flares, and attack frequency were significantly correlated with total GIS, Well-being During Attack, and Gout Concern during Attack (p<0.05 each). Multivariate analysis suggested that history of gouty arthritis, acute attack and attack frequency had a considerable impact on QoL (p<0.05 each).ConclusionsThe GIS showed acceptable reliability and validity in identifying associations between poor QoL and gout characteristics.

P142 Factors associated with change in health-related quality of life in people living with gout: a three-year prospective cohort study in primary care

Abstract Background Gout affects 2.5% of adults in the UK but is often poorly managed. It can impair health-related quality of life (HRQOL), yet little is known about which people with gout are at risk of worse outcomes. We investigated factors associated with change in HRQOL over a three-year period in people living with gout in primary care. Methods People with gout registered with 20 general practices in the West Midlands completed the Gout Impact Scale (GIS), Short-Form-36 Physical Function subscale (PF10) and health assessment questionnaire disability index (HAQ-DI) at five time-points (baseline &amp; 6, 12, 24 and 36 months) via postal questionnaire. Linear mixed modelling (LMM) with multivariate adjustment for baseline and time-varying covariates was used to investigate gout-specific, comorbid and socio-demographic factors associated with change in the Concern Overall (GIS-CO), PF10 and HAQ-DI over three years. Higher scores are worse for GIS-CO and HAQ-DI, but better for PF10. Results Of 1,184 baseline respondents, 818 (80%), 721 (73%), 696 (75%), 605 (68%) responded at 6, 12, 24 and 36 months respectively. Mean age (SD) at baseline was 65.6 (12.5) years. 990 (84%) were male, 494 (42%) reported &amp;gt;2 gout flares in the previous year, 624 (54%) were taking allopurinol and 318 (27%) had an eGFR&amp;lt;60mL/min/1.73m2. Factors identified as being associated with a deterioration in HRQOL over three years (table), were gout flare frequency (GIS-CO, PF10), history of oligo/polyarticular flares (GIS-CO, HAQ-DI), having a flare currently (GIS-CO), allopurinol use (PF10), having body pain (GIS-CO, PF10, HAQ-DI), higher pain severity (GIS-CO, PF10, HAQ-DI), number of comorbidities (PF10), eGFR &amp;lt;60mL/min/1.73m2 (PF10, HAQ-DI), anxiety (GIS-CO), depression (PF10, HAQ-DI), and older age (PF10, HAQ-DI). Factors associated with an improvement in HRQOL were longer gout duration (GIS-CO), older age (GIS-CO), lower socioeconomic deprivation (PF10, HAQ-DI) and more frequent alcohol consumption (PF10, HAQ-DI). Conclusion Gout-specific, comorbid and socio-demographic factors associated with change in HRQOL over a three-year period in people living with gout in primary care were identified, highlighting people at risk of worse outcomes over three years and at greatest need of urate-lowering therapy and other targeted interventions. Disclosures L. Watson None. J. Belcher None. E. Nicholls None. P. Chandratre None. M. Blagojevic-Bucknall None. S. Hider None. S.A. Lawton None. C.D. Mallen None. S. Muller None. K. Rome None. E. Roddy None.

Gout management and outcomes during the COVID-19 pandemic: a cross-sectional internet survey.

Aim:We aimed to assess the gout management during the COVID-19 pandemic.Methods:We assessed medication use, healthcare utilization, gout-specific health-related quality of life (HRQoL) on the Gout Impact Scale (GIS), psychological distress using the patient health questionnaire-4 (PHQ-4), and resilience in people with self-reported physician-diagnosed gout during the COVID-19 pandemic in a cross-sectional Internet survey.Results:Among the 122 survey respondents with physician-diagnosed gout, 82% were prescribed urate-lowering therapy (ULT) and 66% were taking ULT daily; mean age was 54.2 years [standard deviation (SD), 13.8], 65% were male, and 79% were White. More regular use of gout medication was reported during the COVID-19 pandemic: allopurinol, 44%; colchicine, 37%; non-steroidal anti-inflammatory drugs, 36%. Gout flares were common: 63% had ⩾1 gout flare monthly; 11% went to emergency room/urgent care; and 2% were hospitalized with gout flares. Between 41% and 56% of respondents reported more difficulty with gout management and related functional status related to COVID-19; 17–37% had difficulty with healthcare access for gout. HRQOL deficits were evident for gout concern overall, 79.4 (SD, 25); unmet gout treatment need, 64.5 (SD, 27.1); and gout concern during flare, 67.3 (SD, 27.1); but less so for gout medication side effects, 48.9 (SD, 27.4). Psychological distress was moderate in 19% and severe in 15% (mild, 22%; normal, 45%). Resilience score on Connor–Davidson Resilience Scale (CD-RISC2) was 5.6 (SD, 1.8; range 0–8). Compared with no/mild psychological distress, moderate–severe psychological distress during the COVID-19 pandemic was significantly associated with more difficulty getting gout medication filled (p = 0.02), flares treated (p = 0.005), and receiving gout education (p = 0.001).Conclusion:Healthcare gaps, psychological distress, and HRQoL deficits were commonly reported by people with gout during the COVID-19 pandemic. Interventions to address these challenges for people with gout during the COVID-19 pandemic are needed.

An assessment of the psychometric properties of the Chinese version of the Gout Impact Scale

Objective: To assess the psychometric properties of the Chinese version of the Gout Impact Scale (GIS), a gout-specific HRQoL measure.Methods: This was a single-center, cross-sectional, observational survey of patients with gout recruited from the Taipei Medical University Hospital from November 2017 to April 2018. The respondents were recruited by convenience sampling. The reliability of the Chinese GIS was tested by Cronbach’s α coefficient and adjusted using the Spearman–Brown prophecy formula. Content validity was assessed and confirmed by rheumatologists and pharmacists before the administration of the survey. Convergent validity was tested by Spearman correlation analysis to examine the association of the EQ-5D-5L with GIS total and subscale scores. Construct validity of the Chinese GIS was assessed by hypothesis testing.Results: A total of 311 patients were included in the analysis. The majority of these respondents were male (93.2%) with no comorbidities (69.5%) and they had a mean age of 52.9 (±14.2) years. The internal consistency of the Chinese GIS subscales was acceptable to excellent (Cronbach’s α = 0.73–0.98) after adjusting to a 10 item scale with the Spearman–Brown prophecy formula. The GIS total and subscale scores were significantly associated with lower EQ-5D-5L scores ([−0.14] – [−0.27], p < .05). In addition, the GIS total and all subscale scores had a significant positive correlation with gout attack severity (rs = 0.13–0.57, p < .05) and gout attack pain (rs = 0.17–0.54, p < .01). Moreover, respondents’ most recent sUA concentration was associated with both the GIS gout concern overall subscale (rs = 0.13, p < .05) and the unmet gout treatment need subscale (rs = 0.18, p < .01).Conclusions: The present study demonstrates that the Chinese version of the GIS shows good internal consistency and association with gout-related characteristics. Future studies may consider using this gout-specific instrument to assess the HRQoL of gout patients in Taiwan.

Validity and reliability of the Gout Impact Scale in a multi-ethnic Asian population.

The emphasis on capturing patient-reported outcomes (PRO) is increasing, but gout-specific PRO are lacking. We evaluated the reliability and validity of the 24-item Gout Impact Scale (GIS) of the Gout Assessment Questionnaire 2.0 (GAQ2.0) in a multi-ethnic Asian population. Participants with gout in an academic medical center in Singapore completed the GIS which comprises five scales. Confirmatory factor analyses (CFA) were performed. Known-groups validity, divergent validity and internal consistency were evaluated. We analyzed data of 267 participants (mean [SD] age 52.2 [16.08] years, 92.1% men and 76.0% Chinese). CFA based on the original GIS factor structure had good model fit based on Tucker-Lewis Index (TLI) of 0.946 but not when based on Root Mean Square Error Of Approximation (RMSEA), which was 0.123 (90% CI: 0.116-0.130). Internal consistency of GIS exceeded 0.7 in all except one scale, consistent with previous studies. Hypotheses related to known-groups validity were largely supported. Scores were significantly higher (ie greater impact) for participants reporting at least some problem on the EQ-5D-3L anxiety/ depression item across all GIS scales. Correlations between RAND-36 Physical Functioning (PF) scale and all five scales in the GIS were poor (Spearman rank correlation coefficients: -0.2355 to 0.0426), implying that GIS does not measure impact of gout on physical health. The GIS is valid and reliable for assessing gout-specific psychosocial functioning in a multi-ethnic Asian population.

Gout Activity Score has predictive validity and is sensitive to change: results from the Nottingham Gout Treatment Trial (Phase II).

ObjectivesTo examine the predictive validity of the Gout Activity Score (GAS), its correlation with the Gout Impact Scale (GIS) and their sensitivity to change.MethodsData from a clinical trial in which participants with one or more gout flares in the previous year were recruited from primary care and randomized to nurse-led or continuing usual care were used in this study. GAS and GIS were calculated as described, with higher scores indicating worse disease activity and quality of life, respectively. The correlation between GAS and GIS was examined using Spearman’s correlation. Standardized response means (SRMs) were calculated to assess sensitivity to change. The association between GAS at baseline and the number of flares in the next 12 months was evaluated using Poisson regression. Data analyses were performed using STATA version 14, with P-values <0.05 being statistically significant.ResultsThere was low positive correlation between GAS and gout concern overall and unmet treatment need subscales of GIS (r = 0.34–0.45). Female sex associated independently with fewer gout flares, while increasing GAS, BMI and age associated independently with frequent flares. Of all the outcome measures examined, GAS was the most responsive to change (SRM 0.89 to −0.53). Of the GIS domains, the gout concern overall domain had the best sensitivity to change (SRM 1.06–0.01).ConclusionGAS is sensitive to change, has predictive validity and correlates with relevant domains of GIS such as gout concern overall. Additional independent validation of GAS is required before it can be adopted in clinical practice.

Health-related quality of life in gout in primary care: Baseline findings from a cohort study.

ObjectivesTo examine gout-related, comorbid, and sociodemographic characteristics associated with generic and disease-specific health-related quality of life (HRQOL) in gout.MethodsAdults with gout from 20 general practices were mailed a questionnaire containing the Health Assessment Questionnaire-Disability Index (HAQ-DI), Short-Form-36 Physical Function subscale (PF-10), Gout Impact Scale (GIS), and questions about gout-specific, comorbid and sociodemographic characteristics. Variables associated with HRQOL were examined using multivariable linear regression models.ResultsA total of 1184 completed questionnaires were received (response 65.9%). Worse generic and gout-specific HRQOL was associated with frequent gout attacks (≥5 attacks PF-10 β = −4.90, HAQ-DI β = 0.14, GIS subscales β = 8.94, 33.26), current attack (HAQ-DI β = 0.15, GIS β = −1.94, 18.89), oligo/polyarticular attacks (HAQ-DI β = 0.11, GIS β = 0.78, 7.86), body pain (PF-10 β = −10.68, HAQ-DI β = 0.29, GIS β = 2.61, 11.89), anxiety (PF-10 β = −1.81, HAQ-DI β = 0.06, GIS β = 0.38, 1.70), depression (PF-10 β = −1.98, HAQ-DI β = 0.06, GIS 0.42, 1.47) and alcohol non-consumption (PF-10 β = −16.10, HAQ-DI β = 0.45). Gout-specific HRQOL was better in Caucasians than non-Caucasians (GIS β = −13.05, −13.48). Poorer generic HRQOL was associated with diabetes mellitus (PF-10 β = −4.33, HAQ-DI β = 0.14), stroke (PF-10 β = −12.21, HAQ-DI β = 0.37), renal failure (PF-10 β = −9.43, HAQ-DI β = 0.21), myocardial infarction (HAQ-DI β = 0.17), female gender (PF-10 β = −17.26, HAQ-DI β = 0.43), deprivation (PF-10 β = −7.80, HAQ-DI β = 0.19), and body mass index ≥35 kg/m2 (PF-10 β = −6.10, HAQ-DI β = 0.21).ConclusionsHRQOL in gout is impaired by gout-specific, comorbid, and sociodemographic characteristics, highlighting the importance of comorbidity screening and early urate-lowering therapy. Both gout-specific and generic questionnaires identify the impact of disease-specific features on HRQOL but studies focusing on comorbidity should include generic instruments.

First validation of the gout activity score against gout impact scale in a primary care based gout cohort

ObjectivesTo validate the gout activity score (GAS) against the gout impact scale in a primary care based gout cohort. MethodsThis was a single-centre cross-sectional study. People with gout who participated in previous research at academic rheumatology, University of Nottingham, UK, and consented for participation in future studies were mailed a questionnaire in September 2015. Those returning completed questionnaires were invited to attend for a study visit at which blood was collected and musculoskeletal examination was performed. The Gout Assessment Questionnaire, which contains the gout impact scale (GIS), and short form (SF) 36v2 questionnaires were completed. The GAS3-step-c score was calculated. Spearman's correlation coefficient was calculated to examine correlation between GAS and SF-36 v2, and GIS. Statistical analyses were performed using PASW v22. ResultsOne hundred and two (93% men) of the 150 participants who were mailed a questionnaire attended the study visit. Their mean (SD) age, body mass index, serum uric acid and GAS were 67.94 (9.93) years, 29.96 (4.57) kg/m2, 5.25 (1.75) mg/dl, and 2.99 (0.74) respectively. There was moderate correlation between GAS and gout concern overall, unmet gout treatment need, and gout concern during an attack components of GIS (r=0.306 to 0.453), but no to poor correlation between GAS and summary scores and scales of SF-36 v2 (r=–0.090 to –0.251). ConclusionThis first study to validate GAS against the GIS found moderate correlation. However, this study did not examine the predictive validity of GAS, and prospective studies are needed before GAS can be used widely.

Utility of the Morisky Medication Adherence Scale in gout: a prospective study.

BackgroundThe outcomes of any chronic illness often depend on patients’ adherence with their treatment. A tool is lacking to assess adherence in gout that is standardized, allows real-time feedback, and is easy to understand.ObjectiveWe set out to evaluate the utility of the 8-item Morisky Medication Adherence Scale (MMAS-8) in monitoring medication adherence in a multiethnic Asian gout cohort on urate-lowering therapy (ULT).MethodsThis cohort study recruited patients with gout where baseline and 6-monthly clinical data, self-report of adherence, and health status by Gout Impact Scale (GIS) and EuroQoL-5 dimension 3 levels were collected. Those who received at least 9 months of ULT were analyzed. Convergent and construct validities of MMAS-8 were evaluated against medication possession ratio (MPR) and known groups, clinical outcomes, and patient-reported outcomes. Internal consistency and test–retest reliability were assessed using Cronbach’s alpha and intraclass correlation coefficient (ICC), respectively.ResultsOf 91 patients, 92.3% were male, 72.5% Chinese with mean age 53.5 years. MMAS-8 (mean 6.17) and MPR (mean 96.3%) were poorly correlated (r=0.069, P=0.521). MMAS-8 did not differ between those who did or did not achieve target serum urate (SU) <360 µmol/L (P=0.852); or among those whose SU improved, stagnated, or worsened during follow-up (P=0.777). Adherence was associated with age (β=0.256, P=0.015) and education level (P=0.011) but not comorbidities, polypharmacy, or flare frequency. Concerns for medication side effects and anxiety or depression were associated with lower MMAS-8 (P<0.005). Internal consistency was acceptable (α=0.725) and test–retest reliability was satisfactory (ICC =0.70, 95% confidence interval [CI] 0.36–0.88).ConclusionMMAS-8 had limited construct validity in assessing medication adherence to ULT in our gout patients. Nevertheless, it identified patients bothered or worried about ULT side effects, and those with underlying anxiety or depression, for whom targeted education and coping support may be useful.

Racial differences in health-related quality of life and functional ability in patients with gout.

To compare the health-related quality of life (HRQOL) and the functional ability by race in patients with gout. In a 9-month prospective cohort multicentre study, patients with gout self-reported race, dichotomized as Caucasian or African American (others excluded). We calculated HRQOL/function scores adjusted for age, study site and college education for Short Form-36 (SF-36; generic HRQOL), Gout Impact Scale (GIS; disease-specific HRQOL) and HAQ-disability index (HAQ-DI; functional ability). Longitudinally adjusted scores were computed using multivariable mixed-effect regression models with a random patient effect and fixed sequential visit effect (3-monthly visits). Compared with Caucasians (n = 107), African Americans (n = 60) with gout were younger (61.1 vs 67.3 years) and had higher median baseline serum urate (9.0 vs 7.9 mg/dl) (P < 0.01). African Americans with gout had worse HRQOL scores on three SF-36 domains, the mental component summary (MCS) and two of the five GIS scales than Caucasians [mean (se); P ⩽ 0.02 for all]: SF-36 mental health, 39.7 (1.1) vs 45.2 (0.9); SF-36 role emotional, 42.1 (4.2) vs 51.4 (4.2); SF-36 social functioning, 36.0 (1.1) vs 40.0 (0.9) (P = 0.04); SF-36 MCS, 43.2 (3.1) vs 50.0 (3.2); GIS unmet treatment need, 37.6 (1.6) vs 31.5 (1.4); and GIS concern during attacks, 53.3 (3.7) vs 47.4 (3.7). Differences between the respective HAQ-DI total scores were not statistically significant; 0.98 (0.1) vs 0.80 (1.0) (P = 0.11). Racial differences in SF-36 mental health, role emotional and MCS scales exceeded, and for HAQ-DI approached, the minimal clinically important difference thresholds. African Americans with gout have significantly worse HRQOL compared with Caucasians. Further research is necessary in the form of studies targeted at African Americans on how best to improve these outcomes.

Performance of Gout Impact Scale in a longitudinal observational study of patients with gout.

The aim was to evaluate the reliability, validity and responsiveness to change of the Gout Impact Scale (GIS), a disease-specific measure of patient-reported outcomes, in a multicentre longitudinal prospective cohort of gout patients. Subjects completed the GIS, a 24-item instrument with five scales: Concern Overall, Medication Side Effects, Unmet Treatment Need, Well-Being during Attack, and Concern Over Attack. The total GIS score was calculated by averaging the GIS scale scores. HAQ-Disability Index (HAQ-DI), Short Form (SF)-36 physical and mental component summaries (PCS and MCS) and physician and patient gout severity assessments were also completed. Reliability was assessed with Cronbach's α. Baseline GIS scores were compared in subjects with and without gout attacks in the past 3 months using Wilcoxon rank sum tests. Multivariate linear regression was used to evaluate predictors of total GIS. Pearson's correlation coefficients 0.24-0.36 were considered moderate and >0.37 considered large. The effect size for responsiveness to change was interpreted as follows: 0.20-0.49 small, 0.50-0.79 medium and >0.79 large. In 147 subjects, reliability was acceptable for total GIS (0.93) and all GIS scales (0.82-0.94) except Medication Side Effects and Unmet Treatment Need. Total GIS and all scales except Medication Side Effects discriminated between subjects with and without recent gout attacks (P < 0.05). Total GIS showed moderate-to-large correlations with HAQ-DI, SF-36 PCS and MCS (0.33-0.46). Improvement in total GIS tracked with improved physician and patient severity scores. Worsening physician severity score and recent gout attack predicted worsening total GIS. Total GIS score is reliable, valid and responsive to change in patients with gout, and differentiates between subjects with and without recent gout attacks.

Health-related quality of life and treatment satisfaction in patients with gout: results from a cross-sectional study in a managed care setting.

BackgroundPatient satisfaction with treatment directly impacts adherence to medication.ObjectiveThe objective was to assess and compare treatment satisfaction with the Treatment Satisfaction Questionnaire for Medication (TSQM), gout-specific health-related quality of life (HRQoL) with the Gout Impact Scale (GIS), and generic HRQoL with the SF-12v2® Health Survey (SF-12) in patients with gout in a real-world practice setting.MethodsThis cross-sectional mail survey included gout patients enrolled in a large commercial health plan in the US. Patients were ≥18 years with self-reported gout diagnosis, who filled ≥1 prescription for febuxostat during April 26, 2012 to July 26, 2012 and were not taking any other urate-lowering therapies. The survey included the TSQM version II (TSQM vII, score 0–100, higher scores indicate better satisfaction), GIS (score 0–100, higher scores indicate worse condition), and SF-12 (physical component summary and mental component summary). Patients were stratified by self-report of currently experiencing a gout attack or not to assess the discriminant ability of the questionnaires.ResultsA total of 257 patients were included in the analysis (mean age, 54.9 years; 87% male). Patients with current gout attack (n=29, 11%) had worse scores than those without gout attack on most instrument scales. Mean differences between current attack and no current attack for the TSQM domains were: −20.6, effectiveness; −10.6, side effects; −12.1, global satisfaction (all P<0.05); and −6.1, convenience (NS). For the GIS, mean differences were: 30.5, gout overall concern; 14.6, gout medication side effects; 22.7, unmet gout treatment needs; 11.5, gout concern during attack (all P<0.05); and 7.9, well-being during attack (NS). Mean difference in SF-12 was −6.6 for physical component summary (P<0.05) and −2.9 for mental component summary (NS). Correlations between several TSQM and GIS scales were moderate.ConclusionThe TSQM and GIS were complementary in evaluating the impact of gout flare on treatment satisfaction and HRQoL. Correlations between the two instruments supported the relationship between treatment satisfaction and HRQoL.