Global Health Visual Analogue Scale Research Articles

Health-related quality of life and its association with disease activity/functional status in rheumatoid arthritis: A cross-sectional study from South India.

Rheumatoid arthritis (RA) is an autoimmune disease with chronic pain that gradually becomes incapacitating and negatively influences the health-related quality of life (HRQoL). This study estimates HRQoL in RA using the EuroQol five dimensions (EQ-5D) tool and its association with functional status and disease activity. RA patients (n = 320) aged above 18 years, visiting outpatient clinic at a tertiary care multispecialty hospital in south India were the study participants. Sociodemographic, clinical, and laboratory data were collected from them. EQ-5D-5L questionnaire and the EQ Global Health Visual Analogue Scale (EQ-VAS) were used to measure HRQoL. Disease activity was measured using Disease Activity Score-28 (DAS-28), and the Health Assessment Questionnaire (HAQ) was used to assess functional status. Pearson's correlation and multiple linear regression were used to measure association, and statistical significance was considered at p < 0.05. The EQ-5D utility score was 0.54 ± 0.36, pain and anxiety were the most affected domains, and the mean EQ-VAS was 63.05 ± 18.54%. A moderate to high disease activity was present in 85% (DAS-28 > 3.2), and a severe functional disability in 32.8% (HAQ > 1.5) of study participants. The mean EQ-5D scores for RA patients were 0.78 (0.65-0.90) for no disease activity, 0.73 (0.65-0.80) for mild, 0.53 (0.32-0.74) for moderate and 0.47 (0.32-0.62) for high disease activity. In multiple linear regression analysis, HAQ and age independently predicted EQ-5D. RA significantly impacts HRQoL, and interventions focussing on pain and anxiety management are essential. The study's EQ-5D values could help estimate Quality Adjusted Life Years (QALY) while conducting economic evaluation studies in RA within an Indian context.

Postpartum recovery of nulliparous women following scheduled cesarean delivery and spontaneous vaginal delivery: a prospective observational study

Inpatient postpartum recovery trajectories following cesarean delivery and spontaneous vaginal delivery are underexplored. This study primarily aimed to compare recovery following cesarean delivery and spontaneous vaginal delivery in the first postpartum week, and secondarily to evaluate psychometrically the Japanese version of the Obstetric Quality of Recovery-10 scoring tool. Following institutional review board approval, the EQ-5D-3L (EuroQoL 5-Dimension 3-Level) questionnaire and a Japanese version of the Obstetric Quality of Recovery-10 measure were used to evaluate inpatient postpartum recovery in uncomplicated nulliparous parturients delivering via scheduled cesarean delivery or spontaneous vaginal delivery. A total of 48 and 50 women who delivered via cesarean delivery and spontaneous vaginal delivery, respectively, were recruited. Women delivering via scheduled cesarean delivery experienced significantly worse quality of recovery on days 1 and 2 compared with those who had spontaneous vaginal delivery. Quality of recovery significantly improved daily, plateauing at days 4 and 3 for cesarean delivery and spontaneous vaginal delivery groups, respectively. Compared with cesarean delivery, spontaneous vaginal delivery was associated with prolonged time to analgesia requirement, decreased opioid consumption, reduced antiemetic requirement, and reduced times to liquid/solid intake, ambulation, and discharge. Obstetric Quality of Recovery-10-Japanese is a valid (correlates with the EQ-5D-3L including a global health visual analog scale, gestational age, blood loss, opioid consumption, time until first analgesic request, liquid/solid intake, ambulation, catheter removal, and discharge), reliable (Cronbach alpha=0.88; Spearman-Brown reliability estimate=0.94; and intraclass correlation coefficient=0.89), and clinically feasible (98% 24-hour response rate) measure. Inpatient postpartum recovery is significantly better in the first 2 postpartum days following spontaneous vaginal delivery compared with scheduled cesarean delivery. Inpatient recovery is largely achieved within 4 and 3 days following scheduled cesarean delivery and spontaneous vaginal delivery, respectively. Obstetric Quality of Recovery-10-Japanese is a valid, reliable, and feasible measure of inpatient postpartum recovery.

Validation of the Turkish version of the Obstetric Quality-of-Recovery score 11 (ObsQoR-11T) after cesarean delivery

BackgroundTo translate and validate the psychometric characteristics of a Turkish version of the Obstetric Quality-of-Recovery score 11 tool used to measure post-cesarean delivery recovery in Turkish-speaking patients.MethodsAfter the original English version of the Obstetric Quality-of-Recovery score 11 tool was translated into Turkish; it was psychometrically validated to assess the post-cesarean delivery quality of recovery. Validity, reliability, and feasibility were investigated. The Obstetric Quality-of-Recovery score 11 tool was administered to Turkish-speaking patients on postoperative day 1. On postoperative day 1, a global health visual analog scale was used to assess the patient's perceived global recovery.ResultsOne hundred and eighty-six patients completed their questionnaires, providing a completion rate of 97.38%. The Spearman rho (ρ) correlation coefficient between the Obstetric Quality-of-Recovery score and global health visual analog scale (0–100 points) was 0.850 at postoperative day 1 following surgery (P < 0.001). Internal consistency, measured using Cronbach’s alpha, was 0.822. The split-half coefficient was 0.708. The Obstetric Quality-of-Recovery score differed significantly between the emergency and elective cesarean delivery groups (80 (41–104) vs. 83.3 (51–102); P < 0.05). The test–retest reliability of the Obstetric Quality-of-Recovery score items was more than 0.6 in 82% of cases, indicating good repeatability and reliability.ConclusionThe Obstetric Quality-of-Recovery score 11 is a valid and reliable tool to measure the post-cesarean quality of recovery in Turkish-speaking patients. The psychometric properties of the Turkish version of the scale to measure the post-cesarean quality of recovery were similar to those of the seminal English version.

Development and Validation of a Turkish Version of Obstetric Quality of Recovery-10.

The 10-item Obstetric Quality-of-Recovery 10 scale is a validated patient-reported outcome questionnaire that measures the quality of recovery following delivery. This study aims to develop a Turkish version of the Obstetric Quality of Recovery 10 to evaluate its validity, reliability, and clinical feasibility. Term parturients who underwent vaginal delivery or elective caesarean delivery were asked to complete a Turkish version of Obstetric Quality-of-Recovery 10 scoring tool and EuroQol 5-dimension 3L scores (including a global health visual analogue scale) 24 hours after delivery. To validate the Obstetric Quality of Recovery 10-Turkish, we assessed validity, reliability, and clinical feasibility and compared it with the EQ-5D-3L questionnaires. One hundred parturients completed the questionnaire in 24 hours (100% response rate). Obstetric Quality of Recovery 10-Turkish correlated highly with EQ-5D-3L score (r=-0.611) and global health visual analogue scale score (r = 0.652) at 24 hours and discriminated well between good versus poor recovery (global health visual analogue scale score ≥70 vs <70; median interquartile range were 86 [80-90] and 68 [59-75] (P < .001), respectively). Scores were similar for caesarean and vaginal deliveries, 83 (76-89) and 82.5 (69-90), respectively (P = .5). Twenty-four-hour Obstetric Quality of Recovery 10-Turkish scores did not correlate with any baseline demographic and clinical data parameters. Internal consistency was good (Cronbach's alpha=0.87 and inter-item correlation=0.41), and split-half reliability was very good (Spearman-Brown prophesy reliability estimate=0.86). Test-retest reliability was excellent (intra-class correlation coefficient=0.99). No floor or ceiling effects were demonstrated. The Obstetric Quality of Recovery 10-Turkish is a valid, reliable, and clinically feasible measure of inpatient postpartum recovery following caesarean and vaginal delivery modes.

Development and validation of a Portuguese version of Obstetric Quality of Recovery-10 (ObsQoR-10-Portuguese)

BackgroundWe aimed to develop and validate a Portuguese version of the Obstetric Quality of Recovery-10 (ObsQoR-10-Portuguese) patient-reported outcome measure and evaluate its psychometric properties. MethodsAfter ethical approval, we recruited term pregnant women undergoing uncomplicated elective cesarean delivery in a single Brazilian institution. Women were invited to complete the translated ObsQoR-10-Portuguese and EuroQoL (EQ-5D) questionnaires (including a global health visual analog scale [GHVAS]) at 24 h (±6 h) following delivery, and a subset of women an hour later. We assessed validity and reliability of ObsQoR-10-Portuguese. ResultsOne hundred thirteen enrolled women completed the surveys at 24 h and 29 women at 25 h (100% response rate). Validity: (i) convergent validity: ObsQoR-10-Portuguese correlated moderately with EuroQoL score (r = −0.587) and GHVAS score (r = 0.568) at 24 h. (ii) Discriminant validity: ObsQoR-10 discriminated well between good versus poor recovery (GHVAS score ≥ 70 versus < 70; difference in mean scores 14.2; p < 0.001). (iii) Hypothesis testing: 24-h ObsQoR-10-Portuguese scores correlated with gestational age (r = 0.191; p = 0.043). (iv) Cross-cultural validity: differential item functioning analysis suggested bias in 2 items. Reliability: (i) internal consistency was good (Cronbach’s alpha = 0.82 and inter-item correlation = 0.31). (ii) Split-half reliability was very good (Spearman–Brown Prophesy Reliability Estimate = 0.80). (iii) Test re-test reliability was excellent (intra-class correlation coefficient = 0.87). (iv) Floor and ceiling effects: < 5% women scored either 0 or 100 (lowest and highest scores, respectively). ConclusionObsQoR-10-Portuguese is valid and reliable, and should be considered for use in Portuguese-speaking women to assess their quality of inpatient recovery following cesarean delivery.

Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-Related Quality of Life for Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Final Data from the Phase 2 ELOQUENT-3 Trial

Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-Related Quality of Life for Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Final Data from the Phase 2 ELOQUENT-3 Trial

Validation of an obstetric quality of recovery scoring tool (ObsQoR-11) after elective caesarean delivery in a developing country: a prospective observational study

BackgroundThe obstetric quality of recovery scoring tool (ObsQoR-11) was developed and validated in the United Kingdom for use after elective and emergency caesarean delivery. Quality of recovery scoring tools validated in one country may not be valid in other countries with significant cultural, socio-economic and linguistic variations. The aim of the current study was to validate a Hindi version of the ObsQoR-11. MethodsIn this prospective observational study, 100 parturients who underwent elective caesarean delivery in a tertiary care obstetric referral university hospital in North India were asked to complete a Hindi version of the ObsQoR-11 scoring tool 24 h after surgery. The performance of the Hindi version of ObsQoR-11 was assessed using measures of validity, reliability, and feasibility. ResultsThe Hindi version of ObsQoR-11 correlated moderately with the global health visual analogue scale (r=0.45, 95% CI 0.27 to 0.59; P <0.0001) and discriminated well between good and poor recovery (mean (SD) score 84.6 (9.4) vs 75.0 (11.2); P <0.0001). The reliability and internal consistency were moderate (Cronbach’s alpha=0.66; Spearman-Brown Prophesy Reliability estimate=0.57) with good repeatability (intraclass correlation coefficient 0.85, 95% CI 0.69 to 0.93; P <0.0001) and no floor or ceiling effects. All parturients completed the questionnaire in a (median (IQR) time of completion of 3 (1.5 – 5.5) min). ConclusionThe Hindi version of the ObsQoR-11 questionnaire is a promising scoring tool to evaluate quality of recovery after elective caesarean delivery. Further research is needed to evaluate the Hindi tool in other institutions in India as well as in other languages.

Patient-reported outcome measures in systemic lupus erythematosus by a web-based application: A randomized, crossover, agreement study.

Patient-reported outcome measures (PROMs) are evaluated in randomized controlled trials (RCTs) in patients with systemic lupus erythematosus (SLE), but not widely used in clinical practice. However, interest in incorporating PROMs into the management of SLE is increasing as PROMs provide a unique insight into the patient's perception of lupus disease activity. The objective was to assess agreement in PROMs answered using a web app versus an outpatient touchscreen among patients with SLE. In a crossover RCT, SLE patients answered the following PROMs in a random order using the web app and the outpatient touchscreen: Systemic Lupus Erythematosus Activity Questionnaire (SLAQ) Global Health, SLAQ Symptom, SLAQ Total, SLAQ Worsening, Pain Visual Analog Scale (VAS), Fatigue VAS, Patient Global Health VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Acceptable Symptom State (PASS), and an Anchoring Question. Equivalence between the two device types was demonstrated if the 95% confidence interval (95% CI) of the difference in PROM scores was within the prespecified equivalence margin. Agreement between the two device types was assessed using mixed linear models. Thirty-four patients with SLE were included. Equivalence was demonstrated between the two device types for SLAQ Global Health with a difference of -0.21 (95% CI: -0.65 to 0.23). Moreover, equivalence was also found for HAQ-DI, Pain VAS, and Fatigue VAS whereas only comparability within the limits of the Minimal Clinically Important Difference (MCID) was demonstrated for VAS Patient Global Health. Statistical comparability was demonstrated for SLAQ Total, SLAQ Worsening, PASS, and Anchoring Question (no predefined MCID/equivalence margins available). However, a statistically significant difference between device types was observed for the SLAQ Symptom of -0.56 (95% CI: -1.10 to -0.01). The difference was, however, very small when considering the scale range of 0-24; thus, it was not judged to be of clinical relevance. Preference for the web app was very high (91.2%). For the first time ever, equivalence and comparability between two electronic device types for various PROMs were demonstrated among patients with SLE. Implementation of the device is expected to improve the management of SLE.

Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study

Few adequately validated patient-reported outcome measures are available, which can assess recovery profiles following childbirth. We aimed to determine whether quantitative recovery (using the Obstetric Quality of Recovery-10 patient-reported outcome measure) was superior following vaginal delivery compared with cesarean delivery and evaluate validity, reliability, and responsiveness of this patient-reported outcome measure in the obstetrical setting in the United States. Women recruited into this single-center observational cohort study completed the Obstetric Quality of Recovery-10 and EuroQol 5-dimension 3L patient-reported outcome measures within 72 hours of childbirth. We assessed the validity with hypothesis testing and structural validity. In hypothesis testing, the primary outcome was Obstetric Quality of Recovery-10 scores after vaginal vs cesarean delivery. Secondary outcomes were differences in Obstetric Quality of Recovery-10 scores for vaginal delivery following induction of labor vs spontaneous labor and scheduled vs unplanned cesarean delivery, correlation with clinical parameters (American Society of Anesthesiologists classification grade, body mass index, length of hospital stay, estimated blood loss, transfusion requirement, antiemetic use, and neonatal intensive care unit admission), and qualitative ranking of Obstetric Quality of Recovery-10 items for each delivery mode. Structural validity was assessed by determining the correlation of the Obstetric Quality of Recovery-10 scores with the EuroQol 5-dimension 3L and global health visual analog scale scores. Reliability was assessed using Cronbach alpha and inter-item correlation of Obstetric Quality of Recovery-10 items. Responsiveness was assessed by evaluating the change in Obstetric Quality of Recovery-10 scores over the 72-hour postpartum period. Data from 215 women were analyzed. In hypothesis testing, the median (interquartile range) Obstetric Quality of Recovery-10 scores were higher following vaginal delivery than cesarean delivery (86 [77-94] vs 77 [64-86], respectively; P<.001). Multivariate model demonstrated that Obstetric Quality of Recovery-10 scores were significantly lower after cesarean delivery when adjusting for American Society of Anesthesiologists classification grade, age, body mass index, and ethnicity (R=-8.97; P<.001). Obstetric Quality of Recovery-10 scores were similar between induction of labor and spontaneous labor, and scheduled cesarean delivery and unplanned cesarean delivery. Obstetric Quality of Recovery-10 was correlated with length of hospital stay (R=-0.248; P<.001), estimated blood loss (R=-0.3429; P<.001), transfusion requirement (R=-0.140; P=.041), and antiemetic use (R=-0.280; P<.001). The highest ranked Obstetric Quality of Recovery-10 items were ability to hold baby, feeling in control, and ability to look after personal hygiene. The lowest ranked items were pain and shivering. In structural validity, correlation of Obstetric Quality of Recovery-10 score was moderate with the global health visual analog scale (r=0.511) and EuroQol 5-dimension 3L scores (r=-0.509). In reliability, Cronbach alpha was 0.72 and more than 80% of individual items correlated. In responsiveness, Obstetric Quality of Recovery-10 scores did not change significantly over the study period. Quantitative inpatient recovery following vaginal delivery is superior to cesarean delivery. The Obstetric Quality of Recovery-10 appears to be a valid and reliable patient-reported outcome measure following these delivery modes. Further studies are needed to determine how to improve recovery domains identified in this study, to evaluate Obstetric Quality of Recovery-10 in different languages and determine whether these domains impact outcomes beyond hospitalization.

Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study

Study objectiveWe aimed to determine whether patient-reported quality of recovery differed between spontaneous and operative vaginal delivery. We also aimed to psychometrically evaluate the Obstetric Quality of Recovery-10 scoring tool (ObsQoR-10) for use in this setting. DesignSingle center observational cohort study. SettingLabour and delivery ward at a peripheral general hospital within the United Kingdom, over a 10-month period. Patients123 women delivering via either spontaneous (n = 68) or operative vaginal delivery (n = 55). InterventionsWomen were asked to complete the ObsQoR-10 and global health visual analogue scale (0−100) on postpartum day 1. A convenience sample of consenting parturients delivering via spontaneous or operative vaginal delivery (forceps or vacuum assisted), were included. In total, 123 deliveries were included (68 via spontaneous and 55 via operative vaginal delivery), with no dropouts. MeasurementsPrimary outcome was ObsQoR-10 score and secondary outcomes included measures of validity, reliability and feasibility of ObsQoR-10. Main resultsQuality of recovery was better following spontaneous vaginal delivery. ObsQoR-10 scores were 80.2 (95% CI 76.4–83.9) and 72.1 (95% CI 67.3–76.9], (a difference in score of 8.1 [95% CI 2.1–14.0]) following spontaneous and operative vaginal delivery respectively (p = 0.008).Validity: ObsQoR-10 correlated with global health visual analogue scale score (R = 0.52; p = 0.01) and scores were higher in women requiring <36 h compared to ≥36 h postpartum hospital stay (81.3 (95% CI 77.9–84.7) versus 72.6 (95% CI 67.9–77.2] hours respectively, (a difference in score of 8.7 [95% CI 2.8–14.6]; p = 0.004).Reliability: ObsQoR-10 demonstrated good internal consistency (Cronbach's alpha = 0.82 and inter-item correlation = 0.32) good split-half reliability (Spearman-Brown Prophesy Reliability Estimate = 0.88) and excellent test-re-test reliability (intra-class correlation coefficient of 0.86 [95% CI 0.72–0.93]).Feasibility: All women completed the survey with a median completion time of 2.5 min. ConclusionsQuality of recovery appears to be better following spontaneous compared to operative vaginal delivery. This study also demonstrates that ObsQoR-10 is a valid and reliable tool for use following these delivery modes.

Impact of Elotuzumab Plus Pomalidomide and Dexamethasone on Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Enrolled in the ELOQUENT-3 Study

Impact of Elotuzumab Plus Pomalidomide and Dexamethasone on Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Enrolled in the ELOQUENT-3 Study

Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) in Patients with Chronic Lymphocytic Leukemia (CLL)

Introduction: The shift toward long-term, targeted therapies for patients with CLL requires fit-for-purpose patient-reported outcome instruments (PROs) to assess overall treatment benefit. The FACIT-Fatigue is designed to assess fatigue-related symptoms and their impact on daily functioning, with extensive published evidence of its reliability and validity in cancer populations, although not specifically for CLL. This study evaluates the psychometric properties of the FACIT-Fatigue in patients with relapsed or refractory CLL to determine if it is fit-for-purpose in this population. Methods: Data were from baseline assessments in a multicenter, open-label, phase 3 study that enrolled patients with relapsed or refractory CLL (ClinicalTrials.gov Identifier: NCT02970318). Patients completed the following PROs at baseline: FACIT-Fatigue; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-questions (EORTC QLQ-C30); and EuroQol 5-Dimension 5-Level instrument (EQ-5D-5L), including its global health visual analog scale (EQ-VAS). The FACIT-Fatigue includes a 5-item symptom scale (Sx) and an 8-item impact scale (Imp) that together make up the 13-item Total score. Item responses range from 0 ("not at all") to 4 ("very much"). Scores for negatively worded items are reversed, such that higher scores are better (i.e. less fatigue). The EORTC QLQ-C30 contains 8 multi-item function (Physical, Role, Cognitive, Emotional, Social) and symptom (Fatigue, Pain, Nausea/Vomiting) scales, 5 single-item symptom scales (Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea), a Global Health Status scale and a single-item financial impact scale. The EQ-5D-5L comprises five impairment-related dimensions (Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression). EQ-VAS is a 0-100 scale of a patient's health status. FACIT-Fatigue psychometric assessments included descriptive statistics for items and scales, item-to-item and item-to-total analysis, internal consistency reliability and construct (convergent and known-groups) validity. Convergent validity was assessed based on correlations with the EORTC QLQ-C30 and EQ-VAS. Baseline known-groups were defined by Eastern Cooperative Oncology Group (ECOG) status (0 or 1 vs. 2), hemoglobin level (&lt;110 g/L vs. ≥110 g/L) and constitutional symptoms (night sweats, fever, unexplained weight loss, significant fatigue [none vs. ≥1 symptom]). Cluster analysis (based on groupings by FACIT-Fatigue and EORTC QLQ-C30 scores) was performed to identify a FACIT-Fatigue severity cut-off score. Results: Baseline PRO data were available for 263 patients. Mean scores ranged from 1.01 to 1.84 for Sx items and from 0.40 to 2.23 for Imp items. The proportion of patients answering "not at all" was &gt;25% for 1 of 5 Sx items but for 7 of 8 Imp items, indicating that at baseline there was low impact of fatigue on activities. Most item-to-item correlations and all item-to-total correlations were moderate to strong (Spearman's rank correlation coefficient r≥0.3). The FACIT-Fatigue demonstrated good internal consistency reliability, with Cronbach's coefficient α of 0.87, 0.86 and 0.91 for the Sx, Imp and Total scores, respectively. Sx, Imp and Total scores correlated strongly with the EORTC QLQ-C30 Global Health Status, Physical Function, Role Function and Fatigue scale scores, and the EQ-5D-5L VAS score (all Spearman's r≥0.5), demonstrating convergent validity. Weak correlations (r≤0.3) were observed between the FACIT-Fatigue scales and the EORTC QLQ-C30 Insomnia, Constipation and Diarrhea scales, indicating that there is no relationship between fatigue and these symptoms, and demonstrating discriminant validity. Known-groups validity of the FACIT-Fatigue scales was demonstrated by significant differences between groups defined by baseline ECOG status, hemoglobin level, and constitutional symptoms (Table). Cluster analysis supported a FACIT-Fatigue Total score threshold of either 30 or 34 (Cohen's kappa coefficients of 0.76 and 0.67, respectively) to define a severe fatigue population. Conclusions: Psychometric analyses in patients with relapsed or refractory CLL demonstrated that the FACIT-Fatigue has good psychometric properties and is fit-for-purpose in this population. Results support the use of the FACIT-Fatigue in these patients in the clinical trial setting. Disclosures Eek: AstraZeneca: Employment, Equity Ownership. Ivanescu:Astellas: Consultancy. Kool-Houweling:IQVIA: Employment. Cella:FACIT.org: Equity Ownership.

Health-related quality of life in patients with rheumatoid arthritis

BackgroundRheumatoid arthritis (RA) is a chronic systemic autoimmune disease that primarily affects joints with some extraarticular involvement. If inappropriately treated, it usually results in persistent joint pain, irreversible deformities, and functional disability, leading to poor quality of life. Our objective was to evaluate health-related quality of life (HRQoL) and related factors in patients with RA.MethodsFour hundred sixty-four patients from the Rheumatoid Arthritis registries of Siriraj and Phramongkutklao teaching hospitals were enrolled. Sociodemographic, clinical and laboratory data related to disease activity, and functional status were collected. HRQoL was assessed using the Thai version of EuroQol five dimensional questionnaire (EQ-5D) and EQ global health visual analogue scale (EQ VAS). Univariate and multivariate analyses were employed to identify factors related to HRQoL.ResultsEighty-five percent were female with a mean age ± SD of 59.15 ± 11.43 years and a mean disease duration ± SD of 11.53 ± 8.3 years. The mean educational level ± SD was 9.42 ± 5.21 years. Almost half were unemployed or retired (47%). They had moderate disease activity (mean cumulative DAS28 ± SD, 3.5 ± 0.8) and mild functional impairment (mean HAQ ± SD, 0.70 ± 0.68). The mean EQ-5D ± SD (0–1) was 0.87 ± 0.13 and mean EQ VAS ± SD (0–10) was 7.94 ± 1.7. Based on the EQ-5D domain, 49% reported that they had no problem with mobility, 83% had no difficulties with self-care, 65% had no difficulties with usual activity, 30% had no pain or discomfort, and 61% had no depression or anxiety. The relationship between problems of each dimension in EQ-5D significantly increased according to severity of RA assessed by the Disease Activity Score (DAS) 28 and Health Assessment Questionnaire (HAQ) (p < 0.01). In multivariate analyses, high cumulative disease activity, functional disability, depression, and anxiety were negatively associated with EQ-5D (adjusted R20.38, p < 0.001) and EQ VAS (adjusted R20.19, p < 0.001).ConclusionDisease severity and psychological disturbance have a negative impact on quality of life in patients with RA. These factors should be considered in management of RA patients to improve the standard of care.

Effect of Drug Adherence on Treatment Outcome in Rheumatoid Arthritis

Objective. The present study aimed to evaluate the effect of drug adherence on treatment outcome in Korean patients with rheu-matoid arthritis (RA). Methods. A total of 2,694 RA patients who had complete data from annual follow-ups over three years in the Korean Observational Study Network for Arthritis were included in this study. Patients were divided into adherent and non-adherent groups according to data for drug adherence over three years. The European League against Rheumatism re-sponse and rate of disease flare were compared between two groups over three years. We also compared continuous variables representing treatment outcomes between the two groups. Results. After propensity score matching using a ratio of 1:3, patients were allocated into non-adherent (n=522) and adherent (n=1,447) groups. The rate of non-response was higher in the non-ad-herent group over three years; however, there were no significant differences between continuous variables related to treatment outcome between the two groups. To evaluate the difference according to disease duration, patients were classified into early and late RA based on 48-month disease duration. In patients with early RA, the adherent group had lower patient’s global health visual analog scale and lower disease activity 28 scores at three years compared with the non-adherence group. In patients with late RA, the non-adherent group had a higher rate of disease flare. Conclusion. The adherent group tended to show lower dis-ease activity, especially in early RA, whereas the non-adherence group was associated with non-response and higher risk of dis-ease flare. (J Rheum Dis 2019;26:264-272)

Quality-of-Life Outcomes in Patients with Relapsed/Refractory Multiple Myeloma Treated with Elotuzumab Plus Pomalidomide and Dexamethasone: Results from the Phase 2 Randomized Eloquent-3 Study

Quality-of-Life Outcomes in Patients with Relapsed/Refractory Multiple Myeloma Treated with Elotuzumab Plus Pomalidomide and Dexamethasone: Results from the Phase 2 Randomized Eloquent-3 Study

High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis.

BackgroundResponse prediction of certain biologic agents for the treatment of rheumatoid arthritis (RA) remains an unmet need in real-world clinical practice. The contribution of patient-reported components to the 28-joint Disease Activity Score (DAS28) was termed DAS28-P and investigated as a predictor of response to biologic agents, mostly tumor necrosis factor inhibitors. We aimed to evaluate DAS28-P as a predictor of the European League Against Rheumatism (EULAR) response to abatacept in patients with RA.MethodsThe study population was a prospective, observational, multicenter cohort of Korean patients with RA, who were followed up for a nationwide post-marketing surveillance study of abatacept. Correlation of DAS28-P with DAS28, change of DAS28, and EULAR response groups were evaluated. Logistic regression analysis was used to predict good-to-moderate EULAR response to abatacept in the study population.ResultsA total of 341 patients were involved in the analysis stratified on the EULAR response criteria. Presence of comorbidities, previous exposure to biologic agents, baseline DAS28, three of its components (tender joint counts, global health visual analog scale, erythrocyte sedimentation rate), and baseline DAS28-P were significantly associated with EULAR response to abatacept at 6 months. Stratified upon EULAR response, a group with good-to-moderate response had a higher baseline value and lower interval change for DAS28-P. Logistic regression analysis showed that a DAS28-P cut-off of > 0.44 was more positively associated with good-to-moderate EULAR response with abatacept treatment than naivety to biologic agents.ConclusionsThe DAS28-P could be predictive of response to abatacept. A higher baseline DAS28-P is associated with a favorable therapeutic response to abatacept.Trial registrationTrial name, Korean Post-marketing Surveillance for Orencia®. Trial registration number, NCT01583244. Registered on April 20, 2012.Electronic supplementary materialThe online version of this article (10.1007/s40271-018-0347-z) contains supplementary material, which is available to authorized users.

Development and psychometric validation of a brief comprehensive health status assessment scale in older patients with hematological malignancies: The GAH Scale.

The purpose of this study was to develop a new brief, comprehensive geriatric assessment scale for older patients diagnosed with different hematological malignancies, the Geriatric Assessment in Hematology (GAH scale), and to determine its psychometric properties. The 30-item GAH scale was designed through a multi-step process to cover 8 relevant dimensions. This is an observational study conducted in 363 patients aged≥65years, newly diagnosed with different hematological malignancies (myelodysplasic syndrome/acute myeloblastic leukemia, multiple myeloma, or chronic lymphocytic leukemia), and treatment-naïve. The scale psychometric validation process included the analyses of feasibility, floor and ceiling effect, validity and reliability criteria. Mean time taken to complete the GAH scale was 11.9±4.7min that improved through a learning-curve effect. Almost 90% of patients completed all items, and no floor or ceiling effects were identified. Criterion validity was supported by reasonable correlations between the GAH scale dimensions and three contrast variables (global health visual analogue scale, ECOG and Karnofsky), except for comorbidities. Factor analysis (supported by the scree plot) revealed nine factors that explained almost 60% of the total variance. Moderate internal consistency reliability was found (Cronbach's α: 0.610), and test-retest was excellent (ICC coefficients, 0.695-0.928). Our study suggests that the GAH scale is a valid, internally reliable and a consistent tool to assess health status in older patients with different hematological malignancies. Future large studies should confirm whether the GAH scale may be a tool to improve clinical decision-making in older patients with hematological malignancies.