Patient Global Health Assessment Research Articles

Local therapy of the knee osteoarthritis: results of a multicenter study of meloxicam

Osteoarthritis (OA) is a chronic progressive joint disease that leads to disability. One of the main treatment approaches in OA is to reduce pain and increase the functional activity of patients.Objective: to evaluate the efficacy, tolerability and safety of Meloxicam Canon (MC) in the form of a 1% gel for external use as a symptomatic therapy in patients with knee OA, accompanied by pain.Material and methods. The randomized, open, multicenter study included 100 patients aged 50 to 80 years with stage II–III knee OA, who were randomized into two groups in a 1:1 ratio. In the main group, patients applied MC gel topically, and in the comparison group –Amelotex® gel. Patients were examined at baseline, and after 7, 14 and 28 days. The following indicators were studied: intensity of pain during movement on a visual analogue scale (VAS), affected knee circumference (AKC); Lequesne and WOMAC indices; patient global health assessment (PGHA) according to VAS; response to therapy, tolerability according to the number of adverse reactions (AR), safety according to blood and urine tests.Results and discussion. Pain intensity according to VAS by the end of the observation period decreased on average by 65.0±25.6% in the main group, and by 62.8±29.1% in the comparison group (p<0.0001 for each group). AKS significantly decreased by visit 3 in both groups. There was an improvement in PGHA by VAS by 69.7±24.3 and 66.6±26.8% on average, respectively (p><0.0001 for each group). The average decrease in the Lequesne index was 55.0±30.1 and 52.8±38.3%, and in the WOMAC index – 58.9±30.8 and 59.3±31.8%, respectively, in the main group and comparison group (p><0.0001 in each group for both indices), while there were no differences in the dynamics of all indicators between the two groups (p>0.05). During the observation, no negative dynamics in patients’ condition in both groups was noted. No serious ARs or deaths were recorded during the study.Conclusion. The conducted multicenter study demonstrated that MC gel is an effective and safe drug for local use in OA, accompanied by pain.

Impact of rheumatoid arthritis on sexuality: adaptation and validation of the Qualisex questionnaire for use in Spain.

Patients with rheumatoid arthritis (RA) have a significantly increased risk of sexual dysfunction. However, it is not properly included in commonly used questionnaires to assess health-related quality of life in RA. Qualisex is a questionnaire developed in France to assess the impact of RA on patients´ sexual function. Our aim was to adapt and validate this questionnaire for use with Spanish RA patients. Two independent translations and a backward translation were obtained. The final version was tested in a pilot study with 10 RA patients to detect any aspects that could hinder interpretation. The validity and reliability of the linguistically validated questionnaire were studied in a multicenter cross-sectional study, with a longitudinal component for reliability estimation. 125 RA patients were included. The response process, discrimination, internal consistency, internal structure, convergent validity (correlation with MGH-SFQ questionnaire, DAS-28, physician global assessment, patient global health assessment, RAID, HAQ, HADS and SF-12©) and reliability were analyzed. The inclusion of two extra items was proposed in the pilot study. The validity analysis detected responses for item 10 that were not coherent with responses for the rest of items. The Cronbach alpha coefficient was 0.971. The highest correlation (0.665) was obtained with MGH-SFQ (questionnaire measuring sexual functioning), followed by RAID (0.516). The intra-class correlation was 0.880 (95% CI 0.815; 0.923), higher than 0.85, which indicates excellent reliability. All parameters used to assess this questionnaire show highly acceptable values. Qualisex allows for a global score of RA patients' sexual functioning and can be self-administered.

Multimodal rheumatologic complex treatment in patients with spondyloarthritis - a prospective study

IntroductionAim of this study was to prospectively assess the effects of multimodal rheumatologic complex treatment (MRCT), a special concept of in-patient physical treatment (PT) for treating spondyloarthritis (SpA), namely radiographic (r-) and non-radiographic (nr-) axial (ax-) SpA and psoriatic arthritis (PsA). Methodsr-, nr-axSpA and PsA patients receiving a 16-day MRCT were eligible. MRCT was delivered to participants over 64 PT sessions of various modalities with a minimum of 1,400 min of treatment. Primary outcome was a change in pain levels measured on a numeric rating scale (NRS, 0 - 10) between baseline and discharge. Secondary outcomes were assessments of i) disease activity ii) functional disabilities iii) serum cytokine levels iv) analgesic usage v) patient global health assessment and patients’ satisfaction with their therapeutic response to MRCT from baseline to discharge and over a 12-week follow-up. Results50 patients completed the study and were analysed. Pain levels were improved significantly (p < 0.001, 95% confidence interval -2.25 to -0.8,). Further analyses revealed no influencing factors or relevant inter-group differences. Positive effects of MRCT lasted up to 12 weeks after discharge. Analgesic usage was reduced compared to baseline. Patient global health assessment continued to be improved throughout the whole follow-up. No MRCT-related harms were recorded. ConclusionMRCT as a multimodal treatment concept with a strong emphasis on PT reduces pain in SpA meaningfully and facilitates reduced analgesic usage.

The value of the patient global health assessment in polyarticular juvenile idiopathic arthritis: a nested cohort study

ObjectiveThe objectives were: 1) to explore the discordance between the Patient Global Health Assessment (PtGA) scores, the Physician Global Health Assessment (PhGA) scores, and Pain scores; and 2) to explore whether the PtGA during disease remission is associated with future disease flare in pJIA.MethodsData from an NIH funded clinical trial (NCT00792233) evaluating flare were used (N = 137). PtGA, PhGA, and Pain scores were assessed. Flare was defined as any active arthritis. Spearman’s correlation coefficients were calculated, and multivariable logistic regression was performed.Results122 patients had records of flare status, of which 63 developed flare, and 42 of these patients had a visit immediately prior to flare. For study subjects with a visit immediately prior to flare, the PtGA, pain scores, and PhGA all increased at time of flare. For every unit increase in PtGA and Pain scores, there was a 9% and 23% higher odds of developing flare, respectively (p = 0.76, p = 0.40). For every unit increase in the PhGA score, there was a substantially lower odds of developing flare (p = 0.05).ConclusionOur results demonstrate that the PtGA and Pain scores are strongly correlated with each other and increased at the visit prior to flare, while the PhGA scores are not. Further, the PtGA and Pain score have some predictive value for flare, while the PhGA does not. These findings highlight the value of patient input in medical care and decision-making, and support the development and use of more sophisticated PROs in the care of JIA patients.

Effects of multimodal rheumatologic complex treatment in patients with rheumatoid arthritis: a monocentric prospective study.

To prospectively evaluate the effects of multimodal rheumatologic complex treatment (MRCT), a special concept of in-patient physical treatment (PT), in patients with rheumatoid arthritis (RA). RA patients receiving a 16-day MRCT were eligible. MRCT was delivered to participants in 64 PT sessions of various modalities with a minimum of 1.400 Minutes of treatment. The primary outcome was the change in pain levels measured on a numeric rating scale (0-10) between baseline and discharge. Secondary outcomes were assessments of i) disease activity, ii) functional disabilities, iii) serum cytokine levels, iv) analgesic usage, v) patient global health and vi) patient's satisfaction with their therapeutic response to MRCT from baseline to discharge and over a 12-week follow-up. 53 RA patients completed the study and were analysed. Pain levels were reduced significantly and clinically meaningfully (mean ± standard error: -2.1 ± 0.3, p<0.001). Effects of MRCT lasted up to 12 weeks after discharge. After MRCT and during the 12-week follow-up use of analgesics was reduced compared to baseline. Regression analyses revealed no influencing factors on change in pain levels. Patient global health assessment remained improved throughout the entire follow-up period. No MRCT-related side effects were recorded. MRCT as a multimodal treatment concept with a strong emphasis on PT reduces pain significantly and in a clinically meaningful manner allowing for reduced analgesic usage.

Features and Outcomes of Elderly Rheumatoid Arthritis: Does the Age of Onset Matter? A Comparative Study From a Single Center in China.

IntroductionThe aim of this work is to investigate the clinical and radiological characteristics of elderly rheumatoid arthritis and compare the outcomes between the two subgroups, elderly- and young-onset rheumatoid arthritis (EORA and YORA, respectively).MethodsWe conducted a retrospective case-control study on the elderly rheumatoid arthritis patients in our medical center. EORA was defined as the patient whose onset age was above 60.ResultsA total of 142 elderly rheumatoid arthritis patients were admitted, with 79 patients in EORA and 63 in YORA group. Inflammatory parameters including C-reactive protein, D-dimer, serum ferritin, and platelet count levels were all higher in the EORA group than those in YORA. EORA patients showed a higher score of health assessment questionnaire's disability index (p = 0.01) and patient global health assessment (p = 0.049), but a lower status of modified total sharp score (p = 0.001). Bivariate logistic regression analysis revealed that elderly onset of the disease (OR 2.30, 95% CI [1.45–3.77]), age (OR 2.04, 95% CI [1.22–3.41]), high disease activity (OR 1.90, 95% CI [1.17–3.32]), and red blood cell distribution width (OR 1.81, 95% CI [1.03–3.19]) were independent prognostic factors of disability. Age (OR 0.25, 95% CI [0.07–0.91]), disease duration (OR 2.73, 95% CI [0.97–7.70]), and co-morbid diabetes mellitus (OR 118.10, 95% CI [3. 50–3985.57]) independently contributed to radiographic joint damage in the elderly population. EORA patients showed increased death incidents and worse prognosis than YORA. Cox regression analysis reveals that comorbid hypertension (HR 12.02, 95% CI [1.08–133.54]), interstitial lung disease (ILD) (HR 85.04, 95% CI [4.11–1759.19]), and compressive fracture (HR 85.04, 95% CI [4.11–1759.19]) are independent predictors of mortality, and that ILD (HR 50.21, 95% CI [5.56–335.33]) and pulmonary hypertension (HR 25.37, 95% CI [3.03–265.81]) are independent predictors of no disease remission in the EORA patients.ConclusionsThe distinct features of EORA patients make EORA a unique entity different from “classic rheumatoid arthritis”. EORA patients develop an upgraded systemic inflammatory status, more declined life quality, and worse prognosis than the elderly YORA. Better control of the comorbidities like ILD and diabetes mellitus may benefit the management of elderly rheumatoid arthritis. Further investigation regarding the pathogenesis and therapeutic strategies of EORA is urgently warranted.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-020-00267-8.

What Does the Patient Global Health Assessment in Rheumatoid Arthritis Really Tell Us? Contribution of Specific Dimensions of Health-Related Quality of Life.

To estimate the contributions of health-related quality of life domains to the patient global assessment of disease activity (PtGA) in rheumatoid arthritis (RA). Data are drawn from baseline visits of 2 observational RA cohorts. Participants completed forms for patient-reported outcome measures, including PtGA and measures from the Patient-Reported Outcomes Measurement Information System, and clinical data were collected. Factor analysis was used to identify latent variables, and multivariable linear regression was used to estimate determinants of the PtGA. Patients were mostly female (81%), white (78%), and had established disease (mean ± SD 12.3 ± 10.7 years), with 62% in remission or having low disease activity. In cohort 1 (n = 196), the following 2 factors emerged: 1) daily function (moderate-to-strong [i.e., >|0.65|] loadings of physical function, pain interference, social participation, and fatigue, and weak [>0.35] loadings of sleep disturbance); and 2) emotional distress (strong loadings of depression and anxiety). In crude analysis, daily function explained up to 53% and emotional distress up to 20% of the variance in PtGA. In both cohorts, in adjusted analyses, daily function and, to a much lesser extent, swollen joint count independently predicted PtGA; age was inversely related to PtGA in cohort 1 only. These findings suggest that in patients with RA, PtGA ratings largely reflect the extent to which patients feel they can function in everyday roles and are not impacted by mood. This suggests that higher than expected PtGA scores may offer an opportunity to discuss patient expectations regarding roles and activities and the impact of their RA symptoms on daily function.

AB0280 Audio versus Visual: Does IT Matter How You Obtain Patient Global Score for DAS-28 Calculation?

BackgroundThe DAS-28 is the most commonly used score to assess rheumatoid disease activity. It is a composite score based on four variables: tender joint count, swollen joint count, acute phase...

ESSPRI and other patient-reported indices in patients with primary Sjogren's syndrome during 100 consecutive outpatient visits at one rheumatological clinic

A European League Against Rheumatism (EULAR) SS disease activity index (ESSDAI) and a patient-reported index (ESSPRI) have recently been developed and validated. In our previous study the ESSDAI correlated significantly with serum β2 microglobulin concentration. We now aim to establish whether the ESSPRI is also associated with serum β2 microglobulin or with other patient-reported indices. The data on 100 consecutive visits of patients with primary SS (pSS) were reviewed from the patient charts. Patients who had filled out the ESSPRI questionnaire and fulfilled at least four of the revised American-European consensus group criteria for pSS were included. Data were gathered on the ESSPRI (0-10 cm) and on the patient's global health assessment [visual analogue scale (VAS) 0-10 cm] (PGH-VAS), pain-VAS (0-10 cm) and HAQ (range 0-3). The ESSPRI correlated significantly with the PGH-VAS (r = 0.753, P < 0.0001), pain-VAS (r = 0.656, P < 0.0001) and HAQ (r = 0.542, P < 0.0001) (Spearman's correlation). It also correlated weakly with serum β2 microglobulin (r = 0.214, P = 0.043) and ESR levels (r = 0.235, P = 0.019). The ESSPRI correlated significantly with other patient-reported indices, serum β2 microglobulin and ESR in patients with pSS. Our results support the view that the ESSPRI is a useful tool in the follow-up of patients with pSS.

Impaired Health Status and the Effect of Pain and Fatigue on Functioning in Clinical Trial Patients with Systemic Lupus Erythematosus

Our study evaluated the impaired health status of clinical trial patients with systemic lupus erythematosus (SLE) and explored the relationship between changes in fatigue and pain and their effect on overall health status. Pooled treatment and placebo data from a phase Ib clinical trial of adults with moderate/severe SLE were analyzed. Measures included patient-reported Medical Outcome Study Short Form-36 Survey, Version 2 (SF-36v2), Fatigue Severity Scale, and numeric rating scales (NRS) for pain and global health assessment and clinician-reported global assessment of disease activity (MDGA). Disease burden was compared to the US general population. Health status of responders and nonresponders on pain or fatigue were compared. The sample included 161 patients with SLE, predominantly female (96%) and white (72%), with average age of 43 ± 11 years. Mean SF-36v2 component summary scores reflected overall problems with physical [physical component summary (PCS); 35.2 ± 9.7] and mental health (mental component summary; 40.9 ± 12.9). Patients with SLE had worse health status on all SF-36v2 subscales than the US general population and comparable age and sex norms (effect size -0.51 to -2.15). Pain and fatigue responders had greater improvements on SF-36v2 scores (bodily pain, physical functioning, social functioning, PCS), patient global health assessment NRS, and MDGA than nonresponders. There was moderate agreement in responder status, based on global assessments by patients and clinicians (68.1%), with some discrepancy between patients who were MDGA responders but patient assessment nonresponders (27.7%). Improvements in patient-reported pain or fatigue correlated with improvements in overall health. Patient assessments offer a unique perspective on treatment outcomes. Patient-reported outcomes add value in understanding clinical trial treatment benefits.

THU0150 High Acute Phase Reactants Predict Cardiovascular Events and Rapid Radiological Progression in Inflammatory Arthritis

BackgroundInflammatory arthritis (IA) is associated with an increased risk of cardiovascular events1,2, similarly known that high baseline serum amyloid A (SAA) levels and erosive disease are predictors of aggressive arthritis3.ObjectivesTo...

Validity and Reliability Problems with Patient Global as a Component of the ACR/EULAR Remission Criteria as Used in Clinical Practice

To investigate what factors influence patient global health assessment (PtGlobal), and how those factors and the reliability of PtGlobal affect the rate, reliability, and validity of recently published American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) rheumatoid arthritis (RA) remission criteria when used in clinical practice. We examined consecutive patients with RA in clinical practice and identified 77 who met ACR/EULAR joint criteria for remission (≤ 1 swollen joint and ≤ 1 tender joint). We evaluated factors associated with a PtGlobal > 1, because a PtGlobal ≤ 1 defined ACR/EULAR remission in this group of patients who had already met ACR/EULAR joint criteria. Of the 77 patients examined, only 17 (22.1%) had PtGlobal ≤ 1 and thus fully satisfied ACR/EULAR criteria. A large proportion of patients not in remission by ACR/EULAR criteria had high PtGlobal related to noninflammatory issues, including low back pain, fatigue, and functional limitations, and a number of patients clustered in the range of PtGlobal > 1 and ≤ 2. However, the minimal detectable difference for PtGlobal was 2.3. In addition, compared with a PtGlobal severity score, a PtGlobal activity score was 3.3% less likely to be abnormal (> 1). Noninflammatory factors contribute to the level of PtGlobal and result in the exclusion of many patients who would otherwise be in "true" remission according to the ACR/EULAR definition. Reliability problems associated with PtGlobal can also result in misclassification, and may explain the observation of low longterm remission rates in RA. As currently constituted, the use of the ACR/EULAR remission criteria in clinical practice appears to be problematic.

Construct Validity of the Modified Numeric Rating Scale of Patient Global Assessment in Psoriatic Arthritis

The construct validity of the patient global health assessment (PGA) in psoriatic arthritis (PsA) has not been analyzed, despite its common use. We evaluated the construct validity of a numeric rating scale (NRS) of the PGA in PsA. Patients with PsA who fulfilled the ClASsification for Psoriatic ARthritis (CASPAR) criteria were recruited at a tertiary referral center. Demographic data were collected and PGA data were determined from administration of an 11-point NRS (0 to 10 points representing best to worst status). Convergent and discriminant validity were evaluated by correlation between PGA and clinical variables. Patients were grouped as having severe disease based on Disease Activity Score 28-joint count (DAS28) > 5.1, Health Assessment Questionnaire (HAQ) > 1.0, walking with aids, and social welfare-dependent. Patients were grouped as being in remission by DAS28 < 2.6 and the Minimal Disease Activity Criteria. Known-group validity of PGA was evaluated. A total of 125 patients (52% men) were studied. Convergent validity revealed strong correlations of PGA with pain score, HAQ, and DAS28; and weak correlations with skin severity score, physician's global assessment and morning stiffness. In multivariate analysis, PGA was associated with pain, physical function, mental function, and skin severity score. PGA distinguished different levels of severity well, as determined by comparison with different known groups with large effect sizes. Judged on an NRS, the PGA had good construct validity and satisfactorily distinguished all levels of severity in PsA.