Outcome Measure In Rheumatoid Arthritis Research Articles

Use and detailed metric properties of patient-reported outcome measures for rheumatoid arthritis: a systematic review covering two decades

IntroductionThe importance of patient-reported outcome measures (PROMs) for rheumatoid arthritis (RA) clinical studies has been recognised for many years. The current study aims to describe the RA PROMs used over...

Genicular nerve block in rheumatoid arthritis: a randomized clinical trial.

This study highlights the effect of a genicular nerve block (GNB) on pain, function, and inflammation outcome measures in rheumatoid arthritis (RA) knees. A total of sixty-four patients diagnosed with RA using ACR/EULAR 2010 criteria with unilateral persistent knee arthritis were recruited to the study. They were randomly assigned into two groups: group 1 received GNB and group 2 received intra-articular triamcinolone. Both groups were examined by the SOLAR scoring system, visual analog scale (VAS), and Lysholm score at 0, 2, and 12weeks. A semi-quantitative score was used to assess the tenderness and swelling at the same intervals. Function and inflammation improved significantly in group 2 at a 2-week interval as compared to group 1, whereas pain improved in both groups with non-significant differences. After 12weeks, group 1 showed significant improvement as compared with group 2 for the three outcome measures. Neither the disease activity nor the current medication was related to the GNB effect. Disease duration was negatively related to GNB-induced improvement. GNB is a new promising local therapy for RA to control pain, improve function, and alleviate inflammation of the knee joint. Although it has a relatively short-term effect, yet it has outperformed the steroid effect. Key Points • Knee monoarthritis treatment in rheumatoid arthritis is always challenging • GNB has been approved for the treatment of pain in knee osteoarthritis • GNB in this study was able to control active knee arthritis and this effect persisted longer thane intra-articular steroid injection.

The Importance of Outcome Measures in the Management of Inflammatory Rheumatic Diseases.

Rheumatic inflammatory diseases include a diverse and heterogeneous group of multifaceted disorders in which clinical history and physical examination are essential to make treatment choices and for optimizing outcomes. Composite outcome measures have become very relevant in rheumatology to evaluate disease activity as they capture the most important dimensions of the disease into one single measure. Most outcome measures may include disease manifestations, laboratory data, physician examination as well as the patient perspective as different outcome dimensions of the disease into a simple index. These outcome measures have proved their utility for guiding treatment in treat-to- target strategies and personalized medicine, with remission being the ultimate goal. In this narrative review, we go over the most commonly used outcome measures in rheumatoid arthritis, spondyloarthropathies, including psoriatic arthritis, and systemic lupus erythematosus to provide a practical summary for clinicians for everyday routine care.

Assessment of the utility of patient outcome measures in rheumatoid arthritis


 
 

Evaluation of Rheumatoid Arthritis Outcome Measures between Users and Non-Users of the Patient Portal

IntroductionPatient engagement has become a growing focus in healthcare, catalyzed with the passage of the HITECH Act in 2009.  Stage 2 of Meaningful Use has criteria dependent on a patient portal, however whether electronic patient engagement translates into better clinical outcomes is yet to be determined.  To begin an evaluation into this we reviewed outcomes in rheumatoid arthritis patients who had signed up for the patient portal compared to those who did not. MethodsData was obtained from a retrospective chart review of rheumatoid patients seen at the Ohio State University Rheumatology Clinics.  Outcome measures including the most recent sedimentation rate (ESR), Rapid 3, and swollen joint count were evaluated.  Two tailed t tests for these outcomes were done between each the group who had signed up for the patient portal and those that did not. Results132 patients were included with 66 having signed up for the patient portal (Users) and 66 not signed up for the patient portal (Non-users).  103 (78.0%) of patients were female, with a mean age of 55 ±13.79 years.  Outcome measures between the patients who signed up for the patient portal compared to those who had not 14.77 ±7.57 compared to 13.48 ±7.73 (p=0.33) for Rapid 3 scores, 1.97 ±2.25 compared to 2.86 ±4.06 (p=0.16) for swollen joint count, and 39.88 ±29.76 mm/hour compared to 30.61 ±22.04 mm/hour (p=0.04) for ESR. ConclusionsThis initial study cohort does not demonstrate any clinically significant difference in several key outcome measures in rheumatoid arthritis, particularly Rapid 3 scores and swollen joint counts.  However there was a statistical difference between the ESR, with more favorable values in patients using the patient portal.  This data suggests further study is needed to better understand if electronic patient engagement does have an effect on clinical outcomes in RA.

The impact of obesity on disease activity and other health outcome measures in rheumatoid arthritis

Obesity is a common risk factor for noncommunicable diseases such as hypertension and diabetes. It is believed to be a state of low-grade inflammation. Rheumatoid arthritis (RA) is the most prevalent chronic inflammatory arthritis, and obesity is thought to influence its development through adipokines. However, the exact impact of obesity on the disease course of RA is not well understood. This nonsystematic literature review is, therefore, carried out in an effort to understand about how do the obesity affects disease activity (DA) and other health outcome measures in patients with RA. The reviewed evidences suggest that obesity if at all predispose than mostly to the sero-negative RA. Overall, the reviewed data show that obesity may increase DA, but not the radiological joint damage and mortality in patients with RA. However, few evidences also suggest that obesity by itself may actually increase the level of inflammatory markers rather than underlying disease process. These contradictory observations show a definite requirement of further research in this regard and until then weight reduction through reducing fat over lean body mass can be recommended in patients with RA to improve their DA, disability, quality of life, and general cardiovascular status.

Systematic review of the psychometric properties of patient-reported outcome measures for rheumatoid arthritis in the foot and ankle

Objective: To identify self-reported outcome measures specific to the foot and ankle in patients with rheumatoid arthritis and to investigate the methodological quality and psychometric properties of these measures. Method: A systematic review focusing on patients with rheumatoid arthritis. Setting: The search was conducted in the PubMed, SCOPUS, CINAHL, PEDro and Google Scholar databases, based on the following inclusion criteria: population (with rheumatoid arthritis) > 18 years; psychometric or clinimetric validation studies of patient-reported outcomes specific to the foot and ankle, in different languages, with no time limit. Two of the present authors independently assessed the quality of the studies located and extracted the relevant data. Terwee’s criteria and the COSMIN checklist were employed to ensure adequate methodological quality. Results: Of the initial 431 studies considered, 14 met the inclusion criteria, representing 7,793 patients (56.8 years). These instruments were grouped into three dimensions (pain, perceived health status and quality of life and disability). The time to complete any of the PROMs varies around 15 minutes. PROMs criterias with the worst scores by COSMIN, 92.85% and 85.71% were criterion validity, measurement error, internal consistency and responsiveness. 28.57% of PROMs were compared with the measurement properties. Conclusion: the Self-Reported Foot and Ankle Score achieved the highest number of positive criteria (according to Terwee and COSMIN), and is currently the most appropriate for patients with Rheumatoid arthritis.

The use of routinely collected patient-reported outcome measures in rheumatoid arthritis.

This study systematically reviewed commonly used patient-reported outcome measures (PROMs) for rheumatoid arthritis (RA), routinely collected in clinical practice, and evaluated objectives of their use. An additional survey conducted among identified RA registries provided additional information about collection of PROMs. Medline Ovid and Embase were searched for observational studies using data of RA registries/cohorts, published between 2011 and 2016. The search combined a validated search algorithm for PROMs and RA. Study characteristics, objective, registry, country, type of PROMs collected, and time interval of collection were systematically recorded. The survey asked about PROMs collected by the registries, timing, response rates, and barriers to collection. Ninety-eight articles from 15 countries were identified making use of 37 registries and large cohorts. Thirty-three PROMs were collected routinely, with VAS, EQ-5d and HAQ being the most used tools. Health domains reported the most were functional assessment, pain and patient global assessment. Despite the wide variety of collected PROMs, foci of the articles were similar and reported results narrow. This review suggests rethinking the role of PROMs in rheumatology research to use this information as broadly as possible, including evaluation of treatments, economic analyses, and decision-making based on patients' experiences at system, provider, and physician level.

The Use of patient Reported Outcome Measures for Rheumatoid Arthritis in Japan: A Systematic Literature Review.

Background:Patient-reported outcomes (PRO) obtained through routine medical care may identify patients’ day-to-day burden and help tackle the disease from the patients’ perspective. However, there is a paucity of information regarding the availability of PRO data and PRO tools for rheumatoid arthritis (RA) in Japan.Objective: We reviewed the literature on PRO data availability and to identify PRO measures implemented in Japan for RA patients. Method: We conducted a systematic literature review using ICHUSHI and the PubMed databases on PRO measures for RA published from January 2011 to August 2015 in Japan.Results:After removing duplicates, 2423 manuscripts were found. From these, 100 manuscripts were included for review and analysis. We found 29 PRO tools that were used to assess various domains of health such as general well-being, pain, functionality, and fatigue. More than 90% of the studies utilized PRO tools for research purpose. Only one study reported PRO tool implementation in the routine medical care.Conclusion:The importance of PROs is recognized in Japan. PRO tools varied significantly and were mostly used for research purposes, while reports on the use of PRO measures in routine medical care were limited. Despite the awareness of PROs in the research community, unmet needs remain among RA patients in Japan. Further work is needed to investigate ways in which PROs can better reflect these unmet needs and be utilized in routine medical care.

Incorporating the patient's perspective in outcomes research.

Incorporation of the patients' perspective in clinical research is critical to ensure that outcomes measured reflect those, which matter most to patients. This review summarizes recent efforts to include the patients' perspective in the development of outcome measures and the importance of encouraging patient participation in decision-making and self-management. Since the inclusion of fatigue as a patient-endorsed core outcome measure in rheumatoid arthritis (RA) trials, OMERACT has been instrumental in advocating for patient involvement in the development of core domains and instruments; current endeavors include cultivating an understanding of remission through the eyes of patients and gaining a sense of how to measure features of pain and 'stiffness' deemed as important to patients. The concept of remission was further explored in RA patients, highlighting a common goal of returning to normality; additionally, various tools have been developed to assess for unmet needs in rheumatology patients. Advances have also been made in the development and revision of patient-centered core measures in rheumatologic diagnoses outside of RA. Incorporating the patients' perspective is now considered an essential feature in outcomes research. Future research should focus on how best to involve patients in specific research activities.

Stability of clinical outcome measures in rheumatoid arthritis patients with stable disease defined on the basis of the EULAR response criteria.

Natural variation also known as measurement error is assessed in individuals in "steady state." The study aimed to examine inter-visit variations in clinical outcome measures in rheumatoid arthritis (RA) patients with stable disease defined on the basis of the EULAR response criteria. Two hundred thirty-three RA patients with stable disease defined as a change in Disease Activity Score (DAS28-CRP) ≤0.6 between two consecutive visits were identified in the Danish rheumatology registry for biological treatment (DANBIO). Clinical data from a single set of such two visits were extracted for each patient. Using the Bland-Altman method, lower and upper 95% limits of agreement (LLoA; ULoA) between the consecutive assessments and the bias were calculated for each measure. Associations were characterized by Pearson's r-values and standard errors of estimation (SEE). The mean change in DAS28-CRP was 0.0 ± 0.3. Agreements between the assessments were close on the group level but poor on the individual level. For example, LLoA; ULoA [bias] for patient global assessment (0-100) was -28.3; 29.7 [0.7], for fatigue (0-100) -38.1; 36.3 [-0.9] and for 28 swollen joint count -3.3; 3.3 [0.0]. Inter-visit differences were poorly explained by the baseline values (r [SEE] ranging from 0.15 [12.6] for fatigue to 0.58 [1.4] for 28 tender joint count) and by changes in other outcome variables. In conclusion, outcome measures fluctuated substantially and unpredictably in individual RA patients considered in steady state. The observed between-visit differences may be interpreted to reflect natural variation or measurement error that should be taken into account when monitoring patients in the daily clinic.

A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes.

BackgroundMost reported outcome measures in rheumatoid arthritis (RA) trials are composite, whose components comprise single measures that are combined into one outcome. The aims of this review were to assess the range of missing data rates in primary composite outcomes and to document the current practice for handling and reporting missing data in published RA trials compared to the Consolidated Standards of Reporting Trials (CONSORT) recommendations.MethodsA systematic search for randomised controlled trials was conducted for RA trials published between 2008 and 2013 in four rheumatology and four high impact general medical journals.ResultsA total of 51 trials with a composite primary outcome were identified, of which 38 (75 %) used the binary American College of Rheumatology responder index and 13 (25 %) used the Disease Activity Score for 28 joints (DAS28). Forty-four trials (86 %) reported on an intention-to-treat analysis population, while 7 trials (14 %) analysed according to a modified intention-to-treat population. Missing data rates for the primary composite outcome ranged from 2–53 % and were above 30 % in 9 trials, 20–30 % in 11 trials, 10–20 % in 18 trials and below 10 % in 13 trials. Thirty-eight trials (75 %) used non-responder imputation and 10 (20 %) used last observation carried forward to impute missing composite outcome data at the primary time point. The rate of dropout was on average 61 % times higher in the placebo group compared to the treatment group in the 34 placebo controlled trials (relative rate 1.61, 95 % CI: 1.29, 2.02). Thirty-seven trials (73 %) did not report the use of sensitivity analyses to assess the handling of missing data in the primary analysis as recommended by CONSORT guidelines.ConclusionsThis review highlights an improvement in rheumatology trial practice since the revision of CONSORT guidelines, in terms of power calculation and participant’s flow diagram. However, there is a need to improve the handling and reporting of missing composite outcome data and their components in RA trials. In particular, sensitivity analyses need to be more widely used in RA trials because imputation is widespread and generally uses single imputation methods, and in this area the missing data rates are commonly differentially higher in the placebo group.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1402-5) contains supplementary material, which is available to authorized users.

Discrepancies in assessment of patients with rheumatoid arthritis and secondary Sjögren's syndrome by DAS28-ESR and DAS28-CRP.

ObjectivesTo investigate whether a difference exists between DAS28 from CRP and DAS28 from ESR in patients with rheumatoid arthritis (RA) and secondary Sjögren's syndrome (sSS).Material and methodsOne group comprised patients with RA and sSS, the control group comprised patients with RA. The inclusion criteria for the RA and sSS group have been specified as follows: presence of at least one symptom of dryness, and also presence of anti-SS-A and anti-SS-B or at least focus score of one in biopsy.ResultsThe disease activity score 28 (DAS28) was assessed using both ESR and CRP in 60 patients with RA and sSS and 59 patients with RA alone. However, concordance between these two methods was good (Cohen's κ coefficient κ = 0.60, 95% CI: 0.45-0.75 in the first group and κ = 0.71, 95% CI: 0.56-0.86 in the control group). In the group with RA and sSS, the mean value of DAS28-ESR = 5.2, whereas the mean value of DAS28-CRP = 4.7 (p < 0.0001). In the group with RA alone, mean DAS28-ESR = 4.7 while mean DAS28-CRP = 4.6; no significant difference was identified. Moreover, in RA patients with sSS, mean ESR = 39 mm/h compared with mean CRP at 25 mg/l. 79% of all patients demonstrated dysproteinaemia. There were connections between higher ESR and dysproteinaemia. In the control group there was no statistically significant difference between CRP and ESR.ConclusionsBoth DAS28-ESR and DAS28-CRP are useful outcome measures in RA. However, in patients with RA and sSS, DAS28 should be evaluated based on CRP.

The OMERACT MRI in Arthritis Working Group — Update on Status and Future Research Priorities

To provide an update on the status and future research priorities of the Outcome Measures in Rheumatology (OMERACT) magnetic resonance imaging (MRI) in arthritis working group. A summary is provided of the activities of the group within rheumatoid arthritis (RA), psoriatic arthritis (PsA), and osteoarthritis (OA), and its research priorities. The OMERACT RA MRI score (RAMRIS) evaluating bone erosion, bone edema (osteitis), and synovitis is now the standard method of quantifying articular pathology in RA trials. Cartilage loss is another important part of joint damage, and at the OMERACT 12 conference, we provided longitudinal data demonstrating reliability and sensitivity to change of the RAMRIS JSN component score, supporting its use in future clinical trials. The MRI group has previously developed a PsA MRI score (PsAMRIS). At OMERACT 12, PsAMRIS was evaluated in a randomized placebo-controlled trial of patients with PsA, demonstrating the responsiveness and discriminatory ability of applying the PsAMRIS to hands and feet. A hand OA MRI score (HOAMRIS) was introduced at OMERACT 11, and has subsequently been further validated. At OMERACT 12, good cross-sectional interreader reliability, but variable reliability of change scores, were reported. Potential future research areas were identified at the MRI session at OMERACT 12 including assessment of tenosynovitis in RA and enthesitis in PsA and focusing on alternative MRI techniques. MRI has been further developed and validated as an outcome measure in RA, PsA, and OA. The group will continue its efforts to optimize the value of MRI as a robust biomarker in rheumatology clinical trials.

Hand bone mass in rheumatoid arthritis: A review of the literature.

Rheumatoid arthritis (RA) is a common chronic inflammatory disease and periarticular osteoporosis or osteopenia of the inflamed hand joints is an early feature of RA. Quantitative measurement of hand bone loss may be an outcome measure for the detection of joint destruction and disease progression in early RA. This systematic review examines the published literature reporting hand bone mass in patients with RA, particularly those using the dual X-ray absorptiometry (DXA) methods. The majority of the studies reported that hand bone loss is associated with disease activity, functional status and radiological progression in early RA. Quantitative measurement of hand bone mineral density by DXA may be a useful and practical outcome measure in RA and may be predictive for radiographic progression or functional status in patients with early RA.

The effect of exercise on sleep and fatigue in rheumatoid arthritis: a randomized controlled study.

Sleep disturbance and chronic fatigue are common in rheumatoid arthritis (RA) and contribute to disability, symptomatology, and healthcare use. It has long been recognized in other populations that exercise can improve sleep and diminish fatigue. The effect of exercise on sleep quality and fatigue in RA has not been evaluated. Ours is a randomized controlled study in RA to determine the effect of an exercise program on sleep quality and fatigue. These were measured using the Pittsburgh Sleep Quality Index and the Fatigue Severity Scale. Patients were randomized to either a 12-week, home-based exercise intervention or usual care. The exercise program consisted of specific exercises to target individual deficiencies identified using the Health Assessment Questionnaire (HAQ) with cardiovascular work as per the guidelines. The intervention group was evaluated on a 3-week basis. Full evaluation was carried out at baseline and at 12 weeks. Forty patients were randomized to the intervention with 38 controls. In the exercise intervention group, there was a statistically significant improvement in HAQ (p = 0.00), pain (p = 0.05), stiffness (p = 0.05), sleep quality (p = 0.04), and fatigue (p = 0.04). In our control group, there was a statistically significant improvement demonstrated in their overall perceptions of the benefits of exercise, but none of the other variables. Our study demonstrates that an exercise program resulted in significant improvement in sleep quality and fatigue. This is particularly interesting given the importance of fatigue as an outcome measure in RA and gives us yet another reason to prescribe exercise in this population.

AB0955 Determining Optimal Hand Position for Reliable Metacarpophalangeal Joint Width Measurements Using Volumetric Methodology by Hr-Pqct

BackgroundJoint space narrowing is an important outcome measure in rheumatoid arthritis, linked tightly to function and disability. High-resolution peripheral quantitative computed tomography (HR-pQCT) allows detection of bone margins with high...

Outcome measures in rheumatoid arthritis randomised trials over the last 50 years

BackgroundThe development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research. One of the most notable of the current outcome sets began nearly 20 years ago: the World Health Organization and International League of Associations for Rheumatology core set of outcomes for rheumatoid arthritis clinical trials, originating from the OMERACT (Outcome Measures in Rheumatology) Initiative. This study assesses the use of this core outcome set by randomised trials in rheumatology.MethodsAn observational review was carried out of 350 randomised trials for the treatment of rheumatoid arthritis identified through The Cochrane Library (up to and including September 2012 issue). Reports of these trials were evaluated to determine whether or not there were trends in the proportion of trials reporting on the full set of core outcomes over time. Researchers who conducted trials after the publication of the core set were contacted to assess their awareness of it and to collect reasons for non-inclusion of the full core set of outcomes in the study.ResultsSince the introduction of the core set of outcomes for rheumatoid arthritis, the consistency of measurement of the core set of outcomes has improved, although variation in the choice of measurement instrument remains. The majority of trialists who responded said that they would consider using the core outcome set in the design of a new trial.ConclusionsThis observational review suggests that a higher percentage of trialists conducting trials in rheumatoid arthritis are now measuring the rheumatoid arthritis core outcome set. Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.

OP0048 Orthopaedic interventions for RA have changed over the period 1986-2011. An evaluation of joint surgery rates and DMARD/anti-TNF treatment patterns in two UK inception cohorts

BackgroundOrthopaedic surgery is an accepted outcome measure in rheumatoid arthritis (RA) and considered a surrogate marker for joint destruction, but not commonly reported. The need for orthopaedic surgery is expected...

SAT0115 Upper/small joints are emphasized in new ACR/EULAR remission criteria, while physicians have respect for large joints: A nationwide study based on the ninja (national database of rheumatic diseases by IR-net in japan) 2010

ObjectivesTo identify effective predictors of remission in patients with rheumatoid arthritis (RA).MethodsTotal Joint indices (TJI) of upper/large, upper/small, lower/large, and lower/small regions were calculated as the sum of tender and...