Patient-reported Outcomes In Rheumatoid Arthritis Research Articles

Evaluation of patient-based disease activity score (PDAS) in the Japanese rheumatoid arthritis patient registry (NinJa registry).

Patient-reported outcomes (PROs) should be regarded as an important factor in the management of rheumatic diseases. The Patient-based disease activity score (PDAS) was developed as a clinically reliable composite measure for evaluating PROs in rheumatoid arthritis (RA) patients. To replicate and further characterize PDAS, we analyzed PDAS and its clinical relevancy in the National Database of Rheumatic Diseases in Japan (NinJa). Clinical data from the 2022 version of NinJa were analyzed. PDAS1 was calculated for each patient, and statistical analyses, including correlation analyses and multiple regression analysis, were conducted to evaluate the relationship between PDAS1 and other clinical measures. Propensity score (PS) matching was used to compare patients treated with different types of disease-modifying anti-rheumatic drugs (DMARDs). The number of included patients was 11983. PDAS1 demonstrated strong correlations with DAS28(ESR) (R = 0.89, p< 2.2x1016) and CDAI, indicating its utility in assessing disease activity. The majority of patients (71.8%) achieved PDAS1-defined remission, aligning closely with DAS28 and CDAI remission. PDAS1 was significantly associated with serum rheumatoid factor (RF) titers (R = 0.25, p< 0.001), and RF-positive patients exhibited higher PDAS1 scores. Notably, PS matched comparison revealed that PDAS1 was lower in patients treated with IL-6 inhibitors, compared with those treated with TNF inhibitors, reflecting differences in lower patient global assessment. PDAS1 is a reliable and useful tool for evaluating both disease activity and the functional state of RA patients, particularly from the perspective of PROs. Additionally, PDAS1 can be used for conducting clinical studies in RA patients.

Summary of Research: Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA.

This Summary of Research overviews the results of a study that looked at patient-reported outcomes in the VOLTAIRE-RA trial (NCT02137226), originally published in Rheumatology and Therapy. A biosimilar is a biologic medicine made to be very similar to the original biologic medicine (also known as the reference product). The VOLTAIRE-RA trial compared the efficacy and safety of an adalimumab biosimilar (Cyltezo®, adalimumab-admb) with the adalimumab reference product, Humira®, in people with rheumatoid arthritis. As part of the VOLTAIRE-RA study, participants took either adalimumab-adbm or adalimumab reference product for 24weeks. Patient-reported outcomes were captured after 12weeks and after 24weeks of treatment to assess the effects of treatment on each participant's health-related quality of life. People with rheumatoid arthritis who were given adalimumab-adbm or adalimumab reference product experienced similar clinically meaningful improvements in their health-related quality of life after 12weeks of treatment. A high proportion of people in this trial who were given adalimumab-adbm or adalimumab reference product reported greater improvement versus a reference US population matched by age and sex. This is notable, as it represents a treatment goal that was difficult to achieve in earlier rheumatoid arthritis trials of non-biologic treatments.

Effects of a telehealth-delivered Mediterranean diet intervention in adults with Rheumatoid Arthritis (MEDRA): a randomised controlled trial

ObjectiveTo compare the effects a Mediterranean diet (MedDiet) versus the Irish Healthy Eating Guidelines (HEG) on physical function and quality of life in adults with rheumatoid arthritis (RA) in Ireland.MethodsForty-four adults with RA were randomised (1:1) to the MedDiet or HEG for 12 weeks. The intervention included three video teleconsultations and two follow-up telephone calls facilitated by a Registered Dietitian (RD). Changes in physical function by Health Assessment Questionnaire- Disability Index (HAQ-DI) and quality of life by Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL) were the primary outcomes measured. Secondary outcomes included changes in dietary adherence, physical activity by Yale Physical Activity survey (YPAS), patient-perceived pain and general health, and anthropometric measures. All measurements were administered at baseline and repeated at 6 and 12 weeks.ResultsForty participants completed the study. Participants were primarily females (87.5%), mean age was 47.5 ± 10.9 years. At the end of the intervention, participants in the MedDiet group reported significantly better physical function (p = 0.006) and quality of life (p = 0.037) compared to HEG group. From baseline to 12 weeks, physical function significantly improved in both diet groups, MedDiet (0.9 ± 0.5 to 0.5 ± 0.4 units, p < 0.001) and HEG (1.4 ± 0.7 to 1.0 ± 0.6 units, p < 0.001). Quality of life also significantly improved in the MedDiet (10.1 ± 7.5 to 4.0 ± 4.7 units, p < 0.001) and HEG group (11.25 ± 7.2 to 7.9 ± 6.4 units, p = 0.048). Physical activity improved significantly in the MedDiet (56.7 ± 28.6 to 70.6 ± 33.5 points, p = 0.01) but not within the HEG group despite similar recommendations.ConclusionAdhering to the MedDiet and Irish Healthy Eating Guidelines resulted in improvements in RA patient-reported outcomes. The changes observed in both diet groups are likely due to the improvement in overall diet quality irrespective of dietary prescription.Trial registration numberNCT04262505.

Impact of a hybrid medical care model in the rheumatoid arthritis patient-reported outcomes: A non-inferiority crossover randomized study

Objective Patients and physicians can naturally adopt hybrid healthcare models that combine face-to-face consultations with telemedicine. The study's objective was to compare the impact of two healthcare interventions, hybrid care modality and face-to-face consultation, on the patient-reported outcomes of rheumatoid arthritis patients, during the COVID-19 pandemic. Methods Consecutive outpatients reincorporated to a clinic previously in lockdown were invited to a non-inferiority, randomized study (October 2020–-May 2022). Patients were randomized to 6 months of face-to-face consultation or hybrid care modality (intervention period-1) and then the converse modality (intervention period-2). The primary outcome was disease activity/severity behavior (Routine Assessment of Patient Index Data 3). Additional patient-reported outcomes were disability (Health Assessment Questionnaire Disability Index), quality-of-life (World Health Organization quality of life questionnaire-brief version), adherence and satisfaction with medical care, and treatment recommendation. Sample size calculation established 55 patients/healthcare interventions. Results There were 138 patients invited to participate, 130 agreed and 121 completed their study participation. Sixty-one and 60 patients respectively, received face-to-face consultation and hybrid care modality over intervention period-1. Patients were primarily middle-aged females (90.1%), with (median, IQR) 12 (9–16) years of education, long-standing disease, working (62.8%), receiving disease-modifying anti-rheumatic drugs (96.7%), and corticosteroids (61.2%). Patients had low disease activity (median Routine Assessment of Patient Index Data 3: 2.7) and Health Assessment Questionnaire Disability Index score that translated into the absence of disability, while quality of life was compromised. Baseline characteristics were similar between patients assigned to each healthcare intervention. Differences in Routine Assessment of Patient Index Data 3 behavior were below the non-inferiority margin. Results considered the order in which patients received the intervention and baselines scores, and extended to the patient-reported outcomes left. Conclusions Hybrid care modality was non-inferior to in-person consultations in achieving patient-reported outcomes during the COVID-19 pandemic in rheumatoid arthritis patients.

Outcomes of a Mobile App to Monitor Patient-Reported Outcomes in Rheumatoid Arthritis: A Randomized Controlled Trial.

To examine the effects of a smartphone application (app) to monitor longitudinal electronic patient-reported outcomes (ePROs) on patient satisfaction and disease activity in patients with rheumatoid arthritis (RA). We conducted a 6-month randomized controlled trial of care coordination along with an app (intervention) versus care coordination alone (control) in 191 RA patients. Participants in the intervention group were prompted to provide information daily using ePROs. In both the intervention and control groups, a care coordinator contacted participants at 6 and 18 weeks to assess for flares. The main outcome measures were the global satisfaction score from the Treatment Satisfaction Questionnaire for Medication (TSQM), the score from the Perceived Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire, and the Clinical Disease Activity Index (CDAI) score. Groups were similar at baseline. The median TSQM score at 6 months was 83.3 in both groups, and the median PEPPI score at 6 months was 50 in both groups. The median CDAI score at 6 months was 8 in the intervention group versus 10 in the control group. No statistically significant group differences in the medians of TSQM, PEPPI, or CDAI scores at 6 months were detected. Of the 67 intervention participants who completed the exit survey, 90% rated their likelihood of recommending the app as ≥7 of 10. Of the 11 physicians who completed the exit survey, 73% agreed/strongly agreed that they wanted to continue offering the app to patients. A mobile app designed to collect ePRO data on RA symptoms did not significantly improve patient satisfaction or disease activity compared to care coordination alone. However, both patients and physicians reported positive experiences with the app.

Does exercise therapy improve patient-reported outcomes in rheumatoid arthritis? A systematic review and meta-analysis for the update of the 2020 JCR guidelines for the management of rheumatoid arthritis.

This study aimed to evaluate the impact of exercise therapy on patient-reported outcomes (PROs) in rheumatoid arthritis (RA) as part of the process of updating the 2020 Japanese guidelines for the management of RA according to the Grading of Recommendations, Assessment, Development, and Evaluation system. We searched PubMed, Japana Centra Revuo Medicina Web, and the Cochrane Library (from 2009 to 2018) to identify articles that evaluated PROs of exercise therapy and RA disease activity. A total of 662 articles were identified, including nine RCTs, and meta-analyses were performed on six RCTs on systemic exercise therapy and three RCTs on upper extremity exercise therapy. Analyzed exercise therapies were diverse, differing in target population, intervention method, and duration. Significant improvements were observed in the Health Assessment Questionnaire Disability Index (mean difference -0.35, 95% confidence interval (CI): -0.60 to -0.10), pain (standardized mean difference -2.04, 95% CI: -3.77 to -0.32), and SF-36. For upper extremity exercise therapy, significant improvements in PROs (Disabilities of the Arm, Shoulder, and Hand Questionnaire, Michigan Hand Outcome Questionnaire) were observed. Exercise therapy in RA treatment improves patient subjective assessment of pain, physical function, and quality of life.

User experience with a voice-enabled smartphone app to collect patient-reported outcomes in rheumatoid arthritis.

Rheumatoid arthritis (RA) is a chronic disease, requiring frequent patient-provider interaction and self-monitoring. We developed a novel mobile health smartphone app with a voice-enabled feature to help patients virtually track disease activity and ask general questions about RA. With a user-centered design (UCD) approach, we developed a voice-enabled app (VEA) which was then tested in two focus groups of patients (n=8) and one with providers (n=4). Voice enablement and a question and answer (Q & A) library function were previously requested by patients. Based on focus group feedback, the VEA was refined and tested with 26 patients for 56 days. The VEA asked patients to fill in daily patient-reported outcomes (PROs) and complete the trial with a satisfaction survey. Of the 26 patients in the VEA trial, 77% were female and 50% were aged 55 and older. Adherence to daily PROs during the 56-day trial was 66%, with <1% of PROs completed using the voice-enabled feature. PROMIS short forms and RADAI-5 PROs remained stable. Of the 22 satisfaction survey respondents, 86% were satisfied with their overall experience with the app and 18.5% were satisfied with voice enablement. The voice assistant had an 86% success rate at understanding and answering interactions regarding surveys and a 44% success rate regarding Q & A interactions. We developed a novel VEA through a UCD framework and conducted pilot testing. Adherence was moderate and RADAI-5 and PROMIS measures were stable. Based on satisfaction results, PROs may not be the best use of voice enablement technology.

Acceptance, Usage, and Barriers of Electronic Patient-Reported Outcomes Among German Rheumatologists: Survey Study.

BackgroundThe use of patient-reported outcomes (PROs) allows for patient-centered, measurable, and transparent care. Electronic PROs (ePROs) have many benefits and hold great potential to improve current usage of PROs, yet limited evidence exists regarding their acceptance, usage, and barriers among rheumatologists.ObjectiveThis study aims to evaluate the current level of acceptance, usage, and barriers among German rheumatologists regarding the use of ePROs. The importance of different ePRO features for rheumatologists was investigated. Additionally, the most frequently used PROs for patients with rheumatoid arthritis (RA) were identified.MethodsData were collected via an online survey consisting of 18 questions. The survey was completed by members of the Working Group Young Rheumatology of the German Society for Rheumatology (Arbeitsgemeinschaft Junge Rheumatologie der Deutschen Gesellschaft für Rheumatologie [DGRh]) at the 2019 annual DGRh conference. Only members currently working in clinical adult rheumatology were eligible to complete the survey.ResultsA total of 119 rheumatologists completed the survey, of which 107 (89.9%) reported collecting PROs in routine practice and 28 (25.5%) already used ePROs. Additionally, 44% (43/97) were planning to switch to ePROs in the near future. The most commonly cited reason for not switching was the unawareness of suitable software solutions. Respondents were asked to rate the features of ePROs on a scale of 0 to 100 (0=unimportant, 100=important). The most important features were automatic score calculation and display (mean 77.50) and simple data transfer to medical reports (mean 76.90). When asked about PROs in RA, the respondents listed pain, morning stiffness, and patient global assessment as the most frequently used PROs.ConclusionsThe potential of ePROs is widely seen and there is great interest in them. Despite this, only a minority of physicians use ePROs, and the main reason for not implementing them was cited as the unawareness of suitable software solutions. Developers, patients, and rheumatologists should work closely together to help realize the full potential of ePROs and ensure a seamless integration into clinical practice.

Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis.

Electronic patient-reported outcomes (ePROs) transmitted digitally allow patients to communicate with their clinicians and track the activity of chronic diseases, such as RA. Several ePRO smartphone apps have been developed in rheumatology, yet few data have been reported regarding patient adherence. We developed a PRO app for RA and assessed adherence over 6 months. We developed an app to deliver daily assessments to participants (RA App v.1.0). The app was tested as part of a randomized controlled trial examining potential clinical benefits. The current analyses focus on the adherence to the ePRO app for patients randomized to receive the app. We recruited RA patients from an academic rheumatology practice in the USA. Patients randomized to receive the app received daily notifications regarding ePROs. We examined adherence to the PRO questionnaires over the 6-month study and examined factors related to adherence. Seventy-eight patients received the app and have data included in these analyses: 63 (80.7%) were female, mean age was 55.2 years, 71% had attended college or beyond, and the mean Clinical Disease Activity Index at baseline was 9.7 (low disease activity). Median adherence to the daily questions was 79% (interquartile range 48-90%). Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). We developed and tested an ePRO app for RA over a 6-month study. Adherence to the app was strong. There was correlation between older age and better disease control and increased adherence. ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02822521.

THU0625-HPR ELECTRONIC PATIENT-REPORTED OUTCOMES: A SURVEY ABOUT ACCEPTANCE, USAGE AND BARRIERS AMONG GERMAN RHEUMATOLOGISTS

Background:The use of patient-reported outcomes (PROs) allows for patient-centered, measurable and transparent care. Electronic PROs (ePROs) have many benefits and hold great potential to improve current usage of PROs; yet, limited evidence exists regarding acceptance, usage and barriers among rheumatologists.Objectives:This study aimed to evaluate the current level of acceptance, usage, and barriers among German rheumatologists regarding the utilization of ePROs. The importance of different ePRO features for rheumatologists was investigated. Additionally, the most frequently used PROs for patients with rheumatoid arthritis (RA) were identifiedMethods:Data was collected via an online survey consisting of 18 questions. The survey was completed by members of the Working Group Young Rheumatologists of the German Society for Rheumatology (Deutsche Gesellschaft für Rheumatologie (DGRh)) at the annual 2019 DGRh conference. Only members currently working in clinical rheumatology were eligible to complete the survey.Results:A total of 119 rheumatologists completed the survey. 90% reported collecting PROs in routine practice and 25.5% already used ePROs. 44.3% were planning to switch to ePROs in the near future.The main reason for collecting PROs was for clinical decision making (66.4%), followed by research (39.5%), reimbursement (23.5%), internal quality management (21.9%) and patient satisfaction (16.8%). The most commonly cited reason for not switching to ePROs was the unawareness of suitable software solutions (figure 1).Respondents were asked to rate the features for ePROs on a scale of 0-100 (0 = unimportant, 100 = important). The most important features were automatic score calculation and display (score: 77.5), as well as the simple data transfer to medical reports (76.9) (table 1).When asked about PROs in RA, the respondents listed pain, morning stiffness and physician global assessment (PGA) as the most frequently used PROs (figure 2).Table 1.Ratings for features of ePRO on a scale of 0-100 (0 = unimportant, 100 = important))QuestionmeanSDHow important would the graphic display be to you for ePROs?63.531.19How important would the automatic score calculation and display of ePROs be to you?77.527.64How important would the simple transfer of the ePROs in medical report be to you?76.930.07How important would an automatic alarm of yourself be for you if a critical threshold is exceeded by an ePRO?51.6533.5How important would an automatic alarm of the patient be for you if a critical threshold is exceeded by an ePRO?34.5530.61Figure 1.Reasons why ePROs are currently not used (multiple answers were possible for question)Figure 2.PROs being used in clinical practice and their respective frequencyConclusion:The potential of ePROs is widely seen, and there is a great interest in ePROs. Despite this, a minority of physicians only uses ePROs, and the main reason for not implementing was cited as the unawareness of suitable software solutions.Developers, patients and rheumatologists should work closely together to help realize the full potential of ePROs and ensure a seamless integration into clinical practice.Disclosure of Interests:Martin Krusche Consultant of: Sanofi, Novartis and Medac, Speakers bureau: Roche/Chugai, Novartis, Sobi,, Philipp Klemm Consultant of: Lilly, Medac, Manuel Grahammer Shareholder of: MG is MD and shareholder of Abaton GmbH, Johanna Mucke: None declared, Diana Vossen Consultant of: Medac, Novartis, Abvie, Speakers bureau: Abvie, BMS, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, Philipp Sewerin Grant/research support from: AbbVie Deutschland GmbH &amp; Co. KGBristol-Myers Squibb Celgene GmbHLilly Deutschland GmbHNovartis Pharma GmbH Pfizer Deutschland GmbHRheumazentrum Rhein-Ruhr, Consultant of: AMGEN GmbH AbbVie Deutschland GmbH &amp; Co. KG Biogen GmbHBristol-Myers Squibb Celgene GmbH Chugai Pharma arketing Ltd. / Chugai Europe GmbHHexal Pharma Janssen-CilagGmbH Johnson &amp; Johnson Deutschland GmbHLilly Deutschland GmbH / Lilly Europe / Lilly Global Novartis Pharma GmbH Pfizer Deutschland GmbH Roche Pharma Rheumazentrum Rhein-Ruhr Sanofi-Genzyme Deutschland GmbH Swedish Orphan Biovitrum GmbH UCB Pharma GmbH, Speakers bureau: AMGEN GmbH AbbVie Deutschland GmbH &amp; Co. KG Biogen GmbHBristol-Myers Squibb Celgene GmbH Chugai Pharma arketing Ltd. / Chugai Europe GmbHHexal Pharma Janssen-CilagGmbH Johnson &amp; Johnson Deutschland GmbHLilly Deutschland GmbH / Lilly Europe / Lilly Global Novartis Pharma GmbH Pfizer Deutschland GmbH Roche Pharma Rheumazentrum Rhein-Ruhr Sanofi-Genzyme Deutschland GmbH Swedish Orphan Biovitrum GmbH UCB Pharma GmbH, Johannes Knitza Grant/research support from: Research Grant: Novartis

SAT0716-HPR SYSTEMATIC REVIEW OF THE PSYCHOMETRIC PROPERTIES OF PATIENT-REPORTED OUTCOME MEASURES FOR FOOT AND ANKLE IN RHEUMATOID ARTHRITIS

Background Foot problems and pain are common in patients with rheumatoid arthritis. Patient-reported outcome measures provide a standardized method of capturing patients’ perspectives of their functional status and wellbeing. There are many instruments specific to people with feet affected by rheumatoid arthritis but knowledge of their psychometric validation or methodological quality is lacking Objectives To identify patient-reported outcome measures specific to the foot and ankle and rheumatoid arthritis and investigate their methodological quality and psychometric properties Methods Design Systematic review. Data source: A search was conducted for psychometric or validation studies on patient-reported outcomes in Rheumatoid Arthritis published in different languages, by examining the Pubmed; Scopus, CINAHL; PEDro and Google Scholar databases. Review methods. The systematic review performed was based on the following inclusion criteria: psychometric or clinimetric validation studies on patient-reported outcomes specific to the foot and ankle that included patients with Rheumatoid arthritis. Two authors independently assessed the quality of the studies and extracted datas Results Of the initial 431 studies, fourteen instruments met the inclusion criteria. Significant methodological flaws were detected in most with only SEFAS met the COSMIN quality criteria. Conclusion SEFAS had the best quality and was ranked most appropriate for use with patients living with Rheumatoid Arthritis References [1] Terwee CB, Jansma EP, Riphagen II, De Vet HCW. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res. 2009;18(8):1115–23. [2] Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res [Internet]. 2018;27(5):1147–57. Available from: http://dx.doi.org/10.1007/s11136-018-1798-3 [3] Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: An international Delphi study. Qual Life Res. 2010;19(4):539–49. [4] Terwee CB, Lidwine @bullet, Mokkink B, Knol DL, Ostelo RWJG, Bouter LM, et al. Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist. Qual Life Res [Internet]. 2012 [cited 2018 Apr 4];21:651–7. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3323819/pdf/11136_2011_Article_9960.pdf [5] Coster MC, Bremander A, Rosengren BE, Magnusson H, Carlsson A, Karlsson MK. Validity, reliability, and responsiveness of the Self-reported Foot and Ankle Score (SEFAS) in forefoot, hindfoot, and ankle disorders. Acta Orthop [Internet]. 2014 Apr 25 [cited 2018 Apr 24];85(2):187–94. Available from: http://www.tandfonline.com/doi/full/10.3109/17453674.2014.889979 Review registration number PROSPERO (CRD42018090594). Disclosure of Interests None declared

Systematic Review and Meta-analysis: Mindfulness-Based Interventions for Rheumatoid Arthritis.

To determine the efficacy of mindfulness-based interventions (MBIs) on clinical and patient-reported outcomes in rheumatoid arthritis (RA). We identified randomized clinical trials from inception through April 2018 from MEDLINE, PsycINFO, EMBASE, CINAHL, Web of Science, the Cochrane Library, and hand searches. After screening 338 references, we included five trials with one post-hoc analysis that evaluated MBIs and collectively included 399 participants. Outcome instruments were heterogeneous across studies. Three studies evaluated RA clinical outcomes by a rheumatologist; one study found improvements in disease activity. A limited meta-analysis found no statistically significant difference in the levels of DAS28-CRP in the two studies that evaluated this metric (- 0.44 (- 0.99, 0.12); I2 0%). Four studies evaluated heterogeneous psychological outcomes, and all found improvements including depressive symptoms, psychological distress, and self-efficacy. A meta-analysis of pain Visual Analog Scale (VAS) levels post intervention from three included studies was not significantly different between MBI participants and control group (- 0.58 (- 1.26, 0.10); I2 0%) although other studies not included in meta-analysis found improvement. There are few trials evaluating the effect of MBIs on outcomes in patients with RA. Preliminary findings suggest that MBIs may be a useful strategy to improve psychological distress in those with RA.

Relationship between disease activity and patient-reported outcomes in rheumatoid arthritis: Post hoc analyses of overall and Japanese results from two phase 3 clinical trials

Objective: To examine patient-reported outcomes (PROs) in patients with different rheumatoid arthritis (RA) disease activity levels and identify residual symptoms.Methods: Post hoc analyses of overall and Japanese data from two randomized controlled trials including RA patients with previous inadequate responses to methotrexate (NCT01710358) or no/minimal previous disease-modifying antirheumatic drug treatment (NCT01711359) (sponsor: Eli Lilly and Company). Week 24 assessments were disease activity (Simplified Disease Activity Index, Disease Activity Score/Disease Activity Score 28 joints-erythrocyte sedimentation rate) and PROs (pain visual analog scale [VAS], morning joint stiffness [MJS], Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue, and Medical Outcomes Study Short Form 36 Health Survey Physical and Mental Component Scores).Results: Patients achieving remission/low disease activity (LDA) at Week 24 had larger/significant improvements from baseline in pain, MJS, disability, fatigue, and physical and emotional quality of life versus patients with high/moderate disease activity. Some patients achieving remission and LDA, reported residual pain (pain VAS >10 mm): 20.8–39.3% and 48.7–70.0% (overall study populations), 16.0–34.5% and 47.1–62.0% (Japanese patients). Residual MJS and fatigue were also reported.Conclusion: Remission/LDA were associated with improvements in PROs in overall and Japanese patient populations; however, some patients achieving remission had residual symptoms, including pain.

Pixel or Paper? Validation of a Mobile Technology for Collecting Patient-Reported Outcomes in Rheumatoid Arthritis.

BackgroundIn the management of chronic disease, new models for telemonitoring of patients combined with the choice of electronic patient-reported outcomes (ePRO) are being encouraged, with a clear improvement of both patients’ and parents’ quality of life. An Italian study demonstrated that ePRO were welcome in patients with rheumatoid arthritis (RA), with excellent matching data.ObjectiveThe aim of this study is to evaluate the level of agreement between electronic and paper-and-pencil questionnaire responses.MethodsThis is an observational prospective study. Patients were randomly assigned to first complete the questionnaire by paper and pencil and then by tablet or in the opposite order. The questionnaire consisted of 3 independent self-assessment visual rating scales (Visual Analog Scale, Global Health score, Patient Global Assessment of Disease Activity) commonly used in different adult patients, including those with rheumatic diseases.ResultsA total of 185 consecutive RA patients were admitted to hospital and were enrolled and completed the questionnaire both on paper and on electronic versions. For all the evaluated items, the intrarater degree of agreement between 2 approaches was found to be excellent (intraclass correlation coefficient>0.75, P<.001).ConclusionsAn electronic questionnaire is uploaded in a dedicated Web-based tool that could implement a telemonitoring system aimed at improving the follow-up of RA patients. High intrarater reliability between paper and electronic methods of data collection encourage the use of a new digital app with consequent benefit for the overall health care system.

Poverty, Depression, or Lost in Translation? Ethnic and Language Variation in Patient-Reported Outcomes in Rheumatoid Arthritis.

Despite advances in therapies, disparities in outcomes have been documented for rheumatoid arthritis (RA) patients for both ethnicity and English language proficiency. The goals of these analyses were to compare differences in RA patient-reported outcomes, by both self-identification of ethnicity and English language proficiency, and to identify factors that might explain differences among groups. Data were collected through structured telephone interviews of a longitudinal cohort with physician-diagnosed RA (n = 438); only women were included (n = 335). Three groups were defined based on self-reported ethnicity and English proficiency: white/English (n = 219), Hispanic/English (n = 39), and Hispanic/Spanish (n = 77). Outcomes examined were patient-reported physical functioning, pain, and presence of moderate or severe fatigue. Multivariate regression analyses compared outcomes among groups, adjusting for sociodemographic characteristics, health and disease factors, and depression. Hispanic/Spanish women had worse function, pain, and fatigue than either English-proficient group. Depression was associated with all outcomes (P < 0.0001), and accounted for greater differentials in scores than ethnicity/language proficiency. In interaction analyses, differences between women who were and were not depressed were greater for Hispanic/English than for Hispanic/Spanish. Nondepressed Hispanic/Spanish scores were significantly worse than nondepressed Hispanic/English, i.e., the impact of depression was less for Hispanic/Spanish women because both depressed and nondepressed women in this group reported worse outcomes. After adjustment for sociodemographic factors and depression, language remained significantly associated with outcomes. Disparities in patient-reported outcomes may be driven less by ethnicity than by sociodemographic or psychological factors. Measurement instruments that are not culturally appropriate and equivalent may also hamper meaningful analyses of disparities.

Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity.

IntroductionThe effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined.MethodsAdults with RA and an inadequate response to at least one disease-modifying antirheumatic drug were enrolled. PROs assessed included physical function (using the Health Assessment Questionnaire-Disability Index), pain, fatigue, sleep disturbance, Patient Global Assessment of Disease Activity (PtGA), Routine Assessment of Patient Index Data 3 (RAPID3), and Rheumatoid Arthritis Disease Activity Index (RADAI).ResultsEarly significant and clinically meaningful improvements in all PROs were observed to week 12 with CZP vs. placebo and were maintained to the end of the trial (week 28). At week 12, up to one-third more CZP patients showed improvements compared with placebo that were greater than or equal to the minimal clinically important difference (MCID) in fatigue, sleep problems, pain, PtGA, RADAI, and RAPID3. The changes in PROs were correlated with clinical measures of disease activity, including the Disease Activity Score in 28 joints using C-reactive protein as well as tender and swollen joint counts.ConclusionsRapid improvements in PROs were seen in patients with RA treated with CZP. The magnitude of improvement exceeded the MCID in multiple domains and demonstrated that CZP improves aspects of health-related quality of life that are meaningful to patients and superior to placebo. PROs provide information complementary to clinical outcomes in assessment of treatment benefits.Trial registrationClinicalTrials.gov identifier: NCT00717236. Registered on 15 July 2008.

FRI0432 Well-being, sleep and coping had good psychometric properties in rheumatoid arthritis (RA): A subanalysis of an etanercept trial

BackgroundIn RA, there is increasing interest in “unusual” patient-reported outcomes (PROs), over and above pain, function and fatigue; namely, quality of sleep, well-being and ability to cope [1]. Although these...

SAT0019 Preliminary Data Supporting the Feasibility and Construct Validity of Promis Fatigue Instrument in an Academic Rheumatoid Arthritis Clinic.

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) initiative of the National Institutes of Health has created item banks to measure patient-reported health outcomes for physical, mental, and social well–being across...

Modern psychometrics applied in rheumatology–A systematic review

BackgroundAlthough item response theory (IRT) appears to be increasingly used within health care research in general, a comprehensive overview of the frequency and characteristics of IRT analyses within the rheumatic field is lacking. An overview of the use and application of IRT in rheumatology to date may give insight into future research directions and highlight new possibilities for the improvement of outcome assessment in rheumatic conditions. Therefore, this study systematically reviewed the application of IRT to patient-reported and clinical outcome measures in rheumatology.MethodsLiterature searches in PubMed, Scopus and Web of Science resulted in 99 original English-language articles which used some form of IRT-based analysis of patient-reported or clinical outcome data in patients with a rheumatic condition. Both general study information and IRT-specific information were assessed.ResultsMost studies used Rasch modeling for developing or evaluating new or existing patient-reported outcomes in rheumatoid arthritis or osteoarthritis patients. Outcomes of principle interest were physical functioning and quality of life. Since the last decade, IRT has also been applied to clinical measures more frequently. IRT was mostly used for evaluating model fit, unidimensionality and differential item functioning, the distribution of items and persons along the underlying scale, and reliability. Less frequently used IRT applications were the evaluation of local independence, the threshold ordering of items, and the measurement precision along the scale.ConclusionIRT applications have markedly increased within rheumatology over the past decades. To date, IRT has primarily been applied to patient-reported outcomes, however, applications to clinical measures are gaining interest. Useful IRT applications not yet widely used within rheumatology include the cross-calibration of instrument scores and the development of computerized adaptive tests which may reduce the measurement burden for both the patient and the clinician. Also, the measurement precision of outcome measures along the scale was only evaluated occasionally. Performed IRT analyses should be adequately explained, justified, and reported. A global consensus about uniform guidelines should be reached concerning the minimum number of assumptions which should be met and best ways of testing these assumptions, in order to stimulate the quality appraisal of performed IRT analyses.

Effect of Golimumab on Patient-reported Outcomes in Rheumatoid Arthritis: Results from the GO-FORWARD Study

To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52. Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550).