Factors associated with discrepancies in disease activity as assessed by SDAI and RAPID3 in patients with rheumatoid arthritis: Data from a multicenter observational study (T-FLAG).

OBJECTIVES: The present study aimed to examine discrepancies between assessments based on Routine Assessment of Patient Index Data 3 (RAPID3) and Simple Disease Activity Index (SDAI) in RA patients with controlled disease activity. METHODS: Data from 464 RA patients in SDAI remission or low disease activity (REM/LDA) were analyzed. Patient-reported outcome (PRO) measures, including Health Assessment Questionnaire Disability Index (HAQ-DI), 25-question Geriatric Locomotive Function Scale (GLFS-25), and Kihon checklist (KCL), were assessed. Logistic regression models were used to identify factors associated with RAPID3 moderate or high disease activity (MDA/HDA). Cutoff values of RAPID3 MDA/HDA for each PRO evaluation item were determined using receiver operating characteristic curve analysis. RESULTS: Among RA patients in SDAI REM/LDA, 84.9% were in RAPID3 REM/LDA. Multivariable analysis revealed that HAQ-DI, GLFS-25, and KCL were independently associated with RAPID3 MDA/HDA. Subdomain analysis of KCL revealed that activities of daily living, physical function, cognitive function, and depressive mood were significantly associated with RAPID3 MDA/HDA. Cutoff values for HAQ-DI and KCL were 0.38 and 8, respectively. CONCLUSIONS: In RA patients with controlled disease activity, discrepancies between RAPID3 and SDAI assessments were observed, with factors such as HAQ-DI, GLFS-25, and KCL being independently associated with RAPID3 MDA/HDA.

Feasibility of nurses measuring gait speed in older community-dwelling Emergency Department patients.

Gait speed assessment is a rapid, simple and objective measure for predicting risk of unfavorable outcomes which may provide better prognostic and reliable information than existing geriatric ED (Emergency Department) screening tools. This descriptive pilot project was designed to determine feasibility of implementing gait speed screening into routine nursing practice by objectively identifying patients with sub-optimal gait speeds. Participants included community-dwelling adults 65 years and older with plans for discharge following ED treatment. Patients with a gait speed <1.0 m/s were identified as "high-risk" for an adverse event, and referred to the ED social worker for individualized resources prior to discharge. Thirty-five patients were screened and nurse initiated gait speed screens were completed 60% of the time. This project demonstrates ED gait speed screening may be feasible. Implications for practice should consider incorporating gait speed screening into routine nursing assessment to improve provider ED decision-making and disposition planning.

Routine assessment of nutritional, functional and inflammatory criteria in patients with cancer: A systematic review.

BACKGROUND: The review discusses the significant impact of cancer on patients, particularly focusing on cachexia - a condition marked by weight and lean tissue loss. This condition critically affects the nutritional status, quality of life, and treatment outcomes of cancer patients. RESEARCH QUESTION: The review seeks to understand the effectiveness and necessity of routine clinical monitoring of cancer cachexia, and how it can aid in better therapeutic interventions. METHODS: The systematic review followed a pre-defined protocol based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)statement. A systematic search using specific keywords was conducted in PubMed and EMBASE databases on October 24, 2023, supplemented by citations from the original papers. The selection process involved screening titles and abstracts for relevance. RESULTS: The review finds varying levels of effectiveness in the different measurement criteria used for monitoring cachexia. It highlights the potential of the Global Leadership Initiative on Malnutrition (GLIM) framework in defining and managing cancer cachexia, though noting some challenges in standardisation and implementation of measurements. CONCLUSION: The present systematic review highlights the variability and lack of standardization in the application of GLIM criteria for monitoring cachexia in cancer patients. Despite these challenges, it will be important to determine the most efficacious clinically routine nutritional and inflammation assessments in the routine application of GLIM criteria assessment.

A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis.

INTRODUCTION: The impact of upadacitinib on rheumatoid arthritis (RA) symptoms was evaluated during the first 12 weeks of treatment via patient-reported outcomes (PROs) using a mobile health application (app). METHODS: Participating rheumatologists from the CorEvitas RA Registry (prospective, observational cohort) recruited patients with RA initiating upadacitinib treatment. A modified version of the ArthritisPower® app was used to collect PROs, including the Routine Assessment of Patient Index Data 3 (RAPID3), duration of morning joint stiffness, and the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue 7a Short Form at baseline and weeks 1-4, 8, and 12. RAPID3 responses over time were assessed using Kaplan-Meier estimation to determine the proportion of patients achieving disease activity improvement and minimal clinically important difference (MCID). Results were analyzed for all patients initiating upadacitinib and a subsample of TNF inhibitor (TNFi)-experienced patients with moderate to severe disease at baseline. RESULTS: A total of 103 patients with RA initiating upadacitinib (62.1% TNFi-experienced) were included. At week 12, 53 patients (51.4%) completed the study and provided PRO data via the app. Among all patients, improvements in RAPID3, pain, morning stiffness, and fatigue were observed at week 1 and were maintained or further improved through week 12. At week 12, 37.5% of patients achieved RAPID3 low disease activity. Starting at week 1, improvements in RAPID3 disease activity category (19.4% of patients) and achievement of MCID (16.3%) were reported, with nearly 50% of patients achieving these outcomes by week 4 (RAPID3 category: 48.8%; MCID: 49.2%) and 60% by week 12 (RAPID3 category: 59.6%; MCID: 59.8%). TNFi-experienced patients generally reported similar outcomes. Patient-reported medication convenience and compliance were generally high. CONCLUSIONS: In this real-world cohort of patients with RA, treatment with upadacitinib was associated with early and significant improvement in RAPID3, pain, morning stiffness, and fatigue regardless of prior TNFi experience. Clinically meaningful improvement in RAPID3 patient-reported disease activity was observed as early as week 1, with continued improvement reported through week 12.

Randomized Trial Assessing the Impact of Routine Assessment of Health-Related Quality of Life in Patients with Head and Neck Cancer.

The impact of routine assessment of health-related quality of life (HRQoL) on satisfaction with care and the HRQoL of patients with head and neck cancer (HNC) treated with radiotherapy was assessed. Patients with HNC were randomly assigned to two arms, with stratification on sex, cancer localization, and stage of the disease. In the intervention arm, the patients completed the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires first before randomization, then before each medical appointment during radiotherapy (7 weeks), and then every 3 months until 1 year and at 2 years thereafter. In the control arm, the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires were completed before randomization and at 1 year and 2 years thereafter. The primary endpoint was mean change in HRQoL at score at 2 years from baseline assessed by EQ VAS from the EuroQol questionnaire. The secondary endpoint was mean change in satisfaction with care at 2 years from baseline assessed by QLQ-SAT32. Two hundred patients with head and neck cancers were involved in this study (mean age, 58.83 years (range, 36.56-87.89)), of whom 100 were assigned to the intervention arm and 100 to the control arm. Patients in the intervention arm were reported to have a statistically significant increase in EQ VAS at 2 years (p < 0.0001) and exceeded the minimal clinically important difference (mean change at 2 years from baseline = 10.46). In the two arms, mean differences between arms were not statistically significant, but minimal clinically important differences in favor of the intervention arm were found for EQ VAS (mean change difference (MD) = 5.84), satisfaction with care, in particular waiting times (MD = 10.85) and satisfaction with accessibility (MD = 6.52). Routine assessment of HRQoL improves HRQoL and satisfaction with care for patients with HNC treated with radiotherapy.

Electronic capturing of patient-reported outcome measures on a touchscreen computer in clinical diabetes practice (the DiaPROM trial): a feasibility study.

BACKGROUND: Living with type 1 diabetes (T1D) is demanding, and emotional problems may impair ability for diabetes self-management. Thus, diabetes guidelines recommend regular assessment of such problems. Using patient-reported outcome measures (PROMs) to assess diabetes-related distress and psychological well-being is considered useful. It has been proposed that future work should examine the use of PROMs to support the care of individual patients and improve the quality of health services. To our knowledge, the use of PROMs has not been systematically evaluated in diabetes care services in Norway. Electronically captured PROMs can be directly incorporated into electronic patient records. Thus, the study's overall aim was to examine the feasibility and acceptability of capturing PROMs electronically on a touchscreen computer in clinical diabetes practice. METHODS: Adults with T1D age ≥ 40 years completed PROMs on a touchscreen computer at Haukeland University Hospital's diabetes outpatient clinic. We included 46 items related to diabetes-related distress, self-perceived diabetes competence, awareness of hypoglycaemia, occurrence of hyperglycaemia, hypoglycaemia and fluctuating glucose levels, routines for glucose monitoring, general well-being and health-related quality of life. Participants subsequently completed a paper-based questionnaire regarding comprehension and relevance of the PROMs, acceptance of the number of items and willingness to complete electronic PROMs annually. We wrote field notes in the outpatient clinic based on observations and comments from the invited participants. RESULTS: During spring 2017, 69 participants (50.7% men), age 40 to 74 years, were recruited. Generally, the touchscreen computer functioned well technically. Median time spent completing the PROMs was 8 min 19 s. Twenty-nine (42.0%) participants completed the PROMs without missing items, with an 81.4% average instrument completion rate. Participants reported that the PROMs were comprehensible (n = 62) and relevant (n = 46) to a large or very large degree, with an acceptable number of items (n = 51). Moreover, 54 were willing to complete PROMs annually. Participants commented that the focus on living with diabetes was valued. CONCLUSIONS: Capturing PROMs on a touchscreen computer in an outpatient clinic was technically and practically feasible. The participants found the PROMs to be relevant and acceptable with a manageable number of items, and reported willingness to complete PROMs annually.

Supports and barriers to implementation of routine clinical assessment for children with cerebral palsy: A mixed-methods study.

PURPOSE: The purpose of this study is to investigate supports and barriers to evidence-based routine clinical assessment of children with cerebral palsy. METHOD: This mixed methods study included physiotherapists, occupational therapists and speech pathologists providing services to children with cerebral palsy (3-18 years) within five organizations across Australia. Four organizations initiated standardized routine clinical data collection (Commencing organizations), and one had previously mandated routine assessment (Comparison organization). Participants completed the Supports and Barriers Questionnaire (n = 227) and participated in focus groups (n = 8 groups, 37 participants). Quantitative data were summarized descriptively, qualitative data were analyzed thematically and comparisons between organizations assessed. RESULTS: Organizational structures, resources, therapists within organizations, assessment tools, and children and families were, on average, viewed as supportive of routine clinical assessment. There were no differences between the Comparison and Commencing organizations except 'therapists within the organization' were viewed as more supportive by the Commencing organizations (p = 0.037). Five themes were derived from qualitative analyzes: motivation to adopt routine clinical assessment; acquiring and utilizing expertise; ensuring effective ongoing communication; availability and distribution of resources; and therapist perceptions of child and family wishes. CONCLUSIONS: Organizations experience challenges to effective and sustained implementation of routine clinical assessment. Adequate resourcing and positive, clear communication were perceived as critical for success. Implications for Rehabilitation The value of routine clinical assessment of children with cerebral palsy is undisputed. Tailored solutions to organization-specific challenges are required when implementing routine clinical assessment for children with cerebral palsy. Positive, clear communication of organizational priorities by management may assist AHPs to prioritize workload activities when changing practice.

Performance of routine assessment of patient index data 3 (RAPID3) in monitoring disease activity of Chinese rheumatoid arthritis patients.

AIM: To explore the performance of routine assessment of patient index data 3 (RAPID3) in reflecting disease activity in Chinese rheumatoid arthritis (RA) patients. METHOD: The clinical data of 189 consecutive RA patients, including RAPID3 questionnaire, Disease Activity Score based on 28-joint count (DAS28), clinical disease activity index (CDAI) and simplified disease activity index (SDAI), and ultrasonography of hand and wrist joints were collected. The consistency between RAPID3 and DAS28, CDAI, SDAI in RA patients with different disease activities was performed by Spearman's correlations, kappa and/or weighted kappa coefficients. RESULT: RAPID3 score was significantly associated with DAS28 and erythrocyte sedimentation rate (ESR), DAS28 with C-reactive protein (CRP), CDAI, SDAI (r = 0.797, 0.786, 0.784, and 0.760 respectively, P < 0.001 for all). RAPID3 was also significantly correlated with tender joint count, swollen joint count, ESR and CRP. The agreement of RAPID3 with DAS28 scoring systems was better in patients with moderate/high disease activity than those in remission/low disease activity. Ultrasonographic subclinical synovitis was presented in 42.3%-48.6% of patients in remission/low disease activity defined by various scoring criteria including RAPID3 with no significant difference observed (P = 0.22, >0.05). CONCLUSION: RAPID3 showed good correlation with DAS28 scoring systems, especially in patients with moderate/high disease activity. RAPID3 is a reliable and convenient tool to monitor disease activity.

MDHAQ/RAPID3 scores in patients with osteoarthritis are similar to or higher than in patients with rheumatoid arthritis: a cross-sectional study from current routine rheumatology care at four sites.

OBJECTIVE: To compare patients with a primary diagnosis of osteoarthritis (OA) versus rheumatoid arthritis (RA) for scores on a patient self-report MDHAQ/RAPID3 (Multidimensional Health Assessment Questionnaire/Routine Assessment of Patient Index Data 3), and for physician global assessment (DOCGL). METHODS: All patients with all diagnoses complete an MDHAQ/RAPID3 at all routine rheumatology visits in the waiting area before seeing a rheumatologist at four sites, one in Australia and three in the USA. The two-page MDHAQ includes 0-10 scores for physical function (in 10 activities), pain and patient global assessment [on 0-10 visual analogue scales (VAS)], compiled into a 0-30 RAPID3, as well as fatigue and self-report painful joint count scales. Rheumatologists estimate a 0-10 DOCGL VAS. Demographic, MDHAQ/RAPID3 and DOCGL data from a random visit were compared in patients with RA versus patients with OA using multivariate analysis of variance, adjusted for age, disease duration and formal education level. RESULTS: Median RAPID3 was higher in OA versus RA at all four sites (11.7-16.8 vs 6.2-11.8) (p<0.001 at three sites). Median DOCGL in OA versus RA was 5 vs 4, 4 vs 3.7, 2.2 vs 2.5 and 2 vs 1. Patterns were similar for individual RAPID3 items, fatigue and painful joint scales, and in stratified analyses of patients aged 55-70. CONCLUSION: Patient MDHAQ/RAPID3 and physician DOCGL indicate similar or higher disease burden in OA versus RA. Routine MDHAQ/RAPID3 allows direct comparisons of the two diseases. The findings suggest possible revision of current clinical and public policy views concerning OA.

Onset and durability of pain relief in knee osteoarthritis: pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib.

OBJECTIVE: To further characterize time-to-first pain relief, effect size, correlations between various outcome measures and durability of relief for single-tablet naproxen 500 mg/esomeprazole 20 mg (NAP/ESO) given twice daily and celecoxib (CEL) (200 mg) given once daily versus placebo in knee osteoarthritis (OA). METHODS: Unpublished data from two double-blind, double-dummy, placebo-controlled trials in which patients aged ≥50 years with knee OA were randomized to NAP/ESO (n = 487), CEL (n = 486) or placebo (n = 246) were pooled (NCT00664560 and NCT00665431). Acute response endpoints: 1) Time to first significant pain response, 2) Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale and 3) American Pain Society Patient Outcome Questionnaire (APS-POQ) scores. Sustainability endpoints: 1) Routine Assessment of Patient Index Data (RAPID3) and 2) WOMAC Stiffness, Pain and Total scores; and Patient Global Assessment (PGA) at 6 and 12 weeks. Effect sizes for all measures were calculated. Rescue pain medication use also was analyzed, as was the correlation of WOMAC to RAPID3. RESULTS: NAP/ESO produced statistically significant decreases in WOMAC Pain on Days 2-7 and at Weeks 6 and 12 (all p < 0.05); most APS-POQ pain assessments with NAP/ESO were significantly improved on Days 2-7 compared with placebo (all p < 0.05). A good or excellent response occurred in a median of 6 days. RAPID3 and WOMAC total/stiffness/function/PGA scores decreased significantly at Weeks 6 and 12 (all p < 0.05). Placebo-adjusted WOMAC pain effect sizes were 0.44, 0.34 and 0.25 at Day 7, week 6 and week 12, respectively. RAPID3 to WOMAC total and WOMAC pain to RAPID3: Pain scores were highly correlated at 6 and 12 weeks (correlation coefficients >0.80). No significant differences in overall responses were found between CEL and NAP/ESO. CONCLUSION: Naproxen/esomeprazole produced a significant absolute moderate early pain response, which was maintained for 12 weeks. RAPID3 was found to be highly correlated with the typical OA measure (WOMAC) and might be a useful clinical tool for measuring NSAID response. NCT00664560: https://clinicaltrials.gov/ct2/show/NCT00664560, NCT00665431: https://www.clinicaltrials.gov/ct2/show/NCT00665431.

Evaluating patient reported outcomes in routine practice of patients with rheumatoid arthritis treated with biological disease modifying anti rheumatic drugs (b-DMARDs).

OBJECTIVES: In this study the concordance between the Routine Assessment of Patient Index Data 3 (RAPID3) and the Disease Activity Score 28-joint count (DAS28) was investigated in a clinical routine outpatient setting. PATIENTS AND METHODS: A sample of 150 adult patients with stable RA treated with biological DMARDs (bDMARDs) was asked to complete the RAPID3 (digital or on paper) just before their outpatient routine visit during which DAS28 assessment took place. The RAPID3 correlation with and the agreement in four DAS28 categories was studied using Spearman's rank order and Cohen's observed kappa statistics respectively. The positive (PPV) and negative (NPV) predictive values were calculated to test whether RAPID3 could make distinction in active disease (DAS28 >3.2) or not. RESULTS: A moderate correlation (ρ 0.576) and a poor kappa value of 0.13 were found in the whole study population. Patients reported a higher disease severity than was measured by DAS28. The PPV of RAPID3 for active disease by DAS28 was 0.59 (95 % CI 0.50-0.68) and the NPV was 0.91 (95 % CI 0.75-0.98) with a sensitivity and specificity of 96 and 40 % respectively. DISCUSSION: While RAPID3 correlates to some extent with DAS28 at the group level, agreement between RAPID3 and DAS28 at the individual patient level is to poor to rely on RAPID3 results in monitoring patients with RA. RAPID3 tends to over-report disease activity as assessed by DAS28.

Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib.

OBJECTIVE: To further characterize time-to-first pain relief, effect size, correlations between various outcome measures and durability of relief for single-tablet naproxen 500 mg/esomeprazole 20 mg (NAP/ESO) given twice daily and celecoxib (CEL) (200 mg) given once daily versus placebo in knee osteoarthritis (OA). METHODS: Unpublished data from two double-blind, double-dummy, placebo-controlled trials in which patients aged ≥ 50 years with knee OA were randomized to NAP/ESO (n = 487), CEL (n = 486) or placebo (n = 246) were pooled (NCT00664560 and NCT00665431). Acute response endpoints: 1) Time to first significant pain response, 2) Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale and 3) American Pain Society Patient Outcome Questionnaire (APS-POQ) scores. Sustainability endpoints: 1) Routine Assessment of Patient Index Data (RAPID3) and 2) WOMAC Stiffness, Pain and Total scores; and Patient Global Assessment (PGA) at 6 and 12 weeks. Effect sizes for all measures were calculated. Rescue pain medication use also was analyzed, as was the correlation of WOMAC to RAPID3. RESULTS: NAP/ESO produced statistically significant decreases in WOMAC Pain on Days 2-7 and at Weeks 6 and 12 (all p < 0.05); most APS-POQ pain assessments with NAP/ESO were significantly improved on Days 2-7 compared with placebo (all p < 0.05). A good or excellent response occurred in a median of 6 days. RAPID3 and WOMAC total/stiffness/function/PGA scores decreased significantly at Weeks 6 and 12 (all p < 0.05). Placebo-adjusted WOMAC pain effect sizes were 0.44, 0.34 and 0.25 at Day 7, week 6 and week 12, respectively. RAPID3 to WOMAC total and WOMAC pain to RAPID3: Pain scores were highly correlated at 6 and 12 weeks (correlation coefficients >0.80). No significant differences in overall responses were found between CEL and NAP/ESO. CONCLUSION: Naproxen/esomeprazole produced a significant absolute moderate early pain response, which was maintained for 12 weeks. RAPID3 was found to be highly correlated with the typical OA measure (WOMAC) and might be a useful clinical tool for measuring NSAID response. NCT00664560: https://clinicaltrials.gov/ct2/show/NCT00664560, NCT00665431: https://www.clinicaltrials.gov/ct2/show/NCT00665431.