MDHAQ/RAPID3 to Recognize Improvement Over 2 Months in Usual Care of Patients With Osteoarthritis, Systemic Lupus Erythematosus, Spondyloarthropathy, and Gout, as Well as Rheumatoid Arthritis

Castrejón, Isabel; Bergman, Martin; Pincus, Theodore

doi:10.1097/rhu.0b013e3182936b98

Cited by 49 publications

(51 citation statements)

References 26 publications

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“…Furthermore, Tubach [50] has proposed a patient acceptable symptom state (PASS) to address the concept of a partial symptomatic remission from NSAID treatment of knee OA; and these PASS thresholds were met or exceeded in the present analysis at 6 and 12 weeks with NAP/ESO treatment, with the exception of PGA response. The RAPID3 has shown utility as a patient-reported outcome in rheumatoid arthritis and other rheumatic diseases, including OA, potentially decreasing the need for joint counts, radiographic assessments and longer health assessment questionnaires [40,44,45,51]. Our study supports the contention that RAPID3 could be useful in the routine assessment of pain response in knee OA patients, as the correlation between RAPID3 and WOMAC was strong, both acutely and over time.…”

Section: Discussionsupporting

confidence: 77%

“…Analgesic sustainability was measured at weeks 6 and 12 with the WOMAC index, the Multidimensional Health Assessment Questionnaire (MDHAQ9, version R780-NP, physical function, pain and PGA) [40], the Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index [41], and the Routine Assessment of Patient Index Data 3 (RAPID3) [42]. The MDHAQ is a survey in which patients self-report their current health status.…”

Section: Endpointsmentioning

confidence: 99%

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

Holt

Fort²,

Grahn

et al. 2015

The Physician and Sportsmedicine

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(2015) Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib, The Physician and Sportsmedicine, 43:3, 200-212, DOI: 10.1080/00913847.2015 AbstractObjective. 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.

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Section: Discussionsupporting

confidence: 77%

Section: Endpointsmentioning

confidence: 99%

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

Holt

Fort²,

Grahn

et al. 2015

The Physician and Sportsmedicine

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“…Moreover, the RAPID‐3 has been suggested to be useful for tracking outcomes in patients with rheumatic diseases other than RA 18, which may maximize its usefulness within a rheumatology practice, irrespective of the patients’ specific conditions 7, 19. However, the results in Figure 3 show that patients classified as nonresponders by the RAPID‐3 nevertheless achieve improvement in the DAS28‐ESR, which, on average, exceeded the minimum important difference of 1.2.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol

Curtis

Churchill²,

Kivitz

et al. 2015

Arthritis & Rheumatology

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ObjectiveThe aim of the Patient/Physician Reported Efficacy Determination In Clinical Practice Trial (PREDICT; ClinicalTrials identifier NCT01255761) was to compare the patient‐reported Routine Assessment of Patient Index Data 3 (RAPID‐3) instrument with the investigator‐based Clinical Disease Activity Index (CDAI) for assessing certolizumab pegol (CZP) treatment response in rheumatoid arthritis patients at 12 weeks and to predict the treatment response at week 52 using the data from week 12 (coprimary end points).MethodsPatients received 400 mg of CZP at weeks 0, 2, and 4 (loading dose), followed by 200 mg every 2 weeks thereafter. Patients were randomized 1:1 to assessment with the RAPID‐3 or the CDAI. Responder classification was performed at week 12; treatment response was defined as a score of ≤6 or a 20% improvement over baseline on the RAPID‐3 or a score of ≤10 or a 20% improvement over baseline on the CDAI. Long‐term treatment success was defined as a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28‐ESR) of ≤3.2 at week 52. Comparisons were made for the coprimary end points using noninferiority methods. Patients with improvement of <1 on the CDAI score or with no improvement on the RAPID‐3 score at week 12 or patients with high levels of disease activity (CDAI score >22 or RAPID‐3 score >12) at 2 consecutive visits were withdrawn from the study.ResultsPatients had longstanding disease (mean 8.9 years) and high levels of disease activity (mean scores of 6.3 on the DAS28‐ESR, 16.1 on the RAPID‐3, and 40.2 on the CDAI). Previous anti–tumor necrosis factor therapy had failed in 55.5% of them. At week 12, a total of 64.7% (by RAPID‐3) and 76.4% (by CDAI) of the patients were classified as responders (difference of −11.9% [95% confidence interval −18.4%, −5.3%]). At week 52, a total of 31.5% (by RAPID‐3) and 32.3% (by CDAI) of the responders achieved a low level of disease activity on the DAS28‐ESR (difference of −1.3% [95% confidence interval −9.3%, 6.6%]).ConclusionThe CDAI classified more patients as CZP responders at week 12 than did the RAPID‐3. Although these outcome measures were not statistically comparable, the positive predictive value for low disease activity at week 52 was similar. As these tools cover differing domains of therapy response, further evaluation for clinical disease activity assessments and treatment decisions is needed.

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“…Remission criteria based on RAPID3 are similar to ACR/EULAR Boolean and SDAI remission criteria [115] 8. RAPID3 is effective to document change in clinical status in all rheumatic diseases [116] 9. Continuation of courses of DMARDs is more accurately described by observational data from clinical care than by data from clinical trials [64] 10.…”

Section: ) Some Limitations Of Clinical Trials In Ramentioning

confidence: 99%

Evidence from a Multidimensional Health Assessment Questionnaire (MDHAQ) of the Value of a Biopsychosocial Model to Complement a Traditional Biomedical Model in Care of Patients with Rheumatoid Arthritis

2016

Self Cite

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Patient self-report questionnaires such as a multidimensional health assessment questionnaire (MDHAQ) have advanced knowledge concerning prognosis, care, course and outcomes of rheumatoid arthritis (RA). The MDHAQ may overcome some limitations of a "biomedical model," the dominant paradigm of contemporary medical services, including limitations of laboratory tests, radiographs, joint counts, and clinical trials, to predict and depict the long-term course and outcomes of RA. A complementary "biopsychosocial model" captures components of a patient medical history on patient questionnaires as quantitative, standard, "scientific" scores for physical function, pain, fatigue, and other problems, rather than as "subjective" narrative descriptions. A rationale for a biopsychosocial model in RA includes the importance of a patient history in diagnosis and management compared to biomarkers in many chronic diseases such as hypertension and diabetes. Some important observations which support a biopsychosocial model in RA based on patient questionnaires include that MDHAQ physical function scores are far more significant than radiographs or laboratory tests to predict severe RA outcomes such as work disability and premature death; patient self-report measures are more efficient than tender joint counts and laboratory tests to distinguish active from control treatments in RA clinical trials involving biological agents; and MDHAQ scores are more likely than laboratory tests to be abnormal at presentation and to document incomplete responses to methotrexate at initiation of biological agents.

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MDHAQ/RAPID3 to Recognize Improvement Over 2 Months in Usual Care of Patients With Osteoarthritis, Systemic Lupus Erythematosus, Spondyloarthropathy, and Gout, as Well as Rheumatoid Arthritis

Abstract: MDHAQ, RAPID3, and DOCGL document similar baseline and improvement scores in patients with 5 diagnoses. These quantitative data may supplement traditional narrative, "gestalt" descriptions in usual care of patients with any rheumatic disease.

Cited by 49 publications

References 26 publications

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

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

A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol

Evidence from a Multidimensional Health Assessment Questionnaire (MDHAQ) of the Value of a Biopsychosocial Model to Complement a Traditional Biomedical Model in Care of Patients with Rheumatoid Arthritis

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