Measuring physical function in psoriatic arthritis: comparing the Multi-Dimensional Health Assessment Questionnaire to the Health Assessment Questionnaire Disability Index

2021 ◽  
pp. jrheum.200927
Author(s):  
Weiyu Ye ◽  
Simon Hackett ◽  
Claire Vandevelde ◽  
Sarah Twigg ◽  
Philip S. Helliwell ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Physical Function ◽  
Health Assessment Questionnaire ◽  
Health Assessment ◽  
Clinic Visit ◽  
Retest Reliability ◽  
Floor Effects ◽  
Test Retest Reliability ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Objective To compare physical function scales of the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) to the Health Assessment Questionnaire Disability Index (HAQDI) in patients with psoriatic arthritis (PsA), and examine whether either questionnaire is less prone to ‘floor effects’. Methods Data were collected prospectively from 2018 to 2019 across three UK hospitals. All patients completed physical function scales within the MDHAQ and HAQDI in a single clinic visit. Agreement was assessed using medians and the Bland-Altman method. Intraclass correlation coefficients (ICCs) were used to assess test-retest reliability. Results 210 patients completed the clinic visit; one withdrew consent thus 209 were analysed. 60.0% were male, with mean age of 51.7 years and median disease duration of 7 years. In clinic, median MDHAQ and HAQDI including/excluding aids scores were 0.30, 0.50 and 0.50 respectively. Although the median score for HAQDI is higher than MDHAQ, the difference between the two mostly lies within 1.96 standard deviations from the mean suggesting good agreement. The ICCs demonstrated excellent test-retest reliability for both HAQ questionnaires.Similar numbers of patients scored ‘0’ on the MDHAQ and HAQDI including/excluding aids (48, 47, and 49 respectively). Using a score of ≤0.5 as a cut-off for minor functional impairment, 23 patients had a MDHAQ ≤0.5 when their HAQDI including aids >0.5. Conversely, 4 patients had a MDHAQ > 0.5 when the HAQDI including aids ≤0.5. ConclusionBoth HAQ questionnaires appear to be similar in detecting floor effects in patients with PsA.

scholarly journals EP41 The Multidimensional Health Assessment Questionnaire (MDHAQ) and the Heath Assessment Questionnaire Disability Index (HAQDI): a comparison in patients with psoriatic arthritis

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Weiyu Ye ◽  
Simon Hackett ◽  
Claire Vandevelde ◽  
Sarah Twigg ◽  
Laura C Coates
Keyword(s):  
Health Assessment Questionnaire ◽  
Health Assessment ◽  
Retest Reliability ◽  
Bland Altman Method ◽  
Floor Effects ◽  
The Mean ◽  
Test Retest Reliability ◽  
Multidimensional Health ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Abstract Background We compared the Health Assessment Questionnaire Disability Index (HAQDI) and the simpler Multidimensional Health Assessment Questionnaire (MDHAQ) in patients with psoriatic arthritis (PsA), and examined whether either questionnaires are less prone to ‘floor effects’, whereby patients report normal scores despite experiencing functional impairment. Methods Data were collected prospectively across three UK hospital trusts from 2018-2019. All patients completed the MDHAQ, HAQDI and PsA Impact of Disease Questionnaire (PsAID) in a single clinic visit. A subset were given an identical pack to complete one week later. The HAQ questionnaires are scored from 0-3, and the PsAID is scored from 0-10. The PsAID has a validated patient acceptable symptom state (PsAID≤4) to stratify high-impact and low-impact disease. Mean with standard deviation (S.D.) was calculated and variability was assessed using the Bland-Altman method. Intraclass correlation coefficients (ICC, two-way mixed model absolute agreement) was used to assess test-retest reliability. Using pilot data, we calculated that 210 patients were required to detect non-inferiority between the HAQ questionnaires, with a 0.125 margin at a two-sided 0.025 significance level with > 90% power. All analyses were performed using R. This study was approved by London-Surrey Research Ethics Committee. Results 210 patients completed the study; one withdrew consent thus 209 were analysed. 62 patients completed the questionnaires one week later. 60.0% were male, mean age was 51.7 years, and median PsA duration was 7.0 years. In clinic, mean (S.D.) scores on the MDHAQ, HAQDI including/excluding aids, and PsAID were 0.58 (0.64), 0.79 (0.78), 0.70 (0.73), and 3.71 (2.70), respectively. The mean HAQDI tends to be higher than the MDHAQ, for both high and low-impact disease. However, the difference between the two mostly lies within 1.96 S.D. of the mean using the Bland-Altman method, suggesting reasonable agreement. Comparing clinic and 1-week scores, the ICCs for the MDHAQ, HAQDI including/excluding aids, and PsAID were 0.97 (95% CI 0.95-0.98), 0.98 (0.97-0.99), 0.98 (0.96-0.99), and 0.96 (0.93-0.97) respectively, suggesting excellent test-retest reliability. Patients scoring ‘0’ in MDHAQ and HAQDI including/excluding aids were similar (48, 47, 49). Using a score of ≤ 0.5 for low functional impairment, 23 patients had a MDHAQ ≤ 0.5 when their HAQDI including aids > 0.5. This reduced to 17 when using HAQDI excluding aids > 0.5. In contrast, 4 patients had a HAQDI including aids ≤ 0.5 when MDHAQ > 0.5. This increased to 5 patients when using HAQDI excluding aids ≤ 5. Collectively, this suggests the HAQDI is less prone to floor effects compared to the MDHAQ, especially when the score incorporates aids. Conclusion The MDHAQ and HAQDI scores show test-retest reliability and reasonable agreement in patients with PsA. Although the MDHAQ is quicker for patients to complete, it appears more prone to floor effects. Disclosures: W. Ye: None. S. Hackett: None. C. Vandevelde: None. S. Twigg: None. L.C. Coates: None.

scholarly journals SAT0125 ASSOCIATION BETWEEN CHANGE IN HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX AND TREATMENT RESPONSE IN PATIENTS WITH RHEUMATOID ARTHRITIS IN TOCILIZUMAB CLINICAL TRIALS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 998.2-998
Author(s):  
S. Unizony ◽  
J. Dang ◽  
J. Han ◽  
M. Michalska ◽  
J. H. Best
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Disease Activity ◽  
Physical Function ◽  
Health Assessment Questionnaire ◽  
Health Assessment ◽  
Phase Iii ◽  
Link Type ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Background:The efficacy and safety of intravenous (IV) and subcutaneous (SC) tocilizumab (TCZ) in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and as monotherapy in patients with rheumatoid arthritis (RA) has been demonstrated in large clinical trials and real-world data studies. The Health Assessment Questionnaire Disability Index (HAQ-DI) is commonly used to assess physical function in patients with RA. While HAQ-DI outcomes at Week 24 in TCZ clinical trials have been reported, outcomes at Week 12 and results stratified by treatment response categories at Weeks 12 and 24 have not been previously described.Objectives:To report the association between change in HAQ-DI from baseline to Weeks 12 and 24 and Disease Activity Score in 28 joints (DAS28) response categories in patients who received TCZ or comparators in TCZ clinical trials.Methods:Data from patients with active RA who received TCZ or a comparator from 6 Phase III or IV TCZ-IV studies (OPTION [NCT00106548], RADIATE [NCT00106522], TOWARD [NCT00106574] LITHE [NCT00109408], ACT-RAY [NCT00810199] and ADACTA [NCT01119859]) and 1 Phase III TCZ-SC study (BREVACTA [NCT01232569]) were analyzed. Mean change in HAQ-DI score at Weeks 12 and 24 was assessed in patients stratified by DAS28 disease activity level (DAS28 < 2.6 [remission], DAS28 ≥ 2.6 to ≤ 3.2 [low disease activity; LDA], DAS28 > 3.2 to ≤ 5.1 [moderate disease activity; MDA], DAS28 > 5.1 [high disease activity; HDA] at Weeks 12 and 24. The adjusted least squares mean (LSM) change from baseline was estimated using a mixed model with repeated measures, including region (North America vs non-North America), RA duration (> 2 years vs ≤ 2 years), baseline HAQ-DI and DAS28, treatment, visit, visit by treatment and visit by baseline HAQ-DI.Results:Data from 5051 patients were included. Across all studies, the mean duration of RA ranged from 6.3 to 12.6 years. At baseline, patients had severe RA with a mean DAS28 ≥ 6.3; baseline HAQ-DI was ≥ 1.5. At Week 12, patients who achieved remission or LDA had greater improvements in HAQ-DI than those in MDA or HDA (Figure 1). Results were similar at Week 24 (Figure 2). Among patients who received TCZ and achieved remission or LDA, mean improvement in HAQ-DI was ≥ 0.65 and ≥ 0.44, respectively, at Week 12 (Figure 1) and ≥ 0.48 and ≥ 0.43 at Week 24 (Figure 2). Mean changes in HAQ-DI were similar between patients who received TCZ-IV in combination with MTX or as monotherapy (ACT-RAY) and in those who received TCZ-IV or ADA as monotherapy (ADACTA).Conclusion:Patients with long-standing, severe RA who received IV or SC TCZ as monotherapy or in combination with csDMARDs had improvement in physical function and disease activity at Week 12 that was maintained at Week 24. Overall, across all the trials, response to treatment was associated with improvement in physical function.Acknowledgments :This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests: :Sebastian Unizony Grant/research support from: Genentech, Inc., Joseph Dang Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Margaret Michalska Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Jennie H. Best Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.

scholarly journals FRI0048 NUMBER NEEDED TO TREAT TO ACHIEVE MINIMUM CLINICALLY SIGNIFICANT DIFFERENCES IN PATIENT-REPORTED OUTCOMES IN PATIENTS TREATED WITH BARICITINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 599.1-600
Author(s):  
V. Strand ◽  
L. Sun ◽  
J. Ross Terres ◽  
C. L. Kannowski
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Bodily Pain ◽  
Health Assessment ◽  
Number Needed To Treat ◽  
Chronic Illness Therapy ◽  
Sf 36 ◽  
Patient Reported ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Background:Baricitinib (BARI) provided rapid and sustained improvements in patient-reported outcomes (PROs) in randomized, controlled trials (RCTs) in patients (pts) with active rheumatoid arthritis (RA) and inadequate responses (IR) to methotrexate (MTX) (RA-BEAM;NCT01710358)1,2and biologic DMARDs (bDMARD-IR; RA-BEACON;NCT01721044)3,4.Objectives:To determine the number needed to treat (NNT) to report improvements ≥minimum clinically important differences (MCIDs) in multiple PROs at Week (Wk) 12 after treatment with BARI 4-mg in RA-BEAM and BARI 2-mg or BARI 4-mg in RA-BEACON. NNTs ≤10 vs placebo (PBO) are considered clinically meaningful.Methods:Evaluated PROs with respective MCID definitions included Patient Global Assessment of Disease Activity (PtGA, 0-100 mm visual analog scale [VAS], MCID ≥10 mm), pain (0-100 mm VAS, MCID ≥10 mm), physical function (Health Assessment Questionnaire-Disability Index, MCID ≥0.22 points), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], MCID≥4.0), and health-related quality of life (SF-36 physical component summary [PCS: MCID ≥2.5] and domain scores: physical function [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], mental health [MH], MCID ≥5.0).5The percentages of pts reporting improvements ≥MCID were determined at Wk 12. NNTs were calculated as 1/difference in response rates between BARI 2-mg or 4-mg and PBO.Results:At Wk 12, percentages of pts reporting clinically meaningful improvements were greater and statistically different from PBO (p<0.01) with BARI 2-mg and 4-mg across most PROs in both RCTs. Most NNTs were ≤10. (Figure)Conclusion:Across different populations, MTX-IR and bDMARD-IR pts with active RA reported clinically meaningful improvements in PROs after BARI treatment. The NNTs in these analyses indicate that <10 pts need to be treated with BARI 2- or 4-mg to report a clinically meaningful benefit.References:[1]Taylor et al. NEJM, 2017;376: 652-62[2]Keystone et al. Ann Rheum Dis, 2017;76:1853-61[3]Genovese et al. NEJM, 2016; 374: 1243-52[4]Smolen et al. Ann Rheum Dis, 2017; 76: 694-700[5]Strand et al. J Rheumatol, 2011; 38: 1720-27Figure.Percentages of patients reporting improvements ≥MCID with baricitinib vs placebo and associated NNTs for baricitinib in RA-BEAM and RA-BEACON. *p<0.05; **p<0.01; ***p<0.001. Abbreviations: BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; GH, general health; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimum clinically important difference; MH, mental health; NA, not applicable (ie, difference between treatment and placebo is not statistically significant, confidence interval of NNT is not calculated); NNT, numbers needed to treat; Pain, Patient’s assessment of pain; PCS, physical component score; PF, physical function; PtGA, Patient’s Global Assessment of Disease Activity; RE, role emotional; RP, role physical; SF-36, Short Form-36; SF, social functioning; VT, vitalityDisclosure of Interests:Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Luna Sun Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jorge Ross Terres Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company

scholarly journals Efficacy and safety of a single switch from etanercept originator to etanercept biosimilar in a cohort of inflammatory arthritis

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Maria Chiara Ditto ◽  
Simone Parisi ◽  
Marta Priora ◽  
Silvia Sanna ◽  
Clara Lisa Peroni ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Inflammatory Arthritis ◽  
Health Assessment Questionnaire ◽  
Activity Index ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Clinical State ◽  
Assessment Questionnaire

Abstract AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.

scholarly journals PNS53 Population Normative DATA for the Health Assessment Questionnaire Disability INDEX in Hungary

2020 ◽  
Vol 23 ◽  
pp. S652
Author(s):  
M. Péntek ◽  
G. Poór ◽  
V. Brodszky ◽  
Z. Zrubka ◽  
L. Gulácsi ◽  
...  
Keyword(s):  
Health Assessment Questionnaire ◽  
Normative Data ◽  
Health Assessment ◽  
Assessment Questionnaire ◽  
Questionnaire Disability
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