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Abstract Number: 1345

Validation of the Health Assessment Questionnaire for Spondyloarthritis in Patients with Non-Radiographic Axial Spondyloarthritis

Dennis Revicki1, Wen-Hung Chen1, Ying Jin1, Sumati Rao2, Philip J. Mease3 and Mary Cifaldi2, 1United Biosource Corporation, Bethesda, MD, 2Abbott Laboratories, Abbott Park, IL, 3Swedish Rheumatology Research Group, Seattle, WA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Health Assessment Questionnaire, patient questionnaires and spondylarthropathy

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Session Information

Title: Spondylarthropathies and Psoriatic Arthritis: Clinical Aspects and Treatment

Session Type: Abstract Submissions (ACR)

Background/Purpose: To evaluate the psychometric properties of the Health Assessment Questionnaire for Spondyloarthritis (HAQ-S) in patients with non-radiographic axial spondyloarthritis (nr-axSpA).

Methods: Data from 185 nr-axSpA patients receiving the human anti-TNF monoclonal antibody adalimumab (ABILITY-1 -trial) were analyzed. Internal consistency and test–retest reliability were assessed using Cronbach’s alpha and intraclass correlation coefficient (ICC), respectively. Convergent validity was assessed by correlating HAQ-S with Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), EQ-5D™, Patient and Clinical Global Assessment of Disease Activity Visual Analog Scales (PGA-VAS and CGA-VAS), and Patient’s Global Assessment of Pain (PAIN-VAS). Known-groups validity and ability to detect changes were assessed based on Patient Acceptable Symptom State Questionnaire (PASS) and PGA-VAS using analysis of variance. PASS, PGA-VAS, and CGA-VAS were used as anchors to determine the minimally important difference (MID).

Results: The HAQ-S Global and Activity scores demonstrated internal consistency, with good Cronbach’s alpha (0.95 and 0.78, respectively), but Cronbach’s alpha was lower for Driving scores (0.63). The HAQ-S Global, Activity, Driving, and Stiffness scores all demonstrated test–retest reliability, with good ICCs (0.90, 0.82, 0.71, and 0.87, respectively).  The HAQ-S Global, Activity, and Stiffness scores demonstrated good convergent validity, as indicated by the moderate to high correlations with BASFI, BASDAI, EQ-5D™, PGA-VAS, and PAIN-VAS at baseline (0.31–0.76) and week 12 (0.53–0.89). Correlations between the HAQ-S Driving score and the criterion measures were lower (0.24–0.46 at baseline; 0.41–0.63 at week 12). For known-groups validity, mean HAQ-S Global, Activity, Driving, and Stiffness scores at week 12 were significantly different for patients with different PASS responses (P<0.001).   The HAQ-S Global, Activity, and Stiffness scores were significantly different for patients with PGA-VAS scores below and above the sample median at baseline and at week 12 (P<0.001). The HAQ-S Global, Activity, Driving, and Stiffness scores demonstrated significantly larger changes for responders (PASS=“Yes” at week 12) than for non-responders (PASS=“No”), and for responders (PGA-VAS decreased ≥30% at week 12) than for non-responders (PGA-VAS decrease <30% or increased), indicating the ability to detect changes in clinical status. Using anchor-based methods (based on PASS, PGA-VAS, and CGA-VAS), MIDs ranged from –0.17 to –0.42 for HAQ-S Global score, –0.09 to –0.57 for HAQ-S Activity score, 0.10 to –0.29 for HAQ-S Driving score, and –8.8 to –32.7 for HAQ-S Stiffness score. The MID for the HAQ-S Global score should be 0.26 calculated as the average of the MIDs based on PGA-VAS and CGA-VAS anchors.

Conclusion: This study of the HAQ-S indicated that Global, Activity, and Stiffness scores were reliable and valid measures of functional ability in patients with nr-axSpA. The HAQ-S scores also demonstrated ability to detect change in clinical status.


Disclosure:

D. Revicki,

Abbott Laboratories,

2;

W. H. Chen,

Abbott Laboratories,

2;

Y. Jin,

Abbott Laboratories,

2;

S. Rao,

Abbott Laboratories,

1,

Abbott Laboratories,

3;

P. J. Mease,

Abbott Laboratories,

5,

Abbott Laboratories,

2,

Abbott Laboratories,

8;

M. Cifaldi,

Abbott Laboratories,

1,

Abbott Laboratories,

3.

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