Development of a Health Index in Patients With Ankylosing Spondylitis (ASAS HI) – Final Result of a Global Initiative Based On the International Classification of Functioning, Disability and Health (ICF) Guided By Assesment of Spondyloarthritis International Society (ASAS)

Uta Kiltz¹, Désiréé van der Heijde², Annelies Boonen³, Alarcos Cieza⁴, Gerold Stucki⁵, Muhammad Asim Khan⁶, Walter P. Maksymowych⁷, Helena Marzo-Ortega⁸, John D. Reveille⁹, Simon Stebbings¹⁰, Cristina Bostan¹¹ and Juergen Braun¹, ¹Rheumazentrum Ruhrgebiet, Herne, Germany, ²Leiden University Medical Center, Leiden, Netherlands, ³Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center, Maastricht, Netherlands, ⁴Department of Psychology, University Southampton, Southampton, United Kingdom, ⁵University of Lucerne, Lucerne, Switzerland, ⁶Medicine/ Rheumatology, Case Western Reserve University Hospital, Cleveland, OH, ⁷Medicine/Rheumatic Dis Unit, University of Alberta, Edmonton, AB, Canada, ⁸Leeds Musculoskeletal Biomedical Research Unit and University of Leeds, Leeds, United Kingdom, ⁹Division of Rheumatology, Univ of Texas Health Science Center at Houston, Houston, TX, ¹⁰Dunedin School of Medicine, University of Otago, Dunedin, New Zealand, ¹¹Paraplegic Research Unit, Nottwil, Switzerland

Meeting: ACR/ARHP Annual Meeting 2013

Keywords: Ankylosing spondylitis (AS), functional status and spondylarthritis

Session Information

Title: Spondylarthropathies and Psoriatic Arthritis: Clinical Aspects and Treatment: Clinical and Imaging Aspects of Axial Spondyloarthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose:

The impact of ankylosing spondylitis (AS) on a patient’s life can be considerable. Patients suffer from pain, stiffness and fatigue, are limited in their activities, and restricted in social participation. The International Classification of Functioning, Disability and Health (ICF) is a model to systematically classify and describe functioning, disability, and health in human beings. However no ICF-based patient-reported outcome measure has been developed. the objective is to develop a measure to assess health in patients with AS, the ASAS (Assessments of SpondyloArthritis international Society (ASAS)) Health Index, based on the Comprehensive ICF Core Set for AS.

Methods:

Development has been performed in five phases.

Table 1: Phases of development for the ASAS Health Index

	Phase	Objectives	Methods
Ia	Preparatory	Development of a pool of items representing the categories of the Comprehensive ICF Core Set for AS	Linkage of various assessment tools for functioning and health to ICF categories
Ib	Patient meeting	Patient preference and weighting of the items per ICF category	Relative weight to each item, patients distributed 100 points per ICF category.
II	1st postal patient survey	Item reduction (within and across ICF categories)	Factor Analysis, Rasch Analysis, Spearman rank correlation coefficient
III	Expert consultation	Agreement on item reduction	Nominal Consensus Process
IV	2nd postal patient survey	Validation of the draft version and further item reduction	Testing psychometric properties Rasch Analysis
V	Consensus Meeting	Agreement on a final version	Nominal Consensus Process

Results:

Phase 1: The item pool contained 251 items in 44 categories. Phase 2 was performed based on data collected along an international cross sectional study among 1915 AS patients (mean age 51.2±3.6, 53% male, BASDAI 5.5±2.4) in 4 continents. For 82 items of the functioning part a unidimensional scale, fit to the Rasch model and absence of Differential Item Function (DIF) could be confirmed. Phase 3: An expert committee selected 50 functioning items using predefined selection criteria. Phase 4: An international cross sectional study with 628 AS patients (mean age 48.5±14.2, 51.6% male, BASDAI 5.6±2.3) was conducted in 4 continents. Misfit was identified in 4 items and DIF in 15 items. More than 50% of the items showed a residual correlation between each other above a value of 0.2 in the initial round. Phase 5: Based on results of the analyses in step 4, the consensus members agreed on 17 final items. In the 17 items fit to the model, no residual correlation and absence of constant DIF could be confirmed with a Person-Separation Index of 0.82. The item location has been shown to be 0.00 ± 1.84 with a fit residual of 0.06 ± 1.24 and the person location has been shown to be 0.01 ± 1.80 with a fit residual of -0.30 ± 0.67. The chi-square probability was 0.73.

Conclusion: The ASAS HI measure contains 17 dichotomous items addressing categories of pain, emotional functions, sleep, sexual functions, mobility, self-care, community life and employment. In covering much of the ICF Core Set for AS, these items represent a whole range of abilities of patients with AS. The questionnaire will be translated and further tested for sensitivity to change. ASAS HI can be used in clinical trials and clinical practice as a new composite index that captures relevant information on the health status of the patients.

Disclosure:

U. Kiltz,
None;

D. van der Heijde,
None;

A. Boonen,
None;

A. Cieza,
None;

G. Stucki,
None;

M. A. Khan,
None;

W. P. Maksymowych,
None;

H. Marzo-Ortega,
None;

J. D. Reveille,
None;

S. Stebbings,
None;

C. Bostan,
None;

J. Braun,
None.

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