Original articleEvaluating changes in health status: sensitivity to change of the modified Arabic health assessment questionnaire in patients with rheumatoid arthritis
Introduction
Since the disability caused by rheumatoid arthritis (RA) exacts a heavy human and economic toll, the prevention of functional loss is a major therapeutic goal [1], [2]. The importance of preserving function was emphasized in 1985 when the World Health Organization defined a holistic approach to health involving assessments not only of disease activity but also of functional disability [3]. However, in the treatment of diseases such as RA that can interfere with daily activities, it is useful to identify the disease effects that are of greatest concern to the patient. These effects may differ from the clinical manifestations usually measured by clinicians [4]. Function as assessed by self-report questionnaires has been identified by the American College of Rheumatology (ACR) [5] and European groups as a “core set” parameter for disease activity measurement and is now routinely evaluated in randomized clinical trials [6], [7], [8]. Similarly, functional assessment by questionnaires has been strongly recommended for observational studies [9] and clinical practice [10].
By far the most widely used questionnaire is the Health Assessment Questionnaire (HAQ), a self-administered tool that has been found simple, easy to use, and reproducible [11], [12]. Several versions of the HAQ have been developed to take cultural variations into account, and the tool has been translated into Spanish, Swedish, French, Italian, Korean, Chinese, and Portuguese [13], [14], [15], [16], [17], [18], [19].
A modified version of the HAQ in Arabic (Arabic-HAQ) was developed recently [20]. Although this version has been proved reliable, valid, and reproducible, its sensitivity to change has not been evaluated. We, therefore, conducted a prospective study in RA patients to assess correlations between clinical improvements as defined by ACR response criteria and functional improvement as assessed by the Arabic-HAQ and to evaluate the sensitivity to change of the Arabic-HAQ as compared to changes in other disease parameters.
Section snippets
Patients
Eighty-two consecutive patients fulfilling 1987 ACR criteria for RA [21] were included in the study. There were 59 women and 23 men, recruited at the Rheumatology and Rehabilitation Outpatient Clinics of the Ain Shams University Hospital (Egypt, n = 44) and Saudi German Hospital (Saudi Arabia, n = 38) where they were being evaluated for newly diagnosed RA or for a flare occurring in the absence of second-line therapy. Baseline demographic data including a detailed history were recorded. The
Statistical analysis
The study data were reviewed, coded, tabulated, and entered into a PC for statistical analysis. Relative-change variables were created by calculating the percentage change in each disease activity parameter as the difference between the baseline value and the 6- or 12-month value divided by the baseline value of the same variable. The standardized effect size (SES) was calculated as the ratio of the mean difference over the standard deviation of the mean score change. Relative efficiency (RE)
Results
The 82 RA patients ranged in age from 21 to 72 years (mean, 45.6 ± 14.0 years). Median disease duration was 2 years (6 months–25 years) (Table 1). The patients were evaluated then included in the study at methotrexate initiation.
After 6 and 12 months on methotrexate therapy, improvements were noted in all disease activity parameters and all Arabic-HAQ items. The median total Arabic HAQ index decreased from 2.5 at baseline to 1.4 after 6 months and 0.53 after 12 months (Table 2).
The changes in
Discussion
The potential advantages of disease-specific functional status instruments over generic instruments include enhanced validity and clinical relevance, as well as greater sensitivity to change. The reliability and validity of a modified and translated Arabic version of the original HAQ were tested in RA patients in an earlier study [20]. The aim of the present study was to test the sensitivity to change of this Arabic-HAQ in a prospective study of RA patients.
Significant improvements in function
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