Abstract
BackgroundAdaptation of a patient-reported outcomes survey into a new language requires careful translation procedures as well as qualitative and quantitative psychometric testing. This study aimed to evaluate the basic psychometric properties of the new Saudi Arabian SF-36v2 and establish norm data for Saudi Arabia.MethodsTranslation and adaptation of the SF-36v2 used standard methodology. Psychometric validation included two stages: 1) A qualitative study (n = 100) explored the components of health and health-related quality of life considered important in Saudi Arabia and evaluated the content validity of the SF-36v2 in Saudi Arabia, and 2) A quantitative study (n = 6166) evaluated the basic psychometric properties of the Saudi SF-36v2 and established norm data for Saudi Arabia. Comparison with US general population data (n = 4040) evaluated differential item function (DIF) and cross-national differences.ResultsThe qualitative study supported the content validity of the Saudi SF-36v2. Cognitive debriefing identified only few and minor problems. Psychometric analyses supported item convergence within scales and differentiation across scales of the SF-36v2. Scale level exploratory factor analyses did not support the typical distinction between physical health and mental health components. Internal consistency reliability was satisfactory for all scales except the social function scale (alpha = 0.67). Cross-national DIF was identified for 9 items. In the Saudi general population, the average vitality score was lower for women (− 2.71 points) compared to men. For men, older age groups scored lower on the physical function scale (− 3.31) and the physical health component (− 3.06). For women, older age groups scored lower on the role physical (− 3.72), bodily pain (− 3.66), and vitality (− 2.32) scales as well as the physical health component (− 3.52). Compared to the 2009 United States general population, and after adjusting for age, gender, and differential item function, persons in Saudi Arabia had lower average scores for the physical function (− 3.10), role physical (− 4.75), social function (− 4.23), role emotional (− 5.67), and mental health (− 4.82) scales, as well as the mental health component (− 4.57).ConclusionThis Saudi normative study of patient reported outcomes supported the validity and reliability of the new Saudi SF-36v2 and found cross-national differences with the USA.
Highlights
Adaptation of a patient-reported outcomes survey into a new language requires careful translation procedures as well as qualitative and quantitative psychometric testing
Four concepts were endorsed by 50% or more of participants as components of health: physical functioning (70% of participants), normal psychological function and feelings (66%), healthy eating habits and enjoyment of food (61%), normal social functioning (50%); 38% of participants defined absence of disease or illness and 28% being full of energy as components of health (Table 2)
When presented with a list of domains commonly including in the assessment of Health-related Quality of Life (HRQOL), concepts related to all eight Social Function (SF)-36 domains were assessed as “quite” or “very” important for HRQOL (Range 95% - 100%, Table 3)
Summary
Adaptation of a patient-reported outcomes survey into a new language requires careful translation procedures as well as qualitative and quantitative psychometric testing. Evaluation of content validity, construct validity, and reliability as well as establishing national normative data are important steps in the translation and cultural adaptation of a PRO measure [2,3,4,5,6,7,8,9]. Despite these challenges, the literature urges investigators not to “reinvent the wheel” by developing new or ad hoc measures, but rather cross-culturally adapt an existing health and health-related quality of life (HRQOL) measure. A disadvantage of culturespecific instruments is that their results are not generalizable or comparable because each has its conceptual definition and choice of indicators [6]
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