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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.

Background The SF-6Dv2 classification system assesses health states in six domains—physical functioning, role function, bodily pain, vitality, social functioning, and mental health. Scores have previously been derived from the SF-36v2® Health Survey. We aimed to develop a six-item stand-alone SF-6Dv2 Health Utility Survey (SF-6Dv2 HUS) and evaluate its comprehensibility. Methods Two forms of a stand-alone SF-6Dv2 HUS were developed for evaluation. Form A had 6 questions with 5–6 response choices, while Form B used 6 headings and 5–6 statements describing the health levels within each domain. The two forms were evaluated by 40 participants, recruited from the general population. Participants were randomized to debrief one form of the stand-alone SF-6Dv2 HUS during a 75-min interview, using think-aloud techniques followed by an interviewer-led detailed review. Participants then reviewed the other form of SF-6Dv2 and determined which they preferred. Any issues or confusion with items was recorded, as was as overall preference. Data were analyzed using Microsoft Excel and NVivo Software (v12). Results Participants were able to easily complete both forms. Participant feedback supported the comprehensibility of the SF-6Dv2 HUS. When comparing forms, 25/40 participants preferred Form A, finding it clearer and easier to answer when presented in question/response format. The numbered questions and underlining of key words in Form A fostered quick and easy comprehension and completion of the survey. However, despite an overall preference for Form A, almost half of participants (n = 19) preferred the physical functioning item in Form B, with more descriptive response choices. Conclusion The results support using Form A, with modifications to the physical functioning item, as the stand-alone SF-6Dv2 HUS. The stand-alone SF-6Dv2 HUS is brief, easy to administer, and comprehensible to the general population.

Background Patients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health. Methods A qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance). Results Thirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation. Conclusion Pain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.