Barbara Gandek

Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project

This article presents information about the development and evaluation of the SF-36 Health Survey, a 36-item generic measure of health status. It summarizes studies of reliability and validity and provides administrative and interpretation guidelines for the SF-36. A brief history of the International Quality of Life Assessment (IQOLA) Project is also included.

Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project

Data from general population surveys (n = 1483 to 9151) in nine European countries (Denmark, France, Germany, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) were analyzed to cross-validate the selection of questionnaire items for the SF-12 Health Survey and scoring algorithms for 12-item physical and mental component summary measures. In each country, multiple regression methods were used to select 12 SF-36 items that best reproduced the physical and mental health summary scores for the SF-36 Health Survey. Summary scores then were estimated with 12 items in three ways: using standard (U.S.-derived) SF-12 items and scoring algorithms; standard items and country-specific scoring; and country-specific sets of 12 items and scoring. Replication of the 36-item summary measures by the 12-item summary measures was then evaluated through comparison of mean scores and the strength of product-moment correlations. Product-moment correlations between SF-36 summary measures and SF-12 summary measures (standard and country-specific) were very high, ranging from 0.94-0.96 and 0.94-0.97 for the physical and mental summary measures, respectively. Mean 36-item summary measures and comparable 12-item summary measures were within 0.0 to 1.5 points (median = 0.5 points) in each country and were comparable across age groups. Because of the high degree of correspondence between summary physical and mental health measures estimated using the SF-12 and SF-36, it appears that the SF-12 will prove to be a practical alternative to the SF-36 in these countries, for purposes of large group comparisons in which the focus is on overall physical and mental health outcomes.

Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment

Data from general population surveys (n = 1483 to 9151) in nine European countries (Denmark, France, Germany, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) were analyzed to cross-validate the selection of questionnaire items for the SF-12 Health Survey and scoring algorithms for 12-item physical and mental component summary measures. In each country, multiple regression methods were used to select 12 SF-36 items that best reproduced the physical and mental health summary scores for the SF-36 Health Survey. Summary scores then were estimated with 12 items in three ways: using standard (U.S.-derived) SF-12 items and scoring algorithms; standard items and country-specific scoring; and country-specific sets of 12 items and scoring. Replication of the 36-item summary measures by the 12-item summary measures was then evaluated through comparison of mean scores and the strength of product-moment correlations. Product-moment correlations between SF-36 summary measures and SF-12 summary measures (standard and country-specific) were very high, ranging from 0.94-0.96 and 0.94-0.97 for the physical and mental summary measures, respectively. Mean 36-item summary measures and comparable 12-item summary measures were within 0.0 to 1.5 points (median = 0.5 points) in each country and were comparable across age groups. Because of the high degree of correspondence between summary physical and mental health measures estimated using the SF-12 and SF-36, it appears that the SF-12 will prove to be a practical alternative to the SF-36 in these countries, for purposes of large group comparisons in which the focus is on overall physical and mental health outcomes.

Translating Health Status Questionnaires and Evaluating Their Quality : The IQOLA Project Approach

This article describes the methods adopted by the International Quality of Life Assessment (IQOLA) project to translate the SF-36 Health Survey. Translation methods included the production of forward and backward translations, use of difficulty and quality ratings, pilot testing, and cross-cultural comparison of the translation work. Experience to date suggests that the SF-36 can be adapted for use in other countries with relatively minor changes to the content of the form, providing support for the use of these translations in multinational clinical trials and other studies. The most difficult items to translate were physical functioning items, which used examples of activities and distances that are not common outside of the United States; items that used colloquial expressions such as pep or blue; and the social functioning items. Quality ratings were uniformly high across countries. While the IQOLA approach to translation and validation was developed for use with the SF-36, it is applicable to other translation efforts.

Psychometric and Clinical Tests of Validity of the Japanese SF-36 Health Survey

Cross-sectional data from a representative sample of the general population in Japan were analyzed to test the validity of Japanese SF-36 Health Survey scales as measures of physical and mental health. Results from psychometric and clinical tests of validity were compared. Principal components analyses were used to test for the hypothesized physical and mental dimensions of health and the pattern of scale correlations with those components. To test the clinical validity of SF-36 scale scores, self-reports of chronic medical conditions and the Zung Self-Rating Depression Scale were used to create mutually exclusive groups differing in the severity of physical and mental conditions. The pattern of correlations between the SF-36 scales and the two empirically derived components generally confirmed hypotheses for most scales. Results of psychometric and clinical tests of validity were in agreement for the Physical Functioning, Role-Physical, Vitality, Social Functioning, and Mental Health scales. Relatively less agreement between psychometric and clinical tests of validity was observed for the Bodily Pain, General Health, and Role-Emotional scales, and the physical and mental health factor content of those scales was not consistent with hypotheses. In clinical tests of validity, the General Health, Bodily Pain, and Physical Functioning scales were the most valid scales in discriminating between groups with and without a severe physical condition. Scales that correlated highest with mental health in the components analysis (Mental Health and Vitality) also were most valid in discriminating between groups with and without depression. The results of this study provide preliminary interpretation guidelines for all SF-36 scales, although caution is recommended in the interpretation of the Role-Emotional, Bodily Pain, and General Health scales pending further studies in Japan.

Health-related quality of life associated with chronic conditions in eight countries: Results from the International Quality of Life Assessment (IQOLA) Project

Context: Few studies and no international comparisons have examined the impact of multiple chronic conditions on populations using a comprehensive health-related quality of life (HRQL) questionnaire. Objective: The impact of common chronic conditions on HRQL among the general populations of eight countries was assessed. Design: Cross-sectional mail and interview surveys were conducted. Participants and setting: Sample representatives of the adult general population of eight countries (Denmark, France, Germany, Italy, Japan, the Netherlands, Norway and the United States) were evaluated. Sample sizes ranged from 2031 to 4084. Main outcome measures: Self-reported prevalence of chronic conditions (including allergies, arthritis, congestive heart failure, chronic lung disease, hypertension, diabetes, and ischemic heart disease), sociodemographic data and the SF-36 Health Survey were obtained. The SF-36 scale and summary scores were estimated for individuals with and without selected chronic conditions and compared across countries using multivariate linear regression analyses. Adjustments were made for age, gender, marital status, education and the mode of SF-36 administration. Results: More than half (55.1%) of the pooled sample reported at least one chronic condition, and 30.2% had more than one. Hypertension, allergies and arthritis were the most frequently reported conditions. The effect of ischemic heart disease on many of the physical health scales was noteworthy, as was the impact of diabetes on general health, or arthritis on bodily pain scale scores. Arthritis, chronic lung disease and congestive heart failure were the conditions with a higher impact on SF-36 physical summary score, whereas for hypertension and allergies, HRQL impact was low (comparing with a typical person without chronic conditions, deviation scores were around −4 points for the first group and −1 for the second). Differences between chronic conditions in terms of their impact on SF-36 mental summary score were low (deviation scores ranged between −1 and −2). Conclusions: Arthritis has the highest HRQL impact in the general population of the countries studied due to the combination of a high deviation score on physical scales and a high frequency. Impact of chronic conditions on HRQL was similar roughly across countries, despite important variation in prevalence. The use of HRQL measures such as the SF-36 should be useful to better characterize the global burden of disease.

The Short Form Health Survey (SF-36): translation and validation study of the Iranian version.

This was a large population-based study to develop and validate the Iranian version of the Short Form Health Survey (SF-36) for use in health related quality of life assessment in Iran. A culturally comparable questionnaire was developed and pilot tested. Then, the Iranian version of the SF-36 was administered to a random sample of 4163 healthy individuals aged 15 years and over in Tehran. The mean age of the respondents was 35.1 (SD=16.0) years, 52% were female, mostly married (58%) and the mean years of their formal education was 10.0 (SD=4.5). Reliability was estimated using the internal consistency and validity was assessed using known groups comparison and convergent validity. In addition factor analysis was performed. The internal consistency (to test reliability) showed that all eight SF-36 scales met the minimum reliability standard, the Cronbach’s α coefficients ranging from 0.77 to 0.90 with the exception of the vitality scale (α=0.65). Known groups comparison showed that in all scales the SF-36 discriminated between men and women, and old and the young respondents as anticipated (all p values less than 0.05). Convergent validity (to test scaling assumptions) using each item correlation with its hypothesized scale showed satisfactory results (all correlation above 0.40 ranging from 0.58 to 0.95). Factor analysis identified two principal components that jointly accounted for 65.9% of the variance. In general, the Iranian version of the SF-36 performed well and the findings suggest that it is a reliable and valid measure of health related quality of life among the general population.

International quality of life assessment (IQOLA) project

The International Quality of Life Assesment (IQOLA) Project is a 4-year project to translate and adapt the widely used MOS SF-36 Health Survey Questionnaire in up to 15 countries and validate, norm, and document the new translations as required for their use in international studies of health outcomes. In addition to the eight-scale SF-36 health profile, the project will also validate psychometrically based physical and mental health summary scores, as well as health utility indexes incorporating SF-36 scales for use in cost-utility studies.

The factor structure of the SF-36 Health Survey in 10 countries: Results from the IQOLA Project

Studies of the factor structure of the SF-36 Health Survey are an important step in its construct validation. Its structure is also the psychometric basis for scoring physical and mental health summary scales, which are proving useful in simplifying and interpreting statistical analyses. To test the generalizability of the SF-36 factor structure, product-moment correlations among the eight SF-36 Health Survey scales were estimated for representative samples of general populations in each of 10 countries. Matrices were independently factor analyzed using identical methods to test for hypothesized physical and mental health components, and results were compared with those published for the United States. Following simple orthogonal rotation of two principal components, they were easily interpreted as dimensions of physical and mental health in all countries. These components accounted for 76% to 85% of the reliable variance in scale scores across nine European countries, in comparison with 82% in the United States. Similar patterns of correlations between the eight scales and the components were observed across all countries and across age and gender subgroups within each country. Correlations with the physical component were highest (0.64 to 0.86) for the Physical Functioning, Role Physical, and Bodily Pain scales, whereas the Mental Health, Role Emotional, and Social Functioning scales correlated highest (0.62 to 0.91) with the mental component. Secondary correlations for both clusters of scales were much lower. Scales measuring General Health and Vitality correlated moderately with both physical and mental health components. These results support the construct validity of the SF-36 translations and the scoring of physical and mental health components in all countries studied.

The Equivalence of SF-36 Summary Health Scores Estimated Using Standard and Country-Specific Algorithms in 10 Countries: Results from the IQOLA Project

Data from general population surveys (n = 1771 to 9151) in nine European countries (Denmark, France, Germany, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) were analyzed to test the algorithms used to score physical and mental component summary measures (PCS-36/MCS-36) based on the SF-36 Health Survey. Scoring coefficients for principal components were estimated independently in each country using identical methods of factor extraction and orthogonal rotation. PCS-36 and MCS-36 scores were also estimated using standard (U.S.-derived) scoring algorithms, and results were compared. Product-moment correlations between scores estimated from standard and country-specific scoring coefficients were very high (0.98 to 1.00) for both physical and mental health components in all countries. As hypothesized for orthogonal components, correlations between physical and mental components within each country were very low (0.00 to 0.12) for both estimation methods. Mean scores for PCS-36 differed by as much as 3.0 points across countries using standard scoring, and mean scores for MCS-36 differed across countries by as much as 6.4 points. In view of the high degree of equivalence observed within each country, using standard and country-specific algorithms, we recommend use of standard scoring algorithms for purposes of multinational studies involving these 10 countries.