A 12-item short form of the Knee injury and Osteoarthritis Outcome Score (KOOS-12): tests of reliability, validity and responsiveness.

OBJECTIVE: To evaluate reliability, validity and responsiveness of KOOS-12, a 12-item short form of the 42-item Knee injury and Osteoarthritis Outcome Score (KOOS) that provides Pain, Function and Quality of Life (QOL) scale scores and a summary knee impact score. DESIGN: Data from 1,392 knee osteoarthritis (OA) patients from the FORCE-TJR research cohort who completed KOOS before and 6 and 12 months after total knee replacement (TKR) were analyzed. KOOS-12 includes a pain frequency item and three items measuring pain during increasingly difficult (sitting/lying, walking, stairs) activities; function items about standing, rising from sitting, getting in/out of a car, and twisting/pivoting; and the 4-item KOOS QOL scale. Percent computable scale scores, floor and ceiling effects, internal consistency reliability, validity (scale correlations, tests of known groups validity using one-way analysis of variance (ANOVA)) and responsiveness (effect sizes, standardized response means) were compared for the KOOS-12, full-length KOOS, KOOS-PS and KOOS, JR. RESULTS: Internal consistency reliability was above 0.70 for all KOOS-12 scales and ≥0.90 for the KOOS-12 Summary score. Validity and responsiveness of KOOS-12 Pain, Function and QOL scales was satisfactory and reached similar conclusions as comparable full-length KOOS scales. The KOOS-12 Summary score was most responsive in discriminating between groups who differed in global ratings of post-TKR change in physical capabilities and had the highest effect sizes and standardized response means. CONCLUSIONS: KOOS-12 was a reliable and valid alternative to KOOS in TKR patients with moderate to severe OA and provided three domain-specific and summary knee impact scores with substantially reduced respondent burden.

Item selection for 12-item short forms of the Knee injury and Osteoarthritis Outcome Score (KOOS-12) and Hip disability and Osteoarthritis Outcome Score (HOOS-12).

OBJECTIVE: To develop 12-item short forms (KOOS-12, HOOS-12) of the 42-item Knee injury and Osteoarthritis Outcome Score (KOOS) and 40-item Hip disability and Osteoarthritis Outcome Score (HOOS) that represent the full-length instruments sufficiently to provide joint-specific pain, function and quality of life (QOL) domain and summary joint impact scores. This paper describes KOOS-12 and HOOS-12 item selection. Subsequent papers will examine KOOS-12 and HOOS-12 reliability, validity and responsiveness. DESIGN: Items were selected based on qualitative information from patients, clinicians and KOOS/HOOS translators and analysis of data from 1,395 knee osteoarthritis (OA) and 1,281 hip OA patients from the FORCE-TJR cohort who completed KOOS or HOOS before and after total joint replacement (TJR). Item response theory models and computerized adaptive test (CAT) simulations were used to identify items that best measured patients' levels of pain and function pre- and post-TJR. KOOS-12/HOOS-12 items were selected based on content, coverage of a wide measurement range, high item information, item usage in CAT simulations, scale-level properties (reliability, validity, responsiveness), and qualitative information. RESULTS: KOOS-12 and HOOS-12 each included a pain frequency item and three items measuring pain during increasingly difficult activities (sitting/lying, walking, up/down stairs); function items about standing, rising from sitting, getting in/out of a car, and twisting/pivoting (KOOS-12) or walking on an uneven surface (HOOS-12); and the original 4-item QOL scale. CONCLUSIONS: This study demonstrated the benefits of examining patient-reported outcome measures using modern psychometric methods, to create short forms with diverse content that provide domain-specific and summary joint impact scores.

A 12-item short form of the Hip disability and Osteoarthritis Outcome Score (HOOS-12): tests of reliability, validity and responsiveness.

OBJECTIVE: To evaluate reliability, validity and responsiveness of HOOS-12, a 12-item short form of the 40-item Hip disability and Osteoarthritis Outcome Score (HOOS). HOOS-12 provides Pain, Function and Quality of Life (QOL) scale scores and a summary hip impact score. DESIGN: Data from 1,273 FORCE-TJR hip osteoarthritis (OA) patients who completed HOOS before and six and 12 months after total hip replacement (THR) were analyzed. HOOS-12 includes a pain frequency item and three items measuring pain during increasingly difficult (sitting/lying, walking, stairs) activities; function items about standing, rising from sitting, getting in/out of a car, and walking on an uneven surface; and the 4-item HOOS QOL scale. Percent computable scale scores, floor and ceiling effects, internal consistency reliability, validity (scale correlations, tests of known groups validity using one-way analysis of variance (ANOVA)), and responsiveness (effect sizes (ES), standardized response means (SRM)) were compared for HOOS-12, full-length HOOS, HOOS-PS and HOOS, JR. RESULTS: Internal consistency reliability was above 0.70 for all HOOS-12 scales and above 0.90 for the HOOS-12 Summary score. Validity and responsiveness of HOOS-12 Pain, Function and QOL scales were satisfactory and reached similar conclusions as comparable full-length HOOS scales. The HOOS-12 Summary score was highly responsive in discriminating between groups who differed in global ratings of post-THR change in physical capabilities and had high ES and SRM standardized response means. CONCLUSIONS: HOOS-12 was a reliable and valid alternative to HOOS in THR patients with moderate to severe OA and provided three domain-specific and summary hip impact scores with substantially reduced respondent burden.

Translating the Short-Form Headache Impact Test (HIT-6) in 27 countries: methodological and conceptual issues.

The process of translating the Short-Form Headache Impact Test (HIT-6) in 27 countries and the comparability of the content of the translations is discussed. HIT-6 translations were developed using a standard forward-backward translation process, including a cognitive debriefing step and international harmonization of the translations. Prior to translating the HIT-6, modifications were made to the English-language source form, to improve translation equivalence. In general, the HIT-6 was not difficult to translate. The most difficult items included colloquial expressions such as 'fed up' and words whose intended meaning changed in translation such as 'school' or 'lie down.' Subjects generally found the HIT-6 translations to be clear and relevant. The translation process resulted in questionnaires that are both culturally appropriate and comparable in content.

Validation of the Kiswahili version of the SF-36 Health Survey in a representative sample of an urban population in Tanzania.

The objective of this study was to assess the validity of a Kiswahili translation of the SF-36 Health Survey (SF-36) among an urban population in Tanzania, using the method of known-groups validation. People were randomly selected from a demographic surveillance system in Dar es Salaam. The representative sample consisted of 3,802 adults (15 years and older). Health status differences were hypothesized among groups, who differed in sex, age, socioeconomic status and self-reported morbidity. Mean SF-36 scale scores were calculated and compared using t-test and ANOVA. Women had significantly lower mean SF-36 scale scores (indicating worse health status) than men on all scales and scores were lower for older people than younger on all domains, as hypothesized. On five of the eight SF-36 scales, means were higher for people of higher socioeconomic status compared to those of lower socioeconomic status. People who reported an illness within the previous 2 weeks scored significantly lower on all scales compared to those who were healthy, as did people who said they had a disability or a chronic condition.

A Kiswahili version of the SF-36 Health Survey for use in Tanzania: translation and tests of scaling assumptions.

The objective of the study was to translate and adapt the SF-36 Health Survey for use in Tanzania and to test the psychometric properties of the Kiswahili SF-36. A cross-sectional study was conducted as part of a household survey of a representative sample of the adult population of Dar es Salaam, Tanzania. The IQOLA method of forward and backward translation was used to translate the SF-36 into Kiswahili. The translated questionnaire was administered by trained interviewers to 3,802 adults (50% women, mean (SD) age 31 (13) years, 50% married and 60% with primary education). Data quality and psychometric assumptions underlying the scoring of the eight SF-36 scales were evaluated for the entire sample and separately for the least educated subgroup (n = 402), using multitrait scaling analysis. Forward and backward translation procedures resulted in a Kiswahili SF-36 that was considered conceptually equivalent to the US English SF-36. Data quality was excellent: only 1.2% of respondents were excluded because they answered less than half of the items for one or more scales; ninety percent of respondents answered mutually exclusive items consistently. Median item-scale correlations across the eight scales ranged from 0.47 to 0.81 for the entire sample. Median scaling success rates were 100% (range 87.5-100.0). The median internal consistency reliability of the eight scales for the entire sample was 0.81 (range 0.70-0.92). Floor effects were low and ceiling effects were high on five of the eight scales. Results for n = 402 people without formal education did not differ substantially from those of the entire sample. The results of data quality and psychometric tests support the scoring of the eight scales using standard scoring algorithms. The Kiswahili translation of the SF-36 may be useful in estimating the health of people in Dar es Salaam. Evidence for the validity of the SF-36 for use in Tanzania needs to be accumulated.

[Evaluation of health status using Survey SF-36: preliminary results in Mexico]. / Evaluación del estado de salud con la Encuesta SF-36: resultados preliminares en México.

OBJECTIVE: To establish a multidimensional profile of the health status in a population of southeastern Mexico and analyze the psychometric properties of a translation of the SF-36 survey authorized by the International Quality of Life Assessment Project. MATERIAL AND METHODS: The SF-36 was administered to 257 volunteers of a clinic and a control group in a governmental institution. The methodology proposed by the author of the survey to build the health scales was used without modifications. The validity and reliability of the SF-36 adaptation to Mexico was psychometrically analyzed. RESULTS: Eight scales or health concepts related to physical function, physical role, body pain, general health, vitality, social function, emotional role and mental health were constructed. In the health service volunteers, the scale with the lowest mean was general health (63), and that with the highest (89) was physical role. In the control population, the lowest mean was general health (73) and the highest (94.6) was physical function. A comparison of the health scales of both groups showed significant differences in physical function, physical role, body pain, general health and vitality. CONCLUSIONS: Based on the psychometric evaluation, the SF-36 shows satisfactory consistency with its supposed validity and reliability, although the translation of certain items will be further analyzed for subsequent modifications.

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.

Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment.

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.

Cross-cultural comparisons of the content of SF-36 translations across 10 countries: results from the IQOLA Project. International Quality of Life Assessment.

Increasingly, translated and culturally adapted health-related quality of life measures are being used in cross-cultural research. To assess comparability of results, researchers need to know the comparability of the content of the questionnaires used in different countries. Based on an item-by-item discussion among International Quality of Life Assessment (IQOLA) investigators of the content of the translated versions of the SF-36 in 10 countries, we discuss the difficulties that arose in translating the SF-36. We also review the solutions identified by IQOLA investigators to translate items and response choices so that they are appropriate within each country as well as comparable across countries. We relate problems and solutions to ratings of difficulty and conceptual equivalence for each item. The most difficult items to translate were physical functioning items that refer to activities not common outside the United States and items that use colloquial expressions in the source version. Identifying the origin of the source items, their meaning to American English-speaking respondents and American English synonyms, in response to country-specific translation issues, greatly helped the translation process. This comparison of the content of translated SF-36 items suggests that the translations are culturally appropriate and comparable in their content.

Testing the equivalence of translations of widely used response choice labels: results from the IQOLA Project. International Quality of Life Assessment.

The similarity in meaning assigned to response choice labels from the SF-36 Health Survey (SF-36) was evaluated across countries. Convenience samples of judges (range, 10 to 117; median = 48) from 13 countries rated translations of response choice labels, using a variation of the Thurstone method of equal appearing intervals. Judges marked a point on a 10-cm line-representing the magnitude of a response choice label (e.g., "good" relative to the anchors of "poor" and "excellent"). Ratings were evaluated to determine the ordinal consistency of response choice labels within a response scale; the degree to which differences between adjacent response choice labels were equal interval; and the amount of variance due to response choice label, country, judge, and interaction between response choice label and country. Results confirmed the hypothesized ordering of response choice labels; the percentage of ordinal pairs ranged from 88.7% to 100% (median = 98.2%) across countries and response scales. Examination of the average magnitudes of response choice labels supported the "quasi-interval" nature of the scales. Analysis of variance (ANOVA) results supported the generalizability of response choice magnitudes across countries; labels explained 64% to 77% of the variance in ratings, and country explained 1% to 3%. These results support the equivalence of SF-36 response choice labels across countries. Departures from the assumption of equal intervals, when observed, were similar across countries and were greatest for the two response scales that are recalibrated under standard SF-36 scoring. Results provide justification for scoring translations of individual items using standard SF-36 scoring; whether these items form the same scales in other countries as they do in the United States is evaluated with tests of scaling assumptions.

Methods for testing data quality, scaling assumptions, and reliability: the IQOLA Project approach. International Quality of Life Assessment.

Following the translation development stage, the second research stage of the IQOLA Project tests the assumptions underlying item scoring and scale construction. This article provides detailed information on the research methods used by the IQOLA Project to evaluate data quality, scaling and scoring assumptions, and the reliability of the SF-36 scales. Tests include evaluation of item and scale-level descriptive statistics; examination of the equality of item-scale correlations, item internal consistency and item discriminant validity; and estimation of scale score reliability using internal consistency and test-retest methods. Results from these tests are used to determine if standard algorithms for the construction and scoring of the eight SF-36 scales can be used in each country and to provide information that can be used in translation improvement.

Methods for validating and norming translations of health status questionnaires: the IQOLA Project approach. International Quality of Life Assessment.

This article briefly summarizes methods used in the empirical validation of translations of the SF-36 Health Survey. In addition, information about the IQOLA Project norming protocol and 13 general population norming samples analyzed in this supplement is provided.

Testing Dutch and French translations of the SF-36 Health Survey among Belgian angina patients.

The psychometric properties of the Belgian Dutch and French translations of the SF-36 Health Survey were evaluated in a sample of 4448 Belgian patients with angina enrolled in a 6-month treatment study. Missing data were rare (<2%), and tests of both item internal consistency and item discriminant validity were satisfactory in both languages. Cronbach's alpha coefficient ranged from 0.81 to 0.91 (Dutch) and 0.82 to 0.92 (French). SF-36 scales discriminated between groups of patients differing in age and in the number of weekly angina attacks, change over 6 months in the number of weekly angina attacks and physician assessment of change in physical condition both were significantly related to changes in SF-36 scale scores. On average, scale scores for French-speaking patients were lower than for Dutch-speaking patients, most notably for Vitality and Mental Health. The average change in SF-36 scale scores over 6 months, in relation to change in clinical criteria, was similar in both language groups. The psychometric properties of the Belgian Dutch and French translations should be tested further in Belgium to determine whether the generally favorable results reported here can be replicated in other samples.

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.

Translation and psychometric evaluation of a Chinese version of the SF-36 Health Survey in the United States.

Outcome measures are rapidly becoming standard tools in the assessment of clinical effectiveness and in the measurement of health status in populations. In this article we document the development of a self-administered Chinese version of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and report the results of psychometric testing among 156 adult Chinese Americans in Boston, Massachusetts. Following the standard guidelines, a Chinese version of the SF-36 was developed through forward-backward translation techniques and committee review. We used psychometric methods to test assumptions underlying construction and scoring of scales and to evaluate the reliability and validity of the Chinese SF-36 as a measure of health status. The preliminary results indicated that missing value rates for the 36 items were consistently low. Item-discriminant validity was high (over 90% scaling successes) for six of the eight scales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Role-Emotional, and Mental Health). Cronbach's alpha coefficient was above 0.70 criterion for all scales except Social Functioning. Reliability estimates also appeared to vary by sample characteristics. We discuss the implications of these findings and identify where further work will be required.

Tests of scaling assumptions and construct validity of the Chinese (HK) version of the SF-36 Health Survey.

Few health-related quality of life (HRQOL) survey instruments are available to the Chinese, although many have been developed for Western populations. This article describes the testing of the acceptability, conceptual equivalence, scaling assumptions and construct validity of a Chinese (HK [Hong Kong]) version fo the MOS SF-36 Health Survey. A Chinese (HK) SF-36 survey form was developed by an iterative translation process. It was administered to 236 Chinese subjects who also rated the understanding, difficulty, relevance, and acceptability of each question. The scores were tested against the original scaling assumptions. The SF-36 profile of our subjects was compared to U.S. results for conceptual equivalence. Most subjects did not have any problem in understanding and answering the SF-36. Item means were generally clustered as hypothesized. All but a few items satisfied all scaling assumptions. The shape of the eight-scale SF-36 profile was similar to that of American patients, suggesting conceptual equivalence. We conclude that the Chinese (HK) version of the SF-36 Health Survey has achieved conceptual equivalence and satisfied the psychometric scaling assumptions well enough to warrant further use and testing, using the standard scoring algorithms.

Tests of data quality, scaling assumptions, and reliability of the SF-36 in eleven countries: results from the IQOLA Project. International Quality of Life Assessment.

Data from general population samples in 11 countries (n = 1483 to 9151) were used to assess data quality and test the assumptions underlying the construction and scoring of multi-item scales from the SF-36 Health Survey. Across all countries, the rate of item-level missing data generally was low, although slightly higher for items printed in the grid format. In each country, item means generally were clustered as hypothesized within scales. Correlations between items and hypothesized scales were greater than 0.40 with one exception, supporting item internal consistency. Items generally correlated significantly higher with their own scale than with competing scales, supporting item discriminant validity. Scales could be constructed for 93-100% of respondents. Internal consistency reliability of the eight SF-36 scales was above 0.70 for all scales, with two exceptions. Floor effects were low for all except the two role functioning scales; ceiling effects were high for both role functioning scales and also were noteworthy for the Physical Functioning, Bodily Pain, and Social Functioning scales in some countries. These results support the construction and scoring of the SF-36 translations in these 11 countries using the method of summated ratings.

The factor structure of the SF-36 Health Survey in 10 countries: results from the IQOLA Project. International Quality of Life Assessment.

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. International Quality of Life Assessment.

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.