Developing health-related quality-of-life instruments for use in Asia: the issues.

About half of the world's population live in Asia. Mandarin (the official language of China), Hindi and Japanese are among the ten languages spoken by the largest number of primary speakers. The numbers of Tamil and Malay speakers are expected to grow rapidly in the next few decades. Most health-related quality-of-life (HR-QOL) instruments currently used in Asia are translations and/or adaptations of instruments developed in North America and Western Europe. We illustrate and discuss several major issues in the development of HR-QOL instruments for use in Asia. We have seen insufficient quality in translation and semantic equivalence, which is not a uniquely Asian problem. This problem will be alleviated by putting recently proposed guidelines for translation and adaptation of patient-reported outcomes into practice and formally conducting equivalence studies. For copyright or other reasons it is rare to see major adaptations, such as exclusion of a domain in the original instrument or inclusion of a new domain, made to existing instruments. Evidence is limited and mixed as to whether there are differences in the concepts of HR-QOL between Asian and North American/Western European cultures that are important enough to justify such major adaptations, or the development of indigenous instruments, as opposed to the translation/adaptation of existing instruments. There are substantial cultural differences concerning what questions are appropriate to ask and answer. Many HR-QOL instruments are designed for self-completion. This mode of administration is often not feasible in Asia because of low literacy rates and the presence of many different regional languages. Alternative administration methods and analytic strategies that allow for pooling data collected by different modes are needed. The availability of HR-QOL instruments in various Asian countries seems to reflect the status of economic development of the countries rather than their disease burden. For instance, many important HR-QOL instruments are available in Japanese but not in Hindi or Tamil

Validation of the English and Chinese versions of the Quick-FLIC quality of life questionnaire.

A useful measure of quality of life should be easy and quick to complete. Recently, we reported the development and validation of a shortened Chinese version of the Functional Living Index-Cancer (FLIC), which we called the Quick-FLIC. In the present study of 327 English-speaking and 221 Chinese-speaking cancer patients, we validated the English version of the Quick-FLIC and further assessed the Chinese version. The 11 Quick-FLIC items were administered alongside the 11 remaining items of the full FLIC, but there appeared to be little context effect. Validity of the English version of the Quick-FLIC was attested by its strong correlation with two other measures of quality of life, and its ability to detect differences between patients with different performance status and treatment status (each P<0.001). Its internal consistency (alpha=0.86) and test-retest reliability (intraclass correlation=0.76) were also satisfactory. The measure was responsive to changes in performance status (P<0.001). The Chinese version showed similar characteristics. The Quick-FLIC behaved in ways that are highly comparable with the FLIC, even though the Quick-FLIC comprised only 11 items whereas the FLIC comprised 22. Further research is required to see whether the use of shorter instruments can improve data quality and response rates, but the fact that shorter instruments place less burden on the patients is itself inherently important

Order effects: a randomised study of three major cancer-specific quality of life instruments

BACKGROUND: In methodological studies and outcomes research, questionnaires often comprise several health-related quality of life (HRQoL) measures. Previous psychological studies have suggested that changing the sequential order of measurement scales within a questionnaire could alter the pattern of responses. Yet, information on the presence or absence of order effects on the assessment of HRQoL in cancer patients is limited. METHODS: An incomplete block design was used in this study of 1277 cancer patients. Each patient filled out a questionnaire package that contained two of the three major cancer-specific HRQoL instruments, namely the Functional Assessment of Cancer Therapy – General, the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and the Functional Living Index – Cancer. Within a questionnaire package the sequential order of the instruments contained were randomised. Measurement properties of the instruments, including the number of missing values, mean HRQoL scores, known-groups validity and internal consistency were compared between samples of different presentation orders. RESULTS: No effect of presentation order on the four properties aforementioned was found. CONCLUSION: Presentation order is unlikely to alter the responses to these HRQoL instruments administered in cancer patients when any two of them are used together

Are Asians comfortable with discussing death in health valuation studies? A study in multi-ethnic Singapore

BACKGROUND To characterize ease in discussing death (EID) and its influence on health valuation in a multi-ethnic Asian population and to determine the acceptability of various descriptors of death and "pits"/"all-worst" in health valuation. METHODS In-depth interviews (English or mother-tongue) among adult Chinese, Malay and Indian Singaporeans selected to represent both genders and a wide range of ages/educational levels. Subjects rated using 0–10 visual analogue scales (VAS): (1) EID, (2) acceptability of 8 descriptors for death, and (3) appropriateness of "pits" and "all-worst" as descriptors for the worst possible health state. Subjects also valued 3 health states using VAS followed by time trade-off (TTO). The influence of sociocultural variables on EID and these descriptors was studied using univariable analyses and multiple linear regression (MLR). The influence of EID on VAS/TTO utilities with adjustment for sociocultural variables was assessed using MLR. RESULTS Subjects (n = 63, 35% Chinese, 32% Malay, median age 44 years) were generally comfortable with discussing death (median EID: 8.0). Only education significantly influenced EID (p = 0.045). EID correlated weakly with VAS/TTO scores (range: VAS: -0.23 to 0.07; TTO: -0.14 to 0.11). All subjects felt "passed away", "departed" and "deceased" were most acceptable (median acceptability: 8.0) while "sudden death" and "immediate death" were least acceptable (median acceptability: 5.0). Subjects clearly preferred "all-worst" to "pits" (63% vs. 19%, p < 0.001). CONCLUSION Singaporeans were generally comfortable with discussing death and had clear preferences for several descriptors of death and for "all-worst". EID is unlikely to influence health preference measurement in health valuation studies

Difference in prevalence of common mental disorder as measured using four questionnaire delivery methods among young people in rural Zimbabwe.

BACKGROUND: Previous studies have suggested that interviewer-administered questionnaires can under-estimate the prevalence of depression and suicidal ideation when compared with self-administered ones. We report here on differences in prevalence of reporting mental health between four questionnaire delivery modes (QDM). METHODS: Mental health was assessed using the Shona Symptom Questionnaire (SSQ), a locally validated 14-item indigenous measure for common mental affective disorders. A representative sample of 1495 rural Zimbabwean adolescents (median age 18) was randomly allocated to one of four questionnaire delivery modes: self-administered questionnaire (SAQ), SAQ with audio (AASI), interviewer-administered questionnaire (IAQ), and audio computer-assisted survey instrument (ACASI). RESULTS: Prevalence of common affective disorders varied between QDM (52.3%, 48.6%, 41.5%, and 63.6% for SAQ, AASI, IAQ, and ACASI respectively (P<0.001)). Fewer participants failed to complete SSQ using IAQ and ACASI than other methods (1.6% vs. 12.3%; P<0.001). Qualitative data suggested that respondents found it difficult answering questions honestly in front of an interviewer. LIMITATIONS: Direction of accuracy cannot be ascertained due to lack of objective or clinical assessments of affective disorders. CONCLUSIONS: Estimates of prevalence of psychosomatic symptoms and suicidal ideation varied according to mode of interview. As each mode's direction of accuracy remains unresolved evaluations of interventions continue to be hampered

Validation and interval scale transformation of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in patients undergoing knee arthroplasty, using the Rasch model

OBJECTIVES: Interval scale reduce measurement bias compared to ordinal scale. We aimed to evaluate the fit of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to the Rasch model and derive the transformation table for interval scale measurement. METHODS: Data from osteoarthritis patients listed for knee arthroplasty (KA) pre-operatively, and at 6- and 12- months post-operative was used. WOMAC was calibrated for fit to the Rasch model for monotonicity, homogeneity, local item independence and absence of differential item functioning (DIF) in a randomly selected 900 patients, 300 from each time point; parameter estimates were then imported into the full data set. Responsiveness was reported through Standard Error of Measurement (SEM); Smallest Detectable Difference (SDD), %SDD and effect sizes (ES) between baseline and 6-months. WOMAC was transformed from ordinal to interval values. RESULTS: 1136 patients (mean age 65.9 years, 69.9% female) were included. WOMAC pain (0−20), function (0−68) and total scores (0−96) had adequate fit to Rasch model with good reliability (Person Separation Index: 0.76, 0.80 and 0.79). No item deletion was required. The SEM, SDD, %SDD and ES of WOMAC total were 4.4, 6.9, 10.1, and 1.97. No significant DIF was seen for age, sex, body mass index, type of KA, languages, and education level. WOMAC pain, function and total scores were transformed to interval scales. CONCLUSION: WOMAC total, pain and function scales had adequate fit to the Rasch model, providing unidimensional measure with good reliability and responsiveness. Transformation of WOMAC to interval scale measurement is applicable to other studies

The impact of diabetes mellitus and other chronic medical conditions on health-related Quality of Life: Is the whole greater than the sum of its parts?

BACKGROUND: Diabetes mellitus (DM) is an important public health concern, the impact of which is increased by the high prevalence of co-existing chronic medical conditions among subjects with DM. The aims of this study were therefore to (1) evaluate the impact of DM and co-existing chronic medical conditions on health-related quality of life (HRQoL) (which could be additive, synergistic or subtractive); (2) to determine the extent to which the SF-6D (a single-index preference measure) captures the multidimensional information provided by the SF-36 (a profile measure). METHODS: Using data from a cross-sectional, population-based survey of Chinese, Malay and Indians in Singapore, we developed 9 separate multiple linear regression models, with each SF-36 scale or SF-6D index score being the dependent variable for one model. The influence of DM and a second chronic medical condition (hypertension (HTN), heart disease (HD), musculoskeletal illnesses (MS)) and their interactions were studied after adjusting for the influence of potential confounding variables. RESULTS: Among 5,224 subjects, the prevalence of DM, HTN, HD and MS were 5.9%, 10.7%, 2.4% and 26.6% respectively. DM lowered SF-36 scores by more than 2 points on 3 SF-36 scales and lowered SF-6D scores by 0.03 points. Subjects with DM and HTN, DM and HD or DM and MS experienced further lowering of SF-36 scores exceeding 2 points on at least 6 scales and further lowering of SF-6D scores by 0.05, 0.08 and 0.10 points respectively. Generally, DM and co-existing medical conditions exerted additive effects on HRQoL, with the exception of DM and heart disease, where a subtractive effect was noted. SF-6D index scores generally reflected the patterns of influence of DM and chronic medical conditions on SF-36 scores. CONCLUSION: DM and chronic medical conditions generally reduced HRQoL in this multiethnic general population in an additive, rather than synergistic or subtractive fashion. In this study, the SF-6D was a reasonably good summary measure for the SF-36

Risk communication in clinical trials: A cognitive experiment and a survey

10.1186/1472-6947-10-55BMC Medical Informatics and Decision Making101