Showing papers in "Quality of Life Research in 2001"

Can parents rate their child's health-related quality of life? Results of a systematic review.

Abstract: A systematic review was conducted to determine the relationship between ratings of children's health-related quality of life (HRQoL) made by parents and children. This was investigated in relation to four questions:- is agreement greater for some domains (e.g. physical HRQoL) than others?; do parents perceive illness to have a greater impact than their child?; how is agreement affected by child age, gender and illness status?; and is the relationship between proxy ratings affected by the method of data collection? Fourteen studies were identified. Consistent with previous research, there was greater agreement for observable functioning (e.g. physical HRQoL), and less for non-observable functioning (e.g. emotional or social HRQoL). Three studies assessed whether parents perceive the illness to have a greater impact than their child, but no clear conclusions could be drawn given differences in measures used. Agreement is better between parents and chronically sick children compared with parents and their healthy children, but no effects were found for age or gender. All of these results may be dependent on the specific measure of HRQoL employed. There remain strong arguments for obtaining information from both parents and children whenever possible.

Smallest real difference, a link between reproducibility and responsiveness.

Abstract: The aim of this study is to show the relationship between test-retest reproducibility and responsiveness and to introduce the smallest real difference (SRD) approach, using the sickness impact profile (SIP) in chronic stroke patients as an example. Forty chronic stroke patients were interviewed twice by the same examiner, with a 1-week interval. All patients were interviewed during the qualification period preceding a randomized clinical trial. Test-retest reproducibility has been quantified by the intraclass correlation coefficient (ICC), the standard error of measurement (SEM) and the related smallest real difference (SRD). Responsiveness was defined as the ratio of the clinically relevant change to the SD of the within-stable-subject test-retest differences. The ICC for the total SIP was 0.92, whereas the ICCs for the specified SIP categories varied from 0.63 for the category 'recreation and pastime' to 0.88 for the category 'work'. However, both the SEM and the SRD far more capture the essence of the reproducibility of a measurement instrument. For instance, a total SIP score of an individual patient of 28.3% (which is taken as an example, being the mean score in the study population) should decrease by at least 9.26% or approximately 13 items, before any improvement beyond reproducibility noise can be detected. The responsiveness to change of a health status measurement instrument is closely related to its test-retest reproducibility. This relationship becomes more evident when the SEM and the SRD are used to quantify reproducibility, than when ICC or other correlation coefficients are used.

Swedish population health-related quality of life results using the EQ-5D.

Abstract: Health-related quality of life (HRQoL) measured on population level may be useful to guide policies for health. This study aims to describe the HRQoL; in EQ-5D dimensions, mean rating scale (RS) scores and mean EQ-5D index values, in the general population, by certain disease and socio-economic groups, in Stockholm County 1998. The EQ-5D self-classifier and a RS were included in the 1998 cross-sectional postal Stockholm County public health survey to a representative sample (n = 4950, 20-88 years), 63% response rate. Mean RS score ranged from 0.90 (20-29 years) to 0.69 (80-88 years), mean EQ-5D index value ranged from 0.89 (20-29 years) to 0.74 (80-88 years). For different diseases mean RS scores ranged from 0.80 (asthma) to 0.69 (angina pectoris), mean EQ-5D index values ranged from 0.79 (asthma) to 0.66 (low back pain). The mean health state scores (RS and EQ-5D index) were 0.06 lower in the unskilled manual group than in the higher non-manual group after controlling for age and sex (p < 0.0001). This difference was 0.03 after controlling also for different diseases (p < 0.0001). In conclusion, our results show that the HRQoL varies greatly between socio-economic and disease groups. Furthermore, after controlling for age, sex and disease, HRQoL is lower in manual than in non-manual groups.

Interpreting SF-36 summary health measures: a response

Abstract: In response to questions raised about the “accuracy” of SF-36 physical (PCS) and mental (MCS) component summary scores, particularly extremely high and low scores, we briefly comment on: how they were developed, how they are scored, the factor content of the eight SF-36 subscales, cross-tabulations between item-level responses and extreme summary scores, and published and new tests of their empirical validity. Published cross-tabulations between SF-36 items and PCS and MCS scores, reanalyses of public datasets (N = 5919), and preliminary results from the Medicare Health Outcomes Survey (HOS) (N = 172,314) yielded little or no evidence in support of Taft's hypothesis that extreme scores are an invalid artifact of some negative scoring weights. For example, in the HOS, those (N = 432) with “unexpected” PCS scores worse than 20 (which, according to Taft, indicate better mental health rather than worse physical health) were about 25% more likely to die within two years, in comparison with those scoring in the next highest (21– 30)␣category. In this test and in all other empirical tests, results of predictions supported the validity of extreme PCS and MCS scores. We recommend against the interpretation of average differences smaller than one point in studies that seek to detect “false” measurement and we again repeat our 7-year-old recommendation that results based on summary measures should be thoroughly compared with the SF-36 profile before drawing conclusions. To facilitate such comparisons, scoring utilities and user-friendly graphs for SF-36 profiles and physical and mental summary scores (both orthogonal and oblique scoring algorithms) have been made available on the Internet at www.sf-36.com/test.

Do SF-36 summary component scores accurately summarize subscale scores?

Abstract: Standard scoring algorithms were recently made available for aggregating scores from the eight SF-36 subscales in two distinct, higher-order summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Recent studies have suggested, however, that PCS and MCS scores are not independent and may in part be measuring the same constructs. The aims of this paper were to examine and illustrate (1) relationships between SF-36 subscale and PCS/MCS scores, (2) relationships between PCS and MCS scores, and (3) their implications for interpreting research findings. Simulation analyses were conducted to illustrate the contributions of various aspects of the scoring algorithm to potential discrepancies between subscale profile and summary component scores. Using the Swedish SF-36 normative database, correlation and regression analyses were performed to estimate the relationship between the two components, as well as the relative contributions of the subscales to the components. Discrepancies between subscale profile and component scores were identified and explained. Significant correlations (r = −0.74, −0.67) were found between PCS and MCS scores at their respective upper scoring intervals, indicating that the components are not independent. Regression analyses revealed that in these ranges PCS primarily measures aspects of mental health (57% of variance) and MCS measures physical health (65% of variance). Implications of the findings were discussed. It was concluded that the current PCS/MCS scoring procedure inaccurately summarizes subscale profile scores and should therefore be revised. Until then, component scores should be interpreted with caution and only in combination with profile scores.

Elementary school-aged children's reports of their health: a cognitive interviewing study

Abstract: There are no standard methods for assessing the quality of young children's perceptions of their health and well-being and their ability to comprehend the tasks involved in reporting their health. This research involved three cross-sectional studies using cognitive interviews of 5-11-year-old children (N = 114) to determine their ability to respond to various presentations of pictorially illustrated questions about their health. The samples had a predominance of children in the 5-7-year-old range and families of lower and middle socio-economic status. The research questions in Study 1 involved children's ability to convert their health experiences into scaled responses and relate them to illustrated items (n = 35); Study 2 focused on the type of response format most effectively used by children (n = 19); and Study 3 involved testing children's understanding of health-related terms and use of a specific recall period (n = 60). The results of Study 1 showed that children identified with the cartoon drawing of a child depicted in the illustrated items, typically responding that the child was at or near their own age and of the same gender, with no differences related to race. Study 2 results indicated that children responded effectively to circles of graduated sizes to indicate their response and preferred them to same-size circles or a visual analogue scale. Tests of three-, four-, and five-point response formats demonstrated that children could use them all without confusion. In Study 3, expected age-related differences in understanding were obtained. In fact, the 5-year-old children were unable to understand a sufficient number of items to adequately describe their health. Virtually all children 8 years of age and older were able to fully understand the key terms and presentation of items, used the full five-point range of response options, and accurately used a 4-week recall period. Six- and seven-year-olds were more likely than older children to use only the extreme and middle responses on a five-point scale. No pattern of gender differences in understanding or in use of response options was found. We conclude that children as young as eight are able to report on all aspects of their health experiences and can use a five-point response format. Children aged 6-7 had difficulty with some health-related terms and tended to use extreme responses, but they understood the basic task requirements and were able to report on their health experiences. These results provide the guidance needed to develop and test a pediatric health status questionnaire for children 6-11 years old.

The WHO quality of life assessment instrument (WHOQOL-Bref): The importance of its items for cross-cultural research

Abstract: One of the fundamental issues in the area of assessment of quality of life is to determine what is important to the individuals' quality of life This is even more crucial when the instrument is for use in diverse cultural settings This paper reports on the importance ratings on WHOQOL-Bref items obtained as a part of WHOQOL pilot field trial on 4804 respondents from 15 centres from 14 developed and developing countries using 12 languages All items were rated as moderately or more important, but this was expected because the items were selected by extensive qualitative research for their salience across the centres Significant differences on mean importance ratings were found between centres, but rank orders of item for their importance showed highly significant correlations between centres This was especially true for items in the top and the bottom thirds of the item list arranged by overall importance Most items were rated as more important by women compared to men and by younger compared to older persons The results are discussed for their relevance in cross-cultural research on quality of life assessment

Social support and health-related quality of life in chronic heart failure patients.

Abstract: Objectives: Objectives of this study were to: (1) describe perceived social support during a baseline hospitalization and 12 months later among heart failure patients; (2) examine differences in social support as a function of gender and age (less than 65 and 65 years or older); and (3) examine social support as a predictor of health-related quality of life. Background: Social support is a predictor of well-being and mortality, but little is known about support patterns among heart failure patients and how they influence quality of life. Methods: The sample included 227 hospitalized patients with heart failure who completed the Social Support Survey and the Chronic Heart Failure Questionnaire at baseline; 147 patients completed these questionnaires again 12 months after baseline. Results: Mean baseline and 12-month total support scores were 56 and 53, respectively, with a score of 76 indicating the most positive perceptions of support. The ANOVA indicated significant interactions of gender by age for total (F = 5.04; p = 0.03) and emotional/informational support (F = 4.87; p = 0.03) and for positive social interactions (F = 4.43; p = 0.04), with men under age 65 perceiving less support than men aged 65 and older and women in either age group. Baseline support did not predict 12-month health-related quality of life, but changes in social support significantly predicted changes in health-related quality of life (R2 = 0.14). Conclusions: Overall, perceptions of support were moderate to high, but there was wide variation in perceptions over time. Men under age 65 reported less support than other groups of patients. Importantly, changes in social support were significant predictors of changes in health-related quality of life.

Sleep problems, health-related quality of life, work functioning and health care utilization among the chronically ill

Abstract: Objectives: To provide a comprehensive assessment of whether sleep problems among the chronically ill are associated with decrements in functional health and well-being, decreases in work functioning and increases in the use of health care services. Design: Cross-sectional survey of patients from the Medical Outcomes Study (MOS), an observational study of functional health and well-being. Chronically ill patients (n = 3484) were sampled from health maintenance organizations, large multi-specialty groups, and solo or single-specialty group practices in Boston, Los Angeles, and Chicago. Chronic illness subgroups include: clinical depression (n = 527), congestive heart failure (229), diabetes (n = 577), recent myocardial infarction (n = 170), hypertension (n = 2206), asthma (n = 84), back problems (n = 771), and arthritis (n = 672). ANCOVA analyses of the relationship between sleep problems and SF-36 scales and summaries were performed. In addition, a ‘relative impact’ analysis determined what scales or summaries were most associated with sleep problems. Main outcome measures: Eight scales and two summary measures from the SF-36 Health Survey, work productivity and work quality measures and self-reports of health care utilization. Results: Comparing chronically ill patients with no sleep problems to those with mild, moderate, or severe sleep problems revealed a direct association between sleep problems and decrements in health-related quality of life (HRQOL) as measured by SF-36 scales and summaries (MANOVA F 24.1; d.f. 24; p ≤ 0.0001). In addition, significant differences in HRQOL were found when comparing patients with and without sleep problems within most of the disease groups studied. The relative impact analysis revealed that measures of mental health and the mental health summary were most associated with sleep problem severity in the total sample and chronic disease subsets, in comparison with measures of physical health. In addition, monotonic relationships were found between severity of sleep problems and decreases in work productivity and increases in health care utilization, as expected. Conclusions: The analyses revealed that sleep problems go hand in hand with poorer mental health, diminished work productivity and work quality and greater use of health care services. Sleep problems, therefore, may be a significant confounding factor in the interpretation of health outcomes among patients with chronic diseases.

Agreement between patients' and proxies' reports of quality of life in Alzheimer's disease.

Abstract: Agreement between self reports and proxy reports of health-related quality of life (HRQoL) was examined in a sample of 76 patients with mild to moderate Alzheimer's disease and their proxies. Patients and proxies completed an (17-item Duke health profile). The items were rephrased for the proxy. The proportion of exact agreement between patients and proxies on the 17 items ranged from 26.3 to 52.6%. Results reveal poor to moderate agreement (intraclass correlation coefficients (ICCs) from 0.00 to 0.61 for 10 subscales) between patients' and proxies' reports. Agreement was higher for measures of function that are directly observable (physical health, disability) and relatively poor for more subjective measures. Proxy reliability varied according to the relationship of the proxy to the index subject. Spouses and nurses agreed more closely with index subjects than did children or nurses' aides. Agreement decreased with increasing severity of dementia. Statistically significant differences in mean scores were noted for several dimensions, with proxies tending to rate the patients as having a lower quality of life than the patients themselves. This study indicates the importance of considering the information source of a patient's HRQoL. However, assessments by proxies should be used with caution.

Proxy reliability: Health-related quality of life (HRQoL) measures for people with disability

Abstract: Objectives: Research and surveillance activities sometimes require that proxy respondents provide key exposure or outcome information, especially for studies of people with disability (PWD). In this study, we compared the health-related quality of life (HRQoL) responses of index PWD to proxies. Methods: Subjects were selected from nursing home, other assisted living residences, and from several clinic samples of PWD. Each index identified one or more proxy respondents. Computer-assisted interviews used a random order of measures. Proxy reliability was measured by intraclass correlation (ICC) and κ statistics. HRQoL measures tested included the surveillance questions of the Behavioral Risk Factor Surveillance System (BRFSS), basic and instrumental activities of daily living (ADLs and IADLs), medical outcomes study short-form 36 and 12 (SF-36 and SF-12). Results: A total of 131 index-proxy sets were completed. In general, agreement and reliability of proxy responses to the PWD tended to be best for relatives, with friends lower, and health care proxies lowest. For example, the ICC for the physical functioning scale of the SF-36 was 0.68 for relatives, 0.51 for friends, and 0.40 for healthcare proxies. There was a tendency for proxies to overestimate impairment and underestimate HRQoL. This pattern was reversed for measures of pain, which proxies consistently underestimated. The pattern among instruments, proxy types, and HRQoL domains was complex, and individual measures vary from these general results. Conclusions: We suggest caution when using proxy respondents for HRQoL, especially those measuring more subjective domains.

Electronic collection of health-related quality of life data: validity, time benefits, and patient preference.

Abstract: This study sought to validate World Wide Web-compliant software tools used to collect health-related quality of life (HRQOL) data, relative to pencil-and-paper collection. The RAND-36 general health survey and the Seattle Angina questionnaire (SAQ), a disease-specific functional status measure for patients with coronary artery disease, were each administered in paper and electronic format to 55 consecutive patients visiting the cardiology outpatient clinic of a public hospital. All eight sub-scale scores of the RAND-36 (interclass correlation coefficient range = 0.54-0.75, p < 0.01) and all five domains of the SAQ (interclass correlation coefficient range = 0.84-0.90, p < 0.01) collected using the software were significantly correlated with those collected using the paper version of questionnaires. Computer literacy, educational level, age, sex, and race were not significantly associated with the ability to successfully complete the computer-assisted questionnaire. Eighty-two percent of patients preferred the computer-assisted administration to paper, and 89% reported that they would feel comfortable using the software in the future without any technical assistance. This pilot study suggests that HRQOL measures can be reliably collected using software operating over the World Wide Web. Data collected in this manner are valid and of comparable quality to self-reported, HRQOL data obtained via paper survey.

A community-based study of scaling assumptions and construct validity of the English (UK) and Chinese (HK) SF-36 in Singapore.

Abstract: Scaling assumptions and validity of the English (UK) and Chinese (HK) short form 36 health survey (SF-36) were assessed in a community-based survey of 5503 Chinese, Malays and Indians in Singapore using the international quality of life assessment project approach of item and scale level validation. Missing data for SF-36 items and scales occurred in less than 1.0% of subjects. Item level validation of both versions generally supported assumptions underlying Likert scoring and hypothesised item-order clustering. Item level factor analysis supported the eight-scale structure of the SF-36. In scale level validation, SF-36 scale scores showed wide variability and acceptable internal-consistency reliability (Cronbach's α > 0.70 for six English and seven Chinese scales), conformed to hypothesised patterns and generally varied according to hypotheses in subjects known to differ in quality of life. Scale level factor analysis of both versions yielded very similar patterns of factor correlation, comparable to that found in Japan, but differing from that seen in Western populations. Taken together, these results support the validity of the English (UK) and Chinese (HK) SF-36 versions in the multi-ethnic Asian socio-cultural context of Singapore.

Why are we weighting? The role of importance ratings in quality of life measurement.

Abstract: Many Quality of Life (QoL) instruments ask respondents to rate a number of life domains in terms of satisfaction and personal importance, and derive weighted satisfaction scores by multiplying the two ratings. This paper demonstrates that this practice is both undesirable and unnecessary. QoL domains are selected on the basis of their inherent importance, rendering separate importance rating partially redundant. Weighted scores present difficulties in interpretation. Further, we show that multiplicative composites have undesirable psychometric properties. There is evidence that multiplicative composites have little or no advantage over unweighted ratings in correlational or predictive studies. Apart from the face validity and the intuitive appeal of multiplying satisfaction ratings by importance ratings, there appear to be no sound reasons for doing so, and several good reasons not to do so.

Health related quality of life in patients with venous ulceration: use of the Nottingham health profile

Abstract: Introduction: The Nottingham health profile (NHP) has been used in several studies of patients being treated for chronic venous leg ulceration, though there is a paucity of information on the validity of the NHP in this patient group. This study was carried out to determine this validity and to compare and contrast the results with a previous study that had used the MOS short form 36 (SF-36) in this patient group. Methods: Patients in four health trusts suffering from venous ulceration were interviewed at entry and after 12 weeks of treatment using high compression bandaging. Information was collected on ulcer history, general medical history, and the NHP was completed at both time points. After 12 weeks, a record was made of whether all areas of ulceration had cleared from the patients' legs (healed) or whether some ulceration remained (unhealed). Results: Of the 383 patients who made up the study population, 37% experienced complete healing of their ulceration after 12 weeks of treatment. While internal consistencies of the NHP scores were reasonable (Cronbach's α > 0.63), there were a high proportion of patients who scored 0 (best possible health) at entry into the study, most notably for social isolation (67.5%), emotional status (48.9%) and energy (47.4%). Despite these limitations, there was strong evidence that treatment led to significant improvements in all dimensions of the NHP for the total group (all p < 0.01). These improvements were greatest in patients whose ulcers healed compared with patients whose ulcers failed to heal for bodily pain (mean difference d = 9.4, p = 0.004). Patients whose overall health status improved had significantly greater improvements for all dimensions of the NHP (p < 0.05). Conclusion: The NHP, has limitations in terms of a large floor effect (best possible health), but has similar internal consistency to the SF-36 in patients with leg ulceration. However, unlike the SF-36, the NHP is sensitive to change in the patients' ulcer status, and should therefore be considered in studies of venous leg ulcer healing.

Assessing individual quality of life in amyotrophic lateral sclerosis.

Abstract: Background: Quality of life (QoL) assessment in amyotrophic lateral sclerosis (ALS) has typically involved the use of general or disease-specific health status questionnaires. This study assessed the feasibility of using a patient-centered approach to QoL measurement in ALS. Objectives: (1) To assess the internal consistency reliability and validity of the Schedule for the Evaluation of Individual Quality of Life (SEIQoL) as a measure of QoL in ALS. (2) To provide a brief description of QoL in ALS, and to examine the relationships between QoL, illness severity and psychological distress in this group. Methods: Twenty-six patients with ALS were recruited through the Irish Register for ALS/motor neurone disease (MND). Illness severity was assessed with the ALS Functional Rating Scale (ALSFRS). Levels of psychological distress were measured with the Hospital Anxiety and Depression Scale (HADS). Individual QoL was assessed with SEIQoL. Results: Patients were at various stages of ALS. Mean levels of anxiety and depression were in the normal range. Twenty-one patients completed SEIQoL; five patients completed a shorter version, SEIQoL-Direct Weighting (SEIQoL-DW). Internal consistency reliability and validity results for SEIQoL were high. Conclusions: SEIQoL is generally acceptable for use in ALS in terms of its practical feasibility, and has high internal validity and consistency reliability in this patient group. However, patients severely disabled by ALS may not be able to complete SEIQoL; further research is required to confirm the use of SEIQoL-DW as an alternative measure of individual QoL in ALS.

Health-related quality of life in childhood disorders: a modified focus group technique to involve children.

Abstract: Objectives: Qualitative methodology has been under-utilized in child health research due to lack of a specific set of instruments. The objective of this study was to develop a child-centred qualitative research methodology to facilitate direct exploration of health-related quality of life (HRQL) issues and to identify the quality of life elements in pre-adolescent children with a chronic medical condition. Study Design: Purposeful stratified sampling of children, ages 6–12, who function in a regular school class, with active epilepsy who were assembled in small focus groups. The groups met in four phases and were led by moderators who probed preset open questions and activities. Results: The study demonstrated that our modified focus groups process was a powerful exploratory experience eliciting meaningful and important issues in quality of life beyond what parents and health professionals expected, and helped identify HRQL elements in childhood epilepsy. Conclusion: Modified focus groups are appropriate and suitable to explore quality of life issues in pre-adolescent children with a chronic medical condition. The process is feasible and trustworthy.

Functional status, health problems, age and comorbidity in primary care patients

Abstract: Objectives: To determine the relationship between functional status and health problems, age and co-morbidity in primary care patients. Methods: Patients from 60 general practitioners who visited their general practitioner were recruited and asked to complete a written questionnaire, including a list of 25 health problems and the SF-36 to measure functional status. The response rate was 67% (n = 4112). Differences between subgroups were tested with p < 0.01. Results: Poorer functional status which was associated with increased age (except for vitality) and increased co-morbidity. Patients with asthma/bronchitis/COPD, severe heart disease/infarction, chronic backpain, arthrosis of knees, hips or hands, or an ‘other disease’ had poorer scores on at least five dimensions of functional status. Patients with hypertension, diabetes mellitus or cancer did not differ from patients without these conditions on more than one dimension of functional status. In the multiple regression analysis age, had a negative effect on functional status (standardised β-coefficients between −0.03 and −0.34) except for vitality. Co-morbidity had a negative effect on physical role constraints (−0.15) and bodily pain (−0.09). All health problems had effects on dimensions of functional status (coefficients between −0.04 and −0.13). General health and physical dimensions of functional status were better predicted by health problems, age and co-morbidity (between 6.4 and 16.5% of variation explained) than mental dimensions of functional status (between 1.1 and 3.2%). Conclusion: Higher age was a predictor of poorer functional status, but there was little evidence for an independent effect of co-morbidity on functional status. Health problems had differential impact on functional status among primary care patients.

Oncologists' use of quality of life information: results of a survey of Eastern Cooperative Oncology Group physicians.

Abstract: Purpose: Objectives of this study were to obtain data from Eastern Cooperative Oncology Group (ECOG) oncologists regarding their views on quality of life (QOL) information; perform psychometric testing on the MD-QOL questionnaire, develop a model to describe oncologists' willingness to use QOL information and propose data-based interventions to facilitate use of QOL information in clinical decision-making. Methods: A self-administered questionnaire, MD-QOL, designed to assess physician perspective on QOL information was mailed to a random sample of 500 oncologists, members of ECOG; 271 responded. Results: Oncologists' attitude, current behaviour, knowledge of QOL data, and reported willingness to use QOL can be measured using MD-QOL. The attitude, behaviour and willingness scales have high internal consistency. Physician attitude and behaviour account for 59% of the variance in the willingness to use QOL information. Demographic variables influencing physician responses were their primary income source and exposure to trials with a QOL component. Conclusions: This report of ECOG oncologists' views on QOL information suggests a model to describe relationship between physician willingness to use QOL information on the basis of their attitude and behaviour. Data-based interventions are proposed to influence the key variables and thus facilitate the incorporation of QOL data in clinical practice.

Cross-cultural validation of an international questionnaire, the General Measure of the Functional Assessment of Cancer Therapy scale (FACT-G), for Japanese.

Abstract: The General Measure of the Functional Assessment of Cancer Therapy scale (FACT-G) was developed in an English-speaking culture (USA). To determine if FACT-G could be used in Japan, a cross-cultural validation was performed. The Japanese version was created through an iterative forward-backward translation sequence used throughout the FACT multi-lingual translation project. In evaluating psychometric testing, its construct validity was investigated by factor analysis and multi-trait scaling analysis. Clinical validity was estimated by known-groups comparison using stage, performance score (PS) and patient location, and validated longitudinally by PS. The FACT-G (version 3) was given to 180 patients with lung cancer. Analyses showed that the scales of Physical, Functional, Emotional Well-Being, and Relationship with Doctors were constructively valid in Japan. Japanese patients felt that familial relationships were different than those with friends and neighbors, indicating that the Social/Family Well-Being scale needed cultural adaptation. Two items concerning coping with illness and acceptance of illness did not load predictably onto their respective scales and were considered to be cross-culturally problematic. However, clinical validity demonstrated its sensitivity. Japanese version 4 has been improved to address the weakness in an attempt to become an instrument that is applicable across cultures.

A review of the health-related quality of life literature in bipolar disorder

Abstract: This paper reviews the existing literature on health-related quality of life assessments conducted in bipolar disorder patients, and provides recommendations for the use of specific scales to measure health-related quality of life in this population. A comprehensive review of the literature revealed only a handful of studies in bipolar disorder that had incorporated quality of life assessments. While instruments from the medical outcomes study (MOS) were the most frequently used to measure health-related quality of life, a number of other instruments like the physchological general well being scale (PGWB), the streamlined longitudinal interview clinical evaluation from the longitudinal interval follow-up evaluation (SLICE/LIFE), the Euroqol, (EQ-5D), the Lehman's quality of life interview (QLI), and the quality of life in depression scale (QLDS) were also used. Only three studies out of ten reported the psychometric properties of the measures used. In the absence of a disease-targeted measure, a combination of the SF-36 and the PGWB is presently recommended as the battery of choice to assess the health-related quality of life of individuals with bipolar disorder. There is also the need to develop a disease-targeted health-related quality of life measure for bipolar disorder, which will obviate the use of a burdensome battery of generic quality of life instruments.

Problems with the performance of the SF-36 among people with type 2 diabetes in general practice.

Abstract: Objective: To validate the short form-36 (SF-36) among people with type 2 diabetes in general practice, and to make comparisons with the Audit of Diabetis Dependent Quality of Life (ADDQoL). Design: Postal survey with one reminder. Setting: Four general practices. Patients: One hundred and eighty-four eligible patients (30–70 years) with type 2 diabetes on 14 general practitioner lists. Measures: SF-36 response rates, distribution of dimension scores and internal consistency. Median scores in relation to sociodemography and self-reported health. Comparisons with ADDQoL scores. Results: One hundred and thirty-one patients responded (71%). Distributions of SF-36 dimension scores were mostly skewed. Internal consistency and construct validity were acceptable, with predictable sociodemographic trends. People with illness related to or unrelated to diabetes scored significantly lower on most dimensions. SF-36 dimension scores correlated best with relevant diabetes-specific ADDQoL scores amongst respondents reporting no comorbidity. Conclusions: Although valid and reliable, SF-36 scores are strongly affected by non-diabetic comorbidity in type 2 diabetes, supporting the complementary use of a diabetes-specific measure, providing information about the impact of diabetes specifically.

Does electronic implementation of questionnaires used in asthma alter responses compared to paper implementation

Abstract: Background: Electronic implementation of questionnaires has many advantages, but there may be concerns that it alters versions that were validated on paper. Objective: To determine whether electronic implementation alters responses to the SF-36 and asthma quality of life questionnaire (AQLQ), compared to paper implementation. Methods: Patients with asthma presenting to a pneumologist were asked for consent to participate. Each patient completed both forms of each questionnaire. The order of presentation was alternated sequentially, with the first patient completing the electronic version first. Each patient waited at least 2 hours between completions to minimize recollection of answers. For both the SF-36 and AQLQ, intraclass correlations coefficients were calculated to compare patients' scores, for each scale and overall, on the electronic and paper versions. Results: Sixty-eight patients (mean age: 48 years, 50 females) of 311 contacted were enrolled. Overall intraclass correlation coefficients for the SF-36 and AQLQ were excellent (0.965 and 0.991 respectively). For paper versions, eight questions (AQLQ) and 24 (SF-36) were left blank and nine questions (SF-36) were answered incorrectly by patients selecting more than one answer. Electronic data for one patient could not be retrieved. Conclusion: Collecting SF-36 and AQLQ data electronically can decrease the number of spoiled responses without altering the results. Successful implementation depends on proper instruction of the respondent in the handling of the electronic instrument.

The spanish version of the paediatric asthma quality of life questionnaire (PAQLQ): metric characteristics and equivalence with the original version.

Abstract: The Paediatric Asthma Quality of Life Questionnaire (PAQLQ), developed by Juniper etal., assesses the impact of asthma on children's daily life. It contains 23 items, covering three dimensions: symptoms, activities limitation and emotional function. Aims: To develop an equivalent Spanish version of the PAQLQ, and to assess its measurement characteristics. Methods: The forward and back-translation method was used for the adaptation. A longitudinal study (assessments at the 1st and 5th weeks), with patients from the emergency and outpatient departments of three Spanish hospitals, was designed to test the properties of the new adapted version. At each visit, a trained interviewer administered the PAQLQ, a Global Index of Change and a General Health Perception scale. The Peak Expiratory Flow Rate (PEFR) was also recorded daily, together with symptoms, during the prior week. Results: Ninety-nine patients (66.7% males, 42.4% suffering an exacerbation, mean age of 11.3years) with the following types of asthma were evaluated: mild intermittent (31.3%), mild persistent (36.4%), moderate persistent (29.3%) and severe persistent (3%). At the 1st visit, the mean pre-bronchodilator %PEFR was 87.3%. The Cronbach's α ranged from 0.86 to 0.95. As expected, correlations between the PAQLQ scores, and the Asthma Control Score (0.53–0.67), the General Health Perception (0.34–0.55), and the %PEFR (0.44–0.55) were moderate. The PAQLQ scores remained unchanged in stable patients while increased significantly in those showing improvements. Conclusions: After a standard cross-cultural adaptation process, the Spanish version of the PAQLQ has shown to be equivalent to the original, with similar internal consistency reliability, validity and sensitivity to clinical changes.

Psychometric properties of the RAND-36 among three chronic disease (multiple sclerosis, rheumatic diseases and COPD) in the Netherlands

Abstract: Objective: In this article, psychometric properties both of the total RAND-36 and of its subscales, such as unidimensionality, differential item functioning (DIF or item bias), homogeneity and reliabilities, are examined. Methods: The data from populations with three chronic illnesses, multiple sclerosis (n = 448), rheumatism (n = 336) and COPD (n = 259), have been collected in different parts of the Netherlands. The main technique used was Mokken scale analysis for polytomous items. Results: All subscales of the RAND-36 appeared to be unidimensional. For the sub scales ‘mental health’ and ‘general health perceptions’ some minor indications of DIF for the different chronic illnesses were found. Reliabilities of almost all subscales in all subpopulations were higher than 0.80, while the homogeneities of almost all subscales in all subpopulations were higher than 0.50, indicating ‘strong unidimensional, hierarchical scales’. Conclusions: In general, the subscales of the RAND-36 can be used to compare persons with different chronic illnesses. The subscale ‘general health perceptions’ did not function as well as would be preferred.

Efficacy results and quality-of-life measures in men receiving sildenafil citrate for the treatment of erectile dysfunction.

Abstract: The aim of the present study was to evaluate the efficacy of sildenafil citrate and its effects on quality of life (QoL) in men with erectile dysfunction (ED) using data from three multicenter, double-blind, placebo-controlled clinical trials. Efficacy was evaluated using a global efficacy question (improvement of erections) and questions from the International Index of Erectile Function (IIEF) addressing the ability to achieve and maintain erections. QoL directly related to ED was evaluated using questions 13 and 14 of the IIEF, several psychometric instruments, and a questionnaire addressing men's concerns about their erection problems. Seventy-nine [corrected] percent of patients receiving sildenafil reported improved erections compared with 23% of patients receiving placebo (p < 0.0001); also reported were improvements in the ability to achieve and maintain erections with sildenafil but not with placebo (p < 0.0001). Improvements were also seen for other aspects of sexual function (overall satisfaction with sex life, sexual relationships with partners, concerns about erectile problems, p < 0.0001) and general mental health (well-being, self-control, satisfaction with relationship, health relative to 1 year ago, mental health; p < or = 0.05) following treatment with sildenafil. Thus, treatment of ED with sildenafil can significantly improve key QoL parameters related to sexual dysfunction and general mental health.

Translation, cultural adaptation, and initial reliability and multitrait testing of the Kidney Disease Quality of Life instrument for use in Japan.

Abstract: Background: The Kidney Disease Quality of Life instrument (KDQOL™) consists of 79 items: 36 asking about health-related quality of life (HRQOL) in general (the Medical Outcomes Study SF-36) and 43 asking about QOL as it is affected by kidney disease and by dialysis. Aim: Translation, cultural adaptation and initial reliability and multitrait testing of the KDQOL™ for use in Japan. Methods: Translation and cultural adaptation began with two translations into Japanese, two backtranslations into English, and discussions among the translators, the project coordinators in Japan, and the developers of the original (US-English) version. Focus-group discussions and field testing were followed by analyses of test–retest reliability, internal consistency, and convergent and discriminant construct validity. Results: All eight of the SF-36 scales met the criterion for internal consistency (Cronbach's α ranged from 0.73 to 0.92) and were reproducible (intraclass correlations between test and retest scores ranged from 0.60 to 0.82). Of the 10 kidney-disease-targeted scales, only two had α coefficients of less than 0.70: ‘sleep’ (0.61) and ‘quality of social interaction’ (0.35). One item on the ‘quality of social interaction’ scale had a very weak correlation with the remainder of that scale (r = 0.10). Eliminating that item from scoring increased the α coefficient of the scale from 0.35 to 0.64. All three items on the ‘quality of social interaction’ scale had very strong correlations with other scales. Conclusions: First, in Japanese patients receiving dialysis the SF-36 scales are internally consistent and their scores are reproducible. Second, with the possible exception of the ‘quality of social interaction’ scale, the Japanese version of the KDQOL™,can provide psychometrically sound kidney-disease-targeted data on quality of life in such patients.

The relationship of personality dimensions as measured by the temperament and character inventory and quality of life in individuals with schizophrenia or schizoaffective disorder living in the community.

Abstract: The influence of personality factors on the appraisal of subjective quality of life in individuals with schizophrenia or schizoaffective disorder is not much investigated. The present study examined this relationship in a sample of 104 patients living in the community. The temperament and character inventory was used to assess personality and the Lancashire quality of life profile was used to assess quality of life. The results showed that lower levels of harm avoidance and higher levels of self-directedness were significantly correlated to a better subjective quality of life. Regression analyses controlling for psychopathology revealed that a higher level of self-directedness was significantly associated with a better subjective quality in all aspects measured and explained the variance in the latter in the range of 4-12%. It is concluded that personality factors are involved in severely mentally ill individuals' assessment of their quality of life and should be accounted for in evaluations of quality of life assessments. The strength and directions of this influence require further studies.

Comparison of three generic questionnaires measuring quality of life in adolescents and adults with cystic fibrosis: the 36-item short form health survey, the quality of life profile for chronic diseases, and the questions on life satisfaction.

Abstract: Objective: To compare different generic instruments in measuring quality of life and to demonstrate dimensions of quality of life (QL) in patients with cystic fibrosis (CF). Methods: The short-form-36 health survey (SF-36), the quality of life profile for chronic diseases (PLC), and the questions on life satisfaction (FLZM) were simultaneously employed in a cross-sectional study with 70 adolescents and adults with CF. The different concepts of the measures were compared. Internal consistency (Cronbach's α), convergent and construct validity (correlation patterns, common factor analysis), and external validity (correlations with symptom and pulmonary function scores, with intensity of therapy; comparisons with healthy peers) of the three instruments were investigated. Results: Similar reliability, but different validity of the questionnaires are demonstrated. Seventy-three percent of the total variance across the three measures could be explained with a seven-factor-solution: (1) physical functioning (19.3% of total variance), (2) mental health (19.3%), (3) social integration (7.5%), (4) role function/pain (7.5%), (5) economic/material living conditions (7.5%), (6) partnership/family (6.7%) and (7) anxiety (5.2%). Discussion: The different validity of the instruments has to be considered in chosing a questionnaire appropriate to the purpose of measuring. Shortcomings of each instrument can be overcome by multimethod designs and by developing disease-specific scales.

Psychological status and the role of coping style after coronary artery bypass graft surgery. Results of a prospective study.

Abstract: The results of a prospective study in patients who underwent a first coronary artery bypass graft operation are presented. The goals of this project consisted in assessing the psychological changes during the first year after surgery. For that purpose, 330 consecutive patients were recruited. They were assessed by means of several psychological scales before and on three occasions after surgery. These scales were: the Heart Patients' Psychological Questionnaire (HPPQ), the State-Trait Anxiety Scale (STAI), the Symptom Check List (SCL-90), the Maastricht Questionnaire (MQ) and the Marlowe Crowne Desirability Scale. Furthermore, the study focused on the differential influence of three coping styles. The data demonstrate a clear overall improvement in psychological status over the first year, more specifically during the first 6 months after CABG. Patients were less anxious, less depressed, less exhausted and experienced more subjective well-being. However, almost 30% of all patients did not experience that average favourable evolution. The final psychological end-state was predicted by psychological variables, measured pre-operatively (somatic complaints, hostility and dysphoria) and short-term post-operatively (anxiety). No single medical variable could predict patients' psychological end-state. Finally, the most favourable change was made by patients who display the sensitising coping style, resulting in lower anxiety and depression. Health care providers, physicians as well as nursing staff and psychologists, should therefore use psychodiagnostic tools in order to identify patients at risk for negative psychological outcome. Appropriate therapeutic interventions may consequently be developed and evaluated in future research.