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Biomedical subjects

J B Bjorner

Publications and source records attributed to J B Bjorner.

17 recordsLinked to original sources

Health-related quality of life one month after thrombolysis or primary PCI in patients with ST-elevation infarction. A DANAMI-2 sub-study.

OBJECTIVES: To evaluate the health-related quality of life (HRQoL) following Primary percutaneous coronary intervention (PCI) or thrombolytic treatment for ST-elevation myocardial infarction (STEMI). DESIGN: A questionnaire based study on patients randomised in the DANAMI-2 study to Primary PCI or thrombolysis for STEMI. A total of 1 351 patients (93.2% response rate) randomised in the DANAMI-2 study completed the HRQoL questionnaire one month after the infarction. RESULTS: With respect to the primary end-points (SF-36 physical component score, angina pectoris, and dyspnoea), patients randomised to primary PCI scored better on the SF-36 physical component score (PCS) (p=0.007), and reported significantly less angina pectoris (p=0.010) and dyspnoea (p=0.010). Higher scores among PCI patients were also found on the SF-36 scales physical functioning (p=0.015), role-physical (p=0.017), and general health (p=0.009). CONCLUSION: The results in this study support the hypothesis that primary PCI is superior to thrombolysis in treating STEMI, not only in clinical outcome, but also in quality of life outcome.

Adult↗

Use of item response theory to develop a shortened version of the EORTC QLQ-C30 emotional functioning scale.

BACKGROUND: As part of a larger study whose objective is to develop an abbreviated version of the EORTC QLQ-C30 suitable for research in palliative care, analyses were conducted to determine the feasibility of generating a shorter version of the 4-item emotional functioning (EF) scale that could be scored in the original metric. METHODS: We used data from 24 European cancer studies conducted in 10 different languages (n = 8242). Item selection was based on analyses by item response theory (IRT). Based on the IRT results, a simple scoring algorithm was developed to predict the original 4-item EF sum scale score from a reduced number of items. RESULTS: Both a 3-item and a 2-item version (item 21 'Did you feel tense?' and item 24 'Did you feel depressed?') predicted the total score with excellent agreement and very little bias. In group comparisons, the 2-item scale led to the same conclusions as those based on the original 4-item scale with little or no loss of measurement efficiency. CONCLUSION: Although these results are promising, confirmatory studies are needed based on independent samples. If such additional studies yield comparable results, incorporation of the 2-item EF scale in an abbreviated version of the QLQ-C30 for use in palliative care research settings would be justified. The analyses reported here demonstrate the usefulness of the IRT-based methodology for shortening questionnaire scales.

Adult↗

Quality of life in the Danish general population--normative data and validity of WHOQOL-BREF using Rasch and item response theory models.

BACKGROUND: The main objective of this study was to investigate the construct validity of the WHOQOL-BREF by use of Rasch and Item Response Theory models and to examine the stability of the model across high/low scoring individuals, gender, education, and depressive illness. Furthermore, the objective of the study was to estimate the reference data for the quality of life questionnaire WHOQOL-BREF in the general Danish population and in subgroups defined by age, gender, and education. METHODS: Mail-out-mail-back questionnaires were sent to a randomly selected sample of the Danish general population. The response rate was 68.5%, and the sample reported here contained 1101 respondents: 578 women and 519 men (four respondents did not indicate their genders). RESULTS: Each of the four domains of the WHOQOL-BREF scale fitted a two-parameter IRT model, but did not fit the Rasch model. Due to multidimensionality, the total score of 26 items fitted neither model. Regression analysis was carried out, showing a level of explained variance of between 10 and 14%. The mean scores of the WHOQOL-BREF are reported as normative data for the general Danish population. CONCLUSION: The profile of the four WHOQOL-BREF domains is a more adequate expression of quality of life than the total score of all 26 items. Although none of the subscales are statistically sufficient measures of their domains, the profile scores seem to be adequate approximations to the optimal score.

Adult↗

The responsiveness of headache impact scales scored using 'classical' and 'modern' psychometric methods: a re-analysis of three clinical trials.

BACKGROUND: While item response theory (IRT) offers many theoretical advantages over classical test theory in the construction and scoring of patient based measures of health few studies compare scales constructed from both methodologies head to head. OBJECTIVE: Compare the responsiveness to treatment of migraine specific scales scored using summated rating scale methods vs. IRT methods. METHODS: The data came from three clinical studies of migraine treatment that used the Migraine Specific Quality of Life Questionnaire (MSQ). Five methods of quantifying responsiveness were used to evaluate and compare changes from pre- to post-treatment in MSQ scales scored using Likert and IRT scaling methods. RESULTS: Changes in all MSQ scale scores from pre- to post-treatment were highly significant in all three studies. A single index scored from the MSQ using IRT methods was determined to be more responsive than any one of the MSQ subscales across the five methods used to quantify responsiveness. Across 13 of the 15 tests (5 responsiveness methods * 3 studies) conducted, the single index scored from the MSQ using IRT methods was the most responsive measure. CONCLUSIONS: IRT methods increased the responsiveness of the MSQ to the treatment of migraine. The results agree with the psychometric evidence that suggest that it is feasible to score a single index from the MSQ using IRT methods. This approach warrants further testing with other measures of migraine impact.

Adult↗

A six-item short-form survey for measuring headache impact: the HIT-6.

BACKGROUND: Migraine and other severe headaches can cause suffering and reduce functioning and productivity. Patients are the best source of information about such impact. OBJECTIVE: To develop a new short form (HIT-6) for assessing the impact of headaches that has broad content coverage but is brief as well as reliable and valid enough to use in screening and monitoring patients in clinical research and practice. METHODS: HIT-6 items were selected from an existing item pool of 54 items and from 35 items suggested by clinicians. Items were selected and modified based on content validity, item response theory (IRT) information functions, item internal consistency, distributions of scores, clinical validity, and linguistic analyses. The HIT-6 was evaluated in an Internet-based survey of headache sufferers (n = 1103) who were members of America Online (AOL). After 14 days, 540 participated in a follow-up survey. RESULTS: HIT-6 covers six content categories represented in widely used surveys of headache impact. Internal consistency, alternate forms, and test-retest reliability estimates of HIT-6 were 0.89, 0.90, and 0.80, respectively. Individual patient score confidence intervals (95%) of app. +/-5 were observed for 88% of all respondents. In tests of validity in discriminating across diagnostic and headache severity groups, relative validity (RV) coefficients of 0.82 and 1.00 were observed for HIT-6, in comparison with the Total Score. Patient-level classifications based in HIT-6 were accurate 88.7% of the time at the recommended cut-off score for a probability of migraine diagnosis. HIT-6 was responsive to self-reported changes in headache impact. CONCLUSIONS: The IRT model estimated for a 'pool' of items from widely used measures of headache impact was useful in constructing an efficient, reliable, and valid 'static' short form (HIT-6) for use in screening and monitoring patient outcomes.

Adult↗

Fatigue in the Danish general population. Influence of sociodemographic factors and disease.

OBJECTIVE: To measure the levels of fatigue in the general population, and to examine how disease and sociodemographic factors influence fatigue. DESIGN: Cross sectional questionnaire study in the Danish general population. SUBJECTS: A random, age stratified sample of 1608 people aged 20-77 with an equal gender distribution (response rate 67%). MAIN OUTCOME MEASURES: Five fatigue scales from the questionnaire Multidimensional Fatigue Inventory: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation and Mental Fatigue. RESULTS: Fatigue scores were skewed towards absence of fatigue. The General Fatigue and Physical Fatigue scales showed the highest fatigue levels while the Reduced Motivation scale showed lowest levels. Gender differences in fatigue scores were small, but the variability among women was higher-that is, more women had high scores. A multiple linear regression analysis showed that respondents of low social status and respondents with a depression had high fatigue scores on all scales, independent of other factors. Chronic somatic disease had an independent direct effect on Mental Fatigue, but for the rest of the scales, the effect of somatic disease depended on age, gender and/or whether the person was living alone. For example, General and Physical Fatigue decreased with age among healthy people, whereas scores on these scales increased with age among those with a somatic disease. CONCLUSIONS: Physical and mental diseases play essential parts for the level of fatigue and as modulators of the associations between sociodemographic factors and fatigue. These interactions should be taken into account in future research on fatigue and sociodemographic factors and when data from clinical studies are compared with normative data from the general population.

Adult↗

Anxiety and depression in breast cancer patients at low risk of recurrence compared with the general population: a valid comparison?

Breast cancer and its treatment have been associated with psychological morbidity. In this study our aim was to quantify the excess anxiety and depression resulting from breast cancer. We compared 538 newly diagnosed breast cancer patients at low risk of recurrence (87.0% responded) to 872 women randomly selected from the Danish general population (69.7% responded) using the Hospital Anxiety and Depression Scale (HADS). Contrary to expectations, the proportions classified as "cases" of anxiety and depression were not significantly different in the two groups. The breast cancer patients' mean HADS scores were significantly lower than those in the general population sample (anxiety, P = 0.021; depression, P < 0.001), indicating less anxiety and depression. However, we question the validity of this comparison. The HADS may not be suitable for use in the general population and there may be methodological problems in comparisons of groups whose life situations are very different.

Adult↗

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.

Analysis of Variance↗

The Danish SF-36 Health Survey: translation and preliminary validity studies.

This article reports on the Danish translation of SF-36 and discusses the procedures used for translation improvement, translation evaluation, and scale evaluation. We followed the standard procedures of the International Quality of Life Assessment (IQOLA) Project including forward and backward translation, independent assessment of translation quality, assessment of response-choice weighting through visual analogue scale (VAS) investigations, and psychometric testing of the translated questionnaire. We found that backward translation, independent quality assessment, and VAS studies provided useful information for translation improvement. The Danish SF-36 received a favorable translation evaluation by independent rating; however, interrater agreement was low. Preliminary validity studies generally supported the internal consistency and homogeneity of the Danish SF-36, and the questionnaire performed satisfactorily in distinguishing depressive patients from nonpatients. On the basis of this and other studies, we recommend use of the Danish SF-36 in research.

Denmark↗

Tests of data quality, scaling assumptions, and reliability of the Danish SF-36.

We used general population data (n = 4084) to examine data completeness, response consistency, tests of scaling assumptions, and reliability of the Danish SF-36 Health Survey. We compared traditional multitrait scaling analyses to analyses using polychoric correlations and Spearman correlations. The frequency of missing values was low, except for elderly people and people with lower levels of education. Response consistency was high and compared well with results for the U.S. SF-36. For respondents with computable scales in all eight domains, scaling assumptions (item internal consistency, item discriminant validity, equal item-own scale correlations, and equal variances) were satisfactory in the total sample and in all subgroups. The SF-36 could discriminate between levels of health in all subgroups, but there were skewness, kurtosis, and ceiling effects in many subgroups (elderly people and people with chronic diseases excepted). Concerning correlation methods, we found interesting differences indicating advantages of using methods that do not assume a normal distribution of answers as an addition to traditional methods.

Cross-Cultural Comparison↗

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

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

Cross-Cultural Comparison↗

Use of structural equation modeling to test the construct validity of the SF-36 Health Survey in ten countries: results from the IQOLA Project. International Quality of Life Assessment.

A crucial prerequisite to the use of the SF-36 Health Survey in multinational studies is the reproduction of the conceptual model underlying its scoring and interpretation. Structural equation modeling (SEM) was used to test these aspects of the construct validity of the SF-36 in ten IQOLA countries: Denmark, France, Germany, Italy, the Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States. Data came from general population surveys fielded to gather normative data. Measurement and structural models developed in the United States were cross-validated in random halves of the sample in each country. SEM analyses supported the eight first-order factor model of health that underlies the scoring of SF-36 scales and two second-order factors that are the basis for summary physical and mental health measures. A single third-order factor was also observed in support of the hypothesis that all responses to the SF-36 are generated by a single, underlying construct--health. In addition, a third second-order factors, interpreted as general well-being, was shown to improve the fit of the model. This model (including eight first-order factors, three second-order factors, and one third-order factor) was cross-validated using a holdout sample within the United States and in each of the nine other countries. These results confirm the hypothesized relationships between SF-36 items and scales and justify their scoring in each country using standard algorithms. Results also suggest that SF-36 scales and summary physical and mental health measures will have similar interpretations across countries. The practical implications of a third second-order SF-36 factor (general well-being) warrant further study.

Cross-Cultural Comparison↗

Differential item functioning in the Danish translation of the SF-36.

Statistical analyses of Differential Item Functioning (DIF) can be used for rigorous translation evaluations. DIF techniques test whether each item functions in the same way, irrespective of the country, language, or culture of the respondents. For a given level of health, the score on any item should be independent of nationality. This requirement can be tested through contingency-table methods, which are efficient for analyzing all types of items. We investigated DIF in the Danish translation of the SF-36 Health Survey, using two general population samples (USA, n = 1,506; Denmark, n = 3,950). DIF was identified for 12 out of 35 items. These results agreed with independent ratings of translation quality, but the statistical techniques were more sensitive. When included in scales, the items exhibiting DIF had only a little impact on conclusions about cross-national differences in health in the general population. However, if used as single items, the DIF items could seriously bias results from cross-national comparisons. Also, the DIF items might have larger impact on cross-national comparison of groups with poorer health status. We conclude that analysis of DIF is useful for evaluating questionnaire translations.

Adolescent↗

Comparison of Rasch and summated rating scales constructed from SF-36 physical functioning items in seven countries: results from the IQOLA Project. International Quality of Life Assessment.

Rasch models for polytomous items were used to assess the scaling assumptions and compare item response patterns in the 10-item SF-36 physical functioning scale (PF-10) for general population respondents in Denmark, Germany, Italy, the Netherlands, Sweden, the United Kingdom, and the United States. The Rasch model of physical functioning developed in the United States was compared to models for other countries, and each country was compared to a multinational composite. Strong scale congruence across the seven countries was demonstrated; items that varied between countries and from the composite may reflect unique cultural response patterns or differences in translation. Scoring algorithms based on the Rasch model for each country were superior to the current Likert scoring in tests of relative validity (RV) in discriminating among age groups in all countries. In relation to the Likert PF-10 scoring (RV = 1.00), scores estimated using the Rasch rating scale model achieve a median RV of 1.31 (range: 1.01-1.59), while the Rasch partial credit model attained a median RV of 1.44 (range: 1.01-2.23). Rasch models hold good potential for improving health status measures, estimating individual scores when responses to scale items are missing, and equating scores across countries.

Aged↗

Test for item bias in a quality of life questionnaire.

Item bias (differential item functioning) analysis examines whether the construction of an index from two or more variables results in bias in relation to sex, age, or other criteria. Item bias may lead to erroneous conclusions because of distortion or dilution of the effects measured. In comparing groups, item bias analysis, tests whether the information about possible differences between groups, obtained by the variables constituting an index, are correctly passed on by the index score. We examined a quality of life questionnaire answered by 1189 breast cancer patients. We found age-bias or bias in the comparison of groups receiving different treatments in three out of nine indexes. Recommendations for the interpretation of these indexes are made. Item bias analysis is a useful method examining an issue not covered by traditional psychometric tests.

Adult↗

A prospective, randomized multicenter study comparing APD and CAPD treatment.

OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included in the study.Twenty-five patients completed the study. INTERVENTIONS: After randomization, 17 patients were allocated to APD treatment and 17 patients to CAPD treatment for a period of 6 months. Medical and biochemical parameters were evaluated at monthly controls in the CAPD units. Quality-of-life parameters were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters, dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p < 0.001). Although the difference was not significant, there was a tendency for less physical and emotional discomfort caused by dialysis fluid in the APD group. Sleep problems, on the other hand, tended to be more marked in the APD group. Any positive effect of APD compared to CAPD on dialysis-related hospital days or complication rates could not be confirmed. With larger patient samples, it is possible, however, that a significant difference might have been achieved. The running costs for APD treatment were US $75 per day and for CAPD treatment US $61 per day. CONCLUSION: If APD treatment can help to keep selected patients vocationally or socially active, paying the extra cost seems reasonable.

Denmark↗