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Background Patient-reported physical function (PF) is a key endpoint in cancer clinical trials. Using complex statistical methods, common metrics have been developed to compare scores from different patient-reported outcome (PRO) measures, but such methods do not account for possible differences in questionnaire content. Therefore, the aim of our study was a content comparison of frequently used PRO measures for PF in cancer patients. Methods Relying on the framework of the International Classification of Functioning, Disability and Health (ICF) we categorized the item content of the physical domains of the following measures: EORTC CAT Core, EORTC QLQ-C30, SF-36, PROMIS Cancer Item Bank for Physical Function, PROMIS Short Form for Physical Function 20a, and the FACT-G. Item content was linked to ICF categories by two independent reviewers. Results The 118 items investigated were assigned to 3 components (‘d – Activities and Participation’, ‘b – Body Functions’, and ‘e – Environmental Factors’) and 11 first-level ICF categories. All PF items of the EORTC measures but one were assigned to the first-level ICF categories ‘d4 – Mobility’ and ‘d5 – Self-care’, all within the component ‘d – Activities and Participation’. The SF-36 additionally included item content related to ‘d9 – Community, social and civic life’ and the PROMIS Short Form for Physical Function 20a also included content related to ‘d6 – domestic life’. The PROMIS Cancer Item Bank (v1.1) covered, in addition, two first-level categories within the component ‘b – Body Functions’. The FACT-G Physical Well-being scale was found to be the most diverse scale with item content partly not covered by the ICF framework. Discussion Our results provide information about conceptual differences between common PRO measures for the assessment of PF in cancer patients. Our results complement quantitative information on psychometric characteristics of these measures and provide a better understanding of the possibilities of establishing common metrics.

Background European cancer programmes and policies lack a unified health-related quality of life (HRQoL) assessment tool. The European oncology quality of life toolkit (EUonQoL-Kit) is a novel set of HRQoL questionnaires, co-designed with cancer patients and survivors, translated and culturally adapted into 31 European languages, and with both static and dynamic electronic administration modes. The main aim of this study is the psychometric assessment of the static version. Secondary aims include evaluating the EUonQoL-Kit acceptability, cross-validating the administration modes, exploring individual factors potentially affecting HRQoL and HRQoL inequalities between countries. Methods A sample of 4,500 participants, including three groups (active treatment, survivors, and palliative care) from 45 centres in 25 EU Member States and 7 associated countries, will be enrolled in a multicentre observational cross-sectional study. All participants will complete the static EUonQoL-Kit; three subsamples (each 10% of the total sample) will also respectively complete the following: a) dynamic EUonQoL-Kit, based on Item Response Theory (IRT)/Computer Adaptive Testing (CAT), b) FACT-G and EQ-5L-5D, and c) static EUonQoL-Kit (re-test). Psychometric analyses will encompass exploratory and confirmatory factor analyses (measurement model and structural validity), Cronbach's alpha (internal consistency), intraclass correlation coefficient (test–retest reliability), Pearson/Spearman correlation (concurrent validity), comparison of group scores (construct validity), and Differential Item Functioning (cross-country item equivalence). Secondary analyses will evaluate participant response time and rate, and static/dynamic score differences. Regression models will estimate associations between individual factors and HRQoL. Discussion The EUonQoL-Kit will serve to systematically incorporate patient perspectives into European cancer policies and to address HRQoL inequalities across Europe. Trial registration ClinicalTrials.gov Identifier: NCT05947903, 2023–06-28.

Background Cancer patients may experience a decrease in cognitive functioning before, during and after cancer treatment. So far, the Quality of Life Group of the European Organisation for Research and Treatment of Cancer (EORTC QLG) developed an item bank to assess self-reported memory and attention within a single, cognitive functioning scale (CF) using computerized adaptive testing (EORTC CAT Core CF item bank). However, the distinction between different cognitive functions might be important to assess the patients’ functional status appropriately and to determine treatment impact. To allow for such assessment, the aim of this study was to develop and psychometrically evaluate separate item banks for memory and attention based on the EORTC CAT Core CF item bank. Methods In a multistep process including an expert-based content analysis, we assigned 44 items from the EORTC CAT Core CF item bank to the memory or attention domain. Then, we conducted psychometric analyses based on a sample used within the development of the EORTC CAT Core CF item bank. The sample consisted of 1030 cancer patients from Denmark, France, Poland, and the United Kingdom. We evaluated measurement properties of the newly developed item banks using confirmatory factor analysis (CFA) and item response theory model calibration. Results Item assignment resulted in 31 memory and 13 attention items. Conducted CFAs suggested good fit to a 1-factor model for each domain and no violations of monotonicity or indications of differential item functioning. Evaluation of CATs for both memory and attention confirmed well-functioning item banks with increased power/reduced sample size requirements (for CATs ≥ 4 items and up to 40% reduction in sample size requirements in comparison to non-CAT format). Conclusion Two well-functioning and psychometrically robust item banks for memory and attention were formed from the existing EORTC CAT Core CF item bank. These findings could support further research on self-reported cognitive functioning in cancer patients in clinical trials as well as for real-word-evidence. A more precise assessment of attention and memory deficits in cancer patients will strengthen the evidence on the effects of cancer treatment for different cancer entities, and therefore contribute to shared and informed clinical decision-making.

Little is known about the need for palliative care among advanced cancer patients who are not in specialist palliative care. The purpose was to identify prevalence and predictors of symptoms and problems in a nationally representative sample of Danish advanced cancer patients. Patients with cancer stage 3 or 4 from 54 hospital departments (n = 1630) received the EORTC QLQ-C30 questionnaire. Mean scores were calculated according to the scoring manual and in addition a ‘symptom/problem’ and a ‘severe symptom/problem’ was defined and calculated. Multiple logistic regression was used to identify predictors. In total, 977 (60%) patients participated. The most frequent symptoms/problems were fatigue (57%; severe 22%) followed by reduced role function, insomnia and pain. Age, cancer stage, primary tumour, type of department, marital status and whether the patient had recently been hospitalized or not were associated with several symptoms and problems. This is probably the first nationally representative study of its kind. It shows that advanced cancer patients in Denmark have symptoms and problems that deserve attention and that some patient groups are especially at risk.

Background The European Organisation for Research and Treatment of Cancer (EORTC) quality of life colorectal questionnaire module (QLQ-CR38) was developed in 1999, and an update, the QLQ CR29 was published recently. To date the Danish version of the questionnaire has not been validated. The aim of this study was to examine the psychometric properties of the Danish version of EORTC QLQ-CR38. Methods EORTC QLQ-CR38 was administered to 190 patients with colorectal cancer in two Danish hospitals, one month after their operation. A psychometric evaluation of the questionnaire’s structure, reliability, convergent, divergent and known-groups validity was performed. Results Data from 164 (86.3%) patients were available for analysis. The Danish version of EORTC QLQ-CR38 showed satisfactory psychometric properties for the scales: body image, sexual functioning, male sexual problems and defecations problems. Suboptimal psychometric performances were found for the scales: micturition problems, symptoms of the gastrointestinal tract and weight loss. Evaluation of the psychometric properties of the scale chemotherapy side effects was limited by the low number of patients receiving chemotherapy. It was not possible to assess the psychometric properties of the scale female sexual problems and the single item sexual enjoyment due to a high number of missing values. The homogeneity of the study population made the evaluation of known-group validity difficult. Conclusions The results of this study suggest that the validity of the Danish version of EORTC QLQ-CR38 is acceptable. Furthermore, the results support the appropriateness of the updated version, the EORTC QLQ-CR29.

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.

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.

Hypothyroidism is often diagnosed, and subsequently treated, due to health-related quality of life (HRQL) issues. However, HRQL following treatment has never previously been assessed in longitudinal descriptive studies using validated instruments. To investigate disease-specific (ThyPRO) and generic (SF-36) HRQL, following levothyroxine therapy in patients with hypothyroidism due to autoimmune thyroiditis. This prospective cohort study was set at endocrine outpatient clinics at two Danish university hospitals. Seventy-eight consecutive patients were enrolled and completed HRQL questionnaires before, six weeks, and six months after initiation of levothyroxine therapy. Normative ThyPRO (n = 739) and SF-36 (n = 6,638) data were available for comparison and changes in HRQL following treatment were estimated and quantified. Prior to treatment, all ThyPRO scales were significantly impacted (p<0.0001), compared to the general population sample. The same was observed for seven of eight SF-36 scales, the exception being Bodily Pain. Tiredness (ThyPRO) and Vitality (SF-36) were the most markedly impacted scales. After six weeks of treatment, nine of thirteen ThyPRO scales had significantly improved. ThyPRO improvements were consistent at six months, where five of eight SF-36 scales had also significantly improved, but deficits persisted for a subset of both ThyPRO and SF-36 scales. In this population of hypothyroid patients, HRQL was widely affected before treatment, with tiredness as the cardinal impairment according to both ThyPRO and SF-36. Many aspects of HRQL improved during the first six months of LT4 therapy, but full recovery was not obtained. Our results may help clinicians inform patients about expected clinical treatment effects.

The aim of this study was to derive population-based norms for women completing the EORTC QLQ-C30 version 1 which is designed for use with patients who have cancer. The study was conducted using two different questionnaires: one designed for use in female patients with breast cancer, the other for those with gynaecological cancers, but both including the EORTC QLQ-C30. The women were drawn from the Danish Central Population Register without knowledge of their health status and divided at random between the two questionnaires. All procedures for collecting data were identical. The response rate for those receiving the gynaecological cancer (GS) questionnaire was 49% and it was 71% for the breast cancer (BS) questionnaire. Detailed comparison between the two samples revealed several EORTC QLQ-C30 items showing a clear difference in distribution of scores between them. Because of this and the possible bias due to the relative low age-related response rate in GS, only the results from the BS are used for constructing norms. The norms cover all 30 single items on the EORTC QLQ-C30 and the nine derived scales, for women in four 10-year age groups commencing at 30 years and for those aged 70-75. Clear trends in, for example, declining ability to undertake strenuous activity are illustrated and quantified. Levels of certain symptoms, such as pain, are surprisingly high although it is recognized that the population sampled will contain proportion of women with active disease including cancer. We recommend the use of these norms both as an aid to the clinical assessment of an individual patient, and to assist in the interpretation of clinical trial and longitudinal quality of life data. As a secondary result, we note that a population-based sample will have a lower response rate to a questionnaire with more questions, especially if many of these extra questions are on sexual issues.

Introduction: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a widely used health-related quality of life instrument. The main aim of this study is to investigate whether there are international differences in response to the questionnaire that can be explained by cultural factors. Methods: Analyses involved a database of 106 separate studies including data from over 28,000 respondents. Differential item functioning (DIF) analyses using logistic regression were conducted for each item of the EORTC QLQ-C30 with respect to cultural/geographic group. Results were qualitatively compared with previously reported DIF analyses by translation to explore whether the source of the DIF was more likely to be linguistic or cultural in nature. Results: Although most response patterns were similar, there were a number of international differences in how the questionnaire was answered. The largest variations were found in the results for Eastern Europe and East Asia. Results for the UK, the US and Australia tended to be similar. Many of the European results followed patterns that were more clearly explained when grouped by translation than when grouped by geographical region. Discussion: Our results suggest that, in general, the EORTC QLQ-C30 is suitable for use in a wide variety of countries and settings. Some response variations that have the potential to affect the results of international studies were identified, but it was not always clear whether the source of the variation was primarily linguistic or cultural.