Objective: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life questionnaire is one of the most widely used cancer-specific health-related quality of life questionnaires worldwide. General population norm data can facilitate the interpretation of QLQ-C30 data obtained from cancer patients. This study aimed at systematically collecting norm data from the general population to develop European QLQ-C30 norm scores and to generate comparable norm data for individual countries in Europe and North America. Methods: We collected QLQ-C30 data from the general population across 11 European Union (EU) countries, Russia, Turkey, Canada and United States (n ! 1000/country). Representative samples were stratified by sex and age groups (18e39, 40e49, 50e59, 60e69 and ! 70 years). After applying weights based on the United Nations population distribution statistics, we calculated QLQ-C30 domain scores to generate a 'European QLQ-C30 Norm' based on the EU countries. Further, we calculated QLQ-C30 norm scores for all 15 individual countries. Results: A total of 15,386 respondents completed the online survey. For the EU sample, most QLQ-C30 domains showed differences by sex/age, with men scoring somewhat better health than women, while age effects varied across domains. Substantially larger differences were seen in inter-country comparisons, with Austrian and Dutch respondents reporting consistently better health compared with British and Polish respondents. Conclusions: This study is the first to systematically collect EORTC QLQ-C30 general population norm data across Europe and North America applying a consistent data collection method across 15 countries. These new norm data facilitate valid intra-country as well as inter-country comparisons and QLQ-C30 score interpretation.

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.

The computer-adaptive test (CAT) of the European Organisation for Research and Treatment of Cancer (EORTC), the EORTC CAT Core, assesses the same 15 domains as the EORTC QLQ-C30 health-related quality of life questionnaire but with increased precision, efficiency, measurement range and flexibility. CAT parameters for estimating scores have been established based on clinical data from cancer patients. This study aimed at establishing the European Norm for each CAT domain based on general population data. Methods: We collected representative general population data across 11 European Union (EU) countries, Russia, Turkey, Canada and the United States (n ! 1000/country; stratified by sex and age). We selected item subsets from each CAT domain for data collection (totalling 86 items). Differential item functioning (DIF) analyses were conducted to investigate crosscultural measurement invariance. For each domain, means and standard deviations from the EU countries (weighted by country population, sex and age) were used to establish a Tmetric with a European general population mean Z 50 (standard deviation Z 10). Results: A total of 15,386 respondents completed the online survey (n Z 11,343 from EU countries). EORTC CAT Core norm scores for all 15 countries were calculated. DIF had negligible impact on scoring. Domain-specific T-scores differed significantly across countries with small to medium effect sizes. Conclusion: This study establishes the official European Norm for the EORTC CAT Core. The European CAT Norm can be used globally and allows for meaningful interpretation of scores. Furthermore, CAT scores can be compared with sex-and age-adjusted norm scores at a national level within each of the 15 countries.

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.