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Abstract The European Organisation for Research and Treatment of Cancer Quality of Life Multiple Myeloma Questionnaire (EORTC QLQ-MY20) was developed in 1996 to assess health-related quality of life (HRQoL) in patients with multiple myeloma. Since its development new therapies have prolonged survival in patients with myeloma and new combination agents are likely to impact HRQoL outcomes and its measurement. The aim of this review was to explore the use of the QLQ-MY20 and reported methodological issues. An electronic database search was conducted (1996-June 2020) to identify clinical studies/research that used the QLQ-MY20 or assessed its psychometric properties. Data were extracted from full-text publications/conference abstracts and checked by a second rater. The search returned 65 clinical and 9 psychometric validation studies. The QLQ-MY20 was used in interventional (n = 21, 32%) and observational (n = 44, 68%) studies and the publication of QLQ-MY20 data in clinical trials increased over time. Clinical studies commonly included relapsed patients with myeloma patients (n = 15, 68%) and assessed a range of combinations therapies. QLQ-MY20 subscales (disease symptoms [DS], side effects of treatment [SE], future perspectives [FP], body image [BI]) were defined as secondary (n = 12, 55%) or exploratory (n = 7, 32%) trial endpoints, particularly DS (n = 16, 72%) and SE (n = 16, 72%). Validation articles demonstrated that all domains performed well regarding internal consistency reliability (>0.7), test-reset reliability (intraclass correlation coefficient > =0.85), internal and external convergent and discriminant validity. Four articles reported a high percentage of ceiling effects in the BI subscale; all other subscales performed well regarding floor and ceiling effects. The EORTC QLQ-MY20 remains a widely used and psychometrically robust instrument. While no specific problems were identified from the published literature, qualitative interviews are ongoing to ensure new concepts and side effects are included that may arise from patients receiving novel treatments or from longer survival with multiple lines of treatment.

Abstract Background The EORTC Quality of Life Group has developed a questionnaire to evaluate cancer patients’ perception of their communication with healthcare professionals (HCPs): the EORTC QLQ-COMU26. In this study we test the validity and reliability of this novel measure in an international and culturally diverse sample of cancer patients. Methods Cancer patients completed the following EORTC questionnaires at two time points (before and during treatment): the QLQ-COMU26 (including a debriefing questionnaire), the QLQ-C30, and specific IN-PATSAT32 scales. These data were used to assess: the cross-cultural applicability, acceptability, scale structure, reliability, convergent/divergent validity, known-groups validity, and responsiveness to change of the QLQ-COMU26. Results Data were collected from 498 patients with various cancer diagnoses in 10 European countries, Japan, Jordan and India (overall 5 cultural regions). At most, only 3% of patients identified an item as confusing and 0.6% as upsetting, which indicates that the questionnaire was clear and did not trigger negative emotional responses. Confirmatory factor analysis and multi-trait scaling confirmed the hypothesised QLQ-COMU26 scale structure comprising six multi-item scales and four single items (RMSEA = 0.025). Reliability was good for all scales (internal consistency > 0.70; test–retest reliability > 0.85). Convergent validity was supported by correlations of ≥ 0.50 with related scales of the IN-PATSAT32 and correlations

Abstract Objectives Sexuality is an important dimension of health-related quality of life (HRQOL) in cancer patients. Studies evidence that most patients report impairments of their sexual health related to their disease or its treatment. The Quality of Life Group of the European Organization for the Research and Treatment of Cancer (EORTC) developed a patient reported outcome measure assessing multidimensional aspects of sexual health. The validation study for this instrument revealed heterogenous results for patients in palliative oncological treatment. The aim of this secondary analyses is to examine differences in patient related sexual health outcomes between palliative patients with good performance status (GPS) and those with poor performance status (PPS). Methods In this observational cohort study, self-reported sexual health issue scores were compared between the two groups of patients in palliative oncological treatment with GPS vs PPS status. Results Patients with GPS experienced significantly more sexual satisfaction than patients with PPS (p = 0.015). They reported significantly more treatment effects on their sexual activity (p = 0.005) and suffer more from decreased libido (p = 0.008). Patients with PPS reported significantly more fatigue (p = 0.03) and regarded preservation of sexual activity of higher importance than did patients with GPS (p = 0.049). Conclusions Our study demonstrates the importance of sexuality for patients in palliative oncological treatment, especially for those with limited performance status. Considering the patients´ perspective, sexual health reaches beyond physical functioning. Patients in a palliative phase of disease report high levels of psychosexual problems while sexual performance deteriorates. Sexuality is an important aspect of HRQOL for these patients, needs to be addressed by health care providers and sensitively integrated into palliative care plans.

Abstract Background General population normative values for the widely used health-related quality of life (HRQoL) measure EORTC QLQ-C30 support the interpretation of trial results and HRQoL of patients in clinical practice. Here, we provide sex-, age- and health condition-specific normative values for the EORTC QLQ-C30 in the French general population. Methods French general population data was collected in an international EORTC project. Online panels with quota samples were used to recruit sex and age groups. Number and type of comorbidities were assessed. Descriptive statistics were used to calculate general population values for each QLQ-C30 scale, separately for sex, age, and presence of one- and more chronic health conditions. A multivariate linear regression model has been developed to allow estimating the effect of sex, age, and the presence for one- and more chronic health conditions on EORTC QLQ-C30 scores. Data was weighted according to United Nation statistics adjusting for the proportion of sex and age groups. Results In total, 1001 French respondents were included in our analyses. The weighted mean age was 47.9 years, 514 (51.3%) participants were women, and 497 (52.2%) participants reported at least one health condition. Men reported statistically significant better scores for Emotional Functioning (+9.6 points, p = 0.006) and Fatigue (−7.8 point; p = 0.04); women reported better profiles for Role Functioning (+8.7 points; p = 0.008) and Financial Difficulty (−7.8 points, p = 0.011). According to the regression model, the sex effect was statistically significant in eight scales; the effect of increasing age had a statistically significant effect on seven of the 15 EORTC QLQ-C30 scales. The sex- and age effect varied in its direction across the various scales. The presence of health conditions showed a strong negative effect on all scales. Conclusion This is the first publication of detailed French normative values for the EORTC QLQ-C30. It aims to support the interpretation of HRQoL profiles in French cancer populations. The strong impact of health conditions on QLQ-C30 scores highlights the importance of considering the impact of comorbidities in cancer patients when interpreting HRQoL data.

Abstract Background The use of open-ended questions supplementing static questionnaires with closed questions may facilitate the recognition of symptoms and toxicities. The open-ended ‘Write In three Symptoms/Problems (WISP)’ instrument permits patients to report additional symptoms/problems not covered by selected EORTC questionnaires. We evaluated the acceptability and usefulness of WISP with cancer patients receiving active and palliative care/treatment in Austria, Chile, France, Jordan, the Netherlands, Norway, Spain and the United Kingdom. Methods We conducted a literature search on validated instruments for cancer patients including open-ended questions and analyzing their responses. WISP was translated into eight languages and pilot tested. WISP translations were pre-tested together with EORTC QLQ-C30, QLQ-C15-PAL and relevant modules, followed by patient interviews to evaluate their understanding about WISP. Proportions were used to summarize patient responses obtained from interviews and WISP. Results From the seven instruments identified in the literature, only the free text collected from the PRO-CTAE has been analyzed previously. In our study, 161 cancer patients participated in the pre-testing and interviews (50% in active treatment). Qualitative interviews showed high acceptability of WISP. Among the 295 symptoms/problems reported using WISP, skin problems, sore mouth and bleeding were more prevalent in patients in active treatment, whereas numbness/tingling, dry mouth and existential problems were more prevalent in patients in palliative care/treatment. Conclusions The EORTC WISP instrument was found to be acceptable and useful for symptom assessment in cancer patients. WISP improves the identification of symptoms/problems not assessed by cancer-generic questionnaires and therefore, we recommend its use alongside the EORTC questionnaires.

Abstract Background The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Utility-Core 10 Dimensions (QLU-C10D) is a novel cancer-specific preference-based measure (PBM) for which value sets are being developed for an increasing number of countries. This is done by obtaining health preferences from the respective general population. There is an ongoing discussion if instead patients suffering from the disease in question should be asked for their preferences. We used the QLU-C10D valuation survey, originally designed for use in the general population, in a sample of cancer patients in Austria to assess the methodology’s acceptability and applicability in this target group before obtaining QLU-C10D patient preferences. Methods The core of the QLU-C10D valuation survey is a discrete choice experiment in which respondents are asked to give preferences for certain health states (described by a relatively large number of 10 quality of life domains) and an associated survival time. They therewith are asked to trade off quality of life against life time. As this might be a very burdensome task for cancer patients undergoing treatment, a cognitive interview was conducted in a pilot sample to assess burden and potential additional needs for explanation in order to be able to use the DCE for the development of QLU-C10D patient preferences. In addition, responses to general feedback questions on the survey were compared against responses from a matched control group from the already completed Austrian general population valuation survey. Results We included 48 patients (mean age 59.9 years; 46% female). In the cognitive interview, the majority indicated that their experience with the survey was positive (85%) and overall clarity as good (90%). In response to the general feedback questions, patients rated the presentation of the health states less clear than matched controls (p = 0.008). There was no difference between patients and the general population concerning the difficulty in choosing between the health states (p = 0.344). Conclusion Despite the relatively large number of DCE domains the survey was manageable for patients and allows going on with the QLU-C10D patient valuation study.

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868 . Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)

Abstract Background The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a widely used cancer-specific questionnaire assessing 15 domains of health-related quality of life (HRQoL). Our aim was to facilitate the interpretation of scores on this questionnaire by providing Austrian normative data based on a general population sample. Methods The calculation of normative data was based on the EORTC QLQ-C30 data collected from an Austrian general population sample that was part of an international online panel study on the development of European normative data. Data reported herein were stratified and weighted by age and sex. Normative data were calculated for all 15 HRQoL domains of the EORTC QLQ-C30. For precise predictions of EORTC QLQ-C30 scores, a regression model based on sex, age and the presence of health conditions was built. Results The Austrian sample comprised 1002 Austrian participants (50.1% female, 51.4% when weighted by age and sex based on United Nation statistics). The mean age was 53.7 years (weighted: 47.7 years) and 53.6% (weighted: 47.4%) reported at least one health condition. Men reported better physical (Cohen’s d = 0.17) and emotional (Cohen’s d = 0.17) functioning as well as less fatigue (Cohen’s d = 0.18) and insomnia (Cohen’s d = 0.25) compared with women. Younger individuals (

Abstract Background Although patients experience radiation proctitis post radiotherapy no internationally tested instruments exist to measure these symptoms. This Phase IV study tested the scale structure, reliability and validity and cross-cultural applicability of the EORTC proctitis module (QLQ-PRT23) in patients who were receiving pelvic radiotherapy. Methods Patients (n = 358) from six countries completed the EORTC QLQ-C30, QLQ-PRT23 and EORTC Quality of Life Group debriefing questions. Clinicians completed the EORTC Radiation Therapy Oncology Group scale. Questionnaires were completed at four time-points. The module’s scale structure was examined and validated using standard psychometric analysis techniques. Results Three items were dropped from the module (QLQ-PRT23 → QLQ-PRT20). Factor analysis identified five factors in the module: bowel control; bloating and gas; emotional function/lifestyle; pain; and leakage. Inter-item correlations were within r = 0.3–0.7. Test-Retest reliability was high. All multi-item scales discriminated between patients showing symptoms and those without symptomology. The module discriminated symptoms from the clinician completed scoring and for age, gender and comorbidities. Conclusion The EORTC QLQ-PRT20 is designed to be used in addition to the EORTC QLQ-C30 to measure quality of life in patients who receive pelvic radiotherapy. The EORTC QLQ-PRT20 is quick to complete, acceptable to patients, has good content validity and high reliability. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000972224.

Abstract To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ‐22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in‐depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross‐cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbach's alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22‐item short questionnaire resulted in a change of wording in five items and two communication‐related items; no items were removed. Preliminary psychometric analysis revealed a two‐factor solution and 11 single items; both scales showed good reliability indicated by a Cronbach's alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross‐cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large‐scale, cross‐cultural field testing of the EORTC SHQ‐22, has commenced.

Purpose: The rate of missing data on patient-reported health-related quality of life (HRQOL) in brain tumor clinical trials is particularly high over time. One solution to this issue is the use of proxy (i.e., partner, relative, informal caregiver) ratings in lieu of patient-reported outcomes (PROs). In this study we investigated patient-proxy agreement on HRQOL outcomes in high-grade glioma (HGG) patients.Methods: Generic and disease-specific HRQOL were assessed using the EORTC QLQ-C30 and QLQ-BN20 in a sample of 501 patient-proxy dyads participating in EORTC trials 26101 and 26091. Patients were classified as impaired or intact, based on their neurocognitive performance. The level of patient-proxy agreement was measured using Lin's concordance correlation coefficient (CCC) and the Bland-Altman limit of agreement. The Wilcoxon signed-rank test was used to evaluate differences between patients' and proxies' HRQOL.Results: Patient-proxy agreement in all HGG patients (N = 501) ranged from 0.082 to 0.460. Only 18.8% of all patients were neurocognitively intact. Lin's CCC ranged from 0.088 to 0.455 in cognitively impaired patients and their proxies and from 0.027 to 0.538 in cognitively intact patients and their proxies.Conclusion: While patient-proxy agreement on health-related quality of life outcomes is somewhat higher in cognitively intact patients, agreement in high-grade glioma patients is low in general. In light of these findings, we suggest to cautiously consider the use of proxy's evaluation in lieu of patient-reported outcomes, regardless of patient's neurocognitive status. [ABSTRACT FROM AUTHOR]

Background: General population normative values for the widely used health-related quality of life (HRQoL) measure, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), are available for a range of countries. These are mostly countries in northern Europe. However, there is still a lack of such normative values for southern Europe. Therefore, this study aims to provide sex-, age- and health condition-specific normative values for the general Italian population for the EORTC QLQ-C30.Material and Methods: This study is based on Italian EORTC QLQ-C30 general population data previously collected in an international EORTC project comprising over 15,000 respondents across 15 countries. Recruitment and assessment were carried out via online panels. Quota sampling was used for sex and age groups (18‍-‍39, 40-49, 50-59, 60-69 and ≥ 70 years), separately for each country. We applied weights to match the age and sex distribution in our sample with UN statistics for Italy. Along with descriptive statistics, linear regression models were estimated to describe the associations of sex, age and health condition with the EORTC QLQ-C30 scores.Results: A total of 1,036 respondents from Italy were included in our analyses. The weighted mean age was 49.3 years, and 536 (51.7%) participants were female. Having at least one health condition was reported by 60.7% of the participants. Men reported better scores than women on all EORTC QLQ-C30 scales but diarrhoea. While the impact of age differed across scales, older age was overall associated with better HRQoL as shown by the summary score. For all scales, differences were in favour of participants who did not report any health condition, compared to those who reported at least one.Conclusion: The Italian normative values for the EORTC QLQ-C30 scales support the interpretation of HRQoL profiles in Italian cancer populations. The strong impact of health conditions on EORTC QLQ-C30 scores highlights the importance of adjusting for the impact of comorbidities in cancer patients when interpreting HRQoL data. [ABSTRACT FROM AUTHOR]

Background: The European Organization for research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) scales are scored on a 4-point response scale, ranging from not at all to very much. Previous studies have shown that the German translation of the response option quite a bit as mäßig violates interval scale assumptions, and that ziemlich is a more appropriate translation. The present studies investigated differences between the two questionnaire versions.Methods: The first study employed a balanced cross-over design and included 450 patients with different types of cancer from three German-speaking countries. The second study was a representative survey in Germany including 2033 respondents. The main analyses included compared the ziemlich and mäßig version of the questionnaire using analyses of covariance adjusted for sex, age, and health burden.Results: In accordance with our hypothesis, the adjusted summary score was lower in the mäßig than in the ziemlich version; Study 1: - 4.5 (95% CI - 7.8 to - 1.3), p = 0.006, Study 2: - 3.1 (95% CI - 4.6 to - 1.5), p < 0.001. In both studies, this effect was pronounced in respondents with a higher health burden; Study 1: - 6.8 (95% CI - 12.2 to - 1.4), p = 0.013; Study 2: - 4.5 (95% CI - 7.3 to - 1.7), p = 0.002.Conclusions: We found subtle but consistent differences between the two questionnaire versions. We recommend to use the optimized response option for the EORTC QLQ-C30 as well as for all other German modules.Trial Registration: The study was retrospectively registered on the German Registry for Clinical Studies (reference number DRKS00012759, 04th August 2017, https://www.drks.de/DRKS00012759 ). [ABSTRACT FROM AUTHOR]

Background: The EORTC QLU-C10D is a preference-based measure derived from the EORTC QLQ-C30. For use in economic evaluations, country-specific value sets are needed. This study aimed to generate an EORTC QLU-C10 value set for Spain.Methods: A sample of the Spanish general population completed an online discrete choice experiment. An attribute-balanced incomplete block design was used to select 960 choice tasks, with a total of 1920 health states. Each participant was randomly assigned 16 choice sets without replacement. Data were modelled using generalized estimating equations and mixed logistic regressions.Results: A total of 1625 panel members were invited to participate, 1010 of whom were included in the study. Dimension decrements were generally monotonic with larger disutilities at increased severity levels. Dimensions associated with larger decrements were physical functioning and pain, while the dimension with the smallest decrement was sleep disturbances. The PITS state (i.e. worst attainable health) for the Spanish population is - 0.043.Conclusions: This study generated the first Spanish value set for the QLU-C10D. This can facilitate cost-utility analyses when applied to data collected with the EORTC QLQ-C30. [ABSTRACT FROM AUTHOR]

Purpose: General population normative data for the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire facilitates interpretation of data assessed from cancer patients. This study aims to present normative data of the general Spanish population.Methods/patients: Data were obtained from a prior larger study collecting EORTC QLQ-C30 norm data across 15 countries. Data were stratified by sex and age groups (18-39, 40-49, 50-59, 60-69 and > 70 years). Sex and age distribution were weighted according to population distribution statistics. Sex- and age-specific normative values were analysed separately, as were participants with versus those without health conditions. Multiple linear regression was used to estimate the association of each of the EORTC QLQ-C30 scales with the determinants age, sex, sex-by-age interaction term, and health condition.Results: In total, 1,165 Spanish individuals participated in the study. Differences were found by sex and age. The largest sex-related differences were seen in fatigue, emotional functioning, and global QOL (Quality of Life), favouring men. The largest age differences were seen in emotional functioning, insomnia, and pain, with middle-aged groups having the worst scores. Those > 60 years old scored better than those < 60 years old on all scales except for physical functioning. Participants with no health conditions scored better in all QLQ-C30 domains.Conclusions: The present study highlights differences in HRQOL between specific sex/age strata and especially between people with and without a health condition in the general Spanish population. These factors must be considered when comparing general population HRQOL data with that of cancer patients. [ABSTRACT FROM AUTHOR]

Background: In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings.Methods: The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated.Discussion: The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries.Trial Registration: ClinicalTrials.gov NCT04066868 . Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019). [ABSTRACT FROM AUTHOR]

Objective: To develop Austrian, Italian, and Polish general population value sets for the EORTC QLU-C10D, a cancer-specific utility instrument based on the EORTC QLQ-C30, and to descriptively compare their index scores for distinct health states.Methods: The QLU-C10D descriptive system comprises 10 health attributes and each can take on 4 levels. A standardised and pre-tested methodology has been applied for valuations including a web-based discrete choice experiment (DCE). It was administered in 1000 general population respondents per country recruited via online panels, aiming at representativeness for core socio-demographic variables.Results: In all three countries, the attributes with the largest impact on utility were physical functioning, pain, and role functioning. Cancer-specific dimensions with the largest impact were nausea and fatigue or bowel problems. Utility values of the worst health state (i.e. severe problems on all 10 dimension) were -0.111 (Austria), 0.025 (Italy), and 0.048 (Poland). Country-specific utilities differed for a selection of health states across the continuum. Austrian utilities were systematically lower for moderately and severely impaired health states.Conclusion: QLU-C10D cancer-specific utilities can now be calculated in three more countries. Differences between countries indicate that careful consideration is required when using non-country-specific value sets in economic evaluations. [ABSTRACT FROM AUTHOR]

Background: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a widely used cancer-specific questionnaire assessing 15 domains of health-related quality of life (HRQoL). Our aim was to facilitate the interpretation of scores on this questionnaire by providing Austrian normative data based on a general population sample.Methods: The calculation of normative data was based on the EORTC QLQ-C30 data collected from an Austrian general population sample that was part of an international online panel study on the development of European normative data. Data reported herein were stratified and weighted by age and sex. Normative data were calculated for all 15 HRQoL domains of the EORTC QLQ-C30. For precise predictions of EORTC QLQ-C30 scores, a regression model based on sex, age and the presence of health conditions was built.Results: The Austrian sample comprised 1002 Austrian participants (50.1% female, 51.4% when weighted by age and sex based on United Nation statistics). The mean age was 53.7 years (weighted: 47.7 years) and 53.6% (weighted: 47.4%) reported at least one health condition. Men reported better physical (Cohen's d = 0.17) and emotional (Cohen's d = 0.17) functioning as well as less fatigue (Cohen's d = 0.18) and insomnia (Cohen's d = 0.25) compared with women. Younger individuals (< 40 years) reported less dyspnea (Cohen's d = 0.61) and pain (Cohen's d = 0.51), whereas older individuals (≥60 years) reported better emotional functioning (Cohen's d = 0.55).Conclusions: We present Austrian normative data for the EORTC QLQ-C30. Differences by age and sex are mostly in line with the findings of other European normative studies. The Austrian population sample shows higher HRQoL and lower morbidity compared with other European countries. The normative data in this study will facilitate the interpretation of EORTC QLQ-C30 scores in oncological practice and research at a national and international level (including cross-cultural comparisons). [ABSTRACT FROM AUTHOR]

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed computerised adaptive tests (CATs) for the 14 functional and symptom domains of the EORTC QLQ-C30 quality of life questionnaire. This is expected to optimise measurement precision, relevance to patients and flexibility. Here, we present the first international validation of the EORTC CAT Core.Methods: A heterogeneous sample of 699 cancer patients scheduled for chemotherapy and/or radiotherapy was recruited across seven European countries. The EORTC CAT Core and all QLQ-C30 items were administered to participants before and after initiating treatment. Correlations between CAT and QLQ-C30 scores and floor/ceiling effects were calculated. Using several grouping variables, relative validity (cross-sectional known groups difference), responsiveness (changes over time) and relative sample size requirements of the CAT compared to the QLQ-C30 were estimated.Results: Correlations of the CAT and QLQ-C30 ranged from 0.81 to 0.93 across domains. The mean relative reduction in floor and ceiling effects using the CAT was 42% (range 3-99%). Analyses of known groups validity and responsiveness indicated that, across domains, mean sample size requirements for the CAT were 72% and 70%, respectively, of those using the QLQ-C30.Conclusions: The EORTC CAT Core measures the same domains as the QLQ-C30 with reduced floor/ceiling effects. The CAT generally facilitated the use of smaller samples (about 30% smaller on average) without loss of power compared to the QLQ-C30. Based on this study, the EORTC QLG will release the EORTC CAT Core for general use. [ABSTRACT FROM AUTHOR]

The EORTC QLU-C10D is a new multi-attribute utility instrument derived from the widely used cancer-specific quality of life questionnaire, EORTC QLQ-C30. It contains 10 dimensions (physical functioning, role functioning, social functioning, emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems), each with four levels. The aim of this study was to provide U.K. general population utility weights for the QLU-C10D. A U.K. online panel was quota-sampled to align the sample to the general population proportions of sex and age (≥18 years). The online valuation survey included a discrete choice experiment (DCE). Each participant was asked to complete 16 choice-pairs, each comprising two QLU-C10D health states plus duration. DCE data were analysed using conditional logistic regression to generate utility weights. Data from 2,187 respondents who completed at least one choice set were included in the DCE analysis. The final U.K. QLU-C10D utility weights comprised decrements for each level of each health dimension. For nine of the 10 dimensions (all except appetite), the expected monotonic pattern was observed across levels: Utility decreased as severity increased. For the final model, consistent monotonicity was achieved by merging inconsistent adjacent levels for appetite. The largest utility decrements were associated with physical functioning and pain. The worst possible health state (the worst level of each dimension) is -0.083, which is considered slightly worse than being dead. The U.K.-specific utility weights will enable cost-utility analysis (CUA) for the economic evaluation of new oncology therapies and technologies in the United Kingdom, where CUA is commonly used to inform resource allocation. [ABSTRACT FROM AUTHOR]

Purpose: The EORTC QLU-C10D is a new multi-attribute utility instrument derived from the EORTC QLQ-C30, a widely used cancer-specific quality of life questionnaire. It covers ten dimensions: physical, role, social, emotional functioning, pain, fatigue, sleep, appetite, nausea, and bowel problems. To allow national health attitudes to be reflected, country-specific valuations are being performed by collaboration of the Multi-Attribute Utility Cancer (MAUCa) Consortium and the EORTC. The purpose of this paper is to provide German value sets (utility weights) for the QLU-C10D.Methods: Valuations were run in a web-based setting in two general population samples of approximately 2000 adults in total. As the German version of the QLQ-C30 is presently undergoing a revision of the wording of one response category, valuations for both the current and the new version were performed (Germany 1 and 2). Utilities were elicited using a discrete choice experiment (DCE). Data were analyzed by conditional logistic regression and mixed logits.Results: Completion rates were 88.3% (1002/1135) and 90.4% (1016/1124) for Germany 1 and Germany 2 valuations, respectively. Dimensions with the largest impact on utility weights were, in this order: physical functioning, pain, role functioning, social functioning and nausea (same ordering for both German versions). Several violations of the logical ordering of levels were observed for Germany 1; this was largely improved for Germany 2.Conclusion: This study established German utility weights for the cancer-specific utility instrument QLU-C10D. [ABSTRACT FROM AUTHOR]

The article compares patient and health care professionals (HCPs) views of the relevance and importance of sexual health issues to form the questionnaire design. It mentions that validated sexual health measures may facilitate physician‐patient communication. It states that the EORTC Sexual Health Questionnaire can be used to identify sexual health problems in research and clinical practice.

Objective: In this study, we investigated what makes a symptom or functional impairment clinically important, that is, relevant for a patient to discuss with a health care professional (HCP). This is the first part of a European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group project focusing on the development of thresholds for clinical importance for the EORTC QLQ-C30 questionnaire and its corresponding computer-adaptive version.Methods: We conducted interviews with cancer patients and HCPs in 6 European countries. Participants were asked to name aspects of a symptom or problem that make it clinically important and to provide importance ratings for a predefined set of aspects (eg, need for help and limitations of daily functioning).Results: We conducted interviews with 83 cancer patients (mean age, 60.3 y; 50.6% men) and 67 HCPs. Participants related clinical importance to limitations of everyday life (patients, 65.1%; HCPs, 77.6%), the emotional impact of a symptom/problem (patients, 53.0%; HCPs, 64.2%), and duration/frequency (patients, 51.8%; HCPs, 49.3%). In the patient sample, importance ratings were highest for worries by partner or family, limitations in everyday life, and need for help from the medical staff. Health care professionals rated limitations in everyday life and need for help from the medical staff to be most important.Conclusions: Limitations in everyday life, need for (medical) help, and emotional impact on the patient or family/partner were found to be relevant aspects of clinical importance. Based on these findings, we will define anchor items for the development of thresholds for clinical importance for the EORTC measures in a Europe-wide field study. [ABSTRACT FROM AUTHOR]

Introduction: In the process of translating patient-reported outcomes measures (forward translation(s), reconciliation, back translation(s), review, pilot-testing, review, final translation), there is a general consensus amongst the key players in the field that the back translation review is an important step. Despite this, there has been little guidance published on how to perform it. Areas covered: Having assessed the most recent back translation reports reviewed by the Translation Unit at the European Organisation for Research and Treatment of Cancer (EORTC) in Brussels, we have identified two concepts to help guide the back translation review process: the underlying issue (the problem that the item measures) and the structure (the linguistic and formal construction of the item). This paper presents these concepts and how they are used in the review process. Expert commentary: Despite certain difficulties it might pose, back translation review remains one of the standard steps to assure concept equivalence. This paper aims at starting a much-needed exchange of experience and knowledge among people who perform reviews as part of the process of translating patient-reported outcomes measures. [ABSTRACT FROM AUTHOR]