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Purpose: To investigate patients' and health professionals' understanding of and preferences for different graphical presentation styles for individual-level EORTC QLQ-C30 scores.Methods: We recruited cancer patients (any treatment and diagnosis) in four European countries and health professionals in the Netherlands. Using a questionnaire, we assessed objective and self-rated understanding of QLQ-C30 scores and preferences for five presentation styles (bar and line charts, with or without color coding, and a heat map).Results: In total, 548 patients and 227 health professionals participated. Eighty-three percent of patients and 85 % of professionals self-rated the graphs as very or quite easy to understand; this did not differ between graphical presentation styles. The mean percentage of correct answers to questions objectively assessing understanding was 59 % in patients, 78 % in medical specialists, and 74 % in other health professionals. Objective understanding did not differ between graphical formats in patients. For non-colored charts, 49.8 % of patients did not have a preference. Colored bar charts (39 %) were preferred over heat maps (20 %) and colored line charts (12 %). Medical specialists preferred heat maps (46 %) followed by non-colored bar charts (19 %), whereas these charts were equally valued by other health professionals (both 32 %).Conclusion: The substantial discrepancy between participants' high self-rated and relatively low objective understanding of graphical presentation of PRO results highlights the need to provide sufficient guidance when presenting such results. It may be appropriate to adapt the presentation of PRO results to individual preferences. This could be facilitated when PROs are administered and presented to patients and health professionals electronically. [ABSTRACT FROM AUTHOR]

Abstract 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 (18–39, 40–49, 50–59, 60–69 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. Highlights • Updated general population norm data for EORTC QLQ-C 30 based on 15,386 persons across 13 European countries, Canada, and USA. • Study strength: all individual country QLQ-C30 norm data collected based on a common sampling strategy and survey design. • New normative data facilitate valid intracountry and especially intercountry comparisons and QLQ-C30 score interpretation. [ABSTRACT FROM AUTHOR]

Abstract Objective 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 cross-cultural 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 T-metric with a European general population mean = 50 (standard deviation = 10). Results A total of 15,386 respondents completed the online survey (n = 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. Highlights • This study establishes the official European Norm for the computer-adaptive test EORTC CAT Core based on 15,386 persons. • The European CAT Norm can be used globally and allows for meaningful interpretation of scores derived from EORTC CAT Core. • EORTC CAT Core scores can also be compared with sex- and age-adjusted norm scores at national levels of 15 included countries. [ABSTRACT FROM AUTHOR]

Objective: To provide equipercentile equating of physical function (PF) scores from frequently used patient-reported outcome measures (PROMs) in cancer patients to facilitate data pooling and comparisons., Study Design and Setting: Adult cancer patients from five European countries completed the European Organization for Research and Treatment of Cancer (EORTC) computer adaptive test (CAT) Core, EORTC Quality of Life Questionnaire Version 3.0 (QLQ-C30), Functional Assessment of Cancer Therapy - General (FACT-G), 36-item Short Form Health Survey (SF-36), and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 20a short form. The R package "equate" was used to establish conversion tables of PF scores on those measures with a bivariate rank correlation of at least 0.75., Results: In total, 953 patients with cancer (mean age 58.9 years, 54.7% men) participated. Bivariate rank correlations between PF scores from the EORTC CAT Core, EORTC QLQ-C30, SF-36, and PROMIS were all above 0.85, but below 0.69 for the FACT-G. Conversion tables were established for all measures but the FACT-G. These tables indicate which score from one PROM best matches the score from another PROM and provide standard errors of converted scores., Conclusion: Our analysis indicates that linking of PF scores from both EORTC measures (CAT and QLQ-C30) with PROMIS and SF-36 is possible, whereas the physical domain of the FACT-G seems to be different. The established conversion tables may be used for comparing results or pooling data from clinical studies using different PROMs., Competing Interests: Declaration of competing interest David Cella reports to hold a compensated position as President of FACIT.org and an uncompensated position as President of the PROMIS Health Organization and member of its Board of Directors. Bernhard Holzner reports holding intellectual property rights on the software tool CHES. All other coauthors declared no conflicts of interest., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

The 10-item Kessler Psychological Distress scale (K10) and its 6-item short-form version (K6) measure psychological distress, particularly anxiety or depressive symptoms. While these questionnaire scales are widely used in various settings and populations, general population normative data are rarely available. To facilitate the interpretation of K10 and K6 scores, we provide normative general population data from seven European countries. We used an online survey to collect K10 data from general population samples in Austria, Italy, Germany, France, the Netherlands, Poland and Spain. We calculated the age- and sex-specific normative values separately for each country. For more specific estimates of K10 and K6 scores for individuals or groups, we also established a multivariable regression model based on socio-demographic and health data. In total, N = 7,087 adults participated in our study (51.6% women; mean age, 49.6 years). The mean K10 score in the total sample was 8.5 points (standard deviation, 7.3) on 0-40 points metric, with mean scores in individual countries ranging from 6.9 (the Netherlands) to 9.9 (Spain). Women showed higher scores than men and younger participants scored higher than older participants. Our study is the first to present normative K10 and K6 data from several European countries using a consistent sampling approach. These reference values will facilitate the interpretation of K10 and K6 scores in clinical research and practice and also highlight the variation in psychological distress levels across countries and groups according to their socio-demographic and health characteristics., (© 2023. The Author(s).)

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.

Background: To optimise measurement precision, relevance to patients and flexibility, patient-reported outcome measures (PROMs) should ideally be adapted to the individual patient/study while retaining direct comparability of scores across patients/studies. This is achievable using item banks and computerised adaptive tests (CATs). The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) is one of the most widely used PROMs in cancer research and clinical practice. Here we provide an overview of the research program to develop CAT versions of the QLQ-C30's 14 functional and symptom domains., Methods: The EORTC Quality of Life Group's strategy for developing CAT item banks consists of: literature search to identify potential candidate items; formulation of new items compatible with the QLQ-C30 item style; expert evaluations and patient interviews; field-testing and psychometric analyses, including factor analysis, item response theory calibration and simulation of measurement properties. In addition, software for setting up, running and scoring CAT has been developed., Results: Across eight rounds of data collections, 9782 patients were recruited from 12 countries for the field-testing. The four phases of development resulted in a total of 260 unique items across the 14 domains. Each item bank consists of 7-34 items. Psychometric evaluations indicated higher measurement precision and increased statistical power of the CAT measures compared to the QLQ-C30 scales. Using CAT, sample size requirements may be reduced by approximately 20-35% on average without loss of power., Conclusions: The EORTC CAT Core represents a more precise, powerful and flexible measurement system than the QLQ-C30. It is currently being validated in a large independent, international sample of cancer patients., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Purpose: The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies., Methods: Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology., Results: Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate., Conclusion: In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account.

Background: The aim was to carry out phase 4 international field-testing of the European Organisation for Research and Treatment of Cancer (EORTC) breast reconstruction (BRECON) module. The primary objective was finalization of its scale structure. Secondary objectives were evaluation of its reliability, validity, responsiveness, acceptability and interpretability in patients with breast cancer undergoing mastectomy and reconstruction., Methods: The EORTC module development guidelines were followed. Patients were recruited from 28 centres in seven countries. A prospective cohort completed the QLQ-BRECON15 before mastectomy and the QLQ-BRECON24 at 4-8 months after reconstruction. The cross-sectional cohort completed the QLQ-BRECON24 at 1-5 years after reconstruction, and repeated this 2-8 weeks later (test-retest reliability). All participants completed debriefing questionnaires., Results: A total of 438 patients were recruited, 234 in the prospective cohort and 204 in the cross-sectional cohort. A total of 414 reconstructions were immediate, with a comparable number of implants (176) and donor-site flaps (166). Control groups comprised patients who underwent two-stage implant procedures (72, 75 per cent) or delayed reconstruction (24, 25 per cent). Psychometric scale validity was supported by moderate to high item-own scale and item-total correlations (over 0·5). Questionnaire validity was confirmed by good scale-to-sample targeting, and computable scale scores exceeding 50 per cent, except nipple cosmesis (over 40 per cent). In known-group comparisons, QLQ-BRECON24 scales and items differentiated between patient groups defined by clinical criteria, such as type and timing of reconstruction, postmastectomy radiotherapy and surgical complications, with moderate effect sizes. Prospectively, sexuality and surgical side-effects scales showed significant responsiveness over time (P < 0·001). Scale reliability was supported by high Cronbach's α coefficients (over 0·7) and test-retest (intraclass correlation more than 0·8). One item (finding a well fitting bra) was excluded based on high floor/ceiling effects, poor test-retest and weak correlations in factor analysis (below 0·3), thus generating the QLQ-BRECON23 questionnaire., Conclusion: The QLQ-BRECON23 is an internationally validated tool to be used alongside the EORTC QLQ-C30 (cancer) and QLQ-BR23 (breast cancer) questionnaires for evaluating quality of life and satisfaction after breast reconstruction., (© 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.)

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., (Copyright © 2017 John Wiley & Sons, Ltd.)

Background: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer., Methods: In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce., Results: Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions., Conclusions: The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed.

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Group has developed a new multidimensional instrument measuring cancer-related fatigue to be used in conjunction with the quality of life core questionnaire (EORTC QLQ-C30). The module EORTC QLQ-FA13 assesses physical, cognitive, and emotional aspects of cancer-related fatigue., Methods: The methodology follows the EORTC guidelines for phase IV validation of modules. This paper focuses on the results of the psychometric validation of the factorial structure of the module. For validation and cross-validation confirmatory factor analysis (maximum likelihood estimation), intraclass correlation and Cronbach alpha for internal consistency were employed. The study involved an international multicenter collaboration of 11 European and non-European countries., Results: A total of 946 patients with various tumor diagnoses were enrolled. Based on the confirmatory factor analysis, we could approve the three-dimensional structure of the module. Removing one item and reassigning the factorial mapping of another item resulted in the EORTC QLQ-FA12. For the revised scale, we found evidence supporting good local (indicator reliability ≥ 0.60, factor reliability ≥ 0.82) and global model fit (GFI t1|t2 = 0.965/0.957, CFI t1|t2 = 0.976/0.972, RMSEA t1|t2 = 0.060/0.069) for both measurement points. For each scale, test-retest reliability proved to be very good (intraclass correlation: R t1-t2 = 0.905-0.921) and internal consistency proved to be good to high (Cronbach alpha = .79-.90)., Conclusion: Based on the former phase III module, the multidimensional structure was revised as a phase IV module (EORTC FA12) with an improved scale structure. For a comprehensive validation of the EORTC FA12, further aspects of convergent and divergent validity as well as sensitivity to change should be determined., (© The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Objectives: In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting such research., Methods: In this cross-sectional study, we recruited long-term, disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe, and the United Kingdom (UK)., Results: A number of challenges were encountered in recruiting participating centres, obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life (HRQoL) data in a timely manner. The efficiency with which the study could be conducted varied widely across centres and countries. Time to obtain medical ethical approval for the study ranged from 1.5 to 25 months. We encountered most problems with ethical approval in the UK, Italy and Belgium. In most cases, data collection was completed within 3 months (range 10 weeks-1 year). Completed questionnaires were obtained from 68% and 56%, respectively, of the testicular and prostate cancer survivors who were approached., Conclusions: HRQoL research among long-term survivors of EORTC phase III clinical trials is possible, but the process of ethical approval and data collection is a lengthy one. To minimise many of the logistical problems, long-term follow-up of patients should be an integral part of future clinical trials. Moreover, regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is currently developing computerized adaptive testing measures for the Quality of Life Questionnaire Core-30 (QLQ-C30) scales. The work presented here describes the development of an EORTC item bank for emotional functioning (EF), which is one of the core domains of the QLQ-C30., Methods: According to the EORTC guidelines on module development, the development of the EF item bank comprised four phases, of which the phases I-III are reported in the present paper. Phase I involved defining the theoretical framework for the EF item bank and a literature search. Phase II included pre-defined item selection steps and a multi-stage expert review process. In phase III, feedback from cancer patients from different countries was obtained., Results: On the basis of literature search in phase I, a list of 1750 items was generated. These were reviewed and further developed in phase II with a focus on relevance, redundancy, clarity, and difficulty. The development and selection steps led to a preliminary list of 41 items. In phase III, patient interviews (N = 41; Austria, Denmark, Italy, and the UK) were conducted with the preliminary item list, resulting in some minor changes to item wording. The final list comprised 38 items., Discussion: The phases I-III of the developmental process have resulted in an EF item list that was well accepted by patients in several countries. The items will be subjected to larger-scale field testing in order to establish their psychometric characteristics and their fit to an item response theory model., (© 2013 The Authors. Psycho-Oncology published by John Wiley & Sons, Ltd.)

Background: European Organisation for Research and Treatment of Cancer (EORTC) has developed a new multidimensional instrument measuring cancer-related fatigue that can be used in conjunction with the quality of life core questionnaire, EORTC QLQ-C30. The paper focuses on the development of the phase III module, collaborating with seven European countries, including a patient sample of 318 patients., Methods: The methodology followed the EORTC guidelines for developing phase III modules. Patients were assessed by questionnaires (EORTC QLQ-C30 with the EORTC Fatigue Module FA15) followed by an interview, asking for their opinions on the difficulty in understanding, on annoyance and on intrusiveness., Results: The phase II FA15 was revised on the basis of qualitative analyses (comments of the patients), quantitative results (descriptive statistics) as well as the multi-item response theory analyses. The three dimensions (physical, emotional and cognitive) of the scale could be confirmed., Conclusions: As a result, EORTC QLQ-FA13 is now available as a valid phase III module measuring cancer-related fatigue in clinical trials and will be psychometrically improved in the upcoming phase IV., (Copyright © 2012 John Wiley & Sons, Ltd.)

Information disclosure is one of the key areas of support that patients may receive. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has a group working on the development of a questionnaire that evaluates information received by cancer patients at different stages of their disease--EORTC QLQ-INFO30. This instrument is being developed by professionals from most European regions. The questionnaire aims to evaluate the information received by cancer patients on different areas of the disease, diagnosis, treatment and care. Besides, the instrument also assesses qualitative aspects of the information they have received. The present paper presents the first two phases of the module development process that include literature review, interviews with patients and professionals, and formulation of the items. All these steps have been carried out in different countries and have been approved by the EORTC QLG.