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Background: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire., Methods: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures., Results: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status., Conclusion: The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

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: Role functioning (RF) as a core construct of health-related quality of life (HRQOL) comprises aspects of occupational and social roles relevant for patients in all treatment phases as well as for survivors. The objective of the current study was to improve its assessment by developing a computer-adaptive test (CAT) for RF. This was part of a larger project whose objective is to develop a CAT version of the EORTC QLQ-C30 which is one of the most widely used HRQOL instruments in oncology., Methods: In accordance with EORTC guidelines, the development of the RF-CAT comprised four phases. Phase I involved the conceptualization of RF. In Phase II, a provisional list of items was defined and revised by experts in the field. In phase III, feedback was obtained from cancer patients in various countries. Phase IV comprised field testing in an international sample, calibration of the item bank, and evaluation of the psychometric performance of the RF-CAT., Results: Phases I-III yielded a list of 12 items eligible for phase IV field-testing. The field-testing sample included 1,023 patients from Austria, Denmark, Italy, and the UK. Psychometric evaluation and item response theory analyses yielded 10 items with good psychometric properties. The resulting item bank exhibits excellent reliability (mean reliability = 0.85, median = 0.95). Using the RF-CAT may allow sample size savings from 11 % up to 50 % compared to using the QLQ-C30 RF scale., Conclusions: The RF-CAT item bank improves the precision and efficiency with which RF can be assessed, promoting its integration into oncology research and clinical practice.

Objective: To improve measurement precision, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing an item bank for computerized adaptive testing (CAT) of emotional functioning (EF). The item bank will be within the conceptual framework of the widely used EORTC Quality of Life questionnaire (QLQ-C30)., Study Design and Setting: On the basis of literature search and evaluations by international samples of experts and cancer patients, 38 candidate items were developed. The psychometric properties of the items were evaluated in a large international sample of cancer patients. This included evaluations of dimensionality, item response theory (IRT) model fit, differential item functioning (DIF), and of measurement precision/statistical power., Results: Responses were obtained from 1,023 cancer patients from four countries. The evaluations showed that 24 items could be included in a unidimensional IRT model. DIF did not seem to have any significant impact on the estimation of EF. Evaluations indicated that the CAT measure may reduce sample size requirements by up to 50% compared to the QLQ-C30 EF scale without reducing power., Conclusion: On the basis of thorough psychometric evaluations, we have established an EF item bank of 24 items. This will allow for more precise and flexible measurement of EF, while maintaining backward compatibility with the QLQ-C30 EF scale., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: Patient-reported outcomes should ideally be adapted to the individual patient while maintaining comparability of scores across patients. This is achievable using computerized adaptive testing (CAT). The aim here was to develop an item bank for CAT measurement of the pain domain as measured by the EORTC QLQ-C30 questionnaire., Methods: The development process consisted of four steps: (1) literature search, (2) formulation of new items and expert evaluations, (3) pretesting and (4) field-testing and psychometric analyses for the final selection of items., Results: In step 1, we identified 337 pain items from the literature. Twenty-nine new items fitting the QLQ-C30 item style were formulated in step 2 that were reduced to 26 items by expert evaluations. Based on interviews with 31 patients from Denmark, France and the UK, the list was further reduced to 21 items in step 3. In phase 4, responses were obtained from 1103 cancer patients from five countries. Psychometric evaluations showed that 16 items could be retained in a unidimensional item bank. Evaluations indicated that use of the CAT measure may reduce sample size requirements with 15-25% compared to using the QLQ-C30 pain scale., Conclusions: We have established an item bank of 16 items suitable for CAT measurement of pain. While being backward compatible with the QLQ-C30, the new item bank will significantly improve measurement precision of pain. We recommend initiating CAT measurement by screening for pain using the two original QLQ-C30 pain items. The EORTC pain CAT is currently available for "experimental" purposes.

Background: No existing stand-alone measures of spiritual wellbeing have been developed in cross-cultural and multiple linguistic contexts., Aim: Cross-cultural development of a stand-alone European Organisation for Research and Treatment of Cancer (EORTC) measure of spiritual wellbeing for palliative care patients with cancer., Design: Broadly following EORTC Quality of Life Group (QLG) guidelines for developing questionnaires, the study comprised three phases. Phase I identified relevant issues and obtained the views of palliative care patients and professionals about those issues. Phase II operationalised issues into items. Phase III pilot-tested those items with palliative care patients. Amendments to the guidelines included an intermediate Phase IIIa, and debriefing questions specific to the measure., Setting/participants: Phase III pilot-testing recruited 113 people with incurable cancer from hospitals and hospices in six European countries and Japan., Results: A provisional 36-item measure ready for Phase IV field-testing, the EORTC QLQ-SWB36, has been developed. Careful attention to translation and simultaneous development in multiple languages means items are acceptable and consistent between different countries and languages. Phase III data from 113 patients in seven countries show that the items are comprehensible across languages and cultures. Phase III patient participants in several countries used the measure as a starting point for discussing the issues it addresses., Conclusion: The EORTC QLG's rigorous cross-cultural development process ensures that the EORTC QLQ-SWB36 identifies key issues for spiritual wellbeing in multiple cultural contexts, and that items are comprehensible and consistent across languages. Some cross-cultural differences were observed, but data were insufficient to enable generalisation. Phase IV field-testing will investigate these differences further.

Purpose: Computerized adaptive test (CAT) methods, based on item response theory (IRT), enable a patient-reported outcome instrument to be adapted to the individual patient while maintaining direct comparability of scores. The EORTC Quality of Life Group is developing a CAT version of the widely used EORTC QLQ-C30. We present the development and psychometric validation of the item pool for the first of the scales, physical functioning (PF). Methods: Initial developments (including literature search and patient and expert evaluations) resulted in 56 candidate items. Responses to these items were collected from 1,176 patients with cancer from Denmark, France, Germany, Italy, Taiwan, and the United Kingdom. The items were evaluated with regard to psychometric properties. Results: Evaluations showed that 31 of the items could be included in a unidimensional IRT model with acceptable fit and good content coverage, although the pool may lack items at the upper extreme (good PF). There were several findings of significant differential item functioning (DIF). However, the DIF findings appeared to have little impact on the PF estimation. Conclusions: We have established an item pool for CAT measurement of PF and believe that this CAT instrument will clearly improve the EORTC measurement of PF. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aim: A validation study was conducted to evaluate the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). This module was designed to assess disease and treatment specific aspects of the quality of life (QoL) of patients with endometrial cancer. Methods: Two hundred and sixty-eight women with endometrial cancer were recruited in different phases of treatment: after pelvic surgery (Group 1); during adjuvant chemotherapy and/or radiotherapy (Group 2); after completion of treatment (Group 3). Patients completed the EORTC QLQ-C30, the endometrial cancer module and a short debriefing questionnaire. Results: Multi-trait scaling analyses confirmed the hypothesised scale structure of the QLQ-EN24. Internal consistency reliability was good with Cronbach’s alpha coefficients ranging from 0.74 to 0.86 (lymphoedema 0.80, urological symptoms 0.75, gastrointestinal symptoms 0.74, body image problems 0.86 and sexual/vaginal problems 0.86). Convergent and discriminant validity did not show any scaling errors for the subscales. The QLQ-EN24 module discriminated well between clinically different groups of patients. All items exhibited a high completion rate with less than 2% missing values except for the sexuality items (19%). Conclusion: The validation study supports the reliability, the convergent and divergent validity of the EORTC QLQ-EN24. This newly developed QLQ-EN24 module is a useful instrument for the assessment of the QoL in patients treated for endometrial cancer in clinical trials. [Copyright &y& Elsevier]

Abstract: Aim: The EORTC Quality of Life (QOL) Group has developed an instrument to evaluate the information received by cancer patients. This study assessed the psychometric characteristics of the EORTC INFO module in a large international/multi-cultural sample of cancer patients. Methods: The provisional 26-item information module (EORTC INFO26) was administered with the EORTC QLQ-C30 and the information scales of the inpatient satisfaction module EORTC IN-PATSAT32 on two occasions during the patients’ treatment and follow-up period. Questionnaire-hypothesised scale structure, reliability, validity and responsiveness to changes were evaluated through standard psychometric analyses. Patient acceptability was assessed with a debriefing questionnaire. Results: The study comprised 509 patients from 8 countries (7 European countries and Taiwan) with different cancers and disease stages. Multi-trait scaling analysis led to the deletion of one item but confirmed the hypothesised 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. Internal consistency for all scales was good (α >0.70), as was test–retest reliability (intraclass correlations>0.70). All items can be combined to generate a single score (α >0.90). Convergent validity was supported by significant correlations with related areas of IN-PATSAT32 (r >0.40). Low correlations with EORTC QLQ-C30 scales confirmed divergent validity (r <0.30) The EORTC INFO-25 module discriminated among groups based on gender, age, education, levels of anxiety and depression, information wishes and satisfaction. Only one scale captured changes over time. Conclusions: The EORTC QLQ-INFO 25 is a reliable and valid self-reported instrument. The module can be used in cross-cultural observational and intervention studies. [Copyright &y& Elsevier]