IntroductionEarly guidelines for minimally important differences (MIDs) for the EORTC QLQ-C30 proposed ≥10 points change as clinically meaningful for all scales. Increasing evidence that MIDs can... Show moreIntroductionEarly guidelines for minimally important differences (MIDs) for the EORTC QLQ-C30 proposed ≥10 points change as clinically meaningful for all scales. Increasing evidence that MIDs can vary by scale, direction of change, cancer type and estimation method has raised doubt about a single global standard. This paper identifies MID patterns for interpreting group-level change in EORTC QLQ-C30 scores across nine cancer types.MethodsData were obtained from 21 published EORTC Phase III trials that enroled 13,015 patients across nine cancer types (brain, colorectal, advanced breast, head/neck, lung, mesothelioma, melanoma, ovarian, and prostate). Anchor-based MIDs for within-group change and between-group differences in change over time were obtained via mean change method and linear regression, respectively. Separate MIDs were estimated for improvements and deteriorations. Distribution-based estimates were derived and compared with anchor-based MIDs.ResultsAnchor-based MIDs mostly ranged from 5 to 10 points. Differences in MIDs for improvement vs deterioration, for both within-group and between-group, were mostly within a 2-points range. Larger differences between within-group and between-group MIDs were observed for several scales in ovarian, lung and head/neck cancer. Most anchor-based MIDs ranged between 0.3 SD and 0.5 SD distribution-based estimates.ConclusionsOur results reinforce recent claims that no single MID can be applied to all EORTC QLQ-C30 scales and disease settings. MIDs varied by scale, improvement/deterioration, within/between comparisons and by cancer type. Researchers applying commonly used rules of thumb must be aware of the risk of dismissing changes that are clinically meaningful or underpowering analyses when smaller MIDs apply. Show less
Machingura, A.; Taye, M.; Musoro, J.; Ringash, J.; Pe, M.; Coens, C.; ... ; Head Neck Canc Genito Urinary Canc 2022
Introduction: The European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) measures 15 health-related quality of life (HRQoL) scales relevant to... Show moreIntroduction: The European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) measures 15 health-related quality of life (HRQoL) scales relevant to the disease and treatment of patients with cancer. A study by Martinelli (2011) demonstrated that these scales could be grouped into three main clusters: physical, psychological and gastrointestinal. This study aims to validate Martinelli's findings in an independent dataset and evaluate whether these clusters are consistent across cancer types and patient characteristics. Methods: Pre-defined criteria for successful validation were three main clusters should emerge with a minimum R-squared value of 0.51 using pooled baseline-data. A cluster analysis was performed on the 15 QLQ-C30 HRQoL-scales in the overall dataset, as well as by cancer type and selected patient characteristics to examine the robustness of the results. Results: The dataset consisted of 20,066 patients pooled across 17 cancer types. Overall, three main clusters were identified (R-2 = 0.61); physical-cluster included role-functioning, physical functioning, social-functioning, fatigue, pain, and global-health status; psychological-cluster included emotional-functioning, cognitive-functioning, and insomnia; gastro-intestinal-cluster included nausea/vomiting and appetite loss. The results were consistent across different levels of disease severity, socio-demographic and clinical characteristics with minor variations by cancer type. Global-health status was found to be strongly linked to the scales included in the physical-functioning-related cluster. Conclusion: This study successfully validated prior findings by Martinelli (2011): the QLQC30 scales are interrelated and can be grouped into three main clusters. Knowing how these multidimensional HRQoL scales are related to each other can help clinicians and patients with cancer in managing symptom burden, guide policymakers in defining social-support plans and inform selection of HRQoL scales in future clinical trials. (C)2022 Elsevier Ltd. All rights reserved. Show less
Sztankay, M.; Wintner, L.M.; Roggendorf, S.; Nordhausen, T.; Dirven, L.; Taphoorn, M.J.B.; ... ; EORTC Quality Life Grp 2021
Purpose Implementation of patient-reported outcome measures (PROMs) in clinical routine requires knowledge and competences regarding their use. In order to facilitate implementation, an e-learning... Show morePurpose Implementation of patient-reported outcome measures (PROMs) in clinical routine requires knowledge and competences regarding their use. In order to facilitate implementation, an e-learning course for health care professionals (HCPs) on the utilisation of European Organisation for Research and Treatment of Cancer (EORTC) PROMs in oncological clinical practice is being developed. This study aimed to explore future users' educational needs regarding content and learning methods. Methods The sequential mixed methods approach was applied. A scoping literature review informed the guideline for qualitative interviews with HCPs with diverse professional backgrounds in oncology and cancer advocates recruited using a purposive sampling strategy. An international online survey was conducted to validate the qualitative findings. Results Between December 2019 and May 2020, 73 interviews were conducted in 9 countries resulting in 8 topic areas (Basic information on PROs in clinical routine, Benefits of PRO assessments in clinical practice, Implementation of PRO assessments in clinical routine, Setup of PRO assessments for clinical application, Interpretation of PRO data, Integration of PROs into the communication with patients, Use of PROs in clinical practice, Self-management recommendations for patients based on PROs) subsequently presented in the online survey. The online survey (open between 3 June and 19 July 2020) was completed by 233 HCPs from 33 countries. The highest preference was indicated for content on interpretation of PRO data (97%), clinical benefits of assessing PRO data (95.3%) and implementation of routine PRO data assessment (94.8%). Regarding learning methods, participants indicated a high preference for practical examples that use a mixed approach of presentation (written, audio, video and interactive). Conclusion Educational needs for an integration of PROs in communication in clinical care and coherent implementation strategies became evident. These results inform the development of an e-learning course to support HCPs in the clinical use of EORTC PRO measures. Show less
Background. Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all... Show moreBackground. Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients.Methods. Clinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (>0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence.Results. A total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and -4 to -14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and -4 to -16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10).Conclusions. MIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials. Show less
Coens, C.; Pe, M.; Dueck, A.C.; Sloan, J.; Basch, E.; Calvert, M.; ... ; Setting Int Stand Analyzing Patien 2020
Patient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide... Show morePatient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide information about treatment risks, benefits, and tolerability. However, expert opinion and critical review of the literature showed no consensus on optimal methods of PRO analysis in cancer RCTs, hindering interpretation of results. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium was formed to establish PRO analysis recommendations. Four issues were prioritised: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardising statistical terminology related to missing data, and determining appropriate ways to manage missing data. This Policy Review presents recommendations for PRO analysis developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, which provides a foundation for endorsement; ongoing developments of these recommendations are also discussed. Show less
To further advance assessment of patient-reported outcomes, the European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Group has developed computerized adaptive test (CAT... Show moreTo further advance assessment of patient-reported outcomes, the European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Group has developed computerized adaptive test (CAT) versions of all EORTC Quality of Life Core Questionnaire (QLQ-C30) scales/items. The aim of this study was to develop and evaluate an item bank for CAT measurement of insomnia (CAT-SL). In line with the EORTC guidelines, the developmental process comprised four phases: (I) defining the concept insomnia and literature search, (II) selection and formulation of new items, (III) pre-testing and (IV) field-testing, including psychometric analyses of the final item bank. In phase I, the literature search identified 155 items that were compatible with our conceptualisation of insomnia, including both quantity and quality of sleep. In phase II, following a multistep-approach, this number was reduced to 15 candidate items. Pre-testing of these items in cancer patients (phase III) resulted in an item list of 14 items, which were field-tested among 1094 patients in phase IV. Psychometric evaluations showed that eight items could be retained in a unidimensional model. The final item bank yielded greater measurement precision than the original QLQ-C30 insomnia item. It was estimated that administering two or more items from the insomnia item bank with CAT results in a saving in sample size between approximately 15-25%. The 8-item EORTC CAT-SL item bank facilitates precise and efficient measurement of insomnia as part of the EORTC CAT system of health-related quality life assessment in both clinical research and practice. Show less
Bottomley, A.; Reijneveld, J.C.; Koller, M.; Flechtner, H.; Tomaszewski, K.A.; Greimel, E.; ... ; 5th EORTC Quality Life Canc 2019
Purpose: Pain response rates are equivalent after single 8 Gy and fractionated palliative radiation therapy for bone metastases. Reirradiation remains more frequent after a single fraction,... Show morePurpose: Pain response rates are equivalent after single 8 Gy and fractionated palliative radiation therapy for bone metastases. Reirradiation remains more frequent after a single fraction, although this does not simply reflect pain recurrence. Given the possible role of stereotactic radiation therapy in providing durable pain control, measures of durability are required. Net pain relief (NPR), the proportion of remaining life spent with pain response, may provide this. This study assesses the use of NPR as an outcome measure after palliative radiation therapy for bone metastases.Methods and Materials: This is a secondary analysis of data collected in the Dutch Bone Metastasis Study, a randomized trial comparing palliative radiation therapy delivered as 8 Gy in a single fraction and 24 Gy in 6 fractions. NPR was assessed by survival cohorts, treatment regimen, and primary diagnoses. The consequences of missing data upon the use of NPR in future studies were considered within sensitivity analyses.Results: Patients whose pain improved after palliative radiation therapy experienced improvement for 56.6% of their remaining lives. Missing responses in questionnaires mean the range of uncertainty in NPR is 36.1% to 62.1%. When response beyond re-irradiation was excluded, NPR after treatments of single-fraction 8 Gy and 24 Gy in 6 fractions was 49.0% and 56.5%, respectively (P = .004). Differential willingness to reirradiate may be influencing this outcome. When response beyond reirradiation was included, this difference was not seen (NPR of 55.4% vs 57.7%, respectively [P = .191]).Conclusions: Patients who responded to conventional radiation therapy experienced improved pain control for approximately half of their remaining life. NPR may provide valuable information in assessing pain response durability. Missing data are, however, inevitable in this population. This must be minimized and the consequences recognized and reported. Additionally, reirradiation protocols and the frequency and duration of trial follow-up may have a significant impact upon this outcome, requiring careful consideration during trial design if NPR is to be used in future studies. (C) 2019 The Author(s). Published by Elsevier Inc. Show less
Bottomley, A.; Pe, M.; Sloan, J.; Basch, E.; Bonnetain, F.; Calvert, M.; ... ; Setting Int Stand Analyzing 2018
