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Purpose This systematic review was performed to identify all relevant health-related quality of life (HRQoL) issues associated with COVID-19. Methods A systematic literature search was undertaken in April 2020. In four teams of three reviewers each, all abstracts were independently reviewed for inclusion by two reviewers. Using a pre-defined checklist of 93 criteria for each publication, data extraction was performed independently by two reviewers and subsequently compared and discussed. If necessary, a third reviewer resolved any discrepancies. The search was updated in February 2021 to retrieve new publications on HRQoL issues including issues related to the long-term consequences of COVID-19. Results The search in April 2020 identified 3342 potentially relevant publications, and 339 publications were selected for full-text review and data extraction. We identified 75 distinct symptoms and other HRQoL issues categorized into 12 thematic areas; from general symptoms such as fever, myalgia, and fatigue, to neurological and psychological issues. The updated search revealed three extra issues experienced during active disease and long-term problems with fatigue, psychological issues and impaired cognitive function. Conclusion This first comprehensive systematic review provides a detailed overview of the wide range of HRQoL issues experienced by patients with COVID-19 throughout the course of the disease. It demonstrates the devastating impact of the disease and provides critically important information for clinicians, to enable them to better recognize the disease and to provide knowledge important for treatment and follow-up. The results provided the foundation for the international development of a COVID-19 specific patient-reported HRQoL questionnaire.

Purpose The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients ( n  = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions The equivalence testing results support the voice script’s validity for administration of the QLQ-C30 via telephone.

BackgroundThere are different modes and ways to assess patient-reported outcomes (PROs) in clinical trials. However, there is little systematic information on how often different modes of assessment (MOA) are used in cancer clinical trials and how exactly assessments are conducted. The goal of this scoping review is to gain an understanding of the MOA and data management of PROs in cancer randomised controlled trials (RCTs) and the reporting quality thereof.Methods and analysisThis scoping review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Relevant trials will be identified via their indexed publications. We will search PubMed for RCTs conducted in cancer populations that evaluate a biomedical treatment with a PRO endpoint. Trials with publications published between January 2019 and November 2023 will be included. Two independent reviewers will review the references for both the abstract and full-text screening. We will extract data from the publications from a trial and the trial protocol if a protocol can be traced. Data will be summarised at the trial level. We will focus on a descriptive analysis of the MOA of PROs and on the relative frequencies of the different MOA. We will also evaluate the quality of reporting for the relevant SPIRIT and CONSORT guidelines that refer to the assessment of PROs in trials. Due to the scoping nature of our review, we will not perform a dedicated quality assessment of all trials.Ethics and disseminationThe proposed review is based on secondary, published data. Hence, no ethics review is necessary. The review is part of an ongoing project on the use of electronic data capture methods in cancer clinical trials. The findings from the review will support the project and contribute to synthesising guidance to ultimately improve the (electronic) measurement of patient-reported outcome measures in clinical trials.

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 < 0.30 with unrelated QLQ-C30 scales. Known-groups validity was shown according to sex, education, levels of anxiety and depression, satisfaction with communication, disease stage and treatment intention, professional evaluated, and having a companion during the visit. The QLQ-COMU26 captured changes over time in groups that were defined based on changes in the item of satisfaction with communication. Conclusion The EORTC QLQ-COMU26 is a reliable and valid measure of patients’ perceptions of their communication with HCPs. The EORTC QLQ-COMU26 can be used in daily clinical practice and research and in various cancer patient groups from different cultures. This questionnaire can help to improve communication between patients and healthcare professionals.

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 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.

Reconciliation refers to the process through which two or more independent forward translations are merged into one single translation. This critical step in the translation process is difficult to formalize. The purpose of this review is to analyze how reconciliation is specified in leading guidelines for the translation of quality-of-life questionnaires and other patient-reported outcome forms with regard to the number and qualifications of individuals involved, the processes followed, as well as the criteria applied. In general, relatively little attention has been paid to characterizing the process in detail. Based on these findings, we specify criteria to be followed.

Purpose Communication between patients and professionals is one major aspect of the support offered to cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a cancer-specific instrument for the measurement of different issues related to the communication between cancer patients and their health care professionals. Methods Questionnaire development followed the EORTC QLG Module Development Guidelines . A provisional questionnaire was pre-tested (phase III) in a multicenter study within ten countries from five cultural areas (Northern and South Europe, UK, Poland and Taiwan). Patients from seven subgroups (before, during and after treatment, for localized and advanced disease each, plus palliative patients) were recruited. Structured interviews were conducted. Qualitative and quantitative analyses have been performed. Results One hundred forty patients were interviewed. Nine items were deleted and one shortened. Patients’ comments had a key role in item selection. No item was deleted due to just quantitative criteria. Consistency was observed in patients’ answers across cultural areas. The revised version of the module EORTC QLQ-COMU26 has 26 items, organized in 6 scales and 4 individual items. Conclusions The EORTC COMU26 questionnaire can be used in daily clinical practice and research, in various patient groups from different cultures. The next step will be an international field test with a large heterogeneous group of cancer patients.

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.

Quality of life has become an important end point in clinical trials and academic studies. The questionnaires developed by the European Organisation for Research and Treatment of Cancer Quality of Life Group are widely used to measure quality of life in cancer patients. The expanding geographical coverage of current studies and trials implies a continuous rise in requests for new language versions of the questionnaires. Together with normal linguistic problems in translation, cultural differences come into play, especially in translations into non-European languages. Two types of such problems can be differentiated: first, specific issues related to culturally dependent activities or phenomena; second, topical issues related to taboos. These translation challenges have to be carefully addressed to ensure the equivalence and validity of the final questionnaires.

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.