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Background Thresholds for clinical importance (TCIs) were previously established for the cancer-specific patient reported outcome (PRO) measures EORTC QLQ-C30, EORTC QLQ CAT Core, and EORTC QLQ-C15-PAL. TCIs aim to aid the interpretation of scores for individual patients at a single point in time. They intend to indicate whether a symptom or functional health limitation is of clinical relevance, i.e., requires to be discussed with healthcare professionals. In this systematic scoping review, we aimed to describe the uptake of TCIs by the research community and discuss opportunities and threats in their application to PRO data. Methods We systematically searched PubMed and Web of Science databases that contained search terms on the respective PRO measures and TCIs. Additionally, we performed a hand search on citations of the original TCI articles on Google Scholar. Articles were included if they applied TCIs in the analysis or the interpretation of PRO data or in clinical practice. Data concerning the study design, the use of TCIs, the terminology, and the application of TCIs were extracted. Results A total of 512 articles were identified. After title, abstract and full-text screening, data extraction was performed on 117 of these articles. Most articles reported on longitudinal-observational ( n  = 55) or cross-sectional observational ( n  = 49) studies, whereby the most frequent cancer populations having mixed diagnoses ( n  = 25), breast cancer ( n  = 23), haematological malignancies ( n  = 18), or colorectal cancer ( n  = 11). Various terms were used to refer to the concept of TCIs, with “ thresholds for clinical importance” being the most frequently used term (n = 63; 50.8%). Strikingly, 41 of the 117 articles (35.0%) reported that TCIs were applied to group-level data (e.g. mean scores), which is a clearly unintended application of the TCIs. Conclusion TCIs are frequently used by the research community and thus enhanced the interpretability of PRO data in oncology. While most studies correctly applied TCIs in their analysis and interpretation, further guidance and clarification on their use are required. This article aims to contribute to this endeavour.

Lung cancer may cause severe impairment of quality of life. An increasing number of lung cancer patients are receiving outpatient chemotherapy. However, little is known about gender aspects in the areas of impaired QoL in outpatient versus inpatient lung cancer patients. The aim of the study was to investigate this. We report from a prospective, multicenter study to analyze the EORTC QLQ-LC29, a new designed module to assess the QoL of lung cancer patients. The participants filled out the EORTC QLQ-C30 and the recently updated lung cancer module QLQ-LC29. A total of 198 lung cancer patients (73 female and 125 male, mean 64.5 age years) during first-line therapy were enrolled in this study by completing the both questionnaires. Women showed higher symptom scores, when being inpatient. Significant results were found regarding nausea/vomiting (mean women = 17.6 and mean men = 9.3, p = 0.037) and hair loss (mean women = 40.0 and mean men = 21.7, p = 0.010), although women received fewer chemotherapy treatments than their male counterparts (women n = 47, 64.4% and men n = 86, 68.8%). When it comes to global QoL, men report a significant worse QoL than women (mean women = 57.5 and mean men = 46.1, p = 0.016), when being inpatient. As outpatients, men report significant results regarding sore mouth and tongue (mean women = 1.2 and mean men = 13.5, p = 0.012). This study adds to the literature in showing the typical gender difference effect on QoL, suggesting men suffer less than women, is not a universal phenomenon irrespective of being inpatient or outpatient. It also confirms the hypothesis that the symptom burden is higher with inpatients than outpatients.

•This is the first study to investigate the sensitivity of the novel cancer-specific preference-based measures QLU-C10D in a clinical setting.•Our results show, that cancer-specific health state utility values in a myelodysplastic syndrome population may be determined using the QLU-C10D.•In general, our results inform the ongoing discussion on the arguable advantage of disease-specific over generic preference-based measures. The aim was to investigate the relative validity of the preference-based measure EORTC QLU-C10D in comparison with the EQ-5D-3L in myelodysplastic syndromes (MDS) patients. We used data from an international multicentre, observational cohort study of MDS patients. Baseline EORTC QLU-C10D and EQ-5D-3L scores were used and index scores calculated for Italy, Australia, and the UK. Criterion validity was established by Spearman and intraclass correlations (ICC) and Bland-Altman plots. Construct validity was established by the instruments’ ability to discriminate known groups, i.e. groups whose health status is expected to differ. We analyzed data from 619 MDS patients (61.1% male; median age 73.8 years). Correlations between theoretically corresponding domains were largely higher than between unrelated domains. ICCs and Bland-Altman plots indicated moderate to good criterion validity. Ceiling effects were lower for the QLU-C10D (4.7%) than for the EQ-5D-3L (22.6%). The EQ-5D-3L failed to discriminate known-groups in two and the QLU-C10D in one of the comparisons; the QLU-C10D's efficiency in doing so was higher in clinical known-groups. Results were comparable between the countries. The QLU-C10D may be suitable to generate health utilities for economic research in MDS. Responsiveness and minimal important differences need yet to be established.

Low skeletal muscle mass is known to be associated with poor morbidity and mortality outcomes in cancer, but evidence of its impact on health‐related quality of life (HRQOL) is less established. This systematic review and meta‐analysis was performed to investigate the relationship between skeletal muscle mass and HRQOL in adults with cancer. Five databases (Ovid MEDLINE, Embase via Ovid, CINAHL plus, Scopus, and PsycInfo) were systematically searched from 1 January 2007 until 2 September 2020. Studies reporting on the association between measures of skeletal muscle (mass and/or radiodensity) derived from analysis of computed tomography imaging, and a validated measure of HRQOL in adults with cancer, were considered for inclusion. Studies classifying skeletal muscle mass as a categorical variable (low or normal) were combined in a meta‐analysis to investigate cross‐sectional association with HRQOL. Studies reporting skeletal muscle as a continuous variable were qualitatively synthesized. A total of 14 studies involving 2776 participants were eligible for inclusion. Skeletal muscle mass classified as low or normal was used to dichotomize participants in 10 studies (n = 1375). Five different cut points were used for classification across the 10 studies, with low muscle mass attributed to 58% of participants. Low muscle mass was associated with poorer global HRQOL scores [n = 985 from seven studies, standardized mean difference −0.27, 95% confidence interval (CI) −0.40 to −0.14, P < 0.0001], and poorer physical functioning domain HRQOL scores (n = 507 from five studies, standardized mean difference −0.40, 95% CI −0.74 to −0.05, P = 0.02), but not social, role, emotional, or cognitive functioning domain scores (all P > 0.05). Five studies examined the cross‐sectional relationship between HRQOL and skeletal muscle mass as a continuous variable and found little evidence of an association unless non‐linear analysis was used. Two studies investigated the relationship between longitudinal changes in both skeletal muscle and HRQOL, reporting that an association exists across several HRQOL domains. Low muscle mass may be associated with lower global and physical functioning HRQOL scores in adults with cancer. The interpretation of this relationship is limited by the varied classification of low muscle mass between studies. There is a need for prospective, longitudinal studies examining the interplay between skeletal muscle mass and HRQOL over time, and data should be made accessible to enable reanalysis according to different cut points. Further research is needed to elucidate the causal pathways between these outcomes.

Background Cancers of the stomach and esophagus are the fourth and sixth most common causes of cancer‐related deaths worldwide, respectively. Although various tools have been developed to assess the quality of life of patients with esophagogastric cancer, EORTC QLQ‐C30 and EORTC QLQ‐OG25 are the most used all over the world. However, they have not been validated in an Ethiopian context. Therefore, this study aimed to evaluate the psychometric properties of EORTC QLQ‐OG25 among Ethiopian patients with esophageal and gastric cancer. Methods EORTC QLQ‐OG25 is a 25‐item tool with 10 single items and six symptom scales: Eating restrictions, reflux, dysphagia, odynophagia, discomfort and pain, and anxiety. The tool was translated into Amharic according to the EORTC forward‐backward translation protocol. To check its validity and reliability, a cross‐sectional study among 158 patients was conducted from March to May 2020 at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia. The psychometric properties of EORTC QLQ‐C30 and EORTC QLQ‐OG25 were assessed using multitrait scale analysis, known group validity, convergent validity, and divergent validity. Internal consistency was examined with Cronbach's alpha. Result Eighty‐three (52.5%) of the participants were men; the median age was 50 years (IQR = 18 years). The overall item correlation alpha values ranged between 0.39 and 0.7. All item correlations within their scales were greater than 0.4. The correlation coefficients between all items and their own domain were greater than for other domains. The esophagogastric and core questionnaire correlation ranged from −0.65 to 0.62. The tool showed a significant difference between patients with good physical function and those with impaired physical function. Conclusions The findings suggest that the Amharic version of EORTC QLQ‐OG25 is a valid and reliable tool among patients from Ethiopia with esophagus and gastric cancer. Therefore, we recommend that researchers and clinicians use the core tool together with the specific tool.

The objective of this study was to establish thresholds for clinical importance (TCIs) for the five functioning and nine symptom scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). In this diagnostic study, cancer patients with mixed diagnoses and treatments completed the EORTC QLQ-C30 and anchored the questions in each domain in terms of their clinical importance. The anchor questions, concerned limitations in daily life, need for help/care, and the worries of the patient and his/her partner/family. These questions allowed categorizing patients into whether they exhibited a clinically important symptom/functional impairment for each scale and performing a receiver operating characteristic curve analysis to establish TCIs. Data from 498 patients from six European countries (mean age 60.4 years, 55.2% women) were analyzed. For the TCIs generated using the patient questionnaire data, the EORTC QLQ-C30 scales showed sensitivity values between 0.71 and 0.97 and specificity values between 0.62 and 0.92 (area under the curve above 0.80 for all scales). This EORTC Quality of Life Group study provides TCIs for the functioning and symptom scales of the EORTC QLQ-C30. These TCIs can increase the interpretability of the questionnaire results and foster its use in daily clinical practice and in clinical research.

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.

Among the available neuroendocrine neoplasm (NEN)-specific HR-QoL scales, only the EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 questionnaires have been validated in several languages. We aim to assess patients’ perceptions of these questionnaires. A cross-sectional qualitative pilot study was conducted among 65 adults from four countries with well-differentiated advanced gastro-entero-pancreatic (GEP) or unknown primary NENs. Patients completed the EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 questionnaires and then a survey containing statements concerning the questionnaires. The majority of patients had a small intestine NET (52%). Most tumors were functioning (55%) and grade 2 NET (52%). Almost half of the patients identified limitations in the questionnaires, with nine (14%) patients scoring the questionnaires as poor and 16 (25%) patients as moderate. Overall, 37 (57%) patients were positive towards the questionnaires. Approximately a quarter of patients considered the questionnaires not suitable for all ages, missing some of their complaints, not representative of their overall HR-QoL regarding the treatment of their NET and too superficial. The current validated EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 questionnaires may show some limitations in the design of questions and the patients’ final satisfaction reporting of the questionnaire. Large-scale, high-quality prospective studies are required in HR-QoL assessment regarding NETs.

To further evaluate the higher order measurement structure of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), with the aim of generating a summary score. Using pretreatment QLQ-C30 data (N = 3,282), we conducted confirmatory factor analyses to test seven previously evaluated higher order models. We compared the summary score(s) derived from the best performing higher order model with the original QLQ-C30 scale scores, using tumor stage, performance status, and change over time (N = 244) as grouping variables. Although all models showed acceptable fit, we continued in the interest of parsimony with known-groups validity and responsiveness analyses using a summary score derived from the single higher order factor model. The validity and responsiveness of this QLQ-C30 summary score was equal to, and in many cases superior to the original, underlying QLQ-C30 scale scores. Our results provide empirical support for a measurement model for the QLQ-C30 yielding a single summary score. The availability of this summary score can avoid problems with potential type I errors that arise because of multiple testing when making comparisons based on the 15 outcomes generated by this questionnaire and may reduce sample size requirements for health-related quality of life studies using the QLQ-C30 questionnaire when an overall summary score is a relevant primary outcome.

Background Quality of life (QoL) has become an important measure for evaluating cancer patients’ treatment and prognosis. Breast cancer patients are at an increased risk of experiencing poor QoL during active treatment of cancer. This study aimed to assess QoL and it’s influencing factors among breast cancer patients using the newly updated breast cancer specific tool of the European Organisation for Research and Treatment of Cancer EORTC Breast Cancer Specific Quality of Life Questionnaire QLQ-BR45. Methods An institutional based crossectional study was conducted with 248 breast cancer patients at Tikur Anbessa Specialized Hospital (TASH). Descriptive statistics, one-way analysis of variance (ANOVA), and linear regression were used to describe and analyze the data. Results The participant’s Global health status/QoL mean score was 65.6. Among the functional scales, future perspective scored the lowest (57.1, SD ± 37.3). The highest mean score on the symptom scales/items were financial difficulties (50, SD ± 38.6), followed by appetite loss (37.4, SD ± 36.4) and fatigue (34.3, SD ± 27.1) while the lowest symptom score was diarrhoea (6.4 ± 18.4). EORTC QLQ-BR45, future perspective (mean = 57.1, SD ± 37.3) and upset by hair loss (41.8, SD ± 34.6) were the most affected functioning and symptoms scales respectively. An increased stage of tumor was associated with more pain ( P  = 0.041), appetite loss ( P = 0.042), and arm symptoms ( P  = 0.003). Patients who had no comorbidity had better physical ( P  < 0.001), cognitive ( P  = 0.013), and social ( P  = 0.009) function. Conclusion These specific functional scales and symptoms should be assessed individually to address unmet needs. Clinicians could design psychosocial interventions to improve these function and to reduce symptoms.