Health-related quality of life with sacituzumab govitecan in HR+/HER2- metastatic breast cancer in the phase III TROPiCS-02 trial.

BACKGROUND: The TROPiCS-02 study (NCT03901339) demonstrated that sacituzumab govitecan (SG) has superior clinical outcomes over treatment of physician's choice (TPC) chemotherapy in patients with hormone receptor-positive, human epidermal growth factor 2 receptor-negative (HR+/HER2-) metastatic breast cancer (mBC). Here, we present health-related quality of life (HRQoL) patient-reported outcome (PRO) findings from this study. PATIENTS AND METHODS: Eligible adults with HR+/HER2- mBC who previously received a taxane, endocrine-based therapy, a CDK4/6 inhibitor, and 2-4 lines of chemotherapy were randomized 1:1 to receive SG or TPC until progression or unacceptable toxicity. PROs were assessed at baseline and on day 1 of each cycle, using the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 (EORTC QLQ-C30), EQ-5D-5L, and PRO Common Terminology Criteria for Adverse Events (PRO-CTCAE). RESULTS: Compared to TPC, overall least square mean change from baseline was significantly better for SG for physical functioning and dyspnea, but worse for diarrhea. Time to first clinically meaningful worsening or death was significantly longer for SG in global health status/quality of life, physical functioning, fatigue, emotional functioning, dyspnea, insomnia, and financial difficulties of the EORTC QLQ-C30 and the EQ-VAS, but longer for TPC in diarrhea. Few patients in both arms reported experiencing any worsening to level 3 or 4 treatment-related symptomatic events during treatment, as assessed by 16 PRO-CTCAE items, except for diarrhea frequency and amount of hair loss, which favored TPC. CONCLUSIONS: SG was associated with an HRQoL benefit in most symptoms and functioning, compared with TPC. This supports the favorable profile of SG as a treatment option for patients with pretreated HR+/HER2- mBC.

The impact of preoperative 5-alpha reductase inhibitors on functional outcomes and health-related quality of life following radical prostatectomy - A propensity score matched longitudinal study.

OBJECTIVES: While the impact of treatment with 5-alpha Reductase Inhibitors (5-ARI) on the risk of cancer-related mortality in men with prostate cancer (PC) has been extensively studied, little is known about the impact of preoperative 5-ARI use on patient-reported outcomes (PROs) following radical prostatectomy (RP). METHODS: Within our prospectively maintained institutional database of 5899 patients treated with RP for PC (2008- 2021), 99 patients with preoperative 5-ARI therapy were identified. A 1:4 propensity-score matched analysis of 442 men (n = 90 5-ARI, n = 352 no 5-ARI) was conducted. Primary endpoint was continence recovery using daily pad usage and ICIQ-SF. Health-related quality of life (HRQOL) was assessed using the validated EORTC QLQ-C30 and PR25 questionnaires. Multivariable Cox-regression-models tested the effect of preoperative 5-ARI treatment on continence-recovery (p < 0.05). RESULTS: Patients were followed up perioperatively, followed by annual assessments up to 60mo postoperatively. Preoperative mean ICIQ-SF score (2.2 vs. 0.9) was significantly higher in the 5-ARI cohort (p = 0.006). 24mo postoperatively, 68.6% (no 5-ARI) vs. 55.7% (5-ARI) had full continence recovery (p = 0.002). Multivariable Cox regression analysis, revealed preoperative 5-ARI treatment as an independent predictor for impaired continence recovery (HR 0.50, 95% CI 0.27-0.94, p = 0.03) In line, general HRQOL was significantly higher for patients without 5-ARI only up to 24mo postoperatively (70.6 vs. 61.2, p = 0.045). There was no significant impact of preoperative 5-ARI treatment on erectile function, biochemical recurrence-free survival and metastasis-free survival. CONCLUSIONS: Pre-RP 5-ARI treatment was associated with impaired continence outcomes starting 24mo postoperatively, suggesting that preoperative 5-ARI treatment can impair the long-term urinary function recovery following RP.

Estimating the minimally important difference for the EQ-5D-5L and EORTC QLQ-C30 in cancer.

BACKGROUND: The minimal important difference (MID) is a useful tool to interpret changes in patients' health-related quality of life. This study aims to estimate MIDs for interpreting within-patient change for both components of the EQ-5D-5L questionnaire [EQ-Visual Analogue Scale (EQ-VAS) and utility index] and domains of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) for cancer patients. METHODS: Data were obtained from the Cancer 2015 dataset, a longitudinal cohort of Australian cancer patients. Anchor-based approaches were used to estimate MIDs for the EQ-5D-5L index-based utility index [Australia and the United States (US) tariff sets], EQ-VAS scores, and the EORTC QLQ-C30. Clinical [Eastern Cooperative Oncology Group (ECOG) performance status] and patient-reported (items 29 and 30 of the EORTC QLQ-C30 and the EQ-VAS) anchors were assessed for appropriateness by their correlation strength. Clinical change groups (CCGs) were defined a priori for improvement and deterioration based on estimates used in previous literature. MIDs were estimated via linear regression and distribution-based methods. RESULTS: For the index-based utility scores in Australia, the anchor-defined MID estimates were 0.01 to 0.06 for improvement and - 0.04 to -0.03 for deterioration, with a weighted value of 0.03 for improvement and deterioration. The EQ-VAS MID estimate was 5 points for both improvement and deterioration. For the EORTC QLQ-C30, changes of at least 3.64 (improvement) and - 4.28 (deterioration) units on the physical functioning scale, 6.31 (improvement) and - 7.11 (deterioration) units on the role functioning scale, 4.65 (improvement) and - 3.41 (deterioration) units on the emotional functioning scale, and 5.41 (improvement) and - 5.56 (deterioration) units on the social functioning scale were estimated to be meaningful. CONCLUSION: This study identified lower MIDs for the EQ-5D-5L utility index, EQ-VAS, and EORTC QLQ-C30 domain scores, than those reported previously. The use of a real-world cancer-specific panel dataset may reflect smaller MID estimates that are more applicable to cancer patients in the clinical practice, rather than using MIDs that have been estimated from clinical trials.

Exploring the integration of dentistry within a multidisciplinary palliative care team: does bedside dental care improve quality of life and symptom burden in inpatient palliative care patients?

BACKGROUND: Despite the significant impact of oral problems on the quality of life of palliative care patients, comprehensive studies are lacking. This study is the first of its kind to address this gap by including both a dental examination and an intervention and assessing quality of life using the EORTC QLQ OH 15 questionnaire. OBJECTIVES: The objective of this study is to explore the impact of incorporating dentists into inpatient palliative care, with a focus on enhancing quality of life and alleviating symptom burden. METHODS: In this monocentric study, data were gathered from a palliative care unit over an 8-month period. At the beginning of the multidisciplinary treatment, T0, patients underwent both a dental examination and interviews utilizing established questionnaires, the EORTC QLQ-C30 (core, general) and OH 15 (oral health). A week later, at T1, patients underwent a follow-up examination and interview. The QLQ-C30 and OH15 are widely recognized instruments developed by the European Organisation for Research and Treatment of Cancer (EORTC) for evaluating health related quality of life in cancer patients. RESULTS: A total of n = 103 patients (48.5% women) were enrolled in the study. The median duration since their last dental visit was 1 year, and the dental condition at T0 was desolate. At T1, statistically and clinically significant changes in oral quality of life and symptom burden were observed. Noteworthy changes were noted in the OH-QoL score (median 63 vs. 92, p < 0.001), sticky saliva (median 33 vs. 0, p < 0.001), sensitivity to food and drink (median 33 vs. 0, p < 0.001), sore mouth (median 33 vs. 0, p > 0.001), and poorly fitting dentures (median 33 vs. 0 p < 0.001). Additionally, improvements were observed in xerostomia candidiasis and mucositis. CONCLUSION: The study highlights the powerful contribution of integrating a dentist in inpatient palliative care. With very little dental effort and simple ward and bedside treatments, significant improvements in the oral symptom burden of critically ill palliative patients can be achieved. This contributes to improved care status, relief of distressing symptoms, and ultimately improved quality of life. The results strongly support the consideration of dental support as an integral part of palliative care units.

Development of standard computerised adaptive test (CAT) settings for the EORTC CAT Core.

AIMS: Computerised adaptive test (CAT) provides individualised patient reported outcome measurement while retaining direct comparability of scores across patients and studies. Optimal CAT measurement requires an appropriate CAT-setting, the set of criteria defining the CAT including start item, item selection criterion, and stop criterion. The European Organisation for Research and Treatment of Cancer (EORTC) CAT Core allows for assessing the 14 functional and symptom domains covered by the EORTC QLQ-C30 questionnaire. The aim was to present a general approach for selecting CAT-settings and to use this to develop a portfolio of standard settings for the EORTC CAT Core optimised for different purposes and populations. METHODS: Using simulations, the measurement properties of CATs of different length and precision were evaluated and compared allowing for identifying the most suitable settings. All CATs were initiated with the most informative QLQ-C30 item. For each domain two fixed-length and two fixed-precision standard CATs were selected focusing on efficiency (brief version) and precision (long), respectively. RESULTS: The brief fixed-length CATs included 3-5 items each while the long versions included 5-8 items. The fixed-precision CATs aimed for reliability of 0.65-0.95 (brief versions) and 0.85-0.98 (long versions), respectively. Median sample size savings using the CATs compared to the QLQ-C30 scales ranged 20%-31%, although savings varied considerably across the domains. CONCLUSION: The EORTC CAT Core standard settings simplify selection of relevant and appropriate CATs. The CATs prioritise either brevity and efficiency or precision, but all provide increased measurement precision and hence, reduced sample size requirements compared to the QLQ-C30 scales. The CATs may be used as they are or modified to accommodate specific requirements.

Danish value sets for the EORTC QLU-C10D utility instrument.

PURPOSE: In this study, we developed Danish utility weights for the European Organisation for Research and Treatment of Cancer (EORTC) QLU-C10D, a cancer-specific utility instrument based on the EORTC QLQ-C30. METHODS: Following a standardized methodology, 1001 adult participants from the Danish general population were quota-sampled and completed a cross-sectional web-based survey and discrete choice experiment (DCE). In the DCE, participants considered 16 choice sets constructed from the key 10 dimensions of the QLU-C10D and chose their preferred health state for each one. Utility weights were calculated using conditional logistic regression with correction for non-monotonicity. RESULTS: The sample (n = 1001) was representative of the Danish general population with regard to age and gender. The domains with the largest utility decrements, i.e., the domains with the biggest impact on health utility, were physical functioning (- 0.224), pain (- 0.160), and role functioning (- 0.136). The smallest utility decrements were observed for the domains lack of appetite (- 0.024), sleep disorders (- 0.057), and fatigue (- 0.064). Non-monotonicity of severity levels was observed for the domains sleep disturbances, lack of appetite, and bowel problems. Deviations from monotonicity were not statistically significant. CONCLUSION: The EORTC QLU-C10D is a relatively new multi-attribute utility instrument and is a promising cancer-specific health technology assessment candidate measure. The country-specific Danish utility weights from this study can be used for cost-utility analyses in Danish patients and for comparison with other country-specific utility data.

Baseline functioning scales of EORTC QLQ-C30 predict overall survival in patients with gastrointestinal cancer: a meta-analysis.

PURPOSE: A consensus has not been reached on the value of quality of life (QoL) as a prognostic factor for survival in gastrointestinal cancer. This meta-analysis aimed to investigate the association between functioning scales of the EORTC QoL Questionnaire Core 30 (QLQ-C30) and the overall survival (OS) in patients with gastrointestinal cancer. METHODS: A systematic literature search was conducted in PubMed, Web of Science, and Embase databases, until February 7, 2023. The studies included were those that investigated the association between baseline QoL measured by the functioning scales of EORTC QLQ-C30 and OS in patients with gastrointestinal cancer. The prognostic capacity of QoL was calculated by pooling the adjusted hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: Twenty-four studies' analyses reported by 22 eligible articles involving 11,609 patients were included. When compared with good parameters of QoL, poor global QoL (HR 1.81; 95% CI 1.53-2.13), physical functioning (HR 1.51; 95% CI 1.31-1.74), social functioning (HR 1.67; 95% CI 1.30-2.15), and role functioning scale (HR 1.42; 95% CI 1.20-1.29) were significantly associated with decreased OS. For each 10-point increase in QLQ-C30 parameters, the pooled HR of OS was 0.87 (95% CI 0.83-0.92) for global QoL, 0.87 (95% CI 0.83-0.92) for physical functioning, and 0.93 (95% CI 0.88-0.97) for role functioning. However, each 10-point increase in social, emotional, or cognitive functioning scale did not significantly predict OS. CONCLUSIONS: Baseline health-related QoL defined by the physical functioning or global QoL scale of EORTC QLQ-C30 significantly predicts OS in patients with gastrointestinal cancer.

Mapping the EORTC QLQ-C30 and QLQ H&N35 to the EQ-5D-5L and SF-6D for papillary thyroid carcinoma.

PURPOSE: Empirical evidence for the EORTC QLQ C30 scale in thyroid cancer mapping algorithms has not been found in China, which limits the cost-utility analysis of patients with papillary thyroid carcinoma (PTC) population. We developed mapping algorithms that use the EORTC QLQ-C30 and QLQ H&N35 to predict EQ-5D-5L and SF-6D health utility scores for PTC patients. METHODS: Data from 1050 Chinese PTC patients who completed the EORTC QLQ-C30, QLQ H&N35, EQ-5D-5L and SF-6D instruments were collected. Direct mapping (OLS, Tobit, Betamix) and indirect mapping functions (Order Probit) were used to estimate algorithms. The goodness-of-fit of mapping performance was assessed by MAE, RMSE, AIC, BIC, AE, and ICC. A fivefold cross-validation and random sample validation approach were used to test the stability of the models. RESULTS: The mean EQ-5D-5L and SF-6D utility scores were 0.8704 and 0.6368, respectively. We recommend the Betamix model for the EQ-5D-5L (MAE = 0.0363, RMSE = 0.0505, AIC = -3458.73, BIC = -3096.91, AE > 0.05(%) = 48.38, AE > 0.1(%) = 8.67, ICC = 0.8288 for the full sample dataset) and the Betamix model for the SF-6D (MAE = 0.0328, RMSE = 0.0417, AIC = -2788.91, BIC = -2605.51, AE > 0.05(%) = 42.76, AE > 0.1(%) = 3.62, ICC = 0.8657 for the full sample dataset), with EORTC QLQ-C30 all items, QLQ H&N35 all items, age and gender as the predicted variables showing the best performance. CONCLUSION: In the absence of preference-based quality of life tools, the mapping algorithms reported here are effective alternative for predicting the health utility of PTC patients, contributing to the cost-utility analysis studies.

The impact of previous inguinal mesh hernioplasty on oncological and patient-reported outcomes following radical prostatectomy.

BACKGROUND: The impact of previous inguinal mesh hernioplasty (MH) with non-resorbable mesh prostheses on surgical performance of radical prostatectomy (RP) has been controversially discussed, with unknown impact of MH on oncologic outcomes and health-related quality of life (HRQOL) following RP. We therefore aimed to assess the influence of previous MH on metastasis-free survival (MFS), biochemical recurrence-free survival (BRFS), and HRQOL following RP. METHODS: We identified 344 patients with previous MH prior RP within our prospectively assessed institutional database of 6275 patients treated with RP for PC (2008-2019). A 1:3 propensity-score matched analysis of 1345 men (n = 319 previous MH, n = 1026 no previous MH) was conducted. Primary endpoint was MFS and secondary endpoints were BRFS and HRQOL (based on EORTC QLQ-C30). Binary logistic regression, Kaplan-Meier, and Cox regression models tested the effect of previous MH on MFS, BRFS, and HRQOL (p < 0.05). RESULTS: Median follow-up was 47 months. Patients with previous MH had significantly lower 5-year MFS (72% vs. 85%, p < 0.001) and 5-year BRFS estimates (43% vs. 57%, p < 0.001). In multivariate analysis, previous MH was confirmed as an independent predictor for impaired MFS (hazard ratio [HR]: 3.772, 95% CI 1.12-12.64, p = 0.031) and BRFS (HR: 1.862, 95% CI: 1.22-2.85, p = 0.004). These results held true if stratified for surgical approach or limited to patients with successful PLND. We found significantly shorter median time to continence recovery for patients without previous MH (p = 0.001) without significant differences in total continence recovery rates, erectile function recovery, and HRQOL. CONCLUSIONS: Our findings show an impaired oncologic outcome for patients with previous MH following RP with no significant differences regarding continence recovery, erectile function recovery, and general HRQOL.

Health-Related Quality of Life Outcomes With Two Different Starting Doses of Lenvatinib in Combination With Everolimus for Previously Treated Renal Cell Carcinoma.

BACKGROUND: Preserving health-related quality of life (HRQOL) is an important goal during renal cell carcinoma treatment. We report HRQOL outcomes from a phase II trial (NCT03173560). PATIENTS AND METHODS: HRQOL data were collected during a multicenter, randomized, open-label phase II study comparing the safety and efficacy of 2 different starting doses of lenvatinib (18 mg vs. 14 mg daily) in combination with everolimus (5 mg daily), following one prior vascular endothelial growth factor-targeted treatment. HRQOL was measured using 3 different instruments-FKSI-DRS, EORTC QLQ-C30, and EQ-5D-3L-which were all secondary endpoints. Change from baseline was assessed using linear mixed-effects models. Deterioration events for time to deterioration (TTD) analyses were defined using established thresholds for minimally important differences in the change from baseline for each scale. TTD for each treatment arm was estimated using the Kaplan-Meier method. RESULTS: Baseline characteristics of the 343 participants randomly assigned to 18 mg lenvatinib (n = 171) and 14 mg lenvatinib (n = 172) were well balanced. Least-squares mean estimates for change from baseline were favorable for the 18 mg group over the 14 mg group for the FKSI-DRS and most EORTC QLQ-C30 scales, but differences between treatments did not exceed the minimally important thresholds. Median TTD was longer among participants in the 18 mg group than those in the 14 mg group for most scales. CONCLUSIONS: Participants who received an 18 mg lenvatinib starting dose had favorable HRQOL scores and longer TTD on most scales compared with those who received a 14 mg starting dose.

The prognostic value of patient-reported outcomes in allogeneic hematopoietic stem cell transplantation: exploratory analysis of a randomized nutrition intervention trial.

Whether patient-reported outcomes (PROs) can predict overall survival (OS) and non-relapse mortality (NRM) among recipients of allogeneic stem cell transplantation (allo-HSCT), is unclear. We performed an exploratory analysis of the prognostic value of patient-reported outcomes (PROs) among 117 recipients of allogeneic stem cell transplantation (allo-HSCT) who participated in a randomized nutrition intervention trial. Cox proportional hazards models were used to investigate possible associations between PROs collected pre-allo-HSCT (baseline) using scores from the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) and 1-year overall survival (OS), whereas logistic regression was used to study associations between these PROs and 1-year non-relapse mortality (NRM). Multivariable analyses indicated that only the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) and the European Bone Marrow Transplantation (EBMT) risk score were associated with 1-year OS. In the multivariable model including clinical-sociodemographic factors for 1-year NRM, our analysis showed that living alone (p=0.009), HCT-CI (p=0.016), EBMT risk score (p=0.002), and stem cell source (p=0.046) could be associated with 1-year NRM. Moreover, in the multivariable model, our analysis showed that only appetite loss from the QLQ-C30 was associated with 1-year NRM (p=0.026). In conclusion, in this specific setting, our analysis suggests that the commonly used HCT-CI and EBMT risk scores could be predictive for both 1-year OS and 1-year NRM, whereas baseline PROs in general were not.

Associations between modifiable lifestyle factors and health-related quality of life among endometrial carcinoma survivors - A cross-sectional study.

OBJECTIVE: To explore possible associations between modifiable lifestyle factors and health-related quality of life (HRQoL) in endometrial carcinoma survivors by assessing differences in HRQoL between survivors meeting and not meeting the World Health Organization's (WHO) recommendations regarding physical activity, BMI, and smoking. METHODS: This was a cross-sectional population-based study in women having undergone surgery for assumed early-stage endometrial carcinoma. Thresholds for clinical importance based on the EORTC QoL working group were used to interpret scores. Effect size (ES) was interpreted as small (d = 0.2-0.49), medium (d = 0.5-0.8), and large (d > 0.8). RESULTS: In total, 1200 evaluable women were included. Meeting physical activity recommendations and BMI <25 kg/m2 was associated with significantly better global health status, (ES) = 0.18 and ES = -0.11, respectively. On multivariate analysis, women meeting physical activity recommendations had significantly higher scores on physical- (ES = 0.31), role- (ES = 0.15), and social functioning (ES = 0.15), and lower levels of fatigue (ES = -0.16), pain (ES = -0.10), and appetite loss (ES = -0.15) (all p < 0.05) compared to non-meeting survivors. Participants with BMI ≥25 kg/m2 had lower scores for social functioning (ES = -0.10), and higher levels of pain (ES = 0.13) and dyspnea (ES = 0.12) (all p < 0.05) compared to those with BMI <25 kg/m2. Smokers had lower scores for emotional functioning (ES = -0.09) and higher levels of diarrhea (ES = 0.10) (all p < 0.05) compared to non-smokers. CONCLUSION: Meeting WHO recommendations for modifiable life-style factors is associated with better HRQoL among endometrial carcinoma survivors: Being sufficiently physical active and having a BMI <25 kg/m2 are significantly associated with better self-reported global health status. All modifiable factors are associated with better functioning, and reduced symptom-burden.

Health-related quality of life in patients with steroid-refractory acute graft-versus-host disease.

BACKGROUND: Evidence regarding health-related quality of life (HRQoL) in patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD) is lacking. Evaluating HRQoL was a secondary objective of the HOVON 113 MSC trial. Here we describe the outcomes of the EQ-5D-5L, EORTC QLQ-C30, and FACT-BMT for all adult patients who completed these questionnaires at baseline (i.e., before the start of treatment; n = 26). METHODS: Descriptive statistics were used to describe baseline patient and disease characteristics, EQ-5D dimension scores and values, EQ VAS scores, EORTC QLQ-C30 scale/item and summary scores, and FACT-BMT subscale and total scores. RESULTS: The mean EQ-5D value was 0.36. In total, 96% of the patients reported problems with usual activities, 92% with pain/discomfort, 84% with mobility, 80% with self-care, and 72% with anxiety/depression. The mean EORTC QLQ-C30 summary score was 43.50. Mean scale/item scores ranged from 21.79 to 60.00 for functioning scales, from 39.74 to 75.21 for symptom scales, and from 5.33 to 91.67 for single items. The mean FACT-BMT total score was 75.31. Mean subscale scores ranged from 10.09 for physical well-being to 23.94 for social/family well-being. CONCLUSION: Our study showed that HRQoL in patients with SR-aGvHD is poor. Improving HRQoL and symptom management in these patients should be a top priority.

Comparison between Swedish EORTC QLQ-C30 general population norm data published in 2000 and 2019.

BACKGROUND: Normative health-related quality of life (HRQoL) data from the general population are regularly used to facilitate the interpretation of HRQoL as reported by cancer patients participating in cancer clinical trials, especially when conducting long-term follow-up studies after treatment. The aim of the present study is to compare two Swedish normative data sets, published in 2000 and 2019 respectively, and explore whether HRQoL as reported by the Swedish general population has changed over time. MATERIAL AND METHODS: 'Sample 2000' was comprised of normative data from the Swedish general population who responded to the EORTC QLQ-C30 in a Swedish mail survey in 1999 (n = 3069). 'Sample 2019' consisted of data from the Swedish general population collected as part of a European norm data study using online panels, published in 2019 (n = 1027). Data were analyzed stratified by sex and age (40-49; 50-59; 60-69; 70-79 years). RESULTS: For most of the subscales and single items, no age group differences between the two samples were found, with the exception of the oldest age group (70-79 years), where Sample 2019 generally showed better HRQoL as compared to Sample 2000. Lower (worse) levels of Global quality of life and higher (worse) levels of Dyspnoea were found in Sample 2019 for most age groups. CONCLUSION: There were no differences found between the samples for most EORTC QLQ-C30 subscales and single items, with the exception of the oldest age group of both sexes in Sample 2019 who reported better HRQoL on many variables. When deciding which normative dataset to use, the mode of data collection and age group have to be considered.

Using the emotional functioning in clinical practice to detect psychological distress in patients with advanced thoracic and colorectal cancer.

PURPOSE: Patients with advanced cancer suffer significant decline of their psychological state. A rapid and reliable evaluation of this state is essential to detect and treat it and improve quality of life. The aim was to probe the usefulness of the emotional function (EF) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EF-EORTC-QLQ-C30) to assess psychological distress in cancer patients. METHODS: This is a multicenter, prospective, observational study involving 15 Spanish hospitals. Patients diagnosed with unresectable advanced thoracic or colorectal cancer were included. Participants completed the Brief Symptom Inventory 18 (BSI-18), the current the gold standard, and the EF-EORTC-QLQ-C30 to assess their psychological distress prior to initiating systemic antineoplastic treatment. Accuracy, sensitivity, positive predictive value (PPV), specificity, and negative predictive value (NPV) were calculated. RESULTS: The sample comprised 639 patients: 283 with advanced thoracic cancer and 356 with advanced colorectal cancer. According to the BSI scale, 74% and 66% displayed psychological distress with an EF-EORTC-QLQ-C30 accuracy of 79% and 76% in detecting psychological distress in individuals with advanced thoracic and colorectal cancer, respectively. Sensitivity was 79 and 75% and specificity was 79 and 77% with a PPV of 92 and 86% and a NPV of 56 and 61% (scale cut-off point, 75) for patients with advanced thoracic and colorectal cancer, respectively. The mean AUC for thoracic cancer was 0.84 and, for colorectal cancer, it was 0.85. CONCLUSION: This study reveals that the EF-EORTC-QLQ-C30 subscale is a simple and effective tool for detecting psychological distress in people with advanced cancer.

Development and psychometric evaluation of item banks for memory and attention - supplements to the EORTC CAT Core instrument.

BACKGROUND: Cancer patients may experience a decrease in cognitive functioning before, during and after cancer treatment. So far, the Quality of Life Group of the European Organisation for Research and Treatment of Cancer (EORTC QLG) developed an item bank to assess self-reported memory and attention within a single, cognitive functioning scale (CF) using computerized adaptive testing (EORTC CAT Core CF item bank). However, the distinction between different cognitive functions might be important to assess the patients' functional status appropriately and to determine treatment impact. To allow for such assessment, the aim of this study was to develop and psychometrically evaluate separate item banks for memory and attention based on the EORTC CAT Core CF item bank. METHODS: In a multistep process including an expert-based content analysis, we assigned 44 items from the EORTC CAT Core CF item bank to the memory or attention domain. Then, we conducted psychometric analyses based on a sample used within the development of the EORTC CAT Core CF item bank. The sample consisted of 1030 cancer patients from Denmark, France, Poland, and the United Kingdom. We evaluated measurement properties of the newly developed item banks using confirmatory factor analysis (CFA) and item response theory model calibration. RESULTS: Item assignment resulted in 31 memory and 13 attention items. Conducted CFAs suggested good fit to a 1-factor model for each domain and no violations of monotonicity or indications of differential item functioning. Evaluation of CATs for both memory and attention confirmed well-functioning item banks with increased power/reduced sample size requirements (for CATs ≥ 4 items and up to 40% reduction in sample size requirements in comparison to non-CAT format). CONCLUSION: Two well-functioning and psychometrically robust item banks for memory and attention were formed from the existing EORTC CAT Core CF item bank. These findings could support further research on self-reported cognitive functioning in cancer patients in clinical trials as well as for real-word-evidence. A more precise assessment of attention and memory deficits in cancer patients will strengthen the evidence on the effects of cancer treatment for different cancer entities, and therefore contribute to shared and informed clinical decision-making.

Impacts of the preceding cancer-specific health-related quality of life instruments on the responses to the subsequent EQ-5D-5L.

BACKGROUND: In clinical studies, the EQ-5D-5L is often employed with disease-specific health-related quality of life instruments. The questions in the former are more general than the latter; however, it is known that responses to general questions can be influenced by preceding specific questions. Thus, the responses to the EQ-5D-5L have the possibility of being influenced by the preceding disease-specific health-related quality of life instruments. This may lead to bias in the cost-effectiveness analysis results. Therefore, this study aimed to evaluate the impact of the preceding cancer-specific health-related quality of life instruments on the EQ-5D-5L responses. METHODS: We prepared questionnaire booklets containing the EQ-5D-5L, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, and the Functional Assessment of Cancer Therapy General with different orders. Using a quasi-randomized design, they were distributed to the patients undergoing drug therapy for advanced cancer, who were classified into three groups: Groups 1, 2, and 3 (the EQ-5D-5L placed first, second, and last, respectively). We compared the EQ-5D-5L index and the missingness of EQ-5D-5L among the groups. RESULTS: The mean EQ-5D-5L index was 0.796, 0.760, and 0.789 for groups 1 (n = 300), 2 (n = 306), and 3 (n = 331), respectively. The difference between Groups 2 and 1 was - 0.036 (95% CI - 0.065 to - 0.007; p = 0.015). The proportion of patients with an incomplete EQ-5D-5L was 0.11, 0.11, and 0.05 for Groups 1, 2, and 3, respectively. The difference of the proportions between group 3 and 1 and between 3 and 2 was - 0.06 (95% CI - 0.10 to - 0.02; p = 0.003) and - 0.06 (95% CI - 0.10 to - 0.02; p = 0.003), respectively. CONCLUSIONS: Although the EQ-5D-5L index differed according to the instrument orders, the difference size would not be considerably larger than the minimally important difference. The patients tended to complete the EQ-5D-5L when they were placed at the end of the questionnaire.

"Evaluation of quality of life in patients with gastric adenocarcinoma receiving chemoradiotherapy: a cross-sectional study".

PURPOSE: The aim of this study was to evaluate quality of life (QoL) in patients with gastric adenocarcinoma receiving adjuvant chemoradiotherapy (CRT). METHODS: The European Organization for Cancer Research and Treatment Quality of Life Questionnaire-Core 30 (QLQ-C30) and site-specific module for gastric cancer (QLQ-STO22) were administered at four time points to 156 patients admitted to Cumhuriyet University Oncology Center between 2011 and 2018. RESULTS: The patient group comprised 76% men and 24% women with a median age of 61 years (range, 18-88). During CRT, 12 patients (8%) discontinued treatment, 25 (16%) lost weight, and 42 (27%) had reduced performance. There was significant worsening in QLQ-C30 global health status and all functional and symptom scale scores at CRT completion. These changes were also clinically significant except for physical functioning scores and were supported by minimal clinically important difference measurements. In the QLQ-STO22, all symptoms except dry mouth and hair loss were negatively affected at CRT completion. In general, scores were improved at 1 month after CRT and almost all scores reached baseline level by 6 months. Certain scores were more adversely affected in women (global health status, physical functioning, role functioning, fatigue, pain, and insomnia), those who lost weight during CRT (emotional functioning), and those with CRT interruption (emotional functioning and anxiety). CONCLUSION: Although CRT reduces QoL in patients with gastric cancer, the effects tend to resolve within 6 months after completing treatment. Female sex, weight loss, and CRT interruption negatively affected some QoL scores.

Development of a diverse set of standard short forms based on the EORTC CAT Core item banks.

PURPOSE: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed item banks covering the 14 domains of the EORTC QLQ-C30 quality of life questionnaire. These allow for dynamic assessment and for forming population/study specific static short forms. To simplify selection of relevant short forms, we here present a portfolio of standard short forms with measurement properties optimized for different populations. METHODS: For each domain, a brief and a long version were constructed for each of three populations having mild, moderate, and severe symptoms, respectively. The most informative items were prioritised while also taking content into consideration. All short forms included at least one QLQ-C30 item. The measurement precision/power of the short forms was compared to the corresponding QLQ-C30 scales using simulations. RESULTS: In total, 84 short forms were constructed. The brief versions included 3-5 items each, the long versions 5-9 items. Estimated sample size savings using the suggested short forms while maintaining the same power as with the QLQ-C30 ranged 3-50% across domains with median savings of 19% (brief versions) and 28% (long versions), respectively. CONCLUSION: The suggested short forms allow for simple selection of items particularly relevant for patients with mild, moderate, or severe symptoms, respectively. They facilitate the use of smaller samples without loss of power compared to the QLQ-C30 scales. The suggested short forms may be used as they are or adapted to the specific aims of individual studies/settings.

How scoring limits the usability of minimal important differences (MIDs) as responder definition (RD): an exemplary demonstration using EORTC QLQ-C30 subscales.

PURPOSE: The recommended method for establishing a meaningful threshold for individual changes in patient-reported outcome (PRO) scores over time uses an anchor-based method. The patients assess their perceived level of change and this is used to define a threshold on the PRO score which may be considered meaningful to the patient. In practice, such an anchor may not be available. In the absence of alternative information often the meaningful change threshold for assessing between-group differences, the minimally important difference, is used to define meaningful change at the individual level too. This paper will highlight the issues with this, especially where the underlying measurement scale is not continuous. METHODS: Using the EORTC QLQ-C30 as an example, plausible score increments ("state changes") are calculated for each subscale highlighting why commonly used thresholds may be misleading, including leading to sensitivity analyses that are inadvertently testing the same underlying threshold. RESULTS: The minimal possible individual score change varies across subscales; 6.7 for Physical Functioning, 8.3 for Global Health Scale and Emotional Functioning, 11.1 for fatigue, 16.7 for role functioning, cognitive functioning, social functioning, nausea and vomiting, pain and 33.3 for single items. CONCLUSIONS: The determination of meaningful change for an individual patient requires input from the patients but being mindful of the underlying scale ensures that these thresholds are also guided by what is a plausible change for patients to achieve on the scale.