General population normative values for the EORTC QLQ-C30 by age, sex, and health condition for the French general population.

BACKGROUND: General population normative values for the widely used health-related quality of life (HRQoL) measure EORTC QLQ-C30 support the interpretation of trial results and HRQoL of patients in clinical practice. Here, we provide sex-, age- and health condition-specific normative values for the EORTC QLQ-C30 in the French general population. METHODS: French general population data was collected in an international EORTC project. Online panels with quota samples were used to recruit sex and age groups. Number and type of comorbidities were assessed. Descriptive statistics were used to calculate general population values for each QLQ-C30 scale, separately for sex, age, and presence of one- and more chronic health conditions. A multivariate linear regression model has been developed to allow estimating the effect of sex, age, and the presence for one- and more chronic health conditions on EORTC QLQ-C30 scores. Data was weighted according to United Nation statistics adjusting for the proportion of sex and age groups. RESULTS: In total, 1001 French respondents were included in our analyses. The weighted mean age was 47.9 years, 514 (51.3%) participants were women, and 497 (52.2%) participants reported at least one health condition. Men reported statistically significant better scores for Emotional Functioning (+9.6 points, p = 0.006) and Fatigue (-7.8 point; p = 0.04); women reported better profiles for Role Functioning (+8.7 points; p = 0.008) and Financial Difficulty (-7.8 points, p = 0.011). According to the regression model, the sex effect was statistically significant in eight scales; the effect of increasing age had a statistically significant effect on seven of the 15 EORTC QLQ-C30 scales. The sex- and age effect varied in its direction across the various scales. The presence of health conditions showed a strong negative effect on all scales. CONCLUSION: This is the first publication of detailed French normative values for the EORTC QLQ-C30. It aims to support the interpretation of HRQoL profiles in French cancer populations. The strong impact of health conditions on QLQ-C30 scores highlights the importance of considering the impact of comorbidities in cancer patients when interpreting HRQoL data.

The EORTC QLU-C10D discrete choice experiment for cancer patients: a first step towards patient utility weights.

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Utility-Core 10 Dimensions (QLU-C10D) is a novel cancer-specific preference-based measure (PBM) for which value sets are being developed for an increasing number of countries. This is done by obtaining health preferences from the respective general population. There is an ongoing discussion if instead patients suffering from the disease in question should be asked for their preferences. We used the QLU-C10D valuation survey, originally designed for use in the general population, in a sample of cancer patients in Austria to assess the methodology's acceptability and applicability in this target group before obtaining QLU-C10D patient preferences. METHODS: The core of the QLU-C10D valuation survey is a discrete choice experiment in which respondents are asked to give preferences for certain health states (described by a relatively large number of 10 quality of life domains) and an associated survival time. They therewith are asked to trade off quality of life against life time. As this might be a very burdensome task for cancer patients undergoing treatment, a cognitive interview was conducted in a pilot sample to assess burden and potential additional needs for explanation in order to be able to use the DCE for the development of QLU-C10D patient preferences. In addition, responses to general feedback questions on the survey were compared against responses from a matched control group from the already completed Austrian general population valuation survey. RESULTS: We included 48 patients (mean age 59.9 years; 46% female). In the cognitive interview, the majority indicated that their experience with the survey was positive (85%) and overall clarity as good (90%). In response to the general feedback questions, patients rated the presentation of the health states less clear than matched controls (p = 0.008). There was no difference between patients and the general population concerning the difficulty in choosing between the health states (p = 0.344). CONCLUSION: Despite the relatively large number of DCE domains the survey was manageable for patients and allows going on with the QLU-C10D patient valuation study.

Evaluating the Thresholds for Clinical Importance of the EORTC QLQ-C15-PAL in Patients Receiving Palliative Treatment.

Background: The EORTC QLQ-C15-PAL is a shortened version of the widely used EORTC QLQ-C30. This questionnaire was developed to measure the symptoms and functional health of patients receiving palliative care. Objective: To enhance clinical interpretability of the EORTC QLQ-C15-PAL, our aim was to evaluate the sensitivity and specificity of thresholds for clinical importance developed previously for the QLQ-C30 when applied to the QLQ-C15-PAL scales. Design: Cross-sectional observational study. Setting/Subjects: Patients with cancer receiving any type of palliative treatment. Measurement: Patients completed the EORTC QLQ-C15-PAL and anchor items on limitations, worries, and need for help for each of the health domains covered by the questionnaire. The anchor items were summarized in a binary criterion for clinical importance to calculate the sensitivity and specificity of the thresholds for clinical importance. Results: In total, 225 patients participated in the study (mean age 64.5 years). Patients were recruited from Austria, Italy, the Netherlands, Poland, Spain, and the United Kingdom. The thresholds for clinical importance for the QLQ-C15-PAL scales showed a median sensitivity of 0.88 (range: 0.82 for sleep disturbances to 1.00 for dyspnea) and a median specificity of 0.74 (range: 0.54 for dyspnea to 0.89 for constipation). Conclusion: The thresholds for clinical importance showed high sensitivity and mostly high specificity in identifying clinically important symptoms and functional health impairments as assessed by the QLQ-C15-PAL. These thresholds will facilitate interpretation of EORTC QLQ-C15-PAL scores in daily clinical practice and clinical research.

Thresholds for clinical importance were established to improve interpretation of the EORTC QLQ-C30 in clinical practice and research.

OBJECTIVE: 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). STUDY DESIGN AND SETTING: 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. RESULTS: 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). CONCLUSION: 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.

Thresholds for clinical importance were defined for the European Organisation for Research and Treatment of Cancer Computer Adaptive Testing Core-an adaptive measure of core quality of life domains in oncology clinical practice and research.

OBJECTIVES: The aim of this article was to establish thresholds for clinical importance (TCIs) for the European Organisation for Research and Treatment of Cancer (EORTC) Computer Adaptive Testing (CAT) Core measure, the new adaptive version of the EORTC QLQ-C30. STUDY DESIGN AND SETTING: For our diagnostic study, we recruited cancer patients with mixed diagnoses and treatments from six European countries. Patients completed the EORTC CAT Core and a questionnaire with anchor items assessing criteria for clinical importance (limitations in everyday life, need for help/care, and worries by the patient/family/partner) for each EORTC CAT Core domain. We used a binary variable summarizing the anchor items for determining TCIs and for calculating the area under the curve (AUC) in receiving operator characteristic analysis as a measure of diagnostic accuracy. RESULTS: Using data from 498 cancer patients (mean age 60.4 years, 55.2% women), we established TCIs for the 14 domains of the EORTC CAT Core. Median AUC across domains was 0.93 (range 0.84-0.94). Median sensitivity and specificity of the TCIs were 0.91 (range 0.80-0.96) and 0.77 (range 0.66-0.84), respectively. TCIs and AUCs were largely consistent across patient groups. CONCLUSION: We have generated TCIs for the 14 functional health and symptom domains of the EORTC CAT Core. The EORTC CAT Core showed high diagnostic accuracy in identifying clinically important symptoms and functional impairments.

Complementing clinical cancer registry data with patient reported outcomes: A feasibility study on routine electronic patient-reported outcome assessment for the Austrian Myelome Registry.

OBJECTIVES: Routinely assessed patient-reported outcomes (PROs), such as quality of life (QOL), are important to supplement clinical cancer data but requires rigorous implementation. This study aims at depicting the implementation procedure and evaluating the feasibility of routine electronic PRO monitoring (ePRO) for collecting data supplementing the Austrian Myeloma Registry (AMR). METHODS: Integration of ePRO monitoring into clinical routine was planned according to the Replicating Effective Programs framework. QOL data were assessed regularly during treatment and aftercare at the hematooncological outpatient unit at the Medical University of Innsbruck with the EORTC QLQ-C30/ +MY20 and the EQ-5D-5L. Feasibility and usability testing were performed via a multimethod approach. RESULTS: Within the first year, 94.4% of the MM patients (N = 142, mean age 65.4, SD 11.8, 60% male) provided 748 PRO assessment time points overall. Patients and clinicians were satisfied with ePRO monitoring and indicated no to little disruption in clinical routine. Patient preference on assessment time points and completion frequency became evident. CONCLUSIONS: Complementing the AMR with ePRO data proved to be feasible. Our findings provide useful insights for healthcare providers considering introducing ePRO monitoring to their units for informing clinical registries as well as individualised feedback to patients alike.

Treatment Success Following Joint Arthroplasty: Defining Thresholds for the Oxford Hip and Knee Scores.

BACKGROUND: Patient-reported outcome scores are the mainstay method for quantifying success following arthroplasty. However, it is unclear when a "successful outcome" is achieved. We calculated threshold values for the Oxford Hip and Knee Score (OHS and OKS) representing achievement of a successful treatment at 12-month follow-up. METHODS: Questionnaires were administered to patients undergoing total hip (THA) or knee (TKA) arthroplasty before and 12 months after surgery alongside questions assessing key aspects of treatment success. A composite success criterion was used to perform receiver operator characteristic analysis. Thresholds providing maximum sensitivity and specificity were determined for the total sample and subgroups defined by presurgery scores. RESULTS: Data were available for 3203 THA and 2742 TKA patients. Applying the composite treatment success criterion, 67.3% of the TKA and 77.6% of the THA sample reported treatment success. Accuracy for predicting treatment success was high for the OHS and OKS (both areas under the curve, 0.87). For the OHS, a threshold value of 37.5 points showed highest sensitivity and specificity in the total sample, while for the OKS the optimal threshold was 32.5 points. Depending on presurgery scores, optimal thresholds varied between 32.5 and 38.5 for the OHS and 28.5 and 36.5 for the OKS. CONCLUSION: This is the first study to apply a composite "success" anchor to the OHS and OKS to evaluate outcome following total joint arthroplasty. Notably fewer patients report a "successful outcome" using a composite outcome threshold than report being "satisfied."

Following patient pathways to psycho-oncological treatment: Identification of treatment needs by clinical staff and electronic screening.

OBJECTIVE: In this retrospective investigation of patient pathways to psycho-oncological treatment (POT), we compared the number of POT referrals before and after implementation of electronic screening for POT needs and investigated psychosocial predictors for POT wish at a nuclear medicine department. METHODS: We extracted medical chart information about number of referrals and extent of follow-up contacts. During standard referral (November 2014 to October 2015), POT needs were identified by clinical staff only. In the screening-assisted referral period (November 2015 to October 2016), identification was supported by electronic screening for POT needs. Psychosocial predictors for POT wish were examined using logistic regression. RESULTS: We analysed data from 487 patients during standard referral (mean age 56.4 years; 60.2% female, 88.7% thyroid carcinoma or neuroendocrine tumours) of which 28 patients (5.7%) were referred for POT. Of 502 patients in the screening-assisted referral period (mean age 57.0 years; 55.8% female, 86.6% thyroid carcinoma or neuroendocrine tumours), 69 (13.7%) were referred for POT. Of these, 36 were identified by psycho-oncological (PO) screening and 33 by clinical staff. After PO-screening implementation, referrals increased by a factor of 2.4. The strongest predictor of POT wish was depressive mood (P < .001). During both referral periods, about 15% of patients visited the PO outpatient unit additionally to inpatient PO consultations. CONCLUSIONS: Our results provide evidence from a real-life setting that PO screening can foster POT referrals, reduce barriers to express the POT wish, and hence help to meet psychosocial needs of this specific patient group. Differences between patients' needs, wish, and POT uptake should be further investigated.

A cross-cultural convergent parallel mixed methods study of what makes a cancer-related symptom or functional health problem clinically important.

OBJECTIVE: In this study, we investigated what makes a symptom or functional impairment clinically important, that is, relevant for a patient to discuss with a health care professional (HCP). This is the first part of a European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group project focusing on the development of thresholds for clinical importance for the EORTC QLQ-C30 questionnaire and its corresponding computer-adaptive version. METHODS: We conducted interviews with cancer patients and HCPs in 6 European countries. Participants were asked to name aspects of a symptom or problem that make it clinically important and to provide importance ratings for a predefined set of aspects (eg, need for help and limitations of daily functioning). RESULTS: We conducted interviews with 83 cancer patients (mean age, 60.3 y; 50.6% men) and 67 HCPs. Participants related clinical importance to limitations of everyday life (patients, 65.1%; HCPs, 77.6%), the emotional impact of a symptom/problem (patients, 53.0%; HCPs, 64.2%), and duration/frequency (patients, 51.8%; HCPs, 49.3%). In the patient sample, importance ratings were highest for worries by partner or family, limitations in everyday life, and need for help from the medical staff. Health care professionals rated limitations in everyday life and need for help from the medical staff to be most important. CONCLUSIONS: Limitations in everyday life, need for (medical) help, and emotional impact on the patient or family/partner were found to be relevant aspects of clinical importance. Based on these findings, we will define anchor items for the development of thresholds for clinical importance for the EORTC measures in a Europe-wide field study.

Improvement of quality of life and psychological distress after inpatient cancer rehabilitation : Results of a longitudinal observational study.

BACKGROUND: With the growing number of cancer survivors worldwide the need for high quality cancer rehabilitation after primary treatment is steadily increasing. The aim of the present study was to investigate change of psychological distress and health-related quality of life (HRQOL) during multidisciplinary inpatient cancer rehabilitation in a large sample of cancer survivors suffering from different cancer entities. METHODS: We analyzed data from routine HRQOL and distress monitoring at a cancer inpatient rehabilitation center. Cancer survivors completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) and the Hospital Anxiety and Depression Scale (HADS) before and after multidisciplinary rehabilitation treatment. Changes of patients' functioning and symptoms were analyzed using repeated measures analysis of variance (ANOVA) and effect sizes (Cohens' d). Patients' pretreatment and posttreatment scores were compared to reference data from the German general population. RESULTS: A total of 939 patients (mean age 58.6 years, SD 11.9 years; 59.9% women) who attended rehabilitation from January 2014 to September 2015 were included in the analysis. We found clinically meaningful improvement in almost all domains of the EORTC QLQ-C30 as well as in anxiety and depression (HADS). The largest improvements were found for the QLQ-C30 subscales emotional functioning (d = 0.78), fatigue (d = 0.65), and social functioning (d = 0.56). CONCLUSIONS: We found clinically meaningful improvements of patients' HRQOL, anxiety and depression during an oncological inpatient rehabilitation treatment. Our results warrant further prospective controlled studies to evaluate the long-term effectiveness of inpatient rehabilitation.

Impact of Comorbidities on Outcome After Total Hip Arthroplasty.

BACKGROUND: Patient-reported outcome scores gain increasing importance in quantifying clinical success and procedure remuneration. Our aim was to evaluate the impact of comorbidity on joint-specific outcome and general health in patients undergoing elective total hip arthroplasty (THA). METHODS: Longitudinal data on THA procedures were used to evaluate the association between comorbidity and surgical outcome in terms of joint-specific measures and general health (Forgotten Joint Score-12 [FJS-12], Oxford Hip Score [OHS], and Short Form-12) at 1-year follow-up. Comorbidities comprised the Charlson comorbidity index (CCI), low back pain (LBP), pain from other joints (POJ), and body mass index. RESULTS: We analyzed data from 251 THA patients (age: 67.7 ± 11.8 years; 58.2% female). Most common conditions were POJ (75.9%), LBP (55.1%), connective tissue disease (12.1%), and diabetes (5.6%). With regard to postoperative improvement, we did not find statistically significant differences between patients with or without CCI comorbidities (FJS-12, +38.7 vs +43.2, P = .370; OHS, +15.6 vs +17.9, P = .100) or POJ (FJS-12, +39.9 vs +45.1, P = .325; OHS, +17.3 vs +16.6, P = .645). Patients with LBP showed less improvement on the FJS-12 than those without LBP (+35.6 vs +49.1; P = .002), whereas no difference was found for the OHS (+17.9 vs +16.5; P = .266). CONCLUSION: Patients with comorbid conditions report lower preoperative and postoperative outcome scores compared with patients with no such conditions; however, there was no statistically significant association of CCI comorbidities and POJ with postoperative improvement in joint-specific outcomes. LBP was found to have a negative impact on postoperative improvement in terms of joint awareness.