Abstract 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.

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.

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.

Single-item questions assessing patient satisfaction following total hip or knee arthroplasty (THA/TKA) provide immediate and comprehensible information. However, they have limited reliability as satisfaction as a concept is influenced by factors unrelated to surgery. The aim of this retrospective study was to evaluate variation in pain, function and joint awareness relative to the patients’ satisfaction response following THA/TKA. We analysed absolute and improvement scores on the Oxford Knee or Hip score (OKS or OHS) and the Forgotten Joint Score-12 (FJS-12) across satisfaction groups. Patient-reported outcome measures were assessed prior to surgery and at 12-month follow-up. Postoperative satisfaction was assessed using a 5-point Likert scale single-item question. We analysed data from 434 TKA patients (mean age 70.4 ± 9.2 years; 54.8% female) and 247 THA patients (mean age 67.3 ± 11.8 years; 57.5% female). Satisfied or very satisfied patients showed higher absolute scores and better improvement in function, pain and joint awareness at 12 months (both, p < 0.001). 13.4% of (very) satisfied THA patients scored equally or worse on the FJS-12 than before surgery. On the OHS, this percentage was 2.8%. In TKAs, these percentages were 7.0% on the FJS-12 and 3.2% on the OKS. While higher satisfaction is associated with better patient-reported outcomes and stronger postoperative improvement, a certain percentage of patients score poorly while reporting a high satisfaction. Our results highlight the difficulty in interpreting the meaning of a single satisfaction question, as this provides limited information on patients’ treatment outcome and may be biased by factors unrelated to the intervention.

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. (C) 2019 The Authors. Published by Elsevier Inc.

The aim was to assess the influence of femoral derotational osteotomy on patella tilt (PT), axial patella engagement (AEI) and tibial tuberosity trochlear groove distance (TTTG). Derotational femoral osteotomy was performed on ten lower limbs of body donors embalmed with alcohol–glycerine. Femoral torsion, tibial torsion, knee torsion, PT, AEI and TTTG were evaluated on axial CT slices for an absolute femoral torsion of 15°, 20°, 25°, 30°, 35° and 40°. A linear mixed model analysis was used to estimate the effect of femoral torsion on PT, AEI, TTTG and knee torsion adjusted for correlation due to repeated observations. Estimates with 95% confidence intervals were used to represent the mean change in the dependent variables for one unit of change (degree, mm or AEI) in the predictor variable. A significant correlation was observed between femoral torsion and AEI (p < 0.001), PT (p < 0.001) and TTTG distance (p = 0.002). In cases of increased internal femoral torsion, a significant decreased AEI (estimate − 0.003, 95% CI − 0.003 to − 0.002), an increased PT (estimate 0.3, 95% CI 0.2–0.4) and an increased TTTG distance (estimate 0.1, 95% CI 0.1–0.2) were observed. No correlation was seen between change in femoral torsion and knee torsion (n.s.). Derotational femoral osteotomy has a significant impact on patella tilt and axial patella engagement. Moreover, TTTG distance is slightly changed by a derotational femoral osteotomy, which has to be taken into account preoperatively when considering surgical procedures. Level V.

The aim of this study was to investigate the association of femoral (FT), tibial (TT), and knee torsion (KT) on the patella tilt (PT), the axial engagement index (AEI), and the tibial tuberosity–trochlear groove distance (TTTG). Femoral torsion, tibial torsion, knee torsion, patella tilt, the axial engagement index, the TTTG, and trochlear dysplasia were retrospectively evaluated on 59 patients suffering from recurrent patella instability or anterior knee pain with 118 torsional lower limb magnetic resonance imaging studies. FT and TT did not show any significant associations with TTTG, PT, and AEI (n.s.). KT was significantly associated with a higher TTTG, higher PT, and lower AEI (all, p < 0.001). Higher grade trochlear dysplasia was associated with a higher PT and lower AEI (both, p < 0.001). The Dejour classification showed no significant association with FT, TT, KT, and TTTG (n.s.). All measurement parameters showed an excellent interrater agreement (ICC 0.89–0.97). Static patella tilt and patellofemoral axial engagement in knee extension are mainly influenced by knee torsion, TTTG, and trochlear dysplasia but not by femoral or tibial torsion. These findings help to understand the underlying reasons for the patella position in knee extensions in CT and MRI investigations in patients suffering from patella instability and patellofemoral pain syndrome. III.

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. (C) 2019 The Authors. Published by Elsevier Inc.

OBJECTIVES:To assess a targeted 'therapy as required' model of post-discharge outpatient physiotherapy provision. Specifically, we investigated what proportion of patients accessed post-discharge physiotherapy following total hip arthroplasty (THA) and total knee arthroplasty (TKA), whether accessing therapy was associated with post-arthroplasty patient reported outcomes and whether it was possible to predict which patients would access post-discharge physiotherapy from pre-operative data.DESIGN:Prospective, observational, longitudinal cohort study.SETTING:Single National Health Service orthopaedic teaching hospital in the UK.PARTICIPANTS:1395 patients undergoing total hip arthroplasty and 1374 patients undergoing total knee arthroplasty.PRIMARY AND SECONDARY OUTCOME MEASURES:Self-reported access of post-discharge physiotherapy, the Oxford Hip or Knee Score, EuroQol 5-dimension questionnaire and post-operative surgical episode satisfaction metric.RESULTS:662 (48.2%) patients with TKA and 493 (35.3%) patients with THA accessed additional post-discharge physiotherapy. Patient-reported outcomes (p<0.001) and surgical episode satisfaction (p=0.001) in both THA and TKA were higher in patients that did not participate in post-discharge physiotherapy. Regression models using pre-operative symptom burden and demographic data predicted post-discharge therapy access with an accuracy of only 17% greater than chance in patients with THA and 7% greater than chance in patients with TKA.CONCLUSIONS:In a choice-based service model of 'therapy as required' following hip and knee arthroplasty only a third of THA and half of TKA patients accessed post-discharge therapy. Patients who did not access physiotherapy reported greater post-operative outcomes. This variation in the need for post-discharge physiotherapy suggests that targeting of rehabilitation may be a cost-effective model, however it was not possible to reliably predict which patients would access post-discharge physiotherapy from pre-operative data.

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.

Background Volar locking plates with a central notch were designed to reduce the risk of flexor pollicis longus (FPL) tendon irritation after volar plating for distal radius fractures. Objective The purpose of this study was to evaluate the course of the FPL tendon after FPL-plate osteosynthesis to identify a plate position that avoids an impingement with the FPL tendon. Patients and Methods Nineteen patients treated with volar plating using an FPL plate for a distal radius fracture were evaluated. Transverse ultrasound images were used to assess whether the profile of the FPL tendon lied within the plate notch. The position of the FPL tendon on transverse ultrasound images was transferred onto postoperative dorsovolar X-ray images to define an FPL tendon corridor for a plate position not interfering with the FPL tendon. Results The FPL tendon was aligned inside the plate notch completely in three cases, partially in 11 cases, and missed the notch in five cases. An FPL corridor was defined at the level of the watershed line with all FPL tendons being completely (74%) or partially (26%) aligned inside that corridor. There was a moderate correlation between the plate notch being positioned inside this corridor and the FPL tendon being positioned inside the plate notch (r = 0.49;p = 0.033). Conclusion It seems advantageous to place the plate notch within a corridor parallel to the radial shaft between the ulnar edge of the scaphoid tubercle and the scapholunate interval for the FPL tendon protection.

ObjectiveIn 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. MethodsWe 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). ResultsWe conducted interviews with 83 cancer patients (mean age, 60.3y; 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. ConclusionsLimitations 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.

This study investigated the impact of body mass index (BMI) on improvement in patient outcomes (pain, function, joint awareness, general health and satisfaction) following total knee arthroplasty (TKA).

Obese patients undergoing total knee arthroplasty (TKA) face increased risks of complications such as joint infection and early revision. However, the influence of obesity on measures of patient function following TKA is poorly defined.Knee arthroplasty outcome data for procedures carried out over an eight month period was extracted from a regional database in the UK. We analysed the impact of weight categories (BMI<30, BMI=30–34.9, and BMI≥35) on the Forgotten Joint Score – 12 (FJS-12) and Oxford Knee Score (OKS). Data was available preoperatively and 12 months postoperatively. Physical and mental health was assessed with the SF-12 one year after surgery.Data from 256 patients were available. 49.6% had a BMI<30, 27.4% had a BMI 30–34.9 and 23.1% had a BMI≥35. Mean FJS-12 results at 1-year were 48.7 points for patients with a BMI<30, 40.7 points for patients with a BMI=30–34.9 and 34.0 points for patients with a BMI≥35. Effect sizes for change from baseline to 12-month post-op were 3.0 (Cohen's d) in pati...

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."

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.

Background: Joint awareness was recently introduced as a new concept for outcome assessment after total knee arthroplasty (TKA). Findings from qualitative and psychometric studies suggest that joint awareness is a distinct concept especially relevant to patients with good surgical outcome and patients at late follow-up time points. The aim of this study was to improve the understanding of the concept of joint awareness by identifying situations in which patients are aware of their artificial knee joint and to investigate what bodily sensations and psychological factors raise a patient's awareness of her/his knee. In addition, we evaluated the relative importance of patientreported outcome parameters that are commonly assessed in orthopaedics. Methods: Qualitative interviews were conducted with patients being at least 12 months after TKA. The interviews focused on when, where and for what reasons patients were aware of their artificial knee joint. To evaluate the relative importance of ' joint awareness' after TKA among nine commonly assessed outcome parameters (e. g. pain or stiffness), we collected importance ratings ('0' indicating no importance at all and '10' indicating high importance). Results: We conducted interviews with 40 TKA patients (mean age 69.0 years; 65.0% female). Joint awareness was found to be frequently triggered by kneeling on the floor (30%), climbing stairs (25%), and starting up after resting (25%). Patients reported joint awareness to be related to activities of daily living (68%), specific movements (60%), or meteoropathy (18%). Sensations causing joint awareness included pain (45%) or stiffness (15%). Psychological factors raising a patient's awareness of his/her knee comprised for example feelings of insecurity (15%), and fears related to revision surgeries, inflammations or recurring pain (8%). Patients' importance ratings of outcome parameters were generally high and did not allow differentiating clearly among them. Conclusions: We have identified a wide range of situations, activities, movements and psychological factors contributing to patients' awareness of their artificial knee joints. This improves the understanding of the concept of joint awareness and of a patient's perception of his/her artificial knee joint. The diversity of sensations and factors raising patient's awareness of their joint encourages taking a broader perspective on outcome after TKA.

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, broken vertical bar 39.9 vs broken vertical bar 45.1, P = .325; OHS, broken vertical bar 17.3 vs broken vertical bar 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. (C) 2017 Elsevier Inc. All rights reserved.