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Background: To generate an item list for the assessment of joint awareness in shoulder patients and to collect patient feedback on the comprehensibility of the items and the forgotten joint concept., Methods: Item content was generated on the basis of literature search and expert ratings following a stepwise refinement procedure, including final evaluation by an international expert board (n = 12) including members with various professional backgrounds. Items were translated from English to German and evaluated in 30 German-speaking shoulder patients in Switzerland and 30 shoulder patients in the UK., Results: Literature search identified 45 questionnaires covering 805 issues potentially relevant for the assessment of joint awareness. Stepwise item selection resulted in 97 items to be evaluated by the international expert board leaving 70 items for collecting patient feedback. The majority of patients indicated that the introductory text explaining the forgotten joint concept was easy or very easy to understand (79.3%) and that the items were clear (91.4%)., Conclusion: We developed a list of 70 questions for the assessment of joint awareness in shoulder patients and obtained positive patient feedback for these. In a next step, we will administer the items to a large international patient sample to obtain data for psychometric analysis and development of a measurement model, which is the basis for creation of computer-adaptive assessments or static short-forms.

Background: In chemotherapy trials quality of life (QOL) is assessed mostly at the days of chemotherapy administration (i.e. event-driven) during treatment and follows fixed time intervals in the aftercare phase (i.e. time-driven). Specific QOL impairments and treatment side-effects are known to be time dependent following different trajectories. Therefore, acute problems are likely to be missed if assessments are done infrequently or at inappropriate time points. Since the planning of supportive care interventions during chemotherapy depends on knowledge about symptom trajectories, such information may be of substantial importance to a clinician., Methods: Cancer patients receiving chemotherapy at Kufstein County Hospital were assessed using an electronic version of the EORTC QLQ-C30 at the day of chemotherapy administration at the hospital. One and two weeks later assessments were repeated via the internet while patients were at home. Assessments at home and the hospital were conducted using the web-based software CHES. Data were analysed by means of linear mixed models., Results: A sample of 54 chemotherapy outpatients participated in electronic QOL assessments at the hospital and at home. For 9 out of the 15 QOL domains of the EORTC QLQ-C30 patients reported increased burden one week after chemotherapy administration compared to the day of chemotherapy administration. Most pronounced differences were found for Fatigue, Constipation, and Appetite Loss., Conclusions: Our results indicate that patients experience most severe QOL impairments in the week following chemotherapy administration. This is a period that is usually not covered by QOL assessments in chemotherapy trials which may result in underestimation of true treatment burden. Our findings suggest to conduct QOL assessments not only event- or time-driven, but to rely on specific hypotheses on symptom and functioning trajectories.

Purpose: General population reference data are useful in the interpretation of health-related quality of life (HRQoL) results, but for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), such data have been published for only seven countries. In 1992, Danish general population data were collected from women only for EORTC QLQ-C30 version 1. Since no Danish reference data exists for men and women for the QLQ-C30 version 3.0, the aims of this study were to generate such data and to investigate the associations between EORTC QLQ-C30 outcomes and age, gender and morbidity, as well as trends over time., Methods: An age- and gender-stratified random sample of 3,080 Danes was drawn from the Danish Civil Registration System. The EORTC QLQ-C30 was administered electronically and by mail along with a short questionnaire concerning socio-demographics/morbidity., Results: Responses were obtained from 1,832 individuals (60.1% of 3,009 eligible individuals). Response rates varied across age groups, ranging from 41.9% (20-29 years) to 76.1% (70-79 years). The majority of subscales were strongly associated with age and morbidity. Between genders only small, but clinically meaningful and statistically significant differences were found in five out of fifteen scales. When comparing Danish women 20 years ago and today, a tendency toward slightly improved function/reduced symptoms was observed, but the differences were small and statistically significant in only three subscales., Conclusion: This study is the first to present Danish general population reference values for the EORTC QLQ-C30 version 3.0. Age and morbidity are important potential confounders that must be taken into account in HRQoL studies.

Introduction: The efficacy of adjuvant endocrine treatment with aromatase inhibitors (AIs), inhibiting the conversion of androgens to estrogen in adipose tissue, might depend on the overall volume of adipose tissue. However, little evidence is available regarding the pharmacokinetic behavior of AIs in women with obesity. The aim of this study was to investigate the interaction between body mass index (BMI) and anastrozole treatment as well as estrogenic activity., Patients and Methods: A total of 216 postmenopausal patients with early-stage breast cancer who were receiving AI treatment with anastrozole constituted the final sample included in the analysis. During a regular 3-month after-care check-up, sociodemographic and clinical data and BMI were assessed. Blood samples were collected during routine blood testing. Measurement of AI plasma levels was performed by liquid chromatography-tandem mass spectrometry. Follicle stimulating hormone (FSH) and estradiol were measured within the routine blood examination., Results: A median anastrozole plasma concentration of 34.7 ng/mL (mean, 37.4), with a large interindividual variability, was observed (SD, 15.1; range, 5.4-86.5). After age adjustment, it was found that anastrozole plasma concentrations significantly increased with BMI (r = 0.241; P = .001). Anastrozole serum concentrations in women with obesity (BMI ≥ 30) exceeded those of women with normal weight (BMI ≤ 25) by 25%. Women with excess weight had lower mean FSH levels, indicating higher estrogenic activity, compared with women with normal weight., Conclusion: This study indicates that BMI is a vital factor in anastrozole metabolism, as measured by anastrozole plasma concentration and FSH levels. Further research is mandatory to clarify results on the association of obesity and AI treatment efficacy to allow adapting AI treatment accordingly., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting such research., Methods: In this cross-sectional study, we recruited long-term, disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe, and the United Kingdom (UK)., Results: A number of challenges were encountered in recruiting participating centres, obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life (HRQoL) data in a timely manner. The efficiency with which the study could be conducted varied widely across centres and countries. Time to obtain medical ethical approval for the study ranged from 1.5 to 25 months. We encountered most problems with ethical approval in the UK, Italy and Belgium. In most cases, data collection was completed within 3 months (range 10 weeks-1 year). Completed questionnaires were obtained from 68% and 56%, respectively, of the testicular and prostate cancer survivors who were approached., Conclusions: HRQoL research among long-term survivors of EORTC phase III clinical trials is possible, but the process of ethical approval and data collection is a lengthy one. To minimise many of the logistical problems, long-term follow-up of patients should be an integral part of future clinical trials. Moreover, regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is currently developing computerized adaptive testing measures for the Quality of Life Questionnaire Core-30 (QLQ-C30) scales. The work presented here describes the development of an EORTC item bank for emotional functioning (EF), which is one of the core domains of the QLQ-C30., Methods: According to the EORTC guidelines on module development, the development of the EF item bank comprised four phases, of which the phases I-III are reported in the present paper. Phase I involved defining the theoretical framework for the EF item bank and a literature search. Phase II included pre-defined item selection steps and a multi-stage expert review process. In phase III, feedback from cancer patients from different countries was obtained., Results: On the basis of literature search in phase I, a list of 1750 items was generated. These were reviewed and further developed in phase II with a focus on relevance, redundancy, clarity, and difficulty. The development and selection steps led to a preliminary list of 41 items. In phase III, patient interviews (N = 41; Austria, Denmark, Italy, and the UK) were conducted with the preliminary item list, resulting in some minor changes to item wording. The final list comprised 38 items., Discussion: The phases I-III of the developmental process have resulted in an EF item list that was well accepted by patients in several countries. The items will be subjected to larger-scale field testing in order to establish their psychometric characteristics and their fit to an item response theory model., (© 2013 The Authors. Psycho-Oncology published by John Wiley & Sons, Ltd.)

Objective: The aim of this study was to compare the responsiveness of various patient-reported outcome measures (PROMs) and clinician-reported outcomes following total knee arthroplasty (TKA) over a 2-year period., Methods: Data were collected in a prospective cohort study of primary TKA. Patients who had completed Forgotten Joint Score-12 (FJS-12), Western Ontario and McMaster Universities (WOMAC) osteoarthritis (OA) index, EQ-5D, Knee Society Score and range of movement (ROM) assessment were included. Five time points were assessed: pre-operative, 2 months, 6 months, 1 year and 2 years post-operative., Results: Data from 98 TKAs were available for analysis. Largest effect sizes (ES) for change from pre-operative to 2-month follow-up were observed for the Knee Society Score (KSS) Knee score (1.70) and WOMAC Total (-1.50). For the period from 6 months to 1 year the largest ES for change were shown by the FJS-12 (0.99) and the KSS Function Score (0.88). The EQ-5D showed the strongest ceiling effect at 1-year follow-up with 84.4% of patients scoring the maximum score. ES for the time from 1- to 2-year follow-up were largest for the FJS-12 (0.50). All other outcome measures showed ES equal or below 0.30., Conclusion: Outcome measures differ considerably in responsiveness, especially beyond one year post-operatively. Joint-specific outcome measures are more responsive than clinician-reported or generic health outcome tools. The FJS-12 was the most responsive of the tools assessed; suggesting that joint awareness may be a more discerning measure of patient outcome than traditional PROMs., (Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.)

Orthotopic liver transplantation (LTx) has become a routine procedure in the treatment of end-stage liver disease. During the waiting period for transplantation, the patient's family members are also highly affected. We examined the course of distress and quality of life (QOL) in 47 patients awaiting LTx and distress in 24 caregivers at baseline and in intervals of 4-6 weeks, using The Hospital Anxiety and Depression Scale (HADS) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). All subscales of the EORTC QLQ-C30, except emotional functioning, were lower than normal at baseline. Little change in patients' QOL was observed during the waiting period. In the HADS, there were significantly higher anxiety scores in caregivers than in patients both at baseline and after 1-2 months and the third assessment, with the difference after 3-5 months reaching almost significance. Caregivers' anxiety levels increased significantly. Relatives showed more depression than patients only at month 1-2 and a significant increase in depression from baseline to month 1-2. In patients, depression scores remained relatively stable throughout all visits. Our results emphasize the importance of evaluation of psychic stress especially in relatives during the waiting period for LTx., (Copyright © 2013. Published by Elsevier Ireland Ltd.)

Background: Due to the redundancy of molecular pathways simultaneously involved in glioblastoma growth and angiogenesis, therapeutic approaches intervening at multiple levels seem particularly appealing., Methods: This prospective, multicenter, single-arm phase II trial was designed to evaluate the antitumor activity of sunitinib, an oral small-molecule inhibitor of several receptor tyrosine kinases, in patients with first recurrence of primary glioblastoma using a continuous once-daily dosing regimen. Patients received a starting dose of sunitinib 37.5 mg, followed by a maintenance dose between 12.5 mg and 50 mg depending on drug tolerability. The primary endpoint was a 6-month progression-free survival (PFS) rate. Secondary endpoints included median PFS, overall survival (OS), safety/toxicity, quality of life, and translational studies on the expression of sunitinib target molecules., Results: Forty participants were included in this study, and no objective responses were detected. PFS6 was 12.5%, median PFS 2.2 months, and median OS 9.2 months. Five participants (12.5%) showed prolonged stable disease ≥6 months with a median PFS of 16.0 months (range, 6.4-41.4 mo) and a median OS of 46.9 months (range, 21.2-49.2 mo) for this subgroup. c-KIT expression in vascular endothelial cells (n = 14 participants) was associated with improved PFS. The most common toxicities were fatigue/asthenia, mucositis/dermatitis, dysesthesias, gastrointestinal symptoms, cognitive impairment, leukoctopenia, and thrombocytopenia. Two participants (5%) terminated treatment due to toxicity., Conclusion: Continuous daily sunitinib showed minimal antiglioblastoma activity and substantial toxicity when given at higher doses. High endothelial c-KIT expression may define a subgroup of patients who will benefit from sunitinib treatment by achieving prolonged PFS. ClinicalTrials.gov Identifier: NCT00535379.

Background: Patient-reported outcomes (PROs) are important in managing kidney transplant patients. Although, there are many instruments available to assess PROs, such as health-related quality of life (HRQOL), they are rarely collected in routine nephrology practices. Therefore, the aim of this study was the determination of reference values for physical and psychosocial symptom burden in kidney transplant patients., Methods: Patients with a history of kidney transplantation being in aftercare at a nephrological outpatient unit (n = 120) were consecutively recruited, and a computer-based PRO assessment was used to assess their HRQOL reference values. It covered a broad range of clinically relevant physical and psychological symptoms, adherence to immunosuppressants, and disease-specific quality of life. On an average, PROs were assessed 2.9 times per patient, 351 times in total., Results: For PRO monitoring in kidney transplant patients, we consider the 10th/90th percentile as being of particular clinical relevance, as patients exceeding these scores are likely to be in need of additional care., Conclusions: With continuously rising survival rates after kidney transplantation, HRQOL of long-term transplant patients becomes increasingly important, and it is generally accepted that HRQOL improves after successful kidney transplantation. We used a computerized PRO monitoring to determine HRQOL reference values for outpatient kidney transplant patients. Routine PRO monitoring may facilitate the identification of patient issues relevant to treatment, and may contribute to improved symptom and side-effect management. Future studies providing detailed PRO values for stratified patient samples are needed.

Purpose: Fatigue is one of the most common symptoms associated with cancer and its treatment. To obtain a more precise and flexible measure of fatigue, the EORTC Quality of Life Group has developed a computerized adaptive test (CAT) measure of fatigue. This is part of an ongoing project developing a CAT version of the widely used EORTC QLQ-C30 questionnaire., Methods: Based on the literature search and evaluations by experts and patients, 41 new fatigue items were developed (in addition to the three QLQ-C30 fatigue items). Psychometric properties of the items, including evaluations of dimensionality, fit to item response theory (IRT) model, and differential item functioning (DIF), were assessed in an international sample of cancer patients., Results: Responses were obtained from 1,321 cancer patients coming from eight countries. Factor analysis showed that 37 of the items could be included in a unidimensional model (RMSEA = 0.098, TLI = 0.995, CFI = 0.920). Of the 37 items, two were deleted because of poor fit to the IRT model forming the basis for the CAT, and one because of DIF between cancer sites., Conclusions: We have established a 34-item fatigue bank allowing for more precise and flexible measurement of fatigue, while still being backward compatible with the QLQ-C30 fatigue scale.

Background: Most lung cancer patients are diagnosed at an advanced disease stage and predominantly receive palliative treatment, which increasingly consists of several chemotherapy lines. We report on patients' quality of life (QOL) to gain knowledge on QOL during and across multiple lines of chemotherapy. This includes patients with (neo)adjuvant therapy up to 3rd or above line palliative chemotherapy., Methods: Lung cancer patients receiving outpatient chemotherapy at the Kufstein County Hospital completed an electronic version of the EORTC QLQ-C30. Linear mixed models were used for statistical analysis., Results: One hundred and eighty seven patients were included in the study. Surprisingly, irrespective of the chemotherapy line patients reported stable QOL scores during treatment. None of the calculated monthly change rates attained clinical significance, referring to established guidelines that classify a small clinical meaningful change as 5 to 10 points. According to treatment line, 3rd or above line palliative chemotherapy was associated with the worst QOL scores, whereas patients undergoing (neo)adjuvant or 1st line palliative chemotherapy reported fairly comparable QOL., Conclusion: The essential finding of our study is that all QOL aspects of the EORTC QLQ-C30 questionnaire remained unchanged during each chemotherapy line in an unselected population of lung cancer patients. Between treatment lines pronounced differences were found, indicating that later palliative chemotherapy lines are associated with higher QOL impairments. These changes in QOL may not primarily be related to the treatment, but rather refer to impairments due to disease progression and may be partly due to a consequence of the prior therapies.

Objective: The aim of this study was to evaluate recollection, perception and outcome of psychiatric consultation in a general hospital., Methods: 321 patients with three main diagnoses (substance use, affective, and adjustment disorders), who had been examined by consultation-liaison (C-L) psychiatrists within the past twelve months, initially took part in a telephone interview and were subsequently asked to complete and return questionnaires by mail., Results: Response rates for the telephone interview were 75.4%, and 46.7% of patients returned the completed questionnaires. 86.0% of the patients were able to remember seeing the C-L psychiatrist and 43.3% recalled their diagnosis accurately. 70.5% stated that this contact had been helpful. 61.5% remembered being given a psychiatric after-care recommendation, and 43.5% of the patients stated that they either disregarded or prematurely discontinued after-care., Conclusions: Even though the perception of the consultation is generally positive, many patients are not able to retain the given information on diagnosis and treatment recommendation. To increase continuity of care and to better address patients' needs we altered our C-L structure., (© 2013.)

Background: European Organisation for Research and Treatment of Cancer (EORTC) has developed a new multidimensional instrument measuring cancer-related fatigue that can be used in conjunction with the quality of life core questionnaire, EORTC QLQ-C30. The paper focuses on the development of the phase III module, collaborating with seven European countries, including a patient sample of 318 patients., Methods: The methodology followed the EORTC guidelines for developing phase III modules. Patients were assessed by questionnaires (EORTC QLQ-C30 with the EORTC Fatigue Module FA15) followed by an interview, asking for their opinions on the difficulty in understanding, on annoyance and on intrusiveness., Results: The phase II FA15 was revised on the basis of qualitative analyses (comments of the patients), quantitative results (descriptive statistics) as well as the multi-item response theory analyses. The three dimensions (physical, emotional and cognitive) of the scale could be confirmed., Conclusions: As a result, EORTC QLQ-FA13 is now available as a valid phase III module measuring cancer-related fatigue in clinical trials and will be psychometrically improved in the upcoming phase IV., (Copyright © 2012 John Wiley & Sons, Ltd.)

Objective: To investigate the influence of achieved/non-achieved paternity on quality of life (QoL) in testicular cancer (TC) survivors., Patients and Methods: We invited TC survivors treated at our department between 1989 and 2006 to complete a QoL assessment, including the European Organisation for the Research and Treatment of Cancer QoL questionnaire, EORTC QLQ-C30 (version 3.0©)/+ TC26, and follow-up questions. A total of 311 TC survivors answered the questionnaire, of whom 207 patients who did not desire paternity were excluded. The remaining 104 patients who stated a desire for paternity after TC treatment were further divided in group A (TC survivors who achieved paternity; n = 51) and group B (TC survivors who did not achieve paternity; n = 53). The data obtained were statistically analysed., Results: Significant differences between groups regarding QoL were detected for social functioning (P = 0.002), emotional functioning (P = 0.001), general QoL (P = 0.018), fatigue (P = 0.025), pain (P = 0.01), sleeping problems (P = 0.024), treatment satisfaction (P = 0.039), financial aspects (P = 0.006), sexual problems (P = 0.017), body image problems (P < 0.001), dyspnoea (P = 0.005) and cognitive functioning (P = 0.019). For all scales except 'sexual enjoyment', patients in group A were found to have a better long-term QoL than those in group B., Conclusions: Whilst acknowledging the shortcomings in retrospective analyses, we believe our data clearly underline the important impact on QoL for TC survivors of achieved paternity. Counselling patients early at diagnosis as well as using cryopreservation of semen in all potential patients before treatment (only excluding patients definitely claiming they do not wish to achieve paternity) should therefore be regarded as the standard of care., (© 2012 BJU INTERNATIONAL.)

Patient-reported outcomes (PROs) are an important endpoint in orthopedics providing comprehensive information about patients' perspectives on treatment outcome. Computer-adaptive test (CAT) measures are an advanced method for assessing PROs using item sets that are tailored to the individual patient. This provides increased measurement precision and reduces the number of items. We developed a CAT version of the Forgotten Joint Score (FJS), a measure of joint awareness in everyday life. CAT development was based on FJS data from 580 patients after THA or TKA (808 assessments). The CAT version reduced the number of items by half at comparable measurement precision. In a feasibility study we administered the newly developed CAT measure on tablet PCs and found that patients actually preferred electronic questionnaires over paper-pencil questionnaires., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objective: Testicular cancer (TC) is the most common cancer in young men, and its incidence is increasing. The low mortality rate makes quality of life (QOL) an important issue in this patient group. This study aimed to develop a supplementary module of the EORTC QLQ-C30 questionnaire to assess TC-specific aspects of QOL., Methods: Questionnaire development was conducted according to guidelines from the EORTC Quality of Life Group. Phase I comprised generation of QOL issues relevant to TC patients through a literature search and interviews with patients and experts. Phase II included operationalization and assessment of item relevance. In phase III, items were pre-tested in a cross-cultural sample to assess issues such as understandability and intrusiveness of items., Results: In phase I and II, an initial list of 69 QOL issues possibly relevant to TC patients was refined through patient and expert interviews. The remaining 37 issues were operationalized into items and assessed for relevance and priority in an expert sample (n = 28) and a patient sample (n = 62) from Austria, Canada and the Netherlands. After revision of the item list, 26 items were considered eligible for pre-testing in phase III, in which 156 patients from Australia, Austria, Italy and Spain participated. All items passed criteria for pre-testing, thus forming the new EORTC QLQ-TC26., Conclusion: The newly developed EORTC QLQ-TC26 is now available in several languages to assess QOL in TC patients receiving treatment and in TC survivors. Phase IV of questionnaire development will comprise international field testing, including extensive analysis of psychometric characteristics of the EORTC QLQ-TC26.

Objectives: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing a computer-adaptive test (CAT) version of the EORTC Quality of Life Questionnaire (QLQ-C30). We evaluated the measurement properties of the CAT versions of physical functioning (PF) and fatigue (FA) and compared these with the corresponding QLQ-C30 scales., Study Design and Setting: Based on international samples of more than 1,000 cancer patients, we simulated CAT administration of varying numbers of items and compared the resulting scores with those based on all items in the respective item pools. Furthermore, the relative validity (RV) of CATs was compared with that of the QLQ-C30 scales using known groups validity., Results: For both dimensions, CATs of all lengths resulted in unbiased score estimates. CATs consisting of five or more items had reliability>0.90, correlated ≥ 0.97 with the full scale, and had root mean square error <0.25. The average RVs for these CATs ranged 1.02-1.33, indicating possible savings in sample size requirements of 3-42% using CAT., Conclusion: The CAT versions of PF and FA exhibited high levels of measurement precision and efficiency. The potential savings in sample size requirements using CATs compared with those using the original QLQ-C30 scales were typically 20% or more., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Context: Taste alterations (TAs) and smell alterations (SAs) are frequently observed, yet understudied side effects in chemotherapy patients, considerably affecting patients' quality of life., Objectives: This review provides a systematic evaluation of the literature on TAs and SAs in cancer chemotherapy patients and discloses understudied research questions., Methods: A systematic methodology based on the PRISMA guidelines was applied to identify original research articles with TAs and SAs as primary outcomes in chemotherapy patients. MEDLINE and Embase were searched using Medical Subject Heading and free-text terms. Study extraction and evaluation were done by three reviewers using predefined criteria., Results: The search revealed 22 eligible studies, including three randomized controlled trials. Different measurement approaches were identified, with a clear trend toward self-report measures during the past decade. The methodological quality of the included studies varied, especially reports on SAs, which were inconsistent and hard to interpret. Regarding TAs, there is evidence that taste thresholds increase during chemotherapy. Qualitative changes, for example, metallic taste, are frequent but cannot be attributed to specific chemotherapy regimens. There are large research gaps regarding TAs and SAs in different patient populations and the impact of different chemotherapy regimens. Adequate management strategies are rare., Conclusion: Current research results do not allow firm conclusions concerning the occurrence, severity, and quality of TAs and SAs under different chemotherapy regimens. Patient information on TAs and SAs, therefore, largely is based on the clinician's experience. In the palliative care setting, TAs and SAs need further investigation in the light of their importance in preventing food-related problems and maintaining a reasonable quality of life., (Copyright © 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Background: Patient-reported Outcomes (PROs) capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Electronic PRO data capture (ePRO) with software packages to administer questionnaires, storing data, and presenting results has facilitated PRO assessment in hospital settings. Compared to conventional paper-pencil versions of PRO instruments, ePRO is more economical with regard to staff resources and time, and allows immediate presentation of results to the medical staff.The objective of our project was to develop software (CHES - Computer-based Health Evaluation System) for ePRO in hospital settings and at home with a special focus on the presentation of individual patient's results., Methods: Following the Extreme Programming development approach architecture was not fixed up-front, but was done in close, continuous collaboration with software end users (medical staff, researchers and patients) to meet their specific demands. Developed features include sophisticated, longitudinal charts linking patients' PRO data to clinical characteristics and to PRO scores from reference populations, a web-interface for questionnaire administration, and a tool for convenient creating and editing of questionnaires., Results: By 2012 CHES has been implemented at various institutions in Austria, Germany, Switzerland, and the UK and about 5000 patients participated in ePRO (with around 15000 assessments in total). Data entry is done by the patients themselves via tablet PCs with a study nurse or an intern approaching patients and supervising questionnaire completion., Discussion: During the last decade several software packages for ePRO have emerged for different purposes. Whereas commercial products are available primarily for ePRO in clinical trials, academic projects have focused on data collection and presentation in daily clinical practice and on extending cancer registries with PRO data. CHES includes several features facilitating the use of PRO data for individualized medical decision making. With its web-interface it allows ePRO also when patients are home. Thus, it provides complete monitoring of patients'physical and psychosocial symptom burden.

Background: Current studies on adherence to endocrine therapy in breast cancer patients suffer from methodological limitations due to a lack of well-validated methods for assessing adherence. There is no gold standard for measuring adherence. The aim of our study was to compare four different approaches for evaluating adherence to anastrozole therapy for breast cancer with regard to concordance between methods., Methods: Outpatients with early breast cancer treated with anastrozole completed the multi-method assessment of adherence. We implemented a self-report scale (the Simplified Medication Adherence Questionnaire), physician- ratings, refill records and determination of anastrozole serum concentration., Results: Comparison of the four approaches using Spearman rank correlation revealed poor concordance across all methods reflecting weak correlations of 0.2-0.4. Considering this data incomparability across methods, we still observed high adherence rates of 78%-98% across measures., Conclusion: Our findings contribute to the growing body of knowledge on the impact that methodological aspects exert on the results of adherence measurement in breast cancer patients receiving endocrine treatment. Our findings suggest that the development and validation of instruments specific to patients receiving endocrine agents is imperative in order to arrive at a more accurate assessment and to subsequently obtain more precise estimates of adherence rates in this patient population.

Purpose: The aim of this study was to investigate quality of life (QOL) differences between patients receiving first, second, or third-line palliative chemotherapy (CT).Furthermore, QOL was also compared to a sex- and age-matched sample of healthy controls., Methods: Patients with different metastatic cancers receiving palliative CT were approached to complete the EORTC QLQ-C30 questionnaire by means of touch-screen computers before the start of CT, after 3 cycles and at the end of cytostatic treatment., Results: One hundred four patients were recruited for QOL assessment (56.9% of patients in first, 22.5% second and 20.6% third- or above-line palliative CT). Compared to healthy controls, they suffered from substantial QOL impairments in all EORTC QLQ-C30 sub-domains. In regard to CT lines, patients with first-line CT reached better scores in emotional and social functioning than second-line patients and less financial difficulties than third-line patients. Despite the high level of impairment in the patient sample, electronic data collection proved to be feasible and well accepted., Conclusions: The results indicate that patients receiving third- or above-line palliative CT are confronted with stronger QOL impairments than first- and second-line patients. Supported by its feasibility and acceptance of by patients, electronic QOL data capture is an attractive method to screen for symptoms and track their course within clinical routine.

Objective: Postoperative cognitive decline is a common complication after coronary artery bypass graft surgery. As robotically assisted totally endoscopic coronary artery bypass grafting (TECAB) has shown several positive impacts on recovery and quality of life, the aim of this study was to assess psychomotor functioning relevant for car-driving abilities before and after this intervention., Methods: A total of 20 patients who underwent TECAB completed a neuropsychological test battery including conventional and computerized assessments [Trail Making Test (TMT A + B), Leeds Psychomotor Tester (LPT), Test System for Attentional Performance (TAP 2.1)] before surgery (T0) and 1 week (T1) and 3 months (T2) after surgery., Results: Data show no significant cognitive decline between T0, T1, and T2 following TECAB. Significant improvements were measured from T0 to T2 for psychomotoric function and visual attention (TMT A; p = 0.038) and for reaction time, which was significantly shorter after 3 months in comparison with T0 and T1; p = 0.001)., Conclusion: Data of our preliminary study show no relevant cognitive decline caused from TECAB and therefore do not contradict the practice of early car driving after this procedure., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Background: In patients with cancers of the pancreatic and biliary tract quality of life (QOL) improvement is the main treatment goal, since survival can be prolonged only marginally. Up to date, knowledge on QOL impairments throughout the entire treatment process, often including several chemotherapy lines, is scarce. Our study aimed at investigating QOL trajectories from adjuvant treatment to palliative 3rd-line therapy, Methods: Patients were included in routine electronic patient-reported outcome monitoring at Kufstein County Hospital at the time of diagnosis and assessed with the EORTC QLQ-C30 during each chemotherapy cycle., Results: Eighty out of 147 patients with pancreatic cancer or cancer of the bile ducts treated at the Kufstein County Hospital, fulfilled inclusion criteria and could be included in the study (mean age 67.4 years; 53.8% women). Physical, Emotional and Cognitive Functioning, and Global QOL deteriorated across chemotherapy lines, whereas Fatigue, Pain, Dyspnoea, Sleeping Disturbances, Diarrhoea, and Taste Alterations increased. With regard to Physical Functioning, Global QOL, Fatigue, Dyspnoea, Diarrhoea and Taste Alterations, the patients receiving adjuvant or 1st-line palliative chemotherapy did not differ significantly. Most patients in 2nd- or 3rd-line chemotherapy showed significantly higher impairments and symptom burden. However, patients under 1st and 2nd-line treatment showed stable QOL trajectories, whereas 3rd-line patients perceived substantial deteriorations., Conclusions: The results suggest early palliative treatment initiation to stabilise QOL on a level as high as possible. The continuous QOL improvement during adjuvant treatment, probably reflecting post-operative recovery, may indicate that deleterious effects of adjuvant chemotherapy on QOL are highly unlikely.

Objective: The aim of this study was to compare attitudes regarding ski helmet use in helmet wearers and non-wearers., Methods: In total, 924 persons ≥18 years (52% men and 48% women) participating in sport programmes at the University Sports Institute Innsbruck/Austria were interviewed about their attitudes regarding ski helmets and scored 14 statements on a five-level Likert Scale. A factor analysis was employed to determine clusters of underlying attitudes that have subsequently been used as predictors of helmet non-use in a conditional logistic regression analysis., Results: In total, 65% of participants declared to use a helmet during their preferred winter sport activity while more than 80% of helmet wearers and non-wearers totally agreed that helmets protect from head injuries. According to the factor analysis, attitudes about ski helmets clustered around four major dimensions-subjective disadvantages, safety awareness, comfort/style and risk compensation. Adjusted ORs of regression analysis showed that helmet non-use increased with age and decreased with increasing skill level (beginner: OR 5.4, 95% CI 2.6 to 11.1; intermediate: OR 4.3, 95% CI 2.4 to 7.9; advanced: OR 3.1, 95% CI 1.7 to 5.4). In addition, helmet non-use was associated with subjective disadvantages (OR 2.3, 95% CI 1.8 to 2.9). However, a negative association between helmet non-use and safety awareness (OR 0.3, 95% CI 0.2 to 0.4) was found., Conclusion: Helmet use was associated with higher safety awareness, while most arguments against helmet use seem to belong to subjective perception and to represent anticipatory negative cognitions, poorly supported by evidence. Therefore, evidence-based information about wearing a ski helmet should be implemented in preventive helmet campaigns focusing on non-wearers. In addition, health communication programmes should be instituted to get non-helmeted skiers and snowboarders to try out helmets to eliminate their potential prejudices.

The patient's perspective evaluated by patient-reported outcomes (PROs) gains more and more importance, since treatment efficacy is no longer solely linked to clinical outcomes like cure and overall survival. Ailments like pain, fatigue and social isolation can only be assessed by patients' direct expression without any interpretation made by medical staff. PROs facilitate the disclosure of quality of life issues and patients feel a stronger support due to improved communication. PROs offer many further advantages like saving of time, cost and staff, targeted intervention and sensitizing of clinicians. Also, internationally validated questionnaires are available and the development of electronic PROs eases data-collection, calculation and storage. PROs collected within clinical routine are versatile concerning their applicability: They can be used for scientific analyses, quality assurance, and health technology assessment.

Background: Taste alterations (TAs) are frequently reported by chemotherapy patients. However, research on this topic is very scarce. The etiologies of TAs are not fully known and prevalences may vary across tumour types and chemotherapy regimens. The aim of the present study was to longitudinally investigate TAs in patients with breast cancer or gynaecological cancers receiving chemotherapy, and to provide expected values for TAs for these patient populations., Patients and Methods: One hundred and nine cancer patients (32.1% gynaecological cancer, 67.9% breast cancer) receiving chemotherapy at the Department for Internal Medicine of Kufstein County Hospital were consecutively included in the study. At each visit the Quality of Life Questionnaire-Core30 and a screening scale for TAs, consisting of two validated questions taken from the European Organisation for Research and Treatment of Cancer item bank was administered. Statistical analysis was performed using mixed-effect models., Results: The prevalence of TAs in breast cancer and gynaecological cancer patients receiving chemotherapy was high (76.1%). There were differences in the extent of TAs as well as in their time course across treatment groups. The lowest TAs were found in breast cancer and gynaecological cancer patients treated with gemcitabine. The highest TAs were found in breast cancer patients treated with epirubicin/docetaxel/capecitabine. The steepest increase of TAs was found in patients treated with epirubicin/docetaxel. Moreover, significant associations between TAs and appetite loss as well as fatigue were found., Conclusion: The results show that TAs are an issue in breast and gynaecological cancer patients receiving different chemotherapy regimens. There is a need for a more systematic investigation of TAs in chemotherapy patients in general as well as the need to address this issue in clinical practice.

Background: Diagnosis and treatment of ovarian cancer (OC) entail severe symptom burden and a significant loss of quality of life (QOL). Somatic and psychological impairments may persist well beyond active therapy. Although essential for optimal symptom management as well as for the interpretation of treatment outcomes, knowledge on the course of QOL-related issues is scarce. This study aimed at assessing the course of depressive symptoms, anxiety, fatigue and QOL in patients with OC over the course of chemotherapy until early after-care., Methods: 23 patients were assessed longitudinally (eight time points) with regard to symptom burden (depression, anxiety, fatigue, and QOL) by means of patient-reported outcome instruments (HADS, MFI-20, EORTC QLQ-C30/-OV28) and clinician ratings (HAMA/D) at each chemotherapy cycle and at the first two aftercare visits., Results: Statistically significant decrease over time was found for depressive symptoms and anxiety as well as for all fatigue scales. With regard to QOL, results indicated significant increase for 11 of 15 QOL scales, best for Social (effect size = 1.95; p < 0.001), Emotional (e.s. = 1.62; p < 0.001) and Physical Functioning (e.s. = 1.47; p < 0.001). Abdominal Symptoms (e.s. = 1.01; p = 0.009) decreased, Attitudes towards Disease and Treatment (e.s. = 1.80; p < 0.001) improved significantly over time. Analysis of Sexual Functioning was not possible due to a high percentage of missing responses (61.9%)., Conclusions: The present study underlines the importance of longitudinal assessment of QOL in order to facilitate the identification of symptom burden in OC patients. We found that patients show high levels of fatigue, anxiety and depressive symptoms and severely impaired QOL post-surgery (i.e. at start of chemotherapy) but condition improves considerably throughout chemotherapy reaching nearly general population symptoms levels until aftercare.

Background: Patients with cancer often suffer from fatigue and decreased quality of life which might be related to the breakdown of essential amino acid tryptophan., Methods: In 50 patients with lung cancer we examined fatigue and the deterioration of quality of life in patients using the Functional Assessment of Cancer Therapy Anemia (FACT-An) and -Fatigue (FACT-F) subscales of FACT-General and the Mental adjustment to Cancer (MAC) questionnaires. Results were compared with tryptophan breakdown as well as serum concentrations of immune activation markers., Results: Scores of psychological tests correlated significantly with tryptophan breakdown and with circulatory markers of inflammation. However, immune activation and tryptophan breakdown were not related to MAC scores., Conclusions: Tryptophan breakdown relates with fatigue and impaired quality of life in patients with lung cancer, while declining tryptophan levels are not associated with patients'coping strategies.

Introduction: Due to the high mortality of cancer a large number of patients pass a preterminal phase of their illness. Within this phase medical care aims at maintaining patients' quality of life (QOL) and reducing symptom burden. Our study investigated the patient-reported severity of QOL impairments during the last year of life, with a special focus on their course at the end of life., Methods: All patients with cancer receiving palliative care at Natters State Hospital (Austria) were considered as eligible for the study. QOL data were collected with the EORTC QLQ-C30 questionnaire as part of computerized patient-reported outcome monitoring (ePROM) within clinical routine. QOL was investigated longitudinally in regard to its course toward death as well as to changes in determinants of global QOL., Results: Eighty-five patients participated in the ePROM (255 assessments in total). Regarding trajectories, physical, role and cognitive functioning, fatigue and global QOL worsened sharply during the last 3 months of life. A steady decline was found for emotional functioning, pain, appetite loss and taste alterations. The impact of role functioning, sleep disturbances, and taste alterations on global QOL increased within the last 3 months of life., Conclusion: Our results indicate that most aspects of QOL are considerably impaired in patients with advanced cancer. Furthermore, they highlight the importance of assessing QOL in general and taste alterations in particular within palliative care.

Adjuvant endocrine treatment-related adverse effects have a strong impact on patients' quality of life and thereby limit therapy's risk benefit ratio resulting in morbidity and treatment discontinuation. Still, many AI adverse effects remain untreated given that they are unrecognized by conservative methods (e.g., proxy ratings). The ability of complementary patient-reported outcomes (PROs) to provide a more comprehensive assessment of side-effects is to be explored. A cross-sectional study sample of 280 postmenopausal, early stage breast cancer patients was subjected to a comprehensive PRO assessment (FACT-B/+ES) at their after-care appointment. Prevalence and severity of patient-reported physical side-effects and psychosocial burden related to adjuvant AI therapy were compared with prevalences derived from pivotal phase IV trials (ATAC 2005, BIG1-98 2005). Across all symptom categories, highest prevalence rates were found for joint pain (59.6%), hot flushes (52%), lost interest in sexual intercourse (51.4%), and lack of energy (40.3%). Overall, PROs resulted in significantly higher prevalence rates as compared to physician ratings for all symptoms published in pivotal clinical trials except vaginal bleeding and nausea. The treatment duration exerted no significant impact on symptom frequency (P > 0.05). Established prevalence rates of endocrine treatment-related toxicity seem to be underestimated. The incorporation of PRO data should be mandatory or at least highly recommended in clinical treatment planning to arrive at a more accurate assessment of a patient's actual symptom burden enabling improved individualized management of side-effects and mediating the preservation of treatment adherence.

Purpose: Computerized adaptive test (CAT) methods, based on item response theory (IRT), enable a patient-reported outcome instrument to be adapted to the individual patient while maintaining direct comparability of scores. The EORTC Quality of Life Group is developing a CAT version of the widely used EORTC QLQ-C30. We present the development and psychometric validation of the item pool for the first of the scales, physical functioning (PF)., Methods: Initial developments (including literature search and patient and expert evaluations) resulted in 56 candidate items. Responses to these items were collected from 1,176 patients with cancer from Denmark, France, Germany, Italy, Taiwan, and the United Kingdom. The items were evaluated with regard to psychometric properties., Results: Evaluations showed that 31 of the items could be included in a unidimensional IRT model with acceptable fit and good content coverage, although the pool may lack items at the upper extreme (good PF). There were several findings of significant differential item functioning (DIF). However, the DIF findings appeared to have little impact on the PF estimation., Conclusions: We have established an item pool for CAT measurement of PF and believe that this CAT instrument will clearly improve the EORTC measurement of PF.

Introduction: Within an ongoing project of the EORTC Quality of Life Group, we are developing computerized adaptive test (CAT) measures for the QLQ-C30 scales. These new CAT measures are conceptualised to reflect the same constructs as the QLQ-C30 scales. Accordingly, the Fatigue-CAT is intended to capture physical and general fatigue., Methods: The EORTC approach to CAT development comprises four phases (literature search, operationalisation, pre-testing, and field testing). Phases I-III are described in detail in this paper. A literature search for fatigue items was performed in major medical databases. After refinement through several expert panels, the remaining items were used as the basis for adapting items and/or formulating new items fitting the EORTC item style. To obtain feedback from patients with cancer, these English items were translated into Danish, French, German, and Spanish and tested in the respective countries., Results: Based on the literature search a list containing 588 items was generated. After a comprehensive item selection procedure focusing on content, redundancy, item clarity and item difficulty a list of 44 fatigue items was generated. Patient interviews (n = 52) resulted in 12 revisions of wording and translations., Discussion: The item list developed in phases I-III will be further investigated within a field-testing phase (IV) to examine psychometric characteristics and to fit an item response theory model. The Fatigue CAT based on this item bank will provide scores that are backward-compatible to the original QLQ-C30 fatigue scale.

A computer-based tool for the monitoring of patient-related outcomes, the "Computer-based Health Evaluation System" (CHES) was developed at the medical university of Innsbruck. The software-generated graphic QOL profiles were found to be an important tool for screening patients for clinically relevant problems and were successfully used in oncology, geriatrics, psychiatry, and psychosomatics. The authors report their experience with CHES in 34 patients with recurrent gliomas. The computer-based QoL monitoring was repeated in median 5.4 times per patients and found feasible and well accepted by patients and personnel.

Allogenic haematopoietic stem cell transplantation (HCT) has become an effective therapy in patients with various haematological malignancies. GvHD is known to be a major complication in this patient group and is assumed to have a major impact on patients' quality of life (QOL). Patients after BMT or transplantation of mobilized PBSCs were considered for enrolment in the study 6 months after transplantation. QOL and symptom burden were assessed using the EORTC QLQ-C30 and the QLQ-HDC29. Data from age- and sex-matched healthy controls were collected for comparison. In all, 100 patients (55.0% women; mean age 46.3 years) after allogeneic HCT were included in the study. In this patient group, we found a clinically relevant impact of GvHD on role functioning, global QOL, fatigue, dyspnoea, gastrointestinal side effects, worries/anxiety and skin problems. In comparison to healthy controls, various aspects of QOL were severely impaired. Our study revealed severe impairments of QOL in survivors of HCT, in particular in those suffering from GvHD. Taking into account, that the prevalence of GvHD might be higher in patients after PBSCT compared with patients after BMT, PBSCT is expected to lead to more severe impairments of QOL than BMT.

Background: Geriatric assessment (GA) must be integrated into treatment concepts for elderly cancer patients. Aim of this study was to assess the coverage of a large battery of GA instruments by determining the number of independent domains measured., Methods: Thirteen different GA scores were applied in 78 elderly tumor patients (mean age 72.9 years). Data were analyzed by exploratory factor analysis and substantiated by non-parametric correlation analyses., Results: Factor analysis yielded a six-factor solution explaining 77.1% of the total variance. The six domains identified may be described as general functioning in everyday life, health-related quality of life, co-morbidities, social support, cognition, and nutritional status. This factor structure was reasonably well confirmed by correlation analyses. Notably, WHO Performance Status, Karnofsky Index, VES-13 and PPT generally revealed high correlations with functional capacities, but only low correlations with comorbidities, social support, cognitive functioning or nutritional status., Conclusions: From the six domains described a basis for efficient application of GA instruments in elderly cancer patients is worked out. The classical instruments WHO and KI as well as the screening scores VES-13 and PPT, while capturing physical functioning well, fail to cover several other important GA domains., (2009 Elsevier Ireland Ltd. All rights reserved.)

Context: Computerized assessment of quality of life (QOL) in patients with brain tumors can be an essential part of quality assurance with regard to evidence-based medicine in neuro-oncology., Objectives: The aim of this project was the implementation of a computer-based QOL monitoring tool in a neurooncology outpatient unit. A further aim was to derive reference values for QOL scores from the collected data to improve interpretability., Methods: Since August 2005, patients with brain tumors treated at the neuro-oncology outpatient unit of the Innsbruck Medical University were consecutively included in the study. QOL assessment (European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ-C30] plus the EORTC QLQ-brain cancer module [BN20]) was computer-based, using a software tool called the Computer-based Health Evaluation System., Results: A total of 110 patients with primary brain tumors (49% female; mean [standard deviation] age 47.9 [12.6] years; main diagnoses: 30.9% astrocytoma, 17.3% oligodendroglioma, 17.3% glioblastoma, 13.6% meningioma) was included in the study. On average, QOL was assessed 4.74 times per patient, 521 times in total. The user-friendly software was successfully implemented and tested. The routine QOL assessment was found to be feasible and was well accepted by both physicians and patients., Conclusion: The software-generated graphic QOL profiles were found to be an important tool for screening patients for clinically relevant problems. Thus, computer-based QOL monitoring can contribute to an optimization of treatment (e.g., symptom management, psychosocial interventions) and facilitate data collection for research purposes., (Copyright 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Objective: Empirical investigation of formerly proposed criteria for relevant changes of health-related quality of life (QOL) regarding their use for monitoring changes in the individual patient. Suggestion of a new criterion trying to overcome the drawbacks of former criteria., Study Design and Setting: QOL data were collected longitudinally in 160 cancer patients receiving chemotherapy at an oncological outpatient unit, giving rise to a total of 975 QOL assessments. QOL was measured using the European Organization on Research and Treatment of Cancer Quality of Life Core Questionnaire. Several formerly suggested criteria of relevant change (distribution based, anchor based) were compared in terms of both prevalence and statistical significance of the resulting relevant changes., Results: When considering criteria of relevant change suggested in the literature, high proportions (average: 42.3-48.3%) of reputedly relevant changes were found. The majority of these changes (average: 55.8-62.2%) were statistically insignificant. Combination of an increased threshold for clinical relevance with the concept of statistical significance resulted in a more meaningful change criterion., Conclusion: Formerly recommended thresholds of relevant change in QOL appear to be unduly low when focusing on the individual patient. A modified criterion is therefore suggested for this case. However, more research is needed for validation and refinement of the proposed criterion., (Copyright 2010 Elsevier Inc. All rights reserved.)

Background: Taste alterations (TAs) are a frequent but under-recognized treatment side effect in cancer patients undergoing chemotherapy (CT). CT regimens with different toxicity profiles may vary in their impact on TAs, but research on this topic is lacking. This study assesses the prevalence of TAs and their relation to sociodemographic and clinical variables, especially CT regimens. Furthermore, the association between TAs and quality of life (QOL) is investigated., Patients and Methods: TAs and QOL data were collected longitudinally in 197 cancer patients (lung cancer, 54.3%; pancreatic cancer, 19.3%; colorectal cancer, 26.4%; age, 65.2 +/-10.4 years; male, 57.4%) who were receiving CT at the Department of Internal Medicine at Kufstein County Hospital, giving rise to a total of 1,024 assessment times. Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire and two additional questions taken from the EORTC item bank concerning TAs. Statistical analyses were performed using mixed-effect models., Results: The study showed that the prevalence of TAs in chemotherapy patients is alarmingly high (69.9%). There were clear differences in TA scores among treatment groups: patients receiving irinotecan reported significantly more TAs than patients in other treatment groups; patients receiving a combination of gemcitabine and a platinum agent reported the lowest TAs. Additionally, significant associations between TAs and several QOL dimensions were found, especially with appetite loss and fatigue., Conclusion: The high prevalence of TAs and their impact on QOL in CT patients underscore the urgent need for increased attention to this side effect, both in research and in clinical practice.

Introduction: Patients suffering from brain tumours often experience a wide range of cognitive impairments that impair their ability to report on their quality of life and symptom burden. The use of proxy ratings by significant others may be a promising alternative to gain information for medical decision making or research purposes, if self-ratings are not obtainable. Our study investigated the agreement of quality of life and symptom ratings by the patient him/herself or by a significant other., Methods: Patients with primary brain tumours were recruited at the neurooncological outpatient unit of Innsbruck Medical University. Quality of life self- and proxy-ratings were collected using the EORTC QLQ-C30 and its brain cancer module, the QLQ-BN20., Results: Between May 2005 and August 2007, 42 pairs consisting of a patient and his/her significant other were included in the study. Most of the employed quality of life scales showed fairly good agreement between patient- and proxy-ratings (median correlation 0.46). This was especially true for Physical Functioning, Sleeping Disturbances, Appetite Loss, Constipation, Taste Alterations, Visual Disorders, Motor Dysfunction, Communication Deficits, Hair Loss, Itchy Skin, Motor Dysfunction and Hair Loss. Worse rater agreement was found for Social Functioning, Emotional Functioning, Cognitive Functioning, Fatigue, Pain, Dyspnoea and Seizures., Conclusion: The assessment of quality of life in brain cancer patients through ratings from their significant others seems to be a feasible strategy to gain information about certain aspects of patient's quality of life and symptom burden, if the patient is not able to provide information himself.

Objective: In breast cancer patients the diagnosis, treatment and aftercare of the physical disease cause a large amount of psychosocial distress, which can have a variety of negative consequences on patients' physical and mental well-being. Although about one-third of the patients show heightened psychosocial distress that may require psychooncological interventions its detection in daily clinical routine is poor and referral to mental health professionals is insufficient. The aim of the study was to develop a short screening tool for the detection of need for psychooncological treatment (POT) in breast cancer patients., Methods: Over a period of six months, 115 breast cancer outpatients attending the Department of Gynaecology at Innsbruck Medical University were consecutively included in the study. Logistic regression analysis and ROC analyses were used to identify the most predictive item set from a set of questionnaires (EORTC-QLQ-C30, HADS and Hornheide Screening Instrument) and other additional questions., Results: Data from 105 breast cancer patients (mean age 58.8, SD 12.3) were available for analysis. A logistic regression equation containing the EORTC-QLQ-C30 scales Emotional Functioning and Role Functioning as well as the yes-no question after psychiatric/psychological/psychotherapeutic treatment at any point in lifetime showed highest predictive power with regard to need of POT (AUC=0.88; CI 95% 0.82-0.95). A pilot study (n=20) investigating applicability of a computerized version of this screening tool in oncological routine showed high acceptance and feasibility., Conclusion: The developed PO-screening tool showed high diagnostic accuracy regarding POT needs. The short assessment time and good usability of its computerized version allowed easy implementation in daily oncological routine.

Purpose: The purpose of this study was to investigate gender-associated differences in quality of life in colorectal cancer patients and compare such differences to the general population., Methods: Colorectal cancer patients attending three oncological centres in Austria were consecutively recruited and assessed with the EORTC QLQ-C30. For the purpose of comparison, a gender- and age-matched healthy control group was drawn from a representative sample of the Austrian general population., Results: About 206 patients (47.1% women; mean age 64.8 years) with colorectal cancer were included and compared with 206 persons from the general population. A two-way analysis of variance showed significant main effects (gender and colorectal cancer vs. healthy) for most EORTC QLQ-C30 scales, but a significant interaction effect was only found for diarrhea. This means that gender-associated differences specific for colorectal cancer patients were only found for diarrhea., Conclusion: The vast majority of studies on gender-associated differences in quality of life compare male and female oncological patients and neglect the issue of the disease-specificity of such differences. Our study revealed that women and men suffering from colorectal cancer scored differently across many aspects of quality of life, but with the exception of diarrhea, these differences were also found in the general population, i.e. they indicated no gender-specific reaction to disease.

Quality of life (QOL) has become a widely used outcome parameter in the evaluation of treatment modalities in clinical oncology research. By now, many of the practical problems associated with measuring QOL in clinical practice can be overcome by the use of computer-based assessment methods. QOL assessment in oncology is dominated by two measurement systems, the FACT scales and the EORTC QLQ-C30 with its modules. The amount of human resources required to implement routine data collection has been reduced significantly by advanced computer technology allowing data collection in busy clinical practice. Monitoring of QOL can contribute to oncologic care by facilitating detection of physical and psychological problems and tracking the course of disease and treatment over time. Furthermore, the integration of screening for psychosocial problems into QOL monitoring contributes to the identification of patients who are in need of psychooncologic interventions. Computer-based QOL monitoring does not replace the direct physician-patient communication but enables to identify specific impairments and symptoms including psychological problems. Beyond clinical practice, QOL data can be used for research purposes and may help health care planners to determine those patient services that should be maintained or ones that should be developed.

Objective: The objective of this study was to compare the effect of incontinence surgery and pelvic floor training on quality of life (QOL), anxiety and depression in patients with stress urinary incontinence (SUI)., Methods: In a prospective longitudinal study, females with proven SUI were asked to complete a set of standardized questionnaires (sociodemographic data sheet, FACT-G, I-QOL, HADS) before and eight weeks after treatment. The comparison groups consisted of a surgical treatment group and a conservative group that underwent supervised pelvic floor training for eight weeks., Results: From the 67 female patients included in the study a number of 53 patients completed both assessment time points (mean age 57.4, mean years of SUI 7.6). The surgical treatment group consisted of 32 patients of which 21 patients received a modified Burch colposuspension and 11 patients a tension-free mid-urethral tape suspension. The 21 patients in the conservative group attended eight once-weekly supervised pelvic floor training sessions. After treatment the surgical intervention group showed a significantly higher improvement of QOL (FACT-G and I-QOL) and anxiety (HADS) than the pelvic floor training group., Conclusion: For female patients with SUI surgery yielded a better outcome than pelvic floor training with regard to quality of life and anxiety.

Information disclosure is a key factor in the support for cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed a questionnaire to evaluate the level of information received by cancer patients at different stages of their disease and treatment: the EORTC QLQ-INFO26. It can be used in clinical practice and research, including clinical trials. The questionnaire was developed following EORTC Quality of Life Group guidelines. The paper presents the data on 133 patients from eight countries. The resulting EORTC QLQ-INFO26 questionnaire includes four sub-scales on information regarding their cancer, medical tests, treatment and other services and several single items., (Copyright 2006 John Wiley & Sons, Ltd.)

Aim: In this pilot study a computer-assisted cognitive training programme (CAT) was tested and evaluated in patients with depressive syndromes for its effects on neuropsychological parameters, modd and dysfunctional cognitions., Methods: A total of 48 patients were randomized either to the treatment or the control group. The former underwent 20 sessions, 30-45 minutes each, of computer-assisted cognitive training, twice a week. At the beginning and at the end of the training (ten weeks later), both groups were given neuropsychological tests (memory, attention, concentration and information processing speed) and also questionnaires to assess depressive mood, thoughts, negative self communication and locus of control., Results: At the start of the study, both the groups information processing speed. All these were absent in the control group. Also the depressive mood, as well as negative self-communication markedly improved in the training group. As expected, these results were not observed in the control group., Conclusion: According to these results in depressed patients a computer-assisted cognitive training programme might have a positive influence not only on their neuropsychological functions but also on their dysfunctional beliefs. Thus CAT should be part of the treatment of depressive patients.

Objective: To investigate the equivalence of the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) and the Functional Assessment for Cancer Therapy-General (FACT-G) on the basis of corresponding subscales, and where appropriate to derive a scheme for converting QLQ-C30 scores into FACT-G scores and vice versa for use in oncological research., Method: A calibration sample of 737 cancer patients (mean age 51.4+/-7.6 (SD), 63% female, 25% with current chemotherapy) who filled in both quality of life (QOL) questionnaires was used. Both classical test theory and the Rasch measurement model were applied., Results: Three of the four subscales common to both QOL instruments (physical, emotional, functional) proved suitable for equating (acceptable inter-correlations of corresponding subscales physical (r=0.77), emotional domain (r=0.60) role/functional (r=0.63) relative to their internal consistency, sufficient unidimensionality of pooled subscales, satisfactory fit to the Rasch model). Conversion tables for these subscales were generated., Conclusions: The conversion tables developed in this study (physical, emotional and functional/role domain) appear promising for the comparison between EORTC QLQ-C30 and FACT-G scores of patient samples.

In multiprofessional teams, the processes underlying ethical decisions in Palliative Care often become complicated and could cause many conflicts. Different interests and ethical positions often slow down the necessary decision-making. The lack of resources, lack of managerial structures and deficits in competence and education make the situation more difficult. We demonstrated in our case report that an established Palliative Liaison Service could support the creation of consensual decisions by forming multiprofessional ethic round-ups.

Fatigue, a common symptom of cancer patients, particularly those on active treatment, is generally evaluated using self-report methods, yet it remains unclear how self-reported fatigue scores relate to performance of daily activities. This study examines the relationships among self-reported and performance-based measures of function in patients receiving chemotherapy (CT) to link self-reported fatigue measures to self-report and performance-based measures of function. Self-reported fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and self-reported physical function using the physical function 10 subscale of the Short Form 36 (SF-36) (PF-10) were measured in 64 patients within 2 weeks of beginning CT (n=64) and after three cycles of CT (n=48). Motor and cognitive functions were captured using five self-reported and seven observed-performance measures at each time point. Significant correlations between self-reported and observed measures ranged from 0.30 to 0.71. Self-reported fatigue correlated (0.30-0.45) with performance-based function. FACIT-F scores in the range of 30 and below and PF-10 scores in the range of 50 and below were related to an increased difficulty performing everyday activities. Observed measures of physical performance correlate moderately with self-reported fatigue and self-reported physical function. These relationships enable one to begin linking fatigue scores directly to a person's ability to perform everyday activities.