Acceptability and usefulness of the EORTC 'Write In three Symptoms/Problems' (WISP): a brief open-ended instrument for symptom assessment in cancer patients.

BACKGROUND: The use of open-ended questions supplementing static questionnaires with closed questions may facilitate the recognition of symptoms and toxicities. The open-ended 'Write In three Symptoms/Problems (WISP)' instrument permits patients to report additional symptoms/problems not covered by selected EORTC questionnaires. We evaluated the acceptability and usefulness of WISP with cancer patients receiving active and palliative care/treatment in Austria, Chile, France, Jordan, the Netherlands, Norway, Spain and the United Kingdom. METHODS: We conducted a literature search on validated instruments for cancer patients including open-ended questions and analyzing their responses. WISP was translated into eight languages and pilot tested. WISP translations were pre-tested together with EORTC QLQ-C30, QLQ-C15-PAL and relevant modules, followed by patient interviews to evaluate their understanding about WISP. Proportions were used to summarize patient responses obtained from interviews and WISP. RESULTS: From the seven instruments identified in the literature, only the free text collected from the PRO-CTAE has been analyzed previously. In our study, 161 cancer patients participated in the pre-testing and interviews (50% in active treatment). Qualitative interviews showed high acceptability of WISP. Among the 295 symptoms/problems reported using WISP, skin problems, sore mouth and bleeding were more prevalent in patients in active treatment, whereas numbness/tingling, dry mouth and existential problems were more prevalent in patients in palliative care/treatment. CONCLUSIONS: The EORTC WISP instrument was found to be acceptable and useful for symptom assessment in cancer patients. WISP improves the identification of symptoms/problems not assessed by cancer-generic questionnaires and therefore, we recommend its use alongside the EORTC questionnaires.

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

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

Can virtual care reduce treatment burden in pediatric leukemia? A retrospective cost analysis.

We conducted a retrospective analysis to determine the potential reduction in treatment burden through the expansion of virtual care among children with leukemia (n = 152). Patients living in urban areas traveled median distances of 1555 km compared with 7536 km for patients living in rural areas (p < .05). For the latter group, a median reduction in travel distance of 3560 km (interquartile range [IQR], 2136-5787 km), travel time of 51 h (IQR, 26-78 h), and CO2 emissions of 623 kg (IQR, 374-1013 kg) was estimated, if every second visit was replaced by video consultations.

The European Organisation for Research and Treatment of Cancer Quality of Life Utility-Core 10 Dimensions: Development and Investigation of General Population Utility Norms for Canada, France, Germany, Italy, Poland, and the United Kingdom.

OBJECTIVES: The European Organisation for Research and Treatment of Cancer Quality of Life Utility-Core 10 Dimensions (EORTC QLU-C10D) is a cancer-specific preference-based measure, providing health utilities for use in economic evaluations derived from the widely used health-related quality of life measure, EORTC QLQ-C30. Several EORTC QLU-C10D country-specific value sets are available. This article aimed to provide EORTC QLU-C10D general population utility norms for Canada, France, Germany, Italy, Poland, and the United Kingdom, to aid interpretability of obtained utilities in these countries. METHODS: Data were collected in aforementioned countries via a quota-sampled, cross-sectional online survey (n = 100/age-sex group; N = approximately 1000/country). Participants were asked to complete the EORTC QLQ-C30 and provide sociodemographic data. Country-specific utility norms were calculated using the respective country tariff on the country's EORTC QLQ-C30 data after weighting to achieve population representativeness for age and sex. Norm values are provided as means (SDs) by country, age, and sex groups. Tukey's multiple comparison test investigated mean differences among countries. The impact of country, age, and sex on utility values was investigated with a multiple linear regression model. RESULTS: Country-specific mean utilities range from 0.724 (United Kingdom) to 0.843 (Italy). Country-, sex-, and age-specific mean utilities range from 0.664 for 30- to 39-year-old male Canadians to 0.899 for > 70-year-old male Italians. Utilities were lower in females in 4 of 6 countries, and the impact of age differed among countries. Independent of the impact of age and sex, between-country differences were found (P ≤ .05). CONCLUSION: Results showed a varying impact of age and sex on EORTC QLU-C10D utilities and significant between-country differences. Using national utility norms and utility decrements is recommended.

An implementation study of electronic assessment of patient-reported outcomes in inpatient radiation oncology.

PURPOSE: Despite evidence for clinical benefits, recommendations in guidelines, and options for electronic data collection, routine assessment of patient-reported outcomes (PROs) is mostly not implemented in clinical practice. This study aimed to plan, conduct and evaluate the implementation of electronic PRO (e-PRO) assessment in the clinical routine of an inpatient radiation oncology clinic. METHODS: The guideline- and evidence-based, stepwise approach of this single-center implementation study comprised preparatory analyses of current practice, selection of assessment instruments and times, development of staff training, and evidence-based recommendations regarding the use of the e-PRO assessment, as well as on-site support of the implementation. Process evaluation focused on potential clinical benefit (number of documented symptoms and supportive measures), feasibility and acceptance (patient contacts resulting in completion/non-completion of the e-PRO assessment, reasons for non-completion, preconditions, facilitators and barriers of implementation), and required resources (duration of patient contacts to explain/support the completion). RESULTS: Selection of instruments and assessment times resulted in initial assessment at admission (EORTC QLQ-C30, QSR 10), daily symptom monitoring (EORTC single items), and assessment at discharge (EORTC QLQ-C30). Recommendations for PRO-based clinical action and self-management advice for patients concerning nine core symptoms were developed. Staff training comprised group and face-to-face meetings and an additional e-learning course was developed. Analyses of clinical records showed that e-PRO assessment identified more symptoms followed by a higher number of supportive measures compared to records of patients without e-PRO assessment. Analysis of n = 1597 patient contacts resulted in n = 1355 (84.9%) completed e-PROs (initial assessment: n = 355, monitoring: n = 967, final assessment: n = 44) and n = 242 (15.2%) non-completions. Instructions or support to complete e-PROs took on average 5.5 ± 5.3 min per patient contact. The most challenging issue was the integration of the results in clinical practice. CONCLUSION: E-PRO assessment in oncologic inpatient settings is acceptable for patients and can support symptom identification and the initiation of supportive measures. The challenge of making the "data actionable" within the clinical workflow and motivating clinical staff to use the results became evident.

Cancer patients' perceptions regarding their symptoms and functioning are important as they can differ from a professional assessment. Patients' perceptions and self-assessment can be collected via electronic devices. Thus, the clinical staff can see a graphic overview of individual disease-related burden. Despite studies indicating the benefit of this assessment for care and symptom management, it is not integrated into routine care so far. The aim of our study was, to plan, conduct and evaluate the implementation of electronic patient-reported assessment in a radio-oncology inpatient clinic under "real-life" clinical conditions instead of study conditions. Patients could complete an electronic assessment at the beginning/end and during their treatment. Results indicate that electronic self-assessment can identify more symptoms than the assessment of physicians and nurses. Patients completing a self-assessment are more likely to receive supportive measures. The majority of 80­90% of patients were willing to complete a self-assessment. On average 5­6 min were needed to explain or support the completion. While the intervention was feasible and acceptable for patients, motivating clinical staff using its results was most challenging. The importance of technical support became evident.

Estimation of an EORTC QLU-C10 Value Set for Spain Using a Discrete Choice Experiment.

BACKGROUND: The EORTC QLU-C10D is a preference-based measure derived from the EORTC QLQ-C30. For use in economic evaluations, country-specific value sets are needed. This study aimed to generate an EORTC QLU-C10 value set for Spain. METHODS: A sample of the Spanish general population completed an online discrete choice experiment. An attribute-balanced incomplete block design was used to select 960 choice tasks, with a total of 1920 health states. Each participant was randomly assigned 16 choice sets without replacement. Data were modelled using generalized estimating equations and mixed logistic regressions. RESULTS: A total of 1625 panel members were invited to participate, 1010 of whom were included in the study. Dimension decrements were generally monotonic with larger disutilities at increased severity levels. Dimensions associated with larger decrements were physical functioning and pain, while the dimension with the smallest decrement was sleep disturbances. The PITS state (i.e. worst attainable health) for the Spanish population is - 0.043. CONCLUSIONS: This study generated the first Spanish value set for the QLU-C10D. This can facilitate cost-utility analyses when applied to data collected with the EORTC QLQ-C30.

French Value-Set of the QLU-C10D, a Cancer-Specific Utility Measure Derived from the QLQ-C30.

BACKGROUND AND OBJECTIVE: The EORTC Quality of Life Utility Measure-Core 10 Dimensions (QLU-C10D) is a new multi-attribute utility instrument derived from the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30), a widely used cancer-specific quality-of-life questionnaire. It covers ten dimensions: physical, role functioning, social, emotional functioning, pain, fatigue, sleep, appetite, nausea and bowel problems. To allow national health preferences to be reflected, country-specific valuations are being performed through collaboration between the Multi-Attribute Utility Cancer (MAUCa) Consortium and the EORTC. The aim of this study was to determine the utility weights for health states in the French version of the QLU-C10D. METHODS: Valuations were run in a web-based setting in a general population sample of 1033 adults. Utilities were elicited using a discrete-choice experiment (DCE). Data were analyzed by conditional logistic regression and mixed logits. RESULTS: The sample was representative of the general French population in terms of gender and age. Dimensions with the largest impact on utility weights were, in this order: physical functioning, pain and emotional functioning. The impact on utilities was lower for role functioning, nausea, bowel problems and social functioning. The dimensions of sleep, fatigue and lacking appetite were associated with the smallest utility decrement. CONCLUSION: The results of the present study provide utility weights for the QLU-C10D and offer interesting prospects, as some cancer-specific dimensions also received sizeable utility weights (nausea and bowel problems). In fact, the EQ-5D and the HUI 3 are recommended in France and commonly used for cancer-related CUA; however, both these instruments are generic. The availability of a new cancer-specific utility instrument, such as the QLU-C10D, could improve the quality and the pertinence of future CUA in oncology.

Clinical Outcome Assessment in Cancer Rehabilitation and the Central Role of Patient-Reported Outcomes.

The aim of cancer rehabilitation is to help patients regain functioning and social participation. In order to evaluate and optimize rehabilitation, it is important to measure its outcomes in a structured way. In this article, we review the different types of clinical outcome assessments (COAs), including Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs), Performance Outcomes (PerfOs), and Patient-Reported Outcomes (PROs). A special focus is placed on PROs, which are commonly defined as any direct report from the patient about their health condition without any interpretation by a third party. We provide a narrative review of available PRO measures (PROMs) for relevant outcomes, discuss the current state of PRO implementation in cancer rehabilitation, and highlight trends that use PROs to benchmark value-based care. Furthermore, we provide examples of PRO usage, highlight the benefits of electronic PRO (ePRO) collection, and offer advice on how to select, implement, and integrate PROs into the cancer rehabilitation setting to maximize efficiency.

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

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

The EORTC CAT Core-The computer adaptive version of the EORTC QLQ-C30 questionnaire.

BACKGROUND: To optimise measurement precision, relevance to patients and flexibility, patient-reported outcome measures (PROMs) should ideally be adapted to the individual patient/study while retaining direct comparability of scores across patients/studies. This is achievable using item banks and computerised adaptive tests (CATs). The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) is one of the most widely used PROMs in cancer research and clinical practice. Here we provide an overview of the research program to develop CAT versions of the QLQ-C30's 14 functional and symptom domains. METHODS: The EORTC Quality of Life Group's strategy for developing CAT item banks consists of: literature search to identify potential candidate items; formulation of new items compatible with the QLQ-C30 item style; expert evaluations and patient interviews; field-testing and psychometric analyses, including factor analysis, item response theory calibration and simulation of measurement properties. In addition, software for setting up, running and scoring CAT has been developed. RESULTS: Across eight rounds of data collections, 9782 patients were recruited from 12 countries for the field-testing. The four phases of development resulted in a total of 260 unique items across the 14 domains. Each item bank consists of 7-34 items. Psychometric evaluations indicated higher measurement precision and increased statistical power of the CAT measures compared to the QLQ-C30 scales. Using CAT, sample size requirements may be reduced by approximately 20-35% on average without loss of power. CONCLUSIONS: The EORTC CAT Core represents a more precise, powerful and flexible measurement system than the QLQ-C30. It is currently being validated in a large independent, international sample of cancer patients.

Critical appraisal of health-state utility values used in breast cancer-related cost-utility analyses.

PURPOSE: To review the data sources of health-state utility values (HSUVs), as well as their elicitation and use, in 140 breast cancer-related cost-utility analyses (CUAs), and to provide a critical appraisal of these. METHODS: A checklist was developed to guide the process of the critical appraisal. It is divided into three parts: the data source (three questions), elicitation method (four questions), and use (ten questions) of HSUVs in CUAs. Two independent reviewers performed the data extraction. A consensus was reached in case of disagreements. Data sources were categorized as "original study," "derived from the literature," or "other." RESULTS: The data source of HSUVs was always specified. When HSUVs were derived from the literature (90% of cases), the authors referred to a median number of two references as data sources. The critical appraisal of the elicitation of HSUVs in CUAs revealed considerable variability in terms of the quality of the reporting of the data source selection of HSUV. More details were provided by authors when HSUVs were elicited from an original study rather than derived from the literature. The use of HSUVs elicited from an original study was generally better described in terms of the checklist than were those derived from the literature. CONCLUSIONS: Based on the developed checklist, we were able to highlight the challenges that authors are facing when trying to adequately report HSUV used in CUAs. Our proposed checklist offers a good starting point for encouraging more explicit and comprehensive reporting of HSUVs in CUAs.

Evaluation of Noncompletion Bias and Long-Term Adherence in a 10-Year Patient-Reported Outcome Monitoring Program in Clinical Routine.

BACKGROUND: Currently there is little knowledge on real-life sustainability of routine patient-reported outcome (PRO) measurement and the representativeness of collected data. OBJECTIVES: The investigation of routine PRO with regard to noncompletion bias and long-term adher- ence, considering the potential impact of mode of assessment (MOA) (paper-pencil vs. electronic PRO [ePRO]) and patient characteristics. METHODS: At our department, routine PRO measurement in oncological patients is being done since 2005 using different MOA (paper-pencil assessment until 2011 and ePRO assessment from 2011 onward). We analyzed two different patient groups: patients eligible in both periods (both-MOA group) and patients eligible in only one period (one-MOA group). The primary outcome was PRO noncompletion (100% missing questionnaires). The secondary outcome was poor PRO adherence (>20% missing questionnaires). Multivariate logistic regression models were developed, testing the impact of MOA and patient characteristics on the outcomes in the different patient groups. RESULTS: Data from 1484 eligible patients were included in the analyses. Most of the patients could be included in PRO assessment at least once. PRO noncompletion rates were clearly higher during paper-pencil assessment (odds ratios between 2.72 and 4.31), as were poor PRO adherence rates (odd ratio 2.23). Analyses of potential bias by patient characteristics showed that male patients had a higher risk of poor adherence. Other factors with significant impact were age, country, and cancer diagnosis, but results were indecisive. CONCLUSIONS: ePRO increased the feasibility of our clinical routine PRO data for retrospective analyses by increasing completion rates. In general, potential completion bias regarding certain patient characteristics requires attention before generalizing results to the respective populations.

Order of Presentation of Dimensions Does Not Systematically Bias Utility Weights from a Discrete Choice Experiment.

BACKGROUND: Discrete choice experiments (DCEs) are increasingly used to value aspects of health. An issue with their adoption is that results may be sensitive to the order in which dimensions of health are presented in the valuation task. Findings in the literature regarding order effects are discordant at present. OBJECTIVES: To quantify the magnitude of order effect of quality-of-life (QOL) dimensions within the context of a DCE designed to produce country-specific value sets for the EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D), a new utility instrument derived from the widely used cancer-specific QOL questionnaire, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. METHODS: The DCE comprised 960 choice sets, divided into 60 versions of 16 choice sets, with each respondent assigned to a version. Within each version, the order of QLU-C10D QOL dimensions was randomized, followed by life duration in the last position. The DCE was completed online by 2053 individuals in France and Germany. We analyzed the data with a series of conditional logit models, adjusted for repeated choices within respondent. We used F tests to assess order effects, correcting for multiple hypothesis testing. RESULTS: Each F test failed to reject the null hypothesis of no position effect: 1) all QOL order positions considered jointly; 2) last QOL position only; 3) first QOL position only. Furthermore, the order coefficients were small relative to those of the QLU-C10D QOL dimension levels. CONCLUSIONS: The order of presentation of QOL dimensions within a DCE designed to provide utility weights for the QLU-C10D had little effect on level coefficients of those QOL dimensions.

Cost-utility analyses of drug therapies in breast cancer: a systematic review.

The economic evaluation (EE) of health care products has become a necessity. Their quality must be high in order to trust the results and make informed decisions. While cost-utility analyses (CUAs) should be preferred to cost-effectiveness analyses in the oncology area, the quality of breast cancer (BC)-related CUA has been given little attention so far. Thus, firstly, a systematic review of published CUA related to drug therapies for BC, gene expression profiling, and HER2 status testing was performed. Secondly, the quality of selected CUA was assessed and the factors associated with a high-quality CUA identified. The systematic literature search was conducted in PubMed, MEDLINE/EMBASE, and Cochrane to identify published CUA between 2000 and 2014. After screening and data extraction, the quality of each selected CUA was assessed by two independent reviewers, using the checklist proposed by Drummond et al. The analysis of factors associated with a high-quality CUA (defined as a Drummond score ≥7) was performed using a two-step approach. Our systematic review was based on 140 CUAs and showed a wide variety of methodological approaches, including differences in the perspective adopted, the time horizon, measurement of cost and effectiveness, and more specially health-state utility values (HSUVs). The median Drummond score was 7 [range 3-10]. Only one in two of the CUA (n = 74) had a Drummond score ≥7, synonymous of "high quality." The statistically significant predictors of a high-quality CUA were article with "gene expression profiling" topic (p = 0.001), consulting or pharmaceutical company as main location of first author (p = 0.004), and articles with both incremental cost-utility ratio and incremental cost-effectiveness ratio as outcomes of EE (p = 0.02). Our systematic review identified only 140 CUAs published over the past 15 years with one in two of high quality. It showed a wide variety of methodological approaches, especially focused on HSUVs. A critical appraisal of utility values is necessary to better understand one of the main difficulties encountered by authors and propose areas for improvement to increase the quality of CUA. Since the last 5 years, there is a tendency toward an improvement in the quality of these studies, probably coupled with economic context, a better and widely spreading of recommendations and thus appropriation by medical practitioners. That being said, there is an urgent need for mandatory use of European and international recommendations to ensure quality of such approaches and to allow easy comparison.

Patient-reported outcome reference values for patients after kidney transplantation.

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.

Development of a computer-adaptive version of the forgotten joint score.

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.

The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring.

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.

[The benefits of using patient-reported outcomes in cancer treatment: an overview]. / Verwendung und Nutzen von Patient-Reported Outcomes in der onkologischen Behandlung: eine Übersicht.

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.

Monitoring physical and psychosocial symptom trajectories in ovarian cancer patients receiving chemotherapy.

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.

Do neurooncological patients and their significant others agree on quality of life ratings?

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.