Eva Gamper

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

BackgroundPatient-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.MethodsFollowing 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.ResultsBy 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.DiscussionDuring 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.

Quality of life in patients with thyroid cancer compared with the general population.

BACKGROUND Since patients with thyroid cancer have a very good prognosis overall, clinicians may often assume that their quality of life is comparable to the general population. We hypothesized that quality of life of thyroid cancer patients is lower compared with the general population while controlling the effect of age and gender. METHODS At the beginning of their stay at an inpatient rehabilitation clinic, a cohort of n=121 patients with thyroid cancer were assessed using the quality of life core questionnaire of the European Organisation for Research and Treatment of Cancer (QLQ-C30). Data for comparison were derived from a representative German community sample with n=2037. RESULTS The patients reported significantly more problems than the community sample participants independent of gender and age effects in all but two domains, namely constipation and diarrhea. The strongest effects of the group (patients vs. general population) were found in the following domains: insomnia (B=-43.7, p<0.001), fatigue (B=-38.0, p=<0.001), and role functioning (B=29.7, p=<0.001). Significant interactions between age and group occurred in the social functioning, role functioning, fatigue, nausea/vomiting, and financial difficulties domains. Quality of life was unrelated to the stage of the disease, except in the physical function and global health status domains. CONCLUSIONS At the beginning of inpatient rehabilitation, patients with thyroid cancer often experience more problems than controls from community samples, independent of their age and gender. Clinicians should be aware of the fact that quality of life is not directly related to the severity of the cancer prognosis.

Adherence evaluation of endocrine treatment in breast cancer: methodological aspects

BackgroundCurrent 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.MethodsOutpatients 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.ResultsComparison 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.ConclusionOur 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.

Cross-cultural development of an item list for computer-adaptive testing of fatigue in oncological patients

IntroductionWithin 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.MethodsThe 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.ResultsBased 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.DiscussionThe 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.

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.

The EORTC module for quality of life in patients with thyroid cancer: phase III

The purpose of the study was to pilot-test a questionnaire measuring health-related quality of life (QoL) in thyroid cancer patients to be used with the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire EORTC QLQ-C30. A provisional questionnaire with 47 items was administered to patients treated for thyroid cancer within the last 2 years. Patients were interviewed about time and help needed to complete the questionnaire, and whether they found the items understandable, confusing or annoying. Items were kept in the questionnaire if they fulfilled pre-defined criteria: relevant to the patients, easy to understand, not confusing, few missing values, neither floor nor ceiling effects, and high variance. A total of 182 thyroid cancer patients in 15 countries participated (n = 115 with papillary, n = 31 with follicular, n = 22 with medullary, n = 6 with anaplastic, and n = 8 with other types of thyroid cancer). Sixty-six percent of the patients needed 15 min or less to complete the questionnaire. Of the 47 items, 31 fulfilled the predefined criteria and were kept unchanged, 14 were removed, and 2 were changed. Shoulder dysfunction was mentioned by 5 patients as missing and an item covering this issue was added. To conclude, the EORTC quality of life module for thyroid cancer (EORTC QLQ-THY34) is ready for the final validation phase IV.

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.

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

In this retrospective investigation of patient pathways to psycho‐oncological treatment (POT), we compared the number of POT referrals before and after implementation of electronic screening for POT needs and investigated psychosocial predictors for POT wish at a nuclear medicine department.

Quality-of-life priorities in patients with thyroid cancer: A multinational european organisation for research and treatment of cancer phase I study

Background: The objectives of this study were to determine quality of life (QoL) issues that are relevant to thyroid cancer patients cross-culturally, and to identify those with highest relevance to them in addition to the more general issues covered by the core European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Methods: A systematic literature search provided a list of potentially relevant QoL issues to supplement the core questionnaire EORTC QLQ-C30, which is widely used in research and in care and addresses QoL issues relevant to all groups of cancer patients. A panel of experts revised this list, and thyroid cancer patients rated the issues regarding their relevance for QoL by selecting the 25 issues that they would include in a thyroid cancer–specific QoL module. Results: The literature search and expert discussion provided a list of 71 QoL issues that was rated by thyroid cancer patients (n = 110) from seven countries. All issues were of high priority to at...1. Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany 2. CoRPS – Center of Research on Psychology in Somatic diseases, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands 3. Department of Medical Education, Jagiellonian University Medical College, Krakow, Poland 4. Head & Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy 5. Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan 6. Department of Medical Psychology and Medical Sociology, University Medical Centre, Leipzig, Germany 7. Mount Vernon Hospital, Northwood, London, UK 8. Service of Surgical Oncology, Instituto Português do Oncologia do Porto Francisco Gentil, Portugal 9. Department of Nuclear Medicine and Department of Psychiatry and Psychotherapy, Medical University of Innsbruck, Austria 10. European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Translation Unit, Brussels, Belgium 11. National Association of Thyroid Cancer Patients “Bundesverband Schilddrüsenkrebs Ohne Schilddrüse leben e.V.”, Berlin, Germany 12. Surgery Department, Jules Bordet Institute, Brussels, Belgium

Quality of life priorities in patients with thyroid cancer - a multi-national EORTC phase I study.

Background: The objectives of this study were to determine quality of life (QoL) issues that are relevant to thyroid cancer patients cross-culturally, and to identify those with highest relevance to them in addition to the more general issues covered by the core European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Methods: A systematic literature search provided a list of potentially relevant QoL issues to supplement the core questionnaire EORTC QLQ-C30, which is widely used in research and in care and addresses QoL issues relevant to all groups of cancer patients. A panel of experts revised this list, and thyroid cancer patients rated the issues regarding their relevance for QoL by selecting the 25 issues that they would include in a thyroid cancer–specific QoL module. Results: The literature search and expert discussion provided a list of 71 QoL issues that was rated by thyroid cancer patients (n = 110) from seven countries. All issues were of high priority to at...1. Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany 2. CoRPS – Center of Research on Psychology in Somatic diseases, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands 3. Department of Medical Education, Jagiellonian University Medical College, Krakow, Poland 4. Head & Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy 5. Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan 6. Department of Medical Psychology and Medical Sociology, University Medical Centre, Leipzig, Germany 7. Mount Vernon Hospital, Northwood, London, UK 8. Service of Surgical Oncology, Instituto Português do Oncologia do Porto Francisco Gentil, Portugal 9. Department of Nuclear Medicine and Department of Psychiatry and Psychotherapy, Medical University of Innsbruck, Austria 10. European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Translation Unit, Brussels, Belgium 11. National Association of Thyroid Cancer Patients “Bundesverband Schilddrüsenkrebs Ohne Schilddrüse leben e.V.”, Berlin, Germany 12. Surgery Department, Jules Bordet Institute, Brussels, Belgium