Johannes M. Giesinger

Taste Alterations in Cancer Patients Receiving Chemotherapy: A Neglected Side Effect?

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.

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.

Implementation of Computer-Based Quality-of-Life Monitoring in Brain Tumor Outpatients in Routine Clinical Practice

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.

Comparative responsiveness of outcome measures for total knee arthroplasty

Summary 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.

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

IntroductionPatients 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.MethodsPatients 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.ResultsBetween 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.ConclusionThe 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 patients quality of life and symptom burden, if the patient is not able to provide information himself.

Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust

OBJECTIVE To further evaluate the higher order measurement structure of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), with the aim of generating a summary score. STUDY DESIGN AND SETTING Using pretreatment QLQ-C30 data (N = 3,282), we conducted confirmatory factor analyses to test seven previously evaluated higher order models. We compared the summary score(s) derived from the best performing higher order model with the original QLQ-C30 scale scores, using tumor stage, performance status, and change over time (N = 244) as grouping variables. RESULTS Although all models showed acceptable fit, we continued in the interest of parsimony with known-groups validity and responsiveness analyses using a summary score derived from the single higher order factor model. The validity and responsiveness of this QLQ-C30 summary score was equal to, and in many cases superior to the original, underlying QLQ-C30 scale scores. CONCLUSION Our results provide empirical support for a measurement model for the QLQ-C30 yielding a single summary score. The availability of this summary score can avoid problems with potential type I errors that arise because of multiple testing when making comparisons based on the 15 outcomes generated by this questionnaire and may reduce sample size requirements for health-related quality of life studies using the QLQ-C30 questionnaire when an overall summary score is a relevant primary outcome.

Association of psychological status and patient-reported physical outcome measures in joint arthroplasty: a lack of divergent validity.

BackgroundPatient-reported outcome measures have become a well-recognised part of outcome assessment in orthopaedic surgery. These questionnaires claim to measure joint-specific dimensions like pain, function in activities of daily living, joint awareness or stiffness. Interference of the patient’s psychological status with these orthopaedic questionnaires however may make accurate interpretation difficult.MethodsWe recruited 356 patients after unilateral, primary THA or TKA and performed a postal survey including the Brief Symptom Inventory (psychological distress measure), the Catastrophising Scale (from the Coping Strategies Questionnaire), the WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index) and the Forgotten Joint Score – 12 (FJS-12). Associations between the different questionnaires were determined calculating Pearson correlation coefficients. Two multiple linear regression models were used to investigate the impact of socio-demographic variables, clinical variables and of the psychological scales (BSI and Catastrophising Scale) separately for the WOMAC score and the FJS-12.ResultsWOMAC-Total score showed strong correlation to Catastrophising (r = 0.79), BSI-Somatisation (r = 0.63) and BSI-GSI (r = 0.54). The FJS-12 demonstrated modest to strong correlation with Catastrophising (r = −0.60), BSI-Somatisation (r = −0.49) and the BSI-GSI (Global Severity Index) (r = −0.44). BSI-GSI and Catastrophising explained 54.3% of variance in a multivariate regression model for the WOMAC score. The same two scales explained 30.0% of variance for the FJS-12.ConclusionsThere is a strong relationship between psychological status and orthopaedic outcome. The scale names of orthopaedic outcome measures suggest to measure specific dimensions like pain, stiffness, function or joint awareness. In fact they largely include patient’s psychological status indicating poor divergent validity.

Quality of life during chemotherapy in lung cancer patients: results across different treatment lines

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.

International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer

Background:Older people represent the majority of cancer patients but their specific needs are often ignored in the development of health-related quality of life (HRQOL) instruments. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-ELD15 was developed to supplement the EORTC’s core questionnaire, the QLQ-C30, for measuring HRQOL in patients aged >70 years in oncology studies.Methods:Patients (n=518) from 10 countries completed the QLQ-C30, QLQ-ELD15 and a debriefing interview. Eighty two clinically stable patients repeated the questionnaires 1 week later (test–retest analysis) and 107 others, with an expected change in clinical status, repeated the questionnaires 3 months later (response to change analysis, RCA).Results:Information from the debriefing interview, factor analysis and item response theory analysis resulted in the removal of one item (QLQ-ELD15QLQ-ELD14) and revision of the proposed scale structure to five scales (mobility, worries about others, future worries, maintaining purpose and illness burden) and two single items (joint stiffness and family support). Convergent validity was good. In known-group comparisons, the QLQ-ELD14 differentiated between patients with different disease stage, treatment intention, number of comorbidities, performance status and geriatric screening scores. Test–retest and RCA analyses were equivocal.Conclusion:The QLQ-ELD14 is a validated HRQOL questionnaire for cancer patients aged ⩾70 years. Changes in elderly patients’ self-reported HRQOL may be related to both cancer evolution and non-clinical events.

WOMAC, EQ-5D and Knee Society Score Thresholds for Treatment Success After Total Knee Arthroplasty

Our study aimed at developing clinical thresholds (cut-off scores) for the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index, EQ-5D and Knee Society Score for discriminating between patients with and without treatment success following total knee arthroplasty (TKA). We performed a retrospective analysis of 1055 patients 2 months after TKA and 765 patients 1 year after TKA. We considered treatment successful if the patient reported high levels of satisfaction and pain relief, functional increase, and a willingness to undergo the same procedure again. Based on this criterion we identified cut-off scores that will facilitate interpretation of the WOMAC, the EQ-5D and the KSS in TKA patients.