The Added Value of Analyzing Pooled Health-Related Quality of Life Data: A Review of the EORTC PROBE Initiative

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Patient-Reported Outcomes and Behavioural Evidence (PROBE) initiative was established to investigate critical topics to better understand health-related quality of life (HRQOL) of cancer patients and to educate clinicians, policy makers, and healthcare providers. METHODS: The aim of this paper is to review the major research outcomes of the pooled analysis of HRQOL data along with the clinical data. We identified 30 pooled EORTC randomized controlled trials (RCTs), 18 NCIC-Clinical Trials Group RCTs, and two German Ovarian Cancer Study Group RCTs, all using the EORTC QLQ-C30. All statistical tests were two-sided. RESULTS: Evidence was found that HRQOL data can offer prognostic information beyond clinical measures and improve prognostic accuracy in cancer RCTs (by 5.9%-8.3%). Moreover, models that considered both patient- and clinician-reported scores gained more prognostic overall survival accuracy for fatigue (P < .001), vomiting (P = .01), nausea (P < .001), and constipation (P = .01). Greater understanding of the association between symptom and/or functioning scales was developed by identifying physical, psychological, and gastrointestinal clusters. Additionally, minimally important differences in interpreting HRQOL changes for improvement and deterioration were found to vary across different patient populations and disease stages. Finally, HRQOL scores are statistically significantly affected by deviations from the intended time point at which the questionnaire is completed. CONCLUSIONS: The use of existing pooled data shows that it is possible to learn about general aspects of cancer HRQOL and methodology. Our work shows that setting up international pooled datasets holds great promise for understanding patients' unmet psychosocial needs and calls for additional empirical investigation to improve clinical care and understand cancer through retrospective HRQOL analyses

Minimally important differences for interpreting EORTC QLQ-C30 scores in patients with advanced breast cancer

Background We aimed to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in patients with advanced breast cancer. Patients and Methods Data were derived from two published EORTC trials. Clinical anchors, e.g. performance status, were selected using correlation strength and clinical plausibility of their association with a particular QLQ-C30 scale. Three change status groups were formed: deteriorated by one anchor category, improved by one anchor category and no change. Patients with greater anchor changes were excluded. The mean change method was used to estimate MIDs for within-group change and linear regression was used to estimate MIDs for between-group differences in change over time. For a given QLQ-C30 scale, MID estimates from multiple anchors were triangulated to a single value via a correlation-based weighted average. Results MIDs varied by QLQ-C30 scale, direction (improvement versus deterioration) and anchor. MIDs for within-group change ranged from 5 to 14 points (improvement) and –14 to –4 points (deterioration), and MIDs for between-group change over time ranged from 4 to 11 points and from –18 to –4 points. Correlation-weighted MIDs for most QLQ-C30 scales ranged from 4 to 10 points in absolute values. Conclusions Our findings aid interpretation of changes in EORTC QLQ-C30 scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in advanced breast cancer

The effects of age on health-related quality of life in cancer populations: A pooled analysis of randomized controlled trials using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 involving 6024 cancer patients.

Cancer incidence increases exponentially with advancing age, cancer patients live longer than in the past, and many new treatments focus on stabilizing disease and HRQOL. The objective of this study is to examine how cancer affects patients' HRQOL and whether their HRQOL is age-dependent.Data from 25 EORTC randomized controlled trials was pooled. EORTC QLQ-C30 mean scores for the cancer cohort and five general population cohorts were compared to assess the impact of cancer on patients' HRQOL. Within the cancer cohort, multiple linear regressions (two-sided level P-value = 0.05 adjusted for multiple testing.) were used to investigate the association between age and HRQOL, adjusted for gender, WHO performance status (PS), distant metastasis and stratified by cancer site. A difference of 10 points on the 0-100 scale was considered clinically important.Cancer patients generally have worse HRQOL compared to the general population, but the specific HRQOL domains impaired vary with age. When comparing the cancer versus the general population, young cancer patients had worse financial problems, social and role functioning, while the older cancer groups had more appetite loss. Within the cancer cohort, HRQOL was worse with increasing age for physical functioning and constipation, and better with increasing age for social functioning, insomnia and financial problems (all p < 0.05).HRQOL is impaired in cancer patients compared to the general population, but the impact on specific HRQOL domains varies by age. Within the cancer population, some HRQOL components improve with age while others deteriorate. Optimal care for older cancer patients should target HRQOL domains most relevant to this population

Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials

The aim of this study was to determine the smallest changes in health-related quality of life (HRQOL) scores in a subset of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scales, which could be considered as clinically meaningful in patients with non-small-cell lung cancer (NSCLC). WHO performance status (PS) and weight change were used as clinical anchors to determine minimal important differences (MIDs) in HRQOL change scores (range, 0-100) in the EORTC QLQ-C30 scales. Selected distribution-based methods were used for comparison. In a pooled dataset of 812 NSCLC patients undergoing treatment, the values determined to represent the MID depended on whether patients were improving or deteriorating. MID estimates for improvement (based on a one-category change in PS, 5 -aEuro parts per thousand < 20% weight gain) were physical functioning (9, 5); role functioning (14, 7); social functioning (5, 7); global health status (9, 4); fatigue (14, 5); and pain (16, 2). The respective MID estimates for deterioration (based on PS, weight loss) were physical (4, 6); role (5, 5); social (7, 9); global health status (4, 4); fatigue (6, 11); and pain (3, 7). Based on the selected QLQ-C30 scales, the MID may depend upon whether the patients' PS is improving or worsening, but our results are not definitive. The MID estimates for the specified scales can help clinicians and researchers evaluate the significance of changes in HRQOL and assess the value of a health care intervention or compare treatments. The estimates also can be useful in determining sample sizes in the design of future clinical trials

School phobia: Classification, developmental psychopathology, prognosis, and therapeutic approaches

Schulverweigerung ist häufig Ausdruck einer komplexen psychiatrischen Störung. Es besteht eine erhöhte Komorbidität mit Depressionen, Phobien sowie anderen Angststörungen. Therapieprogramme sollten multimodal konzipiert sein und es ist nicht davon auszugehen, dass es zu einer raschen Rückbildung der Symptomatik kommt. Katamnestische Studien belegen eindrucksvoll, dass mit Langzeitfolgen gerechnet werden muss sowohl hinsichtlich der beruflichen Integration als auch der weiteren psychiatrischen Morbidität. Auslösende und aufrechterhaltende Faktoren sind heterogen und es findet sich kein typisches psychosoziales Belastungsmuster.(DIPF/Orig.)In many cases the refusal of school is one manifestation of a complex psychiatric disorder. There is an increased comorbidity with depression, phobia and other anxiety disorders. The program of therapy should be conceptualized as multimodal. In general there is no rapid remission of the symptoms. As catamnestic studies proved, long-term consequences should be anticipated concerning the occupational integration as well as further psychiatric morbidity. Triggering and sustainable factors are heterogeneous and there is no typical psychosocial pattern.(DIPF/Orig.

Disputatio Iuridica de Querela inofficiosi Testamenti

Quam ... in Alma Viadrina, Praeside Henningo Grossen ... Publicae disquisitioni Subiicit Daniel Flechtner/ Gedanens. in Auditorio Iuridico Ad diem April. M.DC.XLVII. ...Vorlageform des Erscheinungsvermerks: Francofurti, Typis Nicolai Kochii Academ. Typogr

Psychosocial stress and quality of life of long-term survivors of HodgkinE1/4s disease: No end of collation, but no initiation of patient-centered intervention?

Over the last decades the treatment of Hodgkin's disease has proved to be increasingly successful so that nowadays questions concerning long-term survivorship receive more and more attention. In addition to side effects and long-term treatment success, many questions arise regarding health-related quality of life, fatigue, psychological sequelae (e.aEurog. depression), fertility, occupational reintegration and patient education. While big data sets already exist regarding patient reported outcomes, this information is hardly systematically used in patient care and has no impact on traditional follow-up concepts. Innovative approaches are necessary, which by the use of modern media, involve patients to a greater extent and relate more in detail to relevant aspects of life planning in this young patient group. Basic principles of the current situation are presented and discussed

Erythropoietin improves quality of life--a response.

In summary, it is important to consider the overall weight of the evidence and the published studies, and not simply focus on selected trials. Our review clearly identified, in general agreement with Littlewood et al, that with better research design and refined methods, we should be able to understand the true significance of recombinant human erythropoietin and its effect on quality of life.status: publishe