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

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

Psychopathologisches Befund-System für Kinder und Jugendliche (CASCAP-2) Psychopathologisches Befund-System für Kinder und Jugendliche

Das Psychopathologische Befund-System für Kinder und Jugendliche (CASCAP-2) dient der Erfassung der wichtigsten Merkmale psychischer Störungen im Kindes- und Jugendalter. Mithilfe des CASCAP-2 können über 100 psychopathologische Merkmale klinisch beurteilt werden. Die Diagnostikerin bzw. der Diagnostiker nimmt die Einschätzung auf der Basis einer klinischen Exploration des Kindes bzw. Jugendlichen und der begleitenden Bezugsperson(en) sowie anhand eigener Beobachtungen in der Untersuchungssituation vor.CASCAP-2 besteht aus drei Komponenten: dem Befundbogen, dem Glossar und dem Explorationsleitfaden. Im Glossar werden die einzelnen Merkmale definiert, Beispiele für eine starke Symptomausprägung gegeben und abzugrenzende Merkmale aufgelistet. Der Explorationsleitfaden beinhaltet Beispielfragen und liegt in zwei Versionen vor, eine für die Exploration des Kindes bzw. des Jugendlichen und eine für die Exploration der Bezugsperson(en). Auf dem separat lieferbaren Befundbogen werden die klinischen Beurteilungen dokumentiert.CASCAP-2 ist der Nachfolger des CASCAP-D. Im Befund-System wurden einige psychopathologische Merkmale hinzugefügt. Entsprechend wurden das Glossar und der Befundbogen überarbeitet und der Explorationsleitfaden erweitert. Im Manual wurden weitere empirische Studien ergänzt und es wird ein neues empirisches Skalenmodell vorgestellt.CASCAP-2 ergänzt die kategoriale Diagnostik durch eine phänomenologische Beschreibung psychischer Störungen von Kindern und Jugendlichen auf der Ebene von Einzelsymptomen. Das für die Praxis konzipierte Instrument lässt sich sehr gut in klinische Routineabläufe integrieren. von Manfred Döpfner, Walter Berner, Hans-Christoph Steinhausen, Gerd Lehmkuhl, Henning Flechtner, Dieter Breue

Neural Mechanisms Underlying the Effects of Novel Sounds on Task Performance in Children With and Without ADHD

Distractibility is one of the key features of attention deficit hyperactivity disorder (ADHD) and has been associated with alterations in the neural orienting and alerting networks. Task-irrelevant stimuli are thus expected to have detrimental effects on the performance of patients with ADHD. However, task-irrelevant presentation of novel sounds seems to have the opposite effect and improve subsequent attentional performance particularly in patients with ADHD. Here, we aimed to understand the neural modulations of the attention networks underlying these improvements. Fifty boys (25 with ADHD) participated in a functional magnetic resonance imaging (fMRI) study in which unique (novel) or repeatedly presented (familiar) sounds were placed before a visual flanker task in 2/3 of the trials. We found that presenting any sound improved task performance in all participants, but the underlying neural mechanisms differed for the type of sound. Familiar sounds led to a stronger increase in activity in the left posterior insula in patients with ADHD compared to typically developing peers. Novel sounds led to activations of the fronto-temporoparietal ventral attention network, likewise in ADHD and TD. These changes in signaling by novelty in the right inferior frontal gyrus were directly related to improved response speed showing that neural orienting network activity following novel sounds facilitated subsequent attentional performance. This mechanism of behavioral enhancement by short distractions could potentially be useful for cognitive trainings or homework situations

Effects of long-term psychodynamic psychotherapy on life quality in mentally disturbed children

Objective: Long-term psychodynamic psychotherapy for children aims not only at improving symptoms but also at changing the quality of life. To our knowledge, no studies exist to date that focused on both aspects. In this paper, we investigated changes in problem behavior and health-related quality of life based on long-term psychodynamic psychotherapy with children suffering from emotional and behavioral disorders. Method: We investigated 76 children in the treatment group and analyzed pre- and post-treatment symptoms. Furthermore, we compared the outcome data with a control group of 27 children of similar age and diagnoses who received no psychotherapy, both under routine care conditions. The children included in the study were treated on average for 66 sessions. Parent and adolescent ratings on the Achenbach Scales and the Quality of Life Inventory for Adolescents were compared before and after treatment. Results: We found a highly significant improvement of internalizing symptomatology based on parent ratings with a large effect. Different from prior investigations based on short-term psychodynamic psychotherapy we found changes in quality of life with large effects. Conclusion: These findings indicate that long-term psychodynamic treatment can improve life quality in children beyond symptom change

Parental palliative cancer: psychosocial adjustment and health-related quality of life in adolescents participating in a German family counselling service

Abstract Background Parental palliative disease is a family affair, however adolescent's well-being and coping are still rarely considered. The objectives of this paper were a) to identify differences in psychosocial adjustment and health-related quality of life (HRQoL) among adolescents and young adults with parents suffering from palliative cancer or cancers in other disease stages, b) to relate psychosocial adjustment and health-related quality of life to adolescent coping, and c) to explore significant mediator and predictor variables. Methods Cross-sectional data were derived from a multi-site research study of families before child-centered counselling. N=86 adolescents and young adults were included, their mean age 13.78 years (sd 2.45), 56% being female. Performed analyses included ANCOVA, multiple linear regression, and mediation analysis. Results Adolescents with parents suffering from palliative cancers reported significantly less total psychosocial problems, and better overall HRQoL. There were no significant group differences regarding coping frequency and efficacy. Our set of coping items significantly mediated the effect of parental disease stage on psychosocial problems and HRQoL. Further, parental disease status and general family functioning predicted psychosocial problems (R2adj =.390) and HRQoL (R2adj =.239) best. Conclusion The study indicates distress among adolescents throughout the entire parental disease process. Our analysis suggests that counselling services could offer supportive interventions which focus particularly on adolescent coping as well as family functioning.</p

Minimally important differences of EORTC QLQ-C30 scales in patients with lung cancer or malignant pleural mesothelioma : interpretation guidance derived from two randomized EORTC trials

Objectives A minimally important difference (MID) is the smallest difference in quality of life (QoL) perceived as relevant by patients or clinicians. MIDs aid interpretation of QOL data in research and clinical practice. We aimed to determine MIDs for the EORTC QLQ-C30 for patients with lung cancer or malignant pleural mesothelioma. Materials and Methods Data were drawn from two EORTC-sponsored randomised clinical trials (RCTs): a three-arm RCT of two cisplatin-based treatments and paclitaxel plus gemcitabine in advanced non–small-cell lung cancer, and an RCT comparing cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. MIDs for interpreting within-group change and between-group differences in change over time were computed using anchor-based approaches, for improvements and deteriorations separately. Distribution-based approaches provided corroborative evidence. Results The combined data from the trials comprised 730 patients. Available data allowed us to determine 8/14 anchor-based MIDs for EORTC scales for improvements, and 9/14 MIDs for deterioration. Furthermore, we provided distribution-based estimates for all 14 QLQ-C30 scales. Most MIDs for improvements ranged between 5 and 10, for both within-group and between-group differences. Outliers were appetite loss and constipation, with MIDs up to 15 score points. MIDs were slightly larger for within-group deterioration, ranging from –5 to -15, with the largest for Nausea/vomiting (-14) and Appetite loss (-15). MIDs for between-group differences in deterioration ranged from -4 (Physical, Role, and Social functioning, and Global quality of life) to -9 (Nausea/vomiting, Appetite loss and Constipation). Conclusions MIDs vary over scales and for between- versus within-group comparisons; this must be taken into account when interpreting changes. Nevertheless, the majority of MIDs range between 5 and 10 score points, in line with previously used thresholds for QLQ-C30. These findings and those from other tumor-specific MID analyses will inform a planned consensus process identifying commonalities and differences across tumor sites

Minimally important differences of EORTC QLQ-C30 scales in patients with lung cancer or malignant pleural mesothelioma – Interpretation guidance derived from two randomized EORTC trials

Objectives: A minimally important difference (MID) is the smallest difference in quality of life (QoL) perceived as relevant by patients or clinicians. MIDs aid interpretation of QOL data in research and clinical practice. We aimed to determine MIDs for the EORTC QLQ-C30 for patients with lung cancer or malignant pleural mesothelioma. Materials and Methods: Data were drawn from two EORTC-sponsored randomized clinical trials (RCTs): a three-arm RCT of two cisplatin-based treatments and paclitaxel plus gemcitabine in advanced non–small-cell lung cancer, and an RCT comparing cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. MIDs for interpreting within-group change and between-group differences in change over time were computed using anchor-based approaches, for improvements and deteriorations separately. Distribution-based approaches provided corroborative evidence. Results: The combined data from the trials comprised 730 patients. Available data allowed us to determine 8/14 anchor-based MIDs for EORTC scales for improvements, and 9/14 MIDs for deterioration. Furthermore, we provided distribution-based estimates for all 14 QLQ-C30 scales. Most MIDs for improvements ranged between 5 and 10, for both within-group and between-group differences. Outliers were appetite loss and constipation, with MIDs up to 15 score points. MIDs were slightly larger for within-group deterioration, ranging from –5 to − 15, with the largest for Nausea/vomiting (−1 to 4) and Appetite loss (−1 to 5). MIDs for between-group differences in deterioration ranged from − 4 (Physical, Role, and Social functioning, and Global quality of life) to −9 (Nausea/vomiting, Appetite loss and Constipation). Conclusions: MIDs vary over scales and for between- versus within-group comparisons; this must be taken into account when interpreting changes. Nevertheless, the majority of MIDs range between 5 and 10 score points, in line with previously used thresholds for QLQ-C30. These findings and those from other tumor-specific MID analyses will inform a planned consensus process identifying commonalities and differences across tumor sites