BackgroundInpatient psychosomatic rehabilitation is a key treatment for patients with mental health issues. However, knowledge about critical success factors for beneficial treatment outcomes is scarce. The aim of this study was to evaluate the association of mentalizing and epistemic trust with the improvement of psychological distress during rehabilitation.MethodsIn this naturalistic longitudinal observational study, patients completed routine assessments of psychological distress (BSI), health-related quality of life (HRQOL; WHODAS), mentalizing (MZQ), and epistemic trust (ETMCQ) before (T1) and after (T2) psychosomatic rehabilitation. Repeated measures ANOVA (rANOVAs) and structural equation models (SEMs) were calculated to investigate the association of mentalizing and epistemic trust with the improvement in psychological distress.ResultsA total sample of n = 249 patients were included in the study. Improvement in mentalizing was correlated with improvement in depression (r = 0.36), anxiety (r = 0.46), and somatization (r = 0.23), as well as improved cognition (r = 0.36), social functioning (r = 0.33), and social participation (r = 0.48; all p < 0.001). Mentalizing partially mediated changes in psychological distress between T1 and T2: the direct association decreased from β = 0.69 to β = 0.57 and the explained variance increased from 47 to 61%. Decreases in epistemic mistrust (β = 0.42, 0.18–0.28; p < 0.001) and epistemic credulity (β = 0.19, 0.29–0.38; p < 0.001) and increases in epistemic trust (β = 0.42, 0.18–0.28; p < 0.001) significantly predicted improved mentalizing. A good model fit was found (χ2 = 3.248, p = 0.66; CFI = 0.99; TLI = 0.99; RMSEA = 0.000).ConclusionMentalizing was identified as a critical success factor in psychosomatic inpatient rehabilitation. A key component to increase mentalizing in this treatment context is the improvement of epistemic mistrust.
Background: Patient-reported outcomes (PROs) are the gold standard to assess the patients' subjective health status. While both the Food and Drug Administration and European Medicines Agency recommend the use of PROs as end-points in paediatric clinical trials to support claims for medical product labelling, it is not known how often PROs are actually used. The aim of this study was to assess the usage of PRO instruments in childhood cancer clinical trials investigating anti-cancer medication. Methods: In June 2020 ClinicalTrials and EudraCT were systematically searched for all trials including children and adolescents ( 21 years) with cancer registered between 2007 and 2020. The use of PRO measures and trials characteristics were analysed. To investigate which trial characteristics are associated with the use of PROs, a binary logistic regression was calculated. Results: Of 4789 identified trials, 711 were included. The most frequent reason for exclusion was age limitation (age >21 years). Of all included trials, only 8.2% used PROs as end-points; .6% as the primary end-point. The most commonly used questionnaire was the PedsQLä (32.8%), followed by the Patient-Reported Outcomes Measurement Information System scales (12.1%). No association was observed between the use of PROs and trial region, number of centres, trial phase, time period or intervention type (all p > .05). The use of PROs did not substantially increase over time. Only 20.3% of the closed studies had published their results.
Rehabilitation is a key element in improving health-related quality of life (HRQOL) for pediatric cancer survivors. The aim of this study was to present data from a multidisciplinary inpatient rehabilitation treatment. Children took part in a four-week multidisciplinary family-oriented inpatient rehabilitation. A total of 236 children (>5–21 years) and 478 parents routinely completed electronic patient-reported outcomes (ePROs), performance-based assessments, and clinician-rated assessments before (T1) and at the end (T2) of rehabilitation. HRQOL was assessed with the PedsQL generic core and PedsQL cancer module. Data were analyzed using repeated measures analysis of variance (ANOVA). Statistically significant improvements with medium to large effect sizes were observed for most HRQOL scales (η2 = 0.09–0.31), as well as performance-based and clinician-rated assessments for physical activity and functional status (η2 > 0.28). Agreement between children’s PROs and parents’ proxy ratings was lower before (rICC = 0.72) than after (rICC = 0.86) rehabilitation. While the concordance between children and parents’ assessment of changes during rehab was low to moderate (r = 0.19–0.59), the use of the performance score led to substantially increased scores (r = 0.29–0.68). The results of this naturalistic observational study thus highlight the benefits of multidisciplinary pediatric inpatient rehabilitation for childhood cancer survivors. The use of the performance score is recommended in this field.
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