With the increase in long-term survivorship of head and neck cancer (HNC), the functional outcomes are gaining importance. We reported the functional outcomes of HNC patients using the HNC-Functional InTegrity (FIT) Scales, which is a validated tool for the rapid clinical assessment of functional status based on observable clinical criteria. Patients with newly diagnosed HNC treated at the Medical University of Innsbruck between 2008 and 2020 were consecutively included, and their status in the six functional domains of food-intake, breathing, speech, pain, mood, and neck and shoulder mobility was scored by the treating physician at oncological follow-up visits on a scale from 0 (loss of function) to 4 (full function). HNC-FIT scales were available for 681 HNC patients at a median of 35 months after diagnosis. The response status was complete remission in 79.5%, 18.1% had recurrent or persistent disease, and 2.4% had a second primary HNC. Normal or near-normal scores (3 and 4) were seen in 78.6% for food intake, 88.7% for breathing, 83.7% for speech, 89% for pain, 91.8% for mood, and 87.5% for neck and shoulder mobility. A normal or near-normal outcome in all six functional domains was observed in 61% of patients. Clinically relevant impairment (score 1–2) in at least one functional domain was observed in 30%, and 9% had loss of function (score 0) in at least one functional domain. The main factors associated with poor functional outcome in a multivariable analysis were recurrence or persistent disease, poor general health (ASA III and IV), and higher T stage. Particularly, laryngeal and hypopharyngeal tumors impaired breathing and speech function, and primary radiation therapy or concomitant systemic therapy and radiotherapy worsened food intake. Clinically relevant persistent functional deficits in at least one functional domain must be expected in 40% of the patients with HNC. The treatment of these functional deficits is an essential task of oncologic follow-up.

Purpose The sino-nasal outcomes test-22 (SNOT-22) represents the reference questionnaire to assess patients with chronic rhinosinusitis (CRS). As weak correlations between objective CRS parameters and SNOT-22 total score have been observed, factor analyses have aimed to identify underlying factorial structures. However, ambiguous factor loadings and problematic item-domain assignments have resulted. Moreover, such factor analyses have mainly been performed in non-European CRS patients, while European data remain sparse. This study thus sought to address these issues. Methods Principal component analysis and confirmatory factor analysis were performed from SNOT-22 questionnaires completed by European CRS patients. Goodness of fit, internal consistencies, and factor loadings were calculated. Item-domain assignment was based on statistical grounds and clinical meaningfulness. Additionally, this study investigated correlations between SNOT-22 domains and external reference criteria, including Lund–Mackay score, Lund–Naclerio score and the brief symptom inventory 18 (BSI-18). Results One hundred and thirty-four European CRS patients were included. Principal component analysis proposed four SNOT-22 domains (“nasal symptoms”, “otologic symptoms”, “sleep symptoms”, “emotional symptoms”), which explained 63.6% of variance. Observed item-domain-assignment differed from previously proposed item-domain assignments. All factor loadings were > 0.5, except “cough” (0.42) and “facial pain or pressure” (0.49). For confirmatory factor analysis, satisfactory goodness of fit (RMSEA = 0.66; CFI = 0.92; TLI = 0.90) and internal consistencies (Cronbach-α: total score = 0.93; domains = 0.75–0.91) were observed. Significant positive correlations were found between the “nasal symptoms” domain and both the Lund–Mackay score (r = 0.48; p < 0.001) and the Lund–Naclerio score (r = 0.27, p < 0.01). Significant positive correlations were also identified between “emotional symptoms” and BSI-18 total score (r = 0.64, p < 0.001). Conclusions Principal component analysis performed for SNOT-22 questionnaires completed by European CRS patients indicated a different item-domain-assignment than previously reported. Confirmatory factor analysis suggested acceptable and clinically plausible psychometric properties for the resulting factorial structure. Significant correlations between the “nasal symptoms” and the “emotional symptoms” domains were observed with objective CRS parameters. The resulting factorial structure with different item-domain assignments may thus be more suitable for European CRS patients.

.Impairment of mentalization may impact coping strategies, regulation of affect and stress. The influence of impaired mentalization on dissociation in patients with adverse childhood experiences (ACEs) could be important for treatment strategies. The aim of this study is to assess the relationship between ACEs, mentalizing and dissociation in adult individuals. Sixty-seven patients with ACEs completed the Mentalization Questionnaire (MZQ), the Essener Trauma Inventory (ETI) and the Brief Symptom Inventory-18 (BSI-18). The SPSS PROCESS macro tool was applied to test if mentalization mediated the relationship of ACEs and dissociation. ACEs were significantly associated with higher dissociation (β = 0.42, p < 0.001) and lower mentalization (β = − 0.49, p < 0.001). When mentalization was added to the model as a predictor, the association of ACEs with dissociation was no longer significant (β = 0.11, p = 0.31) and a statistically significant indirect effect was found (β = 0.32, 95% CI 0.16–0.47). The overall explained variance of dissociation notably improved after inclusion of mentalization (17.5% to 49.1%). Thus, the results indicated that the association of ACEs on dissociation was fully mediated by mentalization. Our results suggest that ACEs are associated with lower mentalization and higher dissociation. Lower mentalization was also associated with worse depression, anxiety, somatization and PTSD symptoms. These findings underline the increasing importance of early treatment of individuals affected by ACEs with a focus to foster the development of mentalization.

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. 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. 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 PedsQL™ (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. Despite recommendations of regulatory agencies, PRO assessment is extremely rare in paediatric oncology clinical trials. More efforts should be undertaken to facilitate implementation of PRO in paediatric trials to guarantee patient-centred research and treatments.

Background: Inpatient 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.Methods: In 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.Results: A 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).Conclusion: Mentalizing 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.