@article{FischerKnopDanhofetal.2022, author = {Fischer, Julia and Knop, Stefan and Danhof, Sophia and Einsele, Hermann and Keller, Daniela and L{\"o}ffler, Claudia}, title = {The influence of baseline characteristics, treatment and depression on health-related quality of life in patients with multiple myeloma: a prospective observational study}, series = {BMC Cancer}, volume = {22}, journal = {BMC Cancer}, doi = {10.1186/s12885-022-10101-9}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-300435}, year = {2022}, abstract = {Background Multiple myeloma (MM) is the third most common hematologic malignancy with increasing importance due to improving treatment strategies and long-term outcomes in an aging population. This study aims to analyse influencing factors on health-related quality of life (HRQoL), such as treatment strategies, participation in a clinical trial and patient characteristics like anxiety, depression, gender, and age. A better understanding of the individual factors in context with HRQoL could provide a helpful instrument for clinical decisions. Methods In this prospective observational study, the HRQoL of MM patients with different therapies (first-line and relapse) was quantified by standardized questionnaires (EORTC QLQ-C30 and -MY20) in the context of sociodemographic data, individual anxiety and depressiveness (PHQ-4), and a selected number of clinical parameters and symptoms at defined time-points before, during, and after therapy. Results In total, 70 patients were included in the study. The median age of the study cohort was 62 years. 44\% were female and 56\% were male patients. More than half of the patients were fully active with an ECOG 0. Global health status was significantly higher in patients with first-line treatment and even increased after start of therapy, while the pain level decreased. In contrast, patients with relapsed MM reported a decreasing global health status and increasing pain. Additionally, there was a higher global health status in less anxious/depressive patients. HRQoL decreased significantly after start of chemotherapy in the parameters body image, side effects of treatment, and cognitive functioning. Tandem stem-cell transplantation was not found to be a risk factor for higher impairment of HRQoL. Participation in a clinical study led to an improvement of most aspects of HRQoL. Among others, increased anxiety and depression, female gender, older age, impaired performance status, and recurrent disease can be early indicators for a reduced HRQoL. Conclusion This study showed the importance of regular longitudinal assessments of patient reported outcomes (PROs) in routine clinical care. For the first time, to our knowledge, we were able to demonstrate a potential impact between participation in clinical trials and HRQoL. However, due to frequently restrictive inclusion criteria for clinical trials, these MM patients might not be directly comparable with patients treated within standard therapy concepts. Further studies are needed to clarify the relevance of this preliminary data in order to develop an individualized, patient-centred, therapy concept.}, language = {en} } @article{DufnerKesslerJustetal.2022, author = {Dufner, Vera and Kessler, Almuth Friederike and Just, Larissa and Hau, Peter and Bumes, Elisabeth and Pels, Hendrik Johannes and Grauer, Oliver Martin and Wiese, Bettina and L{\"o}hr, Mario and Jordan, Karin and Strik, Herwig}, title = {The emesis trial: depressive glioma patients are more affected by chemotherapy-induced nausea and vomiting}, series = {Frontiers in Neurology}, volume = {13}, journal = {Frontiers in Neurology}, issn = {1664-2295}, doi = {10.3389/fneur.2022.773265}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-262859}, year = {2022}, abstract = {Purpose Glioma patients face a limited life expectancy and at the same time, they suffer from afflicting symptoms and undesired effects of tumor treatment. Apart from bone marrow suppression, standard chemotherapy with temozolomide causes nausea, emesis and loss of appetite. In this pilot study, we investigated how chemotherapy-induced nausea and vomiting (CINV) affects the patients' levels of depression and their quality of life. Methods In this prospective observational multicentre study (n = 87), nausea, emesis and loss of appetite were evaluated with an expanded MASCC questionnaire, covering 10 days during the first and the second cycle of chemotherapy. Quality of life was assessed with the EORTC QLQ-C30 and BN 20 questionnaire and levels of depression with the PHQ-9 inventory before and after the first and second cycle of chemotherapy. Results CINV affected a minor part of patients. If present, it reached its maximum at day 3 and decreased to baseline level not before day 8. Levels of depression increased significantly after the first cycle of chemotherapy, but decreased during the further course of treatment. Patients with higher levels of depression were more severely affected by CINV and showed a lower quality of life through all time-points. Conclusion We conclude that symptoms of depression should be perceived in advance and treated in order to avoid more severe side effects of tumor treatment. Additionally, in affected patients, delayed nausea was most prominent, pointing toward an activation of the NK1 receptor. We conclude that long acting antiemetics are necessary totreat temozolomide-induced nausea.}, language = {en} } @article{RoeserEichholzSchwerdtleetal.2012, author = {Roeser, Karolin and Eichholz, Ruth and Schwerdtle, Barbara and Schlarb, Angelika A. and K{\"u}bler, Andrea}, title = {Relationship of sleep quality and health-related quality of life in adolescents according to self- and proxy ratings: a questionnaire survey}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-75953}, year = {2012}, abstract = {Introduction: Sleep disturbances are common in adolescents and adversely affect performance, social contact, and susceptibility to stress. We investigated the hypothesis of a relationship between sleep and health-related quality of life (HRQoL), and applied self- and proxy ratings. Materials and Methods: The sample comprised 92 adolescents aged 11-17 years. All participants and their parents completed a HRQoL measure and the Sleep Disturbance Scale for Children (SDSC ). Children with SDSC T -scores above the normal range (above 60) were classified as poor sleepers. Results: According to self- and proxy ratings, good sleepers reported significantly higher HRQoL than poor sleep- ers. Sleep disturbances were significantly higher and HRQoL significantly lower in self- as compared to parental ratings. Parent-child agreement was higher for subscales measuring observable aspects. Girls experienced significantly stronger sleep disturbances and lower self-rated HRQoL than boys. Discussion: Our findings support the positive relationship of sleep and HRQoL. Furthermore, parents significantly underestimate sleep disturbances and overestimate HRQoL in their children.}, subject = {Psychiatrie}, language = {en} } @article{EiseleBlozikStoerketal.2013, author = {Eisele, Marion and Blozik, Eva and St{\"o}rk, Stefan and Tr{\"a}der, Jens-Martin and Herrmann-Lingen, Christoph and Scherer, Martin}, title = {Recognition of depression and anxiety and their association with quality of life, hospitalization and mortality in primary care patients with heart failure - study protocol of a longitudinal observation study}, series = {BMC Family Practice}, volume = {14}, journal = {BMC Family Practice}, number = {180}, issn = {1471-2296}, doi = {10.1186/1471-2296-14-180}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-121881}, year = {2013}, abstract = {Background: International disease management guidelines recommend the regular assessment of depression and anxiety in heart failure patients. Currently there is little data on the effect of screening for depression and anxiety on the quality of life and the prognosis of heart failure (HF). We will investigate the association between the recognition of current depression/anxiety by the general practitioner (GP) and the quality of life and the patients' prognosis. Methods/Design: In this multicenter, prospective, observational study 3,950 patients with HF are recruited by general practices in Germany. The patients fill out questionnaires at baseline and 12-month follow-up. At baseline the GPs are interviewed regarding the somatic and psychological comorbidities of their patients. During the follow-up assessment, data on hospitalization and mortality are provided by the general practice. Based on baseline data, the patients are allocated into three observation groups: HF patients with depression and/or anxiety recognized by their GP (P+/+), those with depression and/or anxiety not recognized (P+/-) and patients without depression and/or anxiety (P-/-). We will perform multivariate regression models to investigate the influence of the recognition of depression and/or anxiety on quality of life at 12 month follow-up, as well as its influences on the prognosis (hospital admission, mortality). Discussion: We will display the frequency of GP-acknowledged depression and anxiety and the frequency of installed therapeutic strategies. We will also describe the frequency of depression and anxiety missed by the GP and the resulting treatment gap. Effects of correctly acknowledged and missed depression/anxiety on outcome, also in comparison to the outcome of subjects without depression/anxiety will be addressed. In case results suggest a treatment gap of depression/anxiety in patients with HF, the results of this study will provide methodological advice for the efficient planning of further interventional research.}, language = {en} } @article{MatuzBirbaumerHautzingeretal., author = {Matuz, Tamara and Birbaumer, Niels and Hautzinger, Martin and K{\"u}bler, Andrea}, title = {Psychosocial adjustment to ALS: a longitudinal study}, series = {Frontiers in Psychology}, volume = {6}, journal = {Frontiers in Psychology}, number = {1197}, issn = {1664-1078}, doi = {10.3389/fpsyg.2015.01197}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-190208}, abstract = {For the current study the Lazarian stress-coping theory and the appendant model of psychosocial adjustment to chronic illness and disabilities (Pakenham, 1999) has shaped the foundation for identifying determinants of adjustment to ALS. We aimed to investigate the evolution of psychosocial adjustment to ALS and to determine its long-term predictors. A longitudinal study design with four measurement time points was therefore, used to assess patients' quality of life, depression, and stress-coping model related aspects, such as illness characteristics, social support, cognitive appraisals, and coping strategies during a period of 2 years. Regression analyses revealed that 55\% of the variance of severity of depressive symptoms and 47\% of the variance in quality of life at T2 was accounted for by all the T1 predictor variables taken together. On the level of individual contributions, protective buffering, and appraisal of own coping potential accounted for a significant percentage in the variance in severity of depressive symptoms, whereas problem management coping strategies explained variance in quality of life scores. Illness characteristics at T2 did not explain any variance of both adjustment outcomes. Overall, the pattern of the longitudinal results indicated stable depressive symptoms and quality of life indices reflecting a successful adjustment to the disease across four measurement time points during a period of about two years. Empirical evidence is provided for the predictive value of social support, cognitive appraisals, and coping strategies, but not illness parameters such as severity and duration for adaptation to ALS. The current study contributes to a better conceptualization of adjustment, allowing us to provide evidence-based support beyond medical and physical intervention for people with ALS.}, language = {en} } @article{HaussmannSchmidtIllmannetal.2022, author = {Haussmann, Alexander and Schmidt, Martina E. and Illmann, Mona L. and Schr{\"o}ter, Marleen and Hielscher, Thomas and Cramer, Holger and Maatouk, Imad and Horneber, Markus and Steindorf, Karen}, title = {Meta-analysis of randomized controlled trials on yoga, psychosocial, and mindfulness-based interventions for cancer-related fatigue: What intervention characteristics are related to higher efficacy?}, series = {Cancers}, volume = {14}, journal = {Cancers}, number = {8}, issn = {2072-6694}, doi = {10.3390/cancers14082016}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-270753}, year = {2022}, abstract = {Cancer-related fatigue (CRF) is a burdensome sequela of cancer treatments. Besides exercise, recommended therapies for CRF include yoga, psychosocial, and mindfulness-based interventions. However, interventions conducted vary widely, and not all show a significant effect. This meta-analysis aimed to explore intervention characteristics related to greater reductions in CRF. We included randomized controlled trials published before October 2021. Standardized mean differences were used to assess intervention efficacy for CRF and multimodel inference to explore intervention characteristics associated with higher efficacy. For the meta-analysis, we included 70 interventions (24 yoga interventions, 31 psychosocial interventions, and 15 mindfulness-based interventions) with 6387 participants. The results showed a significant effect of yoga, psychosocial, and mindfulness-based interventions on CRF but with high heterogeneity between studies. For yoga and mindfulness-based interventions, no particular intervention characteristic was identified to be advantageous for reducing CRF. Regarding psychosocial interventions, a group setting and work on cognition were related to higher intervention effects on CRF. The results of this meta-analysis suggest options to maximize the intervention effects of psychosocial interventions for CRF. The effects of yoga and mindfulness-based interventions for CRF appear to be independent of their design, although the limited number of studies points to the need for further research.}, language = {en} } @article{KleinschnitzNiemczykRehbergWeberetal.2015, author = {Kleinschnitz, Christoph and Niemczyk, Gabriele and Rehberg-Weber, Karin and Wernsd{\"o}rfer, Colin}, title = {Interferon Beta-1a (AVONEX®) as a treatment option for untreated patients with multiple sclerosis (AXIOM): a prospective, observational study}, series = {International Journal of Molecular Sciences}, volume = {16}, journal = {International Journal of Molecular Sciences}, doi = {10.3390/ijms160715271}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-148487}, pages = {15271-15286}, year = {2015}, abstract = {The efficacy and safety of first-line disease-modifying therapies (DMT) for relapsing-remitting multiple sclerosis (RRMS) has been demonstrated in pivotal, randomized trials, but these studies do not reflect the routine care setting where treatment gaps or switches are common. The Avonex as Treatment Option for Untreated MS Patients (AXIOM) trial assessed the efficacy of newly-initiated intramuscular interferon beta-1a (IM IFNb-1a) after a treatment-free interval, with particular consideration of the previous course of disease and therapy. The AXIOM trial was an open, 12-month, observational, non-interventional study with a retrospective and a prospective part conducted in Germany. RRMS patients with a treatment-free interval of at least three months were included and treated with IFNb-1a for up to 12 months. Relapse rate, disability progression, injection-related parameters and quality of life observed during the prospective part were compared with retrospectively-collected data. Two hundred and thirty five RRMS patients participated in AXIOM. The mean relapse rate decreased from 1.1 in the three months before baseline to 0.2 per quarter during the twelve-month observational period; the Multiple Sclerosis Functional Composite score improved during twelve months of IM IFNb-1a treatment, while the Expanded Disability Status Scale score did not change over the course of this study. Compared to previous DMTs (IM IFNb-1a, subcutaneous IFNb-1a (SC IFNb-1a), SC IFNb-1b, glatiramer acetate), the patients experienced less injection site reactions and flu-like symptoms, with a stated improved quality of life. IM IFNb-1a was effective and well accepted in RRMS patients with no or discontinued previous therapy. These results from the routine care setting may inform optimization of DMT treatment in RRMS, but need confirmation in further studies.}, language = {en} } @article{KuonBlasiUnsoeldetal.2022, author = {Kuon, Jonas and Blasi, Miriam and Uns{\"o}ld, Laura and Vogt, Jeannette and Mehnert, Anja and Alt-Epping, Bernd and Oorschot, Birgitt van and Sistermanns, Jochen and Ahlborn, Miriam and Ritterbusch, Ulrike and Stevens, Susanne and Kahl, Christoph and Ruellan, Anne and Matthias, Kathrin and Kubin, Thomas and Stahlhut, Kerstin and Heider, Andrea and Lordick, Florian and Thomas, Michael}, title = {Impact of molecular alterations on quality of life and prognostic understanding over time in patients with incurable lung cancer: a multicenter, longitudinal, prospective cohort study}, series = {Supportive Care in Cancer}, volume = {30}, journal = {Supportive Care in Cancer}, number = {4}, organization = {Arbeitsgemeinschaft Palliativmedizin (APM) of the German Cancer Society (DKG)}, issn = {0941-4355}, doi = {10.1007/s00520-021-06736-2}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-308211}, pages = {3131-3140}, year = {2022}, abstract = {Purpose The purpose of this study is to investigate changes over time in quality of life (QoL) in incurable lung cancer patients and the impact of determinants like molecular alterations (MA). Methods In a prospective, longitudinal, multicentric study, we assessed QoL, symptom burden, psychological distress, unmet needs, and prognostic understanding of patients diagnosed with incurable lung cancer at the time of the diagnosis (T0) and after 3 (T1), 6 (T2) and 12 months (T3) using validated questionnaires like FACT-L, National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT), PHQ-4, SCNS-SF-34, and SEIQoL. Results Two hundred seventeen patients were enrolled, 22 (10\%) with reported MA. QoL scores improved over time, with a significant trend for DT, PHQ-4, and SCNS-SF-34. Significant determinants for stable or improving scores over time were survival > 6 months, performance status at the time of diagnosis, and presence of MA. Patients with MA showed better QoL scores (FACT-L at T1 104.4 vs 86.3; at T2 107.5 vs 90.0; at T3 100.9 vs 92.8) and lower psychological distress (NCCN DT at T1 3.3 vs 5; at T2 2.7 vs 4.5; at T3 3.7 vs 4.5; PHQ-4 at T1 2.3 vs 4.1; at T2 1.7 vs 3.6; at T3 2.2 vs 3.6), but also a worsening of the scores at 1 year and a higher percentage of inaccurate prognostic understanding (27 vs 17\%) compared to patients without MA. Conclusion Patients with tumors harboring MA are at risk of QoL deterioration during the course of the disease. Physicians should adapt their communication strategies in order to maintain or improve QoL.}, language = {en} } @article{WohnradeVellingMixetal.2023, author = {Wohnrade, Camilla and Velling, Ann-Kathrin and Mix, Lucas and Wurster, Claudia D. and Cordts, Isabell and Stolte, Benjamin and Zeller, Daniel and Uzelac, Zeljko and Platen, Sophia and Hagenacker, Tim and Deschauer, Marcus and Lingor, Paul and Ludolph, Albert C. and Lul{\´e}, Doroth{\´e}e and Petri, Susanne and Osmanovic, Alma and Schreiber-Katz, Olivia}, title = {Health-related quality of life in spinal muscular atrophy patients and their caregivers — a prospective, cross-sectional, multi-center analysis}, series = {Brain Sciences}, volume = {13}, journal = {Brain Sciences}, number = {1}, issn = {2076-3425}, doi = {10.3390/brainsci13010110}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-305048}, year = {2023}, abstract = {Spinal muscular atrophy (SMA) is a disabling disease that affects not only the patient's health-related quality of life (HRQoL), but also causes a high caregiver burden (CGB). The aim of this study was to evaluate HRQoL, CGB, and their predictors in SMA. In two prospective, cross-sectional, and multi-center studies, SMA patients (n = 39) and SMA patient/caregiver couples (n = 49) filled in the EuroQoL Five Dimension Five Level Scale (EQ-5D-5L) and the Short Form Health Survey 36 (SF-36). Caregivers (CGs) additionally answered the Zarit Burden Interview (ZBI) and the Hospital Anxiety and Depression Scale (HADS). Patients were clustered into two groups with either low or high HRQoL (EQ-5D-5L index value <0.259 or >0.679). The latter group was mostly composed of ambulatory type III patients with higher motor/functional scores. More severely affected patients reported low physical functioning but good mental health and vitality. The CGB (mean ZBI = 22/88) correlated negatively with patients' motor/functional scores and age. Higher CGB was associated with a lower HRQoL, higher depression and anxiety, and more health impairments of the CGs. We conclude that patient and CG well-being levels interact closely, which highlights the need to consider the health of both parties while evaluating novel treatments.}, language = {en} } @article{MuysomsCampanelliChampaultetal.2012, author = {Muysoms, F. and Campanelli, G. and Champault, G. G. and DeBeaux, A. C. and Dietz, U. A. and Jeekel, J. and Klinge, U. and K{\"o}ckerling, F. and Mandala, V. and Montgomery, A. and Morales Conde, S. and Puppe, F. and Simmermacher, R. K. J. and Śmietański, M. and Miserez, M.}, title = {EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair}, series = {Hernia}, volume = {16}, journal = {Hernia}, number = {3}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-124728}, pages = {239-250}, year = {2012}, abstract = {Background Although the repair of ventral abdominal wall hernias is one of the most commonly performed operations, many aspects of their treatment are still under debate or poorly studied. In addition, there is a lack of good definitions and classifications that make the evaluation of studies and meta-analyses in this field of surgery difficult. Materials and methods Under the auspices of the board of the European Hernia Society and following the previously published classifications on inguinal and on ventral hernias, a working group was formed to create an online platform for registration and outcome measurement of operations for ventral abdominal wall hernias. Development of such a registry involved reaching agreement about clear definitions and classifications on patient variables, surgical procedures and mesh materials used, as well as outcome parameters. The EuraHS working group (European registry for abdominal wall hernias) comprised of a multinational European expert panel with specific interest in abdominal wall hernias. Over five working group meetings, consensus was reached on definitions for the data to be recorded in the registry. Results A set of well-described definitions was made. The previously reported EHS classifications of hernias will be used. Risk factors for recurrences and co-morbidities of patients were listed. A new severity of comorbidity score was defined. Post-operative complications were classified according to existing classifications as described for other fields of surgery. A new 3-dimensional numerical quality-of-life score, EuraHS-QoL score, was defined. An online platform is created based on the definitions and classifications, which can be used by individual surgeons, surgical teams or for multicentre studies. A EuraHS website is constructed with easy access to all the definitions, classifications and results from the database. Conclusion An online platform for registration and outcome measurement of abdominal wall hernia repairs with clear definitions and classifications is offered to the surgical community. It is hoped that this registry could lead to better evidence-based guidelines for treatment of abdominal wall hernias based on hernia variables, patient variables, available hernia repair materials and techniques.}, language = {en} } @article{FlacheneckerBuresGawliketal.2020, author = {Flachenecker, Peter and Bures, Anna Karoline and Gawlik, Angeli and Weiland, Ann-Christin and Kuld, Sarah and Gusowski, Klaus and Streber, Ren{\´e} and Pfeifer, Klaus and Tallner, Alexander}, title = {Efficacy of an internet-based program to promote physical activity and exercise after inpatient rehabilitation in persons with multiple sclerosis: a randomized, single-blind, controlled study}, series = {International Journal of Environmental Research and Public Health}, volume = {17}, journal = {International Journal of Environmental Research and Public Health}, number = {12}, issn = {1660-4601}, doi = {10.3390/ijerph17124544}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-207863}, year = {2020}, abstract = {Background: Multimodal rehabilitation improves fatigue and mobility in persons with multiple sclerosis (PwMS). Effects are transient and may be conserved by internet-based physical activity promotion programs. Objective: Evaluate the effects of internet-based physical activity and exercise promotion on fatigue, quality of life, and gait in PwMS after inpatient rehabilitation. Methods: PwMS (Expanded Disability Status Scale (EDSS) ≤ 6.0, fatigue: W{\"u}rzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) ≥ 32) were randomized into an intervention group (IG) or a control group (CG). After rehabilitation, IG received 3 months of internet-based physical activity promotion, while CG received no intervention. Primary outcome: self-reported fatigue (WEIMuS). Secondary outcomes: quality of life (Multiple Sclerosis Impact Scale 29, MSIS-29), gait (2min/10m walking test, Tinetti score). Measurements: beginning (T0) and end (T1) of inpatient rehabilitation, 3 (T2) and 6 (T3) months afterwards. Results: 64 of 84 PwMS were analyzed (IG: 34, CG: 30). After rehabilitation, fatigue decreased in both groups. At T2 and T3, fatigue increased again in CG but was improved in IG (p < 0.001). MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG. Gait improvements were more pronounced in IG at T2. Conclusions: The study provides Class II evidence that the effects of rehabilitation on fatigue, quality of life, and gait can be maintained for 3-6 months with an internet-based physical activity and exercise promotion program.}, language = {en} } @article{SchmidtPfetzerSchwabetal.2011, author = {Schmidt, Melanie and Pfetzer, Nadja and Schwab, Micheal and Strauss, Ingrid and Kaemmerer, Ulrike}, title = {Effects of a ketogenic diet on the quality of life in 16 patients with advanced cancer: a pilot train}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-68871}, year = {2011}, abstract = {Background: Tumor patients exhibit an increased peripheral demand of fatty acids and protein. Contrarily, tumors utilize glucose as their main source of energy supply. Thus, a diet supplying the cancer patient with sufficient fat and protein for his demands while restricting the carbohydrates (CHO) tumors thrive on, could be a helpful strategy in improving the patients' situation. A ketogenic diet (KD) fulfills these requirements. Therefore, we performed a pilot study to investigate the feasibility of a KD and its influence on the quality of life of patients with advanced metastatic tumors. Methods: Sixteen patients with advanced metastatic tumors and no conventional therapeutic options participated in the study. The patients were instructed to follow a KD (less than 70 g CHO per day) with normal groceries and were provided with a supply of food additives to mix a protein/fat shake to simplify the 3-month intervention period. Quality of life [assessed by EORTC QLQ-C30 (version 2)], serum and general health parameters were determined at baseline, after every two weeks of follow-up, or after drop out. The effect of dietary change on metabolism was monitored daily by measuring urinary ketone bodies. Results: One patient did not tolerate the diet and dropped out within 3 days. Among those who tolerated the diet, two patients died early, one stopped after 2 weeks due to personal reasons, one felt unable to stick to the diet after 4 weeks, one stopped after 6 and two stopped after 7 and 8 weeks due to progress of the disease, one had to discontinue after 6 weeks to resume chemotherapy and five completed the 3 month intervention period. These five and the one who resumed chemotherapy after 6 weeks report an improved emotional functioning and less insomnia, while several other parameters of quality of life remained stable or worsened, reflecting their very advanced disease. Except for temporary constipation and fatigue, we found no severe adverse side effects, especially no changes in cholesterol or blood lipids. Conclusions: These pilot data suggest that a KD is suitable for even advanced cancer patients. It has no severe side effects and might improve aspects of quality of life and blood parameters in some patients with advanced metastatic tumors.}, subject = {Lebensqualit{\"a}t}, language = {en} } @article{LjunggrenBarrettStoykovetal.2013, author = {Ljunggren, Osten and Barrett, Annabel and Stoykov, Ivaylo and Langdahl, Bente L. and Lems, Willem F. and Walsh, J. Bernard and Fahrleitner-Pammer, Astrid and Rajzbaum, Gerald and Jakob, Franz and Karras, Dimitrios and Marin, Fernando}, title = {Effective osteoporosis treatment with teriparatide is associated with enhanced quality of life in postmenopausal women with osteoporosis: the European Forsteo Observational Study}, series = {BMC Musculoskeletal Disorders}, volume = {14}, journal = {BMC Musculoskeletal Disorders}, number = {251}, issn = {1471-2474}, doi = {10.1186/1471-2474-14-251}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-122057}, year = {2013}, abstract = {Background: To describe changes in health-related quality of life (HRQoL) of postmenopausal women with osteoporosis treated with teriparatide for up to 18 months and followed-up for a further 18 months, and to assess the influence of recent prior and incident fractures. Methods: The European Forsteo Observational Study (EFOS) is an observational, prospective, multinational study measuring HRQoL using the EQ-5D. The primary objective was to assess changes in HRQoL during 36 months in the whole study population. A secondary post-hoc analysis examined fracture impact on HRQoL in four subgroups classified based on recent prior fracture 12 months before baseline and incident clinical fractures during the study. Changes from baseline were analysed using a repeated measures model. Results: Of the 1581 patients, 48.4\% had a recent prior fracture and 15.6\% of these patients had an incident fracture during follow-up. 10.9\% of the 816 patients with no recent prior fracture had an incident fracture. Baseline mean EQ-VAS scores were similar across the subgroups. In the total study cohort (n = 1581), HRQoL (EQ-VAS and EQ-5D index scores) improved significantly from baseline to 18 months and this improvement was maintained over the 18-month post-teriparatide period. Improvements were seen across all five EQ-5D domains during teriparatide treatment that were maintained after teriparatide was discontinued. Subjects with incident clinical fractures had significantly less improvement in EQ-VAS than those without incident fractures. Recent prior fracture did not influence the change in EQ-VAS during treatment. Conclusions: EFOS is the first longitudinal study in women with severe postmenopausal osteoporosis in the real world setting to show a substantial improvement in HRQoL during teriparatide treatment that was sustained during subsequent treatment with other medications. The increase in HRQoL was lower in the subgroups with incident fracture but was not influenced by recent prior fracture. The results should be interpreted in the context of the design of an observational study.}, language = {en} } @article{MusekampSchulerSeekatzetal.2017, author = {Musekamp, Gunda and Schuler, Michael and Seekatz, Bettina and Bengel, J{\"u}rgen and Faller, Hermann and Meng, Karin}, title = {Does improvement in self-management skills predict improvement in quality of life and depressive symptoms? A prospective study in patients with heart failure up to one year after self-management education}, series = {BMC Cardiovascular Disorders}, volume = {17}, journal = {BMC Cardiovascular Disorders}, number = {51}, doi = {10.1186/s12872-017-0486-5}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-157501}, year = {2017}, abstract = {Background: Heart failure (HF) patient education aims to foster patients' self-management skills. These are assumed to bring about, in turn, improvements in distal outcomes such as quality of life. The purpose of this study was to test the hypothesis that change in self-reported self-management skills observed after participation in self-management education predicts changes in physical and mental quality of life and depressive symptoms up to one year thereafter. Methods: The sample comprised 342 patients with chronic heart failure, treated in inpatient rehabilitation clinics, who received a heart failure self-management education program. Latent change modelling was used to analyze relationships between both short-term (during inpatient rehabilitation) and intermediate-term (after six months) changes in self-reported self-management skills and both intermediate-term and long-term (after twelve months) changes in physical and mental quality of life and depressive symptoms. Results: Short-term changes in self-reported self-management skills predicted intermediate-term changes in mental quality of life and long-term changes in physical quality of life. Intermediate-term changes in self-reported self-management skills predicted long-term changes in all outcomes.}, language = {en} } @article{HessMengSchulteetal.2022, author = {Heß, Verena and Meng, Karin and Schulte, Thomas and Neuderth, Silke and Bengel, J{\"u}rgen and Faller, Hermann and Schuler, Michael}, title = {Decreased mental health, quality of life, and utilization of professional help in cancer patients with unexpressed needs: A longitudinal analysis}, series = {Psycho-Oncology}, volume = {31}, journal = {Psycho-Oncology}, number = {5}, doi = {10.1002/pon.5856}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-257662}, pages = {725-734}, year = {2022}, abstract = {Background Cancer patients' mental health and quality of life can be improved through professional support according to their needs. In previous analyses of the UNSAID study, we showed that a relevant proportion of cancer patients did not express their needs during the admission interview of inpatient rehabilitation. We now examine trajectories of mental health, quality of life, and utilization of professional help in cancer patients with unexpressed needs. Methods We enrolled 449 patients with breast, prostate, and colon cancer at beginning (T0) and end (T1) of a 3-week inpatient rehabilitation and 3 (T2) and 9 (T3) months after discharge. We explored depression (PHQ-2), anxiety (GAD-2), emotional functioning (EORTC QLQ-C30), fear of progression (FoP-Q-SF), and global quality of life (EORTC QLQ-C30) using structuring equation models. Furthermore, we evaluated self-reports about expressing needs and utilization of professional help at follow-up. Results Patients with unexpressed needs (24.3\%, n = 107) showed decreased mental health compared to other patients (e.g., depression: d T0 = 0.32, d T1-T3 = 0.39). They showed a significant decline in global quality of life at discharge and follow-up (d = 0.28). Furthermore, they had a higher need for support (Cramer's V T2 = 0.10, T3 = 0.15), talked less about their needs (Cramer's V T2 = 0.18), and made less use of different health care services at follow-up. Conclusion Unexpressed needs in cancer patients may be a risk factor for decreased mental health, quality of life, and non-utilization of professional help in the long term. Further research should clarify causal relationships and focus on this specific group of patients to improve cancer care.}, language = {en} } @article{NeugebauerHeuschmannJuettler2012, author = {Neugebauer, Hermann and Heuschmann, Peter U. and J{\"u}ttler, Eric}, title = {DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY - Registry (DESTINY-R): design and protocols}, series = {BMC Neurology}, volume = {12}, journal = {BMC Neurology}, number = {115}, doi = {10.1186/1471-2377-12-115}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-133892}, year = {2012}, abstract = {Background: Randomized controlled trials (RCT) on the treatment of severe space-occupying infarction of the middle cerebral artery (malignant MCA infarction) showed that early decompressive hemicraniectomy (DHC) is life saving and improves outcome without promoting most severe disablity in patients aged 18-60 years. It is, however, unknown whether the results obtained in the randomized trials are reproducible in a broader population in and apart from an academical setting and whether hemicraniectomy has been implemented in clinical practice as recommended by national and international guidelines. In addition, they were not powered to answer further relevant questions, e. g. concerning the selection of patients eligible for and the timing of hemicraniectomy. Other important issues such as the acceptance of disability following hemicraniectomy, the existence of specific prognostic factors, the value of conservative therapeutic measures, and the overall complication rate related to hemicraniectomy have not been sufficiently studied yet. Methods/Design: DESTINY-R is a prospective, multicenter, open, controlled registry including a 12 months follow-up. The only inclusion criteria is unilateral ischemic MCA stroke affecting more than 50\% of the MCA-territory. The primary study hypothesis is to confirm the results of the RCT (76\% mRS <= 4 after 12 months) in the subgroup of patients additionally fulfilling the inclusion cirteria of the RCT in daily routine. Assuming a calculated proportion of 0.76 for successes and a sample size of 300 for this subgroup, the width of the 95\% CI, calculated using Wilson's method, will be 0.096 with the lower bound 0.709 and the upper bound 0.805. Discussion: The results of this study will provide information about the effectiveness of DHC in malignant MCA infarction in a broad population and a real-life situation in addition to and beyond RCT. Further prospectively obtained data will give crucial information on open questions and will be helpful in the plannig of upcomming treatment studies.}, language = {en} } @article{SeefriedDahirPetryketal.2020, author = {Seefried, Lothar and Dahir, Kathryn and Petryk, Anna and H{\"o}gler, Wolfgang and Linglart, Agn{\`e}s and Martos-Moreno, Gabriel {\´A}ngel and Ozono, Keiichi and Fang, Shona and Rockman-Greenberg, Cheryl and Kishnani, Priya S}, title = {Burden of Illness in Adults With Hypophosphatasia: Data From the Global Hypophosphatasia Patient Registry}, series = {Journal of Bone and Mineral Research}, volume = {35}, journal = {Journal of Bone and Mineral Research}, number = {11}, doi = {10.1002/jbmr.4130}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-217787}, pages = {2171 -- 2178}, year = {2020}, abstract = {Hypophosphatasia (HPP) is a rare, inherited, metabolic disease caused by deficient tissue non-specific alkaline phosphatase activity. This study aims to assess patient-reported pain, disability and health-related quality of life (HRQoL) in a real-world cohort of adults with HPP who were not receiving asfotase alfa during the analysis. Adults (≥18 years old) with HPP (confirmed by ALPL gene mutation and/or low serum alkaline phosphatase activity for age/sex) were identified from the Global HPP Registry (NCT02306720). Demographics, clinical characteristics, and data on patient-reported pain, disability, and HRQoL (assessed by Brief Pain Inventory Short Form [BPI-SF], Health Assessment Questionnaire Disability Index [HAQ-DI], and 36-Item Short-Form Health Survey version 2 [SF-36v2], respectively) were stratified by pediatric- and adult-onset HPP and summarized descriptively. Of the 304 adults included (median [min, max] age 48.6 [18.8, 79.8] years; 74\% women), 45\% had adult-onset HPP and 33\% had pediatric-onset HPP (unknown age of onset, 22\%). Of those with data, 38\% had experienced ≥5 HPP manifestations and 62\% had a history of ≥1 fracture/pseudofracture. Median (Q1, Q3) BPI-SF scores were 3.5 (1.5, 5.3) for pain severity and 3.3 (0.9, 6.2) for pain interference. Median (Q1, Q3) disability on the HAQ-DI was 0.3 (0.0, 0.7). Median (Q1, Q3) physical and mental component summary scores on the SF-36v2 were 42.4 (32.7, 49.9) and 45.3 (36.3, 54.8), respectively. Greater numbers of HPP manifestations experienced/body systems affected correlated significantly with poorer scores on the BPI-SF, HAQ-DI, and SF-36v2 (all p < 0.05). No significant differences between adults with pediatric- and adult-onset HPP were observed for patient-reported outcomes, except for disability and the BPI-SF question "pain at its worst," which were significantly higher among adults with pediatric- versus adult-onset HPP (p = 0.03 and 0.04, respectively). These data from the Global HPP Registry show that adults with HPP have a substantial burden of illness that is associated with reduced patient-reported HRQoL, regardless of age of disease onset.}, language = {en} } @article{KaemmererTribiusCohrsetal.2023, author = {K{\"a}mmerer, Peer W. and Tribius, Silke and Cohrs, Lena and Engler, Gabriel and Ettl, Tobias and Freier, Kolja and Frerich, Bernhard and Ghanaati, Shahram and Gosau, Martin and Haim, Dominik and Hartmann, Stefan and Heiland, Max and Herbst, Manuel and Hoefert, Sebastian and Hoffmann, J{\"u}rgen and H{\"o}lzle, Frank and Howaldt, Hans-Peter and Kreutzer, Kilian and Leonhardt, Henry and Lutz, Rainer and Moergel, Maximilian and Modabber, Ali and Neff, Andreas and Pietzka, Sebastian and Rau, Andrea and Reichert, Torsten E. and Smeets, Ralf and Sproll, Christoph and Steller, Daniel and Wiltfang, J{\"o}rg and Wolff, Klaus-Dietrich and Kronfeld, Kai and Al-Nawas, Bilal}, title = {Adjuvant radiotherapy in patients with squamous cell carcinoma of the oral cavity or oropharynx and solitary ipsilateral lymph node metastasis (pN1) — a prospective multicentric cohort study}, series = {Cancers}, volume = {15}, journal = {Cancers}, number = {6}, issn = {2072-6694}, doi = {10.3390/cancers15061833}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-311024}, year = {2023}, abstract = {(1) Background: Evaluation of impact of adjuvant radiation therapy (RT) in patients with oral squamous cell carcinoma of the oral cavity/oropharynx (OSCC) of up to 4 cm (pT1/pT2) and solitary ipsilateral lymph node metastasis (pN1). A non-irradiated group with clinical follow-up was chosen for control, and survival and quality of life (QL) were compared; (2) Methods: This prospective multicentric comprehensive cohort study included patients with resected OSCC (pT1/pT2, pN1, and cM0) who were allocated into adjuvant radiation therapy (RT) or observation. The primary endpoint was overall survival. Secondary endpoints were progression-free survival and QL after surgery; (3) Results: Out of 27 centers, 209 patients were enrolled with a median follow-up of 3.4 years. An amount of 137 patients were in the observation arm, and 72 received adjuvant irradiation. Overall survival did not differ between groups (hazard ratio (HR) 0.98 [0.55-1.73], p = 0.94). There were fewer neck metastases (HR 0.34 [0.15-0.77]; p = 0.01), as well as fewer local recurrences (HR 0.41 [0.19-0.89]; p = 0.02) under adjuvant RT. For QL, irradiated patients showed higher values for the symptom scale pain after 0.5, two, and three years (all p < 0.05). After six months and three years, irradiated patients reported higher symptom burdens (impaired swallowing, speech, as well as teeth-related problems (all p < 0.05)). Patients in the RT group had significantly more problems with mouth opening after six months, one, and two years (p < 0.05); (4) Conclusions: Adjuvant RT in patients with early SCC of the oral cavity and oropharynx does not seem to influence overall survival, but it positively affects progression-free survival. However, irradiated patients report a significantly decreased QL up to three years after therapy compared to the observation group.}, language = {en} }