TY  - JOUR
A1  - Herrmann, Johannes
A1  - Müller, Kerstin
A1  - Notz, Quirin
A1  - Hübsch, Martha
A1  - Haas, Kirsten
A1  - Horn, Anna
A1  - Schmidt, Julia
A1  - Heuschmann, Peter
A1  - Maschmann, Jens
A1  - Frosch, Matthias
A1  - Deckert, Jürgen
A1  - Einsele, Hermann
A1  - Ertl, Georg
A1  - Frantz, Stefan
A1  - Meybohm, Patrick
A1  - Lotz, Christopher
T1  - Prospective single-center study of health-related quality of life after COVID-19 in ICU and non-ICU patients
JF  - Scientific Reports
N2  - Long-term sequelae in hospitalized Coronavirus Disease 2019 (COVID-19) patients may result in limited quality of life. The current study aimed to determine health-related quality of life (HRQoL) after COVID-19 hospitalization in non-intensive care unit (ICU) and ICU patients. This is a single-center study at the University Hospital of Wuerzburg, Germany. Patients eligible were hospitalized with COVID-19 between March 2020 and December 2020. Patients were interviewed 3 and 12 months after hospital discharge. Questionnaires included the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), patient health questionnaire-9 (PHQ-9), the generalized anxiety disorder 7 scale (GAD-7), FACIT fatigue scale, perceived stress scale (PSS-10) and posttraumatic symptom scale 10 (PTSS-10). 85 patients were included in the study. The EQ5D-5L-Index significantly differed between non-ICU (0.78 ± 0.33 and 0.84 ± 0.23) and ICU (0.71 ± 0.27; 0.74 ± 0.2) patients after 3- and 12-months. Of non-ICU 87% and 80% of ICU survivors lived at home without support after 12 months. One-third of ICU and half of the non-ICU patients returned to work. A higher percentage of ICU patients was limited in their activities of daily living compared to non-ICU patients. Depression and fatigue were present in one fifth of the ICU patients. Stress levels remained high with only 24% of non-ICU and 3% of ICU patients (p = 0.0186) having low perceived stress. Posttraumatic symptoms were present in 5% of non-ICU and 10% of ICU patients. HRQoL is limited in COVID-19 ICU patients 3- and 12-months post COVID-19 hospitalization, with significantly less improvement at 12-months compared to non-ICU patients. Mental disorders were common highlighting the complexity of post-COVID-19 symptoms as well as the necessity to educate patients and primary care providers about monitoring mental well-being post COVID-19.
KW  - health care
KW  - public health
KW  - quality of life
Y1  - 2023
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-357174
VL  - 13
ER  - 
TY  - JOUR
A1  - Hebestreit, Helge
A1  - Zeidler, Cornelia
A1  - Schippers, Christopher
A1  - de Zwaan, Martina
A1  - Deckert, Jürgen
A1  - Heuschmann, Peter
A1  - Krauth, Christian
A1  - Bullinger, Monika
A1  - Berger, Alexandra
A1  - Berneburg, Mark
A1  - Brandstetter, Lilly
A1  - Deibele, Anna
A1  - Dieris-Hirche, Jan
A1  - Graessner, Holm
A1  - Gündel, Harald
A1  - Herpertz, Stephan
A1  - Heuft, Gereon
A1  - Lapstich, Anne-Marie
A1  - Lücke, Thomas
A1  - Maisch, Tim
A1  - Mundlos, Christine
A1  - Petermann-Meyer, Andrea
A1  - Müller, Susanne
A1  - Ott, Stephan
A1  - Pfister, Lisa
A1  - Quitmann, Julia
A1  - Romanos, Marcel
A1  - Rutsch, Frank
A1  - Schaubert, Kristina
A1  - Schubert, Katharina
A1  - Schulz, Jörg B.
A1  - Schweiger, Susann
A1  - Tüscher, Oliver
A1  - Ungethüm, Kathrin
A1  - Wagner, Thomas O. F.
A1  - Haas, Kirsten
T1  - Dual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases (ZSE-DUO): study protocol for a controlled multi-center cohort study
JF  - Orphanet Journal of Rare Diseases
N2  - Background
In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process.
Study design
This multi-center, prospective controlled study has a two-phase cohort design.
Methods
Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare Diseases (CRD): the standard care cohort (control, somatic expertise only) and the innovative care cohort (experimental, combined somatic and mental health expertise). Individuals aged 12 years and older presenting with symptoms and signs which are not explained by current diagnoses will be included. Data will be collected prior to the first visit to the CRD’s outpatient clinic (T0), at the first visit (T1) and 12 months thereafter (T2).
Outcomes
Primary outcome is the percentage of patients with one or more confirmed diagnoses covering the symptomatic spectrum presented. Sample size is calculated to detect a 10 percent increase from 30% in standard care to 40% in the innovative dual expert cohort. Secondary outcomes are (a) time to diagnosis/diagnoses explaining the symptomatology; (b) proportion of patients successfully referred from CRD to standard care; (c) costs of diagnosis including incremental cost effectiveness ratios; (d) predictive value of screening instruments administered at T0 to identify patients with mental disorders; (e) patients’ quality of life and evaluation of care; and f) physicians’ satisfaction with the innovative care approach.
Conclusions
This is the first multi-center study to investigate the effects of a mental health specialist working in tandem with a somatic expert physician in CRDs. If this innovative approach proves successful, it will be made available on a larger scale nationally and promoted internationally. In the best case, ZSE-DUO can significantly shorten the time to diagnosis for a suspected rare disease.
KW  - rare diseases
KW  - multi‑center cohort study
KW  - dual guidance
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-300440
VL  - 17
IS  - 1
ER  - 
TY  - JOUR
A1  - Stangl, Stephanie
A1  - Haas, Kirsten
A1  - Eichner, Felizitas A.
A1  - Grau, Anna
A1  - Selig, Udo
A1  - Ludwig, Timo
A1  - Fehm, Tanja
A1  - Stübner, Tanja
A1  - Rashid, Asarnusch
A1  - Kerscher, Alexander
A1  - Bargou, Ralf
A1  - Hermann, Silke
A1  - Arndt, Volker
A1  - Meyer, Martin
A1  - Wildner, Manfred
A1  - Faller, Hermann
A1  - Schrauder, Michael G.
A1  - Weigel, Michael
A1  - Schlembach, Ulrich
A1  - Heuschmann, Peter U.
A1  - Wöckel, Achim
T1  - Development and proof-of-concept of a multicenter, patient-centered cancer registry for breast cancer patients with metastatic disease — the “Breast cancer care for patients with metastatic disease” (BRE-4-MED) registry
JF  - Pilot and Feasibility Studies
N2  - Background: Patients with metastatic breast cancer (MBC) are treated with a palliative approach with focus oncontrolling for disease symptoms and maintaining high quality of life. Information on individual needs of patients andtheir relatives as well as on treatment patterns in clinical routine care for this specific patient group are lacking or arenot routinely documented in established Cancer Registries. Thus, we developed a registry concept specifically adaptedfor these incurable patients comprising primary and secondary data as well as mobile-health (m-health) data.
Methods: The concept for patient-centered “Breast cancer care for patients with metastatic disease”(BRE-4-MED)registry was developed and piloted exemplarily in the region of Main-Franconia, a mainly rural region in Germanycomprising about 1.3 M inhabitants. The registry concept includes data on diagnosis, therapy, progression, patient-reported outcome measures (PROMs), and needs of family members from several sources of information includingroutine data from established Cancer Registries in different federal states, treating physicians in hospital as well as inoutpatient settings, patients with metastatic breast cancer and their family members. Linkage with routine cancerregistry data was performed to collect secondary data on diagnosis, therapy, and progression. Paper and online-basedquestionnaires were used to assess PROMs. A dedicated mobile application software (APP) was developed to monitorneeds, progression, and therapy change of individual patients. Patient’s acceptance and feasibility of data collection inclinical routine was assessed within a proof-of-concept study. 
Results: The concept for the BRE-4-MED registry was developed and piloted between September 2017 and May 2018.In total n= 31 patients were included in the pilot study, n= 22 patients were followed up after 1 month. Recordlinkage with the Cancer Registries of Bavaria and Baden-Württemberg demonstrated to be feasible. The voluntary APP/online questionnaire was used by n= 7 participants. The feasibility of the registry concept in clinical routine waspositively evaluated by the participating hospitals.
Conclusion: The concept of the BRE-4-MED registry provides evidence that combinatorial evaluation of PROMs, needsof family members, and raising clinical parameters from primary and secondary data sources as well as m-healthapplications are feasible and accepted in an incurable cancer collective.
KW  - Metastatic breast cancer
KW  - Patient-centered registry
KW  - Patient’s needs
KW  - m-Health
KW  - Health care service research
Y1  - 2020
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-229149
VL  - 6
ER  -