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 - TY - JOUR A1 - Schuler, Michael A1 - Murauer, Kathrin A1 - Stangl, Stephanie A1 - Grau, Anna A1 - Gabriel, Katharina A1 - Podger, Lauren A1 - Heuschmann, Peter U. A1 - Faller, Hermann T1 - Pre-post changes in main outcomes of medical rehabilitation in Germany: protocol of a systematic review and meta-analysis of individual participant and aggregated data JF - BMJ Open N2 - Introduction Multidisciplinary, complex rehabilitation interventions are an important part of the treatment of chronic diseases. However, little is known about the effectiveness of routine rehabilitation interventions within the German healthcare system. Due to the nature of the social insurance system in Germany, randomised controlled trials examining the effects of rehabilitation interventions are challenging to implement and scarcely accessible. Consequently, alternative pre-post designs can be employed to assess pre-post effects of medical rehabilitation programmes. We present a protocol of systematic review and meta-analysis methods to assess the pre-post effects of rehabilitation interventions in Germany. Methods and analysis The respective study will be conducted within the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A systematic literature review will be conducted to identify studies reporting the pre-post effects (start of intervention vs end of intervention or later) in German healthcare. Studies investigating the following disease groups will be included: orthopaedics, rheumatology, oncology, pulmonology, cardiology, endocrinology, gastroenterology and psychosomatics. The primary outcomes of interest are physical/mental quality of life, physical functioning and social participation for all disease groups as well as pain (orthopaedic and rheumatologic patients only), blood pressure (cardiac patients only), asthma control (patients with asthma only), dyspnoea (patients with chronic obstructive pulmonary disease only) and depression/anxiety (psychosomatic patients only). We will invite the principal investigators of the identified studies to provide additional individual patient data. We aim to perform the meta-analyses using individual patient data as well as aggregate data. We will examine the effects of both study-level and patient-level moderators by using a meta-regression method. Ethics and dissemination Only studies that have received institutional approval from an ethics committee and present anonymised individual patient data will be included in the meta-analysis. The results will be presented in a peer-reviewed publication and at research conferences. A declaration of no objection by the ethics committee of the University of Würzburg is available (number 20180411 01). KW - medical rehabilitation Y1 - 2019 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-201929 VL - 9 IS - 5 ER -