Study protocol of the HessenKohorte2042: a prospective, longitudinal cohort study characterising quality of life in people with Parkinson's disease and their caregivers using a bio-psycho-social approach.

Autor:	Kleinholdermann U; Philipps-Universitat Marburg, Marburg, Germany., Thieken F; Philipps-Universitat Marburg, Marburg, Germany., Ruppert-Junck MC; Philipps-Universitat Marburg, Marburg, Germany.; Center of Mind, Brain and Behaviour, Philipps-Universitat Marburg, Marburg, Germany., van Munster M; Philipps-Universitat Marburg, Marburg, Germany.; Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands., Pedrosa AJ; Philipps-Universitat Marburg, Marburg, Germany., Stümpel J; Philipps-Universitat Marburg, Marburg, Germany.; Center for Life Ethics, University of Bonn, Bonn, Germany., Hammes V; Philipps-Universitat Marburg, Marburg, Germany., Timmermann L; Philipps-Universitat Marburg, Marburg, Germany.; Center of Mind, Brain and Behaviour, Philipps-Universitat Marburg, Marburg, Germany., Woopen C; Center for Life Ethics, University of Bonn, Bonn, Germany., Schmitz-Luhn B; Center for Life Ethics, University of Bonn, Bonn, Germany., Storms A; Katholische Akademie Die Wolfsburg, Diocese of Essen, Mülheim an der Ruhr, Germany., Golla H; Department of Palliative Medicine, University Hospital Cologne, Cologne, Germany., Nater UM; Department of Psychology, University of Vienna, Vienna, Austria., Skoluda N; Department of Psychology, University of Vienna, Vienna, Austria., Pfefferle PI; Comprehensive Biobank Marburg (CBBMR), Philipps-Universität Marburg, Marburg, Germany., Pedrosa DJ; Philipps-Universitat Marburg, Marburg, Germany david.pedrosa@staff.uni-marburg.de.; Center of Mind, Brain and Behaviour, Philipps-Universitat Marburg, Marburg, Germany.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jul 27; Vol. 14 (7), pp. e080475. Date of Electronic Publication: 2024 Jul 27.
DOI:	10.1136/bmjopen-2023-080475
Abstrakt:	Introduction: Quality of life (QoL) is of paramount importance as an outcome to monitor and guide therapies for people with Parkinson's disease (PwPD). In particular, due to the heterogeneous symptoms that PwPD may experience during their disease course, QoL can deteriorate not only in patients but also in their caregivers, with a variety of psychosocial consequences. However, there is a lack of longitudinal studies that explore how QoL evolves over time and what factors are significant. Furthermore, holistic approaches that consider bio-psycho-social determinants are rare. In the worst cases, these gaps can lead to suboptimal care and therefore unmet needs for patients and their caregivers, resulting in unnecessary symptom burden and increased healthcare costs for society. Methods and Analysis: This prospective, longitudinal study will follow 1000 PwPD along with their caregivers for 20 years, with up to 40 semi-annual assessments. Patient data and sample collection will include clinical assessments, self-reported outcome measures focusing on QoL, biospecimen collection and MRI. Caregiver burden will be systematically assessed through self-administered questionnaires. The use of digitised surveys will allow efficient data collection and convenient assessment at home. Our primary objective is to attain a holistic understanding of QoL in PwPD and establish a tool to measure it. The secondary objective is to explore the psycho-social and biological variables associated with QoL of patients and caregivers over the progression of the disease. This will provide key information for diagnostic and prognostic prediction, therapeutic patient stratification and adaptation of therapy in the future. Ethics and Dissemination: The study was approved by the local ethics committee of the University Hospital of Marburg (study number: 209/19). The results will be disseminated by means of publication in peer-reviewed journals, international conference contributions, annual patient meetings and a dedicated website. Trial Registration Number: German Clinical Trials Register (DRKS00023598). Competing Interests: Competing interests: UK has participated in a DBS training course which was industry funded by Boston Scientific Corp. LT received payments as a consultant for Boston Scientific, honoraria as a speaker on symposia sponsored by UCB, Desitin, Boston Scientific and Abott, within the last year until March 2020. The institution of LT, not LT personally, received funding by the German Research Foundation, the German Ministry of Education and Research, and the Deutsche Parkinson Vereinigung. Neither LT nor any member of his family holds stocks, stock options, patents or financial interests in any of the above-mentioned companies or their competitors. LT is member of the oversight Guidelines Commission of the German Neurological Society. He is participating in the Guideline of Treatment of Parkinson Syndromes. He will be the official delegate of the German Neurological Society in the EU medical devices commission and has been selected to become delegate of the German Neurological Society in the AWMF (German National Institute for Medical Guidelines). DJP has received honoraria for speaking at symposia sponsored by Boston Scientific Corp, Medtronic, AbbVie Inc, Zambon and Esteve Pharmaceuticals GmbH. He has received consultancy fees from Boston Scientific Corp and Bayer, and a grant from Boston Scientific Corp for a project entitled 'Sensor-based Optimisation of Deep Brain Stimulation settings in Parkinson’s disease' (COMPARE-DBS). The institution of DJP, not DJP himself, has received funding from the European Commission, the German Ministry of Education and Research, the International Parkinson’s Foundation and the JNPD. Finally, DJP has received travel grants to attend congresses from Esteve Pharmaceuticals GmbH and Boston Scientific Corp. FT, MCR-J, MvM, AJP, JS, VH, CW, BS-L, AS, HG, UMN, NS and PIP declare no competing interests. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu