Document is current

Article History

Accepted: 18 February 2021

First Online: 19 March 2021

Declarations

:

: Open Access funding enabled and organized by Projekt DEAL. The CLaSP study is funded by the European Commission (Joint Programme, Neurodegenerative Disease Research “European research projects for the evaluation of health care policies, strategies and interventions for Neurodegenerative Diseases”) through national funding bodies in all six countries (Economic and Social Research Council ES/L009250/1; BMBF, Marburg, Germany: 01ED1403A, Munich, Germany: 01ED1403B, Bordeaux, France: ANR-13-JPHC-0001-07, Lisbon, Portugal: HC/0002/2012, Lund, Sweden: HC-559-002, Nijmegen, Holland, the Netherlands: 733051003). Anette Schrag was supported by the National Institute for Health Research UCL/UCLH Biomedical Research Centre.

: Christopher Kruse, Sabrina Kretschmer, Anna Lipinski, Malte Verheyen, David Mengel, Monika Balzer-Geldsetzer, Stefan Lorenzl, Carmen Richinger, Christian Schmotz, Lars Tönges, Dirk Woitalla, Stephan Klebe, Anette Schrag, and Richard Dodel have no conflicts of interest that are directly relevant to the content of this article.

: All study sites received approval of their local ethics committee before study start. The CLaSP study was conducted in compliance with the Helsinki Declaration, i.e., detailed oral and written information was given to the patients and their informant to ensure that the patient fully understood the potential risks and benefits of the study. The study protocol was approved by the local ethics committees of all participating study sites (London: Camden and Islington NRES Committee 14/LO/0612, Bordeaux: South West and Overseas Protection Committee III [South West and Overseas Protection Committee], 2014-A01501–46, Lisbon: Centro Hospitalar Lisboa Norte, DIRCLN-19SET2014–275, Lund: EPN Regionala Etikprovningsnamnden: Lund[(EPN Regional Ethics Name: Lund], JPND NC 559–002, Marburg: Ethik-Kommission der Philipps-Universität Marburg und Ethikkommission bei der Landesarztekammer Hessen [Ethics Commission at the State Medical Association Hesse], MC 309/2014, Munich: Ethikkommission bei der LMU Munchen [Ethics Committee at the LMU Munchen], 193–14, Nijmegen: Radboud Universitair Medisch Centrum, Concernstaf Kwaliteit en Veiligheid, Commissie Mensgebonden Onderzoek Regio Arnhem-Nijmegen [Radboud University Medical Center, Group Staff Quality and Safety Human Research Committee, Arnhem-Nijmegen region], DJ/CMO300).

: Participants (patients and their caregivers) were included in the study after giving their written informed consent. Where the patient lacked capacity to give consent to the study because of severe cognitive impairment, the decision on study participation was made by a legal guardian or consultee, depending on the ethical and legal requirements at each site. All participants (patients and caregivers) could withdraw from the study at any point in time without any negative implications.

: All authors have read the final manuscript and consented publication.

: The datasets generated during and/or analyzed during the current study are available from the corresponding author on a reasonable request.

: The statistical analysis was performed using IBM SPSS Statistics, Version 26.0.0.0 (IBM, Armonk, NY, USA). No custom code was used.

: AS and RD designed the study and ensured its overall coordination. RD and MBG were responsible for the economic study. CK built the costing database and performed the economic analysis. SK, AL, MV, DM, SL, CR, CS, LT, DW, SK, and MLW were responsible for the management and supervision of participants’ clinical follow-up at the different sites. They also collected clinical data and the socio-economic data. The manuscript was drafted by CK and RD. All authors made critical comments on the manuscript draft and approved the final version of the manuscript for submission and agreed to be responsible for all aspects of the work. Principal investigators of the CLaSP study group: Bloem B, Coelho M, Ferreira JJ, Hommel ALAJ, Lorenzl S, Meissner W, Odin P, Wittenberg M.