Consensus definitions and application guidelines for control groups in cerebrospinal fluid biomarker studies in multiple sclerosis

Author:

Teunissen Charlotte1,Menge Til2,Altintas Ayse3,Álvarez-Cermeño José C4,Bertolotto Antonio5,Berven Frode S67,Brundin Lou8,Comabella Manuel9,Degn Matilde10,Deisenhammer Florian11,Fazekas Franz12,Franciotta Diego13,Frederiksen Jette L10,Galimberti Daniela14,Gnanapavan Sharmilee15,Hegen Harald11,Hemmer Bernhard16,Hintzen Rogier17,Hughes Steve18,Iacobaeus Ellen19,Kroksveen Ann C20,Kuhle Jens21,Richert John22,Tumani Hayrettin23,Villar Luisa M24,Drulovic Jelena25,Dujmovic Irena25,Khalil Michael12,Bartos Ales2627

Affiliation:

1. Neurological Laboratory, Innogentecis and Roche, VU University Medical Center, Netherlands

2. Department of Neurology, Heinrich Heine-University, Germany

3. Neurology Department, Cerrahpasa Medical School, Istanbul University, Turkey

4. Department of Neurology, MS Unit, Hospital Ramón y Cajal, IRYCYS, REEM, Spain

5. Neurologia 2, Ospedale S. Luigi, Orbassano, Italy

6. Department of Biomedicine, Proteomics Unit (PROBE), University of Bergen, Norway

7. The Norwegian Multiple Sclerosis Competence Centre, Haukeland University Hospital, Norway

8. Neurology Clinic, Karolinska University Hospital, Sweden

9. Centre d’Esclerosi Múltiple de Catalunya, Hospital Universitari Vall d’Hebron, Spain

10. Department of Neurology, Glostrup University Hospital, University of Copenhagen, Denmark

11. Innsbruck Medical University, Department of Neurology, Austria

12. Department of Neurology, Medical University of Graz, Austria

13. Laboratory of Neuroimmunology, IRCCS - C. Mondino National Neurological Institute, Italy

14. Neurology Unit, Dept. of Pathophysiology and Trasplantation, University of Milan, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Italy

15. Neuroscience Centre, Barts and The London School of Medicine and Dentistry, UK

16. Department of Neurology, Klinikum rechts der Isar, Technische Universität München/ Munich Cluster for Systems Neurology (SyNergy), Munich/German Competence Network Multiple Sclerosis (KKNMS), Munich, Germany

17. Department of Neurology, Erasmus MC, The Netherlands

18. Isis Pharmaceuticals Inc., USA

19. Department of Clinical Neuroscience, Karolinska Institute, Sweden

20. The KG Jebsen Centre for MS-research, University of Bergen, Norway

21. Department of Neurology and Clinical Immunology, University Hospital Basel, Switzerland

22. Global Medical Affairs Department, Biogen Idec Inc., USA

23. University Hospital of Ulm, Germany

24. Department of Immunology, MS Unit, Hospital Ramón y Cajal, IRYCYS, REEM, Spain

25. Clinic of Neurology, University of Belgrade, Serbia

26. Prague Psychiatric Center, Czech Republic

27. Charles University in Prague, Third Faculty of Medicine, Czech Republic

Abstract

The choice of appropriate control group(s) is critical in cerebrospinal fluid (CSF) biomarker research in multiple sclerosis (MS). There is a lack of definitions and nomenclature of different control groups and a rationalized application of different control groups. We here propose consensus definitions and nomenclature for the following groups: healthy controls (HCs), spinal anesthesia subjects (SASs), inflammatory neurological disease controls (INDCs), peripheral inflammatory neurological disease controls (PINDCs), non-inflammatory neurological controls (NINDCs), symptomatic controls (SCs). Furthermore, we discuss the application of these control groups in specific study designs, such as for diagnostic biomarker studies, prognostic biomarker studies and therapeutic response studies. Application of these uniform definitions will lead to better comparability of biomarker studies and optimal use of available resources. This will lead to improved quality of CSF biomarker research in MS and related disorders.

Publisher

SAGE Publications

Subject

Clinical Neurology,Neurology

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