Consensus Recommendations for Standardized Data Elements, Scales, and Time Segmentations in Studies of Human Circadian/Diurnal Biology and Stroke

Author:

Saver Jeffrey L.1ORCID,Klerman Elizabeth B.23ORCID,Buchan Alastair M.4ORCID,Calleja Patricia5ORCID,Lizasoain Ignacio6ORCID,Bahr-Hosseini Mersedeh1ORCID,Lee Sarah7ORCID,Liebeskind David S.1ORCID,Mergenthaler Philipp489ORCID,Mun Katherine T.1ORCID,Ning MingMing2,Pelz David10ORCID,Ray David11ORCID,Rothwell Peter M.12ORCID,Seners Pierre713ORCID,Sreekrishnan Anirudh7ORCID,Sung Eleanor Mina1,Tiedt Steffen14ORCID,Webb Alastair J.S.12ORCID,Wölfer Teresa A.14,Albers Gregory W.7ORCID,

Affiliation:

1. Department of Neurology and Comprehensive Stroke Center, Geffen School of Medicine, University of Los Angeles, CA (J.L.S., M.B.-H., D.S.L., K.T.M., E.M.S.).

2. Department of Neurology, Cardio-Neurology Division, Massachusetts General Hospital (E.B.K., M.N.), Harvard Medical School, Boston.

3. Division of Sleep Medicine (E.B.K.), Harvard Medical School, Boston.

4. Acute Stroke Programme, Radcliffe Department of Medicine (A.M.B., P.M.), University of Oxford, United Kingdom.

5. Department of Neurology and Stroke Center, Doce de Octubre University Hospital (P.C.), Complutense Medical School, Instituto de Investigación Hospital 12 de Octubre (i+12), Madrid, Spain.

6. Department of Pharmacology and Toxicology (I.L.), Complutense Medical School, Instituto de Investigación Hospital 12 de Octubre (i+12), Madrid, Spain.

7. Department of Neurology, Stanford University, Palo Alto, CA (S.L., P.S., A.S., G.W.A.).

8. Center for Stroke Research Berlin (P.M.), Charité–Universitätsmedizin Berlin, Germany.

9. Department of Neurology With Experimental Neurology, Clinical Research Center (P.M.), Charité–Universitätsmedizin Berlin, Germany.

10. Departments of Medical Imaging and Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada (D.P.).

11. Oxford Centre for Diabetes, Endocrinology and Metabolism, and Oxford Kavli Centre for Nanoscience Discovery, Radcliffe Department of Medicine (D.R.), University of Oxford, United Kingdom.

12. Wolfson Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences (P.M.R., A.J.S.W.), University of Oxford, United Kingdom.

13. Neurology Department, Hôpital Fondation A. de Rothschild, Institut de Psychiatrie et Neurosciences de Paris, UMR_S1266, INSERM, Université de Paris, France (P.S.).

14. Institute for Stroke and Dementia Research, University Hospital, LMU Munich, Germany (S.T., T.A.W.).

Abstract

Increasing evidence indicates that circadian and diurnal rhythms robustly influence stroke onset, mechanism, progression, recovery, and response to therapy in human patients. Pioneering initial investigations yielded important insights but were often single-center series, used basic imaging approaches, and used conflicting definitions of key data elements, including what constitutes daytime versus nighttime. Contemporary methodologic advances in human neurovascular investigation have the potential to substantially increase understanding, including the use of large multicenter and national data registries, detailed clinical trial data sets, analysis guided by individual patient chronotype, and multimodal computed tomographic and magnetic resonance imaging. To fully harness the power of these approaches to enhance pathophysiologic knowledge, an important foundational step is to develop standardized definitions and coding guides for data collection, permitting rapid aggregation of data acquired in different studies, and ensuring a common framework for analysis. To meet this need, the Leducq Consortium International pour la Recherche Circadienne sur l’AVC (CIRCA) convened a Consensus Statement Working Group of leading international researchers in cerebrovascular and circadian/diurnal biology. Using an iterative, mixed-methods process, the working group developed 79 data standards, including 48 common data elements (23 new and 25 modified/unmodified from existing common data elements), 14 intervals for time-anchored analyses of different granularity, and 7 formal, validated scales. This portfolio of standardized data structures is now available to assist researchers in the design, implementation, aggregation, and interpretation of clinical, imaging, and population research related to the influence of human circadian/diurnal biology upon ischemic and hemorrhagic stroke.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

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