Data Standards
Organized by domains and subdomains often used in clinical studies, data standards include:
- CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory
- CRF Modules — Template forms that logically organize CDEs for data collection
- Guidance Documents — Provide further information about the CDEs.
- Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)
SCI Start-Up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for SCI study start-up.
SCI Highlight Summary: Overview of all SCI-specific CDE recommendations as they appear on the website.
Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.
Overview
The use of different measures to assess similar study variables and/or differing metrics to assess outcomes may limit important advances in Spinal Cord Injury (SCI) research. Adoption of common data elements, or CDEs, (which include variable definitions and recommended measures), can facilitate comparison of findings across studies. The National Institute of Neurological Disorders and Stroke (NINDS) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research.
To develop the SCI CDEs, scientific experts were invited to participate in subject-specific Working Groups to develop recommendations for specific topic-driven common data elements. The resulting SCI CDE Version 1.0 recommendations were published in Spinal Cord in 2015. The CDEs and case report forms (CRFs) can be viewed on the Data Standards tab. Additional pediatric-specific recommendations were developed in 2015.
The purpose of the International SCI data sets is to standardize the collection and reporting of minimal information necessary to describe a study population that would allow meaningful comparison of study data. The American Spinal Injury Association (ASIA), International Spinal Cord Society (ISCoS) and the NINDS CDE Team collaborated to incorporate the International SCI data sets into the NINDS Spinal Cord Injury CDEs.
The SCI CDE recommendations provide consistent variable names for the data elements and proposed structures for relational data tables. The SCI CDE recommendations will facilitate the adoption of these standardized variables by clinicians and researchers who are developing projects or databases. These recommended variables are intended for free use by researchers and clinicians, so clinical/research data can be easily shared and/or combined.
The References section includes publications that further describe and outline the development of the data sets listed below.
Roster
The Spinal Cord Injury CDE Working Group is comprised of eight different subgroups. The Working Group members have developed the CDEs for their specific subgroups. The SCI CDE Working Group is supported by the NINDS CDE Team. The subgroups began meeting by teleconference in July 2013 and held calls every four to six weeks to define the CDEs for their domains and to recommend standardized, validated instruments for SCI research.
Staff members from the NINDS CDE Team (composed of NINDS Program Directors along with their contractor) approached the Executive Committee of the International SCI Standards and Data Sets committees (ECSCI) after they became aware of the work performed by the various SCI data set working groups. The International Spinal Cord Society (ISCoS) and the American Spinal Injury Association (ASIA) have since collaborated to incorporate the International SCI data sets into the NINDS CDEs. The NINDS CDE Team has worked with members of the Executive Committee of the International SCI Standards and Data Sets committees (ECSCI) to develop the SCI CDEs. The Spinal Cord Injury CDE Oversight Committee was created in 2015.
The complete SCI CDE Working Group roster and the rosters by Subgroup are shown below.
Publications
Publications related to the development of the International Spinal Cord Injury Data Sets
- Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov; 50(11):817–821. PubMed PMID: 22665221.
- Charlifue S, Post MW, Biering-Sørensen F, Catz A, Dijkers M, Geyh S, Horsewell J, Noonan V, Noreau L, Tate D, Sinnott KA. International Spinal Cord Injury Quality of Life Basic Data Set. Spinal Cord. 2012 Sep; 50(9):672–675. PubMed PMID: 22450884.
- Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-Sørensen F. International Spinal Cord Injury Skin and Thermoregulation Function Basic Data Set. Spinal Cord, 2012 Jul; 50(7):512–516. PubMed PMID: 22289898
- Biering-Sørensen F, Krassioukov A, Alexander MS, Donovan W, Karlsson AK, Mueller G, Perkash I, William Sheel A, Wecht J, Schilero GJ.International Spinal Cord Injury Pulmonary Function Basic Data Set. Spinal Cord. 2012 Jun; 50(6):418–421. PubMed PMID: 22270192.
- Bauman WA, Biering-Sørensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct; 49(10):1068–1072. PubMed PMID: 21577217.
- Alexander MS, Biering-Sørensen F, Elliott S, Kreuter M, Sønksen J. International Spinal Cord Injury Male Sexual Function Basic Data Set. Spinal Cord. 2011 Jul; 49(7):795–798. PubMed PMID: 21283085.
- Alexander MS, Biering-Sørensen F, Elliott S, Kreuter M, Sønksen J. International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set. Spinal Cord. 2011 Jul; 49(7):787–790. PubMed PMID: 21383760.
- Devivo MJ, Biering-Sorensen F, New P, Chen Y. Standardization of data analysis and reporting of results from the International Spinal Cord Injury Core Data Set. Spinal Cord. 2011 May; 49 (5): 596–599. PubMed PMID: 21135863.
- Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International Spinal Cord Injury Cardiovascular Function Basic Data Set. Spinal Cord. 2010 Aug; 48(8):586–590. PubMed PMID: 20101250.
- Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele J-J. International urinary tract imaging basic spinal cord injury data set. Spinal Cord. 2009 May; 47(5):379–383. PubMed PMID: 19030013.
- Yue JK, Chan AK, Winkler EA, Upadhyayula PS, Readdy WJ, Dhall SS. A review and update on the guidelines for the acute management of cervical spinal cord injury - Part II. J Neurosurg Sci. 2016 Sep;60(3):367-84. Epub 2015 Sep 9. Review. PubMed PMID: 26354186.
- Biering-Sørensen F, Noonan VK. Standardization of Data for Clinical Use and Research in Spinal Cord Injury. Brain Sci. 2016 Aug 12;6(3). pii: E29. doi: 10.3390/brainsci6030029. Review. PubMed PMID: 27529284.
- Krogh K, Perkash I, Stiens SA, Biering-Sørensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar; 47(3):235–241. PubMed PMID: 18725886.
- Carroll A, Vogel LC, Zebracki K, Noonan VK, Biering-Sørensen F, Mulcahey MJ. Relevance of the international spinal cord injury basic data sets to youth: an Inter-Professional review with recommendations. Spinal Cord. 2017 Feb 28. doi: 10.1038/sc.2017.14. [Epub ahead of print] PubMed PMID: 28244501.
- Krogh K, Perkash I, Stiens SA, Biering-Sørensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar; 47(3):230–234. PubMed PMID: 18725887.
- Widerström-Noga E, Biering-Sørensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards S, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set. Spinal Cord. 2008 Dec; 46(12):818–823. PubMed PMID: 18521092.
- Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord, 2008 Jul; 46(7):513–516. PubMed PMID: 18227849.
- Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International lower urinary tract function basic spinal cord injury data set. Spinal Cord. 2008 May; 46(5):325–330. PubMed PMID: 18040278.
- DeVivo M, Biering-Sørensen F, Charlifue S, Noonan V, Post M, Stripling T, Wing P. International Spinal Cord Injury Core Data Set. Spinal Cord. 2006 Sep; 44(9):535–540. PubMed PMID: 16955073.
- Biering-Sørensen F, Charlifue S, DeVivo M, Noonan V, Post M, Stripling T, Wing P. International Spinal Cord Injury Data Sets. Spinal Cord. 2006 Sep; 44(9):530–534. PubMed PMID: 16955072.
Publications related to the SCI CDE effort
- Bauman WA, Wecht JM, Biering-Sørensen F. International spinal cord injury endocrine and metabolic extended data set. Spinal Cord. 2017 May;55(5):466–477. doi: 10.1038/sc.2016.164. Epub 2017 Mar 21. PubMed PMID: 28322240.
- Mulcahey MJ, Vogel LC, Sheikh M, Arango-Lasprilla JC, Augutis M, Garner E, Hagen EM, Jakeman LB, Kelly E, Martin R, Odenkirchen J, Scheel-Sailer A, Schottler J, Taylor H, Thielen CC, Zebracki K. Recommendations for the National Institute for Neurologic Disorders and Stroke spinal cord injury common data elements for children and youth with SCI. Spinal Cord. 2017;55(4):331–340. PubMed PMID: 27845358.
- Biering-Sørensen F, Alai S, Anderson K, Charlifue S, Chen Y, DeVivo M, Flanders A, Jones L, Kleitman N, Lans A, Noonan V, Odenkirchen J, Steeves J, Tansey K, Widerström-Noga E, Jakeman L. Common data elements for spinal cord injury clinical research: A National Institute for Neurological Disorders and Stroke project. Spinal Cord. 2015 Apr; 53(4):265–277. Pub Med PMID: 25665542.
- Biering-Sørensen F, Charlifue S, Devivo MJ, Grinnon ST, Kleitman N, Lu Y, Odenkirchen J. Using the Spinal Cord Injury Common Data Elements. Top Spinal Cord Inj Rehabil. 2012 Winter; 18(1):23–27. PubMed PMID: 22408366.
- Biering-Sørensen F, Charlifue S, DeVivo MJ, Grinnon ST, Kleitman N, Lu Y, Odenkirchen J. Incorporation of the International Spinal Cord Injury Data Set Elements into the National Institute of Neurological Disorders and Stroke Common Data Elements. Spinal Cord. 2011 Jan; 49(1):60–64. PubMed PMID: 20733589.
Publications related to the development of the International Spinal Cord Injury Data Sets
- Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov; 50(11):817–821. PubMed PMID: 22665221.
- Charlifue S, Post MW, Biering-Sørensen F, Catz A, Dijkers M, Geyh S, Horsewell J, Noonan V, Noreau L, Tate D, Sinnott KA. International Spinal Cord Injury Quality of Life Basic Data Set. Spinal Cord. 2012 Sep; 50(9):672–675. PubMed PMID: 22450884.
- Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-Sørensen F. International Spinal Cord Injury Skin and Thermoregulation Function Basic Data Set. Spinal Cord, 2012 Jul; 50(7):512–516. PubMed PMID: 22289898
- Biering-Sørensen F, Krassioukov A, Alexander MS, Donovan W, Karlsson AK, Mueller G, Perkash I, William Sheel A, Wecht J, Schilero GJ.International Spinal Cord Injury Pulmonary Function Basic Data Set. Spinal Cord. 2012 Jun; 50(6):418–421. PubMed PMID: 22270192.
- Bauman WA, Biering-Sørensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct; 49(10):1068–1072. PubMed PMID: 21577217.
- Alexander MS, Biering-Sørensen F, Elliott S, Kreuter M, Sønksen J. International Spinal Cord Injury Male Sexual Function Basic Data Set. Spinal Cord. 2011 Jul; 49(7):795–798. PubMed PMID: 21283085.
- Alexander MS, Biering-Sørensen F, Elliott S, Kreuter M, Sønksen J. International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set. Spinal Cord. 2011 Jul; 49(7):787–790. PubMed PMID: 21383760.
- Devivo MJ, Biering-Sorensen F, New P, Chen Y. Standardization of data analysis and reporting of results from the International Spinal Cord Injury Core Data Set. Spinal Cord. 2011 May; 49 (5): 596–599. PubMed PMID: 21135863.
- Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International Spinal Cord Injury Cardiovascular Function Basic Data Set. Spinal Cord. 2010 Aug; 48(8):586–590. PubMed PMID: 20101250.
- Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele J-J. International urinary tract imaging basic spinal cord injury data set. Spinal Cord. 2009 May; 47(5):379–383. PubMed PMID: 19030013.
- Yue JK, Chan AK, Winkler EA, Upadhyayula PS, Readdy WJ, Dhall SS. A review and update on the guidelines for the acute management of cervical spinal cord injury - Part II. J Neurosurg Sci. 2016 Sep;60(3):367-84. Epub 2015 Sep 9. Review. PubMed PMID: 26354186.
- Biering-Sørensen F, Noonan VK. Standardization of Data for Clinical Use and Research in Spinal Cord Injury. Brain Sci. 2016 Aug 12;6(3). pii: E29. doi: 10.3390/brainsci6030029. Review. PubMed PMID: 27529284.
- Krogh K, Perkash I, Stiens SA, Biering-Sørensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar; 47(3):235–241. PubMed PMID: 18725886.
- Carroll A, Vogel LC, Zebracki K, Noonan VK, Biering-Sørensen F, Mulcahey MJ. Relevance of the international spinal cord injury basic data sets to youth: an Inter-Professional review with recommendations. Spinal Cord. 2017 Feb 28. doi: 10.1038/sc.2017.14. [Epub ahead of print] PubMed PMID: 28244501.
- Krogh K, Perkash I, Stiens SA, Biering-Sørensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar; 47(3):230–234. PubMed PMID: 18725887.
- Widerström-Noga E, Biering-Sørensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards S, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set. Spinal Cord. 2008 Dec; 46(12):818–823. PubMed PMID: 18521092.
- Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International urodynamic basic spinal cord injury data set. Spinal Cord, 2008 Jul; 46(7):513–516. PubMed PMID: 18227849.
- Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International lower urinary tract function basic spinal cord injury data set. Spinal Cord. 2008 May; 46(5):325–330. PubMed PMID: 18040278.
- DeVivo M, Biering-Sørensen F, Charlifue S, Noonan V, Post M, Stripling T, Wing P. International Spinal Cord Injury Core Data Set. Spinal Cord. 2006 Sep; 44(9):535–540. PubMed PMID: 16955073.
- Biering-Sørensen F, Charlifue S, DeVivo M, Noonan V, Post M, Stripling T, Wing P. International Spinal Cord Injury Data Sets. Spinal Cord. 2006 Sep; 44(9):530–534. PubMed PMID: 16955072.
Publications related to the development of International Spinal Cord Injury
Additional references
Updates
Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.