International Spinal Cord Injury Data Research Articles

International Spinal Cord Injury Data Sets in clinical practice and research

<h3>Research Objectives</h3> To give an update on the International Spinal Cord Injury (SCI) Data Sets. <h3>Design</h3> International consensus. <h3>Setting</h3> The International SCI Data Sets Committee approved by the International Spinal Cord Society and the American Spinal Injury Association. <h3>Participants</h3> Individuals with spinal cord injury of traumatic and non-traumatic etiology. <h3>Interventions</h3> Utilization of the International SCI Data Sets. <h3>Main Outcome Measures</h3> Application of the International SCI Data Sets in registries, electronic medical records, daily clinical practice, and research. <h3>Results</h3> Since the first version of the International SCI Core Data Set was published in 2006, 23 International SCI Basic Data Sets, and 6 International SCI Extended Data Sets are developed: https://www.iscos.org.uk/international-sci-data-sets. The Data Sets are developed and used by nurses, physio- and occupational therapists, psychologists, doctors, and researchers depending on the content. 24 of the Data Sets are included in the National Institute of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), Common Data Elements (CDE): https://www.commondataelements.ninds.nih.gov/Spinal%20Cord%20Injury. Electronic Medical Records like Epic and Cerner have implemented several of the Data Sets. Likewise, International SCI Data Sets or elements from them are used in SCI-registries worldwide, e.g. US National SCI Model Systems Database, Rick Hansen SCI Registry in Canada, Austrian SCI Study – Registry, Nordic SCI Registry, Registry for all SCI centers in the Netherlands, prevention registry covering India, Nepal, Sri Lanka, Bangladesh, Malaysia, and Thailand, Iranian SCI Registry, Australia and more. Translations exist in Chinese, Dutch, Spanish, Portuguese, Italian, French, 5 Nordic languages, Persian, Korean, Hindi, etc. of one or more International SCI Data Sets, and several validity and reliability studies were performed. <h3>Conclusions</h3> Because the International SCI Data Sets are continuously updated and developed according to current evidence using an open and transparent process, where all interested parties are encouraged to participate these standardized and easy to use Data Sets have gained wide international acceptance in clinical practice and research. <h3>Author(s) Disclosures</h3> No Financial Or Non-Financial Interests To Disclose.

Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled study

Study design1-year prospective RCT.ObjectiveExamine the effect of implantable pulse generator and low-frequency stimulation of the pelvic nerves using laparoscopic implantation of neuroprosthesis (LION) compared with neuromuscular electrical stimulation (NMES) in SCI.MethodsInclusion criteria: traumatic spinal cord injury (SCI), age 18–55 years, neurological level-of-injury Th4–L1, time-since-injury >1 year, and AIS-grades A–B. Participants were randomized to (A) LION procedure or (B) control group receiving NMES. Primary outcome measure: Walking Index for Spinal Cord Injury (WISCI-II), which is a SCI specific outcome measure assessing ability to ambulate. Secondary outcome measures: Spinal Cord Independence Measure III (SCIM III), Patient Global Impression of Change (PGIC), Penn Spasm Frequency Scale (PSFS), severity of spasticity measured by Numeric Rating Scale (NRS-11); International Spinal Cord Injury data sets-Quality of Life Basic Data Set (QoLBDS), and Brief Pain Inventory (BPI).ResultsSeventeen SCI individuals, AIS grade A, neurological level ranging from Th4–L1, were randomized to the study. One individual was excluded prior to intervention. Eight participants (7 males) with a mean age (SD) of 35.5 (12.4) years were allocated to the LION procedure, 8 participants (7 males) with age of 38.8 (15.1) years were allocated to NMES. Significantly, 5 LION group participants gained 1 point on the WISCI II scale, (p < 0.013; Fisher´s exact test). WISCI II scale score did not change in controls. No significant changes were observed in the secondary outcome measures.ConclusionThe LION procedure is a promising new treatment for individuals with SCI with significant one-year improvement in walking ability.

The data set development for the National Spinal Cord Injury Registry of Iran (NSCIR-IR): progress toward improving the quality of care.

Study designDescriptive study.ObjectivesThe aim of this manuscript is to describe the development process of the data set for the National Spinal Cord Injury Registry of Iran (NSCIR-IR).SettingSCI community in Iran.MethodsThe NSCIR-IR data set was developed in 8 months, from March 2015 to October 2015. An expert panel of 14 members was formed. After a review of data sets of similar registries in developed countries, the selection and modification of the basic framework were performed over 16 meetings, based on the objectives and feasibility of the registry.ResultsThe final version of the data set was composed of 376 data elements including sociodemographic, hospital admission, injury incidence, prehospital procedures, emergency department visit, medical history, vertebral injury, spinal cord injury details, interventions, complications, and discharge data. It also includes 163 components of the International Standards for the Neurologic Classification of Spinal Cord Injury (ISNCSCI) and 65 data elements related to quality of life, pressure ulcers, pain, and spasticity.ConclusionThe NSCIR-IR data set was developed in order to meet the quality improvement objectives of the registry. The process was centered around choosing the data elements assessing care provided to individuals in the acute and chronic phases of SCI in hospital settings. The International Spinal Cord Injury Data Set was selected as a basic framework, helped by comparison with data from other countries. Expert panel modifications facilitated the implementation of the registry process with the current clinical workflow in hospitals.

Assessment of pain symptoms and quality of life using the International Spinal Cord Injury Data Sets in persons with chronic spinal cord injury

IntroductionTraumatic spinal cord injury (SCI) triggers complex changes that can negatively impact health and quality of life. The International SCI Data Sets were developed to enable more comparable data collection on the complex sequelae of SCI across studies. This should facilitate progress in mechanistic understanding and improving treatments of SCI.Study designProspective observational pilot study.ObjectivesTo collect data on pain symptoms and quality of life (QoL) in adults living with chronic SCI.SettingAcademic medical center, New York, USA.MethodsThe International SCI Basic Pain and Qol Data Sets were used to collect data from participants with chronic SCI (N = 31) at 2 study visits held 6 months apart. The QoL Data Set was also used to collect data from able-bodied persons of similar age and gender distribution (N = 28).ResultsMost participants with SCI had multiple types and locations of pain problems at both study visits, despite reported being treated for pain. At both visits, the worst pain problem type was nociceptive, followed by neuropathic, which was typically rated of higher intensity. QoL scores were significantly lower across all domains of the data set in persons with SCI than able-bodied persons. Persons with pain tended to have lower QoL scores, although this trend was not significant.ConclusionsThis study demonstrates the presence, complexity and stability of pain symptoms refractory to treatment and lower quality of life ratings in persons with chronic SCI.SponsorshipGrants from the Craig H. Neilsen Foundation, New York Empire Clinical Research Program, New York State Spinal Cord Injury Research Board.

A Narrative Review of Pediatric Nontraumatic Spinal Cord Dysfunction.

This article provides a narrative review of seven key issues relevant to pediatric onset of spinal cord damage not due to trauma, or spinal cord dysfunction (SCDys). The first topic discussed is terminology issues. There is no internationally accepted term for spinal cord damage not due to trauma. The implications of this terminology issue and an approach to addressing this are discussed. Second, a brief history of SCDys is presented, focusing on conditions relevant to pediatrics. Third, the classification of SCDys is outlined, based on the International Spinal Cord Injury Data Sets for Non-Traumatic Spinal Cord Injury. Following this, a summary is given of the epidemiology of pediatric SCDys, primarily focused on the incidence, prevalence, and etiology, with a comparison to traumatic spinal cord injury. Next, important clinical rehabilitation principles unique to children with SCDys are highlighted. Then important prevention opportunities for SCDys in children are discussed. Finally, trends, challenges, and opportunities regarding research in SCDys are mentioned.

Implementation of a Standardized Dataset for Collecting Information on Patients With Spinal Cord Injury.

Background: Over the last decade, the International Spinal Cord Injury Data Sets project developed a number of International Spinal Cord Injury Data Sets (ISCIDS) that can be used to collect standardized information on patients with SCI. Objective and Methods: The aim of this article is to describe the process of translating the ISCIDS into Dutch and reaching consensus on a Dutch National SCI Data Set (NDD). The interrater reliability of the NDD and implementation of the NDD at eight rehabilitation centers with a specialty in rehabilitation after SCI in the Netherlands are described. Results: NDD was implemented successfully at all eight centers. Some adaptations were made to the ISCIDS, especially to the core data set. The reliability coefficients of the NDD items were at least sufficient (mean kappa per data set ranged between .68 and .91), and mean agreement per data set ranged from 66% to 97%. Experiences from the participating centers were mainly positive as well. The main obstacle for use was thought to be the absence of a link between the local patient files and the national database, which necessitates double data entry. Conclusion: Although the results on interrater reliability are based on a small sample size and the assessment situation is different from the normal clinical situation, this study showed the NDD to be a useful instrument to collect standardized information on patients with SCI in the Netherlands. In the future, a connection between systems or another way to centrally collect the data is recommended to prevent double data entry and to guarantee continuation of administration of the NDD.

The international spinal cord injury data sets

The international spinal cord injury data sets

International Spinal Cord Injury Data Sets for non-traumatic spinal cord injury

Multifaceted: extensive discussions at workshop and conference presentations, survey of experts and feedback. Present the background, purpose and development of the International Spinal Cord Injury (SCI) Data Sets for Non-Traumatic SCI (NTSCI), including a hierarchical classification of aetiology. International. Consultation via e-mail, presentations and discussions at ISCoS conferences (2006-2009), and workshop (1 September 2008). The consultation processes aimed to: (1) clarify aspects of the classification structure, (2) determine placement of certain aetiologies and identify important missing causes of NTSCI and (3) resolve coding issues and refine definitions. Every effort was made to consider feedback and suggestions from participants. The International Data Sets for NTSCI includes basic and an extended versions. The extended data set includes a two-axis classification system for the causes of NTSCI. Axis 1 consists of a five-level, two-tier (congenital-genetic and acquired) hierarchy that allows for increasing detail to specify the aetiology. Axis 2 uses the International Statistical Classification of Diseases (ICD) and Related Health Problems for coding the initiating diseases(s) that may have triggered the events that resulted in the axis 1 diagnosis, where appropriate. Additional items cover the timeframe of onset of NTSCI symptoms and presence of iatrogenicity. Complete instructions for data collection, data sheet and training cases are available at the websites of ISCoS (http://www.iscos.org.uk) and ASIA (http://www.asia-spinalinjury.org). The data sets should facilitate comparative research involving NTSCI participants, especially epidemiological studies and prevention projects. Further work is anticipated to refine the data sets, particularly regarding iatrogenicity.

International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set

To create the International Spinal Cord Injury (SCI) Female Sexual and Reproductive Function Basic Data Set within the International SCI Data Sets. An international working group. The draft of the data set was developed by an international working group consisting of members appointed by the International Spinal Cord Society (ISCoS), the American Spinal Injury Association (ASIA), and a representative from the Executive Committee of the International SCI Standards and Data Sets. The data set was developed in an iterative process with review and comments by members of the Executive Committee of the International SCI Standards and Data Sets, ISCoS Scientific Committee, ASIA Board and the ISCoS Council, as well as all interested organizations and individuals. In addition, the data set was posted for 2 months at the ISCoS and ASIA websites for comments. ISCoS and ASIA approved the final version of the data set. To make the data set uniform, each variable and each response category within each variable have been specifically designed to promote the collection and reporting of comparable minimal data. Variables included in the International SCI Female Sexual and Reproductive Function Basic Data Set are as follows: date of data collection, interest in discussing sexual issues, sexual issues unrelated to spinal cord lesion, sexual dysfunction related to spinal cord lesion, psychogenic genital arousal, reflex genital arousal, orgasmic function and menstruation. Complete instruction for data collection, data sheet and training cases are available at the websites of ISCoS (http://www.iscos.org.uk) and ASIA (http://www.asia-spinalinjury.org).

International Spinal Cord Injury Male Sexual Function Basic Data Set

To create the International Spinal Cord Injury (SCI) Male Sexual Function Basic Data Set within the International SCI Data Sets. An international working group. The draft of the data set was developed by an international working group consisting of members appointed by the International Spinal Cord Society (ISCoS), the American Spinal Injury Association (ASIA) and a representative from the executive committee of the International SCI Standards and Data Sets. The data set was developed in an iterative process with review and comments by the members of the executive committee of the International SCI Standards and Data Sets, ISCoS scientific committee, ASIA Board and the ISCoS Council, as well as all the interested organizations and individuals. Next, the data set was posted for 2 months at the ISCoS and ASIA's websites for comments. ISCoS and ASIA approved the final version of the data set. To make the data set uniform, each variable and each response category within each variable have been specifically defined in a way that is designed to promote the collection and reporting of comparable minimal data. Variables included in the International SCI Male Sexual Function Basic Data Set are as follows: date of data collection, interest in discussing sexual issues, sexual issues unrelated to spinal cord lesion, sexual dysfunction related to spinal cord lesion, psychogenic erection, reflex erection, ejaculation and orgasmic function. Complete instructions for data collection, data sheet and training cases are available at the website of ISCoS (http://www.iscos.org.uk) and ASIA (http://www.asia-spinalinjury.org).

Recommendations for translation and reliability testing of international spinal cord injury data sets

To provide recommendations regarding translation and reliability testing of International Spinal Cord Injury (SCI) Data Sets. The Executive Committee for the International SCI Standards and Data Sets. Translations of any specific International SCI Data Set can be accomplished by translation from the English version into the target language, and be followed by a back-translation into English, to confirm that the original meaning has been preserved. Another approach is to have the initial translation performed by translators who have knowledge of SCI, and afterwards controlled by other person(s) with the same kind of knowledge. The translation process includes both language translation and cultural adaptation, and therefore shall not be made word for word, but will strive to include conceptual equivalence. At a minimum, the inter-rater reliability should be tested by no less than two independent observers, and preferably in multiple countries. Translations must include information on the name, role and background of everyone involved in the translation process, and shall be dated and noted with a version number. By following the proposed guidelines, translated data sets should assure comparability of data acquisition across countries and cultures. If the translation process identifies irregularities or misrepresentation in either the original English version or the target language, the working group for the particular International SCI Data Set shall revise the data set accordingly, which may include re-wording of the original English version in order to accomplish a compromise in the content of the data set.

Incorporation of the International Spinal Cord Injury Data Set elements into the National Institute of Neurological Disorders and Stroke Common Data Elements

To develop consistent variable names and a common database structure for the data elements in the International Spinal Cord Injury (SCI) Data Sets. National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDE) Project and The Executive Committee of the International SCI Standards and Data Sets committees (ECSCI). The NINDS CDE team creates a variable name for each defined data element in the various International SCI Data Sets. Members of the ECSCI review these in an iterative process to make the variable names logical and consistent across the data sets. Following this process, the working group for the particular data set reviews the variable names, and further revisions and adjustments may be made. In addition, a database structure for each data set is developed allowing data to be stored in a uniform way in databases to promote sharing data from different studies. The International SCI Data Sets variable names and database specifications will be available through the web sites of the International Spinal Cord Society (http://www.iscos.org.uk), the American Spinal Injury Association (http://www.asia-spinalinjury.org) and the NINDS CDE project web site (http://www.CommonDataElements.ninds.nih.gov). This process will continue as additional International SCI Data Sets fulfill the requirements of the development and approval process and are ready for implementation.

International Spinal Cord Injury Data Sets

Discussion and development of final consensus. Present the background, purpose, and process for the International Spinal Cord Injury (SCI) Data Sets development. International. An international meeting on SCI data collection and analysis occurred at a workshop on May 2, 2002, before the combined meeting of the American Spinal Injury Association (ASIA) and the International Spinal Cord Society (ISCoS) in Vancouver, British Columbia, Canada. At this meeting, a process was developed for selection of data elements to be included in International SCI Data Sets. An overall structure and terminology has been developed following the format of the International Classification of Functioning, Disability and Health (ICF). This includes definitions of the Core Data Set, as well as Modules with Basic Questions or Data Sets and Expanded Data Sets. The Core Data Set has been developed and will be presented separately. Working groups for additional modules are being established as well as general guidelines for the development of the modules. The presented format should help in developing data sets and modules within various topics related to SCI.