An analysis of ideal and actual time to surgery after traumatic spinal cord injury in Canada.

STUDY DESIGN: Retrospective analysis of a prospective registry and surgeon survey. OBJECTIVES: To identify surgeon opinion on ideal practice regarding the timing of decompression/stabilization for spinal cord injury and actual practice. Discrepancies in surgical timing and barriers to ideal timing of surgery were explored. SETTING: Canada. METHODS: Patients from the Rick Hansen Spinal Cord Registry (RHSCIR, 2004-2014) were reviewed to determine actual timing of surgical management. Following data collection, a survey was distributed to Canadian surgeons, asking for perceived to be the optimal and actual timings of surgery. Discrepancies between actual data and surgeon survey responses were then compared using χ2 tests and logistic regression. RESULTS: The majority of injury patterns identified in the registry were treated operatively. ASIA Impairment Scale (AIS) C/D injuries were treated surgically less frequently in the RHSCIR data and surgeon survey (odds ratio (OR)= 0.39 and 0.26). Significant disparities between what surgeons identified as ideal, actual current practice and RHSCIR data were demonstrated. A great majority of surgeons (93.0%) believed surgery under 24 h was ideal for cervical AIS A/B injuries and 91.0% for thoracic AIS A/B/C/D injuries. Definitive surgical management within 24 h was actually accomplished in 39.0% of cervical and 45.0% of thoracic cases. CONCLUSION: Ideal surgical timing for traumatic spinal cord injury (tSCI) within 24 h of injury was identified, but not accomplished. Discrepancies between the opinions on the optimal and actual timing of surgery in tSCI patients suggest the need for strategies for knowledge translation and reduction of administrative barriers to early surgery.

Relevance of the international spinal cord injury basic data sets to youth: an Inter-Professional review with recommendations.

STUDY DESIGN: Mixed methods, using the Modified Delphi Technique and Expert Panel Review. OBJECTIVE: To evaluate the utility and relevance of the International Spinal Cord Injury (SCI) Core and Basic Data Sets for children and youth with SCI. SETTING: International. METHODS: Via 20 electronic surveys, an interprofessional sample of healthcare professionals with pediatric SCI experience participated in an iterative critical review of the International SCI Data Sets, and submitted suggestions for modifications for use with four pediatric age groups. A panel of 5 experts scrutinized the utility of all data sets, correlated any modifications with the developing National Institute of Neurological Disorders and Stroke (NINDS) pediatric SCI Common Data Elements (CDE) and distributed final recommendations for modifications required to the adult data sets to the International SCI Data Set Committee and the associated Working Groups. RESULTS: Two International SCI Data Sets were considered relevant and appropriate for use with children without any changes. Three were considered not appropriate or applicable for use with children, regardless of age. Recommendations were made for five data sets to enhance their relevance and applicability to children across the age groups, and recommendations for seven data sets were specific to infants and younger children. CONCLUSIONS: The results of this critical review are significant in that substantive recommendations to align the International SCI Core and Basic Data Sets to pediatric practice were made. SPONSORSHIP: This project was funded by the Rick Hansen Institute Grant# 2015-27.

An evaluation of the International Standards to Document Remaining Autonomic Function after Spinal Cord Injury: input from the international community.

STUDY DESIGN: Interactive workshops with a presurvey-postsurvey. OBJECTIVES: To describe a series of workshops held at international meetings to inform the spinal cord injury (SCI) community about the International Standards to Document Remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) and to obtain feedback on both the workshop and the ISAFSCI assessment. SETTING: Three international conferences of SCI practitioners in Toronto, Las Vegas and Vancouver held between 2012 and 2013. METHODS: The workshops included an overview of the ISAFSCI, sharing experiences using it in clinical practice and interactive cases illustrating how to complete the scoring. A presurvey-postsurvey was administered to obtain feedback on the workshops and the ISAFSCI assessment. RESULTS: One hundred and fourteen participants completed the workshop surveys and 96% (109/114) completed both presurvey and postsurvey. Prior to the workshop, 41% (47/114) of those who had completed the survey reported assessing autonomic function in their practice, and of those, 53% (25/47) reported using the ISAFSCI. After the workshop, 74% (84/114) of participants reported that the case studies were helpful, and 57% (65/114) reported that they wanted to start or continue to use the ISAFSCI in their clinical practice. Suggestions for improving the ISAFSCI included providing further areas to consider when performing the assessment, addressing ambiguity of terms and reporting foreseeable implementation challenges. CONCLUSION: Results from this workshop suggest that more work is needed to inform the SCI community on the ISAFSCI assessment and to further clarify its language. Results from this study will inform future revisions to the ISAFSCI.

Development of the International Spinal Cord Injury Activities and Participation Basic Data Set.

STUDY DESIGN: Consensus decision-making process. OBJECTIVES: The objective of this study was to develop an International Spinal Cord Injury (SCI) Activities and Participation (A&P) Basic Data Set. SETTING: International working group. METHODS: A committee of experts was established to select and define A&P data elements to be included in this data set. A draft data set was developed and posted on the International Spinal Cord Society (ISCoS) and American Spinal Injury Association websites and was also disseminated among appropriate organizations for review. Suggested revisions were considered, and a final version of the A&P Data Set was completed. RESULTS: Consensus was reached to define A&P and to incorporate both performance and satisfaction ratings. Items that were considered core to each A&P domain were selected from two existing questionnaires. Four items measuring activities were selected from the Spinal Cord Independence Measure III to provide basic data on task execution in activities of daily living. Eight items were selected from the Craig Handicap Assessment and Reporting Technique to provide basic data on the frequency of participation. An additional rating of satisfaction on a three-point scale for each item completes the total of 24 A&P variables. CONCLUSION: Collection of the International SCI A&P Basic Data Set variables in all future research on SCI outcomes is advised to facilitate comparison of results across published studies from around the world. Additional standardised instruments to assess activities of daily living or participation can be administered, depending on the purpose of a particular study.

Development and validation of a computerized algorithm for International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).

STUDY DESIGN: Validation study. OBJECTIVES: To describe the development and validation of a computerized application of the international standards for neurological classification of spinal cord injury (ISNCSCI). SETTING: Data from acute and rehabilitation care. METHODS: The Rick Hansen Institute-ISNCSCI Algorithm (RHI-ISNCSCI Algorithm) was developed based on the 2011 version of the ISNCSCI and the 2013 version of the worksheet. International experts developed the design and logic with a focus on usability and features to standardize the correct classification of challenging cases. A five-phased process was used to develop and validate the algorithm. Discrepancies between the clinician-derived and algorithm-calculated results were reconciled. RESULTS: Phase one of the validation used 48 cases to develop the logic. Phase three used these and 15 additional cases for further logic development to classify cases with 'Not testable' values. For logic testing in phases two and four, 351 and 1998 cases from the Rick Hansen SCI Registry (RHSCIR), respectively, were used. Of 23 and 286 discrepant cases identified in phases two and four, 2 and 6 cases resulted in changes to the algorithm. Cross-validation of the algorithm in phase five using 108 new RHSCIR cases did not identify the need for any further changes, as all discrepancies were due to clinician errors. The web-based application and the algorithm code are freely available at www.isncscialgorithm.com. CONCLUSION: The RHI-ISNCSCI Algorithm provides a standardized method to accurately derive the level and severity of SCI from the raw data of the ISNCSCI examination. The web interface assists in maximizing usability while minimizing the impact of human error in classifying SCI. SPONSORSHIP: This study is sponsored by the Rick Hansen Institute and supported by funding from Health Canada and Western Economic Diversification Canada.

Assessment of clinical adherence to the international autonomic standards following spinal cord injury.

STUDY DESIGN: Retrospective chart analysis. OBJECTIVES: To investigate the use of the International Autonomic Standards (IAS, 2009 edition) for classification of remaining autonomic function following spinal cord injury (SCI) over a 1-year period in a rehabilitation center, to determine clinical adherence to use of the IAS, and to examine the most common autonomic dysfunctions, as determined by using the IAS. SETTING: Tertiary rehabilitation hospital. METHODS: A retrospective study was conducted on the use of the IAS at admission and discharge over a 1-year period on patients admitted to an in-patient SCI unit in a tertiary rehabilitation center. We examined the consistency of the form completion, as well as the completion of separate components of the forms. Finally, we examined the prevalence of each autonomic impairment. RESULTS: A total of 70 patients were admitted to the unit. The clinical adherence to the IAS was lower than the International Standards for Neurological Classification of SCI (ISNCSCI) at both admission (63% and 93%, respectively) and discharge (39% and 78%, respectively). Blood pressure dysfunction was most common among the general autonomic function disorders. However, urinary, bowel and sexual dysfunctions were present in almost all individuals with acute SCI. CONCLUSION: The IAS is in the initial stages of being incorporated into routine admission and discharge clinical examinations of individuals with SCI. The current results suggest that the clinical adherence to the IAS is low; however, it is expected that increased education, experience, and accumulating evidence for the IAS will improve its use.

Common data elements for spinal cord injury clinical research: a National Institute for Neurological Disorders and Stroke project.

OBJECTIVES: To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health. SETTING: International Working Groups. METHODS: Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed and provided recommendations for SCI clinical research. The project was carried out in collaboration with and cross-referenced to development of the International Spinal Cord Society (ISCoS) International SCI Data Sets. The recommendations were compiled, subjected to internal review and posted online for external public comment. The final version was reviewed by all working groups and the NINDS CDE team before release. RESULTS: The NINDS SCI CDEs and supporting documents are publically available on the NINDS CDE website and the ISCoS website. The CDEs span the continuum of SCI care and the full range of domains of the International Classification of Functioning, Disability and Health. CONCLUSION: Widespread use of CDEs can facilitate SCI clinical research and trial design, data sharing and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence is obtained.

International Spinal Cord Injury: Spinal Interventions and Surgical Procedures Basic Data set.

STUDY DESIGN: Survey of expert opinion, feedback and final consensus. OBJECTIVE: To describe the development and the variables included in the International Spinal Cord Injury (SCI) Spinal Interventions and Surgical Procedures Basic Data set. SETTING: International working group. METHODS: A committee of experts was established to select and define data elements. The data set was then disseminated to the appropriate committees and organizations for comments. All suggested revisions were considered and both the International Spinal Cord Society and the American Spinal Injury Association endorsed the final version. RESULTS: The data set consists of nine variables: (1) Intervention/Procedure Date and start time (2) Non-surgical bed rest and external immobilization, (3) Spinal intervention-closed manipulation and/or reduction of spinal elements, (4) Surgical procedure-approach, (5) Date and time of the completion of the intervention or surgical closure; (6) Surgical procedure-open reduction, (7) Surgical procedure-direct decompression of neural elements, and (8 and 9) Surgical procedure-stabilization and fusion (spinal segment number and level). All variables are coded using numbers or characters. Each spinal intervention and procedure is coded (variables 1 through 7) and the spinal segment level is described (variables 8 and 9). Sample clinical cases were developed to illustrate how to complete it. CONCLUSION: The International SCI Spinal Interventions and Surgical Procedures Basic Data Set was developed to facilitate comparisons of spinal interventions and surgical procedures among studies, centers and countries.

Reliability of the spine adverse events severity system (SAVES) for individuals with traumatic spinal cord injury.

STUDY DESIGN: Test-retest analysis. OBJECTIVES: To determine the intra- and inter-rater reliability of the Spine Adverse Events Severity System for Spinal Cord Injury (SAVES-SCI) in patients with traumatic SCI. SETTING: Quaternary care spine program in Vancouver, Canada. METHODS: Ten hypothetical patient cases were developed. The cases were completed by 10 raters (seven physicians, one nurse, one physiotherapist and one researcher) who were asked to identify and grade the severity of adverse events using SAVES-SCI twice with 1-week interval. Intra- and inter-rater reliability were calculated using kappa statistics and intraclass correlation coefficients (ICC). RESULTS: Intra-rater reliability for both identifying and grading AEs were high with all AEs (kappa greater than 0.6) except for bone implant, diathermy burn, massive blood loss, myocardial infarction, neurological deterioration, pressure ulcer, return to operating room and tracheostomy requirement. The inter-rater reliability measured with ICC were all above 0.6 for identifying and grading intraoperative, pre and postoperative AEs and consequences of SCI. CONCLUSIONS: The SAVES-SCI demonstrated acceptable intra-and inter-rater reliability for a majority of the AEs. Further clarification and definition of some of the AEs as well as provision of sample training cases for clinicians would assist in reducing measurement errors. The SAVES-SCI is a useful tool to assess and capture AEs in patients with acute traumatic SCI.

Evaluation of a pilot Pressure Ulcer Prevention Initiative (PUPI) for patients with traumatic spinal cord injury.

OBJECTIVE: The purpose of this study was to determine whether implementation of a Pressure Ulcer Prevention Initiative (PUPI) changed the assessment and treatment of patients with a traumatic spinal cord injury (SCI) in an acute care setting, and improved patient outcomes. METHOD: The success of implementation was evaluated by examining the percentage of patients with completed occupational therapist (OT) skin care assessments and prescriptions for therapeutic support surfaces (TSS; i.e., mattresses) before implementation (historical, cohort 1) and after implementation (experimental, cohort 2). Patient outcomes were evaluated by examining changes in PU incidence, severity, timing and recurrence, as well as PU prevalence and satisfaction with life in the community. RESULTS: Final analysis included 70 patients in cohort 1 and 73 in cohort 2. OT skin care assessment documentation (31% to 60%; p<0.001) and TSS prescriptions (31% to 60%; p=0.02) significantly increased following the implementation. The PU incidence based on patient charts (both nursing and OT assessments) did not increase significantly (26% to 36%; p=0.2). However, documented PU incidence according to OT assessments showed a substantial increase (14% to 33%; p=0.002). No effect of the PUPI was seen on immediate or long-term patient outcomes during the study period. CONCLUSION: PUPI was successful in changing clinical practice in PU prevention but no statistically significant improvements in PU-related patient outcomes were demonstrated. Results from this study identified facilitators and barriers to implementation and highlighted the complexity and difficulty of instituting effective preventative or therapeutic interventions for this population in an acute care setting. This information will assist with refinements of the PUPI and inform similar future initiatives.

Knowledge translation and implementation in spinal cord injury: a systematic review.

OBJECTIVE: To conduct a systematic review examining the effectiveness of knowledge translation (KT) interventions in changing clinical practice and patient outcomes. METHODS: MEDLINE/PubMed, CINAHL, EMBASE and PsycINFO were searched for studies published from January 1980 to July 2012 that reported and evaluated an implemented KT intervention in spinal cord injury (SCI) care. We reviewed and summarized results from studies that documented the implemented KT intervention, its impact on changing clinician behavior and patient outcomes as well as the facilitators and barriers encountered during the implementation. RESULTS: A total of 13 articles featuring 10 studies were selected and abstracted from 4650 identified articles. KT interventions included developing and implementing patient care protocols, providing clinician education and incorporating outcome measures into clinical practice. The methods (or drivers) to facilitate the implementation included organizing training sessions for clinical staff, introducing computerized reminders and involving organizational leaders. The methodological quality of studies was mostly poor. Only 3 out of 10 studies evaluated the success of the implementation using statistical analyses, and all 3 reported significant behavior change. Out of the 10 studies, 6 evaluated the effect of the implementation on patient outcomes using statistical analyses, with 4 reporting significant improvements. The commonly cited facilitators and barriers were communication and resources, respectively. CONCLUSION: The field of KT in SCI is in its infancy with only a few relevant publications. However, there is some evidence that KT interventions may change clinician behavior and improve patient outcomes. Future studies should ensure rigorous study methods are used to evaluate KT interventions.

The economic burden of traumatic spinal cord injury in Canada.

INTRODUCTION: The purpose of this study is to estimate the current lifetime economic burden of traumatic spinal cord injury (tSCI) in Canada from a societal perspective, including both direct and indirect costs, using an incidence-based approach. METHODS: Available resource use and cost information for complete/incomplete tetraplegia and paraplegia was applied to the estimated annual incidence of tSCI, by severity, in Canada. RESULTS: The estimated lifetime economic burden per individual with tSCI ranges from $1.5 million for incomplete paraplegia to $3.0 million for complete tetraplegia. The annual economic burden associated with 1389 new persons with tSCI surviving their initial hospitalization is estimated at $2.67 billion. CONCLUSION: While the number of injuries per year in Canada is relatively small, the annual economic burden is substantial.

TITLE: Fardeau économique lié aux traumatismes de la moelle épinière au Canada. INTRODUCTION: Cette étude vise à mesurer, au moyen d'une approche fondée sur l'incidence, le fardeau économique à vie lié aux traumatismes de la moelle épinière (TME) au Canada du point de vue social, en incluant les coûts directs et indirects. MÉTHODOLOGIE: Les ressources disponibles et l'information sur les coûts liés aux cas de tétraplégie et de paraplégie complètes et incomplètes ont été appliquées à l'incidence annuelle estimative des TME au Canada en fonction de leur gravité. RÉSULTATS: Le fardeau économique à vie d'une personne atteinte d'un TME varie de 1,5 million de dollars pour une paraplégie incomplète à 3 millions de dollars pour une tétraplégie complète. Le fardeau économique annuel lié aux 1 389 nouveaux cas de TME où le patient a survécu à son hospitalisation est estimé à 2,67 milliards de dollars. CONCLUSION: Malgré leur fréquence annuelle relativement faible au Canada, ces blessures entraînent un fardeau économique annuel important.

The influence of depression on physical complications in spinal cord injury: behavioral mechanisms and health-care implications.

STUDY DESIGN: This study is a literature review and a proposed conceptual model. OBJECTIVES: The objective of this study is to develop a conceptual model to explore the relationship between the presence of depressive symptoms and secondary physical complications such as pressure ulcers, urinary tract infections and autonomic dysreflexia in spinal cord injury (SCI). SETTING: Community setting for individuals with SCI. METHODS: A conceptual model explaining the mechanism underlying the relationship between depression and secondary physical SCI complications was developed based on the International Classification of Functioning, Disability and Health (ICF). A literature review was conducted to develop the model and to identify potential mechanisms responsible for the association. RESULTS: A conceptual model based on ICF was created, informed by the literature discussing the link between depression and secondary physical SCI complications. Evidence in the literature was located that supports both a causal connection between depression and increased physical complications and/or the potential mechanisms mediating that connection. CONCLUSION: The proposed model can be utilized to encourage further research on the influence of depression on SCI outcomes and the importance of prompt and effective identification and treatment of depressive symptoms. Additional research is needed to assess the relationship between depression and secondary physical SCI complications, and to test the validity of the model.

Use of the Spine Adverse Events Severity System (SAVES) in patients with traumatic spinal cord injury. A comparison with institutional ICD-10 coding for the identification of acute care adverse events.

STUDY DESIGN: Observational cohort comparison. OBJECTIVES: To compare the previously validated Spine Adverse Events Severity system (SAVES) with International Classification of Diseases, Tenth Revision codes (ICD-10) codes for identifying adverse events (AEs) in patients with traumatic spinal cord injury (TSCI). SETTING: Quaternary Care Spine Program. METHODS: Patients discharged between 2006 and 2010 were identified from our prospective registry. Two consecutive cohorts were created based on the system used to record acute care AEs; one used ICD-10 coding by hospital coders and the other used SAVES data prospectively collected by a multidisciplinary clinical team. The ICD-10 codes were appropriately mapped to the SAVES. There were 212 patients in the ICD-10 cohort and 173 patients in the SAVES cohort. Analyses were adjusted to account for the different sample sizes, and the two cohorts were comparable based on age, gender and motor score. RESULTS: The SAVES system identified twice as many AEs per person as ICD-10 coding. Fifteen unique AEs were more reliably identified using SAVES, including neuropathic pain (32 × more; P<0.001), urinary tract infections (1.4 × ; P<0.05), pressure sores (2.9 × ; P<0.001) and intra-operative AEs (2.3 × ; P<0.05). Eight of these 15 AEs more frequently identified by SAVES significantly impacted length of stay (P<0.05). Risk factors such as patient age and severity of paralysis were more reliably correlated to AEs collected through SAVES than ICD-10. CONCLUSION: Implementation of the SAVES system for patients with TSCI captured more individuals experiencing AEs and more AEs per person compared with ICD-10 codes. This study demonstrates the utility of prospectively collecting AE data using validated tools.

Prevalence of non-traumatic spinal cord injury in Victoria, Australia.

STUDY DESIGN: Forecasting using population modelling. OBJECTIVES: To determine the prevalence of non-traumatic spinal cord injury (NTSCI) on 30 June 2010. SETTING: Victoria, Australia. METHODS: Modelling used the following data: incidence of NTSCI based on state-wide, population-based, health-administration database of hospital admissions; state and national population profiles and life tables; levels of NTSCI based on national rehabilitation outcomes data; and life expectancy for persons with SCI. RESULTS: The total population prevalence rate was 367.2 per million, whereas the prevalence in adults aged 16 years and older was estimated to be 2027, equivalent to a population prevalence rate of 455 per million persons. There were more males (1097) with NTSCI (prevalence rate males 197.8 per million population; females 169.1 per million population) and the prevalence was much higher among those with paraplegia (prevalence rate 269.3 per million compared to 97.8 per million with tetraplegia) and incomplete NTSCI. Ventilator dependency (prevalence rate 1.6 per million population) and paediatric NTSCI (prevalence rate 6 per million population ≤ 15 years old) were extremely rare. CONCLUSION: We have reported a method for calculating an estimate of the prevalence of NTSCI that provides information that will be vital to optimise health care planning for this group of highly disabled members of society. It is suggested that refinements to the modelling methods are required to enhance its reliability. Future projects should be directed at refining the mortality ratios and performing cohort survival studies.

International spinal cord injury spinal column injury basic data set.

STUDY DESIGN: Survey of expert opinion, feedback and final consensus. OBJECTIVES: To describe the development of the International Spinal Cord Injury (SCI) Spinal Column Injury Basic Data Set. SETTING: International working group. METHODS: A committee of experts was established to select and define data elements. The data set was then disseminated to the appropriate committees and organizations for comment. All suggested revisions were considered and the final version was endorsed by both the International Spinal Cord Society (ISCoS) and the American Spinal Injury Association (ASIA). RESULTS: The data set consists of seven variables: (1) penetrating or blunt injury, (2) spinal column injury(ies), (3) single or multiple level spinal column injury(ies), (4) spinal column injury level number, (5) spinal column injury level, (6) disc and/or posterior ligamentous complex injury and (7) traumatic translation. All variables are coded using numbers or characters. For variables 1, 2, 3, 4, 6 and 7, response categories are assigned a numeric point score. Variable 5 assigns both characters and numbers to identify level(s) of spinal injured vertebra(e). When there are several distinct and separate levels of injury, then each one is described using variables 4 through 7. CONCLUSION: The International SCI Spinal Column Injury Basic Data Set was developed to facilitate comparisons of spinal column injury data among studies, centres and countries. This data set is part of the National Institute of Neurological Disorders and Stroke Common Data Element project, and tools are now available to assist investigators in collecting this data in their SCI clinical studies.

A review of preference-based health-related quality of life questionnaires in spinal cord injury research.

STUDY DESIGN: Systematic review. OBJECTIVES: Review the use of generic preference-based measures of health-related quality of life (HRQoL) within the context of spinal cord injury (SCI). METHODS: A systematic search was conducted to identify SCI-related publications that contained any of the following preference-based HRQoL instruments: 15D, Assessment of Quality of Life (AQoL)-4D, AQoL-6D, EQ-5D, EQ-5D-5L, Health Utilities Index (HUI)-2, HUI-3, Quality of Well-Being Scale Self-Administered (QWB-SA), SF-6D(SF-36) or SF-6D(SF-12). In addition to providing an overview of how different preference-based measures have been adopted in SCI research to-date, a focus of evaluation was to collate and appraise evidence for measurement properties and identify knowledge gaps. RESULTS: Twenty-two articles were identified. No studies have used preference-based measures in their conventional form, that is, to calculate quality-adjusted life years using patient-level data. Eleven papers reported mean utility scores (across six different instruments). Directly comparable data exists for only one SCI-specific sample, which showed variation across EQ-5D (0.63), HUI-2 (0.81) and HUI-3 (0.68) index scores. Indirect comparisons suggested differences between QWB-SA and SF-6D index scores within tetraplegic and paraplegic patient groups. Only the QWB-SA and SF-6D have undergone (partial) psychometric evaluation, with the respective authors concluding that the measures have potential for SCI research. CONCLUSIONS: Despite 'cost-effectiveness' being an increasingly important consideration for decision makers in all areas of health care, there is a distinct lack of conceptual or empirical research regarding the appropriateness of alternative preference-based HRQoL measures for SCI populations. Given the support for economic evaluation within a cost-utility framework and the paucity of psychometric evidence regarding current instruments, further research is needed.

The Rick Hansen Spinal Cord Injury Registry (RHSCIR): a national patient-registry.

STUDY DESIGN: Development of a prospective patient registry. OBJECTIVE: To develop a patient registry for persons with traumatic spinal cord injuries (SCI), which can be used to answer research questions and improve patient outcomes. SETTING: Nine provinces in Canada. METHODS: The Rick Hansen Spinal Cord Injury Registry (RHSCIR) is part of the Translational Research Program of the Rick Hansen Institute. The launch of RHSCIR in 2004 heralded the initiation of the first nation-wide SCI patient registry within Canada. Currently, RHSCIR is being implemented in 14 cities located in 9 provinces, and there are over 1500 individuals who have sustained an acute traumatic SCI registered to date. Data are captured from the pre-hospital, acute and rehabilitation phases of care, and participants are followed in the community at 1, 2, 5 and then every 5 years post-injury. RESULTS: During the development of RHSCIR, there were many challenges that were overcome in selecting data elements, establishing the governance structure, and creating a patient privacy and confidentiality framework across multiple provincial jurisdictions. The benefits of implementing a national registry are now being realized. The collection of an internationally standardized set of clinical information is helping inform clinicians of beneficial interventions and encouraging a shift towards evidence-based practices. Furthermore, through RHSCIR, a network is forming amongst SCI clinicians and researchers, which is fostering new collaborations and the launch of multi-center clinical trials. CONCLUSIONS: For networks that are establishing SCI registries, the experiences and lessons learned in the development of RHSCIR may provide useful insights and guidance.

Quality of life instruments and definitions in individuals with spinal cord injury: a systematic review.

STUDY DESIGN: A systematic review. OBJECTIVE: To critically review quality of life (QOL) instruments used with spinal cord injury (SCI) populations. SETTING: Vancouver, Canada. METHODS: A systematic literature review was conducted for publications assessing the measurement properties of QOL outcome measures. Pre-established criteria were used to evaluate the measurement properties. RESULTS: Fourteen articles reporting on 13 QOL instruments met the inclusion criteria, including the Patient Reported Impact of Spasticity Measure (PRISM), Quality of Well-being Scale, Qualiveen, Sickness Impact Profile (SIP68), Short Form (SF)-36, SF-36V, SF-12, SF-6D, Quality of Life Index, Quality of Life Profile for Adults with Physical Disabilities (QOLP-PD), Satisfaction with Life Scale, Sense of Well-being Index (SWBI), and the World Health Organization Quality of Life-BREF scale (WHOQOL-BREF). The SF-36 and WHOQOL-BREF have been widely used and validated. The SIP68, QOLP-PD, SF-36V, and SWBI are promising with limited investigation. The Qualiveen and PRISM performed well and are specific to SCI complications. CONCLUSION: The WHOQOL-BREF is presently the most acceptable and established instrument to assess QOL after SCI. The SIP68, QOLP-PD, SF-36V, and SWBI are promising; however, require further evaluation of their measurement properties.

Development of an international spinal injury prevention module: application of the international classification of external cause of injury to spinal cord injury.

STUDY DESIGN: An end-user response survey and assessments of inter-rater reliability before and after training. OBJECTIVES: Evaluate the spinal cord injury (SCI) application of the international classification of external cause of injury (ICECI) in a mixed group of untrained and trained coders to assess agreement, refine coding and training methodology. SETTING: An interactive coding workshop for an international group of coders with varying previous training. METHODS: Evaluate content validity (qualitative survey) and inter-rater reliability (kappa estimate of agreement) of the ICECI in a variety of injury scenarios presented within a computerized data-entry and training module. The results of this evaluation are compared with an earlier published gold standard. RESULTS: The ICECI is a flexible data coding system that appears to work with reasonable content validity in the regions assessed with English-language coders. Training appeared to narrow the difference between the inexperienced and trained coders. This is reflected in a borderline tendency for lower kappa scores pre-training compared with an earlier examined group of expert coders (P=0.073) but no difference in kappa scores after training (P=0.67). Computer-based training on a face-to-face level with computerized data entry appears an effective tool for training coders to use the ICECI. CONCLUSIONS: This report shows that using electronic data-entry and training assistance, inexperienced coders using the SCI-ICECI computerized system quickly approach the levels of agreement of trained coders in related data systems. The content validity of the training data set is adequate but needs to include more cases representative for use in SCI.