Robotic technology (ROBERT®) to enhance muscle strength in the hip flexor muscles following spinal cord injury: a feasibility study.

STUDY DESIGN: Feasibility study. OBJECTIVE: To determine the feasibility of conducting a large trial designed to determine whether the ROBERT® can be used to increase the strength of the hip flexor muscles after spinal cord injury (SCI). The ROBERT® is a robotic device that provides assisted active movement while supporting the weight of the leg. Focus was on recruitment capability, suitability, and acceptability of the intervention and outcome measure. SETTING: Specialised SCI centre in Denmark. METHODS: All first-time admitted patients were screened to assess participant recruitment capability. Four people with SCI < 3 months tested a protocol consisting of 60 repetitions of hip flexion in supine conducted with the assistance of the ROBERT® three times a week for 4 weeks. Feasibility was assessed based on adherence to the protocol and completion rate and from the participants' perspectives. Maximal voluntary contraction (MVC) was accessed at baseline and four weeks. RESULTS: The recruitment rate was 8% (7 months). The four participants completed 44 out of 48 sessions (92%). No adverse events occurred. One physiotherapist was required to set-up and supervise each session. The active exercise time varied from 7.5 to 17 min. The participants found the ROBERT® a good supplement to their usual rehabilitation. We were able to measure MVC in even very weak hip flexor muscles with a dynamometer MicroFET2 fixed to a frame. CONCLUSION: The ROBERT® was feasible and acceptable. The participants perceived it as a supplement, not a replacement to usual physiotherapy. However, recruitment to the study was slow. TRIAL REGISTRATION: ClinicalTrials.gov NCT05558254. Registered 28th September 2022.

Telehealth for people with spinal cord injury: a narrative review.

STUDY DESIGN: Narrative review. OBJECTIVES: To find and discuss what has been published about the use of telehealth, on people with spinal cord injury (teleSCI). SETTING: International. METHOD: Cochrane Library, Ovid Medline, EMBASE and CINAHL, from 1996 till June 2017 have been searched. Searches in  PsycINFO, from 1996 till September 2017, were included afterwards. Extracted data include studies in English language, containing information about spinal cord injury and disorders, and telehealth. Literature reviews, systematic reviews, and studies containing other types of neurological disorders, were excluded. Studies were grouped based on how and to whom telehealth was offered. RESULTS: Twenty nine studies were included in the review. They were categorized according to the way teleSCI was provided, and to what modality was used. Some studies utilized more than one modality. TeleSCI seems to be favorable concerning treatment and follow-up, as well as favorable socioeconomically and environmentally. The studies spanned across several aims and outcomes. There was also heterogeneity in number of participants, the differences in modalities, and in the level of evidence. Thus  it was challenging to compare studies  and make future recommendations. CONCLUSIONS: TeleSCI can be used for examination and guiding purposes. Further research is warranted to evaluate optimal utilization, methodology and efficacy. SPONSORSHIP: The first author has received funding from the Norwegian Extra Foundation.

Development and validation of a bowel-routine-based self-report questionnaire for sacral sparing after spinal cord injury.

STUDY DESIGN: An observational study. OBJECTIVE: To develop a self-administered tool for assessment of sacral sparing after spinal cord injury (SCI) and to test its validity in individuals with SCI. SETTING: Peking University Third Hospital, Beijing, China. METHODS: A 5-item SCI sacral sparing self-report questionnaire was developed based on several events that most patients might experience during bowel routine. 102 participants who sustained SCI within 12 months were asked to complete the questionnaire followed by an anorectal examination. Agreements of answers to the questionnaire and the physical examination were analyzed. Sensitivity, specificity and Youden's index of each item was calculated. RESULTS: The first four questions regarding the S4-5 sensation including deep anal pressure showed high agreement with the results of the physical examination (κ: 0.79-0.93). Sensitivity, specificity and Youden's index were also high (all above 80%). For the fifth question related to the voluntary anal contraction, the agreement was almost perfect with good sensitivity and specificity among patients without increased anal sphincter tone (AST). In patients with increased AST, the agreement was fair. CONCLUSION: The validity of this questionnaire for the assessment of sacral sparing in up to 12 months post injury is good except for the motor function when there was increased AST. In some situations it could be considered as an alternative tool for digital rectal examination, especially when repeated examinations are not feasible. It is suggested that change of sacral sparing may be detected by the questionnaire.

International Spinal Cord Injury Core Data Set (version 2.0)-including standardization of reporting.

STUDY DESIGN: The study design includes expert opinion, feedback, revisions and final consensus. OBJECTIVES: The objective of the study was to present the new knowledge obtained since the International Spinal Cord Injury (SCI) Core Data Set (Version 1.0) published in 2006, and describe the adjustments made in Version 2.0, including standardization of data reporting. SETTING: International. METHODS: Comments received from the SCI community were discussed in a working group (WG); suggestions from the WG were reviewed and revisions were made. All suggested revisions were considered, and a final version was circulated for final approval. RESULTS: The International SCI Core Data Set (Version 2.0) consists of 25 variables. Changes made to this version include the deletion of one variable 'Total Days Hospitalized' and addition of two variables 'Date of Rehabilitation Admission' and 'Date of Death.' The variable 'Injury Etiology' was extended with six non-traumatic categories, and corresponding 'Date of Injury' for non-traumatic cases, was defined as the date of first physician visit for symptoms related to spinal cord dysfunction. A category reflecting transgender was added. A response category was added to the variable on utilization of ventilatory assistance to document the use of continuous positive airway pressure for sleep apnea. Other clarifications were made to the text. The reporting of the pediatric SCI population was updated as age groups 0-5, 6-12, 13-14, 15-17 and 18-21. CONCLUSION: Collection of the core data set should be a basic requirement of all studies of SCI to facilitate accurate descriptions of patient populations and comparison of results across published studies from around the world.

International spinal cord injury endocrine and metabolic extended data set.

OBJECTIVE: The objective of this study was to develop the International Spinal Cord Injury (SCI) Endocrine and Metabolic Extended Data Set (ISCIEMEDS) within the framework of the International SCI Data Sets that would facilitate consistent collection and reporting of endocrine and metabolic findings in the SCI population. SETTING: This study was conducted in an international setting. METHODS: The ISCIEMEDS was developed by a working group. The initial ISCIEMEDS was revised based on suggestions from members of the International SCI Data Sets Committee, the International Spinal Cord Society (ISCoS) Executive and Scientific Committees, American Spinal Injury Association (ASIA) Board, other interested organizations, societies and individual reviewers. The data set was posted for two months on ISCoS and ASIA websites for comments. Variable names were standardized, and a suggested database structure for the ISCIEMEDS was provided by the Common Data Elements (CDEs) project at the National Institute on Neurological Disorders and Stroke (NINDS) of the US National Institute of Health (NIH), and are available at https://commondataelements.ninds.nih.gov/SCI.aspx#tab=Data_Standards. RESULTS: The final ISCIEMEDS contains questions on the endocrine and metabolic conditions related to SCI. Because the information may be collected at any time, the date of data collection is important to determine the time after SCI. ISCIEMEDS includes information on carbohydrate metabolism (6 variables), calcium and bone metabolism (12 variables), thyroid function (9 variables), adrenal function (2 variables), gonadal function (7 variables), pituitary function (6 variables), sympathetic nervous system function (1 variable) and renin-aldosterone axis function (2 variables). CONCLUSION: The complete instructions for data collection and the data sheet itself are freely available on the website of ISCoS (http://www.iscos.org.uk/international-sci-data-sets).

Psychological distress and user experiences with health care provision in persons living with spinal cord injury for more than 20 years.

STUDY DESIGN: Descriptive cross-sectional and retrospective study. OBJECTIVES: To gain more insight into the long-term health status in persons with traumatic spinal cord injury (SCI), especially perceived psychological distress as well as self-reports of utilization of healthcare services. SETTING: Sunnaas Rehabilitation Hospital, Norway. METHODS: In total, 147 persons with SCI were examined for more than 20 years and interviewed (in 2004/2005) using a self-administrated questionnaire and General Health Questionnaire (GHQ-20). Descriptive statistics and a logistic regression analysis were conducted to identify variables associated with psychological distress. RESULTS: Most participants had received SCI follow-up health services at least once after initial rehabilitation; 34% were satisfied, 51% neutral and 18% unsatisfied with the health services provided. Concerning psychological distress, 34 persons were cases according to the GHQ-20. The cases did not differ from non-cases concerning demography, time since injury, injury aetiology, injury severity, marital status or employment status. The regression analysis revealed that cases were associated (P<0.05) with more use of SCI-specific follow-ups. CONCLUSION: In a 20+ years' post-injury SCI population, psychological distress is common and associated with the use of follow-up services. The varying satisfaction of people with SCI about healthcare services is notable, as is the finding that 20% of people with paraplegia did not use specific SCI follow-up services. The experiences of people with SCI with healthcare services need further investigation, and there is also a need for studies that examine the effects of interventions aimed at improving services and patient satisfaction.

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.

International spinal cord injury bowel function basic data set (Version 2.0).

STUDY DESIGN: International expert working group. OBJECTIVES: To revise the International Spinal Cord Injury (SCI) Bowel Function Basic Data Set as a standardized format for the collecting and reporting of a minimal amount of information on bowel function in clinical practice and research. SETTING: Working group appointed by the American Spinal injury association (ASIA) and the International Spinal Cord Society (ISCoS). METHODS: The draft prepared by the working group was reviewed by the International SCI Data Set Committee and later by members of the ISCoS Executive and Scientific Committees and the ASIA board. The revised data set was posted on the ASIA and ISCoS websites for 1 month to allow further comments and suggestions. Changes resulting from a Delphi process among experts in children with SCI were included. Members of ISCoS Executive and Scientific Committees and the ASIA board made a final review and approved the data set. RESULTS: The International SCI Bowel Function Basic Data Set (Version 2.0) consists of the following 16 items: date of data collection, gastrointestinal and anal sphincter dysfunction unrelated to SCI, surgical procedures on the gastrointestinal tract, defecation method and bowel-care procedures, average time required for defecation, frequency of defecation, uneasiness, headache or perspiration during defecation, digital stimulation or evacuation of the anorectum, frequency of fecal incontinence, flatus incontinence, need to wear pad or plug, oral laxatives and prokinetics, anti-diarrheal agents, perianal problems, abdominal pain and discomfort and the neurogenic bowel dysfunction score. CONCLUSION: The International SCI Bowel Function Basic Data Set (Version 2.0) has been developed.

Version 1.1 of the international spinal cord injury skin and thermoregulation function basic data set.

OBJECTIVE: To describe the changes made to the international spinal cord injury (SCI) skin and thermoregulation function basic data set in version 1.1. SETTING: International. METHODS: An international working group reviewed suggested changes to the international SCI skin and thermoregulation function basic data set version 1.0. These changes were discussed and the agreed changes were made. Subsequently, the recommended adjustments were circulated for review to the International Spinal Cord Society (ISCoS) Executive and Scientific Committees, the American Spinal Injury Association (ASIA) Board, around 40 national and international societies, and to interested individuals who had signed up wishing to have the opportunity to review. In addition, the suggested changes were displayed at the ISCoS and ASIA websites for at least a month for possible comments. RESULTS: The recommendation 'largest diameter, including undermining' is changed to: 'Largest undermining', and a description of how to measure this is inserted. The 'smallest opening diameter' is changed to: 'Width' as the maximum dimension perpendicular to the length axis. In the literature, there is a tendency to replace 'grades' or 'stages' with 'categories'; therefore, the word 'category' is used instead of 'grade' or 'stage'. CONCLUSIONS: Impracticable measurements have been adjusted and new terminology adopted. All are to be found on ISCoS website: http://www.iscos.org.uk/international-sci-skin-and-thermoregulation-function-data-sets.

Cardiovascular response during urodynamics in individuals with spinal cord injury.

STUDY DESIGN: Retrospective chart review. OBJECTIVES: To establish the frequency and severity of autonomic dysreflexia (AD) during urodynamics among individuals with chronic spinal cord injury (SCI) and to investigate the possible effect of the number of years since SCI on the severity of AD. SETTING: SCI outpatient clinic. METHODS: A retrospective chart review was undertaken of individuals with SCI who were seen at an outpatient clinic and could potentially develop an episode of AD (T6 and above). Data regarding age, gender, urodynamic examination, lower urinary tract function, cardiovascular parameters and SCI were collected. In addition, information on signs and symptoms of AD were retrieved. RESULTS: A total of 76 individuals with SCI were examined with blood pressure (BP) monitoring. The majority had cervical SCI (79%). The mean age was 47.8±13.9 years. The median duration after SCI was 51.5 months. During urodynamics, a total of 48 (63.2%) individuals showed an increase in systolic BP>20 mm Hg, meeting the criteria for AD. Indicators for higher incidences of AD were cervical SCI, being >2 years after SCI, the presence of detrusor sphincter dyssynergia (DSD) and low bladder compliance. AD was more severe in individuals with complete (American Spinal Cord Association (ASIA) impairment scale (AIS) A) injuries, worse with greater time after SCI. CONCLUSION: Individuals with cervical SCI, DSD, poor bladder compliance or >2 years after SCI were associated with a higher possibility of developing AD during urodynamics. Furthermore, AD was more severe in complete (AIS A) individuals and was exacerbated with time after injury.

Reliability of the International Spinal Cord Injury Musculoskeletal Basic Data Set.

STUDY DESIGN: Psychometric study. OBJECTIVES: To determine the intra- and inter-rater reliability and content validity of the International Spinal Cord Injury (SCI) Musculoskeletal Basic Data Set (ISCIMSBDS). SETTING: Four centers with one in each of the countries in Australia, England, India and the United States of America. METHODS: A total of 117 participants with a C2 to S1 neurological level and American Spinal Injury Association Impairment Scale A to D injury were recruited. The median (interquartile range) time since injury was 9 years (2-29). Fifty-seven participants were assessed by the same assessor, and 60 participants were assessed by two different assessors on two different occasions to determine the intra- and inter-rater reliability, respectively. Kappa statistics or crude agreement was used to measure reliability. Content validity was assessed through focus group interviews of people with SCI and health-care professionals. RESULTS: The intra-rater reliability ranged from κ=0.62 to 1.00 and crude agreement from 75% to 100% for each of the variables on the ISCIMSBDS. The inter-rater reliability ranged from κ=-0.25 to 1.00, with a diverse crude agreement ranging from 0% to 100%. The inter-rater reliability was unsatisfactory for the following variables: 'Date of fracture', 'Fragility fractures', 'Scoliosis, method of assessment', 'Other musculoskeletal problems' and 'Do any of the above musculoskeletal challenges interfere with your activities of daily living (transfers, walking, dressing, showers, etc.)?'. Results from validity discussions implied no major suggestions for changes. CONCLUSION: Overall, the ISCIMSBDS is reliable and valid, although 5 of the 12 variables may benefit from further refinement.

The International Spinal Cord Injury Pain Extended Data Set (Version 1.0).

OBJECTIVES: The objective of this study was to develop the International Spinal Cord Injury Pain Extended Data Set (ISCIPEDS) with the purpose of guiding the assessment and treatment of pain after spinal cord injury (SCI). SETTING: International. METHODS: The ISCIPEDS was reviewed by members of the International SCI Data Sets Committee, the International Spinal Cord Society Executive and Scientific Committees, American Spinal Injury Association and American Pain Society Boards, and the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain, individual reviewers and societies. RESULTS: The working group recommended four assessment domains for the ISCIPEDS: (i) Pain symptoms including variables related to pain type, temporal course, severity, unpleasantness, tolerability of pain and questionnaires assessing pain type and symptom severity; (ii) Sensory signs to detect and quantify sensory abnormalities commonly associated with neuropathic pain, including dynamic mechanical and thermal allodynia, and hyperalgesia; (iii) Treatments (ongoing and past 12 months); and (iv) Psychosocial factors and comorbid conditions. CONCLUSION: The ISCIPEDS was designed to be used together with the International SCI Pain Basic Data Set and provide a brief yet thorough assessment of domains related to chronic pain in individuals with SCI. The data set includes pain-relevant self-reported assessments, questionnaires and sensory examinations. The recommendations were based on (i) their relevance to individuals with SCI and chronic pain, (ii) the existence of published findings supporting the utility of the selected measures for use in individuals with SCI, and to the greatest extent possible (iii) their availability in the public domain free of charge.

Pain, spasticity and quality of life in individuals with traumatic spinal cord injury in Denmark.

STUDY DESIGN: Cross-sectional survey. OBJECTIVES: To estimate the prevalence, predictors and impact of self-reported pain and spasticity and examine variables affecting quality of life in individuals with a traumatic spinal cord injury (SCI). SETTING: Nationwide, Denmark. METHODS: An anonymous questionnaire was sent out to individuals with a traumatic SCI. The questionnaire included questions about demographics and SCI characteristics, pain, spasticity and quality of life. RESULTS: In total, 537 questionnaires were completed. Seventy-three percent reported chronic pain of which 60% used descriptors suggestive of neuropathic pain. The average pain intensity and interference were 5.6 (s.d. 2.3) and 5.0 (s.d. 2.8), respectively, on a 0-10 numeric rating scale (NRS), and 28.1% reported severe pain. Seventy-one percent reported spasticity. Average interference of spasticity was 2.9 (s.d. 2.7). Quality of life scores were 6.5 (s.d. 2.5) for life and life situation, 5.5 (s.d. 2.6) for physical health and 6.7 (s.d. 2.6) for mental health on the NRS (0-10). Female gender was associated with lower mental health scores and tetraplegia with lower physical health scores, and high pain interference and shorter time since injury were associated with lower quality-of-life scores for all three parameters. Pain with descriptors suggestive of neuropathic pain was associated with lower quality-of-life scores than pain without such descriptors. CONCLUSION: Chronic pain and spasticity are common problems after SCI, and in particular, high pain interference is associated with lower quality of life.

Modified Ashworth scale and spasm frequency score in spinal cord injury: reliability and correlation.

STUDY DESIGN: Intra- and inter-rater reliability study. OBJECTIVES: To assess intra- and inter-rater reliability of the Modified Ashworth Scale (MAS) and Spasm Frequency Score (SFS) in lower extremities in a population of spinal cord-injured persons, as well as correlations between the two scales. SETTING: Clinic for Spinal Cord Injuries, Rigshospitalet, Hornbaek, Denmark. METHODS: Thirty-one persons participated in the study and were tested four times in total with MAS and SFS by three experienced raters. Cohen's kappa (κ), simple and quadratic weighted (nominal and ordinal scale level of measurement), was used as a measure of reliability and Spearman's rank correlation coefficient for correlation between MAS and SFS. RESULTS: Neurological level ranged from C2 to L2 and American Spinal Injury Association impairment scale A to D. Time since injury was (mean±s.d.) 3.4±6.5 years. Age was 48.3±20.2 years. Cause of injury was traumatic in 55% and non-traumatic for 45% of the participants. Antispastic medication was used by 61%. MAS showed intra-rater κsimple=-0.11 to 0.46 and κweighted=-0.11 to 0.83. Inter-rater κsimple=-0.06 to 0.32 and κweighted=0.08 to 0.74. SFS showed intra-rater κweighted=0.94 and inter-rater κweighted=0.93. Correlation between MAS and SFS showed non-significant correlation coefficients from-0.11 to 0.90. CONCLUSION: Reliability of MAS is highly affected by the weighting scheme. With a weighted-κ it was overall reliable and simple-κ overall unreliability. Repeated tests should always be performed by the same rater and in a very standardized manner. SFS was found reliable. MAS and SFS are poorly correlated, and ratings were inversely distributed and suggest that it assesses different aspects of spasticity.

Reliability of the radiographic variables in the International Spinal Cord Injury Spinal Column Injury Basic Data Set compared with the AO classification.

STUDY DESIGN: Intra- and interrater reliability study for radiological variables of the International Spinal Cord Injury (SCI) Spinal Column Injury Basic Data Set. OBJECTIVES: To test reliability of the radiological variables in the International SCI Spinal Column Injury Basic Data Set and compare it with the Arbeitsgemeinschaft für Osteosynthesefragen (AO) classification. SETTING: The database of Eastern Denmark Regional SCI Referral Center, Copenhagen, Denmark. METHODS: Ratings of the International SCI Spinal Column Injury Basic Data Set radiological variables and AO classification were obtained by two international observers for all the surgically treated spine trauma patients between 1st October 2010 and 31st December 2012 at the Spine Unit, Rigshospitalet, Denmark. Statistical analyses for intra- and interrater crude agreement and Cohen's unweighted kappa (κ) coefficients were performed. RESULTS: For 283 spine injuries, the intra- and interrater reliability for the individual radiological variables of the International SCI Spinal Column Injury Basic Data Set was at least substantial (κ=0.67-0.97 for interrater, κ=0.79-0.89 for the intrarater agreement). For the AO classification, intrarater reliability was moderate-to-substantial (κ=0.57-0.75), whereas interrater reliability was substantial (κ=0.67-0.69). The crude intra- and interrater agreement for a combined radiographic SCI Spinal Column Injury Basic Data Set variable showed no significant difference compared with the AO classification (P=0.067-0.895). CONCLUSIONS: The reliability of International SCI Spinal Column Injury Basic Data Set radiological variables is comparable to the AO classification system. We encourage its use for spinal column injury description, thus facilitating data collection and comparison between centres and countries.

Forty-five-year follow-up on the renal function after spinal cord injury.

STUDY DESIGN: Retrospective chart review. OBJECTIVES: To investigate the extent of renal deterioration in patients with spinal cord injury (SCI) and to identify risk indicators associated with renal deterioration. SETTING: Clinic for Spinal Cord Injuries, Rigshospitalet, Hornbæk, Denmark. METHODS: This study included 116 patients admitted to our clinic with a traumatic SCI sustained between 1956 and 1975. Results from renography and (51)Cr-EDTA plasma clearance were collected from medical records from time of injury until 2012, and the occurrence of renal deterioration was analysed by cumulative incidence curves. The impact of demographics, neurological level and completeness of SCI, urinary tract stones, dilatation of the upper urinary tract (UUT) and bladder-emptying methods were analysed with Cox proportional hazard ratios. RESULTS: The bladder-emptying methods used for the longest period were reflex triggering (63%), bladder expression (22%), indwelling catheter (5%), normal voiding (4%), ileal conduit (3%) and clean intermittent catheterisation (2%). The cumulative risk of moderate renal deterioration (functional distribution outside 40-60% on renography or relative glomerular filtration rate (GFR) ⩽75% of expected according to age and gender) was 58%. The cumulative risk of severe renal deterioration (functional distribution outside 30-70% on renography or relative GFR⩽51%) was 29% after 45 years postinjury. Only dilatation of UUT and renal/ureter stone requiring removal significantly increased the risk of moderate and severe renal deterioration. CONCLUSION: Renal deterioration occurs at any time after injury, suggesting that lifelong follow-up examinations of the renal function are important, especially in patients with dilatation of UUT and/or renal/ureter stones.

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.

Good validity of the international spinal cord injury quality of life basic data set.

STUDY DESIGN: Cross-sectional validation study. OBJECTIVES: To examine the construct and concurrent validity of the International Spinal Cord Injury (SCI) Quality of Life (QoL) Basic Data Set. SETTING: Dutch community. PARTICIPANTS: People 28-65 years of age, who obtained their SCI between 18 and 35 years of age, were at least 10 years post SCI and were wheelchair users in daily life. MEASURE(S): The International SCI QoL Basic Data Set consists of three single items on satisfaction with life as a whole, physical health and psychological health (0=complete dissatisfaction; 10=complete satisfaction). Reference measures were the Mental Health Inventory-5 and three items of the World Health Organization Quality of Life measure. RESULTS: Data of 261 participants were available. Mean time after SCI was 24.1 years (s.d. 9.1); 90.4% had a traumatic SCI, 81.5% a motor complete SCI and 40% had tetraplegia. Mean age was 47.9 years (s.d. 8.8) and 73.2% were male. Mean scores were 6.9 (s.d. 1.9) for general QoL, 5.8 (s.d. 2.2) for physical health and 7.1 (s.d. 1.9) for psychological health. No floor or ceiling effects were found. Strong inter-correlations (0.48-0.71) were found between the items, and Cronbach's alpha of the scale was good (0.81). Correlations with the reference measures showed the strongest correlations between the WHOQOL general satisfaction item and general QoL (0.64), the WHOQOL health and daily activities items and physical health (0.69 and 0.60) and the Mental Health Inventory-5 and psychological health (0.70). CONCLUSIONS: This first validity study of the International SCI QoL Basic Data Set shows that it appears valid for persons with SCI.