Effectiveness and patient perspective on the use of intravesical gentamicin instillations to treat recurrent urinary tract infections in neurogenic lower urinary tract dysfunction.

INTRODUCTION: Patients with neurogenic lower urinary tract dysfunction (NGLUTD) who require catheterization either with clean intermittent catheters (CIC) or indwelling catheters suffer with frequent urinary tract infections (UTIs). This study assessed the efficacy, patient persistence, satisfaction, and the impact on quality of life (QoL) of gentamicin nightly bladder instillations with 15 mg. METHODS: This is a prospective survey of 36 patients with NGLUTD and recurrent UTIs prescribed long-term gentamicin to prevent UTIs. Eligible patients completed a questionnaire about their use and satisfaction with gentamicin therapy, as well as survey questionnaires to address QoL. A retrospective chart review was also performed to obtain medical history, confirm drug persistence, and obtain accurate UTI data for the 12 months preceding and after starting instillations. RESULTS: The rate of laboratory proven symptomatic UTI requiring antibiotic treatment decreased from 3.9 to 1.1 infections per year with no increase in antibiotic resistance and no significant side effects reported by patients. Eight patients stopped therapy before a full year for various reasons, but the remaining 72% of patients have continued to use the therapy now with a mean of 4.2 years later. Satisfaction among those continuing the medication was very high. CONCLUSION: Gentamicin bladder instillations with 15 mg nightly in patients with indwelling catheters or CIC with NGLUTD are very effective and safe with high patient satisfaction. This therapy can be maintained long-term with continued efficacy.

Incident traumatic spinal cord injury and risk of Alzheimer's disease and related dementia: longitudinal case and control cohort study.

STUDY DESIGN: Retrospective case/control longitudinal cohort study OBJECTIVES: Prevalent traumatic spinal cord injury (TSCI) is associated with Alzheimer's disease and related dementia (ADRD). We examined the hazard ratio for ADRD after incident TSCI and hypothesized that ADRD hazard is greater among adults with incident TSCI compared with their matched control of adults without TSCI. SETTING: Using 2010-2020 U.S. national private administrative claims data, we identified adults aged 45 years and older with probable (likely and highly likely) incident TSCI (n = 657). Our controls included one-to-ten matched cohort of people without TSCI (n = 6553). METHODS: We applied Cox survival models and adjusted them for age, sex, years of living with certain chronic conditions, exposure to six classes of prescribed medications, and neighborhood characteristics of place of residence. Hazard ratios were used to compare the results within a 4-year follow-up. RESULTS: Our fully adjusted model without any interaction showed that incident TSCI increased the risk for ADRD (HR = 1.30; 95% CI, 1.01-1.67). People aged 45-64 with incident TSCI were at high risk for ADRD (HR = 5.14; 95% CI, 2.27-11.67) and no significant risk after age 65 (HR = 1.20; 95% CI, .92-1.55). Our sensitivity analyses confirmed a higher hazard ratio for ADRD after incident TSCI at 45-64 years of age compared with the matched controls. CONCLUSIONS: TSCI is associated with a higher hazard of ADRD. This study informs the need to update clinical guidelines for cognitive screening after TSCI to address the heightened risk of cognitive decline and to shed light on the causality between TSCI and ADRD.

The social dimension of quality of life following spinal cord injury or disease: an international ICF-linking study.

STUDY DESIGN: International Classification of Functioning, Disability and Health (ICF) linking study. OBJECTIVE: Analyze cognitive interview data using the ICF as an analytic framework, to examine aspects of social life relevant to quality of life (QoL) according to people with spinal cord injury or disease (SCI/D). This study builds upon results of an international study about the cross-cultural validity of the International SCI QoL Basic Data Set (QoL-BDS). SETTING: Four specialized outpatient clinics in SCI/D rehabilitation, from the US, Brazil and Australia. METHODS: Analysis of qualitative data from 39 cognitive interviews with SCI/D patients at least one year post onset. Participants were asked to define their concept of QoL, overall life satisfaction, physical health and psychological health, and other relevant matters. Four independent researchers coded text fragments related to the items, and fragments were linked to ICF chapters d6-d9, following established linking rules. RESULTS: The proportion of text referring to social life was 35.8% (definition QoL), 24.9% (QoL life as whole), 6.0% (physical health) and 34.9% (psychological health). The most frequent ICF categories were d760 Family relationships, d770 Intimate relationships and d920 Recreation and leisure. Most frequent responded social topics to the 'other issues' item were d770 Intimate relationships, d760 Formal relationships, and d870 Economic self-sufficiency. CONCLUSION: The importance of social life aspects to the QoL was highlighted based on responses of SCI/D patients, clearly demonstrated through the ICF linking process. Adding a satisfaction with social life item to the QoL-BDS has made this instrument a more comprehensive measure.

Predictors of quality of life of individuals living in Brazil with spinal cord injury/disease.

STUDY DESIGN: A cross-sectional, descriptive study. OBJECTIVES: To investigate the demographic, clinical behavioral, and rehabilitation predictors of the quality of life (QoL) of people with spinal cord injury/disease (SCI/D) in a middle-income country. METHOD: Ninety-five participants living in the community were evaluated with the following instruments: World Health Organization Quality of Life - Bref; International SCI Core DataSet; Clinical Interview; Spinal Cord Secondary Conditions Scale and Patient Health Questionnaire; Numerical Pain Intensity Scale; Short-Form 12 Health Survey - Item 8 (how much pain hinders activities); Patient Health Questionnaire 2, Numerical Fatigue Scale. Data were analyzed via Spearman correlation, univariate analysis, and multiple regression to explain the effects associated with quality-of-life predictors. RESULTS: The main factors that decreased quality of life were fatigue (by 11.5%), depression (by 5.5-12.8%), pain (by 1.3 in total life quality, in the physical domain by 8.6-9.6%), sores (15.6% in the physical domain only). The practice of sports increased the total quality of life by 14.4%, in the physical domain by 11.9%, in the psychological domain by 17.2%, and in the social domain by 23.7%. CONCLUSIONS: Fatigue, risk of depression, pain, and the presence of sores are predictors of poor quality of life, and sports are a predictor of a better quality of life, for people with spinal cord injury. Multidisciplinary rehabilitation, in addition to policies, to increase accessibility and social inclusion, and incentives or subsidies for the practice of sports could improve QoL following SCI/D.

Rasch Analysis of the International Quality of Life Basic Data Set Version 2.0.

OBJECTIVE: To examine the internal construct validity of the International Spinal Cord Injury Quality of Life Basic Data Set Version 2.0 (QoL-BDS V2.0) and compare this with the internal construct validity of the original version of the QoL-BDS. DESIGN: International cross-sectional psychometric study. SETTING: Spinal rehabilitation units, clinics, and community. PARTICIPANTS: The study involved 5 sites and 4 countries, 2 of whose primary language is not English. Each site included a consecutive sample of inpatients with spinal cord injury or disease (SCI/D) and a convenience sample of individuals with SCI/D living in the community (N=565). MAIN OUTCOME MEASURES: The QoL-BDS V2.0 consists of the 3 original items on satisfaction with life as a whole, physical health, psychological health of the QoL-BDS, and an additional item on satisfaction with social life. All 4 items are answered on a 0-10 numeric rating scale. Rasch analysis was performed on versions 1.0 and 2.0 of the QoL-BDS to examine the ordering of the items' response options, item scaling, reliability, item fit, local item independence, differential item functioning, and unidimensionality. RESULTS: The sample included 565 participants with 57% outpatients and 43% inpatients. Mean age was 51.4 years; 71% were male; 65% had a traumatic injury, 40% had tetraplegia, and 67% were wheelchair users. Item thresholds were collapsed for ordering, and subsequent analyses showed good internal construct validity for the QoL-BDS V2.0 with a person separation reliability of 0.76 and Cronbach α of 0.81. Infit and outfit statistics ranged 0.62-0.91. No local dependencies and multidimensionality were found. Differential item functioning was observed only for country and inpatients vs outpatients but not for other participants' characteristics. Differences in internal construct validity between the 3-item and 4-item versions were minimal. CONCLUSIONS: The results of this Rasch analysis support the internal construct validity of the QoL-BDS V2.0.

Validation of the Spinal Cord Injury-Functional Index for Use in Community-Dwelling Individuals With SCI.

OBJECTIVE: To evaluate the psychometric properties of the Spinal Cord Injury-Functional Index (SCI-FI) instruments in a community-dwelling sample. DESIGN: Cross-sectional study. SETTING: Community setting. PARTICIPANTS: Individuals (N=269) recruited from 6 SCI Model Systems sites. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Participants completed computer adaptive test and short form versions of 4 SCI-FI/Capacity (C) banks (ie, Ambulation, Basic Mobility, Fine Motor, Self-Care) and 1 SCI-FI/Assistive Technology (AT) bank (Wheelchair Mobility) at baseline and after 2 weeks. The Self-Report Functional Measure (SRFM) and the clinician-rated motor FIM were used to evaluate evidence of convergent validity. RESULTS: Pearson correlations, intraclass correlation coefficients, minimal detectable change, and Bland-Altman plots supported the test-retest reliability of the SCI-FI instruments. Correlations were large with the SRFM (.69-.89) and moderate-to-large for the FIM instrument (.44-.64), supporting convergent validity. Known-groups validity was demonstrated by a significant main effect of injury level on all instruments and a main effect of injury completeness on the SCI-FI/C instruments. A ceiling effect was detected for individuals with incomplete paraplegia on the Fine Motor/C and Self-Care/C Short Forms. CONCLUSION: Findings support the test-retest reliability, convergent validity, and known-groups validity of the SCI-FI/C instruments and the SCI-FI/AT Wheelchair Mobility instruments for use by community-dwelling individuals.

Physical Function Recovery Trajectories After Spinal Cord Injury.

OBJECTIVE: To explore trajectories of functional recovery that occur during the first 2 years after spinal cord injury (SCI). DESIGN: Observational cohort study. SETTING: Eight SCI Model System sites. PARTICIPANTS: A total of 479 adults with SCI completed 4 Spinal Cord Injury-Functional Index (SCI-FI) item banks within 4 months of injury and again at 2 weeks, 3, 6, 12, and 24 months after baseline assessment (N=479). INTERVENTION: None. MAIN OUTCOME MEASURES: SCI-FI Basic Mobility/Capacity (C), Fine Motor Function/C, Self-care/C, and Wheelchair Mobility/Assistive Technology (AT) item banks. RESULTS: Growth mixture modeling was used to identify groups with similar trajectory patterns. For the Basic Mobility/C and Wheelchair Mobility/AT domains, models specifying 2 trajectory groups were selected. For both domains, a majority class exhibited average functional levels and gradual improvement, primarily in the first 6 months. A smaller group of individuals made gradual improvements but had greater initial functional limitations. The Self Care/C domain exhibited a similar pattern; however, a third, small class emerged that exhibited substantial improvement in the first 6 months. Finally, for individuals with tetraplegia, trajectories of Fine Motor Function/C scores followed 2 patterns, with individuals reporting generally low initial scores and then making either modest or large improvements. In individual growth curve models, injury/demographic factors predicted initial functional levels but less so regarding rates of recovery. CONCLUSIONS: Trajectories of functional recovery followed a small number of change patterns, although variation around these patterns emerged. During the first 2 years after initial hospitalization, SCI-FI scores showed modest improvements; however, substantial improvements were noted for a small number of individuals with severe limitations in fine motor and self-care function. Future studies should further explore the personal, medical, and environmental characteristics that influence functional trajectories during these first 2 years and beyond.

Spinal Cord Injury-Functional Index/Capacity: Responsiveness to Change Over Time.

OBJECTIVE: To establish responsiveness of 3 Spinal Cord Injury-Functional Index/Capacity (SCI-FI/C) item banks in the first year after spinal cord injury (SCI). DESIGN: Longitudinal patient-reported outcomes assessment replicated through secondary analysis of an independent data set. SETTING: A total of 8 SCI Model Systems rehabilitation hospitals in the United States. PARTICIPANTS: Study 1 participants included 184 adults with recent (≤4 months) traumatic SCI and 221 community-dwelling adults (>1 year post injury) (N=405). Study 2 participants were 418 individuals with recent SCI (≤4 months) (N=418). INTERVENTIONS: In study 1, SCI-FI/C computer adaptive tests were presented in a standardized interview format either in person or by phone call at baseline and 6-month follow-up. Responsiveness was examined by comparing 6-month changes in SCI-FI scores within and across samples (recently injured vs community-dwelling) because only the recent injury sample was expected to exhibit change over time. Effect sizes were also computed. In study 2, the study 1 results were cross-validated in a second sample with recent SCI 1 year after baseline measurement. Study 2 also compared the SCI-FI/C measures' responsiveness to that of the Self-reported Functional Measure (SRFM) and stratified results by injury diagnosis and completeness. MAIN OUTCOME MEASURES: The SCI-FI Basic Mobility/C, Self-care/C and Fine Motor/C item banks (study 1 and study 2); Self-reported Functional Measure SRFM (study 2 only). RESULTS: In study 1, changes in SCI-FI/C scores between baseline and 6-month follow-up were statistically significant (P<.01) for recently injured individuals. SCI-FI Basic Mobility/C, Self-care/C, and Fine Motor/C item banks demonstrated small to medium effect sizes in the recently injured sample. In the community-dwelling sample, all SCI-FI/C effects were negligible (ie, effect size<0.08). Study 2 results were similar to study 1. As expected, SCI-FI Basic Mobility/C and Self-care/C were responsive to change for all individuals in study 2, whereas the SCI-FI Fine Motor/C was responsive only for individuals with tetraplegia and incomplete paraplegia. The SRFM demonstrated a medium effect size for responsiveness (effect size=0.65). CONCLUSIONS: The SCI-FI Basic Mobility/C and Self-care/C banks demonstrate adequate sensitivity to change at 6 months and 1 year for all individuals with SCI, while the SCI-FI/C Fine Motor item bank is sensitive to change in individuals with tetraplegia or incomplete paraplegia. All SCI-FI/C banks demonstrate stability in a sample not expected to change. Results provide support for the use of these measures for research or clinical use.

A cross-cultural mixed methods validation study of the spinal cord injury quality of life basic dataset (SCI QoL-BDS).

STUDY DESIGN: Mixed methods inquiry using cognitive interviews and thematic content analysis. OBJECTIVES: Cross-validation of the concept of quality of life (QoL) and of the International Spinal Cord Injury Quality of Life Basic DataSet (SCI QoL-BDS) items across five sites in four countries: United States, Australia, Brazil, and the Netherlands. Analysis aimed to uncover patterns, differences, and similarities suggesting conceptual equivalence for overall QoL and the three SCI QoL-BDS items. SETTING: International, community. METHODS: Semi-structured cognitive interviews with 51 participants across five sites and four countries. Participants with spinal cord injury/disease (SCI/D) completed the SCI QoL-BDS items and one additional question. Interviews were audio recorded and transcribed. Transcripts were coded using NVivo software. Coded data were analyzed using thematic content analysis. Seventeen themes were identified. Responses by sites were compared for conceptual equivalence. RESULTS: Across the five sites, equivalence in the conceptual meaning of QoL was found based on the frequent commonalities in terminology employed to describe it. Despite sample differences in terms of demographic and SCI characteristics, participants across all sites replied to the SCI QoL-BDS items in a similar way, suggesting good item equivalence. Qualitatively, the differences noted with respect to the use of themes for each question suggest some variability on how participants with SCI/D describe QoL. In spite of these contextual differences, there is a high degree of commonalty not explained by participants' demographic or injury/disease characteristics. CONCLUSIONS: The SCI QoL-BDS shows good cross-cultural validity among the international sites included in this study.

Traumatic Spinal Cord Injury and Risk of Early and Late Onset Alzheimer's Disease and Related Dementia: Large Longitudinal Study.

OBJECTIVE: Traumatic spinal cord injury (TSCI) is a life altering event most often causing permanent physical disability. Little is known about the risk of developing Alzheimer disease and related dementia (ADRD) among middle-aged and older adults living with TSCI. Time to diagnosis of and adjusted hazard for ADRD was assessed. DESIGN: Cohort study. SETTING: Using 2007-2017 claims data from the Optum Clinformatics Data Mart, we identified adults (45+) with diagnosis of TSCI (n=7019). Adults without TSCI diagnosis were included as comparators (n=916,516). Using age, sex, race/ethnicity, cardiometabolic, psychological, and musculoskeletal chronic conditions, US Census division, and socioeconomic variables, we propensity score matched persons with and without TSCI (n=6083). Incidence estimates of ADRD were compared at 4 years of enrollment. Survival models were used to quantify unadjusted, fully adjusted, and propensity-matched unadjusted and adjusted hazard ratios (HRs) for incident ADRD. PARTICIPANTS: Adults with and without TSCI (N=6083). INTERVENTION: Not applicable. MAIN OUTCOMES MEASURES: Diagnosis of ADRD. RESULTS: Both middle-aged and older adults with TSCI had higher incident ADRD compared to those without TSCI (0.5% vs 0.2% and 11.7% vs 3.3% among 45-64 and 65+ y old unmatched cohorts, respectively) (0.5% vs 0.3% and 10.6% vs 6.2% among 45-64 and 65+ y old matched cohorts, respectively). Fully adjusted survival models indicated that adults with TSCI had a greater hazard for ADRD (among 45-64y old: unmatched HR: 3.19 [95% confidence interval, 95% CI, 2.30-4.44], matched HR: 1.93 [95% CI, 1.06-3.51]; among 65+ years old: unmatched HR: 1.90 [95% CI, 1.77-2.04], matched HR: 1.77 [1.55-2.02]). CONCLUSIONS: Adults with TSCI are at a heightened risk for ADRD. Improved clinical screening and early interventions aiming to preserve cognitive function are of paramount importance for this patient cohort.

Preliminary psychometric analyses of the International Spinal Cord Injury Quality of Life Basic Data Set.

STUDY DESIGN: Secondary psychometric analysis of cross-sectional previously collected data. OBJECTIVES: Explore the floor and ceiling effects, convergent, and divergent validity of the International Spinal Cord Injury Basic Quality of Life Data Set (SCI QoL-BDS) in a sample of people with spinal cord damage (SCD) from different countries, with different causes (both traumatic and non-traumatic), and different settings. SETTING: Community dwellers with SCD in Australia, Brazil, India, The Netherlands, and USA, and inpatient rehabilitation: India. METHODS: Adults (>18 years) with chronic SCD with either traumatic or non-traumatic aetiologies living in the community (n = 624), in inpatient rehabilitation following the onset of SCI (India; n = 115) and able-bodied controls (Australia; n = 220) had the following data collected by survey or face-face interview: SCI QoL-BDS, demographic and clinical characteristics (e.g., age, gender, years post SCI/SCD, education, employment) and reference measures of quality of life, disability and depression. RESULTS: For the whole sample, there were no notable floor or ceiling effects, internal consistency was good (Cronbach's alpha = 0.84) and the corrected item-total correlations generally were acceptable (all > 0.3 except for in Brazilian cohort). Convergent and divergent validity were largely confirmed though there were some aspects of validity that were suboptimal. CONCLUSIONS: Only minor psychometric issues were identified. This preliminary analysis suggests that there are no reason for concern about the use of the SCI QoL-BDS for clinical or research purposes, notwithstanding the need for further studies.

Reproducibility of the international spinal cord injury quality of life basic data set: an international psychometric study.

STUDY DESIGN: Psychometric study. OBJECTIVES: To examine the reproducibility of the international spinal cord injury quality of life basic data set (QoL-BDS) in an international sample of community-dwelling adults with spinal cord injury or disease (SCI/SCD) and in subgroups with respect to age (< 50 vs. ≥ 50 years) and etiology. SETTING: Outpatient rehabilitation clinics and community. METHODS: Participants were people living with SCI/D in four countries, at least 1 year post onset and at least 18 years of age. The QoL-BDS consists of three items on satisfaction with life as a whole, physical health and psychological health rated on a 0-10 numerical rating scale. A fourth item on satisfaction with social life was included based on feedback from participants. RESULTS: A total of 79 people were included. Median age was 52 years. Most participants (69.6%) had SCI, paraplegia (53%), and 40.5% reported a motor complete injury. Median time between tests was 14 days (range 4-27). Intra-class correlation (ICC) values of the items ranged from 0.66 to 0.80. ICC values of the three-item and four-item total scores were identical and good (0.83; 95% CI 0.75-0.89). Subgroup analyses showed ICC values ranging from 0.76 to 0.83. Bland-Altman plots suggested no bias for the three-item total score, but some bias for the four-item total score. The limits of agreement of both scores were similar, wide at individual level and small at group level. CONCLUSIONS: This study provides evidence of reproducibility of the current version of the QoL-BDS. When adding a fourth item, reproducibility was maintained.

Sensitivity of the SCI-FI/AT in Individuals With Traumatic Spinal Cord Injury.

OBJECTIVE: To examine the ability of the Spinal Cord Injury-Functional Index/Assistive Technology (SCI-FI/AT) measure to detect change in persons with spinal cord injury (SCI). DESIGN: Multisite longitudinal (12-mo follow-up) study. SETTING: Nine SCI Model Systems programs. PARTICIPANTS: Adults (N=165) with SCI enrolled in the SCI Model Systems database. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: SCI-FI/AT computerized adaptive test (CAT) (Basic Mobility, Self-Care, Fine Motor Function, Wheelchair Mobility, and/or Ambulation domains) completed at discharge from rehabilitation and 12 months after SCI. For each domain, effect size estimates and 95% confidence intervals were calculated for subgroups with paraplegia and tetraplegia. RESULTS: The demographic characteristics of the sample were as follows: 46% (n=76) individuals with paraplegia, 76% (n=125) male participants, 57% (n=94) used a manual wheelchair, 38% (n=63) used a power wheelchair, 30% (n=50) were ambulatory. For individuals with paraplegia, the Basic Mobility, Self-Care, and Ambulation domains of the SCI-FI/AT detected a significantly large amount of change; in contrast, the Fine Motor Function and Wheelchair Mobility domains detected only a small amount of change. For those with tetraplegia, the Basic Mobility, Fine Motor Function, and Self-Care domains detected a small amount of change whereas the Ambulation item domain detected a medium amount of change. The Wheelchair Mobility domain for people with tetraplegia was the only SCI-FI/AT domain that did not detect significant change. CONCLUSIONS: SCI-FI/AT CAT item banks detected an increase in function from discharge to 12 months after SCI. The effect size estimates for the SCI-FI/AT CAT vary by domain and level of lesion. Findings support the use of the SCI-FI/AT CAT in the population with SCI and highlight the importance of multidimensional functional measures.

Risk Factors Associated With Neurogenic Bowel Complications and Dysfunction in Spinal Cord Injury.

OBJECTIVES: To (1) assess the factors associated with methods of bowel management and bowel-related complications; and (2) determine the risk factors associated with bowel complications and overall bowel dysfunction, using multivariate modeling. DESIGN: Cross-sectional observational study. SETTING: A Spinal Cord Injury Model System, with additional participants recruited from other sites. PARTICIPANTS: Subjects (N=291) who incurred traumatic spinal cord injury (SCI) with resultant neurogenic bowel who were ≥5 years postinjury at the time of interview. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Constipation, bowel incontinence, and neurogenic bowel dysfunction questionnaire scores. These measures were all derived from the Bowel and Bladder Treatment Index. Data analyses included descriptive and bivariate statistics as well as logistic and linear regression modeling. RESULTS: Risk factors contributing to bowel incontinence included overall bowel dysfunction as measured by the neurogenic bowel dysfunction score, timing of bowel program, being married or having a significant other, urinary incontinence, constipation, and use of diuretics. Constipation was best predicted by age, race/ethnicity, using laxatives/oral medications, incomplete tetraplegia, frequency of bowel movements, abdominal pain, access to clinicians and caregivers, and history of bowel surgeries. Neurogenic bowel dysfunction scores were predicted by neurologic classification; use of laxatives, oral medications, or both; bowel incontinence; and frequency of fiber intake. CONCLUSIONS: These results suggest a number of factors that should be considered when treating neurogenic bowel complications and dysfunction in persons with SCI.

Harmonization of Databases: A Step for Advancing the Knowledge About Spinal Cord Injury.

The objectives of this article are to (1) provide an overview of existing spinal cord injury (SCI) clinical research databases-their purposes, characteristics, and accessibility to users; and (2) present a vision for future collaborations required for cross-cutting research in SCI. This vision highlights the need for validated and relevant data for longitudinal clinical trials and observational and epidemiologic SCI-related studies. Three existing SCI clinical research databases/registries are reviewed and summarized with regard to current formats, collection methods, and uses, including major strengths and weaknesses. Efforts to provide a uniform approach to data collection are also reviewed. The databases reviewed offer different approaches to capture important clinical information on SCI. They vary on size, purpose, data points, inclusion of standard outcomes, and technical requirements. Each presents with a set of limitations including lack of population data and lack of a common platform for data comparisons and exchanges. It is clear that numerous issues need to be considered when planning to establish common ways of collecting data through data sets or patient registries, ranging from a carefully crafted implementation plan that lists purposes, cost, resources required, and policies to guide such development to establishing a framework for dissemination of data and findings. For the present, taking advantage of the vast but different data already collected over many decades may require a variety of statistical skills and epidemiologic techniques. Ultimately, our ability to speak the same language with regard to variables and assessment tools will facilitate international collaborations and enhance comparability, data pooling, and the ability to generalize findings to a broader population.

Spinal Cord Injury-Functional Index/Assistive Technology Short Forms.

OBJECTIVES: To evaluate the psychometric properties of the Spinal Cord Injury-Functional Index/Assistive Technology (SCI-FI/AT) short forms (SFs) in the domains of basic mobility, self-care, fine motor function, and ambulation based on internal consistency; correlations between SFs and full item banks, and a 10-item computerized adaptive test (CAT) version; magnitude of ceiling and floor effects; and measurement precision across a broad range of function in a sample of adults with spinal cord injury (SCI). DESIGN: Cross-sectional cohort study. SETTING: Nine national Spinal Cord Injury Model Systems programs. PARTICIPANTS: A sample of adults with traumatic SCI (N=460) stratified by level of injury (paraplegia/tetraplegia), completeness of injury, and time since SCI. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: SCI-FI/AT full item bank, 10-item CAT, and SFs (with separate Self-Care and Fine Motor Function SFs for persons with tetraplegia and paraplegia). RESULTS: The SCI-FI/AT SFs demonstrated very good internal consistency, group-level reliability, and excellent correlations between SFs and scores based on the CAT version and the total item bank. Ceiling and floor effects are acceptable (except for unacceptable ceiling effects for persons with paraplegia on the Self-Care and Fine Motor Function SFs). The test information functions are excellent across a broad range of functioning typical of persons with paraplegia and tetraplegia. CONCLUSIONS: Clinicians and researchers should consider using the SCI-FI/AT SFs to assess functioning with the use of assistive technology when CAT applications are not available.

Lifetime prevalence of chronic health conditions among persons with spinal cord injury.

OBJECTIVE: To assess lifetime prevalence of 7 chronic health conditions (CHCs) among a cohort of adults with chronic traumatic spinal cord injury (SCI). DESIGN: Cross-sectional. SETTING: Rehabilitation hospital. PARTICIPANTS: Adults with SCI who were ≥18 years of age, were ≥1 year postinjury, and had residual neurologic effects impeding full recovery (n=1678). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: CHCs were measured using questions from the Behavioral Risk Factor Surveillance System for diabetes (not including gestational), heart attack (also called a myocardial infarction), angina or coronary artery disease, stroke, hypertension (not including during pregnancy), high blood cholesterol, or cancer. RESULTS: Of participants, 49.5% reported having at least 1 CHC, with 23.2% reporting ≥2 CHCs. The most frequently reported CHC was high cholesterol (29.3%) followed by hypertension (28.7%) and diabetes (11.8%). Although the prevalence of CHCs significantly increased with increasing age, only hypertension and cancer were significantly associated with years postinjury. Four CHCs (diabetes, coronary artery disease, hypertension, high cholesterol) were significantly related to mobility status as measured by injury level and ambulatory status. However, after controlling for age, years postinjury, sex, and race, mobility status became nonsignificant in relation to coronary artery disease, but it remained significantly associated with diabetes, hypertension, and high cholesterol. CONCLUSIONS: Clinicians should be aware of the risk of CHCs in persons with SCI and should screen for these conditions and regular maintenance activities related to SCI.

Differences in quality of life outcomes among depressed spinal cord injury trial participants.

OBJECTIVE: To assess the role that treatment response plays in a randomized controlled trial of an antidepressant among people with spinal cord injury (SCI) diagnosed with major depressive disorder (MDD) in explaining quality of life (QOL), assessed both globally as life satisfaction and in terms of physical and mental health-related QOL. DESIGN: Multivariable analyses were conducted, controlling for demographic, neurologic, and participatory factors and perceived functional limitations. SETTING: Rehabilitation centers. PARTICIPANTS: Of the 133 persons who were randomized into the Project to Improve Symptoms and Mood after Spinal Cord Injury randomized controlled trial, 124 participated in this study. All participants were between the ages of 18 and 64 years, at least 1 month post-SCI, met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for MDD, and completed the core measures used in this study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The Satisfaction with Life Scale and the physical and mental component summary scores of the Medical Outcomes Study 12-Item Short-Form Health Survey. RESULTS: Reduction in depressive symptoms over the course of a 12-week trial was predictive of increased QOL, which was measured as life satisfaction and mental well-being, within the context of other explanatory factors. However, reduction in symptoms did not explain differences in physical well-being among those with MDD. Perceived functional disability explained all 3 indices of QOL. CONCLUSIONS: Greater recognition has been given to QOL outcomes as endpoints of clinical trials because these often reflect participants' reported outcomes. Our findings support the association of QOL to the reduction of depression symptoms among trial participants. This association differs depending on how QOL is defined and measured, with stronger relations observed with life satisfaction and mental well-being among those diagnosed with MDD. The lack of association between depression and physical well-being may be explained by participants' subjective interpretation of physical well-being after SCI and their expectations and perceptions of improved physical health-related QOL based on the use of assistive technology. Consistent with our findings, pain is likely to play a role in decreasing physical QOL among those with incomplete injuries. Practicing caution is suggested in using physical well-being as an endpoint in trials among people with SCI.

Efficacy of venlafaxine XR for the treatment of pain in patients with spinal cord injury and major depression: a randomized, controlled trial.

OBJECTIVES: To (1) determine the efficacy of venlafaxine XR for the treatment of pain (secondary aim) in individuals with spinal cord injury (SCI) enrolled in a randomized controlled trial (RCT) on the efficacy of venlafaxine XR for major depressive disorder (MDD) (primary aim); and (2) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain. DESIGN: Multisite, double-blind, randomized (1:1) controlled trial with subjects block randomized and stratified by site, lifetime history of substance abuse, and prior history of MDD. SETTING: Six Departments of Physical Medicine and Rehabilitation in university-based medical schools. PARTICIPANTS: Individuals (N=123) with SCI and major depression between 18 and 64 years of age, at least 1 month post-SCI who also reported pain. INTERVENTION: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES: A 0-to-10 numeric rating scale for pain, pain interference items of the Brief Pain Inventory; 30% and 50% responders. RESULTS: The effect of venlafaxine XR on neuropathic pain was similar to that of placebo. However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety, depression, and multiple pain sites within the same individual. For those who achieved a minimally effective dose of venlafaxine XR, some additional evidence of effectiveness was noted for those with mixed (both neuropathic and nociceptive) pain sites. CONCLUSIONS: Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features. Its usefulness for treating central neuropathic pain is likely to be limited. Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD.