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.

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.

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.

Changes in pain and quality of life in depressed individuals with spinal cord injury: does type of pain matter?

OBJECTIVE: To examine the association of neuropathic and nociceptive pain severity and interference with quality of life (QoL) in persons with spinal cord injury (SCI) who underwent a randomized controlled 12-week trial of an antidepressant to treat depression. A secondary objective was to assess the effect of changes in pain on mobility and physical independence. DESIGN: Multivariable ANCOVA models controlling for relevant demographic covariates, treatment condition, and baseline pain and QoL were used. SETTING: Six rehabilitation centers. PARTICIPANTS: Of the 133 persons who were randomized into the trial, 108 provided pain severity and interference ratings through follow-up. INTERVENTIONS: Not applicable. OUTCOME MEASURES: The Satisfaction with Life Scale and the physical and mental component summary scores of the 12-Item Short-Form Health Survey (SF-12). Secondary outcome measures included the mobility and physical independence subscales of the Craig Handicap Assessment and Reporting Technique (CHART). RESULTS: Broadly, few associations between pain and QoL were evident. Results revealed relationships between lower baseline nociceptive pain interference and higher satisfaction with life and mental health-related QoL at 12 weeks. Similarly, lower neuropathic pain interference was associated with change in physical independence, but unrelated to mobility. CONCLUSIONS: Pain interference over time may be differentially related to QoL outcomes based on the type of pain following SCI, but overall, there were no extensive relationships between pain and QoL in this sample of depressed persons with SCI.

Longitudinal analysis of hospitalization after spinal cord injury: variation based on race and ethnicity.

OBJECTIVE: To examine the longitudinal effects of race/ethnicity on hospitalization among adults with spinal cord injury (SCI) in the 10-year period after initial injury. DESIGN: Retrospective analysis of postinjury hospitalizations among non-Hispanic white, non-Hispanic African American, and Hispanic adults with SCI. SETTING: Community. Data were extracted from the 2011 National Spinal Cord Injury Model Systems database. PARTICIPANTS: Patients with traumatic SCI (N= 5146; white, 3175; African American, 1396; Hispanic, 575) who received rehabilitation at one of the relevant SCI Model Systems. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Hospitalization, including rate of hospitalization, number of hospitalizations, and number of days hospitalized during the 12 months before the first-, fifth-, and tenth-year follow-up interviews for the SCI Model Systems. RESULTS: Significant differences were found in rates of hospitalization at 1 and 5 years postinjury, with participants from Hispanic backgrounds reporting lower rates than either whites or African Americans. At 10 years postinjury, no differences were noted in the rate of hospitalization between racial/ethnic groups; however, compared with whites (P=.011) and Hispanics (P=.051), African Americans with SCI had 13 and 16 more days of hospitalization, respectively. Compared with the first year postinjury, the rate of hospitalization declined over time among whites, African Americans, and Hispanics; however, for African Americans, the number of days hospitalized increased by 12 days (P=.036) at 10 years versus 5 years postinjury. CONCLUSIONS: Racial/ethnic variation appears to exist in postinjury hospitalization for individuals with SCI, with Hispanics showing the lowest rates of hospitalization at 1 and 5 years postinjury and African Americans having a significantly higher number of days hospitalized at 10 years postinjury. Potential explanations for these variations are discussed, and recommendations are made for potential changes to policy and clinical care.

Depression and pain among inpatients with spinal cord injury and spinal cord disease: differences in symptoms and neurological function.

PURPOSE: To examine the relationship between depression and pain severity during inpatient rehabilitation for those with new onset of spinal cord injury or spinal cord disease (SCI/D), along with patient characteristics, neurological function and etiology. METHOD: This cross-sectional study reviewed medical records of 100 adults with SCI/D including their admission scores on the Patient Health Questionnaire 9 (PHQ-9), a measure of depression, and pain ratings collected at admission and discharge. RESULTS: Upon admission, 28% reported moderate-to-severe symptoms of depression and 69% reported pain. PHQ-9 scores were associated with pain only among those with the least severe impairments, for whom higher scores were associated with greater pain. While depression levels did not differ by etiology, those with traumatic injuries had higher pain ratings. CONCLUSIONS: In general, depressive symptoms were not associated with pain severity in this sample. Etiology was associated with pain, those with traumatic SCI reporting more pain at admission. Among demographic characteristics, age was related to pain, with younger subjects reporting higher levels. These findings suggest that certain characteristics may predispose patients to pain and depression upon admission to rehabilitation. By determining who is at risk for these symptoms, clinicians can adopt treatments that prevent these from becoming chronic conditions.

Cut point determination in the measurement of pain and its relationship to psychosocial and functional measures after traumatic spinal cord injury: a retrospective model spinal cord injury system analysis.

OBJECTIVE: To evaluate potential pain cutoff scores reflecting mild, moderate, and severe pain in the spinal cord injury (SCI) population and determine the relationship between the derived cutoff scores and both psychosocial and functional outcome measures. DESIGN: Retrospective analysis. SETTING: SCI Model Systems. PARTICIPANTS: Persons (N=6096; age >18y) with traumatic SCI (American Spinal Injury Association Impairment Scale [AIS] grades A-D; injured in 1973-2008). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Numeric rating scale (NRS) of pain severity (11 points), NRS of pain interference (5 points), Satisfaction With Life Scale, Patient Health Questionnaire-9, Craig Handicap Assessment and Reporting Technique Short-Form (CHART-SF), motor component of the FIM (M-FIM), and employment. RESULTS: The best set of pain severity cutoff points are 1 to 3, 4 to 6, and 7 to 10. This was validated by randomly assigning sample members to 2 groups and replicating. There were significant differences in all outcomes as a function of pain severity grouping, although they explained little of the variance in M-FIM and CHART-SF Physical Independence scale scores. Neurologic status differed significantly between pain groups, with incongruence between pain severity and interference in people in the AIS grade D group, who reported the greatest pain interference and least pain severity. CONCLUSION: Pain severity can be categorized into groups that reflect pain interference. These groupings differentiate psychosocial well-being better than activity limitations. They do not provide a comprehensive pain assessment, for which pain type, location, and interference are likely to be necessary.

The influence of secondary conditions on job acquisition and retention in adults with spinal cord injury.

OBJECTIVE: To examine the associations of job acquisition and job retention to secondary conditions, hospitalizations, and nursing home stays for adults with spinal cord injury (SCI). DESIGN: Retrospective analysis of longitudinal data from multicenter study. SETTING: Community setting. PARTICIPANTS: Two samples of adults participating in the SCI Model Systems; the first sample consisted of persons who reported being unemployed at follow-up (n=9501); the second sample consisted of those who reported working at follow-up (n=5,150). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Job acquisition (change from not working at 1 anniversary of injury to working at the following data collection) and job retention (maintenance of work between 2 assessment periods). RESULTS: Discrete time hazard modeling was used to assess how secondary conditions affect job acquisition. After controlling for the effects of demographic and injury characteristics, hospitalizations within the last 12 months were associated with decreased chance of having obtained employment. Hierarchic logistic regression analyses were used to examine job retention. Hospitalizations and the presence of PUs were associated with lower odds of job retention once demographic and injury characteristics were controlled. Secondary conditions from the previous assessment period were not significantly related to either job acquisition or job retention after the variance from demographic and injury characteristics and current secondary conditions were controlled. CONCLUSIONS: Hospitalization, as well as a limited number of secondary conditions, were associated with reduced odds of both job acquisition and job retention among adults with SCI. Interventions that can prevent secondary conditions and reduce the need for hospitalizations may be beneficial in improving employment for this population.

Medical and psychosocial complications associated with method of bladder management after traumatic spinal cord injury.

OBJECTIVES: To determine the relationships between bladder management method and medical complications (renal calculi or decubitus ulcers), number of hospital days, and psychosocial factors. We hypothesized that indwelling catheterization would be associated with more complications, more hospitalizations, and worse psychosocial outcomes compared with other bladder management methods. DESIGN: Inception cohort study. SETTING: Model spinal cord injury (SCI) centers funded by the National Institute on Disability and Rehabilitation Research from 1973 to 2005. PARTICIPANTS: Persons with new traumatic SCI (N=24,762) enrolled in the National SCI Database entire data set forms I and II. Patients were stratified according to the bladder management method recorded at each time of data collection into 1 of 4 groups as follows: indwelling catheterization, spontaneous voiding, condom catheterization, and intermittent catheterization. Those who reported no management method or errors in reporting were excluded (n=1564). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Medical complications, including pressure ulcer number and grade of worst ulcer, kidney stones, and hospitalizations, as well as psychosocial factors (satisfaction with life, perceived health status, societal participation), were stratified by bladder management method. Results were adjusted for level and completeness of neurologic injury and other confounding and modifying factors. RESULTS: Compared with other forms of bladder management, use of an indwelling catheter was associated with more pressure ulcers and longer and more hospitalizations for all causes and urology-specific causes. Indwelling catheter use was associated with the lowest levels of participation, but similar satisfaction with life and perceived health status. CONCLUSIONS: Indwelling catheterization was associated with more medical complications and lower levels of participation than other bladder management methods, but more research is required to ascertain the causality of these complications.

Preliminary reliability and validity of a Spinal Cord Injury Secondary Conditions Scale.

BACKGROUND/OBJECTIVE: Although the impact of secondary conditions after spinal cord injury (SCI) on health, well being, and financial burden have been studied, there are psychometrically sound scales of secondary conditions in the extant literature. The use of such scales allows for cross-sample comparison of secondary condition prevalence rates and associations with functional, medical, and psychosocial factors. Thus, the purpose of this study was to evaluate the preliminary reliability of a SCI secondary conditions scale. METHODS: The Spinal Cord Injury Secondary Conditions Scale (SCI-SCS) is a 16-item scale based on the Seekins Secondary Conditions Scale. Sixty-five individuals with SCI completed written surveys at 5 time-points over 2 years. RESULTS: Internal consistency across each of the time-points exceeded 0.76; test-retest reliability ranged from 0.569 to 0.805. Convergent validity was assessed with 6 physical functioning items from the SF-12. Spearman (coefficients were all statistically significant and ranged from 0.317 (accomplished less because of health problems) to 0.644 (pain). The most prevalent secondary conditions were chronic pain, joint and muscle pain, and sexual dysfunction. CONCLUSIONS: Preliminary testing of the SCI-SCS suggests that it is a reliable and valid scale, and further development (ie, factor analysis, item revision) and examination of validity are recommended with larger and more diverse SCI samples.

Development and factor analysis of an index of post-polio sequelae.

PURPOSE: This present study describes the development, factor structure and initial validation of the Index of Post-Polio Sequelae (IPPS). METHOD: The IPPS was tested on a sample of 849 community-dwelling polio survivors between the ages of 40 and 93 years old who participated in a large, national study of menopause and aging in late polio. Items from the IPPS were submitted to a factor analysis using principal components extraction and rotated to oblique simple structure using promax rotation. Convergent validity was assessed using bivariate correlation. RESULTS: Three factors were extracted that accounted for approximately 53% of the variance in the original IPPS items. Factor 1 (Pain) was loaded most heavily by two items referring to muscle and joint pain. Factor 2 (Atrophy) was loaded by items referring to muscle atrophy, involved muscle weakness, and fatigue. Factor 3 (Bulbar) was comprised of two items referring to breathing and swallowing problems. Bivariate correlations between health and psychosocial variables and each of the factors all were significant and in expected directions. CONCLUSIONS: This first validation of a standardized scale to assess the severity of post-polio sequelae in polio survivors suggests a psychometrically sound instrument whose factor structure represents commonly reported problems in the extant post-polio literature.

Environmental factors and their role in participation and life satisfaction after spinal cord injury.

OBJECTIVES: To investigate environmental barriers reported by people with spinal cord injury (SCI), and to determine the relative impact of environmental barriers compared with demographic and injury characteristics and activity limitations in predicting variation in participation and life satisfaction. DESIGN: Cross-sectional, follow-up survey. SETTING: Individuals rehabilitated at 16 federally designated Model Spinal Cord Injury Systems of care, now living in the community. PARTICIPANTS: People with SCI (N=2726) who completed routine follow-up research interviews between 2000 and 2002. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The Craig Hospital Inventory of Environmental Factors-Short Form (CHIEF-SF), the Craig Handicap Assessment and Reporting Technique-Short Form, and the Satisfaction With Life Scale. RESULTS: The top 5 environmental barriers reported by subjects with SCI, in descending order of importance, were the natural environment, transportation, need for help in the home, availability of health care, and governmental policies. The CHIEF-SF subscales accounted for only 4% or less of the variation in participation; they accounted for 10% of the variation in life satisfaction. CONCLUSIONS: The inclusion of environmental factors in models of disability was supported, but were found to be more strongly related to life satisfaction than to societal participation.

Patterns of alcohol and substance use and abuse in persons with spinal cord injury: risk factors and correlates.

OBJECTIVE: To investigate patterns of alcohol consumption and abuse and substance use among persons with spinal cord injury (SCI), relating these patterns to demographic and injury-related characteristics, as well as to key medical and psychosocial outcomes. DESIGN: Retrospective cross-sectional. PARTICIPANTS: Subjects with traumatic SCI (N=3041) with dates of injury between June 6, 1975, and June 23, 2002, who were interviewed between November 2000 and March 2003. SETTING: Sixteen Model Spinal Cord Injury Systems participating in this collaborative study during the 2000-2005 grant cycle. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Alcohol consumption, substance use, CAGE questionnaire, Satisfaction With Life Scale, Craig Handicap Assessment Reporting Technique, and pain. Data were analyzed using chi-square tests, analysis of variance, analysis of covariance, and logistic regression models. RESULTS: Fourteen percent of the subjects were classified as likely to have an alcohol abuse issue, based on the CAGE, and 11% reported using illegal drugs or prescription medications for nonmedical reasons. Demographic and injury characteristics were associated with alcohol consumption patterns, abuse, and substance use. At-risk drinkers and substance users tended to be younger, single, male, and less educated. Those who were CAGE positive and substance users reported more pain and lower satisfaction with life. Persons who drank without indication of problem drinking had superior occupation outcomes. Pressure ulcers were associated with substance use. CONCLUSIONS: Alcohol abuse and substance use were related to a number of adverse outcomes. The specific role of drinking with increased work activity deserves further exploration.

Quality of life issues in individuals with spinal cord injury.

Assessments of quality of life (QOL) are increasingly used in rehabilitation, embracing a number of conceptual approaches and measurement tools. Very few studies on QOL have addressed the specific needs of persons with spinal cord injury (SCI). Literature reviewed here describes 2 meta-analytical studies on SCI as well as several individual studies that focus on predictors and correlates of QOL applied to SCI. Results from a unique study on QOL after SCI using a qualitative methodology are also discussed. In addition, we describe the findings from another study, which used the Medical Outcomes Study 12-Item Short-Form Health Survey to assess QOL and relate it to the concept of being disabled.