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

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

Screening for neuropathic pain after spinal cord injury with the spinal cord injury pain instrument (SCIPI): a preliminary validation study.

STUDY DESIGN: Cross-sectional. OBJECTIVE: To preliminarily evaluate the validity of an interview-based spinal cord injury (SCI) neuropathic pain screening instrument. SETTING: Six university-based SCI centers in the United States. METHODS: Clinician diagnoses of neuropathic pain (NP) and non-neuropathic pain subtypes were collected independently of descriptions of the pain characteristics provided by the persons with SCI by using the Spinal Cord Injury Pain Instrument (SCIPI); SCIPI information and physician diagnoses for 82 pain sites of which they were most confident were subsequently compared. RESULTS: Four of the SCIPI items correlated significantly with the NP subtype as determined by the clinician. The best cutoff score for identifying NP was an endorsement of two or more of these four items. Using this cutoff, sensitivity of the SCIPI was 78%, specificity was 73% and overall diagnostic accuracy was 76%. CONCLUSION: In this preliminary study, the SCIPI, which can be administered by a nonclinician, appears to have good sensitivity, specificity and diagnostic accuracy in a SCI population; it may have a role as a screening tool for NP after SCI. Further study is needed.

The Walking Index for Spinal Cord Injury (WISCI/WISCI II): nature, metric properties, use and misuse.

STUDY DESIGN: Literature review. OBJECTIVE: To critically review all publications/internet sites that have described/used the Walking Index for Spinal Cord Injury (WISCI II), as a measure of impairment of walking function after spinal cord injury (SCI), in order to identify its psychometric properties, clarify its nature, specify misuse and incorporate the findings in an updated guide. METHOD: A systematic literature search was done of Ovid MEDLINE, CINAHL, PsychINFO, Cochrane Central Register of Controlled Trials, Scopus and electronic sites using key words: WISCI or WISCI II, SCI, paraplegia/ tetraplegia/ quadriplegia and ambulation/gait/walking. Among 1235 citations retrieved, 154 relevant articles/sites were identified, classified and examined by the authors; recommendations were made based on findings. RESULTS AND DISCUSSION: The validity (face/concurrent/content/construct/convergent/criterion) and reliability of the WISCI II has been documented in clinical trials and clinical series, and considered adequate by systematic reviewers. In chronic SCI subjects, reliable determination of the maximum (as opposed to self-selected) WISCI II level requires more time and experience by the assessor. The correct use of WISCI II is clarified for testing acute/chronic phases of recovery after SCI, age of subjects, devices and settings. The WISCI II and walking speed measures may be performed simultaneously. CONCLUSION: The increased use of the WISCI II is attributed to its unique characteristics as a capacity measure of walking function and its strong metric properties. Appropriate use of the WISCI II was clarified and incorporated into a new guide for its use. Combining it with a walking speed measure needs further study.

International Spinal Cord Injury Quality of Life Basic Data Set.

STUDY DESIGN: Survey of expert opinion, feedback, and development of final consensus. OBJECTIVE: Present the background, purpose, development process and results for the International Spinal Cord Injury (SCI) Quality of Life (QoL) Basic Data Set. SETTING: International. METHODS: A committee of experts was established to select and define data elements to be included in an International SCI QoL Basic Data Set. A draft data set was developed and disseminated to appropriate organizations for comment. All suggested revisions were considered, and a final version of the QoL data set was completed. RESULTS: The QoL data set consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied). CONCLUSION: Collection of the International SCI QoL Basic Data Set variables should be a part of all future studies of SCI QoL to facilitate comparison of results across published studies from around the world. Additional standardized instruments to assess other aspects of QoL can be administered based on the purpose of a particular study.

International Spinal Cord Injury Pain (ISCIP) Classification: Part 2. Initial validation using vignettes.

STUDY DESIGN: International validation study using self-administered surveys. OBJECTIVES: To investigate the utility and reliability of the International Spinal Cord Injury Pain (ISCIP) Classification as used by clinicians. METHODS: Seventy-five clinical vignettes (case histories) were prepared by the members of the ISCIP Classification group and assigned to a category by consensus. Vignettes were incorporated into an Internet survey distributed to clinicians. Clinicians were asked, for each vignette, to decide on the number of pain components present and to classify each using the ISCIP Classification. RESULTS: The average respondent had 86% of the questions on the number of pain components correct. The overall correctness in determining whether pain was nociceptive was 79%, whereas the correctness in determining whether pain was neuropathic was 77%. Correctness in determining if pain was musculoskeletal was 84%, whereas for visceral pain, neuropathic at-level spinal cord injury (SCI) and below-level SCI pain it was 85%, 57% and 73%, respectively. Using strict criteria, the overall correctness in determining pain type was 68% (versus an expected 95%), but with maximally relaxed criteria, it increased to 85%. CONCLUSIONS: The reliability of use of the ISCIP Classification by clinicians (who received minimal training in its use) using a clinical vignette approach is moderate. Some subtypes of pain proved challenging to classify. The ISCIP should be tested for reliability by applying it to real persons with pain after SCI. Based on the results of this validation process, the instructions accompanying the ISCIP Classification for classifying subtypes of pain have been clarified.

International spinal cord injury pain classification: part I. Background and description. March 6-7, 2009.

STUDY DESIGN: Discussion of issues and development of consensus. OBJECTIVE: Present the background, purpose, development process, format and definitions of the International Spinal Cord Injury Pain (ISCIP) Classification. METHODS: An international group of spinal cord injury (SCI) and pain experts deliberated over 2 days, and then via e-mail communication developed a consensus classification of pain after SCI. The classification was reviewed by members of several professional organizations and their feedback was incorporated. The classification then underwent validation by an international group of clinicians with minimal exposure to the classification, using case study vignettes. Based upon the results of this study, further revisions were made to the ISCIP Classification. RESULTS: An overall structure and terminology has been developed and partially validated as a merger of and improvement on previously published SCI pain classifications, combined with basic definitions proposed by the International Association for the Study of Pain and pain characteristics described in published empiric studies of pain. The classification is designed to be comprehensive and to include pains that are directly related to the SCI pathology as well as pains that are common after SCI but are not necessarily mechanistically related to the SCI itself. CONCLUSIONS: The format and definitions presented should help experienced and non-experienced clinicians as well as clinical researchers classify pain after SCI.

Exploring the impact of traumatic brain injury on the older couple: 'yes, but how much of it is age, I can't tell you ...'.

PRIMARY OBJECTIVE: To qualitatively explore the partner relationships of older couples faced with traumatic brain injury (TBI). RESEARCH DESIGN: Qualitative analysis comparing individuals with TBI and a comparison group. METHODS AND PROCEDURES: Twenty-one individuals were interviewed using a semi-structured format focusing on various aspects of their partner relationship. A qualitative analysis of transcripts identified general themes. MAIN OUTCOMES AND RESULTS: Variability of relationship experiences (relationship relatedness and persistence of the partnership) was shown across groups. Aspects of relationship commitment to the partnership were revealed. Many individuals with TBI and their partners attributed various relationship changes to ageing and age-related issues and not to the TBI. CONCLUSIONS: These findings suggest that the effects of TBI are not clearly distinguished from age-related causes for change in the partners and their relationship. Older couples' experiences may be different from those of younger couples impacted by TBI, in the areas of sexuality, inter-personal support and role functions.

Searching the literature for information on traumatic spinal cord injury: the usefulness of abstracts.

STUDY DESIGN: Systematic review of abstracts of published papers presumed to contain information on chronic pain in persons with spinal cord injury (SCI). OBJECTIVES: To determine to what degree papers on SCI are abstracted in such a way that they can be retrieved, and evaluated as to the paper's applicability to a reader's questions. SETTING: US--academic department of rehabilitation medicine. METHODS: 868 abstracts published in Medline were independently examined by two out of 13 screeners, who answered four questions on the subjects and nature of the paper with 'Yes', 'No' or 'insufficient information'. Frequency of ratings 'insufficient information', and screener agreement were evaluated as affected by screener and abstract/paper characteristics. RESULTS: Screeners could not determine whether the paper dealt with persons with traumatic SCI for 37% of abstracts; whether chronic pain was a topic could not be determined in 18%. Physicians were less willing than other disciplines to assign 'insufficient information'. Screener agreement was better than chance, but not at the level suggested for quality measurement. Screener discipline and task experience did not make a difference, nor did abstract length, structure, or decade of publication of the paper. CONCLUSION: Authors need to improve the quality of abstracts to make retrieval and screening of relevant papers more effective and efficient. SPONSORSHIP: National Institute on Disability and Rehabilitation Research.

Reporting on reliability and validity of outcome measures in medical rehabilitation research.

PURPOSE: To evaluate the degree to which published medical rehabilitation research offers evidence of reliability, validity and other clinimetric qualities of the data reported. METHOD: Descriptive study of published intervention research papers published in six US medical rehabilitation journals in 1997 and 1998. Selected characteristics of the papers and the outcome measures used were abstracted by one or two raters. RESULTS: The 171 papers identified included 651 outcome measures. Some type of data reliability information was provided for 20.1% of these measures; for validity, this was 6.9%. However, this information was based on data collected for the sample studied for only 7.7% (reliability) and 0.6% (validity). CONCLUSIONS: Most rehabilitation research falls short of standards, including the Standards promulgated by an American Congress of Rehabilitation Medicine Advisory Group. Authors, peer reviewers and editors need to change their practices to improve this situation.

A tale of two countries: environmental impacts on social participation after spinal cord injury.

STUDY DESIGN: Comparative analysis of survey data produced in two countries. OBJECTIVES: To assess the degree to which environmental barriers impact social participation, and to identify the aspects of participation most affected. SETTING: Community-dwelling individuals with spinal cord injury in the USA and Turkey. METHODS: Subjects completed the Functional Independence Measure (FIM) motor score, the Craig Hospital Inventory of Environmental Factors (CHIEF), and the Craig Handicap Assessment and Reporting Technique (CHART). Analysis of co-variance was used to analyze CHIEF and CHART differences within and between country. RESULTS: US subjects reported higher participation scores (CHART) and lower barriers (CHIEF), however, when controls for age, gender, time since injury and motor ability (FIM) were applied, country differences in reports of barriers were limited. Motor ability was the major predictor of participation, which was minimally affected by barriers. CONCLUSION: Conceptualization and measurement issues may have been the reason for the minimal support for the hypothesis that environment affects participation. Suggestions for future research are made. SPONSORSHIP: National Institute on Disability and Rehabilitation Research, Centers for Disease Control and Prevention.

Self-care independence after spinal cord injury: patient and therapist expectations and real life performance.

PURPOSE: To evaluate changes in self-care performance between rehabilitation discharge and 1 year follow-up and to compare patients' and therapists' expectations of self-care independence with actual self-care performance after discharge. METHODS: Prospective study of 55 patients with tetraplegia (21 complete and 34 incomplete) after spinal cord injury (SCI) consecutively admitted to a large urban rehabilitation hospital [injury levels: C4 (5), C5 (33), C6 (9), C7 (4), and C8 (4)]. Data were collected using structured patient interviews, occupational therapists' predictions of patients' self care, and Functional Independence Measure ratings by rehabilitation staff. RESULTS: Analysis showed that for all skills, expectations of patients (mainly African American men) were higher than therapists' predictions, and for 3 of these skills, the differences were statistically significant: eating (Z = -4.47, P < .001 ); bathing (Z = -3.67, P < .001 ); and dressing (Z = -3.16, P = .002). Occupational therapists were better predictors of patients' actual self-care performance at discharge than were patients, although both tended to overestimate patients' performance. There was no evidence that self-care capability declined between discharge and 12 months follow-up, but routine self-care performance varied widely across patient and personal circumstances. CONCLUSIONS: Differential attrition reduced the study sample to 25 SCI patients who were primarily more severely injured African American men. Results showed that these patients maintained their self-care performance 1 year after discharge, but more innovative strategies must be developed to customize self-care retraining to address the unique needs of this patient population.

Measures of social outcomes in disability research.

OBJECTIVES: To describe instruments that have been developed to quantify (aspects of) social outcomes in research on persons with a disability, and to evaluate the clinimetric characteristics of some of the more prominent and promising measures. DATA SOURCES: Literature in social health, social psychiatry, developmental disabilities, independent living, gerontology, medical rehabilitation, and quality of life studies. STUDY SELECTION: Social outcomes are defined as those changes or differences in the social functioning (broadly defined) of persons with disabilities that result directly or indirectly from impairments and functional limitations. Excluded were measures that focus on purely physical or psychologic aspects of functioning, apply to children only, or quantify 1 social domain only. DATA EXTRACTION: For 16 instruments the distribution of items across the participation domains of the International Classification of Impairments, Activities, and Participation is presented, as well as a distribution of items by metrics used. For 5, clinimetric information from published studies were reviewed and summarized in letter grades. DATA SYNTHESIS: Several instruments have broad coverage, acceptable respondent burden, and moderate to good reliability, validity, and sensitivity. CONCLUSIONS: Social outcomes should be more routinely included in disability and rehabilitation research. Recommendations for selection and further development are made.

The Joint Protection Behavior Assessment: a reliability study.

OBJECTIVE: Of the various measures developed for studying persons with rheumatoid arthritis, only one that focuses on joint protection has undergone extensive testing, the Joint Protection Behavior Assessment (JPBA). The purpose of the present study was to examine the interrater and intrarater reliability of the JPBA. METHOD: Six healthy participants performed the JPBA under three test conditions (uninformed, informed, completely guided joint protection behavior). The 18 test performances were videotaped and scored by nine independent raters. RESULTS: Analysis of these data showed that interrater reliability (intraclass correlation coefficient [ICC]) was .90 or higher, and intrarater reliability was .95 or higher (ICC). The correlation between the JPBA and its two shortened versions was .95 or higher (ICC). Internal consistency was also high, with a coefficient alpha of 0.95 for the complete JPBA. Kappa values showed that for most subtasks, there was fair to excellent agreement between raters and consistency of raters over time. CONCLUSION: Our data suggest that the complete JPBA has excellent clinimetric properties and that the shortened versions are adequate for clinical situations. Some improvements in the test manual suggested by the present study may further improve the measure. A repeat of this study under real-world circumstances would provide an estimate of JPBA reliability in clinical practice.

Short versions of the telephone motor Functional Independence Measure for use with persons with spinal cord injury.

OBJECTIVE: To determine if the motor ability of persons with spinal cord injury (SCI) can be reliably estimated using a subset of the 13 Functional Independence Measure (FIM) items. STUDY DESIGN: FIM item subsets of 5, 6, or 7 items were selected using one of five strategies: random, coefficient alpha maximization, spread across the range of item difficulties, optimization by neurologic category, and individual optimization. Motor ability estimated by these 15 subsets was compared to the 13-item estimate, using intraclass correlation coefficient (ICC), Rasch calibration person reliability estimate, and other indices of reliability. SUBJECTS: Subjects were 4,128 persons with SCI, 1 to 25 years postinjury, interviewed for annual research follow-up using the FIM. RESULTS: All subsets had high ICC reliability (>.90). Subsets of 7 items performed generally better than those of 6 or 5 items. The best performance was provided by individual optimization subsets. The ICC for the 7-item set thus selected was .99. CONCLUSION: In annual follow-up, the number of FIM motor items can be reduced almost 50% while maintaining reliable estimates of subjects' motor ability. This approach may also be useful for other applications of interviewing to obtain FIM data, eg, for program evaluation.

Access to the environment and life satisfaction after spinal cord injury.

OBJECTIVE: To determine the potential relation between satisfaction with life after spinal cord injury and access to the environment as measured by selected items from the Craig Handicap Assessment and Reporting Technique (CHART). DESIGN: Prospective, correlational/predictive study using cross-sectional and longitudinal data from 18 Model Spinal Cord Injury Systems of Care. SUBJECTS: Adult persons with traumatic-onset spinal cord injury (n = 650) evaluated at 1 or 2 years postinjury. OUTCOME MEASURE: Satisfaction With Life Scale (SWLS). PREDICTOR VARIABLES: Demographic characteristics, impairment and disability classifications. medical complications, rehabilitation insurance status, occupational status as measured by the CHART Occupation Scale, self-perceived health (from SF-36), and access to the environment as measured by items from the CHART Mobility Scale. RESULTS: Access to the environment was positively and linearly associated with satisfaction with life, demonstrated both positive and negative change over time, and was positively associated with subject's neurologic status. Access to the environment added to the explanatory model to predict life satisfaction even after all other independent measures were accounted for. CONCLUSION: Access to the environment (an "outside the person" factor) is important in predicting satisfaction with life for persons with spinal cord injury. The measure of access to the environment developed here is promising and worthy of further exploration and expansion.

Randomized clinical trials in medical rehabilitation research.

The purpose of this article is to provide researchers and clinicians with a basic understanding of randomized clinical trials and to discuss their potential application to and limitations in the field of physical medicine and rehabilitation. A brief history of the development of randomized clinical trials, definitions of clinical trials, types of trials, and overview of methodological issues related to design are offered. Information is provided about the need to establish clear and concise study objectives and to explicitly define interventions and expected outcomes. Recommendations for developing clinical protocols and determining adequate sample size are presented, and various statistical considerations, including power, are discussed. Issues related to sampling strategies, and recruitment are reviewed. Importance of randomization and blinding is emphasized. Readers are also referred to other resources available on this topic. Finally, the authors describe shortfalls associated with the use of this design in rehabilitation research. These are further explored and discussed in terms of the actual benefits and limitations of randomized clinical trials in physical medicine and rehabilitation research. Recommendations are made regarding the use of this methodology to address relevant needs in clinical practice.

Correlates of life satisfaction among persons with spinal cord injury.

OBJECTIVE: To analyze the correlates of life satisfaction for individuals with spinal cord injury (SCI). STUDY DESIGN: Survey; follow-up of subjects studied prospectively since onset of injury. PARTICIPANTS: A total of 2,183 persons with SCI, from 1 to 20 years postinjury, self-selected for annual research (and clinical) follow-up by one of 18 model systems of SCI care. RESULTS: Life satisfaction, as measured with the Satisfaction With Life Scale (SWLS), is associated with several demographic, social, functional, and clinical characteristics. Stepwise linear regression analysis resulted in a predictor model that included the following: sex (beta weight: .07; p < .001); number of rehospitalizations in the last year (-.05; p < .05); years since injury (.13; p < .0001); sociocognitive disability as measured with the Functional Independence Measure (.06; p < .01); and three handicap components, as measured with the modified Craig Handicap Assessment and Reporting Technique: mobility (.26; p < .0001); occupation (.10; p < .001); and social integration (.11; p < .0001). Impairment (level of injury) contributed indirectly, through its impact on motor disability. Racial/ethnic group membership, motor disability, and education contributed indirectly, through their effects on handicap. CONCLUSIONS: Life satisfaction after SCI can be reliably measured by means of the SWLS. Correlates of subjective well-being parallel those suggested by earlier studies and those for the population at large. The effects of life satisfaction on social participation, health, and other aspects of life need further study.