Evaluating patient perspectives on participating in scientific research and clinical trials for the treatment of spinal cord injury.

A questionnaire was developed to evaluate patients' perspective on research aimed at improving functions and overcoming complications associated with spinal cord injury (SCI). The first three sections were based on published and validated assessment tools. The final section was developed to assess participant perspectives on research for SCI. One thousand patients were approached, of which 159 participated. Fifty-eight percent of participants were satisfied with their 'life as a whole'. Two factors could be generated that reflected the variance in the data regarding participants' life with a SCI: "Psychosocial and physical wellbeing" and "Independent living". The majority of participants stated they would be involved in research (86%) or clinical trials (77%). However, the likelihood of participation dropped when potential risks of the research/trials were explained. Which participants would be willing to participate in research could not be predicted based on the severity of their injury, their psychosocial and physical wellbeing or their independent living. Despite participant establishment of a life with SCI, our data indicates that individuals strive for improvements in function. Participant willingness to be included in research studies is noteworthy and scientists and clinicians are encouraged to involve more patients in all aspects of their research.

Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research.

BACKGROUND/OBJECTIVE: The end goal of clinical care and clinical research involving spinal cord injury (SCI) is to improve the overall ability of persons living with SCI to function on a daily basis. Neurologic recovery does not always translate into functional recovery. Thus, sensitive outcome measures designed to assess functional status relevant to SCI are important to develop. METHOD: Evaluation of currently available SCI functional outcome measures by a multinational work group. RESULTS: The 4 measures that fit the prespecified inclusion criteria were the Modified Barthel Index (MBI), the Functional Independence Measure (FIM), the Quadriplegia Index of Function (QIF), and the Spinal Cord Independence Measure (SCIM). The MBI and the QIF were found to have minimal evidence for validity, whereas the FIM and the SCIM were found to be reliable and valid. The MBI has little clinical utility for use in the SCI population. Likewise, the FIM applies mainly when measuring burden of care, which is not necessarily a reflection of functional recovery. The QIF is useful for measuring functional recovery but only in a subpopulation of people with SCI, and substantial validity data are still required. The SCIM is the only functional recovery outcome measure designed specifically for SCI. CONCLUSIONS: The multinational work group recommends that the latest version of the SCIM (SCIM III) continue to be refined and validated and subsequently implemented worldwide as the primary functional recovery outcome measure for SCI. The QIF may continue to be developed and validated for use as a supplemental tool for the nonambulatory tetraplegic population.

An international age- and gender-controlled model for the Spinal Cord Injury Ability Realization Measurement Index (SCI-ARMI).

Background. A quadratic formula of the Spinal Cord Injury Ability Realization Measurement Index (SCI-ARMI) has previously been published. This formula was based on a model of Spinal Cord Independence Measure (SCIM95), the 95th percentile of the SCIM III values, which correspond with the American Spinal Injury Association Motor Scores (AMS) of SCI patients. Objective. To further develop the original formula. Setting. Spinal cord injury centers from 6 countries and the Statistical Laboratory, Tel-Aviv University, Israel. Methods. SCIM95 of 661 SCI patients was modeled, using a quantile regression with or without adjustment for age and gender, to calculate SCI-ARMI values. SCI-ARMI gain during rehabilitation and its correlations were examined. Results. A new quadratic SCIM95 model was created. This resembled the previously published model, which yielded similar SCIM95 values in all the countries, after adjustment for age and gender. Without this adjustment, however, only 86% of the non-Israeli SCIM III observations were lower than those SCIM95 values (P < .0001). Adding the variables age and gender to the new model affected the SCIM95 value significantly (P < .04). Adding country information did not add a significant effect (P > .1). SCI-ARMI gain was positive (38.8 ± 22 points, P < .0001) and correlated weakly with admission age and AMS. Conclusions. The original quadratic SCI-ARMI formula is valid for an international population after adjustment for age and gender. The new formula considers more factors that affect functional ability following SCI.

Spinal Cord Independence Measure, version III: applicability to the UK spinal cord injured population.

OBJECTIVE: To examine the validity, reliability and usefulness of the Spinal Cord Independence Measure for the UK spinal cord injury population. DESIGN: Multi-centre cohort study. SETTING: Four UK regional spinal cord injury centres. SUBJECTS: Eighty-six people with spinal cord injury. INTERVENTIONS: Spinal Cord Independence Measure and Functional Independence Measure on admission analysed using inferential statistics, and Rasch analysis of Spinal Cord Independence Measure. MAIN OUTCOME MEASURES: Internal consistency, inter-rater reliability, discriminant validity; Spinal Cord Independence Measure subscale match between distribution of item difficulty and patient ability measurements; reliability of patient ability measures; fit of data to Rasch model; unidimensionality of subscales; hierarchical ordering of categories within items; differential item functioning across patient groups. RESULTS: Scale reliability (kappa coefficients range 0.491-0.835; (p < 0.001)), internal consistency (Cronbach's alpha 0.770 and 0.780 for raters), and validity (Pearson correlation; p < 0.01) were all significant. Spinal Cord Independence Measure subscales compatible with stringent Rasch requirements; mean infit indices high; distinct strata of abilities identified; most thresholds ordered; item hierarchy stable across clinical groups and centres. Misfit and differences in item hierarchy identified. Difficulties assessing central cord injuries highlighted. CONCLUSION: Conventional statistical and Rasch analyses justify the use of the Spinal Cord Independence Measure in clinical practice and research in the UK. Cross-cultural validity may be further improved.

Aging, spinal cord injury, and quality of life: structural relationships.

OBJECTIVE: To quantify relationships among 3 sets of factors: demographic factors, health and disability factors, and quality of life (QOL). DESIGN: Part of a program of longitudinal research on aging and spinal cord injury (SCI) involving 3 populations: American, British, and Canadian. The present analysis uses data from the 1999 interval. SETTING: The Canadian sample was derived from the member database of the Ontario and Manitoba divisions of the Canadian Paraplegic Association. The British sample was recruited from a national and a regional SCI center in England. The American sample was recruited through a hospital in Colorado. PARTICIPANTS: A sample of 352 participants was assembled from 4 large, well-established databases. The sample included individuals who had incurred an SCI at least 20 years earlier, were admitted to rehabilitation within 1 year of injury, and were between the ages of 15 and 55 at the time of injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A combination of self-completed questionnaires and interviews. Data included demographics, injury-related variables, health and disability-related factors, QOL, and perceptions about aging. RESULTS: Using linear structural relationships modeling, we found that QOL was affected both directly and indirectly by age, health and disability problems, and perceptions of aging. Two surprising findings were as follows: those who experienced fewer disability-related problems were more likely to report a qualitative disadvantage in aging, and the younger members of the sample were more likely to report fatigue. CONCLUSIONS: Fatigue is a concern because of the relationship of fatigue with perceived temporal disadvantage in aging, health problems, and disability problems. This finding highlights the need for clinical vigilance among those just beginning to experience the effects of aging.

Aging, gender, and spinal cord injury.

OBJECTIVE: To identify differences in the aging experiences of men and women with spinal cord injury (SCI). DESIGN: This study is part of a longitudinal international study of aging and SCI. SETTING: Five centers in England, Canada, and the United States. Three were spinal cord rehabilitation facilities (Stoke-Mandeville Hospital, Southport Hospital, Craig Hospital) and 2 were community agencies (Ontario and Manitoba divisions of the Canadian Paraplegic Association). PARTICIPANTS: A matched sample of 67 men and 67 women with SCI for at least 20 years. The 2 groups were matched on age, country of origin, and duration of disability. Participants had an average age of 57 years and an average disability duration of almost 33 years. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Two measures were taken by interview: demographic form and current status interview. Five others were self-administered and returned by mail: the Perceived Stress Scale, Craig Handicap Assessment and Reporting Technique, Index of Psychological Well-Being, Current Problem Questionnaire, and Life Satisfaction Index. RESULTS: Although both sexes rated their quality of life about equally, women characterized their aging experience as "accelerated," while men characterized it as "complicated." Women reported more effects of pain, fatigue, and skin problems and more transportation problems. Men experienced more health problems, more diabetes, and more adaptive equipment changes. Older men and women with SCI spent their time differently, consistent with traditional gender roles. CONCLUSIONS: These results underline the need for gender-specific consideration of aging experiences associated with SCI and further emphasize the need for primary and preventive care to promote health and well-being as people with SCI survive into old age.