Sukhvinder Kalsi-Ryan, Armin Curt, Mary C. Verrier, and Michael G. Fehlings
Primary outcome measures for the upper limb in trials concerning human spinal cord injury (SCI) need to distinguish between functional and neurological changes and require satisfying psychometric properties for clinical application.
The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) was developed by the International GRASSP Research and Design Team as a clinical outcome measure specific to the upper limbs for individuals with complete and incomplete tetraplegia (that is, paralysis or paresis). It can be administered across the continuum of recovery after acute cervical SCI. An international multicenter study (involving centers in North America and Europe) was conducted to apply the measure internationally and examine its applicability.
The GRASSP is a multimodal test comprising 5 subtests for each upper limb: dorsal sensation, palmar sensation (tested with Semmes-Weinstein monofilaments), strength (tested with motor grading of 10 muscles), and prehension (distinguishes scores for qualitative and quantitative grasping). Thus, administration of the GRASSP results in 5 numerical scores that provide a comprehensive profile of upper-limb function. The established interrater and test-retest reliability for all subtests within the GRASSP range from 0.84 to 0.96 and from 0.86 to 0.98, respectively. The GRASSP is approximately 50% more sensitive (construct validity) than the International Standards of Neurological Classification of SCI (ISNCSCI) in defining sensory and motor integrity of the upper limb. The subtests show concurrence with the Spinal Cord Independence Measure (SCIM), SCIM self-care subscales, and Capabilities of Upper Extremity Questionnaire (CUE) (the strongest concurrence to impairment is with self-perception of function [CUE], 0.57–0.83, p < 0.0001).
The GRASSP was found to demonstrate reliability, construct validity, and concurrent validity for use as a standardized upper-limb impairment measure for individuals with complete or incomplete tetraplegia. Responsiveness (follow-up from onset to 1 year postinjury) is currently being tested in international studies (in North America and Europe). The GRASSP can be administered early after injury, thus making it a tool that can be administered in acute care (in the ICU), rehabilitation, and outpatient clinics.
Jefferson R. Wilson, Paul M. Arnold, Anoushka Singh, Sukhvinder Kalsi-Ryan, and Michael G. Fehlings
While the majority of existing reports focus on complications sustained during the chronic stages after traumatic spinal cord injury (SCI), the objective in the current study was to characterize and quantify acute inpatient complications. In addition, the authors sought to create a prediction model using clinical variables documented at hospital admission to predict acute complication development.
Analyses were based on data from the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS) data registry, which contains prospective information on adult patients with cervical SCIs who were enrolled at 6 North American centers over a 7-year period. All patients who underwent a standardized American Spinal Injury Association (ASIA) neurological examination within 24 hours of injury and whose follow-up information was available at the acute hospital discharge were included in the study. For purposes of classification, complications were divided into 5 major categories: 1) cardiopulmonary, 2) surgical, 3) thrombotic, 4) infectious, and 5) decubitus ulcer development. Univariate statistical analyses were performed to determine the relationship between complication occurrence and individual demographic, injury, and treatment variables. Multivariate logistic regression was subsequently performed to create a complication prediction model. Model discrimination was judged according to the area under the receiver operating characteristic curve.
Complete complication information was available for 411 patients at the acute care discharge. One hundred sixty patients (38.9%) experienced 240 complications. The mean age among those who experienced at least one complication was 45.9 years, as compared with 43.5 years among those who did not have a complication (p = 0.18). In the univariate analysis, patients with complications were less likely to receive steroids at admission (p = 0.01), had a greater severity of neurological injury as indicated by the ASIA Impairment Scale (AIS) grade at presentation (p < 0.01), and a higher frequency of significant comorbidity (p = 0.04). In a multivariate logistic regression model, a severe initial AIS grade (p < 0.01), a high-energy injury mechanism (p = 0.07), an older age (p = 0.05), the absence of steroid administration (p = 0.02), and the presence of comorbid illness (p = 0.02) were associated with a greater likelihood of complication development during the period of acute hospitalization. The area under the curve value for the full model was 0.75, indicating acceptable predictive discrimination.
These results will help clinicians to identify patients with cervical SCIs at greatest risk for complication development and thus allowing for the institution of aggressive complication prevention measures.
Michael G. Fehlings, Neilank K. Jha, Stephanie M. Hewson, Eric M. Massicotte, Branko Kopjar, and Sukhvinder Kalsi-Ryan
Surgical intervention for appropriately selected patients with cervical spondylotic myelopathy (CSM) has demonstrated favorable outcomes. This study evaluates the cost-effectiveness of this type of surgery in terms of cost per quality-adjusted life year (QALY) gained.
As part of a larger prospective multicenter study, the direct costs of medical treatment for 70 patients undergoing surgery for CSM at a single institution in Canada were retrospectively obtained from the hospital expenses database and physician reimbursement data. Utilities were estimated on the entire sample of 278 subjects enrolled in the multicenter study using SF-6D–derived utilities from 12- and 24-month SF-36v2 follow-up information. Costs were analyzed from the payer perspective. A 10-year horizon with 3% discounting was applied to health-utilities estimates. Sensitivity analysis was performed by varying utility gain by 20%.
The SF-6D utility gain was 0.0734 (95% CI 0.0557–0.0912, p < 0.01) at 12 months and remained unchanged at 24 months. The 10-year discounted QALY gain was 0.64. Direct costs of medical treatment were estimated at an average of CaD $21,066. The estimated cost-utility ratio was CaD $32,916 per QALY gained. The sensitivity analysis showed a range of CaD $27,326–$40,988 per QALY gained. These estimates are within the limits for medical procedures that have an acceptable cost-utility ratio.
Surgical treatment for CSM is associated with significant improvement in health utilities as measured by the SF-6D. The direct cost of medical treatment per QALY gained places this form of treatment within the category deemed by payers to be cost-effective.
Allan R. Martin, Sukhvinder Kalsi-Ryan, Muhammad A. Akbar, Anna C. Rienmueller, Jetan H. Badhiwala, Jefferson R. Wilson, Lindsay A. Tetreault, Aria Nouri, Eric M. Massicotte, and Michael G. Fehlings
Degenerative cervical myelopathy (DCM) is among the most common pathologies affecting the spinal cord but its natural history is poorly characterized. The purpose of this study was to investigate functional outcomes in patients with DCM who were managed nonoperatively as well as the utility of quantitative clinical measures and MRI to detect deterioration.
Patients with newly diagnosed DCM or recurrent myelopathic symptoms after previous surgery who were initially managed nonoperatively were included. Retrospective chart reviews were performed to analyze clinical outcomes and anatomical MRI scans for worsening compression or increased signal change. Quantitative neurological assessments were collected prospectively, including modified Japanese Orthopaedic Association (mJOA) score; Quick-DASH; graded redefined assessment of strength, sensation, and prehension–myelopathy version (GRASSP–M: motor, sensory, and dexterity); grip dynamometer; Berg balance scale score; gait stability ratio; and gait variability index. A deterioration of 10% was considered significant (e.g., a 2-point decrease in mJOA score).
A total of 117 patients were included (95 newly diagnosed, 22 recurrent myelopathy), including 74 mild, 28 moderate, and 15 severe cases. Over a mean follow-up of 2.5 years, 57% (95% CI 46%–67%) of newly diagnosed patients and 73% (95% CI 50%–88%) of patients with recurrent DCM deteriorated neurologically. Deterioration was best detected with grip strength (60%), GRASSP dexterity (60%), and gait stability ratio (50%), whereas the mJOA score had low sensitivity (33%) in 50 patients. A composite score had a sensitivity of 81% and a specificity of 82%. The sensitivity of anatomical MRI was 28% (83 patients).
DCM appears to have a poor natural history; however, prospective studies are needed for validation. Serial assessments should include mJOA score, grip strength, dexterity, balance, and gait analysis. The absence of worsening on anatomical MRI or in mJOA scores is not sufficient to determine clinical stability.
Julio C. Furlan, Sukhvinder Kalsi-Ryan, Ahilan Kailaya-Vasan, Eric M. Massicotte, and Michael G. Fehlings
Cervical spondylotic myelopathy (CSM) is the most common cause of spinal dysfunction in the elderly. Operative management is beneficial for most patients with moderate/severe myelopathy. This study examines the potential confounding effects of age, sex, duration of symptoms, and comorbidities on the functional outcomes and postoperative complications in patients who underwent cervical decompressive surgery.
We included consecutive patients who underwent surgery from December 2005 to October 2007. Functional outcomes were assessed using the Nurick grading system and the modified Japanese Orthopaedic Association and Berg Balance scales. Comorbidity indices included the Charlson Comorbidity Index and the number of ICD-9 codes.
There were 57 men and 24 women with a mean age of 57 years (range 32–88 years). The mean duration of symptoms was 25.2 months (range 1–120 months). There was a significant functional recovery from baseline to 6 months after surgery (p < 0.01). Postoperative complications occurred in 18.5% of cases. Although the occurrence of complications was not significantly associated with sex (p = 0.188), number of ICD-9 codes (p = 0.113), duration of symptoms (p = 0.309), surgical approach (p = 0.248), or number of spine levels treated (p = 0.454), logistic regression analysis showed that patients who developed complications were significantly older than patients who had no complications (p = 0.018). Only older age (p < 0.002) and greater number of ICD-9 codes (p < 0.01) were significantly associated with poorer functional recovery after surgical treatment. However, none of the studied factors were significantly associated with clinically relevant functional recovery after surgical treatment for CSM (p > 0.05).
Our results indicate that surgery for CSM is associated with significant functional recovery, which appears to reach a plateau at 6 months after surgery. Age is a potential predictor of complications after decompressive surgery for CSM. Whereas older patients with a greater number of preexisting medical comorbidities had less favorable functional outcomes after surgery for CSM in the multivariate regression analysis, none of the studied factors were associated with clinically relevant functional recovery after surgery in the logistic regression analysis. Therefore, age-matched protocols based on preexisting medical comorbidities may reduce the risk for postoperative complications and improve functional outcomes after surgical treatment for CSM.
Phoenix, Arizona • March 6–9, 2013