This is a review article.
This study discusses the following: (1) concepts and constraints for the determination of minimal clinically important difference (MCID), (2) the contrasts between MCID and ...minimal detectable difference (MDD), (3) MCID within the different domains of International Classification of Functioning, disability and health, (4) the roles of clinical investigators and clinical participants in defining MCID and (5) the implementation of MCID in acute versus chronic spinal cord injury (SCI) studies.
The methods include narrative reviews of SCI outcomes, a 2-day meeting of the authors and statistical methods of analysis representing MDD.
The data from SCI study outcomes are dependent on many elements, including the following: the level and severity of SCI, the heterogeneity within each study cohort, the therapeutic target, the nature of the therapy, any confounding influences or comorbidities, the assessment times relative to the date of injury, the outcome measurement instrument and the clinical end-point threshold used to determine a treatment effect. Even if statistically significant differences can be established, this finding does not guarantee that the experimental therapeutic provides a person living with SCI an improved capacity for functional independence and/or an increased quality of life. The MDD statistical concept describes the smallest real change in the specified outcome, beyond measurement error, and it should not be confused with the minimum threshold for demonstrating a clinical benefit or MCID. Unfortunately, MCID and MDD are not uncomplicated estimations; nevertheless, any MCID should exceed the expected MDD plus any probable spontaneous recovery.
Estimation of an MCID for SCI remains elusive. In the interim, if the target of a therapeutic is the injured spinal cord, it is most desirable that any improvement in neurological status be correlated with a functional (meaningful) benefit.
The 10-m walk test (10MWT) and the 6-min walk test (6MWT) have been recommended for assessment of walking in spinal cord injury (SCI) patients. The study was designed on test-retest analysis of the ...10MWT and 6MWT.
The objective of this study was to assess validity/reliability of different methods of performing the tests.
The study was set at an SCI unit of a rehabilitation hospital.
A total of 37 patients; whose median age was 58.5 years (interquartile range 40-66, full range 19-77); median time since onset of SCI was 24 months (interquartile range 16.25-70.5, full range 6-109). Non-traumatic etiology in 20 out of 37 patients; level: 12C, 14T and 11L; American Spinal Injury Association Impairment Scale grade: 35D/2C. Assessment with the 10MWT (with or without dynamic start) and the 6MWT (short or long track) by two blinded raters to evaluate inter/intra-rater reliabilities.
The 10MWT was performed in a median of 19 s (25th-75th interquartile range 13-28) with the dynamic start and of 18.4 s (25th-75th interquartile range 12.6-29.9) with the static start (P=0.092). The correlation between the results of the two methods was between 0.98 and 0.99. The inter- and intra-rater reliabilities were between 0.95 and 0.99 for both the methods. The 6MWT showed significant differences according to the track length: patients walked a median of 226.7 m (25th-75th interquartile range 123.2-319) on the longer track and of 187.6 m (25th-75th interquartile range 69.7-240.6) on the short one (P<0.001). The correlation between the results of the two methods was between 0.91 and 0.93. The inter- and intra-rater reliabilities were between 0.98 and 0.99.
The 10MWT shows high inter/intra-rater reliability and shows comparable results with both dynamic and static start. The different testing conditions of the 6MWT (track/turns) results in significant differences that need standardization for use in future trials.
Case report.
To report a clinical case of spinal cord infarction due to cocaine use.
Spinal Center, IRCCS Fondazione S. Lucia, Rome (Italy).
Two days after recreational use of cocaine, a 27-year-old ...Caucasic man was admitted to the emergency department for acute cervical pain, weakness in all four limbs, and urinary retention. A cervical spinal magnetic resonance imaging scan, performed after 2 days, showed a "pencil-like" lesion extending from C4 to T1 metamer, compatible with acute ischemia in the anterior spinal artery territory. Other causes of vascular disorders, as well as inflammatory and infectious disorders were ruled out. At admission in our department, the patient had an incomplete tetraplegia at level C6, an indwelling catheter, and was unable to stand and walk. After 3 months of rehabilitation, he had an AIS score D tetraplegia at level C7, was able to stand and walk using parallel bars, and indwelling catheter was replaced by intermittent catheterization.
The etiology of medullary infarction may remain unexplained in nearly 30-40% of cases. Even if rare, cocaine-induced ischemic myelopathy should be considered and ruled out in the differential diagnosis of any acute nontraumatic myelopathy, especially in young patients.
This is an in-depth analysis of discourse markers in Sicily that sheds light on what discourse-pragmatic functions they perform, how they evolve historically, and what their social value is in the ...bilingual speech community.
Retrospective study.
To compare the rehabilitation outcomes of non-traumatic and traumatic spinal cord injury patients.
Spinal cord unit of a rehabilitation hospital in Italy.
In total, 380 patients ...at first rehabilitation stay after the lesion (144 traumatic patients and 236 non-traumatic patients; 244 men and 136 women; mean age 46.1±19.9 years; mean lesion to admission time 49.6±39.8 days).
Not applicable.
American Spinal Injury Association standards; Barthel index (BI), Rivermead mobility index and walking index for spinal cord injury.
Poisson regression models with relative risks and 95% confidence intervals adjusted for the following confounders: age, sex, lesion level and Asia impairment. Models were stratified by age because a strong interaction between different variables and age was found.
Traumatic and non-traumatic populations showed several significant differences with regard to age, level and severity of lesion. When adjusted for these factors patients with traumatic injuries showed a significantly lower BI score at admission and significantly better improvement in the BI score by discharge. The two populations were discharged with similar functional outcome. No significant differences were found with regard to the others outcomes.
In clinically stable patients, spinal cord injury etiology does not seem to affect the rehabilitative prognosis. At admission, traumatic patients show lower autonomy in daily life activities, probably because of the associated lesions that these patients often have. At discharge, traumatic and non-traumatic spinal cord lesion patients achieved similar results with regard to neurological and functional improvement.
Spasticity and neuropathic pain are common in patients after spinal cord injury and negatively affect patients' quality of life. Gabapentin and baclofen are frequently used to treat these conditions. ...We present a flumazenil-reversed gabapentin-induced coma case, which, to our knowledge, is the second one described in scientific literature.
A 70-year-old Caucasian man was admitted to our neurorehabilitation ward following a fall with cervical trauma that resulted in immediate tetraplegia. During his stay, he suffered from lower limb pain, both neuropathic and due to severe spasticity. Gradual baclofen and gabapentin administration was prescribed, with reduction in both pain and spasticity. One morning, the patient was found unresponsive, with a Glasgow Coma Score of 3. Head computerized tomography, electrocardiogram, electroencephalogram, vital signs, blood tests, breathing, and blood oxygenation were normal. Renal and liver failure were ruled out. Intravenous 0.25 mg of flumazenil (Anexate) was administered, resulting in complete neurocognitive recovery with a Glasgow Coma Score of 15.
This case report highlights the importance of the individual response to certain pharmacological agents and suggests that further studies need to be conducted both on flumazenil and gabapentin pharmacodynamics to better understand their molecular-receptor activity, and on possible multiple flumazenil mechanisms of action, beyond its classical strict benzodiazepine antagonist action.
A third version of the Spinal Cord Independence Measure (SCIM III), made up of three subscales, was formulated following comments by experts from several countries and Rasch analysis performed on the ...previous version.
To examine the validity, reliability, and usefulness of SCIM III using Rasch analysis.
Multicenter cohort study.
Thirteen spinal cord units in six countries from North America, Europe, and the Middle-East.
425 patients with spinal cord lesions (SCL).
SCIM III assessments by professional staff members. Rasch analysis of admission scores.
SCIM III subscale match between the distribution of item difficulty grades and the patient ability measurements; reliability of patient ability measures; fit of data to Rasch model requirements; unidimensionality of each subscale; hierarchical ordering of categories within items; differential item functioning across classes of patients and across countries.
Results supported the compatibility of the SCIM subscales with the stringent Rasch requirements. Average infit mean-square indices were 0.79-1.06; statistically distinct strata of abilities were 3 to 4; most thresholds between adjacent categories were properly ordered; item hierarchy was stable across most of the clinical subgroups and across countries. In a few items, however, misfit or category threshold disordering were found.
The scores of each SCIM III subscale appear as a reliable and useful quantitative representation of a specific construct of independence after SCL. This justifies the use of SCIM in clinical research, including cross-cultural trials. The results also suggest that there is merit in further refining the scale.
Administration of the walking index for SCI (WISCI) II is recommended to assess walking in spinal cord injury (SCI) patients. Determining the reliability and reproducibility of the WISCI II in acute ...SCI would be invaluable.
The objective of this study is to assess the reliability and reproducibility of the WISCI II in patients with traumatic, acute SCI.
Test-retest analysis and calculation of reliability and smallest real difference (SRD).
SCI unit of a rehabilitation hospital.
Thirty-three patients, median age 44 years, median time since onset of SCI 40 days. Level: 20 cervical, 8 thoracic, 5 lumbar; ASIA (American Spinal Injury Association) impairment scale (AIS) grade: 32 D/1 C. Assessment of maximum WISCI II levels by two trained, blinded raters to evaluate interrater (IRR) and intrarater reliability.
The intrarater reliability was 0.999 for therapists A and 0.979 for therapists B, for the maximum WISCI II level. The IRR for the maximum WISCI II score was 0.996 on day 1 and 0.975 on day 2. The SRD for the maximum WISCI II score was 1.147 for tetraplegics and 1.682 for paraplegics. These results suggest that a change of two WISCI II levels could be considered real.
The WISCI II has high IRR and intrarater reliability and good reproducibility in the acute and subacute phase when administered by trained raters.
Cross-sectional validation study.
To validate the Italian version of the Spinal Cord Independence Measure Self-Report (SCIM SR).
Two spinal cord injury (SCI) rehabilitation facilities in Italy.
The ...SCIM III comprises items on 19 daily tasks, grouped into three subscales: 'Self-care,' 'Respiration and sphincter management' and 'Mobility'. The total SCIM score ranges between 0 and 100. The Italian self-reported version (SCIM SR) was translated from the German tool. We studied 116 patients on their first hospitalization for rehabilitation after an SCI. At the time of discharge, patients were evaluated by the rehabilitation team using the SCIM III and self-assessed their independence with regard to activities of daily living using the SCIM SR. Pearson's correlation, Bland-Altman method, and stratified and regression analyses were used to examine the differences between evaluations.
On the basis of Pearson's correlation, there was good agreement between the data from the SCIM III and SCIM SR (r=0.918 for 'Self-care,' 0.806 for 'Respiration and sphincter management,' 0.906 for 'Mobility' and 0.934 for total scores). By Bland-Altman analysis, patients rated their functioning nearly the same as professionals-the mean difference between SCIM III and SCIM SR scores was approximately 0 for all subscales and total scores. The stratified and regression analyses failed to identify any specific factor that was associated with differences between SCIM III and SCIM SR scores.
These results support the validity of the Italian version of the SCIM SR, which can facilitate longer-term evaluations of the independence of individuals with SCIs.
Pain is a marker of bodily status, that despite being aversive under most conditions, may also be perceived as a positive experience. However, how bodily states represent, define, and interpret pain ...signals, and how these processes might be reflected in common language, remains unclear.
Qualitative and quantitative methods were used to explore the relationship between bodily awareness, pain reactions, and descriptions. A list of pain-related terms was generated from open-ended interviews with persons with spinal cord injury (SCI), and 138 participants (persons with SCI, health professionals, and a healthy control group) rated each descriptor as representative of pain on a gradated scale. A lexical decision task was used to test the strength of the automatic association of the word "pain" with positive and negative concepts. The behavioral results were related to body awareness, experience of pain, and exposure to pain, by comparing the three groups.
Higher positive and lower negative pain descriptors, as well as slower response times when categorizing pain as an unpleasant experience were found in the SCI group. The effect was not modulated by either the time since the injury or the present pain intensity, but it was linked to the level of subjective bodily awareness. Compared with the SCI group, health experts and non-experts both associated more quickly the word "pain" and unpleasant in the lexical decision task. However, while health professionals attributed positive linguistic qualities to pain, pain was exclusively associated with negative descriptors in healthy controls group.
These findings are discussed in terms of their theoretical and clinical implications. An awareness of bodily signals prominently affects both the sensory and linguistic responses in persons with SCI. Pain should be evaluated more broadly to understand and, by extension, to manage, experiences beyond its adverse side.
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