Mismatch Between Investigator-Determined and Patient-Reported Independence After Spinal Cord Injury

Hedel, Hubertus J. A. van; Dokladal, Petra; Hotz‐Boendermaker, Sabina

doi:10.1177/1545968311407518

Cited by 11 publications

(14 citation statements)

References 42 publications

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“…Thus, in comparison with clinical investigators, newly injured SCI individuals have been observed to overestimate the magnitude of change that they expect to be meaningful and available from any current therapeutic intervention. 59 As recovery progresses, expectations for therapeutic benefits are likely to change, but no careful longitudinal survey of the expectations of people living with SCI has been completed to date.…”

Section: Acute Scimentioning

confidence: 99%

Challenges for defining minimal clinically important difference (MCID) after spinal cord injury

Liu

Tanadini

et al. 2014

Spinal Cord

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Study design: This is a review article. Objectives: 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. Methods: The methods include narrative reviews of SCI outcomes, a 2-day meeting of the authors and statistical methods of analysis representing MDD. Results: 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. Conclusion: 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.

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Section: Acute Scimentioning

confidence: 99%

Challenges for defining minimal clinically important difference (MCID) after spinal cord injury

Liu

Tanadini

et al. 2014

Spinal Cord

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“…These parameters, subjectively rated by the patients on a NRS (from 0 very poor-10 very good) during the last 7 days, were mood, anxiety and, limitation in daily life. General health was rated on a five-point rating scale from very bad to very good [37].…”

Section: Assessment Of Pain and Patient-rated Affective Factorsmentioning

confidence: 99%

“…Functional independence was quantified by the Spinal Cord Independence Measure (SCIM III), which is currently the recommended tool in persons with SCI [3,37]. The SCIM contains three clinically weighted subcategories: self-care, respiration and sphincter management, and mobility.…”

Section: Assessment Of Independence In Activities Of Daily Lifementioning

confidence: 99%

Low depressive symptoms in acute spinal cord injury compared to other neurological disorders

et al. 2011

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The aim of the study was to reveal the incidence and time course of depressive symptoms following acute spinal cord injury (SCI) in relation to clinical outcomes for comparison to other neurological disorders with severe impairment. In patients with acute traumatic SCI (n = 130), combined follow up assessments of neurological and functional outcomes, pain and patient-rated affective factors (e.g. mood, anxiety) were prospectively (1, 3, 6, 12 months after injury) collected during rehabilitation and follow up in out-patient clinics. We related these to the severity of depressive symptoms (no, mild, moderate and severe) based on the Beck Depression Inventory (BDI) scores. The mean 65% of patients showed no depressive symptoms and 30% mild depressive symptoms, while less than 5% presented moderate to severe depressive symptoms. The group findings and symptoms in individual patients remained stable over 1 year though patients revealed significant clinical recovery. Although two-thirds of the patients experienced pain, BDI scores were not related to pain intensity. BDI mean scores were only slightly higher than in control populations, but rather low compared to patients with other neurological disorders (e.g. stroke and multiple sclerosis) that are also associated with severe functional impairment. The prevalence of depressive symptoms following acute SCI is rather low and remains stable within the first year after injury despite the severe neurological impairment and loss of independency. In comparison to other neurological disorders that also involve brain function SCI patients seem to be less challenged by depressive symptoms that constitute additional burdens to respond to the severe functional impairments.

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“…11 Therefore, relying on functional activity instruments (eg, SCIM) to measure the efficacy of a neurological therapeutic (provided acutely or subacutely) is challenged by the extent of compensation that might be achieved by the individual during recovery as well as by a variety of independent variables outside the control of most clinical trials. These include, but are not limited to, the motivation and ability of the individual to learn new movement strategies in rehabilitation, ongoing participation in extensive inpatient/outpatient rehabilitation activities, and the use of assistive devices.…”

Section: Compensation and Neurological Recoverymentioning

confidence: 99%

“…Other findings from this database have been published. 5,[9][10][11][12][13][14] The present study focused on the relationship between ISNCSCI motor outcomes 15 and SCIM [16][17][18] during the year after onset. The most valid SCIM items, relating to upper-extremity motor recovery after cervical sensorimotor-complete (AIS-A) SCI, are found within the domain of self-care 12 for personal grooming, feeding, bathing (upper and lower body), and dressing (upper and lower body).…”

Section: Data Setmentioning

confidence: 99%

Relationship Between Motor Recovery and Independence After Sensorimotor-Complete Cervical Spinal Cord Injury

Kramer

Lammertse

Schubert

et al. 2012

Neurorehabil Neural Repair

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BACKGROUND: For therapeutics directed to the injured spinal cord, a change in neurological impairment has been proposed as a relevant acute clinical study end point. However, changes in neurological function, even if statistically significant, may not be associated with a functional impact, such as a meaningful improvement in items within the self-care subscore of the Spinal Cord Independence Measure (SCIM). OBJECTIVE: The authors examined the functional significance associated with spontaneously recovering upper-extremity motor function after sensorimotor-complete cervical spinal cord injury (SCI). METHODS: Using the European Multi-center Study about Spinal Cord Injury (EMSCI) data set, a retrospective analysis was undertaken of individuals with cervical sensorimotor-complete SCI (initial motor level, C4-C7). Specifically, changes in upper-extremity motor score (UEMS), motor level, and SCIM (total and self-care subscore) were assessed between approximately 1 and 48 weeks after injury (n = 74). RESULTS: The initial motor level did not significantly influence the total UEMS recovered or number of motor levels recovered. SCIM self-care subscore recovery was significantly greater for those individuals regaining 2 motor levels compared with those recovering only 1 or no motor levels. However, the recovery in the SCIM self-care subscore was not significantly different between individuals recovering only 1 motor level and those individuals who showed no motor-level improvement. CONCLUSIONS: A 2 motor-level improvement indicates a clinically meaningful change and might be considered a primary outcome in acute and subacute interventional trials enrolling individuals with cervical sensorimotor-complete SCI.

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Mismatch Between Investigator-Determined and Patient-Reported Independence After Spinal Cord Injury

Cited by 11 publications

References 42 publications

Challenges for defining minimal clinically important difference (MCID) after spinal cord injury

Challenges for defining minimal clinically important difference (MCID) after spinal cord injury

Low depressive symptoms in acute spinal cord injury compared to other neurological disorders

Relationship Between Motor Recovery and Independence After Sensorimotor-Complete Cervical Spinal Cord Injury

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