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

Wu, Xiuhua; Liu, Jie; Tanadini, Lorenzo G.; Lammertse, Daniel P.; Blight, Andrew R.; Kramer, John L. K.; Scivoletto, Giorgio; Jones, Loring; Kirshblum, Steven; Abel, Rainer; Fawcett, James W.; Field-Fote, Edelle C.; Guest, James D.; Levinson, Ben; Maier, Doris; Tansey, Keith E.; Weidner, Norbert; Tetzlaff, Wolfram; Hothorn, Torsten; Curt, Armin; Steeves, John D.

doi:10.1038/sc.2014.232

Cited by 79 publications

(54 citation statements)

References 56 publications

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“…Injuries in humans, and the recovery from these injuries, are so heterogeneous that smaller improvements of function might be difficult to detect, unless very large trials are carried out (Wu et al, 2015). …”

Section: Limitations and Future Possibilitiesmentioning

confidence: 99%

Rat models of spinal cord injury: from pathology to potential therapies

Kjell

Olson

2016

Disease Models &Amp; Mechanisms

292

209

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A long-standing goal of spinal cord injury research is to develop effective spinal cord repair strategies for the clinic. Rat models of spinal cord injury provide an important mammalian model in which to evaluate treatment strategies and to understand the pathological basis of spinal cord injuries. These models have facilitated the development of robust tests for assessing the recovery of locomotor and sensory functions. Rat models have also allowed us to understand how neuronal circuitry changes following spinal cord injury and how recovery could be promoted by enhancing spontaneous regenerative mechanisms and by counteracting intrinsic inhibitory factors. Rat studies have also revealed possible routes to rescuing circuitry and cells in the acute stage of injury. Spatiotemporal and functional studies in these models highlight the therapeutic potential of manipulating inflammation, scarring and myelination. In addition, potential replacement therapies for spinal cord injury, including grafts and bridges, stem primarily from rat studies. Here, we discuss advantages and disadvantages of rat experimental spinal cord injury models and summarize knowledge gained from these models. We also discuss how an emerging understanding of different forms of injury, their pathology and degree of recovery has inspired numerous treatment strategies, some of which have led to clinical trials.

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Section: Limitations and Future Possibilitiesmentioning

confidence: 99%

Rat models of spinal cord injury: from pathology to potential therapies

Kjell

Olson

2016

Disease Models &Amp; Mechanisms

292

209

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“…From a clinical perspective, the relationships between the extent of the spinal cord lesion, the amount of cortical reorganization and the recovery of behavior need to be further investigated in serial studies [72]. Animal models will help us understand not only the influence and ensuing consequences of different lesions, but also which neuroimaging outcome measures have predictive value.…”

Section: Future Directionsmentioning

confidence: 99%

Tracking trauma-induced structural and functional changes above the level of spinal cord injury

Huber

Curt

Freund

2015

Current Opinion in Neurology

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PURPOSE OF REVIEW: This review will highlight the latest findings from neuroimaging studies that track structural and functional changes within the central nervous system at both the brain and spinal cord levels following acute human spinal cord injury (SCI). The putative, underlying biological mechanisms of structural change (e.g. degradation of neural tissue) rostral to the lesion site will be discussed in relation to animal models of SCI and their potential value in clinical studies of human SCI. RECENT FINDINGS: Recent prospective studies in human acute SCI have begun to reveal the timecourse, spatial distribution and extent of structural changes following an acute SCI and their relation to functional outcome. Adaptive changes in sensory and motor pathways above the level of the lesion have prognostic value and complement clinical readouts. SUMMARY: The introduction of sensitive neuroimaging biomarkers will be an essential step forward in the implementation of interventional trials in which proof-of-concept is currently limited to clinical readouts, but more responsive measures are required to improve the sensitivity of clinical trials. Purpose of review This review will highlight the latest findings from neuroimaging studies that track structural and functional changes within the central nervous system at both the brain and spinal cord levels following acute human spinal cord injury (SCI). The putative, underlying biological mechanisms of structural change (e.g. degradation of neural tissue) rostral to the lesion site will be discussed in relation to animal models of SCI and their potential value in clinical studies of human SCI. Recent findingsRecent prospective studies in human acute SCI have begun to reveal the time-course, spatial distribution and extent of structural changes following an acute SCI and their relation to functional outcome. Adaptive changes in sensory and motor pathways above the level of the lesion have prognostic value and complement clinical readouts. SummaryThe introduction of sensitive neuroimaging biomarkers will be an essential step forward in the implementation of interventional trials in which proof-of-concept is currently limited to clinical readouts, but more responsive measures are required to improve the sensitivity of clinical trials.

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“…Our mean FIM Motor subscale was 11.7. For spinal cord injury (SCI) patients, the MCID has yet to be reported due in part to the diversity of injury levels and injury partiality . Likewise, the wide spectrum of multifocal neurologic deficits of LMD patients could make defining an MCID difficult.…”

Section: Discussionmentioning

confidence: 99%

“…For spinal cord injury (SCI) patients, the MCID has yet to be reported due in part to the diversity of injury levels and injury partiality. 29 Likewise, the wide spectrum of multifocal neurologic deficits of LMD patients could make defining an MCID difficult. Future research to determine the FIM MCID of cancer acute inpatient rehabilitation populations is needed.…”

Section: Limitationsmentioning

confidence: 99%

Retrospective Analysis of Acute Rehabilitation Outcomes of Cancer Inpatients with Leptomeningeal Disease

Molinares

Morishita

et al. 2019

PM&R

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Objective Evaluate Functional Independence Measure (FIM) changes and incidence of serious medical complications requiring return to the primary acute care service of acute rehabilitation cancer inpatients with leptomeningeal disease (LMD). Design Retrospective chart review. Setting Tertiary referral based comprehensive cancer center acute inpatient rehabilitation unit. Participants Thirty cancer patients admitted to acute inpatient rehabilitation between 8 January 2014 and 8 August 2018 with pathology confirmed LMD within 6 months. Interventions Not applicable. Main Outcome Measures FIM and incidence of return to the primary acute care service. Results Twenty five of 30 (83.3%) patients were noted to have neurologic impairments and 13/30 (43.3%) were noted to have cognitive impairments. Five of 30 patients (16.7%) received intrathecal chemotherapy and 4/30 (13.3%) received radiation during acute inpatient rehabilitation for LMD treatment. Median days in acute care prior to acute inpatient rehabilitation was 22.5. Median days from acute inpatient rehabilitation admission until death of the 23 deceased patients as of 1 January 2019 was 180.00. Twenty of 30 (66.7%) patients were discharged home, 9/30 (30%) transferred to the primary acute care service, and 1/30 (3.3%) discharged to a skilled nursing facility. Reasons for return to the primary acute care service included additional chemotherapy 3/9 (33%), neurologic decline 2/9 (22%), fever 2/9 (22%), altered mental status 1/9 (11%), and progressive polyarthritis 1/9 (11%). Of the 21 patients who completed acute inpatient rehabilitation without return to the primary acute care service, mean FIM subscore changes from admission to discharge for Activities of Daily Living, Mobility, and Motor were 5.1 (P < .001), 4.8 (P < .001) and 11.7 (P < .001), respectively (Wilcoxon signed rank test, significance P < .05). Conclusion LMD patients who completed acute inpatient rehabilitation made statistically significant improvements on the majority of FIM items. Most patients were discharged home. Our data suggest LMD should not be a reason for exclusion from acute inpatient rehabilitation. Level of Evidence III.

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

Cited by 79 publications

References 56 publications

Rat models of spinal cord injury: from pathology to potential therapies

Rat models of spinal cord injury: from pathology to potential therapies

Tracking trauma-induced structural and functional changes above the level of spinal cord injury

Retrospective Analysis of Acute Rehabilitation Outcomes of Cancer Inpatients with Leptomeningeal Disease

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