Dataset Information

A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Use of Methylprednisolone Sodium Succinate.

ABSTRACT:

Introduction

The objective of this guideline is to outline the appropriate use of methylprednisolone sodium succinate (MPSS) in patients with acute spinal cord injury (SCI).

Methods

A systematic review of the literature was conducted to address key questions related to the use of MPSS in acute SCI. A multidisciplinary Guideline Development Group used this information, in combination with their clinical expertise, to develop recommendations for the use of MPSS. Based on GRADE (Grading of Recommendation, Assessment, Development and Evaluation), a strong recommendation is worded as "we recommend," whereas a weaker recommendation is indicated by "we suggest."

Results

The main conclusions from the systematic review included the following: (1) there were no differences in motor score change at any time point in patients treated with MPSS compared to those not receiving steroids; (2) when MPSS was administered within 8 hours of injury, pooled results at 6- and 12-months indicated modest improvements in mean motor scores in the MPSS group compared with the control group; and (3) there was no statistical difference between treatment groups in the risk of complications. Our recommendations were: (1) "We suggest not offering a 24-hour infusion of high-dose MPSS to adult patients who present after 8 hours with acute SCI"; (2) "We suggest a 24-hour infusion of high-dose MPSS be offered to adult patients within 8 hours of acute SCI as a treatment option"; and (3) "We suggest not offering a 48-hour infusion of high-dose MPSS to adult patients with acute SCI."

Conclusions

These guidelines should be implemented into clinical practice to improve outcomes and reduce morbidity in SCI patients.

SUBMITTER: Fehlings MG

PROVIDER: S-EPMC5686915 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Publications

A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Use of Methylprednisolone Sodium Succinate.

Fehlings Michael G MG Wilson Jefferson R JR Tetreault Lindsay A LA Aarabi Bizhan B Anderson Paul P Arnold Paul M PM Brodke Darrel S DS Burns Anthony S AS Chiba Kazuhiro K Dettori Joseph R JR Furlan Julio C JC Hawryluk Gregory G Holly Langston T LT Howley Susan S Jeji Tara T Kalsi-Ryan Sukhvinder S Kotter Mark M Kurpad Shekar S Kwon Brian K BK Marino Ralph J RJ Martin Allan R AR Massicotte Eric E Merli Geno G Middleton James W JW Nakashima Hiroaki H Nagoshi Narihito N Palmieri Katherine K Skelly Andrea C AC Singh Anoushka A Tsai Eve C EC Vaccaro Alexander A Yee Albert A Harrop James S JS

Global spine journal 20170905 3 Suppl

<h4>Introduction</h4>The objective of this guideline is to outline the appropriate use of methylprednisolone sodium succinate (MPSS) in patients with acute spinal cord injury (SCI).<h4>Methods</h4>A systematic review of the literature was conducted to address key questions related to the use of MPSS in acute SCI. A multidisciplinary Guideline Development Group used this information, in combination with their clinical expertise, to develop recommendations for the use of MPSS. Based on GRADE (Grad ...[more]

PMID: 29164025

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Project description:Study designClinical practice guideline development following the GRADE process.ObjectivesHemodynamic management is one of the only available treatment options that likely improves neurologic outcomes in patients with acute traumatic spinal cord injury (SCI). Augmenting mean arterial pressure (MAP) aims to improve blood perfusion and oxygen delivery to the injured spinal cord in order to minimize secondary ischemic damage to neural tissue. The objective of this guideline was to update the 2013 AANS/CNS recommendations on the hemodynamic management of patients with acute traumatic SCI, acknowledging that much has been published in this area since its publication. Specifically, we sought to make recommendations on 1. The range of mean arterial pressure (MAP) to be maintained by identifying an upper and lower MAP limit; 2. The duration of such MAP augmentation; and 3. The choice of vasopressor. Additionally, we sought to make a recommendation on spinal cord perfusion pressure (SCPP) targets.MethodsA multidisciplinary guideline development group (GDG) was formed that included health care professionals from a wide range of clinical specialities, patient advocates, and individuals living with SCI. The GDG reviewed the 2013 AANS/CNS guidelines and voted on whether each recommendation should be endorsed or updated. A systematic review of the literature, following PRISMA standards and registered in PROSPERO, was conducted to inform the guideline development process and address the following key questions: (i) what are the effects of goal-directed interventions to optimize spinal cord perfusion on extent of neurological recovery and rates of adverse events at any time point of follow-up? and (ii) what are the effects of particular monitoring techniques, perfusion ranges, pharmacological agents, and durations of treatment on extent of neurological recovery and rates of adverse events at any time point of follow-up? The GDG combined the information from this systematic review with their clinical expertise in order to develop recommendations on a MAP target range (specifically an upper and lower limit to target), the optimal duration for MAP augmentation, and the use of vasopressors or inotropes. Using methods outlined by the GRADE working group, recommendations were formulated that considered the balance of benefits and harms, financial impact, acceptability, feasibility and patient preferences.ResultsThe GDG suggested that MAP should be augmented to at least 75-80 mmHg as the "lower limit," but not actively augmented beyond an "upper limit" of 90-95 mmHg in order to optimize spinal cord perfusion in acute traumatic SCI. The quality of the evidence around the "target MAP" was very low, and thus the strength of this recommendation is weak. For duration of hemodynamic management, the GDG "suggested" that MAP be augmented for a duration of 3-7 days. Again, the quality of the evidence around the duration of MAP support was very low, and thus the strength of this recommendation is also weak. The GDG felt that a recommendation on the choice of vasopressor or the use of SCPP targets was not warranted, given the dearth of available evidence.ConclusionWe provide new recommendations for blood pressure management after acute SCI that acknowledge the limitations of the current evidence on the relationship between MAP and neurologic recovery. It was felt that the low quality of existing evidence and uncertainty around the relationship between MAP and neurologic recovery justified a greater range of MAP to target, and for a broader range of days post-injury than recommended in previous guidelines. While important knowledge gaps still remain regarding hemodynamic management, these recommendations represent current perspectives on the role of MAP augmentation for acute SCI.

Project description:IntroductionWhile it is well-established that follow-up care programs play a crucial role in preventing and early detecting secondary health conditions (SHCs) in persons with spinal cord injury [SCI, including spina bifida (SB)], the availability of evidence-based follow-up care programs remains limited. Under the leadership of the German-speaking Medical Society for Paraplegiology (DMGP), we have developed an evidence based clinical practice guideline for follow-up care of SHCs in persons with SCI and identify research gaps.MethodsThis guideline was developed in accordance with the regulations of the Association of the Scientific Medical Societies in Germany (AWMF e.V.). To ensure an evidence-based guidance, we utilized the International Classification of Functioning, Disability and Health (ICF) generic core set and ICF Core Set for individuals with SCI in long-term context as our foundational framework. We conducted a comprehensive literature review to identify existing recommendations for follow-up care and graded the level of evidence according to relevant instruments. Subsequently, we formulated recommendations and achieved consensus through a structured nominal group process involving defined steps and neutral moderation, while adhering to the criteria outlined in the German guideline development instrument (DELBI).ResultsAlthough there is a fair number of literatures describing prevalence and severity of SHCs after SCI, the amount of literature including recommendations was low (19 for SCI and 6 for SB). Based on the current evidence on prevalence and severity of SHCs and available recommendations, a clinical practice guideline on follow-up care of most relevant SHCs was defined. The recommendations for follow-up care are described in the following chapters: (1) Nervous system; (2) (Neuropathic) pain; (3) Cardiovascular diseases; (4) Respiratory System; (5) Immunological system, vaccination and allergies; (6) Gastrointestinal tract and function; (7) Endocrinological system and nutrition; (8) Urogenital system; (9) Contraception, pregnancy, birth and postpartum care; (10) Musculoskeletal system; (11) Pressure injuries; (12) Psychological health; (13) Medication and polypharmacy.ConclusionWe could successfully establish an evidence based clinical practice guideline for follow-up care of SHCs in individuals with SCI. There is however a notable lack of high-quality recommendations for SCI follow-up care.

Project description:IntroductionSpinal cord injury (SCI) is a life-altering injury that leads to a complex constellation of changes in an individual's sensory, motor, and autonomic function which is largely determined by the level and severity of cord impairment. Available SCI-specific clinical practice guidelines (CPG) address specific impairments, health conditions or a segment of the care continuum, however, fail to address all the important clinical questions arising throughout an individual's care journey. To address this gap, an interprofessional panel of experts in SCI convened to develop the Canadian Spinal Cord Injury Best Practice (Can-SCIP) Guideline. This article provides an overview of the methods underpinning the Can-SCIP Guideline process.MethodsThe Can-SCIP Guideline was developed using the Guidelines Adaptation Cycle. A comprehensive search for existing SCI-specific CPGs was conducted. The quality of eligible CPGs was evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument. An expert panel (n = 52) convened, and groups of relevant experts met to review and recommend adoption or refinement of existing recommendations or develop new recommendations based on evidence from systematic reviews conducted by the Spinal Cord Injury Research Evidence (SCIRE) team. The expert panel voted to approve selected recommendations using an online survey tool.ResultsThe Can-SCIP Guideline includes 585 total recommendations from 41 guidelines, 96 recommendations that pertain to the Components of the Ideal SCI Care System section, and 489 recommendations that pertain to the Management of Secondary Health Conditions section. Most recommendations (n = 281, 48%) were adopted from existing guidelines without revision, 215 (36.8%) recommendations were revised for application in a Canadian context, and 89 recommendations (15.2%) were created de novo.ConclusionThe Can-SCIP Guideline is the first living comprehensive guideline for adults with SCI in Canada across the care continuum.

Project description:Spinal cord injury (SCI), characterized by the disruption of neural pathways and an increase in inflammatory cell infiltration, leads to profound and lasting neurological deficits, with a high risk of resulting in permanent disability. Currently, the therapeutic landscape for SCI is notably sparse, with limited effective treatment options available. Methylprednisolone (MP), a widely used clinical anti-inflammatory agent for SCI, requires administration in high doses that are associated with significant adverse effects. In this study, we introduce an innovative approach by substituting cholesterol with MP to engineer a novel Lipid Nanoparticle (MP-LNP). This strategy aims to enhance the localization and concentration of MP at the injury site, thereby amplifying its therapeutic efficacy while mitigating systemic side effects. Furthermore, we explore the integration of C3 transferase mRNA into MP-LNPs. C3 transferase, a potent inhibitor of the RhoA pathway, has shown promise in facilitating neurological recovery in animal models of SCI and is currently being evaluated in clinical trials. The novel formulation, MP-LNP-C3, is designed for direct administration to the injury site during decompression surgery, offering a targeted therapeutic modality for SCI. Our findings reveal several significant advantages of this approach: Firstly, the incorporation of C3 transferase mRNA into MP-LNPs does not compromise the structural integrity of the nanoparticles, ensuring efficient mRNA expression within the spinal cord. Secondly, the MP-LNP formulation effectively attenuates inflammation and reduces the adverse effects associated with high-dose MP treatment in the acute phase of SCI. Lastly, MP-LNP-C3 demonstrates notable neuroprotective properties and promotes enhanced recovery of motor function in SCI mouse models. Together, these results underscore the potential of this innovative LNP-based therapy as a promising avenue for advancing the treatment of clinical SCI.

Dataset Information

A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Use of Methylprednisolone Sodium Succinate.

Introduction

Methods

Results

Conclusions

Publications

A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Use of Methylprednisolone Sodium Succinate.

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