Abstract

Protocol for the development of clinical practice guidelines following the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) standards. Acute SCI or intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. The treatment of SCI has dramatically evolved over the last century as a result of preclinical and clinical research that has addressed important knowledge gaps, including injury mechanisms, disease pathophysiology, medical management, and the role of surgery. In an acute setting, clinicians are faced with critical decisions on how to optimize neurological recovery in patients with SCI that include the role and timing of surgical decompression and the best strategies for hemodynamic management. The lack of consensus surrounding these treatments has prevented standardization of care across centers and has created uncertainty with respect to how to best manage patients with SCI. ISCI is a feared complication that can occur in the best of hands. Unfortunately, there are no systematic reviews or clinical practice guidelines to assist spine surgeons in the assessment and management of ISCI in adult patients undergoing spinal surgery. Given these limitations, it is the objective of this initiative to develop evidence-based recommendations that will inform the management of both SCI and ISCI. This protocol describes the rationale for developing clinical practice guidelines on (i) the timing of surgical decompression in acute SCI; (ii) the hemodynamic management of acute SCI; and (iii) the prevention, identification, and management of ISCI in patients undergoing surgery for spine-related pathology. Systematic reviews were conducted according to PRISMA standards in order to summarize the current body of evidence and inform the guideline development process. The guideline development process followed the approach proposed by the GRADE working group. Separate multidisciplinary, international groups were created to perform the systematic reviews and formulate the guidelines. All potential conflicts of interest were vetted in advance. The sponsors exerted no influence over the editorial process or the development of the guidelines. This process resulted in both systematic reviews and clinical practice guidelines/care pathways related to the role and timing of surgery in acute SCI; the optimal hemodynamic management of acute SCI; and the prevention, diagnosis and management of ISCI. The ultimate goal of this clinical practice guideline initiative was to develop evidence-based recommendations for important areas of controversy in SCI and ISCI in hopes of improving neurological outcomes, reducing morbidity, and standardizing care across settings. Throughout this process, critical knowledge gaps and future directions were also defined.

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