ABSTRACT
STUDY
DESIGN:
Protocol for the development of clinical practice guidelines following the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE)
standards.
OBJECTIVES:
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.
METHODS:
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.
RESULTS:
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.
CONCLUSIONS:
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.