Showing papers by "Daryl R. Fourney published in 2021"

Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial

Abstract: Summary Background Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy. Methods This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18–80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8–14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov , NCT01257828 . Findings From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference −0·38 points (−0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications. Interpretation In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study. Funding AOSpine North America.

A Randomized Controlled Trial of Local Delivery of a Rho Inhibitor (VX-210) in Patients with Acute Traumatic Cervical Spinal Cord Injury

Abstract: Acute traumatic spinal cord injury (SCI) can result in severe, lifelong neurological deficits. After SCI, Rho activation contributes to collapse of axonal growth cones, failure of axonal regenerati...

International comparative study of low back pain care pathways and analysis of key interventions

Abstract: Low back pain (LBP) is a major public health problem worldwide. Significant practice variation exists despite guidelines, including strong interventionist focus by some practitioners. Translation of guidelines into pathways as integrated treatment plans is a next step to improve implementation. The goal of the present study was to analyze international examples of LBP pathways in order to identify key interventions as building elements for care pathway for LBP and radicular pain. International examples of LBP pathways were searched in literature and grey literature. Authors of pathways were invited to fill a questionnaire and to participate in an in-depth telephone interview. Pathways were quantitatively and qualitatively analyzed, to enable the identification of key interventions to serve as pathway building elements. Eleven international LBP care pathways were identified. Regional pathways were strongly organized and included significant training efforts for primary care providers and an intermediate level of caregivers in between general practitioners and hospital specialists. Hospital pathways had a focus on multidisciplinary collaboration and stepwise approach trajectories. Key elements common to all pathways included the consecutive screening for red flags, radicular pain and psychosocial risk factors, the emphasis on patient empowerment and self-management, the development of evidence-based consultable protocols, the focus on a multidisciplinary work mode and the monitoring of patient-reported outcome measures. Essential building elements for the construction of LBP care pathways were identified from a transversal analysis of key interventions in a study of 11 international examples of LBP pathways.

Does a Multidisciplinary Triage Pathway Facilitate Better Outcomes After Spine Surgery

Abstract: STUDY DESIGN Single-center prospective non-randomized matched cohort comparison. OBJECTIVE To compare elective lumbar spine surgery outcomes for cases triaged through a multidisciplinary spine pathway versus conventional referral processes. SUMMARY OF BACKGROUND DATA Many health care systems have facilitated low back pain (LBP) guidelines into primary care practice by creating local or regional "pathways" with the goal of enhanced quality of care, improved patient satisfaction and optimal resource utilization, particularly for imaging and surgery. Few comparative outcomes exist for LBP pathways, particularly for surgical outcomes. METHODS One-hundred-fifty patients (SSP group n = 75; conventional group n = 75) undergoing elective lumbar surgery for degenerative conditions between 2011 and 2016 were analyzed with 1-year follow-up. Patient self-reported outcomes included the Oswestry disability index (ODI), visual analogue pain scores (VAS) for back and leg, and EuroQol Group 5-Dimension self-report (EQ-5D). We also assessed baseline clinical features, indications for surgery, therapies received prior to surgery, type of surgery, wait times, and overall patient satisfaction. RESULTS The groups had equivalent baseline demographics, body mass index, Saskatchewan Spine Pathway (SSP) classification of pain pattern, pain scores, functional scores, quality of life scores, indication for surgery, and type of surgery (instrumented or non-instrumented). There was no difference with respect to wait times to see the surgeon or for surgery. Wait time for magnetic resonance imaging (MRI) was significantly shorter for the SSP group (16.8 vs. 63.0 days, P < 0.001). Patients triaged through the SSP were significantly more likely to utilize multiple nonoperative treatment strategies prior to seeing the surgeon (P < 0.04). Patient satisfaction was significantly higher for SSP patients prior to surgical assessment (P = 0.03) but did not differ between groups after surgery. CONCLUSION The SSP facilitates significantly shorter wait times for MRI and promotes nonoperative treatment strategies. Preoperative patient satisfaction is significantly higher among SSP patients, but there were no significant differences in surgical outcomes.Level of Evidence: 3.

Development of a Patient-Oriented Intervention to Support Patient-Provider Conversations about Unnecessary Lower Back Pain Imaging

Abstract: Background: despite the efforts of multiple stakeholders to promote appropriate care throughout the healthcare system, studies show that two out of three lower back pain (LBP) patients expect to receive imaging. We used the Choosing Wisely Canada patient-oriented framework, prioritizing patient engagement, to develop an intervention that addresses lower back pain imaging overuse. Methods: to develop this intervention, we collaborated with a multidisciplinary advisory team, including two patient partners with lower back pain, researchers, clinicians, healthcare administrators, and the Choosing Wisely Canada lead for Saskatchewan. For this qualitative study, data were collected through two advisory team meetings, two individual interviews with lower back pain patient partners, and three focus groups with lower back pain patient participants. A lower back pain prescription pad was developed as an outcome of these consultations. Results: participants reported a lack of interactive and informative communication was a significant barrier to receiving appropriate care. The most cited content information for inclusion in this intervention was treatments known to work, including physical activity, useful equipment, and reliable sources of educational material. Participants also suggested it was important that benefits and risks of imaging were explained on the pad. Three key themes derived from the data were also used to guide development of the intervention: (a) the role of imaging in LBP diagnosis; (b) the impact of the patient-physician relationship on LBP diagnosis and treatment; and (c) the lack of patient awareness of Choosing Wisely Canada and their recommendations. Conclusions: the lower back pain patient-developed prescription pad may help patients and clinicians engage in informed conversations and shared decision making that could support reduce unnecessary lower back pain imaging.

Nerve root sedimentation sign on MRI: A triage screen for leg dominant symptoms?

Abstract: Surgical indications for lumbar spinal stenosis are controversial, but most agree that leg dominant pain is a better predictor of success after decompression surgery. The objective of this study is to analyze the ability of the Nerve Root Sedimentation Sign (SedSign) on MRI to differentiate leg dominant symptoms from non-specific low back pain. This was a retrospective review of 367 consecutive patients presenting with back and/or leg pain. Baseline clinical characteristics included Oswestry disability index (ODI), visual analog pain scores, EuroQol Group 5-Dimension Self-Report (EQ5D) and Saskatchewan Spine Pathway Classification (SSPc). Inter- and intra-rater reliability for SedSign was 73% and 91%, respectively (3 examiners). SedSign was positive in 111 (30.2%) and negative in 256 (69.8%) patients. On univariate analysis, a positive SedSign was correlated with age, male sex, several ODI components, EQ5D mobility, cross-sectional area (CSA) of stenosis, antero-posterior diameter of stenosis, and SSPc pattern 4 (intermittent leg dominant pain). On multivariate analysis, SedSign was associated with age, male sex, CSA stenosis and ODI walking distance. Patients with a positive SedSign were more likely to be offered surgery after referral (OR 2.65). The sensitivity and specificity for detecting all types of leg dominant pain were 37.4 and 82.8, respectively (ppv 77.5%, npv 43.8%). Patients with a positive SedSign were more likely to be offered surgery, in particular non-instrumented decompression. The SedSign has high specificity for leg dominant pain, but the sensitivity is poor. As such, its use in triaging appropriate surgical referrals is limited.