Robert K. Merrill

Bone morphogenetic protein use in spine surgery in the united states: how have we responded to the warnings?

BACKGROUND CONTEXT Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been widely adopted as a fusion adjunct in spine surgery since its approval in 2002. A number of concerns regarding adverse effects and potentially devastating complications of rhBMP-2 use led to a Food and Drug Administration (FDA) advisory issued in 2008 cautioning its use, and a separate warning about its potential complications was published by The Spine Journal in 2011. PURPOSE To compare trends of rhBMP-2 use in spine surgery after the FDA advisory in 2008 and The Spine Journal warning in 2011. STUDY DESIGN Retrospective cross-sectional study using a national database. PATIENT SAMPLE All patients from 2002 to 2013 who underwent spinal fusion surgery at an institution participating in the Nationwide Inpatient Sample (NIS). OUTCOME MEASURES Proportion of spinal fusion surgeries using rhBMP-2. METHODS We queried the NIS from 2002 to 2013 and used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes to identify spinal fusion procedures and those that used rhBMP-2. Procedures were subdivided into primary and revision fusions, and by region of the spine. Cervical and lumbosacral fusions were further stratified into anterior and posterior approaches. The percentage of cases using BMP was plotted across time. A linear regression was fit to the data from quarter 3 of 2008 (FDA advisory) through quarter 1 of 2011, and a separate regression was fit to the data from quarter 2 of 2011 (The Spine Journal warning) onward. The slopes of these regression lines were statistically compared to determine differences in trends. No funding was received to conduct this study, and no authors had any relevant conflicts of interest. RESULTS A total of 4,167,079 patients in the NIS underwent spinal fusion between 2002 and 2013. We found a greater decrease in rhBMP-2 use after The Spine Journal warning compared with the FDA advisory for all fusion procedures (p=.006), primary fusions (p=.006), and revision fusions (p=.004). Lumbosacral procedures also experienced a larger decline in rhBMP-2 use after The Spine Journal article as compared with the FDA warning (p=.0008). This pattern was observed for both anterior and posterior lumbosacral fusions (p≤.0001 for both). Anterior cervical fusion was the only procedure that demonstrated a decline in rhBMP-2 use after the FDA advisory that was statistically greater than after The Spine Journal article (p=.02). CONCLUSIONS Warnings sanctioned through the spine literature may have a greater influence on practice of the spine surgery community as compared with advisories issued by the FDA.Comprehensive guidelines regarding safe and effective use of rhBMP-2 must be established.

The Impact of Depression on Patient Reported Outcome Measures After Lumbar Spine Decompression

Study Design. A retrospective cohort study. Objective. The aim of this study was to investigate the effect depression has on the improvement of patient-reported outcome measures (PROMs) following lumbar decompression. Summary of Background Data. Decompression without fusion is a viable treatment option for lumbar spine stenosis. Depression reportedly has a negative impact on PROMs after certain types of spine surgery, though verification of this with new, more precise outcome measures is needed. Methods. We included consecutive adult patients who underwent lumbar decompression for lumbar spine stenosis between 2016 and 2017 who had PROM information system (PROMIS) physical function, pain, depression, and Oswestry Disability Index (ODI) questionnaires completed preoperatively and at 6-month follow-up. Patients with a PROMIS depression score >50 or <50 were allocated to the depressed and not depressed groups, respectively. The cohorts were compared using unpaired t tests and repeated-measures two-way analysis of variance (ANOVA) with statistical significance taken at P < 0.05. Results. The analysis included 55 patients without depression and 56 patients with depression. Depressed patients had worse preoperative PROMIS physical function (30.08 vs. 36.66, P = 0.005), PROMIS pain (69.36 vs. 64.69, P < 0.0001), and ODI scores (51.92 vs. 36.35, P < 0.0001). Similarly, the depressed group had worse postoperative PROMIS physical function (36.29 vs. 40.34, P = 0.005), PROMIS pain (60.16 vs. 54.87, P < 0.0001), and ODI scores (37.01 vs. 23.44, P = 0.0003). We observed a statistically significant interaction between depression status and pre to postoperative improvement in outcome for PROMIS physical function (F[1,109] = 102.5, P < 0.0001) and depression scores (F[1,109] = 15.38, P = 0.0002). No interaction was found for pain and ODI scores. Conclusion. Our results suggest that depressed patients experience a greater magnitude of improvement in PROMIS physical function and depression scores than nondepressed patients. Despite this, depressed patients have worse postoperative outcomes for PROMIS physical function, depression, pain, and ODI. These findings are important for risk stratifying and treating depressed patients before lumbar spine decompression. Level of Evidence: 3

Near-Peer Emergency Medicine for Medical Students in Port-au-Prince, Haiti: An Example of Rethinking Global Health Interventions in Developing Countries

BACKGROUND During a 3-year time frame, a partnership between medical trainees in Haiti and the United States was forged with the objective of implementing an emergency response skills curriculum at a medical school in Port-au-Prince. The effort sought to assess the validity of a near-peer, bidirectional, cross-cultural teaching format as both a global health experience for medical students and as an effective component of improving medical education and emergency response infrastructure in developing countries such as Haiti. METHOD Medical students and emergency medicine (EM) residents from a North American medical school designed and taught a module on emergency response skills in PAP and certified medical students in basic cardiac life support (BLS) over 2 consecutive years. Five-point Likert scale self-efficacy (SE) surveys and multiple-choice fund of knowledge (FOK) assessments were distributed pre- and postmodule each year and analyzed with paired t tests and longitudinal follow-up of the first cohort. Narrative evaluations from participants were collected to gather feedback for improving the module. FINDINGS Challenges included bridging language barriers, maintaining continuity between cohorts, and adapting to unexpected schedule changes. Overall, 115 students were certified in BLS with significant postcurriculum improvements in SE scores (2.75 ± 0.93 in 2013 and 2.82 ± 1.06 in 2014; P < 0.001) and FOK scores (22% ± 15% in 2013 and 41% ± 16% in 2014; P < 0.001). Of 24 Haitian students surveyed at 1-year follow-up from the 2013 cohort, 7 (29.3%) reported using taught skills in real-life situations since completing the module. The US group was invited to repeat the project for a third year. CONCLUSIONS Near-peer, cross-cultural academic exchange is an effective method of medical student-centered emergency training in Haiti. Limitations such as successfully implementing sustainability measures, addressing cultural differences, and coordinating between groups persist. This scalable, reproducible, and mutually beneficial collaboration between North American and Haitian medical trainees is a valid conduit for building Haitis emergency response infrastructure and promoting global health.

The 5-year cost-effectiveness of two-level anterior cervical discectomy and fusion or cervical disc replacement: a Markov analysis

BACKGROUND CONTEXT Anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR) are both acceptable surgical options for the treatment of cervical myelopathy and radiculopathy. To date, there are limited economic analyses assessing the relative cost-effectiveness of two-level ACDF versus CDR. PURPOSE The purpose of this study was to determine the 5-year cost-effectiveness of two-level ACDF versus CDR. STUDY DESIGN The study design is a secondary analysis of prospectively collected data. PATIENT SAMPLE Patients in the Prestige cervical disc investigational device exemption (IDE) study who underwent either a two-level CDR or a two-level ACDF were included in the study. OUTCOME MEASURES The outcome measures were cost and quality-adjusted life years (QALYs). MATERIALS AND METHODS A Markov state-transition model was used to evaluate data from the two-level Prestige cervical disc IDE study. Data from the 36-item Short Form Health Survey were converted into utilities using the short form (SF)-6D algorithm. Costs were calculated from the payer perspective. QALYs were used to represent effectiveness. A probabilistic sensitivity analysis (PSA) was performed using a Monte Carlo simulation. RESULTS The base-case analysis, assuming a 40-year-old person who failed appropriate conservative care, generated a 5-year cost of

Comparing the Incidence of Index Level Fusion Following Minimally Invasive Versus Open Lumbar Microdiscectomy

130,417 for CDR and

Negative Sagittal Balance Following Adult Spinal Deformity Surgery

116,717 for ACDF. Cervical disc replacement and ACDF generated 3.45 and 3.23 QALYs, respectively. The incremental cost-effectiveness ratio (ICER) was calculated to be

Is Cervical Bracing Necessary After One- and Two-Level Instrumented Anterior Cervical Discectomy and Fusion? A Prospective Randomized Study:

62,337/QALY for CDR. The Monte Carlo simulation validated the base-case scenario. Cervical disc replacement had an average cost of

Surgical, Radiographic, and Patient-Related Risk Factors for Proximal Junctional Kyphosis: A Meta-Analysis

130,445 (confidence interval [CI]:

Comparing the 5-Year Health State Utility Value of Cervical Disc Replacement and Anterior Cervical Discectomy and Fusion:

108,395-

Investigating the 7-Year Cost-Effectiveness of Single-Level Cervical Disc Replacement Compared to Anterior Cervical Discectomy and Fusion:

152,761) with an average effectiveness of 3.46 (CI: 3.05-3.83). Anterior cervical discectomy and fusion had an average cost of