How Do PROMIS Scores Correspond to Common Physical Abilities?

BACKGROUND: The Patient-Report Outcomes Measurement Information System (PROMIS) is increasingly used as a general-purpose tool for measuring orthopaedic surgery outcomes. This set of questionnaires is efficient, precise, and correlates well with specialty-specific measures, but impactful implementation of patient-specific data, especially at the point of care, remains a challenge. Although clinicians may have substantial experience with established patient-reported outcome measures in their fields, PROMIS is relatively new, and the real-life meaning of PROMIS numerical summary scores may be unknown to many orthopaedic surgeons. QUESTIONS/PURPOSES: We aimed to (1) identify a small subset of important items in the PROMIS Physical Function (PF) item bank that are answered by many patients with orthopaedic conditions and (2) graphically display characteristic responses to these items across the physical function spectrum in order to translate PROMIS numerical scores into physical ability levels using clinically relevant, familiar terms. METHODS: In a cross-sectional study, 97,852 PROMIS PF assessments completed by 37,517 patients with orthopaedic conditions presenting to a tertiary-care academic institution were pooled and descriptively analyzed. Between 2017 and 2020, we evaluated 75,354 patients for outpatient orthopaedic care. Of these, 67% (50,578) were eligible for inclusion because they completed a PROMIS version 2.0 physical function assessment; 17% (12,720) were excluded because they lacked information in the database on individual item responses, and another < 1% (341) were excluded because the assessment standard error was greater than 0.32, leaving 50% of the patients (37,517) for analysis. The PROMIS PF is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10. Anchor-based minimum clinically important differences have been found to be 8 to 10 points in a foot and ankle population, 7 to 8 points in a spine population, and approximately 4 points in a hand surgery population. The most efficient and precise means of administering the PROMIS PF is as a computerized adaptive test (CAT), whereby an algorithm intelligently tailors each follow-up question based on responses to previous questions, requiring only a few targeted questions to generate an accurate result. In this study, the mean PROMIS PF score was 41 ± 9. The questions most frequently used by the PROMIS CAT software were identified (defined in this study as any question administered to > 0.1% of the cohort). To understand the ability levels of patients based on their individual scores, patients were grouped into score categories: < 18, 20 ± 2, 25 ± 2, 30 ± 2, 35 ± 2, 40 ± 2, 45 ± 2, 50 ± 2, 55 ± 2, 60 ± 2, and > 62. For each score category, the relative frequency of each possible response (ranging from "cannot do" to "without any difficulty") was determined for each question. The distribution of responses given by each score group for each question was graphically displayed to generate an intuitive map linking PROMIS scores to patient ability levels (with ability levels represented by how patients responded to the PROMIS items). RESULTS: Twenty-eight items from the 165-question item bank were used frequently (that is, administered to more than 0.1% of the cohort) by the PROMIS CAT software. The top four items constituted 63% of all items. These top four items asked about the patient's ability to perform 2 hours of physical labor, yard work, household chores, and walking more than 1 mile. Graphical displays of responses to the top 28 and top four items revealed how PROMIS scores correspond to patient ability levels. Patients with a score of 40 most frequently responded that they experienced "some difficulty" with physical labor, yard work, household chores, and walking more than 1 mile, compared with "little" or "no" difficulty for patients with a score of 50 and "cannot do" for patients with a score of 30. CONCLUSION: We provided a visual key linking PROMIS numerical scores to physical ability levels using clinically relevant, familiar terms. Future studies might investigate whether using similar graphical displays as a patient education tool enhances patient-provider communication and improves the patient experience. CLINICAL RELEVANCE: The visual explanation of PROMIS scores provided by this study may help new users of the PROMIS understand the instrument, feel empowered to incorporate it into their practices, and use it as a tool for counseling patients about their scores.

The Impact of Halting Elective Admissions in Anticipation of a Demand Surge Due to the Coronavirus Pandemic (COVID-19).

BACKGROUND: In anticipation of a demand surge for hospital beds attributed to the coronavirus pandemic (COVID-19) many US states have mandated that hospitals postpone elective admissions. OBJECTIVES: To estimate excess demand for hospital beds due to COVID-19, the net financial impact of eliminating elective admissions in order to meet demand, and to explore the scenario when demand remains below capacity. RESEARCH DESIGN: An economic simulation to estimate the net financial impact of halting elective admissions, combining epidemiological reports, the US Census, American Hospital Association Annual Survey, and the National Inpatient Sample. Deterministic sensitivity analyses explored the results while varying assumptions for demand and capacity. SUBJECTS: Inputs regarding disease prevalence and inpatient utilization were representative of the US population. Our base case relied on a hospital admission rate reported by the Center for Disease Control and Prevention of 137.6 per 100,000, with the highest rates in people aged 65 years and older (378.8 per 100,000) and 50-64 years (207.4 per 100,000). On average, elective admissions accounted for 20% of total hospital admissions, and the average rate of unoccupied beds across hospitals was 30%. MEASURES: Net financial impact of halting elective admissions. RESULTS: On average, hospitals COVID-19 demand for hospital bed-days fell well short of hospital capacity, resulting in a substantial financial loss. The net financial impact of a 90-day COVID surge on a hospital was only favorable under a narrow circumstance when capacity was filled by a high proportion of COVID-19 cases among hospitals with low rates of elective admissions. CONCLUSIONS: Hospitals that restricted elective care took on a substantial financial risk, potentially threatening viability. A sustainable public policy should therefore consider support to hospitals that responsibly served their communities through the crisis.

Treating the Aging Spine.

Demographic trends make it incumbent on orthopaedic spine surgeons to recognize the special challenges involved in caring for older patients with spine pathology. Unique pathologies, such as osteoporosis and degenerative deformities, must be recognized and treated. Recent treatment options and recommendations for the medical optimization of bone health include vitamin D and calcium supplementation, diphosphonates, and teriparatide. Optimizing spinal fixation in elderly patients who have osteoporosis is critical; cement augmentation of pedicle screws is promising. In the management of geriatric odontoid fractures, nonsurgical support with a collar may be considered for low-demand patients, whereas surgical fixation is favored for high-demand patients. Management of degenerative deformity must address sagittal plane balance, which includes consideration of pelvic incidence. Various osteotomies may prove helpful in this setting.

Avoiding and Managing Intraoperative Complications During Cervical Spine Surgery.

The incidence of intraoperative complications during cervical spine surgery is low; however, if they do occur, intraoperative complications have the potential to cause considerable morbidity and mortality. Spine surgeons should be familiar with methods to minimize intraoperative complications. If they do occur, surgeons must be prepared to immediately treat each potential complication to reduce any associated morbidity.

The effect of aging on posterior intertransverse lumbar fusion: a New Zealand white rabbit model.

STUDY DESIGN: In vivo assessment of lumbar spinal fusion between a younger and older cohort of New Zealand white rabbits. OBJECTIVE: Directly compare fusion within young and aged New Zealand white rabbits to establish an aged spinal fusion model translational research. SUMMARY OF BACKGROUND DATA: Prior studies have utilized skeletally mature young rabbits (6-12 mo old) that may not be appropriate as an analog for studying the aging human spine. METHODS: Ten aged (>36 mo old) and 10 young (12 mo old) New Zealand white rabbits underwent a single-level, bilateral, L5-6 posterolateral intertransverse fusion using autogenous iliac crest bone graft. The animals were killed at 6 weeks postoperatively, and the specimens were then evaluated with quantitative microcomputerized tomography and manual palpation by 6 orthopedic surgeons. The fusions were graded as either fused or not fused by each examiner. The spines were then embedded in poly(methyl methacrylate) and cut into 2-mm-thick sections for histologic analysis. RESULTS: A higher percentage of young rabbits were determined to be successfully fused through manual palpation testing compared with the aged rabbits. Micro-computed tomography (CT) analysis revealed a significantly greater fusion mass volume in the younger rabbits than in the older cohort. In addition, the fusion density of the younger rabbits was found to be significantly lower than that of the older rabbits when normalized to the bone density in the nonfused portion of the spine. Histologic analysis showed that the quality of the bone within the fusion mass was consistent between the young and old rabbits. A greater number of young animals had bilateral continuous bone graft compared with the aged animals. CONCLUSIONS: The aged (>36 mo) New Zealand white rabbit model appears to be a valid model to evaluate the effect of aging on lumbar fusion and has the potential to more accurately model conditions that are present in the older human spine.

Upper cervical injuries - a rational approach to guide surgical management.

CONTEXT: The complex anatomy and the importance of ligaments in providing stability at the upper cervical spine region (O-C1-C2) require the use of many imaging modalities to evaluate upper cervical injuries (UCI). While separate classifications have been developed for distinct injuries, a more practical treatment algorithm can be derived from the injury pattern in UCI. OBJECTIVE: To propose a practical treatment algorithm to guide treatment based on injuries characteristic of UCI. METHODS: A literature review was performed on the Pubmed database using the following keywords: (1) "occipital condyle injury"; (2) "craniocervical dislocation or atlanto-occipital dislocation or craniocervical dislocation"; (3) "atlas fractures"; and (4) "axis fractures". Just articles containing the diagnosis, classification, and treatment of specific UCI were included. The data obtained were analyzed by the authors, dividing the UCI into two groups: Group 1 - patients with clear ligamentous injury and Group 2 - patients with fractures without ligament disruption. RESULTS: Injuries with ligamentous disruption, suggesting surgical treatment, include: atlanto-occipital dislocation, mid-substance transverse ligament injury, and C1-2 and C2-3 ligamentous injuries. In contrast, condyle, atlas, and axis fractures without significant displacement/misalignment can be initially treated using external orthoses. Odontoid fractures with risk factors for non-union are an exception in Group 2 once they are better treated surgically. Patients with neurological deficits may have more unstable injuries. CONCLUSIONS: Ascertaining the status of relevant ligamentous structures, fracture patterns and alignment are important in determining surgical compared with non-surgical treatment for patients with UCI.

Does Operative Level Impact Dysphagia Severity After Anterior Cervical Discectomy and Fusion?: A Multicenter Prospective Analysis.

STUDY DESIGN: Prospective multicenter cohort study. OBJECTIVE: To explore the association between operative level and postoperative dysphagia after anterior cervical discectomy and fusion (ACDF). BACKGROUND: Dysphagia is common after ACDF and has several risk factors, including soft tissue edema. The degree of prevertebral soft tissue edema varies based on the operative cervical level. However, the operative level has not been evaluated as a source of postoperative dysphagia. PATIENTS AND METHODS: Adult patients undergoing elective ACDF were prospectively enrolled at 3 academic centers. Dysphagia was assessed using the Bazaz Questionnaire, Dysphagia Short Questionnaire, and Eating Assessment Tool-10 (EAT-10) preoperatively and at 2, 6, 12, and 24 weeks postoperatively. Patients were grouped based on the inclusion of specific surgical levels in the fusion construct. Multivariable regression analyses were performed to evaluate the independent effects of the number of surgical levels and the inclusion of each particular level on dysphagia symptoms. RESULTS: A total of 130 patients were included. Overall, 24 (18.5%) patients had persistent postoperative dysphagia at 24 weeks and these patients were older, female, and less likely to drink alcohol. There was no difference in operative duration or dexamethasone administration. Patients with persistent dysphagia were significantly more likely to have C4-C5 included in the fusion construct (62.5% vs . 34.9%, P = 0.024) but there were no differences based on the inclusion of other levels. On multivariable regression, the inclusion of C3-C4 or C6-C7 was associated with more severe EAT-10 (ß: 9.56, P = 0.016 and ß: 8.15, P = 0.040) and Dysphagia Short Questionnaire (ß: 4.44, P = 0.023 and (ß: 4.27, P = 0.030) at 6 weeks. At 12 weeks, C3-C4 fusion was also independently associated with more severe dysphagia (EAT-10 ß: 4.74, P = 0.024). CONCLUSION: The location of prevertebral soft tissue swelling may impact the duration and severity of patient-reported dysphagia outcomes at up to 24 weeks postoperatively. In particular, the inclusion of C3-C4 and C4-C5 into the fusion may be associated with dysphagia severity.

Postoperative C5 Palsy after Anterior or Posterior Decompression for Degenerative Cervical Myelopathy: A Subgroup Analysis of the Multicenter, Prospective, Randomized, Phase III, CSM-Protect Clinical Trial.

STUDY DESIGN: Retrospective cohort study of prospectively accrued data. OBJECTIVE: To evaluate a large, prospective, multicentre dataset of surgically-treated DCM cases on the contemporary risk of C5 palsy with surgical approach. SUMMARY OF BACKGROUND DATA: The influence of surgical technique on postoperative C5 palsy after decompression for degenerative cervical myelopathy (DCM) is intensely debated. Comprehensive analyses are needed using contemporary data and accounting for covariates. METHODS: Patients with moderate to severe DCM were prospectively enrolled in the multicenter, randomized CSM-Protect clinical trial and underwent either anterior or posterior decompression between Jan 31, 2012, to May 16, 2017. The primary outcome was the incidence of postoperative C5 palsy, defined as onset of muscle weakness by at least one grade in manual muscle test at the C5 myotome with slight or absent sensory disruption after cervical surgery. Two comparative cohorts were made based on anterior or posterior surgical approach. Multivariate hierarchical mixed-effects logistic regression was used to estimate odds ratios (OR) with 95% confidence intervals (CI) for C5 palsy. RESULTS: A total of 283 patients were included, and 53.4% underwent posterior decompression. The total incidence of postoperative C5 palsy was 7.4% and was significantly higher in patients that underwent posterior decompression compared to anterior decompression (11.26% vs. 3.03%, P=0.008). After multivariable regression, posterior approach was independently associated with greater than four times the likelihood of postoperative C5 palsy (P=0.017). Rates of C5 palsy recovery were comparable between the two surgical approaches. CONCLUSION: The odds of postoperative C5 palsy are significantly higher after posterior decompression compared to anterior decompression for DCM. This may influence surgical decision-making when there is equipoise in deciding between anterior and posterior treatment options for DCM. LEVEL OF EVIDENCE: Therapeutic Level II.

Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial.

Importance: The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery. Objective: To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM. Design, Setting, and Participants: This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023. Intervention: Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery. Main Outcomes and Measures: The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE). Results: Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007). Conclusions and Relevance: In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.

Preoperative Fluoroscopically Guided Regional Erector Spinae Plane Blocks Reduce Opioid Use, Increase Mobilization, and Reduce Length of Stay Following Lumbar Spine Fusion.

STUDY DESIGN: Retrospective review. OBJECTIVE: To determine the effectiveness of erector spinae plane (ESP) blocks at improving perioperative pain control and function following lumbar spine fusions. METHODS: A retrospective analysis was performed on patients undergoing < 3 level posterolateral lumbar fusions. Data was stratified into a control group and a block group. We collected postop MED (morphine equivalent dosages), physical therapy ambulation, and length of stay. PROMIS pain interference (PI) and physical function (PF) scores, ODI, and VAS were collected preop and at the first postop visit. Chi-square and student's t-test (P = .05) were used for analysis. We also validated a novel fluoroscopic technique for ESP block delivery. RESULTS: There were 37 in the block group and 39 in the control group. There was no difference in preoperative opioid use (P = .22). On postop day 1, MED was reduced in the block group (32 vs 51, P < .05), and more patients in the block group did not utilize any opioids (22% vs 5%, P < .05). The block group ambulated further on postop day 1 (312 ft vs 204 ft, P < .05), and had reduced length of stay (2.4 vs 3.2 days, P < .05). The block group showed better PROMIS PI scores postoperatively (58 vs 63, P < .05). The novel delivery technique was validated and successful in targeting the correct level and plane. CONCLUSIONS: ESP blocks significantly reduced postop opioid use following lumbar fusion. Block patients ambulated further with PT, had reduced length of stay, and had improved PROMIS PI postoperatively. Validation of the block demonstrated the effectiveness of a novel fluoroscopic delivery technique. ESP blocks represent an underutilized method of reducing opioid consumption, improving postoperative mobilization and reducing length of stay following lumbar spine fusion.

Risk Factors for Postoperative Ileus in Patients Undergoing Spine Surgery.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: Postoperative ileus (POI) is a common complication following elective spinal surgeries. The aim of this study was to determine the incidence of POI and identify demographic and surgical risk factors for developing POI after elective instrumented fusion of the thoracolumbar spine. METHODS: The University of Utah Institutional Review Board (IRB) approved this retrospective study. The study does not require informed consent given the data reviewed was deidentified and collected in accordance with the institution's standard of care. A designated IRB committee determined that study is exempt under exemption category 7. IRB approval number 00069703. Patients undergoing instrumented thoracolumbar fusion for one or more levels were retrospectively identified from an internal spine surgery database. Cases performed for trauma, infection, or tumors were excluded. Demographics, medical comorbidities, surgical variables, and opioid medication administration (morphine milligram equivalents, MME) were abstracted from the electronic medical record. Univariate analysis was used to identify variables associated with POI. These variables were then tested for independent association with POI using multivariate logistic regression. RESULTS: 418 patients were included in the current study. The incidence of POI was 9.3% in this cohort. There was no significant relationship between development of POI and patient age, gender, BMI, diabetes mellitus, thyroid dysfunction, lung disease, CKD, GERD, smoking status, alcohol abuse, anemia, or prior abdominal surgery. Univariate analysis demonstrated significant association between POI and fusion ≥7 levels compared to fusions of fewer levels (P = .001), as well as intraoperative sufentanil compared to other opioids (35.9% vs 20.1%, P = .02). POI was not significantly associated with total intraoperative MME, approach, use of interbody cage, or osteotomy. Multivariate logistic regression confirmed total 24-hour postoperative MME as an independent risk factor for POI (OR 1.004, P = .04), however, intraoperative sufentanil administration was not an independent risk factor for POI when controlling for other variables. CONCLUSIONS: This retrospective cohort study demonstrates that greater postoperative MME is an independent risk factor for POI after thoracolumbar spine fusion when accounting for demographic, medical, and surgical variables with multiple logistic regression. Prospective studies are warranted to evaluate clinical measures to decrease the risk of POI among patients undergoing instrumented thoracolumbar spinal fusions.

Surgeon input can increase the value of registry data: early experience from the American Spine Registry.

OBJECTIVE: Clear diagnostic delineation is necessary for the development of a strong evidence base in lumbar spinal surgery. Experience with existing national databases suggests that International Classification of Diseases, Tenth Edition (ICD-10) coding is insufficient to support that need. The purpose of this study was to assess agreement between surgeon-specified diagnostic indication and hospital-reported ICD-10 codes for lumbar spine surgery. METHODS: Data collection for the American Spine Registry (ASR) includes an option to denote the surgeon's specific diagnostic indication for each procedure. For cases treated between January 2020 and March 2022, surgeon-delineated diagnosis was compared with the ICD-10 diagnosis generated by standard ASR electronic medical record data extraction. For decompression-only cases, the primary analysis focused on the etiology of neural compression as determined by the surgeon versus that determined on the basis of the related ICD-10 codes extracted from the ASR database. For lumbar fusion cases, the primary analysis compared structural pathology, which may have required fusion, as determined by the surgeon versus that determined on the basis of the extracted ICD-10 codes. This allowed for identification of agreement between surgeon delineation and extracted ICD-10 codes. RESULTS: In 5926 decompression-only cases, agreement between the surgeon and ASR ICD-10 codes was 89% for spinal stenosis and 78% for lumbar disc herniation and/or radiculopathy. Both the surgeon and database indicated no structural pathology (i.e., none) suggesting the need for fusion in 88% of cases. In 5663 lumbar fusion cases, agreement was 76% for spondylolisthesis but poor for other diagnostic indications. CONCLUSIONS: Agreement between surgeon-specified diagnostic indication and hospital-reported ICD-10 codes was best for patients who underwent decompression only. In the fusion cases, agreement with ICD-10 codes was best in the spondylolisthesis group (76%). In cases other than spondylolisthesis, agreement was poor due to multiple diagnoses or lack of an ICD-10 code that reflected the pathology. This study suggested that standard ICD-10 codes may be inadequate to clearly define the indications for decompression or fusion in patients with lumbar degenerative disease.

Development and validation of a large animal ovine model for implant-associated spine infection using biofilm based inocula.

Postoperative implant-associated spine infection remains poorly understood. Currently there is no large animal model using biofilm as initial inocula to study this challenging clinical entity. The purpose of the present study was to develop a sheep model for implant-associated spine infection using clinically relevant biofilm inocula and to assess the in vivo utility of methylene blue (MB) for visualizing infected tissues and guiding debridement. This 28-day study used five adult female Rambouillet sheep, each with two non-contiguous surgical sites- in the lumbar and thoracic regions- comprising randomized positive and negative infection control sites. A standard mini-open approach to the spine was performed to place sterile pedicle screws and Staphylococcus aureus biofilm-covered (positive control), or sterile (negative control) spinal fusion rods. Surgical site bioburden was quantified at the terminal procedure. Negative and positive control sites were stained with MB and staining intensity quantified from photographs. Specimens were analyzed with x-ray, micro-CT and histologically. Inoculation rods contained ∼10.44 log10 colony forming units per rod (CFU/rod). Biofilm inocula persisted on positive-control rod explants with ∼6.16 log10 CFU/rod. There was ∼6.35 log10 CFU/g of tissue in the positive controls versus no identifiable bioburden in the negative controls. Positive controls displayed hallmarks of deep spine infection and osteomyelitis, with robust local tissue response, bone resorption, and demineralization. MB staining was more intense in infected, positive control sites. This work presents an animal-efficient sheep model displaying clinically relevant implant-associated deep spine infection.

Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial.

Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. An international, multi-center, prospective, randomized, double-blinded, placebo-controlled, adaptive, Phase III trial (NCT01597518) was undertaken. Patients with American Spinal Injury Association Impairment Scale (AIS) A-C, cervical (C4-C8) tSCI, and <12 h from injury were randomized to receive either riluzole, at an oral dose of 100 mg twice per day (BID) for the first 24 h followed by 50 mg BID for the following 13 days, or placebo. The primary efficacy end-point was change in Upper Extremity Motor (UEM) scores at 180 days. The primary efficacy analyses were conducted on an intention to treat (ITT) and completed cases (CC) basis. The study was powered at a planned enrolment of 351 patients. The trial began in October 2013 and was halted by the sponsor on May 2020 (and terminated in April 2021) in the face of the global COVID-19 pandemic. One hundred ninety-three patients (54.9% of the pre-planned enrolment) were randomized with a follow-up rate of 82.7% at 180 days. At 180 days, in the CC population the riluzole-treated patients compared with placebo had a mean gain of 1.76 UEM scores (95% confidence interval: -2.54-6.06) and 2.86 total motor scores (CI: -6.79-12.52). No drug-related serious adverse events were associated with the use of riluzole. Additional pre-planned sensitivity analyses revealed that in the AIS C population, riluzole was associated with significant improvement in total motor scores (estimate: standard error [SE] 8.0; CI 1.5-14.4) and upper extremity motor scores (SE 13.8; CI 3.1-24.5) at 6 months. AIS B patients had higher reported independence, measured by the Spinal Cord Independence Measure score (45.3 vs. 27.3; d: 18.0 CI: -1.7-38.0) and change in mental health scores, measured by the Short Form 36 mental health domain (2.01 vs. -11.58; d: 13.2 CI: 1.2-24.8) at 180 days. AIS A patients who received riluzole had a higher average gain in neurological levels at 6 months compared with placebo (mean 0.50 levels gained vs. 0.12 in placebo; d: 0.38, CI: -0.2-0.9). The primary analysis did not achieve the predetermined end-point of efficacy for riluzole, likely related to insufficient power. However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.

Is Discretionary Care Associated with Safety Among Medicare Beneficiaries Undergoing Spine Surgery?

BACKGROUND: Spine surgery and its corresponding costs have increased in recent years and are variable across geographic regions. Discretionary care is the component of spending variation that is independent of illness severity, age, and regional pricing. It is unknown whether greater discretionary care is associated with improved safety for patients undergoing spine surgery, as we would expect from value-based health care. METHODS: We conducted an analysis of 5 spine surgery cohorts based on Medicare claims from 2013 to 2017. Patients were grouped into quintiles based on the Dartmouth Atlas End-of-Life Inpatient Care Index (EOL), reflecting regional spending variation attributed to discretionary care. Multivariable regression examined the association between discretionary care and safety measures while controlling for age, sex, race, comorbidity, and hospital features. RESULTS: We observed a threefold to fourfold variation in 90-day episode-of-care cost across regions, depending on the cohort. Spine-specific spending was correlated with EOL quintile, confirming that spending variation is due more to discretionary care than it is to pricing, age, or illness severity. Greater spending across EOL quintiles was not associated with improved safety, and, in fact, was associated with poorer safety in some cohorts. For example, all-cause readmission was greater in the high-spending EOL quintile relative to the low-spending EOL quintile among the "fusion, except cervical" cohort (14.2% vs. 13.1%; OR = 1.10; 95% CI = 1.05 to 1.20), the "complex fusion" cohort (28.0% vs. 25.4%; OR = 1.15; 95% CI = 1.01 to 1.30), and the "cervical fusion" cohort (15.0% vs. 13.6%; OR = 1.12; 95% CI = 1.05 to 1.20). CONCLUSIONS: Wide variation in spending was not explained by differences in illness severity, age, or pricing, and increased discretionary care did not enhance safety. These findings point to inefficient use of health-care resources, a potential focus of reform. LEVEL OF EVIDENCE: Economic and Decision Analysis Level IV. See Instructions for Authors for a complete description of levels of evidence.

Predictors of Dysphagia After Anterior Cervical Discectomy and Fusion: A Prospective Multicenter Study.

STUDY DESIGN: Multicenter prospective study. OBJECTIVE: Our aim was to evaluate the incidence and predictors of postoperative dysphagia in patients undergoing anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Dysphagia is a common complication after ACDF that can have significant effect on patients' quality of life, but the frequency of occurrence and potential risk factors are not known. METHODS: A multicenter prospective study was undertaken at three academic sites to evaluate patients undergoing ACDF between September 2018 and September 2020. Included patients were aged 18 to 80 years and were undergoing primary or revision ACDF for a degenerative condition. Dysphagia was assessed using the validated Eating Assessment Tool (EAT-10) questionnaire, with dysphagia defined as EAT-10 ≥ 3. RESULTS: A total of 170 patients (53.5% female; mean age at surgery 55.0 yr) were included. At preoperative baseline, 23 patients (13.5%) had dysphagia. Rates of dysphagia increased to 45.3% at 2 weeks postoperatively but gradually decreased to 15.3% at 24weeks. On univariate analysis, patients with dysphagia at 2weeks had longer operations (113.1 ±â€Š58.4 vs. 89.0 ±â€Š39.8 minutes, P   =  0.003) and higher baseline dysphagia rates (18.2% vs. 6.2%, P   =  0.018) and were more likely to be female (66.2% vs. 45.7%, P   =  0.009). Patients with prolonged dysphagia had more levels fused (2.1 ±â€Š1.0 vs. 1.7 ±â€Š0.7, P   =  0.020), longer operations (131.8 ±â€Š63.1 vs. 89.3 ±â€Š44.3 min-minutes, P   <  0.001), and higher baseline dysphagia rates (32% vs. 7.1%, P   <  0.001) and were more likely to be smokers (24% vs. 8%, P   =  0.021). On multivariate analysis to determine associations with prolonged dysphagia, only smoking status (OR 6.2, 95% CI 1.57-24.5, P   =  0.009) and baseline dysphagia (OR 5.1, 95% CI 1.47-17.6, P   =  0.01) remained significant. CONCLUSION: Dysphagia is common immediately after ACDF, but rates of prolonged dysphagia are similar to preoperative baseline rates. We identified dysphagia rates over time and several patient factors associated with development of short- and long-term postoperative dysphagia.Level of Evidence: 3.

Summary of the FDA virtual public workshop on spinal device clinical review held on September 17, 2021.

The mission of Food and Drug Administration (FDA)'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products by providing meaningful and timely information about the products we regulate and the decisions we make. On September 17, 2021, an FDA workshop was held to provide information to stakeholders, including members of the spine community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public regarding FDA regulations, guidance and regulatory pathways related to spinal device clinical review. It was not intended to communicate any new policies, processes, or interpretations regarding medical device marketing authorizations. This workshop consisted of individual presentations, group discussions, question and answer sessions, and audience surveys. Information-sharing included discussions related to patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. Discussions involving external subject matter experts covered topics related to spinal device clinical studies including definition of a target population, enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments. A meeting transcript and webcast workshop link are currently posted on the FDA website. Important related issues and challenges were discussed, and an exciting range of new ideas and concepts were shared which hold promise to advance regulatory science, patient care and future innovation related to spinal devices.

What Does Your PROMIS Score Mean? Improving the Utility of Patient-Reported Outcomes at the Point of Care.

STUDY DESIGN: Prospective cohort. OBJECTIVES: Patient-Reported Outcome Measurement Information System (PROMIS) has been validated for lumbar spine. Use of patient-reported outcome (PRO) measures can improve clinical decision making and health literacy at the point of care. Use of PROMIS, however, has been limited in part because clinicians and patients lack plain language understanding of the meaning of scores and it remains unclear how best to use them at the point of care. The purpose was to develop plain language descriptions to apply to PROMIS Physical Function (PF) and Pain Interference (PI) scores and to assess patient understanding and preferences in presentation of their individualized PRO information. METHODS: Retrospective analysis of prospectively collected PROMIS PF v1.2 and PI v1.1 for patients presenting to a tertiary spine center for back/lower extremity complaints was performed. Patients with missing scores, standard error >0.32, and assessments with <4 or >12 questions were excluded. Scores were categorized into score groups, specifically PROMIS PF groups were: <18, 20 ± 2, 25 ± 2, 30 ± 2, 35 ± 2, 40 ± 2, 45 ± 2, 50 ± 2, 55 ± 2, 60 ± 2, and >62; and PROMIS PI groups were: <48, 50 ± 2, 55 ± 2, 60 ± 2, 65 ± 2, 70 ± 2, 75 ± 2, 80 ± 2, and >82. Representative questions and answers from the PROMIS PI and PROMIS PF were selected for each score group, where questions with <25 assessments or representing <15% of assessments were excluded. Two fellowship-trained spine surgeons further trimmed the questions to create a streamlined clinical tool using a consensus process. Plain language descriptions for PROMIS PF were then used in a prospective assessment of 100 consecutive patients. Patient preference for consuming the score data was recorded and analyzed. RESULTS: In total, 12 712 assessments/5524 unique patients were included for PF and 14 823 assessments/6582 unique patients for PI. More than 90% of assessments were completed in 4 questions. The number of assessments and patients per scoring group were normally distributed. The mean PF score was 37.2 ± 8.2 and the mean PI was 63.3 ± 7.4. Plain language descriptions and compact clinical tool was were generated. Prospectively 100 consecutive patients were surveyed for their preference in receiving their T-score versus plain language description versus graphical presentation. A total of 78% of patients found receiving personalized PRO data helpful, while only 1% found this specifically not helpful. Overall, 80% of patients found either graphical or plain language more helpful than T-score alone, and half of these preferred plain language and graphical descriptions together. In total, 89% of patients found the plain language descriptions to be accurate. CONCLUSIONS: Patients at the point of care are interested in receiving the results of their PRO measures. Plain language descriptions of PROMIS scores enhance patient understanding of PROMIS numerical scores. Patients preferred plain language and/or graphical representation rather than a numerical score alone. While PROs are commonly used for assessing outcomes in research, use at point of care is a growing interest and this study clarifies how they might be utilized in physician-patient communication.

Cost analysis of primary single-level lumbar discectomies using the Value Driven Outcomes database in a large academic center.

BACKGROUND CONTEXT: Improving value is an established point of emphasis to reduce the rapidly rising health care costs in the United States. Back pain is a major driver of costs with a substantial fraction caused by lumbar radiculopathy. The most common surgical treatment for lumbar radiculopathy is microdiscectomy. Research is sparse regarding variables driving cost in microdiscectomies and often limited by cost data derived from payer-based Medicare data. PURPOSE: To identify targets for cost reduction by determining variables associated with significant cost variation in microdiscectomies, using cost data derived from the Value Driven Outcomes tool and actual system costs. STUDY DESIGN: Single-center, retrospective study of prospectively collected registry data. PATIENT SAMPLE: Six hundred twenty-two patients identified by CPT code and manually screened for initial, unilateral, single-level lumbar discectomy performed between 2014 and 2018 at a single institution. OUTCOME MEASURES: Primary outcome measures include total direct cost, clinical length of stay, and OR minutes. Total Direct Cost was further differentiated into facility and nonfacility costs. METHODS: Univariate and multivariate generalized linear models (GLM) were used to identify variables associated with variation in primary outcome measures. Costs were normalized by mean cost for patients with normal body mass index (BMI) and a healthy American Society of Anesthesiologists (ASA) classification. Average marginal effects were reported as percentage of normalized costs. RESULTS: Advanced age, male gender, Hispanic, black, unemployment, obesity, higher ASA class, insurance status, and being retired were positively associated with costs in univariate analysis. Asian, Native American, outpatient procedures, and being a student were associated with decreases in costs. In multivariate analysis, we found that obesity led to higher average marginal total direct (9%), total facility (15%), and facility OR costs (22%), as well as 24 more OR minutes per surgery. While being overweight was not associated with greater total direct costs, it was associated with higher total facility (8%), and facility OR costs (12%), with 11 more OR minutes per surgery. Age was associated with a longer LOS but not with OR costs. As expected, outpatient surgical costs, LOS, and OR time were significantly lower than inpatient procedures. Severe systematic disease was associated with greater total and nonfacility costs. In addition, Medicare patients had higher facility costs (14%) compared to privately insured patients. CONCLUSIONS: Significant drivers of total direct cost in multivariate GLM analysis were obesity, severe systemic disease and inpatient surgery. Average LOS was increased due to age and inpatient status, conversely it was decreased by unemployment and retirement. Significant variables in OR time were male sex, Hispanic race and both obese and overweight BMIs.

Linking Oswestry Disability Index to the PROMIS pain interference CAT with equipercentile methods.

BACKGROUND CONTEXT: When different health care providers use different patient-reported outcome (PRO) instruments, it is challenging to integrate findings that describe particular patient groups or to establish treatment effectiveness across studies. It is therefore critical to develop accurate ways to convert scores between various instruments for clinicians and researchers to make comparisons across health outcomes. PURPOSE: To develop a common metric so that scores on the Oswestry Disability Index (ODI) and scores on the PROMIS Physical Function can be converted interchangeably. STUDY DESIGN/SETTING: Data were collected from a prospective study. A single-group linking design was used. PATIENT SAMPLE: The study population included 9020 patients presented to an orthopedic spine clinic from November 2013 to March 2019. OUTCOME MEASURES: Patients completed the ODI and the PROMIS Pain Interference scale delivered by Computerized Adaptive Testing (CAT) at the same time prior to their visit with a spine clinician. METHODS: Equipercentile linking methods based on log-linear smoothing approach and non-smoothing approach were used to establish a common metric across the two measures. RESULTS: The two measures assess the similar contruct of pain. The correlation between the scores of the ODI and the PROMIS PI was 0.81. The standardized Root Expected Mean Square Difference (REMSD) values for gender, ethnic, and racial groups ranged from 3.55% to 4.81%. Hence, the assumptions for the equipercentile linking method were met. The crosswalk derived linked scores based on the log-linear smoothing method yielded small deviations (Δ = 0.09) from the observed scores. We then identified linked PROMIS-PI scores corresponding to the benchmark ODI scores for the five disability levels and for various categories of patients. CONCLUSIONS: This study is the first to create crosswalks to interchangeably convert scores between the ODI to the PROMIS-PI in a large population of spine patients using the equipercentile linking method. The results of this study provide confidence in the validity and usefulness of the derived crosswalks based on the equipercentile linking approach. The crosswalks are helpful for comparing new and old studies on the two measures and identifying benchmark scores for various diseases and disability levels.