Facets of physical function assessed by patient-reported outcome measures in oncology research.

PURPOSE: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure. METHODS: As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a "card sort" activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item. RESULTS: The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation. CONCLUSION: Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials.

Risk factors for prolonged length of stay in patients undergoing surgery for intramedullary spinal cord tumors.

Primary spine tumors are rare neoplasms that affect about 0.62 per 100,000 individuals in the US. Intramedullary spinal cord tumors (IMSCTs) are the rarest of all primary tumors involving the spine and can cause pain, imbalance, urinary dysfunction and neurological deficits. These types of tumors oftentimes necessitate surgical treatment, yet there is a lack of data on hospital length of stay and complication rates following treatment. Given that treatment candidacy, quality of life, and outcomes are tied so closely to potential for prolonged length of stay and postoperative complications, it is important to better understand the factors that increase the risk of these outcomes in patients with IMSCTs. METHODS: The National Surgical Quality Improvement Program (NSQIP) database was queried for all patients undergoing surgery for treatment of intramedullary spinal cord tumors between 2005 and 2017. Univariate and multivariate analysis were performed to assess patient risk factors influencing prolonged length of stay and post-op complications. RESULTS: A total of 638 patients were included in the analysis. Pre-operative American Society of Anesthesiology (ASA) physical status classification of 3 and above (OR 1.89; p = 0.0005), dependent functional status (OR 2.76; p = 0.0035) and transfer from facilities other than home (OR 8.12; p <0.0001) were independent predictors of prolonged length of stay (>5 days). The most commonly reported complications were pneumonia (5.7%), urinary tract infection (9.4%), septic shock (3.8%), superficial incisional infection (5.7%), organ or space infection (5.7%), pulmonary embolism (11.3%), DVT requiring therapy (15.1%) and wound dehiscence (5.7%). CONCLUSION: Our study demonstrated the significant influence of clinical variables on prolonged hospitalization of IMSCT patients. This should be factored into clinical and surgical decision making and when counseling patients of their expected outcomes.

Percutaneous Lumbar Interbody Fusion With an Expandable Titanium Cage Through Kambin's Triangle: A Case Series With Initial Clinical and Radiographic Results.

BACKGROUND: There has been an increased interest in lumbar interbody fusions through Kambin's triangle. In this study, we describe percutaneous access to the lumbar disc and insertion of an expandable titanium cage through Kambin's triangle without facetectomy. The objective of this study is to determine the feasibility as well as clinical and radiographical outcomes of completely percutaneous lumbar interbody fusion (percLIF) using an expandable titanium cage through Kambin's triangle. METHODS: A retrospective review of patients undergoing single-level percLIF for grade 1 lumbar spondylolisthesis via Kambin's triangle using an expandable titanium cage was performed. Demographic information, Oswestry Disability Index (ODI), preoperative and postoperative radiographic factors, perioperative data, and complications were recorded. Fusion was assessed with 1-year postoperative computed tomography scan or lumbar spine x-ray and defined as bridging disc or posterolateral fusion without evidence of hardware fracture or perihardware lucency. RESULTS: A total of 16 patients (3 males) were included in this study. Spondylolisthesis, anterior disc height, and posterior disc height were significantly improved at 6 weeks, 6 months, and 12 months, postoperatively (P < 0.05). ODI was significantly improved by 24.4% at 12 months postoperatively (P = 0.0036). One patient was readmitted within 30 days for pain control but otherwise there were no complications including permanent neurological injury, infection, deep vein thrombosis, pulmonary embolism, or cardiac events. Fifteen (93.8%) patients had radiographic fusion at their 1-year postoperative imaging. CONCLUSION: Our initial experiences have shown that percLIF can be performed using an expandable titanium cage through Kambin's triangle with excellent radiographic and clinical results. In this series, percLIF is a safe and clinically efficacious procedure for reducing grade 1 lumbar spondylolisthesis and improving radiculopathy. This procedure is completed percutaneously without the use of an endoscope. CLINICAL RELEVANCE: This study highlights improvements in outcomes of minimally invasive surgery. LEVEL OF EVIDENCE: IV.

Hematocrit as a predictor of preoperative transfusion-associated complications in spine surgery: A NSQIP study.

BACKGROUND CONTEXT: Preoperative optimization of medical comorbidities prior to spinal surgery is becoming an increasingly important intervention in decreasing postoperative complications and ensuring a satisfactory postoperative course. The treatment of preoperative anemia is based on guidelines made by the American College of Cardiology (ACC), which recommends packed red blood cell transfusion when hematocrit is less than 21% in patients without cardiovascular disease and 24% in patients with cardiovascular disease. The literature has yet to quantify the risk profile associated with preoperative pRBC transfusion. PURPOSE: To determine the incidence of complications following preoperative pRBC transfusion in a cohort of patients undergoing spine surgery. STUDY DESIGN: Retrospective review of a national surgical database. PATIENT SAMPLE: The national surgical quality improvement program database OUTCOME NEASURES: Postoperative physiologic complications after a preoperative transfusion. Complications were defined as the occurrence of any DVT, PE, stroke, cardiac arrest, myocardial infarction, longer length of stay, need for mechanical ventilation greater than 48 h, surgical site infections, sepsis, urinary tract infections, pneumonia, or higher 30-day mortality. METHODS: The national surgical quality improvement program database was queried, and patients were included if they had any type of spine surgery and had a preoperative transfusion. RESULTS: Preoperative pRBC transfusion was found to be protective against complications when the hematocrit was less than 20% and associated with more complications when the hematocrit was higher than 20%. In patients with a hematocrit higher than 20%, pRBC transfusion was associated with longer lengths of stay, and higher rates of ventilator dependency greater than 48 h, pneumonia, and 30-day mortality. CONCLUSION: This is the first study to identify an inflection point in determining when a preoperative pRBC transfusion may be protective or may contribute to complications. Further studies are needed to be conducted to stratify by the prevalence of cardiovascular disease.

Gender disparities in clinical presentation, treatment, and outcomes in metastatic spine disease.

BACKGROUND: The incidence of metastatic spine disease (MSD) is increasing among cancer patients. Given the poor outcomes and high rates of morbidity associated with MSD, it is important to determine demographic factors that could impact interventions and outcomes for this patient population. The objectives of this study were to compare in-hospital mortality and complication rates, clinical presentation, and interventions between female and male patients diagnosed with MSD. METHODS: Patient data were collected from the United States National Inpatient Sample (NIS) database from the years 2012-2014. Descriptive statistics were used to compare data from 51,800 cases; subsequently, multivariable logistic regression analyses were conducted to assess the effect of gender on outcomes. RESULTS: Males had significantly higher rates of in-hospital mortality (OR 1.30; 95 % CI 1.09-1.56, p = 0.004) and were more likely to have received surgical intervention than females (OR 1.34; 95 % CI 1.16-1.55, p < 0.001). Additionally, female patients were more likely to present with vertebral compression fracture (p < 0.001), while metastatic spinal cord compression (MSCC) and paralysis were more common in male patients (p < 0.001). There was no significant difference in rates of in-hospital complications between female and male patients. CONCLUSION: Given the significant differences in mortality, disease course, treatment, and in-hospital complications between female and male patients diagnosed with MSD, additional prospective studies are necessary to understand how to meaningfully incorporate these differences into clinical care and prognostication going forward.

Biomechanics, evaluation, and management of subaxial cervical spine injuries: A comprehensive review of the literature.

STUDY DESIGN: Literature review. OBJECTIVES: It has been reported that 2.4-3.7% of all blunt trauma victims suffer some element of cervical spine fracture, with the majority of these patients suffering from C3-7 (subaxial) involvement. With the improvement of first-response to trauma in the community, there are an increasing number of patients who survive their initial trauma and thus arrive at the hospital in need of further evaluation, stabilization, and management of these injuries. METHODS: A comprehensive literature review compiled all relevant data on the biomechanics, imaging, evaluation, and medical and surgical management strategies for subaxial cervical spine fractures. RESULTS: After review of the current literature on subaxial cervical spine biomechanics, imaging characteristics, evaluation strategies and surgical and orthopedic management techniques, the authors created a comprehensive review and protocol for management of subaxial cervical spine fractures. CONCLUSIONS: The subaxial cervical spine is biomechanically and anatomically unique from the remainder of the spinal axis. Evaluation of subaxial cervical spine injuries is nuanced, and improper management of these injuries can lead to significant patient morbidity and even death. This provides a comprehensive review combining anatomy, imaging characteristics, evaluation strategies, and surgical and orthopedic management principles for subaxial cervical spine fractures.

Hardware failure in patients with metastatic cancer to the spine.

BACKGROUND: The spine is the most common site of skeletal metastases, affecting approximately 30% of individuals with cancer. The aim of surgical treatment for metastatic spine disease is generally palliative to address pain and/or neurologic compromise, significantly improving patients' quality of life. Patients with metastatic spine disease, however, represent a vulnerable cohort and may have comorbidities or previous treatments that impair the structural integrity of spinal hardware. As such, identifying factors that may contribute to hardware failure is an essential component in treating individuals with metastatic spine disease. OBJECTIVE: The aim of this study was to identify pre-operative risk factors associated with hardware failure in patients undergoing surgical treatment for metastatic spine disease. METHODS: A retrospective cohort study was conducted to include patients surgically treated for metastatic spine tumors between 2003 and 2013, at a single institution. A univariate analysis was initially performed to identify associated factors. Any associated factor with a p-value <0.20 was included in the multivariate analysis. RESULTS: 3 patients (1.9%), of the 159 patients included in the study, had failure of the spine instrumentation. 1 patient had metastatic prostate cancer, and 2 had metastatic breast cancer. Patient demographics, co-morbidities, tumor location, and primary tumor etiology were not found to be statistically significant, with respect to hardware failure. Predictive factors included in the multivariate model were other bone metastasis, visceral metastasis, brain metastasis, Modified Rankin scale, previous systemic chemotherapy, previous radiation to the spine, and mean survival. Previous radiation to the spine was the only factor to be significantly associated (p=0.029), present in all three patients with hardware failure. Of note, there was a trend indicating that patients with longer life expectancies were more likely to experience hardware failure (mean survival of 16.7months in non-failure cohort vs. 33months in failure cohort), though this did not achieve statistical significance due to the limited sample size of patients with hardware failure. CONCLUSION: Hardware failure is a risk for all patients who undergo instrumentation following resection for metastatic spine tumors. This study identified that pre-operative radiation may increase the risk for hardware failure in this population.

Efficacy of primary microvascular decompression versus subsequent microvascular decompression for trigeminal neuralgia.

OBJECTIVE Trigeminal neuralgia (TN) is characterized by intermittent, paroxysmal, and lancinating pain along the distribution of the trigeminal nerve. Microvascular decompression (MVD) directly addresses compression of the trigeminal nerve. The purpose of this study was to determine whether patients undergoing MVD as their first surgical intervention experience greater pain control than patients who undergo subsequent MVD. METHODS A retrospective review of patient records from 1998 to 2015 identified a total of 942 patients with TN and 500 patients who underwent MVD. After excluding several cases, 306 patients underwent MVD as their first surgical intervention and 175 patients underwent subsequent MVD. Demographics and clinicopathological data and outcomes were obtained for analysis. RESULTS In patients who underwent subsequent MVD, surgical intervention was performed at an older age (55.22 vs 49.98 years old, p < 0.0001) and the duration of symptoms was greater (7.22 vs 4.45 years, p < 0.0001) than for patients in whom MVD was their first surgical intervention. Patients who underwent initial MVD had improved pain relief and no improvement in pain rates compared with those who had subsequent MVD (95.8% and 4.2% vs 90.3% and 9.7%, respectively, p = 0.0041). Patients who underwent initial MVD had significantly lower rates of facial numbness in the pre- and postoperative periods compared with patients who underwent subsequent MVD (p < 0.0001). The number of complications in both groups was similar (p = 0.4572). CONCLUSIONS The results demonstrate that patients who underwent other procedures prior to MVD had less pain relief and a higher incidence of facial numbness despite rates of complications similar to patients who underwent MVD as their first surgical intervention.

Adult cervicothoracic lipomyelomeningocele.

Lipomyelomeningocele (LMM) as a cause of tethered cord syndrome (TCS) commonly presents in childhood in the lumbosacral spine. Patients frequently present with cutaneous manifestations, progressive neurological deterioration, bladder dysfunction, and intractable pain. Early surgical intervention with untethering is recommended for symptomatic patients. We report an unusual case of a woman who presented with a subcutaneous lump, pain, and neurological decline found to have a cervicothoracic LMM. The patient underwent laminectomy and subtotal resection of the mass; seventeen years later she was confined to a wheelchair with severe neurological decline ultimately requiring three additional attempts at surgical excision and repair. This case emphasizes the need for early recognition of and intervention in adult patients with LMM.