Adverse events in surgically treated cervical spondylopathic myelopathy: a prospective validated observational study.

STUDY DESIGN: Prospective observational study. OBJECTIVE: Using validated tools to accurately identify and quantify incidence of and risks for inpatient adverse events (AEs) associated with surgical management of cervical spondylopathic myelopathy (CSM) with the goal of assisting physicians and patients in decision making. To identify patient-/disease-/technique-specific, independent risk factors for developing AEs perioperatively and affecting length of stay for patients treated surgically for CSM. SUMMARY OF BACKGROUND DATA: Previous studies have reported an overall perioperative complication rate between 15.6% and 18.52%. METHODS: A total of 104 patients underwent surgery for CSM in our academic quaternary referral center. The average age was 60.3 years (range, 34-86 yr) with a male preponderance (n = 77, 74%). The severity of myelopathy and significant comorbidities was measured and was in keeping with previously assessed populations. Surgical approach was anterior-alone (39.4%), posterior-alone (55.8%), or combined (4.8%) surgery. Inpatient AE data were collected in a rigorous, contemporaneous fashion using the previously validated Spine Adverse Events Severity System (SAVES) tool. RESULTS: A total AE rate of 42.3% was documented in surgically managed patients with CSM (intraoperative = 13.5%, postoperative = 37.5%). Statistically significant risk factors for postoperative AEs were identified, including number of comorbidities (P = 0.012), anterior surgical approach (P = 0.003), and number of levels operated on (P = 0.031). Multiple risk factors for length of stay were also identified, including number of AEs (P < 0.0001), Nurick Score (P < 0.0001), number of levels operated on (P = 0.006), and occurrence of deep wound infection (P < 0.0001). CONCLUSION: We report higher perioperative AE rates than previously recognized, due to the use of a validated, rigorous data collection tool. Multiple novel patient/disease severity/surgical factors with high statistical significance on perioperative AEs have been identified. LEVEL OF EVIDENCE: 3.

Adverse events in emergency oncological spine surgery: a prospective analysis.

OBJECT: Most descriptions of spine surgery morbidity and mortality in the literature are retrospective. Emerging prospective analyses of adverse events (AEs) demonstrate significantly higher rates, suggesting underreporting in retrospective and prospective studies that do not include AEs as a targeted outcome. Emergency oncological spine surgeries are generally palliative to reduce pain and improve patients' neurology and health-related quality of life. In individuals with limited life expectancy, AEs can have catastrophic implications; therefore, an accurate AE incidence must be considered in the surgical decision-making process. The purpose of this study was to determine the true incidence of AEs associated with emergency oncological spine surgery. METHODS: The authors carried out a prospective cohort study in a quaternary care referral center that included consecutive patients admitted between January 1, 2009, and December 31, 2012. Inclusion criteria were all patients undergoing emergency surgery for metastatic spine disease. AE data were reported and collected on standardized AE forms (Spine AdVerse Events Severity System, version 2 [SAVES V2] forms) at weekly dedicated morbidity and mortality rounds attended by attending surgeons, residents, fellows, and nursing staff. RESULTS: A total of 101 patients (50 males, 51 females) met the inclusion criteria and had complete data. Seventy-six patients (76.2%) had at least 1 AE, and 11 patients (10.9%) died during their admission. Intraoperative surgical AEs were observed in 32% of patients (9.9% incidental durotomy, 16.8% blood loss > 2 L). Transient neurological deterioration occurred in 6 patients (5.9%). Infectious complications in this patient population were significant (surgical site 6%, other 50.5%). Delirium complicated the postoperative period in 20.8% of cases. CONCLUSIONS: When evaluated in a rigorous prospective manner, metastatic spine surgery is associated with a higher morbidity rate than previously reported. This AE incidence must be considered by the patient, oncologist, and surgeon to determine appropriate management and preventative strategies to reduce AEs in this fragile patient population.

Prospective analysis of adverse events in surgical treatment of degenerative spondylolisthesis.

BACKGROUND CONTEXT: Surgical adverse event (AE) monitoring is imprecise, of uncertain validity, and tends toward underreporting. Reports focus on specific procedures rather than outcomes in the context of presenting diagnosis. Specific intraoperative (intraop) or postoperative (postop) AEs that may be independently associated with degenerative spondylolisthesis (DS) have never been reported. PURPOSE: The primary purpose was to assess the AE profile of surgically treated patients with L4-L5 DS. The secondary goal was to identify potential risk factors that correlate with those AEs. STUDY DESIGN/SETTING: Prospective cohort and academic quaternary spine center. PATIENT SAMPLE: Ninety-two patients with L4-L5 DS were treated surgically, discharged from Vancouver General Hospital between January 1, 2009 and December 31, 2010. OUTCOME MEASURES: Incidence rates and odds ratios. METHODS: Prospective AE data were analyzed using univariate analyses, forward selection regression models, and Spearman correlation coefficients. Results were compared with outcomes reported in the Spine Patient Outcomes Research Trial. RESULTS: No AEs were seen in 57.6% of patients, one AE in 17.4%, and two or more AEs in 17.4%. Dural tears (6.5%) and intraop bone-implant interface failure requiring revision (3.3%) were the most common intraop AEs. Postoperatively, the most frequent AEs were urinary tract infection (10.9%), delirium (5.4%), neuropathic pain (4.4%), deep wound infection (3.3%), and superficial wound infection (3.3%). The odds of an intraop AE increased by 9% (95% confidence interval [CI] 1-18) per year of age at admission. Adjusted Charlson comorbidity index (CCI) did not correlate with number of AEs experienced. The odds of postop delirium correlated with CCI (odds ratio [OR] 3.39, 95% CI 1.12-10.24) and dural tear (OR 35.84, 95% CI 1.72-747.45). Length of stay was statistically significant and was influenced by two or more AEs, CCI, postop loss of correction, cerebrospinal fluid leak, deep wound infection, noninfected wound drainage, and gender. CONCLUSIONS: Risk of intraop AEs, but not postop AEs, increased with increasing age. Having multiple comorbidities does not predispose to more AEs. Infections predominate among the postop AEs. Patients at increased risk of delirium or of having an increased length of hospital stay may more easily be predicted. Studies specifically designed to prospectively assess AEs have the potential to more accurately identify postop AE rates.

Surgeon-industry conflict of interest: survey of opinions regarding industry-sponsored educational events and surgeon teaching: clinical article.

OBJECT: Conflict of interest (COI) as it applies to medical education and training has become a source of considerable interest, debate, and regulation in the last decade. Companies often pay surgeons as faculty for educational events and often sponsor and give financial support to major professional society meetings. Professional medical societies, industry, and legislators have attempted to regulate potential COI without consideration for public opinion. The practice of evidence-based medicine requires the inclusion of patient opinion along with best available evidence and expert opinion. The primary goal of this study was to assess the opinion of the general population regarding surgeon-industry COI for education-related events. METHODS: A Web-based survey was administered, with special emphasis on the surgeon's role in industry-sponsored education and support of professional societies. A survey was constructed to sample opinions on reimbursement, disclosure, and funding sources for educational events. RESULTS: There were 501 completed surveys available for analysis. More than 90% of respondents believed that industry funding for surgeons' tuition and travel for either industry-sponsored or professional society educational meetings would either not affect the quality of care delivered or would cause it to improve. Similar results were generated for opinions on surgeons being paid by industry to teach other surgeons. Moreover, the majority of respondents believed it was ethical or had no opinion if surgeons had such a relationship with industry. Respondents were also generally in favor of educational conferences for surgeons regardless of funding source. Disclosures of a surgeon-industry relationship, especially if it involves specific devices that may be used in their surgery, appears to be important to respondents. CONCLUSIONS: The vast majority of respondents in this study do not believe that the quality of their care will be diminished due to industry funding of educational events, for surgeon tuition, and/or travel expenses. The results of this study should help form the basis of policy and continued efforts at surgeon-industry COI management.