Remote Assessment of Real-World Surgical Safety Checklist Performance Using the OR Black Box: A Multi-Institutional Evaluation.

BACKGROUND: Large-scale evaluation of surgical safety checklist performance has been limited by the need for direct observation. The operating room (OR) Black Box is a multichannel surgical data capture platform that may allow for the holistic evaluation of checklist performance at scale. STUDY DESIGN: In this retrospective cohort study, data from 7 North American academic medical centers using the OR Black Box were collected between August 2020 and January 2022. All cases captured during this period were analyzed. Measures of checklist compliance, team engagement, and quality of checklist content review were investigated. RESULTS: Data from 7,243 surgical procedures were evaluated. A time-out was performed during most surgical procedures (98.4%, n = 7,127), whereas a debrief was performed during 62.3% (n = 4,510) of procedures. The mean percentage of OR staff who paused and participated during the time-out and debrief was 75.5% (SD 25.1%) and 54.6% (SD 36.4%), respectively. A team introduction (performed 42.6% of the time) was associated with more prompts completed (31.3% vs 18.7%, p < 0.001), a higher engagement score (0.90 vs 0.86, p < 0.001), and a higher percentage of team members who ceased other activities (80.3% vs 72%, p < 0.001) during the time-out. CONCLUSIONS: Remote assessment using OR Black Box data provides useful insight into surgical safety checklist performance. Many items included in the time-out and debrief were not routinely discussed. Completion of a team introduction was associated with improved time-out performance. There is potential to use OR Black Box metrics to improve intraoperative process measures.

Reoperation and complications after anterior cervical discectomy and fusion and cervical disc arthroplasty: a study of 52,395 cases.

PURPOSE: The aim of this study was to analyze rates of perioperative complications and subsequent cervical surgeries in patients treated for cervical degenerative disc disease with anterior cervical discectomy and fusion (ACDF) and those treated with artificial cervical disc arthroplasty (ACDA) for up to 5-year follow-up. METHODS: California's Office of Statewide Health Planning and Development discharge database was analyzed for patients aged 18-65 years undergoing single-level ACDF or ACDA between 2003 and 2010. Medical comorbidities were identified with CMS-Condition Categories. Readmissions for short-term complications of the procedure were identified and rates of subsequent cervical surgeries were calculated at 90-day and 1-, 3-, and 5-year follow-up. Multivariate regression modeling was used to identify associations with complications and subsequent cervical surgeries correcting for patient and provider characteristics. RESULTS: A total of 52,395 eligible cases were identified: 50,926 ACDF and 1469 ACDA. Readmission was less common in the ACDA group (OR: 0.69, 95% CI: 0.48-1.0, p = 0.048). Subsequent cervical spine surgery was more common in the ACDF group in the immediate perioperative period (within 90 days of surgery) (ACDF 3.35% vs. ACDA 2.04%, OR: 0.63, 95% CI: 0.44-0.92, p = 0.015). At 1-, 3-, and 5-year postoperatively, rates of subsequent cervical surgeries were similar between the two cohorts. CONCLUSIONS: We found no protective benefit for ACDA versus ACDF for single-level disease at up to 5-year follow-up in the largest cohort of patients examined to date. Early complications were rare in both cohorts stressing the value of large cohort studies to study risk factors for rare events. These slides can be retrieved under Electronic Supplementary Material.

Clinical and Radiographic Outcomes After Posterior Vertebral Column Resection for Severe Spinal Deformity with Five-Year Follow-up.

BACKGROUND: Short-term studies have shown improved outcomes and alignment after posterior vertebral column resection for severe spinal deformity. Our goal was to report long-term changes in radiographic and health-related quality-of-life measures in a consecutive series of pediatric and adult patients undergoing posterior vertebral column resection with a minimum follow-up of 5 years. METHODS: We reviewed all patients undergoing posterior vertebral column resection by a single surgeon prior to January 1, 2010, at a single institution. Standard preoperative and perioperative data were collected, including the Scoliosis Research Society (SRS)-22/24 instrument. Radiographic and health-related quality-of-life measures changes were evaluated at a minimum follow-up of 5 years. RESULTS: One hundred and nine patients underwent posterior vertebral column resection prior to January 2010, and 54 patients (49.5%) were available for analysis: 31 (57.4%) were pediatric patients, and 23 (42.6%) were adult patients. The mean age (and standard deviation) was 12.5 ± 3 years for the pediatric cohort and 39.3 ± 20 years for the adult cohort. Improvements in the mean major Cobb angle at a minimum follow-up of 5 years were seen: 61.6% correction for the pediatric cohort and 53.9% correction for the adult cohort. The rates of proximal junctional kyphosis, defined as proximal junctional kyphosis of >10°, were 16.1% for the pediatric cohort and 34.8% for the adult cohort, but none underwent a revision surgical procedure for symptomatic proximal junctional kyphosis. Of the 54 patients, 30 (55.6%) sustained complications, 5 (9.3%) experienced postoperative neurological deficits, and 7 (13.0%) required a revision by 5 years postoperatively. Significant improvements were observed in the SRS-Self Image with regard to the pediatric cohort at 0.9 (p = 0.017) and the adult cohort at 1.3 (p = 0.002) and in the SRS-Satisfaction with regard to the pediatric cohort at 1.8 (p = 0.008) and the adult cohort at 1.3 (p = 0.005). CONCLUSIONS: Posterior vertebral column resection offers substantial, sustained improvements in global radiographic alignment and patient outcome scores at 5 years. The major radiographic deformity was reduced by 61.6% in the pediatric cohort and by 53.9% in the adult cohort. Despite the high rate of complications, patients experienced significant improvement in the SRS-Self Image and SRS-Satisfaction domains. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Health-related quality of life outcomes in complex adult spinal deformity surgery.

OBJECTIVE Significant health-related quality of life (HRQOL) benefits have been observed for patients undergoing primary and revision adult spinal deformity (ASD) surgery. The purpose of this study was to report changes in HRQOL measures in a consecutive series of patients undergoing complex spinal reconstructive surgery, using Scoli-RISK-1 (SR-1) inclusion criteria. METHODS This was a single-center, retrospective cohort study. The SR-1 inclusion criteria were used to define patients with complex ASD treated between June 1, 2009, and June 1, 2011. Standard preoperative and perioperative data were collected, including the Scoliosis Research Society (SRS)-22r instrument. The HRQOL changes were evaluated at a minimum 2-year follow-up. Standardized forms were used to collect surgery-related complications data for all patients. Complications were defined as minor, transient major, or permanent major. Patients who achieved a minimum 2-year follow-up were included in the analysis. RESULTS Eighty-four patients meeting SR-1 criteria were identified. Baseline demographic and surgical data were available for 74/84 (88%) patients. Forty-seven of 74 (64%) patients met the additional HRQOL criteria with a minimum 2-year follow-up (mean follow-up 3.4 years, range 2-6.5 years). Twenty-one percent of patients underwent posterior fusion only, 40% of patients had a posterior column osteotomy, and 38% had a 3-column osteotomy. Seventy-five percent of patients underwent a revision procedure. Significant improvements were observed in all SRS-22r domains: Pain: +0.8 (p < 0.001); Self-Image: +1.4 (p < 0.001); Function: +0.46 (p < 0.001); Satisfaction: +1.6 (p < 0.001); and Mental Health: +0.28 (p = 0.04). With the exception of Mental Health, more than 50% of patients achieved a minimum clinically important difference (MCID) in SRS-22r domain scores (Mental Health: 20/47, 42.6%). A total of 65 complications occurred in 31 patients. This includes 29.8% (14/47) of patients who suffered a major complication and 17% (8/47) who suffered a postoperative neurological deficit, most commonly at the root level (10.6%, 5/47). Of the 8 patients who suffered a neurological deficit, 1 (13%) was able to achieve MCID in the SRS Function domain. CONCLUSIONS The majority of patients experienced clinically relevant improvement in SRS-22r HRQOL scores after complex ASD surgery. The greatest improvements were seen in the SRS Pain and SRS Self-Image domains. Although 30% of patients suffered a major or permanent complication, benefits from surgery were still attained. Patients sustaining a neurological deficit or major complication were unlikely to achieve HRQOL improvements meeting or exceeding MCID for the SRS Function domain.