Introductory Medical Spanish Elective: Creating and Evaluating a Case-Based Course Compatible with an 18-Month Pre-Clinical Medical Curriculum.

BACKGROUND: Limited English proficiency patients experience high rates of medical errors and receive lower quality of care. To better prepare the healthcare workforce, Latino Medical Student Association (LMSA) members at Oregon Health & Science University (OHSU) developed an Introductory Medical Spanish course to complement an 18-month pre-clinical curriculum. METHODS: This 10-week elective course consisted of 2 h of weekly instruction, two Cafecito cultural sessions, and one clinical standardized assessment (CSA). The authors used Bloom's taxonomy as a theoretical framework to design course components. Pre- and post-course surveys captured comfort scores with performing a history and physical (H&P) and building rapport in Spanish. Change in comfort was analyzed via paired T-test in STATA. The authors performed a content analysis of CSA feedback and a thematic analysis of Cafecito reflections. RESULTS: Fifteen preclinical medical students in cohort 1 and sixteen in cohort 2 completed the 10-week course. Comfort scores significantly (p < 0.05) increased by 2.87 and 1 point(s) for cohorts 1 and 2, respectively. There were differences between cohorts 1 and 2, including self-reported language fluency (93% vs 47% "beginner" level) and value of the cultural sessions (73% vs 50%), respectively. Qualitative content analysis of CSA feedback and thematic analysis of Cafecito reflections revealed students successfully applied learned material to a new case and developed a newfound appreciation for Latinx public health issues. CONCLUSIONS: This course effectively increased students' comfort using medical Spanish which successfully translated into simulated patient environments. It also provided a space to discuss nuances of health and Latinx cultures with peers. Ultimately, this course's feasible, effective structure can serve as a model to complement condensed pre-clinical undergraduate medical education (UME) curricula.

Proximal Junctional Kyphosis: Inter- and Intraobserver Reliability of Radiographic Measurements in Adult Spinal Deformity.

STUDY DESIGN: Reliability study of radiographic measures of proximal junctional kyphosis (PJK) in patients with adult spinal deformity (ASD). OBJECTIVE: To assess impacts of level of proximal endpoint and vertebral fracture on reliability of measurement of junctional kyphosis. SUMMARY OF BACKGROUND DATA: Radiographic assessment is important in determining management of patients with PJK or proximal junctional failure (PJF). No study to date has evaluated the reliability of radiographic measurement of the junctional kyphotic angle after surgery for ASD. METHODS: Postoperative radiographs from 52 patients with ASD were divided into four categories based on the level of the upper instrumented vertebra (UIV) and the presence or absence of PJF: upper thoracic without failure (UT), thoracolumbar without failure (TL), upper thoracic with PJF (UTF), and thoracolumbar with PJF (TLF). Nine surgeon reviewers performed radiographic measurements of kyphosis between UIV+2 and UIV twice at least 4 weeks apart. Intraclass correlation coefficients (ICC) were calculated to determine inter- and intraobserver reliability. RESULTS: Interobserver reliability for measurements of UT, TL, UTF, and TLF were all "almost perfect" with ICC scores of 0.917, 0.965, 0.956, and 0.882, and 0.932, 0.975, 0958, and 0.989, for sessions 1 and 2, respectively. Similarly, ICCs for kyphosis measurements for the TL and TLF group had "almost perfect" agreement with means of 0.898 (range: 0.817-0.969) and 0.976 (range: 0.931-0.995), respectively. ICCs for measurements for the UT and UTF groups all had "substantial" or "almost perfect" agreement with means of 0.801 (range: 0.662-0.942) and 0.879 (range: 0.760-0.988), respectively. CONCLUSION: The present study demonstrates high inter- and intraobserver reliability of PJK measurement following instrumented fusion for ASD, independent of the presence or absence of PJF. Although slightly lower for upper thoracic than for thoracolumbar proximal endpoints, all ICCs consistently reached at least "substantial agreement" and "near perfect agreement" for most. LEVEL OF EVIDENCE: 4.

Inter- and Intra-rater Reliability of the Hart-ISSG Proximal Junctional Failure Severity Scale.

STUDY DESIGN: Reliability/external validation study. OBJECTIVE: Investigate inter- and intrarater reliability of the Hart-International Spine Study Group (ISSG) Proximal Junctional Failure Severity Scale (PJFSS) and its correlation with operative revision in patients with proximal junctional failure (PJF). SUMMARY OF BACKGROUND DATA: The Hart-ISSG PJFSS is a validated classification system for PJF. Reliability of the PJFSS has not been assessed. METHODS: Sixteen detailed clinical scenarios were assessed using the ISSG PJFSS classification in six categories: neurologic status, axial pain, instrumentation issue, proximal kyphotic angle, level of upper instrumented vertebrae (UIV), and severity of UIV/UIV+1 fracture. Eleven spine surgeons evaluated each case in all six categories during two different assessments, and provided recommendations regarding operative revision or observation for each case. Inter- and intrarater reliability were calculated based on intraclass correlation coefficients. RESULTS: All intraclass correlation coefficients demonstrated "almost perfect"' (0.817-0.988) inter-rater agreement for both assessments, except UIV/UIV+1 fracture severity during the second assessment, which demonstrated "substantial" agreement' (0.692). Five of six categories had "almost perfect" mean intrarater reliability (0.805-0.981), while "instrumentation issue" demonstrated "substantial" mean agreement (0.757). Inter-rater reliability for recommendation of surgical intervention was "almost perfect" during both assessments (0.911 and 0.922, respectively). Mean PJFSS scores between the two assessments were significantly higher for cases recommended for operative revision (8.43 ±â€Š0.90) versus cases recommended for observation (P < 0.0001). CONCLUSION: The ISSG PJFSS is a reliable and repeatable classification system for assessing patients with PJF. Higher PJFSS scales correlate with recommendation for operative revision, extending prior external validation of the PJFSS. LEVEL OF EVIDENCE: 3.

Patient Satisfaction After Adult Spinal Deformity Surgery Does Not Strongly Correlate With Health-Related Quality of Life Scores, Radiographic Parameters, or Occurrence of Complications.

STUDY DESIGN: This is a multicenter retrospective review of prospectively collected cases. OBJECTIVE: Our objective was to evaluate the relationship between patient satisfaction, health-related quality of life (HRQoL) scores, complications, and radiographic measures at 2 years postoperative follow-up. SUMMARY OF BACKGROUND DATA: For patients receiving operative management for adult spine deformity (ASD), the relationship between HRQoL measures, radiographic parameters, postoperative complications, and self-reported satisfaction remains unclear. METHODS: Data from 248 patients across 11 centers within the United States who underwent thoracolumbar fusion for ASD and had a minimum of 2 years follow-up was collected. Pre- and postoperative scores were obtained from the Scoliosis Research Society 22-item (SRS-22r), the Oswestry Disability Index (ODI), the 36-Item Short Form Health Survey (SF-36), and the Visual Analogue Scale. Sagittal vertical axis, coronal C7 plumbline, lumbar lordosis, pelvic tilt, T1 pelvic angle, and the difference between pelvic incidence and lumbar lordosis were assessed using postoperative radiographic films. Satisfaction (SAT) was assessed using the SRS-22r; patients were categorized as highly satisfied (HS) or less satisfied (LS). The correlation between SAT and HRQoL scores, radiographic parameters, and complications was determined. RESULTS: When compared with LS (n = 60) patients, HS (n = 188) patients demonstrated greater improvement in final ODI, SF-36 component scores, SRS-Total, and Visual Analogue Scale back scores (P < 0.05). The correlations between SAT and the final follow-up and 2 year change from baseline values were moderate for Mental Component Summary, Physical Component Summary, and ODI or weak for HRQoL scores (P < 0.0001). The HS and LS groups were equal in pre- or final postoperative radiographic parameters. Occurrence of complications had no effect on satisfaction. CONCLUSION: Among operatively treated ASD patients, satisfaction was moderately correlated with some HRQoL measures, and not with radiographic changes or postoperative complications. Other factors, such as patient expectations and relationship with the surgeon, may be stronger drivers of patient satisfaction. LEVEL OF EVIDENCE: 3.

Selecting caudal fusion levels: 2 year functional and stiffness outcomes with matched pairs analysis in multilevel fusion to L5 versus S1.

PURPOSE: Controversy persists as to whether to end multilevel thoracolumbar fusions caudally at L5 or S1. Some argue that stopping at L5 may preserve greater function, but there are few data comparing functional limitations due to lumbar stiffness in patients with fusion to L5 versus S1. The aim of this study was to evaluate whether patients undergoing multilevel thoracolumbar fusions with an L5 caudal endpoint have a better lumbosacral function than patients with an S1 caudal endpoint. METHODS: Patients undergoing successful thoracolumbar fusion of 5 or more levels to L5 or S1, with solid fusion at 2 year follow-up, were examined from a single European center in addition to a multi-center North American database of 237 patients. In total, 40 patients with a distal stopping point of L5 were matched with a subset of 40 patients with a distal endpoint of S1 ± pelvic fixation. The L5 and S1 groups were matched for the final Oswestry Disability Index (ODI), Sagittal Vertical Axis (SVA C7-S1), number of fusion levels, and age. Impacts of lumbar stiffness on function as measured by the Lumbar Stiffness Disability Index (LSDI) were compared using the conditional logistic regression. RESULTS: After matching, there was no significant difference between the S1 and L5 groups for the final ODI (29.22 ± 21.6 for S1 versus 29.21 ± 21.7 for L5; p = 0.98), SVA (29.5 ± 40.3 mm for S1 versus 33.7 ± 37.1 mm for L5; p = 0.97), mean age (61.6 ± 11.0 years for S1 versus 58.3 ± 12.6 years for L5; p = 0.23), and number of fusion levels (9.7 ± 3.3 levels for S1 versus 9.0 ± 3 levels for L5; p = 0.34). The final 2-year postoperative LSDI scores were not significantly different between the S1 group (28.08 ± 21.47) and L5 group (29.21 ± 21.66) (hazard ratio 0.99, 95 % CI 0.97-1.03, p = 0.81). CONCLUSION: The analysis of patients with multilevel thoracolumbar fusions demonstrated that after minimum 2 year follow-up, self-reported functional impacts of lumbar stiffness were not significantly different between the patients with distal endpoints of L5 versus S1. The choice of distal fusion level of L5 does not appear to retain sufficient spinal flexibility to substantially affect postoperative function. LEVEL OF EVIDENCE: Level III.

Hospital charges associated with "never events": comparison of anterior cervical discectomy and fusion, posterior lumbar interbody fusion, and lumbar laminectomy to total joint arthroplasty.

OBJECTIVE Beginning in 2008, the Centers for Medicare and Medicaid Service (CMS) determined that certain hospital-acquired adverse events such as surgical site infection (SSI) following spine surgery should never occur. The following year, they expanded the ruling to include deep vein thrombosis (DVT) and pulmonary embolism (PE) following total joint arthroplasty. Due to their ruling that "never events" are not the payers' responsibility, CMS insists that the costs of managing these complications be borne by hospitals and health care providers, rather than billings to health care payers for additional care required in their management. Data comparing the expected costs of such adverse events in patients undergoing spine and orthopedic surgery have not previously been reported. METHODS The California State Inpatient Database (CA-SID) from 2008 to 2009 was used for the analysis. All patients with primary procedure codes indicating anterior cervical discectomy and fusion (ACDF), posterior lumbar interbody fusion (PLIF), lumbar laminectomy (LL), total knee replacement (TKR), and total hip replacement (THR) were analyzed. Patients with diagnostic and/or treatment codes for DVT, PE, and SSI were separated from patients without these complication codes. Patients with more than 1 primary procedure code or more than 1 complication code were excluded. Median charges for treatment from primary surgery through 3 months postoperatively were calculated. RESULTS The incidence of the examined adverse events was lowest for ACDF (0.6% DVT, 0.1% PE, and 0.03% SSI) and highest for TKA (1.3% DVT, 0.3% PE, 0.6% SSI). Median inpatient charges for uncomplicated LL was $51,817, compared with $73,432 for ACDF, $143,601 for PLIF, $74,459 for THR, and $70,116 for TKR. Charges for patients with DVT ranged from $108,387 for TKR (1.5 times greater than index) to $313,536 for ACDF (4.3 times greater than index). Charges for patients with PE ranged from $127,958 for TKR (1.8 times greater than index) to $246,637 for PLIF (1.7 times greater than index). Charges for patients with SSI ranged from $168,964 for TKR (2.4 times greater than index) to $385,753 for PLIF (2.7 times greater than index). CONCLUSIONS Although incidence rates are low, adverse events of spinal procedures substantially increase the cost of care. Charges for patients experiencing DVT, PE, and SSI increased in this study by factors ranging from 1.8 to 4.3 times those for patients without such complications across 5 common spinal and orthopedic procedures. Cost projections by health care providers will need to incorporate expected costs of added care for patients experiencing such complications, assuming that the cost burden of such events continues to shift from payers to providers.

Adverse Event Recording and Reporting in Clinical Trials Comparing Lumbar Disk Replacement with Lumbar Fusion: A Systematic Review.

Study Design Systematic review. Objectives (1) To compare the quality of adverse event (AE) methodology and reporting among randomized trials comparing lumbar fusion with lumbar total disk replacement (TDR) using established AE reporting systems; (2) to compare the AEs and reoperations of lumbar spinal fusion with those from lumbar TDR; (3) to make recommendations on how to report AEs in randomized controlled trials (RCTs) so that surgeons and patients have more-detailed and comprehensive information when making treatment decisions. Methods A systematic search of PubMed, the Cochrane collaboration database, and the National Guideline Clearinghouse through May 2015 was conducted. Randomized controlled trials with at least 2 years of follow-up comparing lumbar artificial disk replacement with lumbar fusion were included. Patients were required to have axial or mechanical low back pain of ≥3 months' duration due to degenerative joint disease defined as degenerative disk disease, facet joint disease, or spondylosis. Outcomes included the quality of AE acquisition methodology and results reporting, and AEs were defined as those secondary to the procedure and reoperations. Individual and pooled relative risks and their 95% confidence intervals comparing lumbar TDR with fusion were calculated. Results RCTs demonstrated a generally poor description of methods for assessing AEs. There was a consistent lack of clear definition or grading for these events. Furthermore, there was a high degree of variation in reporting of surgery-related AEs. Most studies lacked adequate reporting of the timing of AEs, and there were no clear distinctions between acute or chronic AEs. Meta-analysis of the pooled data demonstrated a twofold increased risk of AEs in patients having lumbar fusion compared with patients having lumbar TDR at 2-year follow-up, and this relative risk was maintained at 5 years. Furthermore, the pooled data demonstrated a 1.7 times greater relative risk of reoperation in the fusion group compared with lumbar TDR, although this risk decreased to 1.1 at 5-year follow-up. However, given the lack of quality and consistency in the methods of recording and reporting of AEs, we are unable to make a clear recommendation of one treatment over the other. Conclusions Based on the currently available literature, lumbar TDR appears to be comparable in safety to lumbar fusion. However, due to lack of consistency in reporting of AEs, it is difficult to make conclusions regarding the true safety profile of lumbar TDR. Standardization in AE reporting will significantly improve the reliability of the current literature.

Technology in MicroRNA Profiling: Circulating MicroRNAs as Noninvasive Cancer Biomarkers in Breast Cancer.

This report describes technologies to identify and quantify microRNAs (miRNAs) as potential cancer biomarkers, using breast cancer as an example. Most breast cancer patients are not diagnosed until the disease has advanced to later stages, which decreases overall survival rates. Specific miRNAs are up- or downregulated in breast cancer patients at various stages, can be detected in plasma and serum, and have shown promising preliminary clinical sensitivity and specificity for early cancer diagnosis or staging. Nucleic acid testing methods to determine relative concentrations of selected miRNAs include reverse transcription, followed by quantitative PCR (RT-qPCR), microarrays, and next-generation sequencing (NGS). Of these methods, NGS is the most powerful approach for miRNA biomarker discovery, whereas RT-qPCR shows the most promise for eventual clinical diagnostic applications.