Comparative Anatomy of the Contralateral Transmaxillary Approach Alone and With Ipsilateral Transpterygoid Extension: Quantitative Insights on Surgical Exposure and Maneuverability in the Petroclival Region.

BACKGROUND AND OBJECTIVES: Beyond qualitative evidence legitimizing endoscopic corridors through contralateral transmaxillary (CTM) and endonasal ipsilateral transpterygoid (ITP) corridors to the petrous apex and petroclival region, surgical feasibility by direct quantitative comparative anatomy is sparse. Our cadaveric study addresses this by performing the CTM approach followed by ITP extension to quantify the extent of petrous apex resection, instrument maneuverability, and working distance to petrous apex. METHODS: Anatomic dissections were performed bilaterally on 5 latex-injected human cadaveric heads (10 petrous bones). After CTM dissections were quantified, the ITP approach was added enlarging initial exposure. Differences were measured with statistical significance when P values are < .05. RESULTS: The mean petrosectomy volume was 0.958 cm3 with CTM and 1.987 cm3 with CTM + ITP, corresponding to 14.53% and 30.52% petrous apex resection, respectively. Craniocaudal instrument mobility was more limited in the lateral extent of dissection compared with the midline for both CTM (8.062° vs 14.416°) and CTM + ITP (5.4° vs 14.4°). The CTM approach achieved the lateral-most dissection at the body of the petrous apex (15.936 mm), with lateralization more limited in the superior petroclival region (9.628 mm) and the inferior petroclival region (8.508 mm). Angle of surgical maneuverability increased superiorly vs inferiorly in the CTM approach (mean 12.596° vs 8.336°, respectively). The CTM approach offered the shortest mean working distance (88.624 mm) to the petroclival region compared with the bi-nares approach (100.5 mm). CTM + ITP achieved greater lateralization in the superior (21.237 mm) and inferior (22.087 mm) aspects of the petroclival region compared with the CTM approach. CONCLUSION: Operative considerations are discussed in accessing target neurovascular structures through the uniquely shaped corridors formed by the CTM or combined CTM + ITP. Allowing mobilization of the internal carotid artery laterally and eustachian tube inferiorly, addition of the ITP allowed for larger petrosectomy than CTM alone, especially in the inferior and lateral aspects of the petrous bone.

Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.

BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041.

Refining the predictive value of preoperative apparent diffusion coefficient (ADC) by whole-tumor analysis for facial nerve outcomes in vestibular schwannomas.

BACKGROUND: Apparent diffusion coefficient (ADC) in MRI has been shown to correlate with postoperative House-Brackmann (HB) scores in patients with vestibular schwannoma despite limited methodology. To rectify limitations of single region of interest (ROI) sampling, we hypothesize that whole-tumor ADC histogram analysis will refine the predictive value of this preoperative biomarker related to postoperative facial nerve function. METHODS: Of 155 patients who underwent resection of vestibular schwannoma (2014-2020), 125 patients were included with requisite clinical and radiographic data. After volumetric analysis and whole-tumor ADC histogram, regression tree analysis identified ADC cutoff for significant differences in HB grade. Outcomes were extent of resection, facial nerve function, hospital length of stay (LOS), and complications. RESULTS: Regression tree analysis defined three quantitative ADC groups (× 10-6 mm2/s) as high (> 2248.77; HB 1.7), mid (1468.44-2248.77; HB 3.1), and low (< 1468.44; HB 2.3) range (p 0.04). The mid-range ADC group had significantly worse postoperative HB scores and longer hospital LOS. Large tumor volume was independently predictive of lower rates of gross total resection (p <0.0001), higher postoperative HB score (p 0.002), higher rate of complications (p 0.04), and longer LOS (p 0.003). CONCLUSIONS: Whole-tumor histogram yielded a robust regression tree analysis that defined three ADC groups with significantly different facial nerve outcomes. This likely reflects tumor heterogeneity better than solid-tumor ROI sampling. Whole-tumor ADC warrants further study as a useful radiographic biomarker in patients with vestibular schwannoma who are considering surgical resection.

Novel classification of foramen magnum meningiomas predicted by topographic position relative to neurovascular bundle.

PURPOSE: Proximity to critical neurovascular structures can create significant obstacles during surgical resection of foramen magnum meningiomas (FMMs) to the detriment of treatment outcomes. We propose a new classification that defines the tumor's relationship to neurovascular structures and assess correlation with postoperative outcomes. METHODS: In this retrospective review, 41 consecutive patients underwent primary resection of FMMs through a far lateral approach. Groups defined based on tumor-neurovascular bundle configuration included Type 1, bundle ventral to tumor; Type 2a-c, bundle superior, inferior, or splayed, respectively; Type 3, bundle dorsal; and Type 4, nerves and/or vertebral artery encased by tumor. RESULTS: The 41 patients (range 29-81 years old) had maximal tumor diameter averaging 30.1 mm (range 12.7-56 mm). Preoperatively, 17 (41%) patients had cranial nerve (CN) dysfunction, 12 (29%) had motor weakness and/or myelopathy, and 9 (22%) had sensory deficits. Tumor type was relevant to surgical outcomes: specifically, Type 4 demonstrated lower rates of gross total resection (65%) and worse immediate postoperative CN outcomes. Long-term findings showed Types 2, 3, and 4 demonstrated higher rates of permanent cranial neuropathy. Although patients with Type 4 tumors had overall higher ICU and hospital length of stay, there was no difference in tumor configuration and rates of postoperative complications or 30-day readmission. CONCLUSION: The four main types of FMMs in this proposed classification reflected a gradual increase in surgical difficulty and worse outcomes. Further studies are warranted in larger cohorts to confirm its reliability in predicting postoperative outcomes and possibly directing management decisions.

Health Differs by Foster Care Eligibility: A Nine-Year Retrospective Observational Study Among Medicaid-Enrolled Children.

OBJECTIVE: This study sought to determine the prevalence and rates of physical, behavioral, and chronic health conditions among Medicaid-enrolled Colorado children by foster care eligibility codes over 9 years. METHODS: This retrospective, population-based study used Colorado's Medicaid administrative data for all enrolled children, aged <19 years old, from July 2011 to August 2020 to determine the period prevalence and rates of physical, behavioral, and chronic health conditions. We identified children in foster care by Medicaid eligibility codes and used the Pediatric Medical Complexity Algorithm version 3.0 to describe health condition outcomes. We report frequencies and percentages by foster care eligibility status, birth year cohort, and sex. RESULTS: Among 1,084,026 children, we identified 34,971 children in the foster cohort. Rates of physical (1105.0 per 100,000 person-months (PMs)) and behavioral health conditions (583.6 per 100,000 PMs) were two to threefold higher among the foster cohort than peers (physical 685.1 per 100,000 PMs; behavioral 212.2 per 100,000 PMs). By birth cohort, rates of behavioral health conditions among children in foster care were up to 8 times greater than peers. The foster cohort had greater prevalence of chronic conditions with (55.2%) and without (38.6%) behavioral health inclusion. CONCLUSIONS: This study provides a broader health assessment among Medicaid-enrolled children and finds condition disparities concentrated among youth in foster care. A more complete understanding of health problems among children in foster care is critical for health, child welfare, and Medicaid systems to improve health outcomes through coordinated and evidence-based interventions, programs, and policies.

Surgical outcomes in large vestibular schwannomas: should cerebellopontine edema be considered in the grading systems?

PURPOSE: Large (> 3 cm) vestibular schwannomas pose complexity in surgical management because of narrow working corridors and proximity to the cranial nerves, brainstem, and inner ear structures. With current vestibular schwannoma classifications limited in information regarding cerebellopontine edema, our retrospective series examined this radiographic feature relative to clinical outcomes and its possible role in preoperative scoring. METHODS: Of 230 patients who underwent surgical resection of vestibular schwannoma (2014-2020), we identified 107 patients with Koos grades 3 or 4 tumors for radiographic assessment of edema in the middle cerebellar peduncle (MCP), brainstem, or both. Radiographic images were graded and patients grouped into Koos grades 3 or 4 or our proposed grade 5 with edema. Tumor volumes, radiographic features, clinical presentations, and clinical outcomes were evaluated. RESULTS: The 107 patients included 22 patients with grade 3 tumors, 39 with grade 4, and 46 with grade 5. No statistical differences were noted among groups for demographic data or complication rates. Unlike grades 3 and 4 patients, grade 5 patients presented with worse hearing (p < 0.001), larger tumors (p < 0.001), lower rates of gross total resection (GTR), longer hospital stays, and higher rates of balance dysfunction. CONCLUSION: With edema detected in 43% of this cohort, special considerations are warranted for grade 5 vestibular schwannomas given the preoperative findings of worse hearing, lower GTR rates, longer hospital stays, and 96% who pursued postoperative balance therapy. We propose that grade 5 with edema offers a more nuanced interpretation of a radiographic feature that holds relevance to treatment selection and patient outcomes.

Postsurgical morbidity and mortality favorably informs deep brain stimulation for new indications including schizophrenia and schizoaffective disorder.

Background: Deep brain stimulation (DBS) shows promise for new indications like treatment-refractory schizophrenia in early clinical trials. In the first DBS clinical trial for treatment refractory schizophrenia, despite promising results in treating psychosis, one of the eight subjects experienced both a symptomatic hemorrhage and an infection requiring device removal. Now, ethical concerns about higher surgical risk in schizophrenia/schizoaffective disorder (SZ/SAD) are impacting clinical trial progress. However, insufficient cases preclude conclusions regarding DBS risk in SZ/SAD. Therefore, we directly compare adverse surgical outcomes for all surgical procedures between SZ/SAD and Parkinson's disease (PD) cases to infer relative surgical risk relevant to gauging DBS risks in subjects with SZ/SAD. Design: In the primary analysis, we used browser-based statistical analysis software, TriNetX Live (trinetx.com TriNetX LLC, Cambridge, MA), for Measures of Association using the Z-test. Postsurgical morbidity and mortality after matching for ethnicity, over 39 risk factors, and 19 CPT 1003143 coded surgical procedures from over 35,000 electronic medical records, over 19 years, from 48 United States health care organizations (HCOs) through the TriNetX Research Network™. TriNetXis a global, federated, web-based health research network providing access and statistical analysis of aggregate counts of deidentified EMR data. Diagnoses were based on ICD-10 codes. In the final analysis, logistic regression was used to determine relative frequencies of outcomes among 21 diagnostic groups/cohorts being treated with or considered for DBS and 3 control cohorts. Results: Postsurgical mortality was 1.01-4.11% lower in SZ/SAD compared to the matched PD cohort at 1 month and 1 year after any surgery, while morbidity was 1.91-2.73% higher and associated with postsurgical noncompliance with medical treatment. Hemorrhages and infections were not increased. Across the 21 cohorts compared, PD and SZ/SAD were among eight cohorts with fewer surgeries, nine cohorts with higher postsurgical morbidity, and fifteen cohorts within the control-group range for 1-month postsurgical mortality. Conclusions: Given that the subjects with SZ or SAD, along with most other diagnostic groups examined, had lower postsurgical mortality than PD subjects, it is reasonable to apply existing ethical and clinical guidelines to identify appropriate surgical candidates for inclusion of these patient populations in DBS clinical trials.

The Psychosocial Needs of Patients Participating in Diabetes Shared Medical Appointments.

BACKGROUND: Patient reported outcomes (PROs) for diabetes are self-reported and often give insight into outcomes important to people with diabetes. Federally Qualified Health Centers (FQHCs) see patients who may have higher levels of diabetes distress and lower levels of self-care behaviors. METHODS: The Invested in Diabetes study is a comparative effectiveness trial of diabetes Shared Medical Appointments (SMAs) in FQHCs and non-FQHC settings. PROs measure outcomes including validated measures on diabetes distress. SETTING AND PARTICIPANTS: 616 people from 22 practices completed PROs prior to SMAs. At FQHCs, participants were younger (average 57.7 years vs 66.9 years, p < 0.0001), more likely to be female (36.8% vs 46.1%, p = 0.02), and fewer spoke English (72.7% vs 99.6%, p < 0.0001). RESULTS: At FQHCs, diabetes distress was higher (2.1 vs 1.8, P = .02), more people were current smokers (14.3% vs 4.7%, P = .0002), on insulin (48.9% vs 22.3%, P < .0001) and reported food insecurity (52.7% vs 26.2%, P < .0001). After controlling for sociodemographic factors, these differences were nonsignificant. CONCLUSIONS: Higher numbers of patients at FQHCs report diabetes distress and food insecurity compared with patients in non-FQHC settings, indicating that patient social circumstances need to be considered as part of program implementation.

Impact of Surgical Timing on Neurological Outcomes for Spinal Arachnoid Cyst: A Single Institution Series.

OBJECTIVE: Spinal arachnoid cysts (SACs) are rare lesions that often present with back pain and myelopathy. There is a paucity of literature evaluating the impact of surgical timing on neurological outcomes for primary SAC management. To compare long-term neurological outcomes in patients who were managed differently and to understand natural progression of SAC. METHODS: We conducted a retrospective analysis of adult patients treated for SAC at our institution from 2010 to 2021, stratified into 3 groups (conservative management only, surgical management, or conservative followed by surgical management). Study outcome measures were neurological outcomes as measured by modified McCormick Neurologic Scale (MNS), postoperative complications, and cyst recurrence. Nonparametric analysis was performed to evaluate differences between groups for selected endpoints. RESULTS: Thirty-six patients with SAC were identified. Eighteen patients were managed surgically. The remaining 18 patients were managed conservatively with outpatient serial imaging, 7 of whom (38.9%) ultimately underwent surgical treatment due to neurological decline. Most common presenting symptoms included back pain (50.0%), extremity weakness (36.1%), and numbness/paresthesia (36.1%). Initial/preoperative (p = 0.017) and 1-year postoperative (p = 0.006) MNS were significantly different between the 3 groups, but not at 6 weeks or 6 months postoperatively (p > 0.05). Additionally, at 1 year, there was no difference in MNS between patients managed surgically and those managed conservatively but ultimately underwent surgery (p > 0.99). CONCLUSION: Delayed surgical intervention in minimally symptomatic patients does not seem to result in worse long-term neurofunctional outcomes. At 1 year, postoperative MNS were significantly higher in both surgical groups, when compared to the conservative group highlighting worsening clinical picture regardless of preoperative observational status.

Methods for capturing and analyzing adaptations: implications for implementation research.

BACKGROUND: Interventions are often adapted; some adaptations may provoke more favorable outcomes, whereas some may not. A better understanding of the adaptations and their intended goals may elucidate which adaptations produce better outcomes. Improved methods are needed to better capture and characterize the impact of intervention adaptations. METHODS: We used multiple data collection and analytic methods to characterize adaptations made by practices participating in a hybrid effectiveness-implementation study of a complex, multicomponent diabetes intervention. Data collection methods to identify adaptations included interviews, observations, and facilitator sessions resulting in transcripts, templated notes, and field notes. Adaptations gleaned from these sources were reduced and combined; then, their components were cataloged according to the framework for reporting adaptations and modifications to evidence-based interventions (FRAME). Analytic methods to characterize adaptations included a co-occurrence table, statistically based k-means clustering, and a taxonomic analysis. RESULTS: We found that (1) different data collection methods elicited more overall adaptations, (2) multiple data collection methods provided understanding of the components of and reasons for adaptation, and (3) analytic methods revealed ways that adaptation components cluster together in unique patterns producing adaptation "types." These types may be useful for understanding how the "who, what, how, and why" of adaptations may fit together and for analyzing with outcome data to determine if the adaptations produce more favorable outcomes rather than by adaptation components individually. CONCLUSION: Adaptations were prevalent and discoverable through different methods. Enhancing methods to describe adaptations may better illuminate what works in providing improved intervention fit within context. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov under Trial number NCT03590041 , posted July 18, 2018.

Long-term Neurologic Outcome After Spinal Ependymoma Resection With Multimodal Intraoperative Electrophysiological Recording: Cohort Study and Review of the Literature.

OBJECTIVE: To evaluate how multimodal intraoperative neuromonitoring (IONM) changes during spinal ependymoma (SE) resection correlate with long-term neuro-functional outcomes. METHODS: A retrospective analysis of patients aged 18 years or older who underwent surgical resection for SE over a 10-year period was conducted. IONM changes were defined as sustained transcranial motor evoked potential (TcMEP) and/or somatosensory evoked potential (SSEP) signal decrease of 50% or greater from baseline. Primary endpoints were postoperative modified McCormick Neurologic Scale (MNS) scores at postoperative day (POD) < 2, 6 weeks, 1 year, and 2 years. Univariate and multivariate analyses were performed. RESULTS: Twenty-nine patients were identified. Average age was 44.2 ± 15.4 years. Sixteen (55.2%) were male and 13 (44.8%) were female. Tumor location was 10 cervical-predominant (34.5%), 13 thoracic-predominant (44.8%), and 6 lumbar/conus-predominant (20.7%). A majority (69.0%) were World Health Organization grade 2 tumors. Twentyfour patients (82.8%) achieved gross total resection. Thirteen patients (44.8%) had a sustained documented IONM signal change and 10 (34.5%) had a TcMEP change with or without derangement in SSEP. At POD < 2, 6 weeks, 1 year, and 2 years, MNS was significantly higher for those when analyzing subgroups with either any sustained IONM or TcMEP ± SSEP signal attenuation > 50% below baseline (all p < 0.05). CONCLUSION: Sustained IONM derangements > 50% below baseline, particularly for TcMEP, are significantly associated with higher MNS postoperatively out to 2 years. Intraoperative and postoperative management of these patients warrant special consideration to limit neurologic morbidity.

Decreases in daily ambulation forecast post-surgical re-admission.

BACKGROUND: Surgical readmissions are clinically and financially problematic. Our purpose is to determine if a decrease in postoperative ambulation (steps/day) is associated with hospital readmission. METHODS: In this prospective cohort study, patients undergoing elective operations wore an accelerometer activity tracker to measure steps/day for 28 consecutive postoperative days. The primary outcome was hospital readmission. The change in steps/day over two consecutive days prior to the day of the readmission were examined. Predetermined thresholds for decreases of consecutive daily ambulation levels were used to calculate sensitivity and specificity for the outcome of hospital readmission. RESULTS: 215 patients (aged 63 ± 12 years) were included. Readmission occurred in 10% (n = 21). For each of the first 28-postoperative days, the entire cohort had an average daily step increase of 136 ± 146 steps/day (Spearman correlation rho = 0.990; p < 0.001). A decrease in steps for two consecutive days of >50% from the prior day had a 79% sensitivity and 90% specificity for hospital readmission. CONCLUSIONS: A decrease of >50% daily ambulation (steps/day) over two consecutive post-discharge days accurately forecasts hospital readmission. The implications of these findings are that monitoring daily ambulation could serve as a form of outpatient telemetry aiding to forecast post-surgical readmissions.

Prognosis Based Definition of Resectability in Pancreatic Cancer: A Road Map to New Guidelines.

OBJECTIVE: To identify objective preoperative prognostic factors that are able to predict long-term survival of patients affected by PDAC. SUMMARY OF BACKGROUND DATA: In the modern era of improved systemic chemotherapy for PDAC, tumor biology, and response to chemotherapy are essential in defining prognosis and an improved approach is needed for classifying resectability beyond purely anatomic features. METHODS: We queried the National Cancer Database regarding patients diagnosed with PDAC from 2010 to 2016. Cox proportional hazard models were used to select preoperative baseline factors significantly associated with survival; final models for overall survival (OS) were internally validated and formed the basis of the nomogram. RESULTS: A total of 7849 patients with PDAC were included with a median follow-up of 19 months. On multivariable analysis, factors significantly associated with OS included carbohydrate antigen 19-9, neoadjuvant treatment, tumor size, age, facility type, Charlson/Deyo score, primary site, and sex; T4 stage was not independently associated with OS. The cumulative score was used to classify patients into 3 groups: good, intermediate, and poor prognosis, respectively. The strength of our model was validated by a highly significant randomization test, Log-rank test, and simple hazard ratio; the concordance index was 0.59. CONCLUSION: This new PDAC nomogram, based solely on preoperative variables, could be a useful tool to patients and counseling physicians in selecting therapy. This model suggests a new concept of resectability that is meant to reflect the biology of the tumor, thus partially overcoming existing definitions, that are mainly based on tumor anatomic features.

Early identification of patients at risk for delayed recovery of ambulation after elective abdominal surgery.

BACKGROUND: Recovery of preoperative ambulation levels 1 month after surgery represents an important patient-centered outcome. The objective of this study is to identify clinical factors associated with the inability to regain baseline preoperative ambulation levels 28 days postoperatively. METHODS: This is a prospective cohort study enrolling patients scheduled for elective inpatient abdominal operations. Daily ambulation (steps/day) was measured with a wristband accelerometer. Preoperative steps were recorded for at least 3 full calendar days before surgery. Postoperatively, daily steps were recorded for at least 28 days. The primary outcome was delayed recovery of ambulation, defined as inability to achieve 50% of preoperative baseline steps at 28 days postoperatively. RESULTS: A total of 108 patients were included. Delayed recovery (< 50% of baseline preoperative steps/day) occurred in 32 (30%) patients. Clinical factors associated with delayed recovery after multivariable logistic regression included longer operative time (OR 1.37, 95% CI 1.05-1.79), open operative approach (OR 4.87, 95% CI 1.64-14.48) and percent recovery on POD3 (OR 0.73, 95% CI 0.56-0.96). In addition, patients with delayed ambulation recovery had increased rates of postoperative complications (16% vs 1%, p < 0.01) and readmission (28% vs 5%, p < 0.01). CONCLUSION: After elective inpatient abdominal operations, nearly one in three patients do not recover 50% of their baseline preoperative steps 28 days postoperatively. Factors that can be used to identify these patients include longer operations, open operations and low ambulation levels on postoperative day #3. These data can be used to target rehabilitation efforts aimed at patients at greatest risk for poor ambulatory recovery.

Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

BACKGROUND: This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. METHODS: We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. RESULTS: In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. CONCLUSIONS: We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. TRIAL REGISTRATION: Clinicaltrials.gov Registration ID: NCT03590041 .

How neuropsychiatric comorbidity, modulatory indication, demographics, and other factors impact deep brain stimulation inpatient outcomes in the United States: A population-based study of 27,956 patients.

OBJECTIVE: To determine how neuropsychiatric comorbidity, modulatory indication, demographics, and other characteristics affect inpatient deep brain stimulation (DBS) outcomes. METHODS: This is a retrospective study of 45 months' worth of data from the National Inpatient Sample. Patients were aged ≥ 18 years old and underwent DBS for Parkinson Disease (PD), essential tremor (ET), general dystonia and related disorders, other movement disorder (non-PD/ET), or obsessive-compulsive disorder (OCD) at a US hospital. Primary endpoints were prolonged length of stay (PLOS), high-end hospital charges (HEHCs), unfavorable disposition, and inpatient complications. Logistic models were constructed with odds ratios under 95% confidence intervals. A p-value of 0.05 determined significance. RESULTS: Of 214,098 records, there were 27,956 eligible patients. Average age was 63.9 ± 11.2 years, 17,769 (63.6%) were male, and 10,182 (36.4%) patients were female. Most of the cohort was White (51.1%), Medicare payer (64.3%), and treated at a large-bed size (80.7%), private non-profit (76.9%), and metro-teaching (94.0%) hospital. Neuropsychiatric comorbidity prevalence ranged from 29.9% to 47.7% depending on indication. Compared with PD, odds of complications and unfavorable disposition were significantly higher with other movement disorders and dystonia, whereas OCD conferred greater risk for HEHCs (p < 0.05). Patients with ET had favorable outcomes. Neuropsychiatric comorbidity, Black race, and Charlson Comorbidity Index > 0 were significantly associated with unfavorable outcomes (p < 0.05). CONCLUSION: The risk of adverse inpatient outcomes for DBS in the United States is independently correlated with non-PD/ET disorders, neuropsychiatric comorbidity, and non-White race, reflecting the heterogeneity and infancy of widespread DBS for these patients.

The Volume-Outcome Effect Calls for Centralization of Care in Esophageal Adenocarcinoma: Results From a Large National Cancer Registry.

INTRODUCTION: Using the National Cancer Database, we assessed the relationship between facility overall esophageal adenocarcinoma (EAC) case volume and survival. METHODS: We categorized facilities into volume quintiles based on annual EAC patient volume and performed a multivariable Cox proportional hazards regression between facility patient volume and survival. RESULTS: In a cohort of 116,675 patients, facilities with higher vs lower (≥25 vs 1-4 cases) annual EAC patient volume demonstrated improved survival (adjusted hazard ratio: 0.80. 95% confidence interval: 0.70-0.91). DISCUSSION: This robust volume-outcome effect calls for centralization of care for EAC patients at high annual case volume facilities.

A National Study of Emergency Thoracotomy for Trauma.

INTRODUCTION: The role of resuscitative thoracotomy in the emergency department (ED) for patients that have suffered severe thoracoabdominal trauma has been the subject of much debate. Most studies that characterize emergency thoracotomy are from urban, academic, and trauma centers. We sought to describe patient and hospital characteristics of a nationally representative sample of ED thoracotomy (EDT). METHODS: The health-care cost and utilization project 2013 National ED Sample (NEDS) and the 2013 National Inpatient Sample (NIS) maintained by the agency for health-care research and quality were used to generate a nationally representative estimate of resuscitative thoracotomies performed in the ED. We obtained patient demographics and clinical characteristics and compared the descriptive statistics of the two datasets. RESULTS: The NEDS dataset identified 124 unsuccessful EDTs, whereas the NIS dataset identified 77 admissions for thoracotomy. When weighted to create a national estimate, these represent 952 emergency thoracotomies performed in the US in 2013. Most were male (82.5% and 88.2% in NEDS and NIS, respectively). In addition, 32.9% and 36.4% in NEDS and NIS, respectively, were between the ages of 20 and 29. The majority of thoracotomies were performed at metropolitan teaching hospitals (64.2% and 75.3%, NEDS and NIS, respectively). The mean total ED charges for patients who had an unsuccessful thoracotomy were $32,664 and the mean total inpatient charges were $141,215. CONCLUSION: Nearly 1000 thoracotomies are performed annually on the day of presentation to U. S. hospitals. Although emergency thoracotomy for trauma is an infrequently performed procedure, it almost always occurs at an urban, high volume, and level I or level II trauma centers.

A Stitch in Time Saves Clots: Venous Thromboembolism Chemoprophylaxis in Traumatic Brain Injury.

BACKGROUND: Venous thromboembolism chemoprophylaxis (VTE-CHEMO) is often delayed in patients with traumatic brain injury because of the concern for intracranial hemorrhage (ICH) progression. We hypothesize that (1) late time to VTE-CHEMO (≥48 h) is associated with higher incidence of VTE, and (2) VTE-CHEMO use does not correlate with ICH progression. MATERIALS AND METHODS: This is a multiinstitutional retrospective study of patients with traumatic brain injury admitted between 2014 and 2016. Inclusion criteria were head Abbreviated Injury Code ≥2, ICH present on initial head computed tomography, and two or more head computed tomography scans after admission. The primary outcome was VTE, and the secondary outcome was ICH progression. Patients were classified as receiving VTE-CHEMO early (<48 h) or late (≥48 h). Multivariable analysis with Cox proportional hazards regression was performed. RESULTS: Overall, 1803 patients were included. Patients with VTE (n = 137) were more likely to have spinal cord injury, blunt cerebrovascular injury, pelvic or femur fractures, and missed VTE-CHEMO doses. After multivariable regression, body mass index >30 (hazard ratio [HR], 1.05; P = 0.002), Injury Severity Score (HR, 1.004; P < 0.001), pelvic or femur fractures (HR, 1.05; P < 0.0001), spinal cord injury (HR, 1.28; P = 0.02), and missed VTE-CHEMO doses (HR, 1.08; P = 0.01) were significant predictors of VTE. In those who required neurosurgery, late VTE-CHEMO predicted VTE (HR, 1.21; P = 0.0001). Overall, 32% patients experienced ICH progression, which did not correlate with VTE-CHEMO use or timing. CONCLUSIONS: This multicenter study highlights benefits from early VTE-CHEMO and identifies high-risk groups who may benefit from more aggressive prophylaxis. These data also emphasize risk to patients by withholding VTE-CHEMO.