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.

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.

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.

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 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.

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 .

The predictive value of preoperative apparent diffusion coefficient (ADC) for facial nerve outcomes after vestibular schwannoma resection: clinical study.

OBJECT: Diffusion MRI has been used to predict intraoperative consistency of tumors. Apparent diffusion coefficient (ADC) has shown predictive value as an imaging biomarker in many CNS tumors but has not been studied in a large cohort of patients with vestibular schwannoma. In this study, we examine the utility of ADC as a predictive biomarker for intraoperative tumor characteristics and postoperative facial nerve outcome. METHODS: A retrospective review of patients who underwent vestibular schwannoma resection at our institution from 2008 to 2018 yielded 87 patients, of which 72 met inclusion criteria. Operative reports and clinical records were reviewed for clinical data; MRI data were interpreted in a blinded fashion for qualitative and quantitative biomarkers, including tumor ADC. RESULTS: Mean tumor ADC values did not predict intraoperative consistency or adherence (p = 0.63). Adherent tumors were associated with worse facial nerve outcomes (p = 0.003). Regression tree analysis identified 3 ADC categories with statistically different facial nerve outcomes. The categories identified were ADC < 1006.04 × 10-6 mm2/s; ADC 1006.04-1563.93 × 10-6 mm2/s and ADC ≥ 1563.94 × 10-6 mm2/s. Postoperative and final House-Brackmann (HB) scores were significantly higher in the intermediate ADC group (2.3, p = 0.0038). HB outcomes were similar between the group with ADC < 1006.04 × 10-6 mm2/s and ≥ 1563.94 × 10-6 mm2/s (1.3 vs 1.3). CONCLUSIONS: Middle-range preoperative ADC in vestibular schwannoma suggests a less favorable postoperative HB score. Preoperative measurement of ADC in vestibular schwannoma may provide additional information regarding prognostication of facial nerve outcomes.

Striatal and Thalamic Auditory Response During Deep Brain Stimulation for Essential Tremor: Implications for Psychosis.

INTRODUCTION: The P50, a positive auditory-evoked potential occurring 50 msec after an auditory click, has been characterized extensively with electroencephalography (EEG) to detect aberrant auditory electrophysiology in disorders like schizophrenia (SZ) where 61-74% have an auditory gating deficit. The P50 response occurs in primary auditory cortex and several thalamocortical regions. In rodents, the gated P50 response has been identified in the reticular thalamic nucleus (RT)-a deep brain structure traversed during deep brain stimulation (DBS) targeting of the ventral intermediate nucleus (VIM) of the thalamus to treat essential tremor (ET) allowing for interspecies comparison. The goal was to utilize the unique opportunity provided by DBS surgery for ET to map the P50 response in multiple deep brain structures in order to determine the utility of intraoperative P50 detection for facilitating DBS targeting of auditory responsive subterritories. MATERIALS AND METHODS: We developed a method to assess P50 response intraoperatively with local field potentials (LFP) using microelectrode recording during routine clinical electrophysiologic mapping for awake DBS surgery in seven ET patients. Recording sites were mapped into a common stereotactic space. RESULTS: Forty significant P50 responses of 155 recordings mapped to the ventral thalamus, RT and CN head/body interface at similar rates of 22.7-26.7%. P50 response exhibited anatomic specificity based on distinct positions of centroids of positive and negative responses within brain regions and the fact that P50 response was not identified in the recordings from either the internal capsule or the dorsal thalamus. CONCLUSIONS: Detection of P50 response intraoperatively may guide DBS targeting RT and subterritories within CN head/body interface-DBS targets with the potential to treat psychosis and shown to modulate schizophrenia-like aberrancies in mouse models.

Wearable Technology-A Pilot Study to Define "Normal" Postoperative Recovery Trajectories.

BACKGROUND: Emerging wearable technology has the potential to quantify both preoperative and postoperative patient activity. The purpose of this study was to characterize postoperative recovery trajectories for 1 mo after common surgical procedures. MATERIALS AND METHODS: Patients included were scheduled for common elective operations. A wearable activity device was worn for at least 3 d preoperatively and 28 d postoperatively. Postoperative steps per day were compared with preoperative baseline steps, with recovery trajectories reported as a percentage of patients' baseline values. Recovery trajectories were compared between groups based on admission type and operation type. RESULTS: Two hundred ten patients were enrolled, and 143 patients (68%) completed follow-up. Patients took a median 5342 steps per day preoperatively and had significantly decreased steps on the first postoperative day, including those undergoing inguinal hernia repair (22% of baseline steps, P < 0.001). Four weeks postoperatively, steps per day had not returned to baseline in patients undergoing minimally invasive abdominal (88% of baseline, P = 0.035), open abdominal (64% of baseline, P = 0.002), and thoracic (32% of baseline, P = 0.002) operations. All groups of patients showed a rapid recovery of steps during the first postoperative week, followed by a slower return to baseline. Recovery trajectories differed based on both admission type and operation type. CONCLUSIONS: Wearable activity monitors provide useful technology for quantification of postoperative activity recovery trajectories of steps per day in comparison to preoperative activity levels, with internal validity differentiating recovery trajectories grouping by broad categorization of operation type and by admission type. Activity recovery is a patient-centered outcome that can be used for counseling as well as for intervening to improve activity levels after surgery.

Improved survival in rectal cancer patients who are treated with long-course versus short-course neoadjuvant radiotherapy: A propensity-matched analysis of the NCDB.

BACKGROUND: Randomized controlled trials have demonstrated comparable survival outcomes for short-course (SCRT) and long-course neoadjuvant radiotherapy (LCRT) in patients with rectal cancer. METHODS: Using the National Cancer Data Base (2004-2015), a propensity score was used to match 188 patients with rectal cancer receiving SCRT to 376 patients receiving LCRT. Perioperative, oncologic, and survival outcomes were compared. RESULTS: Patient and clinical tumor characteristics were similar between groups. Patients in the LCRT were more likely to undergo surgery (91% vs 85%; P = 0.03). The LCRT group were more likely to have tumor (T) (56% vs 43%) and nodal (N) (25% vs 19%) downstaging, and a complete pathological response (15% vs 6%) compared with the SCRT group (all P < 0.05). Length of stay (6 vs 8 days), 30-day (1% vs 5%) mortality, and 90-day mortality (1% vs 10%) were significantly lower in the LCRT group (all P < 0.05). After adjusting for patient and tumor-related characteristics, LCRT was associated with a 50% reduction in the risk of mortality compared with SCRT (hazard ratios, 0.50; 95% confidence interval, 0.35-0.70). CONCLUSIONS: In this analysis, LCRT was superior to SCRT in terms of tumor response to neoadjuvant therapy, perioperative mortality, and overall survival. These findings provide evidence for the use of LCRT when neoadjuvant therapy is indicated.

A nomogram to predict node positivity in patients with thin melanomas helps inform shared patient decision making.

OBJECTIVE: To develop a nomogram to estimate the probability of positive sentinel lymph node (+SLN) for patients with thin melanoma and to characterize its potential impact on sentinel lymph node biopsy (SLNB) rates. METHODS: Patients diagnosed with thin (0.5-1.0 mm) melanoma were identified from the National Cancer Database 2012 to 2015. A multivariable logistic regression model was used to examine factors associated with +SLN, and a nomogram to predict +SLN was constructed. Nomogram performance was evaluated and diagnostic test statistics were calculated. RESULTS: Of the 21 971 patients included 10 108 (46.0%) underwent SLNB, with a 4.0% +SLN rate. On multivariable analysis, age, Breslow thickness, lymphovascular invasion, ulceration, and Clark level were significantly associated with SLN status. The area under the receiver operating curve was 0.67 (95% confidence interval, 0.65-0.70). While 15 249 (69.4%) patients had either T1b tumors or T1a tumors with at least one adverse feature, only 2846 (13.0%) had a nomogram predicted probability of a +SLN ≥5%. Using this cut-off, the indication for a SLNB in these patients would be reduced by 81.3% as compared to the American Joint Committee on Cancer 8th edition staging criteria. CONCLUSIONS: The risk predictions obtained from the nomogram allow for more accurate selection of patients who could benefit from SLNB.

Influence of Nonindex Hospital Readmission on Length of Stay and Mortality.

IMPORTANCE: Hospitals and health care systems face increasing accountability for postdischarge outcomes of patients, but it is unclear how frequently hospital readmissions in particular occur at a different hospital than the index hospitalization and whether this is associated with worse outcomes. OBJECTIVE: Describe the prevalence of nonindex 30-day readmissions in a nationally representative sample of all payers and associations with outcomes. DESIGN: Secondary retrospective analysis of the 2013 Nationwide Readmissions Database. SETTING: Nonfederal hospitals from 21 states representing half of hospitalizations in the United States annually. PARTICIPANTS: Our overall sample included all adults discharged alive from an inpatient stay with 30 days of follow-up; we also created 3 additional cohorts: patients with Medicare as the payer (Medicare cohort), patients discharged to home health or skilled nursing facilities after discharge (postacute care cohort), and Medicare patients with any of the current Hospital Readmission Reduction Program's penalized conditions (readmission penalty cohort). EXPOSURE: Readmission within 30 days to "index" hospital (where index stay occurred) or "nonindex" hospital. MAIN OUTCOME(S) AND MEASURE(S): In-hospital mortality and length of stay during the readmission. RESULTS: The weighted overall sample included 22,884,505 hospital discharges from 2004 unique hospitals. The overall 30-day readmission rate was 11.9%, of these, 22.5% occurred at a nonindex hospital. Readmissions to nonindex facilities were associated with increased odds of in-hospital mortality (odds ratio, 1.21; 95% confidence interval, 1.17-1.25) and longer hospital length of stay (hazard ratio for hospital discharge, 0.87; 95% confidence interval, 0.86-0.88) in the overall sample and in the 3 cohorts. CONCLUSIONS AND RELEVANCE: Nonindex readmissions are common and associated with worse outcomes; the common findings across cohorts highlight the importance for hospitals and care systems participating in value-based payment models. Hospitals and care systems should invest in improved methods for real-time identification and intervention for these patients.

Comparison of laparoscopic to open pancreaticoduodenectomy in elderly patients with pancreatic adenocarcinoma.

INTRODUCTION: The purpose of the study is to compare perioperative and survival outcomes in elderly patients undergoing laparoscopic pancreaticoduodenectomy (LPD) to those undergoing open pancreaticoduodenectomy (OPD). METHODS: Patients aged ≥ 75 years with pancreatic adenocarcinoma undergoing LPD or OPD were identified from the NCDB (2010-2013). Baseline characteristics and perioperative outcomes were compared using a χ 2 and Student's t test. The Kaplan-Meier method was used to generate survival curves, and differences were tested using a log-rank test. A multivariate cox proportional hazard model was applied to estimate the hazard ratio (HR) of LPD on overall survival (OS). RESULTS: We identified 1768 patients aged ≥ 75 years who underwent LPD (n = 248, 14.0%) or OPD (n = 1520, 86.0%). The majority of patients in the LPD group had their surgery at facilities performing less than 5 LPDs per year (n = 165, 66.5%). 90-day mortality was significantly lower in the LPD compared to the OPD (7.2 vs. 12.2%, p = 0.049). The laparoscopic conversion rate was 30% (n = 74) and was associated with higher readmission rates (13.5 vs. 8.1%), 30-day mortality (8.0 vs. 3.8%), and 90-day mortality (10.4 vs. 6.0%), but these did not reach statistical significance. Median OS was significantly longer in the LPD group (19.8 vs. 15.6 months, p = 0.022). After adjusting for patient and tumor-related characteristics, there was a trend towards improved survival in the LPD group (HR 0.85, 95% CI 0.69-1.03). CONCLUSION: The vast majority of the NCDB participating facilities perform less than 5 LPD cases per year, which was associated with an increased risk of perioperative mortality. Overall 90-day mortality was significantly lower in the LPD group and there was a trend towards improved OS in the LPD group compared to the OPD group after adjusting for patient and tumor-related characteristics. Studies with increased sample size and longer follow-up are needed before definitive conclusions can be made.

Morbidity of endovascular abdominal aortic aneurysm repair is directly related to diameter.

OBJECTIVE: Previous randomized controlled trials have defined specific size thresholds to guide surgical decision-making in patients presenting with an abdominal aortic aneurysm (AAA). With recent advances in endovascular techniques, the anatomic considerations of AAA repair are rapidly changing. Our specific aims were to evaluate the most recent national population data to compare anatomic differences and perioperative outcomes in patients with AAA. METHODS: The American College of Surgeons National Surgical Quality Improvement Program was queried from 2011 to 2015 using the targeted vascular public use file. Patients with AAA undergoing elective open or endovascular repair were included. Risk factors and outcomes were stratified by size and divided into quartiles for categorical comparison. A logistic regression model was used to compare the impact of size on morbidity and mortality with each technique. A risk adjustment model used all preoperative criteria to generate observed and expected values for open and endovascular repair. RESULTS: There were 10,026 patients who underwent elective AAA repair, 8182 (81.6%) endovascular and 1844 (18.4%) open. Repairs were divided into density quartiles for a logistic analysis: smallest quartile, 3.5 to 5 cm; second quartile, 5.01 to 5.5 cm; third quartile, 5.51 to 6.2 cm; and largest quartile, >6.2 cm. Patients with larger aneurysms (>6.2 cm) were more likely to be male, to have a dependent functional status, and to have increased blood urea nitrogen concentration and American Society of Anesthesiologists score (P < .05). Larger aneurysms had longer operative time (162 vs 135 minutes) and greater extension toward the renal and iliac vessels (all P < .05). Risk adjustment revealed an observed/expected morbidity plot that favored endovascular repair throughout the size range but confirmed lack of size effect within the open repair category. The adjusted increase in morbidity with endovascular repair is 9.7% per centimeter increase in size of AAA. These trends remained true with an infrarenal subgroup analysis. CONCLUSIONS: Patients with a larger AAA have comorbidities and anatomic factors associated with a more difficult repair. The higher morbidity seen with larger aneurysms represents both anatomic and patient factors but seems to have a greater impact on endovascular repairs. However, endovascular repair still results in fewer near-term complications than open repair across all size strata.

Impact of neoadjuvant chemoradiation on perioperative outcomes in patients with rectal cancer.

BACKGROUND AND OBJECTIVES: Neoadjuvant chemoradiation for rectal cancer is associated with lower local recurrence rates. The objective of this study is to assess the impact of neoadjuvant therapy on perioperative complications in patients with rectal cancer. METHODS: Using the ACS-NSQIP database (2005-2012), a propensity score was used to match 3592 patients with rectal cancer receiving neoadjuvant therapy to 3592 patients undergoing surgery alone. The association between neoadjuvant chemoradiation and perioperative outcomes was evaluated. RESULTS: Among all patients, overall morbidity was significantly higher in the neoadjuvant therapy group (n = 1170, 29.9%) compared to the surgery alone (n = 2350, 26.4%; P < 0.0001), but 30-day mortality was lower in the neoadjuvant group (n = 27, 0.7%) compared to the surgery alone group (n = 112, 1.3%; P = 0.0043). However, in propensity-matched patients, there was no difference in overall morbidity (OR 0.912, 95% CI 0.825-1.008) or 30-day mortality (OR 0.639, 95% CI 0.38-1.05). Overall morbidity and 30-day mortality were 29.3% (n = 1054) and 0.7% (n = 25) in the neoadjuvant group, respectively, compared to 31.3% (n = 1124) and 1.1% (n = 39) in the surgery alone group, respectively. CONCLUSION: Patients with newly diagnosed rectal cancer could be evaluated for neoadjuvant therapy prior to surgical resection without the fear of upfront therapy causing a significant increase in perioperative complications.

Laparoscopic colectomy in obese patients: a comparison of laparoscopic and hand-assisted laparoscopic techniques.

BACKGROUND: Recent American College of Surgeons National Surgical Quality Improvement Project (ACS-NSQIP)-based evidence indicates that laparoscopic (LAP) colectomy results in improved outcomes compared to hand-assisted laparoscopic (HAL) colectomy in the general population. Previous comparative studies demonstrated that the HAL technique offers distinct advantages for obese patients. The aim of this study was to perform comparative analyses of HAL and LAP colectomy and low anterior resection (LAR) in obese patients. METHODS: The ACS-NSQIP public use file and targeted colectomy dataset, 2012-2014, were utilized for patients undergoing colectomy and LAR. Only obese patients (BMI > 30) and laparoscopic or hand-assisted operations were included. Patient, operation, and outcome variables were compared in two separate cohorts: colectomy and LAR. Bivariate analysis compared the approaches, followed by multivariable regression. RESULTS: Of 9610 obese patients included, HAL and LAP colectomy were performed in 3126 and 3793 patients and LAR in 1431 and 1260 patients, respectively. In comparison to LAP colectomy, HAL colectomy patients had increased comorbidities including class 2 and 3 obesity. HAL colectomy was associated with higher overall morbidity (20 vs. 16%, p < 0.001), infectious complications (10.2 vs. 7.7%, p < 0.001), anastomotic leaks (3.0 vs. 2.2%, p = 0.03), and ileus (11 vs. 8%, p < 0.001). Multivariate analysis indicated that overall morbidity (OR 1.27, 95% CI 1.11-1.44), infectious complications (OR 1.35, 95% CI 1.14-1.59), and ileus (OR 1.33, 95% CI 1.12-1.57) were each increased in the HAL colectomy cohort but not different for HAL and LAP LAR. CONCLUSIONS: In comparison to LAP colectomy, the HAL technique is used more often in obese patients with an increased operative risk profile. While inherent bias and unmeasured variables limit the analysis, the available data indicate that the HAL technique is associated with increased perioperative morbidity. Alternatively, HAL and LAP LAR are performed in obese patients with a similar risk profile and result in similar postoperative outcomes.

Dynamic-ETL: a hybrid approach for health data extraction, transformation and loading.

BACKGROUND: Electronic health records (EHRs) contain detailed clinical data stored in proprietary formats with non-standard codes and structures. Participating in multi-site clinical research networks requires EHR data to be restructured and transformed into a common format and standard terminologies, and optimally linked to other data sources. The expertise and scalable solutions needed to transform data to conform to network requirements are beyond the scope of many health care organizations and there is a need for practical tools that lower the barriers of data contribution to clinical research networks. METHODS: We designed and implemented a health data transformation and loading approach, which we refer to as Dynamic ETL (Extraction, Transformation and Loading) (D-ETL), that automates part of the process through use of scalable, reusable and customizable code, while retaining manual aspects of the process that requires knowledge of complex coding syntax. This approach provides the flexibility required for the ETL of heterogeneous data, variations in semantic expertise, and transparency of transformation logic that are essential to implement ETL conventions across clinical research sharing networks. Processing workflows are directed by the ETL specifications guideline, developed by ETL designers with extensive knowledge of the structure and semantics of health data (i.e., "health data domain experts") and target common data model. RESULTS: D-ETL was implemented to perform ETL operations that load data from various sources with different database schema structures into the Observational Medical Outcome Partnership (OMOP) common data model. The results showed that ETL rule composition methods and the D-ETL engine offer a scalable solution for health data transformation via automatic query generation to harmonize source datasets. CONCLUSIONS: D-ETL supports a flexible and transparent process to transform and load health data into a target data model. This approach offers a solution that lowers technical barriers that prevent data partners from participating in research data networks, and therefore, promotes the advancement of comparative effectiveness research using secondary electronic health data.