Outcomes of ventriculoperitoneal shunt placement with or without laparoscopic assistance: An analysis of the national inpatient sample.

Background: Ventriculoperitoneal shunt (VPS) can be placed solely by a neurosurgeon often via an open-laparotomy approach, or laparoscopically as a collaborative effort between a neurosurgeon and a general surgeon. Prior studies have shown conflicting results when examining outcomes regarding infection, revision rate, hospital charges, length of stay, and mortality between the open mini-laparotomy and the laparoscopic approaches. Objective: The current study uses the National Inpatient Sample (NIS) to compare outcomes of open mini-laparotomy vs. laparoscopic collaborative approach in VPS placement. Methods: We performed a retrospective database study of the NIS from October 2015-December 2017 utilizing International Classification of Diseases, 10th Revision coding to identify all cases of VPS placement. All analyses accounted for the sampling design of the NIS. Results: A total of 6580 cases (4969 with open mini-laparotomy approach and 1611 with laparoscopic collaborative approach) met inclusion criteria. Hospital charges, infection rates, and revision rates were similar between approaches. There were no significant differences in length of stay, mortality, or complication rates between the two approaches. Conclusion: The collaborative, laparoscopic approach to VPS placement has similar outcomes and is non-inferior to the traditional open mini-laparotomy approach.

Factors Associated With Upstaging of Melanoma Thickness on Final Excision.

INTRODUCTION: The incidence and risk factors associated with upstaging from initial biopsy to definitive excision in cutaneous melanoma have not been established. The aim of this study was to determine the incidence of tumor stage upstaging and associated risk factors using the National Cancer Database. METHODS: A retrospective study of the National Cancer Database between 2012 and 2016 was performed. The cohort of patients undergoing excision of melanoma with available data comprised 133,592 patients. Differences in characteristics for upstaging were determined using Wilcox rank-sum, chi-square, or Fisher's exact tests. Multivariable analysis was performed using logistic regression to determine factors associated with upstaging. RESULTS: Incidence of upstaging was 5.2%. Upstaged patients were older, male, of non-White race, and of lower education level (P < 0.001). Lesions of the head/neck and lower extremity had increased incidence of upstaging compared to the trunk (P < 0.001). Nodular and acral lentiginous melanoma was associated with higher incidence of upstaging compared to superficial spreading melanoma (P < 0.001). Patients with lymphovascular invasion had increased risk of upstaging (P < 0.001). CONCLUSIONS: Upstaging of melanoma is infrequent but is significantly more prevalent in non-White patients and those with lower educational status. Provider and patient education should include the higher risk of upstaging in these groups and the possible need for further surgical intervention, such as re-excision of margins and sentinel lymph node biopsy.

How many days are needed? Measurement reliability of wearable device data to assess physical activity.

INTRODUCTION/PURPOSE: Physical activity studies often utilize wearable devices to measure participants' habitual activity levels by averaging values across several valid observation days. These studies face competing demands-available resources and the burden to study participants must be balanced with the goal to obtain reliable measurements of a person's longer-term average. Information about the number of valid observation days required to reliably measure targeted metrics of habitual activity is required to inform study design. METHODS: To date, the number of days required to achieve a desired level of aggregate long-term reliability (typically 0.80) has often been estimated by applying the Spearman-Brown Prophecy formula to short-term test-retest reliability data from studies with single, relatively brief observation windows. Our work, in contrast, utilizes a resampling-based approach to quantify the long-term test-retest reliability of aggregate measures of activity in a cohort of 79 participants who were asked to wear a FitBit Flex every day for approximately one year. RESULTS: The conventional approach can produce reliability estimates that substantially overestimate the actual test-retest reliability. Six or more valid days of observation for each participant appear necessary to obtain 0.80 reliability for the average amount of time spent in light physical activity; 8 and 10 valid days are needed for sedentary time and moderate/vigorous activity respectively. CONCLUSION: Protocols that result in 7-10 valid observation days for each participant may be needed to obtain reliable measurements of key physical activity metrics.

The weekend effect on mechanical thrombectomy: A nationwide analysis before and after the pivotal 2015 trials.

OBJECTIVES: As hospitals rapidly implement mechanical thrombectomy (MT) into stroke protocols following the pivotal trials in 2015, access to and outcomes from MT may be poorer for weekend-admitted patients. We sought to investigate whether a "weekend effect" influences MT outcomes nationally. MATERIALS AND METHODS: We identified stroke patients from 2010-2014 (pre-trials) to 2015-2017 (posttrials) using the Nationwide Readmissions Database. On multivariate analyses, we determined factors independently associated with receiving MT. Among MT patients, we then determined whether weekend admission was independently associated with inpatient mortality and unfavorable discharge. RESULTS: We identified 2,121,462 patients from 2010 to 2014, of whom 1.11% of weekday-admitted and 1.08% of weekend-admitted patients underwent MT. Of the 1,286,501 patients identified from 2015 to 2017, MT was performed in 2.82% and 2.91%, respectively. In the earlier cohort, weekend admission was independently associated with reduced odds of MT (odds ratio [OR] = 0.92, 95% confidence interval [CI]: 0.89-0.95, P < 0.0001), although this was not statistically significant in the later cohort. During both periods, age >80 years was independently associated with a reduced likelihood of receiving MT, and status as a teaching or large bed-size hospital was associated with a greater likelihood. Weekend admission was independently associated with unfavorable discharge only in the 2015-2017 cohort (OR = 1.11, 95% CI: 1.02-1.22, P = 0.02). CONCLUSIONS: While nationwide access to MT has improved for weekend-admitted patients, the elderly and those at smaller, nonteaching hospitals remain underserved. Although we found no effect of weekend admission on inpatient mortality, since the major shift in practice, an emerging "weekend effect" may influence discharge outcomes. Data suggest that some hospitals are being challenged to provide this new standard of care efficiently and equitably.

Characteristics and Outcomes of Discharge Against Medical Advice and 30-Day Readmissions After Concussion: Analysis of the Nationwide Readmissions Database.

BACKGROUND: Little is known about the impact of discharge against medical advice (DAMA) in patients admitted with concussion. OBJECTIVE: To explore the prevalence of DAMA and its effect on 30-day readmissions and cost in concussion using a nationally representative sample. METHODS: The Nationwide Readmissions Database was queried for concussion admissions and their disposition at discharge between 2010 and 2014. Included patients were ≥18 years old who were admitted with concussion and had <1 hour loss of consciousness. We excluded in-hospital deaths or discharge dispositions other than home or against medical advice. Univariate and multivariate analyses were performed to determine characteristics associated with DAMA and 30-day readmissions. RESULTS: A total of 38 919 index admissions were identified, which resulted in 998 (2.6%) DAMA. In multivariate analysis, characteristics associated with DAMA included younger age (odds ratio [OR] = 0.84, 95% CI 0.80-0.88), male sex (1.47, 1.22-1.76), an Elixhauser comorbidity index >3 (1.67, 1.15-1.60), and assault (2.02, 1.48-2.75) and fall injuries (1.28, 1.03-1.60). The highest-income quartile was negatively associated with DAMA (0.91, 0.73-1.13). In multivariate analysis, DAMA (1.63, 1.29-2.06), higher comorbidity index (2.61, 2.22-3.06), and self-inflicted mode of injury (2.28, 1.30-4.02) were independently associated with 30-day readmission. The most common indication for readmission in both routine and DAMA groups was traumatic injury (21.1% and 24.5%, respectively). CONCLUSION: DAMA is an independent risk factor for readmission in patients admitted for concussion. The variables associated with DAMA identified in this study can be used to design patient-centered interventions that can be implemented to reduce DAMA and its impact on clinical outcomes in patients with traumatic brain injury.

Real-world evaluation of the impact of two anti-SARS-CoV-2 monoclonal antibody regimens on COVID-19 hospitalizations in older adults.

Evidence from clinical trials suggest anti-SARS-CoV-2 monoclonal antibodies (mABs) may reduce coronavirus disease 2019 (COVID-19)-related hospitalizations. The purpose of this study was to assess the real-world impact of mAB administration on COVID-19 hospitalization among patients 65 years or older. This was a retrospective, propensity-matched cohort study that included patients aged 65 years and older who presented to the emergency department (ED) within 10 days of symptom onset of mild to moderate COVID-19 infection. Outcomes were compared between those who did and did not receive mAB therapy. The primary endpoint was the rate of hospitalization for COVID-19 within 30 days of index ED visit. A total of 137 patients receiving mABs were matched to 137 controls. Hospitalization occurred in 2.9% of mAB-treated patients compared to 14.6% of patients of the standard of care (SOC) arm (odds ratio: 0.20 [95% CI: 0.07-0.59]). There were zero intubations and zero deaths compared to 3 (2.2%) and 2 (1.5%) in the SOC group. Among the 223 patients receiving mAB in the overall cohort, adverse drug events occurred in 10 (4.5%). Treatment with mAB therapy for mild to moderate COVID-19 was associated with a substantially reduced risk of hospitalization among patients at least 65 years of age.

Save the Quinolones! Impact of a Non-Restrictive Fluoroquinolone Reduction Initiative on Antibiotic Use and Resistance at an Urban Teaching Hospital.

BACKGROUND: Many antibiotic stewardship programs have sought to reduce fluoroquinolone use due to their association with a myriad of negative consequences. In hospital settings with fewer resources, initiatives that are less labor intensive may offer a more feasible approach to addressing fluoroquinolone use and improving patient care. OBJECTIVE: This study assessed the impact of a non-restrictive fluoroquinolone reduction initiative on antibiotic use and resistance. METHODS: This was a retrospective pre- and post-interventional ecological study conducted from 2016 to 2017. The fluoroquinolone reduction initiative consisted of education on risks and alternatives. Buttons promoting "Save the Quinolones" were also worn to increase visibility. Outcome measures were the rate of fluoroquinolone use and antibiotic resistance in Staphylococcus aureus, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, and Pseudomonas aeruginosa before and after the intervention. RESULTS: Overall, fluoroquinolone use decreased throughout the study, but there was a significantly greater rate of decrease in the post-intervention period (monthly decrease of 3.3% (1.3, 5.1) v. 7.4% (5, 9.8) p = 0.043). S. aureus susceptibility to oxacillin increased from 47.2% to 55.2% (difference 8.0, 95%CI 1.2 to 14.7). P. aeruginosa susceptibility to levofloxacin increased from 60% to 70.7% (difference 10.7, 95%CI 0.8 to 20.6). No differences in susceptibility rates of E. coli, P. mirabilis or K. pneumoniae were detected. CONCLUSION: This non-restrictive fluoroquinolone reduction initiative led to a significant decrease in fluoroquinolone use that was associated with decreased antibiotic resistance in S. aureus and P. aeruginosa.

Long-term Outcomes After Lung Cancer Resection in Smokers: Analysis of the National Lung Screening Trial.

BACKGROUND: Smoking is a known risk factor for perioperative complications after lung resection; however, little data exists looking at the impact of smoking status (current versus former) on long-term oncologic outcomes after lung cancer surgery. We sought to compare overall survival (OS), progression-free survival (PFS), and cancer-specific mortality (CSM) in current and former smokers using data from the National Lung Screening Trial (NLST). Additionally, we performed subset analysis in current smokers in order to evaluate the effect of modern surgical techniques on long-term outcomes. METHODS: Patients with clinical stage IA or IB NSCLC who underwent upfront resection within 180 days of diagnosis were identified in the NLST database. Cox proportional hazard regression models were used to assess differences in patient and treatment characteristics with respect to OS and PFS, with a cause-specific hazard model used for CSM. RESULTS: A total of 593 patients were included in the study (269 former smokers, 324 current smokers). Lobar resection (LR) was performed more often than sublobar resection (SLR) (481 vs. 112), and thoracotomy was performed more often than thoracoscopy (482 vs. 86). Comparison of current versus former smokers showed no difference in OS or PFS after resection. Higher CSM was seen in current smokers (p = 0.049). Subset analysis of current smokers revealed no difference in OS or PFS between sub-lobar and lobar resection or thoracotomy and thoracoscopy. Although higher CSM was associated with thoracoscopy versus thoracotomy in this group, this finding was limited by a relatively small thoracoscopy sample size of 44 patients (p = 0.026). CONCLUSION: Our analysis of the NLST database shows no significant difference in OS and PFS when comparing current and former smokers undergoing resection for stage I NSCLC. Active smoking status was associated with higher CSM. Subset analysis of current smokers showed no difference in OS or PFS between sub-lobar and lobar resection or thoracotomy and thoracoscopy. Higher CSM was seen in current smokers who underwent thoracoscopy compared to thoracotomy; however, this finding was limited by a small sample size.

National Rates, Reasons, and Risk Factors for 30- and 90-Day Readmission and Reoperation Among Patients Undergoing Anterior Cervical Discectomy and Fusion: An Analysis Using the Nationwide Readmissions Database.

STUDY DESIGN: Retrospective cohort study of the Nationwide Readmissions Database (NRD). OBJECTIVE: To determine causes of and independent risk factors for 30- and 90-day readmission in a cohort of anterior cervical discectomy and fusion (ACDF) patients. SUMMARY OF BACKGROUND DATA: Identifying populations at high-risk of 30-day readmission is a priority in healthcare reform so as to reduce cost and patient morbidity. However, among patients undergoing ACDF, nationally-representative data have been limited, and have seldom described 90-day readmissions, early reoperation, or socioeconomic influences. METHODS: We queried the NRD, which longitudinally tracks 49.3% of hospitalizations, for all adult patients undergoing ACDF. We calculated the rates of, and determined reasons for, readmission and reoperation at 30 and 90 days, and determined risk factors for readmission at each timepoint. RESULTS: We identified 50,126 patients between January and September 2014. Of these, 2294 (4.6%) and 4152 (8.3%) were readmitted within 30 and 90 days of discharge, respectively, and were most commonly readmitted for infections, medical complications, and dysphagia. The characteristics most strongly associated with readmission were Medicare or Medicaid insurance, length of stay greater than or equal to 4 days, three or more comorbidities, and non-routine discharge, whereas surgical factors (e.g., greater number of vertebrae fused) were more modest. By 30 and 90 days, 8.2% and 11.7% of readmitted patients underwent an additional spinal procedure, respectively. CONCLUSION: Our analysis uses the NRD to thoroughly characterize readmission in the general ACDF population. Readmissions are often delayed (after 30 days), strongly associated with insurance status, and many result in reoperation. Our results are crucial for risk-stratifying future ACDF patients and developing interventions to reduce readmission.Level of Evidence: 3.

Impact of postoperative complications on long-term survival after esophagectomy in older adults: A SEER-Medicare analysis.

BACKGROUND: Esophagectomy is a complex procedure associated with a high rate of postoperative complications. It is not clear whether postoperative complications effect long-term survival. Most studies report the results from single institutions. METHODS: We examined the Surveillance, Epidemiology and End Results (SEER)-Medicare database to assess whether long-term overall and cancer-specific mortality of patients undergoing esophagectomy for cancer is impacted by postoperative complications. RESULTS: Nine hundred and forty patients underwent esophagectomy from 2007 to 2014, of which 50 died, resulting in a cohort of 890 patients. Majority were males (n = 764, 85.8%) with adenocarcinoma of the lower esophagus. Almost 60% of the group had no neoadjuvant therapy. Four hundred and fifty-five patients had no major complications (51.1%), while 285 (32.0%) and 150 (16.9%) patients had one, two, or more major complications, respectively. Overall survival at 90 days was 93.1%. Multivariate analysis of patients followed up for a minimum of 90 days demonstrated that the number of complications was significantly associated with decreased overall survival but no impact on cancer-specific survival. CONCLUSIONS: Our population-based analysis with its inherent limitations suggests that patients undergoing esophagectomy who experience complications have worse overall survival but not cancer-specific survival if they survive at least 90 days from the date of surgery.

Enhanced recovery after surgery for sleeve gastrectomies: improved patient outcomes.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) is a paradigm shift in perioperative care and incorporates patient-centered, evidence-based, and multidisciplinary team-developed pathways for a surgical specialty. ERAS pathways aim to reduce the patient's surgical stress response, optimize their physiologic function, facilitate recovery, and reduce the length of stay. The bariatric program at our institution was previously managed by many surgeons with anecdotal preferences, resulting in increased costs, lengths of stay, and opioid prescribing. OBJECTIVES: To describe a standardized ERAS pathway for patients undergoing a laparoscopic sleeve gastrectomy procedure in order to enhance perioperative care and reduce opioid usage. SETTING: ERAS bariatric program in New Jersey. METHODS: The ERAS bariatric program at our institution was implemented in January 2018. All patients who underwent sleeve gastrectomy from January 2016 to November 2017 (preimplementation) as well as from February 2018 to October 2020 (postimplementation) were included in this retrospective study, with those undergoing procedures in December 2017 and January 2018 excluded due to the transition to the ERAS protocol. Differences in lengths of stay, direct costs, and 30-day readmission rates were compared between the pre- and postimplementation periods. The primary goal of our ERAS pathway was to optimize patient care with reduced opioid usage, and the secondary goal was to reduce the costs for care. RESULTS: A total of 1988 patients who underwent sleeve gastrectomy were identified, with 789 patients in the preimplementation group and 1199 patients in the postimplementation group. In a multivariate analysis, the mean length of a hospital stay in the postimplementation period was 18% lower (95% confidence interval [CI], 14-22) than that of the preimplementation period (P < .001), while the average opioid morphine milligram equivalents administered in the postoperative period was 61% (95% CI, 57%-65%) less than that of the preimplementation period (P < .001). Average direct costs decreased by $155 (95% CI, -$358 to $48) per case in the postimplementation period (P = .133), and there was no significant difference in the 30-day readmission rate between the pre- and postimplementation periods (3.8% versus 3.0%, respectively; odds ratio, .81; 95% CI, .49-1.35; P = .413). CONCLUSION: In this study, patient outcomes after ERAS pathway implementation were significantly better than in historical cases. Implementing the bariatric ERAS program for laparoscopic sleeve gastrectomy at our institution has led to rapid postoperative recovery of patients, shorter lengths of stay, reduced opioid usage, and decreased costs per case, thereby increasing the overall cost savings to the hospital. ERAS pathways in bariatric surgery represent an opportunity to enhance patient care while decreasing overall costs. We propose that cost-effective, tailor-made ERAS pathways for sleeve gastrectomy should be implemented in all designated centers of excellence, as they can have a great economic impact on the healthcare system.

Phase 3 Randomized Controlled Trial of Androgen Deprivation Therapy with or Without Docetaxel in High-risk Biochemically Recurrent Prostate Cancer After Surgery (TAX3503).

BACKGROUND: No standard of care exists for patients with high-risk biochemical recurrence (BCR) after prostatectomy. OBJECTIVE: To evaluate whether addition of docetaxel to androgen deprivation therapy (ADT) improved progression-free survival (PFS) in high-risk BCR patients. DESIGN, SETTING, AND PARTICIPANTS: TAX3503 was a multicenter phase 3 trial that randomized patients with high-risk BCR to ADT for 18 mo ± docetaxel (75 mg/m2 q3w for ten cycles). Eligibility included prostate-specific antigen (PSA) ≥1.0 ng/ml after prostatectomy alone or after postoperative radiation therapy, PSA doubling time ≤9 mo, and absence of metastases on computed tomography and bone scintigraphy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was PFS following testosterone recovery to noncastrate levels (testosterone >50 ng/dl). Secondary endpoints included time to testosterone recovery, overall survival (OS), quality of life, and safety. RESULTS AND LIMITATIONS: Between September 2007 and May 2011, 413 patients were assigned to ADT ± docetaxel. In 2012, following completion of accrual and treatment, the sponsor withdrew support of the study, and in 2013, a registry was created to secure the primary endpoint. The final analysis included data from the original trial and registry. At a median follow-up of 33.6 mo, 260 patients demonstrated testosterone recovery, which occurred similarly between groups. ADT plus docetaxel trended toward a nonclinically meaningful improvement in PFS (median 26.2 vs 24.7 mo) for the testosterone-recovered population (218 events, hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.61-1.04) and in OS for the intention-to-treat population (medians not reached, HR 0.51, 95% CI 0.23-1.10). Grade ≥3 adverse events occurred more frequently in the ADT plus docetaxel group (48.0% vs 10.8%). CONCLUSIONS: TAX3503 did not demonstrate a meaningful benefit of adding docetaxel to ADT in patients with high-risk BCR. Testosterone recovery was unaffected by addition of docetaxel to ADT. PATIENT SUMMARY: Addition of docetaxel to androgen deprivation therapy did not meaningfully improve outcomes for men with high-risk biochemically recurrent prostate cancer.

Arsenic trioxide therapy predisposes to herpes zoster reactivation despite minimally myelosuppressive therapy.

Acute Promyelocytic Leukemia (APL) is a unique subtype of acute myeloid leukemia that is highly responsive to minimally myelosuppressive therapy with all-trans retinoic acid (ATRA) and arsenic trioxide (ATO). We and others have observed a higher than expected incidence of herpes zoster reactivation in APL patients treated with ATO. Memorial Sloan Kettering Cancer Center (MSKCC) has been using ATO since 1997 in all relapsed APL patients, and more recently has included it in our front-line APL regimens. Here we present a retrospective analysis of the factors contributing to herpes zoster reactivation among APL patients.

Effectiveness of Clinical Decision Tools in Predicting Pulmonary Embolism.

OBJECTIVE: The Wells criteria and revised Geneva score are two commonly used clinical decision tools (CDTs) developed to assist physicians in determining when computed tomographic angiograms (CTAs) should be performed to evaluate the high index of suspicion for pulmonary embolism (PE). Studies have shown varied accuracy in these CDTs in identifying PE, and we sought to determine their accuracy within our patient population. METHODS: Patients admitted to the Emergency Department (ED) who received a CTA for suspected PE from 2019 Jun 1 to 2019 Aug 31 were identified. Two CDTSs, the Wells criteria and revised Geneva score, were calculated based on data available prior to CTA and using the common D-Dimer cutoff of >500 µg/L. We determined the association between confirmed PE and CDT values and determined the association between the D-Dimer result and PE. RESULTS: 392 CTAs were identified with 48 (12.1%) positive PE cases. The Wells criteria and revised Geneva score were significantly associated with PE but failed to identify 12.5% and 70.4% of positive PE cases, respectively. Within our cohort, a D-Dimer cutoff of >300 µg/L was significantly associated with PE and captured 95.2% of PE cases. CONCLUSIONS: Both CDTs were significantly associated with PE but failed to identify PE in a significant number of cases, particularly the revised Geneva score. Alternative D-Dimer cutoffs may provide better accuracy in identifying PE cases.

Early clinical outcomes with tocilizumab for severe COVID-19: a two-centre retrospective study.

Severe COVID-19 (coronavirus disease 2019) is associated with elevated inflammatory markers, consistent with cytokine release syndrome (CRS). Tocilizumab is an interleukin-6 (IL-6) inhibitor effective in treating CRS secondary to chimeric antigen receptor T-cell (CAR T-cell) therapy. The efficacy of tocilizumab in treating COVID-19 is unknown. This was a retrospective cohort study conducted at two hospitals in northern New Jersey (USA). All patients treated with tocilizumab for confirmed or suspected COVID-19 between 10 March 2020 and 9 April 2020 at the study sites were included. The primary endpoint was clinical improvement on Day 7 after treatment as assessed by respiratory status. Univariate analysis compared data between those who improved and those who did not. A total of 45 severe and critically ill patients treated with tocilizumab for COVID-19 were evaluated. Of the 45 patients, 11 (24.4%), 22 (48.9%) and 12 (26.7%) patients improved, had no change or worsened by Day 7 after treatment, respectively. Lower white blood cell count and lactate dehydrogenase at the time of drug administration as well as shorter time from supplemental oxygen initiation to dosing were significantly associated with clinical improvement in the univariate analysis. In conclusion, tocilizumab administration was associated with a low rate of clinical improvement within 7 days in this cohort of severe and critically ill patients with COVID-19.

Combining the Disease Risk Index and Hematopoietic Cell Transplant Co-Morbidity Index provides a comprehensive prognostic model for CD34+-selected allogeneic transplantation.

T cell depletion by CD34+ cell selection of hematopoietic stem cell allografts ex vivo reduces the incidence and severity of GvHD, without increased risk of relapse in patients with acute leukemia in remission or MDS. The optimal candidate for CD34+-selected HCT remains unknown, however. Objective: To determine outcomes based on both disease- and patient-specific factors, we evaluated a prognostic model combining the Disease Risk Index (DRI) and Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI), an approach recently shown to predicted overall survival in a broad population of allograft recipients (1). Methods: This was a retrospective analysis of 506 adult recipients of first allogeneic HCT with CD34+ selected PBSCs from 7/8- or 8/8-matched donors for AML (n = 290), ALL (n = 72), or MDS (n = 144). The Kaplan-Meier method estimated OS and RFS. The cumulative incidence method for competing risks estimated relapse and non-relapse mortality (NRM). We evaluated the univariate association between variables of interest and OS and RFS using the log-rank test. Cox regression models assessed the adjusted effect of covariates on OS/RFS. Results: Stratification of patients based on a composite of DRI (low/intermediate vs. high/very high) and HCT-CI (0-2 vs. ≥ 3) revealed differences in OS and RFS between the 4 groups. Compared with reference groups of patients with low/intermediate DRI and low or high HCT-CI, those with high DRI had a greater risk of death (HR 2.30; 95% CI 1.39, 3.81) and relapse or death (HR 2.50; 95% CI 1.55, 4.05) than patients with any HCT-CI but low/intermediate DRI (HR death 1.80; 95% CI 1.34, 2.43; HR relapse/death 1.68; 95% CI 1.26, 2.24). Conclusions and Clinical Implications: A model combining DRI and HCT-CI predicted survival after CD34+ cell-selected HCT. Application of this combined model to other cohorts, both in retrospective analyses and prospective trials, will enhance clinical decision making and patient selection for different transplant approaches. Data Availability Statement: The data that support the findings of this study are available on request from the corresponding author, C Cho. In order to protect the privacy of research participants, the data are not publicly available.

Big data, machine learning, and artificial intelligence: a field guide for neurosurgeons.

Big data has transformed into a trend phrase in healthcare and neurosurgery, becoming a pervasive and inescapable phrase in everyday life. The upsurge in big data applications is a direct consequence of the drastic boom in information technology as well as the growing number of internet-connected devices called the Internet of Things in healthcare. Compared with business, marketing, and other sectors, healthcare applications are lagging due to a lack of technical knowledge among healthcare workers, technological limitations in acquiring and analyzing the data, and improper governance of healthcare big data. Despite these limitations, the medical literature is flooded with big data-related articles, and most of these are filled with abstruse terminologies such as machine learning, artificial intelligence, artificial neural network, and algorithm. Many of the recent articles are restricted to neurosurgical registries, creating a false impression that big data is synonymous with registries. Others advocate that the utilization of big data will be the panacea to all healthcare problems and research in the future. Without a proper understanding of these principles, it becomes easy to get lost without the ability to differentiate hype from reality. To that end, the authors give a brief narrative of big data analysis in neurosurgery and review its applications, limitations, and the challenges it presents for neurosurgeons and healthcare professionals naive to this field. Awareness of these basic concepts will allow neurosurgeons to understand the literature regarding big data, enabling them to make better decisions and deliver personalized care.

Improved Outcomes With an Enhanced Recovery Approach to Cesarean Delivery.

OBJECTIVE: To examine the results of a quality-improvement study that implemented an enhanced recovery after surgery (ERAS) program for cesarean delivery. METHODS: A pre-post design was used to assess changes in opioid use, length of stay, and costs among all patients undergoing cesarean delivery before and after implementation of an evidence-based ERAS pathway for the preoperative, intraoperative, and postoperative management of patients beginning December 2018. RESULTS: A total of 3,679 cesarean deliveries (scheduled and emergent) were included from January 1, 2018, through August 31, 2019, of which 2,171 occurred before implementation on December 17, 2018, and 1,508 occurred postimplementation. Eighty-four percent of patients received opioids as inpatients after cesarean delivery during the preimplementation period, as compared with 24% in the postimplementation period (odds ratio [OR] 16.8, 95% CI 14.3-19.9). Among patients who required any opioids, the total morphine milligram equivalents also significantly decreased (median 56.5 vs 15.0, mean relative change 0.32, 95% CI 0.28-0.35). Compared with the preimplementation period, those in the postimplementation period had a shorter postcesarean length of stay (3.2 vs 2.7 days, mean relative change 0.82, 95% CI 0.80-0.83, median 3 days in both periods), lower median direct costs by $349 (mean relative change 0.93, 95% CI 0.91-0.95), and no change in the 30-day readmission rate (1.4% vs 1.7%, OR 0.83, 95% CI 0.49-1.41). CONCLUSION: An ERAS approach for the cesarean delivery population is associated with improved outcomes including decreases in opioid use, length of stay, and costs.

Enhanced Detection of Treatment Effects on Metastatic Colorectal Cancer with Volumetric CT Measurements for Tumor Burden Growth Rate Evaluation.

PURPOSE: Mathematical models combined with new imaging technologies could improve clinical oncology studies. To improve detection of therapeutic effect in patients with cancer, we assessed volumetric measurement of target lesions to estimate the rates of exponential tumor growth and regression as treatment is administered. EXPERIMENTAL DESIGN: Two completed phase III trials were studied (988 patients) of aflibercept or panitumumab added to standard chemotherapy for advanced colorectal cancer. Retrospectively, radiologists performed semiautomated measurements of all metastatic lesions on CT images. Using exponential growth modeling, tumor regression (d) and growth (g) rates were estimated for each patient's unidimensional and volumetric measurements. RESULTS: Exponential growth modeling of volumetric measurements detected different empiric mechanisms of effect for each drug: panitumumab marginally augmented the decay rate [tumor half-life; d [IQR]: 36.5 days (56.3, 29.0)] of chemotherapy [d: 44.5 days (67.2, 32.1), two-sided Wilcoxon P = 0.016], whereas aflibercept more significantly slowed the growth rate [doubling time; g = 300.8 days (154.0, 572.3)] compared with chemotherapy alone [g = 155.9 days (82.2, 347.0), P ≤ 0.0001]. An association of g with overall survival (OS) was observed. Simulating clinical trials using volumetric or unidimensional tumor measurements, fewer patients were required to detect a treatment effect using a volumetric measurement-based strategy (32-60 patients) than for unidimensional measurement-based strategies (124-184 patients). CONCLUSIONS: Combined tumor volume measurement and estimation of tumor regression and growth rate has potential to enhance assessment of treatment effects in clinical studies of colorectal cancer that would not be achieved with conventional, RECIST-based unidimensional measurements.