Attitudes Towards Conflicts of Interest in Medical Research: A Survey of US Medical Students.

Industry funds nearly two-thirds of US healthcare research, and industry-sponsorship may produce more favorable research results and conclusions. Medical students report feeling inadequately prepared to avoid negative industry influence. Research of educational interventions that educate students on the potential effects of industry influence is lacking, and no interventions have demonstrated long-term benefit. Surveying and assessing student opinions of the relationship between industry and research may help improve future educational interventions. We surveyed preclinical and clinical students at seven US medical schools regarding their attitudes towards industry conflicts of interest (COIs) in medical research. A total of 466 medical students including 232 preclinical and 234 clinical students completed the survey. Of those who had research experience, clinical students were more likely than preclinical students to look for COIs (62.0% v 45.9%, p = .014) and to consider whether author COIs are pertinent to the article (68.1% v 54.1%, p = .023). Many disagreed that they felt adequately educated on the issue of COIs (42.7%), but most agreed that medical school should take a role in guiding student interactions with industry (65.0%). Students responded that all listed financial relationships between industry and investigator, except for providing food and/or beverage, would likely bias the investigator's research. Many students feel inadequately educated on industry issues in biomedical research, and most believe medical schools should help guide interactions with industry. Our findings support further development of educational interventions that prepare students to navigate the relationship between industry and medical research during and after medical school.

Multimodal approach utilising a weight management programme prior to bariatric surgery in patients with BMI ≥50 kg/m2: A propensity score matching retrospective cohort study.

We evaluated preoperative weight loss and days from initial consult to surgery in patients with BMI ≥50 kg/m2 who were and were not enrolled in medical weight management (MWM) prior to laparoscopic sleeve gastrectomy. We retrospectively identified patients with BMI ≥50 kg/m2 who had primary sleeve gastrectomy between 2014 and 2019 at two bariatric surgery centres in our healthcare system. Patients presenting after 2017 that received preoperative MWM (n = 28) were compared to a historical cohort of non-MWM patients (n = 118) presenting prior to programme initiation in 2017 on preoperative percent total body weight loss (%TBWL) and days from initial consult to surgery. A total of 151 patients (MWM, 33; non-MWM, 118) met inclusion criteria. BMI was significantly greater in MWM versus non-MWM (p = .018). After propensity score matching, median BMI at initial consult in non-MWM versus MWM no longer differed (p = .922) neither were differences observed on the basis of weight, age, sex, race or ethnicity. After PSM, MWM had significantly lower BMI at surgery (p = .018), lost significantly more weight from consult to surgery (p < .001) and achieved significantly greater median %TBWL from consult to surgery (p < .001). We noted no difference between groups on 6-month weight loss (p = .533). Days from initial consult to surgery did not differ between groups (p < .863). A preoperative MWM programme integrated into multimodal treatment for obesity in patients with a BMI ≥50 kg/m2 resulted in clinically significant weight loss without prolonging time to surgery.

Five-year outcomes of revisional bariatric surgery: gastric band to sleeve gastrectomy or to Roux-en-Y gastric bypass.

BACKGROUND: Revisional bariatric surgery after an index adjustable gastric band (AGB) may be indicated to remedy weight relapse or band-related complications. We examined outcomes five years following revision from AGB to laparoscopic sleeve gastrectomy (AGB-LSG) or to Roux-en-Y gastric bypass (AGB-RYGB). METHODS: We conducted a retrospective review to identify patients (men and women, age 18-80) who underwent one revisional bariatric procedure with AGB as the index procedure at two medical centers in our healthcare system between January 2012 and February 2017. We only included patients with a pre-revision BMI > 30 kg/m2 for whom 5-year follow-up data were available. We compared 5-year weight loss and remission of comorbidities in patients undergoing AGB-LSG and AGB-RYGB conversion. RESULTS: A total of 114 patients met inclusion criteria (65 AGB-LSG, 49 AGB-RYGB). At 5-year post-revision, percent total weight loss (3.4% vs 19.9%; p < 0.001), percent excess weight loss (7.0% vs 50.8%; p < 0.001) and decrease in BMI (1.5 vs 8.8; p < 0.001) was greater in AGB-RYGB vs. AGB-LSG. No significant difference in remission or development of new comorbidities was observed. CONCLUSION: Conversion of AGB to RYGB is associated with superior intermediate-term weight loss compared to conversion of AGB to LSG. Future multicenter studies with larger sample sizes are necessary to further describe the intermediate-term outcomes of revisional bariatric surgery.

Liposomal bupivacaine provides superior pain control compared to bupivacaine with adjuvants in interscalene block for total shoulder replacement: a prospective double-blinded, randomized controlled trial.

INTRODUCTION: Optimal pain control methods after total shoulder arthroplasty (TSA) achieve reduced opioid consumption, shortened hospital stay, and improved patient satisfaction in addition to adequate analgesia. Interscalene brachial plexus block is the gold standard for TSA, yet it typically does not provide pain relief lasting beyond 24 hours. Liposomal bupivacaine (LB) purportedly provides prolonged analgesia, yet it has been minimally explored for interscalene block, and it is significantly more expensive than standard bupivacaine. METHODS: This is a prospective, 2-arm, double-blinded randomized controlled trial. Subjects presenting for anatomic or reverse TSA were randomized in a 1:1 ratio to receive interscalene brachial plexus block with either LB plus bupivacaine (LBB group) or bupivacaine plus dexamethasone and epinephrine (BDE group). The primary outcome was 120-hour postoperative opioid consumption. Secondary outcomes were pain scores up to 96 hours postoperatively, pain control satisfaction, complications, level of distress from block numbness, and hospital stay. RESULTS: Ninety patients, 45 per group, were included in the intention-to-treat analysis and randomized. Because of withdrawal of consent and loss to follow-up, 40 in each group completed enrollment through postoperative day 60. Total 120-hour postoperative opioid consumption was similar between groups (P = .127), with no differences within 24- or 48-hour time intervals. Postoperative pain scores at 24-48 hours, 48-72 hours, 72-96 hours, and day 60 were significantly lower for the LBB group. DISCUSSION: LB interscalene brachial plexus block before total shoulder arthroplasty did not reduce 120-hour postoperative opioid consumption but significantly reduced postoperative pain between 24 and 96 hours and at postoperative day 60.

Prostate Cancer Detection and Complications of Transperineal Versus Transrectal Magnetic Resonance Imaging-fusion Guided Prostate Biopsies.

OBJECTIVE: To assess the rates of detection of clinically significant prostate cancer (csPCa) and complications associated with transperineal (TP) and transrectal (TR) biopsy approaches to magnetic resonance imaging (MRI)-fusion targeted biopsy. MATERIALS AND METHODS: We retrospectively identified men who underwent TP or TR MRI-targeted biopsy with concurrent systematic random biopsy from August 2020 to August 2021. Primary outcomes were detection rates of csPCa and 30-day complication rates between the 2 MRI-biopsy groups. Data were additionally stratified by prior biopsy status. RESULTS: A total of 361 patients were included in the analysis. No demographic differences were observed. No significant differences were observed between TP and TR approaches on any of the outcomes of interest. TR MRI-targeted biopsies identified csPCa in 47.2% of patients, and TP MRI-targeted biopsies identified csPCa in 48.6% of patients (P = .78). No significant differences were observed in csPCa detection between the 2 approaches for patients on active surveillance (P = .59), patients with prior negative biopsy (P = .34), and patients who were biopsy naïve (P = .19). Complication rates did not vary by approach (P = .45). CONCLUSION: Neither the identification of csPCa by MRI-targeted biopsy nor rates of complications differed significantly based on a TR or TP approach. No differences were seen between MRI-targeted approaches based on prior biopsy or active surveillance status.

Outcomes over 20 years performing robot-assisted laparoscopic prostatectomy: a single-surgeon experience.

OBJECTIVE: To evaluate a single surgeon's 20-year experience with robotic radical prostatectomy. METHODS: Patients who had undergone robot-assisted laparoscopic prostatectomy by a single surgeon were identified via an IRB approved prospectively maintained prostate cancer database. Patients were divided into 5-year cohorts (cohort A 2001-2005; cohort B 2006-2010; cohort C 2011-2015; cohort D 2016-2021) for analysis. Oncologic and quality of life outcomes were recorded at the time of follow-up visits. Continence was defined as 0-1 pad with occasional dribbling. Potency was defined as intercourse or an erection sufficient for intercourse within the last 4 weeks. RESULTS: Three thousand one hundred fifty-two patients met criteria for inclusion. Clavien ≥ 3 complication rates decreased from 5.9% to 3.2%, p = 0.021. There was considerable Gleason grade group (GG) and stage migration to more advanced disease between cohort A (6.4% GG4 or GG5, 16.2% pT3 or pT4, 1.2% N1) and cohort D (17% GG4 or GG5, 45.5% pT3 or pT4, 14.4% N1; p < 0.001). Consistent with this, an increasing proportion of patients required salvage treatments over time (14.6% of cohort A vs 22.5% of cohort D, p < 0.001). 1-year continence rates improved from 74.8% to greater than 92.4%, p < 0.001. While baseline potency and use of intraoperative nerve spare decreased, for patients potent at baseline, there were no significant differences for potency at one year (p = 0.065). CONCLUSIONS: In this 20-year review of our experience with robotic prostatectomy, complication rates and continence outcomes improved over time, and there was a migration to more advanced disease at the time of surgery.

The Effect of a Peritoneal Iliac Flap on Lymphocele Formation After Robotic Radical Prostatectomy: Results From the PLUS Trial.

OBJECTIVE: To assess the effectiveness of a peritoneal flap on the formation of lymphoceles after robotic assisted radical prostatectomy with bilateral extended pelvic lymph node dissection. METHODS: We conducted a single surgeon, assessor blinded prospective randomized controlled trial (the Prospective Lymphocele Ultrasound Study) in men undergoing robotic assisted radical prostatectomy with bilateral extended pelvic lymph node dissection. At the conclusion of the node dissection, patients were block randomized 1:1 to either standard of care (no bladder peritoneal flap) or to the creation of a bladder peritoneal flap. Lymphocele formation was assessed by pelvic ultrasound postoperatively. The primary outcome was lymphocele formation. Rates of lymphocele formation and complications were analyzed using chi-square. Other outcomes, including length of stay, number of lymph nodes removed, lymphocele volume, and quality of life measures, were analyzed by t-tests or Wilcoxon Ranked Sum Tests, as appropriate. An a priori power calculation was performed using O'Brien-Fleming alpha sharing for the interim analyses. Two preplanned interim analyses were performed when 45 and 90 patients per group had follow-up ultrasounds. RESULTS: A statistically significant difference in lymphocele formation was seen on the second interim analysis for 183 patients (4.3% vs. 15.6%, p = .011) stopping enrollment; this remained significant in the final analysis of 216 patients (3.6% vs 14.2%, p = .006). No other significant differences were observed. CONCLUSION: This prospective randomized trial supports the implementation of this simple modification for robotic assisted radical prostatectomy with bilateral extended pelvic lymph node dissection.

What is the most effective way to ensure that patients successfully undergo germline testing for prostate cancer?

INTRODUCTION: We sought to identify the most effective way to refer patients with prostate cancer to germline testing. METHODS: After IRB approval, we queried the electronic medical records (EMR) to identify patients (ages 18-89) with prostate cancer who were referred for or offered germline testing for prostate cancer from May 1, 2019 to February 24, 2021 through either telephone referral, EMR referral or in-office testing. The 3 cohorts were compared on receipt of testing and time to testing. Multivariate logistic regression and Cox regression evaluated the influence of referral cohort and reason for testing on receipt of testing and time to testing, respectively. RESULTS: A total of 184 patients met study inclusion criteria; 47 were referred for germline testing via telephone, 70 were referred through the EMR and 67 were offered testing in the office. No significant demographic or clinical differences were observed. Telephone referral yielded the lowest response (17%; P < 0.001) with the longest time interval between referral and testing (103 days; P < 0.001); in-office testing yielded the highest response (66%). More patients were referred because of both family history and high risk characteristics in the EMR and in-office testing cohorts (21.4% and 25.4% respectively). Referral method was significantly (P < 0.001) associated with receipt of test, while reason for testing was not. Referral method was also independently related to time to testing (P < 0.001) while reason for referral was not. CONCLUSIONS: Urologists should offer germline testing in the office for the most effective and expedient results.

A randomized controlled trial of an enhanced recovery after surgery protocol in patients undergoing laparoscopic sleeve gastrectomy.

BACKGROUND: The purpose of this study was to evaluate the effect of an enhanced recovery after surgery (ERAS) protocol on opioid and anti-emetic use, length of stay and safety after laparoscopic sleeve gastrectomy (LSG). METHODS: Patients who underwent LSG between March 2018 and January 2019 at our accredited, high-volume bariatric surgery center were randomized to either standard of care (SOC) or ERAS. ERAS included a pre- and post-surgical medication regimen designed to reduce postoperative nausea, vomiting and pain. Outcomes included post-operative symptom scores, opioid use, anti-emetic use, time to achieve readiness for discharge (RFD) and inpatient and 30-day adverse events, readmissions and emergency department visits. RESULTS: The final analysis included 130 patients, (SOC 65; ERAS 65). Groups did not differ on demographics or comorbidities. Relative to SOC, fewer ERAS patients utilized opioids in the hospital ward (72.3% vs. 95.4%; p < .001), peak pain scores were significantly lower, and median time to achieve RFD was shorter (28.0 h vs. 44.4 h; p = 0.001). More ERAS patients were discharged on post-operative day 1 (38.5% vs. 15.4%; p < .05). The overall use of rescue anti-emetic medications was not different between groups. Rates of postoperative 30-day events, readmissions, and emergency department visits did not differ between groups. CONCLUSION: Relative to SOC, ERAS was associated with earlier discharge, lower pain scores, less frequent use of opioids and use in lower amounts after LSG with no differences in 30 day safety outcomes.

Tactics for hemorrhagic shock: A virtual course and visual aid for improved resuscitation.

BACKGROUND: Our trauma performance improvement initiative recognized missed treatment opportunities for patients undergoing massive transfusion. To improve patient care, we developed a novel cognitive aid in the form of a poster entitled "TACTICS for Hemorrhagic Shock." We hypothesized that this reference and corresponding course would improve the performance of trauma leaders caring for simulated patients requiring massive transfusion. METHODS: First, residents and physician assistants participated in a one-on-one, socially distanced, screen-based virtual patient simulation. Next, they watched a short presentation introducing the TACTICS visual aid. They then underwent a similar second virtual simulation during which they had access to the reference. In both simulations, the participants were assessed using a scoring system developed to measure their ability to provide appropriate predetermined interventions while leading a trauma resuscitation (score range, 0-100%). Preintervention and postintervention scores were compared using a one-group pre-post within-subject design. Participants' feedback was obtained anonymously. RESULTS: Thirty-two participants (21 residents and 11 physician assistants) completed the course. The median score for the first simulation without the use of the visual aid was 43.8% (interquartile range, 33.3.8-61.5%). Commonly missed treatments included giving tranexamic acid (success rate, 37.5%), treating hypothermia (31.3%), and reversing known anticoagulation (28.1%). All participants' performance improved using the visual aid, and the median score of the second simulation was 89.6% (interquartile range, 79.2-94.8%; p < 0.001). Ninety-two percent of survey respondents "strongly agreed" that the TACTICS visual aid would be a helpful reference during real-life trauma resuscitations. CONCLUSION: The TACTICS visual aid is a useful tool for improving the performance of the trauma leader and is now displayed in our emergency department resuscitation rooms. This performance improvement course, the associated simulations, and visual aid are easily and virtually accessible to interested trauma programs. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Potential Embolic Sources Differ in Patients With Embolic Stroke of Undetermined Source According to Age: A 15-Year Study.

Introduction: Understanding the potential embolic source in young patients with ESUS may improve the diagnosis and treatment of such patients. Hypothesis: Potential embolic sources (PES) differ in young vs. older patients with ESUS, and, therefore, not all patients with ESUS have the same risk profile for stroke recurrence. Methods: Young patients (age 18-49) with ESUS, who were admitted to our stroke center from 2006 to 2019, were identified retrospectively and matched with next consecutive older patients (age 50-99) with ESUS by admission date. PES were categorized as atrial cardiopathy, AFib diagnosed during follow-up, left ventricular disease (LVD), cardiac valvular disease (CVD), PFO or atrial septal aneurysm (ASA), and arterial disease. Patients, who had cancer or thrombophilia, were excluded. The type and number of PES and stroke recurrence rates were determined and compared between young and older patients. Results: In young patients (55.3% women, median age 39 years), the most common PES was PFO/ASA, and the rate of other PES was low (2-7%). Half of the young patients (54.1%) had a single PES, only 10% had multiple PES, and 35.3% of young patients did not have any PES identified. In older patients (41.7% women, median age 74 years), the 3 most common PES were atrial cardiopathy (38.1%), LVD (35.7%), and arterial disease (23.8%). Nearly half of older patients (42.9%) had multiple PES. The rate of stroke recurrence tended to be lower in young patients as compared to older patients (4.9 vs. 11.4%, p = 0.29). During a median follow-up of 3 years, only 3 young patients (4.9%) had a recurrent stroke, and two of them had unclosed PFO. There were no recurrent strokes among young patients with no PES identified. Conclusions: It was noted that PES differ in patients with ESUS according to age and differences in recurrence. PFO is the only common PES in young patients with ESUS. Future studies prospectively evaluating PES in both age groups are needed.

Female Sex is Associated with Worse Outcomes following Complex Fenestrated or Branched Endovascular Aortic Repair.

BACKGROUND: Sex-related discrepancies after standard endovascular aneurysm repair (EVAR) are noted to disproportionally affect females. A growing body of literature suggests similar disparities may extend to complex fenestrated or branched endovascular aneurysm repair (FBEVAR). However, recent examination of complex FBEVAR by a consortium of high-volume centers noted equivalent mortality among sexes. Whether similar results extend to non-trial data is unknown. METHODS: We examined all juxta-renal through type IV thoraco-abdominal aneurysms (sealing zones 6-8) which underwent elective FBEVAR within the Vascular Quality Initiative (VQI) database from January 2012 to December 2020. Urgent, symptomatic, ruptured, and staged cases were excluded, as were parallel stent grafts. Demographics, comorbid conditions, and technical factors were compared between sexes. Univariate analysis with Wilcoxon ranked sum tests and Chi-square tests of proportion were performed, followed by multivariate logistic regression for failure of target vessel technical success, reintervention, complications, and in-hospital mortality. RESULTS: Our analysis included 1,521 patients, 1,180 males (77.6%) and 341 females (22.4%). There were noted differences in pre-operative demographics, medical optimization, and technical aspects of the procedure. However, no difference was noted in proximal or distal sealing stents, number of fenestrations, or immediate endoleaks. On a multi variate logistic regression, female sex was an independent predictor of failure of target vessel technical success (odds ratio (OR) 3.339, 95% confidence interval (CI): 2.173-5.132, P < 0.001), reintervention (OR 2.192, 95% CI: 1.304-3.683, P = 0.003), complications (OR 1.747, 95% CI: 1.282-2.381, P < 0.001), and in-hospital mortality (OR 2.836, 95% CI: 1.510-5.328, P = 0.001). CONCLUSIONS: Females suffer worse outcomes after FBEVAR despite similar extent of disease, number of fenestrations, and incidence of immediate endoleak. Notable discrepancies were higher rates of chronic obstructive pulmonary disease (COPD) and lower rates of pre-operative aspirin, statin, and beta blocker therapy in females. Controlling for pre-operative demographics, female sex remained an independent predictor of worse outcomes. These discrepancies warrant further examination and should impact case planning for female patients undergoing complex aortic aneurysm repair.

Outcomes of MRI fusion-guided versus systematic standard prostate biopsies.

INTRODUCTION: The current utility of MRI-fusion targeted biopsy as either an adjunct to or replacement for systematic template biopsy for the detection of clinically significant prostate cancer is disputed. The purpose of this study is to assess the current effectiveness of MRI-targeted versus systematic template prostate biopsies at two institutions and to consider possible underlying factors that could impact variability between detection rates in our patient population compared to others. MATERIALS AND METHODS: A retrospective review from our prospectively maintained prostate cancer databases was conducted. Patients with prostate MRI lesions (PI-RADSv2) receiving concurrent systematic 12-core and MRI-fusion targeted biopsies were reviewed. Clinically significant cancer was considered to be Grade Group ≥ 2. RESULTS: A total of 457 patients were included in the analysis; 255 patients received their biopsy at Institution A and 202 at Institution B. Overall cancer detection rate was 68%; the clinically significant cancer detection rate was 34%. Both MRI-targeted and systematic biopsies identified unique cases of clinically significant prostate cancer that the other modality missed. Out of 157 cases of clinically significant prostate cancer, MRI-targeted biopsy identified 29/157 cases (18%) missed by systematic biopsy, while systematic biopsy identified 37/157 cases (24%) missed by MRI-targeted biopsy (p = .39). Individual biopsy performance was similar when stratified by active surveillance or prior biopsy status, PI-RADSv2 score, and institution. CONCLUSIONS: MRI-fusion targeted and systematic biopsy each identified unique cases of clinically significant prostate cancer. Both biopsy modalities should be utilized in order to provide the greatest sensitivity for the detection of clinically significant prostate cancer.

Utility of a Novel Scale to Assess Readiness for Discharge After Bariatric Surgery.

BACKGROUND: The safe release of a patient from hospital care after bariatric surgery depends upon the achievement of satisfactory health status. Here, we describe a new objective scale (the Readiness for Discharge, RFD Scale) to measure the patient's suitability for hospital discharge after bariatric surgery. METHODS: We conducted a retrospective, observational analysis of data collected in a randomized clinical trial of an enhanced recovery after surgery protocol for laparoscopic sleeve gastrectomy from 3/15/2018 to 1/12/2019. Nursing staff assessed 122 patients every 4-8 h after surgery using a checklist to document 5 components: ambulation, vital signs, pain, nausea, and oral intake of clear fluid. Satisfaction of each component was scored as "1" (satisfactory) or "0" (not satisfactory). Scores were summed and analyzed for patterns. RFD = 5 marked the patient as ready for discharge. RESULTS: Sufficient intake of clear liquid was the last RFD component satisfied in 87% of patients. Two overall response patterns emerged: "Steady Progressors" (n = 51) whose RFD score rose steadily from 0 to 5 without reversion to a lower score; and "Oscillators" (n = 71) who had at least one temporary decrease in RFD score on the way to attaining 5, or showed a simultaneous oscillation of components without change in RFD. CONCLUSIONS: The RFD checklist allows objective scoring of medical readiness for discharge after LSG and has the potential to improve clinical communication.

Acute urinary retention rates following early removal or no placement in colon and rectal surgery: a single-center analysis.

BACKGROUND: The adequate duration of urinary drainage following colorectal surgery remains debated. The purpose of this study was to compare acute urinary retention (AUR) rates among various durations of urinary catheterization following colon and rectal surgery. METHODS: We conducted a retrospective analysis of patients undergoing elective colorectal resection enrolled in the Enhanced Recovery After Surgery (ERAS) protocol from 2018 to 2019. Patients were placed into four groups: no catheter placement (NC), catheter removed immediately after surgery (CRAS), removal less than 24 h (CR < 24), and removal greater than 24 h (CR > 24). Our primary endpoint was the rate of AUR in each group. Secondary endpoints included hospital length of stay and urinary tract infections (UTI). A multivariate logistic regression analysis was done to predict AUR. RESULTS: A total 641 patients were included in this study. 27 patients (4.2%) had NC with an AUR rate of 3.7%. 249 patients (38.8%) had CRAS with an AUR rate of 6.8%. 214 patients (33.4%) had CR < 24 with an AUR rate of 4.2%. 151 patients (23.6%) had CR > 24 with an AUR rate of 2.6%. There was no significant difference in AUR among the groups (p = 0.264). In our multivariant logistic regression, pelvic surgery was an independent risk factor for AUR (p = 0.008). There was a statistically significant higher hospital length of stay (p = 0.001) and rate of UTIs (p = 0.017) in patients with prolonged catheterization. CONCLUSION: Deferral or early removal of urinary catheters is safe and feasible following colorectal surgery without a significant increase in AUR. Avoiding prolonged indwelling urinary catheterization may decrease associated complications such as UTI and hospital length of stay.

Identification of a five gene signature to predict time to biochemical recurrence after radical prostatectomy.

BACKGROUND: Identification of novel biomarkers associated with high-risk prostate cancer or biochemical recurrence can drive improvement in detection, prognosis, and treatment. However, studies can be limited by small sample sizes and sparse clinical follow-up data. We utilized a large sample of prostate specimens to identify a predictive model of biochemical recurrence following radical prostatectomy and we validated this model in two external data sets. METHODS: We analyzed prostate specimens from patients undergoing radical prostatectomy at Hartford Hospital between 2008 and 2011. RNA isolated from formalin-fixed paraffin-embedded prostates was hybridized to a custom Affymetrix microarray. Regularized (least absolute shrinkage and selection operator [Lasso]) Cox regression was performed with cross-validation to identify a model that incorporated gene expression and clinical factors to predict biochemical recurrence, defined as postoperative prostate-specific antigen (PSA) > 0.2 ng/ml or receipt of triggered salvage treatment. Model performance was assessed using time-dependent receiver operating curve (ROC) curves and survival plots. RESULTS: A total of 606 prostate specimens with gene expression and both pre- and postoperative PSA data were available for analysis. We identified a model that included Gleason grade and stage as well as five genes (CNRIP1, endoplasmic reticulum protein 44 [ERP44], metaxin-2 [MTX2], Ras homolog family member U [RHOU], and OXR1). Using the Lasso method, we determined that the five gene model independently predicted biochemical recurrence better than a model that included Gleason grade and tumor stage alone. The time-dependent ROCAUC for the five gene signature including Gleason grade and tumor stage was 0.868 compared to an AUC of 0.767 when Gleason grade and tumor stage were included alone. Low and high-risk groups displayed significant differences in their recurrence-free survival curves. The predictive model was subsequently validated on two independent data sets identified through the Gene Expression Omnibus. The model included genes (RHOU, MTX2, and ERP44) that have previously been implicated in prostate cancer biology. CONCLUSIONS: Expression of a small number of genes is associated with an increased risk of biochemical recurrence independent of classical pathological hallmarks.

Intraoperative electroencephalographic changes during transcarotid artery revascularization are more frequent than previously reported.

OBJECTIVE: Up to 14% of patients undergoing carotid endarterectomy with continuous electroencephalographic (EEG) neuromonitoring will require shunt placement because of EEG changes. However, the initial studies of transcarotid artery revascularization (TCAR) found only one patient with temporary EEG changes. We report our experience with intraoperative EEG monitoring during TCAR. METHODS: We conducted a retrospective review of patients who underwent TCAR at two urban hospitals within an integrated healthcare network from May 2017 to January 2020. The data included demographic information, patient comorbidities, symptom status, previous carotid interventions, anatomic details, contralateral disease, intraoperative vital signs and EEG changes, and postoperative major adverse events (transient ischemic attack, stroke, myocardial infarction [MI], and death) both initially and at 30 days postoperatively. The Fisher exact test was used for categorical data and the Wilcoxon rank sum test for continuous data. RESULTS: A total of 89 patients underwent TCAR during the study period, of whom 71 (79.8%) received intraoperative EEG neuromonitoring. Of the 89 patients, 70.8% were men and 29.2% were women. The median age was 75 years (IQR, 68-82.5 years). Symptomatic patients accounted for 41.6% of the cohort. Of the 71 patients who received continuous neuromonitoring, 9 experienced EEG changes during TCAR (12.7%). The changes resolved in seven patients with pressure augmentation in three and switching to a low flow toggle in three. One patient who had sustained EEG changes had a new postoperative neurologic deficit. The median carotid stenosis percentage on preoperative computed tomography angiography was lower for patients with EEG changes than for those without (67% vs 80%; P = .01). No correlation was found between symptom status or 30-day stroke in patients with and without EEG changes (P = .49 and P = .24, respectively). Overall, three postoperative strokes, two postoperative deaths, and one MI occurred, for a composite 30-day stroke, death, and MI rate of 6.7%. CONCLUSIONS: Changes in continuous EEG monitoring were more frequent in our study than previously reported. Less severe carotid stenosis might be associated with a greater incidence of EEG changes. Limited data are available on the prognostic ability of EEG to detect clinically relevant changes during TCAR, and further studies are warranted.

Does post prostatectomy decipher score predict biochemical recurrence and impact care?

PURPOSE: To examine the ability of the Decipher test to predict early biochemical recurrence after radical prostatectomy and to impact clinical decisions in advance of metastasis and death. METHODS: We identified Decipher tests ordered after radical prostatectomy for adverse pathology in men treated for prostate cancer between 1/1/14 and 8/31/18. Biochemical recurrence was defined as prostate-specific antigen > 0.02 ng/mL. Decipher score is reported as lower risk (< 0.6) and higher risk ≥ 0.60). Kaplan-Meier analysis was used to examine the relationship between Decipher score and time to biochemical recurrence (months). Cox regression was used to analyze the relationship between Decipher score and time to biochemical recurrence while controlling for a number of clinical characteristics. Secondary analyses focused on a subset of men with prostate-specific antigen > 0.02 and < 0.20 ng/mL to determine if high-risk Decipher scores were associated with receipt of salvage treatment. RESULTS: A total of 203 cases were analyzed: 37.9% and 62.1% had lower and higher risk Decipher scores respectively, and 56.2% had a biochemical recurrence. Median (inter-quartile range) follow-up was 20 (13.5, 25.3) months. Decipher score was significantly associated with time to biochemical recurrence (p = 0.027) while in the secondary analyses, high-risk Decipher scores (≥ 0.60) were associated with salvage treatment (p = 0.018). Stage category and Decipher score were significant predictors of time from elevated PSA to salvage treatment in the secondary analyses. CONCLUSION: While it might not contribute statistically, Decipher score can be clinically useful in helping patients reach treatment decisions.

C Peptide Fails to Improve the Utility of the DiaRem Algorithm in Predicting Remission of Type II Diabetes After Bariatric Surgery.

We evaluated the utility of C peptide as an addition to the DiaRem score for predicting type 2 diabetes (T2D) remission 1 year after bariatric surgery in 175 patients. DiaRem score was significantly correlated with C peptide (r = - .43; p < .001). Both DiaRem and C peptide were significant predictors of remission of T2D (OR (95% CI) = .81 (.75-.86); p < 0001 and OR (95% CI) = 1.35 (1.15-1.60); p < .001, respectively). ROC analysis indicated that DiaRem was a significantly stronger predictor than C peptide (p < .001). Hierarchical regression indicated that C peptide failed to significantly improve the prediction of diabetes remission after accounting for DiaRem (OR (95% CI) = 1.079 (.87-1.26); p = .406). This study does not support the inclusion of C peptide in the DiaRem algorithm.

Increased P450 aromatase levels in post-menopausal women after acute ischemic stroke.

BACKGROUND: Sex differences in stroke have been attributed to the neuroprotective effects of estrogen, yet most clinical trials of estrogen supplementation for stroke prevention have failed. The contribution of sex hormones to stroke outcome remains a subject of debate. Aromatization of testosterone to estradiol in neural tissue leads to sexual differentiation. Emerging data suggests aromatase activity increases in response to brain injury, and increased aromatase expression is seen in the ischemic penumbra in animal models. The objective of this study was to examine the levels of endogenous sex steroids after acute ischemic stroke and determine if levels of sex steroids were associated with acute stroke outcomes. METHODS: Peripheral blood from ischemic stroke patients and controls was collected under an approved IRB within 24 h of symptom onset. 17ß-estradiol, testosterone, and aromatase levels were measured in the serum of both men and women using ELISA. Hormone levels were compared in men vs. women in stroke and control groups and correlated with outcomes (NIHSS and change in the modified Rankin Scale (mRS), defined as the difference of premorbid and discharge mRS) using multivariate regression. RESULTS: We found no significant difference in estradiol levels 24 h after stroke in men (p = 0.86) or women (p = 0.10). In men, testosterone significantly decreased after stroke as compared with controls (1.83 ± 0.12 vs. 2.86 ± 0.65, p = 0.01). Aromatase levels were significantly increased in women after stroke as compared with controls (2.27 ± 0.22 vs. 0.97 ± 0.22, p = 0.002), but not in men (p = 0.84). Estradiol levels positively correlated with change in mRS in both women (r = 0.38, p = 0.02) and men (r = 0.3, p = 0.04). CONCLUSIONS: Estradiol levels correlated with functional outcomes (change in mRS) in both men and women, at least in the acute phase (24 h) of stroke. However, no significant difference in estradiol levels is seen 24 h post-stroke in men or women. Testosterone levels decrease at 24 h after stroke in men. As seen in animal models, aromatase levels increase after acute ischemic stroke, but this was only true for women. These indicate an active aromatization process in post-menopausal women after acute ischemic stroke.