Publications by authors named "Shiva Gautam"

140 Publications

COVID-19 and Gender Disparities in Pediatric Cardiologists with Dependent Care Responsibilities.

Am J Cardiol 2021 Feb 25. Epub 2021 Feb 25.

Department of Pediatrics, University of Florida School of Medicine, Jacksonville, FL.

The COVID-19 pandemic disproportionately affects females in the home and workplace. This study aimed to acquire information regarding the gender-specific effects of the COVID-19 lockdown on aspects of professional and personal lives of a subset of pediatric cardiologists. We sent an online multiple-choice survey to a listserv of Pediatric Cardiologists. Data collected included demographics, dependent care details, work hours, leave from work, salary cut, childcare hours before and after the COVID-19 peak lockdown/stay at home mandate and partner involvement. Two hundred forty-two pediatric cardiologists with dependent care responsibilities responded (response rate of 20.2%). A significantly higher proportion of females reported a salary cut (29.1% of females vs 17.6% of males, p = 0.04) and scaled back or discontinued work (14% vs 5.3%; p = 0.03). Prior to the COVID-19 lockdown phase, females provided more hours of dependent care. Females also reported a significantly greater increase in childcare hours overall per week (45 hours post/30 hours pre vs 30 hours post/20 hours pre for men; p < 0.001).  Male cardiologists were much more likely to have partners who reduced work hours (67% vs 28%; p < 0.001) and reported that their partners took a salary cut compared with partners of female cardiologists (51% vs 22%; p < 0.001). In conclusion, gender disparity in caregiver responsibilities existed among highly skilled pediatric cardiologists even before the COVID-19 pandemic. The pandemic has disproportionately affected female pediatric cardiologists with respect to dependent care responsibilities, time at work, and financial compensation.
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http://dx.doi.org/10.1016/j.amjcard.2021.02.017DOI Listing
February 2021

Pathology grade influences competing mortality risks in elderly men with prostate cancer.

Urol Oncol 2020 Dec 19. Epub 2020 Dec 19.

Department of Urology, University of Florida, Jacksonville, FL.

Background: Recent guidelines recommend active management of prostate cancer (CaP), especially high-risk disease, in elderly men. However, descriptive data from a large cohort with extended follow up on the risk of death from CaP in men diagnosed over 70 years of age and its relationship to Gleason score (GS) and serum prostate specific antigen (PSA) level is lacking. Using the Surveillance, Epidemiology, and End Results database, we evaluated the influence of GS and serum PSA levels on the risks of mortality from PC (PCM) and mortality from other causes in localized (LPC) and metastatic (MPC) disease in elderly population.

Methods: Men diagnosed with PC over 70 years of age between 2004 and 2016 were divided into LPC and MPC groups, categorized by age: 70-74, 75-79, 80-84, 85-89, and ≥90 years and stratified by GS <7, 7, and >7, and serum PSA level <4, 4-10, 10-20, 20-50, and >50 ng/mL. Competing risk estimates for PCM and mortality from other causes were generated for both groups.

Results: Of the 85,649 men, 85.5 % were LPC at diagnosis. Overall, at a median follow up of 4 years, 15% of the men had died including a third from PC. While <15% of men with GS ≤7 died from PC, the PCM was >30% in men with GS >7 in LPC group, which accounted for almost half of total deaths for age 70-84 years. The GS >7 was also significantly associated with PCM in men with MPC. Furthermore, PCM directly correlated with serum PSA levels, with mortality rates reaching up to 50% and 70% for PSA >50 ng/dl for LPC and MPC, respectively.

Conclusions: There is a substantial risk of dying in men diagnosed with LPC over 70 years of age with GS >7 or a serum PSA >20 ng/mL. Furthermore, the risk for death for MPC directly correlated with GS with PCM increasing from 10%-30% for GS ≤7 to >50% for GS >7. The data, in conjunction with other clinical parameters such as comorbidities could be used to counsel elderly men on management options of PC for both localized and metastatic PC.
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http://dx.doi.org/10.1016/j.urolonc.2020.12.004DOI Listing
December 2020

Macro- and micro- vascular reactivity during repetitive exposure to shortened sleep: sex differences.

Sleep 2020 Nov 29. Epub 2020 Nov 29.

Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School.

Epidemiological studies have reported strong association between sleep loss and hypertension with unknown mechanisms. This study investigated macrovascular and microcirculation changes and inflammatory markers during repetitive sleep restriction. Sex differences were also explored. Forty-five participants completed a 22-day in-hospital protocol. Participants were assigned to: 1) Eight-hour sleep per night (control), or 2) Sleep restriction (SR) condition: participants slept from 0300-0700 hours for three nights followed by a recovery night of 8-h sleep, repeated four times. Flow mediated dilation (FMD) and microcirculation reactivity tests were performed at baseline, last day of each experimental block and during recovery at the end. Cell adhesion molecules and inflammatory marker levels were measured in blood samples. No duration of deprivation (SR block) by condition interaction effects were found for FMD, microcirculation, norepinephrine, cell adhesion molecules, IL-6 or IL-8. However, when men and women were analyzed separately, there was a statistical trend (p=0.08) for increased IL-6 across SR blocks in women, but not in men. Interestingly, men showed a significant progressive (dose dependent) increase in skin vasodilatation (p=0.02). A novel and unexpected finding was that during the recovery period, men that had been exposed to repeated SR blocks had elevated IL-8 and decreased norepinephrine. Macrocirculation, microcirculation, cell adhesion molecules and markers of inflammation appeared to be resistant to this model of short-term repetitive exposures to the blocks of shortened sleep in healthy sleepers. However, men and women responded differently, with women showing mild inflammatory response and men showing more vascular system sensitivity to the repetitive SR.
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http://dx.doi.org/10.1093/sleep/zsaa257DOI Listing
November 2020

Intracorporeal versus extracorporeal urinary diversion following robot-assisted radical cystectomy: a meta-analysis, cumulative analysis, and systematic review.

J Robot Surg 2020 Nov 22. Epub 2020 Nov 22.

Department of Urology, University of Florida, 655 8th St W, Jacksonville, FL, 32209, USA.

Over the last decade, the increased utilization of robot-assisted radical cystectomy (RARC) in the surgical treatment of muscle-invasive bladder cancer has led to an uptrend in intracorporeal urinary diversions (ICUD). However, the operative results comparing ICUD to extracorporeal urinary diversion (ECUD) have varied widely. We performed a meta-analysis to analyze perioperative outcomes and complications of ICUD compared to ECUD following RARC. This study is registered at International Prospective Register of Systematic Reviews (PROSPERO) CRD42020164074. A systematic literature review was conducted using PubMed, EMBASE, and Cochrane databases in August 2019. A total of six studies comparing ICUD vs ECUD were identified and meta-analysis was conducted on these studies. In addition, a cumulative analysis was also performed on 83 studies that reported perioperative outcomes after RARC and ICUD or ECUD. The Weighed Mean Difference of operative time and blood loss between ICUD and ECUD group was (16; 95% confidence interval - 34 to 66) and (- 86; 95% confidence interval - 124 to - 48), respectively. ICUD and ECUD had comparable early (30-day) and mid-term (30-90-day) complication rate (RR 1.19; 95% confidence interval 0.71-2.0; p = 0.5) and (RR 0.91; 95% confidence interval 0.71-1.15 p = 0.4) respectively. In the 83 studies that were included in the cumulative analysis, the mean operative time for ileal conduit and neobladders by ICUD were 307 and 428 min, respectively, compared to ECUD 428 and 426 min, respectively. ICUD and ECUD have comparable short- and mid-term complication rate. The ICUD group has lower blood loss and lower rate of blood transfusion compared to ECUD.
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http://dx.doi.org/10.1007/s11701-020-01174-4DOI Listing
November 2020

An Erythritol-Sweetened Beverage Induces Satiety and Suppresses Ghrelin Compared to Aspartame in Healthy Non-Obese Subjects: A Pilot Study.

Cureus 2020 Nov 10;12(11):e11409. Epub 2020 Nov 10.

Medicine, University of Florida College of Medicine, Gainesville, USA.

Despite the reduced caloric content of artificially sweetened beverages (ASBs) relative to those sweetened with sucrose, consumption of ASBs fail to consistently decrease the risk of obesity and associated diseases. This failure may be due to the inability of ASBs to effectively reduce appetite and hence overall caloric intake. A variety of non-nutritive sweeteners (NNS), however, remain to be screened for effectiveness in promoting satiety and reducing calorie consumption. Erythritol is well-tolerated, low-calorie sugar alcohol widely used as a sugar substitute. It is unique among NNS due to its low sweetness index relative to glucose, meaning that it is typically served at much higher concentrations than other common NNS. Animal and human studies have noted correlations between osmolarity, satiety, and levels of satiety hormones, independent of the effects of sweetness or nutritive value. We hypothesized that consumption of a beverage sweetened with erythritol to the sweetness and osmolarity of a common soft drink will improve self-reported satiety and more strongly affect the magnitude of changes in the hormone ghrelin than would an iso sweet beverage sweetened only with aspartame, a sweetener with a high sweetness index relative to glucose. Using a randomized double-blind crossover trial, we found that serum ghrelin was significantly decreased after consumption of an erythritol-sweetened beverage compared to aspartame. Likewise, consumption of the erythritol-sweetened beverage increased various measures of satiety in volunteers. Knowledge gained from this project demonstrates that high-osmolarity NNS may be useful in formulating ASBs that are satiating and low in calories.
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http://dx.doi.org/10.7759/cureus.11409DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657312PMC
November 2020

Socioeconomic Status, Race and Parental Initial Response to Children's Mental Illness.

J Immigr Minor Health 2020 Oct 9. Epub 2020 Oct 9.

Department of Psychiatry, College of Medicine- Jacksonville, University of Florida, 580 W 8th Street, Jacksonville, FL, 32209, USA.

To examine how socioeconomic status (SES) and race affect parents' initial response (IR) to their child's mental illness (MI) including 1. Parental confidant(s); 2. Lag time in professional help-seeking; and 3. Referral source. 70 parents of patients new to a Child Psychiatry clinic completed a survey to assess their IR to their child's MI. SES was determined using the United States Census Bureau median income by zip codes. Summary statistics are frequencies and percentages for categorical data, and medians and quartiles for continuous data. Twenty-five percent of parents reported low SES and 31% Non-Caucasian Children (NCC). Confidants of Caucasian and NCC were Pediatrician (77% vs 50%, p = 0.03), and family (73% vs 32%, p = 0.002). Comparing help-seeking Lag Times 66% reported a delay of 1 year or more (p = 0.040). Overall Pediatricians were the leading confidant. Lag times were one year or more with stronger trends in NCC.
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http://dx.doi.org/10.1007/s10903-020-01098-zDOI Listing
October 2020

An Indirect Comparison of Newer Minimally Invasive Treatments for Benign Prostatic Hyperplasia: A Network Meta-Analysis Model.

J Endourol 2021 Jan 25. Epub 2021 Jan 25.

Department of Urology, University of Florida, Jacksonville, Florida, USA.

This study was designed to provide an indirect comparison of the urinary and sexual domain outcomes and complications after newer minimally invasive surgical therapy (MIST) of Aquablation, Rezum, and UroLift for benign prostatic hyperplasia (BPH) for transurethral resection of prostate (TURP). We searched Embase, Medline, and Cochrane in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, in December 2019. Only randomized clinical trials (RCTs) that reported outcomes after treatment of BPH for prostate less than 80 g with Aquablation, Rezum, or UroLift were included in the analysis. A total of four RCTs reporting the outcomes after treatment with newer MIST for BPH were identified. Patients undergoing the resective procedures, that is, TURP and Aquablation, had greater improvement in urinary domain outcomes: International Prostate Symptom Score, quality of life, peak flow rate, and postvoiding residual compared to patients undergoing nonresective procedures: UroLift and Rezum. Patients in UroLift group maintained a higher sexual function domain score compared to TURP, but not Aquablation. Our multiple comparison analysis did not reveal a significant difference in urinary and sexual domain scores between patients undergoing UroLift and Rezum at 24 months of follow-up. Aquablation and TURP necessitate general or regional anesthesia and both produced significantly better urinary domain scores compared to Rezum and UroLift. On the other hand, UroLift demonstrated better sexual function domain scores compared to TURP, but not Aquablation. There was no significant difference in urinary domain scores between UroLift and Rezum at 24 months of follow-up.
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http://dx.doi.org/10.1089/end.2020.0739DOI Listing
January 2021

Predicting Pain-Related 30-Day Emergency Department Return Visits in Middle-Aged and Older Adults.

Pain Med 2020 11;21(11):2748-2756

Department of Emergency Medicine, University of Florida College of Medicine, Jacksonville, Florida.

Objective: The objective of this study was to determine predictive factors for pain-related emergency department returns in middle-aged and older adults. Design, Setting, and Subjects. This was a subanalysis of patients > 55 years of age enrolled in a prospective observational study of adult patients presenting within 30 days of an index visit to a large, urban, academic center.

Methods: Demographic and clinical data were collected and compared to determine significant differences between patients who returned for pain and those who did not. Multiple logistic regressions were used to determine significant predictive variables for return visits.

Results: The majority of the 130 enrolled patients > 55 years of age returned for pain (57%), were African American (78%), were younger (55-64 years old, 67%), had a high emergency department acuity level (level 1 or 2) at their index visit (56%), had low health literacy (Rapid Estimate of Adult Literacy in Medicine [REALM] score, 62%), lived in an area of extreme deprivation (69%), and were admitted (61%) during their index visit. Age (odds ratio [OR] = 0.9, 95% CI = 0.8-0.9, P = 0.047), health literacy (REALM scores; OR = 3.1, 95% CI = 1.3-7.5, P = 0.011), and index visit pain scores (OR = 1.1, 95% CI = 1.0-1.2, P = 0.004) were predictive of emergency department returns for pain in middle-aged and older adults.

Conclusions: The likelihood of emergency department return visits for pain in middle-aged and older adults decreased with older age, increased with higher health literacy (REALM scores), and increased with increase in pain scores.
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http://dx.doi.org/10.1093/pm/pnaa213DOI Listing
November 2020

The effects of a brief memory enhancement course on individuals with epilepsy.

Epilepsy Behav 2020 11 26;112:107347. Epub 2020 Aug 26.

Office of Research Affairs, University of Florida Health Sciences Center/Jacksonville, 580 West Eighth Street, Jacksonville, FL 32209, USA.

Purpose: The purpose of the study was to determine whether a brief memory enhancement course in persons with epilepsy (PWE) can improve cognitive abilities, quality of life, self-management, and seizure severity.

Methods: Thirty-nine PWE completed a 1-hour memory enhancement course. This was preceded by a baseline/preintervention assessment (BA/PRE), followed by postintervention assessment (POST) at 1 & 1/2 to 3 months, and a delayed postintervention assessment evaluation (DPOST) at 4 & 1/2 to 6 months after course completion. In order to assess for retesting bias, an additional 30 PWE underwent a separate BA and PRE.

Results: There was significant improvement on the Patient-Reported Outcomes Patient Information System version 2.0 Cognitive Function Abilities Subset and the Epilepsy Self-Management Scale (ESMS) on both POST and DPOST when compared with BA/PRE. Retesting bias did not occur. On ESMS subscale evaluation, significant improvement occurred on the Lifestyle Management subscale. There was no improvement in quality of life and seizure severity. There was good patient acceptability for the memory program.

Conclusion: A brief memory enhancement course results in sustained improvement in cognitive functioning and self-management of PWE.
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http://dx.doi.org/10.1016/j.yebeh.2020.107347DOI Listing
November 2020

Impact of Monthly A1C Values Obtained at Home on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Clin Diabetes 2020 Jul;38(3):230-239

Latino Diabetes Initiative, Joslin Diabetes Center, Boston, MA.

The purpose of this randomized controlled clinical trial was to determine whether an A1C value obtained at home by participants followed by a phone discussion of the result with a clinician would lead to ) a more rapid and significant decrease in A1C, ) more effective advancement of diabetes treatment, and ) improvement in diabetes self-care behaviors. The study included 307 participants with type 2 diabetes, most of whom were of Latino origin. All study participants experienced a statistically significant reduction in mean A1C (control subjects -0.3%, = 0.04; intervention subjects -0.5%, = 0.0002), but there was a statistically significant difference in the number of people who achieved a reduction of ≥0.5% by 6 months, favoring the intervention (33.6 vs. 46.7%, = 0.05).
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http://dx.doi.org/10.2337/cd19-0086DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7364448PMC
July 2020

Risk factors predicting the loss of functional independence after obliterative procedures for pelvic organ prolapse.

Int Urogynecol J 2021 Feb 10;32(2):267-272. Epub 2020 Jul 10.

Division of Female Pelvic Medicine Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, FL, USA.

Introduction And Hypothesis: To determine the risk factors associated with loss of functional independence after obliterative procedures for pelvic organ prolapse (POP).

Methods: The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database was used to collect data on women who underwent obliterative vaginal procedures from 2011 to 2016, using current procedural terminology (CPT) codes for LeFort colpocleisis (57120) and vaginectomy (57110). The criterion for loss of functional independence was a transition from a functionally independent status to a dependent status (discharge to a post-care facility) or death within the 30-day postoperative period. Multivariate regression analysis was utilized to determine factors associated with loss of functional independence.

Results: A total of 1847 women were included in the analysis. A loss of functional independence was noted in 50 of the 1847 women (2.6%). The women who suffered loss of functional independence were older than those who were independent postoperatively (mean age 79.3 years, SD 7.47 vs. 76.7 years, SD 8.1, respectively). On multiple logistic regression analysis, age ≥ 80 years (OR 2.8, 95% CI 1.4-5.5), American Society of Anesthesiologists (ASA) classification ≥ 3 (OR 2.3, CI 1.1-4.7) and length of stay ≥ 5 days (OR 15.2, 95% CI 6.2-37.1) remained significantly associated with an increased risk of loss of functional independence.

Conclusions: Age ≥ 80 years, ASA classification ≥ 3 and longer length of stay are associated with an increased risk of loss of functional independence after an obliterative procedure for pelvic organ prolapse. Consideration of these factors during the preoperative decision-making process may help improve outcomes in this cohort.
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http://dx.doi.org/10.1007/s00192-020-04424-zDOI Listing
February 2021

Comparative efficacy of apalutamide darolutamide and enzalutamide for treatment of non-metastatic castrate-resistant prostate cancer: A systematic review and network meta-analysis.

Urol Oncol 2020 11 28;38(11):826-834. Epub 2020 Jun 28.

Department of Urology, University of Florida, Jacksonville, FL. Electronic address:

Introduction: Studies using apalutamide, enzalutamide, or darolutamide have shown improved metastasis free survival (MFS) rates, leaving clinicians with a dilemma of choosing one over the other, for nonmetastatic castration recurrent prostate cancer (nmCRPC). We performed a network meta-analysis to provide an indirect comparison of oncologic outcomes and adverse events (AEs) of these medications.

Material And Methods: We searched PubMed, MEDLINE, and SCOPUS databases, for studies reporting apalutamide, enzalutamide, or darolutamide until January 25, 2020. Results were input into an EndNote library, and data were extracted into a predefined template. Progression free survival (PFS) was defined as radiologic progression or death. Network meta-analysis was done using R and meta-analysis was performed with RevMan v. 5. Surface under the cumulative ranking (SUCRA) value was used to provide rank probabilities.

Results: We found 3 studies reporting results for apalutamide, enzalutamide, and darolutamide. MFS was significantly lower in patients receiving darolutamide compared to both apalutamide (hazard ratio [HR]: 0.73, 95% confidence interval [CI]: 0.55-0.97) and enzalutamide (HR: 0.71, 95% CI: 0.54-0.93). MFS was similar for enzalutamide and apalutamide (HR: 0.97, 95% CI: 0.73-1.28). In PFS, apalutamide showed a slightly higher rate compared to darolutamide (HR: 0.76, 95% CI: 0.59-0.99). There was no difference in overall survival (OS) between any of the medications. There was no statistically significant difference in AEs profile of the 3 medications. However, darolutamide had the highest SUCRA value and probability of being the most preferred medication based on AEs profile.

Conclusion: Enzalutamide and apalutamide had similar and higher MFS rate in indirect comparison with darolutamide. In cases where AEs are concerning, darolutamide might be the preferred agent.
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http://dx.doi.org/10.1016/j.urolonc.2020.03.022DOI Listing
November 2020

Assessment of the American College of Surgeons National Surgical Quality Improvement Program Calculator in Predicting Outcomes and Length of Stay After Ivor Lewis Esophagectomy: A Single-Center Experience.

J Surg Res 2020 11 27;255:355-360. Epub 2020 Jun 27.

Department of Surgery, University of Florida-Jacksonville, Jacksonville, Florida.

Background: The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) calculator is a useful tool used by physicians to better inform patients on the surgical risk of postoperative complications. It makes use of the NSQIP database to derive the chance for several adverse outcomes to occur postoperatively given certain patient's factors. The aim of this study was to assess its applicability in a series of patients undergoing an Ivor Lewis esophagectomy.

Methods: Data from 100 consecutive patients who underwent an Ivor Lewis esophagectomy between September 2013 and November 2017 at our institution were reviewed. Each patient was assessed using the ACS NSQIP surgical risk calculator. Actual events in this group were compared with their particular NSQIP-assessed risk. Logistic regression models were used to compare surgical risk calculator estimates binary outcomes such as incidence of postoperative complications such as cardiac events, renal events, surgical site infection, and death. Mixed linear model was used for length of stay (LOS) duration versus observed LOS. C-statistic was for predictive accuracy each binary outcome and intraclass correlation was used for LOS.

Results: C-statistic values were higher than the cutoff (0.75) for surgical site infection and death. The ACS NSQIP risk calculator was poorly predictive of other reported outcomes by the calculator such as cardiac or renal complications. Corroboration between observed LOS and predicted LOS was weak (8 d versus 11 d, respectively, intraclass coefficient 0.04).

Conclusions: This study suggests that the risk calculator is useful for identifying risk of death or surgical site infection but poor at discriminating likelihood of other reported outcomes occurring, such as pneumonia, acute renal failure and cardiac complications for patients who underwent an Ivor Lewis esophagectomy. Estimations for procedure-specific complications for esophagectomy may need reevaluated.
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http://dx.doi.org/10.1016/j.jss.2020.05.080DOI Listing
November 2020

Combination Therapy for Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis.

Am J Clin Oncol 2020 07;43(7):477-483

Department of Urology.

Introduction: Randomized clinical trials have shown combination therapy to be superior in progression-free survival (PFS) rates when compared with sunitinib alone. However, there have been no direct comparisons among the combination strategies making it unclear as to which may be the preferred option. We performed a network meta-analysis of the combination therapy (immune checkpoint inhibitor plus axitinib or bevacizumab) used in metastatic renal cell carcinoma (mRCC) and provided a rank order preference based on PFS, and adverse events (AEs).

Materials And Methods: A systematic search on the treatment of mRCC using combination therapy till July 2019 was done. Studies reporting on combination therapies with immune checkpoint inhibitor plus axitinib or bevacizumab for mRCC were selected. Frequentist method was used for rank order generation.

Results: A total of 3 studies consisting of 2672 patients were selected. All combination therapies demonstrated improved PFS when compared with sunitinib alone. The rank order for PFS showed combination of pembrolizumab plus axitinib had the highest probability of favorability followed by avelumab plus axitinib and atezolizumab plus bevacizumab (surface under the cumulative ranking 0.9, 0.7, and 0.4, respectively). For AEs, pembrolizumab plus axitinib had the least AEs ≥grade 3, followed by avelumab plus axitinib and atezolizumab plus bevacizumab (surface under the cumulative ranking 0, 0.5, 1.0).

Conclusions: This network meta-analysis demonstrates that combination of pembrolizumab plus axitinib may be the preferred option based on efficacy and side effect profile compared with avelumab plus axitinib or atezolizumab plus bevacizumab. However, all the 3 combination strategies were superior to sunitinib alone in improving PFS in patients with mRCC.
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http://dx.doi.org/10.1097/COC.0000000000000695DOI Listing
July 2020

Clinical impact of a pharmacist-led antimicrobial stewardship initiative evaluating patients with colitis.

J Investig Med 2020 04 16;68(4):888-892. Epub 2020 Feb 16.

Department of Pharmacy, University of Florida Health at Jacksonville, Jacksonville, Florida, USA

is the most common cause of healthcare-associated infection and gastroenteritis-associated death in the USA. Adherence to guideline recommendations for treatment of severe infection (CDI) is associated with improved clinical success and reduced mortality. The purpose of this study was to determine whether implementation of a pharmacist-led antimicrobial stewardship program (ASP) CDI initiative improved adherence to CDI treatment guidelines and clinical outcomes. This was a single-center, retrospective, quasi-experimental study evaluating patients with CDI before and after implementation of an ASP initiative involving prospective audit and feedback in which guideline-driven treatment recommendations were communicated to treatment teams and documented in the electronic health record via pharmacy progress notes for all patients diagnosed with CDI. The primary endpoint was the proportion of patients treated with guideline adherent definitive regimens within 72 hours of CDI diagnosis. Secondary objectives were to evaluate the impact on clinical outcomes, including length of stay (LOS), infection-related LOS, 30-day readmission rates, and all-cause, in-hospital mortality. A total of 233 patients were evaluated. The proportion of patients on guideline adherent definitive CDI treatment regimen within 72 hours of diagnosis was significantly higher in the post-interventional group (pre: 42% vs post: 58%, p=0.02). No differences were observed in clinical outcomes or proportions of patients receiving laxatives, promotility agents, or proton pump inhibitors within 72 hours of diagnosis. Our findings demonstrate that a pharmacist-led stewardship initiative improved adherence to evidence-based practice guidelines for CDI treatment.
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http://dx.doi.org/10.1136/jim-2019-001173DOI Listing
April 2020

Meta-analysis and systematic review of intermediate-term follow-up of prostatic urethral lift for benign prostatic hyperplasia.

Int Urol Nephrol 2020 Jun 17;52(6):999-1008. Epub 2020 Feb 17.

Department of Urology, University of Florida, 655 8th St W, Jacksonville, FL, 32209, USA.

Background: Prostatic urethral lift (PUL), is a relatively new minimally invasive procedure for treatment of benign prostatic hyperplasia (BPH).This article is a systematic review and meta-analysis of all the articles published including follow-up of at least 24 months to analyze sustainability of results.

Methods: We performed a critical review in according to the preferred reporting items for systematic review and meta-analysis (PRISMA) guidelines. From a total 768 published articles that matched our search terms, 5 studies with minimum follow-up of 24 months were selected for comparison and data analyzed in terms of baseline characteristics, functional, and sexual health outcomes.

Results: Included in the analyses are five studies with a minimum follow-up of 24 months. A total of 386 patients underwent PUL and 322 patients (83.4%) are available for follow-up at 24 months. The randomized studies are grouped as group A and non-randomized studies as group B. At 24 months, the mean reduction in International Prostate Symptom Score (IPSS) from baseline was 9.1 in group A and 10.4 in group B. The mean improvement in peak flow rate (Q) was 3.7 mL/s in group A and 3 mL/s in group B, and quality of life (QoL) improved by 2.2 in both groups.

Conclusion: PUL is a well-tolerated, minimally invasive therapy for BPH that provides favorable and durable symptomatic, sexual health, and functional outcomes up to 24 months. Longer follow-up and randomized studies comparing to current standards are required to further confirm the long-term sustainability of PUL.
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http://dx.doi.org/10.1007/s11255-020-02408-yDOI Listing
June 2020

Comparison of extubation success using noninvasive positive pressure ventilation (NIPPV) versus noninvasive neurally adjusted ventilatory assist (NI-NAVA).

J Perinatol 2020 08 7;40(8):1202-1210. Epub 2020 Jan 7.

Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.

Objective: Compare rates of initial extubation success in preterm infants extubated to NIPPV or NI-NAVA.

Study Design: In this pilot study, we randomized 30 mechanically ventilated preterm infants at the time of initial elective extubation to NI-NAVA or NIPPV in a 1:1 assignment. Primary study outcome was initial extubation success.

Results: Rates of continuous extubation for 120 h were 92% in the NI-NAVA group and 69% in the NIPPV group (12/13 vs. 9/13, respectively, p = 0.14). Infants extubated to NI-NAVA remained extubated longer (median 18 vs. 4 days, p = 0.02) and experienced lower peak inspiratory pressures (PIP) than infants managed with NIPPV throughout the first 3 days after extubation. Survival analysis through 14 days post extubation showed a sustained difference in the primary study outcome until 12 days post extubation.

Conclusions: Our study is the first to suggest that a strategy of extubating preterm infants to NI-NAVA may be more successful.
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http://dx.doi.org/10.1038/s41372-019-0578-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7222927PMC
August 2020

Correction to: Risk factors for lymphopenia in patients with relapsing-remitting multiple sclerosis treated with dimethyl fumarate.

J Neurol 2020 01;267(1):132

Division of Neuro-Immunology, Department of Neurology, Beth Israel Deaconess Medical Center, Multiple Sclerosis Center, Harvard Medical School, 330 Brookline Ave, Ks212, Boston, MA, 02115, USA.

Unfortunately, the given name and family name of first author was incorrectly tagged in the xml data, therefore it is abbreviated wrongly as "Morales FS" in Pubmed. The correct given name is Fabian and family name is Sierra Morales. Auhtor name should be abbreviated as Sierra Morales F.
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http://dx.doi.org/10.1007/s00415-019-09626-0DOI Listing
January 2020

Prognostic significance of venous invasion in node-negative head and neck squamous cell carcinoma.

J Oral Pathol Med 2020 Feb 1;49(2):150-155. Epub 2019 Dec 1.

Department of Pathology, University of Florida College of Medicine, Jacksonville, Florida.

Background: Venous invasion (VI) is not frequently evaluated on routine histologic examination of head and neck squamous cell carcinoma (HNSCC), and the prognostic significance is largely unknown. Studies have shown that extramural venous invasion is an adverse prognostic factor in colorectal carcinoma. To our knowledge, this is the first study evaluating the prognostic significance of venous invasion in node-negative (without clinical or pathologic evidence of lymph node involvement) HNSCC, utilizing the elastic stain.

Methods: A total of 105 consecutive lymph node-negative (N0) HNSCC were evaluated for the presence of venous channel invasion by tumor utilizing the elastin stain. Clinical, demographic, and follow-up data were recorded.

Results: Of 37 patients with venous invasion, 19% had loco-regional recurrence, as opposed to 12% of those without. Univariate analysis revealed statistically significant decreased recurrence-free survival in the presence of venous invasion (log-rank [Mantel-Cox] test P-value .025).

Conclusion: Identification of VI is greatly aided by elastic stain. In patients with node-negative HNSCC, presence of VI resulted in decreased recurrence-free survival on univariate analysis. The impact of VI as a prognostic marker should be further evaluated.
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http://dx.doi.org/10.1111/jop.12975DOI Listing
February 2020

Developing and testing models to predict mortality in the general population.

Inform Health Soc Care 2020 1;45(2):188-203. Epub 2019 Nov 1.

Department of Internal Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.

We have previously proposed an approach using information collected from published reports to generate prediction models. The goal of this project was to validate this technique to develop and test various prediction models. A risk indicator () is calculated as a linear combination of the hazard ratios for the following predictors: age, male gender, diabetes, albuminuria, and either CKD, CVD or both. We developed a linear and two exponential expressions to predict the probability of the outcome of 2-year mortality and compared to actual outcome in the target dataset from NHANES. The risk indicator demonstrated good performance with area under ROC curve of 0.84. The linear and two exponential expressions generated similar predictions in the lower categories of risk indicator ( ≤ 6). However, in the groups with higher value, the linear expression tends to predict lower, and the exponential expressions higher, probabilities than the observed outcome. A Combined model which averaged the linear and logistic expressions was shown to approximate the actual outcome data the best. A simple technique (named Woodpecker™) allows derivation functional prediction models and risk stratification tools from reports of clinical outcome studies and their application to new populations by using only summary statistics of the new population.
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http://dx.doi.org/10.1080/17538157.2019.1656209DOI Listing
November 2020

Risk factors for lymphopenia in patients with relapsing-remitting multiple sclerosis treated with dimethyl fumarate.

J Neurol 2020 01 3;267(1):125-131. Epub 2019 Oct 3.

Division of Neuro-Immunology, Department of Neurology, Beth Israel Deaconess Medical Center, Multiple Sclerosis Center, Harvard Medical School, 330 Brookline Ave, Ks212, Boston, MA, 02115, USA.

Objectives: To identify risk factors for DMF-induced lymphopenia and characterize its impact on T lymphocyte subsets in MS patients.

Methods: We performed a retrospective analysis of 194 RRMS patients treated with DMF at the Beth Israel Deaconess Medical Center (BIDMC) over a median of 17 months. We reviewed demographics, ethnic background, prior medication history, complete blood counts and T lymphocyte subsets. Possible lymphopenia risk factors examined included age, prior natalizumab exposure, vitamin D levels, and concomitant exposure to carbamazepine, opiates, tobacco, or steroids. Lymphopenia was defined as grade 1: absolute lymphocytes count (ALC) 800-999/μl; grade 2: ALC 500-799/μl; grade 3: ALC 200-499/μl; and grade 4: ALC < 200/μl.

Results: Of 194 DMF-treated patients, 73 (38%) developed lymphopenia and reached an ALC nadir after a median of 504 days (range 82-932). Risk of developing DMF-induced lymphopenia increased with BMI 25-30, older age, white ethnicity, non-smoking status, and lowest quartile baseline ALC. Prior exposure to natalizumab or concomitant steroid, opiates or carbamazepine/oxcarbamazepine use was not associated with lymphopenia. Compared to baseline levels, CD8 T cells were significantly more reduced than CD4 cells. CD8 counts were more commonly reduced with age or white ethnicity. Subjects with BMI 25-30 was associated with a higher risk of abnormal CD4 cell count reductions. In contrast, non-smokers were more likely to experience reductions in both CD4 and CD8 counts while on DMF.

Conclusions: Patients with low baseline lymphocyte counts, with intermediate BMI, with white ethnicity, with advanced age, or with no tobacco use, had a significantly higher incidence of lymphopenia on DMF. Intermediate BMI or lowest quartile baseline ALC predicted low CD4 levels, while advanced age or white ethnicity predicted low CD8 levels from DMF exposure.
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http://dx.doi.org/10.1007/s00415-019-09557-wDOI Listing
January 2020

Effect of race and ethnicity on renal transplant referral
.

Clin Nephrol 2019 Nov;92(5):221-225

Background: Multiple studies have revealed disparity in renal healthcare access and outcomes in racial/ethnic minorities with the socioeconomic status explaining the majority but not all of the disparity. We wanted to determine if racial/ethnic disparities existed at the first step toward renal transplantation, the renal transplant referral process.

Materials And Methods: A cohort of 200 adult end-stage renal disease patients was followed retrospectively for 2 years from January 2016 to February 2018. The study exposure was based on self-declared race/ethnicity of the patients, who were categorized as Black, White, and Hispanic. The study outcome was based on medical team patient evaluation and consisted of the patients who refused referral, who were not referred, and who were referred for transplant. Medical and demographic factors collected were age, gender, socioeconomic status, hemoglobin A1c ≥ 7, body mass index ≥ 40, left ventricular ejection fraction ≤ 40%, the presence of coronary or peripheral arterial disease, albumin level, history of smoking, cirrhosis, and cancer. The data were analyzed using univariate analyses and multinomial logistic regression.

Results: In the adjusted analysis, there was no difference in the likelihood of transplant referral between Black and White patients (OR = 0.71, 95% CI 0.22 - 2.3, p = 0.56). However, both Black (OR = 16, 95% CI 3.3 - 77, p = 0.0006) and White (OR = 22, 95% CI 3.4 - 150, p = 0.0013) patients were more likely to be referred for transplant when compared with Hispanic patients. Odds of transplant refusal were not different across race/ethnic groups.

Conclusion: Hispanic patients are disadvantaged in the referral for renal transplant when compared to Black and White patients for reasons unclear at this time.
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http://dx.doi.org/10.5414/CN109858DOI Listing
November 2019

Response to the Letter: "Bias estimation of predictors and internal validity of the study 'Admission characteristics predictive of in-hospital death from hospital-acquired sepsis: A comparison to community-acquired sepsis'".

J Crit Care 2020 04 26;56:322. Epub 2019 Apr 26.

University of Florida College of Medicine, Jacksonville, Department of Emergency Medicine, Jacksonville, FL, United States of America. Electronic address:

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http://dx.doi.org/10.1016/j.jcrc.2019.04.023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6815234PMC
April 2020

Pediatric guanfacine exposures reported to the National Poison Data System, 2000-2016.

Clin Toxicol (Phila) 2020 01 22;58(1):49-55. Epub 2019 Apr 22.

Center for Health Equity and Quality Research, UF Health - Jacksonville, Jacksonville, FL, USA.

The purpose of this study was to characterize the frequency, reasons for exposure, clinical manifestations, treatments, duration of effects, and medical outcomes of pediatric guanfacine exposures reported to the National Poison Data System (NPDS) from 2000 to 2016. Data extracted from poison control center call records for pediatric (0-5 years, 6-12 years, and 13-19 years), single-substance guanfacine ingestions reported to NPDS between 2000 and 2016 was retrospectively analyzed. A total of 10927 cases were identified for analysis. Pediatric single-substance guanfacine exposures reported to NPDS increased significantly during the study period, with a marked increase among 6-12-year-olds. The most commonly documented clinical effects across age groups were drowsiness ( = 4262, 39%), bradycardia ( = 1696, 15.5%), and hypotension ( = 1127, 10.3%). The duration of effect for most cases was >8 hours but ≤24 hours (n = 2395, 44.2%). The median documented quantity of guanfacine ingested was 0.11 mg/kg (range: 0.004-7.8 mg/kg). The difference between mg/kg ingested in and groups compared to and groups was statistically significant in all three age groups. Pediatric guanfacine exposures reported to U.S. poison centers have increased significantly in the last fifteen years. The most common clinical findings secondary to guanfacine exposure were bradycardia, hypotension, and CNS depression. There was a statistically significant difference between the mg/kg of guanfacine ingested in the groups experiencing or compared to or effects. However, the maximum ingested dose reported among 0-5-year-olds in the group was 2.72 mg/kg, while the minimum dose eliciting a in both 0-5 and 6-12-year-olds was 0.05 mg/kg. The overall incidence of effects was very low, with the vast majority of patients experiencing minor symptoms or less. Based on this data, we agree with current recommendations that any symptomatic pediatric patient exposed to guanfacine should be observed in a health care facility for at least 24 hours.
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http://dx.doi.org/10.1080/15563650.2019.1605076DOI Listing
January 2020

A Statewide Study of the Epidemiology of Emergency Medical Services' Management of Pediatric Asthma.

Pediatr Emerg Care 2019 Feb 14. Epub 2019 Feb 14.

College of Pharmacy, University of Florida, Jacksonville, FL.

Objectives: Little is known about emergency medical services' (EMS') management of pediatric asthma. This study's objective was to describe the demographic, clinical, and geographic characteristics of current EMS' management of pediatric asthma in the state with the fourth-largest pediatric population.

Methods: This was a retrospective observational study of EMS patients ages 2 to 18 years with an asthma exacerbation from 2011 to 2016. Patients from Florida's EMS Tracking and Reporting System were included if their EMS chief complaint indicated respiratory distress, if they received at least 1 albuterol treatment, and if they were transported to a hospital.

Results: A total of 11,226 patients met the inclusion criteria. The median age was 9 years, and 49% were African-American. Geospatial analysis revealed 4 rural counties with disproportionate numbers of African-American patients. In addition to albuterol, 37% of patients received ipratropium bromide and 9% received systemic corticosteroids. Adjusted logistic regression revealed that the strongest predictors of receiving systemic corticosteroids from EMS were intravenous access (odds ratio, 33.4; 95% confidence interval, 24.4-45.6) and intravenous magnesium sulfate administration (odds ratio, 5.0; 95% confidence interval, 3.4-7.3), indicating a more severe presentation.

Conclusions: This statewide study demonstrated low rates of EMS administration of ipratropium bromide and systemic corticosteroids, both evidence-based treatments for asthma exacerbations. Targeted EMS education should attempt to increase utilization of both those medications. In addition, the feasibility and efficacy of EMS administration of oral systemic corticosteroids for children should be explored.
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http://dx.doi.org/10.1097/PEC.0000000000001743DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6693989PMC
February 2019

Admission characteristics predictive of in-hospital death from hospital-acquired sepsis: A comparison to community-acquired sepsis.

J Crit Care 2019 06 19;51:145-148. Epub 2019 Feb 19.

University of Florida College of Medicine-Jacksonville, Department of Emergency Medicine, Jacksonville, FL, United States of America. Electronic address:

Purpose: Healthcare associated (HA) sepsis is associated with increased resource utilization and mortality compared with community acquired (CA) sepsis. The purpose of this study was to identify independent predictors of in-hospital mortality from HA-sepsis.

Materials And Methods: Retrospective study of adult patients admitted with HA or CA-sepsis. Predictors were identified using logistic regression.

Results: There were 3917 sepsis encounters, of which 3186 were CA and 731 were HA. History of stroke (83/731, 11%) and myocardial infarction (70/731, 10%) were higher in HA than CA-sepsis (stroke: 258/3186, 8%, p = .005; myocardial infarction: 213/3186, 7%, p = .007). HA-sepsis patients required more mechanical ventilation (153/731, 21%) than CA-patients (218/3186, 7%, p < .001) and had a higher rate of vasopressor use (334/731, 46%) than CA patients (832/3186, 26%, p < .001). The HA group had longer ICU lengths of stay (LOS) than CA patients did at 9 days and 2.8 days, respectively (p < .0001). Moderate to severe liver disease (OR = 27, 95%CI 1.4, 513, p = .031) and congestive heart failure (CHF, 5.81, 95% CI 1.3, 26, p = .025) were predictive of in-hospital mortality from HA-sepsis.

Conclusions: Liver disease and CHF were independent predictors of in-hospital mortality in HA-sepsis. HA-sepsis patients had increased prevalence of previous stroke, myocardial infarction, and liver disease.
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http://dx.doi.org/10.1016/j.jcrc.2019.02.023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6668610PMC
June 2019

Identification of unique characteristics and the management of blunt traumatic aortic injuries occurring at unusual locations in the descending thoracic aorta.

J Vasc Surg 2019 01;69(1):40-46

Division of Vascular Surgery, Department of Surgery, University of Florida, College of Medicine, Jacksonville, Fla.

Background: The usual location of thoracic blunt traumatic aortic injury (BTAI) is just distal to the left subclavian artery; however, injuries can also be found in other locations in the descending thoracic aorta (DTA).

Methods: This is a single-institution, retrospective study, using 74 consecutive BTAI in the DTA. The patients were separated into two groups based on the location of the injury. The proximal group included injuries within 5 cm of the left subclavian artery, whereas the distal group included injuries in the rest of the DTA. A total of 27 factors were compared.

Results: Between 2010 and July 2017, we identified 14 of 74 patients (19%) with BTAI in the distal zone. Females were 9 of the 14 (64%) in the distal zone group, whereas females were 16 of 60 (27%) in the proximal zone group (P < .012). Thoracic spine fractures occurred in 7 of the 14 patients (50%) with injuries at the distal zone, whereas they occurred in 12 of the 60 patients (20%) in the proximal zone group (P < .038). Eleven of the 14 distal zone injuries (79%) were grade 1 or 2 compared with 15 of 60 injuries (25%) at the proximal zone (P = .016). Only 2 of the 14 injuries (14%) in the distal zone required an endovascular repair as opposed to 39 of 60 (65%) in the proximal zone (P < .001). The mean hospital duration of stay in patients with BTAI at the distal zone was 8.5 days compared with 20.3 days for patients in the proximal zone group (P < .004). Mortality occurred in 5 of 14 patients (36%) in the distal zone group compared with 5 of 60 patients (8%) in the proximal zone group (P = .017). The odds of mortality from an injury in the distal zone were almost 6-fold greater than the odds of mortality from an injury in the proximal zone (odds ratio, 5.9; 95% confidence interval, 1.2-31.8). No mortalities were related to the BTAI itself. The association of location with mortality remained significant even after adjusting for other significant factors like Injury Severity Score and patient age. Patients who died from injuries in the distal zone had a shorter duration of stay (5 days vs 20 days; P = .0002).

Conclusions: BTAI in the distal zone of DTA are associated with unique characteristics. They are (1) more frequently associated with thoracic spine fractures, (2) more common in women, (3) tend to be lower grade, (4) less likely to require intervention, and (5) seem to have a higher mortality owing to other associated traumatic injuries.
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http://dx.doi.org/10.1016/j.jvs.2018.06.208DOI Listing
January 2019

Overutilization of Computed Tomography for Odontogenic Infections.

J Oral Maxillofac Surg 2019 Mar 7;77(3):528-535. Epub 2018 Nov 7.

Residency Program Director and Assistant Professor, Department of Oral and Maxillofacial Surgery, University of Florida Health-Jacksonville, Jacksonville, FL. Electronic address:

Purpose: There is clear overuse of computed tomography (CT) in the emergency setting, which is associated with a long-term potential for malignancy. This study aimed to determine the rate of overuse of CT for odontogenic infection workup and the correlation of history and physical examination (H&P) findings to diagnose moderate- to high-risk infections.

Materials And Methods: A retrospective cross-sectional study was implemented to determine the rate of overuse of CT for odontogenic infections. Included patients presented through the emergency department for evaluation of an odontogenic infection. CT was deemed unnecessary if patients presented without "red-flag" signs at physical examination, which included voice change, elevated floor of mouth, signs of inflammation of deep fascial spaces, periorbital edema, nonpalpable inferior border of the mandible, dyspnea, dysphagia or odynophagia, and trismus. Patients could have no evidence of involvement of a moderate- to high-risk space or airway change at CT. Infection severity was low, moderate, or high risk based on anatomic proximity to the airway and critical structures. Sensitivity, specificity, and positive predictive and negative predictive values of H&P findings to predict moderate- to high-risk infections were calculated and included 95% confidence intervals.

Results: For the 470 included patients, 389 CT scans were performed, with 220 (56.6%) deemed unnecessary. Unnecessary scans were most prevalent in patients with low-risk infections, in whom 284 CT scans were performed, with 222 (78.2%) deemed unnecessary. There was a strong correlation between red-flag signs and moderate- to high-risk infections.

Conclusion: There is overuse of CT for odontogenic infections that is most prevalent in low-risk infections without indicative findings in the workup. H&P findings can help accurately diagnose a higher-risk infection before subjecting a patient to CT.
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http://dx.doi.org/10.1016/j.joms.2018.10.025DOI Listing
March 2019

Heart rate variability rebound following exposure to persistent and repetitive sleep restriction.

Sleep 2019 02;42(2)

Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA.

While it is well established that slow-wave sleep electroencephalography (EEG) rebounds following sleep deprivation, very little research has investigated autonomic nervous system recovery. We examined heart rate variability (HRV) and cardiovagal baroreflex sensitivity (BRS) during four blocks of repetitive sleep restriction and sequential nights of recovery sleep. Twenty-one healthy participants completed the 22-day in-hospital protocol. Following three nights of 8-hr sleep, they were assigned to a repetitive sleep restriction condition. Participants had two additional 8-hr recovery sleep periods at the end of the protocol. Sleep EEG, HRV, and BRS were compared for the baseline, the four blocks of sleep restriction, and the second (R2) and third (R3) nocturnal recovery sleep periods following the last sleep restriction block. Within the first hour of each sleep period, vagal activation, as indexed by increase in high frequency (HF; HRV spectrum analysis), showed a rapid increase, reaching its 24-hr peak. HF was more pronounced (rebound) in R2 than during baseline (p < 0.001). The BRS increased within the first hour of sleep and was higher across all sleep restriction blocks and recovery nights (p = 0.039). Rebound rapid eye movement sleep was observed during both R2 and R3 (p = 0.004), whereas slow-wave sleep did not differ between baseline and recovery nights (p > 0.05). Our results indicate that the restoration of autonomic homeostasis requires a time course that includes at least three nights, following an exposure to multiple nights of sleep curtailed to about half the normal nightly amount.
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http://dx.doi.org/10.1093/sleep/zsy226DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6369727PMC
February 2019