CI For Difference Research Articles

Low-cost oral metronomic versus intravenous chemotherapy in recurrent, inoperable and metastatic head and neck cancer: Phase III Metro-CIS study.

6506 Background: The NCCN preferred regimens for palliation in head and neck cancer, either EXTREME or KEYNOTE-048 are the only two regimens which have improved outcomes over chemotherapy, but they have limited applicability (1-3%) in low and middle-income countries due to the cost. Oral metronomic chemotherapy (OMC) has shown better outcomes than intravenous cisplatin; these results were obtained with a low incidence of adverse events and the cost of 1/100th of NCCN-preferred regimens in a Phase II study. Methods: This was a randomized Phase III non-inferiority open-label study. Adult patients with relapsed-recurrent or metastatic upfront palliatively treated squamous cell carcinoma of head and neck and ECOG PS 0-1 were eligible. Patients were randomized 1:1 between OMC (oral methotrexate 15 mg/m2 weekly with celecoxib 200 mg once daily or intravenous cisplatin (IVC) 75 mg/m2, 3-weekly for 6 cycles. CTCAE version 4.0 was used for adverse event recording. Response assessment (RECIST version 1.1) was performed every 2 months. EORTC QLQ-C 30 and EORTC QLQ -H&N 35 questionnaires were self-administered at baseline and 2-monthly thereafter. The primary endpoint was overall survival (OS) and was measured from the date of randomization to death. Assuming a 6-month OS in IVC arm of 40%, the non-inferiority margin of 13%, type 1 error of 5% (2-sided), type 2 error of 20% and lost-to-follow up rate of 20%, a total sample size of 422 subjects was required. Kaplan Meier method was used for the estimation of OS and progression-free survival (PFS). To determine non-inferiority the upper limit of 95% CI of difference between 6 months OS of the 2 arms had to be below 13%. Results: In the intention to treat analysis, the 6-months OS was 50.89% (95% CI, 43.3-57.97) and 62.26% (95% CI, 54.72-68.9) in the IVC and OMC arm respectively. The difference in 6-months OS between the 2 arms was - 11.37% (95% CI, -20.77 to -0.97). The median OS was 6.1 (95% CI, 5.33-6.93) versus 7.5 (95% CI, 6.5-8.8) months in IVC arm and OMC arm respectively ( P= .026). The unadjusted hazard ratio for death was 0.773 (95% CI, 0.615-0.97, P= .026). The median PFS was 1.67 (95% CI, 1.47-2.03) versus 3.23 (95% CI, 2.57-4.13) months in IVC and OMC arms respectively ( P< 0.001). Any grade 3 or above adverse events were seen in 61 (30.2%) versus 37 (18.9%) patients in IVC and OMC arm respectively ( P= .01). Conclusions: OMC improves outcomes in palliatively treated head and neck cancer and is a new standard of care in this setting, in addition to the EXTREME and KEYNOTE-048 regimen. Clinical trial information: CTRI/2015/11/006388 .

PD56-05 THREE-YEAR OUTCOMES AFTER AQUABLATION COMPARED TO TURP: EFFICACY AND EJACULATORY IMPROVEMENTS SUSTAINED

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III (PD56)1 Apr 2020PD56-05 THREE-YEAR OUTCOMES AFTER AQUABLATION COMPARED TO TURP: EFFICACY AND EJACULATORY IMPROVEMENTS SUSTAINED Peter Gilling*, Neil Barber, Mo Bidair, Paul Anderson, Mark Sutton, Tev Aho, Eugene Kramolowsky, Andrew Thomas, Barrett Cowan, Ronald Kaufman, Andrew Trainer, Andrew Arther, Gopal Badlani, Mark Plante, Mihir Desai, Leo Doumanian, Alexis Te, Mark DeGuenther, and Claus Roehrborn Peter Gilling*Peter Gilling* More articles by this author , Neil BarberNeil Barber More articles by this author , Mo BidairMo Bidair More articles by this author , Paul AndersonPaul Anderson More articles by this author , Mark SuttonMark Sutton More articles by this author , Tev AhoTev Aho More articles by this author , Eugene KramolowskyEugene Kramolowsky More articles by this author , Andrew ThomasAndrew Thomas More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Ronald KaufmanRonald Kaufman More articles by this author , Andrew TrainerAndrew Trainer More articles by this author , Andrew ArtherAndrew Arther More articles by this author , Gopal BadlaniGopal Badlani More articles by this author , Mark PlanteMark Plante More articles by this author , Mihir DesaiMihir Desai More articles by this author , Leo DoumanianLeo Doumanian More articles by this author , Alexis TeAlexis Te More articles by this author , Mark DeGuentherMark DeGuenther More articles by this author , and Claus RoehrbornClaus Roehrborn More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000966.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To compare three-year (last follow-up of the protocol) safety and efficacy outcomes after Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) related to benign prostate hyperplasia (BPH). METHODS: 181 patients with BPH were assigned at random (2:1 ratio) to either Aquablation or TURP. Patients and follow-up assessors at each site were blinded to treatment. Assessments included International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and uroflow. RESULTS: At three years, IPSS scores improved by 14.2 points in the Aquablation group and 15 points in TURP (p=.7050, 95% CI for difference –3.6 to 5.3 points). Three-year improvements in maximum flow rate (Qmax) were large in both groups at 10 and 9.7 cc/sec for Aquablation and TURP, respectively (p=.9078, 95% CI for difference –2.9 to 6.4). Sexual function as assessed by MSHQ-EjD was stable in the Aquablation group and decreased slightly in the TURP group; these changes persisted at year 3. At three years, PSA was reduced significantly in both groups but showed no difference between groups (p=.4074 for difference). The average annual retreatment occurrence was less than 2% in both treatment groups. CONCLUSIONS: Three-year efficacy outcomes after TURP and Aquablation were similar and the rate of surgical retreatment was low and similar to TURP. Efficacy results have maintained their improvement since the 90 day follow-up for both groups that are consistent with all other resective surgical techniques. Source of Funding: PROCEPT BioRobotics © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1189-e1189 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Peter Gilling* More articles by this author Neil Barber More articles by this author Mo Bidair More articles by this author Paul Anderson More articles by this author Mark Sutton More articles by this author Tev Aho More articles by this author Eugene Kramolowsky More articles by this author Andrew Thomas More articles by this author Barrett Cowan More articles by this author Ronald Kaufman More articles by this author Andrew Trainer More articles by this author Andrew Arther More articles by this author Gopal Badlani More articles by this author Mark Plante More articles by this author Mihir Desai More articles by this author Leo Doumanian More articles by this author Alexis Te More articles by this author Mark DeGuenther More articles by this author Claus Roehrborn More articles by this author Expand All Advertisement PDF downloadLoading ...

The relationship between living in urban and rural areas of Scotland and children\u2019s physical activity and sedentary levels: a country-wide cross-sectional analysis

BackgroundLiving in urban or rural environments may influence children’s levels of physical activity and sedentary behaviours. We know little about variations in device-measured physical activity and sedentary levels of urban and rural children using nationally representative samples, or if these differences are moderated by socioeconomic factors or seasonal variation. Moreover, little is known about the influence of ‘walkability’ in the UK context. A greater understanding of these can better inform intervention strategies or policy initiatives at the population level.MethodsCountry-wide cross-sectional study in Scotland in which 774 children (427 girls, 357 boys), aged 10/11 years, wore an accelerometer on one occasion for at least four weekdays and one weekend day. Mean total physical activity, time spent in sedentary, light, and moderate-to-vigorous physical activity (MVPA), per day were extracted for weekdays, weekend days, and all days combined. Regression analyses explored associations between physical activity outcomes, urban/rural residence, and a modified walkability index (dwelling density and intersection density); with interactions fitted for household equivalised income and season of data collection. Sensitivity analyses assessed variation in findings by socioeconomic factors and urbanicity.ResultsRural children spent an average of 14 min less sedentary (95% CI of difference: 2.23, 26.32) and 13 min more in light intensity activity (95% CI of difference, 2.81, 24.09) per day than those from urban settlements. No urban-rural differences were found for time spent in MVPA or in total levels of activity. Our walkability index was not associated with any outcome measure. We found no interactions with household equivalised income, but there were urban/rural differences in seasonal variation; urban children engaged in higher levels of MVPA in the spring months (difference: 10 mins, p = 0.06, n.s) and significantly lower levels in winter (difference: 8.7 mins, p = 0.036).ConclusionsExtrapolated across one-year, rural children would accumulate approximately 79 h (or just over 3 days) less sedentary time than urban children, replacing this for light intensity activity. With both outcomes having known implications for health, this finding is particularly important. Future work should prioritise exploring the patterns and context in which these differences occur to allow for more targeted intervention/policy strategies.

Timing of electronic reminders did not improve trial participant questionnaire response: a randomized trial and meta-analyses

ObjectivesThe objective of this study was to assess whether timing of short messaging service (SMS) reminders improved postal questionnaire return rates from participants in a randomized controlled trial (RCT). Study Design and SettingA Study Within A Trial (SWAT) embedded in a multicenter RCT evaluating three treatments for the frozen shoulder. Participants who provided a mobile telephone number were randomized to either prenotification SMS on the day of the questionnaire mail-out or postnotification SMS 4 days after questionnaire mail-out for the 3-month follow-up. The primary outcome was the proportion of participants who returned a valid questionnaire. A systematic review was undertaken to identify other embedded trials to perform a meta-analysis. ResultsOf the 269 participants, 122/135 (90.4%) returned a valid questionnaire in the prenotification arm and 119/134 (88.8%) in the postnotification arm (difference of −1.6%; 95% CI of difference: −8.9%, 5.7%). There was no difference in time to response (HR = 1.04; 95% CI: 0.80 to 1.34) or need for additional reminders (OR = 0.71; 95% CI: 0.43 to 1.17). Meta-analysis of two RCTs showed no difference in response rates between prenotification and postnotification reminders (OR = 0.78 95% CI: 0.42 to 1.45). ConclusionTiming of SMS reminders did not improve response rates and time to response or affect the need for additional reminders.

Simulation Training for Critical Care Airway Management: Assessing Translation to Clinical Practice Using a Small Video-Recording Device

Critical care airway management (CCAM) is a key skill for critical care physicians. Simulation-based training (SBT) may be an effective modality in training intensivists in CCAM. Is SBT of critical care fellows an effective means of providing training in CCAM, in particular in urgent endotracheal intubation? Thirteen first-year pulmonary critical care medicine (PCCM) fellows at an academic training program underwent SBT with a computerized patient simulator (CPS) in their first month of fellowship training. At the end of the training period, the fellows underwent video-based scoring using a 46-item checklist (of which 40 points could be scored) while performing a complete CCAM sequence on the CPS. They were then tested, using video-based scoring on their first real-life CCAM. Maintenance of skill at CCAM was assessed during the fellows' second and third year of training, using the same scoring method. For the first-year fellows, the score on the CPS was 38.3 ± 0.75 SD out of a maximum score of 40. The score on their first real-life patient CCAM was 39.0 ± 0.81 SD (P= .003 for equivalence; 95%CI for difference between real-life patient CCAM and CPS scores, 0.011-1.373). Sixteen second- and third-year fellows were tested at a real-life CCAM event later in their fellowship to examine for maintenance of skill. The mean maintenance of skill score of this group was 38.7 ± 1.14 SD. Skill acquired through SBT of critical care fellows for CCAM transfers effectively to the real-life patient care arena. Second- and third-year fellows who had initially received SBT maintained skill at CCAM.

Cardiovascular Drift and Maximal Oxygen Uptake during Running and Cycling in the Heat.

Greater cardiovascular (CV) drift occurs during cycling compared to running in temperate conditions. CV drift also corresponds to proportional reductions in maximal oxygen uptake (V˙O2max) during heat stress. Whether exercise mode differentially affects CV drift-and accompanying declines in V˙O2max-during heat stress is uncertain. The purpose of this study was to test the hypothesis that a greater magnitude of CV drift, accompanied by a greater decrement in V˙O2max, occurs during cycling compared to running in hot conditions. 7 active men (mean ± SD; age = 25 ± 6 yr, percent body fat = 11.9% ± 2.4%) completed a control graded exercise test (GXT) on a cycle ergometer and treadmill. Then on separate, counterbalanced occasions they completed 15 or 45 min of cycling or running at 60% V˙O2max in 35°C, immediately followed by a GXT to measure V˙O2max (4 trials total). The separate 15- and 45-min trials were designed to measure CV drift and V˙O2max over the same time interval. Heart rate increased 19% and 17% and stroke volume decreased 20% and 15% between 15 and 45 min during running and cycling, respectively, but modes were not different (all P > 0.05). Despite a 1.8°C larger core-to-skin thermal gradient during running, decrements in V˙O2peak were not different between exercise modes (95% CI for difference in change scores between 15 and 45 min: -0.2, 0.3). CV strain (indexed as CV drift) during prolonged exercise in the heat corresponds to reduced V˙O2max, irrespective of exercise mode or the thermal gradient. As such, the upward drift in heart rate associated with CV drift reflects increased relative metabolic intensity (%V˙O2max) during prolonged cycling or running in the heat.

Single- versus double-injection costoclavicular block: a randomized comparison

BackgroundThe costoclavicular approach targets the brachial plexus in the proximal infraclavicular fossa, where the lateral, medial, and posterior cords are tightly bundled together. This randomized trial compared single- and double-injection...

Providing the best chest compression quality: Standard CPR versus chest compressions only in a bystander resuscitation model.

Aim of the studyBystander-initiated basic life support (BLS) for the treatment of prehospital cardiac arrest increases survival but is frequently not performed due to fear and a lack of knowledge. A simple flowchart can improve motivation and the quality of performance. Furthermore, guidelines do recommend a chest compression (CC)-only algorithm for dispatcher-assisted bystander resuscitation, which may lead to increased fatigue and a loss of compression depth. Consequently, we wanted to test the hypothesis that CCs are more correctly delivered in a flowchart-assisted standard resuscitation algorithm than in a CC-only algorithm.MethodsWith the use of a manikin model, 84 laypersons were randomized to perform either flowchart-assisted standard resuscitation or CC-only resuscitation for 5min. The primary outcome was the total number of CCs.ResultsThe total number of correct CCs did not significantly differ between the CC-only group and the standard group (63 [±81] vs. 79 [±86]; p = 0.394; 95% CI of difference: 21–53). The total hand-off time was significantly lower in the CC-only group than in the standard BLS group. The relative number of correct CCs (the fraction of the total number of CCs achieving 5-6cm) and the level of exhaustion after BLS did not significantly differ between the groups.ConclusionStandard BLS did not lead to an increase in correctly delivered CCs compared to CC-only resuscitation and exhibited significantly more hand-off time. The low rate of CCs in both groups indicates the need for an increased focus on performance during BLS training.

Factors associated with first-pass success of emergency endotracheal intubation

Study objectiveEndotracheal intubation is frequently performed in emergency departments (EDs). First-pass success is important because repeated attempts are associated with poor outcomes. We sought to identify factors associated with first-pass success in emergency endotracheal intubation. MethodsWe analyzed emergency orotracheal intubations on adult patients in an ED located in South Korea from Jan. 2013 to Dec. 2016. Various operator-, procedure- and patient-related factors were screened with univariable logistic regression. Using variables with P-values less than 0.2, a multiple logistic regression model was constructed to identify independent predictors. ResultsThere were 1154 eligible cases. First-pass success was achieved in 974 (84.4%) cases. Among operator-related factors, clinical experience (OR: 2.93, 5.26, 3.80 and 5.71; 95% CI: 1.62–5.26, 2.80–9.84, 1.81–8.13 and 2.07–18.67 for PGY 3, 4 and 5 residents and EM specialists, respectively, relative to PGY 2 residents) and physician based outside the ED (OR: 0.10; 95% CI: 0.04–0.25) were independently associated with first-pass success. There was no statistically or clinically significant difference for first-pass success rate as determined by operator's gender (83.6% for female vs. 84.8% for male; 95% CI for difference: −3.1% to 5.8%). Among patient-related factors, restricted mouth opening (OR: 0.47; 95% CI: 0.31–0.72), restricted neck extension (OR: 0.57; 95% CI: 0.39–0.85) and swollen tongue (OR: 0.46; 95% CI: 0.28–0.77) were independent predictors of first-pass success. ConclusionsOperator characteristics, including clinical experience and working department, and patient characteristics, including restricted mouth opening, restricted neck extension and swollen tongue, were independent predictors of first-pass success in emergency endotracheal intubation.

Reliability of residents\u2019 assessments of their postgraduate medical education learning environment: an observational study

BackgroundEven in anonymous evaluations of a postgraduate medical education (PGME) program, residents may be reluctant to provide an honest evaluation of their PGME program, because they fear embarrassment or repercussions from their supervisors if their anonymity as a respondent is endangered. This study was set up to test the hypothesis that current residents in a PGME program provide more positive evaluations of their PGME program than residents having completed it. We therefore compared PGME learning environment evaluations of current residents in the program to leaving residents having completed it.MethodsThis observational study used data gathered routinely in the quality cycle of PGME programs at two Dutch teaching hospitals to test our hypothesis. At both hospitals, all current PGME residents are requested to complete the Scan of Postgraduate Education Environment Domains (SPEED) annually. Residents leaving the hospital after completion of the PGME program are also asked to complete the SPEED after an exit interview with the hospital’s independent residency coordinator. All SPEED evaluations are collected and analysed anonymously. We compared the residents’ grades (on a continuous scale ranging from 0 (poor) to 10 (excellent)) on the three SPEED domains (content, atmosphere, and organization of the program) and their mean (overall department grade) between current and leaving residents.ResultsMean (SD) overall SPEED department grades were 8.00 (0.52) for 287 current residents in 39 PGME programs and 8.07 (0.48) for 170 leaving residents in 39 programs. Neither the overall SPEED department grades (t test, p = 0.53, 95% CI for difference − 0.16 to 0.31) nor the department SPEED domain grades (MANOVA, F(3, 62) = 0.79, p = 0.51) were significantly different between current and leaving residents.ConclusionsResidents leaving the program did not provide more critical evaluations of their PGME learning environment than current residents in the program. This suggests that current residents’ evaluations of their postgraduate learning environment were not affected by social desirability bias or fear of repercussions from faculty.

Abstract 15: Public Access Defibrillators: Sex-Based Inequities in Access and Application

Introduction: It is unclear if the benefits of public access defibrillator (PAD) programs are similar between men and women. We investigated the location of out-of-hospital cardiac arrests (OHCA) stratified by sex to determine what proportion was eligible for PAD application. Second, we sought to determine if patient sex was associated with PAD utilization. Methods: We analyzed prospectively collected data from the North American Resuscitation Outcomes Consortium (ROC) Epistry dataset (2011 - 2015), excluding emergency medical services (EMS)-witnessed cases, those not treated by EMS, and children aged less than 10. We compared sex-based differences in public vs private location, and location type (street or highway, public building, place of recreation, industrial place, home residence, farm or ranch, healthcare facility, residential institution, other public property, or other private location). Among public location OHCAs with bystander interventions, we fit an adjusted logistic regression model to estimate the association between sex and PAD application. Results: Among the 61,473 cases, 20,933 (34%) were female, 30,353 had resuscitation attempted by bystander, and 13,597 had initial shockable rhythms. The OHCA incidence in a public location for women and men was 8.8% and 18%, respectively (95% CI for difference 8.7 - 9.7). Women had a significantly lower proportion of OHCAs on the street/highway, in public buildings, places of recreation, and farms, but a significantly higher proportion in the home, healthcare facilities, and residential institutions. Among public location OHCAs with bystander interventions, female sex was associated with a lower odds of bystander PAD application (adjusted OR 0.83, 95% CI 0.70-0.99). Conclusion: Women had fewer OHCAs in public locations eligible for PAD application. Further, among public OHCAs with bystander interventions, women were less likely to have PADs applied.

Peripheral blood BDNF-TrkB signaling in first-episode, drug-free patients with major depressive disorder and schizophrenia

Brain-derived neurotrophic factor (BDNF) has been implicated in the pathogenesis of psychiatric disorders, and studies have shown BDNF aberrations in major psychiatric diseases including schizophrenia (SCZ) and major depressive disorder (MDD). However, data from clinical studies were inconsistent. In this study, we recruited 34 patients with MDD, 77 patients with SCZ and 65 healthy control (HC) subjects to clarify the circulating BDNF levels in MDD and SCZ patients, and to assess whether serum BDNF levels were associated with the disease severity. Our results showed that serum BDNF levels were significantly decreased in the patients with SCZ (Mean difference = −4.517, 95%CI of difference = −7.854 to −1.180, p < 0.01) and MDD (Mean difference = −5.699, 95%CI of difference = −9.892 to −1.506, p < 0.01) when compared with HC subjects. Sub-group analyses suggested that BDNF levels were significantly reduced in the female SCZ (Mean difference = −5.700, 95%CI of difference = −10.21 to -1.189, p < 0.01) and MDD (Mean difference = −5.840, 95%CI of difference = −10.66 to −1.019, p < 0.05) patients, but not in male patients. Further analyses indicated that serum BDNF levels were not correlated with disease severity of MDD and SCZ. In addition, the transcriptional expression of TrkB was significantly down-regulated in the blood of MDD patients, but not in SCZ patients. However, there was no significant correlation between BDNF concentrations and TrkB mRNA levels. Taken together, our results revealed differential changes of BDNF-TrkB signaling in MDD and SCZ patients, therefore contributed to a better understanding of MDD and SCZ pathophysiology.

TOTAL AND POST-DISCHARGE 30-DAY EPISODE PAYMENTS FOR BENEFICIARIES WITH ALZHEIMER’S AND DEMENTIA

There exists lack of evidence regarding incremental post-discharge cost and utilization of healthcare services for older adults with Alzheimer’s and dementia (AD). We quantified episode payments associated with AD vs. non-AD 30 days after medical or surgical procedures. We utilized administrative claims between January 2012 and June 2017 from the Michigan Value Collaborative (MVC) across 31 different medical and surgical services. We identified all patients with any AD diagnosis code throughout their enrollment using ICD-9-CM, ICD-10-CM codes. We price standardized 30-day episode payments and split them based on patient setting. Payments were risk adjusted and winsorized at the 99th /1st percentile. Propensity score matching using calipers without replacement adjusted for clinically relevant surgical and medical procedures, HCCs, insurance type, and age to control for selection bias. We identified 66,676 AD episodes and 656,235 non-AD episodes. After propensity score matching, there were 58,485 AD and non-AD episodes with significant differences in total episode payments of ($22,378 vs. $19,595, 95% CI Diff: ($2,658, $2,910)). Post-acute care and readmission payments were significant ($4,561 vs. $3,272, 95% CI Diff: ($1,235, $1,342)) and ($1,807 vs. $1,165, 95% CI Diff: ($595, $691)), respectively. AD episodes had a higher readmission rate (21.6% vs. 14.8%, p<0.0001). County variation in payments for AD episodes was substantial (Median: $4,370, Range: $3,881). AD patients are at higher risk of readmission and more resource intensive to hospitals and health systems. Examining drivers of post-discharge cost variation can influence practice pattern changes in management of AD patients.

INCREMENTAL COST AND READMISSIONS ASSOCIATED WITH COLECTOMY PATIENTS UNDERGOING HOME HEALTH SERVICES

Home health services has been considered a recommended form of post-discharge management of older patients undergoing surgery. In this study, we examined total 30-day episode payments and 30-day readmission rates for those who were and were not utilizers of home health services following colectomies. We utilized administrative claims data (2012-2017) from the Michigan Value Collaborative across 77 hospitals in Michigan. Post-acute care includes skilled nursing facility, inpatient/outpatient rehabilitation, emergency department visits, home health services, and other outpatient visits. All payments were risk adjusted using generalized linear models using Hierarchical Condition Categories, age, sex, insurance type, and prior 6-month payments. Controlling for selection bias for those utilizing home health services, we performed propensity score matching at a caliper of 0.001 without replacement. We identified 15,531 colectomies with 4,397 (28.3%) utilizing home health services within 30 days. There were 4,197 home health users and non-users with home health users having significantly higher adjusted 30-day episode payments ($33,254 vs. $30,463, 95% CI Diff: ($2,097, $3,486)). While there were only slight differences in adjusted index surgical base payments between home health users ($21,531, 95% CI: ($21,279, $21,783) and non-users ($20,703, 95% CI: ($20,409, $20,998)), there were substantially larger post-discharge payments for home health users ($3,617 vs, $1,839, 95% CI Diff: ($1,597, $1,959)). Colectomy patients utilizing home health services had a higher readmission rate (21.5% vs. 15.6%, p <0.0001). Colectomy patients utilizing home health services are more resource intensive in the post-discharge period. Recommendation for home health services increases costs and readmission.

1511. Effect of Discharge Antibiotic Route on Clinical Outcomes in Children with Methicillin-Resistant Staphylococcus aureus (MRSA) Osteomyelitis with Bacteremia

BackgroundChildren with osteomyelitis transitioned to oral step-down therapy experience similar outcomes to those treated with outpatient parenteral antibiotic therapy (OPAT). Compared with OPAT, oral therapy has lower costs and avoids catheter complications. However, few studies have specifically compared patient outcomes between those receiving oral therapy vs. OPAT for osteomyelitis with associated bacteremia caused by MRSA.MethodsWe performed a retrospective cohort study comparing early oral therapy (EOT), defined as transition to oral therapy at or prior to discharge vs. use of OPAT at discharge. We identified hospitalized children <19 years of age with MRSA osteomyelitis with bacteremia between 2007 and 2014 from three children’s hospitals. The primary outcome was treatment failure within 6 months of discharge, defined as unplanned change in antibiotic after discharge, development of chronic osteomyelitis, need for an operative procedure after discharge, or recrudescence of bacteremia. The secondary outcome was treatment-related events, defined as documented adverse drug events in the medical record and/or central venous catheter complications. Between-group comparisons were made using Fisher exact test for binomial distributions and the Wilcoxon rank-sum test for continuous variables.ResultsWe included 61 patients with MRSA osteomyelitis with bacteremia. Twenty-five patients (41%) received EOT and 36 (59%) received OPAT. Duration of bacteremia and hospital length of stay was similar between groups (Table 1). Clindamycin was the most commonly used antibiotic in both the EOT (24/25; 96%) and OPAT (22/36; 61%) groups. Clinical failure occurred in 1/25 (4%) children receiving EOT and in 5/36 (14%) in the OPAT group (95% CI of difference: −29 to 6%; P = 0.38, Table 1). Treatment-related adverse events occurred in 1/25 (4%) children receiving EOT compared with 9/36 (25%) receiving OPAT (95% CI of difference: −49 to –7%; P = 0.04, Table 1).ConclusionChildren receiving EOT for MRSA osteomyelitis with bacteremia did not experience higher rates of clinical failure and had fewer treatment-related complications compared with OPAT. Oral step-down therapy can be considered for children with MRSA osteomyelitis with bacteremia. Disclosures All authors: No reported disclosures.

Allodynia in Menstrually Related Migraine: Score Assessment by Allodynia Symptom Checklist (ASC-12).

The aim of this study was to compare the allodynia score in headache attacks related and not related to menstruation in women diagnosed with menstrually related migraine without aura. Allodynia is an important symptom in migraine and has been associated with migraine chronification. No study has yet compared prospectively allodynia in menstrual vs non-menstrual attacks within the same cohort of patients. This is a prospective cohort study, where participants had the 12-item Allodynia Symptom Checklist (ASC-12) assessed after 1, 2, 4, and 24hours from the onset of migraine attacks in 2 different conditions, with menstrual migraine attack (MM+) and with non-menstrual migraine attack (MM-). A total of 600 women with headache complaints were screened from March 2013 to July 2014 in a headache outpatient or headache tertiary clinic. From these, 55 participants were recruited, and 32 completed the study. Participants' mean age was 27 years, BMI was 22.1, menarche age 12 years, migraine history was 11.5 years, and most women were young (ranged from 17 to 44 years of age), were in higher school (13/32=41%), single (20/32=63%), and used contraceptives (22/32=69%). Multiple pairwise comparisons of ANCOVA's test showed significant higher ASC-12 scores in MM+ group compared to MM- group at 2hours [mean, 95% CI of difference: 2.3 (0.31, 4.7), P=.049)]. For the ASC-12 categorical scores (absent, mild, moderate, and severe) MM+ yielded higher scores than MM- at 1hour (z=-3.08, P=.021) and 4hours (z=-2.97, P=.03). This study demonstrated that in the patents from tertiary headache center assessed, menstrual-related migraine attacks augment allodynia scores in the beginning of attacks compared to non-menstrual migraine attacks.

Pediatric obstructive sleep apnea screening questionnaire and post-operative outcomes: A prospective observational study

IntroductionObstructive Sleep Apnea (OSA) and Sleep Disordered Breathing (SDB) in children tend to be a more complex and multifactorial disease than in adults. Although adult screening tools, such as the STOP-BANG questionnaire, their application limited in pediatrics. We used our previously described 6-point questionnaire to identify OSA in children and evaluated its use for predicting post-operative respiratory events. MethodsChildren from 3 to 18 years of age presenting for surgery were eligible. Exclusion criteria were emergency surgery or refusal to participate. A 6-question survey regarding symptoms of OSA/SDB was administered preoperatively. Neck circumference was measured. Height and weight were recorded from preoperative data and the body mass index (BMI) percentile obtained. Results749 patients were enrolled in the study. 707 patients were in the final analysis (359 boys and 348 girls, mean age 12 ± 4 years). The median 6-item questionnaire score was 1 (interquartile range: 0, 2) and 186 (26%) scored ≥ 2 of 6 points. Children with predicted OSA (yes on ≥ 2 questions) were more likely than without predicted OSA to require supplemental oxygen in the PACU (24% vs. 17%; 95% confidence interval [CI] of difference: −0.3%, 13%; p = 0.049). Amongst 681 patients with available data on Post Anesthesia Care Unit (PACU) length of stay (LOS), prolonged LOS (>1 h) was not more likely among children with predicted OSA (42%) compared to those without predicted OSA (39%; 95% CI of difference: −5%, 11%; p = 0.479). Outcomes assessed after PACU discharge noted no differences. Specifically, overnight hospital stay was required in 33% of patients with predicted OSA as compared to 29% of those without (95% CI of difference: −4%, 11%; p = 0.399). On POD 0, supplemental oxygen was used on the inpatient ward for 6% of patients with predicted OSA compared to 4% of patients without predicted OSA (95% CI of difference: −2%, 6%; p = 0.272). ConclusionThe incidence of OSA/SDB is under-appreciated in children presenting for non-otolaryngological surgical procedures. Although patients judged to have OSA on the 6-item question may need for supplemental oxygen longer in the PACU, no other outcomes differences were noted.

Quantification of PpIX-fluorescence of cerebral metastases: a pilot study.

5-ALA fluorescence-guided surgery (FGS) is a major advance in neuro-oncological surgery. So far, Protoporphyrin IX (PpIX)-fluorescence has been observed in about half of cerebral metastases resected with routinely equipped microscopes during 5-ALA FGS. The aim of the present pilot study was to quantify PpIX-induced fluorescence of cerebral metastases with a spectrometer. We hypothesize that non-fluorescing metastases under the operating microscope may have spectrometrically measurable levels of fluorescence. A second aim was to analyze correlations between quantified 5-ALA fluorescence and histology or primary tumor type, respectively. Standard FGS was performed in all patients. The fluorescence intensity of the metastasis was semi-quantitatively determined in vivo by a senior surgeon using a special surgical microscope equipped for FGS. A systematic spectrometric ex vivo evaluation of tumor specimens and PpIX-induced fluorescence was performed using a spectrometer connected by optic fibers to a handheld probe. Quantification of 5-ALA-derived fluorescence was measured in a standardized manner with direct contact between mini-spectrometer and metastasis. The difference between the maximum PpIX-fluorescence at 635nm and the baseline fluorescence was defined as the PpIX fluorescence intensity of the metastasis and given in arbitrary units (AU). Diagnosis of a cerebral metastasis was confirmed by histopathological analysis. A total of 29 patients with cerebral metastases were included. According to neuropathological analysis, 11 patients suffered from non-small cell lung cancer, 10 patients from breast cancer, 6 patients from cancer originating in the gastro-intestinal tract, 1 patient suffered from a malignant melanoma and one patient from renal cancer. The mean age was 63years (37-81years). 15 patients were female, 14 patients male. 13 cerebral metastases were considered as ALA-positive by the surgeon. In nine metastases, 5-ALA fluorescence was not visible to the naked eye and could only be detected using the spectrometer. The threshold for an ALA signal rated as "positive" by the surgeon was PpIX fluorescence above 1.1 × 106 AU. The mean PpIX fluorescence of all analyzed cerebral metastases was 1.29 × 106 ± 0.23 × 106 AU. After quantification, we observed a significant difference between the mean 5-ALA-derived fluorescence in NSCLC and breast cancer metastases (Mean Diff: - 1.2 × 106; 95% CI of difference: - 2.2 × 106 to - 0.15 × 106; Šidák-adjusted p = 0.026). In our present pilot series, about half of cerebral metastases showed a 5-ALA fluorescence invisible to the naked eye. Over 50% of these non-fluorescent metastases show a residual 5-ALA fluorescence which can be detected and quantified using a spectrometer. Moreover, the quantified 5-ALA signal significantly differed with respect to the primary tumor of the corresponding cerebral metastasis. Further studies should evaluate the predictive value of the 5-ALA signal and if a quantified 5-ALA signal enables a reliable intraoperative differentiation between residual tumor tissue and edematous brain-in particular in metastases with a residual fluorescence signal invisible to the naked eye.

Hepatic triglyceride content does not affect circulating CETP: lessons from a liraglutide intervention trial and a population-based cohort

Cholesteryl ester transfer protein (CETP) is mainly expressed by Kupffer cells in the liver. A reduction of hepatic triglyceride content (HTGC) by pioglitazone or caloric restriction is accompanied by a decrease in circulating CETP. Since GLP-1 analogues also reduce HTGC, we assessed whether liraglutide decreases CETP. Furthermore, we investigated the association between HTGC and CETP in a population-based cohort. In a placebo-controlled trial, 50 patients with type 2 diabetes were randomly assigned to treatment with liraglutide or placebo added to standard care. In this trial and in 1,611 participants of the Netherlands Epidemiology of Obesity (NEO) study, we measured HTGC and circulating CETP by proton magnetic resonance spectroscopy and ELISA, respectively. The HTGC was decreased in the liraglutide group (−6.3%; 95%CI of difference [−9.5, −3.0]) but also in the placebo group (−4.0%; 95%CI[−6.0, −2.0]), without between-group differences. CETP was not decreased by liraglutide (−0.05 µg/mL; 95%CI[−0.13, 0.04]) or placebo (−0.04 µg/mL; 95%CI[−0.12, 0.04]). No association was present between HTGC and CETP at baseline (β: 0.002 µg/mL per %TG, 95%CI[−0.005, 0.009]) and between the changes after treatment with liraglutide (β: 0.003 µg/mL per %TG, 95%CI[−0.010, 0.017]) or placebo (β: 0.006 µg/mL per %TG, 95%CI[−0.012,0.024]). Also, in the cohort n o association between HTGC and CETP was present (β: −0.001 µg/mL per SD TG, 95%CI[−0.005, 0.003]). A reduction of HTGC after treatment with liraglutide or placebo does not decrease circulating CETP. Also, no association between HTGC and CETP was present in a large cohort. These findings indicate that circulating CETP is not determined by HTGC.Clinical Trial Registration: Clinicaltrials.gov (NCT01761318).

The effect of suprainguinal fascia iliaca block on the recovery of patients after arthroscopic hip surgery.

Adolescent and young adult patients undergoing arthroscopic hip surgery experience significant pain in the immediate postoperative period. There is a small body of evidence that indicates suprainguinal fascia iliaca blocks can improve comfort during recovery from this intervention. Our hypothesis was that patients undergoing hip surgery would consume fewer opioids and have less pain in the perioperative time frame if they received the block as part of their analgesic regimen. In this study, we evaluated the outcomes of 716 patients, including 275 who received a suprainguinal fascia iliaca block, and 441 who did not have a block. Inclusion criteria included all age groups and American Society of Anesthesiologists, functional classes 1-2. Patients who received other concurrent procedures or those with incomplete data sets were excluded. We utilized a regional anesthesia database that combined data from various repositories into one web-based relational system. The primary outcomes were total opioid consumption and pain scores in the recovery room. Secondary outcomes included opioid side effects, block-related complications, and total recovery room time. Multivariable logistic regression analysis was used to evaluate opioid consumption, side effects, and total recovery times. Pearson chi-square was applied to assess the level of pain between the two groups. Total opioid consumption was significantly less in the block group compared to those not receiving a block (0.28mg/kg vs 0.35mg/kg, P<0.001, 95% CI of difference in medians 0.04-0.10mg/kg), but there was no statistical difference in pain scores. Patients with the regional block had a lower frequency of emesis in the PACU (0.7% vs 4.3%; P<0.005, 95% CI of difference: 2-25) and shorter PACU times (93 vs 108minutes, P<0.001, 95% CI of difference: 8-23minutes). Our study supports the clinical effectiveness of suprainguinal fascia iliaca blocks in young patients undergoing arthroscopic hip surgery.