Prospective Observational Outcome Research Articles

P046 The influence of deprivation in the outcomes of Psoriatic Arthritis within the UK - utilising Outcomes of Treatment in Psoriatic Arthritis Study Syndicate data

Abstract Background/Aims Psoriatic arthritis (PsA) is a chronic inflammatory arthropathy, which affects approximately 30% of patients with psoriasis and is associated with a high degree of morbidity. The introduction of biological disease-modifying antirheumatic drugs (bDMARDs) revolutionised treatment strategies for patients with PsA, however response is not universal. Deprivation and its associated risk factors may impact the initiation of and response to treatment with bDMARDs. There is limited data exploring the effect of deprivation on disease response to biologics in PsA. Psoriasis patients with a higher socioeconomic status have been shown to be more likely to respond to biologics, to our knowledge this has not been investigated in PsA. This study aimed to assess the impact of deprivation on initiation of and clinical response to biologic DMARDs. Methods Patients commencing a bDMARD were recruited to the UK prospective observational study Outcome of Treatment in Psoriatic Arthritis Studies Syndicate (OUTPASS REC ref:13/NW/0068). Index of Multiple Deprivation (IMD), the official measure of relative deprivation in England, was the exposure of interest. Subjects were ranked based on their IMD and split into the 20% most deprived (deciles 1-2), middle 40% (deciles 3-6) and 40% least deprived (deciles 7-10). This was done to aid analysis as IMD weightings provide greater differentiation among the least advantaged areas with fewer distinctions for less deprived areas. Treatment response was measured using changes in DAS28/PsARC, analysed using multivariate linear regression and multivariate logistic regression, respectively. Response was measured at three months as NICE guidance advises review of biological therapies at this time. Results There was no difference in the distribution of patients between the three groups (most deprived=138, middle deprived=207, least deprived=193). There were no statistically significant differences in the time from diagnosis to starting biologics in the most deprived group compared to the middle (p = 0.62) or least deprived p = 0.42) groups. There was no statistically significant difference in treatment responses between the groups. DAS28 change and PsARC improvement at three months remained similar between the most deprived, the middle deprived (p = 0.71, p = 0.08) and least deprived groups (p = 0.81, p = 0.22). Conclusion There was no difference in the distribution of IMD in patients recruited to OUTPASS, suggesting that the study is inclusive in recruiting across IMD subgroups. There was no difference in time from diagnosis to starting bDMARD therapy or response to treatment across the deprivation spectrum. These findings suggest that the NHS in England is performing its role of providing care according to need and regardless of circumstance. The study assesses deprivation in the context of free healthcare and may not be applicable to fee-paying healthcare systems. Further research is required to determine the relationship between deprivation and other outcomes, including work instability, in PsA. Disclosure M. Lyon: None. S. Zhao: None. A. Barton: Member of speakers’ bureau; speaker fees from Chugai-Roche and Galapagos. Grants/research support; grant funding from BMS, Pfizer, all unrelated to the work presented. H. Chinoy: Corporate appointments; Advisory Board member for Astra Zeneca, Pfizer, Argenx, Galapagos; Data and Science Monitoring Board chair for Horizon Therapeutics.. Consultancies; Consulting for PTC Therapeutics. Member of speakers’ bureau; fees as a speaker for GSK, UCB. M. Jani: None. J. Bluett: Grants/research support; research grant award from Pfizer and travel/conference fees from UCB, Fresenius Kabi, Pfizer and Eli Lilly.

Abstract Number ‐ 49: Risk of HT with Early DOACs after Acute Ischemic Stroke: A Pooled Analysis

Introduction The risk of hemorrhagic transformation (HT) in the early phase of acute ischemic stroke (AIS) remains unknown, leading to potential unnecessary delays in initiation of anticoagulation for secondary stroke prevention. We sought to assess the rate of HT associated withdirect oral anticoagulant (DOAC) initiation within and beyond 48 hours after AIS, using a pooled analysis of available published data. Methods A pooled analysis of 6 studies (4 prospective observational blinded outcome studies and2 randomized trials) of DOAC initiation within 14 days of AIS or transient ischemic attack (TIA) was conducted. The primary endpoint was incident radiographic HT on follow‐up imaging. Secondary endpoints included symptomatic HT, new parenchymal hemorrhage, recurrent ischemic events, extracranial hemorrhage, mortality within the study period, and follow‐up modified Rankin Scale score.The results were reported as odds ratio (OR) andhazard ratio (HR)with 95% confidence interval (CI). Results We evaluated 509 patients; median infarct volume was1.5 (0.1‐7.8) ml, andmedian National Institutes of Health Stroke Scale was2 (0‐3).Incident radiographic HT was seen on follow‐up scan in 34 (6.8%) patients.DOAC initiation within 48 hours from index event was not associated with incident HT (adjusted OR 0.67, [0.30 – 1.50]P = 0.32).No patients developed symptomatic HT.Conversely, 31 (6.1%) patients developedrecurrent ischemic events, 64% of which occurred within 14 days.Initiating a DOAC within 48 hours of onset was associated with a trend towards lower rates of recurrent ischemic events, but this was not statistically significant (HR 0.42, [0.17 – 1.008]P = 0.052). In contrast to HT,recurrent ischemic events were associated with poor functional outcomes (OR = 6.8, [2.84 – 16.24], p< 0.001). Conclusions Initiation of DOAC within 48 hours after stroke was not associated with decreased risk of recurrent ischemic events, or increasedincident risk of HT. Both recurrent ischemic events and incident HT occurred at similar rates.Unlike HT, however, recurrent ischemic events were associated with poor outcomes.

Remineralization of lytic spinal metastases after radiotherapy

BACKGROUND CONTEXTPalliative radiotherapy (RT) can lead to remineralization of osteolytic lesions thereby potentially restoring some of the weight-bearing capacity and preventing vertebral collapse. It is not clear, however, under which circumstances remineralization of osteolytic lesions occurs. PURPOSEThe aim of this study was to investigate the change in bone mineral density in spinal metastases after RT compared to a reference region, and find associated factors. STUDY DESIGNRetrospective analysis within prospective observational cohort OUTCOME MEASURESchange in bone mineral density measured in Hounsfield Units (HU). PATIENT SAMPLEpatients treated with RT for (painful) bone metastases. METHODSPatients with spinal metastases were included if computed tomography scans both pre- and post-RT were available. Bone density was measured in HU. A region of interest (ROI) was drawn manually in the metastatic lesion. As a reference, a measurement of bone density in adjacent, unaffected, and non-irradiated vertebrae was used. Factors tested for association were origin of the primary tumor, RT dose and fractionation scheme, and concomitant use of bisphosphonates. RESULTSA total of 31 patients with 49 spinal metastases, originating from various primary tumors, were included. The median age on baseline was 58 years (IQR: 53–63) and median time between baseline and follow-up scan was 8.2 months (IQR: 3.0–18.4). Difference in HU in the lesion before and after treatment was 146.9 HU (95% CI 68.4–225.4; p<.01). Difference in HU in the reference vertebra between baseline and first follow-up was 19.1 HU (95% CI -47.9 to 86.0; p=.58). Difference between reference vertebrae and metastatic lesions on baseline was -194.1 HU (95% CI -276.2 to -112.0; p<.01). After RT, this difference was reduced to -50.3 HU (95% CI -199.6 to 99.0; p=.52). Patients using bisphosphonates showed a greater increase in HU, 194.1 HU versus 60.6 HU, p=.01. CONCLUSIONSPalliative radiation of osteolytic lytic spinal metastases is positively associated with an increased bone mineral density at follow-up. The use of bisphosphonates was linked to an increased bone mineral density when used during or after RT.

Abstract 12563: Creation of an Artificial Intelligence Model For Prediction of Major Adverse Cardiovascular Events Late After Tetralogy of Fallot Repair

Introduction and Hypothesis: Despite successful tetralogy of Fallot repair (rTOF) in childhood, advancing age is associated with escalating risk of morbidity and mortality. Published risk scores for prediction of major adverse cardiovascular events (MACE) typically incorporate invasive and/or specialized measures. We hypothesized that an artificial intelligence (AI) model using an array of parameters available in routine clinical practice could successfully predict MACE in rTOF. Methods: Adults with rTOF were identified using institutional databases (the prospective observational Comprehensive Outcomes Registry Late After Tetralogy of Fallot Repair [CORRELATE] and the retrospective Toronto Outcomes Registry of Congenital Heart disease [TORCH]). A random forest AI model for prediction of MACE was trained on CORRELATE using repeated random sub-sampling validation. External validation was achieved using non-overlapping retrospective data from TORCH. The MACE composite outcome included all-cause mortality, resuscitated sudden death, sustained ventricular tachycardia (&gt;30 seconds) or heart failure (hospital admission&gt;24 hours). Results: In total, 804 subjects were studied and MACE was observed in 73 (9%) subjects. Patients were either included in the training dataset (n=312, 59% male, median age 32 years [IQR 23-43], median follow-up 6 years [IQR 4-7]) or the testing dataset (n=492, 58% male, median age 26 years [IQR 20-37], median follow up 10 years [IQR 6-10]). Variables incorporated into the AI model are shown (Figure 1). Predictive capacity of the AI models were similar in testing (AUC 0.81, CI 0.75-0.86) and training (AUC 0.88, CI 0.71-0.99) datasets with excellent receiver operating characteristics (Figure 1). Conclusions: An AI model based on routinely used and widely available clinical and imaging variables could successfully predict MACE in rTOF. Further study is required to determine the value of AI for risk management in rTOF.

A novel transition clinic structure for adolescent and young adult patients with childhood onset rheumatic disease improves transition outcomes

BackgroundThe transition of health care from Pediatric to Adult providers for adolescents and young adults with chronic disease is associated with poor outcomes. Despite the importance of this transition, over 80% of these patients do not receive the services necessary to transition to Adult health care. In 2018, we initiated a transition clinic structure, integrating an Internal Medicine - Pediatrics trained Adult Rheumatologist in a Pediatric Rheumatology clinic to guide this transition. Our goal was to improve transition outcomes. We report the methods of this clinic and its preliminary outcomes.MethodsFor patients referred to the transition clinic, the Adult Rheumatologist assumed medical management and implemented a six-part modular transition curriculum. This curriculum included a Transition Policy, Transition Readiness Assessment, medication review and education, diagnosis review and education, and counseling on differences between Pediatric and Adult-oriented care. Eligible patients and their families were enrolled in a prospective observational outcomes research registry. Initial data from this transition clinic is reported including adherence with certain aspects of the transition curriculum and clinic utilization.ResultsThe transition clinic Adult Rheumatologist saw 177 patients in 2 years, and 57 patients were eligible for, approached, and successfully enrolled in the registry. From this registry, all patients reviewed the Transition Policy with the Adult Rheumatologist and 45 (78.9%) completed at least one Transition Readiness Assessment. Of the 22 patients for whom transition was indicated, all were successfully transitioned to an Adult Rheumatologist. 17 (77.3%) continued care post-transition with the transition clinic Adult Rheumatologist, and 5 (22.7%) continued care post-transition with a different Adult Rheumatologist. The median time between the last transition clinic visit and first Adult clinic visit was 5.1 months.ConclusionsOur experience demonstrated the success of our clinic model regarding participation in the transition curriculum and improved clinic utilization data. Our results are an improvement over transition rates reported elsewhere that did not implement our model. We believe that this structure could be applied to other primary care and subspecialty clinics.Trial registrationThis research was approved by the University of Utah Institutional Review Board (IRB) in January 2019 (IRB_00115964). Patients were retrospectively registered if involved prior to this date.

A Prospective Observational Study Ondemographic Profile and Clinical Outcomes of Acutepoisoning Cases in a Tertiary Care Hospital in Southern India

Background: The profile of acute poisoning cases is fast changing in last few years, due to advancements in agriculture, construction, sanitation, cosmetic industry and not the least in pharmacology. The advancements and invention of new chemical agents in these industries have increased the access to wide range of materials with quite varied chemical nature, which is reflected in the profile of acute poisonings.Methods: The study is a prospective observational study for a period of 18 months .The study population included all the patients presenting to the emergency department with history of acute poisoning excluding accidental non-self- poisoning.Conclusion: In the current study, highest proportion of subjects in the overall study group was between 26 to 40 years. The proportion of males and females were almost equal whereas in OPC poisoning group the proportion of males was much higher than females. Majority of the affected population were married, living in urban areas, educated ,belonged to lower class. Highest proportion was constituted by housewives and students .Organophosphorous poisoning was the most common poisoning reported followed by benzodiazepines and rat killer in thestudy.The overall mortality rate in the study was 10.53%.Mortality was highest when the subjects were presented beyond 6 hours. Among the type of poisons OPC poisoning had highest mortality.

Extracorporeal Septoplasty for anterior septal deviation and deviated nose

Background: Deviated nose and septum is challenging, which results in functional and cosmetic problems. It blocks the nose and makes person ugly. The classical septoplasty approach becomes unsuitable for such severe deviations. Extracorporeal septoplasty is a surgical technique for correcting a severely deviated nasal septum, which also corrects the aesthetic part of the nose. The objective of this study was to describe extracorporeal septoplasty for Deviated nose and anterior septal deviation.&#x0D; Methods: A prospective observational outcome study was done in patients with Deviated nose and anterior septal deviation who underwent extracorporeal septorhinoplasty. Preoperative and postoperative evaluation was performed using a photographs, computerized tomography (CT) scan, and Nasal obstruction symptoms evaluation scale.&#x0D; Results: A total of 38 consecutive patients were enrolled, out of which majority were male (24, 63.2%) with only 14 (36.8%) female. The ratio of male female was 1.7:1. All the subjects had deviated nasal septum. Among these, nose deviation was externally noticeable in 20 (52.6%) cases, whereas in remaining cases it was inconspicuous. There were 21(55.3%) patients where Nasal Septum was deviated to the right side followed by 17(44.7%) with left side deviation. There was a significant improvement in mean nasal obstruction symptoms evaluation postoperatively (71.2 versus 22.7 with p value equal to 0.01). According to the pre and postoperative photographs 17(44.7%) patients had good improvement, nine (23.6%) showed excellent improvement and the result was fair in six (15.7%) patients.&#x0D; Conclusions: Extracorporeal septoplasty is effective in improving both nasal airway function and aesthetics in patients with severe Nasal Septal deviation.

Peritoneal dialysis in critically ill children in resource-limited setting: A prospective cohort study.

Peritoneal dialysis (PD) is easily available and simple lifesaving procedure in children with renal impairment. There is paucity of reports on efficacy of PD in critically ill children in presence of shock and those requiring mechanical ventilation. In this prospective observational study, efficacy and outcome of PD were evaluated in 50 critically ill children aged 1 month to 14 years admitted in pediatric intensive care unit of a tertiary care teaching hospital in India. Indication of PD was acute kidney injury (AKI) in 66% of patients followed by chronic kidney disease with acute deterioration due to infectious complications in 34%. Bacterial sepsis was the most common cause of AKI (22%), others being malaria (14%) and severe dengue (12%). At initiation of PD, 26% of patients were in shock and 46% were mechanically ventilated. PD was effective and improvement in pH, bicarbonate, and lactate started within hours, with consistent improvement in estimated glomerular filtration rate by 24 h, which continued till the end of procedure, including the subgroup of patients with shock and mechanical ventilation. Total complications were seen in 14% and of which peritonitis was present in 4.0% of patients. Mortality was seen in 14% (7/50) of patients. Shock at initiation of PD (odds ratio (OR), 5.03; 95% confidence interval (CI), 0.95-26.69; p < 0.04) and requirement of mechanical ventilation (OR, 9.17; 95% CI, 1.01-83.10; p < 0.02) were associated with mortality. Acute PD in critically ill children with renal impairment is a lifesaving procedure. Treatment of shock with resuscitative measures and respiratory failure with mechanical ventilation, along with PD, resulted in favorable renal outcome.

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients

PurposeTo assess the temporary health impact of prostate multiparametric MRI (mpMRI) and transrectal prostate biopsy in an active surveillance prostate cancer population. MethodsA two-arm institutional review board–approved HIPAA-compliant prospective observational patient-reported outcomes study was performed from November 2017 to July 2018. Inclusion criteria were men with Gleason 6 prostate cancer in active surveillance undergoing either prostate mpMRI or transrectal prostate biopsy. A survey instrument was constructed using validated metrics in consultation with the local patient- and family-centered care organization. Study subjects were recruited at the time of diagnostic testing and completed the instrument by phone 24 to 72 hours after testing. The primary outcome measure was summary testing-related quality of life (summary utility score), derived from the testing morbidities index (TMI) (scale: 0 = death and 1 = perfect health). TMI is stratified into seven domains, with each domain scored from 1 (no health impact) to 5 (extreme health impact). Testing-related quality-of-life measures in the two cohorts were compared with Mann-Whitney U test. ResultsIn all, 122 subjects were recruited, and 90% (110 of 122 [MRI 55 of 60, biopsy 55 of 62]) successfully completed the survey instrument. The temporary quality-of-life impact of transrectal biopsy was significantly greater than that of prostate mpMRI (0.82, 95% confidence interval [CI] 0.79-0.85, versus 0.95, 95% CI 0.94-0.97; P < .001). The largest mean domain-level difference was for intraprocedural pain (transrectal biopsy 2.6, 95% CI 2.4-2.8, versus mpMRI 1.3, 95% CI 1.1-1.5; P < .001). ConclusionTransrectal prostate biopsy has greater temporary health impact (lower testing-related quality-of-life measure) than prostate mpMRI.

Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study

BackgroundAdrenomedullin (ADM) regulates vascular tone and endothelial permeability during sepsis. Levels of circulating biologically active ADM (bio-ADM) show an inverse relationship with blood pressure and a direct relationship with vasopressor requirement. In the present prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock 1 (, AdrenOSS-1) study, we assessed relationships between circulating bio-ADM during the initial intensive care unit (ICU) stay and short-term outcome in order to eventually design a biomarker-guided randomized controlled trial.MethodsAdrenOSS-1 was a prospective observational multinational study. The primary outcome was 28-day mortality. Secondary outcomes included organ failure as defined by Sequential Organ Failure Assessment (SOFA) score, organ support with focus on vasopressor/inotropic use, and need for renal replacement therapy. AdrenOSS-1 included 583 patients admitted to the ICU with sepsis or septic shock.ResultsCirculating bio-ADM levels were measured upon admission and at day 2. Median bio-ADM concentration upon admission was 80.5 pg/ml [IQR 41.5–148.1 pg/ml]. Initial SOFA score was 7 [IQR 5–10], and 28-day mortality was 22%. We found marked associations between bio-ADM upon admission and 28-day mortality (unadjusted standardized HR 2.3 [CI 1.9–2.9]; adjusted HR 1.6 [CI 1.1–2.5]) and between bio-ADM levels and SOFA score (p < 0.0001). Need of vasopressor/inotrope, renal replacement therapy, and positive fluid balance were more prevalent in patients with a bio-ADM > 70 pg/ml upon admission than in those with bio-ADM ≤ 70 pg/ml. In patients with bio-ADM > 70 pg/ml upon admission, decrease in bio-ADM below 70 pg/ml at day 2 was associated with recovery of organ function at day 7 and better 28-day outcome (9.5% mortality). By contrast, persistently elevated bio-ADM at day 2 was associated with prolonged organ dysfunction and high 28-day mortality (38.1% mortality, HR 4.9, 95% CI 2.5–9.8).ConclusionsAdrenOSS-1 shows that early levels and rapid changes in bio-ADM estimate short-term outcome in sepsis and septic shock. These data are the backbone of the design of the biomarker-guided AdrenOSS-2 trial.Trial registrationClinicalTrials.gov, NCT02393781. Registered on March 19, 2015.

Intravenous Thrombolysis Prior to Mechanical Thrombectomy in Acute Ischemic Stroke: Silver Bullet or Useless Bystander?

Background and PurposeRecent single-center series and meta-analyses suggest that mechanical thrombectomy (MT) without prior intravenous thrombolysis (IVT) might be equally effective to bridging therapy. We analyzed, within the Endovascular Treatment in Ischemic Stroke (ETIS) prospective observational registry, the angiographic and clinical outcomes after IVT+MT versus MT alone. MethodsFrom December 2012 to December 2016, a total of 1,507 consecutive patients with a proximal arterial occlusion of the anterior circulation were treated by MT. Of these, 975 (64.7%) received prior IVT. Immediate angiographic and clinical outcomes at 90 days (modified Rankin Scale [mRS]) were compared between the two groups while checking for propensity score, matched-propensity score and by inverse probability of treatment weighting (IPTW) propensity score method. ResultsFavorable outcome (mRS 0 to 2) was more frequently achieved after IVT+MT (n=523, 53.6%) than after MT alone (n=222, 41.8%) with an unadjusted odds ratio (OR) for bridging therapy of 1.61 (95% confidence interval [CI], 1. 29 to 2.01). This difference remained not significant in matched-propensity score cohort (OR, 1.21; 95% CI, 0.90 to 1.63) although it remained according to adjusted propensity score (OR, 1.31; 95% CI, 1.02 to 1.68) and IPTW (OR, 1.37; 95% CI, 1.09 to 1.73) analyses. A significant difference was found in terms of excellent outcome (mRS 0 to 1) (adjusted OR, 1.63; 95% CI, 1.25 to 2.11) and successful reperfusion (adjusted OR, 1.58; 95% CI, 1.33 to 2.15). No differences in intracerebral hemorrhage or in allcause mortality within 90 days were found between groups. ConclusionsIVT prior to MT is associated with increased excellent outcome and successful reperfusion rates. These findings support the use of bridging therapy.

Do FSH/LH ratio and gonadal hormone levels predict clinical improvement in postmenopausal schizophrenia women?

Menopause is a process characterized by a decline in estrogen levels and is therefore a period of biological vulnerability for psychotic relapse in women with schizophrenia. Our goal was to correlate not only gonadal hormone levels but also follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels with improvement in specific clinical symptoms. Thirty-seven acutely ill postmenopausal schizophrenia women with a newly initiated, clinically determined change in antipsychotic medication participated in a 12-week prospective observational outcome study. Scales used were the PANSS scale for psychotic symptoms, the PSP for functioning, and CGI for global clinical impression. Circulating FSH, LH, estradiol, progesterone, and testosterone serum levels were determined by chemiluminescent immunoassay. Partial correlational analyses were performed along with a Bonferroni significance correction (p<0.0007). After adjustment for confounding factors, the FSH/LH ratio correlated positively with mean changes in PANSS positive scores, and there was a correlation with worsening of CGI total and cognitive scores. Testosterone was also positively associated with improvement in PANSS positive scores. However, after correction for multiple testing, the initial correlations were no longer statistically significant. In summary, while the hormone assays we did in this small sample did not prove to be significantly linked to clinical improvement in any of the schizophrenia symptom domains, we recommend further investigation of pituitary, adrenal, and gonadal hormone ratios as potential markers of clinical improvement in this population.

Efficacy of a 4-Food Elimination Diet for Children With Eosinophilic Esophagitis

A 6-food elimination diet induces remission in most children and adults with eosinophilic esophagitis (EoE). The effectiveness of empiric elimination of only 4 foods has not been studied in children. We performed a prospective observational outcome study in children with EoE treated with dietary exclusion of cow's milk, wheat, egg, and soy. The objective was to assess the clinical, endoscopic, and histologic efficacy of this treatment in EoE. We recruited children (1-18 years old, diagnosed per consensus guidelines) from 4 medical centers. Study participants (n= 78) were given a proton pump inhibitor twice daily and underwent a baseline esophagogastroduodenoscopy. Subjects were instructed on dietary exclusion of cow's milk, wheat, egg, and soy. Clinical, endoscopic, and histologic assessments were made after 8 weeks. Responders had single foods reintroduced for 8 weeks, with repeat endoscopy to assess for recurrence of active disease. The primary endpoint was histologic remission (fewer than 15 eosinophils per high-powered field). Secondary endpoints included symptom and endoscopic improvements and identification of foods associated with active histologic disease. After 8 weeks on 4-food elimination diet, 50 subjects were in histologic remission (64%). The subjects' mean baseline clinical symptoms score was 4.5, which decreased to 2.3 after 8 weeks of 4-food elimination diet (P < .001). The mean endoscopic baseline score was 2.1, which decreased to 1.3 (P < .001). After food reintroduction, the most common food triggers that induced histologic inflammation were cow's milk (85%), egg (35%), wheat (33%), and soy (19%). One food trigger that induced recurrence of esophageal inflammation was identified in 62% of patients and cow's milk-induced EoE was present in 88% of these patients. In a prospective study of children with EoE, 8 weeks of 4-food elimination diet induced clinical, endoscopic, and histologic remission in more than 60% of children with EoE. Although less restrictive than 6-food elimination diet, 4-food elimination diet was nearly as effective, and can be recommended as a treatment for children with EoE.

Patient Uptake and Outcomes

INTRODUCTION: In-hospital placement of long-acting reversible contraception (LARC) is increasingly popular after vaginal and cesarean delivery and responds to maternal motivation for highly effective postpartum contraception. The present study assessed in-hospital provision and expulsion of immediate postpartum copper T380 IUD (Cu IUD), levonorgestrel (LNG) IUDs, and contraceptive implants. METHODS: Women presenting to the University of Utah Labor and Delivery Unit between October 2013 and March 2015 who requested an IUD or implant were offered enrollment in this prospective observational trial. Eligible patients received devices through the Ryan Residency Training LARC program. Data on expulsions and discontinuations at 3 months was obtained via patient report and supplemented with chart abstraction. Predictors of IUD expulsion were assessed. RESULTS: During the study period, 404 patients requested a postpartum IUD or implant during prenatal care and 358 devices were placed (88% uptake) prior to discharge from the hospital. A total of 246 women enrolled in the prospective observational outcome study: 73 (30%) Cu IUD users, 93 (38%) LNG IUD users, and 80 (33%) implant users. To date, 85% (n=209) have reached 3 months postpartum and 89% (n=185) have completed follow-up. Three months postpartum, 15/67 (22%) of the LNG IUD users and 3/60 (5%) of the Cu IUD users had an expulsion (P<.01). Among LNG IUD users, primiparity and vaginal delivery were predictors of expulsion (P<.05). CONCLUSION: Immediate postpartum LNG IUD users have higher expulsion rates than Cu IUD users. LNG IUD expulsion rates are highest for primiparous women having a vaginal delivery.

Hemodialysis delivery, dialysis dose achievement, and vascular access types in hemodialysis patients from the Gulf Cooperation Council countries enrolled in the dialysis outcomes and practice patterns study phase 5 (2012-2015).

The prospective observational Dialysis Outcomes and Practice Patterns Study (DOPPS) was initiated in late 2012 in national samples of hemodialysis (HD) units (n = 41 study sites) in all six Gulf Cooperation Council (GCC) countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates). For many years, guidelines have recommended single pool Kt/V ≥1.2 as the minimum adequate dose for chronic HD patients. Here, we report initial DOPPS results regarding HD practices related to dialysis dose achievement in the GCC. A total of 928 adult HD patients were included in this analysis from 41 centers representing all six GCC countries. Baseline descriptive statistics (e.g., mean, standard deviation, median, interquartile range, or percentage) were calculated for the study sample. Results were weighted according to the fraction of HD patients sampled within each participating study site. Mean age varied between 51 years in Bahrain, Oman, and Saudi Arabia, 55 years in the United Arab Emirates (UAE) and Kuwait, and 62 years in Qatar. Mean body mass index (BMI) was the lowest in Oman patients (23.9 kg/m 2 , but the remaining GCC countries had mean BMIs of 25.7-28.9 kg/m 2 and substantial fractions of overweight patients. Median dialysis vintage ranged from 1.52 years in Kuwait to 3.52 years in Oman. Mean treatment time per session varied from 202 min in Saudi Arabia to 230 min in Qatar while mean blood flow rate (BFR) ranged between 267 mL/min in Oman and 310 mL/min in Saudi Arabia. Interdialytic weight gain varied considerably among GCC countries between 3.1 and 4.0 kg. Central venous catheter use was high among GCC countries, ranging from 29% in Oman to 56% in Kuwait, with other countries averaging 30-40% catheter use. Data were available only for 50-76% of patients in four GCC countries (Kuwait, Qatar, Saudi Arabia, and UAE) for calculating single pool Kt/V to indicate dialysis adequacy. When calculated for patients with vintage >1 year and dialyzing three times per week, mean single pool Kt/V was highest in Qatar and the UAE (1.50-1.51), intermediate in Kuwait (1.35), and lowest in Saudi Arabia (1.29). A higher risk of mortality was observed for patients having a single pool Kt/V <1.2 (vs. ≥1.2) [hazard ratio (HR) = 1.71, 95% confidence interval [CI]: 1.01-2.92]. Achievement of Kt/V in the GCC, although lower than in other DOPPS regions such as Europe/ANZ and North America, was similar to that in Japan. Japan and the GCC also share the practice of having a lower blood volume filtered per HD session per kg body weight. These findings suggest that increasing mean BFR and treatment time in the GCC, along with reducing catheter use, would substantially increase overall achievement of Kt/V >1.2 in the GCC, and hence, may improve survival. These mortality findings will need to be confirmed with up-coming GCC-DOPPS 6 analysis.

Evaluation of Improvement in Nasal Obstruction Following Nasal Valve Correction in Patients With a History of Failed Septoplasty.

Patients with a septal deviation and concerns about nasal obstruction often undergo septoplasty to improve nasal airflow. Following primary septoplasty, however, some patients have persistent symptoms due to nasal valve dysfunction and may require nasal valve surgery. To evaluate the change in disease-specific quality of life for patients who undergo nasal valve correction after failed septoplasty using the Nasal Obstruction Symptom Evaluation (NOSE) survey and to determine whether identifiable anatomical risk factors are more common in patients with a history of failed septoplasty. Prospective observational outcomes study conducted at a tertiary care medical center. Forty patients who underwent nasal valve correction through an open approach from January 1, 2012, through December 31, 2014, with a history of septoplasty for nasal obstruction were included. Data analysis was conducted from January 1, 2013, through May 1, 2015. [corrected]. Demographic information, a standardized nasal examination, and preoperative and postoperative NOSE scores were collected and reviewed. Comparison between preoperative and postoperative NOSE scores at 2, 4, and more than 6 months after surgery. Forty patients were included in the study; 23 (57%) were male and 17 (43%) were female. The mean age was 39.3 years. Findings from preoperative nasal examination demonstrated moderate or severe internal nasal valve narrowing in 38 (95%) patients, internal nasal valve collapse in 19 (48%), external nasal valve narrowing in 18 (45%), or external nasal valve collapse in 16 (40%). The most common anatomical cause of obstruction was internal nasal valve narrowing in 38 (95%) patients, dorsal septum deflection in 26 (65%), and narrowed middle vault in 16 (40%). The mean (SD) preoperative NOSE score was 75.7 (20.1). Mean (SD) postoperative NOSE scores at 2, 4, and greater than 6 months were 31.4 (27.2), 34.0 (19.8), and 22.1 (18.8), respectively, with significantly improved NOSE scores at each time point compared with before surgery (P < .001). Nasal valve dysfunction remains an underdiagnosed entity and should be considered in all patients with septal deviation before septoplasty, especially in patients with a severe dorsal deflection and a narrow middle vault. In this study, surgical nasal valve correction demonstrated a significant reduction in nasal obstruction, as measured by a validated outcome measure, in patients for whom a previous septoplasty had failed. 4.

Noise Exposure in the Neonatal Intensive Care Unit: A Prospective Study

Objectives: 1) Describe the sound pressure levels experienced by premature infants in a neonatal intensive care unit (NICU) over an entire admission, compared to neonatal standards for sound exposure by the American Academy of Pediatrics (AAP) and Journal of Perinatology (JP), as well as adult standards by the National Institute for Occupational Safety and Health. 2) Determine whether this population may be at higher risk for noise-induced hearing loss. Methods: Prospective observational outcomes study from August 2012- present. Condition Studied: noise-induced hearing loss. Subjects: Admissions to the NICU, &lt;37 weeks gestational age. Outcome Measurements: Sound pressure levels/cumulative sound exposure dosage. Independent Variables: bed type, location, number of patients per room, machine therapies. Preliminary Analyses: This dataset represents preliminary data from an ongoing study with a target enrollment of 150 over 12 months. Results: The average sound pressure level per admission ranged from 57.4 to 67.8 dBA. Neonates in enclosed beds experienced a trend toward higher decibel levels than those in open beds. Neonates on machines such as ventilators, continuous positive airway pressure (CPAP), or phototherapy were found to experience higher decibel levels. Conclusions: All infants received sound exposures that substantially exceeded AAP and JP guidelines of &lt;45 dBA and &lt;50 dBA for the NICU. Reducing NICU decibel levels should concentrate on bed design, individual alarm noise, and staff education regarding the sources and consequences of sound exposure. Newborn hearing screening protocols should consider additional testing to determine the risk of noise-induced hearing loss.

Differences in DPOAE and AABR in Noise‐Exposed Infants in the Neonatal Intensive Care Unit

Objectives: 1) Describe the differences in distortion product otoacoustic emissions (DPOAE) and automated auditory brainstem response (AABR) results in premature infants in the neonatal intensive care unit (NICU) with noise exposure. 2) Discuss optimal newborn hearing screen protocols for capturing at-risk NICU graduates. Methods: Prospective observational outcomes study from August to the present. Subjects: Admissions to the NICU, &lt;37 weeks gestational age. Setting: NICU. Outcome Measurements: DPOAE, AABR, and follow-up audiometry collected by the Oregon Early Hearing Detection and Intervention (EHDI) program. Independent variables: Sound pressure levels and cumulative sound dosage. Preliminary analyses: This dataset represents preliminary data from an ongoing study with a target enrollment of 150 over 12 months. Results: The average sound pressure level per individual admission ranged from 57.4 to 67.8 dBA. DPOAE demonstrated a greater rate of abnormalities in the high frequency range of 4000-10000 Hz (40-45%) compared to lower frequencies (10-15%). AABR generated only a 5% rate of referrals; however, 50% of DPOAEs obtained showed abnormal results in at least 2/3 of the high frequencies tested. Conclusions: All infants received sound exposures that substantially exceeded AAP guidelines. More abnormalities were found on DPOAE than AABR, with a significantly higher rate in the high frequencies compared to lower frequencies, consistent with possible noise-induced cochlear dysfunction. Neonatal intensive care units should consider adding DPOAE to their hearing screen protocols so that infants at risk for noise-induced hearing loss are not missed.

Outcome of Surgical Treatment of 200 Children With Cushing's Disease

Factors influencing the outcome of surgical treatment of pediatric Cushing's disease (CD) have not been fully established. The aim of this study was to examine features influencing the outcome of surgery for pediatric CD. In this prospective observational study, the clinical, imaging, endocrinological, and operative outcomes were analyzed in consecutive patients treated at the National Institutes of Health (NIH) from 1982 through 2010. The study was conducted in a tertiary referral center. Two hundred CD patients (106 females, 94 males) were included. Mean age at symptom development was 10.6 ± 3.6 years (range, 4.0 to 19.0 y). Mean age at NIH operation was 13.7 ± 3.7 years. Twenty-seven patients (13%) had prior surgery at another institution. Magnetic resonance imaging identified adenomas in 97 patients (50%). When positive, magnetic resonance imaging accurately defined a discrete adenoma in 96 of the 97 patients (99%), which was more accurate than the use of ACTH ratios during inferior petrosal sinus sampling to determine adenoma lateralization (accurate in 72% of patients without prior surgery). A total of 195 of the 200 patients (98%) achieved remission after surgery (189 [97%] were hypocortisolemic; 6 [3%] were eucortisolemic postoperatively). Factors associated with initial remission (P < .05) included identification of an adenoma at surgery, immunohistochemical ACTH-producing adenoma, and noninvasive ACTH adenoma. Younger age, smaller adenoma, and absence of cavernous sinus wall or other dural invasion were associated with long-term remission (P < .05). A minimum morning serum cortisol of less than 1 μg/dl after surgery had a positive predictive value for lasting remission of 96%. With rare disorders, such as pediatric CD, enhanced outcomes are obtained by evaluation and treatment at centers with substantial experience. Resection of pituitary adenomas in pediatric CD in that setting can be safe, effective, and durable. Early postoperative endocrine testing predicts lasting remission. Because lasting remission is associated with younger age at surgery, smaller adenomas, and lack of dural invasion, early diagnosis should improve surgical outcome.

Clinical Outcomes Analysis of Conservative and Surgical Treatment of Patients With Clinical Indications of Prearthritic, Intra-articular Hip Disorders

To describe outcomes of the conservative treatment of patients who had the clinical presentation of a prearthritic, intra-articular hip disorder, including acetabular labral tears, developmental hip dysplasia, and femoroacetabular impingement. Prospective observational clinical outcomes study. Outpatient orthopedic clinic at a tertiary university hospital. Patients presenting with prearthritic, intra-articular hip disorders were recruited. Fifty-eight consecutive patients were enrolled; 6 were lost to follow-up, and 52 subjects completed the study. Patients were recruited on the basis of symptoms, distribution of pain, and the findings of a physical examination. Radiographic measurements of the hip were obtained for all subjects to describe the presence or absence and extent of deformity and/or osteoarthritis. All subjects completed a directed course of conservative treatment. After 3 months of conservative care, subjects with continued limitations, reduction of symptoms with a diagnostic intra-articular hip injection, and a surgically amenable lesion found on a magnetic resonance arthrogram proceeded to surgery. Numeric Pain Score (0-10), Short Form-12, Modified Harris Hip Score, Western Ontario and McMaster Universities Osteoarthritis Index, Nonarthritic Hip Score, Baecke Questionnaire of Habitual Activity, and patient choice to have surgery. Fifty-eight patients (9 men and 49 women) with a mean age of 35 ± 11 years (range, 18-50 years) enrolled in the study. Fifty-two subjects completed the study. Twenty-three subjects (44%) reported satisfaction with conservative care. Twenty-nine subjects (56%) chose to have surgery. Both groups demonstrated equally significant improvement (P value ranges: P = .03 to P = .0001) in all outcome measures from baseline to 1-year follow-up. Subjects who chose surgery had higher baseline activity scores compared with the conservative treatment group (P = .02). All subjects with signs and symptoms of prearthritic, intra-articular hip disorders who were treated with conservative treatment alone and with conservative treatment followed by surgery demonstrated significant improvement in pain and functioning from baseline to 1 year. Forty-four percent of patients improved with conservative care alone, and 56% chose to have surgery after receiving conservative care. Persons with more active lifestyles were more likely to choose surgery. These data suggest that a trial of conservative management for persons with prearthritic, intra-articular hip disorders should be considered before engaging in surgical intervention.