Results Of Prospective Observational Study Research Articles

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.

Acute Gvhd Diagnosis and Adjudication in a Multicenter Trial – a Report from the BMT CTN 1202 Biorepository Study

Accurate and reproducible methods to diagnose, grade and report acute graft vs. host disease (GVHD) are critical for evaluation of new treatments and biomarkers. BMTCTN 1202 created a biorepository and clinical data bank for the study of GVHD biomarkers and other transplant outcomes. To create a representative study population any pt >10 kg undergoing alloHCT was eligible (Table 1). Symptoms suggestive of GVHD, biopsy results, immunosuppressive medications, and possible etiologies were reported weekly until day 100. An end-point review committee (ERC) performed a near real time adjudication of reported symptoms at their onset and assigned a confidence level (Confirmed, Probable, Possible or Negative) for each organ according to Harris, BBMT, 2016. The final repository included 41,468 annotated biospecimens from 1709 alloHCT patients (pts) transplanted at U.S. centers from 2012-2016. Although 90% of pts developed symptoms at least once, physicians suspected GVHD in only 23% of cases and GVHD was considered the only etiology in 12%. Biopsies (bx) were performed in 40% of pts, most often for upper or lower GI symptoms. Bx results were equivocal in 11% although the range among centers was broad (0-45%). Equivocal results were most likely for skin bx and during the 2nd week after transplant. Systemic steroids were administered to 70% of pts at least once, often for non-GVHD reasons (41% of steroid courses). When GVHD was in the differential diagnosis, systemic steroids were started 81% of the time. The ERC adjudicated 2,008 cases with symptoms suggestive of GVHD onset. In 12.3% of cases the ERC modified either the center reported diagnosis of GVHD (4.6%) or the automated generated severity grade (7.7%). GVHD was diagnosed in 1025 pts and categorized as confirmed (31%), probable (50%), or possible (19%). The proportion of definitive diagnoses (Confirmed or Negative) increased with longer time post-transplant (Fig 1). ERC adjudication substantially lowered the incidence of GVHD grade 2-4 from 30% as reported by centers to 23% (confirmed or probable) by ERC. An adjudicated diagnosis of GVHD strongly associated with 6 month NRM, adjusted for patient age, gender and HLA matching (HR = 2.0, p In summary, the largest prospective observational study of GVHD outcomes demonstrated that symptoms in GVHD target organs are almost universal after transplant, their differential diagnosis is broad, tissue biopsies are infrequently done and their results are often equivocal, and steroids are often prescribed for reasons other than acute GVHD. These limitations undermine the current methods of diagnosis and reporting of acute GVHD on clinical trials. A robust reporting and adjudication system has significant value and may improve the chances of success of prospective clinical trials.

Venous thromboembolism in the critically ill: A prospective observational study of occurrence, risk factors and outcome.

The aim of the study was to explore occurrence, risk factors and outcome of venous thromboembolism (VTE) in intensive care unit (ICU) patients. Prospective observational study of ICU patients receiving thromboprophylaxis at Oslo University Hospital in Norway. Adult medical and surgical patients with ICU length of stay (LOS) longer than 48hours were included. For detection of VTE, Doppler ultrasound screening of neck, upper and lower extremity veins was used, and computed tomography angiography when clinically indicated for any medical reason. Among 70 included patients, 79% were males and mean age was 62 (±12.1) years. All received thromboprophylaxis with dalteparin, and 44 (63%) used graduated compression stockings. VTE was found in 19 (27%) patients; deep vein thrombosis in 15 (21%) and pulmonary embolism in 4 (6%). Among the VTEs, 11 (58%) presented within the first 48hours after admission, two (11%) were located in the lower limbs and five (26%) were symptomatic. Risk factors for VTE in multivariable analyses were malignancy, abdominal surgery and SAPS II score <41 with an AuROC (95% CI) of 0.72 (0.58-0.85, P=0.01). Patients with and without VTE had comparable ICU LOS (13 vs 11days, P=0.27) and mortality (16% vs 20%, P=0.72). Venous thromboembolism was observed in 27% of ICU patients receiving thromboprophylaxis. Factors associated with increased risk of VTE were malignancy, abdominal surgery and SAPS II score <41. Presence of VTE did not impact on patient outcome.

Intermediate Results of Prospective Observational Study: The 2-year Experience of Ibrutinib Therapy in Relapsed/Refractory Mantle Cell Lymphoma in Clinical Practice

Aim. To assess efficacy and toxicity of ibrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL). Materials &amp; Methods. In this group of patients ibrutinib has been used since April 2016. Ibrutinib administration criteria were the age &gt; 18 years and the confirmed MCL diagnosis with nuclear hyperexpression of cyclin D1 and t(11;14) (q13;q32) translocation. Poor physical status, pancytopenia, infectious complications (except for life-threatening conditions), blastoid variant, and the number of previous treatment lines were not regarded as contraindications to ibrutinib therapy. Oral ibrutinib was administered once a day at a dose of 560 mg before progression and until intolerable toxicity was observed. Results. From April 20, 2016 to April 6, 2018 ibrutinib therapy was provided to 42 patients with relapsed/refractory MCL. The median age was 69 years (range 40-81); 64 % of patients were men; ECOG &gt; 2 was registered in 14 % of patients; 38 % of patients had blastoid variant; the median number of previous treatment lines was 2 (range 1-11). The overall response rate was 85 % (35 % were in complete remission); 57 % (24/42) of patients remain on ibrutinib treatment for the period of 4-667 days. The median event-free survival (EFS) was 365 days (95% confidence interval was 31-698 days). The median overall survival was not achieved. In blastoid variant the median EFS was 92 days, in the alternative group the median was not achieved and EFS was 76 % for 12 months (p &lt; 0.001). In the majority of cases ibrutinib was well tolerated by patients. The most common complications were myalgia and muscle cramps (57 % cases), diarrhea (46 %, and grade 3 in 5 % cases), hemorrhagic complications (63 %, all of them of grade 1-2), and arrhythmia (7 %). Infectious complications were reported in 31 % of patients. In one case the start of ibrutinib treatment appeared to be problematic due to neutropenia of grade 4. Relative dose intensity was &gt; 98 % (range 91.6-100 %). In 10 (24 %) patients ibrutinib treatment had to be adjusted (dose reduction or treatment interruption) due to toxicity and planned surgeries. None of ibrutinib recipients had to completely discontinue ibrutinib therapy due to complications. Conclusion. These data on the use of ibrutinib in actual clinical practice are comparable with the results of international multicenter studies (PCYC-1104, SPARK, and RAY). Reduced toxicity profile and rather high speed of antitumor response allow for ibrutinib administration in cases of poor physical status, low blood count, and even infectious complications. However, some adverse effects are manifested not earlier than after 6-month treatment, which calls for continuous monitoring, especially when preparing for surgeries.

356P - A prospective observational study of mobile application-based patient-reported outcomes (PRO) in advanced breast cancer: Interim baseline data from the MADELINE study

356P - A prospective observational study of mobile application-based patient-reported outcomes (PRO) in advanced breast cancer: Interim baseline data from the MADELINE study

Assessing the long-term effectiveness of interferon-beta and glatiramer acetate in multiple sclerosis: final 10-year results from the UK multiple sclerosis risk-sharing scheme

BackgroundBecause multiple sclerosis (MS) is a chronic disease causing disability over decades, it is crucial to know if the short-term effects of disease-modifying therapies reported in randomised controlled trials reduce...

Wednesday, September 26, 2018 3:35 PM – 5:05 PM Preserving Spinal Motion: 88. Cervical artificial disc replacement with Prodisc-C: 10-year clinical and radiographic results of prospective observational study in a single institute

BACKGROUND CONTEXT Cervical artificial disc replacement (ADR) is indicated for the treatment of severe radiculopathy permitting neural decompression and maintenance of motion. Previous reports of short and mid-term results have shown that cervical ADR using Prodisc-C is safe and effective in symptomatic CDD between C3 and C7 PURPOSE The objective of this study is to evaluate long-term clinical and radiologic results of ADR using the Prodisc-C in patients with single-level cervical disc disease (CDD) in minimum 10-year follow-up. STUDY DESIGN/SETTING This study is a retrosepctive observational analyisis of prespective registry. PATIENT SAMPLE Data were collected through a prospective registry, with retrospective analysis performed on 79 consecutive patients treated with cervical ADR with the Prodisc-C device (DePuy Synthes, West Chester, PA, USA) in a single institution. OUTCOME MEASURES Clinical outcome measures included visual analog scale (VAS) for neck and arm pain and Owestry Disability Index (ODI). Serial flexion-extension cervical radiographs and CT scans were performed to assess range of motion (ROM) of index segment, adjacent segment degenerations (ASD), implant-related complications (migration, subsidence, lucency) and heterotopic ossification (HO) using McAfee classification system. METHODS All enrollees were evaluated pre- and postoperatively at regular intervals using both clinical and radiologic parameters. RESULTS Out of 79 patients enrolled, 79.7% (63/79) continued regular outpatient visits at the 5-year follow-up period. However, after 10 years, only 22.9% (17/71) of patients remained with the study. Average follow-up was 10.7 years. After 5-year follow-up, neck and arm pain improved 68.6% and 86.8%, respectively, and ODI had an improvement of 85.7%. However, after the last visit, neck pain improvement decreased to 29.7%, whereas arm pain and ODI remained at 74.6% and 68.9%, respectively. Neurologic success rate was 82.3% after final assessment. There were no episodes of device failure except one case of subsidence. Mean ROM of the device decreased from 6.7°at 5-year to 5.4°at final assessment. Radiographic ASD developed in 58.8% of patients (mild; 29.4%, moderate; 23.5%, severe; 5.8%, respectively) and 58.8% demonstrated HO at the final follow-up, however, only 17.6% were symptomatic requiring second surgery. CONCLUSIONS The Prodisc-C device for cervical ADR appears to be safe and effective for the treatment of CDD after long-term follow-up. Despite radiographic evidence of ASD and HO on final assessment, Prodisc-C ADR provided maintenance of segmental motion at the index level and good neurologic success rate. FDA DEVICE/DRUG STATUS Prodisc-C: FDA status unavailable from the author at press time.

Is Afamin a novel biomarker for gestational diabetes mellitus? A pilot study

BackgroundIn search of potential early biomarkers for timely prediction of gestational diabetes mellitus (GDM), we focused on afamin, a vitamin E–binding protein in human plasma.. Afamin plays a role in anti-apoptotic cellular processes related to oxidative stress and is associated with insulin resistance and other features of metabolic syndrome. During uncomplicated pregnancy its serum concentrations increase linearly. The aim of this study was to investigate the suitability of afamin as early marker for predicting GDM.MethodsIn a first-trimester cohort from a prospective observational study of adverse pregnancy outcomes we secondarily analyzed afamin concentrations in 59 patients diagnosed with GDM and 51 controls. Additionally, afamin concentrations were cross-sectionally examined in a mid-trimester cohort of 105 women and compared with results from a simultaneously performed oral glucose tolerance test (OGTT). Subgroup analysis comparing patients treated with either insulin (iGDM) or dietary intervention (dGDM) was performed in both cohorts. Patients were recruited at the University Hospital Essen, Germany, between 2003 and 2016.ResultsResults were adjusted for body-mass-index (BMI) and gestational age. First and mid-trimester cohorts yielded significantly elevated afamin concentrations in patients with pathological OGTT compared to patients without GDM (first trimester cohort: mean, 113.4 mg/l; 95% CI, 106.4–120.5 mg/l and 87.2 mg/l; 95% CI, 79.7–94.7 mg/l; mid-trimester cohort: mean, 182.9 mg/l; 95% CI, 169.6–196.2 mg/l and 157.3 mg/l; 95% CI, 149.1–165.4 mg/l, respectively). In the first-trimester cohort, patients developing iGDM later in pregnancy presented with significantly higher afamin concentrations compared to patients developing dGDM and compared to patients without GDM. In the mid-trimester cohort, mean concentrations of afamin differed significantly between patients with dGDM compared to controls and between patients with iGDM and controls. Patients with iGDM showed only slightly higher afamin levels compared to patients with dGDM.ConclusionAfamin may serve as a new early biomarker for pathological glucose metabolism during pregnancy. Further research is needed to determine afamin’s concentrations during pregnancy, its predictive value for early detection of pregnancies at high risk to develop GDM and its diagnostic role during the second trimester.

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.

A Single Center Prospective Observational Study of Outcomes With Tonic Cervical Spinal Cord Stimulation

Spinal cord stimulation (SCS) has been a valuable resource for the treatment of chronic, nonmalignant pain that persists in the face of maximal medical management. A recent study demonstrated efficacy of cervical SCS in a multicenter registry. Here, in our single center study, we are able to delve into patient specifics, explore outcomes with percutaneous vs. paddle implants, and examine impact of patient symptomatology. We prospectively collected data on subjects who underwent cervical SCS via numeric rating scale (NRS), McGill Pain Questionnaire, Oswestry Disability Index (ODI), and Beck Depression Inventory. Subjects completed this battery pre-operatively, at six months and at one year. Data were analyzed via repeated measures ANOVA, bivariate correlation analysis, and paired t-tests. In 30 consecutive subjects, 24 had a complete data set. The diagnosis was failed neck surgery syndrome (13%), Complex regional pain syndrome (29%), and neuropathic pain (58%). Compared with baseline, NRS score significantly improved at six months (p = 0.021) and one year (p = 0.047). ODI score also improved at one year (p = 0.009). At both six months and one year, subjects with percutaneous implants reported significantly less disability on ODI (p = 0.016 and 0.034, respectively), as compared with those who received paddle implants. There was no difference in NRS score or any other outcome measure based on type of implant. Diagnosis or region of pain did not correlate with any measure of outcome. We demonstrate that neck and arm pain can be improved with cervical SCS at six month and one-year follow-ups. Both percutaneous and paddle implants have benefit. We tend to place percutaneous implants for radicular pain and retrograde C1-2 paddles for axial pain that is ineffectively treated during the trial.

Devenir neurodéveloppemental des nouveau-nés issus de grossesses monochoriales compliquées avec interruption sélective par ablation par radiofréquence

ObjectiveTo describe perinatal data and to evaluate the neonatal neurological outcome of monochorionic twin pregnancies with selective termination by radiofrequency ablation. MethodsRetrospective data of perinatal data for nine consecutive monochorionic pregnancies eligible for radiofrequency ablation from January 2013 to August 2015 were collected. A prospective observational study of the neurological outcome of nine children was conducted using the Ages & Stages Questionnaire (ASQ), 2nd edition, French version, adapted to the age. ResultsThe radiofrequency procedures were performed at a mean gestational age (GA) of 21.4 weeks (±7 weeks). The indications for a selective interruption of a pregnancy were: acardiac twin (n=4), brain malformation (n=1), severe intrauterine growth restriction (IUGR) with massive cerebral ischemia in the context of twin-twin transfusion syndrome grade III (n=1), severe selective IUGR associated with a polymalformative syndrome (n=1) and severe selective IUGR (n=2). The mean GA at birth was 36.7 weeks GA (±3.8 weeks). No infant showed neurological neonatal morbidity. Any ASQ area explored was pathological (<−2SD) for the nine children (mean age at follow-up [±SD], 14.8 months [±8.8 months]). ConclusionThis work constitutes a preliminary study for developing long-term follow-up and early care programs for those children born subsequent to a radiofrequency ablation for selective reduction.

A prospective observational study of outcomes from rehabilitation of elderly patients with moderate to severe cognitive impairment

Objectives: To evaluate rehabilitation outcomes in patients with moderate to severe cognitive impairment. Design: Prospective observational cohort study. Setting: Rehabilitation unit for older people. Subjects: A total of 116 patients (70F) mean age (SD) 86.3 (6.4). Group 1: 89 patients with moderate cognitive impairment (Mini-Mental State Examination 11–20); and Group 2: 27 patients with severe cognitive impairment (Mini-Mental State Examination 0–10). Intervention: A personalised rehabilitation plan. Main measures: Barthel Activity of Daily Living score on admission and discharge, length of stay and discharge destination. Results: Of 116 patients, 64 (55.2%) showed an improvement in Barthel score. Mini-Mental State Examination was significantly higher in those who improved, 15.4 (SD 3.7) vs.13.2 (SD 5.1): p = 0.01. The mean Barthel score improved in both groups; Group 1 – 14.7 (SD 19.1) vs. Group 2 – 9.3 (SD 16.3): p = 0.17. Of 84 home admissions in Group 1, more patients returning home showed improvements of at least 5 points in the Barthel score compared with nursing/residential home discharges (32/37 – 86.5% vs. 10/28 – 35.7%: p = 0.0001). In Group 2 of 17 home admissions, 6/6 (100%) home discharges showed improvement compared with 3/7 (42.8%) discharges to nursing/residential home (p = 0.07). In Group 1, a discharge home was associated with significantly greater improvement in number of Barthel items than a nursing/residential home discharge (3.27 (SD 2.07) vs. 1.86 (SD 2.32): p = 0.007). A similar non-significant pattern was noted for severe cognitive impairment patients (3.5 (3.06) vs. 1.14 (1.06); p = 0.1). Conclusion: Patients with moderate to severe cognitive impairment demonstrated significant improvements in Barthel score and Barthel items showing that such patients can and do improve with rehabilitation.

PTU-022 Needleknife Assisted Cannulation in a UK Tertiary Referral Centre – Utilisation and Complications in Standard Practice

Introduction Needleknife assisted cannulation has been shown to be effective in ERCPs where standard techniques have failed. Concerns regarding risk of complication, particularly pancreatitis and perforation, have led to it being used only as a last resort. We evaluated the current practice and safety profile in a regional tertiary referral centre. Methods We performed a prospective observational study of ERCP outcomes in patients with intact ampullae. Experienced endoscopists with HPB expertise performed all ERCPs, and were asked to follow their standard practice. We used three ampulla classifications; non-prominent, prominent and distorted by tumour. The number of attempts at cannulation was recorded, as were the techniques used. Primary outcome measures were cannulation success and complication rates. Results Over a period of 8 months, 222 procedures were performed on patients who had not had previous ERCP. Successful cannulation in this group was achieved in 91.7%. Needleknife assisted cannulation was performed in 37 cases (17%). All needleknife cuts were started at the ampullary orifice. Needleknife use varied between different ampulla types (p = 0.44). Needleknife cannulation was most frequently attempted in ampullae involving tumour (33% attempted) but often unsuccessful (60% failure), compared to non-distorted (16.7% attempted, 22% failure rate). There was a wide range in the number of cannulation attempts made in both the needleknife and non needleknife groups (range 1–25) but there was a significant difference between the number of cannulation attempts in the standard cannulation and needleknife groups (p Conclusion Needleknife assisted cannulation is more likely to be used where the ampulla is involved with tumour and where ERCP is indicated for malignant disease. However, in this context, needleknife assisted cannulation is more likely to fail. Reassuringly despite being used after failed attempts at cannulation using standard techniques, the complication rate for needleknife-assisted cannulation is not statistically different. The likelihood of progression to needleknife use may be predicted by ERCP indication and ampullary characteristics. This may facilitate consideration of an early conversion to needleknife-assisted cannulation, but also early abandonment of procedure for alternative methods (percutaneous or surgical) in these groups. Disclosure of Interest None Declared

Chronic Kidney Disease and Health Status Outcomes Following Acute Myocardial Infarction.

BackgroundThe association between chronic kidney disease (CKD) and health status outcomes after acute myocardial infarction (AMI) is unknown.Methods and ResultsPatients were enrolled between 2005 and 2008 in the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) registry, a prospective multicenter observational study of AMI outcomes. The Seattle Angina Questionnaire and Short Form‐12 were collected at baseline and at 1, 6, and 12 months following AMI. CKD was defined by an estimated glomerular filtration rate <60 mL/min, calculated during the AMI hospitalization. Linear repeated‐measures models assessed the association between CKD and health status after AMI, accounting for the propensity to have follow‐up heath status measures. Of 3617 patients, 576 (16%) had CKD and 3041 (84%) did not have CKD. Patients with CKD were older and had more comorbidity. Patients with CKD were more likely to have multivessel coronary disease and less likely to undergo revascularization. Among AMI survivors, patients with and without CKD had similar health‐related quality of life (adjusted difference of 0.24, 95% CI −1.46 to 1.95), angina frequency (adjusted difference of 1.27, 95% CI −0.05 to 2.58), and mental health (adjusted difference of −0.07, 95% CI −0.90 to 0.75). In contrast, patients with CKD had lower physical health (adjusted difference −1.61, 95% CI −2.49 to −0.74), which was not clinically significant, compared with patients without CKD.ConclusionsAmong AMI survivors, patients with CKD not only had more comorbidities but also, after adjusting for these patient differences, had similar health status compared with patients without CKD. Interventions aimed at improving health status after AMI should not focus on CKD status.

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.

A prospective observational study of prevalence and outcomes of patients with Gold Standard Framework criteria in a tertiary regional Australian Hospital

ObjectivesReport the use of an objective tool, UK Gold Standards Framework (GSF) criteria, to describe the prevalence, recognition and outcomes of patients with palliative care needs in an Australian acute...

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.

Emergency Department Management of Atrial Fibrillation and Flutter and Patient Quality of Life at One Month Postvisit

We identify characteristics of patients with atrial fibrillation or flutter associated with favorable assessments of emergency department (ED) effectiveness and 30-day quality of life. As part of a prospective observational study of ED management and short-term outcomes of patients with nonvalvular atrial fibrillation or flutter, we adapted a disease-specific quality-of-life instrument. By telephone, we administered the Atrial Fibrillation Effect on Quality-of-life survey to patients 30 days after an ED visit in which they were treated for newly diagnosed or recent-onset atrial fibrillation or flutter and discharged home. We also asked respondents to rate the effectiveness of ED treatment. Using data prospectively collected in the ED and extracted from electronic health records, we recorded rhythm management (cardioversion attempts and type) and patient and ED treatment characteristics. Using multivariable regression, we examined the association between these characteristics and patient-reported effectiveness of ED treatment ("very effective" or not) and any atrial fibrillation or flutter quality-of-life effect. Six hundred fifty-two eligible ED patients (response rate 89%) treated between May 2011 and November 2012 completed follow-up. Of these patients, 454 (69.6%) reported that their ED treatment was "very effective" and 113 (17.3%) reported no quality-of-life influence. In multivariable analyses, there was an association between ED electrocardioversion and perceived ED effectiveness (P<.05) but none between treatment strategy and 30-day atrial fibrillation or flutter quality-of-life score. Respondents who were younger, women, and had worse pre-ED self-reported health (P<.05) were more likely to report a quality-of-life effect. In this observational study, ED rhythm management strategy was associated with greater perceived effectiveness of the ED visit but not with a difference in 30-day quality-of-life score.

Abstract OT3-2-03: Prospective observational study of clinical outcomes for the NanoString® technologies Prosigna™ test by the West German Study Group

Abstract Background: Current diagnostic tools for breast cancer (BC), including screening, diagnostic breast imaging and biopsy, do not provide information about subtype classification. However, the subtype classification is crucial for the assessment of the recurrence risk and for the choice of optimal adjuvant treatment. A vast amount of data from recent research, clinical trials, and peer reviewed publications support the value of intrinsic subtyping based on gene expression analyses to assess prognosis and treatment options for patients with early BC. Trial design: The multicenter (n=8), prospective study examines whether the Prosigna™ test influences physician and patient adjuvant treatment selection over and above currently used prognostic factors. It also examines the impact of the test results on patients’ reported outcomes including their decisional conflict status, anxiety levels, and functional status. Prosigna™ is a standardized test measuring the expression levels of 50 classifier genes in formalin-fixed, paraffin-embedded tissue samples and provides a subtype classification based on the fundamental biology of individual patient’s tumor (intrinsic subtyping), as well as a prognostic score (risk of recurrence (ROR) score) that predicts the probability of cancer recurrence over 10 years. Eligibility criteria: Postmenopausal women with resected N0, estrogen-receptor-positive (ER) (by immunohistochemistry (IHC); &amp;gt;1% of stained tumor cells is considered positive), HER2-negative (IHC and/or in-situ fluorescence hybridization by local laboratory), early-stage invasive BC (T1-T2, pN0 (i+/mol+), M0). Patients must be able to give consent and must be eligible for treatment with adjuvant chemotherapy (Ctx) (ECOG performance status ≤1). Patients with non-invasive (e.g. Paget’s disease, DCIS), ER-negative or HER2-positive BC must not be included. Metastatic disease and contraindications for adjuvant Ctx (age, ECOG &amp;gt;1, significant comorbidities) are exclusion criteria. Patients unable to complete patient reported outcome surveys will be excluded. Specific aims: Primary endpoint is the proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna™ result. Secondary endpoints include the proportion of patients whose choice of treatment is changed stratified by ROR groups (low, intermediate, high) and who have cancer recurrence risk proximal to the cutoff points between risk strata (± 5% from cutoff point). Investigators’ confidence in treatment recommendations before/after Prosigna™ results and change in patients’ decisional conflict status, anxiety levels, and functional status, stratified by cancer recurrence risk strata, will be investigated. Rate and severity of treatment-related adverse events stratified by whether patient received adjuvant Ctx and agreement in molecular subtyping between Prosigna™ and local IHC will be evaluated. Statistical methods: Sample size of 200 produces a one-sided 95% lower-limit CI with a distance from the sample proportion to the lower limit that is equal to 0.05 when the sample proportion is 0.25. Present and target accrual: A total of 200 patients will be included, current accrual is n=111 as of 3rd June 2014. Citation Format: Rachel Wuerstlein, Karl Sotlar, Burkhard Otremba, Oleg Gluz, Enrico Pelz, Daniel Hofmann, Ronald E Kates, Isabelle Witzel, Christian Schindlbeck, Wolfgang Janni, Christian Schem, Hans Tesch, Nadia Harbeck. Prospective observational study of clinical outcomes for the NanoString® technologies Prosigna™ test by the West German Study Group [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr OT3-2-03.