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Background and Aims: This post hoc analysis was performed as part of the multicenter, prospective observational trial NEO-ACQUA (NEOnatal Adequate Care for QUAlity of Life), with the aim of investigating QOL in the first 18 months of life of very preterm infants treated or not with surfactant and infants born at term.

Background and Aim: The present study was performed as part of the multicenter, prospective observational trial NEO-ACQUA (NEOnatal Adequate Care for QUAlity of Life) conducted in 25 tertiary level NICUs with the aim of investigating the differences between preterm infants treated or not with surfactant in terms of respiratory outcomes and QOL.

221 Background: Preoperative systemic treatment is commonly employed for women with locally advanced breast cancer. Women with early-stage breast cancer, whose resections may be delayed for 30 to 60 days while they undergo preoperative evaluation, may benefit from receiving preoperative endocrine therapy while awaiting surgery. One rationale for not initiating such treatment is that the cancer may be rendered less chemosensitive. The 21-gene assay is a proven predictor of chemotherapy responsiveness. The objective of this study is to examine the association between recurrence score (RS) and ER, PR, and HER2 RT-PCR values in core biopsy and surgical specimens from patients treated with short term pre-operative endocrine therapy. Methods: Pre- and postmenopausal women with clinical T1-N0-M0, sonographically visible, ER-positive, HER2-negative breast cancer were eligible. Patients were treated with 4-8 weeks of preoperative endocrine therapy; letrozole if postmenopausal or tamoxifen if premenopausal. Clinical breast examination and ultrasound were conducted every two weeks, with the final ultrasound immediately prior to surgery. Tumor blocks from the core biopsy and surgical excision were submitted to Genomic Health, Inc., where RS, ER, PR, and HER2 results were obtained from each of the paired specimens. Results: Nineteen matching core biopsy and surgical specimens were available for analysis. Pearson correlation coefficients between core biopsy and excisional sample results were 0.89 for RS, 0.87 for ER, 0.72 for PR, and 0.77 for HER2. On average, small but statistically significant increases in RS and decreases in ER and PR were observed (all p < 0.005 from paired t-test). No obvious associations between these markers and clinical response were observed. Conclusions: In this small, hypothesis-generating study, paired RS and RT-PCR for ER/PR/HER2 remained correlated after short-term preoperative endocrine therapy. This study provides no suggestion of decreasing chemosensitivity during preoperative endocrine therapy, but additional research is warranted to explore these findings further.

3547 Background: Total mesorectal excision (TME) has become standard of care in rectal cancer surgery, leading to a massive reduction in local recurrence rate. However, incomplete TME is associated with an increase in local recurrences. To date, there are no reliable data on clinical factors predicting incomplete TME in patients undergoing rectal cancer surgery. We used the data set of the German Quality Assurance in Rectal Cancer Surgery prospective multicenter observational trial to investigate this issue under routine clinical care conditions. Methods: This is a retrospective analysis of a prospectively gathered data set involving >300 German hospitals of all levels of care. Patients undergoing low anterior rectal resection for rectal cancer between 01/01/05 and 12/31/09 were included. Multivariate analysis using a stepwise logistic regression model was performed in order to identify factors predicting suboptimal TME as determined at postoperative histopathology. Risk factors analyzed included age, BMI...

1139 Background: PLD is approved for the treatment of MBC. In 2 randomized phase III studies in MBC patients (pts), PLD showed equal efficacy vs doxorubicin or vinorelbine in 1st- or 2nd-line setti...

Background/Aims Hot flashes are the most common side effect of tamoxifen treatment. We conducted a prospective observational trial to evaluate factors that influenced hot flash severity after tamoxifen treatment. Methods Hot flashes frequency and severity were recorded in 7-day hot flashes diaries before, and 1, 4, 8, 12 months after tamoxifen treatment in 122 subjects. Hot flashes composit scores were calculated. Demographic information was collected at baseline, and estrogen receptor (ESR1 & 2) genotyping was also performed. Results Pre-menopausal women showed the biggest increase in hot flashes severity, from 5.2±10.5 at baseline to 28.5±51.6 at 4 month (P

Patients with ADHD may have better adherence to treatment with modified-release methylphenidate (MPH-MR) formulations, which are taken once daily, compared with immediate-release (IR) formulations, which need to be taken several times a day. Data on long-term outcomes such as adherence may be lacking from randomised controlled trials as these are usually only short-term. Observational studies, if performed and reported appropriately, can provide valuable long-term data on such outcomes, as well as additional information on effectiveness and efficiency, from a real-life setting. By reviewing previous observational studies that have investigated switching treatment from MPH-IR to MPH-MR, results from a new, naturalistic observational study, the OBSEER study, are put into context. We conclude that, based on observational trial data, switching from MPH-IR to MPH-MR is a valid clinical approach, with the potential for improved clinical outcome and treatment adherence. peerReviewed

Objectives This study sought to evaluate the effect of catheter-based patent foramen ovale (PFO) closure on the occurrence of arterial bubbles after simulated dives. Background PFO is a risk factor of decompression sickness in divers due to paradoxical embolization of bubbles. To date, the effectiveness of catheter-based PFO closure in the reduction of arterial bubbles has not been demonstrated. Methods A total of 47 divers (age 35.4 ± 8.6 years, 81% men) with a PFO (PFO group) or treated with a catheter-based PFO closure (closure group) were enrolled in this case-controlled observational trial. All divers were examined after a simulated dive in a hyperbaric chamber: 34 divers (19 in the PFO group, 15 in the closure group) performed a dive to 18 m for 80 min, and 13 divers (8 in the PFO group, 5 in the closure group) performed a dive to 50 m for 20 min. Within 60 min after surfacing, the presence of venous and arterial bubbles was assessed by transthoracic echocardiography and transcranial color-coded sonography, respectively. Results After the 18-m dive, venous bubbles were detected in 74% of divers in the PFO group versus 80% in the closure group (p = 1.0), and arterial bubbles were detected in 32% versus 0%, respectively (p = 0.02). After the 50-m dive, venous bubbles were detected in 88% versus 100%, respectively (p = 1.0), and arterial bubbles were detected in 88% versus 0%, respectively (p Conclusions No difference was observed in the occurrence of venous bubbles between the PFO and closure groups, but the catheter-based PFO closure led to complete elimination of arterial bubbles after simulated dives. (Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure; NCT01854281 )

Background: Invasive lobular carcinoma (ILC) has distinguishing features when compared to invasive ductal carcinoma of no special type (NST). In this study, we explored the distributional and prognostic characteristics of circulating tumor cells (CTCs) in metastatic ILC and NST. Materials and methods: Patients were included in an observational trial (ClinicalTrials.gov NCT01322893) with ILC (n = 28) and NST (n = 111). CTC count (number/7.5 mL blood) was evaluated with serial sampling (CellSearch). The primary endpoint was progression-free survival (PFS). Results: The CTC counts were higher in ILC (median 70) than in NST cases (median 2) at baseline (p < 0.001). The evidence for ≥5 CTCs as a prognostic factor for PFS in ILC was weak, but stronger with higher cut-offs (CTC ≥ 20: hazard ratio (HR) 3.0, p = 0.01) (CTC ≥ 80: HR 3.6, p = 0.004). In NST, however, the prognostic effect of CTCs ≥5 was strong. Decline in CTC count from baseline to three months was associated with improved prognosis in ILC and NST. Conclusions: The number of CTCs is higher in ILC than in NST, implying that a higher CTC cut-off could be considered for ILC when applying the CellSearch technique.

Objectives To determine whether relevant comorbidities stratify patients with and without IE and whether these may improve the diagnostic accuracy, in addition to the modified Duke criteria. Methods and Results 261 consecutive patients (aged 60.1 ± 16.1 years, 62.8% male) with suspected IE were prospectively included in this single-center observational trial. Modified Duke criteria and relevant comorbidities as well as clinical characteristics, were assessed. Forty-seven patients had IE, as confirmed by a clinical event committee. Patients with IE had a higher frequency of positive blood cultures (70.2% vs. 36.9%, p Conclusion Modified Duke criteria provide excellent diagnostic value for evaluating suspected IE, mainly driven by transesophageal echocardiography. Trial registration NCT03365193.

Background Malnutrition is commonly known as a risk factor in surgical procedures. The nutritional status seems particularly relevant to the clinical outcome of patients undergoing hepatic resection. Thus, identifying affected individuals and taking preventive therapeutic actions before surgery is an important task. However, there are only very few studies, that investigate which existing nutritional assessment score (NAS) is suited best to predict the postoperative outcome in liver surgery. Objective Nutritional Risk in Major Abdominal Surgery (NURIMAS) Liver is a prospective observational trial that analyses the predictive value of 12 different NAS for postoperative morbidity and mortality after liver resection. Methods After admission to the surgical department of the University Hospital in Heidelberg or the municipal hospital of Karlsruhe, all patients scheduled for elective liver resection will be screened for eligibility. Participants will fill in a questionnaire and undergo a physical examination in order to evaluate nutritional status according to Nutritional Risk Index, Nutritional Risk Screening Score, Subjective Global Assessment, Malnutrition Universal Screening Tool, Mini Nutritional Assessment, Short Nutritional Assessment Questionnaire, Imperial Nutritional Screening System, Imperial Nutritional Screening System II, Nutritional Risk Classification and the ESPEN malnutrition criteria. Postoperative morbidity and mortality will be tracked prospectively throughout the postoperative course. The association of malnutrition according to each score and occurrence of at least one major complication will be analysed using both chi-squared tests and a multivariable logistic regression analysis. Already established risk factors in liver surgery will be added as covariates. Discussion NURIMAS Liver is a bicentric, prospective observational trial. The aim of this study is to investigate the predictive value of clinical nutritional assessment scores on postoperative morbidity and mortality after hepatic resection. This is necessary, as only a validated identification of malnourished patients at high risk for postoperative complications, enables targeted preventive action.

Background. Noninvasive neurally adjusted ventilatory assist (NAVA) has been shown to improve patient-ventilator interaction in many settings. There is still scarce data with regard to postoperative patients indicated for noninvasive ventilation (NIV) which this study elates. The purpose of this trial was to evaluate postoperative patients for synchrony and comfort in noninvasive pressure support ventilation (NIV-PSV) vs. NIV-NAVA. Methods. Twenty-two subjects received either NIV-NAVA or NIV-PSV in an object-blind, prospective, randomized, crossover fashion (observational trial). We evaluated blood gases and ventilator tracings throughout as well as comfort of ventilation at the end of each ventilation phase. Results. There was an effective reduction in ventilator delays (p<0.001) and negative pressure duration in NIV-NAVA as compared to NIV-PSV (p<0.001). Although we used optimized settings in NIV-PSV, explaining the overall low incidence of asynchrony, NIV-NAVA led to reductions in the NeuroSync-index (p<0.001) and all types of asynchrony except for double triggering that was significantly more frequent in NIV-NAVA vs. NIV-PSV (p=0.02); ineffective efforts were reduced to zero by use of NIV-NAVA. In our population of previously lung-healthy subjects, we did not find differences in blood gases and patient comfort between the two modes. Conclusion. In the postoperative setting, NIV-NAVA is well suitable for use and effective in reducing asynchronies as well as a surrogate for work of breathing. Although increased synchrony was not transferred into an increased comfort, there was an advantage with regard to patient-ventilator interaction. The trial was registered at the German clinical Trials Register (DRKS no.: DRKS00005408).

Background 1.7 billion Muslims worldwide obey divine commands of fasting for a month. This may increase the probability of the acute complications of diabetes during the fasting period. Design and methods We primarily aimed to compare the incidences and duration of Diabetic ketoacidosis (DKA) admissions during Ramadan compared to the month before (Shaaban) and the month after (Shawal) as well as the average pre-Ramadan six months' admissions. Our secondary objective was to assess the different incidence of DKA between Ramadan and the other months regarding precipitating factors, fasting practices in people admitted with DKA and gender differences. This was a prospective study that included all Muslims who were admitted with DKA to major hospitals in the United Arab Emirates, Sudan, Tunisia and Morocco during the pre-Ramadan month, Ramadan and post-Ramadan month, in addition to the average monthly admissions during the last six months before Ramadan. Demographics, clinical, and laboratory indices were collected and analyzed to assess primary and secondary end points. Results One hundred seventy patients were admitted during the study duration, 56 were admitted during Ramadan and 63 in Shawal. Six months before Ramadan showed an average admission of 56 + 7 per month. All those admitted during Ramadan were people with type1 diabetes. 29.8 % of those admitted during Ramadan did not receive structured education program on diabetes management in Ramadan. Non-compliance to medications represented the commonest cause for admission in the whole study period. Hospital stay was comparable through different months, but the duration of acidosis was longest during Ramadan month. Conclusion In concordance with DKAR1, DKAR international showed higher rates of DKA during Ramadan when compared to preceding Lunar month (Shaaban). In Shawal, however, the rates of DKA admission were higher than the average monthly DKA admissions. The duration of acidosis was longer in Ramadan group and positively correlated with duration of diabetes. Many patients did not receive structured education about diabetes and fasting Ramadan. Our study calls for formal pre-Ramadan education and enforces the need for advice against fasting in patients who already experienced DKA in the months preceding Ramadan.

Background Home telemonitoring (HTM) of chronic heart failure (HF) promises to improve care by timely indications when a patient’s condition is worsening. Simple rules of sudden weight change have been demonstrated to generate many alerts with poor sensitivity. Trend alert algorithms and bio-impedance (a more sensitive marker of fluid change), should produce fewer false alerts and reduce workload. However, comparisons between such approaches on the decisions made and the time spent reviewing alerts has not been studied. Methods Using HTM data from an observational trial of 91 HF patients, a simulated telemonitoring station was created and used to present virtual caseloads to clinicians experienced with HF HTM systems. Clinicians were randomised to either a simple (i.e. an increase of 2 kg in the past 3 days) or advanced alert method (either a moving average weight algorithm or bio-impedance cumulative sum algorithm). Results In total 16 clinicians reviewed the caseloads, 8 randomised to a simple alert method and 8 to the advanced alert methods. Total time to review the caseloads was lower in the advanced arms than the simple arm (80 ± 42 vs. 149 ± 82 min) but agreements on actions between clinicians were low (Fleiss kappa 0.33 and 0.31) and despite having high sensitivity many alerts in the bio-impedance arm were not considered to need further action. Conclusion Advanced alerting algorithms with higher specificity are likely to reduce the time spent by clinicians and increase the percentage of time spent on changes rated as most meaningful. Work is needed to present bio-impedance alerts in a manner which is intuitive for clinicians. Electronic supplementary material The online version of this article (doi:10.1186/s12911-016-0398-9) contains supplementary material, which is available to authorized users.

Abstract 3955 Background: MGUS counts for the majority of monoclonal gammopathies and can be found in approximately 3% of adults older than 50 years. MGUS progresses to active Multiple Myeloma (MM) at a rate of 1–2% per year, thus imparting an average risk of 25% for progression (PRO) over a lifetime once diagnosed. Unfortunately no single laboratory, molecular or imaging variable can reliably predict PRO. S0120 accrued 363 patients at 69 sites across the US between January 1, 2004 and November 1, 2011, of whom 166 had MGUS and 190 AMM, defined according to IMWG criteria, on whom laboratory, gene expression and imaging studies were collected in a prospective fashion. Here we report the results of imaging studies as predictors of progression. Methods: 262 patients with evaluable follow-up were enrolled at the University of Arkansas for Medical Sciences (UAMS) site. MRI and PET-CT studies were performed at baseline and serially thereafter until PRO to symptomatic MM defined by standard variables of M-protein, bone marrow findings and CRAB criteria, according to protocol. Lab studies were performed at three months, six months and one year after registration, then every 12 months for a total of 5 years from registration as well as within 14 days of decision to discontinue observation or within 14 days of progression. MRI parameters included the number of focal lesions (FL) recognized by short TI inversion recovery (STIR) analysis of the axial bone marrow along with an account of bone marrow background intensity compared to adjacent muscles (hypo-, iso-, hyper-intense). PET-CT parameters included number of FDG-avid focal lesions (PET-FL), SUVmax of PET-FL, presence of extra-medullary disease (EMD) as well as the FDG avidity score at L5 (SUV-L5). Evaluable baseline MRI and PET studies were available for 235 and 224 patients, respectively. Results: In the 262 eligible patients enrolled and followed at UAMS, the two subgroups of MGUS and AMM differed by definition in M-protein and bone marrow plasmacytosis; in addition, IgA subclass and Hyperdiploidy molecular subgroup were overrepresented in the AMM group. Patients in the AMM group also had higher risk scores defined by the GEP 70-gene risk model (GEP70). At 24 months from study entry, 18.8% of all patients had progressed to MM (25.6% of AMM patients and 8.2% of MGUS patients) and 11.5% had begun MM therapy (15.8% of AMM patients and 4.5% of MGUS patients). Univariate Cox regression strongly indicated that age ≥ 65, serum albumin +3.5mg/L, detection of any cytogenetic abnormalities (CA), and suppression of uninvolved light chains were adversely associated with time to PRO. The AMM-constituting features, bone marrow plasmacytosis >10%, M-protein >30g/L, and abnormal K/L ratio also conferred greater hazard of PRO. Risk scores > −0.26 and >1.5 for GEP70 and GEP80, respectively, as well as detection of focal lesions by MRI at baseline carried an elevated HR for PRO. A multivariate Cox regression showed only elevated M-protein, abnormal K/L ratio and GEP70 risk scores > =0.26 to be strongly associated with time to PRO. In the context of this MV model, disease subtype (AMM v MGUS) was insignificant. Inclusion of development of MRI-FL or and PET-FL as time-dependent variables showed that they were associated with time to PRO with HRs of 27.12 and 32.18 respectively. Abnormal K/L ratio and elevated M-protein were lost in this MV model. Analyzing variables linked to initiation of MM therapy, abnormal K/L ratio, elevated BM plasmacytosis, elevated M-protein, GEP70 risk scores >-0.26 as well as detection of MRI-FL at baseline (≥1 FL: HR=4.90; ≥3FL: HR=10.00) were univariately significant. On multivariate analysis, abnormal K/L ratio, elevated M-protein and GEP70 risk scores > – 0.26 were associated with time to treatment for MM. Inclusion of development of MRI-FL or PET-FL as a time dependent variable were associated with time to treatment with HRs of 29.12 and 36.50 respectively. Conclusion: To our knowledge, this is the first comprehensive effort that has used available imaging modalities along with established laboratory and pathology investigations in an attempt to distinguish features predictive of PRO from MGUS to active MM. In addition to the established “high-risk” MGUS/AMM features, we found that presence of MRI-FL at baseline, presence of CA and GEP70 scores >-0.26 carry a higher risk of PRO. Disclosures: Shaughnessy: Myeloma Health, Celgene, Genzyme, Novartis: Consultancy, Employment, Equity Ownership, Honoraria, Patents & Royalties. Barlogie:Celgene: Consultancy, Honoraria, Research Funding; IMF: Consultancy, Honoraria; MMRF: Consultancy; Millennium: Consultancy, Honoraria, Research Funding; Genzyme: Consultancy; Novartis: Research Funding; NCI: Research Funding; Johnson & Johnson: Research Funding; Centocor: Research Funding; Onyx: Research Funding; Icon: Research Funding.

Background Accidents are the leading cause of death in adults prior to middle age. The care of severely injured patients is an interdisciplinary challenge. Limited evidence is available concerning pre-hospital trauma care training programs and the advantage of such programs for trauma patients. The effect on trauma care procedures or on the safety of emergency crews on the scene is limited; however, there is a high level of experience and expert opinion.

Introduction Fasting of Ramadan is a religious obligation that is practiced by the Muslim population in the world. However, there is a lack of scientific literature regarding the effects on cardiovascular disorders such as hypertension. Objective This study was conducted to assess the impact of Ramadan fasting on blood pressure in treated hypertensive patients. Materials and Methods This prospective observational trial was conducted on 18 patients treated for hypertension, who were determined to end the fast of Ramadan. All subjects were on antihypertensive therapy. Measurements of blood pressure was performed by Holter blood pressure before and after the month of Ramadan. Results The mean age of subjects was 57.61±12.64 years; with a female predominance. There was a significant decrease in average diastolic 24-h ambulatory blood pressure, as well as average diastolic awake ambulatory blood pressure after Ramadan (70,72±9,24mmHg vs 65,06±8,23mmHg, P=0,01 et 73,72 ± 10,10mmHg vs 70,06 ± 9,43mmHg, P=0,01). Average systolic 24-h ambulatory blood pressure, as well as average awake systolic and average asleep systolic and diastolic ambulatory blood pressure was similar before and after Ramadan (125,50 ± 11,62mmHg vs 122,94 ± 10,09mmHg, P=0,08 ; 128,44 ± 12,19mmHg vs 126,11 ± 10,80mmHg, P=0,06 ; 120,67± 13,20mmHg vs 119,83 ± 13,76mmHg, P=0,73 ; 65,72 ± 8,84mmHg vs 65,72 ± 8,84mmHg, P=0,81). Conclusion We conclude that, according to our results, hypertensive patients can continue their treatment as the traditional fasting during Ramadan can be performed safely.