Difference In Proportion Of Patients Research Articles

Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial.

We aimed to evaluate perioperative outcomes in patients undergoing pancreaticoduodenectomy with or without a cardiac output goal directed therapy (GDT) algorithm. We conducted a multicentre randomised controlled trial in four high volume hepatobiliary-pancreatic surgery centres. We evaluated whether the additional impact of a intraoperative fluid optimisation algorithm would influence the amount of fluid delivered, reduce fluid related complications, and improve length of hospital stay. Fifty-two consecutive adult patients were recruited. The median (IQR) duration of surgery was 8.6 hours (7.1:9.6) in the GDT group vs. 7.8 hours (6.8:9.0) in the usual care group (p = 0.2). Intraoperative fluid balance was 1005mL (475:1873) in the GDT group vs. 3300mL (2474:3874) in the usual care group (p<0.0001). Total volume of fluid administered intraoperatively was also lower in the GDT group: 2050mL (1313:2700) vs. 4088mL (3400:4525), p<0.0001 and vasoactive medications were used more frequently. There were no significant differences in proportions of patients experiencing overall complications (p = 0.179); however, fewer complications occurred in the GDT group: 44 vs. 92 (Incidence Rate Ratio: 0.41; 95%CI 0.24 to 0.69, p = 0.001). Median (IQR) length of hospital stay was 9.5 days (IQR: 7.0, 14.3) in the GDT vs. 12.5 days in the usual care group (IQR: 9.0, 22.3) for an Incidence Rate Ratio 0.64 (95% CI 0.48 to 0.85, p = 0.002). In conclusion, using a surgery-specific, patient-specific goal directed restrictive fluid therapy algorithm in this cohort of patients, can justify using enough fluid without causing oedema, yet as little fluid as possible without causing hypovolaemia i.e. “precision” fluid therapy. Our findings support the use of a perioperative haemodynamic optimization plan that prioritizes preservation of cardiac output and organ perfusion pressure by judicious use of fluid therapy, rational use of vasoactive drugs and timely application of inotropic drugs. They also suggest the need for further larger studies to confirm its findings.

Evaluating safety of thrombolysis in chronic kidney disease patients presenting with pulmonary embolism using propensity score matching.

To assess the safety of thrombolytic therapy in chronic kidney disease (CKD) patients who present with pulmonary embolism (PE). We used the Nationwide Inpatient Sample Database to identify patients who underwent thrombolysis for PE between 2010 and 2014. The patients were divided into two groups: (1) No CKD and (2) CKD. Patients with and without CKD were matched using 1:1 propensity score matching and a caliper width of 0.01. The primary outcomes were in-hospital mortality and hemorrhagic events. The secondary outcomes were blood transfusions, length of stay and total hospitalization charge. Two separate, multivariate analyses were also performed to determine the predictors for primary outcomes. The No CKD group had 16,238 and CKD group had 1341 patients prior to matching. Patients with CKD were older (Median age 67 vs. 57years; p < 0.01), male (60.6 vs. 51.8%) and had a higher prevalence of coronary artery disease, congestive heart failure, diabetes, hyperlipidemia, hypertension, and prior stroke among other comorbidities. They also had significantly higher rate of in-hospital mortality (OR 1.66) and hemorrhagic events (OR 1.47) prior to matching. Post-matching, there was no difference in hospital mortality (22.9 vs. 21.8%; p = 0.51) or hemorrhagic events (3.8 vs. 3.0%; p = 0.27) between CKD and No CKD groups. Patients with CKD had a longer length of stay, but no difference in proportion of patients receiving a blood transfusion and total hospitalization charges post-matching. Multivariate analysis showed that CKD did not predict mortality (OR 0.88, 0.75-1.02; p = 0.09) or hemorrhagic events (OR 0.89, 95% CI 0.76-1.04; 0.13). There was no increase in rate of hospital mortality or hemorrhagic events among CKD patients who underwent thrombolysis for PE.

Genetic consultation embedded in a gynecologic oncology clinic improves compliance with guideline-based care.

Analyze the impact of embedding genetic counseling services in gynecologic oncology on clinician referral and patient uptake of cancer genetics services. Data were reviewed for a total of 737 newly diagnosed epithelial ovarian cancer patients seen in gynecologic oncology at a large academic medical center including 401 from 11/2011-7/2014 (a time when cancer genetics services were provided as an off-site consultation). These data were compared to data from 8/2014-9/2016 (n=336), when the model changed to the genetics embedded model (GEM), incorporating a cancer genetic counselor on-site in the gynecologic oncology clinic. A statistically significant difference in proportion of patients referred pre- and post-GEM was observed (21% vs. 44%, p<0.0001). Pre-GEM, only 38% of referred patients were actually scheduled for genetics consultation and post-GEM 82% were scheduled (p<0.00001). The difference in the time from referral to scheduling in genetics was also statistically significant (3.92months pre-GEM vs. 0.79months post-GEM, p<0.00001) as was the time from referral to completion of genetics consultation (2.52months pre-GEM vs. 1.67months post-GEM, p<0.01). Twenty-five percent of patients referred post GEM were seen by the genetic counselor on the same day as the referral. Providing cancer genetics services on-site in gynecologic oncology and modifying the process by which patients are referred and scheduled significantly increases referral to cancer genetics and timely completion of genetics consultation, improving compliance with guideline-based care. Practice changes are critical given the impact of genetic test results on treatment and familial cancer risks.

Pilot Study of a Palliative Care and Medical Oncology Co-Rounding Model for Advanced Cancer Inpatients in a Tertiary Hospital in Singapore.

Our aim was to obtain initial estimates of the effect of a palliative care and medical oncology co-rounding model on hospital length of stay, proportion of patients reviewed by specialist palliative care (SPC), and proportion of patients who were readmitted within 7 and 30 days of hospital discharge. Earlier timing of palliative care improves patient outcomes, but current consultative models of palliative care service delivery are not feasible for widespread implementation. We conducted a pilot pre-post intervention study of a palliative care and medical oncology co-rounding model of care in the inpatient hospital setting. All patients admitted under the care of an inpatient oncology team during the study period were included. Hospital length of stay, proportion of patients reviewed by SPC, and readmission data were retrieved from the electronic administrative database. There were 595 unique patients (352 in the "consultative" group and 243 in the "co-rounding" group). There was no significant difference in the proportion of patients who were reviewed by a SPC physician (consultative model 21.02% vs. co-rounding model 25.10%, p = 0.243). The hospital length of stay was shorter for the co-rounding group (median 3 days, interquartile range 2-7 days) compared with the consultative group (median 4 days, interquartile range 2-7 days) (p = 0.025). There was no significant difference in proportion of patients readmitted within 30 days of hospital discharge (consultative model 29.78% vs. co-rounding model 28.90%, p = 0.773). In our target population, the co-rounding model was associated with a shorter hospital length of stay.

Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma: a historical cohort study using a US health claims database.

ObjectiveThe objective of this study was to determine whether the effectiveness of budesonide comparator is non-inferior to budesonide reference in the prevention of asthma exacerbations. Asthma-related hospitalizations and safety were also examined.MethodsThis study used a matched, historic cohort design. Data were drawn from the Clinformatics™ Data Mart US claims database and included a 1-year baseline, starting 1 year before the index prescription date, and a 1-year outcome period. Patients received budesonide comparator or reference treatment. The primary outcome was the rate of asthma exacerbations. Non-inferiority for budesonide comparator vs budesonide reference was established if the 95% confidence interval (CI) upper limit of mean difference in proportions between treatments was <15%. Secondary outcomes examined rate of asthma-related hospitalizations and adverse events (AEs).ResultsThe budesonide comparator and reference-matched cohorts each included 3109 patients. The adjusted upper 95% CI for the difference in proportions of patients experiencing asthma exacerbations was 0.035 (3.5%), demonstrating non-inferiority. Cohorts did not significantly differ in the rate of asthma exacerbations (adjusted rate ratio [RR]=1.04, 95% CI: 0.95–1.14) or rate of asthma-related hospitalizations (adjusted RR=1.10, 95% CI: 0.99–1.24) after adjusting for baseline confounders. No asthma exacerbations occurred during the outcome period in 72.9% of budesonide comparator patients and 71.8% of budesonide reference patients. No asthma-related hospitalizations occurred in 77.9% of patients in the budesonide comparator cohort and 79.0% of patients in the budesonide reference cohort. The most frequent AEs were throat irritation (≤0.4% of patients) and hoarseness/dysphonia (0.02% of patients). AEs did not significantly differ between treatment cohorts.ConclusionIn this real-life study, non-inferiority of the budesonide comparator vs reference was met for the primary end point of asthma exacerbation rates. Asthma-related hospitalization and AE rates did not differ between the two treatment cohorts. The budesonide comparator is an effective and safe treatment alternative for asthma exacerbations.

The effectiveness of a value-based EMOtion-cognition-Focused educatIonal programme to reduce diabetes-related distress in Malay adults with Type 2 diabetes (VEMOFIT): study protocol for a cluster randomised controlled trial

BackgroundType 2 diabetes mellitus (T2DM) patients experience many psychosocial problems related to their diabetes. These often lead to emotional disorders such as distress, stress, anxiety and depression, resulting in decreased self-care, quality of life and disease control. The purpose of the current study is to evaluate the effectiveness of a brief value-based emotion-focused educational programme in adults with T2DM on diabetes-related distress (DRD), depressive symptoms, illness perceptions, quality of life, diabetes self-efficacy, self-care and clinical outcomes.MethodsA cluster randomised controlled trial will be conducted in 10 public health clinics in Malaysia, all providing diabetes care according to national clinical practice guidelines. Patients’ inclusion criteria: Malay, ≥ 18 years with T2DM for at least 2 years, on regular follow-up with one of three biomarkers HbA1c, systolic blood pressure and LDL-cholesterol sub-optimally controlled, and with a mean 17-item Diabetes Distress Scale (DDS-17) score ≥ 3. The intervention consists of four sessions and one booster over a period of 4 months that provide information and skills to assist patients in having proper perceptions of their T2DM including an understanding of the treatment targets, understanding and managing their emotions and goal-setting. The comparator is an attention-control group with three meetings over a similar period. With an estimated intra-cluster correlation coefficient ρ of 0.015, a cluster size of 20 and 20% non-completion, the trial will need to enroll 198 patients. Primary outcome: the between groups difference in proportion of patients achieving a mean DDS-17 score < 3 (non-significant distress) at 6 months post-intervention. Secondary outcomes will be the differences in the above mentioned variables between groups.DiscussionWe hypothesize that primary and secondary outcomes will improve significantly after the intervention compared to the comparator group. The results of this study can contribute to better care for T2DM patients with DRD.Trial registrationClinicalTrials.gov NCT02730078. Registered on 29 March 2016, last updated on 4 January 2017.

A prospective randomized controlled multicentre trial comparing intravesical DMSO and chondroïtin sulphate 2% for painful bladder syndrome/interstitial cystitis.

ABSTRACTObjective To compare effectiveness of intravesical chondroïtin sulphate (CS) 2% and dimethyl sulphoxide (DMSO) 50% in patients with painful bladder syndrome/interstitial cystitis (PBS/IC).Materials and methods Patients were randomized to receive either 6 weekly instillations of CS 2% or 50% DMSO. Primary endpoint was difference in proportion of patients achieving score 6 (moderately improved) or 7 (markedly improved) in both groups using the Global Response Assessment (GRA) scale. Secondary parameters were mean 24-hours frequency and nocturia on a 3-day micturition dairy, changes from baseline in O’Leary-Sant questionnaire score and visual analog scale (VAS) for suprapubic pain.Results Thirty-six patients were the intention to treat population (22 in CS and 14 in DMSO group). In DMSO group, 57% withdrew consent and only 6 concluded the trial. Major reasons were pain during and after instillation, intolerable garlic odor and lack of efficacy. In CS group, 27% withdrew consent. Compared with DMSO group, more patients in CS group (72.7% vs. 14%) reported moderate or marked improvement (P=0.002, 95% CI 0.05-0.72) and achieved a reduction in VAS scores (20% vs. 8.3%). CS group performed significantly better in pain reduction (-1.2 vs. -0.6) and nocturia (-2.4 vs. -0.7) and better in total O’Leary reduction (-9.8 vs. -7.2). CS was better tolerated. The trial was stopped due to high number of drop-outs with DMSO.Conclusions Intravesical CS 2% is viable treatment for PBS/IC with minimal side effects. DMSO should be used with caution and with active monitoring of side effects. More randomized controlled studies on intravesical treatments are needed.

Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism

Secondary hyperparathyroidism contributes to extraskeletal calcification and is associated with all-cause and cardiovascular mortality. Control is suboptimal in the majority of patients receiving hemodialysis. An intravenously (IV) administered calcimimetic could improve adherence and reduce adverse gastrointestinal effects. To evaluate the relative efficacy and safety of the IV calcimimetic etelcalcetide and the oral calcimimetic cinacalcet. A randomized, double-blind, double-dummy active clinical trial was conducted comparing IV etelcalcetide vs oral placebo and oral cinacalcet vs IV placebo in 683 patients receiving hemodialysis with serum parathyroid hormone (PTH) concentrations higher than 500 pg/mL on active therapy at 164 sites in the United States, Canada, Europe, Russia, and New Zealand. Patients were enrolled from August 2013 to May 2014, with end of follow-up in January 2015. Etelcalcetide intravenously and oral placebo (n = 340) or oral cinacalcet and IV placebo (n = 343) for 26 weeks. The IV study drug was administered 3 times weekly with hemodialysis; the oral study drug was administered daily. The primary efficacy end point was noninferiority of etelcalcetide at achieving more than a 30% reduction from baseline in mean predialysis PTH concentrations during weeks 20-27 (noninferiority margin, 12.0%). Secondary end points included superiority in achieving biochemical end points (>50% and >30% reduction in PTH) and self-reported nausea or vomiting. The mean (SD) age of the trial participants was 54.7 (14.1) years and 56.2% were men. Etelcalcetide was noninferior to cinacalcet on the primary end point. The estimated difference in proportions of patients achieving reduction in PTH concentrations of more than 30% between the 198 of 343 patients (57.7%) randomized to receive cinacalcet and the 232 of 340 patients (68.2%) randomized to receive etelcalcetide was -10.5% (95% CI, -17.5% to -3.5%, P for noninferiority, <.001; P for superiority, .004). One hundred seventy-eight patients (52.4%) randomized to etelcalcetide achieved more than 50% reduction in PTH concentrations compared with 138 patients (40.2%) randomized to cinacalcet (P = .001; difference in proportions, 12.2%; 95% CI, 4.7% to 19.5%). The most common adverse effect was decreased blood calcium (68.9% vs 59.8%). Among patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism, the use of etelcalcetide was not inferior to cinacalcet in reducing serum PTH concentrations over 26 weeks; it also met superiority criteria. Further studies are needed to assess clinical outcomes as well as longer-term efficacy and safety. clinicaltrials.gov Identifier: NCT1896232.

Ustekinumab Is Effective for the Induction and Maintenance of Response in Crohnʼs Disease: A Multi-center Cohort Study

Introduction: While ustekinumab is not yet approved to treat Crohn's disease (CD), clinicians have begun to prescribe it off-label due to promising clinical trials. We assess the real-world efficacy of ustekinumab for induction of clinical response in CD patients. We also evaluate the proportion of ustekinumab primary responders who develop secondary loss of response during maintenance therapy. Methods: A retrospective multicenter cohort study was performed at two academic institutions on patients with CD who received ustekinumab between 2011-2016. The primary outcome was induction of clinical response at 3 months, defined by reduction in Harvey Bradshaw Index of >2 points and tapering off corticosteroids. Secondary loss of response was defined by clinical, endoscopic, or radiographic disease activity requiring dose escalation, rescue steroids/immunomodulators, surgical resection, or ustekinumab discontinuation. Patients were stratified by weight-adjusted induction dose (3 vs. 6mg/kg), method of induction (intravenous vs. subcutaneous), and initial maintenance regimen (q8 vs. 12 weeks). The proportion of patients on ustekinumab with clinical response was determined at 3, 6, and 12 months. Results: 82 CD patients met inclusion criteria. Median follow-up was 45.6 weeks (IQR 33.0-66.6). 75 patients (91.4%) had previously failed anti-TNF therapy and 61 patients (74.4%) had failed more than one biologic. 55 patients (67.1%) had clinical response to induction therapy at 3 months. Among 78 CD patients who were followed for or discontinued drug prior to 6 months, 67.9% (53/78) were still on treatment and in clinical response. 49.3% (33/67) of patients followed for 12 months or discontinuing drug prior to 12 months were on drugt and responding at 1 year. There were no differences in proportion of patients achieving response at 3, 6, or 12 months when stratified by induction dose (p=0.40-0.94), maintenance dose (p=0.30-0.75), or induction method (p=0.12-0.58). Among 55 primary induction responders, 60.0% (33/55) maintained response to end of follow-up. Median time to secondary loss of response was 45.6 weeks (IQR 33.0-66.6 weeks). Twenty-six patients (31.7%) experienced an adverse effect, predominantly arthralgias (11.0%) and infections (13.4%). Conclusion: In this cohort of CD outpatients, the majority of whom had previously failed multiple biologic agents, ustekinumab was effective for inducing clinical response and this response was maintained over long-term follow-up.Table 1: Baseline patient demographic and clinical characteristics of 82 patients treated with ustekinumab between 2011 and 2015

Impact and Feasibility of Personalized Decision Support for Older Patients with Diabetes: A Pilot Randomized Trial.

Diabetes guidelines recommend individualizing glycemic goals (A1C) for older patients. The aim of this study was to assess a personalized Web-based decision support tool. We randomized physicians and their patients with type 2 diabetes (≥65 years of age) to a support tool or educational pamphlet (75:25 patients). Prior to a visit, intervention patients interacted with the tool, which provided personalized risk predictions and elicited treatment preferences. Main outcomes included 1) patient-doctor communication, 2) decisional conflict, 3) changes in goals, and 4) intervention acceptability. We did not find significant differences in proportions of patients who had an A1C discussion (91% intervention v. 76% control; P = 0.19). Intervention patients had larger declines in the informed subscale of decisional conflict (-20 v. 0, respectively; P = 0.04). There were no significant differences in proportions of patients with changes in goals (49% v. 28%, respectively; P = 0.08). Most intervention patients reported that the tool was easy to use (91%) and helped them to communicate (84%). A limitation was that this was a pilot trial at one academic institution. Web-based decision support tools may be a practical approach to facilitating the personalization of goals for chronic conditions. NCT02169999 ( https://clinicaltrials.gov/show/NCT02169999 ).

Frail older adults with minor fractures show lower health-related quality of life (SF-12) scores up to six months following emergency department discharge.

BackgroundMinor fractures (e.g. wrist, ankle) are risk factors for lower physical health-related quality of life (HRQoL) in seniors. Recent studies found that measures of frailty were associated with decreased physical and mental HRQoL in older people. As most people with minor fractures go to emergency departments (EDs) for treatment, measuring their frailty status in EDs may help stratify their level of HRQoL post-injury and provide them with appropriate health care and services after discharge. This study thus examines the HRQoL of seniors visiting EDs for minor fractures at 3 and 6 months after discharge, according to their frailty status.MethodsThis prospective sub-study was conducted within the larger Canadian Emergency Team Initiative (CETI) cohort. Independent seniors (≥65 years) were recruited in 7 Canadian EDs after treatment for various minor fractures. Frailty status in the ED phase was assessed by the Canadian Study of Health and Aging--Clinical Frailty Scale (CSHA-CFS). The SF-12 questionnaire was completed at 3 and 6 months after ED discharge to ascertain HRQoL. Demographic and clinical data were collected. Linear mixed models were used to test for differences between frailty levels and HRQoL outcomes, controlling for confounding variables and repeated measures over time.ResultsThe sample comprised 334 participants with minor fractures. Prevalence of frailty was as follows: 56.6 % very fit-well; 32.3 % well with treated comorbidities-apparently vulnerable; and 11.1 % mildly-moderately frail. After adjusting for confounding variables, the frailest group showed significantly lower mean HRQoL scores than the fittest group on the physical scale at 3 months (49.3 ± 3.7 vs 60.9 ± 2.0) and 6 months (48.7 ± 3.8 vs 61.1 ± 1.8), as well as on the mental scale at 3 months (59.5 ± 4.4 vs 69.6 ± 1.9). Analyses exploring differences in proportion of patients with HRQoL < 50/100 between the three groups produced similar results.ConclusionsOlder adults with minor fractures who were frail had lower physical and mental HRQoL scores at 3 and 6 months after ED discharge than their fittest counterparts. Measuring the frailty status of older adults who suffered a minor fracture in ED might help clinical decision-making at the time of discharge by providing them with appropriate health care and services to improve their HRQoL in the following months.

Abstract P4-11-12: Quality of life, anxiety and depression during treatment of ductal carcinoma in situ and invasive breast cancer

Abstract INTRODUCTION Patients with ductal carcinoma in situ (DCIS) have excellent overall survival rates. Yet, previous studies suggested that quality of life (QoL) between patients with DCIS and patients with early-invasive breast cancer (early-IBC) are similar after treatment. We compared anxiety, depression and quality of life of patients with DCIS and patients with early-IBC during treatment, at the initiation of postsurgical radiotherapy. METHODS We conducted this study within a prospective observational cohort of breast cancer patients indicated to receive adjuvant radiation treatment at the department of Radiation Oncology at the University Medical Center Utrecht, the Netherlands ('the UMBRELLA cohort'). At the time of inclusion all cohort participants consented to the collection of clinical and patient reported outcomes (PROMs) at regular intervals. Patient reported outcomes on QoL (i.e. EORTC QLQ-C30) and anxiety and depression (i.e. HADS) were collected at the start of postsurgical radiotherapy. All patients who were diagnosed between October 2013 and January 2015 with DCIS or early-IBC (i.e. pT1 and pT2 without lymph node involvement) were included in this analysis. To analyze differences in mean levels of PROMs (i.e. anxiety and depression, QoL) between patients with DCIS and early-IBC, two sample t-tests were used. Differences in proportions of patients with high anxiety or high depressive scores (i.e. scores ≥11) were analyzed with the Pearson-Chi square test. We compared PROMS of DCIS and early-IBC patients with those of patients with advanced-invasive breast cancer from the UMBRELLA cohort using analyses of variance (ANOVA). RESULTS Forty-six patients were diagnosed with DCIS and 227 with early-IBC. DCIS and early-IBC patients did not show statistically significant differences in levels of anxiety (mean DCIS 4.5, early-IBC 5.2, p=0.18), depression (mean DCIS 2.6, early-IBC 3.0, p=0.73) or QoL (mean DCIS 78.3, early-IBC 74.7 p=0.70). Seven percent of women with DCIS women reported severe anxious symptoms, compared to 8% in women with early-IBC (p=0.22). Severe symptoms of depression were seen in 2% of DCIS patients and 4% of early-IBC (p=0.30). Patients with advanced invasive breast cancer (n=118) reported significantly higher anxiety (mean 6.3, p&amp;lt;0.005) and depression (mean 4.6, p&amp;lt;0.001) scores and poorer QoL levels (69.9) as compared to patients with DCIS and early-invasive breast cancer. CONCLUSION Despite excellent survival probabilities and less invasive treatment, women with DCIS report similar levels of anxiety, depression and quality of life during treatment as compared to women with early-invasive breast cancer. Citation Format: Young-Afat DA, Gregorowitsch ML, Pignol J-P, van Gils CH, van Vulpen M, van den Bongard DJ, Verkooijen HM. Quality of life, anxiety and depression during treatment of ductal carcinoma in situ and invasive breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-11-12.

Myelodysplastic Syndromes (MDS) with Erythroid Hyperplasia: Enumerating Blasts from Non-Erythroid Cell Compartment Improves the Risk Stratification of MDS with Excess of Blasts

Introduction: WHO classification of MDS is based on cytopenias, dysplasia, percentage of blasts in PB and BM, and cytogenetics. IPSS-R establishes BM blast subgroups (≤2%,2-<5%,5%-10% and >10%) with independent impact in OS. Erythroid hyperplasia (≥50% of total BM cells) is common in MDS. Concerning MDS with expanded erythropoiesis, there is no consensus whether the proportion of BM blasts should be considered on the basis of all nucleated cells (approach-A) or in non-erythroid cells (approach-B).Aim: To elucidate this issue, we reassess percentage of BM blasts of MDS with erythropoiesis ≥50% from the Spanish registry (RESMD), according to both definitions.Methods: We performed a retrospective analysis of 507 primary MDS diagnosed according to WHO 2008. Proportion of red-cells was calculated in 500 nucleated cells. Erythroid hyperplasia was documented in 10.4% of patients from RESMD.Results: Median age of presentation was 74years (25-94years) and 63% were males. Median follow-up was 29.4 months and median OS was 47.14 months. Table 1 shows distribution of WHO subtypes of the series according to both approaches. Of note, following WHO recommendations, RAEB-2 diagnosis was not possible; formally all of them were diagnosed with erythroleukemia. Distribution of patients according to IPSS-R blast-categories by both methods is shown in Table 2. It is noteworthy that 14/389pts (3.6%) with blasts <5% using approach-A were reclassified in 10-<20% category (RAEB-2) when the approach-B was applied. However, their survival did not differ significantly from those who remained in low-count blast categories. Using approach-A, IPSS-R blast categories discriminate significantly OS of blast subgroups <5% (0-2% vs. 2-<5%, 81 vs. 44 months, p =0.011). Nevertheless, categories with ≥5% blasts showed no differences (5-10% vs. 10-20%; 18 vs. 13 months, p =0.39). With approach-B, significant differences were observed among categories with <10% blasts (0-2% vs. 2-<5% vs. 5-10%; 82 vs. 65 vs. 41 months, p =0.032). However, as in IPSS-R, no differences were observed >10% (10-20% vs. >20%; 20 vs. 14 months, p =0.53). Figure 1. Applying approach-A, significant differences in proportion of patients with high-risk karyotype defined by IPSS were seen between ≥5% blasts vs. <5%, but not between 5-<10% and 10-20%. Using approach-B, these differences appeared in 10% cut-off, without differences between 10-<20% and >20%. Therefore, high-risk patients (>10% blasts and high-risk cytogenetics) were better defined by the second method.Conclusion: In agreement with WHO committee recommendations, these results suggest that there is no a uniform criteria for assessment of medullary blasts. Considering percentage of blasts on the basis of non-erythroid compartment might improve the classification and prognostication of MDS with ≥5% blast cells. However in low-blast count patients this approach could overestimate their risk. [Display omitted] [Display omitted] [Display omitted] DisclosuresValcárcel:Celgene Corporation: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Ramos:GlaxoSmithKline: Honoraria; Janssen-Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria; Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria.

Acute and Chronic Pheochromocytoma-Induced Cardiomyopathies: Different Prognoses?: A Systematic Analytical Review.

Pheochromocytoma and paraganglioma (PPG) are rare and late-diagnosed catecholamine secreting tumors, which may be associated with unrecognized and/or severe cardiomyopathies.We performed a computer-assisted systematic search of the electronic Medline databases using the MESH terms “myocarditis,” “myocardial infarction,” “Takotsubo,” “stress cardiomyopathy,” “cardiogenic shock”, or “dilated cardiomyopathy,” and “pheochromocytoma” or “paraganglioma” from 1961 to August 2012. All detailed case reports of cardiomyopathy due to a PPG, without coronary stenosis, and revealed by acute symptoms were included and analyzed.A total of 145 cases reports were collected (49 Takotsubo Cardiomyopathies [TTC] and 96 other Catecholamine Cardiomyopathies [CC]). At initial presentation, prevalence of high blood pressure (87.7%), chest pain (49.0%), headaches (47.6%), palpitations (46.9%), sweating (39.3%), and shock (51.0%) were comparable between CC and TTC. Acute pulmonary edema (58.3% vs 38.8%, P = 0.03) was more frequent in CC. There was no difference in proportion of patients with severe left ventricular systolic dysfunction (LV Ejection Fraction [LVEF] < 30%) at initial presentation between both groups (P = 0.15). LVEF recovery before (64.9% vs 40.8%, P = 0.005) and after surgical resection (97.7% vs73.3%, P = 0.001) was higher in the TTC group. Death occurred in 11 cases (7.6%). In multivariate analysis, only TTC was associated with a better LV recovery (0.15 [0.03–0.67], P = 0.03).Pheochromocytoma and paraganglioma can lead to different cardiomyopathies with the same brutal and life-threatening initial clinical presentation but with a different recovery rate. Diagnosis of unexplained dilated cardiomyopathy or TTC should lead clinicians to a specific search for PPG.

Decreasing the load? Is a Multidisciplinary Multistep Medication Review in older people an effective intervention to reduce a patient's Drug Burden Index? Protocol of a randomised controlled trial

IntroductionOlder people often use medications with anticholinergic or sedative side effects which increase the risk of falling and worsen cognitive impairment. The Drug Burden Index (DBI) is a measure of...

Abstract 15849: Exercise Training in Patients With Implantable Cardioverter Defibrillator: A Meta-analysis of Efficacy and Safety Outcomes

Introduction: Implantable cardioverter defibrillators have been shown to improve survival, however, many patients with ICDs experience fear of shocks and avoid physical activity. Little data exist on efficacy and safety of exercise training in heart failure patients with ICDs. We performed a meta-analysis of currently available randomized clinical trials to assess the efficacy and safety of exercise training in this patient population. Methods: Randomized clinical trials that evaluated the efficacy of exercise training in patients with ICDs were included in the pooled meta-analysis. Primary efficacy outcome was change in cardiorespiratory fitness measured as peak oxygen uptake during a maximal treadmill test (CRF, mL/kg/ per minute). Primary safety outcome was difference in proportion of patients experiencing ICD shocks between exercise and control groups. Results: We included study level data from 1,532 patients (812 in exercise group and 720 in control group) derived from 5 studies which met the inclusion criteria. In the pooled analysis (figure panel 1), patients with ICD undergoing exercise training had significantly improved CRF [Weighted mean difference (95% CI): 1.86 ml/kg/min (0.71 to 3.01)]. There was also a significant reduction in the likelihood of ICD shocks (figure panel 2) in the exercise group compared to control group [Pooled odds ratio (95% CI): 0.71 (0.55 to 0.92)]. Conclusion: Exercise training is associated with significant improvements in CRF levels and reduction in the likelihood of ICD shocks among patients with ICDs.

The Impact of the Risk Evaluation Mitigation Strategy for Erythropoiesis-Stimulating Agents on Their Use and the Incidence of Stroke in Medicare Subjects with Chemotherapy-Induced Anemia with Lung and/or Breast Cancers.

Erythropoiesis-stimulating agents (ESAs), found to be effective in reducing anemia in chemotherapy-treated cancer patients, also are associated with an increased risk of cardiovascular events, including stroke. In an attempt to mitigate the risk, the Food and Drug Administration implemented a Risk Evaluation Mitigation Strategy (REMS) in February 2010. The purpose of this study is to evaluate change over time in the incidence of stroke among these patients before and after implementation of REMS. A retrospective data analysis using the Medicare 5% Sample Dataset, 2008-2011, was performed. Patients had to be 65 years of age or older at the start of at least 1 year of continuous enrollment and to have lung and/or breast cancers along with chemotherapy-induced anemia (CIA) in both pre-REMS and post-REMS periods (1Q2008 through 4Q2009 and 1Q2010 through 4Q2011, respectively). Logistic regression was used to evaluate differences in proportions of patients who received ESAs and experienced a stroke pre and post REMS. The pre-REMS cohort included 1252 eligible patients prescribed ESAs; the post-REMS cohort included 949 patients. No statistically significant change in stroke incidence was observed post REMS among patients with CIA who received ESAs. There was a 29.5% decrease in ESA use in patients with lung cancer and a 27.8% decrease in patients with breast cancer. Both were statistically significant. Results adjusted for baseline characteristics and comorbid conditions were similar. There was a statistically significant decrease in ESA use in patients with breast and/or lung cancers post REMS; no statistically significant reduction in the incidence of stroke was observed regardless of cancer type.

Risk evaluation mitigation strategy: impact of application of the Food and Drug Adminstration's strategy on use of erythropoiesis-stimulating agents and transfusion in patients with chemotherapy-induced anaemia

The Food and Drug Administration (FDA) instituted a risk evaluation mitigation strategy (REMS) for erythropoiesis-stimulating agent (ESA) use in patients with cancer in February 2010. Implementation of REMS was considered likely to reduce ESA use and increase red blood cell transfusions. We aimed to quantify ESA and transfusion use pre- and post-REMS. A retrospective data analysis was conducted using the Medicare 5% Sample Database from 2008 through 2011. Patients were 66years of age or older and had lung and/or breast cancers along with chemotherapy-induced anaemia. Patients initiated chemotherapy in pre-REMS and post-REMS periods (1Q2008 through 4Q2009 and 1Q2010 through 4Q2011, respectively). Logistic regression was used to evaluate differences in proportions of patients receiving ESAs and transfusions pre-REMS and post-REMS. The pre-REMS group included 1526 patients and the post-REMS group included 1689 patients. ESA use in patients with lung cancer decreased 30·2% from pre- to post-REMS and 33·1% in patients with breast cancer. Both decreases were statistically significant. Transfusion rates increased 22·1% from the pre-REMS period to the pre-REMS period in patients with breast cancer (P<0·0001), but there was no statistically significant change over time in patients with lung cancer. Erythropoiesis-stimulating agent use decreased in patients with both lung and breast cancer (P<0·0001), and transfusion rates increased significantly post-REMS in patients with breast cancer (P<0·0001) but not in those with lung cancer.

Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial

Objective To evaluate whether a disease activity guided strategy of dose reduction of two tumour necrosis factor (TNF) inhibitors, adalimumab or etanercept, is non-inferior in maintaining disease control in patients...

Epilepsy in primary intracranial tumors in a neurosurgical hospital in Enugu, South-East Nigeria.

Seizures may be manifestation of intracranial tumor (IT) and demand thorough neurological evaluation. This paper examines epidemiology, lesion characteristics and outcome of seizures associated with primary IT. Retrospective analysis of medical records, computed tomography and magnetic resonance imaging of patients diagnosed with IT who presented with seizure from 2003 to 2013 at Memfys Hospital for Neurosurgery Enugu. Postoperative seizure outcome was based on Engel classification and correlated with tumor histology, patient age, anatomical location, time of presentation and extent of tumor resection. Data were analyzed using descriptive and inferential statistics. Sixty-two patients (34.6%) presenting with seizures were analyzed. Peak age at presentation was in 6 th decade. Age of seizure onset had bimodal peak at 4 th and 6 th decades. Apart from IT located in posterior fossa with mortality of 62.5%, postoperative mortality did not depend on anatomical location of tumor. Postoperative seizure outcome and mortality depend on tumor histology (P = 0.025) and preoperative seizure duration (P = 0.036). Seizure duration shorter than 1 month had poor postoperative seizure outcome and high mortality. Although more patients with meningioma experienced seizures compared to glioma (P = 0.025), there was no difference in proportion of patients with meningioma and glioma who presented with seizure (P = 1.00). Extent of resection predicts postoperative seizure outcome based on meningioma sub-group analysis. Overall, 59.7% of patients had good postoperative seizure outcome, 21.0% had poor outcome and 19.3% died. Seizures of short duration, IT located in posterior fossa and gliomas are associated with poor postoperative seizure outcome and high patient mortality. Tumor histology does not seem to affect seizure predisposition. Most seizures associated with IT occur in fifth and sixth decades of life and affect frontal lobe most often.