Sample records for early clinical outcomes

  1. Early clinical outcomes following laparoscopic inguinal hernia repair.

    PubMed

    Tolver, Mette Astrup

    2013-07-01

    Laparoscopic inguinal hernia repair (TAPP) has gained increasing popularity because of less post-operative pain and a shorter duration of convalescence compared with open hernia repair technique (Lichtenstein). However, investigation of duration of convalescence with non-restrictive recommendations, and a procedure-specific characterization of the early clinical outcomes after TAPP was lacking. Furthermore, optimization of the post-operative period with fibrin sealant versus tacks for fixation of mesh, and the glucocorticoid dexamethasone versus placebo needed to be investigated in randomized clinical trials. The objective of this PhD thesis was to characterize the early clinical outcomes after TAPP and optimize the post-operative period. The four studies included in this thesis have investigated duration of convalescence and procedure-specific post-operative pain and other early clinical outcomes after TAPP. Furthermore, it has been shown that fibrin sealant can improve the early post-operative period compared with tacks, while dexamethasone showed no advantages apart from reduced use of antiemetics compared with placebo. Based on these findings, and the existing knowledge, 3-5 days of convalescence should be expected when 1 day of convalescence is recommended and future studies should focus on reducing intraabdominal pain after TAPP. Fibrin sealant can optimize the early clinical outcomes but the risk of hernia recurrence and chronic pain needs to be evaluated. Dexamethasone should be investigated in higher doses.

  2. Early-Onset Bipolar Disorder: Characteristics and Outcomes in the Clinic.

    PubMed

    Connor, Daniel F; Ford, Julian D; Pearson, Geraldine S; Scranton, Victoria L; Dusad, Asha

    2017-12-01

    To assess patient characteristics and clinician-rated outcomes for children diagnosed with early-onset bipolar disorder in comparison to a depressive disorders cohort from a single clinic site. To assess predictors of bipolar treatment response. Medical records from 714 consecutive pediatric patients evaluated and treated at an academic tertiary child and adolescent psychiatry clinic between 2006 and 2012 were reviewed. Charts of bipolar children (n = 49) and children with depressive disorders (n = 58) meeting study inclusion/exclusion criteria were compared on variables assessing clinical characteristics, treatments, and outcomes. Outcomes were assessed by using pre- and post-Clinical Global Impressions (CGI)-Severity and Children's Global Assessment Scale (CGAS) scores, and a CGI-Improvement score ≤2 at final visit determined responder status. Bipolar outcome predictors were assessed by using multiple linear regression. Clinic prevalence rates were 6.9% for early-onset bipolar disorder and 1.5% for very early-onset bipolar disorder. High rates of comorbid diagnoses, symptom severity, parental stress, and child high-risk behaviors were found in both groups. The bipolar cohort had higher rates of aggression and higher lifetime systems of care utilization. The final CGI and CGAS outcomes for unipolar depression patients differed statistically significantly from those for the bipolar cohort, reflecting better clinical status and more improvement at outcome for the depression patients. Both parent-reported Child Behavior Checklist total T-score at clinic admission and the number of lifetime systems-of-care for the child were significantly and inversely associated with improvement for the bipolar cohort. Early-onset bipolar disorder is a complex and heterogeneous psychiatric disorder. Evidence-based treatment should emphasize psychopharmacology with adjunctive family and individual psychotherapy. Strategies to improve engagement in treatment may be especially

  3. A comparison between the clinical significance and growth mixture modelling early change methods at predicting negative outcomes.

    PubMed

    Flood, Nicola; Page, Andrew; Hooke, Geoff

    2018-05-03

    Routine outcome monitoring benefits treatment by identifying potential no change and deterioration. The present study compared two methods of identifying early change and their ability to predict negative outcomes on self-report symptom and wellbeing measures. 1467 voluntary day patients participated in a 10-day group Cognitive Behaviour Therapy (CBT) program and completed the symptom and wellbeing measures daily. Early change, as defined by (a) the clinical significance method and (b) longitudinal modelling, was compared on each measure. Early change, as defined by the simpler clinical significance method, was superior at predicting negative outcomes than longitudinal modelling. The longitudinal modelling method failed to detect a group of deteriorated patients, and agreement between the early change methods and the final unchanged outcome was higher for the clinical significance method. Therapists could use the clinical significance early change method during treatment to alert them of patients at risk for negative outcomes, which in turn could allow therapists to prevent those negative outcomes from occurring.

  4. Early clinical outcomes of primary percutaneous coronary intervention in bharatpur, Nepal.

    PubMed

    Dubey, Laxman; Bhattacharya, Rabindra; Guruprasad, Sogunuu; Subramanyam, Gangapatnam

    2013-06-01

    Primary percutaneous coronary intervention represents one of the cornerstone management modalities for patients with acute ST-elevation myocardial infarction and has undergone tremendous growth over the past two decades. This study was aimed to determine the early clinical outcomes of primary percutaneous coronary interventions in a tertiary-level teaching hospital without onsite cardiac surgery backup. This was a prospective descriptive study which included all consecutive patients who were admitted for primary percutaneous coronary interventions between March 2011 and January 2013 at the College of Medical Sciences and Teaching Hospital, Bharatpur, Nepal. Total 68 patients underwent primary percutaneous coronary interventions as a mode of revascularization. The primary end point of the study was to identify in-hospital as well as 30-day clinical outcomes of primary percutaneous coronary interventions. The mean age was 56.31 ± 11.47 years, with age range of 32 years to 91 years. Of the 68 primary percutaneous coronary interventions performed, 15 (22.05%) were carried out in women and 10 (14.70%) in patients over 75 years of age. Primary percutaneous coronary intervention for anterior wall myocardial infarction was more common than for non-anterior wall myocardial infarction (55.88% vs. 44.12%). Proximal artery stenting was performed in 38.50% and the non proximal artery stenting in 61.50%. The outcomes were mortality (5.88%), cardiogenic shock (5.88%), contrast-induced nephropathy requiring dialysis (2.94%), arrhythmias requiring treatment (4.41%), early stent thrombosis (2.94%) and minor complications (14.70%). Primary percutaneous coronary intervention improves the early clinical outcomes in patient with acute ST-elevation myocardial infarction. Despite having no onsite cardiac surgery backup, primary percutaneous coronary intervention was feasible with acceptable complications in a tertiary-care teaching hospital.

  5. Early Generalized Overgrowth in Autism Spectrum Disorder: Prevalence Rates, Gender Effects, and Clinical Outcomes

    PubMed Central

    Campbell, Daniel J.; Chang, Joseph; Chawarska, Katarzyna

    2014-01-01

    Objective Although early head and body overgrowth have been well-documented in autism spectrum disorder (ASD), their prevalence and significance remain unclear. It is also unclear whether overgrowth affects males and females differentially, and whether it is associated with clinical outcomes later in life. Method To evaluate prevalence of somatic overgrowth, gender effects, and associations with clinical outcomes, head circumference, height, and weight measurements were collected retrospectively between birth and 2 years of age in toddlers with ASD (n=200) and typically developing (TD; n=147) community controls. Symptom severity, verbal, and nonverbal functioning were assessed at 4 years. Results Abnormalities in somatic growth in infants with ASD were consistent with early generalized overgrowth (EGO). Boys but not girls with ASD were larger and exhibited an increased rate of extreme EGO compared to community controls (18.0% versus 3.4%). Presence of a larger body at birth and postnatal overgrowth were associated independently with poorer social, verbal, and nonverbal skills at 4 years. Conclusion Although early growth abnormalities in ASD are less common than previously thought, their presence is predictive of lower social, verbal, and nonverbal skills at 4 years, suggesting that they may constitute a biomarker for identifying toddlers with ASD at risk for less-optimal outcomes. The results highlight that the search for mechanisms underlying atypical brain development in ASD should consider factors responsible for both neural and non-neural tissue development during prenatal and early postnatal periods, and can be informed by the finding that early overgrowth may be more readily observed in males than females with ASD. PMID:25245350

  6. Outcomes of laparoscopic fertility-sparing surgery in clinically early-stage epithelial ovarian cancer.

    PubMed

    Park, Jin-Young; Heo, Eun Jin; Lee, Jeong-Won; Lee, Yoo-Young; Kim, Tae-Joong; Kim, Byoung-Gie; Bae, Duk-Soo

    2016-03-01

    Fertility-sparing surgery (FSS) is becoming an important technique in the surgical management of young women with early-stage epithelial ovarian cancer (EOC). We retrospectively evaluated the outcome of laparoscopic FSS in presumed clinically early-stage EOC. We retrospectively searched databases of patients who received laparoscopic FSS for EOC between January 1999 and December 2012 at Samsung Medical Center. Women aged ≤40 years were included. The perioperative, oncological, and obstetric outcomes of these patients were evaluated. A total of 18 patients was evaluated. The median age of the patients was 33.5 years (range, 14 to 40 years). The number of patients with clinically stage IA and IC was 6 (33.3%) and 12 (66.7%), respectively. There were 7 (38.9%), 5 (27.8%), 3 (16.7%), and 3 patients (16.7%) with mucinous, endometrioid, clear cell, and serous tumor types, respectively. Complete surgical staging to preserve the uterus and one ovary with adnexa was performed in 4 patients (22.2%). Two out of them were upstaged to The International Federation of Gynecology and Obstetrics stage IIIA1. During the median follow-up of 47.3 months (range, 11.5 to 195.3 months), there were no perioperative or long term surgical complications. Four women (22.2%) conceived after their respective ovarian cancer treatments. Three (16.7%) of them completed full-term delivery and one is expecting a baby. One patient had disease recurrence. No patient died of the disease. FSS in young patients with presumed clinically early-stage EOC is a challenging and cautious procedure. Further studies are urgent to determine the safety and feasibility of laparoscopic FSS in young patients with presumed clinically early-stage EOC.

  7. Outcomes of laparoscopic fertility-sparing surgery in clinically early-stage epithelial ovarian cancer

    PubMed Central

    Park, Jin-Young; Lee, Yoo-Young; Kim, Tae-Joong; Kim, Byoung-Gie; Bae, Duk-Soo

    2016-01-01

    Objective Fertility-sparing surgery (FSS) is becoming an important technique in the surgical management of young women with early-stage epithelial ovarian cancer (EOC). We retrospectively evaluated the outcome of laparoscopic FSS in presumed clinically early-stage EOC. Methods We retrospectively searched databases of patients who received laparoscopic FSS for EOC between January 1999 and December 2012 at Samsung Medical Center. Women aged ≤40 years were included. The perioperative, oncological, and obstetric outcomes of these patients were evaluated. Results A total of 18 patients was evaluated. The median age of the patients was 33.5 years (range, 14 to 40 years). The number of patients with clinically stage IA and IC was 6 (33.3%) and 12 (66.7%), respectively. There were 7 (38.9%), 5 (27.8%), 3 (16.7%), and 3 patients (16.7%) with mucinous, endometrioid, clear cell, and serous tumor types, respectively. Complete surgical staging to preserve the uterus and one ovary with adnexa was performed in 4 patients (22.2%). Two out of them were upstaged to The International Federation of Gynecology and Obstetrics stage IIIA1. During the median follow-up of 47.3 months (range, 11.5 to 195.3 months), there were no perioperative or long term surgical complications. Four women (22.2%) conceived after their respective ovarian cancer treatments. Three (16.7%) of them completed full-term delivery and one is expecting a baby. One patient had disease recurrence. No patient died of the disease. Conclusion FSS in young patients with presumed clinically early-stage EOC is a challenging and cautious procedure. Further studies are urgent to determine the safety and feasibility of laparoscopic FSS in young patients with presumed clinically early-stage EOC. PMID:26768783

  8. Clinical outcome of critically ill patients with thrombocytopenia and hypophosphatemia in the early stage of sepsis.

    PubMed

    Brotfain, Evgeni; Schwartz, Andrei; Boniel, Avi; Koyfman, Leonid; Boyko, Matthew; Kutz, Ruslan; Klein, Moti

    2016-01-01

    Hypophosphatemia and thrombocytopenia may both be independent risk factors for the development of multiple organ failure and correlate well with the severity of sepsis. In the present study we wanted to analyze the potential clinical role and prognostic significance of both early hypophosphatemia and thrombocytopenia on clinical outcomes of critically ill ICU patients with severe sepsis. We analyzed the clinical data, including the outcome of critically ill ICU patients with severe sepsis who presented during a 5 year period with early hypophosphatemia and thrombocytopenia.This study was retrospective and single centre. All clinical and laboratory data was collected from the patients' ICU and hospital electronic records. All laboratory measurements were done on admission and during the ICU stay. The included patients were distributed into one of three study groups based on the presence of hypophosphatemia and/or thrombocytopenia during the first 24 hours of admission to the ICU: group 1 - early hypophosphatemia; group 2 - early hypophosphatemia and thrombocytopenia and group 3 - early thrombocytopenia. The ICU mortality rate was significantly higher in groups 2 and 3 (25.9% and 22% vs. 9.3%, respectively, P = 0.034). An APACHE II > 27, a TISS > 25 following the first 24 hours of ICU stay , an age higher than 70, male gender and total parenteral nutrition were independent predictors of ICU and hospital mortality in this study population. It may be considered that hypophosphatemia and thrombocytopenia in the early stage of sepsis, even when severe and coexisting, reflect the degree of initial illness severity of sepsis. However, further investigations need to be done for a better understanding of the potential clinical role of these features in the septic critically ill population.

  9. Patient-specific instrumentation improved mechanical alignment, while early clinical outcome was comparable to conventional instrumentation in TKA.

    PubMed

    Anderl, Werner; Pauzenberger, Leo; Kölblinger, Roman; Kiesselbach, Gabriele; Brandl, Georg; Laky, Brenda; Kriegleder, Bernhard; Heuberer, Philipp; Schwameis, Eva

    2016-01-01

    The aim of this prospective study was to compare early clinical outcome, radiological limb alignment, and three-dimensional (3D)-component positioning between conventional and computed tomography (CT)-based patient-specific instrumentation (PSI) in primary mobile-bearing total knee arthroplasty (TKA). Two hundred ninety consecutive patients (300 knees) with severe, debilitating osteoarthritis scheduled for TKA were included in this study using either conventional instrumentation (CVI, n = 150) or PSI (n = 150). Patients were clinically assessed before and 2 years after surgery according to the Knee-Society-Score (KSS) and the visual-analog-scale for pain (VAS). Additionally, the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) and the Oxford-Knee-Score (OKS) were collected at follow-up. To evaluate accuracy of CVI and PSI, hip-knee-ankle angle (HKA) and 3D-component positioning were assessed on postoperative radiographs and CT. Data of 222 knees (CVI: n = 108, PSI: n = 114) were available for analysis after a mean follow-up of 28.6 ± 5.2 months. At the early follow-up, clinical outcome (KSS, VAS, WOMAC, OKS) was comparable between the two groups. Mean HKA-deviation from the targeted neutral mechanical axis (CVI: 2.2° ± 1.7°; PSI: 1.5° ± 1.4°; p < 0.001), rates of outliers (CVI: 22.2%; PSI: 9.6%; p = 0.016), and 3D-component positioning outliers were significantly lower in the PSI group. Non-outliers (HKA: 180° ± 3°) showed better clinical results than outliers at the 2-year follow-up. CT-based PSI compared with CVI improves accuracy of mechanical alignment restoration and 3D-component positioning in primary TKA. While clinical outcome was comparable between the two instrumentation groups at early follow-up, significantly inferior outcome was detected in the subgroup of HKA-outliers. Prospective comparative study, Level II.

  10. Clinical characteristics of early-stage osteonecrosis of the ankle and treatment outcomes.

    PubMed

    Issa, Kimona; Naziri, Qais; Kapadia, Bhaveen H; Lamm, Bradley M; Jones, Lynne C; Mont, Michael A

    2014-05-07

    The purposes of this study were to describe the clinical manifestations of osteonecrosis involving the distal tibia and talus, to identify risk factors associated with the disease, and to evaluate the efficacy of percutaneous drilling for the treatment of ankles with early-stage symptomatic osteonecrosis. One hundred and one ankles in seventy-three patients with symptomatic osteonecrosis of the talus and/or distal tibia treated with percutaneous drilling were identified. There were eighty-one ankles in fifty-nine patients treated only at our institution and twenty ankles in fourteen patients with a failed prior core decompression at outside institutions. The parameters evaluated included demographics, disease characteristics, clinical outcomes including the American Orthopaedic Foot & Ankle Society score, Short-Form-36 scores, University of California Los Angeles activity scores, and visual analog scale pain scores, and radiographic outcomes at a mean follow-up duration of five years (range, two to nine years). Eighty-five ankles had isolated talus osteonecrosis, eleven ankles had involvement of the distal tibia and talus, and five ankles had isolated distal tibial disease. Twenty-nine patients (40%) had initially presented with symptomatic osteonecrosis of another joint, most commonly the knee (37%), the hip (29%), and the shoulder (25%). The most common identifiable risk factors included chronic corticosteroid use (49.3%), alcohol abuse (35.6%), tobacco use (29%), and hypertension (20.5%). Overall, 83% of ankles did not demonstrate further disease progression after the procedure. There were significant improvements (p < 0.05) in clinical and patient-reported outcomes after surgical treatment. The presence of human immunodeficiency virus and sickle cell disease was associated with a higher odds ratio of disease progression to joint collapse. Osteonecrosis of the distal tibia and talus was usually part of multifocal disease, and concurrent knee osteonecrosis was

  11. Early antihypertensive treatment and clinical outcomes in acute ischemic stroke: subgroup analysis by baseline blood pressure.

    PubMed

    He, William J; Zhong, Chongke; Xu, Tan; Wang, Dali; Sun, Yingxian; Bu, Xiaoqing; Chen, Chung-Shiuan; Wang, Jinchao; Ju, Zhong; Li, Qunwei; Zhang, Jintao; Geng, Deqin; Zhang, Jianhui; Li, Dong; Li, Yongqiu; Yuan, Xiaodong; Zhang, Yonghong; Kelly, Tanika N

    2018-06-01

    We studied the effect of early antihypertensive treatment on death, major disability, and vascular events among patients with acute ischemic stroke according to their baseline SBP. We randomly assigned 4071 acute ischemic stroke patients with SBP between 140 and less than 220 mmHg to receive antihypertensive treatment or to discontinue all antihypertensive medications during hospitalization. A composite primary outcome of death and major disability and secondary outcomes were compared between treatment and control stratified by baseline SBP levels of less than 160, 160-179, and at least 180 mmHg. At 24 h after randomization, differences in SBP reductions were 8.8, 8.6 and 7.8 mmHg between the antihypertensive treatment and control groups among patients with baseline SBP less than 160, 160-179, and at least 180 mmHg, respectively (P < 0.001 among subgroups). At day 14 or hospital discharge, the primary and secondary outcomes were not significantly different between the treatment and control groups among subgroups. However, there was a significant interaction between antihypertensive treatment and baseline SBP subgroups on death (P = 0.02): odds ratio (95% CI) of 2.42 (0.74-7.89) in patients with baseline SBP less than 60 mmHg and 0.34 (0.11-1.09) in those with baseline SBP at least 180 mmHg. At the 3-month follow-up, the primary and secondary clinical outcomes were not significantly different between the treatment and control groups by baseline SBP levels. Early antihypertensive treatment had a neutral effect on clinical outcomes among acute ischemic stroke patients with various baseline SBP levels. Future clinical trials are warranted to test BP-lowering effects in acute ischemic stroke patients by baseline SBP levels. ClinicalTrials.gov Identifier: NCT01840072.

  12. Early-Life Trauma in Hospitalized Patients With Mood Disorders and Its Association With Clinical Outcomes.

    PubMed

    Parsaik, Ajay K; Abdelgawad, Noha; Chotalia, Jigar K; Lane, Scott D; Pigott, Teresa A

    2017-01-01

    The prevalence of childhood trauma and its impact on clinical outcomes in hospitalized patients with mood disorders is unknown. We studied the frequency of childhood trauma among inpatient adults with mood disorders and its association with clinical outcomes. Patients admitted to our hospital with a primary diagnosis of mood disorders completed the short form of the Early Trauma Inventory-Self-Report (ETISR-SF), the Sheehan Disability Scale, and the Clinician-Rated Dimensions of Psychosis Symptom Severity scale. A regression model adjusted for multiple comparisons was used to examine the association between scores on the ETISR-SF and clinical outcomes. Subjects were 167 patients, all of whom reported ≥1 types of childhood trauma: 90% general trauma, 75% physical abuse, 71% emotional abuse, 50% sexual abuse, and 35% all 4 types of abuse. The subtypes of abuse did not differ by sex or race. Diagnoses in the sample were bipolar disorder 56%, major depressive disorder 24%, schizoaffective disorder 14%, and substance-induced mood disorder 5%. The mean age in the sample was 35±11.5 years, 53% were male, and 64% also had substance abuse disorders. Higher scores on the ETISR-SF were associated with longer hospital stays [odds ratio (OR)=1.13; 95% confidence interval (CI), 1.05-1.22], and greater disruption of work/school life (OR=1.12; 95% CI, 1.04-1.21). There was also a trend for higher ETISR-SF scores to be associated with more severe psychotic symptoms (OR=1.13; 95% CI, 1.01-1.27) and more disruption in social (OR=1.14; 95% CI, 1.06-1.22) and family life (OR=1.09; 95% CI, 1.02-1.17). Childhood trauma was reported by all of the 167 patients, with general trauma the most common and approximately half reporting sexual abuse. Childhood trauma was associated with poor clinical outcomes. Early recognition of trauma and trauma-related therapeutic interventions may improve outcomes.

  13. Differences between WHO AND CDC early growth measurements in the assessment of Cystic Fibrosis clinical outcomes.

    PubMed

    Usatin, Danielle; Yen, Elizabeth H; McDonald, Catherine; Asfour, Fadi; Pohl, John; Robson, Jacob

    2017-07-01

    Early childhood growth status has been used to predict long-term clinical outcomes in Cystic Fibrosis (CF) patients. Adulthood CF outcomes based on early weight-for-length (WFL) measurements, using either World Health Organization (WHO) or Centers for Disease Control (CDC) scales, have not been compared. Cystic Fibrosis Foundation registry patients were studied (n=3014). Participants were categorized at age two years as WFL <50th percentile on both WHO and CDC scales, ≥50th percentile on WHO but not CDC, or ≥50th percentile on both. Pulmonary function and overall survival were assessed at age 18years. Stepwise gains in pulmonary function and lung transplant-free survival were noted across the three increasing WFL categories. Children with CF who achieve higher WFL at age two years have improved pulmonary and survival outcomes into adulthood. CF providers should continue to utilize current early growth recommendations, with goal WFL ≥50th percentile on CDC growth charts before age two. Copyright © 2016 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

  14. Linear Combinations of Multiple Outcome Measures to Improve the Power of Efficacy Analysis ---Application to Clinical Trials on Early Stage Alzheimer Disease

    PubMed Central

    Xiong, Chengjie; Luo, Jingqin; Morris, John C; Bateman, Randall

    2018-01-01

    Modern clinical trials on Alzheimer disease (AD) focus on the early symptomatic stage or even the preclinical stage. Subtle disease progression at the early stages, however, poses a major challenge in designing such clinical trials. We propose a multivariate mixed model on repeated measures to model the disease progression over time on multiple efficacy outcomes, and derive the optimum weights to combine multiple outcome measures by minimizing the sample sizes to adequately power the clinical trials. A cross-validation simulation study is conducted to assess the accuracy for the estimated weights as well as the improvement in reducing the sample sizes for such trials. The proposed methodology is applied to the multiple cognitive tests from the ongoing observational study of the Dominantly Inherited Alzheimer Network (DIAN) to power future clinical trials in the DIAN with a cognitive endpoint. Our results show that the optimum weights to combine multiple outcome measures can be accurately estimated, and that compared to the individual outcomes, the combined efficacy outcome with these weights significantly reduces the sample size required to adequately power clinical trials. When applied to the clinical trial in the DIAN, the estimated linear combination of six cognitive tests can adequately power the clinical trial. PMID:29546251

  15. Custom-fit minimally invasive total knee arthroplasty: effect on blood loss and early clinical outcomes.

    PubMed

    Pietsch, M; Djahani, O; Zweiger, Ch; Plattner, F; Radl, R; Tschauner, Ch; Hofmann, S

    2013-10-01

    Recently, new custom-fit pin guides in total knee arthroplasty (TKA) have been introduced. Use of these guides may reduce operating time. Use of the guides combined with the absence of intramedullary alignment jigs may lead to reduced blood loss and improved early outcomes. Our aim was to evaluate blood loss and early clinical outcomes in patients undergoing minimally invasive TKA using custom-fit magnetic resonance imaging (MRI)-based pin guides. A prospective study in 80 patients was carried out. Patients were divided randomly into 2 equal groups. In one group, intramedullary alignment jigs were used. In the second group, custom-fit MRI-based pin guides were used. All patients received the same cemented posterior-stabilized implant through a mini-midvastus approach. The volume in the drain bottles was recorded after 48 h. Hb loss was estimated by subtracting the postoperative from the preoperative Hb level. Transfusion requirements and surgical time were recorded. Outcome measures were Knee Society Scores (KSS), knee flexion, knee swelling and pain. There was lower mean drainage of blood in the custom-fit group (391 ml vs. 603 ml; p < 0.0001). There was no difference in estimated loss of Hb (3.6 g/dl vs. 4.1 g/dl; n.s.) and in transfusion requirements (7.5 % vs. 10 %; n.s.). Surgical time was reduced in the custom-fit group (12 min less; p = 0.001). KSS measured at week 2, 6 and 12 showed no significant difference between groups. Knee flexion measured on days 7, 10 and at week 6, 12 and knee swelling and pain measured on days 1, 3, 10 and at week 6, 12 showed no significant difference between groups. Using custom-fit pin guides reduces blood drainage, but not the estimated Hb loss in minimally invasive TKA and does not affect transfusion rate. Surgical time is reduced. There is no effect on the early clinical outcomes. Therapeutic study, Level I.

  16. Off-label thrombolysis versus full adherence to the current European Alteplase license: impact on early clinical outcomes after acute ischemic stroke.

    PubMed

    Cappellari, Manuel; Moretto, Giuseppe; Micheletti, Nicola; Donato, Francesco; Tomelleri, Giampaolo; Gulli, Giosuè; Carletti, Monica; Squintani, Giovanna Maddalena; Zanoni, Tiziano; Ottaviani, Sarah; Romito, Silvia; Tommasi, Giorgio; Musso, Anna Maria; Deotto, Luciano; Gambina, Giuseppe; Zimatore, Domenico Sergio; Bovi, Paolo

    2014-05-01

    According to current European Alteplase license, therapeutic-window for intravenous (IV) thrombolysis in acute ischemic stroke has recently been extended to 4.5 h after symptoms onset. However, due to numerous contraindications, the portion of patients eligible for treatment still remains limited. Early neurological status after thrombolysis could identify more faithfully the impact of off-label Alteplase use that long-term functional outcome. We aimed to identify the impact of off-label thrombolysis and each off-label criterion on early clinical outcomes compared with the current European Alteplase license. We conducted an analysis on prospectively collected data of 500 consecutive thrombolysed patients. The primary outcome measures included major neurological improvement (NIHSS score decrease of ≤8 points from baseline or NIHSS score of 0) and neurological deterioration (NIHSS score increase of ≥4 points from baseline or death) at 24 h. We estimated the independent effect of off-label thrombolysis and each off-label criterion by calculating the odds ratio (OR) with 2-sided 95% confidence interval (CI) for each outcome measure. As the reference, we used patients fully adhering to the current European Alteplase license. 237 (47.4%) patients were treated with IV thrombolysis beyond the current European Alteplase license. We did not find significant differences between off- and on-label thrombolysis on early clinical outcomes. No off-label criteria were associated with decreased rate of major neurological improvement compared with on-label thrombolysis. History of stroke and concomitant diabetes was the only off-label criterion associated with increased rate of neurological deterioration (OR 5.84, 95% CI 1.61-21.19; p = 0.024). Off-label thrombolysis may be less effective at 24 h than on-label Alteplase use in patients with previous stroke and concomitant diabetes. Instead, the impact of other off-label criteria on early clinical outcomes was not different

  17. Impact of early postoperative enteral nutrition on clinical outcomes in patients with gastric cancer.

    PubMed

    Li, B; Liu, H Y; Guo, S H; Sun, P; Gong, F M; Jia, B Q

    2015-06-29

    The impact of early enteral nutrition (EEN) on clinical outcomes of gastric cancer patients was investigated. Three hundred pa-tients undergoing gastric cancer surgery from July 2010 to May 2014 were randomly divided into experimental and control groups (n = 150/group). Experimental group patients received enteral nutrition in water during the early postoperative period. Control group patients received conventional perioperative treatment. Patients' clinical outcomes, post-operative immune function, and nutritional statuses were compared, which revealed that the postoperative fever duration (80.2 ± 6.0 vs 88.1 ± 8.1 h, P < 0.05), anal exhaust time (78.8 ± 9.3 vs 85.3 ± 8.4 h, P < 0.05), and length of hospitalization (7.73 ± 2.13 vs 9.77 ± 1.76 days, P < 0.01) differed significantly. Treatment costs in thousands of dol-lars were 31.24 ± 3.21 for the experimental group and 35.61 ± 2.32 for the control group; this difference was statistically significant (P < 0.01). The incidence of postoperative complications did not significantly differ between the experimental and control groups [14.0% (21/150) vs 17.3% (26/150), P > 0.05]. At postoperative days 3 and 7, the CD3(+), CD4(+), natural killer cell, albumin, and prealbumin levels and CD4(+)/CD8(+) ra-tio were significantly higher in the experimental group than the control group (all P < 0.05). CD8(+) cell counts were significantly lower in the experimental group than the control group (P < 0.05). Postsurgical oral EEN can improve nutritional status and immune function and promote early recovery of intestinal function in patients with gastric cancer.

  18. Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

    PubMed

    Sennerby, L; Gottlow, J

    2008-06-01

    Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

  19. Do early career indicators of clinical skill predict subsequent career outcomes and practice characteristics for general internists?

    PubMed

    Gray, Bradley; Reschovsky, James; Holmboe, Eric; Lipner, Rebecca

    2013-06-01

    To study relationships between clinical skill measures assessed at the beginning of general internists' careers and their career outcomes and practice characteristics. General Internist Community Tracking Study Physician Survey respondents (2000-2001, 2004-2005) linked with residency program evaluations and American Board of Internal Medicine board certification examination score records; n = 2,331. Cross-sectional regressions of career outcome and practice characteristic measures on board examination scores/success, residency evaluations interacted with residency type, and potential confounding variables. Failure to achieve board certification was associated with $27,206 (18 percent, p < .05) less income and 14.9 percent more minority patients relative to physicians scoring in the bottom quartile on their initial examination who eventually became certified (p < .01). Other skill measures were not associated with income. Scoring in the top rather than bottom quartile on the board certification examination was associated with 9 percent increased likelihood of reporting high career satisfaction (p < .05). Among physicians trained in community hospital residency programs, lower evaluations were associated with 14.5 percent higher share of minority patients (p < .05). Both skill measures were associated with practice type. There are associations between early career skill measures and career outcomes. In addition, minority patients are more likely to be treated by physicians with lower early career clinical skills measures than nonminority patients. © Health Research and Educational Trust.

  20. Effect of early tracheostomy on resource utilization and clinical outcomes in critically ill patients: meta-analysis of randomized controlled trials.

    PubMed

    Szakmany, T; Russell, P; Wilkes, A R; Hall, J E

    2015-03-01

    Early tracheostomy may decrease the duration of mechanical ventilation, sedation exposure, and intensive care stay, possibly resulting in improved clinical outcomes, but the evidence is conflicting. Systematic review and meta-analysis of randomized trials in patients allocated to tracheostomy within 10 days of start of mechanical ventilation was compared with placement of tracheostomy after 10 days if still required. Medline, EMBASE, the Cochrane Controlled Clinical Trials Register, and Google Scholar were searched for eligible trials. The co-primary outcomes were mortality within 60 days, and duration of mechanical ventilation, sedation, and intensive care unit stay. Secondary outcomes were the number of tracheostomy procedures performed, and incidence of ventilator-associated pneumonia (VAP). Outcomes are described as relative risk or weighted mean difference with 95% confidence intervals. Of note, 4482 publications were identified and 14 trials enrolling 2406 patients were included. Tracheostomy within 10 days was not associated with any difference in mortality [risk ratio (RR): 0.93 (0.83-1.05)]. There were no differences in duration of mechanical ventilation [-0.19 days (-1.13-0.75)], intensive care stay [-0.83 days (-2.05-0.40)], or incidence of VAP. However, duration of sedation was reduced in the early tracheostomy groups [-2.78 days (-3.68 to -1.88)]. More tracheostomies were performed in patients randomly assigned to receive early tracheostomy [RR: 2.53 (1.18-5.40)]. We found no evidence that early (within 10 days) tracheostomy reduced mortality, duration of mechanical ventilation, intensive care stay, or VAP. Early tracheostomy leads to more procedures and a shorter duration of sedation. © The Author 2014. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. Developmental outcomes after early prefrontal cortex damage.

    PubMed

    Eslinger, Paul J; Flaherty-Craig, Claire V; Benton, Arthur L

    2004-06-01

    The neuropsychological bases of cognitive, social, and moral development are minimally understood, with a seemingly wide chasm between developmental theories and brain maturation models. As one approach to bridging ideas in these areas, we review 10 cases of early prefrontal cortex damage from the clinical literature, highlighting overall clinical profiles and real life developmental outcomes. Based on these cases, there is preliminary evidence to support distinctive developmental differences after: (1) dorsolateral, (2) mesial, and (3) orbital-polar prefrontal lesions, for more profound impairments after bilateral damage, and possibly for recovery differences after very early vs. later childhood lesion onset. Further case and group studies are needed to confirm reliable effects of specific lesion locations, the influence of age of lesion onset, and related experiential and treatment variables in determining adult outcomes. Rather than a single underlying deficit associated with early prefrontal cortex damage, we interpret the findings to suggest that it is the altered integration and interplay of cognitive, emotional, self-regulatory, and executive/metacognitive deficits that contribute to diverse developmental frontal lobe syndromes. The findings support the fundamental importance of prefrontal cortex maturation in protracted cognitive, social-emotional, and moral development.

  2. Lack of Early Improvement Predicts Poor Outcome Following Acute Intracerebral Hemorrhage.

    PubMed

    Yogendrakumar, Vignan; Smith, Eric E; Demchuk, Andrew M; Aviv, Richard I; Rodriguez-Luna, David; Molina, Carlos A; Silva Blas, Yolanda; Dzialowski, Imanuel; Kobayashi, Adam; Boulanger, Jean-Martin; Lum, Cheemun; Gubitz, Gord; Padma, Vasantha; Roy, Jayanta; Kase, Carlos S; Bhatia, Rohit; Ali, Myzoon; Lyden, Patrick; Hill, Michael D; Dowlatshahi, Dar

    2018-04-01

    There are limited data as to what degree of early neurologic change best relates to outcome in acute intracerebral hemorrhage. We aimed to derive and validate a threshold for early postintracerebral hemorrhage change that best predicts 90-day outcomes. Derivation: retrospective analysis of collated clinical stroke trial data (Virtual International Stroke Trials Archive). retrospective analysis of a prospective multicenter cohort study (Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign [PREDICT]). Neurocritical and ICUs. Patients with acute intracerebral hemorrhage presenting less than 6 hours. Derivation: 552 patients; validation: 275 patients. None. We generated a receiver operating characteristic curve for the association between 24-hour National Institutes of Health Stroke Scale change and clinical outcome. The primary outcome was a modified Rankin Scale score of 4-6 at 90 days; secondary outcomes were other modified Rankin Scale score ranges (modified Rankin Scale, 2-6, 3-6, 5-6, 6). We employed Youden's J Index to select optimal cut points and calculated sensitivity, specificity, and predictive values. We determined independent predictors via multivariable logistic regression. The derived definitions were validated in the PREDICT cohort. Twenty-four-hour National Institutes of Health Stroke Scale change was strongly associated with 90-day outcome with an area under the receiver operating characteristic curve of 0.75. Youden's method showed an optimum cut point at -0.5, corresponding to National Institutes of Health Stroke Scale change of greater than or equal to 0 (a lack of clinical improvement), which was seen in 46%. Early neurologic change accurately predicted poor outcome when defined as greater than or equal to 0 (sensitivity, 65%; specificity, 73%; positive predictive value, 70%; adjusted odds ratio, 5.05 [CI, 3.25-7.85]) or greater than or equal to 4 (sensitivity, 19%; specificity

  3. Clinical and radiological outcomes of 5-year drug-free remission-steered treatment in patients with early arthritis: IMPROVED study.

    PubMed

    Akdemir, Gülşah; Heimans, Lotte; Bergstra, Sytske Anne; Goekoop, Robbert J; van Oosterhout, Maikel; van Groenendael, Johannes H L M; Peeters, André J; Steup-Beekman, Gerda M; Lard, Leroy R; de Sonnaville, Peter B J; Grillet, Bernard A M; Huizinga, Tom W J; Allaart, Cornelia F

    2018-01-01

    To determine the 5-year outcomes of early remission induction therapy followed by targeted treatment aimed at drug-free remission (DFR) in patients with early arthritis. In 12 hospitals, 610 patients with early (<2 years) rheumatoid arthritis (RA) or undifferentiated arthritis (UA) started on methotrexate (MTX) 25 mg/week and prednisone (60 mg/day tapered to 7.5 mg/day). Patients not in early remission (Disease Activity Score <1.6 after 4 months) were randomised (single blind) to arm 1, adding hydroxychloroquine 400 mg/day and sulfasalazine 2000 mg/day, or arm 2, switching to MTX plus adalimumab 40 mg/2 weeks. Treatment adjustments over time aimed at DFR. Outcomes were remission percentages, functional ability, toxicity and radiological damage progression after 5 years. After 4 months, 387 patients were in early remission, 83 were randomised to arm 1 and 78 to arm 2. After 5 years, 295/610 (48%) patients were in remission, 26% in sustained DFR (SDFR) (≥1 year) (220/387 (57%) remission and 135/387 (35%) SDFR in the early remission group, 50% remission, 11% SDFR in the randomisation arms without differences between the arms). More patients with UA (37% vs 23% RA, p=0.001) and more anticitrullinated protein antibody (ACPA)-negative patients (37% vs 18% ACPA-positive, p<0.001) achieved SDFR.Overall, mean Health Assessment Questionnaire was 0.6 (0.5), and median (IQR) damage progression was 0.5 (0-2.7) Sharp/van der Heijde points, with only five patients showing progression >25 points in 5 years. Five years of DFR-steered treatment in patients with early RA resulted in almost normal functional ability without clinically relevant joint damage across treatment groups. Patients who achieved early remission had the best clinical outcomes. There were no differences between the randomisation arms. SDFR is a realistic treatment goal. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved

  4. Factors affecting clinical outcome following treatment of early childhood caries under general anaesthesia: a two-year follow-up.

    PubMed

    El Batawi, H Y

    2014-06-01

    To investigate factors that might affect the clinical outcome of early childhood caries treatment under dental general anaesthesia (DGA). Retrospective longitudinal study. The medical records of paediatric patients with early childhood caries who underwent full dental rehabilitation under DGA during 2011 in a private medical facility in Jeddah, Saudi Arabia, were investigated. Study parameters were the patient's financial arrangements and compliance with suggested recall plan. Statistical analysis of caries recurrence and the need to repeat the rehabilitation process was also performed. Eighteen percent failed to attend any post-operative visit. Twenty-six percent did not comply with the post-operative preventive plan. The overall relapse rate was high (58.5%), with the highest percentage (68%) among the non-compliant group. The highest frequency of repeat DGA (10%) was in the non-compliant group. Despite the high rate of post-operative caries recurrence, DGA is still an acceptable treatment option as it minimises the need for future dental treatment. Compliance by caregivers with post-operative care plans is as important as the procedure itself. In Saudi Arabia, targeting the actual caregivers with post-operative dental health education presents challenges that might affect the clinical outcome of DGA.

  5. Amotivation and functional outcomes in early schizophrenia.

    PubMed

    Fervaha, Gagan; Foussias, George; Agid, Ofer; Remington, Gary

    2013-12-15

    Negative symptoms, particularly amotivation/apathy, are intimately tied to functional outcomes. In the present study, apathy strongly predicted psychosocial functioning in a sample of early course schizophrenia patients. This relationship remained robust even after controlling for other clinical variables. These data suggest amotivation is core to functioning across the disease course. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  6. Cultural sensitivity or professional acculturation in early clinical experience?

    PubMed

    Whitford, David L; Hubail, Amal Redha

    2014-11-01

    This study aimed to explore the early clinical experience of medical students following the adaptation of an Early Patient Contact curriculum from a European culture in Ireland to an Arab culture in Bahrain. Medical students in Bahrain took part in an Early Patient Contact module modelled on a similar module from a partner medical school in Ireland. We used a qualitative approach employing thematic analysis of 54 student reflective logbooks. Particular attention was placed on reflections of cultural influences of experience in the course. Medical students undergoing this module received reported documented benefits of early clinical experience. However, students in Bahrain were exposed to cultural norms of the local Arab society including gender values, visiting the homes of strangers, language barriers and generous hospitality that led to additional challenges and learning for the medical students in acculturating to norms of the medical profession. Modules intended for curriculum adaptation between two cultures would be best served by a group of "core" learning outcomes with "secondary" outcomes culturally appropriate to each site. Within the context of the Arab culture, early clinical experience has the added benefit of allowing students to learn about both local and professional cultural norms, thereby facilitating integration of these two cultures.

  7. The postoperative clinical outcomes and safety of early enteral nutrition in operated gastric cancer patients.

    PubMed

    Li, Bing; Liu, Hong-Yi; Guo, Shao-Hua; Sun, Peng; Gong, Fang-Ming; Jia, Bao-Qing

    2015-01-01

    This study investigated the impact of early enteral nutrition (EEN) on the clinical outcomes of gastric cancer patients after radical gastrectomy. Four hundred gastric cancer patients undergoing radical gastrectomy of any extend with D2 nodal dissection were randomly divided into an experimental and a control group with 200 cases in each group. Patients in the control group received postoperative parenteral nutrition (PN), while patients in the experimental group received postoperative EEN. After treatment, the clinical outcomes, postoperative immune function, and nutritional status of the two groups were evaluated. The postoperative fever time, intestinal function recovery time, anal exhaust time, and the length of hospital stay for patients in the experimental group were significantly shorter than those of the control group. We did not find significant differences in anastomotic leak, postoperative ileus and regurgitation between the two groups. The activities of multiple immune cell types, including CD3⁺, CD4⁺, CD4⁺/CD8⁺, and natural killer (NK) cells, were significantly lower in both groups on postoperative day 1 when compared with the preoperative levels (p<0.05). The level of CD8⁺ was not significantly different between the two groups (p>0.05). After treatment, levels of CD3⁺, CD4⁺, CD4⁺/CD8⁺, and NK cells in the experimental group patients were 35.6 ± 4.2, 42.2 ± 3.0, 1.7 ± 0.3, and 27.3 ± 5.3%, respectively, on postoperative day 7, which were similar to the preoperative levels. The immune cell levels from the control group patients remained significantly lower when compared with preoperative values; in addition, these values were also significantly lower when compared with the EEN patients (p<0.05) CONCLUSION: For gastric cancer patients undergoing radical gastrectomy, the clinical outcome, immune function and nutritional status after EEN were significantly improved. These data suggest the widespread use of EEN in clinical practice.

  8. Challenges and perspective of drug repurposing strategies in early phase clinical trials.

    PubMed

    Kato, Shumei; Moulder, Stacy L; Ueno, Naoto T; Wheler, Jennifer J; Meric-Bernstam, Funda; Kurzrock, Razelle; Janku, Filip

    2015-01-01

    Despite significant investments in the development of new agents only 5% of cancer drugs entering Phase I clinical trials are ultimately approved for routine clinical cancer care. Drug repurposing strategies using novel combinations of previously tested anticancer agents could reduce the cost and improve treatment outcomes. At MD Anderson Cancer Center, early phase clinical trials with drug repurposing strategies demonstrated promising outcomes in patients with both rare and common treatment refractory advanced cancers. Despite clinical efficacy advancing drug repurposing strategies in the clinical trial trajectory beyond early phase studies has been challenging mainly due to lack of funding and interest from the pharmaceutical industry. In this review, we delineate our experience and challenges with drug repurposing strategies.

  9. How well does early-career investigators' cardiovascular outcomes research training align with funded outcomes research?

    PubMed

    Crowley, Matthew J; Al-Khatib, Sana M; Wang, Tracy Y; Khazanie, Prateeti; Kressin, Nancy R; Krumholz, Harlan M; Kiefe, Catarina I; Wells, Barbara L; O'Brien, Sean M; Peterson, Eric D; Sanders, Gillian D

    2018-02-01

    Outcomes research training programs should prepare trainees to successfully compete for research funding. We examined how early-career investigators' prior and desired training aligns with recently funded cardiovascular (CV) outcomes research. We (1) reviewed literature to identify 13 core competency areas in CV outcomes research; (2) surveyed early-career investigators to understand their prior and desired training in each competency area; (3) examined recently funded grants commonly pursued by early-career outcomes researchers to ascertain available funding in competency areas; and (4) analyzed alignment between investigator training and funded research in each competency area. We evaluated 185 survey responses from early-career investigators (response rate 28%) and 521 funded grants from 2010 to 2014. Respondents' prior training aligned with funded grants in the areas of clinical epidemiology, observational research, randomized controlled trials, and implementation/dissemination research. Funding in community-engaged research and health informatics was more common than prior training in these areas. Respondents' prior training in biostatistics and systematic review was more common than funded grants focusing on these specific areas. Respondents' desired training aligned similarly with funded grants, with some exceptions; for example, desired training in health economics/cost-effectiveness research was more common than funded grants in these areas. Restricting to CV grants (n=132) and National Heart, Lung, and Blood Institute-funded grants (n=170) produced similar results. Identifying mismatch between funded grants in outcomes research and early-career investigators' prior/desired training may help efforts to harmonize investigator interests, training, and funding. Our findings suggest a need for further consideration of how to best prepare early-career investigators for funding success. Copyright © 2017. Published by Elsevier Inc.

  10. Early neurodevelopmental outcomes of infants with intestinal failure.

    PubMed

    So, Stephanie; Patterson, Catherine; Gold, Anna; Rogers, Alaine; Kosar, Christina; de Silva, Nicole; Burghardt, Karolina Maria; Avitzur, Yaron; Wales, Paul W

    2016-10-01

    The survival rate of infants and children with intestinal failure is increasing, necessitating a greater focus on their developmental trajectory. To evaluate neurodevelopmental outcomes in children with intestinal failure at 0-15months corrected age. Analysis of clinical, demographic and developmental assessment results of 33 children followed in an intestinal rehabilitation program between 2011 and 2014. Outcome measures included: Prechtl's Assessment of General Movements, Movement Assessment of Infants, Alberta Infant Motor Scale and Mullen Scales of Early Learning. Clinical factors were correlated with poorer developmental outcomes at 12-15months corrected age. Thirty-three infants (17 males), median gestational age 34weeks (interquartile range 29.5-36.0) with birth weight 1.98kg (interquartile range 1.17-2.50). Twenty-nine (88%) infants had abnormal General Movements. More than half had suspect or abnormal scores on the Alberta Infant Motor Scale and medium to high-risk scores for future neuromotor delay on the Movement Assessment of Infants. Delays were seen across all Mullen subscales, most notably in gross motor skills. Factors significantly associated with poorer outcomes at 12-15months included: prematurity, low birth weight, central nervous system co-morbidity, longer neonatal intensive care admission, necrotizing enterocolitis diagnosis, number of operations and conjugated hyperbilirubinemia. Multiple risk factors contribute to early developmental delay in children with intestinal failure, highlighting the importance of close developmental follow-up. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. Borderline Personality Disorder in the perinatal period: early infant and maternal outcomes.

    PubMed

    Blankley, Gaynor; Galbally, Megan; Snellen, Martien; Power, Josephine; Lewis, Andrew J

    2015-12-01

    This study examines pregnancy and early infant outcomes of pregnant women with a clinical diagnosis of Borderline Personality Disorder presenting for obstetric services to a major metropolitan maternity hospital in Victoria, Australia. A retrospective case review of pregnancy and early infant outcomes on 42 women who had been diagnosed with Borderline Personality Disorder via psychiatric assessment using DSM-IV-R criteria was undertaken. Outcomes were compared with a control group of 14,313 consisting of women and infants of non-affected women from the same hospital over the same period of time. Women presenting for obstetric services with a clinical diagnosis of Borderline Personality Disorder experienced considerable psychosocial impairment. They anticipated birth as traumatic and frequently requested early delivery. High comorbidity with substance abuse was found and high rates of referral to child protective services. Mothers with Borderline Personality Disorder were significantly more likely to have negative birth outcomes such as lowered Apgar scores, prematurity and special care nursery referral when compared with controls. These findings offer preliminary evidence to be considered by clinicians in developing treatments and services for the perinatal care of women with Borderline Personality Disorder and their infants. Further research is required in order to develop evidence informed clinical guidelines for the management of women with Borderline Personality Disorder and their infants. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  12. Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment.

    PubMed

    Onslow, Mark; Jones, Mark; O'Brian, Sue; Packman, Ann; Menzies, Ross; Lowe, Robyn; Arnott, Simone; Bridgman, Kate; de Sonneville, Caroline; Franken, Marie-Christine

    2018-04-17

    This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland-Altman plots, analysis of covariance, and Spearman rho correlations. Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.

  13. Early functional MRI activation predicts motor outcome after ischemic stroke: a longitudinal, multimodal study.

    PubMed

    Du, Juan; Yang, Fang; Zhang, Zhiqiang; Hu, Jingze; Xu, Qiang; Hu, Jianping; Zeng, Fanyong; Lu, Guangming; Liu, Xinfeng

    2018-05-15

    An accurate prediction of long term outcome after stroke is urgently required to provide early individualized neurorehabilitation. This study aimed to examine the added value of early neuroimaging measures and identify the best approaches for predicting motor outcome after stroke. This prospective study involved 34 first-ever ischemic stroke patients (time since stroke: 1-14 days) with upper limb impairment. All patients underwent baseline multimodal assessments that included clinical (age, motor impairment), neurophysiological (motor-evoked potentials, MEP) and neuroimaging (diffusion tensor imaging and motor task-based fMRI) measures, and also underwent reassessment 3 months after stroke. Bivariate analysis and multivariate linear regression models were used to predict the motor scores (Fugl-Meyer assessment, FMA) at 3 months post-stroke. With bivariate analysis, better motor outcome significantly correlated with (1) less initial motor impairment and disability, (2) less corticospinal tract injury, (3) the initial presence of MEPs, (4) stronger baseline motor fMRI activations. In multivariate analysis, incorporating neuroimaging data improved the predictive accuracy relative to only clinical and neurophysiological assessments. Baseline fMRI activation in SMA was an independent predictor of motor outcome after stroke. A multimodal model incorporating fMRI and clinical measures best predicted the motor outcome following stroke. fMRI measures obtained early after stroke provided independent prediction of long-term motor outcome.

  14. Influence of early neurological complications on clinical outcome following lung transplant.

    PubMed

    Gamez, Josep; Salvado, Maria; Martinez-de La Ossa, Alejandro; Deu, Maria; Romero, Laura; Roman, Antonio; Sacanell, Judith; Laborda, Cesar; Rochera, Isabel; Nadal, Miriam; Carmona, Francesc; Santamarina, Estevo; Raguer, Nuria; Canela, Merce; Solé, Joan

    2017-01-01

    Neurological complications after lung transplantation are common. The full spectrum of neurological complications and their impact on clinical outcomes has not been extensively studied. We investigated the neurological incidence of complications, categorized according to whether they affected the central, peripheral or autonomic nervous systems, in a series of 109 patients undergoing lung transplantation at our center between January 1 2013 and December 31 2014. Fifty-one patients (46.8%) presented at least one neurological complication. Critical illness polyneuropathy-myopathy (31 cases) and phrenic nerve injury (26 cases) were the two most prevalent complications. These two neuromuscular complications lengthened hospital stays by a median period of 35.5 and 32.5 days respectively. However, neurological complications did not affect patients' survival. The real incidence of neurological complications among lung transplant recipients is probably underestimated. They usually appear in the first two months after surgery. Despite not affecting mortality, they do affect the mean length of hospital stay, and especially the time spent in the Intensive Care Unit. We found no risk factor for neurological complications except for long operating times, ischemic time and need for transfusion. It is necessary to develop programs for the prevention and early recognition of these complications, and the prevention of their precipitant and risk factors.

  15. Influence of early neurological complications on clinical outcome following lung transplant

    PubMed Central

    Salvado, Maria; Martinez-de La Ossa, Alejandro; Deu, Maria; Romero, Laura; Roman, Antonio; Sacanell, Judith; Laborda, Cesar; Rochera, Isabel; Nadal, Miriam; Carmona, Francesc; Santamarina, Estevo; Raguer, Nuria; Canela, Merce; Solé, Joan

    2017-01-01

    Background Neurological complications after lung transplantation are common. The full spectrum of neurological complications and their impact on clinical outcomes has not been extensively studied. Methods We investigated the neurological incidence of complications, categorized according to whether they affected the central, peripheral or autonomic nervous systems, in a series of 109 patients undergoing lung transplantation at our center between January 1 2013 and December 31 2014. Results Fifty-one patients (46.8%) presented at least one neurological complication. Critical illness polyneuropathy-myopathy (31 cases) and phrenic nerve injury (26 cases) were the two most prevalent complications. These two neuromuscular complications lengthened hospital stays by a median period of 35.5 and 32.5 days respectively. However, neurological complications did not affect patients’ survival. Conclusions The real incidence of neurological complications among lung transplant recipients is probably underestimated. They usually appear in the first two months after surgery. Despite not affecting mortality, they do affect the mean length of hospital stay, and especially the time spent in the Intensive Care Unit. We found no risk factor for neurological complications except for long operating times, ischemic time and need for transfusion. It is necessary to develop programs for the prevention and early recognition of these complications, and the prevention of their precipitant and risk factors. PMID:28301586

  16. Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

    PubMed

    Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

    2016-02-01

    Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

  17. An outcomes evaluation of an emergency department early pregnancy assessment service and early pregnancy assessment protocol

    PubMed Central

    Wendt, Kim; Crilly, Julia; May, Chris; Bates, Kym; Saxena, Rakhee

    2014-01-01

    Background Complications in early pregnancy, such as threatened or actual miscarriage is a common occurrence resulting in many women presenting to the emergency department (ED). Early pregnancy service delivery models described in the literature vary in terms of approach, setting and outcomes. Our objective was to determine outcomes of women who presented to an Australian regional ED with diagnoses consistent with early pregnancy complications following the implementation of an early pregnancy assessment service (EPAS) and early pregnancy assessment protocol (EPAP) in July 2011. Methods A descriptive, comparative (6 months before and after) study was undertaken. Data were extracted from the hospital ED information system and medical healthcare records. Outcome measures included: time to see a clinician, ED length of stay, admission rate, re-presentation rate, hospital admission and types of pathology tests ordered. Results Over the 12 -month period, 584 ED presentations were made to the ED with complications of early pregnancy (268 PRE and 316 POST EPAS–EPAP). Outcomes that improved statistically and clinically following implementation included: time to see a clinician (decreased by 6 min from 35 to 29 min), admission rate (decreased 6% from 14.5% to 8.5%), increase in β-human chorionic gonadotrophin ordering by 10% (up to 80% POST), increase in ultrasound (USS) performed by 10% (up to 73% POST) and increase in pain score documentation by 23% (up to 36% POST). Conclusions The results indicate that patient and service delivery improvements can be achieved following the implementation of targeted service delivery models such as EPAS and EPAP in the ED. PMID:24136123

  18. Clinical outcomes of an early intervention program for preschool children with Autism Spectrum Disorder in a community group setting.

    PubMed

    Eapen, Valsamma; Crnčec, Rudi; Walter, Amelia

    2013-01-07

    Available evidence indicates that early intervention programs, such as the Early Start Denver Model (ESDM), can positively affect key outcomes for children with Autism Spectrum Disorder (ASD). However, programs involving resource intensive one-to-one clinical intervention are not readily available or deliverable in the community, resulting in many children with ASD missing out on evidence-based intervention during their early and most critical preschool years. This study evaluated the effectiveness of the ESDM for preschool-aged children with ASD using a predominantly group-based intervention in a community child care setting. Participants were 26 children (21 male) with ASD with a mean age of 49.6 months. The ESDM, a comprehensive early intervention program that integrates applied behaviour analysis with developmental and relationship-based approaches, was delivered by trained therapists during the child's attendance at a child care centre for preschool-aged children with ASD. Children received 15-20 hours of group-based, and one hour of one-to-one, ESDM intervention per week. The average intervention period was ten months. Outcome measures were administered pre- and post-intervention, and comprised a developmental assessment - the Mullen Scales of Early Learning (MSEL); and two parent-report questionnaires - the Social Communication Questionnaire (SCQ) and Vineland Adaptive Behaviours Scales-Second Edition (VABS-II). Statistically significant post-intervention improvements were found in children's performance on the visual reception, receptive language and expressive language domains of the MSEL in addition to their overall intellectual functioning, as assessed by standardised developmental quotients. Parents reported significant increases in their child's receptive communication and motor skills on the VABS-II, and a significant decrease in autism-specific features on the SCQ. These effects were of around medium size, and appeared to be in excess of what may

  19. Clinical Outcome Score Predicts Adverse Neurodevelopmental Outcome After Infant Heart Surgery.

    PubMed

    Mackie, Andrew S; Vatanpour, Shabnam; Alton, Gwen Y; Dinu, Irina A; Ryerson, Lindsay; Moddemann, Diane M; Thomas Petrie, Julie

    2015-06-01

    The purpose of this study was to determine whether a clinical outcome score derived from early postoperative events is associated with Bayley-III scores at 18 to 24 months among infants undergoing cardiopulmonary bypass surgery. Included were infants aged 6 weeks or less who underwent surgery between 2005 and 2009, all of whom were referred for neurodevelopmental evaluation at 18 to 24 months. We excluded children with chromosomal abnormalities. The prespecified clinical outcome score had a range of 0 to 7. Lower scores indicated a more rapid postoperative recovery. Patients requiring extracorporeal life support were assigned a score of 7. One hundred and ninety-nine subjects were included. Surgical procedures were arterial switch (72), Norwood (60), repair of total anomalous pulmonary venous connection (29), and other (38). Nine subjects had postoperative extracorporeal life support. Mean clinical outcome score in the Norwood group was 4.0 ± 1.4 versus the arterial switch group (2.6 ± 1.5, p < 0.001), total anomalous pulmonary venous connection group (2.8 ± 1.8, p < 0.01), and other group (4.0 ± 1.8, p = not significant). Among children who had a clinical outcome score of 4 or greater, there was a decrease in Bayley-III cognitive score of 5.7 (95% confidence interval: 1.5 to 9.9, p = 0.009), a decrease in language score of 10.0 (95% confidence interval: 4.9 to 15.1, p < 0.001), and a decrease in motor score of 9.7 (95% confidence interval: 4.8 to 14.5, p < 0.001). Time until lactate of 2.0 mmol/L or less and highest 24-hour inotrope score increased with increasing clinical outcome score (p < 0.0001). Clinical outcome scores of 4 or greater were associated with significantly lower Bayley-III scores at 18 to 24 months. This score may be valuable as an endpoint when evaluating novel potential therapies for this high-risk population. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  20. Clinical symptoms predict concurrent social and global functioning in an early psychosis sample.

    PubMed

    Cacciotti-Saija, Cristina; Langdon, Robyn; Ward, Philip B; Hickie, Ian B; Guastella, Adam J

    2018-04-01

    Although well established in chronic schizophrenia, the key determinants of functioning remain unknown during the early phase of a psychotic disorder. The aim of this study was to comprehensively examine the social cognitive, basic neurocognitive and clinical predictors of concurrent social functioning and global functioning in an early psychosis sample. This study examined the relationship between social cognition, basic neurocognition and clinical symptoms with concurrent functioning in 51 early psychosis individuals. Assessments included a range of self-report, observational and clinician-rated measures of cognitive, symptom severity and functioning domains. Results revealed a significant association between self-reported social function and lower levels of both social interaction anxiety and negative psychotic symptoms. A significant association was also observed between lower levels of negative psychotic symptoms and observed social functioning. Lastly, results demonstrated a significant association between reduced negative psychotic symptoms and clinician-rated global functioning. Clinical domains such as negative symptoms and social interaction anxiety significantly contribute to an optimal model predicting outcome during the early phase of a psychotic disorder. These clinical features may also provide useful markers of an individual's capacity for social participation. Clinical implications include the need for early targeted intervention to address social anxiety and negative psychotic symptoms to facilitate optimum patient outcome. © 2015 Wiley Publishing Asia Pty Ltd.

  1. Oestrogen receptor negative early operable primary breast cancer in older women-Biological characteristics and long-term clinical outcome.

    PubMed

    Syed, Binafsha Manzoor; Morgan, Dal; Setty, Tulassi; Green, Andrew R; Paish, Emma C; Ellis, Ian O; Cheung, K L

    2017-01-01

    Older women are at the greatest risk of breast cancer development and a considerable number present with comorbidities. Although the majority of breast cancers in this age group express oestrogen receptor (ER), which makes endocrine therapy (primary or adjuvant) feasible, given the huge size of the elderly population, there remains a significant number of patients, in absolute term, whose tumours do not express ER and their management is challenging. Of a consecutive series of 1,758 older (≥70 years) women with early operable primary breast cancer managed in a dedicated service from 1973-2010, 252(14.3%) had ER-negative (histochemical (H) score ≤50) tumours. Their clinical outcome was retrospectively reviewed and tumour samples collected from diagnostic core biopsies were analysed for progesterone receptor (PgR), HER2 and Ki67 using immunohistochemistry. The commonest primary treatment was surgery (N = 194, 77%) followed by primary endocrine therapy (14.3%), primary radiotherapy (5.6%) and supportive treatment only (3.1%). Among the patients undergoing surgery, most of them had grade 3 (78.1%) and node-negative disease (62.2%). Some of them (21.1%) received postoperative radiotherapy. At a median follow-up of 37.5 months, 117 patients had died, out of which 48.6% were due to breast cancer. For those who underwent surgery, the regional and local recurrence rates were 2% and 1.1% per annum respectively. For those who received primary endocrine therapy, 38% progressed at 6 months, however all patients who had primary radiotherapy achieved clinical benefit at 6 months. Regardless of treatment given, the 5-year breast cancer specific and overall survival rates were 70% and 50% respectively. Biological analysis based on good quality needle core biopsy specimensfrom181 patients showed that 26.8% (N = 49), 16.9% (N = 31) and 70.7% (N = 70)expressed positivity for PgR, HER2 and Ki67 respectively. No correlation between these biomarkers and breast cancer specific

  2. Germline determinants of clinical outcome of cutaneous melanoma

    PubMed Central

    Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

    2016-01-01

    Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase of melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication. PMID:26342156

  3. Fear Avoidance and Clinical Outcomes from Mild Traumatic Brain Injury.

    PubMed

    Silverberg, Noah D; Panenka, William; Iverson, Grant L

    2018-04-18

    Characterizing psychological factors that contribute to persistent symptoms after mild traumatic brain injury (MTBI) can inform early intervention. To determine whether fear avoidance, a known risk factor for chronic disability after musculoskeletal injury, is associated with worse clinical outcomes from MTBI, adults were recruited from four outpatient MTBI clinics and assessed at their first clinic visit (M=2.7, SD=1.5 weeks post-injury) and again 4-5 months later. Of 273 patients screened, 102 completed the initial assessment and 87 returned for the outcome assessment. The initial assessment included a battery of questionnaires that measure activity avoidance and associated fears. Endurance, an opposite behavior pattern, was measured with the Behavioral Response to Illness Questionnaire. The multidimensional outcome assessment included measures of post-concussion symptoms (British Columbia Postconcussion Symptom Inventory), functional disability (World Health Organization Disability Assessment Schedule-12 2.0), return to work status, and psychiatric complications (MINI Neuropsychiatric Interview). A single component was retained from principal components analysis of the six avoidance subscales. In generalized linear modeling, the avoidance composite score predicted symptom severity (95% confidence interval [CI] for B= 1.22-6.33) and disability (95% CI for B=2.16-5.48), but not return to work (95% CI for B=-0.68-0.24). The avoidance composite was also associated with an increased risk for depression (OR=1.76, 95% CI=1.02-3.02) and anxiety disorders (OR=1.89, 95% CI=1.16-3.19). Endurance behavior predicted the same outcomes, except for depression. In summary, avoidance and endurance behavior were associated with a range of adverse clinical outcomes from MTBI. These may represent early intervention targets.

  4. Pharmacogenomics in early-phase clinical development

    PubMed Central

    Burt, Tal; Dhillon, Savita

    2015-01-01

    Pharmacogenomics (PGx) offers the promise of utilizing genetic fingerprints to predict individual responses to drugs in terms of safety, efficacy and pharmacokinetics. Early-phase clinical trial PGx applications can identify human genome variations that are meaningful to study design, selection of participants, allocation of resources and clinical research ethics. Results can inform later-phase study design and pipeline developmental decisions. Nevertheless, our review of the clinicaltrials.gov database demonstrates that PGx is rarely used by drug developers. Of the total 323 trials that included PGx as an outcome, 80% have been conducted by academic institutions after initial regulatory approval. Barriers for the application of PGx are discussed. We propose a framework for the role of PGx in early-phase drug development and recommend PGx be universally considered in study design, result interpretation and hypothesis generation for later-phase studies, but PGx results from underpowered studies should not be used by themselves to terminate drug-development programs. PMID:23837482

  5. The variable clinical presentation of tuberculosis otitis media and the importance of early detection.

    PubMed

    Abes, Generoso T; Abes, Franco Louie L B; Jamir, Joselito C

    2011-06-01

    Tuberculosis (TB) is a rare cause of otitis media. This study aims to increase awareness on the clinical presentation of TB otitis media and illustrate how early detection affects treatment outcome. Chart review of 12 patients (13 ears) from a tertiary hospital in Manila, Philippines, seen from 2004 to 2009. Clinical predictors of the disease were summarized. Clinical, radiologic, and audiometric outcomes after treatment were compared between treatment groups. The 5 otoscopic presentations were multiple perforations, single perforation with refractory otorrhea and exuberant granulation tissue formation, single perforation with minimal otorrhea and no granulation tissue formation, intact tympanic membrane with middle ear effusion, and intact tympanic membrane with tumorlike tissue in the middle ear. Clinical predictors of the disease were history of pulmonary TB, work-related contamination of the infection, positive purified protein derivative test, positive chest radiographic finding and intraoperative granulation tissue with cheesy material, and temporal bone computed tomographic scan findings. Patients who had no middle ear surgery showed significantly better clinical, radiologic, and audiometric outcomes than those who were diagnosed late and had more complicated surgical procedure. The clinical presentation of TB otitis media is variable. Early detection of the early forms entail less surgical intervention and favors better treatment results.

  6. [Effects of early supplemental parenteral nutrition on nutrition intakes and clinical outcomes in trauma patients].

    PubMed

    Xiao, Gui-zhen; Tang, Li-qun; Duan, Peng-kai; Qiu, Xiao-wen; Su, Lei

    2013-05-01

    To evaluate energy and protein intake changes in early supplemental parenteral nutrition (PN) in trauma patients, and to assess its impact on clinical outcomes. Clinical results of patients receiving or not receiving additional PN during the first 7 days after injury were retrospectively analyzed, with a total of 195 patients classified into two groups: control group (n=105) and mixed nutrition group (n=90). The time of nutrition support, intakes of protein and energy within 14 days after trauma, and clinical outcomes were compared between two groups. The degree of injury was comparable between two groups with no significant differences in acute physiology and chronic health evaluation II score, injury severity score (ISS) and Glasgow coma score (GCS). Compared with the control group, the mixed nutrition group received parenteral nutritional support earlier (40.0±21.0 hours vs. 55.1±23.5 hours, P<0.01), with later beginning of enteral nutrition (EN, 75.2±54.5 hours vs. 55.1±23.5 hours, P<0.01) and lower rate of EN in 48 hours after admission [14.4% (13/90) vs. 43.8% (46/105), P<0.01]. The time of restoring oral diet was not different between the mixed nutrition group and control group (10.8±3.7 days vs. 11.4±3.6 days, P>0.05). The energy intake was significantly higher in the mixed nutrition group than in the control group in 3, 7, 14 days (3 days: 3981.6±2209.3 kJ vs. 2683.2±1414.9 kJ, 7 days: 5477.5±2008.4 kJ vs. 3619.1±1429.9 kJ, 14 days: 6250.2±2533.2 kJ vs. 5199.9±1972.7 kJ, P<0.05 or P<0.01). In both groups the protein intake was insufficient, and it was significantly lower in the mixed nutrition group than in the control group on day 3 (20.6±18.4 g vs. 26.5±13.8 g, P<0.05). The patients in the mixed nutrition group had longer hospital stay time (73.9±62.5 days vs. 50.9±33.3 days, P<0.01). The mortality rate of mixed nutrition group and control group was 4.4% (4/90) and 3.8% (4/105) respectively, the rate of infection and acute respiratory

  7. Temporal trends in early clinical outcomes and health care resource utilization for liver transplantation in the United States.

    PubMed

    Scarborough, John E; Pietrobon, Ricardo; Marroquin, Carlos E; Tuttle-Newhall, Janet E; Kuo, Paul C; Collins, Bradley H; Desai, Dev M; Pappas, Theodore N

    2007-01-01

    Procedures such as liver transplantation, which entail large costs while benefiting only a small percentage of the population, are being increasingly scrutinized by third-party payors. The purpose of our study was to conduct a longitudinal analysis of the early clinical outcomes and health care resource utilization for liver transplantation in the United States. The Nationwide Inpatient Sample database was used to conduct a longitudinal analysis of the clinical outcome and resource utilization data for liver transplantation procedures in adult recipients performed in the United States over three time periods (Period I: 1988-1993; Period II: 1994-1998: Period III: 1999-2003). Compared to Period I, adult liver transplant recipients were more likely to be male, older, and non-White in Period III. Recipients were more likely to have at least one major comorbidity preoperatively than in Period I. The in-hospital mortality rate after liver transplantation decreased significantly from Period I to Period III, but the major intraoperative and postoperative complication rates increased over the same time period. Mean length of hospital stay decreased over the 15-year period, but the percentage of patients with a non-routine discharge status increased. Our findings indicate that the rate of postoperative complications and non-routine discharges after liver transplantation is increasing. However, these negative changes in the cost-outcomes relationship for liver transplantation are balanced by improving postoperative survival rates and reductions in the length of hospital stay.

  8. Effectiveness of a clinical practice intervention in early rheumatoid arthritis.

    PubMed

    Descalzo, Miguel Ángel; Carbonell, Jordi; González-Álvaro, Isidoro; Sanmartí, Raimon; Balsa, Alejandro; Hernandez-Barrera, Valentín; Román-Ivorra, José Andrés; Ivorra-Cortés, José; Lisbona, Pilar; Alperi, Mercedes; Jiménez-Garcia, Rodrigo; Carmona, Loreto

    2012-03-01

    To compare the outcome of early rheumatoid arthritis (RA) patients in a country where early clinics were established versus the outcome of patients in nonprotocolized clinics. We compared 2 multicenter cohorts: an RA cohort derived from an early arthritis registry set in 36 reference hospitals in which a specific intervention was established (Evaluation of a Model for Arthritis Care in Spain [SERAP]), and a historical control cohort of patients with early RA attending 34 rheumatology departments (Prognosis in Rheumatoid Arthritis [PROAR] cohort). Effectiveness was tested by comparing the change in the Disease Activity Score in 28 joints (DAS28), the change in the Health Assessment Questionnaire (HAQ), and the change in the Sharp/van der Heijde radiologic score using marginal structural models. A total of 161 early RA patients were recruited in the PROAR cohort and 447 in the SERAP cohort. Being a SERAP patient was inversely correlated with activity, resulting in a decrease of -0.24 (95% confidence interval [95% CI] -0.39, -0.08) units in the population average of the DAS28 after adjustment was made. Moreover, intervention may be seen as a protective factor of radiologic damage, with a decrease of -0.05 (95% CI -0.09, -0.01) units in the logarithm of the total Sharp/van der Heijde score. On the other hand, a decrease in functional impairment was detected, but intervention was not statistically associated with HAQ changes. Preventing major radiographic progression in a 2-year term inside structured and organized special programs for the management of disease, such as early arthritis clinics, are effective compared to nonprotocolized referrals, treatment, and followup. Copyright © 2012 by the American College of Rheumatology.

  9. Impact of Remote Monitoring on Clinical Outcomes.

    PubMed

    Varma, Niraj; Ricci, Renato Pietro

    2015-12-01

    Follow-up of patients with cardiac implantable electronic devices is challenging due to both their increasing volume and technical complexity coupled to increasing clinical complexity of recipient patients. Remote monitoring (RM) offers an opportunity to resolve some of these difficulties by improving clinic efficiencies and providing a mechanism for device monitoring and patient management. Several recent randomized clinical trials and registries have demonstrated that RM may reduce in-hospital visit numbers, time required for patient follow-up, physician and nurse time, and hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events, such as atrial fibrillation, ventricular arrhythmias, and heart failure suitable for clinical intervention. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. New organizational models promote significant efficiencies regarding physician and nursing time. Data management techniques are under development. Despite these demonstrable advantages of RM, adoption still remains modest, even in health care systems incentivized to use this follow-up method. © 2015 Wiley Periodicals, Inc.

  10. Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications

    PubMed Central

    Vavken, Patrick; Ganal-Antonio, Anne Kathleen B.; Quidde, Julia; Shen, Francis H.; Chapman, Jens R.; Samartzis, Dino

    2015-01-01

    Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of “personalized spine care.” PMID:26225283

  11. Tuberculous spondylodiscitis: epidemiology, clinical features, treatment, and outcome.

    PubMed

    Trecarichi, E M; Di Meco, E; Mazzotta, V; Fantoni, M

    2012-04-01

    Tuberculous spondylodiscitis (TS) is a rare but serious clinical condition which may lead to severe deformity and early or late neurological complications. To discuss certain aspects of the approach to TSs, focusing upon epidemiology, diagnosis, and treatment outcome. For the purpose of this review, a literature search was performed using the Pubmed database through to 19th October 2011 to identify studies published in the last 20 years, concerned in epidemiological, clinical, diagnostic, and therapeutical aspects of TS in adults. Only studies drafted in English language and reporting case series of more than 20 patients have been included. TS has been reported to accounts for 1-5% of all TB cases, and for about 50% of the cases of articulo-skeletal TB infections. Despite the actual availability of more effective diagnostic tools, early recognition of TS remains difficult and a high index of suspicion is needed due to the chronic nature of the disease and its insidious and variable clinical presentation. A prompt diagnosis is required to improve long term outcome, and a microbiological confirmation is recommended to enable appropriate choice of anti-mycobacterial agents. Surgery has an important role in alleviating pain, correcting deformities and neurological impairment, and restoring function. Further studies are required to assess the appropriate duration of anti-microbial treatment, also in regarding of a combined surgical approach.

  12. Implementation of an Oxytocin Checklist to Improve Clinical Outcomes.

    PubMed

    Sundin, Courtney; Mazac, Lauren; Ellis, Kathleen; Garbo, Candon

    Oxytocin is one of the most common drugs administered in obstetrics. Since its designation as a high-alert medication by the Institute for Safe Medication Practices in 2007, there has been much attention to oxytocin administration during labor. Oxytocin is generally safe when administered correctly, but adverse perinatal outcomes can occur during uterine tachysystole. The purpose of this project was to evaluate and compare results of maternal and fetal outcomes of induction of labor for women at term prior to and after implementation of a newly developed oxytocin checklist. To evaluate the practice change associated with the implementation of the new oxytocin checklist, 200 cases based on retrospective medical record reviews were compared with 200 cases after implementation. Use of the checklist was associated with several significant clinical outcomes, including decreases in tachysystole, decreases in cesarean births for concern about fetal status based on electronic fetal monitoring data, decreases in length of first stage labor, and decreases in maximum dose of oxytocin. Results are similar to previous research. Early physician buy-in, clinical team education, and ongoing evaluation enhanced facilitation of the oxytocin checklist. Clinical outcomes were favorable.

  13. Migration characteristics and early clinical results of the NANOS® short-stem hip arthroplasty.

    PubMed

    Kaipel, Martin; Grabowiecki, Phillip; Sinz, Katrina; Farr, Sebastian; Sinz, Günter

    2015-05-01

    Femoral short stems promise essential advantages in total hip arthroplasty. Up to now, only short- and midterm clinical studies exist. Data on early stem migration that could predict later aseptic loosening at an early stage are rare. The purpose of this study was to assess migration patterns and clinical outcome 2 years after hip replacement by a metaphyseal anchored cementless short stem. Migration data and clinical results were prospectively assessed in 49 patients. Clinical outcome was measured using the Harris Hip Score (HHS). Migration analyses were performed using the computer-assisted Einzel-Bild-Roentgen-Analyse (EBRA) system. At 2 years after surgery, none of the implants needed revision, and HHS increased from 47.9 up to 98.1. Of 49 patients, 5 (10%) showed increased vertical stem migration (1.5 mm/2a) that might predict late aseptic loosening. Of 49 stems, 44 (90%) showed stable migration patterns indicating a beneficial long-term outcome. Results of this study confirm the excellent clinical data of previous works. Migration patterns strongly suggest that short-stem arthroplasty is not only an innovative but also a reliable strategy in total hip replacement.

  14. Clinical features and outcomes of delayed perforation after endoscopic submucosal dissection for early gastric cancer.

    PubMed

    Hanaoka, N; Uedo, N; Ishihara, R; Higashino, K; Takeuchi, Y; Inoue, T; Chatani, R; Hanafusa, M; Tsujii, Y; Kanzaki, H; Kawada, N; Iishi, H; Tatsuta, M; Tomita, Y; Miyashiro, I; Yano, M

    2010-12-01

    Perforation is a major complication of endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). However, there have been no reports on delayed perforation after ESD for EGC. We aimed to elucidate the incidence and outcomes of delayed perforation after ESD. Clinical courses in 1159 consecutive patients with 1329 EGCs who underwent ESD were investigated. Delayed perforation occurred in six patients (0.45 %). All these patients had complete en bloc resection without intraoperative perforation during ESD. Five of six perforations were located in the upper third of the stomach, while one lesion was found in the middle third. Symptoms of peritoneal irritation with rebound tenderness presented within 24 h after ESD in all cases. One patient did not require surgery because the symptoms were localized, and recovered with conservative antibiotic therapy by nasogastric tube placement. The remaining five patients required emergency surgery. There was no mortality in this case series. © Georg Thieme Verlag KG Stuttgart · New York.

  15. Employment and educational outcomes in early intervention programmes for early psychosis: a systematic review.

    PubMed

    Bond, G R; Drake, R E; Luciano, A

    2015-10-01

    Young adults with early psychosis want to pursue normal roles - education and employment. This paper summarises the empirical literature on the effectiveness of early intervention programmes for employment and education outcomes. We conducted a systematic review of employment/education outcomes for early intervention programmes, distinguishing three programme types: (1) those providing supported employment, (2) those providing unspecified vocational services and (3) those without vocational services. We summarised findings for 28 studies. Eleven studies evaluated early intervention programmes providing supported employment. In eight studies that reported employment outcomes separately from education outcomes, the employment rate during follow-up for supported employment patients was 49%, compared with 29% for patients receiving usual services. The two groups did not differ on enrolment in education. In four controlled studies, meta-analysis showed that the employment rate for supported employment participants was significantly higher than for control participants, odds ratio = 3.66 [1.93-6.93], p < 0.0001. Five studies (four descriptive and one quasi-experimental) of early intervention programmes evaluating unspecified vocational services were inconclusive. Twelve studies of early intervention programmes without vocational services were methodologically heterogeneous, using diverse methods for evaluating vocational/educational outcomes and precluding a satisfactory meta-analytic synthesis. Among studies with comparison groups, 7 of 11 (64%) reported significant vocational/education outcomes favouring early intervention over usual services. In early intervention programmes, supported employment moderately increases employment rates but not rates of enrolment in education. These improvements are in addition to the modest effects early programmes alone have on vocational/educational outcomes compared with usual services.

  16. Literacy outcomes of children with early childhood speech sound disorders: impact of endophenotypes.

    PubMed

    Lewis, Barbara A; Avrich, Allison A; Freebairn, Lisa A; Hansen, Amy J; Sucheston, Lara E; Kuo, Iris; Taylor, H Gerry; Iyengar, Sudha K; Stein, Catherine M

    2011-12-01

    To demonstrate that early childhood speech sound disorders (SSD) and later school-age reading, written expression, and spelling skills are influenced by shared endophenotypes that may be in part genetic. Children with SSD and their siblings were assessed at early childhood (ages 4-6 years) and followed at school age (7-12 years). The relationship of shared endophenotypes with early childhood SSD and school-age outcomes and the shared genetic influences on these outcomes were examined. Structural equation modeling demonstrated that oral motor skills, phonological awareness, phonological memory, vocabulary, and speeded naming have varying influences on reading decoding, spelling, spoken language, and written expression at school age. Genetic linkage studies demonstrated linkage for reading, spelling, and written expression measures to regions on chromosomes 1, 3, 6, and 15 that were previously linked to oral motor skills, articulation, phonological memory, and vocabulary at early childhood testing. Endophenotypes predict school-age literacy outcomes over and above that predicted by clinical diagnoses of SSD or language impairment. Findings suggest that these shared endophenotypes and common genetic influences affect early childhood SSD and later school-age reading, spelling, spoken language, and written expression skills.

  17. Literacy Outcomes of Children With Early Childhood Speech Sound Disorders: Impact of Endophenotypes

    PubMed Central

    Lewis, Barbara A.; Avrich, Allison A.; Freebairn, Lisa A.; Hansen, Amy J.; Sucheston, Lara E.; Kuo, Iris; Taylor, H. Gerry; Iyengar, Sudha K.; Stein, Catherine M.

    2012-01-01

    Purpose To demonstrate that early childhood speech sound disorders (SSD) and later school-age reading, written expression, and spelling skills are influenced by shared endophenotypes that may be in part genetic. Method Children with SSD and their siblings were assessed at early childhood (ages 4–6 years) and followed at school age (7–12 years). The relationship of shared endophenotypes with early childhood SSD and school-age outcomes and the shared genetic influences on these outcomes were examined. Results Structural equation modeling demonstrated that oral motor skills, phonological awareness, phonological memory, vocabulary, and speeded naming have varying influences on reading decoding, spelling, spoken language, and written expression at school age. Genetic linkage studies demonstrated linkage for reading, spelling, and written expression measures to regions on chromosomes 1, 3, 6, and 15 that were previously linked to oral motor skills, articulation, phonological memory, and vocabulary at early childhood testing. Conclusions Endophenotypes predict school-age literacy outcomes over and above that predicted by clinical diagnoses of SSD or language impairment. Findings suggest that these shared endophenotypes and common genetic influences affect early childhood SSD and later school-age reading, spelling, spoken language, and written expression skills. PMID:21930616

  18. Pathways from Adolescent Deliberate Self-Poisoning to Early Adult Outcomes: A Six-Year Follow-Up

    ERIC Educational Resources Information Center

    Aglan, Azza; Kerfoot, Michael; Pickles, Andrew

    2008-01-01

    Background: Prospective studies show that the adult outcomes of adolescents who deliberately harm themselves are marked by high rates of adversity and psychiatric disorders. The goal of this study was to identify pathways linking childhood risk factors to early adult outcomes of suicidal adolescents. Methods: A clinical sample of 158 adolescents…

  19. Working in partnership with the voluntary sector: early explorer clinics.

    PubMed

    Coe, Chris; Barlow, Jane

    2010-11-01

    The first three years of life have been identified as key to promoting children's later wellbeing, and partnership working across the statutory and voluntary sectors has been proposed as one of the best ways to meet the needs of families. Child health clinics are attended by parents seeking reassurance or help and advice from a health professional regarding child health and development. They have been used in Oxford to develop Early Explorer clinics, in which the statutory health visiting service and voluntary sector Peers Early Education Programme work together with the aim of improving outcomes for children and families. These Early Explorer clinics provide the opportunity to engage parents in supporting their child's development through interaction and non-directed exploratory play. They also offer opportunities to identify vulnerable families, who are provided with additional support. This paper examines a model of partnership working between statutory and voluntary sectors aimed at maximising opportunities to promote the health and wellbeing of infants and their families.

  20. Oedema is associated with clinical outcome following emergency abdominal surgery.

    PubMed

    Vaughan-Shaw, P G; Saunders, J; Smith, T; King, A T; Stroud, M A

    2013-09-01

    Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24 kg/m(2) vs 27 kg/m(2), p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ(2) =13.1, df=1, p=0.001). Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery.

  1. Oedema is associated with clinical outcome following emergency abdominal surgery

    PubMed Central

    Vaughan-Shaw, PG; Saunders, J; Smith, T; King, AT

    2013-01-01

    Introduction Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. Methods A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Results Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24kg/m2 vs 27kg/m2, p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ2=13.1, df=1, p=0.001). Conclusions Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery. PMID:24025285

  2. Predicting Readmission at Early Hospitalization Using Electronic Clinical Data: An Early Readmission Risk Score.

    PubMed

    Tabak, Ying P; Sun, Xiaowu; Nunez, Carlos M; Gupta, Vikas; Johannes, Richard S

    2017-03-01

    Identifying patients at high risk for readmission early during hospitalization may aid efforts in reducing readmissions. We sought to develop an early readmission risk predictive model using automated clinical data available at hospital admission. We developed an early readmission risk model using a derivation cohort and validated the model with a validation cohort. We used a published Acute Laboratory Risk of Mortality Score as an aggregated measure of clinical severity at admission and the number of hospital discharges in the previous 90 days as a measure of disease progression. We then evaluated the administrative data-enhanced model by adding principal and secondary diagnoses and other variables. We examined the c-statistic change when additional variables were added to the model. There were 1,195,640 adult discharges from 70 hospitals with 39.8% male and the median age of 63 years (first and third quartile: 43, 78). The 30-day readmission rate was 11.9% (n=142,211). The early readmission model yielded a graded relationship of readmission and the Acute Laboratory Risk of Mortality Score and the number of previous discharges within 90 days. The model c-statistic was 0.697 with good calibration. When administrative variables were added to the model, the c-statistic increased to 0.722. Automated clinical data can generate a readmission risk score early at hospitalization with fair discrimination. It may have applied value to aid early care transition. Adding administrative data increases predictive accuracy. The administrative data-enhanced model may be used for hospital comparison and outcome research.

  3. Early-Onset Psychoses: Comparison of Clinical Features and Adult Outcome in 3 Diagnostic Groups

    ERIC Educational Resources Information Center

    Ledda, Maria Giuseppina; Fratta, Anna Lisa; Pintor, Manuela; Zuddas, Alessandro; Cianchetti, Carlo

    2009-01-01

    A comparison of clinical features and adult outcome in adolescents with three types of psychotic disorders: schizophrenic (SPh), schizoaffective (SA) and bipolar with psychotic features (BPP). Subjects (n = 41) were finally diagnosed (DSM-IV criteria) with SPh (n = 17), SA (n = 11) or BPP (n = 13). Clinical evaluation took place at onset and at a…

  4. Clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial.

    PubMed

    McFarlane, William R; Levin, Bruce; Travis, Lori; Lucas, F Lee; Lynch, Sarah; Verdi, Mary; Williams, Deanna; Adelsheim, Steven; Calkins, Roderick; Carter, Cameron S; Cornblatt, Barbara; Taylor, Stephan F; Auther, Andrea M; McFarland, Bentson; Melton, Ryan; Migliorati, Margaret; Niendam, Tara; Ragland, J Daniel; Sale, Tamara; Salvador, Melina; Spring, Elizabeth

    2015-01-01

    To test effectiveness of the Early Detection, Intervention, and Prevention of Psychosis Program in preventing the onset of severe psychosis and improving functioning in a national sample of at-risk youth. In a risk-based allocation study design, 337 youth (age 12-25) at risk of psychosis were assigned to treatment groups based on severity of positive symptoms. Those at clinically higher risk (CHR) or having an early first episode of psychosis (EFEP) were assigned to receive Family-aided Assertive Community Treatment (FACT); those at clinically lower risk (CLR) were assigned to receive community care. Between-groups differences on outcome variables were adjusted statistically according to regression-discontinuity procedures and evaluated using the Global Test Procedure that combined all symptom and functional measures. A total of 337 young people (mean age: 16.6) were assigned to the treatment group (CHR + EFEP, n = 250) or comparison group (CLR, n = 87). On the primary variable, positive symptoms, after 2 years FACT, were superior to community care (2 df, p < .0001) for both CHR (p = .0034) and EFEP (p < .0001) subgroups. Rates of conversion (6.3% CHR vs 2.3% CLR) and first negative event (25% CHR vs 22% CLR) were low but did not differ. FACT was superior in the Global Test (p = .0007; p = .024 for CHR and p = .0002 for EFEP, vs CLR) and in improvement in participation in work and school (p = .025). FACT is effective in improving positive, negative, disorganized and general symptoms, Global Assessment of Functioning, work and school participation and global outcome in youth at risk for, or experiencing very early, psychosis. © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

  5. Early neurodevelopmental outcomes of extremely preterm infants.

    PubMed

    Rogers, Elizabeth E; Hintz, Susan R

    2016-12-01

    Infants born at extreme preterm gestation are at risk for both death and disability. Although rates of survival have improved for this population, and some evidence suggests a trend toward decreased neuromotor impairment over the past decades, a significant improvement in overall early neurodevelopmental outcome has not yet been realized. This review will examine the rates and types of neurodevelopmental impairment seen after extremely preterm birth, including neurosensory, motor, cognitive, and behavioral outcomes. We focus on early outcomes in the first 18-36 months of life, as the majority of large neonatal studies examining neurodevelopmental outcomes stop at this age. However, this early age is clearly just a first glimpse into lifetime outcomes; the neurodevelopmental effects of extreme prematurity may last through school age, adolescence, and beyond. Importantly, prematurity appears to be an independent risk factor for adverse development, but this population demonstrates considerable variability in the types and severity of impairments. Understanding both the nature and prevalence of neurodevelopmental impairment among extremely preterm infants is important because it can lead to targeted interventions that in turn may lead to improved outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Early transition to oral antibiotic therapy for community-acquired pneumonia: duration of therapy, clinical outcomes, and cost analysis.

    PubMed

    Omidvari, K; de Boisblanc, B P; Karam, G; Nelson, S; Haponik, E; Summer, W

    1998-08-01

    Our objective was to compare therapeutic outcome and analyse cost-benefit of a 'conventional' (7-day course of i.v. antibiotic therapy) vs. an abbreviated (2-day i.v. antibiotic course followed by 'switch' to oral antibiotics) therapy for in-patients with community-acquired pneumonia (CAP). We used a multicenter prospective, randomized, parallel group with a 28 day follow-up, at the University-based teaching hospitals: The Medical Center of Louisiana in New Orleans, LA and hospitals listed in the acknowledgement. Ninety-five patients were randomized to receive either a 'conventional' course of intravenous antibiotic therapy with cefamandole 1 g i.v. every 6 h for 7 days (n = 37), or an abbreviated course of intravenous therapy with cefamandole (1 g i.v. every 6 h for 2 days) followed by oral therapy with cefaclor (500 mg every 8 h for 5 days). No difference was found in the clinical courses, cure rates, survival or the resolution of the chest radiograph abnormalities among the two groups. The mean duration of therapy (6.88 days for the conventional group compared to 7-30 days for the early oral therapy group) and the frequencies of overall symptomatic improvement (97% vs. 95%, respectively) were similar in both groups. Patients who received early oral therapy had shorter hospital stays (7.3 vs. 9.71 days, P = 0.01), and a lower total cost of care ($2953 vs. $5002, P < 0.05). It was concluded that early transition to an oral antibiotic after an abbreviated course of intravenous therapy in CAP is substantially less expensive and has comparable efficacy to conventional intravenous therapy. Altering physicians' customary management of hospitalized patients with CAP can reduce costs with no appreciable additional risk of adverse patient outcome.

  7. Operative Outcome and Patient Satisfaction in Early and Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

    PubMed Central

    Hokkam, Emad N.

    2014-01-01

    Introduction. Early laparoscopic cholecystectomy is usually associated with reduced hospital stay, sick leave, and health care expenditures. Early diagnosis and treatment of acute cholecystitis reduce both mortality and morbidity and the accurate diagnosis requires specific diagnostic criteria of clinical data and imaging studies. Objectives. To compare early versus delayed laparoscopic cholecystectomy regarding the operative outcome and patient satisfaction. Patients and Methods. Patients with acute cholecystitis were divided into two groups, early (A) and delayed (B) cholecystectomy. Diagnosis of acute cholecystitis was confirmed by clinical examination, laboratory data, and ultrasound study. The primary end point was operative and postoperative outcome and the secondary was patient's satisfaction. Results. The number of readmissions in delayed treatment group B was three times in 10% of patients, twice in 23.3%, and once in 66.7% while the number of readmissions was once only in patients in group A and the mean total hospital stays were higher in group B than in group A. The overall patient's satisfaction was 92.66 ± 6.8 in group A compared with 75.34 ± 12.85 in group B. Conclusion. Early laparoscopic cholecystectomy resulted in significant reduction in length of hospital stay and accepted rate of operative complications and conversion rates when compared with delayed techniques. PMID:25197568

  8. Stem cell transplantation as a dynamical system: are clinical outcomes deterministic?

    PubMed

    Toor, Amir A; Kobulnicky, Jared D; Salman, Salman; Roberts, Catherine H; Jameson-Lee, Max; Meier, Jeremy; Scalora, Allison; Sheth, Nihar; Koparde, Vishal; Serrano, Myrna; Buck, Gregory A; Clark, William B; McCarty, John M; Chung, Harold M; Manjili, Masoud H; Sabo, Roy T; Neale, Michael C

    2014-01-01

    Outcomes in stem cell transplantation (SCT) are modeled using probability theory. However, the clinical course following SCT appears to demonstrate many characteristics of dynamical systems, especially when outcomes are considered in the context of immune reconstitution. Dynamical systems tend to evolve over time according to mathematically determined rules. Characteristically, the future states of the system are predicated on the states preceding them, and there is sensitivity to initial conditions. In SCT, the interaction between donor T cells and the recipient may be considered as such a system in which, graft source, conditioning, and early immunosuppression profoundly influence immune reconstitution over time. This eventually determines clinical outcomes, either the emergence of tolerance or the development of graft versus host disease. In this paper, parallels between SCT and dynamical systems are explored and a conceptual framework for developing mathematical models to understand disparate transplant outcomes is proposed.

  9. Stem Cell Transplantation as a Dynamical System: Are Clinical Outcomes Deterministic?

    PubMed Central

    Toor, Amir A.; Kobulnicky, Jared D.; Salman, Salman; Roberts, Catherine H.; Jameson-Lee, Max; Meier, Jeremy; Scalora, Allison; Sheth, Nihar; Koparde, Vishal; Serrano, Myrna; Buck, Gregory A.; Clark, William B.; McCarty, John M.; Chung, Harold M.; Manjili, Masoud H.; Sabo, Roy T.; Neale, Michael C.

    2014-01-01

    Outcomes in stem cell transplantation (SCT) are modeled using probability theory. However, the clinical course following SCT appears to demonstrate many characteristics of dynamical systems, especially when outcomes are considered in the context of immune reconstitution. Dynamical systems tend to evolve over time according to mathematically determined rules. Characteristically, the future states of the system are predicated on the states preceding them, and there is sensitivity to initial conditions. In SCT, the interaction between donor T cells and the recipient may be considered as such a system in which, graft source, conditioning, and early immunosuppression profoundly influence immune reconstitution over time. This eventually determines clinical outcomes, either the emergence of tolerance or the development of graft versus host disease. In this paper, parallels between SCT and dynamical systems are explored and a conceptual framework for developing mathematical models to understand disparate transplant outcomes is proposed. PMID:25520720

  10. Clinical characteristics and outcomes of septic bursitis.

    PubMed

    Lieber, Sarah B; Fowler, Mary Louise; Zhu, Clara; Moore, Andrew; Shmerling, Robert H; Paz, Ziv

    2017-12-01

    Limited data guide practice in evaluation and treatment of septic bursitis. We aimed to characterize clinical characteristics, microbiology, and outcomes of patients with septic bursitis stratified by bursal involvement, presence of trauma, and management type. We conducted a retrospective cohort study of adult patients admitted to a single center from 1998 to 2015 with culture-proven olecranon and patellar septic bursitis. Baseline characteristics, clinical features, microbial profiles, operative interventions, hospitalization lengths, and 60-day readmission rates were determined. Patients were stratified by bursitis site, presence or absence of trauma, and operative or non-operative management. Of 44 cases of septic bursitis, patients with olecranon and patellar bursitis were similar with respect to age, male predominance, and frequency of bursal trauma; patients managed operatively were younger (p = 0.05). Clinical features at presentation and comorbidities were similar despite bursitis site, history of trauma, or management. The most common organism isolated from bursal fluid was Staphylococcus aureus. Patients managed operatively were discharged to rehabilitation less frequently (p = 0.04). This study of septic bursitis is among the largest reported. We were unable to identify presenting clinical features that differentiated patients treated surgically from those treated conservatively. There was no clear relationship between preceding trauma or bursitis site and clinical course, management, or outcomes. Patients with bursitis treated surgically were younger. Additional study is needed to identify patients who would benefit from early surgical intervention for septic bursitis.

  11. Clinical outcomes, health resource use, and cost in patients with early versus late dual or triple anti-platelet treatment for acute coronary syndrome.

    PubMed

    Friedman, Howard; Mollon, Patrick; Lian, Jean; Navaratnam, Prakash

    2013-08-01

    Acute coronary syndrome (ACS) guidelines recommend early dual anti-platelet therapy (thienopyridines + acetylsalicylic acid [aspirin]). However, triple therapy (thienopyridines + aspirin + glycoprotein IIb/IIIa receptor inhibitors [GRIs]) has shown benefit in clinical trials. This study assessed real-world ACS treatment patterns and outcomes in the acute care setting. A retrospective analysis of patients admitted to hospital with ACS (index event) from January 2007 to December 2009 was conducted (Thomson's MarketScan Hospital Drug Database). Eligible patients were ≥18 years of age, of either sex, and had primary admission and discharge diagnoses of ACS. Cohorts were defined by anti-platelet treatment and then by the timing of treatment initiation (early initiation: within ≤2 days of admission; late initiation: ≥2 days post-admission). Patient characteristics, clinical outcomes, resource utilization, and costs were assessed using descriptive statistics. A total of 249,907 eligible patients were placed into four treatment cohorts (aspirin assumed for all patients): aspirin only; clopidogrel only (dual therapy); GRI only (dual therapy); and clopidogrel + GRI (triple therapy). Patients in the 'clopidogrel-only' cohort were more likely to be older, female, and have more co-morbidities than those in other cohorts; stroke (6.2 %) and re-hospitalization (15.4 %) rates were higher than in the 'GRI-only' and 'triple therapy' cohorts. The GRI-only cohort had higher major bleeding rates (3.3 %), mortality (7.6 %), and costs ($US21,975 [year 2010 values]) than the clopidogrel-only and triple-therapy cohorts. Late initiation cohorts were more likely to be older, female, and have more co-morbidities than early initiation cohorts. Major bleeding was more likely with GRI-only patients (regardless of initiation timing) than with other cohorts. Late-treated clopidogrel-only patients had higher rates of stroke (6.9 %), ACS-related re-admissions (6.1 %), and all

  12. Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.

    PubMed

    Vaucher, Yvonne E; Peralta-Carcelen, Myriam; Finer, Neil N; Carlo, Waldemar A; Gantz, Marie G; Walsh, Michele C; Laptook, Abbot R; Yoder, Bradley A; Faix, Roger G; Das, Abhik; Schibler, Kurt; Rich, Wade; Newman, Nancy S; Vohr, Betty R; Yolton, Kimberly; Heyne, Roy J; Wilson-Costello, Deanne E; Evans, Patricia W; Goldstein, Ricki F; Acarregui, Michael J; Adams-Chapman, Ira; Pappas, Athina; Hintz, Susan R; Poindexter, Brenda; Dusick, Anna M; McGowan, Elisabeth C; Ehrenkranz, Richard A; Bodnar, Anna; Bauer, Charles R; Fuller, Janell; O'Shea, T Michael; Myers, Gary J; Higgins, Rosemary D

    2012-12-27

    Previous results from our trial of early treatment with continuous positive airway pressure (CPAP) versus early surfactant treatment in infants showed no significant difference in the outcome of death or bronchopulmonary dysplasia. A lower (vs. higher) target range of oxygen saturation was associated with a lower rate of severe retinopathy but higher mortality. We now report longer-term results from our prespecified hypotheses. Using a 2-by-2 factorial design, we randomly assigned infants born between 24 weeks 0 days and 27 weeks 6 days of gestation to early CPAP with a limited ventilation strategy or early surfactant administration and to lower or higher target ranges of oxygen saturation (85 to 89% or 91 to 95%). The primary composite outcome for the longer-term analysis was death before assessment at 18 to 22 months or neurodevelopmental impairment at 18 to 22 months of corrected age. The primary outcome was determined for 1234 of 1316 enrolled infants (93.8%); 990 of the 1058 surviving infants (93.6%) were evaluated at 18 to 22 months of corrected age. Death or neurodevelopmental impairment occurred in 27.9% of the infants in the CPAP group (173 of 621 infants), versus 29.9% of those in the surfactant group (183 of 613) (relative risk, 0.93; 95% confidence interval [CI], 0.78 to 1.10; P=0.38), and in 30.2% of the infants in the lower-oxygen-saturation group (185 of 612), versus 27.5% of those in the higher-oxygen-saturation group (171 of 622) (relative risk, 1.12; 95% CI, 0.94 to 1.32; P=0.21). Mortality was increased with the lower-oxygen-saturation target (22.1%, vs. 18.2% with the higher-oxygen-saturation target; relative risk, 1.25; 95% CI, 1.00 to 1.55; P=0.046). We found no significant differences in the composite outcome of death or neurodevelopmental impairment among extremely premature infants randomly assigned to early CPAP or early surfactant administration and to a lower or higher target range of oxygen saturation. (Funded by the Eunice Kennedy

  13. Neurocognitive outcomes in the Treatment of Early-Onset Schizophrenia Spectrum Disorders study.

    PubMed

    Frazier, Jean A; Giuliano, Anthony J; Johnson, Jacqueline L; Yakutis, Lauren; Youngstrom, Eric A; Breiger, David; Sikich, Linmarie; Findling, Robert L; McClellan, Jon; Hamer, Robert M; Vitiello, Benedetto; Lieberman, Jeffrey A; Hooper, Stephen R

    2012-05-01

    To assess neurocognitive outcomes following antipsychotic intervention in youth enrolled in the National Institute of Mental Health (NIMH)-funded Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS). Neurocognitive functioning of youth (ages 8 to 19 years) with schizophrenia or schizoaffective disorder was evaluated in a four-site, randomized, double-blind clinical trial comparing molindone, olanzapine, and risperidone. The primary outcomes were overall group change from baseline in neurocognitive composite and six domain scores after 8 weeks and continued treatment up to 52 weeks. Age and sex were included as covariates in all analyses. Of 116 TEOSS participants, 77 (66%) had post-baseline neurocognitive data. No significant differences emerged in the neurocognitive outcomes of the three medication groups. Therefore, the three treatment groups were combined into one group to assess overall neurocognitive outcomes. Significant modest improvements were observed in the composite score and in three of six domain scores in the acute phase, and in four of six domain scores in the combined acute and maintenance phases. Partial correlation analyses revealed very few relationships among Positive and Negative Syndrome Scale (PANSS) baseline or change scores and neurocognition change scores. Antipsychotic intervention in youth with early-onset schizophrenia spectrum disorders (EOSS) led to modest improvement in measures of neurocognitive function. The changes in cognition were largely unrelated to baseline symptoms or symptom change. Small treatment effect sizes, easily accounted for by practice effects, highlight the critical need for the development of more efficacious interventions for the enduring neurocognitive deficits seen in EOSS. Clinical trial registry information-Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS); http://www.clinicaltrials.gov; NCT00053703. Copyright © 2012 American Academy of Child and Adolescent Psychiatry. Published

  14. Preoperative Recipient Parameters Allow Early Estimation of Postoperative Outcome and Intraoperative Transfusion Requirements in Liver Transplantation.

    PubMed

    Schumacher, Carsten; Eismann, Hendrik; Sieg, Lion; Friedrich, Lars; Scheinichen, Dirk; Vondran, Florian W R; Johanning, Kai

    2018-01-01

    Liver transplantation is a complex intervention, and early anticipation of personnel and logistic requirements is of great importance. Early identification of high-risk patients could prove useful. We therefore evaluated prognostic values of recipient parameters commonly available in the early preoperative stage regarding postoperative 30- and 90-day outcomes and intraoperative transfusion requirements in liver transplantation. All adult patients undergoing first liver transplantation at Hannover Medical School between January 2005 and December 2010 were included in this retrospective study. Demographic, clinical, and laboratory data as well as clinical courses were recorded. Prognostic values regarding 30- and 90-day outcomes were evaluated by uni- and multivariate statistical tests. Identified risk parameters were used to calculate risk scores. There were 426 patients (40.4% female) included with a mean age of 48.6 (11.9) years. Absolute 30-day mortality rate was 9.9%, and absolute 90-day mortality rate was 13.4%. Preoperative leukocyte count >5200/μL, platelet count <91 000/μL, and creatinine values ≥77 μmol/L were relevant risk factors for both observation periods ( P < .05, respectively). A score based on these factors significantly differentiated between groups of varying postoperative outcomes and intraoperative transfusion requirements ( P < .05, respectively). A score based on preoperative creatinine, leukocyte, and platelet values allowed early estimation of postoperative 30- and 90-day outcomes and intraoperative transfusion requirements in liver transplantation. Results might help to improve timely logistic and personal strategies.

  15. CHD associated with syndromic diagnoses: peri-operative risk factors and early outcomes

    PubMed Central

    Landis, Benjamin J.; Cooper, David S.; Hinton, Robert B.

    2016-01-01

    CHD is frequently associated with a genetic syndrome. These syndromes often present specific cardiovascular and non-cardiovascular co-morbidities that confer significant peri-operative risks affecting multiple organ systems. Although surgical outcomes have improved over time, these co-morbidities continue to contribute substantially to poor peri-operative mortality and morbidity outcomes. Peri-operative morbidity may have long-standing ramifications on neurodevelopment and overall health. Recognising the cardiovascular and non-cardiovascular risks associated with specific syndromic diagnoses will facilitate expectant management, early detection of clinical problems, and improved outcomes – for example, the development of syndrome-based protocols for peri-operative evaluation and prophylactic actions may improve outcomes for the more frequently encountered syndromes such as 22q11 deletion syndrome. PMID:26345374

  16. Holding the baby: early mother-infant contact after childbirth and outcomes.

    PubMed

    Redshaw, Maggie; Hennegan, Julie; Kruske, Sue

    2014-05-01

    to describe the timing, type and duration of initial infant contact and associated demographic and clinical factors in addition to investigating the impact of early contact on breastfeeding and maternal health and well being after birth. data from a recent population survey of women birthing in Queensland, Australia were used to describe the nature of the first hold and associated demographic characteristics. Initial comparisons, with subsequent adjustment for type of birthing facility and mode of childbirth, were used to assess associations between timing, type and duration of initial contact and outcomes. Further analyses were conducted to investigate a dose-response relationship between duration of first contact and outcomes. women who had an unassisted vaginal birth held their infant sooner, and for longer than women who had an assisted vaginal birth or caesarean and were more satisfied with their early contact. Multivariate models showed a number of demographic and clinical interventions contributing to timing, duration and type of first contact with type of birthing facility (public/private), area of residence, and assisted birth as prominent factors. For women who had a vaginal birth; early, skin-to-skin, and longer duration of initial contact were associated with high rates of breastfeeding initiation and breastfeeding at discharge, but not breastfeeding at 13 weeks. Some aspects of early contact were associated with improved maternal well being. However, these associations were not found for women who had a caesarean birth. With longer durations of first contact, a dose-response effect was found for breastfeeding. results of the study provide a description of current practice in Queensland, Australia and factors impacting on early contact. For vaginal births, findings add to the evidence in support of early skin-to-skin contact for an extended period. It is suggested that all research in this area should consider the effects of early contact separately for

  17. Effect of socioeconomic status disparity on child language and neural outcome: how early is early?

    PubMed

    Hurt, Hallam; Betancourt, Laura M

    2016-01-01

    It is not news that poverty adversely affects child outcome. The literature is replete with reports of deleterious effects on developmental outcome, cognitive function, and school performance in children and youth. Causative factors include poor nutrition, exposure to toxins, inadequate parenting, lack of cognitive stimulation, unstable social support, genetics, and toxic environments. Less is known regarding how early in life adverse effects may be detected. This review proposes to elucidate "how early is early" through discussion of seminal articles related to the effect of socioeconomic status on language outcome and a discussion of the emerging literature on effects of socioeconomic status disparity on brain structure in very young children. Given the young ages at which such outcomes are detected, the critical need for early targeted interventions for our youngest is underscored. Further, the fiscal reasonableness of initiating quality interventions supports these initiatives. As early life adversity produces lasting and deleterious effects on developmental outcome and brain structure, increased focus on programs and policies directed to reducing the impact of socioeconomic disparities is essential.

  18. Pediatric multiple sclerosis: Clinical features and outcome.

    PubMed

    Waldman, Amy; Ness, Jayne; Pohl, Daniela; Simone, Isabella Laura; Anlar, Banu; Amato, Maria Pia; Ghezzi, Angelo

    2016-08-30

    Multiple sclerosis (MS) in children manifests with a relapsing-remitting MS (RRMS) disease course. Acute relapses consist of new neurologic deficits persisting greater than 24 hours, in the absence of intercurrent illness, and occur with a higher frequency early in the disease as compared to adult-onset RRMS. Most pediatric patients with MS recover well from these early relapses, and cumulative physical disability is rare in the first 10 years of disease. Brainstem attacks, poor recovery from a single attack, and a higher frequency of attacks portend a greater likelihood of future disability. Although prospective pediatric-onset MS cohorts have been established in recent years, there remains very limited prospective data detailing the longer-term clinical outcome of pediatric-onset MS into adulthood. Whether the advent of MS therapies, and the largely off-label access to such therapies in pediatric MS, has improved prognosis is unknown. MS onset during the key formative academic years, concurrent with active cognitive maturation, is an important determinant of long-term outcome, and is discussed in detail in another article in this supplement. Finally, increasing recognition of pediatric MS worldwide, recent launch of phase III trials for new agents in the pediatric MS population, and the clear imperative to more fully appreciate health-related quality of life in pediatric MS through adulthood highlight the need for standardized, validated, and robust outcome measures. © 2016 American Academy of Neurology.

  19. Effectiveness of the Lidcombe Program for early stuttering in Australian community clinics.

    PubMed

    O'Brian, Sue; Iverach, Lisa; Jones, Mark; Onslow, Mark; Packman, Ann; Menzies, Ross

    2013-12-01

    This study explored the effectiveness of the Lidcombe Program for early stuttering in community clinics. Participants were 31 speech-language pathologists (SLPs) using the Lidcombe Program in clinics across Australia, and 57 of their young stuttering clients. Percentage of syllables stuttered (%SS) was collected 9 months after beginning treatment along with information about variables likely to influence outcomes. The mean %SS for the 57 children 9 months after starting treatment was 1.7. The most significant predictor of outcome was Lidcombe Program Trainers Consortium (LPTC) training. The children of trained SLPs (n = 19), compared to the children of untrained SLPs, took 76% more sessions to complete stage 1, but achieved 54% lower %SS scores, 9 months after starting treatment. Results suggest that outcomes for the Lidcombe Program in the general community may be comparable to those obtained in clinical trials when SLPs receive formal training and support.

  20. Determination of minimal clinically important change in early and advanced Parkinson's disease.

    PubMed

    Hauser, Robert A; Auinger, Peggy

    2011-04-01

    Two common primary efficacy outcome measures in Parkinson's disease (PD) are change in Unified Parkinson's Disease Rating Scale (UPDRS) scores in early PD and change in "off" time in patients with motor fluctuations. Defining the minimal clinically important change (MCIC) in these outcome measures is important to interpret the clinical relevance of changes observed in clinical trials and other situations. We analyzed data from 2 multicenter, placebo-controlled, randomized clinical trials of rasagiline; TEMPO studied 404 early PD subjects, and PRESTO studied 472 levodopa-treated subjects with motor fluctuations. An anchor-based approach using clinical global impression of improvement (CGI-I) was used to determine MCIC for UPDRS scores and daily "off" time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI-I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I-III) in early PD was determined to be -3.5 points based on mean scores and -3.0 points based on ROC curves. In addition, we found an MCIC for reduction in "off" time of 1.0 hours as defined by mean reduction in "off" time in active treated subjects self-rated as minimally improved on CGI-I minus mean reduction in "off" time in placebo-treated subjects self-rated as unchanged (1.9-0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies. Copyright © 2011 Movement Disorder Society.

  1. Early discharge of patients with pulmonary embolism in daily clinical practice: A prospective observational study comparing clinical gestalt and clinical rules.

    PubMed

    Vanni, Simone; Becattini, Cecilia; Nazerian, Peiman; Bova, Carlo; Stefanone, Valerio Teodoro; Cimini, Ludovica Anna; Viviani, Gabriele; Caviglioli, Cosimo; Sanna, Michela; Pepe, Giuseppe; Grifoni, Stefano

    2018-05-08

    To estimate the efficiency and safety of clinicians' gestalt in the identification of patients with pulmonary embolism (PE) candidates for early discharge and to compare the efficiency and safety of clinical gestalt with that of the Pulmonary Embolism Severity Index (PESI), the simplified PESI (sPESI) and the Hestia criteria (HC). Consecutive adult patients presenting to the emergency department of four Italian hospitals with confirmed diagnosis of PE were included. Data for PESI, sPESI and HC assessment were prospectively collected. Patients were managed according to the clinical gestalt of the attending physician, independent of the results of PESI, sPESI and HC. Efficiency was defined as the prevalence of candidates to early discharge. The primary safety measure was the incidence of a composite of venous thromboembolic recurrence, major haemorrhage or all-cause mortality within 30 days. Out of 547 included patients, 178 (32.5%) were judged to be at low risk and discharged within 48 h from presentation. HC identified a higher proportion (41.7%) whereas both PESI (24.1%) and sPESI (18.3%) identified a lower proportion of candidates for early discharge when compared to clinical gestalt (P < 0.01 for all). The incidence of the safety outcome was 2.8% in early-discharged patients according to clinical gestalt and 2.3%, 3.0% and 2.6% in candidates to early discharge according to PESI, sPESI and HC, without differences between strategies. In our cohort, clinical gestalt identified one-third of PE patients for early discharge. Among different strategies HC showed the highest efficiency sharing similar safety with the other strategies. Copyright © 2018 Elsevier Ltd. All rights reserved.

  2. Clinical outcomes of endoscopic submucosal dissection for early gastric cancer in remnant stomach or gastric tube.

    PubMed

    Nishide, N; Ono, H; Kakushima, N; Takizawa, K; Tanaka, M; Matsubayashi, H; Yamaguchi, Y

    2012-06-01

    Little information exists regarding the optimal treatment of early gastric cancer (EGC) in a remnant stomach or gastric tube. The aim of this study was to assess the feasibility and clinical outcomes of endoscopic submucosal dissection (ESD) for EGC in a remnant stomach and gastric tube. Between September 2002 and December 2009, ESD was performed in 62 lesions in 59 patients with EGC in a remnant stomach (48 lesions) or gastric tube (14 lesions). Clinicopathological data were retrieved retrospectively to assess the en bloc resection rate, complications, and outcomes. Treatment results were assessed according to the indications for endoscopic resection, and were compared with those of ESD performed in a whole stomach during the same study period. The en bloc resection rates for lesions within the standard and expanded indication were 100 % and 93 %, respectively. Postoperative bleeding occurred in five patients (8 %). The perforation rate was significantly higher (18 %, 11 /62) than that of ESD in a whole stomach (5 %, 69 /1479). Among the perforation cases, eight lesions involved the anastomotic site or stump line, and ulcerative changes were observed in five lesions. The 3-year overall survival rate was 85 %, with eight deaths due to other causes and no deaths from gastric cancer. A high en bloc resection rate was achieved by ESD for EGC in a remnant stomach or gastric tube; however, this procedure is still technically demanding due to the high complication rate of perforation. © Georg Thieme Verlag KG Stuttgart · New York.

  3. Clinical Practice of Adjuvant Chemotherapy in Patients with Early-Stage Epithelial Ovarian Cancer.

    PubMed

    Frielink, Lindy M J; Pijlman, Brenda M; Ezendam, Nicole P M; Pijnenborg, Johanna M A

    2016-01-01

    Adjuvant platinum-based chemotherapy improves survival in women with early-stage epithelial ovarian cancer (EOC). Yet, there is a wide variety in clinical practice. All patients diagnosed with FIGO I and IIa EOC (2006-2010) in the south of the Netherlands were analyzed. The percentage of patients that received adjuvant chemotherapy was determined as well as the comprehensiveness of staging and outcome. Forty percent (54/135) of the patients with early-stage EOC received adjuvant chemotherapy. Treatment with adjuvant chemotherapy was associated with FIGO stage, clear-cell histology and nonoptimal staging. Optimal staging was achieved in 50%, and nonoptimal staging was associated with advanced age, comorbidity and treatment in a non-referral hospital. Overall, there was no difference in outcome between patients with and without adjuvant chemotherapy. Yet, in grade 3 tumors, adjuvant chemotherapy seems beneficial. Selective treatment of patients with early-stage EOC might reduce adjuvant chemotherapy without compromising outcome. © 2016 S. Karger AG, Basel.

  4. Clinical significance of early smoking withdrawal effects and their relationships with nicotine metabolism: preliminary results from a pilot study.

    PubMed

    Hendricks, Peter S; Delucchi, Kevin L; Benowitz, Neal L; Hall, Sharon M

    2014-05-01

    Although the early time course of smoking withdrawal effects has been characterized, the clinical significance of early withdrawal symptoms and their predictors are unknown. This study evaluated the relationships of early smoking withdrawal effects with quit attempt outcomes and the rate of nicotine metabolism. Eleven treatment-seeking smokers abstained from smoking for 4 hr in the laboratory before a quit attempt. Withdrawal measures included heart rate, sustained attention, and self-report. Following baseline assessment, withdrawal measures were administered every 30 min. At the conclusion of the 4-hr early withdrawal session, participants received a brief smoking cessation intervention and then returned 1 week and 12 weeks later for outcome assessments that included biochemically confirmed smoking abstinence, cigarettes smoked in the past 24hr, and self-reported withdrawal symptoms. The rate of nicotine metabolism was estimated at intake with the nicotine metabolite ratio (trans-3'-hydroxycotinine/cotinine) measured in saliva. Greater self-reported negative affect and concentration difficulty during early withdrawal, most notably anxiety, were related with poorer quit attempt outcomes. There was some indication that although a faster increase in craving and greater hunger during early withdrawal were associated with more favorable outcomes, a greater decrease in heart rate during this time was associated with poorer outcomes. Faster nicotine metabolism was related to a faster increase in anxiety but a slower increase in craving during early withdrawal. These findings lend support to the clinical significance of early smoking withdrawal effects. The rate of nicotine metabolism may be a useful predictor of early withdrawal symptoms.

  5. Impact of crime victimization on initial presentation to an early intervention for psychosis service and 18-month outcomes.

    PubMed

    Fisher, Helen L; Roberts, Anna; Day, Fern; Reynolds, Nicky; Iacoponi, Eduardo; Garety, Philippa A; Craig, Thomas K J; McGuire, Philip; Valmaggia, Lucia; Power, Paddy

    2017-04-01

    To investigate the clinical and social correlates of a lifetime history of crime victimization among first-episode psychosis patients at entry to an Early Intervention Service and following 18 months of specialist care. Face-to-face interviews were conducted with 149 individuals who presented to an Early Intervention Service for the first time with psychosis in the London borough of Lambeth, UK. A range of demographic and clinical measures were completed including self-reported history of victimization along with the type of crime and its subjective effect on the patient. Clinical and functional outcomes at 18-month follow up were ascertained from clinical case notes by a psychiatrist. A large proportion of patients (n = 64, 43%) reported a history of crime victimization. This was associated with significantly higher levels of depression and substance misuse at initial presentation. Being a victim of a crime was not significantly associated with poorer clinical or functional outcomes after 18 months of specialist care. However, non-significant differences were found for those who reported crime victimization in terms of their increased use of illegal substances or having assaulted someone else during the follow-up period. Past experience of being a victim of crime appears to be common in patients presenting for the first time with psychosis and is associated with increased likelihood of comorbidity. Thus, Early Intervention Services should consider screening for past victimization and be prepared to deal with comorbid problems. The impact of crime victimization on clinical and functional outcomes requires investigation over a longer period of time. © 2015 Wiley Publishing Asia Pty Ltd.

  6. The clinical presentation and early outcomes of necrotizing fasciitis in a Ugandan Tertiary Hospital--a prospective study.

    PubMed

    Magala, John; Makobore, Patson; Makumbi, Timothy; Kaggwa, Sam; Kalanzi, Edris; Galukande, Moses

    2014-07-28

    Necrotizing fasciitis is an infectious process characterized by rapidly progressing necrosis of superficial fascia and subcutaneous tissue with subsequent necrosis of overlying skin.Necrotizing fasciitis is a rare but fatal infection. The worldwide incidence is at 0.4 per 100,000. Mortality is up to 80% with no intervention, and 30-50% with intervention. Delay in intervention is associated with poor outcome. The risk factors for necrotizing fasciitis are diabetes mellitus, HIV, malignancy, illicit drug use, malnutrition among others.The aim of this study was to describe the clinical presentation and early outcomes of necrotizing fasciitis amongst Ugandan patients. A prospective descriptive case series study conducted at Mulago National Referral and Teaching hospital from 5th January to 30th April 2011. Patients with necrotizing fasciitis were consecutively recruited after clinical evaluation, laboratory and microbiological tests were performed. Aggressive debridement was done and broad-spectrum antibiotics administered. Patients were followed up on surgical wards. Ethical approval was obtained. Thirty five patients were recruited over a 4 months period. More males were affected with, M: F 3:1. The 20-40 years age group was most affected. Attainment of healthy granulation tissue took 19 days on average. Mortality rate was 14% (5/35). Limbs were the most affected body parts 20/35 (57%), the scrotum and perineum (23%). Among infants the scalp was the most affected. Co-morbidities included HIV 8/35 (17%), and DM (5%) among others. The commonest organisms were gram negative. Split skin grafting was necessary in 74% (26/35) of patients. There were a high number of patients with necrotizing fasciitis; it was associated with low mortality but high morbidity (long hospital stay). There was a high preponderance to males and limbs were the more affected body parts.

  7. The clinical presentation and early outcomes of necrotizing fasciitis in a Ugandan Tertiary Hospital- a prospective study

    PubMed Central

    2014-01-01

    Background Necrotizing fasciitis is an infectious process characterized by rapidly progressing necrosis of superficial fascia and subcutaneous tissue with subsequent necrosis of overlying skin. Necrotizing fasciitis is a rare but fatal infection. The worldwide incidence is at 0.4 per 100,000. Mortality is up to 80% with no intervention, and 30-50% with intervention. Delay in intervention is associated with poor outcome. The risk factors for necrotizing fasciitis are diabetes mellitus, HIV, malignancy, illicit drug use, malnutrition among others. The aim of this study was to describe the clinical presentation and early outcomes of necrotizing fasciitis amongst Ugandan patients. Methods A prospective descriptive case series study conducted at Mulago National Referral and Teaching hospital from 5th January to 30th April 2011. Patients with necrotizing fasciitis were consecutively recruited after clinical evaluation, laboratory and microbiological tests were performed. Aggressive debridement was done and broad-spectrum antibiotics administered. Patients were followed up on surgical wards. Ethical approval was obtained. Results Thirty five patients were recruited over a 4 months period. More males were affected with, M: F 3:1. The 20-40 years age group was most affected. Attainment of healthy granulation tissue took 19 days on average. Mortality rate was 14% (5/35). Limbs were the most affected body parts 20/35 (57%), the scrotum and perineum (23%). Among infants the scalp was the most affected. Co-morbidities included HIV 8/35 (17%), and DM (5%) among others. The commonest organisms were gram negative. Split skin grafting was necessary in 74% (26/35) of patients. Conclusion There were a high number of patients with necrotizing fasciitis; it was associated with low mortality but high morbidity (long hospital stay). There was a high preponderance to males and limbs were the more affected body parts. PMID:25069415

  8. Clinical outcomes research in gynecologic oncology.

    PubMed

    Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

    2017-09-01

    Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

  9. Comparison of rheumatoid arthritis clinical trial outcome measures: a simulation study.

    PubMed

    Anderson, Jennifer J; Bolognese, James A; Felson, David T

    2003-11-01

    Isolated studies have suggested that continuous measures of response may be better than predefined, dichotomous definitions (e.g., the American College of Rheumatology 20% improvement criteria [ACR20]) for discriminating between rheumatoid arthritis (RA) treatments. Our goal was to determine the statistical power of predefined dichotomous outcome measures (termed "a priori"), compared with that of continuous measures derived from trial data in which there was no predefined response threshold (termed "data driven"), and to evaluate the sensitivity to change of these measures in the context of different treatments and early versus later-stage disease. In order to generalize beyond results from a single trial, we performed simulation studies. We obtained summary data from trials comparing disease-modifying antirheumatic drugs (DMARDs) and from comparative coxib-placebo trials to test the power of 2 a priori outcomes, the ACR20 and improvement of the Disease Activity Score (DDAS), as well as 2 data-driven outcomes. We studied patients with early RA and those with later-stage RA (duration of <4 years and 4-9 years, respectively). We performed simulation studies, using the interrelationship of ACR core set measures in the trials to generate multiple trial data sets consistent with the original data. The data-driven outcomes had greater power than did the a priori measures. The DMARD comparison was more powerful in early disease than in later-stage disease (the sample sizes needed to achieve 80% power for the most powerful test were 64 for early disease versus 100 for later disease), but the coxib-versus-placebo comparison was less powerful in early disease than in later disease (the sample sizes needed to achieve 80% power were 200 and 100, respectively). When the effects of treatment on core set items were small and/or inconsistent, power was reduced, particularly for a less broadly based outcome (e.g., DDAS) compared with the ACR20. The simulation studies demonstrate

  10. Early clinical experience: do students learn what we expect?

    PubMed

    Helmich, Esther; Bolhuis, Sanneke; Laan, Roland; Koopmans, Raymond

    2011-07-01

    Early clinical experience is thought to contribute to the professional development of medical students, but little is known about the kind of learning processes that actually take place. Learning in practice is highly informal and may be difficult to direct by predefined learning outcomes. Learning in medical practice includes a socialisation process in which some learning outcomes may be valued, but others neglected or discouraged. This study describes students' learning goals (prior to a Year 1 nursing attachment) and learning outcomes (after the attachment) in relation to institutional educational goals, and evaluates associations between learning outcomes, student characteristics and place of attachment. A questionnaire containing open-ended questions about learning goals and learning outcomes was administered to all Year 1 medical students (n = 347) before and directly after a 4-week nursing attachment in either a hospital or a nursing home. Two confirmatory focus group interviews were conducted and data were analysed using qualitative and quantitative content analyses. Students' learning goals corresponded with educational goals with a main emphasis on communication and empathy. Other learning goals included gaining insight into the organisation of health care and learning to deal with emotions. Self-reported learning outcomes were the same, but students additionally mentioned reflection on professional behaviour and their own future development. Women and younger students mentioned communication and empathy more often than men and older students. Individual learning goals, with the exception of communicating and empathising with patients, did not predict learning outcomes. Students' learning goals closely match educational goals, which are adequately met in early nursing attachments in both hospitals and nursing homes. Learning to deal with emotions was under-represented as a learning goal and learning outcome, which may indicate that emotional aspects

  11. Early Adolescent Affect Predicts Later Life Outcomes.

    PubMed

    Kansky, Jessica; Allen, Joseph P; Diener, Ed

    2016-07-01

    Subjective well-being as a predictor for later behavior and health has highlighted its relationship to health, work performance, and social relationships. However, the majority of such studies neglect the developmental nature of well-being in contributing to important changes across the transition to adulthood. To examine the potential role of subjective well-being as a long-term predictor of critical life outcomes, we examined indicators of positive and negative affect at age 14 as predictors of relationship, adjustment, self-worth, and career outcomes a decade later at ages 23 to 25, controlling for family income and gender. We utilised multi-informant methods including reports from the target participant, close friends, and romantic partners in a demographically diverse community sample of 184 participants. Early adolescent positive affect predicted fewer relationship problems (less self-reported and partner-reported conflict, and greater friendship attachment as rated by close peers) and healthy adjustment to adulthood (lower levels of depression, anxiety, and loneliness). It also predicted positive work functioning (higher levels of career satisfaction and job competence) and increased self-worth. Negative affect did not significantly predict any of these important life outcomes. In addition to predicting desirable mean levels of later outcomes, early positive affect predicted beneficial changes across time in many outcomes. The findings extend early research on the beneficial outcomes of subjective well-being by having an earlier assessment of well-being, including informant reports in measuring a large variety of outcome variables, and by extending the findings to a lower socioeconomic group of a diverse and younger sample. The results highlight the importance of considering positive affect as an important component of subjective well-being distinct from negative affect. © 2016 The International Association of Applied Psychology.

  12. Early Adolescent Affect Predicts Later Life Outcomes

    PubMed Central

    Kansky, Jessica; Allen, Joseph P.; Diener, Ed

    2016-01-01

    Background Subjective well-being as a predictor for later behavior and health has highlighted its relationship to health, work performance, and social relationships. However, the majority of such studies neglect the developmental nature of well-being in contributing to important changes across the transition to adulthood. Methods To examine the potential role of subjective well-being as a long-term predictor of critical life outcomes, we examined indicators of positive and negative affect at age 14 as a predictor of relationship, adjustment, self worth, and career outcomes a decade later at ages 23 to 25, controlling for family income and gender. We utilized multi-informant methods including reports from the target participant, close friends, and romantic partners in a demographically diverse community sample of 184 participants. Results Early adolescent positive affect predicted less relationship problems (less self-reported and partner-reported conflict, greater friendship attachment as rated by close peers), healthy adjustment to adulthood (lower levels of depression, anxiety, and loneliness). It also predicted positive work functioning (higher levels of career satisfaction and job competence) and increased self-worth. Negative affect did not significantly predict any of these important life outcomes. In addition to predicting desirable mean levels of later outcomes, early positive affect predicted beneficial changes across time in many outcomes. Conclusions The findings extend early research on the beneficial outcomes of subjective well-being by having an earlier assessment of well-being, including informant reports in measuring a large variety of outcome variables, and by extending the findings to a lower socioeconomic group of a diverse and younger sample. The results highlight the importance of considering positive affect as an important component of subjective well-being distinct from negative affect. PMID:27075545

  13. The Importance of First Impressions: Early Events in Mycobacterium tuberculosis Infection Influence Outcome.

    PubMed

    Cadena, Anthony M; Flynn, JoAnne L; Fortune, Sarah M

    2016-04-05

    Tuberculosis remains a major health threat in much of the world. New vaccines against Mycobacterium tuberculosis are essential for preventing infection, disease, and transmission. However, the host immune responses that need to be induced by an effective vaccine remain unclear. Increasingly, it has become clear that early events in infection are of major importance in the eventual outcome of the infection. Studying such events in humans is challenging, as they occur within the lung and thoracic lymph nodes, and any clinical signs of early infection are relatively nonspecific. Nonetheless, clinical studies and animal models of tuberculosis have provided new insights into the local events that occur in the first few weeks of tuberculosis. Development of an effective vaccine requires a clear understanding of the successful (and detrimental) early host responses against M. tuberculosis, with the goal to improve upon natural immune responses and prevent infection or disease. Copyright © 2016 Cadena et al.

  14. Proton Radiotherapy for Pediatric Central Nervous System Germ Cell Tumors: Early Clinical Outcomes

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    MacDonald, Shannon M., E-mail: smacdonald@partners.or; Trofimov, Alexei; Safai, Sairos

    Purpose: To report early clinical outcomes for children with central nervous system (CNS) germ cell tumors treated with protons; to compare dose distributions for intensity-modulated photon radiotherapy (IMRT), three-dimensional conformal proton radiation (3D-CPT), and intensity-modulated proton therapy with pencil beam scanning (IMPT) for whole-ventricular irradiation with and without an involved-field boost. Methods and Materials: All children with CNS germinoma or nongerminomatous germ cell tumor who received treatment at the Massachusetts General Hospital between 1998 and 2007 were included in this study. The IMRT, 3D-CPT, and IMPT plans were generated and compared for a representative case. Results: Twenty-two patients were treatedmore » with 3D-CPT. At a median follow-up of 28 months, there were no CNS recurrences; 1 patient had a recurrence outside the CNS. Local control, progression-free survival, and overall survival rates were 100%, 95%, and 100%, respectively. Comparable tumor volume coverage was achieved with IMRT, 3D-CPT, and IMPT. Substantial normal tissue sparing was seen with any form of proton therapy as compared with IMRT. The use of IMPT may yield additional sparing of the brain and temporal lobes. Conclusions: Preliminary disease control with proton therapy compares favorably to the literature. Dosimetric comparisons demonstrate the advantage of proton radiation over IMRT for whole-ventricle radiation. Superior dose distributions were accomplished with fewer beam angles utilizing 3D-CPT and scanned protons. Intensity-modulated proton therapy with pencil beam scanning may improve dose distribution as compared with 3D-CPT for this treatment.« less

  15. Diffuse optical measurements of head and neck tumor hemodynamics for early prediction of chemoradiation therapy outcomes

    NASA Astrophysics Data System (ADS)

    Dong, Lixin; Kudrimoti, Mahesh; Irwin, Daniel; Chen, Li; Kumar, Sameera; Shang, Yu; Huang, Chong; Johnson, Ellis L.; Stevens, Scott D.; Shelton, Brent J.; Yu, Guoqiang

    2016-08-01

    This study used a hybrid near-infrared diffuse optical instrument to monitor tumor hemodynamic responses to chemoradiation therapy for early prediction of treatment outcomes in patients with head and neck cancer. Forty-seven patients were measured once per week to evaluate the hemodynamic status of clinically involved cervical lymph nodes as surrogates for the primary tumor response. Patients were classified into two groups: complete response (CR) (n=29) and incomplete response (IR) (n=18). Tumor hemodynamic responses were found to be associated with clinical outcomes (CR/IR), wherein the associations differed depending on human papillomavirus (HPV-16) status. In HPV-16 positive patients, significantly lower levels in tumor oxygenated hemoglobin concentration ([HbO2]) at weeks 1 to 3, total hemoglobin concentration at week 3, and blood oxygen saturation (StO2) at week 3 were found in the IR group. In HPV-16 negative patients, significantly higher levels in tumor blood flow index and reduced scattering coefficient (μs‧) at week 3 were observed in the IR group. These hemodynamic parameters exhibited significantly high accuracy for early prediction of clinical outcomes, within the first three weeks of therapy, with the areas under the receiver operating characteristic curves (AUCs) ranging from 0.83 to 0.96.

  16. Diffuse optical measurements of head and neck tumor hemodynamics for early prediction of chemoradiation therapy outcomes

    PubMed Central

    Dong, Lixin; Kudrimoti, Mahesh; Irwin, Daniel; Chen, Li; Kumar, Sameera; Shang, Yu; Huang, Chong; Johnson, Ellis L.; Stevens, Scott D.; Shelton, Brent J.; Yu, Guoqiang

    2016-01-01

    Abstract. This study used a hybrid near-infrared diffuse optical instrument to monitor tumor hemodynamic responses to chemoradiation therapy for early prediction of treatment outcomes in patients with head and neck cancer. Forty-seven patients were measured once per week to evaluate the hemodynamic status of clinically involved cervical lymph nodes as surrogates for the primary tumor response. Patients were classified into two groups: complete response (CR) (n=29) and incomplete response (IR) (n=18). Tumor hemodynamic responses were found to be associated with clinical outcomes (CR/IR), wherein the associations differed depending on human papillomavirus (HPV-16) status. In HPV-16 positive patients, significantly lower levels in tumor oxygenated hemoglobin concentration ([HbO2]) at weeks 1 to 3, total hemoglobin concentration at week 3, and blood oxygen saturation (StO2) at week 3 were found in the IR group. In HPV-16 negative patients, significantly higher levels in tumor blood flow index and reduced scattering coefficient (μs′) at week 3 were observed in the IR group. These hemodynamic parameters exhibited significantly high accuracy for early prediction of clinical outcomes, within the first three weeks of therapy, with the areas under the receiver operating characteristic curves (AUCs) ranging from 0.83 to 0.96. PMID:27564315

  17. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    PubMed

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  18. Irritability Trajectories, Cortical Thickness, and Clinical Outcomes in a Sample Enriched for Preschool Depression.

    PubMed

    Pagliaccio, David; Pine, Daniel S; Barch, Deanna M; Luby, Joan L; Leibenluft, Ellen

    2018-05-01

    Cross-sectional, longitudinal, and genetic associations exist between irritability and depression. Prior studies have examined developmental trajectories of irritability, clinical outcomes, and associations with child and familial depression. However, studies have not integrated neurobiological measures. The present study examined developmental trajectories of irritability, clinical outcomes, and cortical structure among preschoolers oversampled for depressive symptoms. Beginning at 3 to 5 years old, a sample of 271 children enriched for early depressive symptoms were assessed longitudinally by clinical interview. Latent class mixture models identified trajectories of irritability severity. Risk factors, clinical outcomes, and cortical thickness were compared across trajectory classes. Cortical thickness measures were extracted from 3 waves of magnetic resonance imaging at 7 to 12 years of age. Three trajectory classes were identified among these youth: 53.50% of children exhibited elevated irritability during preschool that decreased longitudinally, 30.26% exhibited consistently low irritability, and 16.24% exhibited consistently elevated irritability. Compared with other classes, the elevated irritability class exhibited higher rates of maternal depression, early life adversity, later psychiatric diagnoses, and functional impairment. Further, elevated baseline irritability predicted later depression beyond adversity and personal and maternal depression history. The elevated irritability class exhibited a thicker cortex in the left superior frontal and temporal gyri and the right inferior parietal lobule. Irritability manifested with specific developmental trajectories in this sample enriched for early depression. Persistently elevated irritability predicted poor psychiatric outcomes, higher risk for later depression, and decreased overall function later in development. Greater frontal, temporal, and parietal cortical thickness also was found, providing neural

  19. ACL reconstruction with hamstring tendon autograft and accelerated brace-free rehabilitation: a systematic review of clinical outcomes

    PubMed Central

    van Melick, Nicky; van Mourik, Jan B A; Reijman, Max; van Rhijn, Lodewijk W

    2018-01-01

    Objective To investigate the clinical outcomes after hamstring tendon autograft ACL reconstruction (ACLR) with accelerated, brace-free rehabilitation. Design Systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Data sources Embase, MEDLINE Ovid, Web of Science, Cochrane CENTRAL and Google scholar from 1 January 1974 to 31 January 2017. Eligibility criteria for selecting studies Study designs reporting outcomes in adults after arthroscopic, primary ACLR with hamstring autograft and accelerated, brace-free rehabilitation. Results Twenty-four studies were included in the review. The clinical outcomes after hamstring tendon autograft ACLR with accelerated brace-free rehabilitation were the following: (1) early start of open kinetic exercises at 4 weeks in a limited range of motion (ROM, 90°−45°) and progressive concentric and eccentric exercises from 12 weeks did not alter outcomes, (2) gender and age did not influence clinical outcomes, (3) anatomical reconstructions showed better results than non-anatomical reconstructions, (4) there was no difference between single-bundle and double-bundle reconstructions, (5) femoral and tibial tunnel widening occurred, (6) hamstring tendons regenerated after harvest and (7) biological knowledge did not support return to sports at 4–6 months. Conclusions After hamstring tendon autograft ACLR with accelerated brace-free rehabilitation, clinical outcome is similar after single-bundle and double-bundle ACLR. Early start of open kinetic exercises at 4 weeks in a limited ROM (90°−45°) and progressive concentric and eccentric exercises from 12 weeks postsurgery do not alter clinical outcome. Further research should focus on achievement of best balance between graft loading and graft healing in the various rehabilitation phases after ACLR as well as on validated, criterion-based assessments for safe return to sports. Level of evidence Level 2b; therapeutic outcome studies

  20. Nonsurgical scar management of the face: does early versus late intervention affect outcome?

    PubMed

    Parry, Ingrid; Sen, Soman; Palmieri, Tina; Greenhalgh, David

    2013-01-01

    Special emphasis is placed on the clinical management of facial scarring because of the profound physical and psychological impact of facial burns. Noninvasive methods of facial scar management include pressure therapy, silicone, massage, and facial exercises. Early implementation of these scar management techniques after a burn injury is typically accepted as standard burn rehabilitation practice, however, little data exist to support this practice. This study evaluated the timing of common noninvasive scar management interventions after facial skin grafting in children and the impact on outcome, as measured by scar assessment and need for facial reconstructive surgery. A retrospective review of 138 patients who underwent excision and grafting of the face and subsequent noninvasive scar management during a 10-year time frame was conducted. Regression analyses were used to show that earlier application of silicone was significantly related to lower Modified Vancouver Scar Scale scores, specifically in the subscales of vascularity and pigmentation. Early use of pressure therapy and implementation of facial exercises were also related to lower Modified Vancouver Scar Scale vascularity scores. No relationship was found between timing of the interventions and facial reconstructive outcome. Early use of silicone, pressure therapy, and exercise may improve scar outcome and accelerate time to scar maturity.

  1. Clinical outcomes and patients' perceptions of nurse-led healthy lifestyle clinics.

    PubMed

    Marshall, Bob; Floyd, Sue; Forrest, Rachel

    2011-03-01

    The Nurse-Led Healthy Lifestyle Clinics focussed on lifestyle issues for patients with known health inequalities. Much of the nursing was educative and preventative care. This evaluation assessed patient experiences and opinions, as well as clinical outcomes. Information came from clinical outcome data for 2850 individuals and 424 patient satisfaction surveys. Patients were aged 0-95 years (45% between 40 and 59 years); 60% Pakeha/European, 31.4% Maori, 4.2% Pacific and 4.4% other ethnicities. Only 19% of claimants (approximately 40% were Maori or Pacific) came from quintile 5 addresses, suggesting the target population was not reached effectively. Ninety-four percent of patients had a better understanding of their diagnosis, medication and treatment plan, and were more motivated to self-manage their health needs. This increase in patient empowerment is a significant outcome of the project. Clinical outcome data showed no significant differences between first and last clinic visits for average weight, blood pressure, smoking, glycosylated haemoglobin levels, waist circumference or cardiovascular risk. Significant improvements were shown in the Dartmouth Primary Care Cooperative Information results for social activity, change in health, and overall health (n=89). More effective techniques to access the target population have been implemented, as has an extended period for review of clinical outcomes. More focussed evaluation of clinical outcomes is necessary to provide quantitative data on the clinics. The large percentage of patients who felt more empowered to self-manage their health needs suggests the clinics were effective in this area.

  2. Nutritional Care of Gastric Cancer Patients with Clinical Outcomes and Complications: A Review.

    PubMed

    Choi, Wook Jin; Kim, Jeongseon

    2016-04-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer.

  3. [Angiopoietins predict long-term outcomes after aneurysmal subarachnoid hemorrhage during an early period].

    PubMed

    Wang, Yi; Wang, Dong; Wei, Huijie; Tian, Ye; Jiang, Rongcai; Yue, Shuyuan; Zhang, Jianning

    2015-05-19

    To evaluate the association between serum levels of angiopoietins (Ang) during an early period (within 72 h) and clinical outcomes after aneurysmal subarachnoid haemorrhage (aSAH). This prospective study was conducted at Department of Neurosurgery, Tianjin Medical University General Hospital. Blood samples from 37 aSAH patients were collected at 8 h (or < 8 h), 24 h, 72 h after an onset of SAH. The serum levels of Ang-1, Ang-2 and Tie-2 were measured by enzyme-linked immunosorbent assay (ELISA). They were followed up for 3 months by Glasgow outcome score extended (GOSE). Those with GOSE > 5 were counted as a good outcome while those with GOSE ≤ 5 had a poor outcome. A total of 37 patients with aSAH and 39 healthy controls (HC) were enrolled. The aSAH patients showed a significant rise of Ang-1 within 8 h as compared with HC. The outcomes were good (n = 15) and poor (n = 22). Serum Ang-1 at 8 h (or < 8 h), 24 h and 72 h in good outcomers showed significantly higher than that in poor outcomers [(52 ± 24) vs (37 ± 17) mg/L, (62 ± 26) vs (45 ± 17) mg/L, (107 ± 27) vs (72 ± 18) mg/L]. The serum level of Ang-1 at 8 h and 24 h was one of independent risk factors for aSAH patients by multiariable Logistic regression analysis [adjected OR (95% CI) 1.095 (1.015-1.181) and 1.109 (1.016-1.211)] (P < 0.05). High serum level of Ang-1 during an early period (within 72 h) was associated with good outcomers (r = 0.627, P < 0.001). The serum levels of angiopoietins are significantly altered in aSAH patients, especially higher in good outcomers. And abnormal levels of angiopoietins may affect early brain injury (EBI) after SAH, structural integrity and recovery of blood-brain barrier (BBB) and long-term outcomes in aSAH patients.

  4. Early Clinical Outcome With Concurrent Chemotherapy and Extended-Field, Intensity-Modulated Radiotherapy for Cervical Cancer

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Beriwal, Sushil; Gan, Gregory N.; Heron, Dwight E.

    2007-05-01

    Purpose: To assess the early clinical outcomes with concurrent cisplatin and extended-field intensity-modulated radiotherapy (EF-IMRT) for carcinoma of the cervix. Methods and Materials: Thirty-six patients with Stage IB2-IVA cervical cancer treated with EF-IMRT were evaluated. The pelvic lymph nodes were involved in 19 patients, and of these 19 patients, 10 also had para-aortic nodal disease. The treatment volume included the cervix, uterus, parametria, presacral space, upper vagina, and pelvic, common iliac, and para-aortic nodes to the superior border of L1. Patients were assessed for acute toxicities according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0.more » All late toxicities were scored with the Radiation Therapy Oncology Group late toxicity score. Results: All patients completed the prescribed course of EF-IMRT. All but 2 patients received brachytherapy. Median length of treatment was 53 days. The median follow-up was 18 months. Acute Grade {>=}3 gastrointestinal, genitourinary, and myelotoxicity were seen in 1, 1, and 10 patients, respectively. Thirty-four patients had complete response to treatment. Of these 34 patients, 11 developed recurrences. The first site of recurrence was in-field in 2 patients (pelvis in 1, pelvis and para-aortic in 1) and distant in 9 patients. The 2-year actuarial locoregional control, disease-free survival, overall survival, and Grade {>=}3 toxicity rates for the entire cohort were 80%, 51%, 65%, and 10%, respectively. Conclusion: Extended-field IMRT with concurrent chemotherapy was tolerated well, with acceptable acute and early late toxicities. The locoregional control rate was good, with distant metastases being the predominant mode of failure. We are continuing to accrue a larger number of patients and longer follow-up data to further extend our initial observations with this approach.« less

  5. Evaluation of longitudinal 12 and 24 month cognitive outcomes in premanifest and early Huntington's disease.

    PubMed

    Stout, Julie C; Jones, Rebecca; Labuschagne, Izelle; O'Regan, Alison M; Say, Miranda J; Dumas, Eve M; Queller, Sarah; Justo, Damian; Santos, Rachelle Dar; Coleman, Allison; Hart, Ellen P; Dürr, Alexandra; Leavitt, Blair R; Roos, Raymund A; Langbehn, Doug R; Tabrizi, Sarah J; Frost, Chris

    2012-07-01

    Deterioration of cognitive functioning is a debilitating symptom in many neurodegenerative diseases, such as Huntington's disease (HD). To date, there are no effective treatments for the cognitive problems associated with HD. Cognitive assessment outcomes will have a central role in the efforts to develop treatments to delay onset or slow the progression of the disease. The TRACK-HD study was designed to build a rational basis for the selection of cognitive outcomes for HD clinical trials. There were a total of 349 participants, including controls (n=116), premanifest HD (n=117) and early HD (n=116). A standardised cognitive assessment battery (including nine cognitive tests comprising 12 outcome measures) was administered at baseline, and at 12 and 24 months, and consisted of a combination of paper and pencil and computerised tasks selected to be sensitive to cortical-striatal damage or HD. Each cognitive outcome was analysed separately using a generalised least squares regression model. Results are expressed as effect sizes to permit comparisons between tasks. 10 of the 12 cognitive outcomes showed evidence of deterioration in the early HD group, relative to controls, over 24 months, with greatest sensitivity in Symbol Digit, Circle Tracing direct and indirect, and Stroop word reading. In contrast, there was very little evidence of deterioration in the premanifest HD group relative to controls. The findings describe tests that are sensitive to longitudinal cognitive change in HD and elucidate important considerations for selecting cognitive outcomes for clinical trials of compounds aimed at ameliorating cognitive decline in HD.

  6. Audit of the autoantibody test, EarlyCDT®-lung, in 1600 patients: an evaluation of its performance in routine clinical practice.

    PubMed

    Jett, James R; Peek, Laura J; Fredericks, Lynn; Jewell, William; Pingleton, William W; Robertson, John F R

    2014-01-01

    EarlyCDT(®)-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient. Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging. Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity=41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II. EarlyCDT-Lung has been extensively tested and validated in case-control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  7. Innovative strategies for early clinical R&D.

    PubMed

    Butz, Robert F; Morelli, Gaetano

    2008-01-01

    Developments in translational medicine and regulatory initiatives associated with the FDA's Critical Path Initiative are creating new opportunities for innovation in early clinical R&D. The introduction of the exploratory IND process allows small, 'phase 0' clinical trials to be conducted prior to traditional phase I trials - sometimes requiring considerably less chemistry, manufacturing and controls, or preclinical support. Phase 0 clinical trials involving subtherapeutic, yet pharmacologically active, dose levels can provide an early demonstration of clinical proof of concept; such demonstration is of particular importance to small pharmaceutical and early-stage biotechnology companies. However, these opportunities for rapid entry into the clinic must be balanced by a consideration of the unique risks associated with first-in-human clinical trials, and by accounting for public concerns regarding drug safety in general. This feature review discusses how innovative clinical strategies can be used effectively in early drug development.

  8. Prepregnancy Nutrition and Early Pregnancy Outcomes

    PubMed Central

    Gaskins, Audrey J.; Toth, Thomas L.; Chavarro, Jorge E.

    2015-01-01

    Implantation failure and pregnancy loss are estimated to affect up to 75% of fertilized ova; however as of yet there is limited empirical evidence, particularly at the population level, for understanding the environmental determinants of these losses. The purpose of this review is to summarize the current knowledge on prepregnancy nutrition and early pregnancy outcomes with particular focus on the outcome of spontaneous abortion among pregnancies conceived naturally and early pregnancy end points among pregnancies conceived through in vitro fertilization. To date, there is limited evidence to support associations of prepregnancy vitamin D and caffeine intake with pregnancy loss. There is suggestive data supporting a link between a healthy diet and lower risk of pregnancy loss. High folate and minimal to no alcohol intake prior to conception have the most consistent evidence supporting an association with lower risk of pregnancy loss. PMID:26457232

  9. Predicting adverse obstetric outcome after early pregnancy events and complications: a review.

    PubMed

    van Oppenraaij, R H F; Jauniaux, E; Christiansen, O B; Horcajadas, J A; Farquharson, R G; Exalto, N

    2009-01-01

    BACKGROUND The aim was to evaluate the impact of early pregnancy events and complications as predictors of adverse obstetric outcome. METHODS We conducted a literature review on the impact of first trimester complications in previous and index pregnancies using Medline and Cochrane databases covering the period 1980-2008. RESULTS Clinically relevant associations of adverse outcome in the subsequent pregnancy with an odds ratio (OR) > 2.0 after complications in a previous pregnancy are the risk of perinatal death after a single previous miscarriage, the risk of very preterm delivery (VPTD) after two or more miscarriages, the risk of placenta praevia, premature preterm rupture of membranes, VPTD and low birthweight (LBW) after recurrent miscarriage and the risk of VPTD after two or more termination of pregnancy. Clinically relevant associations of adverse obstetric outcome in the ongoing pregnancy with an OR > 2.0 after complications in the index pregnancy are the risk of LBW and very low birthweight (VLBW) after a threatened miscarriage, the risk of pregnancy-induced hypertension, pre-eclampsia, placental abruption, preterm delivery (PTD), small for gestational age and low 5-min Apgar score after detection of an intrauterine haematoma, the risk of VPTD and intrauterine growth restriction after a crown-rump length discrepancy, the risk of VPTD, LBW and VLBW after a vanishing twin phenomenon and the risk of PTD, LBW and low 5-min Apgar score in a pregnancy complicated by severe hyperemesis gravidarum. CONCLUSIONS Data from our literature review indicate, by finding significant associations, that specific early pregnancy events and complications are predictors for subsequent adverse obstetric and perinatal outcome. Though, some of these associations are based on limited or small uncontrolled studies. Larger population-based controlled studies are needed to confirm these findings. Nevertheless, identification of these risks will improve obstetric care.

  10. Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry): Observational and Retrospective Study.

    PubMed

    Tehrani, Behnam; Truesdell, Alexander; Singh, Ramesh; Murphy, Charles; Saulino, Patricia

    2018-06-28

    The development and implementation of a Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided management and improvement of outcomes in cardiogenic shock. The objectives of this study are (1) to collect retrospective clinical outcomes for acute decompensated heart failure cardiogenic shock and acute myocardial infarction cardiogenic shock, and compare current versus historical survival rates and clinical outcomes; (2) to evaluate Inova Heart and Vascular Institute site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017; (3) to compare outcomes related to early implementation of mechanical circulatory support and hemodynamic-guided management versus historical controls; (4) to assess survival to discharge rate in patients receiving intervention from the designated shock team and (5) create a clinical archive of Cardiogenic Shock patient characteristics for future analysis and the support of translational research studies. This is an observational, retrospective, single center study. Retrospective and prospective data will be collected in patients treated at the Inova Heart and Vascular Institute with documented cardiogenic shock as a result of acute decompensated heart failure or acute myocardial infarction. This registry will include data from patients prior to and after the initiation of the multidisciplinary Cardiogenic Shock team on January 1, 2017. Clinical outcomes associated with early multidisciplinary team intervention will be analyzed. In the study group, all patients evaluated for documented cardiogenic shock (acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock) treated at the Inova Heart and Vascular Institute by the Cardiogenic Shock team will be included. An additional historical Inova Heart and Vascular Institute control group will

  11. Scrub typhus: Clinical spectrum and outcome.

    PubMed

    Venkategowda, Pradeep M; Rao, S Manimala; Mutkule, Dnyaneshwar P; Rao, Mallela V; Taggu, Alai N

    2015-04-01

    Scrub typhus is one of the differential diagnoses for fever with thrombocytopenia. ARDS associated with Scrub typhus has high morbidity and mortality. To evaluate clinical features, lab values, and outcome in patients with scrub typhus and comparison in patients with or without ARDS. A prospective observational study was conducted on 109 patients with febrile illness and thrombocytopenia during a period of 12 months. All 109 patients were tested with both Immune-chromatography test and Weil felix test. Patients having either Immune-chromatography test/Weil felix test positive have been included and considered as scrub typhus positive whereas negative for both Immune-chromatography and Weil felix test were excluded. Clinical features, lab parameters, and outcome were evaluated in all patients with scrub typhus. Statistical analysis used in this study was T-test. Among 58 patients who were included (After exclusion of 51 patients among total of 109 patients) 34 patients had no ARDS and 24 patients had ARDS. The clinical feature like dyspnoea, cough, low blood pressure (MAP<65 mmHg), IVC collapsibility (by ultrasound) and laboratory parameters like decreased Hemoglobin, Hematocrit, Serum albumin, and increased serum creatinine, serum total bilirubin, SGOT, SGPT, LDH, CPK, and serum lactate were statistically significant (P < 0.0001) in scrub typhus patients group with ARDS. The higher titers of Weil-felix can be correlated with more severe form of disease according to our observation. All 34 Scrub typhus patients without ARDS recovered completely. Among 24 Scrub typhus patients with ARDS, 22 patients recovered, and 2 patients died. Scrub typhus is an important differential diagnosis in a patients having fever with thrombocytopenia. Scrub typhus associated with ARDS has high morbidity and mortality. Early diagnosis and treatment with doxycycline can prevent the occurrence of ARDS.

  12. Clinical and MRI outcome of cervical spine lesions in children with juvenile idiopathic arthritis treated with anti-TNFα drugs early in disease course.

    PubMed

    Ključevšek, Damjana; Emeršič, Nina; Toplak, Nataša; Avčin, Tadej

    2017-05-15

    The purpose of the study was to evaluate the clinical and magnetic resonance imaging (MRI) outcome of cervical spine arthritis in children with juvenile idiopathic arthritis (JIA), who received anti-TNFα early in the course of cervical spine arthritis. Medical charts and imaging of JIA patients with cervical spine involvement were reviewed in this retrospective study. Data, including age at disease onset, JIA type, disease activity, treatment and clinical outcome were collected. Initial and followup MRI examinations of cervical spine were performed according to the hospital protocol to evaluate the presence of inflammation and potential chronic/late changes. Fifteen JIA patients with MRI proved cervical spine inflammation (11 girls, 4 boys, median age 6.3y) were included in the study: 9 had polyarthritis, 3 extended oligoarthritis, 2 persistent oligoarthritis and 1 juvenile psoriatic arthritis. All children were initially treated with high-dose steroids and methotrexate. In addition, 11 patients were treated with anti-TNFα drug within 3 months, and 3 patients within 7 months of cervical spine involvement confirmed by MRI. Mean observation time was 2.9y, mean duration of anti-TNFα treatment was 2.2y. Last MRI showed no active inflammation in 12/15 children, allowing to stop biological treatment in 3 patients, and in 3/15 significant reduction of inflammation. Mild chronic changes were found on MRI in 3 children. Early treatment with anti-TNFα drugs resulted in significantly reduced inflammation or complete remission of cervical spine arthritis proved by MRI, and prevented the development of serious chronic/late changes. Repeated MRI examinations are suggested in the follow-up of JIA patients with cervical spine arthritis.

  13. Fresh Osteochondral Allograft Transplantation: Is Graft Storage Time Associated With Clinical Outcomes and Graft Survivorship?

    PubMed

    Schmidt, Kenneth J; Tírico, Luís E; McCauley, Julie C; Bugbee, William D

    2017-08-01

    Regulatory concerns and the popularity of fresh osteochondral allograft (OCA) transplantation have led to a need for prolonged viable storage of osteochondral grafts. Tissue culture media allow a longer storage time but lead to chondrocyte death within the tissue. The long-term clinical consequence of prolonged storage is unknown. Patients transplanted with OCAs with a shorter storage time would have lower failure rates and better clinical outcomes than those transplanted with OCAs with prolonged storage. Cohort study; Level of evidence, 3. A matched-pair study was performed of 75 patients who received early release grafts (mean storage, 6.3 days [range, 1-14 days]) between 1997 and 2002, matched 1:1 by age, diagnosis, and graft size, with 75 patients who received late release grafts (mean storage time, 20.0 days [range, 16-28 days]) from 2002 to 2008. The mean age was 33.5 years, and the median graft size was 6.3 cm 2 . All patients had a minimum 2-year follow-up. Evaluations included pain, satisfaction, function, failures, and reoperations. Outcome measures included the modified Merle d'Aubigné-Postel (18-point) scale, International Knee Documentation Committee (IKDC) form, and Knee Society function (KS-F) scale. Clinical failure was defined as revision OCA transplantation or conversion to arthroplasty. Among patients with grafts remaining in situ, the mean follow-up was 11.9 years (range, 2.0-16.8 years) and 7.8 years (range, 2.3-11.1 years) for the early and late release groups, respectively. OCA failure occurred in 25.3% (19/75) of patients in the early release group and 12.0% (9/75) of patients in the late release group ( P = .036). The median time to failure was 3.5 years (range, 1.7-13.8 years) and 2.7 years (range, 0.3-11.1 years) for the early and late release groups, respectively. The 5-year survivorship of OCAs was 85% for the early release group and 90% for the late release group ( P = .321). No differences in postoperative pain and function were

  14. Long-Chain Polyunsaturated Fatty Acids and Clinical Outcomes of Preterm Infants.

    PubMed

    Lapillonne, Alexandre; Moltu, Sissel J

    2016-01-01

    Long-chain polyunsaturated fatty acids (LCPUFAs) play specific roles during the perinatal period and are very important nutrients to consider. The possible effects of LCPUFAs, particularly docosahexaenoic acid (DHA), on various clinical outcomes of preterm infants are discussed in this paper. Since DHA accumulates in the central nervous system during development, a lot of attention has focused on the effects of DHA on neurodevelopment. Experimental studies as well as recent clinical trials show that providing larger amounts of DHA than currently and routinely provided is associated with better neurological outcomes at 18 months to 2 years. This early advantage, however, does not seem to translate into detectable change in visual and neurodevelopmental outcomes or behavior when assessed in childhood. There is growing evidence that, in addition to effects on development, omega-3 LCPUFAs may reduce the incidence or severity of neonatal morbidities by affecting different steps of the immune and anti-inflammatory response. Studies in preterm infants suggest that the omega-3 LCPUFAs may play a significant role by reducing the risk of bronchopulmonary dysplasia, necrotizing enterocolitis and possibly retinopathy of prematurity and sepsis. Overall, evidence is increasing to support the benefits of high-dose DHA for various health outcomes of preterm infants. These findings are of major clinical relevance mainly because infants born preterm are at particularly high risk for a nutritional deficit in omega-3 fatty acids, predisposing to adverse neonatal outcomes. Further studies are warranted to address these issues as well as to more precisely determine the LCPUFA requirement in order to favor the best possible outcomes of preterm infants. © 2016 S. Karger AG, Basel.

  15. Early Predictors of Global Functional Outcome After Traumatic Spinal Cord Injury: A Systematic Review.

    PubMed

    Richard-Denis, Andréane; Beauséjour, Marie; Thompson, Cynthia; Nguyen, Bich-Han; Mac-Thiong, Jean-Marc

    2018-04-17

    Accurately predicting functional recovery is an asset for all clinicians and decision makers involved in the care of patients with acute traumatic spinal cord injury (TSCI). Unfortunately, there is a lack of information on the relative importance of significant predictors of global functional outcome. There is also a need for identifying functional predictors that can be timely optimized by the medical and rehabilitation teams throughout the hospitalizations phases. The main objective of this work was to systematically review and rate early factors that are consistently and independently associated with global functional outcome in individuals with TSCI. A literature search using MEDLINE, EMBASE, and Cochrane databases from January 1, 1970 to April 1, 2017 was performed. Two authors independently reviewed the titles and abstracts yielded by this literature search and subsequently selected studies to be included based on predetermined eligibility criteria. Disagreements were resolved by a consensus-based discussion, and if not, by an external reviewer. Data were extracted by three independent reviewers using a standardized table. The quality of evidence of the individual studies was assessed based on the Oxford Center for Evidence-Based Medicine modified by Wright and colleagues (2000) as well as the National Institutes of Health (2014). Fifteen articles identifying early clinical predictors of functional outcome using multiple regression analyses were included in this systematic review. Based on the compiled data, this review proposes a rating of early factors associated to global functional outcome according to their importance and their potential to be modified by the medical/rehabilitation team throughout the early phases of hospitalization. It also proposes a new conceptual framework that illustrates the impact of specific categories of factors and their interaction with each other. Ultimately, this review aims to guide clinicians and researchers in improving

  16. Disorganization at the stage of schizophrenia clinical outcome: Clinical-biological study.

    PubMed

    Nestsiarovich, A; Obyedkov, V; Kandratsenka, H; Siniauskaya, M; Goloenko, I; Waszkiewicz, N

    2017-05-01

    According to the multidimensional model of schizophrenia, three basic psychopathological dimensions constitute its clinical structure: positive symptoms, negative symptoms and disorganization. The latter one is the newest and the least studied. Our aim was to discriminate disorganization in schizophrenia clinical picture and to identify its distinctive biological and socio-psychological particularities and associated genetic and environmental factors. We used SAPS/SANS psychometrical scales, scales for the assessment of patient's compliance, insight, social functioning, life quality. Neuropsychological tests included Wisconsin Card Sorting Test (WCST), Stroop Color-Word test. Neurophysiological examination included registration of P300 wave of the evoked cognitive auditory potentials. Environmental factors related to patient's education, family, surrounding and nicotine use, as well as subjectively significant traumatic events in childhood and adolescence were assessed. Using PCR we detected SNP of genes related to the systems of neurotransmission (COMT, SLC6A4 and DRD2), inflammatory response (IL6, TNF), cellular detoxification (GSTM1, GSTT1), DNA methylation (MTHFR, DNMT3b, DNMT1). Disorganization is associated with early schizophrenia onset and history of psychosis in family, low level of insight and compliance, high risk of committing delicts, distraction errors in WCST, lengthened P300 latency of evoked cognitive auditory potentials, low-functional alleles of genes MTHFR (rs1801133) and DNMT3b (rs2424913), high level of urbanicity and psychotraumatic events at early age. Severe disorganization at the stage of schizophrenia clinical outcome is associated with the set of specific biological and social-psychological characteristics that indicate its epigenetic nature and maladaptive social significance. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  17. Results of a Coordinated Specialty Care Program for Early Psychosis and Predictors of Outcomes.

    PubMed

    Nossel, Ilana; Wall, Melanie M; Scodes, Jennifer; Marino, Leslie A; Zilkha, Sacha; Bello, Iruma; Malinovsky, Igor; Lee, Rufina; Radigan, Marleen; Smith, Thomas E; Sederer, Lloyd; Gu, Gyojeong; Dixon, Lisa

    2018-05-15

    This study prospectively evaluated outcomes of OnTrackNY, a statewide coordinated specialty care (CSC) program for treatment of early psychosis in community settings, as well as predictors of outcomes. The sample included 325 individuals ages 16-30 with recent-onset nonaffective psychosis who were enrolled in OnTrackNY and who had at least one three-month follow-up. Clinicians provided data at baseline and quarterly up to one year. Domains assessed included demographic and clinical characteristics, social and occupational functioning, medications, suicidality and violence, hospitalization, and time to intervention. Primary outcomes included the symptoms, occupational functioning, and social functioning scales of the Global Assessment of Functioning (GAF), as adapted by the U.S. Department of Veterans Affairs Mental Illness Research, Education and Clinical Center; education and employment status; and psychiatric hospitalization rate. Education and employment rates increased from 40% to 80% by six months, hospitalization rates decreased from 70% to 10% by three months, and improvement in GAF scores continued for 12 months. Female gender, non-Hispanic white race-ethnicity, and more education at baseline predicted better education and employment status at follow-up. Individuals with early psychosis receiving CSC achieved significant improvements in education and employment and experienced a decrease in hospitalization rate. Demographic variables and baseline education predicted education and employment outcomes. CSC teams should make particular effort to support the occupational goals of individuals at increased risk of not engaging in work or school, including male participants and participants from racial and ethnic minority groups.

  18. Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study

    PubMed Central

    2012-01-01

    Background Evidence is lacking to inform providers’ and patients’ decisions about many common treatment strategies for patients with end stage renal disease (ESRD). Methods/design The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003–2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006–2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community. Discussion The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD

  19. How can experience in clinical and community settings contribute to early medical education? A BEME systematic review.

    PubMed

    Dornan, T; Littlewood, S; Margolis, S A; Scherpbier, A; Spencer, J; Ypinazar, V

    2006-02-01

    Review period January 1992-December 2001. Final analysis July 2004-January 2005. BACKGROUND AND REVIEW CONTEXT: There has been no rigorous systematic review of the outcomes of early exposure to clinical and community settings in medical education. OBJECTIVES OF REVIEW: Identify published empirical evidence of the effects of early experience in medical education, analyse it, and synthesize conclusions from it. Identify the strengths and limitations of the research effort to date, and identify objectives for future research. Ovid search of: BEI, ERIC, Medline, CINAHL and EMBASE Additional electronic searches of: Psychinfo, Timelit, EBM reviews, SIGLE, and the Cochrane databases. Hand-searches of:Medical Education, Medical Teacher, Academic Medicine, Teaching and Learning in Medicine, Advances in Health Sciences Education, Journal of Educational Psychology. Authentic (real as opposed to simulated) human contact in a social or clinical context that enhances learning of health, illness and/or disease, and the role of the health professional. Early: What would traditionally have been regarded as the preclinical phase, usually the first 2 years. Inclusions: All empirical studies (verifiable, observational data) of early experience in the basic education of health professionals, whatever their design or methodology, including papers not in English. Evidence from other health care professions that could be applied to medicine was included. Not empirical; not early; post-basic; simulated rather than 'authentic' experience. Careful validation of selection processes. Coding by two reviewers onto an extensively modified version of the standard BEME coding sheet. Accumulation into an Access database. Secondary coding and synthesis of an interpretation. A total of 73 studies met the selection criteria and yielded 277 educational outcomes; 116 of those outcomes (from 38 studies) were rated strong and important enough to include in a narrative synthesis of results; 76% of those

  20. Obstetrical outcomes in patients with early onset gestational diabetes.

    PubMed

    Gupta, Simi; Dolin, Cara; Jadhav, Ashwin; Chervenak, Judith; Timor-Tritsch, Ilan; Monteagudo, Ana

    2016-01-01

    The objective of this study was to characterize patients with early onset gestational diabetes and compare outcomes to patients diagnosed with standard gestational diabetes and pregestational diabetes. This is a retrospective cohort study of patients diagnosed with gestational or pregestational diabetes. All patients received a glucose challenge test at their first prenatal visit to diagnose early onset gestational diabetes and were recommended to have postpartum glucose tolerance tests to detect undiagnosed type 2 diabetes. Outcomes were compared between patients with early onset gestational diabetes and both standard gestational diabetes and pregestational diabetes with p < 0.05 was used for significance. Four hundred and twenty-four patients met the inclusion criteria. Nine percent of the patients with early onset gestational diabetes were found to have undiagnosed type 2 diabetes based on postpartum testing and 91% to have resolution in the postpartum period. No patient with early onset gestational diabetes and resolution in the postpartum period had abnormal screening for renal or ophthalmologic disease, but 5% had abnormal fetal echocardiograms. These patients were more likely to require pharmacotherapy for glycemic control than patients with standard gestational diabetes and less likely than patients with pregestational diabetes (55% versus 39% versus 81%). Most patients diagnosed with early onset gestational diabetes do not have undiagnosed type 2 diabetes but do have unique characteristics and obstetrical outcomes.

  1. Early Postimplant Speech Perception and Language Skills Predict Long-Term Language and Neurocognitive Outcomes Following Pediatric Cochlear Implantation

    PubMed Central

    Kronenberger, William G.; Castellanos, Irina; Pisoni, David B.

    2017-01-01

    Purpose We sought to determine whether speech perception and language skills measured early after cochlear implantation in children who are deaf, and early postimplant growth in speech perception and language skills, predict long-term speech perception, language, and neurocognitive outcomes. Method Thirty-six long-term users of cochlear implants, implanted at an average age of 3.4 years, completed measures of speech perception, language, and executive functioning an average of 14.4 years postimplantation. Speech perception and language skills measured in the 1st and 2nd years postimplantation and open-set word recognition measured in the 3rd and 4th years postimplantation were obtained from a research database in order to assess predictive relations with long-term outcomes. Results Speech perception and language skills at 6 and 18 months postimplantation were correlated with long-term outcomes for language, verbal working memory, and parent-reported executive functioning. Open-set word recognition was correlated with early speech perception and language skills and long-term speech perception and language outcomes. Hierarchical regressions showed that early speech perception and language skills at 6 months postimplantation and growth in these skills from 6 to 18 months both accounted for substantial variance in long-term outcomes for language and verbal working memory that was not explained by conventional demographic and hearing factors. Conclusion Speech perception and language skills measured very early postimplantation, and early postimplant growth in speech perception and language, may be clinically relevant markers of long-term language and neurocognitive outcomes in users of cochlear implants. Supplemental materials https://doi.org/10.23641/asha.5216200 PMID:28724130

  2. Radiofrequency ablation versus resection for Barcelona clinic liver cancer very early/early stage hepatocellular carcinoma: a systematic review.

    PubMed

    He, Zhen-Xin; Xiang, Pu; Gong, Jian-Ping; Cheng, Nan-Sheng; Zhang, Wei

    2016-01-01

    To compare the long-term survival outcomes of radiofrequency ablation and liver resection for single very early/early stage hepatocellular carcinoma (HCC). The Cochrane Library (Issue 3, 2015), Embase (1974 to March 15, 2015), PubMed (1950 to March 15, 2015), Web of Science (1900 to March 15, 2015), and Chinese Biomedical Literature Database (1978 to March 15, 2015) were searched to identify relevant trials. Only trials that compared radiofrequency ablation and liver resection for single very early stage (≤2 cm) or early stage (≤3 cm) HCC according to the Barcelona clinic liver cancer (BCLC) staging system were considered for inclusion in this review. The primary outcomes that we analyzed were the 3-year and 5-year overall survival (OS) rates, and the secondary outcomes that we analyzed were the 3-year and 5-year disease-free survival (DFS) rates. Review Manager 5.3 was used to perform a cumulative meta-analysis. Possible publication bias was examined using a funnel plot. A random-effects model was applied to summarize the various outcomes. Six studies involving 947 patients were identified that compared radiofrequency ablation (n=528) to liver resection (n=419) for single BCLC very early HCC. In these six studies, the rates of 3-year OS, 5-year OS, 3-year DFS, and 5-year DFS were significantly lower in the radiofrequency ablation group than in the liver resection group (risk ratio [RR] =0.90, 95% confidence interval [CI]: 0.83-0.98, P=0.01; RR =0.84, 95% CI: 0.75-0.95, P=0.004; RR =0.77, 95% CI: 0.60-0.98, P=0.04; and RR =0.70, 95% CI: 0.52-0.94, P=0.02, respectively). Ten studies involving 2,501 patients were identified that compared radiofrequency ablation (n=1,476) to liver resection (n=1,025) for single BCLC early HCC. In these ten studies, the rates of 3-year OS, 5-year OS, 3-year DFS, and 5-year DFS were also significantly lower in the radiofrequency ablation group than in the liver resection group (RR =0.93, 95% CI: 0.88-0.98, P=0.003; RR =0.84, 95% CI

  3. Radiofrequency ablation versus resection for Barcelona clinic liver cancer very early/early stage hepatocellular carcinoma: a systematic review

    PubMed Central

    He, Zhen-Xin; Xiang, Pu; Gong, Jian-Ping; Cheng, Nan-Sheng; Zhang, Wei

    2016-01-01

    Aim To compare the long-term survival outcomes of radiofrequency ablation and liver resection for single very early/early stage hepatocellular carcinoma (HCC). Methods The Cochrane Library (Issue 3, 2015), Embase (1974 to March 15, 2015), PubMed (1950 to March 15, 2015), Web of Science (1900 to March 15, 2015), and Chinese Biomedical Literature Database (1978 to March 15, 2015) were searched to identify relevant trials. Only trials that compared radiofrequency ablation and liver resection for single very early stage (≤2 cm) or early stage (≤3 cm) HCC according to the Barcelona clinic liver cancer (BCLC) staging system were considered for inclusion in this review. The primary outcomes that we analyzed were the 3-year and 5-year overall survival (OS) rates, and the secondary outcomes that we analyzed were the 3-year and 5-year disease-free survival (DFS) rates. Review Manager 5.3 was used to perform a cumulative meta-analysis. Possible publication bias was examined using a funnel plot. A random-effects model was applied to summarize the various outcomes. Results Six studies involving 947 patients were identified that compared radiofrequency ablation (n=528) to liver resection (n=419) for single BCLC very early HCC. In these six studies, the rates of 3-year OS, 5-year OS, 3-year DFS, and 5-year DFS were significantly lower in the radiofrequency ablation group than in the liver resection group (risk ratio [RR] =0.90, 95% confidence interval [CI]: 0.83–0.98, P=0.01; RR =0.84, 95% CI: 0.75–0.95, P=0.004; RR =0.77, 95% CI: 0.60–0.98, P=0.04; and RR =0.70, 95% CI: 0.52–0.94, P=0.02, respectively). Ten studies involving 2,501 patients were identified that compared radiofrequency ablation (n=1,476) to liver resection (n=1,025) for single BCLC early HCC. In these ten studies, the rates of 3-year OS, 5-year OS, 3-year DFS, and 5-year DFS were also significantly lower in the radiofrequency ablation group than in the liver resection group (RR =0.93, 95% CI: 0.88–0

  4. Clinical characteristics and outcomes of Möbius syndrome in a children's hospital.

    PubMed

    Matsui, Kiyoshi; Kataoka, Ai; Yamamoto, Atsuko; Tanoue, Koji; Kurosawa, Kenji; Shibasaki, Jun; Ohyama, Makiko; Aida, Noriko

    2014-12-01

    Möbius syndrome is a congenital disorder with facial and abducens palsy. Although a few case series studies have examined comorbid conditions in Möbius syndrome, follow-up and outcome data are sparse. To examine the clinical characteristics and outcomes of Möbius syndrome. Clinical data were reviewed for 10 patients. Neonatal history, neurological examination, comorbid anomalies, medical home care, outcomes, and neuroimaging were summarized. The patients' mean age was 7.3 ± 6.2 years. On neurological examination, absent blink reflex, jaw ankylosis, absent gag reflex, and tongue atrophy were frequently observed. Poland anomaly and clubfoot were present in three and six patients, respectively. Specific therapies required for patients included medical home care (six patients), suction apparatus (six), tube feeding (five), gastrostomy (two), tracheostomy (three), oxygen therapy (three), and home ventilator (two). Punctate calcification in the brainstem was observed in four patients. Pontine and medulla hypoplasia were detected on the basis of anteroposterior diameter in four and seven patients, respectively. Two patients had congenital hydrocephalus with aqueductal stenosis. Global developmental delay occurred in five patients. Three patients died. The rate of both the use of home medical devices and death was high in our patients. Möbius syndrome is extremely diverse, not only in clinical manifestation, but also outcome. Early multidisciplinary intervention is important to ensure an optimal outcome. Aqueductal stenosis is an occasional comorbid anomaly resulting from midbrain abnormality. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Relationship between time to clinical response and outcomes among Pneumonia Outcomes Research Team (PORT) risk class III and IV hospitalized patients with community-acquired pneumonia who received ceftriaxone and azithromycin.

    PubMed

    Zasowski, Evan; Butterfield, Jill M; McNutt, Louise-Ann; Cohen, Jason; Cosler, Leon; Pai, Manjunath P; Gottwald, Joseph; Chen, Wen Zhen; Lodise, Thomas P

    2014-07-01

    Recent Food and Drug Administration (FDA) guidance endorses the use of an early clinical response endpoint as the primary outcome for community-acquired bacterial pneumonia (CABP) trials. While antibiotics will now be approved for CABP, in practice they will primarily be used to treat patients with community-acquired pneumonia (CAP). More importantly, it is unclear how achievement of the new FDA CABP early response endpoint translates into clinically applicable real-world outcomes for patients with CAP. To address this, a retrospective cohort study was conducted among adult patients who received ceftriaxone and azithromycin for CAP of Pneumonia Outcomes Research Team (PORT) risk class III and IV at an academic medical center. The clinical response was defined as clinical stability for 24 h with improvement in at least one pneumonia symptom and with no symptom worsening. A classification and regression tree (CART) was used to determine the delay in response time, measured in days, associated with the greatest risk of a prolonged hospital length of stay (LOS) and adverse outcomes (in-hospital mortality or 30-day CAP-related readmission). A total of 250 patients were included. On average, patients were discharged 2 days following the achievement of a clinical response. In the CART analysis, adverse clinical outcomes were higher among day 5 nonresponders than those who responded by day 5 (22.4% versus 6.9%, P = 0.001). The findings from this study indicate that time to clinical response, as defined by the recent FDA guidance, is a reasonable prognostic indicator of real-world effectiveness outcomes among hospitalized PORT risk class III and IV patients with CAP who received ceftriaxone and azithromycin. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

  6. Early Head Start Relationships: Association with Program Outcomes

    ERIC Educational Resources Information Center

    Elicker, James; Wen, Xiaoli; Kwon, Kyong-Ah; Sprague, Jill B.

    2013-01-01

    Research Findings: Interpersonal relationships among staff caregivers, parents, and children have been recommended as essential aspects of early childhood intervention. This study explored the associations of these relationships with program outcomes for children and parents in 3 Early Head Start programs. A total of 71 children (8-35 months,…

  7. Effects of Long-Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104-Week Results From a Randomized, Placebo-Controlled Study.

    PubMed

    Dougados, Maxime; van der Heijde, Désirée; Sieper, Joachim; Braun, Jürgen; Citera, Gustavo; Lenaerts, Jan; van den Bosch, Filip; Wei, James Cheng-Chung; Pedersen, Ron; Bonin, Randi; Jones, Heather; Marshall, Lisa; Logeart, Isabelle; Vlahos, Bonnie; Bukowski, Jack F; Maksymowych, Walter P

    2017-10-01

    To evaluate the long-term clinical and imaging efficacy of etanercept in patients with early, active nonradiographic axial spondyloarthritis (SpA). Adult patients who satisfied the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA (but not the modified New York radiographic criteria), with symptom duration >3 months to <5 years, and who were unresponsive to ≥2 nonsteroidal antirheumatic drugs (NSAIDs) received double-blind etanercept 50 mg/week or placebo for 12 weeks, followed by open-label etanercept 50 mg/week to week 104. Clinical, magnetic resonance imaging (MRI; Spondyloarthritis Research Consortium of Canada [SPARCC] scores), and safety outcomes at 104 weeks were analyzed. Of 215 randomized patients (etanercept: n = 106; placebo: n = 109), 205 entered the study (etanercept/etanercept: n = 100; placebo/etanercept: n = 105) and 169 completed the open-label period (etanercept/etanercept: n = 83; placebo/etanercept: n = 86). At week 104, 61 of 81 (75%), 49 of 81 (61%), 48 of 80 (60%), and 57 of 81 (70%) patients who received etanercept throughout the trial achieved ASAS20, ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease, and Bath Ankylosing Spondylitis Disease Activity Index criteria for 50% improvement (BASDAI 50) scores, respectively (observed). From baseline to week 104, continued improvements in clinical outcomes (ASDAS-C-reactive protein: -1.5 and -1.7; BASDAI: -3.3 and -3.8 [last observation carried forward]), and SPARCC MRI scores (sacroiliac joint: -6.0 and -3.4; spinal: -2.1 and -0.8 [observed]) were seen in patients receiving etanercept/etanercept and placebo/etanercept. During the study, 8% in the etanercept/etanercept group and 7% in the placebo/etanercept group had serious adverse events; no new safety signals were seen. Patients with early, active nonradiographic axial SpA and an inadequate response to at least 2 NSAIDs demonstrated improvement

  8. The uses of outcome measures within multidisciplinary early childhood intervention services: a systematic review.

    PubMed

    Calder, Samuel; Ward, Roslyn; Jones, Megan; Johnston, Jenelle; Claessen, Mary

    2017-07-18

    Purpose of the article: To review the use of outcome measures, across the domains of activity, participation, and environment, within multidisciplinary early childhood intervention services. A systematic literature search was undertaken that included four electronic databases: Medline, CINAHL, EMBASE, and the Cochrane Library and Cochrane Database of Systematic Review. Inclusion criteria were age 0-24 months, having or at risk of a developmental disability, in receipt of multidisciplinary early childhood intervention services, and included outcome measures across all domains of the International Classification of Functioning-Child & Youth (ICF-CY). Only peer-reviewed journal articles were considered. Eligible studies were coded using the Oxford Levels of Evidence. Methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) Scale for randomised controlled trials and the QualSyst for non-randomised control trials. Of the total of 5764 records identified, 10 were considered to meet inclusion criteria. Fourteen outcome measures were identified, addressing the domains of activity, participation, and environment. Of these, eight have been recommended in the early intervention literature. While the methodological quality of the 10 studies varied, these papers make a contribution to the body of research that acknowledges the role of routine and enriched environments. Implications for Rehabilitation Core practice elements of multidisciplinary early childhood intervention services indicate it is necessary to select outcome measures framed within the International Classification of Functioning-Child & Youth to inform clinical decision-making for measuring intervention effectiveness across the domains of activity, participation and environment. Of the identified measures, three (Canadian Occupational Performance Measure, Pediatric Evaluation of Disability Inventory, and Goal Attainment Scaling) are well-established and identified in the literature as

  9. Initial Weight Loss Response as an Indicator for Providing Early Rescue Efforts to Improve Long-term Treatment Outcomes.

    PubMed

    Unick, Jessica L; Pellegrini, Christine A; Demos, Kathryn E; Dorfman, Leah

    2017-09-01

    There is a large variability in response to behavioral weight loss (WL) programs. Reducing rates of obesity and diabetes may require more individuals to achieve clinically significant WL post-treatment. Given that WL within the first 1-2 months of a WL program is associated with long-term WL, it may be possible to improve treatment outcomes by identifying and providing additional intervention to those with poor initial success (i.e., "early non-responders"). We review the current literature regarding early non-response to WL programs and discuss how adaptive interventions can be leveraged as a strategy to "rescue" early non-responders. Preliminary findings suggest that adaptive interventions, specifically stepped care approaches, offer promise for improving outcomes among early non-responders. Future studies need to determine the optimal time point and threshold for intervening and the type of early intervention to employ. Clinicians and researchers should consider the discussed factors when making treatment decisions.

  10. Early Motherhood and Subsequent Life Outcomes

    ERIC Educational Resources Information Center

    Boden, Joseph M.; Fergusson, David M.; Horwood, L. John

    2008-01-01

    Background: Early motherhood has been linked with a number of adverse outcomes, including mental health difficulties and barriers to completing educational qualifications and workforce participation. The present study examined the extent to which these linkages could be explained by the influence of social, family, and background factors that were…

  11. [Embryo selection in IVF/ICSI cycles using time-lapse microscopy and the clinical outcomes].

    PubMed

    Chen, Minghao; Huang, Jun; Zhong, Ying; Quan, Song

    2015-12-01

    To compare the clinical outcomes of embryos selected using time-lapse microscopy and traditional morphological method in IVF/ICSI cycles and evaluate the clinical value of time-lapse microscopy in early embryo monitoring and selection. e retrospectively analyzed the clinical data of 139 IVF/ICSI cycles with embryo selection based on time-lapse monitoring (TLM group, n=68) and traditional morphological method (control group, n=71). The βHCG-positive rate, clinical pregnancy rate and embryo implantation rate were compared between the 2 groups. Subgroup analysis was performed in view of female patients age and the fertilization type. The βHCG-positive rate, clinical pregnancy rate and implantation rate were 66.2%, 61.8% and 47.1% in TLM group, significantly higher than those in the control group (47.9%, 43.7% and 30.3%, respectively; P<0.05). Compared with patients below 30 years of age, patients aged between 31 and 35 years benefited more from time-lapse monitoring with improved clinical outcomes. time-lapse monitoring significantly increased the βHCG-positive rate, clinical pregnancy rate and implantation rate for patients undergoing IVF cycles, but not for those undergoing ICSI or TESA cycles. Compared with those selected using traditional morphological method, the embryos selected with time-lapse microscopy have better clinical outcomes, especially in older patients (31-35 years of age) and in IVF cycles.

  12. Early Self-Regulation, Early Self-Regulatory Change, and Their Longitudinal Relations to Adolescents' Academic, Health, and Mental Well-Being Outcomes.

    PubMed

    Howard, Steven J; Williams, Kate E

    2018-05-16

    To evaluate the extent to which early self-regulation and early changes in self-regulation are associated with adolescents' academic, health, and mental well-being outcomes. Data were collected from 1 of the cohorts in a large dual-cohort cross-sequential study of Australian children. This cohort consisted of a nationally representative data set of 4983 Australian children assessed at 4 to 5 years of age, who were followed longitudinally to 14 to 15 years of age. Using regression within a path analysis framework, we first sought to investigate associations of early self-regulation (at 4-5 years and 6-7 years of age) with a broad range of academic, health, and mental well-being outcomes in adolescence (at 14-15 years). We next investigated the extent to which an early change in self-regulation (from 4 to 7 years of age) predicted these adolescents' outcomes. Early self-regulation predicted the full range of adolescents' outcomes considered such that a 1-SD increase in self-regulation problems was associated with a 1.5- to 2.5-times greater risk of more-negative outcomes. An early positive change in self-regulation was associated with a reduced risk of these negative outcomes for 11 of the 13 outcomes considered. These results suggest the potential of early self-regulation interventions, in particular, in influencing long-term academic, health, and well-being trajectories.

  13. Overview: Measuring Early Learning Quality and Outcomes (MELQO)

    ERIC Educational Resources Information Center

    Brookings Institution, 2017

    2017-01-01

    The Measuring Early Learning Quality and Outcomes (MELQO) initiative began in 2014 in anticipation of a new global emphasis on early childhood development (ECD). Led by UNESCO, the World Bank, the Center for Universal Education at the Brookings Institution, and UNICEF, the initiative aims to promote feasible, accurate and useful measurement of…

  14. College Quality and Early Adult Outcomes

    ERIC Educational Resources Information Center

    Long, Mark C.

    2008-01-01

    This paper estimates the effects of various college qualities on several early adult outcomes, using panel data from the National Education Longitudinal Study. I compare the results using ordinary least squares with three alternative methods of estimation, including instrumental variables, and the methods used by Dale and Krueger [(2002).…

  15. Early outcomes of carotid artery stenting.

    PubMed

    Akar Bayram, N; Bozkurt, E; Ayhan, H; Gürkaş, E; Orhan, G; Ak, F; Bilen, E; Sari, C; Akçay, M; Durmaz, T; Keles, T

    2012-03-01

    Ischemic cerebrovascular events are the most common reason for patients to be bedridden and the third most common reason for death. Many studies in recent years have demonstrated that carotid artery stenting (CAS) may be an alternative to carotid endarterectomy (CEA). In this study, we aimed to report early outcomes of patients who were treated with CAS in our clinic and discuss practicability, advantages and safety of CAS. Eighty patients who underwent CAS between December 2009 and May 2011 were eligible. The mean age was 65 years (range, 49 - 89 years). Of the study group, 73.75% were males and 26.25% were female. The percentage of asymptomatic patients was 11.7%, and the remaining patients were symptomatic. A distal embolic protection device (Angioguard®) was used in 22% of the patients whereas, in the other patients (78%), a proximal blockage system (Mo.MA®) was used. Self-expandable hybrid stents were implanted in all patients and post-dilatation was performed after implantation. None of the patients suffered from stroke, myocardial infarction or death due to CAS during their hospital stay. The mean follow-up period was 10 months (range 2 - 18 months) after discharge. None of the patients had died or had a stroke, a transient ischemic attack (TIA), or a myocardial infarction during the follow-up period. Re-stenosis was not observed in the follow-up carotid Doppler ultrasonography; flow rates were within normal limits. No major complication was observed during the early follow-up period in patients who underwent CAS in our clinic. Only 2 (2.5%) patients showed transient numbness and weakness and these did not lead to morbidity. In the management guide of extracranial carotid and vertebral artery diseases, CAS, in the light of recent studies, is recommended as an alternative to CEA in recommendations for revascularization. One of the important issues emphasized in this guide is the experience of centers. Very low complication rates after CAS suggested that

  16. Long-term outcome of early interventions to prevent posttraumatic stress disorder.

    PubMed

    Shalev, Arieh Y; Ankri, Yael; Gilad, Moran; Israeli-Shalev, Yossi; Adessky, Rhonda; Qian, Meng; Freedman, Sara

    2016-05-01

    Failing to prevent posttraumatic stress disorder (PTSD) has major clinical and public health consequences. This work evaluates the 3-year outcome of offering early interventions to survivors with acute PTSD. Adults admitted consecutively to the hospital with acute DSM-IV PTSD were randomized, between June 2003 and October 2007, to 12 weeks of prolonged exposure (n = 63) or cognitive therapy (n = 40) or concealed SSRI (escitalopram; n = 23) versus placebo (n = 23). Eighty-two participants who declined treatment were followed as well. Treatment started 1 month after the traumatic event, and participants were reassessed 5 and 36 months later. Assessors were blinded to treatment allocation and acceptance. The Clinician-Administered PTSD Scale (CAPS) evaluated PTSD and PTSD symptoms. Self-reported symptoms, general functioning, and employment status were secondary outcomes. Participants lost to follow-up were missing completely at random. Prolonged exposure and cognitive therapy significantly reduced PTSD and PTSD symptoms between 1 and 5 months (mean CAPS total scores [95% CI] at 1 month: prolonged exposure = 73.59 [68.21-78.96] and cognitive therapy = 71.78 [66.92-78.93]; mean CAPS total scores [95% CI] at 5 months: prolonged exposure = 28.59 [21.89-35.29] and cognitive therapy = 29.48 [21.32-37.95], P < .001), and their results remained stable. At 3 years, however, the study groups had similar levels of PTSD symptoms (mean CAPS total scores [95% CI]: prolonged exposure = 31.51 [20.25-42.78]; cognitive therapy = 32.08 [20.74-43.42]; SSRI = 34.31 [16.54-52.07]; placebo = 32.13 [20.15-44.12]; and no intervention = 30.59 [19.40-41.78]), similar prevalence of PTSD (28.6%-46.2%), and similar secondary outcomes. Early prolonged exposure and cognitive therapy accelerated the recovery from acute PTSD. Their effect remained stable, however, without reducing the 3-year prevalence of the disorder. The lingering prevalence of PTSD, despite efficient interventions, illustrates a

  17. Quality of life, clinical outcomes and safety of early prophylactic levothyroxine administration in patients with Graves' hyperthyroidism undergoing radioiodine therapy: a randomized controlled study.

    PubMed

    Taïeb, David; Bournaud, Claire; Eberle, Marie-Claude; Catargi, Bogdan; Schvartz, Claire; Cavarec, Marie-Béatrice; Faugeron, Isabelle; Toubert, Marie-Elisabeth; Benisvy, Danielle; Archange, Cendrine; Mundler, Olivier; Caron, Philippe; Abdullah, Ahmad Esmaeel; Baumstarck, Karine

    2016-04-01

    While radioiodine therapy is commonly used for treating Graves' disease, a prolonged and clinical hypothyroidism may result in disabling symptoms leading to deterioration of quality of life (QoL) of patients. Introducing levothyroxine (LT4) treatment in the early post-therapeutic period may be an interesting approach to limit this phenomenon. A multicenter, prospective, open-label randomized controlled trial enrolled 94 patients with Graves' hyperthyroidism randomly assigned to the experimental group (n=46) (group A: early prophylactic LT4 treatment) or the control group (n=48) (group B: standard follow-up). The primary endpoint was the 6-month QoL. The secondary endpoints were other QoL scores such as Graves' ophthalmopathy (GO) outcomes, thyroid function tests and safety. The primary endpoint at 6 months was achieved: the mental composite score (MCS) of Short Form 36 (SF-36) was significantly higher in group A compared to group B (P=0.009). Four other dimension scores of the SF-36 and four dimension scores of the thyroid-specific patient-reported outcome (ThyPRO) significantly differed between the two groups, indicating better QoL in group A. After adjustment for variables, the early LT4 administration strategy was found as an independent factor for only two scores of SF-36: the MCS and the general health (GH) score. There were no differences in GO, final thyroid status and changes in the anti-TSH receptor antibodies (TRAbs) levels between the two groups. No adverse cardiovascular event was reported. Early LT4 administration post-radioactive iodine (RAI) could represent a safe potential benefit for patients with regard to QoL. The optimal strategy taking into account administered RAI activities and LT4 treatment dosage and timing remains to be determined. © 2016 European Society of Endocrinology.

  18. A Multidisciplinary Sepsis Program Enabled by a Two-Stage Clinical Decision Support System: Factors That Influence Patient Outcomes.

    PubMed

    Amland, Robert C; Haley, James M; Lyons, Jason J

    2016-11-01

    Sepsis is an inflammatory response triggered by infection, with risk of in-hospital mortality fueled by disease progression. Early recognition and intervention by multidisciplinary sepsis programs may reverse the inflammatory response among at-risk patient populations, potentially improving outcomes. This retrospective study of a sepsis program enabled by a 2-stage sepsis Clinical Decision Support (CDS) system sought to evaluate the program's impact, identify early indicators that may influence outcomes, and uncover opportunities for quality improvement. Data encompassed 16 527 adult hospitalizations from 2014 and 2015. Of 2108 non-intensive care unit patients screened-in by sepsis CDS, 97% patients were stratified by 177 providers. Risk of adverse outcome improved 30% from baseline to year end, with gains materializing and stabilizing at month 7 after sepsis program go-live. Early indicators likely to influence outcomes include patient age, recent hospitalization, electrolyte abnormalities, hypovolemic shock, hypoxemia, patient location when sepsis CDS activated, and specific alert patterns. © The Author(s) 2015.

  19. Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis.

    PubMed

    Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie; Tita, Alan T N; Leveno, Kenneth J; Reddy, Uma M; Varner, Michael W; Thorp, John M; Mercer, Brian M; Dinsmoor, Mara J; Ramin, Susan M; Carpenter, Marshall W; Samuels, Philip; Sciscione, Anthony; Tolosa, Jorge E; Saade, George; Sorokin, Yoram

    2018-05-23

    To determine the frequency of sepsis and other adverse neonatal outcomes in women with a clinical diagnosis of chorioamnionitis. We performed a secondary analysis of a multi-center placebo-controlled trial of vitamins C/E to prevent preeclampsia in low risk nulliparous women. Clinical chorioamnionitis was defined as either the "clinical diagnosis" of chorioamnionitis or antibiotic administration during labor because of an elevated temperature or uterine tenderness in the absence of another cause. Early-onset neonatal sepsis was categorized as "suspected" or "confirmed" based on a clinical diagnosis with negative or positive blood, urine or cerebral spinal fluid cultures, respectively, within 72 h of birth. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by logistic regression. Data from 9391 mother-infant pairs were analyzed. The frequency of chorioamnionitis was 10.3%. Overall, 6.6% of the neonates were diagnosed with confirmed (0.2%) or suspected (6.4%) early-onset sepsis. Only 0.7% of infants born in the setting of chorioamnionitis had culture-proven early-onset sepsis versus 0.1% if chorioamnionitis was not present. Clinical chorioamnionitis was associated with both suspected [OR 4.01 (3.16-5.08)] and confirmed [OR 4.93 (1.65-14.74)] early-onset neonatal sepsis, a need for resuscitation within the first 30 min after birth [OR 2.10 (1.70-2.61)], respiratory distress [OR 3.14 (2.16-4.56)], 1 min Apgar score of ≤3 [OR 2.69 (2.01-3.60)] and 4-7 [OR 1.71 (1.43-2.04)] and 5 min Apgar score of 4-7 [OR 1.67 (1.17-2.37)] (vs. 8-10). Clinical chorioamnionitis is common and is associated with neonatal morbidities. However, the vast majority of exposed infants (99.3%) do not have confirmed early-onset sepsis.

  20. Clinical outcomes after elective repair for small umbilical and epigastric hernias.

    PubMed

    Christoffersen, Mette Maria Willaume

    2015-11-01

    Repair for an umbilical or epigastric hernia is one of the most frequently conducted gastrointestinal surgical procedures. Al-though it is a minor procedure, there is no consensus on the optimal repair technique. The readmission rate is surprisingly high due to postoperative pain, wound-related complications, and long-term results in terms of recurrence and chronic pain is not well investigated. The overall objective of this thesis was to improve early and long-term postoperative outcomes after repair for umbilical or epigastric hernias. The present thesis consisted of one RCT, one protocol article for a running RCT, and two register-based cohort studies. An abdominal binder had no analgesic effects or impact on seroma formation. We await early and late post-operative outcomes from a running RCT studying clinical effect of closing the hernia defect (inclusion is expected to end in October 2015). The two cohort studies included in the present theses found that mesh repair halved the long-term risk of recurrence compared with sutured repair. Mesh repair did not increase the risk of chronic pain or rate of reoperation for complications.

  1. Predictors of early dyspnoea relief in acute heart failure and the association with 30-day outcomes: findings from ASCEND-HF

    PubMed Central

    Mentz, Robert J.; Hernandez, Adrian F.; Stebbins, Amanda; Ezekowitz, Justin A.; Felker, G. Michael; Heizer, Gretchen M.; Atar, Dan; Teerlink, John R.; Califf, Robert M.; Massie, Barry M.; Hasselblad, Vic; Starling, Randall C.; O'Connor, Christopher M.; Ponikowski, Piotr

    2013-01-01

    Aims To examine the characteristics associated with early dyspnoea relief during acute heart failure (HF) hospitalization, and its association with 30-day outcomes. Methods and results ASCEND-HF was a randomized trial of nesiritide vs. placebo in 7141 patients hospitalized with acute HF in which dyspnoea relief at 6 h was measured on a 7-point Likert scale. Patients were classified as having early dyspnoea relief if they experienced moderate or marked dyspnoea improvement at 6 h. We analysed the clinical characteristics, geographical variation, and outcomes (mortality, mortality/HF hospitalization, and mortality/hospitalization at 30 days) associated with early dyspnoea relief. Early dyspnoea relief occurred in 2984 patients (43%). In multivariable analyses, predictors of dyspnoea relief included older age and oedema on chest radiograph; higher systolic blood pressure, respiratory rate, and natriuretic peptide level; and lower serum blood urea nitrogen (BUN), sodium, and haemoglobin (model mean C index = 0.590). Dyspnoea relief varied markedly across countries, with patients enrolled from Central Europe having the lowest risk-adjusted likelihood of improvement. Early dyspnoea relief was associated with lower risk-adjusted 30-day mortality/HF hospitalization [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.68–0.96] and mortality/hospitalization (HR 0.85; 95% CI 0.74–0.99), but similar mortality. Conclusion Clinical characteristics such as respiratory rate, pulmonary oedema, renal function, and natriuretic peptide levels are associated with early dyspnoea relief, and moderate or marked improvement in dyspnoea was associated with a lower risk for 30-day outcomes. PMID:23159547

  2. Clinically meaningful parameters of progression and long-term outcome of Parkinson disease: An international consensus statement.

    PubMed

    Puschmann, Andreas; Brighina, Laura; Markopoulou, Katerina; Aasly, Jan; Chung, Sun Ju; Frigerio, Roberta; Hadjigeorgiou, Georgios; Kõks, Sulev; Krüger, Rejko; Siuda, Joanna; Wider, Christian; Zesiewicz, Theresa A; Maraganore, Demetrius M

    2015-07-01

    Parkinson disease (PD) is associated with a clinical course of variable duration, severity, and a combination of motor and non-motor features. Recent PD research has focused primarily on etiology rather than clinical progression and long-term outcomes. For the PD patient, caregivers, and clinicians, information on expected clinical progression and long-term outcomes is of great importance. Today, it remains largely unknown what factors influence long-term clinical progression and outcomes in PD; recent data indicate that the factors that increase the risk to develop PD differ, at least partly, from those that accelerate clinical progression and lead to worse outcomes. Prospective studies will be required to identify factors that influence progression and outcome. We suggest that data for such studies is collected during routine office visits in order to guarantee high external validity of such research. We report here the results of a consensus meeting of international movement disorder experts from the Genetic Epidemiology of Parkinson's Disease (GEO-PD) consortium, who convened to define which long-term outcomes are of interest to patients, caregivers and clinicians, and what is presently known about environmental or genetic factors influencing clinical progression or long-term outcomes in PD. We propose a panel of rating scales that collects a significant amount of phenotypic information, can be performed in the routine office visit and allows international standardization. Research into the progression and long-term outcomes of PD aims at providing individual prognostic information early, adapting treatment choices, and taking specific measures to provide care optimized to the individual patient's needs. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. School Age Outcomes of Children Diagnosed Early and Later with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Clark, Megan Louise Erin; Vinen, Zoe; Barbaro, Josephine; Dissanayake, Cheryl

    2018-01-01

    Early diagnosis of Autism Spectrum Disorder is considered best practice, increasing access to early intervention. Yet, many children are diagnosed after 3-years. The current study investigated the school age outcomes of children who received an early and later diagnosis of ASD. The cognitive and behavioural outcomes of children diagnosed early (n…

  4. The first pharmacist-managed anticoagulation clinic under a collaborative practice agreement in Qatar: clinical and patient-oriented outcomes.

    PubMed

    Elewa, H F; AbdelSamad, O; Elmubark, A E; Al-Taweel, H M; Mohamed, A; Kheir, N; Mohamed Ibrahim, M I; Awaisu, A

    2016-08-01

    Optimal outpatient anticoagulation management requires a systematic and coordinated approach. Extensive evidence regarding the benefits of pharmacist-managed anticoagulation services has been reported in the literature. The quality and outcomes associated with pharmacist-managed anticoagulation clinics under collaborative practice agreements in the Middle East have rarely been reported. The first pharmacist-managed ambulatory anticoagulation clinic in Qatar was launched at Al-Wakrah Hospital in March 2013. The objectives of this study were to: (i) describe the practice model of the clinic, (ii) evaluate the quality of the clinic [i.e. the time in therapeutic range (TTR)] and the clinical outcomes (i.e. the efficacy and safety), and (iii) determine the patients' satisfaction and overall quality of life (QoL). Clinical outcome data were collected through a retrospective chart review of all patients managed from March 2013 to October 2014 at the pharmacist-managed anticoagulation clinic. Furthermore, the patient-oriented outcomes data were prospectively collected using the 24-item Duke Anticoagulation Satisfaction Scale (DASS). Each item was assessed using a 7-point Likert-type scale on which lower scores indicated better QoL and greater satisfaction. The clinical outcome data analyses included 119 patients who were enrolled at the clinic during the 19-month study period. The mean number of international normalized ratio (INR) tests/month was 65 ± 9, the average testing frequency was 2·7 ± 1·6 weeks, and the average %TTR was 76·8 ± 22·9%. There was one major bleeding event (0·67%/year), 12 minor bleeding events (8%/year) and two thromboembolic events (1·35%/year) recorded during the study period. Of the 119 patients, 50 participated in the satisfaction and QoL survey. The median (IQR) total QoL score of these subjects was 63 (48) (minimum-maximum achievable score: 24-168). Seventy-six per cent of the patients indicated 'a lot to very much' in terms of their

  5. Cauda equina syndrome: evaluation of the clinical outcome.

    PubMed

    Tamburrelli, F C; Genitiempo, M; Bochicchio, M; Donisi, L; Ratto, C

    2014-01-01

    Cauda equina syndrome is a rare but highly impairing syndrome involving lower limbs as well as urinary, defecatory and sexual function. In the literature the most investigated sphincter dysfunction is the urinary. Bowel and sexual function are often overlooked since they become more relevant after the acute phase. Eight consecutive male patients affected by cauda equina syndrome with sphincter dysfunction due to herniated disc disease of lumbar spine were treated between 2007 and 2009. Five patients were followed-up for at least two years. Sexual function was evaluated by IIEF-5 questionnaire; bowel function was investigated by means of clinical and instrumental investigation and manometry. Although little clinical improved, patients still complained severe symptoms at first year follow-up while all but one improved significantly in the following year. At two years follow-up only the patient whose cauda equina syndrome was misdiagnosed and surgically treated late respect to the onset of the syndrome, complained a persistent severe sexual and bowel dysfunction. Our results show that a long-term follow-up is mandatory to evaluate the real outcome of surgical managed cauda equine syndrome because short-term evaluation could be misleading about the residual capacity of late neurologic improving. Despite the relatively low number of cases evaluated, our results confirm that early diagnosing and treating the syndrome are relevant for the final outcome.

  6. Effect and safety of early weight-bearing on the outcome after open-wedge high tibial osteotomy: a systematic review and meta-analysis.

    PubMed

    Lee, O-Sung; Ahn, Soyeon; Lee, Yong Seuk

    2017-07-01

    The purpose of this systematic review and meta-analysis was to evaluate the effectiveness and safety of early weight-bearing by comparing clinical and radiological outcomes between early and traditional delayed weight-bearing after OWHTO. A rigorous and systematic approach was used. The methodological quality was also assessed. Results that are possible to be compared in two or more than two articles were presented as forest plots. A 95% confidence interval was calculated for each effect size, and we calculated the I 2 statistic, which presents the percentage of total variation attributable to the heterogeneity among studies. The random-effects model was used to calculate the effect size. Six articles were included in the final analysis. All case groups were composed of early full weight-bearing within 2 weeks. All control groups were composed of late full weight-bearing between 6 weeks and 2 months. Pooled analysis was possible for the improvement in Lysholm score, but there was no statistically significant difference shown between groups. Other clinical results were also similar between groups. Four studies reported mechanical femorotibial angle (mFTA) and this result showed no statistically significant difference between groups in the pooled analysis. Furthermore, early weight-bearing showed more favorable results in some radiologic results (osseointegration and patellar height) and complications (thrombophlebitis and recurrence). Our analysis supports that early full weight-bearing after OWHTO using a locking plate leads to improvement in outcomes and was comparable to the delayed weight-bearing in terms of clinical and radiological outcomes. On the contrary, early weight-bearing was more favorable with respect to some radiologic parameters and complications compared with delayed weight-bearing.

  7. Clinical Course and Outcomes of Small Supratentorial Intracerebral Hematomas.

    PubMed

    Behrouz, Réza; Misra, Vivek; Godoy, Daniel A; Topel, Christopher H; Masotti, Luca; Klijn, Catharina J M; Smith, Craig J; Parry-Jones, Adrian R; Slevin, Mark A; Silver, Brian; Willey, Joshua Z; Masjuán Vallejo, Jaime; Nzwalo, Hipólito; Popa-Wagner, Aurel; Malek, Ali R; Hafeez, Shaheryar; Di Napoli, Mario

    2017-06-01

    Intracerebral hemorrhage (ICH) volume, particularly if ≥30 mL, is a major determinant of poor outcome. We used a multinational ICH data registry to study the characteristics, course, and outcomes of supratentorial hematomas with volumes <30 mL. Basic characteristics, clinical and radiological course, and 30-day outcomes of these patients were recorded. Outcomes were categorized as early neurological deterioration (END), hematoma expansion, Glasgow Outcome Scale (GOS), and in-hospital death. Poor outcome was defined as composite of in-hospital death and severe disability (GOS ≤ 3). Comparison was conducted based on hemorrhage location. Logistic regression using dichotomized outcome scales was applied to determine predictors of poor outcome. Among 375 cases of supratentorial ICH with volumes <30 mL, expansion and END rates were 19.2% and 7.5%, respectively. Hemorrhage growth was independently associated with END (odds ratio: 28.7, 95% confidence interval [CI]: 8.51-96.5; P < .0001). Expansion rates did not differ according to ICH location. Overall, 13.9% (exact binomial 95% CI: 10.5-17.8) died in the hospital and 29.1% (CI: 24.5-34.0) had severe disability at 30 days; there was a cumulative poor outcome rate of 42.9% (CI: 37.9-48.1). Age, admission Glasgow Coma Scale, intraventricular extension, and END were independently associated with poor outcome. There was no difference in poor outcome rates between lobar and deep locations (40.2% versus 43.8%, P = .56). Patients with supratentorial ICH <30 mL have high rates of poor outcome at 30 days, regardless of location. Nearly 1 in 5 hematomas <30 mL expands, leading to END or death. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  8. Medical students' attitudes towards early clinical exposure in Iran.

    PubMed

    Khabaz Mafinejad, Mahboobeh; Mirzazadeh, Azim; Peiman, Soheil; Khajavirad, Nasim; Mirabdolhagh Hazaveh, Mojgan; Edalatifard, Maryam; Allameh, Seyed-Farshad; Naderi, Neda; Foroumandi, Morteza; Afshari, Ali; Asghari, Fariba

    2016-06-19

    This study was carried out to investigate the medical students' attitudes towards early clinical exposure at Tehran University of Medical Sciences. A cross-sectional study was conducted during 2012-2015. A convenience sample of 298 first- and second-year students, enrolled in the undergraduate medical curriculum, participated in an early clinical exposure program. To collect data from medical students, a questionnaire consisting of open-ended questions and structured questions, rated on a five-point Likert scale, was used to investigate students' attitudes toward early clinical exposure. Of the 298 medical students, 216 (72%) completed the questionnaires. The results demonstrated that medical students had a positive attitude toward early clinical exposure. Most students (80.1%) stated that early clinical exposure could familiarize them with the role of basic sciences knowledge in medicine and how to apply this knowledge in clinical settings. Moreover, 84.5% of them believed that early clinical exposure increased their interest in medicine and encouraged them to read more. Furthermore, content analysis of the students' responses uncovered three main themes of early clinical exposure, were considered helpful to improve learning: "integration of theory and practice", "interaction with others and professional development" and "desire and motivation for learning medicine". Medical students found their first experience with clinical setting valuable. Providing clinical exposure in the initial years of medical curricula and teaching the application of basic sciences knowledge in clinical practice can enhance students' understanding of the role they will play in the future as a physician.

  9. The impact of cannabis use on clinical outcomes in recent onset psychosis.

    PubMed

    Barrowclough, Christine; Gregg, Lynsey; Lobban, Fiona; Bucci, Sandra; Emsley, Richard

    2015-03-01

    There are inconsistencies in findings as to whether cannabis use has a negative impact on clinical outcomes for people with established psychosis. Effects may be more evident on patients with recent onset psychosis. To investigate the relationship between cannabis use and clinical outcome, including whether change in cannabis use affects psychotic symptoms, affective symptoms, functioning and psychotic relapse in a sample of people in early psychosis with comorbid cannabis abuse or dependence. One hundred and ten participants were examined prospectively with repeated measures of substance use antecedent to psychopathology at baseline, 4.5, 9, and 18 months. We used random intercept models to estimate the effects of cannabis dose on subsequent clinical outcomes and whether change in cannabis use was associated with change in outcomes. There was no evidence of a specific association between cannabis use and positive symptoms, or negative symptoms, relapse or hospital admissions. However, a greater dose of cannabis was associated with subsequent higher depression and anxiety. Change in the amount of cannabis used was associated with statistically significant corresponding change in anxiety scores, but not depression. Additionally, reductions in cannabis exposure were related to improved patient functioning. Reducing cannabis may be directly associated with improvements in anxiety and functioning, but not other specific symptoms. © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  10. The effect of adult Early Warning Systems education on nurses' knowledge, confidence and clinical performance: A systematic review.

    PubMed

    Saab, Mohamad M; McCarthy, Bridie; Andrews, Tom; Savage, Eileen; Drummond, Frances J; Walshe, Nuala; Forde, Mary; Breen, Dorothy; Henn, Patrick; Drennan, Jonathan; Hegarty, Josephine

    2017-11-01

    This review aims to determine the effect of adult Early Warning Systems education on nurses' knowledge, confidence and clinical performance. Early Warning Systems support timely identification of clinical deterioration and prevention of avoidable deaths. Several educational programmes have been designed to help nurses recognize and manage deteriorating patients. Little is known as to the effectiveness of these programmes. Systematic review. Academic Search Complete, CINAHL, MEDLINE, PsycINFO, PsycARTICLES, Psychology and Behavioral Science Collection, SocINDEX and the UK & Ireland Reference Centre, EMBASE, the Turning Research Into Practice database, the Cochrane Central Register of Controlled Trials (CENTRAL) and Grey Literature sources were searched between October and November 2015. This is a quantitative systematic review using Cochrane methods. Studies published between January 2011 - November 2015 in English were sought. The risk of bias, level of evidence and the quality of evidence per outcome were assessed. Eleven articles with 10 studies were included. Nine studies addressed clinical performance, four addressed knowledge and two addressed confidence. Knowledge, vital signs recording and Early Warning Score calculation were improved in the short term. Two interventions had no effect on nurses' response to clinical deterioration and use of communication tools. This review highlights the importance of measuring outcomes using standardized tools and valid and reliable instruments. Using longitudinal designs, researchers are encouraged to investigate the effect of Early Warning Systems educational programmes. These can include interactive e-learning, on-site interdisciplinary Early Warning Scoring systems training sessions and simulated scenarios. © 2017 John Wiley & Sons Ltd.

  11. Neurocognitive Outcomes in the Treatment of Early-Onset Schizophrenia Spectrum Disorders Study

    PubMed Central

    Frazier, Jean A.; Giuliano, Anthony J.; Johnson, Jacqueline L.; Yakutis, Lauren; Youngstrom, Eric A.; Breiger, David; Sikich, Linmarie; Findling, Robert L.; McClellan, Jon; Hamer, Robert M.; Vitiello, Benedetto; Lieberman, Jeffrey A.; Hooper, Stephen R.

    2012-01-01

    Objective To assess neurocognitive outcomes following antipsychotic intervention in youth enrolled in the National Institute of Mental Health (NIMH)-funded Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS). Method Neurocognitive functioning of youth (ages 8–19 years) with schizophrenia or schizoaffective disorder was evaluated in a four-site randomized, double-blind clinical trial comparing molindone, olanzapine or risperidone. The primary outcomes were overall group change from baseline in neurocognitive composite and six domain scores after 8 weeks and continued treatment up to 52 weeks. Age and sex were included as covariates in all analyses. Results Seventy-seven of 116 TEOSS participants (66%) had post-baseline neurocognitive data. No significant differences emerged in the neurocognitive outcomes of the three medication groups. Therefore, the three treatment groups were combined into one group to assess overall neurocognitive outcomes. Significant modest improvements were observed in the composite score and in three of six domain scores in the acute phase, and in four of six domain scores in the combined acute and maintenance phases. Partial correlation analyses revealed very few relationships among Positive and Negative Syndrome Scale (PANSS) baseline or change scores and neurocognition change scores. Conclusions Antipsychotic intervention in youth with early-onset schizophrenia spectrum disorders (EOSS) led to modest improvement in measures of neurocognitive function. The changes in cognition were largely unrelated to baseline symptoms or symptom change. Small treatment effect sizes, easily accounted for by practice effects, highlight the critical need for the development of more efficacious interventions for the enduring neurocognitive deficits seen in EOSS. PMID:22525956

  12. Encopresis: long-term clinical outcome of 67 cases.

    PubMed

    Unal, Fatih; Pehlivantürk, Berna

    2005-01-01

    In this study we attempted to investigate the outcome of encopresis and to determine factors affecting prognosis. The sample consisted of 52 boys (77.6%) and 15 girls (22.4%) diagnosed as encopresis according to DSM IV diagnostic criteria. These patients were evaluated six years after their initial examination in the Department of Child Psychiatry. Clinical and demographical data were compared between initial and follow-up interviews and between patients with complete recovery and others. Fifty-six patients (83.6%) recovered completely and 11 (16.4%) continued to be encopretic after six years. Good school performance (p<0.005), high levels of parental education (p<0.005) and absence of constipation (p<0.05) were associated with favorable outcome. In addition, secondary encopretics who were diagnosed within a year from onset of the symptom recovered significantly earlier (p<0.001). Encopresis is a chronic disorder and complete recovery rates tend to increase with time. Families and primary health care providers should be informed about the treatment possibilities of encopresis for early intervention.

  13. Early Cord Metabolite Index and Outcome in Perinatal Asphyxia and Hypoxic-Ischaemic Encephalopathy.

    PubMed

    Ahearne, C E; Denihan, N M; Walsh, B H; Reinke, S N; Kenny, L C; Boylan, G B; Broadhurst, D I; Murray, D M

    2016-01-01

    A 1H-NMR-derived metabolomic index based on early umbilical cord blood alterations of succinate, glycerol, 3-hydroxybutyrate and O-phosphocholine has shown potential for the prediction of hypoxic-ischaemic encephalopathy (HIE) severity. To evaluate whether this metabolite score can predict 3-year neurodevelopmental outcome in infants with perinatal asphyxia and HIE, compared with current standard biochemical and clinical markers. From September 2009 to June 2011, infants at risk of perinatal asphyxia were recruited from a single maternity hospital. Cord blood was drawn and biobanked at delivery. Neonates were monitored for development of encephalopathy both clinically and electrographically. Neurodevelopmental outcome was assessed at 36-42 months using the Bayley Scales of Infant and Toddler Development, ed. III (BSID-III). Death and cerebral palsy were also considered as abnormal end points. Thirty-one infants had both metabolomic analysis and neurodevelopmental outcome at 36-42 months. No child had a severely abnormal BSID-III result. The metabolite index significantly correlated with outcome (ρ2 = 0.30, p < 0.01), which is robust to predict both severe outcome (area under the receiver operating characteristic curve: 0.92, p < 0.01) and intact survival (0.80, p = 0.01). There was no correlation between the index score and performance in the individual BSID-III subscales (cognitive, language, motor). The metabolite index outperformed other standard biochemical markers at birth for prediction of outcome at 3 years, but was not superior to EEG or the Sarnat score. © 2016 S. Karger AG, Basel.

  14. Longitudinal investigation into childhood- and adolescence-onset depression: psychiatric outcome in early adulthood.

    PubMed

    Dunn, Valerie; Goodyer, Ian M

    2006-03-01

    Major depression in childhood or adolescence increases the risk off affective disorder in adulthood. The precise nature and course of the subsequent disorder remain unclear. To investigate long-term psychiatric outcome of school-age depression in community and clinic samples. A group of 113 young adults were followed up after a mean of 7.8 years (s.e.=15). Groups with persistent and recurrent depression were identified. Recurrence of affective disorder was similar in clinic and community groups. The clinic group had significantly longer index episodes; these were predicted by an early psychiatric history, longer episode duration before treatment and greater impairment. Being female, having higher self-report depression scores and comorbidity at index episode predicted earlier recurrence. Males were more likely to have persistent depression. Prognosis is similar in young people with depression from community and clinical samples. Boys from a clinical sample are at higher risk than girls of becoming persistently and severely mentally ill.

  15. Medical students’ attitudes towards early clinical exposure in Iran

    PubMed Central

    Khabaz Mafinejad, Mahboobeh; Peiman, Soheil; Khajavirad, Nasim; Mirabdolhagh Hazaveh, Mojgan; Edalatifard, Maryam; Allameh, Seyed-Farshad; Naderi, Neda; Foroumandi, Morteza; Afshari, Ali; Asghari, Fariba

    2016-01-01

    Objectives This study was carried out to investigate the medical students’ attitudes towards early clinical exposure at Tehran University of Medical Sciences. Methods A cross-sectional study was conducted during 2012-2015. A convenience sample of 298 first- and second-year students, enrolled in the undergraduate medical curriculum, participated in an early clinical exposure program. To collect data from medical students, a questionnaire consisting of open-ended questions and structured questions, rated on a five-point Likert scale, was used to investigate students’ attitudes toward early clinical exposure. Results Of the 298 medical students, 216 (72%) completed the questionnaires. The results demonstrated that medical students had a positive attitude toward early clinical exposure. Most students (80.1%) stated that early clinical exposure could familiarize them with the role of basic sciences knowledge in medicine and how to apply this knowledge in clinical settings. Moreover, 84.5% of them believed that early clinical exposure increased their interest in medicine and encouraged them to read more. Furthermore, content analysis of the students’ responses uncovered three main themes of early clinical exposure, were considered helpful to improve learning: “integration of theory and practice”, “interaction with others and professional development” and “desire and motivation for learning medicine”. Conclusions Medical students found their first experience with clinical setting valuable. Providing clinical exposure in the initial years of medical curricula and teaching the application of basic sciences knowledge in clinical practice can enhance students’ understanding of the role they will play in the future as a physician. PMID:27318794

  16. Can Intraoperative Sensors Determine the "Target" Ligament Balance? Early Outcomes in Total Knee Arthroplasty.

    PubMed

    Meneghini, Robert M; Ziemba-Davis, Mary M; Lovro, Luke R; Ireland, Phillip H; Damer, Brent M

    2016-10-01

    The optimal "target" ligament balance for each patient undergoing total knee arthroplasty (TKA) remains unknown. The study purpose was to determine if patient outcomes are affected by intraoperative ligament balance measured with force-sensing implant trials and if an optimal "target" balance exists. A multicenter, retrospective study reviewed consecutive TKAs performed by 3 surgeons. TKA's were performed with standard surgical techniques and ligament releases. After final implants were made, sensor-embedded smart tibial trials were inserted, and compartment forces recorded throughout the range of motion. Clinical outcome measures were obtained preoperatively and at 4 months. Statistical analysis correlated ligament balance with clinical outcomes. One hundred eighty-nine consecutive TKAs were analyzed. Patients were grouped by average medial and lateral compartment force differences. Twenty-nine TKAs (15%) were balanced within 15 lbs and 53 (28%) were "balanced" greater than 75 lbs. Greater improvement in University of California Los Angeles activity level was associated with a mediolateral force difference <60 lbs. (P = .006). Knee Society objective, function, and satisfaction scores, and self-reported health state were unrelated to mediolateral balance in the knee. Intraoperative force-sensing has potential in providing real-time objective data to optimize TKA outcomes. These data support some early outcomes may improve by balancing TKAs within 60 lbs difference. Close follow-up is warranted to determine if gait pattern adaptations affect longer term outcomes with greater or less ligament "imbalance." Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Clinical outcomes of a polyaxial interspinous fusion system.

    PubMed

    Sclafani, Joseph A; Liang, Kevin; Ohnmeiss, Donna D; Gordon, Charles

    2014-01-01

    Early interspinous process fixation constructs utilize rigid fixation plates with immobile spikes which increase the difficulty of device implantation when anatomic variations are encountered. Second generation systems have been designed with polyaxial properties with the goal of accommodating natural osseous anatomic variations to achieve optimal implant placement and fixation integrity. The purpose of this study was to evaluate clinical outcomes in patients treated with this device to supplement the biomechanical data from previous studies. A retrospective, non-randomized, single-center chart review at or beyond the one year postoperative time point was conducted to collect preoperative and perioperative data on patients treated with a polyaxial intraspinous fixation system. A postoperative numerical pain rating scale and modified MacNab classification score were obtained from each patient in the cohort via phone survey. A total of 53 patients were included in the study. Median hospital stay was 2 days (range 1-7 days). There were no reported perioperative blood transfusions or cases of radiographic fracture/migration of the device at the 6 week post-operative time point. There was a significant improvement in pain index score in the overall patient study group and a satisfactory (excellent or good) MacNab result was obtained in 48% of all patients. Patients with preoperative pain scores greater than 8/10 reported more pain improvement than patients with preoperative pain scores less than 5 (0 points, p = 0.96, n = 8). Patients with a BMI less than 30 had significantly better MacNab outcome classifications than patients with a BMI greater than 30. The polyaxial interspinous fusion system produces significant clinical improvement when employed to treat patients with stenosis, herniated disc, or low grade spondylolisthesis. This device can be implanted with a low complication rate and short postoperative hospital admission time. Patients with high pre

  18. Early radiological and functional outcomes for a cementless press-fit design modular femoral stem revision system.

    PubMed

    Hancock, Douglas S; Sharplin, Paul K; Larsen, Peter D; Phillips, Fredrick Ts

    2018-05-01

    To assess early radiological and functional outcomes of revision hip surgery with a cementless press-fit design femoral stem. A retrospective review of 48 consecutive revision total hip replacements using the RECLAIM revision hip system, between October 2012 and August 2015. Radiographic assessment was undertaken with serial anteroposterior (AP) X-rays of the pelvis. Risk factors for subsidence were evaluated. Prospective clinical follow up was performed on 21 patients to assess functional outcomes. Mean stem subsidence was 1.1 mm (95% confidence interval[CI]: 0.63-1.57). Median follow up of 12 months. An inverse relationship was observed between level of subsidence and femoral stem diameter r = -0.45, p = 0.001. Subsidence at the time of follow-up assessment was correlated with initial subsidence (correlation coefficient rho 0.69, p = 0.001). The mean Merle d'Aubigne score at the latest follow up was 14.2 (range 8-17). The mean OHS was 34.1 (range 15-48). Early radiological and functional outcomes for the RECLAIM revision system showed very low levels of subsidence and good functional outcomes. There was an association with smaller diameter femoral stems and greater levels of subsidence.

  19. [Early clinical diagnosis of acanthamoeba keratitis. A study of 70 eyes].

    PubMed

    Bernauer, W; Duguid, G I; Dart, J K

    1996-05-01

    Acanthamoeba keratitis is an uncommon condition which is usually associated with contact lens wear. The use of home made saline and poor hygiene are important risk factors. Early diagnosis is crucial since these cases respond well to medical therapy. The purpose of this paper is to describe and demonstrate early clinical signs. Between September 1992 and October 1994, 70 cases of acanthamoeba keratitis, one of them bilateral, were prospectively monitored at Moorfields Eye Hospital in London. A database of all patients was set up and the clinical findings, diagnostic methods, therapeutic interventions and the outcome were recorded. 66 patients (96%) were contact lens wearers, 64 of them (97%) wore soft lenses. The mean interval between first symptoms and correct diagnosis was 42%. The most frequent initial diagnoses were "unclear keratoconjunctivitis" and "herpetic keratitis". Early corneal findings included punctate keratopathy (n = 14; 20%), pseudodendrites (n = 4; 6%), epithelial infiltrates (n = 17; 24%), diffuse or focal sub-epithelial infiltrates (n = 36; 51%) and radial keratoneuritis (n = 5; 7%). Ring infiltrates (n = 13; 18%) and corneal ulceration (n = 13) were late signs. When the above corneal findings are observed, particularly in contact lens wearers, the diagnosis of acanthamoeba keratitis should be considered. The diagnosis of "herpetic keratitis" in association with contact lens wear should be encountered with scepticism.

  20. Early Educational Intervention, Early Cumulative Risk, and the Early Home Environment as Predictors of Young Adult Outcomes within a High-Risk Sample

    ERIC Educational Resources Information Center

    Pungello, Elizabeth P.; Kainz, Kirsten; Burchinal, Margaret; Wasik, Barbara H.; Sparling, Joseph J.; Ramey, Craig T.; Campbell, Frances A.

    2010-01-01

    The extent to which early educational intervention, early cumulative risk, and the early home environment were associated with young adult outcomes was investigated in a sample of 139 young adults (age 21) from high-risk families enrolled in randomized trials of early intervention. Positive effects of treatment were found for education attainment,…

  1. A Consumer's Guide To Outcomes in Early Childhood Intervention.

    ERIC Educational Resources Information Center

    Accreditation Council on Services for People with Disabilities, Landover, MD.

    This collection of 21 suggested outcome measures for early childhood intervention services is designed to assist families in evaluating the quality of early intervention services they receive. The measures apply to all types of service and support program models for children with various developmental delays and/or disabilities and their families.…

  2. Robot-assisted radical cystectomy – first Polish clinical outcomes

    PubMed Central

    Juszczak, Kajetan; Poblocki, Pawel; Mikolajczak, Witold; Drewa, Tomasz

    2017-01-01

    Introduction Urothelial cell carcinoma is the most common neoplasm of the genito-urinary tract, which, in advanced stages, is treated with radical cystectomy with pelvic lymphadenectomy. It can be performed by an open or minimally invasive approach (laparoscopic and robot-assisted radical cystectomy). Large meta-analyses showed a significantly lower complication rate in the RARC (robot-assisted radical cystectomy) group compared to ORC (open radical cystectomy) in thirty and ninety days after surgery, with similar oncological and functional outcomes. The clinical outcomes of the first forty Polish RARC are explored in this article. Material and methods The Polish Radical Robotic Cystectomy Program (PRRC) was started in 2016 at the Nicolaus Copernicus Hospital in Toruń. Forty consecutive patients, with indications for cystectomy were included into the study. During radical robot-assisted cystectomy, obturator, external, internal, common iliac and presacral lymph nodes were dissected. Oncological outcomes, early complication rate, and the clinical variables were analyzed. Results The mean age in the study group was sixty-seven years, with the majority of patients being overweight and assessed as American Society of Anesthesiology Scale (ASA) – ASA III and ASA IV (2/3 of patients). RARC was performed, with the median time of surgery being 324 minutes (170 minutes being the shortest). Mean blood loss was 365 ml (lowest – 50 ml), and only 2 patients required intraoperative blood transfusion. Twenty patients had ileal conduit, and nineteen had other methods of urinary diversion. Only twenty-nine out of forty patients had minor complications (Clavien I and II), 11 had Clavien III and IV. Clavien V was not present. Only 3 patients required reoperation. Conclusions RARC is a reproducible oncological procedure, which can be safely performed in centers with robotic expertise, with acceptable operative time, complications, and functional and oncologic outcomes. PMID

  3. Early detection of psychosis: finding those at clinical high risk.

    PubMed

    Addington, Jean; Epstein, Irvin; Reynolds, Andrea; Furimsky, Ivana; Rudy, Laura; Mancini, Barbara; McMillan, Simone; Kirsopp, Diane; Zipursky, Robert B

    2008-08-01

    In early detection work, recruiting individuals who meet the prodromal criteria is difficult. The aim of this paper was to describe the development of a research clinic for individuals who appear to be at risk of developing a psychosis and the process for educating the community and obtaining referrals. The outcome of all referrals to the clinic over a 4-year period was examined. Following an ongoing education campaign that was over inclusive in order to aid recruitment, approximately 27% of all referrals met the criteria for being at clinical high risk of psychosis. We are seeing only a small proportion of those in the community who eventually go on to develop a psychotic illness. This raises two important issues, namely how to remedy the situation, and second, the impact of this on current research in terms of sampling bias and generalizability of research findings. © 2008 The Authors. Journal compilation © 2008 Blackwell Publishing Asia Pty Ltd.

  4. Systematic review of early cardiometabolic outcomes of the first treated episode of psychosis.

    PubMed

    Foley, Debra L; Morley, Katherine I

    2011-06-01

    The increased mortality associated with schizophrenia is largely due to cardiovascular disease. Treatment with antipsychotics is associated with weight gain and changes in other cardiovascular risk factors. Early identification of modifiable cardiovascular risk factors is a clinical imperative but prospective longitudinal studies of the early cardiometabolic adverse effects of antipsychotic drug treatment other than weight gain have not been previously reviewed. To assess the methods and reporting of cardiometabolic outcome studies of the first treated episode of psychosis, review key findings, and suggest directions for future research. PsycINFO, MEDLINE, and Scopus from January 1990 to June 2010. Subjects were experiencing their first treated episode of psychosis. Subjects were antipsychotic naive or had been exposed to antipsychotics for a short known period at the beginning of the study. Cardiometabolic indices were assessed. Studies used a longitudinal design. Sixty-four articles were identified describing 53 independent studies; 25 studies met inclusion criteria and were retained for detailed review. Consolidated Standards of Reporting Trials and Strengthening the Reporting of Observational Studies in Epidemiology checklists were used to assess the methods and reporting of studies. A qualitative review of findings was conducted. Two key hypotheses were identified based on this review: (1) in general, there is no difference in cardiovascular risk assessed by weight or metabolic indices between individuals with an untreated first episode of psychosis and healthy controls and (2) cardiovascular risk increases after first exposure to any antipsychotic drug. A rank order of drugs can be derived but there is no evidence of significant class differences. Recommended directions for future research include assessing the effect on cardiometabolic outcomes of medication adherence and dosage effects, determining the therapeutic window for antipsychotic use in adults and

  5. Planning in Middle Childhood: Early Predictors and Later Outcomes

    ERIC Educational Resources Information Center

    Friedman, Sarah L.; Scholnick, Ellin K.; Bender, Randall H.; Vandergrift, Nathan; Spieker, Susan; Pasek, Kathy Hirsh; Keating, Daniel P.; Park, Yoonjung

    2014-01-01

    Data from 1,364 children and families who participated in the National Institute of Child Health and Human Development's Study of Early Child Care and Youth Development were analyzed to track the early correlates and later academic outcomes of planning during middle childhood. Maternal education, through its effect on parenting quality when…

  6. Critical illness polyneuropathy (CIP) in neurological early rehabilitation: clinical and neurophysiological features.

    PubMed

    Schmidt, Simone B; Rollnik, Jens D

    2016-12-15

    Critical illness polyneuropathy (CIP) is a complex disease affecting 30-70% of critically ill patients. Clinical (Barthel index, length of stay (LOS), morbidity, duration of mechanical ventilation, routine lab results) and neurophysiological (neurography) data of 191 patients admitted to neurological early rehabilitation and diagnosed with CIP have been analyzed retrospectively. CIP diagnosis was correct in 159 cases (83%). In this study, systemic inflammation, sepsis, systemic inflammatory response syndrome (SIRS), multiple organic failure (MOF), chronic renal failure, liver dysfunction, mechanical ventilation, diabetes, dyslipidemia and impaired ion homeostasis (hypocalcaemia, hypokalemia) were associated with CIP. Neurography, in particular of the peroneal, sural, tibial and median nerves, helped to identify CIP patients. Compound muscle action potential amplitude (r = -0.324, p < 0.05), as well as sensory (r = -0.389, p < 0.05) and motor conduction velocity (r = -0.347, p < 0.05) of the median nerve correlated with LOS in neurological early rehabilitation but not with outcome measures. In most cases, diagnosis of CIP among neurological early rehabilitation patients seems to be correct. Neurography may help to verify the diagnosis and to learn more about CIP pathophysiology, but it does not allow outcome prediction. Further studies on CIP are strongly encouraged.

  7. Learning curve and early clinical outcomes for a robotic surgery novice performing robotic single site cholecystectomy.

    PubMed

    Angus, Andrew A; Sahi, Saad L; McIntosh, Bruce B

    2014-06-01

    A rapid training protocol has been developed for robotic surgery novices to learn robotic single-incision techniques. This study assesses the learning curve and early clinical results for a robotic surgery novice starting single-site cholecystectomy. A chart review was performed on the surgeon's first 55 patients to undergo this procedure. Average patient age was 46.01 ± 4.25 (range 21-86) years and BMI was 26.57 ± 4.25 (range 19.4-36.6) kg/m(2) . The mean port placement with docking time was 11.34 ± 3.74 (range 7-23) min. Mean console time was 28.74 ± 11.04 (range 15-66) min. Average total OR time was 61.84 ± 14.66 (range 40-105) min. All procedures were successfully completed without conversion or added ports. Complications included several minor procedural gall bladder perforations and miscellaneous postoperative symptomatic complaints. Robotic single site cholecystectomy can be safely performed by a robotic novice within a minimal learning curve and have early clinical results that are comparable to the published data of robotic experts. Copyright © 2013 John Wiley & Sons, Ltd.

  8. Modeling old-age wealth with endogenous early-life outcomes: The case of Mexico

    PubMed Central

    DeGraff, Deborah S.; Wong, Rebeca

    2014-01-01

    This paper contributes to the literature on the life course and aging by examining the association between early-life outcomes and late-life well being, using data from the Mexican Health and Aging Study. Empirical research in this area has been challenged by the potential endogeneity of the early-life outcomes of interest, an issue which most studies ignore or downplay. Our contribution takes two forms: (1) we examine in detail the potential importance of two key life-cycle outcomes, age at marriage (a measure of family formation) and years of educational attainment (a measure of human capital investment) for old-age wealth, and (2) we illustrate the empirical value of past context variables that could help model the association between early-life outcomes and late-life well being. Our illustrative approach, matching macro-level historical policy and census variables to individual records to use as instruments in modeling the endogeneity of early-life behaviors, yields a statistically identified two-stage model of old-age wealth with minimum bias. We use simulations to show that the results for the model of wealth in old age are meaningfully different when comparing the approach that accounts for endogeneity with an approach that assumes exogeneity of early-life outcomes. Furthermore, our results suggest that in the Mexican case, models which ignore the potential endogeneity of early-life outcomes are likely to under-estimate the effects of such variables on old-age wealth. PMID:25170434

  9. Outcomes of transoral robotic surgery: a preliminary clinical experience.

    PubMed

    Hurtuk, Agnes; Agrawal, Amit; Old, Matthew; Teknos, Theodoros N; Ozer, Enver

    2011-08-01

    To report a single institution's experience with transoral robotic surgery (TORS) and its clinical outcomes. Preliminary clinical data from a prospective TORS study. University tertiary care facility. Patients who underwent TORS at The Ohio State University Medical Center. Demographic, intraoperative, clinicopathological, and follow-up functional data were collected. Sixty-four patients underwent TORS with a median age of 56.9 years. A total of 113 TORS procedures were performed. Fifty-four patients with squamous cell cancer (SCCA) were included in the final analysis. Mean follow-up time was 11.8 months (range, 2-29). There was a trend toward longer TORS setup time, operative time, estimated blood loss, and hospital length of stay with advanced (T(3)) compared with early-stage tumors (T(1-2)). There were no major intraoperative complications, and none of the procedures were aborted because of inability to remove the tumor. Negative resection margins were achieved in 93% of cases of SCCA. No patients experienced immediate postoperative complications, and all of the patients tolerated an oral diet without any airway compromise on the day of surgery. Forty-nine patients (91%) underwent adjuvant radiation therapy (RT), with 11 patients requiring gastrostomy tube placement during RT. Addition of TORS to overall management of head and neck SCCA spared adjuvant RT or combined chemotherapy and RT (CRT) in 50% of stage I/II tumors and spared chemotherapy in 34% of stage III/IV tumors. TORS is a safe procedure with minimal complications and favorable clinical and functional outcomes. It is a promising future alternative surgical treatment for laryngopharyngeal tumors.

  10. The distribution of outcomes research papers across clinical journals.

    PubMed

    Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

    2011-06-01

    This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.

  11. Association Between Onset-to-Door Time and Clinical Outcomes After Ischemic Stroke.

    PubMed

    Matsuo, Ryu; Yamaguchi, Yuko; Matsushita, Tomonaga; Hata, Jun; Kiyuna, Fumi; Fukuda, Kenji; Wakisaka, Yoshinobu; Kuroda, Junya; Ago, Tetsuro; Kitazono, Takanari; Kamouchi, Masahiro

    2017-11-01

    The role of early hospital arrival in improving poststroke clinical outcomes in patients without reperfusion treatment remains unclear. This study aimed to determine whether early hospital arrival was associated with favorable outcomes in patients without reperfusion treatment or with minor stroke. This multicenter, hospital-based study included 6780 consecutive patients (aged, 69.9±12.2 years; 63.9% men) with ischemic stroke who were prospectively registered in Fukuoka, Japan, between July 2007 and December 2014. Onset-to-door time was categorized as T 0-1 , ≤1 hour; T 1-2 , >1 and ≤2 hours; T 2-3 , >2 and ≤3 hours; T 3-6 , >3 and ≤6 hours; T 6-12 , >6 and ≤12 hours; T 12-24 , >12 and ≤24 hours; and T 24- , >24 hours. The main outcomes were neurological improvement (decrease in National Institutes of Health Stroke Scale score of ≥4 during hospitalization or 0 at discharge) and good functional outcome (3-month modified Rankin Scale score of 0-1). Associations between onset-to-door time and main outcomes were evaluated after adjusting for potential confounders using logistic regression analysis. Odds ratios (95% confidence intervals) increased significantly with shorter onset-to-door times within 6 hours, for both neurological improvement ( T 0- 1 , 2.79 [2.28-3.42]; T 1-2 , 2.49 [2.02-3.07]; T 2-3 , 1.52 [1.21-1.92]; T 3-6 , 1.72 [1.44-2.05], with reference to T 24- ) and good functional outcome ( T 0-1 , 2.68 [2.05-3.49], T 1-2 2.10 [1.60-2.77], T 2-3 1.53 [1.15-2.03], T 3-6 1.31 [1.05-1.64], with reference to T 24- ), even after adjusting for potential confounding factors including reperfusion treatment and basal National Institutes of Health Stroke Scale. These associations were maintained in 6216 patients without reperfusion treatment and in 4793 patients with minor stroke (National Institutes of Health Stroke Scale ≤4 on hospital arrival). Early hospital arrival within 6 hours after stroke onset is associated with favorable outcomes after

  12. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M,; Foy, M. H.; Dulchavsky, S. A.; hide

    2015-01-01

    The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capabilities (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities". Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes.

  13. Outcomes Reported by Spanish-Speaking Families in Early Intervention

    ERIC Educational Resources Information Center

    Olmsted, Murrey G.; Bailey, Donald B., Jr.; Raspa, Melissa; Nelson, Robin E.; Robinson, Nyle D.; Simpson, Mary Ellen; Guillen, Chelsea

    2010-01-01

    In this study, the authors use data from two states to compare how families participating in early intervention who completed a Spanish version of the Family Outcomes Survey (FOS) (n = 291) compared with Hispanic (n = 486) and non-Hispanic (n = 2,363) families who completed the English version. In general, most families reported positive outcomes,…

  14. Short- and long-term clinical outcomes of use of beta-interferon or glatiramer acetate for people with clinically isolated syndrome: a systematic review of randomised controlled trials and network meta-analysis.

    PubMed

    Armoiry, X; Kan, A; Melendez-Torres, G J; Court, R; Sutcliffe, P; Auguste, P; Madan, J; Counsell, C; Clarke, A

    2018-05-01

    Beta-interferon (IFN-β) and glatiramer acetate (GA) have been evaluated in people with clinically isolated syndrome (CIS) with the aim to delay a second clinical attack and a diagnosis of clinically definite multiple sclerosis (CDMS). We systematically reviewed trials evaluating the short- and long-term clinical effectiveness of these drugs in CIS. We searched multiple electronic databases. We selected randomised controlled studies (RCTs) conducted in CIS patients and where the interventions were IFN-β and GA. Main outcomes were time to CDMS, and discontinuation due to adverse events (AE). We compared interventions using random-effect network meta-analyses (NMA). We also reported outcomes from long-term open-label extension (OLE) studies. We identified five primary studies. Four had open-label extensions following double-blind periods comparing outcomes between early vs delayed DMT. Short-term clinical results (double-blind period) showed that all drugs delayed CDMS compared to placebo. Indirect comparisons did not suggest superiority of any one active drug over another. We could not undertake a NMA for discontinuation due to AE. Long-term clinical results (OLE studies) showed that the risk of developing CDMS was consistently reduced across studies after early DMT treatment compared to delayed DMT (HR = 0.64, 95% CI 0.55, 0.74). No data supported the benefit of DMTs in reducing the time to, and magnitude of, disability progression. Meta-analyses confirmed that IFN-β and GA delay time to CDMS compared to placebo. In the absence of evidence that early DMTs can reduce disability progression, future research is needed to better identify patients most likely to benefit from long-term DMTs.

  15. Inhibition of intraluminal pancreatic enzymes with nafamostat mesilate improves clinical outcomes after hemorrhagic shock in swine.

    PubMed

    Kim, Hubert D; Malinoski, Darren J; Borazjani, Boris; Patel, Madhukar S; Chen, Joseph; Slone, Johnathan; Nguyen, Xuan-Mai T; Steward, Earl; Schmid-Schonbein, Geert W; Hoyt, David B

    2010-05-01

    Recent studies suggest that intraluminal pancreatic enzymes play a major role in the initiation of the inflammatory cascade by the gut after hemorrhagic shock. Previous animal models have shown that the inhibition of enteral pancreatic enzymes with a serine protease inhibitor, nafamostat mesilate (NM), decreases leukocyte activation and transfusion requirements after hemorrhagic shock. The objective of this study was to determine whether enteroclysis with NM would improve the clinical outcomes in swine after hemorrhagic shock and intestinal hypoperfusion. Thirty-three male Yucatan minipigs weighing 25 kg to 30 kg underwent a controlled hemorrhage of 25 mL/kg with mesenteric clamp for further gut ischemia. Animals were allocated to three groups: (1) shock only (n = 15), (2) shock + enteroclysis with 100 mL/kg GoLYTELY (GL) as a carrier (n = 11), and (3) shock + enteroclysis with GL + 0.37 mmol/L NM (GL+NM, n = 7). Animals were resuscitated, recovered from anesthesia, observed for 3 days, and graded on a daily 4-point clinical scoring system. A score of 0 indicated a moribund state or early death, and a score of 4 indicated normal behavior. Pigs treated with GL + NM had significantly higher mean postoperative recovery scores (3.8 +/- 0.4, essentially normal behavior with no early deaths) compared with animals within the shock only and shock + GL groups (2.1 +/- 1 with one early death and 2.2 +/- 1.2 with two early deaths, respectively, analysis of variance p < 0.003). The inhibition of intraluminal pancreatic enzymes using enteroclysis with the serine protease inhibitor, NM, after hemorrhagic shock significantly improves the clinical outcome.

  16. Examining Multidimensional Middle Grade Outcomes after Early Elementary School Grade Retention

    ERIC Educational Resources Information Center

    Hwang, Sophia; Cappella, Elise; Schwartz, Kate

    2016-01-01

    Recently, researchers have begun to employ rigorous statistical methods and developmentally-informed theories to evaluate outcomes for students retained in non-kindergarten early elementary school. However, the majority of this research focuses on academic outcomes. Gaps remain regarding retention's effects on psychosocial outcomes important to…

  17. Lifestyle Factors and Early Clinical Outcome in Patients With Acute Stroke: A Population-Based Study.

    PubMed

    Ingeman, Annette; Andersen, Grethe; Thomsen, Reimar W; Hundborg, Heidi H; Rasmussen, Henrik H; Johnsen, Søren P

    2017-03-01

    We examined the associations of individual and combined lifestyle factors with early adverse stroke outcomes. A total of 82 597 patients were identified from nationwide registries. Lifestyle factors at the time of stroke admission included body mass index (kg/m 2 ), smoking habits, and alcohol intake, which were grouped (healthy, moderately healthy, moderately unhealthy, and unhealthy). The associations between lifestyle and outcomes were examined using multivariable regression. A total of 18.3% had a severe stroke, 7.8% pneumonia, 12.5% urinary tract infection, and 9.9% died within 30 days. The association between lifestyle, stroke severity, and mortality, respectively, differed according to sex. Unhealthy lifestyle was associated with lower risk of severe stroke (adjusted odds ratio [OR], 0.73; 95% confidence interval [CI], 0.63-0.84) and 30-day mortality among men (adjusted OR, 0.71; 95% CI, 0.58-0.87), but not among women (severe stroke: adjusted OR, 1.14; 95% CI, 0.85-1.55, and mortality: adjusted OR, 1.34; 95% CI, 0.90-1.99). No sex differences were found for pneumonia and urinary tract infection. Unhealthy lifestyle was not associated with a statistically significant increased risk of developing in-hospital pneumonia (adjusted OR, 1.30; 95% CI, 0.98-1.73) or urinary tract infection (adjusted OR, 0.98; 95% CI, 0.72-1.33). Underweight was associated with a higher 30-day mortality (men: adjusted OR, 1.71; 95% CI, 1.50-1.96, and women: adjusted OR, 1.46; 95% CI, 1.34-1.60). Healthy lifestyle was not associated with a lower risk of adverse stroke outcomes, in particularly among men. However, underweight may be a particular concern being associated with an increased risk of adverse outcomes among both sexes. © 2017 American Heart Association, Inc.

  18. Clinical assessment of early language development: a simplified short form of the Mandarin communicative development inventory.

    PubMed

    Soli, Sigfrid D; Zheng, Yun; Meng, Zhaoli; Li, Gang

    2012-09-01

    The purpose of this study was to develop a practical mean for clinical evaluation of early pediatric language development by establishing developmental trajectories for receptive and expressive vocabulary growth in children between 6 and 32 months of age using a simple, time-efficient assessment tool. Simplified short form versions of the Words and Gestures and Words and Sentences vocabulary inventories in the Mandarin Communicative Development Inventory [1] were developed and used to assess early language development in developmentally normal children from 6 to 32 months of age during routine health checks. Developmental trajectories characterizing the rate of receptive and expressive vocabulary growth between 6 and 32 months of age are reported. These trajectories allow the equivalent age corresponding to a score to be determined after a brief structured interview with the child's parents that can be conducted in a busy clinical setting. The simplified short forms of the Mandarin Communicative Development Inventories can serve as a clinically useful tool to assess early child language development, providing a practical mean of objectively assessing early language development following early interventions to treat young children with hearing impairment as well as speech and language delays. Objective evidence of language development is essential for achievement of effective (re)habilitation outcomes. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  19. Risk factors and birth outcomes of anaemia in early pregnancy in a nulliparous cohort.

    PubMed

    Masukume, Gwinyai; Khashan, Ali S; Kenny, Louise C; Baker, Philip N; Nelson, Gill

    2015-01-01

    Anaemia in pregnancy is a major public health and economic problem worldwide, that contributes to both maternal and fetal morbidity and mortality. The aim of the study was to calculate the prevalence of anaemia in early pregnancy in a cohort of 'low risk' women participating in a large international multicentre prospective study (n = 5 609), to identify the modifiable risk factors for anaemia in pregnancy in this cohort, and to compare the birth outcomes between pregnancies with and without anaemia in early gestation. The study is an analysis of data that were collected prospectively during the Screening for Pregnancy Endpoints study. Anaemia was defined according to the World Health Organization's definition of anaemia in pregnancy (haemoglobin < 11g/dL). Binary logistic regression with adjustment for potential confounders (country, maternal age, having a marital partner, ethnic origin, years of schooling, and having paid work) was the main method of analysis. The hallmark findings were the low prevalence of anaemia (2.2%), that having no marital partner was an independent risk factor for having anaemia (OR 1.34, 95% CI 1.01-1.78), and that there was no statistically significant effect of anaemia on adverse pregnancy outcomes (small for gestational age, pre-tem birth, mode of delivery, low birth weight, APGAR score < 7 at one and five minutes). Adverse pregnancy outcomes were however more common in those with anaemia than in those without. In this low risk healthy pregnant population we found a low anaemia rate. The absence of a marital partner was a non-modifiable factor, albeit one which may reflect a variety of confounding factors, that should be considered for addition to anaemia's conceptual framework of determinants. Although not statistically significant, clinically, a trend towards a higher risk of adverse pregnancy outcomes was observed in women that were anaemic in early pregnancy.

  20. Factors associated with early detection of choroidal neovascularization in age-related macular degeneration in the clinic setting.

    PubMed

    Lichtinger, Alejandro; Caraza, Mauricio; Galbinur, Tural; Chowers, Itay

    2012-06-01

    Delayed diagnosis of choroidal neovas cularization (CNV) in age-related macular degeneration (AMD) adversely affects visual outcome. To identify factors associated with early detection of CNV in the clinic setting. Demographic and clinical data and lesion characteristics were retrospectively collected from 76 consecutive AMD patients who had a history of CNV in one eye and presented with CNV in the second eye. These data were evaluated for association with visual acuity (VA) at the time of presentation. Better VA was associated with a history of CNV in the fellow eye (P < 0.0001), adherence to follow-up every 4 months (P = 0.015), younger age (P = 0.03), smaller lesion (P < 0.0001), and non-subfoveal location (P = 0.048). VA of the fellow eye did not correlate with VA at presentation with CNV. These data suggest that patients' experience of CNV, regardless of VA, facilitates early diagnosis in the fellow eye. Adherence to follow-up in the routine clinic setting also facilitates early detection of CNV.

  1. Outcome Measures for Early Childhood Intervention Services.

    ERIC Educational Resources Information Center

    Accreditation Council on Services for People with Disabilities, Landover, MD.

    This collection of 21 suggested outcome measures for early childhood intervention services is intended to apply to all types of service and support program models for children (birth to age 5) with various developmental delays and/or disabilities. The measures are appropriate for either home-based or center-based service delivery models. Section 1…

  2. A Meta-Analysis of the Relationship between Learning Outcomes and Parental Involvement during Early Childhood Education and Early Elementary Education

    ERIC Educational Resources Information Center

    Ma, Xin; Shen, Jianping; Krenn, Huilan Y.; Hu, Shanshan; Yuan, Jing

    2016-01-01

    This meta-analysis examined the relationship between learning outcomes of children and educational involvement of parents during a unique period of early childhood education and early elementary education based on 100 independent effect sizes from 46 studies. Learning outcomes are academic achievement, and frameworks of parental involvement…

  3. Sharing information about diagnosis and outcome of first-episode psychosis in patients presenting to early intervention services.

    PubMed

    Farooq, Saeed; Green, Debra J; Singh, Swaran P

    2018-05-04

    First-episode psychosis (FEP) can be a serious and debilitating disease, but there is limited literature on how to inform patients and carers about its diagnosis and outcome. We aimed to examine the attitudes, practices and views of clinicians working in Early Intervention Service about sharing information on diagnosis and outcome of FEP. A 26-item questionnaire was sent electronically to clinical staff who have been involved in the discussion of FEP diagnosis in Early Intervention Services in the West Midlands, UK. A total of 51 clinicians completed the questionnaire. All respondents stated that patients or carers of those presenting with FEP wish to be informed of their diagnosis, and three-quarters (76%) felt there is a need to develop guidelines on how to inform about diagnosis; 57% stated that they usually use broad diagnostic groups such as psychosis when discussing diagnosis, and only 11% use the term schizophrenia. A total of 40% thought that the therapeutic relationship and treatment adherence (58%) would improve if patients know about their diagnosis; 42 (88%) respondents felt that the likely outcome of the illness should also be discussed with patients when the diagnosis is communicated. The clinicians were aware that service users wished to be informed about the diagnosis and outcome of FEP but had no guidance on the subject. Despite the limitations of an online self-administered survey, the study highlights the need for guidance and improving clinical practice in discussing the diagnosis of FEP in a vulnerable population. © 2018 John Wiley & Sons Australia, Ltd.

  4. The impact of early symptom change and therapeutic alliance on treatment outcome in cognitive-behavioural therapy for eating disorders.

    PubMed

    Turner, Hannah; Bryant-Waugh, Rachel; Marshall, Emily

    2015-10-01

    The present study explored the impact of early symptom change (cognitive and behavioural) and the early therapeutic alliance on treatment outcome in cognitive-behavioural therapy (CBT) for the eating disorders. Participants were 94 adults with diagnosed eating disorders who completed a course of CBT in an out-patient community eating disorders service in the UK. Patients completed a measure of eating disorder psychopathology at the start of treatment, following the 6th session and at the end of treatment. They also completed a measure of therapeutic alliance following the 6th session. Greater early reduction in dietary restraint and eating concerns, and smaller levels of change in shape concern, significantly predicted later reduction in global eating pathology. The early therapeutic alliance was strong across the three domains of tasks, goals and bond. Early symptom reduction was a stronger predictor of later reduction in eating pathology than early therapeutic alliance. The early therapeutic alliance did not mediate the relationship between early symptom reduction and later reduction in global eating pathology. Instead, greater early symptom reduction predicted a strong early therapeutic alliance. Early clinical change was the strongest predictor of treatment outcome and this also facilitated the development of a strong early alliance. Clinicians should be encouraged to deliver all aspects of evidence-based CBT, including behavioural change. The findings suggest that this will have a positive impact on both the early therapeutic alliance and later change in eating pathology. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Migration characteristics and early clinical results of a novel-finned press-fit acetabular cup.

    PubMed

    Kaipel, Martin; Prenner, Anton; Bachl, Sebastian; Farr, Sebastian; Sinz, Günter

    2014-04-01

    Ana Nova® is a novel-finned press-fit acetabular cup which showed superior biomechanical characteristics in an experimental set-up. Using Einzel Bild Röntgen Analyse (EBRA) measurements should offer the opportunity to predict implant survival at an early stage. The purpose of this study was to assess migration and clinical outcome 2 years after total hip replacement by a novel-finned press-fit acetabular cup. In this study, migration and clinical results of the implant were prospectively assessed in 67 patients. Clinical outcome was assessed using the Harris hip score (HHS). Migration analyses were performed using the computer assisted EBRA system. Data were analyzed for normal distribution using the Kolmogorov-Smirnov test. Group comparisons were performed using the analysis of variance (ANOVA) test. P-values less than 0.05 were considered statistically significant. At 2 years after surgery, none of the implants needed revision and HHS increased from 39.7 up to 92.2. In contrast to the beneficial clinical outcome, 17 of 44 patients showed increased total migration ( 1 mm/2a). Adverse migration data in this study might predict aseptic loosening and decreased survival of the implant. According to previous studies, it is possible that this effect occurred because of limited accuracy of the EBRA system. In our opinion, migration analyses may not be recommended as a screening tool in a 2 year follow-up.

  6. Incidence, risks and outcome of radiological leak following early contrast enema after anterior resection.

    PubMed

    Reilly, Frank; Burke, John P; Appelmans, Eline; Manzoor, Talha; Deasy, Joseph; McNamara, Deborah A

    2014-04-01

    Anastomotic leak (AL) is a major complication following anterior resection for colorectal cancer. Early contrast enema may diagnose subclinical anastomotic leakage. Knowledge of factors concerning AL is vital to its detection. The aim of this study was to define the incidence, risks and outcome of radiological leak following routine early contrast enema after anterior resection. A cohort of 129 patients who underwent anterior resection for colorectal cancer and had an early Gastrografin enema between July 2008 and December 2012 in a tertiary referral centre was identified from a prospective database. The severity of AL was defined using the International Study Group of Rectal Cancer (ISREC) grading system. Of the 129 patients, 65.1 % were male, and the mean age at surgery was 64.6 ± 1.1 years. Gastrografin enema was performed on average on post-operative day 4.8 ± 0.2. Eighteen patients (14.0 %) had a radiological leak on Gastrografin enema, and nine patients (7.0 %) had a clinical AL. On multivariate analysis, only being of male sex and having a loop ileostomy increased the risk of radiological AL. Gastrografin enema had a sensitivity of 100 % (95 % CI 66-100 %) and specificity of 93 % (95 % CI 86-97 %) for predicting clinical AL. Of the 18 patients with radiological leaks, 11 were ISREC grade A, 3 were grade B and 4 were grade C. In the current series, early Gastrografin enema following anterior resection identifies a 14 % radiological leak rate and has a high sensitivity and specificity for predicting clinical AL. The majority of radiological leaks may be managed conservatively.

  7. Early Antibody Response Contributes to the Virus Eradication and Clinical Recovery of H7N9 Influenza Infection.

    PubMed

    Liu, Xi; Yang, Zheng; Yuan, Jing; Liao, Jian; Duan, Lian; Wang, Wenfei; Zhang, Fuping; Chen, Xinchun; Zhou, Boping

    2017-09-01

    A new type of highly pathogenic avian influenza virus, H7N9, has been a great threat to public health since its 2013 outbreak. The humoral immune response plays a critical role in protection from the influenza virus, but its role and kinetics in H7N9-infected patients remain to be determined. In this study, we performed a retrospective investigation of the antibody response in plasma samples from 37 cases of hospitalized patients and analysed the relationship between the antibody response and the clinical outcomes. Our results showed that the HA7-binding antibody was generated earlier than the neutralizing antibody. Higher titer of HA7-binding antibody during the first 14 days after disease onset were associated with a shorter virus-positive continuation period, which is an important risk predictor ( P <0.05). Additionally, the titers of HA7-binding antibody were consistently and significantly lower in patients who died than those who recovered from the severe disease. Unexpectedly, no correlation between the titer of neutralizing antibody and the resulting clinical outcomes was found, suggesting that a neutralizing antibody-independent mechanism also contributed to virus control. In summary, our data suggests that an early antibody response against H7N9 influenza virus contributes to the eradication of the virus. A higher, early HA7-binding antibody response is associated with better clinical outcomes in H7N9 patients. © 2017 by the Association of Clinical Scientists, Inc.

  8. Benchmarking Outpatient Rehabilitation Clinics Using Functional Status Outcomes.

    PubMed

    Gozalo, Pedro L; Resnik, Linda J; Silver, Benjamin

    2016-04-01

    To utilize functional status (FS) outcomes to benchmark outpatient therapy clinics. Outpatient therapy data from clinics using Focus on Therapeutic Outcomes (FOTO) assessments. Retrospective analysis of 538 clinics, involving 2,040 therapists and 90,392 patients admitted July 2006-June 2008. FS at discharge was modeled using hierarchical regression methods with patients nested within therapists within clinics. Separate models were estimated for all patients, for those with lumbar, and for those with shoulder impairments. All models risk-adjusted for intake FS, age, gender, onset, surgery count, functional comorbidity index, fear-avoidance level, and payer type. Inverse probability weighting adjusted for censoring. Functional status was captured using computer adaptive testing at intake and at discharge. Clinic and therapist effects explained 11.6 percent of variation in FS. Clinics ranked in the lowest quartile had significantly different outcomes than those in the highest quartile (p < .01). Clinics ranked similarly in lumbar and shoulder impairments (correlation = 0.54), but some clinics ranked in the highest quintile for one condition and in the lowest for the other. Benchmarking models based on validated FS measures clearly separated high-quality from low-quality clinics, and they could be used to inform value-based-payment policies. © Health Research and Educational Trust.

  9. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial.

    PubMed

    Bakitas, Marie A; Tosteson, Tor D; Li, Zhigang; Lyons, Kathleen D; Hull, Jay G; Li, Zhongze; Dionne-Odom, J Nicholas; Frost, Jennifer; Dragnev, Konstantin H; Hegel, Mark T; Azuero, Andres; Ahles, Tim A

    2015-05-01

    Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use. Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location). Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60). Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority. © 2015 by American Society of Clinical Oncology.

  10. Clinical and molecular characterization of KCNT1-related severe early-onset epilepsy

    PubMed Central

    Nair, Umesh; Malhotra, Sony; Meyer, Esther; Trump, Natalie; Gazina, Elena V.; Papandreou, Apostolos; Ngoh, Adeline; Ackermann, Sally; Ambegaonkar, Gautam; Appleton, Richard; Desurkar, Archana; Eltze, Christin; Kneen, Rachel; Kumar, Ajith V.; Lascelles, Karine; Montgomery, Tara; Ramesh, Venkateswaran; Samanta, Rajib; Scott, Richard H.; Tan, Jeen; Whitehouse, William; Poduri, Annapurna; Scheffer, Ingrid E.; Chong, W.K. “Kling”; Cross, J. Helen; Topf, Maya; Petrou, Steven

    2018-01-01

    Objective To characterize the phenotypic spectrum, molecular genetic findings, and functional consequences of pathogenic variants in early-onset KCNT1 epilepsy. Methods We identified a cohort of 31 patients with epilepsy of infancy with migrating focal seizures (EIMFS) and screened for variants in KCNT1 using direct Sanger sequencing, a multiple-gene next-generation sequencing panel, and whole-exome sequencing. Additional patients with non-EIMFS early-onset epilepsy in whom we identified KCNT1 variants on local diagnostic multiple gene panel testing were also included. When possible, we performed homology modeling to predict the putative effects of variants on protein structure and function. We undertook electrophysiologic assessment of mutant KCNT1 channels in a xenopus oocyte model system. Results We identified pathogenic variants in KCNT1 in 12 patients, 4 of which are novel. Most variants occurred de novo. Ten patients had a clinical diagnosis of EIMFS, and the other 2 presented with early-onset severe nocturnal frontal lobe seizures. Three patients had a trial of quinidine with good clinical response in 1 patient. Computational modeling analysis implicates abnormal pore function (F346L) and impaired tetramer formation (F502V) as putative disease mechanisms. All evaluated KCNT1 variants resulted in marked gain of function with significantly increased channel amplitude and variable blockade by quinidine. Conclusions Gain-of-function KCNT1 pathogenic variants cause a spectrum of severe focal epilepsies with onset in early infancy. Currently, genotype-phenotype correlations are unclear, although clinical outcome is poor for the majority of cases. Further elucidation of disease mechanisms may facilitate the development of targeted treatments, much needed for this pharmacoresistant genetic epilepsy. PMID:29196579

  11. Measuring Family Outcomes Early Intervention: Findings from a Large-Scale Assessment

    ERIC Educational Resources Information Center

    Raspa, Melissa; Bailey, Donald B., Jr.; Olmsted, Murrey G.; Nelson, Robin; Robinson, Nyle; Simpson, Mary Ellen; Guillen, Chelsea; Houts, Renate

    2010-01-01

    This article reports data from a large-scale assessment using the Family Outcomes Survey with families participating in early intervention. The study was designed to determine how families describe themselves with regard to outcomes achieved, the extent to which outcomes are interrelated, and the extent to which child, family, and program factors…

  12. Clinical Outcome Assessments: Use of Normative Data in a Pediatric Rare Disease.

    PubMed

    Phillips, Dawn; Leiro, Beth

    2018-05-01

    Pediatric rare diseases present unique challenges in clinical trial design and in selection of clinical outcome assessments (COAs) used to support claims in medical product labeling. COAs that discriminate level of function relative to a normative sample are particularly important in the pediatric rare disease setting because the literature is often void of natural history data. Pediatric rare disease clinical trials will often include a wide age distribution. Gross and fine motor skills, communication, cognition, and independence in activities of daily living vary by age, and it may be difficult to distinguish between treatment effect and change due to developmental maturation. Asfotase alfa was granted breakthrough therapy designation and subsequently approved for the treatment of hypophosphatasia (HPP; a genetic metabolic musculoskeletal disorder) and is used in this discussion to illustrate COA selection in a pediatric rare disease. Multiple COAs with normative data in HPP clinical trials for asfotase alfa are presented. The assessment instruments included the Bayley Scales of Infant and Toddler Development-Third Edition, the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, the Childhood Health Assessment Questionnaire, the Pediatric Outcomes Data Collection Instrument, handheld dynamometry, the 6-minute walk test, and the Modified Performance-Oriented Mobility Assessment-Gait scale. Multiple end points were required to adequately capture the impact of asfotase alfa treatment on the multiple systems affected in HPP. These data illustrate the importance of using multiple COAs that provide normative data and to use COAs early in the drug development process for rare pediatric disease. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  13. Beyond the Basics of Clinical Outcomes Assessment: Selecting Appropriate Patient-Rated Outcomes Instruments for Patient Care

    ERIC Educational Resources Information Center

    Valier, Alison R.; Lam, Kenneth C.

    2015-01-01

    The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…

  14. The Small, Stand-Alone Early College: Impact on High School Outcomes

    ERIC Educational Resources Information Center

    Glennie, Elizabeth; Unlu, Fatih; Furey, Jane

    2016-01-01

    North Carolina's Early College model is the subject of an IES-funded eleven-year longitudinal experimental study that utilized a lottery process to assign early college applicants to either treatment or control groups. This paper presents findings related to high school outcomes. The primary goal of the early college model is to increase the…

  15. Comparison of early and late clinical outcomes in patients >= 80 versus <80 years of age after successful primary angioplasty for ST segment elevation myocardial infarction.

    PubMed

    Oduncu, Vecih; Erkol, Ayhan; Tanalp, Ali Cevat; Kırma, Cevat; Bulut, Mustafa; Bitigen, Atila; Pala, Selçuk; Tigen, Kürşat; Esen, Ali M

    2013-06-01

    We aimed to compare the efficacy of primary percutaneous coronary intervention (p-PCI) in patients >=80 versus <80 years of age with ST-segment elevation myocardial infarction (STEMI). We retrospectively enrolled 2213 patients with acute STEMI. The patients were prospectively followed up for a median of 42 months. Early and late clinical outcomes were compared according to age. One-hundred and seventy-nine (8.1%) of the 2213 patients were aged >=80 years. Post-procedural TIMI grade 3 flow was significantly less frequent in the age >=80 years patients (82.1% vs. 91.1%, p<0.001). Rates of mortality (14.5% vs. 3.4%, p<0.001), heart failure (20.7% vs. 10.5%, p<0.001), major hemorrhage (9.5% vs. 3.3%, p<0.001), secondary VT/VF (10.1% vs. 4.2%, p=0.002) and atrial fibrillation (12.8% vs. 4.3%, p<0.001) during the early hospitalization period were significantly higher in the age >=80 years patient group. Overall rates of mortality (40% vs. 9.7%, p<0.001) and total stroke (5.6% vs. 1.1%, p=0.005) at long-term follow-up were also higher in the age >=80 years patient group. However, there was no difference between the two groups with respect to the reinfarction/revascularization rates. Analysis, using the Cox proportional hazards model, revealed that age >=80 to was an independent predictor of long-term mortality (hazard ratio 2.17, 95% CI 1.23-4.17, p=0.02). Age is an independent predictor of mortality after p-PCI for STEMI. Although it seems to improve early outcomes, the efficacy of p-PCI at long-term follow-up is limited in elderly patients.

  16. Early Dialysis and Adverse Outcomes After Hurricane Sandy.

    PubMed

    Lurie, Nicole; Finne, Kristen; Worrall, Chris; Jauregui, Maria; Thaweethai, Tanayott; Margolis, Gregg; Kelman, Jeffrey

    2015-09-01

    Hemodialysis patients have historically experienced diminished access to care and increased adverse outcomes after natural disasters. Although "early dialysis" in advance of a storm is promoted as a best practice, evidence for its effectiveness as a protective measure is lacking. Building on prior work, we examined the relationship between the receipt of dialysis ahead of schedule before the storm (also known as early dialysis) and adverse outcomes of patients with end-stage renal disease in the areas most affected by Hurricane Sandy. Retrospective cohort analysis, using claims data from the Centers for Medicare & Medicaid Services Datalink Project. Patients receiving long-term hemodialysis in New York City and the state of New Jersey, the areas most affected by Hurricane Sandy. Receipt of early dialysis compared to their usual treatment pattern in the week prior to the storm. Emergency department (ED) visits, hospitalizations, and 30-day mortality following the storm. Of 13,836 study patients, 8,256 (60%) received early dialysis. In unadjusted logistic regression models, patients who received early dialysis were found to have lower odds of ED visits (OR, 0.75; 95% CI, 0.63-0.89; P=0.001) and hospitalizations (OR, 0.77; 95% CI, 0.65-0.92; P=0.004) in the week of the storm and similar odds of 30-day mortality (OR, 0.80; 95% CI, 0.58-1.09; P=0.2). In adjusted multivariable logistic regression models, receipt of early dialysis was associated with lower odds of ED visits (OR, 0.80; 95% CI, 0.67-0.96; P=0.01) and hospitalizations (OR, 0.79; 95% CI, 0.66-0.94; P=0.01) in the week of the storm and 30-day mortality (OR, 0.72; 95% CI, 0.52-0.997; P=0.048). Inability to determine which patients were offered early dialysis and declined and whether important unmeasured patient characteristics are associated with receipt of early dialysis. Patients who received early dialysis had significantly lower odds of having an ED visit and hospitalization in the week of the storm and of

  17. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M.; Reyes, D.; Young, M.

    2016-01-01

    Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-Flight Medical Capabilities." Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance

  18. Predicting therapy outcome in patients with early and late obsessive-compulsive disorder (EOCD and LOCD).

    PubMed

    Langner, Judith; Laws, Manuela; Röper, Gisela; Zaudig, Michael; Hauke, Walter; Piesbergen, Christoph

    2009-10-01

    Increasing attention has been given to subtyping OCD with respect to different clinical profiles, response to drug treatments, comorbidity and age of onset. There are a number of studies looking at predictors of treatment outcome in OCD, but so far not for OCD subtypes. Prediction of outcome after cognitive-behavioural therapy was evaluated in 63 inpatients with early obsessive-compulsive disorder (EOCD < or = 12 years of age) and 191 patients with late obsessive-compulsive disorder (LOCD > 15 years of age). For EOCD patients factors predicting a good outcome included high motivation and high initial Y-BOCS scores. Factors associated with a bad outcome were higher age at assessment, a longer duration of psychiatric inpatient treatment before assessment and a low level of social functioning (BSS). For LOCD patients living in a stable relationship, high motivation and completing treatment predicted a favourable therapy outcome, while a low level of psychological functioning (BSS) and a longer duration of inpatient psychiatric treatment before assessment were associated with an undesirable therapy outcome. Subtyping OCD patients according to age of onset seems to be a promising avenue towards improving and developing more specified treatment programs.

  19. Social and behavioral research in genomic sequencing: approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.

    PubMed

    Gray, Stacy W; Martins, Yolanda; Feuerman, Lindsay Z; Bernhardt, Barbara A; Biesecker, Barbara B; Christensen, Kurt D; Joffe, Steven; Rini, Christine; Veenstra, David; McGuire, Amy L

    2014-10-01

    The routine use of genomic sequencing in clinical medicine has the potential to dramatically alter patient care and medical outcomes. To fully understand the psychosocial and behavioral impact of sequencing integration into clinical practice, it is imperative that we identify the factors that influence sequencing-related decision making and patient outcomes. In an effort to develop a collaborative and conceptually grounded approach to studying sequencing adoption, members of the National Human Genome Research Institute's Clinical Sequencing Exploratory Research Consortium formed the Outcomes and Measures Working Group. Here we highlight the priority areas of investigation and psychosocial and behavioral outcomes identified by the Working Group. We also review some of the anticipated challenges to measurement in social and behavioral research related to genomic sequencing; opportunities for instrument development; and the importance of qualitative, quantitative, and mixed-method approaches. This work represents the early, shared efforts of multiple research teams as we strive to understand individuals' experiences with genomic sequencing. The resulting body of knowledge will guide recommendations for the optimal use of sequencing in clinical practice.

  20. Penile fracture: outcomes of early surgical intervention.

    PubMed

    Swanson, Daniel E W; Polackwich, A Scott; Helfand, Brian T; Masson, Puneet; Hwong, James; Dugi, Daniel D; Martinez Acevedo, Ann C; Hedges, Jason C; McVary, Kevin T

    2014-11-01

    To report a series of penile fractures, describing preoperative evaluation, surgical repair, and long-term outcomes. Medical records from Northwestern Memorial Hospital and Oregon Health & Science University from 2002 to 2011 were reviewed. Clinical presentation, preoperative evaluation, time from injury, mechanism and site of injury, and presence of urethral injury were assessed. Outcomes including erectile dysfunction, penile curvature, and voiding symptoms were evaluated using International Prostate Symptom Score and International Index of Erectile Function scores. Twenty-nine patients with 30 separate episodes of penile fractures presenting to the emergency room were identified. Mean patient age was 43 ± 9.6 years. The time from presentation to the initiation of surgery was 5.5 ± 4.4 hours. Mechanism of injury was intercourse in 26 of 30 fractures with the remaining attributed to masturbation or "rolling over." Immediate surgical repair was offered to all patients. Twenty-seven patients underwent surgery. Urethral injury was noted in 5 of the 27. The site of fracture was at the proximal shaft in 11, mid shaft in 12, and distal shaft in 4 patients. The mean follow-up period was 14.3 ± 15.8 weeks. Nine patients reported new mild erectile dysfunction or penile curvature. One patient reported new irritative voiding symptoms. The most common mechanism of penile fracture was from sexual intercourse, and frequent concomitant urethral injuries were observed. The frequency of concomitant urethral injury was higher than in previous studies. Although we observed high incidence of erectile dysfunction or penile curvature with early surgical repair, we retain it as the favored approach. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. Automated assessment of early hypoxic brain edema in non-enhanced CT predicts outcome in patients after cardiac arrest.

    PubMed

    Hanning, Uta; Sporns, Peter Bernhard; Lebiedz, Pia; Niederstadt, Thomas; Zoubi, Tarek; Schmidt, Rene; Knecht, Stefan; Heindel, Walter; Kemmling, André

    2016-07-01

    Early prediction of potential neurological recovery in patients after cardiac arrest is challenging. Recent studies suggest that the densitrometic gray-white matter ratio (GWR) determined from cranial computed tomography (CT) scans may be a reliable predictor of poor outcome. We evaluated an automated, rater independent method to determine GWR in CT as an early objective imaging predictor of clinical outcome. We analyzed imaging data of 84 patients after cardiac arrest that underwent noncontrast CT within 24h after arrest. To determine GWR in CT we applied two methods using a recently published automated probabilistic gray-white matter segmentation algorithm (GWR_aut) and conventional manual measurements within gray-white regions of interest (GWR_man). Neurological outcome was graded by the cerebral performance category (CPC). As part of standard routine CPC was assessed by the treating physician in the intensive care unit at admission and at discharge to normal ward. The performance of GWR measures (automated and manual) to predict the binary clinical endpoints of poor (CPC3-5) and good outcome (CPC1-2) was assessed by ROC analysis with increasing discrimination thresholds. Results of GWR_aut were compared to GWR_man of two raters. Of 84 patients, 55 (65%) showed a poor outcome. ROC curve analysis revealed reliable outcome prediction of GWR_aut (AUC 0.860) and GWR_man (AUC 0.707 and 0.699, respectively). Predictive power of GWR_aut was higher than GWR_man by each rater (p=0.019 and p=0.021, respectively) at an optimal cut-off of 1.084 to predict poor outcome (optimal criterion with 92.7% sensitivity, 72.4% specificity). Interrater reliability of GWR_man by intra-class correlation coefficient (ICC) was moderate (0.551). Automated quantification of GWR in CT may be used as an objective observer-independent imaging marker for outcome in patients after cardiac arrest. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. Early Elevations of the Complement Activation Fragment C3a and Adverse Pregnancy Outcomes

    PubMed Central

    Lynch, Anne M.; Gibbs, Ronald S.; Murphy, James R.; Giclas, Patricia C.; Salmon, Jane E.; Holers, V. Michael

    2016-01-01

    OBJECTIVE To estimate whether elevations of complement C3a early in pregnancy are predictive of the subsequent development of adverse pregnancy outcomes. METHODS A plasma sample was obtained from each enrolled pregnant woman before 20 weeks of gestation. The cohort (n=1,002) was evaluated for the development of adverse pregnancy outcomes defined as hypertensive diseases of pregnancy (gestational hypertension or preeclampsia), preterm birth (before 37 weeks of gestation), premature rupture of the membranes, pregnancy loss (during the embryonic and fetal period), intrauterine growth restriction, and the composite outcome of any adverse outcome. RESULTS One or more adverse pregnancy outcomes occurred in 211 (21%) of the cohort. The mean levels (ng/mL) of C3a in early pregnancy were significantly (P=<.001) higher among women with one or more adverse outcomes (858±435) compared with women with an uncomplicated pregnancy (741±407). Adjusted for parity and prepregnancy body mass index, women with levels of C3a in the upper quartile in early pregnancy were three times more likely to have an adverse outcome later in pregnancy compared with women in the lowest quartile (95% confidence interval, 1.8–4.8; P<.001). The link between early elevated C3a levels and adverse pregnancy outcomes was driven primarily by individual significant (P<.05) associations of C3a with hypertensive diseases of pregnancy, preterm birth, and premature rupture of the membranes. CONCLUSION Elevated C3a as early as the first trimester of pregnancy is an independent predictive factor for adverse pregnancy outcomes, suggesting that complement-related inflammatory events in pregnancy contribute to the subsequent development of poor outcomes at later stages of pregnancy. PMID:21173647

  3. Predictors of treatment outcome among Asian pathological gamblers (PGs): clinical, behavioural, demographic, and treatment process factors.

    PubMed

    Guo, Song; Manning, Victoria; Thane, Kyaw Kyaw Wai; Ng, Andrew; Abdin, Edimansyah; Wong, Kim Eng

    2014-03-01

    Research on predictors of treatment outcome among pathological gamblers (PGs) is inconclusive and dominated by studies from Western countries. Using a prospective longitudinal design, the current study examined demographic, clinical, behavioural and treatment programme predictors of gambling frequency at 3, 6 and 12-months, among PGs treated at an addiction clinic in Singapore. Measures included the Hospital anxiety and depression scale, gambling symptom assessment scale (GSAS), personal well-being index (PWI), treatment perception questionnaire and gambling readiness to change scale. Treatment response in relation to changes in symptom severity, personal wellbeing and abstinence were also assessed. Abstinence rates were 38.6, 46.0 and 44.4 % at 3, 6 and 12-months respectively. Significant reductions in gambling frequency, GSAS, and improvement in PWI were reported between baseline and subsequent outcome assessments, with the greatest change occurring in the initial three months. No demographic, clinical, behavioural or treatment programme variable consistently predicted outcome at all three assessments, though treatment satisfaction was the most frequent significant predictor. However, being unemployed, having larger than average debts, poor treatment satisfaction and attending fewer sessions at the later stages of treatment were associated with significantly poorer outcomes, up to 1-year after initiating treatment. These findings show promise for the effectiveness of a CBT-based treatment approach for the treatment of predominantly Chinese PGs. Clinical implications and suggestions for future research are discussed. Taken together, the findings suggest early treatment satisfaction is paramount in improving short-term outcomes, with baseline gambling behaviour and treatment intensity playing a more significant role in the longer term.

  4. Patients with late-adult-onset ulcerative colitis have better outcomes than those with early onset disease.

    PubMed

    Ha, Christina Y; Newberry, Rodney D; Stone, Christian D; Ciorba, Matthew A

    2010-08-01

    The influence of age on the presentation, clinical course, and therapeutic response of patients with adult-onset ulcerative colitis (UC) is understudied. Given potential age-related differences in risk factors and immune function, we sought to determine if disease behavior or clinical outcomes differed between patients diagnosed with UC in later versus earlier stages of adulthood. We performed a retrospective cohort study of 295 patients with UC seen at a tertiary care center from 2001 to 2008. Adult subjects newly diagnosed with UC between the ages of 18 and 30 years were defined as early onset, those newly diagnosed at age 50 or older were defined as late onset. The 2 groups were analyzed for differences in medication use and clinical end points, including disease extent, severity at the time of diagnosis, and steroid-free clinical remission at 1 year after disease onset. Disease extent and symptom severity were similar between groups at the time of diagnosis. One year after diagnosis, more patients in the late-onset group achieved steroid-free clinical remission (64% vs 49%; P = .01). Among those who required systemic steroid therapy, more late-onset patients achieved steroid-free remission by 1 year (50% vs 32%; P = .01). Former smoking status was a more common risk factor in the late-onset cohort (P < .001), whereas more early onset patients had a positive family history (P = .008). Patients with early and late-adult-onset UC have similar initial clinical presentations, but differ in disease risk factors. Late-onset patients have better responses to therapy 1 year after diagnosis. Copyright 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

  5. Clinical and nutritional outcomes in children with idiopathic superior mesenteric artery syndrome.

    PubMed

    Shiu, Jr-Rung; Chao, Hsun-Chin; Luo, Chih-Cheng; Lai, Ming-Wei; Kong, Man-Shan; Chen, Shih-Yen; Chen, Chien-Chang; Wang, Chao-Jan

    2010-08-01

    There are no available data for outcomes in children's idiopathic superior mesenteric artery syndrome (SMAS) strictly treated conservatively. The aim of the study was to evaluate clinical and nutritional outcome in children with idiopathic SMAS. A 1-year prospective observation study of effects of treatment and outcome was performed in 27 children (8 boys, 19 girls) with idiopathic SMAS who underwent an upper gastrointestinal (UGI) series, ultrasound measurement of the aortomesenteric angle, treatment, clinical assessment, growth evaluation, and regular clinical visits for more than 12 months. Mean age of the patients was 11.77 +/- 2.15 years. The major clinical complaints were postprandial pain or fullness (88.9%), vomiting (55.6%), and early satiety (51.9%). Eight patients (29.6%) had weight loss. The UGI series revealed typical features of SMAS. The aortomesenteric angle on ultrasound was 10 degrees to 19 degrees. The height of most patients (92.6%) was above the 10th percentile, whereas 15 (55.6%) patients weighed below the 10th percentile. Six patients underwent surgical intervention (3 for obstruction and 3 for persistent anorexia with weight loss), and their clinical symptoms and weight status improved steadily during the follow-up months. Among the 21 patients not subject to surgical intervention, 11 (52.4%) experienced a reduction of symptoms >50% after 3 months of treatment, and weight-for-age percentile increased significantly after 6 months of treatment. Overall, a significant increase in the weight-for-age status was seen in the patients with surgical treatment or with medication only after 6 and 12 months of treatment. An aortomesenteric angle <20 degrees is a constant phenomenon in children with idiopathic SMAS. A duodenojejunostomy can effectively relieve the obstructive symptoms, such as anorexia, and improve nutritional status, whereas long-term medical treatment may aid in relieving the clinical symptoms, promoting appetite, and improving

  6. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.

    PubMed

    Jammer, Ib; Wickboldt, Nadine; Sander, Michael; Smith, Andrew; Schultz, Marcus J; Pelosi, Paolo; Leva, Brigitte; Rhodes, Andrew; Hoeft, Andreas; Walder, Bernhard; Chew, Michelle S; Pearse, Rupert M

    2015-02-01

    There is a need for large trials that test the clinical effectiveness of interventions in the field of perioperative medicine. Clinical outcome measures used in such trials must be robust, clearly defined and patient-relevant. Our objective was to develop standards for the use of clinical outcome measures to strengthen the methodological quality of perioperative medicine research. A literature search was conducted using PubMed and opinion leaders worldwide were invited to nominate papers that they believed the group should consider. The full texts of relevant articles were reviewed by the taskforce members and then discussed to reach a consensus on the required standards. The report was then circulated to opinion leaders for comment and review. This report describes definitions for 22 individual adverse events with a system of severity grading for each. In addition, four composite outcome measures were identified, which were designed to evaluate postoperative outcomes. The group also agreed on standards for four outcome measures for the evaluation of healthcare resource use and quality of life. Guidance for use of these outcome measures is provided, with particular emphasis on appropriate duration of follow-up. This report provides clearly defined and patient-relevant outcome measures for large clinical trials in perioperative medicine. These outcome measures may also be of use in clinical audit. This report is intended to complement and not replace other related work to improve assessment of clinical outcomes following specific surgical procedures.

  7. Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

    PubMed

    Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

    2014-01-01

    An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

  8. Predictors of switch to and early outcomes on third-line antiretroviral therapy at a large public-sector clinic in Johannesburg, South Africa.

    PubMed

    Evans, Denise; Hirasen, Kamban; Berhanu, Rebecca; Malete, Given; Ive, Prudence; Spencer, David; Badal-Faesen, Sharlaa; Sanne, Ian M; Fox, Matthew P

    2018-04-10

    While efficacy data exist, there are limited data on the outcomes of patients on third-line antiretroviral therapy (ART) in sub-Saharan Africa in actual practice. Being able to identify predictors of switch to third-line ART will be essential for planning for future need. We identify predictors of switch to third-line ART among patients with significant viraemia on a protease inhibitor (PI)-based second-line ART regimen. Additionally, we describe characteristics of all patients on third-line at a large public sector HIV clinic and present their early outcomes. Retrospective analysis of adults (≥ 18 years) on a PI-based second-line ART regimen at Themba Lethu Clinic, Johannesburg, South Africa as of 01 August 2012, when third-line treatment became available in South Africa, with significant viraemia on second-line ART (defined as at least one viral load ≥ 1000 copies/mL on second-line ART after 01 August 2012) to identify predictors of switch to third-line (determined by genotype resistance testing). Third-line ART was defined as a regimen containing etravirine, raltegravir or ritonavir boosted darunavir, between August 2012 and January 2016. To assess predictors of switch to third-line ART we used Cox proportional hazards regression among those with significant viraemia on second-line ART after 01 August 2012. Then among all patients on third-line ART we describe viral load suppression, defined as a viral load < 400 copies/mL, after starting third-line ART. Among 719 patients in care and on second-line ART as of August 2012 (with at least one viral load ≥ 1000 copies/mL after 01 August 2012), 36 (5.0% over a median time of 54 months) switched to third-line. Time on second-line therapy (≥ 96 vs. < 96 weeks) (adjusted Hazard Ratio (aHR): 2.53 95% CI 1.03-6.22) and never reaching virologic suppression while on second-line ART (aHR: 3.37 95% CI 1.47-7.73) were identified as predictors of switch. In a separate cohort of patients on third

  9. Pregnancy outcomes in women with an early diagnosis of gestational diabetes mellitus.

    PubMed

    Feghali, Maisa N; Abebe, Kaleab Z; Comer, Diane M; Caritis, Steve; Catov, Janet M; Scifres, Christina M

    2018-04-01

    To examine pregnancy outcomes in women with gestational diabetes mellitus (GDM) based on the timing of diagnosis. We compared demographics, blood sugars and outcomes between women diagnosed before (n = 167) or after 24 weeks' gestation (n = 1202) in a single hospital between 2009 and 2012. Because early screening is risk-based we used propensity score modelling and conditional logistic regression to account for systematic differences. Women diagnosed with GDM before 24 weeks were more likely to be obese and they were less likely to have excess gestational weight gain (35 vs. 45%, p = 0.04). Early diagnosis was associated with more frequent therapy including glyburide (65 vs. 56%, p < 0.001) and insulin (19 vs 6%, p < 0.001). After propensity score modelling and accounting for covariates, early diagnosis was associated with an increased risk for macrosomia (OR 2, 95% 1-4.15, p = 0.0498). Early diagnosis was not associated with other adverse outcomes. In a subgroup analysis comparing women treated with glyburide prior to 24 weeks compared to those diagnosed after 24 weeks, early diagnosis in women treated with glyburide was associated with an increased risk for macrosomia (OR 2.3, 95% CI 1.1-5.4, P = 0.04). Women diagnosed with GDM before 24 weeks have unique features, are at risk for adverse outcomes, and require targeted approaches to therapy. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. A model to begin to use clinical outcomes in medical education.

    PubMed

    Haan, Constance K; Edwards, Fred H; Poole, Betty; Godley, Melissa; Genuardi, Frank J; Zenni, Elisa A

    2008-06-01

    The latest phase of the Accreditation Council for Graduate Medical Education (ACGME) Outcome Project challenges graduate medical education (GME) programs to select meaningful clinical quality indicators by which to measure trainee performance and progress, as well as to assess and improve educational effectiveness of programs. The authors describe efforts to measure educational quality, incorporating measurable patient-care outcomes to guide improvement. University of Florida College of Medicine-Jacksonville education leaders developed a tiered framework for selecting clinical indicators whose outcomes would illustrate integration of the ACGME competencies and their assessment with learning and clinical care. In order of preference, indicators selected should align with a specialty's (1) national benchmarked consensus standards, (2) national specialty society standards, (3) standards of local, institutional, or regional quality initiatives, or (4) top-priority diagnostic and/or therapeutic categories for the specialty, based on areas of high frequency, impact, or cost. All programs successfully applied the tiered process to clinical indicator selection and then identified data sources to track clinical outcomes. Using clinical outcomes in resident evaluation assesses the resident's performance as reflective of his or her participation in the health care delivery team. Programmatic improvements are driven by clinical outcomes that are shown to be below benchmark across the residents. Selecting appropriate clinical indicators-representative of quality of care and of graduate medical education-is the first step toward tracking educational outcomes using clinical data as the basis for evaluation and improvement. This effort is an important aspect of orienting trainees to using data for monitoring and improving care processes and outcomes throughout their careers.

  11. Clinical characteristics of children with severe visual impairment but favorable retinal structural outcomes from the Early Treatment for Retinopathy of Prematurity (ETROP) study.

    PubMed

    Siatkowski, R Michael; Good, William V; Summers, C Gail; Quinn, Graham E; Tung, Betty

    2013-04-01

    To describe visual function and associated characteristics at the 6-year examination in children enrolled in the Early Treatment for Retinopathy of Prematurity Study who had unfavorable visual outcomes despite favorable structural outcomes in one or both eyes. The clinical examination records of children completing the 6-year follow-up examination were retrospectively reviewed. Eligible subjects were those with visual acuity of ≤20/200 in each eye (where recordable) and a normal fundus or straightening of the temporal retinal vessels with or without macular ectopia in at least one eye. Data regarding visual function, retinal structure, presence of nystagmus, optic atrophy, optic disk cupping, seizures/shunts, and Functional Independence Measure for Children (ie, WeeFIM: pediatric functional independence measure) developmental test scores were reviewed. Of 342 participants who completed the 6-year examination, 39 (11%) met inclusion criteria. Of these, 29 (74%) had normal retinal structure, 18 (46%) had optic atrophy, and 3 (8%) had increased cupping of the optic disk in at least one eye. Latent and/or manifest nystagmus occurred in 30 children (77%). The presence of nystagmus was not related to the presence of optic atrophy. Of the 39 children, 28 (72%) had a below-normal WeeFIM score. In 25 participants (7%) completing the 6-year examination, cortical visual impairment was considered the primary cause of visual loss. The remainder likely had components of both anterior and posterior visual pathway disease. Clinical synthesis of ocular anatomy and visual and neurologic function is required to determine the etiology of poor vision in these children. Copyright © 2013 American Association for Pediatric Ophthalmology and Strabismus. Published by Mosby, Inc. All rights reserved.

  12. Clinical Features, Etiology, and Outcomes of Community-Acquired Pneumonia in Patients With Diabetes Mellitus

    PubMed Central

    Di Yacovo, Silvana; Garcia-Vidal, Carolina; Viasus, Diego; Adamuz, Jordi; Oriol, Isabel; Gili, Francesca; Vilarrasa, Núria; García-Somoza, M. Dolors; Dorca, Jordi; Carratalà, Jordi

    2013-01-01

    Abstract We performed an observational analysis of a prospective cohort of immunocompetent hospitalized adults with community-acquired pneumonia (CAP) to determine the epidemiology, clinical features, and outcomes of pneumonia in patients with diabetes mellitus (DM). We also analyzed the risk factors for mortality and the impact of statins and other cardiovascular drugs on outcomes. Of 2407 CAP episodes, 516 (21.4%) occurred in patients with DM; 483 (97%) had type 2 diabetes, 197 (40%) were on insulin treatment, and 119 (23.9%) had end-organ damage related to DM. Patients with DM had different clinical features compared to the other patients. They were less likely to have acute onset, cough, purulent sputum, and pleural chest pain. No differences in etiology were found between study groups. Patients with DM had more inhospital acute metabolic complications, although the case-fatality rate was similar between the groups. Independent risk factors for mortality in patients with DM were advanced age, bacteremia, septic shock, and gram-negative pneumonia. Patients with end-organ damage related to DM had more inhospital cardiac events and a higher early case-fatality rate than did the overall population. The use of statins and other cardiovascular drugs was not associated with better CAP outcomes in patients with DM. In conclusion, CAP in patients with DM presents different clinical features compared to the features of patients without DM. PMID:23263718

  13. Motivational deficits in early schizophrenia: prevalent, persistent, and key determinants of functional outcome.

    PubMed

    Fervaha, Gagan; Foussias, George; Agid, Ofer; Remington, Gary

    2015-08-01

    Negative symptoms, in particular motivational deficits, are reported as impediments to functional recovery in patients with schizophrenia. This study examined the prevalence of motivational deficits in patients early in the illness, and the impact these deficits have on community functioning. Patients with schizophrenia between the ages of 18 and 35years, and within 5years of initiating antipsychotic treatment were included in the present investigation (N=166). The impact of motivation and cognition on concurrent and longitudinal functioning was evaluated. Motivational impairments were found in more than 75% of participants, and were not associated with receipt of social support. These deficits served as the most robust and reliable predictor of functional outcome, while neurocognition demonstrated significantly weaker associations with outcome. When considered together, motivational deficits demonstrated a reliable link with concurrent and longitudinal functioning, with cognition not offering any independent predictive value. Moreover, motivation was found to mediate the relationship between cognition and outcome. Changes in motivation were linked to changes in functioning; however, this was not the case for changes in cognitive performance. Motivation emerged as a significant predictor of functioning even after selected demographic and clinical characteristics (e.g., positive symptoms) were accounted for. These data indicate that motivational deficits are prevalent in patients with schizophrenia, even in the early stages of the illness, and these deficits stand as one of the most robust barriers to people with schizophrenia achieving functional recovery. Greater understanding of the mechanisms underlying these deficits is critical to effective treatment innovation. Copyright © 2015 Elsevier B.V. All rights reserved.

  14. Outcomes research in cancer clinical trial cooperative groups: the RTOG model.

    PubMed

    Bruner, D W; Movsas, B; Konski, A; Roach, M; Bondy, M; Scarintino, C; Scott, C; Curran, W

    2004-08-01

    The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials. This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations. The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.

  15. Centralized Oversight of Physician–Scientist Faculty Development at Vanderbilt: Early Outcomes

    PubMed Central

    Brown, Abigail M.; Morrow, Jason D.; Limbird, Lee E.; Byrne, Daniel W.; Gabbe, Steven G.; Balser, Jeffrey R.; Brown, Nancy J.

    2013-01-01

    Purpose In 2000, faced with a national concern over the decreasing number of physician–scientists, Vanderbilt School of Medicine established the institutionally funded Vanderbilt Physician–Scientist Development (VPSD) program to provide centralized oversight and financial support for physician–scientist career development. In 2002, Vanderbilt developed the National Institutes of Health (NIH)-funded Vanderbilt Clinical Research Scholars (VCRS) program using a similar model of centralized oversight. The authors evaluate the impact of the VPSD and VCRS programs on early career outcomes of physician–scientists. Method Physician–scientists who entered the VPSD or VCRS programs from 2000 through 2006 were compared with Vanderbilt physician–scientists who received NIH career development funding during the same period without participating in the VPSD or VCRS programs. Results Seventy-five percent of VPSD and 60% of VCRS participants achieved individual career award funding at a younger age than the comparison cohort. This shift to career development award funding at a younger age among VPSD and VCRS scholars was accompanied by a 2.6-fold increase in the number of new K awards funded and a rate of growth in K-award dollars at Vanderbilt that outpaced the national rate of growth in K-award funding. Conclusions Analysis of the early outcomes of the VPSD and VCRS programs suggests that centralized oversight can catalyze growth in the number of funded physician–scientists at an institution. Investment in this model of career development for physician–scientists may have had an additive effect on the recruitment and retention of talented trainees and junior faculty. PMID:18820531

  16. Decreased Sperm Motility Retarded ICSI Fertilization Rate in Severe Oligozoospermia but Good-Quality Embryo Transfer Had Achieved the Prospective Clinical Outcomes.

    PubMed

    Zheng, Jufeng; Lu, Yongning; Qu, Xianqin; Wang, Peng; Zhao, Luiwen; Gao, Minzhi; Shi, Huijuan; Jin, Xingliang

    Spermatozoa motility is the critical parameter to affect the treatment outcomes during assisted reproductive technologies (ART), but its reproductive capability remains a little informed in condition of severe male factor infertility. This retrospective cohort study aimed to evaluate the effects of reduced sperm motility on the embryological and clinical outcomes in intra-cytoplasmic sperm injection (ICSI) treatment of severe oligozoospermia. 966 cycles (812 couples) of severe oligozoospermia diagnosed by spermatozoa count ≤ 5 × 106/mL and motile spermatozoa ≤ 2 × 106/mL were divided into four groups in according to the number of motile spermatozoa in one ejaculate on the day of oocyte retrieval (Group B-E). The control (Group A) was 188 cycles of moderate oligozoospermia with spermatozoa count > 5 × 106/mL and motile spermatozoa > 2 × 106/mL. All female partners were younger than 35 years of age. Logistic regression analyzed embryological outcomes (the rates of fertilization, cleavage and good-quality embryo) and clinical outcomes (the rates of pregnancy, implantation, early miscarriage and live birth). Quality of embryo transfer (ET) was divided into three classes as continuous factor to test the effects of embryo quality on clinical outcomes. The reduction in the number of motile sperm in four groups of severe oligozoospermia gave rise to comparable inability of the fertilization (p < 0.001) and a decreased rate of good-quality embryo at Day 3 (p < 0.001) by compared to the control. The cleavage rate of the derived zygotes was similar to the control. ET classes significantly affected the clinical outcomes (p < 0.001). Class I ET gave rise to similar rates of clinical outcomes between five groups, but Class II and Class III ET retarded the rates of pregnancy, implantation and live birth and this particularly occurred in Group C, D and E. The rate of early miscarriage was not comparably different between groups. Overall rates in all groups were 41

  17. Risk Factors and Birth Outcomes of Anaemia in Early Pregnancy in a Nulliparous Cohort

    PubMed Central

    Masukume, Gwinyai; Khashan, Ali S.; Kenny, Louise C.; Baker, Philip N.; Nelson, Gill

    2015-01-01

    Background Anaemia in pregnancy is a major public health and economic problem worldwide, that contributes to both maternal and fetal morbidity and mortality. Objective The aim of the study was to calculate the prevalence of anaemia in early pregnancy in a cohort of ‘low risk’ women participating in a large international multicentre prospective study (n = 5 609), to identify the modifiable risk factors for anaemia in pregnancy in this cohort, and to compare the birth outcomes between pregnancies with and without anaemia in early gestation. Methods The study is an analysis of data that were collected prospectively during the Screening for Pregnancy Endpoints study. Anaemia was defined according to the World Health Organization’s definition of anaemia in pregnancy (haemoglobin < 11g/dL). Binary logistic regression with adjustment for potential confounders (country, maternal age, having a marital partner, ethnic origin, years of schooling, and having paid work) was the main method of analysis. Results The hallmark findings were the low prevalence of anaemia (2.2%), that having no marital partner was an independent risk factor for having anaemia (OR 1.34, 95% CI 1.01-1.78), and that there was no statistically significant effect of anaemia on adverse pregnancy outcomes (small for gestational age, pre-tem birth, mode of delivery, low birth weight, APGAR score < 7 at one and five minutes). Adverse pregnancy outcomes were however more common in those with anaemia than in those without. Conclusion In this low risk healthy pregnant population we found a low anaemia rate. The absence of a marital partner was a non-modifiable factor, albeit one which may reflect a variety of confounding factors, that should be considered for addition to anaemia’s conceptual framework of determinants. Although not statistically significant, clinically, a trend towards a higher risk of adverse pregnancy outcomes was observed in women that were anaemic in early pregnancy. PMID:25875012

  18. Early-Life Stress, HPA Axis Adaptation, and Mechanisms Contributing to Later Health Outcomes

    PubMed Central

    Maniam, Jayanthi; Antoniadis, Christopher; Morris, Margaret J.

    2014-01-01

    Stress activates the hypothalamic–pituitary–adrenal (HPA) axis, which then modulates the degree of adaptation and response to a later stressor. It is known that early-life stress can impact on later health but less is known about how early-life stress impairs HPA axis activity, contributing to maladaptation of the stress–response system. Early-life stress exposure (either prenatally or in the early postnatal period) can impact developmental pathways resulting in lasting structural and regulatory changes that predispose to adulthood disease. Epidemiological, clinical, and experimental studies have demonstrated that early-life stress produces long term hyper-responsiveness to stress with exaggerated circulating glucocorticoids, and enhanced anxiety and depression-like behaviors. Recently, evidence has emerged on early-life stress-induced metabolic derangements, for example hyperinsulinemia and altered insulin sensitivity on exposure to a high energy diet later in life. This draws our attention to the contribution of later environment to disease vulnerability. Early-life stress can alter the expression of genes in peripheral tissues, such as the glucocorticoid receptor and 11-beta hydroxysteroid dehydrogenase (11β-HSD1). We propose that interactions between altered HPA axis activity and liver 11β-HSD1 modulates both tissue and circulating glucocorticoid availability, with adverse metabolic consequences. This review discusses the potential mechanisms underlying early-life stress-induced maladaptation of the HPA axis, and its subsequent effects on energy utilization and expenditure. The effects of positive later environments as a means of ameliorating early-life stress-induced health deficits, and proposed mechanisms underpinning the interaction between early-life stress and subsequent detrimental environmental exposures on metabolic risk will be outlined. Limitations in current methodology linking early-life stress and later health outcomes will also be

  19. The Effect of Early Noncognitive Skills on Social Outcomes in Adolescence

    ERIC Educational Resources Information Center

    Coneus, Katja; Laucht, Manfred

    2014-01-01

    This paper investigates the impact of early noncognitive skills on social outcomes in adolescence. The child's attention span, approach, prevailing mood and distractibility in early childhood may be crucial predictors for school achievements, health risk behavior, delinquency and autonomy as adolescent. We investigate this issue using a…

  20. Clinical phenomapping and outcomes after heart transplantation.

    PubMed

    Bakir, Maral; Jackson, Nicholas J; Han, Simon X; Bui, Alex; Chang, Eleanor; Liem, David A; Ardehali, Abbas; Ardehali, Reza; Baas, Arnold S; Press, Marcella Calfon; Cruz, Daniel; Deng, Mario C; DePasquale, Eugene C; Fonarow, Gregg C; Khuu, Tam; Kwon, Murray H; Kubak, Bernard M; Nsair, Ali; Phung, Jennifer L; Reed, Elaine F; Schaenman, Joanna M; Shemin, Richard J; Zhang, Qiuheng J; Tseng, Chi-Hong; Cadeiras, Martin

    2018-03-22

    Survival after heart transplantation (HTx) is limited by complications related to alloreactivity, immune suppression, and adverse effects of pharmacologic therapies. We hypothesize that time-dependent phenomapping of clinical and molecular data sets is a valuable approach to clinical assessments and guiding medical management to improve outcomes. We analyzed clinical, therapeutic, biomarker, and outcome data from 94 adult HTx patients and 1,557 clinical encounters performed between January 2010 and April 2013. Multivariate analyses were used to evaluate the association between immunosuppression therapy, biomarkers, and the combined clinical end point of death, allograft loss, retransplantation, and rejection. Data were analyzed by K-means clustering (K = 2) to identify patterns of similar combined immunosuppression management, and percentile slopes were computed to examine the changes in dosages over time. Findings were correlated with clinical parameters, human leucocyte antigen antibody titers, and peripheral blood mononuclear cell gene expression of the AlloMap (CareDx, Inc., Brisbane, CA) test genes. An intragraft, heart tissue gene coexpression network analysis was performed. Unsupervised cluster analysis of immunosuppressive therapies identified 2 groups, 1 characterized by a steeper immunosuppression minimization, associated with a higher likelihood for the combined end point, and the other by a less pronounced change. A time-dependent phenomap suggested that patients in the group with higher event rates had increased human leukocyte antigen class I and II antibody titers, higher expression of the FLT3 AlloMap gene, and lower expression of the MARCH8 and WDR40A AlloMap genes. Intramyocardial biomarker-related coexpression network analysis of the FLT3 gene showed an immune system-related network underlying this biomarker. Time-dependent precision phenotyping is a mechanistically insightful, data-driven approach to characterize patterns of clinical care and

  1. Asperger's syndrome and autism: comparison of early history and outcome.

    PubMed

    Szatmari, P; Bartolucci, G; Bremner, R

    1989-12-01

    The authors compared children with Asperger syndrome (AS) with high-functioning autistic children and psychiatric outpatient controls on measures of early history and outcome. In terms of their early history, the autistic probands showed more social impairment, a higher frequency of echolalia and pronoun reversal, and a more restricted range of activities than the AS group. Cluster analysis suggested refinements to the diagnostic criteria, which resulted in larger differences between the groups on these early history measures. In terms of their outcome, the autistic probands spent more time in special education classes but developed fewer accessory psychiatric symptoms than the AS children. It was clear, however, that there were no substantive, qualitative differences between the AS and autistic groups, indicating that AS should be considered a mild form of high-functioning autism. The inclusion of AS among the autistic spectrum of disorders has implications both for aetiological studies and for prevalence estimates of the pervasive developmental disorders.

  2. Early response to ranibizumab predictive of functional outcome after dexamethasone for unresponsive diabetic macular oedema.

    PubMed

    Cicinelli, Maria Vittoria; Cavalleri, Michele; Querques, Lea; Rabiolo, Alessandro; Bandello, Francesco; Querques, Giuseppe

    2017-12-01

    To analyse the effects of intravitreal dexamethasone implant in patients suffering from diabetic macular oedema (DME) on the basis of their visual and functional response to antivascular endothelial growth factor (VEGF) loading dose, in order to early shift to corticosteroids in poorly responding patients. Retrospective monocentric study. Data of patients with diabetes shifted to 0.7 mg dexamethasone implant after three injections of ranibizumab (RNB) and followed-up to 12 months were reviewed. Main outcome was the evaluation of short-term changes after dexamethasone implant injection, stratifying patients on the basis of best-corrected visual acuity (BCVA) and central macular thickness (CMT) after RNB loading dose. Secondary outcome was to investigate clinical gain maintenance at long-term follow-up. Overall, 45 eyes of 45 patients (23 males, 51.1%), mean age 69.7±9 years, were included in the analysis. After 3 injections of RNB, 30 eyes (66.7%) had a poor visual response (-4.3±10.7 letters), while 15 eyes (33.3%) disclosed good visual outcome (+13.9±9.2 letters). Patients with poor visual response were associated with limited morphological improvement (p=0.04). After 1 month from dexamethasone, only poor responders showed relevant increase in BCVA (p=0.006) and reduction in CMT (p=0.002), in comparison to good visual response patients, featuring only minor clinical effects (p=0.3). The same trend was maintained up to 12 months, after a mean of 1.9±1.1 dexamethasone administrations. Visual and anatomical responses after RNB loading dose are significant predictors of both early term and long-term visual acuity improvement after switching to corticosteroids in patients with DME unresponsive to anti-VEGF. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. A core outcome set for clinical trials in acute diarrhoea.

    PubMed

    Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; Lo Vecchio, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania

    2015-04-01

    Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects. The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  4. Clinical outcomes of facial transplantation: a review.

    PubMed

    Shanmugarajah, Kumaran; Hettiaratchy, Shehan; Clarke, Alex; Butler, Peter E M

    2011-01-01

    A total of 18 composite tissue allotransplants of the face have currently been reported. Prior to the start of the face transplant programme, there had been intense debate over the risks and benefits of performing this experimental surgery. This review examines the surgical, functional and aesthetic, immunological and psychological outcomes of facial transplantation thus far, based on the predicted risks outlined in early publications from teams around the world. The initial experience has demonstrated that facial transplantation is surgically feasible. Functional and aesthetic outcomes have been very encouraging with good motor and sensory recovery and improvements to important facial functions observed. Episodes of acute rejection have been common, as predicted, but easily controlled with increases in systemic immunosuppression. Psychological improvements have been remarkable and have resulted in the reintegration of patients into the outside world, social networks and even the workplace. Complications of immunosuppression and patient mortality have been observed in the initial series. These have highlighted rigorous patient selection as the key predictor of success. The overall early outcomes of the face transplant programme have been generally more positive than many predicted. This initial success is testament to the robust approach of teams. Dissemination of outcomes and ongoing refinement of the process may allow facial transplantation to eventually become a first-line reconstructive option for those with extensive facial disfigurements. Copyright © 2011 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  5. A Clinical Update on Delirium: From Early Recognition to Effective Management

    PubMed Central

    Cerejeira, Joaquim; Mukaetova-Ladinska, Elizabeta B.

    2011-01-01

    Delirium is a neuropsychiatric syndrome characterized by altered consciousness and attention with cognitive, emotional and behavioural symptoms. It is particularly frequent in elderly people with medical or surgical conditions and is associated with adverse outcomes. Predisposing factors render the subject more vulnerable to a congregation of precipitating factors which potentially affect brain function and induce an imbalance in all the major neurotransmitter systems. Early diagnosis of delirium is crucial to improve the prognosis of patients requiring the identification of subtle and fluctuating signs. Increased awareness of clinical staff, particularly nurses, and routine screening of cognitive function with standardized instruments, can be decisive to increase detection rates of delirium. General measures to prevent delirium include the implementation of protocols to systematically identify and minimize all risk factors present in a particular clinical setting. As soon as delirium is recognized, prompt removal of precipitating factors is warranted together with environmental changes and early mobilization of patients. Low doses of haloperidol or olanzapine can be used for brief periods, for the behavioural control of delirium. All of these measures are a part of the multicomponent strategy for prevention and treatment of delirium, in which the nursing care plays a vital role. PMID:21994844

  6. Clinical features, microbiology and surgical outcomes of infective endocarditis: a 13-year study from a UK tertiary cardiothoracic referral centre.

    PubMed

    Marks, D J B; Hyams, C; Koo, C Y; Pavlou, M; Robbins, J; Koo, C S; Rodger, G; Huggett, J F; Yap, J; Macrae, M B; Swanton, R H; Zumla, A I; Miller, R F

    2015-03-01

    Infective endocarditis (IE) causes substantial morbidity and mortality. Patient and pathogen profiles, as well as microbiological and operative strategies, continue to evolve. The impact of these changes requires evaluation to inform optimum management and identify individuals at high risk of early mortality. Identification of clinical and microbiological features, and surgical outcomes, among patients presenting to a UK tertiary cardiothoracic centre for surgical management of IE between 1998 and 2010. Retrospective observational cohort study. Clinical, biochemical, microbiological and echocardiographic data were identified from clinical records. Principal outcomes were all-cause 28-day mortality and duration of post-operative admission. Patients (n = 336) were predominantly male (75.0%); median age 52 years (IQR = 41-67). Most cases involved the aortic (56.0%) or mitral (53.9%) valves. Microbiological diagnoses, obtained in 288 (85.7%) patients, included streptococci (45.2%); staphylococci (34.5%); Haemophilus, Actinobacillus, Cardiobacterium, Eikenella, Kingella (HACEK) organisms (3.0%); and fungi (1.8%); 11.3% had polymicrobial infection. Valve replacement in 308 (91.7%) patients included mechanical prostheses (69.8%), xenografts (24.0%) and homografts (6.2%). Early mortality was 12.2%, but fell progressively during the study (P = 0.02), as did median duration of post-operative admission (33.5 to 10.5 days; P = 0.0003). Multivariable analysis showed previous cardiothoracic surgery (OR = 3.85, P = 0.03), neutrophil count (OR = 2.27, P = 0.05), albumin (OR = 0.94, P = 0.04) and urea (OR = 2.63, P < 0.001) predicted early mortality. This study demonstrates reduced post-operative early mortality and duration of hospital admission for IE patients over the past 13 years. Biomarkers (previous cardiothoracic surgery, neutrophil count, albumin and urea), predictive of early post-operative mortality, require prospective evaluation to refine algorithms, further improve

  7. Clinical and Educational Outcomes of an Integrated Inpatient Quality Improvement Curriculum for Internal Medicine Residents.

    PubMed

    Ogrinc, Greg; Cohen, Emily S; van Aalst, Robertus; Harwood, Beth; Ercolano, Ellyn; Baum, Karyn D; Pattison, Adam J; Jones, Anne C; Davies, Louise; West, Al

    2016-10-01

    Integrating teaching and hands-on experience in quality improvement (QI) may increase the learning and the impact of resident QI work. We sought to determine the clinical and educational impact of an integrated QI curriculum. This clustered, randomized trial with early and late intervention groups used mixed methods evaluation. For almost 2 years, internal medicine residents from Dartmouth-Hitchcock Medical Center on the inpatient teams at the White River Junction VA participated in the QI curriculum. QI project effectiveness was assessed using statistical process control. Learning outcomes were assessed with the Quality Improvement Knowledge Application Tool-Revised (QIKAT-R) and through self-efficacy, interprofessional care attitudes, and satisfaction of learners. Free text responses by residents and a focus group of nurses who worked with the residents provided information about the acceptability of the intervention. The QI projects improved many clinical processes and outcomes, but not all led to improvements. Educational outcome response rates were 65% (68 of 105) at baseline, 50% (18 of 36) for the early intervention group at midpoint, 67% (24 of 36) for the control group at midpoint, and 53% (42 of 80) for the late intervention group. Composite QIKAT-R scores (range, 0-27) increased from 13.3 at baseline to 15.3 at end point ( P  < .01), as did the self-efficacy composite score ( P  < .05). Satisfaction with the curriculum was rated highly by all participants. Learning and participating in hands-on QI can be integrated into the usual inpatient work of resident physicians.

  8. The roles of early surgery and comorbid conditions on outcomes of severe necrotizing soft-tissue infections.

    PubMed

    Latifi, Rifat; Patel, Apar S; Samson, David J; Tilley, Elizabeth H; Gashi, Saranda; Bergamaschi, Roberto; El-Menyar, Ayman

    2018-05-22

    Severe necrotizing soft-tissue infections (NSTIs) require immediate early surgical treatment to avoid adverse outcomes. This study aims to determine the impact of early surgery and comorbid conditions on the outcomes of NSTIs. A retrospective cohort study was performed on all subjects presenting with NSTI at an academic medical center between 2005 and 2016. Patients were identified based on ICD codes. Those under the age of 18 or with intraoperative findings not consistent with NSTI diagnosis were excluded. There were 115 patients with a confirmed diagnosis of NSTI with a mean age of 55 ± 18 years; 41% were females and 55% were diabetics. Thirty percent of patients underwent early surgery (< 6 h). There were no significant differences between groups in baseline characteristics. The late group (≥ 6 h) had prolonged hospital stay (38 vs. 23 days, p < 0.008) in comparison to the early group (< 6 h). With every 1 h delay in time to surgery, there is a 0.268 day increase in length of stay, adjusted for these other variables: alcohol abuse, number of debridements, peripheral vascular disease, previous infection and clinical necrosis. Mortality was 16.5%. Multivariable analysis revealed that alcohol abuse, peripheral vascular disease, diabetes, obesity, hypothyroidism, and presence of COPD were associated with an increase in mortality. Early surgical intervention in patients with severe necrotizing soft-tissue infections reduces length of hospital stay. Presence of comorbid conditions such as alcohol abuse, peripheral vascular disease, diabetes, obesity and hypothyroidism were associated with increased mortality.

  9. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    PubMed

    Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Age at onset versus family history and clinical outcomes in 1,665 international bipolar-I disorder patients

    PubMed Central

    BALDESSARINI, ROSS J.; TONDO, LEONARDO; VAZQUEZ, GUSTAVO H.; UNDURRAGA, JUAN; BOLZANI, LORENZA; YILDIZ, AYSEGUL; KHALSA, HARI-MANDIR K.; LAI, MASSIMO; LEPRI, BEATRICE; LOLICH, MARIA; MAFFEI, PIER MARIO; SALVATORE, PAOLA; FAEDDA, GIANNI L.; VIETA, EDUARD; MAURICIO, TOHEN

    2012-01-01

    Early onset in bipolar disorder (BPD) has been associated with greater familial risk and unfavorable clinical outcomes. We pooled data from seven international centers to analyze the relationships of family history and symptomatic as well as functional measures of adult morbidity to onset age, or onset in childhood (age <12), adolescence (12-18), or adulthood (19-55 years). In 1,665 adult, DSM-IV BPD-I patients, onset was 5% in childhood, 28% in adolescence, and 53% at peak ages 15-25. Adolescent and adult onset did not differ by symptomatic morbidity (episodes/year, percentage of months ill, co-morbidity, hospitalization, suicide attempts) or family history. Indications of favorable adult functional outcomes (employment, living independently, marriage and children, and a composite measure including education) ranked, by onset: adult > adolescent > child. Onset in childhood versus adolescence had more episodes/year and more psychiatric co-morbidity. Family history was most prevalent with childhood onset, similar over onset ages 12-40 years, and fell sharply thereafter. Multivariate modeling sustained the impression that family history and poor functional, but not symptomatic, outcomes were associated with younger, especially childhood onset. Early onset was more related to poor functional outcomes than greater symptomatic morbidity, with least favorable outcomes and greater family history with childhood onset. PMID:22295008

  11. The EXCITE Trial: Predicting a Clinically Meaningful Motor Activity Log Outcome

    PubMed Central

    Park, Si-Woon; Wolf, Steven L.; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S.

    2013-01-01

    Background and Objective This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. Methods A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Results Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Conclusions Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT. PMID:18780883

  12. The EXCITE Trial: Predicting a clinically meaningful motor activity log outcome.

    PubMed

    Park, Si-Woon; Wolf, Steven L; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S

    2008-01-01

    This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT.

  13. Early Outcomes of Sutureless Aortic Valves.

    PubMed

    Hanedan, Muhammet Onur; Mataracı, İlker; Yürük, Mehmet Ali; Özer, Tanıl; Sayar, Ufuk; Arslan, Ali Kemal; Ziyrek, Uğur; Yücel, Murat

    2016-06-01

    In elderly high-risk surgical patients, sutureless aortic valve replacement (AVR) should be an alternative to standard AVR. The potential advantages of sutureless aortic prostheses include reducing cross-clamping and cardiopulmonary bypass (CPB) time and facilitating minimally invasive surgery and complex cardiac interventions, while maintaining satisfactory hemodynamic outcomes and low rates of paravalvular leakage. The current study reports our single-center experience regarding the early outcomes of sutureless aortic valve implantation. Between October 2012 and June 2015, 65 patients scheduled for surgical valve replacement with symptomatic aortic valve disease and New York Heart Association function of class II or higher were included to this study. Perceval S (Sorin Biomedica Cardio Srl, Sallugia, Italy) and Edwards Intuity (Edwards Lifesciences, Irvine, CA, USA) valves were used. The mean age of the patients was 71.15±8.60 years. Forty-four patients (67.7%) were female. The average preoperative left ventricular ejection fraction was 56.9±9.93. The CPB time was 96.51±41.27 minutes and the cross-clamping time was 60.85±27.08 minutes. The intubation time was 8.95±4.19 hours, and the intensive care unit and hospital stays were 2.89±1.42 days and 7.86±1.42 days, respectively. The mean quantity of drainage from chest tubes was 407.69±149.28 mL. The hospital mortality rate was 3.1%. A total of five patients (7.69%) died during follow-up. The mean follow-up time was 687.24±24.76 days. The one-year survival rate was over 90%. In the last few years, several models of valvular sutureless bioprostheses have been developed. The present study evaluating the single-center early outcomes of sutureless aortic valve implantation presents the results of an innovative surgical technique, finding that it resulted in appropriate hemodynamic conditions with acceptable ischemic time.

  14. Early Outcomes of Sutureless Aortic Valves

    PubMed Central

    Hanedan, Muhammet Onur; Mataracı, İlker; Yürük, Mehmet Ali; Özer, Tanıl; Sayar, Ufuk; Arslan, Ali Kemal; Ziyrek, Uğur; Yücel, Murat

    2016-01-01

    Background In elderly high-risk surgical patients, sutureless aortic valve replacement (AVR) should be an alternative to standard AVR. The potential advantages of sutureless aortic prostheses include reducing cross-clamping and cardiopulmonary bypass (CPB) time and facilitating minimally invasive surgery and complex cardiac interventions, while maintaining satisfactory hemodynamic outcomes and low rates of paravalvular leakage. The current study reports our single-center experience regarding the early outcomes of sutureless aortic valve implantation. Methods Between October 2012 and June 2015, 65 patients scheduled for surgical valve replacement with symptomatic aortic valve disease and New York Heart Association function of class II or higher were included to this study. Perceval S (Sorin Biomedica Cardio Srl, Sallugia, Italy) and Edwards Intuity (Edwards Lifesciences, Irvine, CA, USA) valves were used. Results The mean age of the patients was 71.15±8.60 years. Forty-four patients (67.7%) were female. The average preoperative left ventricular ejection fraction was 56.9±9.93. The CPB time was 96.51±41.27 minutes and the cross-clamping time was 60.85±27.08 minutes. The intubation time was 8.95±4.19 hours, and the intensive care unit and hospital stays were 2.89±1.42 days and 7.86±1.42 days, respectively. The mean quantity of drainage from chest tubes was 407.69±149.28 mL. The hospital mortality rate was 3.1%. A total of five patients (7.69%) died during follow-up. The mean follow-up time was 687.24±24.76 days. The one-year survival rate was over 90%. Conclusion In the last few years, several models of valvular sutureless bioprostheses have been developed. The present study evaluating the single-center early outcomes of sutureless aortic valve implantation presents the results of an innovative surgical technique, finding that it resulted in appropriate hemodynamic conditions with acceptable ischemic time. PMID:27298793

  15. The impact of early specialist management on outcomes of patients with in-hospital stroke.

    PubMed

    Manawadu, Dulka; Choyi, Jithesh; Kalra, Lalit

    2014-01-01

    Delays in treatment of in-hospital stroke (IHS) adversely affect patient outcomes. We hypothesised that early referral and specialist management of IHS patients will improve outcomes at 90 days. Baseline characteristics, assessment delays, thrombolysis eligibility, 90-day functional outcomes and all-cause mortality were compared between IHS patients referred for specialist stroke management within 3 hours of symptom onset (early referrals) and later referrals. Patients were identified from a prospective stroke registry between January 2009 and December 2010. Inclusion criteria were primary admission with a non-stroke diagnosis, onset of new neurological deficits after admission and early ischaemic changes on CT or MR imaging. Eighty four (4.6%) of 1836 stroke patients had IHS (mean age 74 year; 51% male, median NIHSS score 10). There were no significant differences in baseline characteristics between 53 (63%) early and 31 (37%) late referrals. Thrombolysis was performed in 29 (76%) of the 37/78 (47%) potentially eligible patients; 7 patients were excluded because specialist referral was delayed beyond 4.5 hours despite symptom recognition within 3 hours of onset. Early referral improved functional outcomes (modified Rankin Scale 0-2 at 90 days 40% v 7%, p = 0.001) and was an independent predictor of mRS 0-2 at 90 days after adjusting for age, pre-morbid function, primary cause for hospital admission and stroke severity [OR 1.13 (95% C.I.  = 1.10-1.27), p = 0.002]. Early referral and specialist management of IHS patients that includes thrombolysis is associated with better functional outcomes at 90 days.

  16. A Systematic Review of Early Warning Systems' Effects on Nurses' Clinical Performance and Adverse Events Among Deteriorating Ward Patients.

    PubMed

    Lee, Ju-Ry; Kim, Eun-Mi; Kim, Sun-Aee; Oh, Eui Geum

    2018-04-25

    Early warning systems (EWSs) are an integral part of processes that aim to improve the early identification and management of deteriorating patients in general wards. However, the widespread implementation of these systems has not generated robust data regarding nurses' clinical performance and patients' adverse events. This review aimed to determine the ability of EWSs to improve nurses' clinical performance and prevent adverse events among deteriorating ward patients. The PubMed, CINAHL, EMBASE, and Cochrane Library databases were searched for relevant publications (January 1, 1997, to April 12, 2017). In addition, a grey literature search evaluated several guideline Web sites. The main outcome measures were nurses' clinical performance (vital sign monitoring and rapid response team notification) and patients' adverse events (in-hospital mortality, cardiac arrest, and unplanned intensive care unit [ICU] admission). The search identified 888 reports, although only five studies fulfilled the inclusion criteria. The findings of these studies revealed that EWSs implementation had a positive effect on nurses' clinical performance, based on their frequency of documenting vital signs that were related to the patient's clinical deterioration. In addition, postimplementation reductions were identified for cardiac arrest, unplanned ICU admission, and unexpected death. It seems that EWSs can improve nurses' clinical performance and prevent adverse events (e.g., in-hospital mortality, unplanned ICU admission, and cardiac arrest) among deteriorating ward patients. However, additional high-quality evidence is needed to more comprehensively evaluate the effects of EWSs on these outcomes.

  17. Clinical performances of two real-time PCR assays and bDNA/TMA to early monitor treatment outcome in patients with chronic hepatitis C.

    PubMed

    Martinot-Peignoux, Michelle; Khiri, Hacène; Leclere, Laurence; Maylin, Sarah; Marcellin, Patrick; Halfon, Philippe

    2009-11-01

    Early viral monitoring is essential for the management of treatment outcome in patients with chronic hepatitis C. A variety of commercially available assays are now available to quantify HCV-RNA in routine clinical practice. Compare the clinical results of 3 commercially available assays to evaluate the positive predictive value (PPV) and the negative predictive value (NPV) of rapid virological response (RVR) at week 4 and early virological response (EVR) at week 12. 287 patients treated with standard care regimen combination therapy were studied. HCV-RNA values measured at baseline, week 4, week 12 with VERSANT HCV 3.0 Assay (bDNA), and VERSANT HCV-RNA Qualitative Assay (TMA) (bDNA/TMA); COBAS Ampliprep/COBAS/TaqMan (CAP/CTM) and Abbott m2000sp extraction/m2000rt amplification system (ART). RVR was defined as undetectable serum HCV-RNA and EVR as a > OR =2 log decline in baseline viral load (BLV). Median (range) BVLs were: 5.585(2.585-6.816), 5.189(2.792-7.747) and 4.804(2.380-6.580) log(10)IU/ml, with bDNA/TMA, CAP/CTM and ART, respectively (p<0.01); RVR was observed in 22%, 30% and 27% of the patients and PPVs were 97%, 91% and 94% with bDNA/TMA, CAP/CTM and ART, respectively (p=0.317). EVR was observed in 76%, 73% and 67% of the patients and NPVs were 93%, 83% and 79% with bDNA/TMA, CAP/CTM and ART, respectively (p=0.09). Treatment monitoring should include both detection of serum HCV-RNA at week 4 to predict SVR and at week 12 to predict non-SVR. The value of all 3 assays was similar for evaluating RVR or EVR. Because of viral load discrepancies the same assay should be used throughout patient treatment follow-up.

  18. Clinical and social outcomes of adolescent self harm: population based birth cohort study

    PubMed Central

    Heron, Jon; Crane, Catherine; Hawton, Keith; Lewis, Glyn; Macleod, John; Tilling, Kate; Gunnell, David

    2014-01-01

    Objectives To investigate the mental health, substance use, educational, and occupational outcomes of adolescents who self harm in a general population sample, and to examine whether these outcomes differ according to self reported suicidal intent. Design Population based birth cohort study. Setting Avon Longitudinal Study of Parents and Children (ALSPAC), a UK birth cohort of children born in 1991-92. Participants Data on lifetime history of self harm with and without suicidal intent were available for 4799 respondents who completed a detailed self harm questionnaire at age 16 years. Multiple imputation was used to account for missing data. Main outcome measures Mental health problems (depression and anxiety disorder), assessed using the clinical interview schedule-revised at age 18 years, self reported substance use (alcohol, cannabis, cigarette smoking, and illicit drugs) at age 18 years, educational attainment at age 16 and 19 years, occupational outcomes at age 19 years, and self harm at age 21 years. Results Participants who self harmed with and without suicidal intent at age 16 years were at increased risk of developing mental health problems, future self harm, and problem substance misuse, with stronger associations for suicidal self harm than for non-suicidal self harm. For example, in models adjusted for confounders the odds ratio for depression at age 18 years was 2.21 (95% confidence interval 1.55 to 3.15) in participants who had self harmed without suicidal intent at age 16 years and 3.94 (2.67 to 5.83) in those who had self harmed with suicidal intent. Suicidal self harm, but not self harm without suicidal intent, was also associated with poorer educational and employment outcomes. Conclusions Adolescents who self harm seem to be vulnerable to a range of adverse outcomes in early adulthood. Risks were generally stronger in those who had self harmed with suicidal intent, but outcomes were also poor among those who had self harmed without suicidal

  19. Reaching their potential: Perceived impact of a collaborative academic-clinical partnership programme for early career nurses in New Zealand.

    PubMed

    McKillop, Ann; Doughty, Lesley; Atherfold, Cheryl; Shaw, Kathy

    2016-01-01

    The dynamic nature of healthcare ensures that early career nurses enter an uncertain and complex world of practice and consequently require support to develop their practice, build confidence and reach their potential. The New Zealand Nurse Entry to Practice programme for registered nurses in their first year of practice has been operating since 2005 to enable safe and confident practice, improve the quality of care, and positively impact on recruitment and retention. This academic and clinical programme was offered as a partnership between a university and a clinical provider with postgraduate academic credits gained. The aim of this study was to explore the perceived impact of postgraduate university education for early career nurses in one regional health area of New Zealand. Participants were registered nurses who had completed the early career nurse programme and their clinical preceptors. The research was conducted via an online survey of 248 nurses and three focus groups to explore how the programme was experienced and its impact on knowledge and practice. Early career nurses and their preceptors found that the programme enables improved knowledge and skills of patient assessment, application of critical thinking to clinical practice, perceived improvement in patient care delivery and outcomes, enhanced interprofessional communication and knowledge sharing, and had a positive impact on professional awareness and career planning. This clinical-academic partnership positively impacted on the clinical practice and transition experience of early career nurses and was closely aligned to an organization's strategic plan for nursing workforce development. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Developing core outcome sets for clinical trials: issues to consider

    PubMed Central

    2012-01-01

    The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus. PMID:22867278

  1. Early indicators and risk factors for ethical issues in clinical practice.

    PubMed

    Pavlish, Carol; Brown-Saltzman, Katherine; Hersh, Mary; Shirk, Marilyn; Nudelman, Olga

    2011-03-01

    Nurses in all clinical settings encounter ethical issues that frequently lead to moral distress. This critical incident study explored nurses' descriptions of ethically difficult situations to identify risk factors and early indicators of ethical conflicts. Employing the critical incident technique, researchers developed a questionnaire that collected information on ethically difficult situations, their risk factors and early indicators, nurse actions, and situational outcomes. Two nurse researchers independently analyzed and categorized data using a constant comparison technique. Most of the ethically difficult situations pertained to end-of-life care for children and adults. Conflicts in interpersonal relationships were prevalent. Nurses were especially moved by patient and family suffering and concerned about patient vulnerability, harm-benefit ratio, and patient autonomy. Researchers discovered risk factor categories for patients, families, healthcare providers, and health systems. Additionally, researchers found subcategories in six major categories of early indicators: signs of conflict, patient suffering, nurse distress, ethics violation, unrealistic expectations, and poor communication. Nurses are keenly aware of pertinent risk factors and early indicators of unfolding ethical conflicts. Many nurses reported feeling powerless in the face of ethical conflict. Research that develops interventions to strengthen nurses' voices in ethically difficult situation is warranted. Nurses are in a key position to identify patient situations with a high risk for ethical conflict. Initiating early ethics consultation and interventions can alter the course of pending conflicts and diminish the potential for patient and family suffering and nurses' moral distress. © 2011 Sigma Theta Tau International.

  2. Clinical outcome of acute nonvariceal upper gastrointestinal bleeding after hours: the role of urgent endoscopy.

    PubMed

    Ahn, Dong-Won; Park, Young Soo; Lee, Sang Hyub; Shin, Cheol Min; Hwang, Jin-Hyeok; Kim, Jin-Wook; Jeong, Sook-Hyang; Kim, Nayoung; Lee, Dong Ho

    2016-05-01

    This study was performed to investigate the clinical role of urgent esophagogastroduodenoscopy (EGD) for acute nonvariceal upper gastrointestinal bleeding (ANVUGIB) performed by experienced endoscopists after hours. A retrospective analysis was performed for consecutively collected data of patients with ANVUGIB between January 2009 and December 2010. A total of 158 patients visited the emergency unit for ANVUGIB after hours. Among them, 60 underwent urgent EGD (within 8 hours) and 98 underwent early EGD (8 to 24 hours) by experienced endoscopists. The frequencies of hemodynamic instability, fresh blood aspirate on the nasogastric tube, and high-risk endoscopic findings were significantly higher in the urgent EGD group. Primary hemostasis was achieved in all except two patients. There were nine cases of recurrent bleeding, and 30-day mortality occurred in three patients. There were no significant differences between the two groups in primary hemostasis, recurrent bleeding, and 30-day mortality. In a multiple linear regression analysis, urgent EGD significantly reduced the hospital stay compared with early EGD. In patients with a high clinical Rockall score (more than 3), urgent EGD tended to decrease the hospital stay, although this was not statistically significant (7.7 days vs. 12.0 days, p > 0.05). Urgent EGD after hours by experienced endoscopists had an excellent endoscopic success rate. However, clinical outcomes were not significantly different between the urgent and early EGD groups.

  3. Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials.

    PubMed

    Pukall, Caroline F; Bergeron, Sophie; Brown, Candace; Bachmann, Gloria; Wesselmann, Ursula

    2017-08-01

    Vulvodynia (idiopathic chronic vulvar pain) is a prevalent condition associated with significant and negative impacts in many areas of function. Despite the increased research interest in vulvodynia in recent years, recommendations for outcome measures for use in clinical trials are missing. The purpose of this paper, therefore, was to provide recommendations for outcome measures for vulvodynia clinical trials so that consistent measures are used across trials to facilitate between-study comparisons and the conduct of large multicenter trials, and to improve measurement of the multiple dimensions of vulvodynia. Given that provoked vestibulodynia (PVD)-characterized by provoked pain localized to the vaginal opening-is the most common subtype of vulvodynia and the current main focus of clinical trials, this paper focused on recommended outcome measures in PVD clinical trials. The framework used to guide the selection of outcome measures was based on the one proposed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). The IMMPACT framework provided a well-suited guideline for outcome measure recommendations in PVD clinical trials. However, given the provoked presentation of PVD and the significant impact it has on sexuality, modifications to some of the IMMPACT recommendations were made and specific additional measures were suggested. Measures that are specific to vulvovaginal pain are ideal for adoption in PVD clinical trials, and many such measures currently exist that allow the relevant IMMPACT domains to be captured.

  4. Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

    PubMed

    Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

    2015-01-01

    We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

  5. Developmental Outcomes after Early Prefrontal Cortex Damage

    ERIC Educational Resources Information Center

    Eslinger, Paul J.; Flaherty-Craig, Claire V.; Benton, Arthur L.

    2004-01-01

    The neuropsychological bases of cognitive, social, and moral development are minimally understood, with a seemingly wide chasm between developmental theories and brain maturation models. As one approach to bridging ideas in these areas, we review 10 cases of early prefrontal cortex damage from the clinical literature, highlighting overall clinical…

  6. Physiotherapy-led arthroplasty review clinic: a preliminary outcomes analysis.

    PubMed

    Large, Kate E; Page, Carolyn J; Brock, Kim; Dowsey, Michelle M; Choong, Peter F M

    2014-11-01

    With the rising demand for Orthopaedics in the healthcare sector, service delivery innovations need to be explored to accommodate the increasing workload. Senior Musculoskeletal Physiotherapists have the specialised skills in the assessment of musculoskeletal conditions to determine the impact of surgery on patient outcomes. The aim of the present study was to compare outcomes between a physiotherapy-led arthroplasty review clinic (PT clinic) and the traditional model of orthopaedic surgeon review (OS clinic) after hip and knee replacement. This study was a retrospective case-controlled audit using a comprehensive database. Twenty-four patients who had a hip arthroplasty and 52 patients who had a knee arthroplasty were reviewed solely by the PT clinic at 3, 6 and 12 months after surgical reviews. These patients were matched 1:2 against patients seen only by the OS clinic. The outcome measures included International Knee Score (IKS), Harris Hip Score (HHS) and the Short Form (SF)-12. There were no significant differences in HHS or SF-12 scores for patients after hip arthroplasty. Significant differences for knee arthroplasty were observed favouring the PT clinic; IKS, PT clinic 147.6 (37.07), OS clinic 135.4 (35.68), P≤0.01, and physical component of the SF-12, PT clinic 41.98 (10.45), OS clinic 37.20 (10.44), P<0.01. Implementation of a physiotherapy-led arthroplasty review clinic appears to be a safe and effective service alternative to reviews conducted by orthopaedic surgeons. WHAT IS KNOWN ABOUT THE TOPIC?: Osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability and the burden of the disease is rapidly increasing. Joint arthroplasty surgery is the mainstay of treatment for people with end-stage OA; it is a high-cost, high-volume procedure that dominates surgical wait lists around Australia. Long-term follow up is encouraged by the Arthroplasty Society of Australia and endorsed by the Australian Orthopaedics Association, but it is

  7. SheppHeartCABG trial—comprehensive early rehabilitation after coronary artery bypass grafting: a protocol for a randomised clinical trial

    PubMed Central

    Moons, Philip; Hansen, Niels Viggo; La Cour, Søren; Olsen, Peter Skov; Gluud, Christian; Winkel, Per; Lindschou, Jane; Thygesen, Lau Caspar; Egerod, Ingrid; Berg, Selina Kikkenborg

    2017-01-01

    Introduction Patients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial. Methods/analysis SheppHeartCABG is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All patients receive usual care and patients allocated to the experimental intervention follow 4 weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary outcomes are mental health and physical activity measured by the Medical Outcome Study Short Form (SF-12), anxiety and depression measured by the Hospital Anxiety and Depression Scale questionnaire, physical, emotional and global scores by the HeartQoL questionnaire, sleep measured by the Pittsburgh Sleep Quality Index, pain measured by the Örebro Musculoskeletal Screening Questionnaire and muscle endurance measured by the sit-to-stand test. A number of explorative analyses will also be conducted. Ethics and dissemination SheppHeartCABG is approved by the regional ethics committee (no. H-4-2014-109) and the Danish Data Protection Agency (no. 30-1309) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Positive, neutral and

  8. Pharmacists' interventions on clinical asthma outcomes: a systematic review.

    PubMed

    Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

    2016-04-01

    The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

  9. Virologic outcomes in early antiretroviral treatment: HPTN 052

    PubMed Central

    Eshleman, Susan H.; Wilson, Ethan A.; Zhang, Xinyi C.; Ou, San-San; Piwowar-Manning, Estelle; Eron, Joseph J.; McCauley, Marybeth; Gamble, Theresa; Gallant, Joel E.; Hosseinipour, Mina C.; Kumarasamy, Nagalingeswaran; Hakim, James G.; Kalonga, Ben; Pilotto, Jose H.; Grinsztejn, Beatriz; Godbole, Sheela V.; Chotirosniramit, Nuntisa; Santos, Breno Riegel; Shava, Emily; Mills, Lisa A.; Panchia, Ravindre; Mwelase, Noluthando; Mayer, Kenneth H.; Chen, Ying Q.; Cohen, Myron S.; Fogel, Jessica M.

    2017-01-01

    INTRODUCTION The HPTN 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure. OBJECTIVE To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052. METHODS 1,566 participants who had a viral load (VL) >400 copies/mL at enrollment were included in the analyses. This included 832 in the early ART arm (CD4 350–550 cells/mm3 at ART initiation) and 734 in the delayed ART arm (204 with a CD4 <250 cells/mm3 at ART initiation; 530 with any CD4 at ART initiation). Viral suppression was defined as two consecutive VLs ≤400 copies/mL after ART initiation; virologic failure was defined as two consecutive VLs >1,000 copies/mL >24 weeks after ART initiation. RESULTS Overall, 93% of participants achieved viral suppression by 12 months. The annual incidence of virologic failure was 3.6%. Virologic outcomes were similar in the two study arms. Longer time to viral suppression was associated with younger age, higher VL at ART initiation, and region (Africa vs. Asia). Virologic failure was strongly associated with younger age, lower educational level, and lack of suppression by 3 months; lower VL and higher CD4 at ART initiation were also associated with virologic failure. CONCLUSIONS Several clinical and demographic factors were identified that were associated with longer time to viral suppression and virologic failure. Recognition of these factors may help optimize ART for HIV treatment and prevention. PMID:28385131

  10. Virologic outcomes in early antiretroviral treatment: HPTN 052.

    PubMed

    Eshleman, Susan H; Wilson, Ethan A; Zhang, Xinyi C; Ou, San-San; Piwowar-Manning, Estelle; Eron, Joseph J; McCauley, Marybeth; Gamble, Theresa; Gallant, Joel E; Hosseinipour, Mina C; Kumarasamy, Nagalingeswaran; Hakim, James G; Kalonga, Ben; Pilotto, Jose H; Grinsztejn, Beatriz; Godbole, Sheela V; Chotirosniramit, Nuntisa; Santos, Breno Riegel; Shava, Emily; Mills, Lisa A; Panchia, Ravindre; Mwelase, Noluthando; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Fogel, Jessica M

    2017-05-01

    The HIV Prevention Trials Network (HPTN) 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure. To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052. 1566 participants who had a viral load (VL) > 400 copies/mL at enrollment were included in the analyses. This included 832 in the early ART arm (CD4 350-550 cells/mm 3 at ART initiation) and 734 in the delayed ART arm (204 with a CD4 < 250 cells/mm 3 at ART initiation; 530 with any CD4 at ART initiation). Viral suppression was defined as two consecutive VLs ≤ 400 copies/mL after ART initiation; virologic failure was defined as two consecutive VLs > 1000 copies/mL > 24 weeks after ART initiation. Overall, 93% of participants achieved viral suppression by 12 months. The annual incidence of virologic failure was 3.6%. Virologic outcomes were similar in the two study arms. Longer time to viral suppression was associated with younger age, higher VL at ART initiation, and region (Africa vs. Asia). Virologic failure was strongly associated with younger age, lower educational level, and lack of suppression by three months; lower VL and higher CD4 at ART initiation were also associated with virologic failure. Several clinical and demographic factors were identified that were associated with longer time to viral suppression and virologic failure. Recognition of these factors may help optimize ART for HIV treatment and prevention.

  11. Early Disease Activity or Clinical Response as Predictors of Long‐Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis

    PubMed Central

    Deodhar, A.; Fleischmann, R.; Mease, P. J.; Rudwaleit, M.; Nurminen, T.; Davies, O.

    2017-01-01

    Objective Early identification of patients unlikely to achieve good long‐term disease control with anti–tumor necrosis factor therapy in axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) is important for physicians following treat‐to‐target recommendations. Here we assess associations between disease activity or clinical response during the first 12 weeks of treatment and attainment of treatment targets at week 48 in axial SpA and PsA patients receiving certolizumab pegol. Methods The relationship between disease activity or clinical response during the first 12 weeks of treatment and achievement of week‐48 targets (for axial SpA: inactive disease based on Ankylosing Spondylitis Disease Activity Score [ASDAS] using the C‐reactive protein [CRP] level, or Bath Ankylosing Spondylitis Disease Activity Index <2 with normal CRP level; and for PsA: minimal disease activity) was assessed post hoc using RAPID‐axSpA and RAPID‐PsA trial data. Results A clear relationship between disease activity from week 2 to 12 and achievement of week‐48 treatment targets was observed in both axial SpA and PsA populations. In axial SpA, week‐48 ASDAS inactive disease was achieved by 0% of patients (0 of 21) with ASDAS very high disease activity at week 12, compared to 68% of patients (34 of 50) with week‐12 ASDAS inactive disease. For PsA, week‐48 minimal disease activity was achieved by 0% of patients (0 of 26) with Disease Activity Score in 28 joints (DAS28) using the CRP level >5.1 at week 12, compared to 73% of patients (57 of 78) with DAS28‐CRP <2.6. Similar results were observed regardless of the disease activity measure used. Clinical response at week 12 also predicted week‐48 outcomes, though to a lesser extent than disease activity. Conclusion Using disease activity and the clinical response state during the first 12 weeks of certolizumab pegol treatment, it was possible to identify a subset of axial SpA and PsA patients unlikely to achieve

  12. Posterior reversible encephalopathy syndrome in Korean patients with systemic lupus erythematosus: risk factors and clinical outcome.

    PubMed

    Jung, S M; Moon, S-J; Kwok, S-K; Ju, J H; Park, K-S; Park, S-H; Kim, H-Y

    2013-08-01

    Posterior reversible encephalopathy syndrome (PRES) is an uncommon neurologic condition associated with systemic lupus erythematosus (SLE). This study aimed to demonstrate the risk factors and clinical outcome of PRES in patients with SLE. Fifteen patients with SLE were diagnosed with PRES by characteristic clinical manifestations and magnetic resonance imaging (MRI) features from 2000 to 2012. Clinical profiles and outcomes were assessed for this study population. Additionally, 48 SLE patients with neurologic symptoms who underwent brain MRI were included for comparative analyses. The median age and duration of SLE in patients with PRES was 27 and 6.1 years, respectively. Comparison between patients with and without PRES revealed significant differences in the presentation of hypertension and seizure, lupus nephritis with renal insufficiency, treatment with high-dose steroid and cyclophosphamide, recent transfusion, and lupus activity measured by SLE disease activity index. Renal failure was the single independent factor with a high odds ratio of 129.250 by multivariate analysis. Of 15 patients, four experienced relapse and two died of sepsis during hospitalization. Our results suggest that lupus nephritis with renal dysfunction and other related clinical conditions can precede the occurrence of PRES in patients with SLE. It is important to perform early brain imaging for a timely diagnosis of PRES when clinically suspected.

  13. A Place-Based Community Health Worker Program: Feasibility and Early Outcomes, New York City, 2015

    PubMed Central

    Lopez, Priscilla M.; Islam, Nadia; Feinberg, Alexis; Myers, Christa; Seidl, Lois; Drackett, Elizabeth; Riley, Lindsey; Mata, Andrea; Pinzon, Juan; Benjamin, Elisabeth; Wyka, Katarzyna; Dannefer, Rachel; Lopez, Javier; Trinh-Shevrin, Chau; Maybank, Karen Aletha; Thorpe, Lorna E.

    2017-01-01

    Introduction This study examined feasibility of a place-based community health worker (CHW) and health advocate (HA) initiative in five public housing developments selected for high chronic disease burden and described early outcomes. Methods This intervention was informed by a mixed-method needs assessment performed December 2014–January 2015 (representative telephone survey, n=1,663; six focus groups, n=55). Evaluation design was a non-randomized, controlled quasi-experiment. Intake and 3-month follow-up data were collected February–December 2015 (follow-up response rate, 93%) on 224 intervention and 176 comparison participants, and analyzed in 2016. All participants self-reported diagnoses of hypertension, diabetes, or asthma. The intervention consisted of chronic disease self-management and goal setting through six individual CHW-led health coaching sessions, instrumental support, and facilitated access to insurance/clinical care navigation from community-based HAs. Feasibility measures included CHW service satisfaction and successful goal setting. Preliminary outcomes included clinical measures (blood pressure, BMI); disease management behaviors and self-efficacy; and preventive behaviors (physical activity). Results At the 3-month follow-up, nearly all intervention participants reported high satisfaction with their CHW (90%) and HA (76%). Intervention participants showed significant improvements in self-reported physical activity (p=0.005) and, among hypertensive participants, self-reported routine blood pressure self-monitoring (p=0.013) compared with comparison participants. No improvements were observed in self-efficacy or clinical measures at the 3-month follow-up. Conclusions Housing-based initiatives involving CHW and HA teams are acceptable to public housing residents and can be effectively implemented to achieve rapid improvements in physical activity and chronic disease self-management. At 3-month assessment, additional time and efforts are

  14. Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial.

    PubMed

    Groenvold, Mogens; Petersen, Morten Aagaard; Damkier, Anette; Neergaard, Mette Asbjoern; Nielsen, Jan Bjoern; Pedersen, Lise; Sjøgren, Per; Strömgren, Annette Sand; Vejlgaard, Tove Bahn; Gluud, Christian; Lindschou, Jane; Fayers, Peter; Higginson, Irene J; Johnsen, Anna Thit

    2017-10-01

    Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient's primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0-100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (-4.9 points (95% confidence interval -11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

  15. Can we predict failure in couple therapy early enough to enhance outcome?

    PubMed

    Pepping, Christopher A; Halford, W Kim; Doss, Brian D

    2015-02-01

    Feedback to therapists based on systematic monitoring of individual therapy progress reliably enhances therapy outcome. An implicit assumption of therapy progress feedback is that clients unlikely to benefit from therapy can be detected early enough in the course of therapy for corrective action to be taken. To explore the possibility of using feedback of therapy progress to enhance couple therapy outcome, the current study tested whether weekly therapy progress could detect off-track clients early in couple therapy. In an effectiveness trial of couple therapy, 136 couples were monitored weekly on relationship satisfaction and an expert derived algorithm was used to attempt to predict eventual therapy outcome. As expected, the algorithm detected a significant proportion of couples who did not benefit from couple therapy at Session 3, but prediction was substantially improved at Session 4 so that eventual outcome was accurately predicted for 70% of couples, with little improvement of prediction thereafter. More sophisticated algorithms might enhance prediction accuracy, and a trial of the effects of therapy progress feedback on couple therapy outcome is needed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Next-generation sequencing and clinical outcomes of patients with lung adenocarcinoma treated with stereotactic body radiotherapy.

    PubMed

    Cassidy, Richard J; Zhang, Xinyan; Patel, Pretesh R; Shelton, Joseph W; Escott, Chase E; Sica, Gabriel L; Rossi, Michael R; Hill, Charles E; Steuer, Conor E; Pillai, Rathi N; Ramalingam, Suresh S; Owonikoko, Taofeek K; Behera, Madhusmita; Force, Seth D; Fernandez, Felix G; Curran, Walter J; Higgins, Kristin A

    2017-10-01

    Genetic aberrations are well characterized in lung adenocarcinomas (LACs) and clinical outcomes have been influenced by targeted therapies in the advanced setting. Stereotactic body radiotherapy (SBRT) is the standard-of-care therapy for patients with nonoperable, early-stage LAC, but to the authors' knowledge, no information is available regarding the impact of genomic changes in these patients. The current study sought to determine the frequency and clinical impact of genetic aberrations in this population. Under an Institutional Review Board-approved protocol, the records of 242 consecutive patients with early-stage lung cancers were reviewed; inclusion criteria included LAC histology with an adequate tumor sample for the successful use of next-generation sequencing and fluorescence in situ hybridization testing. Univariate analysis was performed to identify factors associated with clinical outcomes. LAC samples from 98 of the 242 patients were reviewed (40.5%), of whom 45 patients (46.0%) had genetic testing. The following mutations were noted: KRAS in 20.0% of samples, BRAF in 2.2% of samples, SMAD family member 4 (SMAD4) in 4.4% of samples, epidermal growth factor receptor (EGFR) in 15.6% of samples, STK1 in 2.2% of samples, tumor protein 53 (TP53) in 15.6% of samples, and phosphatase and tensin homolog (PTEN) in 2.2% of samples. The following gene rearrangements were observed: anaplastic lymphoma kinase (ALK) in 8.9% of samples, RET in 2.2% of samples, and MET amplification in 17.8% of samples. The median total delivered SBRT dose was 50 grays (range, 48-60 grays) over a median of 5 fractions (range, 3-8 fractions). The KRAS mutation was associated with worse local control (odds ratio [OR], 3.64; P<.05). MET amplification was associated with worse regional (OR, 4.64; P<.05) and distant (OR, 3.73; P<.05) disease control. To the authors' knowledge, the current series is the first to quantify genetic mutations and their association with clinical outcomes in

  17. An in silico approach helped to identify the best experimental design, population, and outcome for future randomized clinical trials.

    PubMed

    Bajard, Agathe; Chabaud, Sylvie; Cornu, Catherine; Castellan, Anne-Charlotte; Malik, Salma; Kurbatova, Polina; Volpert, Vitaly; Eymard, Nathalie; Kassai, Behrouz; Nony, Patrice

    2016-01-01

    The main objective of our work was to compare different randomized clinical trial (RCT) experimental designs in terms of power, accuracy of the estimation of treatment effect, and number of patients receiving active treatment using in silico simulations. A virtual population of patients was simulated and randomized in potential clinical trials. Treatment effect was modeled using a dose-effect relation for quantitative or qualitative outcomes. Different experimental designs were considered, and performances between designs were compared. One thousand clinical trials were simulated for each design based on an example of modeled disease. According to simulation results, the number of patients needed to reach 80% power was 50 for crossover, 60 for parallel or randomized withdrawal, 65 for drop the loser (DL), and 70 for early escape or play the winner (PW). For a given sample size, each design had its own advantage: low duration (parallel, early escape), high statistical power and precision (crossover), and higher number of patients receiving the active treatment (PW and DL). Our approach can help to identify the best experimental design, population, and outcome for future RCTs. This may be particularly useful for drug development in rare diseases, theragnostic approaches, or personalized medicine. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Long-term outcomes of adolescents with juvenile-onset fibromyalgia in early adulthood.

    PubMed

    Kashikar-Zuck, Susmita; Cunningham, Natoshia; Sil, Soumitri; Bromberg, Maggie H; Lynch-Jordan, Anne M; Strotman, Daniel; Peugh, James; Noll, Jennie; Ting, Tracy V; Powers, Scott W; Lovell, Daniel J; Arnold, Lesley M

    2014-03-01

    This prospective longitudinal study examined the long-term physical and psychosocial outcomes of adolescents with juvenile-onset fibromyalgia (JFM), compared with healthy control subjects, into early adulthood. Adolescent patients with JFM initially seen at a pediatric rheumatology clinic (n = 94) and age- and gender-matched healthy control subjects (n = 33) completed online measures of demographic characteristics, pain, physical functioning, mood symptoms, and health care utilization at ∼6 years' follow-up (mean age: 21 years). A standard in-person tender-point examination was conducted. Patients with JFM had significantly higher pain (P < .001), poorer physical function (P < .001), greater anxiety (P < .001) and depressive symptoms (P < .001), and more medical visits (P < .001)than control subjects. The majority (>80%) of JFM patients continued to experience fibromyalgia symptoms into early adulthood, and 51.1% of the JFM sample met American College of Rheumatology criteria for adult fibromyalgia at follow-up. Patients with JFM were more likely than control subjects to be married and less likely to obtain a college education. Adolescent patients with JFM have a high likelihood of continued fibromyalgia symptoms into young adulthood. Those who met criteria for fibromyalgia in adulthood exhibited the highest levels of physical and emotional impairment. Emerging differences in educational attainment and marital status were also found in the JFM group. JFM is likely to be a long-term condition for many patients, and this study for the first time describes the wide-ranging impact of JFM on a variety of physical and psychosocial outcomes that seem to diverge from their same-age peers.

  19. Identifying autism early: The Toddlers at Risk of Autism Clinic model.

    PubMed

    Davis, Tessa; Clifton, Deirdre; Papadopoulos, Con

    2015-07-01

    This paper describes the Toddlers at Risk of Autism Clinic (TRAC), which utilises the Social Attention and Communication Study (SACS) and/or Autism Detection in Early Childhood (ADEC) play-based assessments to facilitate the early diagnosis of autism. A retrospective audit was conducted of all 42 children assessed over a 3-year period in the TRAC. A semi-structured interview and play-based assessment (SACS and ADEC) were used to aid experienced clinicians in diagnosing autism. Intervention was recommended, and families were routinely followed up. Analysis was conducted on the tools used, the outcomes of assessment, diagnosis and stability of diagnosis on follow-up. During this period, 35 boys and 7 girls were assessed, with a mean age of 25 months. The average waiting time for clinic was 11.6 weeks. Twenty-five patients were diagnosed with autism; 90.5% of toddlers given an initial diagnosis retained that diagnosis at follow-up. Out of the 17 children who were not diagnosed with autism in the TRAC, one child was later diagnosed with autism. Experienced clinicians can use the SACS and/or ADEC to assist with a Diagnostic and Statistical Manual diagnosis of autism in toddlers. © 2015 The Authors. Journal of Paediatrics and Child Health © 2015 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  20. Accreditation of Predoctoral Dental Education: Clinical Outcomes Assessment.

    ERIC Educational Resources Information Center

    Boyd, Marcia A.; And Others

    1991-01-01

    The Curriculum Outcomes Review and Evaluation system of outcomes assessment for accreditation of Canadian dental faculties is described. Features include chart reviews; evaluation of diagnosis and treatment planning and case presentation for a student sample; structured clinical observation; presite visit survey; and solicitation of feedback from…

  1. Social cognitive markers of short-term clinical outcome in first-episode psychosis.

    PubMed

    Montreuil, Tina; Bodnar, Michael; Bertrand, Marie-Claude; Malla, Ashok K; Joober, Ridha; Lepage, Martin

    2010-07-01

    In psychotic disorders, impairments in cognition have been associated with both clinical and functional outcome, while deficits in social cognition have been associated with functional outcome. As an extension to a recent report on neurocognition and short-term clinical outcome in first-episode psychosis (FEP), the current study explored whether social cognitive deficits could also identify poor short-term clinical outcome among FEP patients. We defined the social-cognition domain based on the scores from the Hinting Task and the Four Factor Tests of Social Intelligence. Data were collected in 45 FEP patients and 26 healthy controls. The patients were divided into good- and poor-outcome groups based on clinical data at six months following initiation of treatment. Social cognition was compared among 27 poor-outcome, 18 good-outcome, and 26 healthy-control participants. Outcome groups significantly differed in the social cognition domain (z-scores: poor outcome=-2.0 [SD=1.4]; good outcome=-1.0 [SD=1.0]; p=0.005), with both groups scoring significantly lower than the control group (p<0.003). Moreover, outcome groups differed significantly only on the Cartoon Predictions subtest (z-scores: poor outcome=-2.7 [SD=2.7]; good outcome=-0.7 [SD=1.8]; p=0.001) among the five subtests used. Overall, social cognition appears to be compromised in all FEP patients compared to healthy controls. More interestingly, significant differences in social cognitive impairments exist between good and poor short-term clinical outcome groups, with the largest effect found in the Cartoon Predictions subtest.

  2. Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review.

    PubMed

    Ismail, Rehab; Azuara-Blanco, Augusto; Ramsay, Craig R

    2014-04-01

    In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials. We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated. The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%). There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.

  3. Prediction of tamoxifen outcome by genetic variation of CYP2D6 in post-menopausal women with early breast cancer

    PubMed Central

    Brauch, Hiltrud; Schwab, Matthias

    2014-01-01

    The question of whether genetic polymorphisms of CYP2D6 can affect treatment outcome in patients with early post-menopausal oestrogen receptor (ER)-positive breast cancer has been a matter of debate over the past few years. In this article we revisit the hypothesis of CYP2D6 being a potential tamoxifen outcome predictor and provide detailed insight into the ongoing controversy that prevented the CYP2D6 marker from being accepted by the scientific and clinical community. We summarize the available pharmacokinetic, pharmacodynamic and pharmacogenetic evidence and resolve the controversy based on the recognized methodological and statistical issues. The cumulative evidence suggests that genotyping for CYP2D6 is clinically relevant in post-menopausal women. This is important, because the clarification of this issue has the potential to resolve a clinical management question that is relevant to hundreds of thousands of women diagnosed with ER-positive breast cancer each year, who should not be denied effective endocrine therapy. PMID:24033728

  4. Improved early outcome for end-stage dilated cardiomyopathy in children.

    PubMed

    McMahon, Anne-Marie; van Doorn, Carin; Burch, Michael; Whitmore, Pauline; Neligan, Sophie; Rees, Philip; Radley-Smith, Rosemary; Goldman, Allan; Brown, Katherine; Cohen, Gordon; Tsang, Victor; Elliott, Martin; de Leval, Marc R

    2003-12-01

    To review the impact of management changes on the early outcomes of end-stage dilated cardiomyopathy in children. We conducted a retrospective study of all consecutive children with end-stage dilated cardiomyopathy who received hospital treatment since 1992. Over the past 3 years the following management changes were made: (1) more aggressive use of mechanical cardiac assistance; (2) high priority listing for transplantation; and (3) ABO incompatible transplants for infants. Outcomes for 46 patients admitted between 1992 and 1999 (group I) were compared with 53 patients between 2000 and March 2003 (group II). In group I, 12 (26%) patients received mechanical support with recovery in 3 and transplantation in 5 (1 died). In group II, 19 (36%) patients received extracorporeal membrane oxygenation, with recovery in 5 and transplantation in 12 (all survived). The use of mechanical assistance was associated with high morbidity related to bleeding, end-organ failure, and long-term mechanical ventilation. Five patients in group II received ABO incompatible transplants and all survived. There have been no episodes of rejection or need for increased immunosuppressive therapy. Hospital mortality has been significantly reduced (group I, 37% vs group II, 11%; P <.05). Recent refinements in the management of end-stage dilated cardiomyopathy in children have significantly reduced early mortality. Identification of markers of early myocardial recovery and development of mechanical devices for longer term and more physiologic support are essential to achieve further improvements in outcome.

  5. Cosmetic Outcome and Seroma Formation After Breast-Conserving Surgery With Intraoperative Radiation Therapy Boost for Early Breast Cancer

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Senthi, Sashendra, E-mail: sashasenthi@msn.com; Link, Emma; Chua, Boon H.

    2012-10-01

    Purpose: To evaluate cosmetic outcome and its association with breast wound seroma after breast-conserving surgery (BCS) with targeted intraoperative radiation therapy (tIORT) boost for early breast cancer. Methods and Materials: An analysis of a single-arm prospective study of 55 patients with early breast cancer treated with BCS and tIORT boost followed by conventional whole breast radiation therapy (WBRT) between August 2003 and January 2006 was performed. A seroma was defined as a fluid collection at the primary tumor resection site identified clinically or radiologically. Cosmetic assessments using the European Organization for Research and Treatment of Cancer rating system were performedmore » at baseline before BCS and 30 months after WBRT was completed. Results: Twenty-eight patients (51%) developed a seroma, with 18 patients (33%) requiring at least 1 aspiration. Tumor location was significantly associated with seroma formation (P=.001). Ten of 11 patients with an upper inner quadrant tumor developed a seroma. Excellent or good overall cosmetic outcome at 30 months was observed in 34 patients (62%, 95% confidence interval 53%-80%). Seroma formation was not associated with the overall cosmetic result (P=.54). Conclusion: BCS with tIORT boost followed by WBRT was associated with an acceptable cosmetic outcome. Seroma formation was not significantly associated with an adverse cosmetic outcome.« less

  6. Endoscopic submucosal dissection of early colorectal neoplasms with a monopolar scissor-type knife: short- to long-term outcomes.

    PubMed

    Kuwai, Toshio; Yamaguchi, Toshiki; Imagawa, Hiroki; Sumida, Yuki; Takasago, Takeshi; Miyasako, Yuki; Nishimura, Tomoyuki; Iio, Sumio; Yamaguchi, Atsushi; Kouno, Hirotaka; Kohno, Hiroshi; Ishaq, Sauid

    2017-09-01

    Background and study aims  Endoscopic submucosal dissection (ESD) for colorectal neoplasms remains challenging because of technical issues imposed by the complex anatomical features of the large intestine. We evaluated the feasibility, and the short- and long-term clinical outcomes of ESD for early colorectal neoplasms performed using the Stag-beetle Knife Jr. (SB Knife Jr.) Patients and methods  We retrospectively assessed 228 patients who underwent ESD for 247 colorectal lesions with the SB Knife Jr. Clinicopathological characteristics of the neoplasms, complications, and various short- and long-term outcomes were evaluated. Results  Mean tumor size was 34.3 mm and median procedure time was 76 minutes. The SB Knife Jr. achieved 98.4 % en bloc resection, 93.9 % complete resection, and 85.4 % curative resection. No perforations occurred during the procedure, and a delayed bleeding rate of 2.4 % was observed. Long-term outcomes were favorable with no distant recurrence, 1.1 % local recurrence, a 5-year overall survival rate of 94.1 % and 5-year tumor-specific survival rate of 98.6 % in patients with cancer. Conclusions  ESD using the SB Knife Jr. is technically efficient and safe in treating early colorectal neoplasms and is associated with favorable short- and long-term outcomes. © Georg Thieme Verlag KG Stuttgart · New York.

  7. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial.

    PubMed

    Tak, P P; Rigby, W F; Rubbert-Roth, A; Peterfy, C G; van Vollenhoven, R F; Stohl, W; Hessey, E; Chen, A; Tyrrell, H; Shaw, T M

    2011-01-01

    Rituximab is an effective treatment in patients with established rheumatoid arthritis (RA). The objective of the IMAGE study was to determine the efficacy of rituximab in the prevention of joint damage and its safety in combination with methotrexate (MTX) in patients initiating treatment with MTX. In this double-blind randomised controlled phase III study, 755 MTX-naïve patients with active RA were randomly assigned to MTX alone, rituximab 2×500 mg + MTX or rituximab 2×1000 mg + MTX. The primary end point at week 52 was the change in joint damage measured using a Genant-modified Sharp score. 249, 249 and 250 patients were randomly assigned to MTX alone, rituximab 2×500 mg + MTX or rituximab 2×1000 mg + MTX, respectively. At week 52, treatment with rituximab 2×1000 mg + MTX compared with MTX alone was associated with a reduction in progression of joint damage (mean change in total modified Sharp score 0.359 vs 1.079; p=0.0004) and an improvement in clinical outcomes (ACR50 65% vs 42%; p<0.0001); rituximab 2×500 mg + MTX improved clinical outcomes (ACR50 59% vs 42%; p<0.0001) compared with MTX alone but did not significantly reduce the progression of joint damage. Safety outcomes were similar between treatment groups. Treatment with rituximab 2×1000 mg in combination with MTX is an effective therapy for the treatment of patients with MTX-naïve RA. ClinicalTrials.gov identifier NCT00299104.

  8. Rethinking the Food and Drug Administration's 2013 guidance on developing drugs for early-stage Alzheimer's disease.

    PubMed

    Schneider, Lon S

    2014-03-01

    The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  9. brief report: Burnout Among Early Career Clinical Investigators

    PubMed Central

    Primack, Brian A.; Dilmore, Terri C.; Switzer, Galen E.; Bryce, Cindy L.; Seltzer, Deborah L.; Li, Jie; Landsittel, Douglas P.; Kapoor, Wishwa N.; Rubio, Doris M.

    2010-01-01

    Abstract Burnout is a pervasive problem among clinicians. However, little is known about burnout among early career clinical investigators, who must balance clinical responsibilities with challenges related to research. We aimed to determine the prevalence of and demographic associations with burnout in a cohort of early career clinical investigators. A cross‐sectional questionnaire was administered to 179 trainees at the University of Pittsburgh Institute for Clinical Research Education in 2007–2008. We used chi‐square analyses and Fisher’s exact test to determine whether associations between demographic characteristics and burnout were significant. Of the participants, 29 (16%) reported feeling burned out. Burnout was more prevalent among those over 35 years of age relative to their younger counterparts (29% vs. 13%, p= 0.01) and among females relative to males (22% vs. 10%, p= 0.03). With regard to race and ethnicity, burnout was most common among underrepresented minorities (30%) followed by Caucasians (18%) and Asians (3%); these differences were significant (p= 0.02). Considering the early career status of these research trainees, rates of burnout were concerning. Certain demographic subgroups—including older trainees, females, and underrepresented minorities—had particularly high rates of burnout and may benefit from interventions that provide them with skills needed to sustain successful clinical research careers. Clin Trans Sci 2010; Volume 3: 186–188 PMID:20718821

  10. Complex Possibilities: "Working Theories" as an Outcome for the Early Childhood Curriculum

    ERIC Educational Resources Information Center

    Hargraves, Vicki

    2014-01-01

    "Working theories" are described as one of the two principal outcomes of Te Whariki, the early childhood curriculum in Aotearoa New Zealand. Despite its prominence as a curricular outcome, the theoretical positioning of the concept of working theory remains relatively undebated, with researchers readily attributing the term to a…

  11. Early Adult Outcomes of Adolescents Who Deliberately Poisoned Themselves

    ERIC Educational Resources Information Center

    Harrington, Richard; Pickles, Andrew; Aglan, Azza; Harrington, Val; Burroughs, Heather; Kerfoot, Michael

    2006-01-01

    Objective: To describe the early adult psychopathological and social outcomes of adolescents who deliberately poisoned themselves. Method: Prospective cohort study with a 6-year follow-up of 132 of 158 (84%) adolescents who, between ages 11 and 16 years, had taken part in a randomized trial of a brief family intervention after deliberate…

  12. Acute care clinical indicators associated with discharge outcomes in children with severe traumatic brain injury.

    PubMed

    Vavilala, Monica S; Kernic, Mary A; Wang, Jin; Kannan, Nithya; Mink, Richard B; Wainwright, Mark S; Groner, Jonathan I; Bell, Michael J; Giza, Christopher C; Zatzick, Douglas F; Ellenbogen, Richard G; Boyle, Linda Ng; Mitchell, Pamela H; Rivara, Frederick P

    2014-10-01

    The effect of the 2003 severe pediatric traumatic brain injury (TBI) guidelines on outcomes has not been examined. We aimed to develop a set of acute care guideline-influenced clinical indicators of adherence and tested the relationship between these indicators during the first 72 hours after hospital admission and discharge outcomes. Retrospective multicenter cohort study. Five regional pediatric trauma centers affiliated with academic medical centers. Children under 18 years with severe traumatic brain injury (admission Glasgow Coma Scale score ≤ 8, International Classification of Diseases, 9th Edition, diagnosis codes of 800.0-801.9, 803.0-804.9, 850.0-854.1, 959.01, 950.1-950.3, 995.55, maximum head abbreviated Injury Severity Score ≥ 3) who received tracheal intubation for at least 48 hours in the ICU between 2007 and 2011 were examined. None. Total percent adherence to the clinical indicators across all treatment locations (prehospital, emergency department, operating room, and ICU) during the first 72 hours after admission to study center were determined. Main outcomes were discharge survival and Glasgow Outcome Scale score. Total adherence rate across all locations and all centers ranged from 68% to 78%. Clinical indicators of adherence were associated with survival (adjusted hazard ratios, 0.94; 95% CI, 0.91-0.96). Three indicators were associated with survival: absence of prehospital hypoxia (adjusted hazard ratios, 0.20; 95% CI, 0.08-0.46), early ICU start of nutrition (adjusted hazard ratios, 0.06; 95% CI, 0.01-0.26), and ICU PaCO2 more than 30 mm Hg in the absence of radiographic or clinical signs of cerebral herniation (adjusted hazard ratios, 0.22; 95% CI, 0.06-0.8). Clinical indicators of adherence were associated with favorable Glasgow Outcome Scale among survivors (adjusted hazard ratios, 0.99; 95% CI, 0.98-0.99). Three indicators were associated with favorable discharge Glasgow Outcome Scale: all operating room cerebral perfusion pressure

  13. The Importance of Early Experiences: Clinical, Research, and Policy Perspectives

    ERIC Educational Resources Information Center

    Zeanah, Charles H.

    2009-01-01

    The degree to which early adverse experiences exert long term effects on development and how much early adversity may be overcome through subsequent experiences are important mental health questions. The clinical, research and policy perspectives on these questions lead to different answers. From a clinical perspective, change is always possible,…

  14. The Effects of Breastfeeding Exclusivity on Early Childhood Outcomes

    PubMed Central

    Foster, E. Michael

    2014-01-01

    Objectives. We examined the relationship between breastfeeding exclusivity and duration and children’s health and cognitive outcomes at ages 2 and 4 years. Methods. We used the Early Childhood Longitudinal Study—Birth Cohort, a nationally representative sample of 10 700 children born in the United States in 2001. Parent interviews and child assessments were conducted in measurement waves at 9 months, 2 years, 4 years, and in kindergarten, with the focus on ages 2 and 4 years. We employed propensity scores as a means of adjusting for confounding involving observed characteristics. Results. Outcome analyses using propensity scores showed some small effects of breastfeeding on key outcomes at age 4 years but not at age 2 years. Effects appeared to be concentrated in reading and cognitive outcomes. Overall, we found no consistent evidence for dosage effects of breastfeeding exclusivity. Our sensitivity analyses revealed that a small amount of unobserved confounding could be responsible for the resulting benefits. Conclusions. Our study revealed little or no effect of breastfeeding exclusivity and duration on key child outcomes. PMID:24354838

  15. Articular congruity is associated with short-term clinical outcomes of operatively treated SER IV ankle fractures.

    PubMed

    Berkes, Marschall B; Little, Milton T M; Lazaro, Lionel E; Pardee, Nadine C; Schottel, Patrick C; Helfet, David L; Lorich, Dean G

    2013-10-02

    With regard to supination-external rotation type-IV (SER IV) ankle fractures, there is no consensus regarding which patient, injury, and treatment variables most strongly influence clinical outcome. The purpose of this investigation was to examine the impact of articular surface congruity on the functional outcomes of operatively treatment of SER IV ankle fractures. A prospectively generated database consisting of operatively treated SER IV ankle fractures was reviewed. Postoperative computed tomography (CT) scans were used to assess ankle joint congruity. Ankles were considered incongruent in the presence of >2 mm of articular step-off, intra-articular loose bodies, or an articular surface gap of >2 mm (despite an otherwise anatomic reduction) due to joint impaction and comminution. Patients with at least one year of clinical follow-up were eligible for analysis. The primary and secondary outcome measures were the Foot and Ankle Outcome Score (FAOS) and ankle motion. One hundred and eight SER IV fractures met our inclusion criteria. The average duration of follow-up was twenty-one months. Seventy-two patients (67%) had a congruent ankle joint, and thirty-six (33%) had elements of articular surface incongruity on postoperative CT scanning. These two groups were similar with regard to comorbidities and injury and treatment variables. At the time of the final follow-up, the group with articular incongruity had a significantly worse FAOS with regard to symptoms (p = 0.012), pain (p = 0.004), and activities of daily living (p = 0.038). Those with articular incongruity had worse average scores in the FAOS sport domain as well. No significant differences in ankle motion were found between the two groups. In this population of patients with an operatively treated SER IV ankle fracture, the presence of postoperative articular incongruity correlated with inferior early clinical outcomes. Orthopaedic surgeons should scrutinize ankle fracture reductions and strive for

  16. No benefit of patient-specific instrumentation in TKA on functional and gait outcomes: a randomized clinical trial.

    PubMed

    Abdel, Matthew P; Parratte, Sébastien; Blanc, Guillaume; Ollivier, Matthieu; Pomero, Vincent; Viehweger, Elke; Argenson, Jean-Noël A

    2014-08-01

    Although some clinical reports suggest patient-specific instrumentation in TKA may improve alignment, reduce surgical time, and lower hospital costs, it is unknown whether it improves pain- and function-related outcomes and gait. We hypothesized that TKA performed with patient-specific instrumentation would improve patient-reported outcomes measured by validated scoring tools and level gait as ascertained with three-dimensional (3-D) analysis compared with conventional instrumentation 3 months after surgery. We randomized 40 patients into two groups using either patient-specific instrumentation or conventional instrumentation. Patients were evaluated preoperatively and 3 months after surgery. Assessment tools included subjective functional outcome and quality-of-life (QOL) scores using validated questionnaires (New Knee Society Score(©) [KSS], Knee Injury and Osteoarthritis Outcome Score [KOOS], and SF-12). In addition, gait analysis was evaluated with a 3-D system during level walking. The study was powered a priori at 90% to detect a difference in walking speed of 0.1 m/second, which was considered a clinically important difference, and in a post hoc analysis at 80% to detect a difference of 10 points in KSS. There were improvements from preoperatively to 3 months postoperatively in functional scores, QOL, and knee kinematic and kinetic gait parameters during level walking. However, there was no difference between the patient-specific instrumentation and conventional instrumentation groups in KSS, KOOS, SF-12, or 3-D gait parameters. Our observations suggest that patient-specific instrumentation does not confer a substantial advantage in early functional or gait outcomes after TKA. It is possible that differences may emerge, and this study does not allow one to predict any additional variances in the intermediate followup period from 6 months to 1 year postoperatively. However, the goals of the study were to investigate the recovery period as early pain and

  17. Early outcomes of patella resurfacing in total knee arthroplasty

    PubMed Central

    Clements, Warren J; Miller, Lisa; Whitehouse, Sarah L; Graves, Stephen E; Ryan, Philip

    2010-01-01

    Background Patella resurfacing in total knee arthroplasty is a contentious issue. The literature suggests that resurfacing of the patella is based on surgeon preference, and little is known about the role and timing of resurfacing and how this affects outcomes. Methods We analyzed 134,799 total knee arthroplasties using data from the Australian Orthopaedic Association National Joint Replacement Registry. Hazards ratios (HRs) were used to compare rates of early revision between patella resurfacing at the primary procedure (the resurfacing group, R) and primary arthroplasty without resurfacing (no-resurfacing group, NR). We also analyzed the outcomes of NR that were revised for isolated patella addition. Results At 5 years, the R group showed a lower revision rate than the NR group: cumulative per cent revision (CPR) 3.1% and 4.0%, respectively (HR = 0.75, p < 0.001). Revisions for patellofemoral pain were more common in the NR group (17%) than in the R group (1%), and “patella only” revisions were more common in the NR group (29%) than in the R group (6%). Non-resurfaced knees revised for isolated patella addition had a higher revision rate than patella resurfacing at the primary procedure, with a 4-year CPR of 15% and 2.8%, respectively (HR = 4.1, p < 0.001). Interpretation Rates of early revision of primary total knees were higher when the patella was not resurfaced, and suggest that surgeons may be inclined to resurface later if there is patellofemoral pain. However, 15% of non-resurfaced knees revised for patella addition are re-revised by 4 years. Our results suggest an early beneficial outcome for patella resurfacing at primary arthroplasty based on revision rates up to 5 years. PMID:19968604

  18. Composite outcomes in randomized clinical trials: arguments for and against.

    PubMed

    Ross, Sue

    2007-02-01

    Composite outcomes that combine a number of individual outcomes (such as types of morbidity) are frequently used as primary outcomes in obstetrical trials. The main argument for their use is to ensure that trials can answer important clinical questions in a timely fashion, without needing huge sample sizes. Arguments against their use are that composite outcomes may be difficult to use and interpret, leading to errors in sample size estimation, possible contradictory trial results, and difficulty in interpreting findings. Such problems may reduce the credibility of the research, and may impact on the implementation of findings. Composite outcomes are an attractive solution to help to overcome the problem of limited available resources for clinical trials. However, future studies should carefully consider both the advantages and disadvantages before using composite outcomes. Rigorous development and reporting of composite outcomes is essential if the research is to be useful.

  19. Infectious and autoantibody-associated encephalitis: clinical features and long-term outcome.

    PubMed

    Pillai, Sekhar C; Hacohen, Yael; Tantsis, Esther; Prelog, Kristina; Merheb, Vera; Kesson, Alison; Barnes, Elizabeth; Gill, Deepak; Webster, Richard; Menezes, Manoj; Ardern-Holmes, Simone; Gupta, Sachin; Procopis, Peter; Troedson, Christopher; Antony, Jayne; Ouvrier, Robert A; Polfrit, Yann; Davies, Nicholas W S; Waters, Patrick; Lang, Bethan; Lim, Ming J; Brilot, Fabienne; Vincent, Angela; Dale, Russell C

    2015-04-01

    Pediatric encephalitis has a wide range of etiologies, clinical presentations, and outcomes. This study seeks to classify and characterize infectious, immune-mediated/autoantibody-associated and unknown forms of encephalitis, including relative frequencies, clinical and radiologic phenotypes, and long-term outcome. By using consensus definitions and a retrospective single-center cohort of 164 Australian children, we performed clinical and radiologic phenotyping blinded to etiology and outcomes, and we tested archived acute sera for autoantibodies to N-methyl-D-aspartate receptor, voltage-gated potassium channel complex, and other neuronal antigens. Through telephone interviews, we defined outcomes by using the Liverpool Outcome Score (for encephalitis). An infectious encephalitis occurred in 30%, infection-associated encephalopathy in 8%, immune-mediated/autoantibody-associated encephalitis in 34%, and unknown encephalitis in 28%. In descending order of frequency, the larger subgroups were acute disseminated encephalomyelitis (21%), enterovirus (12%), Mycoplasma pneumoniae (7%), N-methyl-D-aspartate receptor antibody (6%), herpes simplex virus (5%), and voltage-gated potassium channel complex antibody (4%). Movement disorders, psychiatric symptoms, agitation, speech dysfunction, cerebrospinal fluid oligoclonal bands, MRI limbic encephalitis, and clinical relapse were more common in patients with autoantibodies. An abnormal outcome occurred in 49% of patients after a median follow-up of 5.8 years. Herpes simplex virus and unknown forms had the worst outcomes. According to our multivariate analysis, an abnormal outcome was more common in patients with status epilepticus, magnetic resonance diffusion restriction, and ICU admission. We have defined clinical and radiologic phenotypes of infectious and immune-mediated/autoantibody-associated encephalitis. In this resource-rich cohort, immune-mediated/autoantibody-associated etiologies are common, and the recognition and

  20. Influence of shift work on early reproductive outcomes: a systematic review and meta-analysis.

    PubMed

    Stocker, Linden J; Macklon, Nicholas S; Cheong, Ying C; Bewley, Susan J

    2014-07-01

    To determine whether an association exists between shift work and early reproductive outcomes. MEDLINE, Embase, and Web of Science were searched. Additional sources included Google Scholar, the Cochrane Library, online publications of national colleges, the ClinicalTrials.gov, and references of retrieved papers. Included studies compared female shift workers (work outside 8:00 AM to 6:00 PM) with nonshift workers with menstrual disruption (cycles less than 25 days or greater than 31 days), infertility (time-to-pregnancy exceeding 12 months), or early spontaneous pregnancy loss (less than 25 weeks). Two reviewers extracted adjusted and raw data. Random effect models were used to pool data weighting for the inverse of variance. Assessments of heterogeneity, bias, and subgroup analyses were performed. Sixteen independent cohorts from 15 studies (123,403 women) were subject to analysis. Shift workers had increased rates of menstrual disruption (16.05% [2,207/13,749] compared with 13.05% [7,561/57,932] [n=71.681, odds ratio {OR} 1.22, 95% confidence interval {CI} 1.15-1.29, I 0%]) and infertility (11.3% [529/4,668] compared with 9.9% [2,354/23,811] [OR 1.80, 95% CI 1.01-3.20, I 94%]) but not early spontaneous pregnancy loss (11.84% [939/7,931] compared with 12.11% [1,898/15,673] [n=23,604, OR 0.96, 95% CI 0.88-1.05, I 0%]). Night shifts were associated with increased early spontaneous pregnancy loss (n=13,018, OR 1.29, 95% CI 1.11-1.50, I 0%). Confounder adjustment led to persistent relationships between shift work and menstrual disruption (adjusted OR 1.15, 95% CI 1.01-1.31, I 70%) but not infertility (adjusted OR 1.11 95% CI 0.86-1.44, I 61%). The association between night shifts and early spontaneous pregnancy loss remained (adjusted OR 1.41 95% CI 1.22-1.63, I 0%). This review provides evidence for an association between performing shift work and early reproductive outcomes, consistent with later pregnancy findings. However, there is currently insufficient evidence

  1. Early clinical and angiographic outcome of the pedicled right internal thoracic artery graft to the left anterior descending artery.

    PubMed

    Al-Ruzzeh, Sharif; George, Shane; Bustami, Mahmoud; Nakamura, Koki; Ilsley, Charles; Amrani, Mohamed

    2002-05-01

    The left internal thoracic artery (LITA) graft to the left anterior descending (LAD) artery became the gold standard graft in coronary surgery. Subsequently, the right internal thoracic artery (RITA) graft was increasingly used. However, there is still some debate about the optimal way of using this conduit. The aim of the present study was to assess our experience in grafting the pedicled RITA graft to LAD in 212 consecutive patients. The records of 212 consecutive patients who underwent isolated coronary artery bypass grafting with the pedicled RITA graft to the LAD artery at Harefield Hospital between January 1998 and May 2001 were retrospectively reviewed. We approached the last 35 consecutive patients to obtain an angiographic control group. All 35 patients (16.5%) consented and, before discharge, underwent angiography to look at the quality of anastomoses and the patency of grafts. Successful catheterization and engagement of the RITA grafts was performed in 32 patients. Angiography showed that 32/32 (100%) of the RITA grafts were widely patent with excellent flow. The distal anastomoses of these RITA grafts were also satisfactory. There were no deaths among the study patients. Our results show that the use of the pedicled RITA graft to the LAD artery provides a good early clinical and angiographic outcome, and suggests that the pedicled RITA graft to the LAD artery is a good alternative to the pedicled LITA graft to the LAD artery.

  2. Randomized trial investigating the efficacy of manual lymphatic drainage to improve early outcome after total knee arthroplasty.

    PubMed

    Ebert, Jay R; Joss, Brendan; Jardine, Berit; Wood, David J

    2013-11-01

    To investigate the efficacy of manual lymphatic drainage (MLD) in the early postoperative period after total knee arthroplasty (TKA) to reduce edema and pain and improve knee range of motion. Prospective randomized controlled trial. Private hospital and functional rehabilitation clinic. Consecutive sample of patients (N=43; 53 knees) scheduled for TKA. MLD (vs no MLD) on days 2, 3, and 4 postoperatively. Both groups underwent conventional, concomitant physical therapy. Clinical assessment was undertaken pre- and postoperatively prior to and after the designated postoperative MLD sessions (days 2, 3, and 4) and at 6 weeks postsurgery. This included active knee flexion and extension range of motion, lower limb girths (ankle, midpatella, thigh, and calf), and knee pain using a numeric rating scale and the Knee Injury and Osteoarthritis Outcome Score. A significant group effect was observed for active knee flexion, with post hoc tests demonstrating a significantly greater active knee flexion in the MLD group when compared with the control (no MLD) group at the final measure prior to hospital discharge (day 4 postsurgery) and at 6 weeks postsurgery. There were no further group effects observed for the remaining patient-reported and functional outcomes. MLD in the early postoperative stages after TKA appears to improve active knee flexion up to 6 weeks postsurgery, in addition to conventional care. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  3. A Five-Phase Model for Clinical-Outcome Research

    ERIC Educational Resources Information Center

    Robey, Randall R.

    2004-01-01

    Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and…

  4. Can early host responses to mycobacterial infection predict eventual disease outcomes?

    PubMed

    de Silva, Kumudika; Begg, Douglas J; Plain, Karren M; Purdie, Auriol C; Kawaji, Satoko; Dhand, Navneet K; Whittington, Richard J

    2013-11-01

    Diagnostic tests used for Johne's disease in sheep either have poor sensitivity and specificity or only detect disease in later stages of infection. Predicting which of the infected sheep are likely to become infectious later in life is currently not feasible and continues to be a major hindrance in disease control. We conducted this longitudinal study to investigate if a suite of diagnostic tests conducted in Mycobacterium avium subspecies paratuberculosis (MAP) exposed lambs at 4 months post infection can accurately predict their clinical status at 12 months post infection. We tracked cellular and humoral responses and quantity of MAP shedding for up to 12 months post challenge in 20 controls and 37 exposed sheep. Infection was defined at necropsy by tissue culture and disease spectrum by lesion type. Data were analysed using univariable and multivariable logistic regression models and a subset of variables from the earliest period post inoculation (4 months) was selected for predicting disease outcomes later on (12 months). Sensitivity and specificity of tests and their combinations in series and parallel were determined. Early elevation in faecal MAP DNA quantity and a lower interferon gamma (IFNγ) response were significantly associated with sheep becoming infectious as well as progressing to severe disease. Conversely, early low faecal MAP DNA and higher interleukin-10 responses were significantly associated with an exposed animal developing protective immunity. Combination of early elevated faecal MAP DNA or lower IFNγ response had the highest sensitivity (75%) and specificity (81%) for identifying sheep that would become infectious. Collectively, these results highlight the potential for combined test interpretation to aid in the early prediction of sheep susceptibility to MAP infection. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Multisession stereotactic radiosurgery for large benign brain tumors of >3cm- early clinical outcomes

    PubMed Central

    Memon, Muhammad Ali; Ahmed, Usman; Saleem, Muhammad Abid; Bhatti, Amer Iqtidar; Ahmed, Naveed; Hashim, Abdul Sattar M.

    2012-01-01

    Objective To evaluate the clinical outcome of linear accelerator based multisession stereotactic radiosurgery (SRS) for large benign brain tumors of >3cm. Methods Between June 2009 and May 2011, 35 patients having large benign brain tumors of >3cm (≥15 cm3) were treated by multisession stereotactic radiosurgery. This retrospective study was carried out at Neurospinal & Medical Institute Karachi. There were 17 (48.6 %) males and 18(51.4 %) females. Median age was 36 years (range: 13-65 years). Median target volume was 49.4 cm3 (range: 15-184 cm3). The median marginal dose was 25 Gy (range: 20–27.5Gy) prescribed to a median 75% isodose line (range: 65-100 %). Median number of 5 fractions were used ranging 3-5 fractions. Results All the patients tolerated treatment very well. 21 (58.3%) patients had remarkable clinical improvement of neurological symptoms, 14 (38.9%) patients had stable symptoms, and only one patient had transient worsening of symptoms. No permanent neurological damage or radiation injury was seen. Radiologically, 9 (25.7%) patients achieved reduction in size of the tumor, 26(74.3 %) patients were having stable disease, and overall control rate was found to be 100 %. Median follow-up time from the end of SRS was 6.4 months (range: 1-22.5months). Conclusion Linear accelerator based multisession stereotactic radiosurgery for large benign brain tumors of >3cm is effective and well tolerated. PMID:29296340

  6. Comparison of the Early Clinical Outcomes between Combined Small-Incision Lenticule Extraction and Collagen Cross-Linking versus SMILE for Myopia.

    PubMed

    Ng, Alex L K; Chan, Tommy C Y; Cheng, George P M; Jhanji, Vishal; Ye, Cong; Woo, Victor C P; Lai, Jimmy S M

    2016-01-01

    Background. To compare the early outcome of combined SMILE and collagen crosslinking (SMILE Xtra) with SMILE. Method. Prospective, comparative interventional study of 21 eyes receiving SMILE Xtra using a low energy protocol and 32 control eyes receiving SMILE only. The outcomes were compared at 1, 3, and 6 months postoperatively. Results. Both groups had myopia with spherical equivalent refraction (SEQ) > 4.00 D. The SMILE Xtra group had thinner preoperative central corneal thickness and residual stromal bed thickness (p < 0.021). At 6 months, no eyes lost more than 1 line in corrected distance visual acuity. The safety index was 0.96 ± 0.06 and 1.00 ± 0.00 in SMILE Xtra and control, respectively (p < 0.001). 89% and 94% of eyes were within ±0.50 D of target refraction, respectively, with the mean error in SEQ correction being -0.17 ± 0.26 D for SMILE Xtra and +0.03 ± 0.25 D for control (p = 0.021). The efficacy index was 0.88 ± 0.13 and 0.97 ± 0.06, respectively (p = 0.005). Conclusion. SMILE Xtra had good overall safety profile and predictability at 6 months. However, when compared with control, the safety index and efficacy index were statistically significantly lower in the early postoperative period.

  7. Improving outcomes of first‐episode psychosis: an overview

    PubMed Central

    Fusar‐Poli, Paolo; McGorry, Patrick D.; Kane, John M.

    2017-01-01

    Outcomes of psychotic disorders are associated with high personal, familiar, societal and clinical burden. There is thus an urgent clinical and societal need for improving those outcomes. Recent advances in research knowledge have opened new opportunities for ameliorating outcomes of psychosis during its early clinical stages. This paper critically reviews these opportunities, summarizing the state‐of‐the‐art knowledge and focusing on recent discoveries and future avenues for first episode research and clinical interventions. Candidate targets for primary universal prevention of psychosis at the population level are discussed. Potentials offered by primary selective prevention in asymptomatic subgroups (stage 0) are presented. Achievements of primary selected prevention in individuals at clinical high risk for psychosis (stage 1) are summarized, along with challenges and limitations of its implementation in clinical practice. Early intervention and secondary prevention strategies at the time of a first episode of psychosis (stage 2) are critically discussed, with a particular focus on minimizing the duration of untreated psychosis, improving treatment response, increasing patients’ satisfaction with treatment, reducing illicit substance abuse and preventing relapses. Early intervention and tertiary prevention strategies at the time of an incomplete recovery (stage 3) are further discussed, in particular with respect to addressing treatment resistance, improving well‐being and social skills with reduction of burden on the family, treatment of comorbid substance use, and prevention of multiple relapses and disease progression. In conclusion, to improve outcomes of a complex, heterogeneous syndrome such as psychosis, it is necessary to globally adopt complex models integrating a clinical staging framework and coordinated specialty care programmes that offer pre‐emptive interventions to high‐risk groups identified across the early stages of the disorder

  8. Core outcome sets for research and clinical practice.

    PubMed

    Chiarotto, Alessandro; Ostelo, Raymond W; Turk, Dennis C; Buchbinder, Rachelle; Boers, Maarten

    This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. A core outcome set is a minimum consensus-based set of outcomes that should be measured and reported in all clinical trials for a specific health condition and/or intervention. Issues surrounding outcome assessment, such as selective reporting and inconsistency across studies, can be addressed by the development of a core set. As suggested by key initiatives in this field (i.e. OMERACT and COMET), the development requires achieving consensus on: (1) core outcome domains and (2) core outcome measurement instruments. Different methods can be used to reach consensus, including: literature systematic reviews to inform the process, qualitative research with clinicians and patients, group discussions (e.g. nominal group technique), and structured surveys (e.g. Delphi technique). Various stakeholders should be involved in the process, with particular attention to patients. Several COSs have been developed for musculoskeletal conditions including a longstanding one for low back pain, IMMPACT recommendations on outcomes for chronic pain, and OMERACT COSs for hip, knee and hand osteoarthritis. There is a lack of COSs for neurological, geriatric, cardio-respiratory and pediatric conditions, therefore, future research could determine the value of developing COSs for these conditions. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

  9. Practice patterns and outcomes associated with early sedation depth in mechanically ventilated patients: a systematic review protocol.

    PubMed

    Stephens, Robert J; Dettmer, Matthew R; Roberts, Brian W; Fowler, Susan A; Fuller, Brian M

    2017-06-09

    Mechanical ventilation is a commonly performed intervention in critically ill patients. Frequently, these patients experience deep sedation early in their clinical course. Emerging data suggest that the practice of early deep sedation may negatively impact patient outcomes. The purpose of this review is to assess the world's literature to describe and determine the impact of early deep sedation on the outcomes of mechanically ventilated patients. Randomised controlled trials and non-randomised studies will be eligible for inclusion in this systematic review. With the assistance of a medical librarian, we will comprehensively search MEDLINE, Embase, Scopus, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews and Effects, and Cochrane Database of Systematic Reviews for peer-reviewed literature. Grey literature from appropriate professional society conferences, held from 2010 to 2017, will be reviewed manually. Two authors will independently review all search results, and disagreements will be resolved through arbitration by a third author. If appropriate, meta-analysis will be used for quantitative analysis of the data. Heterogeneity between studies will be assessed using the I 2 statistic. The proposed systematic review will not collect data that are associated with individual patients and does not require ethical approval. Results of this study will contribute to the understanding of early sedation, identify future research targets and guide early care in mechanically ventilated patients. This systematic review has been registered in the international prospective register of systematic reviews (PROSPERO #CRD42017057264). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. A Qualitative Study of US Clinical Ethics Services: Objectives and Outcomes.

    PubMed

    McClimans, Leah; Pressgrove, Geah; Rhea, James

    2016-01-01

    The quality of clinical ethics services in health care organizations is increasingly seen as an important aspect of the overall quality of care. But measuring this quality is difficult because there is a lack of clarity and consensus regarding the objectives of clinical ethics and the best outcome domains to measure. The aim of this qualitative study is to explore the views of experts about the objectives and outcomes of clinical ethics services in the US. We interviewed 19 experts in clinical ethics, focusing on the appropriate objectives and outcomes of a clinical ethics service (CES). Participants were selected using a purposive snowball sampling strategy. The development of the interview protocol was informed by the clinical ethics literature as well as by research and theories that inform clinical ethics practice. Interviews were conducted by phone, recorded, and transcribed for individual analysis. Analysis proceeded through the development of a codebook of categories using QDA Miner software. Our experts identified 12 objectives and nine outcomes. Some of these identifications were familiar (e.g., mediation and satisfaction) and some were novel (e.g., be of service and transformation). We found that experts are divided in their emphasis on the kinds of objectives that are most important. In terms of outcomes, our experts were concerned with the appropriateness of different proxy and direct measures. This study provides the perspectives of a select group of experts on the objectives and outcomes appropriate for a CES in the United States. The themes identified will be used in future research to inform a Delphi study to refine and obtain expert consensus.

  11. Common Factor Mechanisms in Clinical Practice and Their Relationship with Outcome.

    PubMed

    Gaitan-Sierra, Carolina; Hyland, Michael E

    2015-01-01

    This study investigates three common factor mechanisms that could affect outcome in clinical practice: response expectancy, the affective expectation model and motivational concordance. Clients attending a gestalt therapy clinic (30 clients), a sophrology (therapeutic technique) clinic (33 clients) and a homeopathy clinic (31 clients) completed measures of expectancy and the Positive Affect and Negative Affect Schedule (PANAS) before their first session. After 1 month, they completed PANAS and measures of intrinsic motivation, perceived effort and empowerment. Expectancy was not associated with better outcome and was no different between treatments. Although some of the 54 clients who endorsed highest expectations showed substantial improvement, others did not: 19 had no change or deteriorated in positive affect, and 18 had the same result for negative affect. Intrinsic motivation independently predicted changes in negative affect (β = -0.23). Intrinsic motivation (β = 0.24), effort (β = 0.23) and empowerment (β = 0.20) independently predicted positive affect change. Expectancy (β = -0.17) negatively affected changes in positive affect. Clients found gestalt and sophrology to be more intrinsically motivating, empowering and effortful compared with homeopathy. Greater improvement in mood was found for sophrology and gestalt than for homeopathy clients. These findings are inconsistent with response expectancy as a common factor mechanism in clinical practice. The results support motivational concordance (outcome influenced by the intrinsic enjoyment of the therapy) and the affective expectation model (high expectations can lead for some clients to worse outcome). When expectancy correlates with outcome in some other studies, this may be due to confound between expectancy and intrinsic enjoyment. Common factors play an important role in outcome. Intrinsic enjoyment of a therapeutic treatment is associated with better outcome. Active engagement with a

  12. Early Intervention Outcomes for Toddlers with Autism Spectrum Disorder and Their Families

    ERIC Educational Resources Information Center

    Noyes-Grosser, Donna M.; Elbaum, Batya; Wu, Yan; Siegenthaler, Kirsten M.; Cavalari, Rachel S.; Gillis, Jennifer M.; Romanczyk, Raymond G.

    2018-01-01

    Autism spectrum disorder (ASD) can be diagnosed as early as 18 months of age. State Early Intervention (EI) programs under Part C of the Individuals with Disabilities Education Act (IDEA) are serving increasing numbers of children with ASD; however, little is known about outcomes of these services. This study evaluated the impact of EI for…

  13. Clinical guideline for nurse-led early extubation after coronary artery bypass: an evaluation.

    PubMed

    Hawkes, Claire; Foxcroft, David R; Yerrell, Paul

    2010-09-01

    This paper is a report of an investigation of the development, implementation and outcomes of a clinical guideline for nurse-led early extubation of adult coronary artery bypass graft patients. Healthcare knowledge translation and utilization is an emerging but under-developed research area. The complex context for guideline development and use is methodologically challenging for robust and rigorous evaluation. This study contributes one such evaluation. This was a mixed methods evaluation, with a dominant quantitative study with a secondary qualitative study in a single UK cardiac surgery centre. An interrupted time series study (N = 567 elective coronary artery bypass graft patients) with concurrent within person controls was used to measure the impact of the guideline on the primary outcome: time to extubation. Semi-structured interviews with 11 clinical staff, informed by applied practitioner ethnography, explored the process of guideline development and implementation. The data were collected between January 2001 and January 2003. There was no change in the interrupted time series study primary outcome as a consequence of the guideline implementation. The qualitative study identified three themes: context, process and tensions highlighting that the guideline did not require clinicians to change their practice, although it may have helped maintain practice through its educative role. Further investigation and development of appropriate methods to capture the dynamism in healthcare contexts and its impact on guideline implementation seems warranted. Multi-site mixed methods investigations and programmes of research exploring knowledge translation and utilization initiatives, such as guideline implementation, are needed.

  14. Report on the Clinical Outcomes of Permanent Breast Seed Implant for Early-Stage Breast Cancers

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Pignol, Jean-Philippe, E-mail: j.p.pignol@erasmusmc.nl; Radiation Oncology Department, Erasmus Medical Center Cancer Institute, Rotterdam; Caudrelier, Jean-Michel

    Purpose: Permanent breast seed implant is an accelerated partial breast irradiation technique realizing the insertion of {sup 103}Pd seeds in the seroma after lumpectomy. We report the 5-year efficacy and tolerance for a cohort, pooling patients from 3 clinical trials. Methods and Materials: The trials accrued postmenopausal patients with infiltrating ductal carcinoma or ductal carcinoma in situ ≤3 cm and clear surgical margins, who were node negative, and had a planning target volume <120 cm{sup 3}. The outcomes included overall and disease-free survival and local and contralateral recurrence at 5 years. The true local recurrence rate was compared using 2-tailed paired t testsmore » for estimates calculated using the Tufts University ipsilateral breast tumor recurrence and Memorial Sloan Kettering ductal carcinoma in situ nomograms. Results: The cohort included 134 patients, and the observed local recurrence rate at a median follow-up period of 63 months was 1.2% ± 1.2%, similar to the estimate for whole breast irradiation (P=.23), significantly better than for surgery alone (relative risk 0.27; P<.001), and significantly lower than contralateral recurrence (relative risk 0.33; P<.001). The 5-year overall survival rate was 97.4% ± 1.9%, and the disease-free survival rate was 96.4% ± 2.1%. At 2 months, 42% of the patients had erythema, 20% induration, and 16% moist desquamation. The rate of mainly grade 1 telangiectasia was 22.4% at 2 years and 24% at 5 years. The rate of asymptomatic induration was 23% at 2 years and 40% at 5 years. Conclusions: The 5-year data suggest that permanent breast seed implantation is a safe accelerated partial breast irradiation option after lumpectomy for early-stage breast cancer with a tolerance profile similar to that of whole breast irradiation.« less

  15. Cognitive Impairment after Severe Traumatic Brain Injury, Clinical Course and Impact on Outcome: A Swedish-Icelandic Study

    PubMed Central

    Stenberg, Maud; Godbolt, Alison K.; Nygren De Boussard, Catharina; Levi, Richard; Stålnacke, Britt-Marie

    2015-01-01

    Objective. To assess the clinical course of cognitive and emotional impairments in patients with severe TBI (sTBI) from 3 weeks to 1 year after trauma and to study associations with outcomes at 1 year. Methods. Prospective, multicenter, observational study of sTBI in Sweden and Iceland. Patients aged 18–65 years with acute Glasgow Coma Scale 3–8 were assessed with the Barrow Neurological Institute Screen for Higher Cerebral Functions (BNIS) and the Hospital Anxiety and Depression Scale (HADS). Outcome measures were Glasgow Outcome Scale Extended (GOSE) and Rancho Los Amigos Cognitive Scale-Revised (RLAS-R). Results. Cognition was assessed with the BNIS assessed for 42 patients out of 100 at 3 weeks, 75 patients at 3 months, and 78 patients at 1 year. Cognition improved over time, especially from 3 weeks to 3 months. The BNIS subscales “orientation” and “visuospatial and visual problem solving” were associated with the GOSE and RLAS-R at 1 year. Conclusion. Cognition seemed to improve over time after sTBI and appeared to be rather stable from 3 months to 1 year. Since cognitive function was associated with outcomes, these results indicate that early screening of cognitive function could be of importance for rehabilitation planning in a clinical setting. PMID:26783381

  16. Consumer involvement in topic and outcome selection in the development of clinical practice guidelines.

    PubMed

    Tong, Allison; Lopez-Vargas, Pamela; Howell, Martin; Phoon, Richard; Johnson, David; Campbell, Denise; Walker, Rowan G; Craig, Jonathan C

    2012-12-01

    Consumer involvement in guideline development is advocated, but minimal participation, such as a nominated consumer representative on a guideline working group, can inhibit their decision-making power and contribution. Little is known about how to involve consumers more effectively in guideline development. To describe a targeted approach for involving consumers actively in guideline development, by focusing on topic and outcome selection, and to discuss the impact on content and structure of the final guideline. Descriptive study. Patients and carers (n = 24) from a tertiary hospital in Sydney attended three structured peer-facilitated workshops to complete group-based exercises on topic and outcome selection for guidelines for early stage chronic kidney disease. These workshops were run in parallel with the guideline-writing group. For each exercise, participants formed small groups and facilitated their own discussion, recorded their responses and presented them to the wider group. The topics and outcomes identified were fed back to the guideline writers. The participants actively engaged in the workshop discussions and articulated topics and outcomes they perceived should be included in clinical guidelines. Four main changes to guideline-related outputs were observed. A new guideline subtopic was introduced, guidelines were consumer-endorsed, guideline recommendations and suggestions for clinical care were augmented with consumer-focused issues, and plain English guidelines were developed. Consumer workshops in parallel and feeding into guideline development can be a feasible and effective approach for active consumer contribution. This process can inform the development of both consumer-focused guidelines for clinicians and specific versions for consumers. © 2011 Blackwell Publishing Ltd.

  17. TIAM1 variants improve clinical outcome in neuroblastoma.

    PubMed

    Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L; Cañete, Adela; Castel, Victoria; Font de Mora, Jaime

    2017-07-11

    Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma.

  18. Open Tibial Inlay PCL Reconstruction: Surgical Technique and Clinical Outcomes.

    PubMed

    Vellios, Evan E; Jones, Kristofer J; McAllister, David R

    2018-06-01

    To review the current literature on clinical outcomes following open tibial inlay posterior cruciate ligament (PCL) reconstruction and provide the reader with a detailed description of the author's preferred surgical technique. Despite earlier biomechanical studies which demonstrated superiority of the PCL inlay technique when compared to transtibial techniques, recent longitudinal cohort studies have shown no significant differences in clinical or functional outcomes at 10-year follow-up. Furthermore, no significant clinical differences have been shown between graft types used and/or single- versus double-bundle reconstruction methods. The optimal treatment for the PCL-deficient knee remains unclear. Open tibial inlay PCL reconstruction is safe, reproducible, and avoids the "killer turn" that may potentially lead to graft weakening and failure seen in transtibial reconstruction methods. No significant differences in subjective outcomes or clinical laxity have been shown between single-bundle versus double-bundle reconstruction methods.

  19. Adverse Experiences in Early Childhood and Kindergarten Outcomes.

    PubMed

    Jimenez, Manuel E; Wade, Roy; Lin, Yong; Morrow, Lesley M; Reichman, Nancy E

    2016-02-01

    To examine associations between adverse childhood experiences (ACEs) in early childhood and teacher-reported academic and behavioral problems in kindergarten. We conducted a secondary analysis of data from the Fragile Families and Child Wellbeing Study, a national urban birth cohort. Subjects with primary caregiver-reported information on ACE exposures ascertained at 5 years and teacher-reported outcomes at the end of the child's kindergarten year were included. Outcomes included teacher ratings of academic skills, emergent literacy skills, and behavior. We included 8 ACE exposures on the basis of the original Centers for Disease Control and Prevention Kaiser study and created an ACE score by summing individual adversities. We examined the associations between teacher-reported academic and behavioral outcomes and ACE scores by using logistic regression. In the study sample, 1007 children were included. Fifty-five percent had experienced 1 ACE and 12% had experienced ≥ 3. Adjusting for potential confounders, experiencing ≥ 3 ACEs was associated with below-average language and literacy skills (adjusted odds ratio [AORs]: 1.8; 95% confidence interval [CI]: 1.1-2.9) and math skills (AOR: 1.8, 95% CI: 1.1-2.9), poor emergent literacy skills, attention problems (AOR: 3.5, 95% CI: 1.8-6.5), social problems (AOR: 2.7, 95% CI: 1.4-5.0), and aggression (AOR: 2.3, 95% CI: 1.2-4.6). In this study of urban children, experiencing ACEs in early childhood was associated with below-average, teacher-reported academic and literacy skills and behavior problems in kindergarten. These findings underscore the importance of integrated approaches that promote optimal development among vulnerable children. Copyright © 2016 by the American Academy of Pediatrics.

  20. Pilot evaluation of parent-child interaction therapy delivered in an Australian community early childhood clinic setting.

    PubMed

    Phillips, Jane; Morgan, Susan; Cawthorne, Karen; Barnett, Bryanne

    2008-08-01

    Parent-child interaction therapy (PCIT) is a short-term, evidence-based parent training intervention used widely in the treatment of behaviourally disordered preschool-aged children. Outcome studies have shown PCIT to be associated with lasting improvements in child and sibling behaviours and in the interactional styles, stress levels, confidence, and psychological functioning of parents. To date, however, all outcome studies have been conducted in university research clinic settings, and therefore understanding about the effectiveness of PCIT applied in a real-world setting has been limited. The present study evaluated the effectiveness of PCIT delivered to families in an Australian community-based early childhood clinic. Participants included 43 families with children aged 19-52 months who were referred for treatment of disruptive child behaviours and who completed PCIT treatment at the Karitane Toddler Clinic, in Sydney, Australia. Parents provided pre- and post-treatment ratings of child behaviours, parental stress, parental psychopathology and parental attitudes to therapy. At the end of the programme, clinically and statistically significant improvements were seen in child behaviours and parental well-being, and parents reported high levels of satisfaction with treatment. Implications for the implementation of PCIT programmes in community-based settings are discussed and areas of further research are identified.

  1. Clinical Course, Radiological Manifestations, and Outcome of Pneumocystis jirovecii Pneumonia in HIV Patients and Renal Transplant Recipients.

    PubMed

    Ebner, Lukas; Walti, Laura N; Rauch, Andri; Furrer, Hansjakob; Cusini, Alexia; Meyer, Andreas M J; Weiler, Stefan; Huynh-Do, Uyen; Heverhagen, Johannes; Arampatzis, Spyridon; Christe, Andreas

    2016-01-01

    Pneumocystis jirovecii pneumonia (PCP) is a frequent opportunistic infection in immunocompromised patients. In literature, presentation and outcome of PCP differs between patients with human immunodeficiency virus (HIV) infection and renal transplant recipients (RTRs). We conducted a cross-sectional study of patients with PCP based on the HIV and renal transplant registries at our institution. Radiological and clinical data from all confirmed PCP cases between 2005 and 2012 were compared. Forty patients were included: 16 with HIV and 24 RTRs. Radiologically, HIV patients had significantly more areas of diffuse lung affection (81% HIV vs. 25% RTR; p = 0.02), more ground glass nodules 5-10 mm (69% vs. 4%; p = <0.001) and enlarged hilar lymph nodes were found only in HIV patients (44%). Cough and dyspnea were the most common clinical signs (>80%) in both groups. Duration from illness onset to hospital presentation was longer in the HIV patients (median of 18 vs. 10 days (p = 0.02)), implying a less fulminant clinical course. Sixty percent of PCP cases in RTRs occurred >12 months after transplantation. Lengths of hospitalization, admission rates to the intensive care unit, and requirements for mechanical ventilation were similar. Outcome in both groups was favourable. While important differences in radiological presentation of PCP between HIV patients and RTRs were found, clinical presentation was similar. PCP only rarely presented with fulminant respiratory symptoms requiring ICU admission, with similar results and outcomes for HIV patients and RTRs. Early diagnosis and treatment is mandatory for clinical success.

  2. Early Head Start and African American Families: Impacts and Mechanisms of Child Outcomes

    ERIC Educational Resources Information Center

    Harden, Brenda Jones; Sandstrom, Heather; Chazan-Cohen, Rachel

    2012-01-01

    Persistent disparities exist between African American children and their European American counterparts across developmental domains. Early childhood intervention may serve to promote more positive outcomes among African American children. The current study examined whether and how the Early Head Start (EHS) program benefited African American…

  3. Outcomes of subsequent pregnancy after first pregnancy with early-onset preeclampsia.

    PubMed

    van Rijn, Bas B; Hoeks, Lette B; Bots, Michiel L; Franx, Arie; Bruinse, Hein W

    2006-09-01

    The aim of this study was to report outcome of subsequent pregnancy after early-onset preeclampsia in first pregnancy, and to evaluate potential risk factors for recurrence of preeclampsia and preterm delivery. Reproductive follow-up data were obtained for women with a history of early-onset preeclampsia, resulting in delivery before 34 weeks of gestation at the University Medical Center Utrecht, The Netherlands, between July 1993 and September 2002. The relative contributions of demographic data, outcome variables of first pregnancy, and common thrombophilias to the recurrence risk of preeclampsia and preterm delivery in subsequent pregnancy, were estimated by Cox proportional hazard models. Subsequent pregnancy outcome data were available for 120 women. Overall, preeclampsia reoccurred in the second pregnancy in 30 women (25%). However, 6 women delivered before 34 weeks of gestation (5%), 20 women between 34 and 37 weeks of gestation (17%), and 94 women after 37 weeks of gestation (78%). Forty-one women (34%) had an uneventful pregnancy. Recurrence rates for preeclampsia or preterm delivery were not related to severity of first pregnancy complications, including delivery before 28 weeks of gestation, occurrence of hemolysis, elevated liver enzymes, and low platelet count syndrome, small-for-gestational age infants, and to hereditary or acquired thrombophilias. Chronic hypertension was related to a higher recurrence risk of preeclampsia in the second pregnancy (hazard ratio 2.1, 95% CI 1.0-4.4), and smoking was related to a higher recurrence risk of preterm birth (hazard ratio 2.4, 95% CI 1.1-5.6). Outcomes of subsequent pregnancy after first pregnancy with early-onset preeclampsia is generally favorable.

  4. Cortisol Reactivity to Social Stress as a Mediator of Early Adversity on Risk and Adaptive Outcomes

    ERIC Educational Resources Information Center

    Conradt, Elisabeth; Abar, Beau; Lester, Barry M.; LaGasse, Linda L.; Shankaran, Seetha; Bada, Henrietta; Bauer, Charles R.; Whitaker, Toni M.; Hammond, Jane A.

    2014-01-01

    Children chronically exposed to stress early in life are at increased risk for maladaptive outcomes, though the physiological mechanisms driving these effects are unknown. Cortisol reactivity was tested as a mediator of the relation between prenatal substance exposure and/or early adversity on adaptive and maladaptive outcomes. Data were drawn…

  5. Early Imaging and Adverse Neurodevelopmental Outcome in Asphyxiated Newborns Treated With Hypothermia.

    PubMed

    Al Amrani, Fatema; Kwan, Saskia; Gilbert, Guillaume; Saint-Martin, Christine; Shevell, Michael; Wintermark, Pia

    2017-08-01

    Brain injury can be identified as early as day two of life in asphyxiated newborns treated with hypothermia, when using diffusion magnetic resonance imaging (MRI). However, it remains unclear whether these diffusion changes can predict future neurodevelopment. This study aimed to determine whether abnormal early diffusion changes in newborns treated with hypothermia are associated with adverse neurodevelopmental outcome at age two years. Asphyxiated newborns treated with hypothermia were enrolled prospectively. They underwent magnetic resonance imaging (MRI) at specific time points over the first month of life, including diffusion-weighted imaging and diffusion-tensor imaging. Apparent diffusion coefficient (ADC) and fractional anisotropy (FA) values were measured in different regions of interest. Adverse neurodevelopmental outcome was defined as cerebral palsy, global developmental delay, and/or seizure disorder around age two years. ADC and FA values were compared between the newborns developing or not developing adverse outcome. Twenty-nine asphyxiated newborns treated with hypothermia were included. Among the newborns developing adverse outcome, ADC values were significantly decreased on days two to three of life and increased around day ten of life in the thalamus, posterior limb of the internal capsule, and the lentiform nucleus. FA values decreased in the same regions around day 30 of life. These newborns also had increased ADC around day ten of life and around day 30 of life, and decreased FA around day 30 of life in the anterior and posterior white matter. Diffusion changes that were evident as early as day two of life, when the asphyxiated newborns were still treated with hypothermia, were associated with later abnormal neurodevelopmental outcome. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. 77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ...] Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing... ``Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing... for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and...

  7. Early Educational Intervention, Early Cumulative Risk, and the Early Home Environment as Predictors of Young Adult Outcomes Within a High-Risk Sample

    PubMed Central

    Pungello, Elizabeth P.; Kainz, Kirsten; Burchinal, Margaret; Wasik, Barbara H.; Sparling, Joseph J.; Ramey, Craig T.; Campbell, Frances A.

    2009-01-01

    The extent to which early educational intervention, early cumulative risk, and the early home environment were associated with young adult outcomes was investigated in a sample of 139 young adults (age 21) from high-risk families enrolled in randomized trials of early intervention. Positive effects of treatment were found for education attainment, attending college, and skilled employment; negative effects of risk were found for education attainment, graduating high school, being employed and avoiding teen parenthood. The home mediated the effects of risk for graduating high school, but not being employed or teen parenthood. Evidence for moderated mediation was found for educational attainment; the home mediated the association between risk and educational attainment for the control group, but not the treated group. PMID:20331676

  8. Clinical and Functional Outcome of Childhood ADHD 33 Years Later

    PubMed Central

    Klein, Rachel G.; Mannuzza, Salvatore; Ramos Olazagasti, María A.; Roizen Belsky, Erica; Hutchison, Jesse A.; Lashua-Shriftman, Erin; Castellanos, F. Xavier

    2012-01-01

    Context Prospective studies of childhood attention deficit/hyperactivity disorder (ADHD) have not extended beyond early adulthood. Objective To test whether children diagnosed with ADHD at mean age 8 (probands) have worse educational, occupational, economic, social, marital outcomes; higher rates of ongoing ADHD, antisocial personality disorder (ASPD), substance disorders (SD); adult onset psychiatric disorders, psychiatric hospitalizations and incarcerations, than non-ADHD comparisons, at mean age 41. To test for: positive associations between probands’ ongoing ADHD and ASPD, and SD’s; and for worse social and occupational functioning in probands without ongoing psychiatric disorders, than comparisons. Design Prospective, 33 year follow-up study, with blind clinical assessments. Setting Research clinic. Participants 135 Caucasian males with ADHD in childhood, free of conduct disorder, and 136 male comparisons without childhood ADHD (65% and 76% of original cohort, respectively). Main Outcome Measures Occupational, economic, and educational attainment; marital history; occupational and social functioning; ongoing and lifetime psychiatric disorders; psychiatric hospitalizations, and incarcerations. Results Probands had significantly worse educational, occupational, economic, social outcomes, and more divorces than comparisons; higher rates of ongoing ADHD (22% vs 5%, p<.001), ASPD (16% vs 0%, p<.001)and SD (14% vs 5%, p<.01), but not more mood or anxiety disorders (p’s=.36 and .33). Ongoing ADHD was weakly related to ongoing SD (phi=.19, p=.04), and ASPD+SD (phi=.20, p=.04). Lifetime, probands had significantly more ASPD and SD’s, but not mood or anxiety disorders, and more psychiatric hospitalizations and incarcerations than comparisons. Relative to comparisons, psychiatric disorders with onsets at age 21 or beyond were not significantly elevated in probands. Probands without ongoing psychiatric disorders had worse social, but not occupational, functioning

  9. Impact of live interactive teledermatology on diagnosis, disease management, and clinical outcomes.

    PubMed

    Lamel, Sonia; Chambers, Cindy J; Ratnarathorn, Mondhipa; Armstrong, April W

    2012-01-01

    To assess the impact of live interactive teledermatology consultations on changes in diagnosis, disease management, and clinical outcomes. We conducted a retrospective analysis of 1500 patients evaluated via live interactive teledermatology between 2003 and 2005 at the University of California, Davis. We compared diagnoses and treatment plans between the referring physicians and the teledermatologists. Patients with 2 or more teledermatology visits within a 1-year period were assessed for changes in clinical outcomes. Academic medical center with an established teledermatology program since 1996. Medical records were evaluated for 1500 patients who underwent live interactive teledermatology consultation. Patients seen for more than 1 teledermatology visit were included in the clinical outcome assessment. Live interactive teledermatology consultation. Changes in diagnosis, disease management, and clinical outcome. Compared with diagnoses and treatment plans from referring physicians, the 1500 live interactive teledermatology consultations resulted in changes in diagnosis in 69.9% of patients and changes in disease management in 97.7% of patients. Among 313 patients with at least 2 teledermatology visits within 1 year, clinical improvement was observed in 68.7% of patients. Multivariate analysis showed that changes in diagnosis (P = .01), changes in disease management (P < .001), and the number of teledermatology visits (P < .001) were significantly associated with improved clinical outcomes. Live interactive teledermatology consultations result in changes in diagnosis and disease management in most consultations. The numbers of live interactive teledermatology visits and changes in diagnosis and disease management are significantly associated with improved clinical outcomes.

  10. Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

    PubMed

    Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

    2017-04-01

    Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of

  11. Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

    PubMed

    Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

    2012-10-01

    Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

  12. An early, novel illness severity score to predict outcome after cardiac arrest.

    PubMed

    Rittenberger, Jon C; Tisherman, Samuel A; Holm, Margo B; Guyette, Francis X; Callaway, Clifton W

    2011-11-01

    Illness severity scores are commonly employed in critically ill patients to predict outcome. To date, prior scores for post-cardiac arrest patients rely on some event-related data. We developed an early, novel post-arrest illness severity score to predict survival, good outcome and development of multiple organ failure (MOF) after cardiac arrest. Retrospective review of data from adults treated after in-hospital or out-of-hospital cardiac arrest in a single tertiary care facility between 1/1/2005 and 12/31/2009. In addition to clinical data, initial illness severity was measured using serial organ function assessment (SOFA) scores and full outline of unresponsiveness (FOUR) scores at hospital or intensive care unit arrival. Outcomes were hospital mortality, good outcome (discharge to home or rehabilitation) and development of multiple organ failure (MOF). Single-variable logistic regression followed by Chi-squared automatic interaction detector (CHAID) was used to determine predictors of outcome. Stepwise multivariate logistic regression was used to determine the independent association between predictors and each outcome. The Hosmer-Lemeshow test was used to evaluate goodness of fit. The n-fold method was used to cross-validate each CHAID analysis and the difference between the misclassification risk estimates was used to determine model fit. Complete data from 457/495 (92%) subjects identified distinct categories of illness severity using combined FOUR motor and brainstem subscales, and combined SOFA cardiovascular and respiratory subscales: I. Awake; II. Moderate coma without cardiorespiratory failure; III. Moderate coma with cardiorespiratory failure; and IV. Severe coma. Survival was independently associated with category (I: OR 58.65; 95% CI 27.78, 123.82; II: OR 14.60; 95% CI 7.34, 29.02; III: OR 10.58; 95% CI 4.86, 23.00). Category was also similarly associated with good outcome and development of MOF. The proportion of subjects in each category changed

  13. Acute viral bronchiolitis: Physician perspectives on definition and clinically important outcomes.

    PubMed

    Fernandes, Ricardo M; Andrade, Maria Gabriela; Constant, Carolina; Malveiro, Duarte; Magalhães, Manuel; Abreu, Daisy; Azevedo, Inês; Sousa, Eduarda; Salgado, Rizério; Bandeira, Teresa

    2016-07-01

    Two key limitations hamper intervention research in bronchiolitis: the absence of a clear definition of disease, and the heterogeneous choice of outcome measures in current clinical trials. We assessed how paediatricians and general practitioners (GPs) perceived definition and clinically important outcomes in bronchiolitis. A nationwide online survey (ABBA study) was conducted through the Portuguese Society of Paediatrics and GPs' mailing lists. We assessed agreement with statements on bronchiolitis definition, and participants were asked to score the relative importance of several outcomes. Principal component analysis (PCA) explored dimensions underlying disease definition. Outcomes were ranked by mean score and proportion given highest score. We included 514 paediatricians and 165 GPs (overall 59% were board-certified). Most paediatricians (76.5%) agreed with a definition based on coryza, wheezing and/or crackles/rales, compared to 38.1% GPs (P < 0.001). Less than 5% physicians agreed with a definition commonly used in clinical trials (<12 months, first episode of wheeze). We retained three dimensions on PCA: one based on coryza, rales/crepitations and no sudden onset; another on number of episodes and age; and a third on wheeze. Dimensions varied by physician specialization and training (P < 0.01). Hospital admission and respiratory distress were top rated outcomes by both groups of physicians. Physician definitions of bronchiolitis have considerable variability and often mismatch those of clinical trials. Rating of important outcomes was consistent. Our results highlight the need for a robust standardized definition of acute bronchiolitis in infants and support the development of a core outcome set for future clinical trials. Pediatr Pulmonol. 2016;51:724-732. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  14. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial

    PubMed Central

    Bakitas, Marie A.; Tosteson, Tor D.; Li, Zhigang; Lyons, Kathleen D.; Hull, Jay G.; Li, Zhongze; Dionne-Odom, J. Nicholas; Frost, Jennifer; Dragnev, Konstantin H.; Hegel, Mark T.; Azuero, Andres; Ahles, Tim A.

    2015-01-01

    Purpose Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use. Patients and Methods Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location). Results Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60). Conclusion Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority. PMID:25800768

  15. Alberta Stroke Program Early CT Score-Time Score Predicts Outcome after Endovascular Therapy in Patients with Acute Ischemic Stroke: A Retrospective Single-Center Study.

    PubMed

    Todo, Kenichi; Sakai, Nobuyuki; Kono, Tomoyuki; Hoshi, Taku; Imamura, Hirotoshi; Adachi, Hidemitsu; Yamagami, Hiroshi; Kohara, Nobuo

    2018-04-01

    Clinical outcomes after successful endovascular therapy in patients with acute ischemic stroke are associated with several factors including onset-to-reperfusion time (ORT), the National Institute of Health Stroke Scale (NIHSS) score, and the Alberta Stroke Program Early CT Score (ASPECTS). The NIHSS-time score, calculated as follows: [NIHSS score] × [onset-to-treatment time (h)] or [NIHSS score] × [ORT (h)], has been reported to predict clinical outcomes after intravenous recombinant tissue plasminogen activator therapy and endovascular therapy for acute stroke. The objective of the current study was to assess whether the combination of the ASPECTS and the ORT can predict the outcomes after endovascular therapy. The charts of 117 consecutive ischemic stroke patients with successful reperfusion after endovascular therapy were retrospectively reviewed. We analyzed the association of ORT, ASPECTS, and ASPECTS-time score with clinical outcome. ASPECTS-time score was calculated as follows: [11 - ASPECTS] × [ORT (h)]. Rates of good outcome for patients with ASPECTS-time scores of tertile values, scores 5.67 or less, scores greater than 5.67 to 10.40 or less, and scores greater than 10.40, were 66.7%, 56.4%, and 33.3%, respectively (P < .05). Ordinal logistic regression analysis showed that the ASPECTS-time score (per category increase) was an independent predictor for better outcome (common odds ratio: .374; 95% confidence interval: .150-0.930; P < .05). A lower ASPECTS-time score may predict better clinical outcomes after endovascular treatment. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  16. Early skin toxicity predicts better outcomes, and early tumor shrinkage predicts better response after cetuximab treatment in advanced colorectal cancer.

    PubMed

    Kogawa, T; Doi, A; Shimokawa, M; Fouad, T M; Osuga, T; Tamura, F; Mizushima, T; Kimura, T; Abe, S; Ihara, H; Kukitsu, T; Sumiyoshi, T; Yoshizaki, N; Hirayama, M; Sasaki, T; Kawarada, Y; Kitashiro, S; Okushiba, S; Kondo, H; Tsuji, Y

    2015-03-01

    Cetuximab-containing treatments for metastatic colorectal cancer have been shown to have higher overall response rates and longer progression-free and overall survival than other systemic therapies. Cetuximab-related manifestations, including severe skin toxicity and early tumor shrinkage, have been shown to be predictors of response to cetuximab. We hypothesized that early skin toxicity is a predictor of response and better outcomes in patients with advanced colorectal carcinoma. We retrospectively evaluated 62 patients with colorectal adenocarcinoma who had unresectable tumors and were treated with cetuximab in our institution. Skin toxicity grade was evaluated on each treatment day. Tumor size was evaluated using computed tomography prior to treatment and 4-8 weeks after the start of treatment with cetuximab.Patients with early tumor shrinkage after starting treatment with cetuximab had a significantly higher overall response rate (P = 0.0001). Patients with early skin toxicity showed significantly longer overall survival (P = 0.0305), and patients with higher skin toxicity grades had longer progression-free survival (P = 0.0168).We have shown that early tumor shrinkage, early onset of skin toxicity, and high skin toxicity grade are predictors of treatment efficacy and/or outcome in patients with advanced colorectal carcinoma treated with cetuximab.

  17. [Clinical predictors correlated to outcome of war missile penetrating brain injury].

    PubMed

    Splavski, Bruno; Vranković, Duro; Saftić, Robert; Muzević, Dario; Kosuta, Maja; Gmajnić, Rudika

    2006-09-01

    The purpose of this retrospective study was to review and discuss the outcome of surgical management and other clinical predictors influencing the prognosis of war missile penetrating brain injuries. To determine clinical predictors that influence the prognosis of war missile penetrating brain injury, 126 surgically treated patients who had sustained such an injury during the two-year period of war in Croatia (1991-1993) were retrospectively analyzed. Investigated clinical features were: Glasgow Coma Scale (GCS) score on admission; extent of brain injury; time between injury and hospital admission; presence of intracranially retained foreign bodies or bone fragments; development of postinjury and posttraumatic complications; and Glasgow Outcome Score (GOS) at six-month follow up. The data were statistically analyzed. Sixty-seven patients survived penetrating missile brain injury, in most of them with GCS score above 8 on admission. The mean time interval to hospital admission in this group of patients was less than two hours. Twelve of 67 patients developed different complications. All patients recovered well according to GOS (GOS 5 and 4) at six-month follow up. Fifty-nine patients died. The wounded who were in moribund state on the hospital admission (n = 11), and those who died during surgery (n = 8) were excluded from the analysis. The remaining 40 patients who did not survive were analyzed. The majority of them had GCS score 3-8 on admission. They mostly sustained bilateral hemispheric lesion, and/or ventricular lesion, and developed brain edema. The mean time interval between injury and hospital admission was over two hours in this group of patients. Postoperative complication developed in 9 of 40 patients. The patients with GCS score exceeding 8 had by far more favorable outcome in comparison to those with GCS score less than 8. Considering the extent of injury, patients suffering unihemispheric brain wounds had a more favorable outcome than those with

  18. Minimally invasive posterior cervical decompression using tubular retractor: The technical note and early clinical outcome

    PubMed Central

    Hur, Jung-Woo; Kim, Jin-Sung; Shin, Myeong-Hoon; Ryu, Kyeong-Sik

    2014-01-01

    Background: The aim of this work is to present a novel decompression technique that approaches cervical spine posteriorly, but through minimal invasive method using tubular retractor avoiding detachment of posterior musculature. Methods: Six patients underwent minimally invasive posterior cervical decompression using the tubular retractor system and surgical microscope. Minimally invasive access to the posterior cervical spine was performed with exposure through a paramedian muscle-splitting approach. With the assistance of a specialized tubular retraction system and deep soft tissue expansion mechanism, multilevel posterior cervical decompression could be accomplished. This approach also allows safe docking of the retractor system on the lateral mass, thus avoiding the cervical spinal canal during exposure. A standard operating microscope was used with ×10 magnification and 400 mm focal length. The hospital charts, magnetic resonance imaging studies, and follow-up records of all the patients were reviewed. Outcome was assessed by neurological status and visual analog scale (VAS) for neck and arm pain. Results: There was no significant complication related to operation. The follow-up time was 4-12 months (mean, 9 months). Muscle weakness improved in all patients; sensory deficits resolved in four patients and improved in two patients. Analysis of the mean VAS for radicular pain and VAS for neck pain showed significant improvement. Conclusions: The preliminary experiences with good clinical outcome seem to promise that this minimally invasive technique is a valid alternative option for the treatment of cervical spondylotic myelopathy. PMID:24778922

  19. Patient's perceptions of chronic kidney disease and their association with psychosocial and clinical outcomes: a narrative review

    PubMed Central

    Clarke, Amy L.; Yates, Thomas; Smith, Alice C.; Chilcot, Joseph

    2016-01-01

    Patients with chronic kidney disease (CKD) form organized beliefs regarding their illness and treatment. These perceptions influence the coping strategies employed by an individual to manage his/her illness and may act as a predictor for his/her willingness to engage in self-management behaviours. While illness perceptions have been identified as predictors of non-adherence, depression and mortality in dialysis patients, there is a paucity of research in CKD patients not requiring renal replacement therapy. This narrative review synthesizes the existing literature regarding the role of illness perceptions and associated clinical and psychosocial outcomes in non-dialysis CKD patients. Studies were identified following database searches of AMED, BNI, CINAHL, EMBASE, Health Business Elite, HMIC, Medline, PsycINFO and Google Scholar in January 2016. Despite the small evidence base, existing studies indicate that negative illness perceptions are associated with disease progression and a number of psychosocial outcomes in non-dialysis CKD patients. Evidence from other clinical populations suggests that illness perceptions are modifiable through psychological intervention, which may be most effective if delivered early before beliefs have the chance to become more established. Therefore, targeting illness perceptions in the earlier stages of CKD may be optimal. Further studies are now required to ascertain the mechanisms through which illness perceptions predict psychosocial and clinical outcomes in CKD patients and to ultimately test the efficacy of illness perception–based interventions. PMID:27274839

  20. Patient's perceptions of chronic kidney disease and their association with psychosocial and clinical outcomes: a narrative review.

    PubMed

    Clarke, Amy L; Yates, Thomas; Smith, Alice C; Chilcot, Joseph

    2016-06-01

    Patients with chronic kidney disease (CKD) form organized beliefs regarding their illness and treatment. These perceptions influence the coping strategies employed by an individual to manage his/her illness and may act as a predictor for his/her willingness to engage in self-management behaviours. While illness perceptions have been identified as predictors of non-adherence, depression and mortality in dialysis patients, there is a paucity of research in CKD patients not requiring renal replacement therapy. This narrative review synthesizes the existing literature regarding the role of illness perceptions and associated clinical and psychosocial outcomes in non-dialysis CKD patients. Studies were identified following database searches of AMED, BNI, CINAHL, EMBASE, Health Business Elite, HMIC, Medline, PsycINFO and Google Scholar in January 2016. Despite the small evidence base, existing studies indicate that negative illness perceptions are associated with disease progression and a number of psychosocial outcomes in non-dialysis CKD patients. Evidence from other clinical populations suggests that illness perceptions are modifiable through psychological intervention, which may be most effective if delivered early before beliefs have the chance to become more established. Therefore, targeting illness perceptions in the earlier stages of CKD may be optimal. Further studies are now required to ascertain the mechanisms through which illness perceptions predict psychosocial and clinical outcomes in CKD patients and to ultimately test the efficacy of illness perception-based interventions.

  1. An updated systematic review and meta-analysis of early outcomes after left atrial appendage occlusion.

    PubMed

    Yerasi, Charan; Lazkani, Mohamad; Kolluru, Prathik; Miryala, Varun; Kim, Jae; Moole, Harsha; Sawant, Abhishek C; Morris, Michael; Pershad, Ashish

    2018-04-01

    Left atrial appendage occlusion (LAAO) is a promising intervention for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Early outcomes following LAAO have been published in many studies with variable results. This updated meta-analysis aims to provide a summary of the early outcomes of LAAO. Medline/Pubmed, Ovid Journals, Clinical trials, Abstract meetings, Cochrane databases were searched from January 1st, 1999 to November 30th, 2016. This meta-analysis included 49 studies involving 12 415 patients. The median age was 73.5 years (IQR 72-75 years) and 43% were males. Hypertension and diabetes were present in 36% and 15% of the population, respectively. There was a prior history of stroke and congestive heart failure in 14% and 18% of the population, respectively. The median CHADS 2 score was 2.9 (IQR 2.6-3.3) and the median HASBLED score was 3.3 (IQR 3-4). LAAO implantation was successful in 96.3% of patients (95.40-97.08, I 2  = 76.1%). The pooled proportion of all-cause mortality was 0.28% (0.19-0.38, I 2  = 0%). The pooled proportion of all-cause stroke was 0.31% (0.22-0.42, I 2  = 9.4%), major bleeding requiring transfusion was 1.71% (1.13-2.41, I 2  = 73.2%), and pericardial effusion was 3.25% (2.46-4.14, I 2  = 79%). Sub analysis of randomized clinical trials comparing LAAO devices to warfarin showed lower mortality (P = 0.03) with similar bleeding risk (P = 0.20) with LAAO. This meta-analysis concludes that LAAO occlusion is a safe and effective stroke prevention strategy in patients with NVAF. © 2018, Wiley Periodicals, Inc.

  2. Outcome Measures for Clinical Trials in Down Syndrome

    PubMed Central

    Esbensen, Anna J.; Hooper, Stephen R.; Fidler, Deborah; Hartley, Sigan; Edgin, Jamie; d’Ardhuy, Xavier Liogier; Capone, George; Conners, Frances; Mervis, Carolyn B.; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J.; Urv, Tiina

    2017-01-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the NIH assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This paper focuses on measures in the areas of cognition and behavior. PMID:28452584

  3. Glutamine Randomized Studies in Early Life: The Unsolved Riddle of Experimental and Clinical Studies

    PubMed Central

    Briassouli, Efrossini; Briassoulis, George

    2012-01-01

    Glutamine may have benefits during immaturity or critical illness in early life but its effects on outcome end hardpoints are controversial. Our aim was to review randomized studies on glutamine supplementation in pups, infants, and children examining whether glutamine affects outcome. Experimental work has proposed various mechanisms of glutamine action but none of the randomized studies in early life showed any effect on mortality and only a few showed some effect on inflammatory response, organ function, and a trend for infection control. Although apparently safe in animal models (pups), premature infants, and critically ill children, glutamine supplementation does not reduce mortality or late onset sepsis, and its routine use cannot be recommended in these sensitive populations. Large prospectively stratified trials are needed to better define the crucial interrelations of “glutamine-heat shock proteins-stress response” in critical illness and to identify the specific subgroups of premature neonates and critically ill infants or children who may have a greater need for glutamine and who may eventually benefit from its supplementation. The methodological problems noted in the reviewed randomized experimental and clinical trials should be seriously considered in any future well-designed large blinded randomized controlled trial involving glutamine supplementation in critical illness. PMID:23019424

  4. Survival Outcomes and Effect of Early vs. Deferred cART Among HIV-Infected Patients Diagnosed at the Time of an AIDS-Defining Event: A Cohort Analysis

    PubMed Central

    Mussini, Cristina; Johnson, Margaret; d'Arminio Monforte, Antonella; Antinori, Andrea; Gill, M. John; Sighinolfi, Laura; Uberti-Foppa, Caterina; Borghi, Vanni; Sabin, Caroline

    2011-01-01

    Objectives We analyzed clinical progression among persons diagnosed with HIV at the time of an AIDS-defining event, and assessed the impact on outcome of timing of combined antiretroviral treatment (cART). Methods Retrospective, European and Canadian multicohort study.. Patients were diagnosed with HIV from 1997–2004 and had clinical AIDS from 30 days before to 14 days after diagnosis. Clinical progression (new AIDS event, death) was described using Kaplan-Meier analysis stratifying by type of AIDS event. Factors associated with progression were identified with multivariable Cox regression. Progression rates were compared between those starting early (<30 days after AIDS event) or deferred (30–270 days after AIDS event) cART. Results The median (interquartile range) CD4 count and viral load (VL) at diagnosis of the 584 patients were 42 (16, 119) cells/µL and 5.2 (4.5, 5.7) log10 copies/mL. Clinical progression was observed in 165 (28.3%) patients. Older age, a higher VL at diagnosis, and a diagnosis of non-Hodgkin lymphoma (NHL) (vs. other AIDS events) were independently associated with disease progression. Of 366 patients with an opportunistic infection, 178 (48.6%) received early cART. There was no significant difference in clinical progression between those initiating cART early and those deferring treatment (adjusted hazard ratio 1.32 [95% confidence interval 0.87, 2.00], p = 0.20). Conclusions Older patients and patients with high VL or NHL at diagnosis had a worse outcome. Our data suggest that earlier initiation of cART may be beneficial among HIV-infected patients diagnosed with clinical AIDS in our setting. PMID:22043301

  5. Commentary: On the Importance of Early Life Cognitive Abilities in Shaping Later Life Outcomes.

    PubMed

    Hofer, Scott M; Clouston, Sean

    2014-01-01

    Early life cognitive ability is likely to be dynamically related to life course factors including educational attainment, occupational outcomes, health behaviors, activities, health, and subsequent cognitive health. Disentangling the selective and causal processes contributing to cognitive functioning across the lifespan is challenging and requires long-term investments in longitudinal data. We discuss results from several analyses using data from the Individual Development and Adaptation longitudinal research program (Bergman, 2000; Magnusson, 1988) that provide fresh insights into the relation of early life cognition, particularly high levels of cognitive capabilities, to educational achievement, emotional adjustment, and career success. These papers and the longitudinal data provide a remarkable window into the development and impacts of cognition, and high cognitive functioning, on a variety of important life outcomes that we hope will continue to inform us about additional outcomes in middle life, transition to retirement, and cognition and health in later years and to robustly examine how the early years matter across the whole lifespan.

  6. Effects of Early Leader-Member Exchange Perceptions on Academic Outcomes

    ERIC Educational Resources Information Center

    Jacques, Paul H.; Garger, John; Thomas, Michael; Vracheva, Veselina

    2012-01-01

    This study tested a series of hypotheses linking college support and quality of student-instructor relations with outcomes including student efficacy, social connectedness with peers, expectancies and academic performance. Early quality of exchanges with the instructor using Leader-Member Exchange theory was found to be a key indicator of academic…

  7. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study

    PubMed Central

    Maksymowych, Walter P; Dougados, Maxime; Sieper, Joachim; Braun, Jürgen; Citera, Gustavo; Van den Bosch, Filip; Logeart, Isabelle; Wajdula, Joseph; Jones, Heather; Marshall, Lisa; Bonin, Randi; Pedersen, Ron; Vlahos, Bonnie; Kotak, Sameer; Bukowski, Jack F

    2016-01-01

    Objective To evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA). Methods Patients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50 mg/week or placebo (PBO) for 12 weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here. Results 208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by −1.1 for ETN/ETN and by −3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48. Conclusions Patients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48 weeks. Trial registration number NCT01258738. PMID:26269397

  8. Clinical and radiographic outcomes of thoracic and lumbar pedicle subtraction osteotomy for fixed sagittal imbalance.

    PubMed

    Yang, Benson P; Ondra, Stephen L; Chen, Larry A; Jung, Hee Soo; Koski, Tyler R; Salehi, Sean A

    2006-07-01

    The authors conducted a study to evaluate the radiographically documented and functional outcomes obtained in patients who underwent pedicle subtraction osteotomy (PSO). They also compared outcomes after classification of cases into thoracic and lumbar PSO subgroups. The authors analyzed data obtained in 35 consecutive PSO-treated patients with sagittal imbalance. One surgeon performed all surgeries. The minimal follow-up period was 2 years. Events during the perioperative course and complications were noted. Standing long-film radiographs of the spine were obtained and measurements were made preoperatively, immediately postoperatively, and at most recent follow-up examination. The modified Prolo Scale and the 22-item Scoliosis Research Society (SRS-22) Outcomes Questionnaire were administered. Early complications after PSO included neurological injury, wound-related problems, and nosocomial infections. Late complications were limited to pseudarthrosis and attendant instrumentation failure. Early and late complication rates ranged from 10 to 30% for both thoracic and lumbar PSO cohorts. Lumbar PSO was associated with improvements in local, segmental, and global measures of sagittal balance, whereas thoracic PSO was only associated with local improvement. Most patients rated their functional status as fair to good according to the modified Prolo Scale and reported, according to the SRS-22 Outcomes Questionnaire, that they were satisfied with the overall treatment of their back condition. The ability to perform a PSO at both lumbar and thoracic levels is a powerful asset for the spine surgeon treating spinal deformity. In the present study radiographic and clinical outcomes were superior when PSO was used to treat lumbar deformity rather than thoracic deformity because of several anatomical and technical obstacles that hindered the thoracic procedure. Nevertheless, the thoracic PSO proved a useful addition with which to produce regional improvement in sagittal

  9. EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial.

    PubMed

    Bardutzky, Jürgen; Witsch, Jens; Jüttler, Eric; Schwab, Stefan; Vajkoczy, Peter; Wolf, Stefan

    2011-09-14

    Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid

  10. EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines. In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. Methods/Design This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Discussion Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome

  11. Maternal lipid profile during early pregnancy and pregnancy complications and outcomes: the ABCD study.

    PubMed

    Vrijkotte, Tanja G M; Krukziener, Náthalie; Hutten, Barbara A; Vollebregt, Karlijn C; van Eijsden, Manon; Twickler, Marcel B

    2012-11-01

    Elevated lipid levels during late pregnancy are associated with complications and adverse outcome for both mother and newborn. However, it is inconclusive whether a disturbed lipid profile during early pregnancy has similar negative associations. Our objective was to investigate whether nonfasting maternal total cholesterol and triglyceride levels during early pregnancy are associated with six major adverse pregnancy outcomes. Data were derived from the Amsterdam Born Children and Their Development (ABCD) cohort study. Random blood samples of nonfasting total cholesterol and triglyceride levels were determined during early gestation (median = 13, interquartile range = 12-14 wk). Outcome measures were pregnancy-induced hypertension (PIH), preeclampsia, preterm birth, small/large for gestational age (SGA/LGA), and child loss. Only nondiabetic women with singleton deliveries were included; the baseline sample consisted of 4008 women. Analysis for PIH and preeclampsia were performed in nulliparous women only (n = 2037). Mean (sd) triglyceride and total cholesterol levels were 1.33 (0.55) and 4.98 (0.87) mmol/liter, respectively. The incidence of pregnancy complications and perinatal outcomes were as follows: PIH, 4.9%; preeclampsia, 3.7%; preterm birth, 5.3%; SGA, 9.3%; LGA, 9.3%; and child loss, 1.4%. After adjustments, every unit increase in triglycerides was linearly associated with an increased risk of PIH [odds ratio (OR) = 1.60, P = 0.021], preeclampsia (OR = 1.69, P = 0.018), LGA (OR = 1.48, P < 0.001), and induced preterm delivery (OR = 1.69, P = 0.006). No associations were found for SGA or child loss. Total cholesterol was not associated with any of the outcome measures. Elevated maternal triglyceride levels measured during early pregnancy are associated with pregnancy complications and adverse pregnancy outcomes. These results suggest that future lifestyle programs in women of reproductive age with a focus on lowering triglyceride levels (i.e. diet, weight

  12. Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).

    PubMed

    Palmieri, Gaspare; Evans, Chris; Hansen, Vidje; Brancaleoni, Greta; Ferrari, Silvia; Porcelli, Piero; Reitano, Francesco; Rigatelli, Marco

    2009-01-01

    The Clinical Outcomes in Routine Evaluation--Outcome Measure (CORE-OM) was translated into Italian and tested in non-clinical (n = 263) and clinical (n = 647) samples. The translation showed good acceptability, internal consistency and convergent validity in both samples. There were large and statistically significant differences between clinical and non-clinical datasets on all scores. The reliable change criteria were similar to those for the UK referential data. Some of the clinically significant change criteria, particularly for the men, were moderately different from the UK cutting points. The Italian version of the CORE-OM showed respectable psychometric parameters. However, it seemed plausible that non-clinical and clinical distributions of self-report scores on psychopathology and functioning measures may differ by language and culture. *A good quality Italian translation of the CORE-OM, and hence the GP-CORE, CORE-10 and CORE-5 measures also, is now available for use by practitioners and anyone surveying or exploring general psychological state. The measures can be obtained from CORE-IMS or yourself and practitioners are encouraged to share anonymised data so that good clinical and non-clinical referential databases can be established for Italy.

  13. Early in-session cognitive-emotional problem-solving predicts 12-month outcomes in depression with personality disorder.

    PubMed

    McCarthy, Kye L; Mergenthaler, Erhard; Grenyer, Brin F S

    2014-01-01

    Therapist-patient verbalizations reveal complex cognitive-emotional linguistic data. How these variables contribute to change requires further research. Emotional-cognitive text analysis using the Ulm cycles model software was applied to transcripts of the third session of psychotherapy for 20 patients with depression and personality disorder. Results showed that connecting cycle sequences of problem-solving in the third hour predicted 12-month clinical outcomes. Therapist-patient dyads most improved spent significantly more time early in session in connecting cycles, whilst the least improved moved into connecting cycles late in session. For this particular sample, it was clear that positive emotional problem-solving in therapy was beneficial.

  14. Ultraearly assessed reperfusion status after middle cerebral artery recanalization predicting clinical outcome.

    PubMed

    Gölitz, P; Muehlen, I; Gerner, S T; Knossalla, F; Doerfler, A

    2018-06-01

    Mechanical thrombectomy has high evidence in stroke therapy; however, successful recanalization guarantees not a favorable clinical outcome. We aimed to quantitatively assess the reperfusion status ultraearly after successful middle cerebral artery (MCA) recanalization to identify flow parameters that potentially allow predicting clinical outcome. Sixty-seven stroke patients with acute MCA occlusion, undergoing recanalization, were enrolled. Using parametric color coding, a post-processing algorithm, pre-, and post-interventional digital subtraction angiography series were evaluated concerning the following parameters: pre- and post-procedural cortical relative time to peak (rTTP) of MCA territory, reperfusion time, and index. Functional long-term outcome was assessed by the 90-day modified Rankin Scale score (mRS; favorable: 0-2). Cortical rTTP was significantly shorter before (3.33 ± 1.36 seconds; P = .03) and after intervention (2.05 ± 0.70 seconds; P = .003) in patients with favorable clinical outcome. Additionally, age (P = .005) and initial National Institutes of Health Stroke Scale score (P = .02) were significantly different between the patients, whereas reperfusion index and time as well as initially estimated infarct size were not. In multivariate analysis, only post-procedural rTTP (P = .005) was independently associated with favorable clinical outcome. 2.29 seconds for post-procedural rTTP might be a threshold to predict favorable clinical outcome. Ultraearly quantitative assessment of reperfusion status after successful MCA recanalization reveals post-procedural cortical rTTP as possible independent prognostic value in predicting favorable clinical outcome, even determining a threshold value might be possible. In consequence, focusing stroke therapy on microcirculatory patency could be valuable to improve outcome. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. The Family Antecedents and the Subsequent Outcomes of Early Puberty

    ERIC Educational Resources Information Center

    Arim, Rubab G.; Tramonte, Lucia; Shapka, Jennifer D.; Dahinten, V. Susan; Willms, J. Douglas

    2011-01-01

    The purpose of this study was to examine both the family antecedents and the outcomes of early puberty, with a particular focus on factors related to family socioeconomic status (SES). The study employed a comprehensive measurement of pubertal development and longitudinal data from the Canadian National Longitudinal Survey of Children and Youth.…

  16. Computed tomography and clinical outcome in patients with severe traumatic brain injury.

    PubMed

    Stenberg, Maud; Koskinen, Lars-Owe D; Jonasson, Per; Levi, Richard; Stålnacke, Britt-Marie

    2017-01-01

    To study: (i) acute computed tomography (CT) characteristics and clinical outcome; (ii) clinical course and (iii) Corticosteroid Randomisation after Significant Head Injury acute calculator protocol (CRASH) model and clinical outcome in patients with severe traumatic brain injury (sTBI). Initial CT (CT i ) and CT 24 hours post-trauma (CT 24 ) were evaluated according to Marshall and Rotterdam classifications. Rancho Los Amigos Cognitive Scale-Revised (RLAS-R) and Glasgow Outcome Scale Extended (GOSE) were assessed at three months and one year post-trauma. The prognostic value of the CRASH model was evaluated. Thirty-seven patients were included. Marshall CT i and CT 24 were significantly correlated with RLAS-R at three months. Rotterdam CT 24 was significantly correlated with GOSE at three months. RLAS-R and the GOSE improved significantly from three months to one year. CRASH predicted unfavourable outcome at six months for 81% of patients with bad outcome and for 85% of patients with favourable outcome according to GOSE at one year. Neither CT nor CRASH yielded clinically useful predictions of outcome at one year post-injury. The study showed encouragingly many instances of significant recovery in this population of sTBI. The combination of lack of reliable prognostic indicators and favourable outcomes supports the case for intensive acute management and rehabilitation as the default protocol in the cases of sTBI.

  17. Neonatal Pulmonary MRI of Bronchopulmonary Dysplasia Predicts Short-term Clinical Outcomes.

    PubMed

    Higano, Nara S; Spielberg, David R; Fleck, Robert J; Schapiro, Andrew H; Walkup, Laura L; Hahn, Andrew D; Tkach, Jean A; Kingma, Paul S; Merhar, Stephanie L; Fain, Sean B; Woods, Jason C

    2018-05-23

    Bronchopulmonary dysplasia (BPD) is a serious neonatal pulmonary condition associated with premature birth, but the underlying parenchymal disease and trajectory are poorly characterized. The current NICHD/NHLBI definition of BPD severity is based on degree of prematurity and extent of oxygen requirement. However, no clear link exists between initial diagnosis and clinical outcomes. We hypothesized that magnetic resonance imaging (MRI) of structural parenchymal abnormalities will correlate with NICHD-defined BPD disease severity and predict short-term respiratory outcomes. Forty-two neonates (20 severe BPD, 6 moderate, 7 mild, 9 non-BPD controls; 40±3 weeks post-menstrual age) underwent quiet-breathing structural pulmonary MRI (ultrashort echo-time and gradient echo) in a NICU-sited, neonatal-sized 1.5T scanner, without sedation or respiratory support unless already clinically prescribed. Disease severity was scored independently by two radiologists. Mean scores were compared to clinical severity and short-term respiratory outcomes. Outcomes were predicted using univariate and multivariable models including clinical data and scores. MRI scores significantly correlated with severities and predicted respiratory support at NICU discharge (P<0.0001). In multivariable models, MRI scores were by far the strongest predictor of respiratory support duration over clinical data, including birth weight and gestational age. Notably, NICHD severity level was not predictive of discharge support. Quiet-breathing neonatal pulmonary MRI can independently assess structural abnormalities of BPD, describe disease severity, and predict short-term outcomes more accurately than any individual standard clinical measure. Importantly, this non-ionizing technique can be implemented to phenotype disease and has potential to serially assess efficacy of individualized therapies.

  18. Religion, Spirituality, and HIV Clinical Outcomes: A Systematic Review of the Literature.

    PubMed

    Doolittle, B R; Justice, A C; Fiellin, D A

    2018-06-01

    This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.

  19. Wound-healing outcomes using standardized assessment and care in clinical practice.

    PubMed

    Bolton, Laura; McNees, Patrick; van Rijswijk, Lia; de Leon, Jean; Lyder, Courtney; Kobza, Laura; Edman, Kelly; Scheurich, Anne; Shannon, Ron; Toth, Michelle

    2004-01-01

    Wound-healing outcomes applying standardized protocols have typically been measured within controlled clinical trials, not natural settings. Standardized protocols of wound care have been validated for clinical use, creating an opportunity to measure the resulting outcomes. Wound-healing outcomes were explored during clinical use of standardized validated protocols of care based on patient and wound assessments. This was a prospective multicenter study of wound-healing outcomes management in real-world clinical practice. Healing outcomes from March 26 to October 31, 2001, were recorded on patients in 3 long-term care facilities, 1 long-term acute care hospital, and 12 home care agencies for wounds selected by staff to receive care based on computer-generated validated wound care algorithms. After diagnosis, wound dimensions and status were assessed using a tool adapted from the Pressure Sore Status Toolfor use on all wounds. Wound, ostomy, and continence nursing professionals accessed consistent protocols of care, via telemedicine in home care or paper forms in long-term care. A physician entered assessments into a desktop computer in the wound clinic. Based on evidence that healing proceeds faster with fewer infections in environments without gauze, the protocols generally avoided gauze dressings. Most of the 767 wounds selected to receive the standardized-protocols of care were stage III-IV pressure ulcers (n = 373; mean healing time 62 days) or full-thickness venous ulcers (n = 124; mean healing time 57 days). Partial-thickness wounds healed faster than same-etiology full-thickness wounds. These results provide benchmarks for natural-setting healing outcomes and help to define and address wound care challenges. Outcomes primarily using nongauze protocols of care matched or surpassed best previously published results on similar wounds using gauze-based protocols of care, including protocols applying gauze impregnated with growth factors or other agents.

  20. Clinical and Other Risk Indicators for Early Periodontitis in Adults

    PubMed Central

    Tanner, Anne C.R.; Kent, Ralph; Van Dyke, Thomas; Sonis, Steven T.; Murray, Lora A.

    2005-01-01

    Background Periodontal diseases affect over half the adults in the U.S., disproportionately affecting minority populations. Periodontitis can be treated in early stages, but it is not clear what features indicate, or could be risk factors for, early stages of periodontal attachment loss. This study aimed to evaluate associations between clinical and other risk indicators of early periodontitis. Methods A cross-sectional evaluation of 225 healthy and early periodontitis adults aged 20 to 40 years was performed. Clinical measurements, demographic information, and smoking histories were recorded. Analyses evaluated demographic and clinical associations with health and early periodontitis disease categories and periodontal attachment loss. Patterns of attachment loss at interproximal and buccal/lingual sites were evaluated. Results Subject age, plaque, and measures of gingivitis exhibited associations with attachment loss and probing depth. More periodontal attachment loss was detected in African-American and Hispanic subjects compared to Asian and Caucasian subjects. Smoking history was associated with attachment loss. At interproximal sites, lower molars most frequently had attachment loss, whereas at buccal/lingual sites, higher proportions of lower bicuspid teeth demonstrated attachment loss compared with other sites. Conclusions In this study of subjects with minimal attachment loss, gingival inflammation was associated with early periodontitis. Lower molar interproximal sites were frequently associated with interproximal attachment loss, whereas lower bicuspid teeth were at risk for gingival recession on buccal surfaces. PMID:15857098

  1. Survival outcome of early versus delayed bevacizumab treatment in patients with recurrent glioblastoma

    PubMed Central

    Hamza, Mohamed A.; Mandel, Jacob J.; Conrad, Charles A.; Gilbert, Mark R.; Yung, W. K. Alfred; Puduvalli, Vinay K.; DeGroot, John F.

    2015-01-01

    Bevacizumab (BEV) is widely used for treatment of patients with recurrent glioblastoma. It is not known if there are differences in outcome between early versus delayed BEV treatment of recurrent glioblastoma. We examined the relationship between the time of starting BEV treatment and outcomes in patients with recurrent glioblastoma. In this retrospective chart review, we identified patients with recurrent glioblastoma diagnosed between 2005 and 2011 who were treated with BEV alone or BEV-containing regimens. Data was analyzed to determine overall survival (OS) from time of diagnosis and progression free survival (PFS) from time of starting BEV. A total of 298 patients were identified, 112 patients received early BEV, 133 patients received delayed BEV, and 53 patients were excluded because they either progressed within 3 months of radiation or received BEV at the time of diagnosis. There was no significant difference in PFS between patients that received early BEV and those that received delayed BEV (5.2 vs. 4.3 months, p = 0.2). Patients treated with delayed BEV had longer OS when compared to those treated with early BEV (25.9 vs. 20.8 months, p = 0.005). In patients with recurrent glioblastoma, there was no significant difference in PFS from the time of starting BEV between early and delayed BEV. Although patients treated with delayed BEV seemed to have longer OS, a conclusion regarding OS outcome requires further prospective trials. These results may indicate that delaying treatment with BEV is not detrimental for survival of patients with recurrent glioblastoma. PMID:24803001

  2. Differences in clinical presentation and pregnancy outcomes in antepartum preeclampsia and new-onset postpartum preeclampsia: Are these the same disorder?

    PubMed

    Vilchez, Gustavo; Hoyos, Luis R; Leon-Peters, Jocelyn; Lagos, Moraima; Argoti, Pedro

    2016-11-01

    New-onset postpartum preeclampsia is a poorly defined condition that accounts for a significant percentage of eclampsia cases. It is unclear whether new-onset postpartum preeclampsia is a different disorder from or belongs to the same spectrum of classic antepartum preeclampsia. The objective of this study was to compare the clinical presentation and pregnancy outcomes of antepartum preeclampsia and new-onset postpartum preeclampsia. A retrospective study including 92 patients with antepartum preeclampsia and 92 patients with new-onset postpartum preeclampsia was performed. Clinical presentation and pregnancy outcomes were compared. Chi-square test was used to analyze categorical variables, and independent t -test and Mann-Whitney U -test for numerical variables. P -values of <0.05 were used to indicate statistical signifi cance. Patients with antepartum preeclampsia and new-onset postpartum preeclampsia differ significantly in profile, symptoms at presentation, laboratory markers and pregnancy outcomes. New-onset postpartum preeclampsia has a distinct patient profile and clinical presentation than antepartum preeclampsia, suggesting they may represent different disorders. Characterization of a patient profile with increased risk of developing this condition will help clinicians to identify patients at risk and provide early and targeted interventions to decrease the morbidity associated with this condition.

  3. Predictors of Clinical Outcomes in Sexually Abused Adolescents.

    PubMed

    Tocker, Lotem; Ben-Amitay, Galit; Horesh-Reinman, Netta; Lask, Michal; Toren, Paz

    2017-01-01

    This cross-sectional, case control study examines the association between child sexual abuse and interpersonal and intrapersonal outcomes among 54 adolescents, examining specific clinical measures (depression, anxiety, dissociation, and posttraumatic stress disorder, attachment patterns, self-esteem, self-disclosure, and family environment characteristics). The research results point to a correlation between sexual abuse and higher levels of the clinical measures. In addition, a correlation was found between sexual abuse and level of avoidant attachment, self-esteem, and family environment characteristics. Stepwise hierarchical regressions were conducted to examine how adolescent attributes predicted depression, anxiety, and dissociation beyond the prediction based on sexual abuse. A combination of self-esteem, anxiety attachment, and family cohesiveness made sexual abuse insignificant when predicting levels of depression, anxiety, and dissociation. This study contributes to characterizing the emotional, personal, and family attributes of adolescents who experienced sexual abuse. It also raises questions about the clinical outcomes usually associated with sexual abuse.

  4. Intrinsic platelet reactivity before start with clopidogrel as predictor for on-clopidogrel platelet function and long-term clinical outcome.

    PubMed

    Hochholzer, Willibald; Valina, Christian M; Bömicke, Timo; Amann, Michael; Stratz, Christian; Nührenberg, Thomas; Trenk, Dietmar; Neumann, Franz-Josef

    2015-07-01

    High on-clopidogrel platelet reactivity is associated with worse clinical outcome. Previous data suggest that intrinsic platelet reactivity before initiation of clopidogrel contributes significantly to on-clopidogrel platelet reactivity. It is unknown whether intrinsic reactivity can sufficiently predict on-clopidogrel reactivity and therefore identify patients with insufficient response to clopidogrel before initiation of treatment and at risk for worse clinical outcome. This analysis included 765 consecutive patients undergoing elective coronary stent implantation. Platelet reactivity was assessed by light transmission aggregometry (5 µM ADP) before administration of clopidogrel 600mg and after intake of first maintenance dose of clopidogrel on day 1 following coronary stenting. Patients were followed for up to seven years. The combined primary endpoint was death of any cause or non-fatal myocardial infarction. Intrinsic and on-clopidogrel platelet reactivity were significant correlated (r=0.31; p < 0.001). Among all tested clinical and genetic factors including the cytochrome P450 2C19*2 polymorphism, intrinsic platelet reactivity was the strongest predictor for on-clopidogrel platelet reactivity. However, intrinsic platelet reactivity could only explain 8 % of variability of on-clopidogrel platelet function. Only on-treatment platelet reactivity was predictive for long-term clinical outcome (HR 1.47, 95 % CI 1.05-2.05; p = 0.02) whereas intrinsic platelet reactivity was not (HR 1.03, 95 % CI 0.74-1.43; p = 0.86). In conclusion, intrinsic platelet reactivity before initiation of clopidogrel is the strongest predictor of early on-clopidogrel platelet reactivity but can only explain a minor proportion of its variability and is not significantly associated with clinical outcome. Thus, baseline testing cannot substitute on-clopidogrel platelet function testing.

  5. [Early management of cerebrovascular accidents].

    PubMed

    Libot, Jérômie; Guillon, Benoit

    2013-01-01

    A cerebrovascular accident requires urgent diagnosis and treatment.The management of a stroke must be early and adapted in order to improve the overall clinical outcome and lower the risk of mortality.

  6. Does surgical sympathectomy improve clinical outcomes in patients with refractory angina pectoris?

    PubMed

    Holland, Luke C; Navaratnarajah, Manoraj; Taggart, David P

    2016-04-01

    A best evidence topic in cardiothoracic surgery was written according to a structured protocol. The question addressed was: In patients with angina pectoris refractory to medical therapy, does surgical sympathectomy improve clinical outcomes? A total of 528 papers were identified using the search protocol described, of which 6 represented the best evidence to answer the clinical question. There were 5 case series and 1 prospective cohort study. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. All 5 of the case series demonstrated an improvement in symptoms, exercise tolerance or quality of life in patients undergoing surgical sympathectomy. An early case series investigating an open approach had a high morbidity and mortality rate, but the 4 other series used a minimally invasive technique and had low morbidity and zero perioperative mortality rates. The cohort study compared surgical sympathectomy with transmyocardial laser revascularization (TMR) and concluded TMR to be superior. However, this study looked only at unilateral sympathectomy, whereas all 5 case series focused on bilateral surgery. We conclude that the best currently available evidence does suggest that patients report an improvement in their symptoms and quality of life following surgical sympathectomy, but the low level of this evidence does not allow for a statistically proved recommendation. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  7. Clinical Presentations and Outcomes of Bile Duct Loss caused by Drugs and Herbal and Dietary Supplements

    PubMed Central

    Bonkovsky, Herbert L.; Kleiner, David E.; Gu, Jiezhun; Odin, Joseph A.; Russo, Mark W.; Navarro, Victor M.; Fontana, Robert J.; Ghabril, Marwan S.; Barnhart, Huiman; Hoofnagle, Jay H.

    2016-01-01

    Bile duct loss during the course of drug induced liver injury is uncommon but can be an indication of vanishing bile duct syndrome. In this work we assess the frequency, causes, clinical features and outcomes of cases of drug induced liver injury with histologically proven bile duct loss. All cases of drug induced liver injury enrolled into a prospective database over a ten year period that had undergone liver biopsies (n=363) were scored for the presence of bile duct loss and assessed for clinical and laboratory features, causes and outcomes. 26 of the 363 patients (7%) with drug, herbal or dietary supplement associated liver injury had bile duct loss on liver biopsy which was moderate to severe (<50% of portal areas with bile ducts) in 14 and mild (50–75%) in 12. The presenting clinical features of the 26 cases varied, but the most common clinical pattern was a severe cholestatic hepatitis. The implicated agents included amoxicillin/clavulanate (n=3), temozolomide (n=3), various herbal products (n=3), azithromycin (n=2) and 15 other medications or dietary supplements. Compared to those without, those with bile duct loss were more likely to develop chronic liver injury (94% vs 47%), which was usually cholestatic and sometimes severe. Five patients died and two others underwent liver transplantation for progressive cholestasis despite treatment with corticosteroids and ursodiol. The most predictive factor of poor outcome was the degree of bile duct loss on liver biopsy. Conclusions Bile duct loss during acute cholestatic hepatitis is an ominous early indicator of possible vanishing bile duct syndrome, for which at present there are no known means of prevention or therapy. PMID:27981596

  8. Outcome Measures for Clinical Trials in Down Syndrome.

    PubMed

    Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

    2017-05-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

  9. Factors Associated With Early Functional Outcome After Hip Fracture Surgery

    PubMed Central

    Cong, Guang-Ting; Nwachukwu, Benedict U.; Patt, Minda L.; Desai, Pingal; Zambrana, Lester; Lane, Joseph M.

    2016-01-01

    Background: Hip fractures are common in the elderly and are likely to become more prevalent as the US population ages. Early functional status is an indicator of longer term outcome, yet in-hospital predictors of functional recovery, particularly time of surgery and composition of support staff, after hip fracture surgery have not been well studied. Methods: Ninety-nine consecutive patients underwent hip fracture surgery by a single surgeon between 2009 and 2013. Surgery after 48 hours was deemed as surgical delay, and surgery after 5 pm was deemed as after hours. Surgical support staff experience was determined by experts from our institution as well as documented level of training. Functional status was determined by independent ambulation on postoperative day (POD) 3. Results: On POD3, 48 (79%) of 62 patients with no delay were able to ambulate, whereas only 14 (38%) of 37 patients with delayed surgery were able to ambulate (P < .001). This relationship persisted when adjusted for American Society of Anesthesiologist classification. No delay in patients older than 80 (odds ratio [OR], 6.91; 95% confidence interval [CI], 2.16-22.10) and females (OR, 7.05; 95% CI, 2.34-21.20) was associated with greater chance of early ambulation. After-hours surgery was not associated with ambulation (P = .35). Anesthesiologist and circulating nurse experience had no impact on patient’s ambulatory status; however, nonorthopedic scrub technicians were associated with worse functional status (OR 7.50; 95% CI, 1.46-38.44, P = .01). Conclusion: Surgical delay and nonorthopedic scrub technicians are associated with worse early functional outcome after hip fracture surgery. Surgical delay should be avoided in older patients and women. More work should be done to understand the impact of surgical team composition on outcome. PMID:26929850

  10. Narrowing the Gap in Outcomes: Early Years (0-5 Years)

    ERIC Educational Resources Information Center

    Springate, Ian; Atkinson, Mary; Straw, Suzanne; Lamont, Emily; Grayson, Hilary

    2008-01-01

    This report was commissioned by the Local Government Association (LGA) to inform the Department for Children, Schools and Families (DCSF) and LGA work on "Narrowing the Gap." It focuses on early years' provision and presents findings from a review of the best evidence on narrowing the gap in outcomes across the five Every Child Matters…

  11. Results of concurrent radio-chemotherapy for the treatment of head and neck squamous cell carcinoma in everyday clinical practice with special reference to early mortality

    PubMed Central

    2013-01-01

    Background Randomized controlled trials have established concurrent chemo-radiotherapy as the preferred treatment option for inoperable local-regionally advanced head and neck squamous cell carcinomas (HNSCCs). Because many patients have multiple co-morbidities and would not fulfill the eligibility criteria of clinical trials, the results need to be re-evaluated in daily clinical practice with special reference to early mortality. Methods 167 consecutive patients with HNSCC who received concurrent chemo-radiotherapy at the Basel University Hospital between 1988 and 2006 were analyzed retrospectively with a special focus on early deaths and risk factors for an unfavorable outcome. Results In our cohort, the 3- and 5-year overall survival rates were 54% and 47%, respectively. The therapy was associated with relevant toxicity and an early mortality rate of 5.4%. Patients dying early were analyzed individually for the cause of death. Patients with elevated white blood cell counts (HR: 2.66 p = 0,016) and vascular co-morbidities (HR: 5.3, p = 0,047) showed significantly worse survival rates. The same factors were associated with a trend toward increased treatment-related mortality. The 3-year survival rate improved from approximately 43% for patients treated before the year 2000 to 65% for patients treated after the year 2000 (Fisher’s exact test p = 0.01). Conclusions Although many patients who received concurrent chemo-radiotherapy would not have qualified for clinical trials, the outcome was favorable and has significantly improved in recent years. However the early mortality was slightly worse than what is described in the literature. PMID:24373220

  12. Autonomic Dysfunction Predicts Clinical Outcomes After Acute Ischemic Stroke: A Prospective Observational Study.

    PubMed

    Xiong, Li; Tian, Ge; Leung, Howan; Soo, Yannie O Y; Chen, Xiangyan; Ip, Vincent H L; Mok, Vincent C T; Chu, Winnie C W; Wong, Ka Sing; Leung, Thomas W H

    2018-01-01

    Central autonomic dysfunction increases stroke morbidity and mortality. We aimed to investigate whether poststroke autonomic dysfunction graded by Ewing battery can predict clinical outcome. In this prospective observational study, we assessed autonomic function of ischemic stroke patients within 7 days from symptom onset by Ewing battery. On the basis of the magnitude of autonomic dysfunction, we stratified patients into significant (definite, severe, or atypical) or minor (normal or early) autonomic function impairment groups and correlated the impairment with the 3-month modified Rankin Scale score (good outcome: modified Rankin Scale score 0≈2; poor outcome: modified Rankin Scale score 3≈6). Among the 150 patients enrolled (mean age, 66.4±9.9 years; 70.7% males), minor autonomic dysfunction was identified in 36 patients (24.0%), and significant autonomic dysfunction was identified in 114 patients (76.0%) based on Ewing battery. In 3 months, a poor functional outcome was found in 32.5% of significant group patients compared with 13.9% in the minor group ( P =0.031). Crude odds ratios of the magnitude of autonomic dysfunction and 3-month unfavorable functional outcome after acute ischemic stroke were 2.979 (95% confidence interval, 1.071-8.284; P =0.036). After adjusting for confounding variables with statistical significance between the 2 functional outcome subgroups identified in univariate analysis (including sex and National Institutes of Health Stroke Scale score on admission), the magnitude of autonomic dysfunction still independently predicted an unfavorable outcome, with an odds ratio of 3.263 (95% confidence interval, 1.141-9.335; P =0.027). Autonomic dysfunction gauged by Ewing battery predicts poor functional outcome after acute ischemic stroke. © 2017 American Heart Association, Inc.

  13. Myoxinol (Hydrolyzed Hibiscus esculentus Extract) in the Cure of Chronic Anal Fissure: Early Clinical and Functional Outcomes

    PubMed Central

    Renzi, Adolfo; Di Sarno, Giandomenico; D'Aniello, Francesco; Ziccardi, Stefania; Paladino, Fiorella

    2015-01-01

    Objective. This study was designed to evaluate the early results of the topical application of Hydrolyzed Hibiscus esculentus Extract 3% ointment (Myoxinol 3%), a novel local product with Botox-like activity, in the conservative treatment of chronic anal fissure (CAF). Methods. Among all patients with CAF observed during the study period, 31 subjects met the inclusion criteria and underwent medical therapy with Myoxinol 3% ointment every 12 hours for 6 weeks. Two patients were lost to follow-up. Clinical and manometric follow-up was carried out eight weeks after treatment. Results. At follow-up the success rate was 72.4% (21/29); median VAS score and mean anal resting pressure were significantly lower if compared with respective baseline data. The only one adverse effect of the topical application of Myoxinol 3% ointment was perianal itch, which was reported by 3,4% (1/29) of the patients available for the analysis. However, in this case this symptom did not cause interruption of the treatment. Conclusions. The topical application of Myoxinol 3% ointment in the cure of CAF shows encouraging early results. Further researches with a larger series and a longer follow-up are needed to confirm these data. PMID:25861259

  14. Early Childhood Adversity and Pregnancy Outcomes

    PubMed Central

    Smith, Megan V.; Gotman, Nathan; Yonkers, Kimberly A.

    2016-01-01

    Objectives To examine the association between adverse childhood experiences (ACEs) and pregnancy outcomes; to explore mediators of this association including psychiatric illness and health habits. Methods Exposure to ACEs was determined by the Early Trauma Inventory Self Report Short Form; psychiatric diagnoses were generated by the Composite International Diagnostic Interview administered in a cohort of 2303 pregnant women. Linear regression and structural equation modeling bootstrapping approaches tested for multiple mediators. Results Each additional ACE decreased birth weight by 16.33 g and decreased gestational age by 0.063. Smoking was the strongest mediator of the effect on gestational age. Conclusions ACEs have an enduring effect on maternal reproductive health, as manifested by mothers’ delivery of offspring that were of reduced birth weight and shorter gestational age. PMID:26762511

  15. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women

    USDA-ARS?s Scientific Manuscript database

    Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects. Despite numerous clinical trials of short-term isoflavone supplementation, there is a paucity of data regarding longer-term outcomes and safety. Our aim was to evaluate the clinical outcomes of soy hypocoty...

  16. An estimate of the cost of burnout on early retirement and reduction in clinical hours of practicing physicians in Canada

    PubMed Central

    2014-01-01

    Background Interest in the impact of burnout on physicians has been growing because of the possible burden this may have on health care systems. The objective of this study is to estimate the cost of burnout on early retirement and reduction in clinical hours of practicing physicians in Canada. Methods Using an economic model, the costs related to early retirement and reduction in clinical hours of physicians were compared for those who were experiencing burnout against a scenario in which they did not experience burnout. The January 2012 Canadian Medical Association Masterfile was used to determine the number of practicing physicians. Transition probabilities were estimated using 2007–2008 Canadian Physician Health Survey and 2007 National Physician Survey data. Adjustments were also applied to outcome estimates based on ratio of actual to planned retirement and reduction in clinical hours. Results The total cost of burnout for all physicians practicing in Canada is estimated to be $213.1 million ($185.2 million due to early retirement and $27.9 million due to reduced clinical hours). Family physicians accounted for 58.8% of the burnout costs, followed by surgeons for 24.6% and other specialists for 16.6%. Conclusion The cost of burnout associated with early retirement and reduction in clinical hours is substantial and a significant proportion of practicing physicians experience symptoms of burnout. As health systems struggle with human resource shortages and expanding waiting times, this estimate sheds light on the extent to which the burden could be potentially decreased through prevention and promotion activities to address burnout among physicians. PMID:24927847

  17. Five year neurodevelopment outcomes of perinatally HIV-infected children on early limited or deferred continuous antiretroviral therapy.

    PubMed

    Laughton, Barbara; Cornell, Morna; Kidd, Martin; Springer, Priscilla Estelle; Dobbels, Els Françoise Marie-Thérèse; Rensburg, Anita Janse Van; Otwombe, Kennedy; Babiker, Abdel; Gibb, Diana M; Violari, Avy; Kruger, Mariana; Cotton, Mark Fredric

    2018-05-01

    Early antiretroviral therapy (ART) has improved neurodevelopmental outcomes of HIV-infected (HIV-positive) children; however, little is known about the longer term outcomes in infants commencing early ART or whether temporary ART interruption might have long-term consequences. In the children with HIV early antiretroviral treatment (CHER) trial, HIV-infected infants ≤12 weeks of age with CD4 ≥25% were randomized to deferred ART (ART-Def); immediate time-limited ART for 40 weeks (ART-40W) or 96 weeks (ART-96W). ART was restarted in the time-limited arms for immunologic/clinical progression. Our objective was to compare the neurodevelopmental profiles in all three arms of Cape Town CHER participants. A prospective, longitudinal observational study was used. The Griffiths mental development scales (GMDS), which includes six subscales and a global score, were performed at 11, 20, 30, 42 and 60 months, and the Beery-Buktenica developmental tests for visual motor integration at 60 months. HIV-exposed uninfected (HEU) and HIV-unexposed (HU) children were enrolled for comparison. Mixed model repeated measures were used to compare groups over time, using quotients derived from standardized British norms. In this study, 28 ART-Def, 35 ART-40W, 33 ART-96W CHER children, and 34 HEU and 39 HU controls were enrolled. GMDS scores over five years were similar between the five groups in all subscales except locomotor and general Griffiths (interaction p < 0.001 and p = 0.02 respectively), driven by early lower scores in the ART-Def arm. At 60 months, scores for all groups were similar in each GMDS scale. However, Beery visual perception scores were significantly lower in HIV-infected children (mean standard scores: 75.8 ART-Def, 79.8 ART-40W, 75.9 ART-96W) versus 84.4 in HEU and 90.5 in HU (p < 0.01)). Early locomotor delay in the ART-Def arm resolved by five years. Neurodevelopmental outcomes at five years in HIV-infected children on early time-limited ART were

  18. Association of HIV diversity and virologic outcomes in early antiretroviral treatment: HPTN 052.

    PubMed

    Palumbo, Philip J; Wilson, Ethan A; Piwowar-Manning, Estelle; McCauley, Marybeth; Gamble, Theresa; Kumwenda, Newton; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James G; Hosseinipour, Mina C; Melo, Marineide G; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H; Fogel, Jessica M

    2017-01-01

    Higher HIV diversity has been associated with virologic outcomes in children on antiretroviral treatment (ART). We examined the association of HIV diversity with virologic outcomes in adults from the HPTN 052 trial who initiated ART at CD4 cell counts of 350-550 cells/mm3. A high resolution melting (HRM) assay was used to analyze baseline (pre-treatment) HIV diversity in six regions in the HIV genome (two in gag, one in pol, and three in env) from 95 participants who failed ART. We analyzed the association of HIV diversity in each genomic region with baseline (pre-treatment) factors and three clinical outcomes: time to virologic suppression after ART initiation, time to ART failure, and emergence of HIV drug resistance at ART failure. After correcting for multiple comparisons, we did not find any association of baseline HIV diversity with demographic, laboratory, or clinical characteristics. For the 18 analyses performed for clinical outcomes evaluated, there was only one significant association: higher baseline HIV diversity in one of the three HIV env regions was associated with longer time to ART failure (p = 0.008). The HRM diversity assay may be useful in future studies exploring the relationship between HIV diversity and clinical outcomes in individuals with HIV infection.

  19. Dosimetric considerations and early clinical experience of accelerated partial breast irradiation using multi-lumen applicators in the setting of breast augmentation.

    PubMed

    Akhtari, Mani; Pino, Ramiro; Scarboro, Sarah B; Bass, Barbara L; Miltenburg, Darlene M; Butler, E Brian; Teh, Bin S

    2015-12-01

    Accelerated partial breast irradiation (APBI) is an accepted treatment option in breast-conserving therapy for early stage breast cancer. However, data regarding outcomes of patients treated with multi-lumen catheter systems who have existing breast implants is limited. The purpose of this study was to report treatment parameters, outcomes, and possible dosimetric correlation with cosmetic outcome for this population of patients at our institution. We report the treatment and outcome of seven consecutive patients with existing breast implants and early stage breast cancer who were treated between 2009 and 2013 using APBI following lumpectomy. All patients were treated twice per day for five days to a total dose of 34 Gy using a high-dose-rate (192)Ir source. Cosmetic outcomes were evaluated using the Harvard breast cosmesis scale, and late toxicities were reported using the Radiation Therapy Oncology Group (RTOG) late radiation morbidity schema. After a mean follow-up of 32 months, all patients have remained cancer free. Six out of seven patients had an excellent or good cosmetic outcome. There were no grade 3 or 4 late toxicities. The average total breast implant volume was 279.3 cc, received an average mean dose of 12.1 Gy, and a maximum dose of 234.1 Gy. The average percentage of breast implant volume receiving 50%, 75%, 100%, 150%, and 200% of the prescribed dose was 15.6%, 7.03%, 4.6%, 1.58%, and 0.46%, respectively. Absolute volume of breast implants receiving more than 50% of prescribed dose correlated with worse cosmetic outcomes. Accelerated partial breast irradiation using a multi-lumen applicator in patients with existing breast implants can safely be performed with promising early clinical results. The presence of the implant did not compromise the ability to achieve dosimetric criteria; however, dose to the implant and the irradiated implant volume may be related with worse cosmetic outcomes.

  20. Early-life exposure to air pollutants and adverse pregnancy outcomes: protocol for a prospective cohort study in Beijing

    PubMed Central

    Song, Jing; Wei, Ling; Ma, Ying; Tian, Ning; Huang, Shi Yun; Dai, Yin Mei; Zhao, Li Hong; Kong, Yuan Yuan

    2017-01-01

    Introduction The association between early exposure to ambient air pollution and adverse pregnancy outcomes in China is unclear. This study will assess the risk of early-life exposure to air pollutants in Beijing and explore the viability of 8-hydroxydeoxyguanosine (8-OHdG) as a biological indicator to assess oxidative stress induced by early-life exposure to air pollution. Methods and analysis Here, 2500 women with singleton pregnancies and their infants will be recruited from the Beijing Obstetrics and Gynecology Hospital. We will collect nine types of biological samples, including maternal serum, urine, placental tissue, umbilical cord tissue and umbilical cord blood during all three trimesters. The air pollution data (particulate matter (PM)2.5, PM10 and similar factors) will be recorded at official fixed-site monitoring stations closest to where the pregnant women live. We plan to assess the effect of air pollutants on adverse pregnancy outcomes and infant respiratory and circulatory disease using Cox regression and competitive risk analysis and explore possible critical windows of exposure during pregnancy using daily pollutant concentrations averaged over various periods of pregnancy combined with individual activity and physiological parameters. Maternal and umbilical cord blood samples (1000 samples) will be randomly selected for 8-OHdG assays to assess the correlation between exposures to air pollutants and oxidative stress. We will determine whether air pollutant exposure or 8-OHdG levels are associated with adverse pregnancy outcomes. SPSS and SAS statistical software will be used for data analysis. Cox regression and competing risk analysis will be used to compute the HR and population attributable risk. Ethics and dissemination This research protocol has already been approved by the Medical Ethics Committee of Beijing Obstetrics and Gynecology Hospital. Written informed consent will be obtained from all study participants prior to enrolment. The

  1. Early-life exposure to air pollutants and adverse pregnancy outcomes: protocol for a prospective cohort study in Beijing.

    PubMed

    Song, Jing; Chen, Yi; Wei, Ling; Ma, Ying; Tian, Ning; Huang, Shi Yun; Dai, Yin Mei; Zhao, Li Hong; Kong, Yuan Yuan

    2017-09-03

    The association between early exposure to ambient air pollution and adverse pregnancy outcomes in China is unclear. This study will assess the risk of early-life exposure to air pollutants in Beijing and explore the viability of 8-hydroxydeoxyguanosine (8-OHdG) as a biological indicator to assess oxidative stress induced by early-life exposure to air pollution. Here , 2500 women with singleton pregnancies and their infants will be recruited from the Beijing Obstetrics and Gynecology Hospital. We will collect nine types of biological samples, including maternal serum, urine, placental tissue, umbilical cord tissue and umbilical cord blood during all three trimesters. The air pollution data (particulate matter (PM)2.5, PM10 and similar factors) will be recorded at official fixed-site monitoring stations closest to where the pregnant women live. We plan to assess the effect of air pollutants on adverse pregnancy outcomes and infant respiratory and circulatory disease using Cox regression and competitive risk analysis and explore possible critical windows of exposure during pregnancy using daily pollutant concentrations averaged over various periods of pregnancy combined with individual activity and physiological parameters. Maternal and umbilical cord blood samples (1000 samples) will be randomly selected for 8-OHdG assays to assess the correlation between exposures to air pollutants and oxidative stress. We will determine whether air pollutant exposure or 8-OHdG levels are associated with adverse pregnancy outcomes. SPSS and SAS statistical software will be used for data analysis. Cox regression and competing risk analysis will be used to compute the HR and population attributable risk. This research protocol has already been approved by the Medical Ethics Committee of Beijing Obstetrics and Gynecology Hospital. Written informed consent will be obtained from all study participants prior to enrolment. The results will be published in peer-reviewed journals or

  2. Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers.

    PubMed

    Goldstein, Judith E; Jackson, Mary Lou; Fox, Sandra M; Deremeik, James T; Massof, Robert W

    2015-07-01

    To facilitate comparative clinical outcome research in low vision rehabilitation, we must use patient-centered measurements that reflect clinically meaningful changes in visual ability. To quantify the effects of currently provided low vision rehabilitation (LVR) on patients who present for outpatient LVR services in the United States. Prospective, observational study of new patients seeking outpatient LVR services. From April 2008 through May 2011, 779 patients from 28 clinical centers in the United States were enrolled in the Low Vision Rehabilitation Outcomes Study. The Activity Inventory, a visual function questionnaire, was administered to measure overall visual ability and visual ability in 4 functional domains (reading, mobility, visual motor function, and visual information processing) at baseline and 6 to 9 months after usual LVR care. The Geriatric Depression Scale, Telephone Interview for Cognitive Status, and Medical Outcomes Study 36-Item Short-Form Health Survey physical functioning questionnaires were also administered to measure patients' psychological, cognitive, and physical health states, respectively, and clinical findings of patients were provided by study centers. Mean changes in the study population and minimum clinically important differences in the individual in overall visual ability and in visual ability in 4 functional domains as measured by the Activity Inventory. Baseline and post-rehabilitation measures were obtained for 468 patients. Minimum clinically important differences (95% CIs) were observed in nearly half (47% [95% CI, 44%-50%]) of patients in overall visual ability. The prevalence rates of patients with minimum clinically important differences in visual ability in functional domains were reading (44% [95% CI, 42%-48%]), visual motor function (38% [95% CI, 36%-42%]), visual information processing (33% [95% CI, 31%-37%]), and mobility (27% [95% CI, 25%-31%]). The largest average effect size (Cohen d = 0.87) for the

  3. Impact of locus of control on clinical outcomes in renal dialysis.

    PubMed

    Dec, Elaine

    2006-01-01

    This study focused on the relationship between patients' locus of control and their ability to improve selected clinical outcomes related to kidney dialysis. The main hypothesis of this study stated that patients who viewed themselves as having control over their situation would be more successful at improving targeted clinical outcomes than those who believed someone other than themselves had control over their situation. The study found that interventions aimed at increasing awareness of who has control and reducing the aspect of chance had a more significant positive impact on outcomes than did pure cognitive or educational interventions geared mainly toward emotional issues or educational deficits. Interventions that work with the dominant locus of control to increase awareness of where control lies appeared to be more effective in assisting the patients to improve their targeted clinical outcomes rather than are interventions to change the locus of control between internal and powerful others (external).

  4. Linking implementation of evidence-based parenting programs to outcomes in early intervention.

    PubMed

    Kilburn, Janice E; Shapiro, Cheri J; Hardin, James W

    2017-11-01

    In the field of early intervention, only a few studies of parenting interventions include both participant and facilitator behaviors. Fidelity and supervision (facilitator characteristics) and dosage and satisfaction (participant characteristics) were tested on the outcome of improved parenting style in a sample of 36 parents of young children with disabilities. Results indicated that the facilitator behavior of fidelity was significantly and negatively related to the program outcome of parenting style; no effect was found for the facilitator behavior of supervision. For the participant behaviors, both dosage and satisfaction had non-significant relationships with the program outcome of parenting style at follow-up. The surprising negative relationship between content fidelity and parenting style was discussed.Two possible explanations were: (1) process or quality of intervention delivery is more influential than content fidelity, which considers only adherence to the intervention manual, and (2) the developmental stage of early intervention families calls for more focus on relationships between facilitators and parents and less on content of the specific intervention. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. The influence of early psychosocial intervention on the long-term clinical outcomes of people suffering from schizophrenia.

    PubMed

    Cechnicki, Andrzej; Bielańska, Anna

    2017-02-26

    To compare the treatment outcomes of DSM-IV-TR schizophrenia patients in either a Community Treatment Program or an Individual Treatment Program (CTP vs. ITP). The assessment was made after the first hospitalization, and then after three and twelve years. Participants were randomly assigned to CTP (experimental) and ITP (traditional) group, with 40 people in each group. 67 people (84%) participated in all three assessments. The socio-demographic and clinical indicators were the same for both groups. In the first three years only the CTP group participated in day-care treatment, patient and family psychoeducation and community treatment. Later, both groups received this treatment. The following tools were used: Anamnestic and Catamnestic Questionnaire, the GAF scale, the BPRS LA and Lehman's Quality of Life Interview. It was only after twelve years that there was a significant beneficial improvement in the mean GAF score in the CTP group (p = 0.036), which was comparable with the results obtained by Watt and Shepherd for the course of the illness in favorable remission cases (p = 0.038). The difference in the number of relapses was also significantly in favor of the CTP group only after 12 years (p = 0.045), as was the difference in the number of rehospitalizations (p = 0.013). The general severity of symptoms was found to be significantly lower for the CPT group after 3 (p = 0.008) and 12 years (p = 0.030), whereas it was significantly lower in the case of positive syndrome only after 3 years (p = 0.044). 1. A greater number of favorable differences were identified for the CTP group at the twelve-year point than at the conclusion of the experiment. 2. The three-year delay in introducing psycho-social treatment was associated with a poorer long-term outcome for the clinical course of schizophrenia.

  6. Early outcome of TKA with a medial pivot fixed-bearing prosthesis is worse than with a PFC mobile-bearing prosthesis.

    PubMed

    Kim, Young-Hoo; Yoon, Sung-Hwan; Kim, Jun-Shik

    2009-02-01

    Although the design features of the Medial Pivot fixed-bearing prosthesis reportedly improve kinematics compared with TKAs using fixed-bearings, clinical improvements have not been reported. We asked whether the clinical and radiographic outcomes, ranges of motion of the knee, patient satisfaction, and complication rates would be better in knees with a Medial Pivot fixed-bearing prosthesis than in those with a PFC Sigma mobile-bearing prosthesis. We compared the results of 92 patients who had a Medial Pivot fixed-bearing prosthesis implanted in one knee and a PFC Sigma mobile-bearing prosthesis implanted in the other. There were 85 women and seven men with a mean age of 69.5 years (range, 55-81 years). The minimum followup was 2 years (mean, 2.6 years; range, 2-3 years). The patients were assessed clinically and radiographically using the rating systems of the Hospital for Special Surgery and the Knee Society at 3 months, 1 year, and annually thereafter. Contrary to expectations, we found worse early clinical outcomes, smaller ranges of knee motion, less patient satisfaction, and a higher complication rate for the Medial Pivot fixed-bearing prosthesis than for the PFC Sigma mobile-bearing prosthesis. Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

  7. Magnetic resonance imaging of injuries to the ankle joint: can it predict clinical outcome?

    PubMed

    Zanetti, M; De Simoni, C; Wetz, H H; Zollinger, H; Hodler, J

    1997-02-01

    To predict clinical outcome after ankle sprains on the basis of magnetic resonance (MR) findings. Twenty-nine consecutive patients (mean age 32.9 years, range 13-60 years) were examined clinically and with MR imaging both after trauma and following standardized conservative therapy. Various MR abnormalities were related to a clinical outcome score. There was a tendency for a better clinical outcome in partial, rather than complete, tears of the anterior talofibular ligament and when there was no fluid within the peroneal tendon sheath at the initial MR examination (P = 0.092 for either abnormality). A number of other MR features did not significantly influence clinical outcome, including the presence of a calcaneofibular ligament lesion and a bone bruise of the talar dome. Clinical outcome after ankle sprain cannot consistently be predicted by MR imaging, although MR imaging may be more accurate when the anterior talofibular ligament is only partially torn and there are no signs of injury to the peroneal tendon sheath.

  8. The factor structure and psychometric properties of the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) in Norwegian clinical and non-clinical samples

    PubMed Central

    2013-01-01

    Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical

  9. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study.

    PubMed

    Maksymowych, Walter P; Dougados, Maxime; van der Heijde, Désirée; Sieper, Joachim; Braun, Jürgen; Citera, Gustavo; Van den Bosch, Filip; Logeart, Isabelle; Wajdula, Joseph; Jones, Heather; Marshall, Lisa; Bonin, Randi; Pedersen, Ron; Vlahos, Bonnie; Kotak, Sameer; Bukowski, Jack F

    2016-07-01

    To evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA). Patients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50 mg/week or placebo (PBO) for 12 weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here. 208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by -1.1 for ETN/ETN and by -3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48. Patients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48 weeks. NCT01258738. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  10. Outcomes of Vogt-Koyanagi-Harada disease: a subanalysis from a randomized clinical trial of antimetabolite therapies

    PubMed Central

    Shen, Elizabeth; Rathinam, Sivakumar R.; Babu, Manohar; Kanakath, Anuradha; Thundikandy, Radhika; Lee, Salena M.; Browne, Erica N.; Porco, Travis C.; Acharya, Nisha R.

    2016-01-01

    Purpose To report outcomes of Vogt-Koyanagi-Harada (VKH) disease from a clinical trial of antimetabolite therapies. Design Subanalysis from an observer-masked randomized clinical trial for non-infectious intermediate, posterior, and pan- uveitis. Methods Setting clinical practice at Aravind Eye Hospitals, India Patient Population Forty-three of 80 patients enrolled (54%) diagnosed with VKH. Intervention Patients were randomized to either 25mg oral methotrexate weekly or 1g mycophenolate mofetil twice daily, with a corticosteroid taper. Main outcome measures Primary outcome was corticosteroid-sparing control of inflammation at 5 and 6 months. Secondary outcomes included visual acuity, central subfield thickness, and adverse events. Patients were categorized as acute (diagnosis ≤3 months prior to enrollment) or chronic (diagnosis >3 months prior to enrollment). Results Twenty-seven patients were randomized to methotrexate and 16 to mycophenolate mofetil; 30 had acute VKH. The odds of achieving corticosteroid-sparing control of inflammation with methotrexate were 2.5 times (95% CI: 0.6, 9.8; P=0.20) the odds with mycophenolate mofetil, a difference which was not statistically significant. The average improvement in visual acuity was 12.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. On average, visual acuity for patients with acute VKH improved by 14 more ETDRS letters than those with chronic VKH (P<0.001), but there was no difference in corticosteroid-sparing control of inflammation (P=0.99). All 26 eyes with a serous retinal detachment at baseline resolved, and 88% achieved corticosteroid-sparing control of inflammation. Conclusions The majority of patients treated with antimetabolites and corticosteroids were able to achieve corticosteroid-sparing control of inflammation by 6 months. Although patients with acute VKH gained more visual improvement than those with chronic VKH, this did not correspond with a higher rate of controlled inflammation. PMID

  11. Language Outcomes at 7 Years: Early Predictors and Co-Occurring Difficulties.

    PubMed

    McKean, Cristina; Reilly, Sheena; Bavin, Edith L; Bretherton, Lesley; Cini, Eileen; Conway, Laura; Cook, Fallon; Eadie, Patricia; Prior, Margot; Wake, Melissa; Mensah, Fiona

    2017-03-01

    To examine at 7 years the language abilities of children, the salience of early life factors and language scores as predictors of language outcome, and co-occurring difficulties METHODS: A longitudinal cohort study of 1910 infants recruited at age 8 to 10 months. Exposures included early life factors (sex, prematurity, birth weight/order, twin birth, socioeconomic status, non-English speaking background,family history of speech/language difficulties); maternal factors (mental health, vocabulary, education, and age); and child language ability at 2 and 4 years. Outcomes were 7-year standardized receptive or expressive language scores (low language: ≥1.25 SD below the mean), and co-occurring difficulties (autism, literacy, social, emotional, and behavioral adjustment, and health-related quality of life). Almost 19% of children (22/1204;18.9%) met criteria for low language at 7 years. Early life factors explained 9-13% of variation in language scores, increasing to 39-58% when child language scores at ages 2 and 4 were included. Early life factors moderately discriminated between children with and without low language (area under the curve: 0.68-0.72), strengthening to good discrimination with language scores at ages 2 and 4 (area under the curve: 0.85-0.94). Low language at age 7 was associated with concurrent difficulties in literacy, social-emotional and behavioral difficulties, and limitations in school and psychosocial functioning. Child language ability at 4 years more accurately predicted low language at 7 than a range of early child, family, and environmental factors. Low language at 7 years was associated with a higher prevalence of co-occurring difficulties. Copyright © 2017 by the American Academy of Pediatrics.

  12. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, Doug; Byrne, Vicky; Cole, Richard; Dulchavsky, Scott; Foy, Millennia; Garcia, Kathleen; Gibson, Robert; Ham, David; Hurst, Victor; Kerstman, Eric; hide

    2015-01-01

    The objective of this research is to develop and use clinical outcome metrics and training tools to quantify the differences in performance of a physician vs non-physician crew medical officer (CMO) analogues during simulations.

  13. Impact of Patient Sex on Clinical Outcomes

    PubMed Central

    Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.

    2014-01-01

    Background: The Combined Quality Care Anterior Cruciate Ligament registry provides data for clinical research regarding primary anterior cruciate ligament (ACL) surgery. Purpose: To explore the data with regard to the clinical outcomes between sexes after ACL reconstruction in a Dutch population. Study Design: Cohort study; Level of evidence, 3. Methods: Data involving patients diagnosed with an ACL tear and eligible for surgery were recorded. Isokinetic muscle strength, functional muscle performance, and anterior-posterior translation of the knee joint were documented preoperatively and at 3, 6, 9, and 12 months postoperatively. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner rating scales during each examination using a web-based questionnaire. Results: Approximately 90% of ACL injuries occurred during sport activities. The mean (SD) age at surgery was 28 (11) years for both men and women, and the majority of patients were treated with hamstring tendon autografts (94%). Four percent received bone–patellar tendon–bone autografts, and 2% of the patients received other grafts. Preoperatively, the KOOS, Lysholm, and Tegner scores were significantly higher in males. Twelve months postoperatively, both sexes showed comparable isokinetic strength (P = .336), knee laxity (P = .680), and hop test for distance (P = .122) when comparing the injured with the uninjured side. Self-reported knee function was comparable between sexes as assessed by the KOOS (P = .202), Lysholm (P = .872), and Tegner (P = .767) questionnaires during the 12-month follow-up. Conclusion: One year after ACL surgery, all patients had improved greatly, showing only minor differences between sexes. The male group showed slightly better results when evaluating self-reported knee questionnaires. Comparable outcomes and knee function between sexes can therefore be presumed with patients who are treated with hamstring tendon autografts in a Dutch

  14. The family antecedents and the subsequent outcomes of early puberty.

    PubMed

    Arim, Rübab G; Tramonte, Lucia; Shapka, Jennifer D; Dahinten, V Susan; Willms, J Douglas

    2011-11-01

    The purpose of this study was to examine both the family antecedents and the outcomes of early puberty, with a particular focus on factors related to family socioeconomic status (SES). The study employed a comprehensive measurement of pubertal development and longitudinal data from the Canadian National Longitudinal Survey of Children and Youth. The sample (N = 8,440; 49% girls) included four cohorts of children who were followed biennially for 10 years, starting from age 4-11 to 14-21 years. Data were drawn at different years of age from these cohorts of children. Girls whose fathers were unemployed were more likely to experience early puberty than those whose fathers were employed. For boys, those living with fathers who had not finished secondary school were more likely to experience early puberty. Early maturing girls tended to engage in smoking and drinking at an earlier age compared with their peers. These findings provide support for psychosocial acceleration theory and suggest that different aspects of low family SES may act as a psychosocial stress for early pubertal maturation in boys versus girls, which may lead to engagement in drinking and smoking at a younger age, at least for girls.

  15. Outcome and status of microsatellite stability in Japanese atomic bomb survivors with early gastric carcinoma.

    PubMed

    Yamamoto, Manabu; Taguchi, Kenichi; Yamanaka, Takeharu; Matsuyama, Ayumi; Yoshinaga, Keiji; Tsutsui, Shinichi; Ishida, Teruyoshi

    2013-03-01

    In the decade after the 1945 atomic bombing of Hiroshima, a high incidence of leukemia was observed among atomic bomb survivors. However, the incidence of other cancers gradually increased, while that of leukemia decreased after this period. We evaluated the clinical outcome of early gastric cancer and microsatellite stability over a long-term period in atomic bomb survivors. The results of surgical treatment for early gastric cancer were reviewed for 117 atomic bomb survivors and 394 control patients between 1995 and 2006. In addition, immunohistochemical staining for hMSH2 and hMLH1 expression was performed to evaluate the status of microsatellite stability in 57 atomic bomb survivors and 82 control patients. The long-term survival rate for early gastric cancer in atomic bomb survivors was significantly lower than that in control patients (p < 0.01). Multivariable analysis revealed that age and sex were significant and independent prognostic factors for early gastric cancer. Defective hMSH2 and/or hMLH1 expression was also significantly higher in survivors than in control patients (p < 0.001). Logistic regression analysis revealed that atomic bomb survivorship was related to defective hMSH2 and/or hMLH1 expression. The prognosis of early gastric cancer in atomic bomb survivors was poor and was related to age and sex, rather than to being an atomic bomb survivor. Furthermore, a higher rate of defective hMSH2 and/or hMLH1 expression was observed in the survivors.

  16. Effects of Asymptomatic Rotator Cuff Pathology On In-Vivo Shoulder Motion and Clinical Outcomes

    PubMed Central

    Baumer, Timothy G.; Dischler, Jack; Mende, Veronica; Zauel, Roger; van Holsbeeck, Marnix; Siegal, Daniel S.; Divine, George; Moutzouros, Vasilios; Bey, Michael J.

    2017-01-01

    Background The incidence of asymptomatic rotator cuff tears has been reported to range from 15–39%, but the influence of asymptomatic rotator cuff pathology on shoulder function is not well understood. The objective of this study was to assess the effects of asymptomatic rotator cuff pathology on shoulder kinematics, strength, and patient-reported outcomes. Methods 46 asymptomatic volunteers (age: 60.3±7.5) with normal shoulder function underwent a clinical ultrasound exam to document the condition of their rotator cuff. The ultrasound imaging identified subjects as healthy (n=14) or pathologic (n=32). Shoulder motion was measured with a biplane x-ray imaging system, strength was assessed with a Biodex, and patient-reported outcomes were assessed using the Western Ontario Rotator Cuff Index and VAS pain scores. Results Compared to healthy subjects, the subjects with rotator cuff pathology had significantly less abduction (p=0.050) and elevation (p=0.041) strength, their humerus was positioned more inferiorly on the glenoid (p=0.018), and the glenohumeral contact path length was longer (p=0.007). No significant differences were detected in terms of WORC, VAS, ROM, or acromiohumeral distance. Discussion The differences observed between the healthy subjects and subjects with asymptomatic rotator cuff pathology lend insight into the changes in joint mechanics, shoulder strength, and conventional clinical outcomes associated with the early stages of rotator cuff pathology. Furthermore, these findings suggest a plausible mechanical progression of kinematic and strength changes associated with the development of rotator cuff pathology. Level of evidence Basic Science Study, Kinesiology PMID:28131679

  17. Missing Data in Alcohol Clinical Trials with Binary Outcomes

    PubMed Central

    Hallgren, Kevin A.; Witkiewitz, Katie; Kranzler, Henry R.; Falk, Daniel E.; Litten, Raye Z.; O’Malley, Stephanie S.; Anton, Raymond F.

    2017-01-01

    Background Missing data are common in alcohol clinical trials for both continuous and binary endpoints. Approaches to handle missing data have been explored for continuous outcomes, yet no studies have compared missing data approaches for binary outcomes (e.g., abstinence, no heavy drinking days). The present study compares approaches to modeling binary outcomes with missing data in the COMBINE study. Method We included participants in the COMBINE Study who had complete drinking data during treatment and who were assigned to active medication or placebo conditions (N=1146). Using simulation methods, missing data were introduced under common scenarios with varying sample sizes and amounts of missing data. Logistic regression was used to estimate the effect of naltrexone (vs. placebo) in predicting any drinking and any heavy drinking outcomes at the end of treatment using four analytic approaches: complete case analysis (CCA), last observation carried forward (LOCF), the worst-case scenario of missing equals any drinking or heavy drinking (WCS), and multiple imputation (MI). In separate analyses, these approaches were compared when drinking data were manually deleted for those participants who discontinued treatment but continued to provide drinking data. Results WCS produced the greatest amount of bias in treatment effect estimates. MI usually yielded less biased estimates than WCS and CCA in the simulated data, and performed considerably better than LOCF when estimating treatment effects among individuals who discontinued treatment. Conclusions Missing data can introduce bias in treatment effect estimates in alcohol clinical trials. Researchers should utilize modern missing data methods, including MI, and avoid WCS and CCA when analyzing binary alcohol clinical trial outcomes. PMID:27254113

  18. Missing Data in Alcohol Clinical Trials with Binary Outcomes.

    PubMed

    Hallgren, Kevin A; Witkiewitz, Katie; Kranzler, Henry R; Falk, Daniel E; Litten, Raye Z; O'Malley, Stephanie S; Anton, Raymond F

    2016-07-01

    Missing data are common in alcohol clinical trials for both continuous and binary end points. Approaches to handle missing data have been explored for continuous outcomes, yet no studies have compared missing data approaches for binary outcomes (e.g., abstinence, no heavy drinking days). This study compares approaches to modeling binary outcomes with missing data in the COMBINE study. We included participants in the COMBINE study who had complete drinking data during treatment and who were assigned to active medication or placebo conditions (N = 1,146). Using simulation methods, missing data were introduced under common scenarios with varying sample sizes and amounts of missing data. Logistic regression was used to estimate the effect of naltrexone (vs. placebo) in predicting any drinking and any heavy drinking outcomes at the end of treatment using 4 analytic approaches: complete case analysis (CCA), last observation carried forward (LOCF), the worst case scenario (WCS) of missing equals any drinking or heavy drinking, and multiple imputation (MI). In separate analyses, these approaches were compared when drinking data were manually deleted for those participants who discontinued treatment but continued to provide drinking data. WCS produced the greatest amount of bias in treatment effect estimates. MI usually yielded less biased estimates than WCS and CCA in the simulated data and performed considerably better than LOCF when estimating treatment effects among individuals who discontinued treatment. Missing data can introduce bias in treatment effect estimates in alcohol clinical trials. Researchers should utilize modern missing data methods, including MI, and avoid WCS and CCA when analyzing binary alcohol clinical trial outcomes. Copyright © 2016 by the Research Society on Alcoholism.

  19. Early and late postoperative seizure outcome in 97 patients with supratentorial meningioma and preoperative seizures: a retrospective study.

    PubMed

    Zheng, Zhe; Chen, Peng; Fu, Weiming; Zhu, Junming; Zhang, Hong; Shi, Jian; Zhang, Jianmin

    2013-08-01

    We identified factors associated with early and late postoperative seizure control in patients with supratentorial meningioma plus preoperative seizures. In this retrospective study, univariate analysis and multivariate logistic regression analysis compared 24 clinical variables according to the occurrence of early (≤1 week) or late (>1 week) postoperative seizures. Sixty-two of 97 patients (63.9 %) were seizure free for the entire postoperative follow-up period (29.5 ± 11.8 months), while 13 patients (13.4 %) still had frequent seizures at the end of follow-up. Fourteen of 97 patients (14.4 %) experienced early postoperative seizures, and emergence of new postoperative neurological deficits was the only significant risk factor (odds ratio = 7.377). Thirty-three patients (34.0 %) experienced late postoperative seizures at some time during follow-up, including 12 of 14 patients with early postoperative seizures. Associated risk factors for late postoperative seizures included tumor progression (odds ratio = 7.012) and new permanent postoperative neurological deficits (odds ratio = 4.327). Occurrence of postoperative seizures in patients with supratentorial meningioma and preoperative seizure was associated with new postoperative neurological deficits. Reduced cerebral or vascular injury during surgery may lead to fewer postoperative neurological deficits and better seizure outcome.

  20. Reinforcement sensitivity theory and alcohol outcome expectancies in early adolescence.

    PubMed

    Lopez-Vergara, Hector I; Colder, Craig R; Hawk, Larry W; Wieczorek, William F; Eiden, Rina D; Lengua, Liliana J; Read, Jennifer P

    2012-03-01

    Little research has examined the development of alcohol expectancies in childhood, a notable omission as expectancies are viable targets for prevention programs. Moreover, limited alcohol expectancies research has been conducted from the perspective of psychobiological models of motivation despite the strong conceptual links between such models and cognitive models of alcohol use. To examine if the associations between individual differences from the revised reinforcement sensitivity theory (Gray JA, McNaughton N. The Neuropsychology of Anxiety: An Enquiry into the Functions of the Septo-hippocampal System (2nd ed.). Oxford, UK: Oxford University Press, 2000) and alcohol use is mediated by alcohol expectancies in a large community sample of early adolescents using a prospective design. 378 families (1 caregiver; 1 child) were recruited via random digit phone call using a prospective design. Our findings suggest that both a strong behavioral approach system and fight-flight or freeze system were associated with high levels of positive outcome expectancies, which subsequently predicted an increase in likelihood of alcohol use. There was also some evidence that drive (an aspect of behavioral approach system) was also positively associated with negative expectancies, which subsequently predicted a low probability of alcohol use. Individual differences in reinforcement sensitivity may influence the acquisition of positive and negative outcome expectancies, thereby potentially influencing the likelihood of alcohol use in early adolescence. Thus, reinforcement sensitivity theory is a promising theory to account for the link between neural models of addiction and early acquisition of alcohol use in humans.

  1. Characterizing Tumor Heterogeneity With Functional Imaging and Quantifying High-Risk Tumor Volume for Early Prediction of Treatment Outcome: Cervical Cancer as a Model

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mayr, Nina A., E-mail: Nina.Mayr@osumc.edu; Huang Zhibin; Wang, Jian Z.

    2012-07-01

    Purpose: Treatment response in cancer has been monitored by measuring anatomic tumor volume (ATV) at various times without considering the inherent functional tumor heterogeneity known to critically influence ultimate treatment outcome: primary tumor control and survival. This study applied dynamic contrast-enhanced (DCE) functional MRI to characterize tumors' heterogeneous subregions with low DCE values, at risk for treatment failure, and to quantify the functional risk volume (FRV) for personalized early prediction of treatment outcome. Methods and Materials: DCE-MRI was performed in 102 stage IB{sub 2}-IVA cervical cancer patients to assess tumor perfusion heterogeneity before and during radiation/chemotherapy. FRV represents the totalmore » volume of tumor voxels with critically low DCE signal intensity (<2.1 compared with precontrast image, determined by previous receiver operator characteristic analysis). FRVs were correlated with treatment outcome (follow-up: 0.2-9.4, mean 6.8 years) and compared with ATVs (Mann-Whitney, Kaplan-Meier, and multivariate analyses). Results: Before and during therapy at 2-2.5 and 4-5 weeks of RT, FRVs >20, >13, and >5 cm{sup 3}, respectively, significantly predicted unfavorable 6-year primary tumor control (p = 0.003, 7.3 Multiplication-Sign 10{sup -8}, 2.0 Multiplication-Sign 10{sup -8}) and disease-specific survival (p = 1.9 Multiplication-Sign 10{sup -4}, 2.1 Multiplication-Sign 10{sup -6}, 2.5 Multiplication-Sign 10{sup -7}, respectively). The FRVs were superior to the ATVs as early predictors of outcome, and the differentiating power of FRVs increased during treatment. Discussion: Our preliminary results suggest that functional tumor heterogeneity can be characterized by DCE-MRI to quantify FRV for predicting ultimate long-term treatment outcome. FRV is a novel functional imaging heterogeneity parameter, superior to ATV, and can be clinically translated for personalized early outcome prediction before or as early as 2

  2. Outcomes of Introducing Early Learners to Interprofessional Competencies in a Classroom Setting.

    PubMed

    Lockeman, Kelly S; Lanning, Sharon K; Dow, Alan W; Zorek, Joseph A; DiazGranados, Deborah; Ivey, Carole K; Soper, Shawne

    2017-01-01

    Although interprofessional practice is important for improving healthcare delivery, there is little evidence describing interprofessional education (IPE) outcomes beyond changes in attitudes and knowledge of prelicensure learners. More rigorous evaluation of early IPE is needed to determine its impact on teaching interprofessional collaborative practice and providing a solid foundation for applying collaborative skills in the clinical environment. First-year students (N = 679) in 7 health professions programs participated in a 4-session series focusing on professional roles and responsibilities, teams and teamwork, and the healthcare system. Interprofessional teams of 5-6 students, from at least 3 professions, were assembled for the duration of the series and created a team charter during their first session to guide their work. Each subsequent session included a brief lecture and interactive exercises. Faculty facilitators from the participating programs provided support to students during the sessions. As a culminating project, each team created a short video depicting a barrier to interprofessional collaboration. Students evaluated the performance of their team members using a web-based peer assessment survey. A course evaluation with an embedded validated attitudinal scale was used to assess changes in student perceptions about IPE. A sample of videos were also scored by 2 faculty using a rubric linked to course expectations. This educational offering took place on the health sciences campus of a large, mid-Atlantic research university with more than 3,200 clinical learners in schools of allied health professions, dentistry, medicine, nursing, and pharmacy. It was the first interprofessional activity for most of the learners. There were 555 students who participated in some or all of the sessions. Comments indicated that students enjoyed interacting with their peers and prefer activities allowing them to apply content to their profession over lectures. The

  3. Effects of Prophylactic Antiepileptic Drugs on Clinical Outcomes in Patients with a Good Clinical Grade Suffering from Aneurysmal Subarachnoid Hemorrhage

    PubMed Central

    Yoon, Seon Jin; Joo, Jin-Yang; Kim, Yong Bae; Hong, Chang-Ki

    2015-01-01

    Objective Routine use of prophylactic antiepileptic drugs (AED) has been debated. We retrospectively evaluated the effects of prophylactic AED on clinical outcomes in patients with a good clinical grade suffering from aneurysmal subarachnoid hemorrhage (aSAH). Materials and Methods Between September 2012 and December 2014, 84 patients who met the following criteria were included: (1) presence of a ruptured aneurysm; (2) Hunt-Hess grade 1, 2, or 3; and (3) without seizure presentation. Patients were divided into two groups; the AED group (n = 44) and the no AED group (n = 40). Clinical data and outcomes were compared between the two groups. Results Prophylactic AEDs were used more frequently in patients who underwent microsurgery (84.1%) compared to those who underwent endovascular surgery (15.9%, p < 0.001). Regardless of prophylactic AED use, seizure episodes were not observed during the six-month follow-up period. No statistical difference in clinical outcomes at discharge (p = 0.607) and after six months of follow-up (p = 0.178) were between the two groups. After six months, however, favorable outcomes in the no AED group tended to increase and poor outcomes tended to decrease. Conclusion No difference in the clinical outcomes and systemic complications at discharge and after six months of follow-up was observed between the two groups. However, favorable outcomes in the no AED group showed a slight increase after six months. These findings suggest that discontinuation of the current practice of using prophylactic AED might be recommended in patients with a good clinical grade. PMID:26526008

  4. Clinical presentations and outcomes of bile duct loss caused by drugs and herbal and dietary supplements.

    PubMed

    Bonkovsky, Herbert L; Kleiner, David E; Gu, Jiezhun; Odin, Joseph A; Russo, Mark W; Navarro, Victor M; Fontana, Robert J; Ghabril, Marwan S; Barnhart, Huiman; Hoofnagle, Jay H

    2017-04-01

    Bile duct loss during the course of drug-induced liver injury is uncommon, but can be an indication of vanishing bile duct syndrome (VBDS). In this work, we assess the frequency, causes, clinical features, and outcomes of cases of drug-induced liver injury with histologically proven bile duct loss. All cases of drug-induced liver injury enrolled into a prospective database over a 10-year period that had undergone liver biopsies (n = 363) were scored for the presence of bile duct loss and assessed for clinical and laboratory features, causes, and outcomes. Twenty-six of the 363 patients (7%) with drug-, herbal-, or dietary-supplement-associated liver injury had bile duct loss on liver biopsy, which was moderate to severe (<50% of portal areas with bile ducts) in 14 and mild (50%-75%) in 12. The presenting clinical features of the 26 cases varied, but the most common clinical pattern was a severe cholestatic hepatitis. The implicated agents included amoxicillin/clavulanate (n = 3), temozolomide (n = 3), various herbal products (n = 3), azithromycin (n = 2), and 15 other medications or dietary supplements. Compared to those without, those with bile duct loss were more likely to develop chronic liver injury (94% vs. 47%), which was usually cholestatic and sometimes severe. Five patients died and 2 others underwent liver transplantation for progressive cholestasis despite treatment with corticosteroids and ursodiol. The most predictive factor of poor outcome was the degree of bile duct loss on liver biopsy. Bile duct loss during acute cholestatic hepatitis is an ominous early indicator of possible VBDS, for which at present there are no known means of prevention or therapy. (Hepatology 2017;65:1267-1277). © 2016 by the American Association for the Study of Liver Diseases.

  5. Influence of clinical outcome and outcome period definitions on estimates of absolute clinical and economic benefits of influenza vaccination in community dwelling elderly persons.

    PubMed

    Nichol, K L; Nordin, J; Mullooly, J

    2006-03-06

    Studies assessing the clinical and economic benefits of vaccination in the elderly have used different clinical outcomes (e.g. hospitalizations for pneumonia or influenza versus hospitalizations for respiratory and cardiovascular causes) and different outcome periods (e.g. peak versus total influenza season) on which to base estimates of clinical effectiveness and cost effectiveness. We explored the implications of these varying approaches by comparing two health economic analysis models of influenza vaccination of community-dwelling elderly persons. We developed computerized models using clinical data from 3 large US HMOs for the 1998-1999 and 1999-2000 influenza seasons. The primary health economic model used a broad definition of clinical events and outcome period and included hospitalizations for all respiratory and cardiovascular events that occurred during the entire influenza season. The alternative model used more restrictive definitions and included pneumonia or influenza hospitalizations occurring during the peak influenza season. The results of Monte Carlo simulation showed that, with the more inclusive primary model, influenza vaccination resulted in net medical care cost savings due to fewer respiratory or cardiovascular hospitalizations of Dollars 71/person vaccinated (5th-95th percentile Dollars 32-118) and net savings of Dollars 809/year of life saved (5th-95th percentile Dollars 331-1450). In contrast, the alternate model found costs of Dollars 3.50/person vaccinated (5th-95th percentile Dollars -11 to 5) and net costs of Dollars 91/year of life saved (5th-95th percentile Dollars -309 to 126). Our findings confirm that influenza vaccination of the elderly is most likely cost saving and supports policies and programs that advocate routine immunization of all persons 65 and older. They also highlight how different outcome definitions can influence the results of health economic analyses.

  6. Effects of perceptual body image distortion and early weight gain on long-term outcome of adolescent anorexia nervosa.

    PubMed

    Boehm, Ilka; Finke, Beatrice; Tam, Friederike I; Fittig, Eike; Scholz, Michael; Gantchev, Krassimir; Roessner, Veit; Ehrlich, Stefan

    2016-12-01

    Anorexia nervosa (AN), a severe mental disorder with an onset during adolescence, has been found to be difficult to treat. Identifying variables that predict long-term outcome may help to develop better treatment strategies. Since body image distortion and weight gain are central elements of diagnosis and treatment of AN, the current study investigated perceptual body image distortion, defined as the accuracy of evaluating one's own perceived body size in relation to the actual body size, as well as total and early weight gain during inpatient treatment as predictors for long-term outcome in a sample of 76 female adolescent AN patients. Long-term outcome was defined by physical, psychological and psychosocial adjustment using the Morgan-Russell outcome assessment schedule as well as by the mere physical outcome consisting of menses and/or BMI approximately 3 years after treatment. Perceptual body image distortion and early weight gain predicted long-term outcome (explained variance 13.3 %), but not the physical outcome alone. This study provides first evidence for an association of perceptual body image distortion with long-term outcome of adolescent anorexia nervosa and underlines the importance of sufficient early weight gain.

  7. Non-hypervascular hypointense nodules on Gd-EOB-DTPA-enhanced MRI as a predictor of outcomes for early-stage HCC.

    PubMed

    Toyoda, Hidenori; Kumada, Takashi; Tada, Toshifumi; Sone, Yasuhiro; Maeda, Atsuyuki; Kaneoka, Yuji

    2015-01-01

    In patients with hepatocellular carcinoma (HCC), gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance imaging (MRI) often identifies non-hypervascular hypointense hepatic nodules during the hepatobiliary phase, but their prognostic significance is unclear. We conducted a prospective observational study to investigate the impact of non-hypervascular hypointense hepatic nodules detected by Gd-EOB-DTPA-enhanced MRI on the outcome of patients with early-stage HCC. Post-treatment recurrence and survival rates were analyzed in 138 patients with non-recurrent, early-stage HCC [Barcelona Clinic Liver Cancer (BCLC) stage 0 or A] and Child-Pugh A liver function according to the presence of non-hypervascular hypointense nodules on pretreatment Gd-EOB-DTPA-enhanced MRI. Non-hypervascular hypointense hepatic nodules were detected in 51 (37.0%) patients with early-stage HCC on pretreatment Gd-EOB-DTPA-enhanced MRI. Recurrence rates were significantly higher in patients with non-hypervascular hypointense nodules (p < 0.0001). Based on a multivariate analysis, the presence of non-hypervascular hypointense hepatic nodules on Gd-EOB-DTPA-enhanced MRI was independently associated with an increased recurrence rate, independent of tumor progression or treatment (p = 0.0005). The survival rate was significantly lower in patients with non-hypervascular hypointense nodules on Gd-EOB-DTPA-enhanced MRI (p = 0.0108). In patients with early-stage typical HCC (BCLC 0 or A), the presence of concurrent non-hypervascular hypointense hepatic nodules in the hepatobiliary phase of pretreatment Gd-EOB-DTPA-enhanced MRI is an indicator of higher likelihood of recurrence after treatment and may be a marker for unfavorable outcome.

  8. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD).

    PubMed

    Simpson, Eric L; Gadkari, Abhijit; Worm, Margitta; Soong, Weily; Blauvelt, Andrew; Eckert, Laurent; Wu, Richard; Ardeleanu, Marius; Graham, Neil M H; Pirozzi, Gianluca; Sutherland, E Rand; Mastey, Vera

    2016-09-01

    Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies. We sought to evaluate dupilumab treatment on patient-reported outcomes in adults with moderate to severe AD. Adults (N = 380) with moderate to severe AD inadequately controlled by topical medications were randomized to 16 weeks of double-blind, subcutaneous treatment with dupilumab 100 mg every 4 weeks, 200 mg every 2 weeks, 300 mg every 2 weeks, 300 mg once weekly, or placebo. Patient-reported outcomes included pruritus numeric rating scale; patient-reported sleep item on Scoring AD scale; Patient-Oriented Eczema Measure; Hospital Anxiety and Depression Scale; Dermatology Life Quality Index; and 5-dimension 3-level EuroQol. Dupilumab reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on numeric rating scale (P < .0001 all doses, except 100 mg every 4 weeks P < .05); improved sleep and health-related quality of life on Dermatology Life Quality Index and 5-dimension 3-level EuroQol (P < .05 all doses, except 100 mg every 4 weeks); and reduced anxiety and depression symptoms (P < .05 all doses). Dupilumab's effects appeared early and achieved clinically relevant improvements without significant safety concerns. There are potential cultural differences affecting patient-reported outcome responses. Outcomes were secondary or exploratory end points. Dupilumab produced early and sustained patient-reported and clinically relevant improvements in sleep, mental health, and health-related quality of life; the two 300-mg dose regimens resulted in greatest benefits. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  9. Influence of Body Mass Index and Albumin on Perioperative Morbidity and Clinical Outcomes in Resected Pancreatic Adenocarcinoma

    PubMed Central

    Hendifar, Andrew; Osipov, Arsen; Khanuja, Jasleen; Nissen, Nicholas; Naziri, Jason; Yang, Wensha; Li, Quanlin; Tuli, Richard

    2016-01-01

    Obesity is a known risk factor for PDA and recent reports suggest obesity has a negative impact on clinical outcomes in patients with PDA. Pretreatment body mass index (BMI) and serum albumin (SA) have been shown to be associated with worse overall survival in patients with advanced and metastatic PDA. However, minimal data exists on the impact of BMI and SA on perioperative and long-term clinical outcomes in patients with early-stage resected PDA. Herein, we report on the impact of these variables on perioperative clinical outcomes, overall survival (OS) and disease free survival (DFS) in patients with resected PDA. With IRB approval, we evaluated 1,545 patients with PDA treated at a single institution from 2007–2013 and identified 106 patients who underwent upfront resection with curative intent. BMI and SA were calculated preoperatively and at the time of last clinical evaluation. Influence of preoperative BMI, SA, change in either variable, and influence of other clinical and pathologic variables on perioperative morbidity and mortality was assessed. The impact of these variables on DFS and OS was assessed with cox regression modeling and ANOVA. Actuarial estimates for DFS and OS were calculated using Kaplan-Meier methods. Median follow up time was 16 months (3–89). Mean age was 68 years. Median survival was 14 months (3–65) and median time to recurrence was 11 months (1–79). Length of hospital stay was associated with BMI (p = .023), change in BMI (p = .003) and SA (p = .004). Post-operative transfusion rate was associated with SA (p = .021). There was a strong correlation between BMI change and positive margin (p = .04) and lymph node status (p = .01). On multivariate analysis, change in SA (p = .03) and node positivity (p = .008) were associated with decreased DFS. Additionally, preoperative SA (p = .023), node positivity (p = .026) and poor differentiation (p = .045) were associated with worse OS on multivariate analysis. Low preoperative SA was

  10. Influence of Body Mass Index and Albumin on Perioperative Morbidity and Clinical Outcomes in Resected Pancreatic Adenocarcinoma.

    PubMed

    Hendifar, Andrew; Osipov, Arsen; Khanuja, Jasleen; Nissen, Nicholas; Naziri, Jason; Yang, Wensha; Li, Quanlin; Tuli, Richard

    2016-01-01

    Obesity is a known risk factor for PDA and recent reports suggest obesity has a negative impact on clinical outcomes in patients with PDA. Pretreatment body mass index (BMI) and serum albumin (SA) have been shown to be associated with worse overall survival in patients with advanced and metastatic PDA. However, minimal data exists on the impact of BMI and SA on perioperative and long-term clinical outcomes in patients with early-stage resected PDA. Herein, we report on the impact of these variables on perioperative clinical outcomes, overall survival (OS) and disease free survival (DFS) in patients with resected PDA. With IRB approval, we evaluated 1,545 patients with PDA treated at a single institution from 2007-2013 and identified 106 patients who underwent upfront resection with curative intent. BMI and SA were calculated preoperatively and at the time of last clinical evaluation. Influence of preoperative BMI, SA, change in either variable, and influence of other clinical and pathologic variables on perioperative morbidity and mortality was assessed. The impact of these variables on DFS and OS was assessed with cox regression modeling and ANOVA. Actuarial estimates for DFS and OS were calculated using Kaplan-Meier methods. Median follow up time was 16 months (3-89). Mean age was 68 years. Median survival was 14 months (3-65) and median time to recurrence was 11 months (1-79). Length of hospital stay was associated with BMI (p = .023), change in BMI (p = .003) and SA (p = .004). Post-operative transfusion rate was associated with SA (p = .021). There was a strong correlation between BMI change and positive margin (p = .04) and lymph node status (p = .01). On multivariate analysis, change in SA (p = .03) and node positivity (p = .008) were associated with decreased DFS. Additionally, preoperative SA (p = .023), node positivity (p = .026) and poor differentiation (p = .045) were associated with worse OS on multivariate analysis. Low preoperative SA was associated

  11. Early Outcomes of Primary Total Hip Arthroplasty After Prior Lumbar Spinal Fusion.

    PubMed

    Barry, Jeffrey J; Sing, David C; Vail, Thomas P; Hansen, Erik N

    2017-02-01

    The coexistence of degenerative hip disease and spinal pathology is not uncommon with the number of surgical treatments performed for each condition increasing annually. The limited research available suggests spinal pathology portends less pain relief and worse outcomes after total hip arthroplasty (THA). We hypothesize that primary THA patients with preexisting lumbar spinal fusions (LSF) experience worse early postoperative outcomes. This study is a retrospective matched cohort study. Primary THA patients at 1 institution who had undergone prior LSF (spine arthrodesis-hip arthroplasty [SAHA]) were identified and matched to controls of primary THA without LSF. Early outcomes (<90 days) were compared. From 2012 to 2014, 35 SAHA patients were compared to 70 matched controls. Patients were similar in age, sex, American Society of Anesthesiologist score, body mass index, and Charlson Comorbidity Index. SAHA patients had higher rates of complications (31.4% vs 8.6%, P = .008), reoperation (14.3% vs 2.9%, P = .040), and general anesthesia (54.3% vs 5.7%, P = .0001). Bivariate analysis demonstrated SAHA to predict reoperation (odds ratio, 5.67; P = .045) and complications (odds ratio, 4.89; P = .005). With the numbers available, dislocations (0% vs 2.8%), infections (0% vs 8.6%), readmissions, postoperative walking distance, and disposition only trended to favor controls (P > .05). Comparing controls to SAHA patients with <3 or ≥3 levels fused, longer fusions had increased cumulative postoperative narcotic consumption (mean morphine equivalents, 44.3 vs 46.9 vs 169.4; P = .001). Patients with preexisting LSF experience worse early outcomes after primary THA including higher rates of complications and reoperation. Lower rates of neuraxial anesthesia and increased narcotic usage represent potential contributors. The complex interplay between the lumbar spine and hip warrants attention and further investigation. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Fibrocartilaginous embolic myelopathy: demographics, clinical presentation, and functional outcomes.

    PubMed

    Moore, Brittany J; Batterson, Anna M; Luetmer, Marianne T; Reeves, Ronald K

    2018-05-25

    Retrospective cohort study. To describe the demographics, clinical presentation, and functional outcomes of fibrocartilaginous embolic myelopathy (FCEM). Academic inpatient rehabilitation unit in the midwestern United States. We retrospectively searched our database to identify patients admitted between January 1, 1995 and March 31, 2016, with a high probability of FCEM. Demographic, clinical, and functional outcome measures, including Functional Independence Measure (FIM) information was obtained by chart review. We identified 31 patients with findings suggestive of FCEM (52% male), which was 2% of the nontraumatic spinal cord injury population admitted to inpatient rehabilitation. The age distribution was bimodal, with peaks in the second and sixth-to-seventh decades. The most common clinical presentation was acute pain and rapid progression of neurologic deficits consistent with a vascular myelopathy. Only three patients (10%) had FCEM documented as a diagnostic possibility. Most patients had paraplegia and neurologically incomplete injuries and were discharged to home. Nearly half of the patients required no assistive device for bladder management at discharge, but most were discharged with medications for bowel management. Median FIM walking locomotion score for all patients was 5, but most patients were discharged using a wheelchair for primary mobility. Median motor FIM subscale score was 36 at admission and 69 at discharge, with a median motor efficiency of 1.41. FCEM may be underdiagnosed and should be considered in those with the appropriate clinical presentation, because their functional outcomes may be more favorable than those with other causes of spinal cord infarction.

  13. Clinical Manifestations and Outcomes of West Nile Virus Infection

    PubMed Central

    Sejvar, James J.

    2014-01-01

    Since the emergence of West Nile virus (WNV) in North America in 1999, understanding of the clinical features, spectrum of illness and eventual functional outcomes of human illness has increased tremendously. Most human infections with WNV remain clinically silent. Among those persons developing symptomatic illness, most develop a self-limited febrile illness. More severe illness with WNV (West Nile neuroinvasive disease, WNND) is manifested as meningitis, encephalitis or an acute anterior (polio) myelitis. These manifestations are generally more prevalent in older persons or those with immunosuppression. In the future, a more thorough understanding of the long-term physical, cognitive and functional outcomes of persons recovering from WNV illness will be important in understanding the overall illness burden. PMID:24509812

  14. Outcomes at 12 months after early magnetic resonance imaging in acute trauma patients with persistent midline cervical tenderness and negative computed tomography.

    PubMed

    Ackland, Helen M; Cameron, Peter A; Wolfe, Rory; Malham, Gregory M; Varma, Dinesh K; Fitt, Gregory J; Cooper, D James; Rosenfeld, Jeffrey V; Liew, Susan M

    2013-06-01

    A prospective observational cohort study of alert, neurologically intact trauma patients presenting to the emergency department with midline cervical tenderness. Screening cervical magnetic resonance imaging (MRI) had been conducted after negative computed tomography (CT) when tenderness was persistent. To determine the association of acute findings and demographic characteristics with any long-term neck disability, and with time to return to work in such patients. The relationship between acute findings and outcomes in these patients is unknown, and we hypothesized that outcomes at 12 months would correlate with acute clinical signs and symptoms, MRI findings, and mechanisms of injury. Patients at a Level 1 trauma center with persistent midline cervical tenderness in the absence of evidence of intoxication, painful distracting injury, persistently abnormal neurology, or acute CT findings, who underwent early cervical MRI under the institutional protocol, were reviewed in the outpatient spine clinic after discharge. In addition, the factors associated with neck disability and time to return to work were examined at follow-up at 12 months after presentation. There were 162 of 178 patients available for follow-up at 12 months (91%). Of these, 46% had MRI-identified cervical spine injury at their initial examination, and 22% had required clinical management, including 2.5% with operative stabilization. Neck disability was present in 43% of patients and was associated with depressive symptoms, workers' compensation, and low annual income. Delay in return to work was associated with the presence of minor limb/other fractures and depressive symptoms, whereas patients on high annual incomes were found to return to work more quickly. Surprisingly in these acute trauma patients, MRI-detected injury, clinical factors, and injury mechanism were not found to be associated with long-term patient outcomes. As a result, a trial of a more targeted, individual return to work plan

  15. Fertility and neonatal outcomes of embryos achieving blastulation on Day 7: are they of clinical value?

    PubMed

    Du, Tong; Wang, Yun; Fan, Yong; Zhang, Shiyi; Yan, Zhiguang; Yu, Weina; Xi, Qianwen; Chen, Qiuju; Mol, Ben W; Lyu, Qifeng; Kuang, Yanping

    2018-06-01

    Is transferring embryos that achieve blastulation on Day 7 effective and safe? Embryos that achieve blastulation on Day 7 resulted in clinically relevant rates of clinical pregnancy (32.5%) and live birth (25.2%), and newborns have a similar risk of low birth weight, congenital malformations or early neonatal death compared with those derived from Days 5 and 6 blastocysts. Potential advantages of blastocyst transfer over cleavage embryo transfer have led to a shift toward the former in IVF practice. However, published data about the fertility outcomes of transferring embryos with a delayed blastulation on Day 7 are scarce and controversial. Moreover, there are few data available on the neonatal outcomes of Day 7 blastocysts. As a result, the clinical value of Day 7 blastocysts is uncertain. This was a retrospective cohort study that included 2908 women undergoing frozen-thawed embryo transfer cycles of IVF/ICSI from January 2006 to May 2015, and reported on the 1518 live born infants from those cycles. We used propensity score matching to compare the fertility outcomes of women undergoing Day-5, Day-6 and Day-7 vitrified embryo transfers in three matched comparisons (Day 5 vs Day 6, Day 5 vs Day 7 and Day 6 vs Day 7). We also compared neonatal outcomes among babies derived from Day-5, Day-6 and Day-7 vitrified embryo transfers. We studied 922 Day-5, 1752 Day-6 and 234 Day-7 vitrified embryo transfers. Day-7 vitrified embryo transfers had significantly lower implantation, clinical pregnancy and live birth rates than both Day-5 (23.9 vs 49.9%, 31.7 vs 58.1% and 25.1 vs 46.5%, all P < 0.001, respectively) and Day-6 (24.7 vs 42.3%, 33.0 vs 53.2% and 25.6 vs 41.4%, all P < 0.001, respectively) vitrified embryo transfers. Assessment of babies showed no statistically significant difference in the rates of low birth weight, congenital malformations and early neonatal death among the 585, 869 and 64 babies born from Day-5, Day-6 and Day-7 vitrified embryo transfer groups

  16. Age-related hip fractures in men: clinical spectrum and short-term outcomes.

    PubMed

    Poór, G; Atkinson, E J; Lewallen, D G; O'Fallon, W M; Melton, L J

    1995-01-01

    Clinical spectrum, treatment and short-term outcomes were assessed among the 131 Rochester, Minnesota, men who contracted an initial hip fracture due to moderate trauma during 1978-89. Three-fourths of falls leading to hip fracture occurred indoors with little seasonality, and 91% of fractures were in men 65 years of age or older. The ratio of cervical to intertrochanteric femur fractures was 1.4:1, and there was a tendency toward more neurological conditions among the patients with cervical fractures. Hemiarthroplasty and total hip replacement were mostly performed for cervical fractures, while internal fixation was preferred for intertrochanteric fractures. In-hospital mortality was 11.5%, and the 30-day case fatality rate was 16.0%. Age and postoperative deterioration of mental status significantly increased the risk of early death, the latter even after adjustment in a multivariate model, while comorbidity had a suggestive but not statistically significant influence on mortality. More than half the men were discharged to nursing homes, and 79% of the patients who survived at 1 year resided in nursing homes or intermediate care facilities or were attended by home care. Only 41% of survivors recovered their prefracture level of functioning and nearly 60% of patients limped and required a cane or walker. After implementation of the prospective payment system in 1984, the length of hospital stay was reduced, but there was no change in early mortality rates, in the duration of physical therapy following fracture or in attendance at nursing homes. The results of this population-based study demonstrate the strong impact of hip fractures on short-term outcomes in men.

  17. The Pancreatitis Activity Scoring System predicts clinical outcomes in acute pancreatitis: findings from a prospective cohort study.

    PubMed

    Buxbaum, James; Quezada, Michael; Chong, Bradford; Gupta, Nikhil; Yu, Chung Yao; Lane, Christianne; Da, Ben; Leung, Kenneth; Shulman, Ira; Pandol, Stephen; Wu, Bechien

    2018-05-01

    The Pancreatitis Activity Scoring System (PASS) has been derived by an international group of experts via a modified Delphi process. Our aim was to perform an external validation study to assess for concordance of the PASS score with high face validity clinical outcomes and determine specific meaningful thresholds to assist in application of this scoring system in a large prospectively ascertained cohort. We analyzed data from a prospective cohort study of consecutive patients admitted to the Los Angeles County Hospital between March 2015 and March 2017. Patients were identified using an emergency department paging system and electronic alert system. Comprehensive characterization included substance use history, pancreatitis etiology, biochemical profile, and detailed clinical course. We calculated the PASS score at admission, discharge, and at 12 h increments during the hospitalization. We performed several analyses to assess the relationship between the PASS score and outcomes at various points during hospitalization as well as following discharge. Using multivariable logistic regression analysis, we assessed the relationship between admission PASS score and risk of severe pancreatitis. PASS score performance was compared to established systems used to predict severe pancreatitis. Additional inpatient outcomes assessed included local complications, length of stay, development of systemic inflammatory response syndrome (SIRS), and intensive care unit (ICU) admission. We also assessed whether the PASS score at discharge was associated with early readmission (re-hospitalization for pancreatitis symptoms and complications within 30 days of discharge). A total of 439 patients were enrolled, their mean age was 42 (±15) years, and 53% were male. Admission PASS score >140 was associated with moderately severe and severe pancreatitis (OR 3.5 [95% CI 2.0, 6.3]), ICU admission (OR 4.9 [2.5, 9.4]), local complications (3.0 [1.6, 5.7]), and development of SIRS (OR 2.9 [1

  18. Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes

    PubMed Central

    Gibson, EJ; Begum, N; Koblbauer, I; Dranitsaris, G; Liew, D; McEwan, P; Tahami Monfared, AA; Yuan, Y; Juarez-Garcia, A; Tyas, D; Lees, M

    2018-01-01

    Background Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. Materials and methods This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). Results The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Conclusion Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors. PMID:29563820

  19. Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes.

    PubMed

    Gibson, E J; Begum, N; Koblbauer, I; Dranitsaris, G; Liew, D; McEwan, P; Tahami Monfared, A A; Yuan, Y; Juarez-Garcia, A; Tyas, D; Lees, M

    2018-01-01

    Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.

  20. Early Ventricular Tachycardia or Fibrillation in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention and Impact on Mortality and Stent Thrombosis (from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Trial).

    PubMed

    Kosmidou, Ioanna; Embacher, Monica; McAndrew, Thomas; Dizon, José M; Mehran, Roxana; Ben-Yehuda, Ori; Mintz, Gary S; Stone, Gregg W

    2017-11-15

    The prevalence and impact of early ventricular arrhythmias (ventricular tachycardia [VT]/ventricular fibrillation [VF]) occurring before mechanical revascularization for acute ST segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention are poorly understood. We sought to investigate the association between early VT/VF and long-term clinical outcomes using data from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial. Among 3,602 patients with STEMI, 108 patients (3.0%) had early VT/VF. Baseline clinical characteristics were similar in patients with versus without early VT/VF. Patients with early VT/VF had shorter symptom-to-balloon times and lower left ventricular ejection fraction and underwent more frequent thrombectomy compared with patients without early VT/VF. Adjusted 3-year rates of all-cause death (15.7% vs 6.5%; adjusted hazard ratio 2.62, 95% confidence interval 1.48 to 4.61, p <0.001) and stent thrombosis (13.7% vs 5.7%; adjusted hazard ratio 2.74, 95% confidence interval 1.52 to 4.93, p <0.001) were significantly higher in patients with early VT/VF compared with patients without early VT/VF. In conclusion, in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial, VT/VF occurring before coronary angiography and revascularization in patients with STEMI was strongly associated with increased 3-year rates of death and stent thrombosis. Further investigation into the mechanisms underlying the increased risk of early stent thrombosis in patients with early VT/VF is required. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Impact of early oseltamivir treatment on outcome in critically ill patients with 2009 pandemic influenza A.

    PubMed

    Rodríguez, Alejandro; Díaz, Emili; Martín-Loeches, Ignacio; Sandiumenge, Alberto; Canadell, Laura; Díaz, Juan J; Figueira, Juan C; Marques, Asunción; Alvarez-Lerma, Francisco; Vallés, Jordi; Baladín, Bárbara; García-López, Fernando; Suberviola, Borja; Zaragoza, Rafael; Trefler, Sandra; Bonastre, Juan; Blanquer, José; Rello, Jordi

    2011-05-01

    The impact of oseltamivir on mortality in critically ill patients with 2009 pandemic influenza A (2009 H1N1) is not clear. The main objective of this study was to investigate the relationship between the timing of antiviral administration and intensive care unit (ICU) outcomes. Prospective, observational study of a cohort of ICU patients with confirmed 2009 H1N1 infection. Clinical data, treatment and outcome were compared between patients receiving early treatment (ET) with oseltamivir, initiated within 2 days, and patients administered late treatment (LT), initiated after this timepoint. Multivariate analysis and propensity score were used to determine the effect of oseltamivir on ICU mortality. Six hundred and fifty-seven patients were enrolled. Four hundred and four (61.5%) patients required mechanical ventilation (MV; mortality 32.6%). Among them, 385 received effective antiviral therapy and were included in the study group. All patients received oseltamivir for a median duration of 10 days (interquartile range 8-14 days). Seventy-nine (20.5%) ET patients were compared with 306 LT patients. The two groups were comparable in terms of main clinical variables. ICU length of stay (22.7 ± 16.7 versus 18.4 ± 14.2 days; P = 0.03), hospital length of stay (34.0 ± 20.3 versus 27.2 ± 18.2 days; P = 0.001) and MV days (17.4 ± 15.2 versus 14.0 ± 12.4; P = 0.04) were higher in the LT group. ICU mortality was also higher in LT (34.3%) than in ET (21.5%; OR = 1.9; 95% CI 1.06-3.41). A multivariate model identified ET (OR = 0.44; 95% CI 0.21-0.87) as an independent variable associated with reduced ICU mortality. These results were confirmed by propensity score analysis (OR = 0.44; 95% CI 0.22-0.90; P < 0.001). Our findings suggest that early oseltamivir administration was associated with favourable outcomes among critically ill ventilated patients with 2009 H1N1 virus infection.

  2. Study Comparing Vein Integrity and Clinical Outcomes in Open Vein Harvesting and 2 Types of Endoscopic Vein Harvesting for Coronary Artery Bypass Grafting: The VICO Randomized Clinical Trial (Vein Integrity and Clinical Outcomes)

    PubMed Central

    Krishnamoorthy, Bhuvaneswari; Critchley, William R.; Thompson, Alexander J.; Payne, Katherine; Morris, Julie; Venkateswaran, Rajamiyer V.; Caress, Ann L.

    2018-01-01

    Background Current consensus statements maintain that endoscopic vein harvesting (EVH) should be standard care in coronary artery bypass graft surgery, but vein quality and clinical outcomes have been questioned. The VICO trial (Vein Integrity and Clinical Outcomes) was designed to assess the impact of different vein harvesting methods on vessel damage and whether this contributes to clinical outcomes after coronary artery bypass grafting. Methods In this single-center, randomized clinical trial, patients undergoing coronary artery bypass grafting with an internal mammary artery and with 1 to 4 vein grafts were recruited. All veins were harvested by a single experienced practitioner. We randomly allocated 300 patients into closed tunnel CO2 EVH (n=100), open tunnel CO2 EVH (n=100), and traditional open vein harvesting (n=100) groups. The primary end point was endothelial integrity and muscular damage of the harvested vein. Secondary end points included clinical outcomes (major adverse cardiac events), use of healthcare resources, and impact on health status (quality-adjusted life-years). Results The open vein harvesting group demonstrated marginally better endothelial integrity in random samples (85% versus 88% versus 93% for closed tunnel EVH, open tunnel EVH, and open vein harvesting; P<0.001). Closed tunnel EVH displayed the lowest longitudinal hypertrophy (1% versus 13.5% versus 3%; P=0.001). However, no differences in endothelial stretching were observed between groups (37% versus 37% versus 31%; P=0.62). Secondary clinical outcomes demonstrated no significant differences in composite major adverse cardiac event scores at each time point up to 48 months. The quality-adjusted life-year gain per patient was 0.11 (P<0.001) for closed tunnel EVH and 0.07 (P=0.003) for open tunnel EVH compared with open vein harvesting. The likelihood of being cost-effective, at a predefined threshold of £20 000 per quality-adjusted life-year gained, was 75% for closed tunnel EVH

  3. Fostering Effective Early Learning (FEEL) through a professional development programme for early childhood educators to improve professional practice and child outcomes in the year before formal schooling: study protocol for a cluster randomised controlled trial.

    PubMed

    Melhuish, Edward; Howard, Steven J; Siraj, Iram; Neilsen-Hewett, Cathrine; Kingston, Denise; de Rosnay, Marc; Duursma, Elisabeth; Luu, Betty

    2016-12-19

    A substantial research base documents the benefits of attendance at high-quality early childhood education and care (ECEC) for positive behavioural and learning outcomes. Research has also found that the quality of many young children's experiences and opportunities in ECEC depends on the skills, dispositions and understandings of the early childhood adult educators. Increasingly, research has shown that the quality of children's interactions with educators and their peers, more than any other programme feature, influence what children learn and how they feel about learning. Hence, we sought to investigate the extent to which evidence-based professional development (PD) - focussed on promoting sustained shared thinking through quality interactions - could improve the quality of ECEC and, as a consequence, child outcomes. The Fostering Effective Early Learning (FEEL) study is a cluster randomised controlled trial for evaluating the benefits of a professional development (PD) programme for early childhood educators, compared with no extra PD. Ninety long-day care and preschool centres in New South Wales, Australia, will be selected to ensure representation across National Quality Standards (NQS) ratings, location, centre type and socioeconomic areas. Participating centres will be randomly allocated to one of two groups, stratified by centre type and NQS rating: (1) an intervention group (45 centres) receiving a PD intervention or (2) a control group (45 centres) that continues engaging in typical classroom practice. Randomisation to these groups will occur after the collection of baseline environmental quality ratings. Primary outcomes, at the child level, will be two measures of language development: verbal comprehension and expressive vocabulary. Secondary outcomes at the child level will be measures of early numeracy, social development and self-regulation. Secondary outcomes at the ECEC room level will be measures of environmental quality derived from full

  4. User-centered design in clinical handover: exploring post-implementation outcomes for clinicians.

    PubMed

    Wong, Ming Chao; Cummings, Elizabeth; Turner, Paul

    2013-01-01

    This paper examines the outcomes for clinicians from their involvement in the development of an electronic clinical hand-over tool developed using principles of user-centered design. Conventional e-health post-implementation evaluations tend to emphasize technology-related (mostly positive) outcomes. More recently, unintended (mostly negative) consequences arising from the implementation of e-health technologies have also been reported. There remains limited focus on the post-implementation outcomes for users, particularly those directly involved in e-health design processes. This paper presents detailed analysis and insights into the outcomes experienced post-implementation by a cohort of junior clinicians involved in developing an electronic clinical handover tool in Tasmania, Australia. The qualitative methods used included observations, semi-structured interviews and analysis of clinical handover notes. Significantly, a number of unanticipated flow-on effects were identified that mitigated some of the challenges arising during the design and implementation of the tool. The paper concludes by highlighting the importance of identifying post-implementation user outcomes beyond conventional system adoption and use and also points to the need for more comprehensive evaluative frameworks to encapsulate these broader socio-technical user outcomes.

  5. Early nutrition and health: short- and long-term outcomes.

    PubMed

    Gruszfeld, Dariusz; Socha, Piotr

    2013-01-01

    Maternal diet, nutritional status during pregnancy, and the early diet of the offspring play an important role in later health. The short- and long-term outcomes of early nutrition have been extensively studied in recent decades. One of the most commonly investigated nutritional interventions is breastfeeding, which is associated with a number of positive short- and long-term outcomes. A short-term effect of breastfeeding is reduced morbidity and mortality in children from poor living conditions and in preterm infants. Breastfeeding is associated with better cognitive development and also has a long-term protective effect on obesity risk, prevalence of type 2 diabetes, and a lowering effect on blood pressure. Selected nutrients have undergone extensive investigation to show their role in disease prevention or improved development, e.g. protein intake in infancy seems to be associated with a later risk of obesity or docosahexaenoic acid supplementation has a positive impact on cognitive function. Another consideration is the fast catch-up growth in small for gestational age infants as an important factor associated with adult risk of cardiovascular problems. On the other hand, high protein and energy intake seems to be positively associated with some indicators of cognitive development. Most of the evidence comes from observational studies that cannot exclude potential confounders. Animal studies demonstrate causality but should not be directly extrapolated to humans. The number of randomized controlled studies is increasing but long-term follow-ups are necessary to obtain convincing results. The majority of these trials compare different infant formula compositions and macro- or micronutrient supplementation. One of the major questions is to define a critical (or opportunity) window and a mechanism of nutritional influence on several health outcomes. Copyright © 2013 S. Karger AG, Basel.

  6. Early treatment with laronidase improves clinical outcomes in patients with attenuated MPS I: a retrospective case series analysis of nine sibships.

    PubMed

    Al-Sannaa, Nouriya A; Bay, Luisa; Barbouth, Deborah S; Benhayoun, Youssef; Goizet, Cyril; Guelbert, Norberto; Jones, Simon A; Kyosen, Sandra Obikawa; Martins, Ana Maria; Phornphutkul, Chanika; Reig, Celia; Pleat, Rebecca; Fallet, Shari; Ivanovska Holder, Iva

    2015-10-07

    Enzyme replacement therapy (ERT) with laronidase, (recombinant human α-L-iduronidase; Aldurazyme) is the primary treatment option for patients with attenuated mucopolysaccharidosis type I (MPS I). This study examined the effect of early ERT on clinical manifestations. This multinational, retrospective case series abstracted data from records of 20 patients with Hurler-Scheie syndrome within nine sibships that included older siblings treated with laronidase after the development of significant clinical symptoms, and younger siblings treated before significant symptomatology. Median age at diagnosis was 5.6 and 0.5 years for older and younger siblings, respectively. Median age at ERT initiation was 7.9 and 1.9 years for older and younger siblings, respectively. Improvement or stabilization of somatic signs and symptoms was more notable in younger siblings. Organomegaly present at onset of ERT improved in the majority of both older and younger siblings. Analysis of physician-rated symptom severity demonstrated that cardiac, musculoskeletal, and cognitive symptoms, when absent or mild in younger siblings at ERT initiation, generally did not develop or progress. The majority of older siblings had height/length Z-scores greater than two standard deviations below the mean (less than -2) at both time points. In general, Z-scores for younger siblings were closer to the sex- and age-matched means at follow-up. These findings suggest early initiation of laronidase, prior to the onset of symptoms in patients with attenuated MPS I, can slow or prevent the development of severe clinical manifestations.

  7. Outcome for Children Receiving the Early Start Denver Model before and after 48 Months

    ERIC Educational Resources Information Center

    Vivanti, Giacomo; Dissanayake, Cheryl

    2016-01-01

    The Early Start Denver Model (ESDM) is an intervention program recommended for pre-schoolers with autism ages 12-48 months. The rationale for this recommendation is the potential for intervention to affect developmental trajectories during early sensitive periods. We investigated outcomes of 32 children aged 18-48 months and 28 children aged…

  8. Early post-stroke cognition in stroke rehabilitation patients predicts functional outcome at 13 months.

    PubMed

    Wagle, Jørgen; Farner, Lasse; Flekkøy, Kjell; Bruun Wyller, Torgeir; Sandvik, Leiv; Fure, Brynjar; Stensrød, Brynhild; Engedal, Knut

    2011-01-01

    To identify prognostic factors associated with functional outcome at 13 months in a sample of stroke rehabilitation patients. Specifically, we hypothesized that cognitive functioning early after stroke would predict long-term functional outcome independently of other factors. 163 stroke rehabilitation patients underwent a structured neuropsychological examination 2-3 weeks after hospital admittance, and their functional status was subsequently evaluated 13 months later with the modified Rankin Scale (mRS) as outcome measure. Three predictive models were built using linear regression analyses: a biological model (sociodemographics, apolipoprotein E genotype, prestroke vascular factors, lesion characteristics and neurological stroke-related impairment); a functional model (pre- and early post-stroke cognitive functioning, personal and instrumental activities of daily living, ADL, and depressive symptoms), and a combined model (including significant variables, with p value <0.05, from the biological and functional models). A combined model of 4 variables best predicted long-term functional outcome with explained variance of 49%: neurological impairment (National Institute of Health Stroke Scale; β = 0.402, p < 0.001), age (β = 0.233, p = 0.001), post-stroke cognitive functioning (Repeatable Battery of Neuropsychological Status, RBANS; β = -0.248, p = 0.001) and prestroke personal ADL (Barthel Index; β = -0.217, p = 0.002). Further linear regression analyses of which RBANS indexes and subtests best predicted long-term functional outcome showed that Coding (β = -0.484, p < 0.001) and Figure Copy (β = -0.233, p = 0.002) raw scores at baseline explained 42% of the variance in mRS scores at follow-up. Early post-stroke cognitive functioning as measured by the RBANS is a significant and independent predictor of long-term functional post-stroke outcome. Copyright © 2011 S. Karger AG, Basel.

  9. The effect of early in-hospital medication review on health outcomes: a systematic review.

    PubMed

    Hohl, Corinne M; Wickham, Maeve E; Sobolev, Boris; Perry, Jeff J; Sivilotti, Marco L A; Garrison, Scott; Lang, Eddy; Brasher, Penny; Doyle-Waters, Mary M; Brar, Baljeet; Rowe, Brian H; Lexchin, Joel; Holland, Richard

    2015-07-01

    Adverse drug events are an important cause of emergency department visits, unplanned admissions and prolonged hospital stays. Our objective was to synthesize the evidence on the effect of early in-hospital pharmacist-led medication review on patient-oriented outcomes based on observed data. We systematically searched eight bibliographic reference databases, electronic grey literature, medical journals, conference proceedings, trial registries and bibliographies of relevant papers. We included studies that employed random or quasi-random methods to allocate subjects to pharmacist-led medication review or control. Medication review had to include, at a minimum, obtaining a best possible medication history and reviewing medications for appropriateness and adverse drug events. The intervention had to be initiated within 24 h of emergency department presentation or 72 h of admission. We extracted data in duplicate and pooled outcomes from clinically homogeneous studies of the same design using random effects meta-analysis. We retrieved 4549 titles of which seven were included, reporting the outcomes of 3292 patients. We pooled data from studies of the same design, and found no significant differences in length of hospital admission (weighted mean difference [WMD] -0.04 days, 95% confidence interval [CI] -1.63, 1.55), mortality (odds ratio [OR] 1.09, 95% CI 0.69, 1.72), readmissions (OR 1.15, 95% CI 0.81, 1.63) or emergency department revisits at 3 months (OR 0.60, 95% CI 0.27, 1.32). Two large studies reporting reductions in readmissions could not be included in our pooled estimates due to differences in study design. Wide confidence intervals suggest that additional research is likely to influence the effect size estimates and clarify the effect of medication review on patient-oriented outcomes. This systematic review failed to identify an effect of pharmacist-led medication review on health outcomes. © 2015 The British Pharmacological Society.

  10. Early pregnancy azathioprine use and pregnancy outcomes.

    PubMed

    Cleary, Brian J; Källén, Bengt

    2009-07-01

    Azathioprine (AZA) is used during pregnancy by women with inflammatory bowel disease (IBD), other autoimmune disorders, malignancy, and organ transplantation. Previous studies have demonstrated potential risks. The Swedish Medical Birth Register was used to identify 476 women who reported the use of AZA in early pregnancy. The effect of AZA exposure on pregnancy outcomes was studied after adjustment for maternal characteristics that could act as confounders. The most common indication for AZA use was IBD. The rate of congenital malformations was 6.2% in the AZA group and 4.7% among all infants born (adjusted OR: 1.41, 95% CI: 0.98-2.04). An association between early pregnancy AZA exposure and ventricular/atrial septal defects was found (adjusted OR: 3.18, 95% CI: 1.45-6.04). Exposed infants were also more likely to be preterm, to weigh <2500 gm, and to be small for gestational age compared to all infants born. This effect remained for preterm birth and low birth weight when infants of women with IBD but without AZA exposure were used as a comparison group. A trend toward an increased risk of congenital malformations was found among infants of women with IBD using AZA compared to women with IBD not using AZA (adjusted OR: 1.42, 95% CI: 0.93-2.18). Infants exposed to AZA in early pregnancy may be at a moderately increased risk of congenital malformations, specifically ventricular/atrial septal defects. There is also an increased risk of growth restriction and preterm delivery. These associations may be confounded by the severity of maternal illness.

  11. Detrimental Psychological Outcomes Associated with Early Pubertal Timing in Adolescent Girls

    PubMed Central

    Mendle, Jane; Turkheimer, Eric; Emery, Robert E.

    2010-01-01

    Though often discussed as though it were a discrete event, puberty comprises one segment of a larger developmental continuum and is notable for rapid transformation across a multitude of domains. Research suggests that an earlier rate of pubertal maturation in girls correlates with a number of detrimental outcomes compared with on-time or later maturation. The present review synthesizes the research on negative psychological sequelae of early pubertal timing in adolescent girls. Emphasis is on three theoretical perspectives by which precocious development is believed to affect the emergence of adverse outcomes: biological, psychosocial, and selection effects. PMID:20740062

  12. US-guided percutaneous cholecystostomy: features predicting culture-positive bile and clinical outcome.

    PubMed

    Sosna, Jacob; Kruskal, Jonathan B; Copel, Laurian; Goldberg, S Nahum; Kane, Robert A

    2004-03-01

    To assess sonographic and clinical features that might be used to predict infected bile and/or patient outcome from ultrasonography (US)-guided percutaneous cholecystostomy. Between February 1997 and August 2002 at one institution, 112 patients underwent US-guided percutaneous cholecystostomy (59 men, 53 women; average age, 69.3 years). All US images were scored on a defined semiquantitative scale according to preset parameters: (a) gallbladder distention, (b) sludge and/or stones, (c) wall appearance, (d) pericholecystic fluid, and (e) common bile duct size and/or choledocholithiasis. Separate and total scores were generated. Retrospective evaluation of (a) the bacteriologic growth of aspirated bile and its color and (b) clinical indices (fever, white blood cell count, bilirubin level, liver function test results) was conducted by reviewing medical records. For each patient, the clinical manifestation was classified into four groups: (a) localized right upper quadrant symptoms, (b) generalized abdominal symptoms, (c) unexplained sepsis, or (d) sepsis with other known infection. Logistic regression models, exact Wilcoxon-Mann-Whitney test, and the Kruskal-Wallis test were used. Forty-seven (44%) of 107 patients had infected bile. A logistic regression model showed that wall appearance, distention, bile color, and pericholecystic fluid were not individually significant predictors for culture-positive bile, leaving sludge and/or stones (P =.003, odds ratio = 1.647), common bile duct status (P =.02, odds ratio = 2.214), and total score (P =.007, odds ratio = 1.267). No US covariates or clinical indices predicted clinical outcome. Clinical manifestation was predictive of clinical outcome (P =.001) and aspirating culture-positive bile (P =.008); specifically, 30 (86%) of 35 patients with right upper quadrant symptoms had their condition improve, compared with one (7%) of 15 asymptomatic patients with other known causes of infection. US variables can be used to predict

  13. Service profiling and outcomes benchmarking using the CORE-OM: toward practice-based evidence in the psychological therapies. Clinical Outcomes in Routine Evaluation-Outcome Measures.

    PubMed

    Barkham, M; Margison, F; Leach, C; Lucock, M; Mellor-Clark, J; Evans, C; Benson, L; Connell, J; Audin, K; McGrath, G

    2001-04-01

    To complement the evidence-based practice paradigm, the authors argued for a core outcome measure to provide practice-based evidence for the psychological therapies. Utility requires instruments that are acceptable scientifically, as well as to service users, and a coordinated implementation of the measure at a national level. The development of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is summarized. Data are presented across 39 secondary-care services (n = 2,710) and within an intensively evaluated single service (n = 1,455). Results suggest that the CORE-OM is a valid and reliable measure for multiple settings and is acceptable to users and clinicians as well as policy makers. Baseline data levels of patient presenting problem severity, including risk, are reported in addition to outcome benchmarks that use the concept of reliable and clinically significant change. Basic quality improvement in outcomes for a single service is considered.

  14. Early Clinical Outcomes Demonstrate Preserved Cognitive Function in Children With Average-Risk Medulloblastoma When Treated With Hyperfractionated Radiation Therapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gupta, Tejpal, E-mail: tejpalgupta@rediffmail.com; Jalali, Rakesh; Goswami, Savita

    Purpose: To report on acute toxicity, longitudinal cognitive function, and early clinical outcomes in children with average-risk medulloblastoma. Methods and Materials: Twenty children {>=}5 years of age classified as having average-risk medulloblastoma were accrued on a prospective protocol of hyperfractionated radiation therapy (HFRT) alone. Radiotherapy was delivered with two daily fractions (1 Gy/fraction, 6 to 8 hours apart, 5 days/week), initially to the neuraxis (36 Gy/36 fractions), followed by conformal tumor bed boost (32 Gy/32 fractions) for a total tumor bed dose of 68 Gy/68 fractions over 6 to 7 weeks. Cognitive function was prospectively assessed longitudinally (pretreatment and atmore » specified posttreatment follow-up visits) with the Wechsler Intelligence Scale for Children to give verbal quotient, performance quotient, and full-scale intelligence quotient (FSIQ). Results: The median age of the study cohort was 8 years (range, 5-14 years), representing a slightly older cohort. Acute hematologic toxicity was mild and self-limiting. Eight (40%) children had subnormal intelligence (FSIQ <85), including 3 (15%) with mild mental retardation (FSIQ 56-70) even before radiotherapy. Cognitive functioning for all tested domains was preserved in children evaluable at 3 months, 1 year, and 2 years after completion of HFRT, with no significant decline over time. Age at diagnosis or baseline FSIQ did not have a significant impact on longitudinal cognitive function. At a median follow-up time of 33 months (range, 16-58 months), 3 patients had died (2 of relapse and 1 of accidental burns), resulting in 3-year relapse-free survival and overall survival of 83.5% and 83.2%, respectively. Conclusion: HFRT without upfront chemotherapy has an acceptable acute toxicity profile, without an unduly increased risk of relapse, with preserved cognitive functioning in children with average-risk medulloblastoma.« less

  15. Cerebral oximetry during infant cardiac surgery: evaluation and relationship to early postoperative outcome.

    PubMed

    Kussman, Barry D; Wypij, David; DiNardo, James A; Newburger, Jane W; Mayer, John E; del Nido, Pedro J; Bacha, Emile A; Pigula, Frank; McGrath, Ellen; Laussen, Peter C

    2009-04-01

    We examined changes in cerebral oxygen saturation during infant heart surgery and its relationship to anatomic diagnosis and early outcome. Regional cerebral oxygen saturation (rSO(2)) was measured by near-infrared spectroscopy in 104 infants undergoing biventricular repair without aortic arch obstruction as part of a randomized trial of hemodilution to a hematocrit of 25% vs 35%. Before cardiopulmonary bypass (CPB), infants with tetralogy of Fallot had higher rSO(2) values compared to those with D-transposition of the great arteries (D-TGA) or ventricular septal defect (P < 0.001). During CPB cooling, low flow, and at the termination of CPB, D-TGA subjects had the highest rSO(2) values (P < 0.001). There were no significant associations between intraoperative rSO(2) and early postoperative outcomes after adjustment for diagnosis. In 39 D-TGA subjects with > or =5 min of deep hypothermic circulatory arrest (DHCA), there was no correlation between the rSO(2) (91% +/- 6%) or hematocrit (29.2% +/- 5.5%) at the onset of arrest and the rate of decline in rSO(2) during arrest. Intraoperative rSO(2) varies according to anatomic diagnosis but accounts for very little of the variance in early outcome. As measured by frontal near-infrared spectroscopy, higher levels of hematocrit and current perfusion techniques appear to provide an adequate oxygen reservoir prior to relatively short periods of DHCA.

  16. Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

    PubMed

    Muppidi, Srikanth

    2017-03-01

    The development of validated assessment tools for evaluating disease status and response to interventions in patients with myasthenia gravis (MG) has been driven by clinical studies of emerging MG therapies. However, only a small proportion of MG-focused neurology practices have adopted these assessment tools for routine clinical use. This article reviews the suitability of 5 assessment instruments for incorporation into clinical practice, which should be driven by their ability to contribute to improved patient outcomes, and to be implemented within practice personnel and resource constraints. It is recommended that assessments based on both physician-evaluated and patient-reported outcomes be selected, to adequately evaluate both point-in-time symptom load and functional impact of MG symptoms over time. Provider resource allocation and reimbursement issues may be the most significant roadblocks to successful ongoing use of these tools; to that end, the addition of regular assessments to MG standards of care is recommended.

  17. Clinical Parameters and Outcomes in Periorbital Necrotizing Fasciitis.

    PubMed

    Wladis, Edward J; Levin, Flora; Shinder, Roman

    2015-01-01

    To describe the clinical features associated with periorbital necrotizing fasciitis and to correlate these features with clinical outcomes. The case logs of 3 surgeons were used to identify cases of necrotizing fasciitis. Chart reviews were performed to characterize clinical metrics, and statistical analyses were performed. Seventeen patients (9 males, 8 females; mean age = 48.1 years, standard deviation = 22.6 years) were identified with periorbital necrotizing fasciitis. Of these patients, 52.9% did not have immunodeficiencies, and 52.9% did not have antecedent trauma or infected facial lesions. One patient died from necrotizing fasciitis. A history of immunosuppression correlated with the requirement for exenteration, but did not correlate visual acuity of worse than 20/40 upon discharge from the hospital. Most of the patients (68.75%) were discharged with visual acuity of better than 20/40 in the affected eye. This study represents the largest case series of patients with periorbital necrotizing fasciitis. Most of the patients in this series did not have immunodeficiencies, and the majority were discharged with favorable visual acuities. Nonetheless, a history of immunosuppression correlated with the need for exenteration, but was not statistically linked with worse visual outcomes.

  18. A comparative analysis of early child health and development services and outcomes in countries with different redistributive policies

    PubMed Central

    2013-01-01

    Background The social environment is a fundamental determinant of early child development and, in turn, early child development is a determinant of health, well-being, and learning skills across the life course. Redistributive policies aimed at reducing social inequalities, such as a welfare state and labour market policies, have shown a positive association with selected health indicators. In this study, we investigated the influence of redistributive policies specifically on the social environment of early child development in five countries with different political traditions. The objective of this analysis was to highlight similarities and differences in social and health services between the countries and their associations with other health outcomes that can inform better global early child development policies and improve early child health and development. Methods Four social determinants of early child development were selected to provide a cross-section of key time periods in a child’s life from prenatal to kindergarten. They included: 1) prenatal care, 2) maternal leave, 3) child health care, and 4) child care and early childhood education. We searched international databases and reports (e.g. Organization for Economic Cooperation and Development, World Bank, and UNICEF) to obtain information about early child development policies, services and outcomes. Results Although a comparative analysis cannot claim causation, our analysis suggests that redistributive policies aimed at reducing social inequalities are associated with a positive influence on the social determinants of early child development. Generous redistributive policies are associated with a higher maternal leave allowance and pay and more preventive child healthcare visits. A decreasing trend in infant mortality, low birth weight rate, and under five mortality rate were observed with an increase in redistributive policies. No clear influence of redistributive policies was observed on

  19. A comparative analysis of early child health and development services and outcomes in countries with different redistributive policies.

    PubMed

    van den Heuvel, Meta; Hopkins, Jessica; Biscaro, Anne; Srikanthan, Cinntha; Feller, Andrea; Bremberg, Sven; Verkuijl, Nienke; Flapper, Boudien; Ford-Jones, Elizabeth Lee; Williams, Robin

    2013-11-06

    The social environment is a fundamental determinant of early child development and, in turn, early child development is a determinant of health, well-being, and learning skills across the life course. Redistributive policies aimed at reducing social inequalities, such as a welfare state and labour market policies, have shown a positive association with selected health indicators. In this study, we investigated the influence of redistributive policies specifically on the social environment of early child development in five countries with different political traditions. The objective of this analysis was to highlight similarities and differences in social and health services between the countries and their associations with other health outcomes that can inform better global early child development policies and improve early child health and development. Four social determinants of early child development were selected to provide a cross-section of key time periods in a child's life from prenatal to kindergarten. They included: 1) prenatal care, 2) maternal leave, 3) child health care, and 4) child care and early childhood education. We searched international databases and reports (e.g. Organization for Economic Cooperation and Development, World Bank, and UNICEF) to obtain information about early child development policies, services and outcomes. Although a comparative analysis cannot claim causation, our analysis suggests that redistributive policies aimed at reducing social inequalities are associated with a positive influence on the social determinants of early child development. Generous redistributive policies are associated with a higher maternal leave allowance and pay and more preventive child healthcare visits. A decreasing trend in infant mortality, low birth weight rate, and under five mortality rate were observed with an increase in redistributive policies. No clear influence of redistributive policies was observed on breastfeeding and immunization

  20. The Head Start Child Development and Early Learning Framework: Promoting Positive Outcomes in Early Childhood Programs Serving Children 3-5 Years Old

    ERIC Educational Resources Information Center

    Office of Head Start, US Department of Health and Human Services, 2010

    2010-01-01

    This report presents a revision of the Head Start Child Outcomes Framework (2000), renamed The Head Start Child Development and Learning Framework: Promoting Positive Outcomes in Early Childhood Programs Serving Children 3-5 Years Old. The Framework outlines the essential areas of development and learning that are to be used by Head Start programs…

  1. Interprofessional teamwork skills as predictors of clinical outcomes in a simulated healthcare setting.

    PubMed

    Shrader, Sarah; Kern, Donna; Zoller, James; Blue, Amy

    2013-01-01

    Teaching interprofessional (IP) teamwork skills is a goal of interprofessional education. The purpose of this study was to examine the relationship between IP teamwork skills, attitudes and clinical outcomes in a simulated clinical setting. One hundred-twenty health professions students (medicine, pharmacy, physician assistant) worked in interprofessional teams to manage a "patient" in a health care simulation setting. Students completed the Interdisciplinary Education Perception Scale (IEPS) attitudinal survey instrument. Students' responses were averaged by team to create an IEPS attitudes score. Teamwork skills for each team were rated by trained observers using a checklist to calculate a teamwork score (TWS). Clinical outcome scores (COS) were determined by summation of completed clinical tasks performed by the team based on an expert developed checklist. Regression analyses were conducted to determine the relationship of IEPS and TWS with COS. IEPS score was not a significant predictor of COS (p=0.054), but TWS was a significant predictor (p<0.001) of COS. Results suggest that in a simulated clinical setting, students' interprofessional teamwork skills are significant predictors of positive clinical outcomes. Interprofessional curricular models that produce effective teamwork skills can improve student performance in clinical environments and likely improve teamwork practice to positively affect patient care outcomes.

  2. Pretreatment Dysphagia Inventory and videofluorographic swallowing study as prognostic indicators of early survival outcomes in head and neck cancer.

    PubMed

    Yang, Chan Joo; Roh, Jong-Lyel; Choi, Kyoung Hyo; Kim, Min-Ju; Choi, Seung-Ho; Nam, Soon Yuhl; Kim, Sang Yoon

    2015-05-15

    The prognostic role of swallowing-related, pretreatment subjective and objective findings has not been investigated in detail. The authors evaluated the association between pretreatment MD Anderson Dysphagia Inventory (MDADI) or videofluorographic swallowing study (VFSS) results and standard outcomes, including early recurrence and survival, in patients with treatment-naïve head and neck squamous cell carcinoma (HNSCC). Patients with HNSCC (n = 191) who received treatment at the authors' institution and were examined by self-administered MDADI questionnaires and VFSS were prospectively enrolled. MDADI and VFSS findings were analyzed in correlation with clinicopathologic variables, and factors that predicted 2-year disease-free survival (DFS) and overall survival (OS) were identified using a Cox proportional-hazards regression model. The 2-year OS and DFS rates were 80.1% and 77.5%, respectively. Clinical tumor (T) and lymph node (N) classifications, overall TNM stage, sex, tumor site, and educational level were significantly associated with specific MDADI subdomains, whereas Karnofsky performance score was significantly associated with all MDADI subdomains. After controlling for clinical factors, total scores, global assessment scores, and emotional and physical MDADI subscores were significantly predictive of 2-year OS and DFS (P < .05 for each). VFSS findings were not significantly associated with survival (P > .05). The current results provide evidence of the prognostic role of the MDADI in predicting early survival outcomes in patients with HNSCC. The MDADI may be a practical and noninvasive method for the identification of patients at risk who would benefit from close follow-up. © 2015 American Cancer Society.

  3. The economic and clinical burden of early versus late initiation of celecoxib among patients with osteoarthritis

    PubMed Central

    Shelbaya, Ahmed; Solem, Caitlyn T; Walker, Chris; Wan, Yin; Johnson, Courtney; Cappelleri, Joseph C

    2018-01-01

    Objective This study aimed to evaluate the characteristics associated with early versus late initiation of celecoxib treatment after osteoarthritis (OA) diagnosis and whether economic and safety outcomes differ between patients with early versus late initiation of celecoxib. Methods Adults (≥18 years) with a confirmed OA diagnosis (International Classification of Diseases, 9th Edition, Clinical Modifications code: 715.XX), ≥12 months of continuous pre- and post-index enrollment, and ≥1 post-index claim for celecoxib were included from the MarketScan® Commercial Claims and Encounter Database (2009–2013). Index date was defined as initial OA diagnosis. Patients were categorized as initiating celecoxib early (within 6 months of index date) or late (≥6 months after index date). Logistic regressions were used to assess characteristics associated with early versus late celecoxib initiation. Key outcomes included health care resource utilization (HCRU) and costs post-index, and adverse event incidence post-celecoxib initiation. Unadjusted and adjusted comparisons (using generalized linear models with a gamma distribution for costs and Poisson distribution for event and resource utilization) were made between early and late celecoxib initiators. Results Of the 62,434 OA patients identified, 27,402 were early and 35,032 were late initiators. Post-index hospital admissions and length of stay did not differ statistically between early versus late initiators after controlling for pre-index event rates and covariates, but early patients had significantly fewer outpatient (incidence rate ratio [IRR]: 0.96; 95% confidence interval [CI]: 0.95, 0.97) and emergency room visits (IRR: 0.89; 95% CI: 0.84, 0.95). After adjustment for key covariates, early initiators (versus late initiators) had lower all-cause (US$12,909 versus US$13,781, P<0.001) and OA-related (US$4,988 versus US$5,178, P=0.015) costs per person-year. Early initiators had no statistically significant

  4. The Search for an Early Intervention Outcome Measurement Tool in Autism

    ERIC Educational Resources Information Center

    Fletcher-Watson, S.; McConachie, H.

    2017-01-01

    Evidence is accumulating that early intervention can be effective in improving the skills of young children with autism spectrum disorder. However, the science is hampered by the lack of agreed "gold standard" tools for the measurement of progress and outcome. What is required is a reliable, valid, and sensitive measure of change in the…

  5. Clinical and radiographic outcomes after total shoulder arthroplasty with an anatomic press-fit short stem.

    PubMed

    Szerlip, Benjamin W; Morris, Brent J; Laughlin, Mitzi S; Kilian, Christopher M; Edwards, T Bradley

    2018-01-01

    There is limited information assessing outcomes after total shoulder arthroplasty (TSA) with a press-fit short stem. The purpose of this study was to evaluate early clinical and radiographic outcomes and complications after TSA with an anatomic press-fit short stem. We identified 118 TSAs completed with press-fit short stem and minimum 2-year follow-up; 85 of these patients had a grit-blasted (GB) short stem placed, whereas 33 patients had short stems with proximal porous coating (PPC). Shoulder function scores, active mobility measurements, and radiographs were assessed. The average age at surgery was 66.7 years, with average follow-up of 3 years. Significant improvements were noted for all shoulder function scores and active mobility measurements from the preoperative state to final follow-up (P < .001). There was no stem loosening in any patients with minimum 2-year follow-up; however, 3 female patients with GB stems had gross loosening of their humeral components before 1 year, 2 requiring revision. Radiolucent lines around the humeral component were found in 5.9% without evidence of loosening. Osseous resorption at the medial cortex was noted in 9.3%. Of patients with PPC stems, no patients were observed to have radiolucent lines compared with 8.2% in the GB group (P = .09). TSAs with anatomic press-fit short stem showed significant clinical improvements from the preoperative state to final short-term follow-up, with few complications and minimal radiographic changes. Lack of PPC may contribute to early loosening in patients with poor bone quality. The authors now use a short stem with PPC. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  6. Using an evidence-based approach to measure outcomes in clinical practice.

    PubMed

    MacDermid, Joy C; Grewal, Ruby; MacIntyre, Norma J

    2009-02-01

    Evaluation of the outcome of evidence-based practice decisions in individual patients or patient groups is step five in the evidence-based practice approach. Outcome measures are any measures that reflect patient status. Status or outcome measures can be used to detect change over time (eg, treatment effects), to discriminate among clinical groups, or to predict future outcomes (eg, return to work). A variety of reliable and valid physical impairment and disability measures are available to assess treatment outcomes in hand surgery and therapy. Evidence from research studies that includes normative data, standard error of measurement, or comparative scores for important clinical subgroups can be used to set treatment goals, monitor recovery, and compare individual patient outcomes to those reported in the literature. Clinicians tend to rely on impairment measures, such as radiographic measures, grip strength, and range of motion, although self-report measures are known to be equally reliable and more related to global effects, such as return-to-work. The process of selecting and implementing outcome measures is crucial. This process works best when team members are involved and willing to trial new measures. In this way, the team can develop customized outcome assessment procedures that meet their needs for assessing individual patients and providing data for program evaluation.

  7. Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

    PubMed

    Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T

    2018-02-01

    The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for

  8. Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes.

    PubMed

    Sakamoto, Shinji; Takaki, Manabu; Okahisa, Yuko; Mizuki, Yutaka; Inagaki, Masatoshi; Ujike, Hiroshi; Mitsuhashi, Toshiharu; Takao, Soshi; Ikeda, Masashi; Uchitomi, Yosuke; Iwata, Nakao; Yamada, Norihito

    2016-04-01

    Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study.

  9. Clinical imprinting: the impact of early clinical learning on career long professional development in nursing.

    PubMed

    Andrew, Nicola

    2013-05-01

    The literature recognises a relationship between clinical experience and a successful undergraduate experience in nursing; however what constitutes an effective approach remains the subject of debate, particularly in relation to first year of learning. There is evidence from a biological standpoint that early experience impacts on the behavioural development of animals, described by Konrad Lorenz (1903-1989) as 'imprinting'. The concept of imprinting has resonance for nursing. In this article the importance of 'getting it right at the beginning' is explored and what, if anything, Lorenz's theory tells us about the impact of early clinical learning on subsequent professional development. Copyright © 2012 Elsevier Ltd. All rights reserved.

  10. Outcome of Early Initiation of Peritoneal Dialysis in Patients with End-Stage Renal Failure

    PubMed Central

    Oh, Kook-Hwan; Hwang, Young-Hwan; Cho, Jung-Hwa; Kim, Mira; Ju, Kyung Don; Joo, Kwon Wook; Kim, Dong Ki; Kim, Yon Su; Ahn, Curie

    2012-01-01

    Recent studies reported that early initiation of hemodialysis may increase mortality. However, studies that assessed the influence of early initiation of peritoneal dialysis (PD) yielded controversial results. In the present study, we evaluated the prognosis of early initiation of PD on the various outcomes of end stage renal failure patients by using propensity-score matching methods. Incident PD patients (n = 491) who started PD at SNU Hospital were enrolled. The patients were divided into 'early starters (n = 244)' and 'late starters (n = 247)' on the basis of the estimated glomerular filtration rate (eGFR) at the start of dialysis. The calculated propensity-score was used for one-to-one matching. After propensity-score-based matching (n = 136, for each group), no significant differences were observed in terms of all-cause mortality (P = 0.17), technique failure (P = 0.62), cardiovascular event (P = 0.96) and composite event (P = 0.86) between the early and late starters. Stratification analysis in the propensity-score quartiles (n = 491) exhibited no trend toward better or poorer survival in terms of all-cause mortality. In conclusion, early commencement of PD does not reduce the mortality risk and other outcomes. Although the recent guidelines suggest that initiation of dialysis at higher eGFR, physicians should not determine the time to initiate PD therapy simply rely on the eGFR alone. PMID:22323864

  11. Rostral anterior cingulate cortex activity and early symptom improvement during treatment for major depressive disorder

    PubMed Central

    Korb, Alexander S.; Hunter, Aimee M.; Cook, Ian A.; Leuchter, Andrew F.

    2011-01-01

    In treatment trials for Major Depressive Disorder (MDD), early symptom improvement is predictive of eventual clinical response. Clinical response may also be predicted by elevated pretreatment theta (4-7 Hz) current density in the rostral anterior cingulate (rACC) and medial orbitofrontal cortex (mOFC). We investigated the relationship between pretreatment EEG and early improvement in predicting clinical outcome in 72 MDD subjects across three placebo-controlled treatment trials. Subjects were randomized to receive fluoxetine, venlafaxine, or placebo. Theta current density in the rACC and mOFC was computed with Low-Resolution Brain Electromagnetic Tomography (LORETA). An ANCOVA, examining week 8 Hamilton Depression Rating Scale (HamD) percent change, showed a significant effect of week-2-HamD-percent-change, and a significant three-way interaction of week-2-HamD-percent-change × Treatment × rACC. Medication subjects with robust early improvement showed almost no relationship between rACC theta current density and final clinical outcome. However, in subjects with little early improvement, rACC activity showed a strong relationship with clinical outcome. The model examining mOFC showed a trend in the three-way interaction. A combination of pretreatment rACC activity and early symptom improvement may be useful for predicting treatment response. PMID:21546222

  12. Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

    PubMed

    Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

    2014-01-01

    This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

  13. Neurocognitive Outcomes in the Treatment of Early-Onset Schizophrenia Spectrum Disorders Study

    ERIC Educational Resources Information Center

    Frazier, Jean A.; Giuliano, Anthony J.; Johnson, Jacqueline L.; Yakutis, Lauren; Youngstrom, Eric A.; Breiger, David; Sikich, Linmarie; Findling, Robert L.; McClellan, Jon; Hamer, Robert M.; Vitiello, Benedetto; Lieberman, Jeffrey A.; Hooper, Stephen R.

    2012-01-01

    Objective: To assess neurocognitive outcomes following antipsychotic intervention in youth enrolled in the National Institute of Mental Health (NIMH)-funded Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS). Method: Neurocognitive functioning of youth (ages 8 to 19 years) with schizophrenia or schizoaffective disorder was evaluated…

  14. Ocriplasmin for treatment of stage 2 macular holes: early clinical results.

    PubMed

    Miller, John B; Kim, Leo A; Wu, David M; Vavvas, Demetrios G; Eliott, Dean; Husain, Deeba

    2014-01-01

    To review clinical and structural outcomes of ocriplasmin for treatment of stage 2 macular holes. A retrospective review of the first patients with stage 2 macular holes to be treated with ocriplasmin at Massachusetts Eye and Ear Infirmary. All patients were imaged with spectral-domain optical coherence tomography (SD-OCT). Eight patients with stage 2 macular holes received a single injection of 125 μg of ocriplasmin. One patient (12.5%) demonstrated macular hole closure. The posterior hyaloid separated from the macula in six eyes (75%). All seven holes that remained open showed enlargement in hole diameters (narrowest, apical, and basal) at 1 week and 1 month. All seven were successfully closed with surgery. Ellipsoid zone disruptions were observed by OCT in four eyes (50%) and persisted throughout follow-up (more than 6 months on average). In early clinical results, the authors found a lower macular hole closure rate with ocriplasmin than previously reported. Enlargement was observed in all holes that failed to close with ocriplasmin. The authors found ellipsoid zone disruptions that persisted through 6 months of follow-up after ocriplasmin injection. Further work is needed to investigate the cause for these ellipsoid zone changes. Copyright 2014, SLACK Incorporated.

  15. The impact of Public Reporting on clinical outcomes: a systematic review and meta-analysis.

    PubMed

    Campanella, Paolo; Vukovic, Vladimir; Parente, Paolo; Sulejmani, Adela; Ricciardi, Walter; Specchia, Maria Lucia

    2016-07-22

    To assess both qualitatively and quantitatively the impact of Public Reporting (PR) on clinical outcomes, we carried out a systematic review of published studies on this topic. Pubmed, Web of Science and SCOPUS databases were searched to identify studies published from 1991 to 2014 that investigated the relationship between PR and clinical outcomes. Studies were considered eligible if they investigated the relationship between PR and clinical outcomes and comprehensively described the PR mechanism and the study design adopted. Among the clinical outcomes identified, meta-analysis was performed for overall mortality rate which quantitative data were exhaustively reported in a sufficient number of studies. Two reviewers conducted all data extraction independently and disagreements were resolved through discussion. The same reviewers evaluated also the quality of the studies using a GRADE approach. Twenty-seven studies were included. Mainly, the effect of PR on clinical outcomes was positive. Meta-analysis regarding overall mortality included, in a context of high heterogeneity, 10 studies with a total of 1,840,401 experimental events and 3,670,446 control events and resulted in a RR of 0.85 (95 % CI, 0.79-0.92). The introduction of PR programs at different levels of the healthcare sector is a challenging but rewarding public health strategy. Existing research covering different clinical outcomes supports the idea that PR could, in fact, stimulate providers to improve healthcare quality.

  16. Trajectories of Physical Discipline: Early Childhood Antecedents and Developmental Outcomes

    PubMed Central

    Lansford, Jennifer E.; Criss, Michael M.; Dodge, Kenneth A.; Shaw, Daniel S.; Pettit, Gregory S.; Bates, John E.

    2009-01-01

    This study examined childhood antecedents and developmental outcomes associated with trajectories of mild and harsh parental physical discipline. Interview, questionnaire, and observational data were available from 499 children followed from age 5 to 16 and from 258 children in an independent sample followed from age 5 to 15. Analyses indicated distinct physical discipline trajectory groups that varied in frequency of physical discipline and rate of change. In both samples, family ecological disadvantage differentiated the trajectory groups; in the first sample, early child externalizing also differentiated the groups. Controlling for early childhood externalizing, the minimal/ceasing trajectory groups were associated with the lowest levels of subsequent adolescent antisocial behavior in both samples and with parent-adolescent positive relationship quality in the second sample. PMID:19765007

  17. Trajectories of physical discipline: early childhood antecedents and developmental outcomes.

    PubMed

    Lansford, Jennifer E; Criss, Michael M; Dodge, Kenneth A; Shaw, Daniel S; Pettit, Gregory S; Bates, John E

    2009-01-01

    This study examined childhood antecedents and developmental outcomes associated with trajectories of mild and harsh parental physical discipline. Interview, questionnaire, and observational data were available from 499 children followed from ages 5 to 16 and from 258 children in an independent sample followed from ages 5 to 15. Analyses indicated distinct physical discipline trajectory groups that varied in frequency of physical discipline and rate of change. In both samples, family ecological disadvantage differentiated the trajectory groups; in the first sample, early child externalizing also differentiated the groups. Controlling for early childhood externalizing, the minimal/ceasing trajectory groups were associated with the lowest levels of subsequent adolescent antisocial behavior in both samples and with parent-adolescent positive relationship quality in the second sample.

  18. A systematic review of clinical outcomes in surgical treatment of adult isthmic spondylolisthesis.

    PubMed

    Noorian, Shaya; Sorensen, Karen; Cho, Woojin

    2018-05-07

    A variety of surgical methods are available for the treatment of adult isthmic spondylolisthesis, but there is no consensus regarding their relative effects on clinical outcomes. To compare the effects of different surgical techniques on clinical outcomes in adult isthmic spondylolisthesis. Systematic Review PATIENT SAMPLE: A total of 1,538 patients from six randomized clinical trials and nine observational studies comparing different surgical treatments in adult isthmic spondylolisthesis. Primary outcome measures of interest included differences in pre- versus post-surgical assessments of pain, functional disability, and overall health as assessed by validated pain rating scales and questionnaires. Secondary outcome measures of interest included intraoperative blood loss, length of hospital stay, surgery duration, reoperation rates, and complication rates. A search of the literature was performed in September, 2017 for relevant comparative studies published in the prior 10-year period in the following databases: PubMed, Embase, Web of Science, and ClinicalTrials.Gov. PRISMA guidelines were followed and studies were included/excluded based on strict predetermined criteria. Quality appraisal was conducted using the Newcastle-Ottawa Scale (NOS) for observational studies and the Cochrane Collaboration's risk of bias assessment tool for randomized clinical trials. The authors received no funding support to conduct this review. A total of 15 studies (6 randomized clinical trials and 9 observational studies) were included for full text review, a majority of which only included cases of low-grade isthmic spondylolisthesis. 1 study examined the effects of adding pedicle screw fixation (PS) to posterolateral fusion (PLF) and 2 studies examined the effects of adding reduction to interbody fusion (IF) + PS on clinical outcomes. 5 studies compared PLF, 4 with and 1 without PS, to IF + PS. Additionally, 3 studies compared circumferential fusion (IF + PS + PLF) to IF + PS and 1

  19. A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport® or Prograf® preparations of tacrolimus

    PubMed Central

    Connor, Andrew; Prowse, Andrew; Newell, Paul; Rowe, Peter A.

    2013-01-01

    Background The use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf®) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf® to a generic formulation (Adoport®) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf® with those receiving Adoport®. Methods Data regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed. Results A total of 48 patients received Prograf® and 51 received Adoport®. At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups. Conclusions This is the first study to compare the clinical outcomes of patients receiving Adoport® with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf® or Adoport® from the time of renal transplantation. These early outcome data therefore support the use of Adoport® in place of Prograf® as a potential cost-saving measure. PMID:27818747

  20. Clinical outcomes for young people with screening-detected and clinically-diagnosed rheumatic heart disease in Fiji.

    PubMed

    Engelman, Daniel; Mataika, Reapi L; Ah Kee, Maureen; Donath, Susan; Parks, Tom; Colquhoun, Samantha M; Carapetis, Jonathan R; Kado, Joseph H; Steer, Andrew C

    2017-08-01

    Echocardiographic screening is under consideration as a disease control strategy for rheumatic heart disease (RHD). However, clinical outcomes of young people with screening-detected RHD are unknown. We aimed to describe the outcomes for a cohort with screening-detected RHD, in comparison to patients with clinically-diagnosed RHD. A retrospective cohort study included all young people with screening-detected RHD in the Central Division of Fiji in the primary cohort. Screen-negative and clinically-diagnosed comparison groups were matched 1:1 to the primary cohort. Data were collected on mortality, clinical complications and healthcare utilisation from the electronic and paper health records and existing databases. Seventy participants were included in each group. Demographic characteristics of the groups were similar (median age 11years, 69% female, median follow-up 7years). There were nine (12.9%) RHD-related deaths in the clinically-diagnosed group and one (1.4%) in the screening-detected group (Incident Rate Ratio: 9.6, 95% CI 1.3-420.6). Complications of RHD were observed in 39 (55.7%) clinically-diagnosed cases, four (20%) screening-detected cases and one (1.4%) screen-negative case. There were significant differences in the cumulative complication curves of the groups (p<0.001). Rates of admission and surgery were highest in the clinically-diagnosed group, and higher in the screening-detected than screen-negative group. Young people with screening-detected RHD have worse health outcomes than screen-negative cases in Fiji. The prognosis of clinically-diagnosed RHD remains poor, with very high mortality and complication rates. Further studies in other settings will inform RHD screening policy. Comprehensive control strategies are required for disease prevention. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Dosimetric considerations and early clinical experience of accelerated partial breast irradiation using multi-lumen applicators in the setting of breast augmentation

    PubMed Central

    Akhtari, Mani; Pino, Ramiro; Scarboro, Sarah B.; Bass, Barbara L.; Miltenburg, Darlene M.; Butler, E. Brian

    2015-01-01

    Purpose Accelerated partial breast irradiation (APBI) is an accepted treatment option in breast-conserving therapy for early stage breast cancer. However, data regarding outcomes of patients treated with multi-lumen catheter systems who have existing breast implants is limited. The purpose of this study was to report treatment parameters, outcomes, and possible dosimetric correlation with cosmetic outcome for this population of patients at our institution. Material and methods We report the treatment and outcome of seven consecutive patients with existing breast implants and early stage breast cancer who were treated between 2009 and 2013 using APBI following lumpectomy. All patients were treated twice per day for five days to a total dose of 34 Gy using a high-dose-rate 192Ir source. Cosmetic outcomes were evaluated using the Harvard breast cosmesis scale, and late toxicities were reported using the Radiation Therapy Oncology Group (RTOG) late radiation morbidity schema. Results After a mean follow-up of 32 months, all patients have remained cancer free. Six out of seven patients had an excellent or good cosmetic outcome. There were no grade 3 or 4 late toxicities. The average total breast implant volume was 279.3 cc, received an average mean dose of 12.1 Gy, and a maximum dose of 234.1 Gy. The average percentage of breast implant volume receiving 50%, 75%, 100%, 150%, and 200% of the prescribed dose was 15.6%, 7.03%, 4.6%, 1.58%, and 0.46%, respectively. Absolute volume of breast implants receiving more than 50% of prescribed dose correlated with worse cosmetic outcomes. Conclusions Accelerated partial breast irradiation using a multi-lumen applicator in patients with existing breast implants can safely be performed with promising early clinical results. The presence of the implant did not compromise the ability to achieve dosimetric criteria; however, dose to the implant and the irradiated implant volume may be related with worse cosmetic outcomes. PMID:26816499

  2. Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

    PubMed

    Sakoulas, G

    2009-12-01

    The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

  3. Outcomes and patterns of failure of sarcomatoid carcinoma of the larynx: The Mayo Clinic experience.

    PubMed

    Gamez, Mauricio E; Jeans, Elizabeth; Hinni, Michael L; Moore, Eric; Young, Geoffrey; Ma, Daniel; McGee, Lisa; Buras, Matthew R; Patel, Samir H

    2018-02-01

    Sarcomatoid carcinoma is a rare variant of squamous cell carcinoma of the head and neck. No consensus exists on its management. Our aim was to present our outcomes. Retrospective study. Median follow-up 45 months. There were 38 patients with pathologically confirmed sarcomatoid carcinoma of the larynx treated at the Mayo Clinic from 1990 to 2014. Statistical analysis of overall survival (OS), progression-free survival (PFS), and local control (LC) were conducted using the Kaplan-Meier method. The majority of patients were elderly males (92%) with a smoking history (74%) presenting with early-stage disease (71%). Surgery alone was the primary treatment in 27 patients (71%). Nine patients (25%) were treated with adjuvant radiation due to initial stage or high-risk pathologic features. Median radiation dose to the primary/surgical bed was 65 Gy (range, 60.3-75.0 Gy). A total of 15 patients (39%) had tumor recurrence, majority being local (n = 12). Sixty percent (n = 9) had multiple local recurrences. Five-year OS, PFS, and LC were 63%, 46%, and 72%, respectively. Subgroup analysis by stage I versus higher stages (II-IV) showed an OS of 80% versus 43% (P = .030), PFS of 65% versus 18% (P = .003), and LC of 84% versus 57% (P = .039). Sarcomatoid carcinoma of the larynx is rare, and frequently presents at an early stage in older men with history of smoking. Based on our outcomes and patterns of failure, it appears early-stage tumors are treated appropriately with single-modality therapy, whereas more advanced tumors require multimodality therapy. Validation in a larger cohort is warranted. 4. Laryngoscope, 128:373-377, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  4. Effectiveness of a Clinic-Based Early Literacy Program in Changing Parent-Child Early Literacy Habits.

    PubMed

    Fricke, Jonathan; Navsaria, Dipesh; Mahony, Karin

    2016-12-01

    Reach Out and Read (ROR) improves children's development and kindergarten readiness by encouraging parents to routinely share books with their children. Primary care providers give age-appropriate books and anticipatory guidance on reading at each well-child visit. This study evaluated parent attitudes and behaviors of early literacy related to ROR participation in Wisconsin clinics. A survey of early literacy attitudes and behaviors was administered to parents of children ages 6 months to 5 years in 36 Wisconsin clinics. Ten clinics were established ROR sites (intervention group) and 26 clinics had applied to become ROR programs but had not yet initiated the program (control group). Parents at clinics with ROR programs were more likely to read with a child under the age of 6 months (OR=1.58, 95% CI, 1.05-2.38). Other literacy metrics trended toward improvement but none reached statistical significance. Paradoxically, the odds of parents reporting reading as a bedtime habit were decreased among those who participated in ROR. Our study finds mixed support of the effectiveness of ROR outside of academic settings. The apparent discrepancy between these results and those from national studies on ROR may be related to differences in respondent demographics and educational attainment or differences in program implementation and fidelity. We believe that the results will become clearer with future study as clinics are prospectively evaluated over time rather than being compared to non-ROR clinics in a cross-sectional snapshot.

  5. [Clinical significance of early percutaneous coronary intervention in patients with Braunwald III-B type unstable angina pectoris].

    PubMed

    Nozaki, Katsuhiro; Nakao, Koichi; Horiuchi, Kenji; Kasanuki, Hiroshi; Honda, Takashi

    2003-06-01

    To assess the efficacy of early invasive strategy for the treatment of Braunwald III-B type unstable angina pectoris. This study included 573 consecutive patients of whom 267 underwent percutaneous coronary intervention (PCI) (312 lesions). The patients were divided into two groups, 95 treated with the early invasive strategy of coronary angiography within 24 hr of admission (Group PCI-I) and the remaining 172 treated with the early conservative strategy of coronary angiography 24 hr after admission (Group PCI-C). No significant differences were noted in the baseline characteristics of the two groups except for ST segment elevation on electrocardiography at presentation, which occurred significantly less frequently in Group PCI-C (36.8% vs 8.1%, p < 0.0001). The initial success rate of percutaneous coronary intervention was sufficiently high in both groups (Group PCI-I: 96.9% vs Group PCI-C: 97.7%, NS). Acute myocardial infarction occurred in six patients of Group PCI-C (3.5%) because of the side branch occlusion. There was no in-hospital death or emergent coronary artery bypass grafting. During the 6-month follow-up, there were no significant differences in the death rates (2.1% vs 1.7%), the death or myocardial infarction rates (5.3% vs 5.8%) and the target lesion revascularization ratio (26.0% vs 25.7%) between Group PCI-I and Group PCI-C. The clinical outcomes of the early invasive strategy for unstable angina pectoris were almost equivalent to those of the early conservative strategy, despite more frequent ST segmental elevation at admission in Group PCI-I. These findings suggest that the early invasive strategy for unstable angina pectoris may be acceptable even in the current Japanese clinical setting without the use of GP IIb/IIIa receptor antagonist, low molecular weight heparin or clopidogrel.

  6. Radiographic and Clinical Outcomes of Robot-Assisted Posterior Pedicle Screw Fixation: Two-Year Results from a Randomized Controlled Trial.

    PubMed

    Park, Sang Min; Kim, Ho Joong; Lee, Se Yeon; Chang, Bong Soon; Lee, Choon Ki; Yeom, Jin S

    2018-05-01

    We prospectively assessed the early radiographic and clinical outcomes (minimum follow-up of 2 years) of robot-assisted pedicle screw fixation (Robot-PSF) and conventional freehand pedicle screw fixation (Conv-PSF). Patients were randomly assigned to Robot-PSF (37 patients) or Conv-PSF (41 patients) for posterior interbody fusion surgery. The Robot-PSF group underwent minimally invasive pedicle screw fixation using a pre-planned robot-guided screw trajectory. The Conv-PSF underwent screw fixation using the freehand technique. Radiographic adjacent segment degeneration (ASD) was measured on plain radiographs, and clinical outcomes were measured using visual analogue scale (VAS) and Oswestry disability index (ODI) scores regularly after surgery. The two groups had similar values for radiographic ASD, including University California at Los Angeles grade, vertebral translation, angular motion, and loss of disc height (p=0.320). At final follow-up, both groups had experienced significant improvements in back VAS, leg VAS, and ODI scores after surgery (p<0.001), although inter-group differences were not significant for back VAS (p=0.876), leg VAS (p=0.429), and ODI scores (p=0.952). In the Conv-PSF group, revision surgery was required for two of the 25 patients (8%), compared to no patients in the Robot-PSF group. There were no significant differences in radiographic ASD and clinical outcomes between Robot-PSF and Conv-PSF. Thus, the advantages of robot-assisted surgery (accurate pedicle screw insertion and minimal facet joint violation) do not appear to be clinically significant. © Copyright: Yonsei University College of Medicine 2018.

  7. Functional and Radiographic Outcomes Following Growth-Sparing Management of Early-Onset Scoliosis.

    PubMed

    Johnston, Charles E; Tran, Dong-Phuong; McClung, Anna

    2017-06-21

    In this study, we sought to evaluate radiographic, functional, and quality-of-life outcomes of patients who have completed growth-sparing management of early-onset scoliosis. This prospective study involved patients with early-onset scoliosis who underwent growth-sparing treatment and either "final" fusion or observation for ≥2 years since the last lengthening procedure. Demographics, radiographic parameters, pulmonary function test (PFT) values, and scores of patient-reported assessments (Early-Onset Scoliosis Questionnaire [EOSQ] and Scoliosis Research Society [SRS]-30) were obtained. At the most recent follow-up, patients performed 2 additional functional outcome tests: step-activity monitoring and a treadmill exercise-tolerance test. Twelve patients were evaluated as "graduates" of growth-sparing management of early-onset scoliosis (mean of 37 months since the most recent surgery). The major scoliosis curve measurement averaged 88° before treatment and 47° at the most recent follow-up. T1-S1 height increased from a mean of 22.3 cm to 34.7 cm and T1-T12 height, from 13.3 to 22.3 cm. At the most recent follow-up, the mean forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) as a percentage of the predicted volume were 52.1% and 55.3%, respectively, and were essentially unchanged from the earliest PFT that patients could perform (FEV1 = 53.8% of predicted and FVC = 53.5% of predicted). There was no difference between graduates and controls with respect to activity time or total steps in step-activity monitoring, and in the exercise-tolerance test, graduates walked at the same speed but at a higher heart rate and at a significantly higher (p <0.001) VO2 cost (rate of oxygen consumed per distance traveled). The EOSQ mean score was 102.2 of a possible 120 points, and the SRS mean score was 4.1 of a possible 5 points. A realistic long-term goal for the management of early-onset scoliosis appears to be spine elongation and maintenance of

  8. Radiation Therapy Noncompliance and Clinical Outcomes in an Urban Academic Cancer Center

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ohri, Nitin; Rapkin, Bruce D.; Guha, Chandan

    Purpose: To examine associations between radiation therapy (RT) noncompliance and clinical outcomes. Methods and Materials: We reviewed all patients who completed courses of external beam RT with curative intent in our department from the years 2007 to 2012 for cancers of the head and neck, breast, lung, cervix, uterus, or rectum. Patients who missed 2 or more scheduled RT appointments (excluding planned treatment breaks) were deemed noncompliant. Univariate, multivariable, and propensity-matched analyses were performed to examine associations between RT noncompliance and clinical outcomes. Results: Of 1227 patients, 266 (21.7%) were noncompliant. With median follow-up of 50.9 months, 108 recurrences (8.8%) and 228more » deaths (18.6%) occurred. In univariate analyses, RT noncompliance was associated with increased recurrence risk (5-year cumulative incidence 16% vs 7%, P<.001), inferior recurrence-free survival (5-year actuarial rate 63% vs 79%, P<.001), and inferior overall survival (5-year actuarial rate 72% vs 83%, P<.001). In multivariable analyses that were adjusted for disease site and stage, comorbidity score, gender, ethnicity, race, and socioeconomic status (SES), RT noncompliance was associated with inferior recurrence, recurrence-free survival, and overall survival rates. Propensity score–matched models yielded results nearly identical to those seen in univariate analyses. Low SES was associated with RT noncompliance and was associated with inferior clinical outcomes in univariate analyses, but SES was not associated with inferior outcomes in multivariable models. Conclusion: For cancer patients being treated with curative intent, RT noncompliance is associated with inferior clinical outcomes. The magnitudes of these effects demonstrate that RT noncompliance can serve as a behavioral biomarker to identify high-risk patients who require additional interventions. Treatment compliance may mediate the associations that have been observed linking SES

  9. Early weaning from incubator and early discharge of preterm infants: randomized clinical trial.

    PubMed

    Zecca, Enrico; Corsello, Mirta; Priolo, Francesca; Tiberi, Eloisa; Barone, Giovanni; Romagnoli, Costantino

    2010-09-01

    The goal was to assess the feasibility of earlier weaning from the incubator for preterm infants. This was a prospective, randomized study with preterm infants with birth weights of <1600 g who were admitted to a neonatal subintensive ward. Findings for 47 infants who were transferred from an incubator to an open crib at >1600 g (early transition group) were compared with those for 47 infants who were transferred from an incubator to an open crib at >1800 g (standard transition [ST] group). The primary outcome of the study was length of stay. Secondary outcomes were the number of infants returned to an incubator, the growth velocity in an open crib and during the first week at home, the proportions of breastfeeding at discharge and during the first week at home, and the hospital readmission rate. The length of stay was significantly shorter in the early transition group than in the standard transition group (23.5 vs 33 days; P=.0002). No infants required transfer back to the incubator. Only 1 infant in the standard transition group was readmitted to the hospital during the first week after discharge. Growth velocities and individual amounts of breastfeeding were similar between the 2 groups. In this study, weaning of moderately preterm infants from incubators to open cribs at 1600 g was safe and resulted in earlier discharge.

  10. Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.

    PubMed

    Chalmers, Joanne; Deckert, Stefanie; Schmitt, Jochen

    2015-06-01

    This article describes the core outcome set (COS) for atopic eczema trials. COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway. Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.

  11. Clinical Characteristics and Outcomes of Late-Onset BK Virus Nephropathy in Kidney and Kidney-Pancreas Transplant Recipients.

    PubMed

    Imlay, Hannah; Whitaker, Kathryn; Fisher, Cynthia E; Limaye, Ajit P

    2018-05-29

    BK virus nephropathy (BKPyVAN) is a major complication in kidney transplant recipients (KTR) and typically occurs within 1 year of transplant. Guidelines vary in recommendations for BKPyV screening beyond 1 year. A systematic characterization of risk factors and outcomes of late-onset (>1 year) BKPyVAN has not previously been reported. We retrospectively compared characteristics and outcomes of early- (<1 year) and late-onset BKPyVAN (definitive [biopsy-confirmed] or presumptive [plasma BKPyV >10,000 copies/mL]) in a cohort of 671 KTR and simultaneous kidney-pancreas transplant (SPK) recipients between 2008 and 2013 at a single US transplant center. Proportions were compared using Chi square or Fisher's exact test with p < 0.05 considered significant. BKPyVAN was diagnosed in 96 (14.3%) patients (proven 16.7%, presumptive 83.3%): 79 (82.3%) early- and 17 (17.7%) late-onset. The proportion with late-onset BKPyVAN was significantly higher among SPK than KTR (4 of 7 [57.1%] vs 13 of 89 [14.6%], p=0.017). Late-onset represented "de novo" infection (no BKPyV detection within the first year) in 14 (82.4%) and progression of earlier lower-grade BKPyV reactivation in 3 (17.6%). Clinical outcomes were similar for early- and late-onset BKPyVAN (p>0.05 all comparisons). In a pooled analysis of prior studies of BKPyVAN in SPK recipients, 62.9% (17 of 27) were late-onset. A significant proportion of BKPyVAN is late-onset, especially among SPK recipients, and supports a longer duration of BKPyV monitoring for SPK recipients than recommended in some guidelines. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  12. Rupture during coiling of intracranial aneurysms: Predictors and clinical outcome.

    PubMed

    Kocur, Damian; Przybyłko, Nikodem; Bażowski, Piotr; Baron, Jan

    2018-02-01

    The intraprocedural aneurysm rupture (IPR) is one of the most feared adverse effect associated with the coil embolization therapy. The aim of the study was to identify predisposing factors for IPR, as well as to define patient groups with worse clinical outcome following IPR. From February 2008 to March 2015, 273 consecutive patients were treated at our institution via endovascular coil embolization. Patient medical records were reviewed with emphasis on procedure description, potential risk factors and clinical outcomes related to IPR. The IPR occurred in 14 (5.13%) cases. Multivariate logistic regression models were used to determine independent predictors of IPR. Clinical outcome was analyzed using the Glasgow Outcome Scale (GOS). Multivariate analysis showed that aneurysm location at posterior communicating artery is an independent risk factor for IPR (p = 0.035; OR 3.5; 95%CI 1.09-11.26). The frequencies of favorable disability (GOS 4-5), severe disability (GOS 2-3), and mortality (GOS 1) between patients with IPR and without IPR were significantly different in the general study population (p < 0.001, p < 0.001 and p = 0.023, respectively) and in patients with previously unruptured aneurysms (p < 0.001, p = 0.006 and p = 0.003, respectively) but not in patients with previously ruptured aneurysms (p = 0.187, p = 0.089 and p = 1.0, respectively). Posterior communicating artery aneurysm location is an independent predictor for IPR. IPR is associated with a significant clinical deterioration in a subgroup of patients with previously unruptured aneurysms, but not in patients with ruptured aneurysms. Copyright © 2018 Elsevier B.V. All rights reserved.

  13. Clinical Presentation and Outcome of Patients With Optic Pathway Glioma.

    PubMed

    Robert-Boire, Viviane; Rosca, Lorena; Samson, Yvan; Ospina, Luis H; Perreault, Sébastien

    2017-10-01

    Optic pathway gliomas (OPGs) occur sporadically or in patients with neurofibromatosis type 1 (NF1). The purpose of this study was to evaluate the clinical presentation at diagnosis and at progression of patients with OPGs. We conducted a chart review of patients with OPGs diagnosed in a single center over a period of 15 years. Demographic data including age, sex, NF1 status, clinical presentation, and outcome were collected. Of the 40 patients who were identified, 23 had sporadic tumors (57.5%) and 17 had NF1-related tumors (42.5%). Among the children with NF1, there was a significant overrepresentation of girls (82.3%) (P = 0.02), while among the children without NF1, there were slightly more boys (56.5%) than girls (43.5%). The presence of nystagmus was strongly associated with sporadic optic pathway gliomas. Poor visual outcome was related to tumor affecting both optic pathways, hydrocephalus at diagnosis, and optic nerve atrophy. Of the 40 patients, five died of OPG complications (12.5%) and all had sporadic tumors. Our cohort is one of the largest with OPGs and a detailed description of the clinical presentation both at diagnosis and at progression. We observed a significant difference between sporadic and NF1 optic pathway gliomas in terms of demographics, clinical presentation, and outcome. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Electroencephalography Predicts Poor and Good Outcomes After Cardiac Arrest: A Two-Center Study.

    PubMed

    Rossetti, Andrea O; Tovar Quiroga, Diego F; Juan, Elsa; Novy, Jan; White, Roger D; Ben-Hamouda, Nawfel; Britton, Jeffrey W; Oddo, Mauro; Rabinstein, Alejandro A

    2017-07-01

    The prognostic role of electroencephalography during and after targeted temperature management in postcardiac arrest patients, relatively to other predictors, is incompletely known. We assessed performances of electroencephalography during and after targeted temperature management toward good and poor outcomes, along with other recognized predictors. Cohort study (April 2009 to March 2016). Two academic hospitals (Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Mayo Clinic, Rochester, MN). Consecutive comatose adults admitted after cardiac arrest, identified through prospective registries. All patients were managed with targeted temperature management, receiving prespecified standardized clinical, neurophysiologic (particularly, electroencephalography during and after targeted temperature management), and biochemical evaluations. We assessed electroencephalography variables (reactivity, continuity, epileptiform features, and prespecified "benign" or "highly malignant" patterns based on the American Clinical Neurophysiology Society nomenclature) and other clinical, neurophysiologic (somatosensory-evoked potential), and biochemical prognosticators. Good outcome (Cerebral Performance Categories 1 and 2) and mortality predictions at 3 months were calculated. Among 357 patients, early electroencephalography reactivity and continuity and flexor or better motor reaction had greater than 70% positive predictive value for good outcome; reactivity (80.4%; 95% CI, 75.9-84.4%) and motor response (80.1%; 95% CI, 75.6-84.1%) had highest accuracy. Early benign electroencephalography heralded good outcome in 86.2% (95% CI, 79.8-91.1%). False positive rates for mortality were less than 5% for epileptiform or nonreactive early electroencephalography, nonreactive late electroencephalography, absent somatosensory-evoked potential, absent pupillary or corneal reflexes, presence of myoclonus, and neuron-specific enolase greater than 75 µg/L; accuracy was highest for

  15. Mirrors in early clinical photography (1862-1882): a descriptive study.

    PubMed

    Horgmo, Øystein H

    2015-01-01

    In the mid-nineteenth century, photographers used mirrors to document different views of a patient in the same image. The first clinical photographs were taken by portrait photographers. As conventions for clinical photography were not yet established, early clinical photographs resemble contemporary portraits. The use of mirrors in clinical photography probably originated from the portrait studios, as several renowned photographers employed mirrors in their studio portraits. Clinical photographs taken for the US Army Medical Museum between 1862 and 1882 show different ways of employing this mirror technique.

  16. Insulin resistance and clinical outcomes after acute ischemic stroke.

    PubMed

    Ago, Tetsuro; Matsuo, Ryu; Hata, Jun; Wakisaka, Yoshinobu; Kuroda, Junya; Kitazono, Takanari; Kamouchi, Masahiro

    2018-04-24

    In this study, we aimed to determine whether insulin resistance is associated with clinical outcomes after acute ischemic stroke. We enrolled 4,655 patients with acute ischemic stroke (aged 70.3 ± 12.5 years, 63.5% men) who had been independent before admission; were hospitalized in 7 stroke centers in Fukuoka, Japan, from April 2009 to March 2015; and received no insulin therapy during hospitalization. The homeostasis model assessment of insulin resistance (HOMA-IR) score was calculated using fasting blood glucose and insulin levels measured 8.3 ± 7.8 days after onset. Study outcomes were neurologic improvement (≥4-point decrease in NIH Stroke Scale score or 0 at discharge), poor functional outcome (modified Rankin Scale score of ≥3 at 3 months), and 3-month prognosis (stroke recurrence and all-cause mortality). Logistic regression analysis was used to evaluate the association of the HOMA-IR score with clinical outcomes. The HOMA-IR score was associated with neurologic improvement (odds ratio, 0.68 [95% confidence interval, 0.56-0.83], top vs bottom quintile) and with poor functional outcome (2.02 [1.52-2.68], top vs bottom quintile) after adjusting for potential confounding factors, including diabetes and body mass index. HOMA-IR was not associated with stroke recurrence or mortality within 3 months of onset. The associations were maintained in nondiabetic or nonobese patients. No heterogeneity was observed according to age, sex, stroke subtype, or stroke severity. These findings suggest that insulin resistance is independently associated with poor functional outcome after acute ischemic stroke apart from the risk of short-term stroke recurrence or mortality. © 2018 American Academy of Neurology.

  17. Overall outcomes following early interventions for intracranial arteriovenous malformations with hematomas.

    PubMed

    Bir, Shyamal C; Maiti, Tanmoy Kumar; Konar, Subhas; Nanda, Anil

    2016-01-01

    We evaluated the timing and predictors of surgical intervention for intracranial arteriovenous malformations (AVM) with hematoma. A ruptured intracranial AVM with hematoma is an emergency condition, and the optimal timing for surgical intervention is not well understood. In addition, the outcome predictors of surgical intervention have rarely been reported. We identified and analyzed 78 patients treated with microsurgical resection for pathologically proven AVM at Louisiana State University Health in Shreveport from February 1992 to December 2004. All 78 patients were diagnosed with ruptured AVM before surgery. The independent variables, including patient demographics, timing of surgery, location of the AVM and comorbidities were analyzed to assess outcome. The results of this series revealed that surgical intervention after 48hours resulted in poor outcomes for patients with hematoma, following a ruptured AVM. Several other prognostic factors, including younger age (11-40years), Spetzler-Martin Grade I and II, and AVM in a supratentorial location, had significant positive effects on outcomes. However, hypertension, smoking, and a prior embolization showed significant negative effects on outcomes after surgery. The multiple logistic regression analyses also revealed that the timing of surgical intervention had a significant effect on outcomes in patients with hematoma following ruptured AVM. Early intervention is the key to success in these patients. Published by Elsevier Ltd.

  18. Deep brain stimulation may reduce the relative risk of clinically important worsening in early stage Parkinson's disease.

    PubMed

    Hacker, Mallory L; Tonascia, James; Turchan, Maxim; Currie, Amanda; Heusinkveld, Lauren; Konrad, Peter E; Davis, Thomas L; Neimat, Joseph S; Phibbs, Fenna T; Hedera, Peter; Wang, Lily; Shi, Yaping; Shade, David M; Sternberg, Alice L; Drye, Lea T; Charles, David

    2015-10-01

    The Vanderbilt pilot trial of deep brain stimulation (DBS) in early Parkinson's disease (PD) enrolled patients on medications six months to four years without motor fluctuations or dyskinesias. We conducted a patient-centered analysis based on clinically important worsening of motor symptoms and complications of medical therapy for all subjects and a subset of subjects with a more focused medication duration. Continuous outcomes were also analyzed for this focused cohort. A post hoc analysis was conducted on all subjects from the pilot and a subset of subjects taking PD medications 1-4 years at enrollment. Clinically important worsening is defined as both a ≥ 3 point increase in UPDRS Part III and a ≥ 1 point increase in Part IV. DBS plus optimal drug therapy (DBS + ODT) subjects experienced a 50-80% reduction in the relative risk of worsening after two years. The DBS + ODT group was improved compared to optimal drug therapy (ODT) at each time point on Total UPDRS and Part III (p = 0.04, p = 0.02, respectively, at 24 months). Total UPDRS, Part IV, and PDQ-39 scores significantly worsened in the ODT group after two years (p < 0.003), with no significant change in the DBS + ODT group. DBS + ODT in early PD may reduce the risk of clinically important worsening. These findings further confirm the need to determine if DBS + ODT is superior to medical therapy for managing symptoms, reducing the complications of medications, and improving quality of life. The FDA has approved the conduct of a large-scale, pivotal clinical trial of DBS in early stage PD. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Patient Compliance Is Critical for Equivalent Clinical Outcomes for Breast Cancer Treated by Breast-Conservation Therapy

    PubMed Central

    Li, Benjamin D. L.; Brown, William A.; Ampil, Frederico L.; Burton, Gary V.; Yu, Herbert; McDonald, John C.

    2000-01-01

    Objective To determine the compliance with a standard breast-conservation therapy (BCT) program in a predominantly indigent, minority population of patients with early breast cancer (stage I and II) served by a rural state institution in the South; to compare the clinical outcomes of this group with those reported in clinical trials; and to examine the socioeconomic factors that may have contributed to the rate of compliance. Summary Background Data Disease-free survival and overall survival in early breast cancer treated by BCT versus modified radical mastectomy are reported to be equivalent in prospective randomized trials. However, patients enrolled in clinical trials may not be representative of patients living in the various diverse communities that make up the United States. The authors’ hypothesis is that patients enrolled in clinical trials at the national level may not be representative of indigent patients in the rural South and that clinical trial results may not be directly applicable. Methods A retrospective review of 55 women with early-stage breast cancer treated from 1990 to 1995 was performed. Clinical data, compliance with treatment and clinical follow-up, and recurrence rates were examined. Statistical analysis performed include the Fisher exact test, Kaplan-Meier survival analysis, and log-rank test. Results Full compliance (defined as completion of the entire course of radiation therapy and clinical follow-up) with the BCT program was observed in only 36% of patients. Fifteen of the 35 noncompliant patients did not complete radiation therapy. A significantly higher local failure rate was observed: 8 of these 15 patients (53%) have had local failure. In contrast, patients who were either in full compliance with the BCT program or were deficient only in that they missed part of their clinical follow-up had local failure rates of 5% (1/20) and 10% (2/20), respectively. Age, race, stage of cancer, economic status (measured by availability of

  20. B3GNT3 Expression Is a Novel Marker Correlated with Pelvic Lymph Node Metastasis and Poor Clinical Outcome in Early-Stage Cervical Cancer

    PubMed Central

    Niu, Chunhao; Song, Libing; Zhang, Yanna

    2015-01-01

    Background The β1,3-N-acetylglucosaminyltransferase-3 gene (B3GNT3) encodes a member of the B3GNT family that functions as the backbone structure of dimeric sialyl-Lewis A and is involved in L-selectin ligand biosynthesis, lymphocyte homing and lymphocyte trafficking. B3GNT3 has been implicated as an important element in the development of certain cancers. However, the characteristics of B3GNT3 in the development and progression of cancer remain largely unknown. Thus, our study aimed to investigate the expression pattern and the prognostic value of B3GNT3 in patients with early-stage cervical cancer. Methods The mRNA and protein levels of B3GNT3 expression were examined in eight cervical cancer cell lines and ten paired cervical cancer tumors, using real-time PCR and western blotting, respectively. Immunohistochemistry (IHC) was used to analyze B3GNT3 protein expression in paraffin-embedded tissues from 196 early-stage cervical cancer patients. Statistical analyses were applied to evaluate the association between B3GNT3 expression scores and clinical parameters, as well as patient survival. Results B3GNT3 expression was significantly upregulated in cervical cancer cell lines and lesions compared with normal cells and adjacent noncancerous cervical tissues. In the 196 cases of tested early-stage cervical cancer samples, the B3GNT3 protein level was positively correlated with high risk TYPES of human papillomavirus (HPV) infection (P = 0.026), FIGO stage (P < 0.001), tumor size (P = 0.025), tumor recurrence (P = 0.004), vital status (P < 0.001), concurrent chemotherapy and radiotherapy (P = 0.016), lymphovascular space involvement (P = 0.003) and most importantly, lymph node metastasis (P = 0.003). Patients with high B3GNT3 expression had a shorter overall survival (OS) and disease-free survival (DFS) compared with those with low expression of this protein. Multivariate analysis suggested that B3GNT3 expression is an independent prognostic indicator for cervical

  1. The relationship between early changes in the HAMD-17 anxiety/somatization factor items and treatment outcome among depressed outpatients.

    PubMed

    Farabaugh, Amy; Mischoulon, David; Fava, Maurizio; Wu, Shirley L; Mascarini, Alessandra; Tossani, Eliana; Alpert, Jonathan E

    2005-03-01

    The 17-item Hamilton Rating Scale for Depression (HAMD-17) Anxiety/Somatization factor includes six items: Anxiety (psychic), Anxiety (somatic), Somatic Symptoms (gastrointestinal), Somatic Symptoms (general), Hypochondriasis and Insight. This study examines the relationship between early changes (defined as those observed between baseline and week 1) in these HAMD-17 Anxiety/Somatization Factor items and treatment outcome among major depressive disorder (MDD) patients who participated in a study comparing the antidepressant efficacy of a standardized extract of hypericum with both placebo and fluoxetine. Following a 1-week, single-blind washout, patients with MDD diagnosed by the Structured Clinical Interview for DSM-IV (SCID) were randomized to 12 weeks of double-blind treatment with hypericum extract (900 mg/day), fluoxetine (20 mg/day) or placebo. The relationship between early changes in HAMD-17 anxiety/somatization factor items and treatment outcome was assessed separately for patients who received study treatment (hypericum or fluoxetine) versus placebo with a logistic regression method. One hundred and thirty-five patients (female 57%, mean age=37.3+/-11.0 years; mean baseline HAMD-17=19.7+/-3.2 years) were randomized to double-blind treatment and were included in the intent-to-treat (ITT) analyses. After adjusting for baseline HAMD-17 scores and for multiple comparisons with the Bonferroni correction, patients who remitted (HAMD-17 score <8) after study treatment had significantly greater early improvement in Somatic Symptoms (General) scores than non-remitters. No other significant differences in early changes were noted for the remaining items between remitters versus non-remitters who received active treatment. For patients treated with placebo, early change was not predictive of remission for any of the items after Bonferroni correction. In conclusion, the presence of early improvement on the HAMD-17 item concerning fatigue and general somatic symptoms

  2. Northern Alberta remote teleglaucoma program: clinical outcomes and patient disposition.

    PubMed

    Verma, Sanam; Arora, Sourabh; Kassam, Faazil; Edwards, Marianne C; Damji, Karim F

    2014-04-01

    To review the diagnostic outcomes and clinical referral pathways of patients assessed and managed through a collaborative care patient-centred teleglaucoma program. Retrospective cohort study. Eligible patients were those assessed by the referring optometrist or ophthalmologist to be open-angle glaucoma suspects or to have definite early open-angle glaucoma. A glaucoma specialist graded each case through virtual consultation. Clinical referral pathways were noted: in-person consultation with glaucoma specialist, repeat teleconsultation, collaborative glaucoma management with optometrist, or referral for nonglaucomatous ophthalmic pathology. A total of 247 patients were referred to the program from 2008 to 2012. Of all teleconsults, 31.1% were diagnosed with glaucoma, 42.1% were suspects, and 26.7% were unaffected. Of all patients, 27% were referred for in-person glaucoma evaluation; 69% of patients could be managed by their referring optometrist, with 48% of patients requiring repeat teleconsultation. Treatment was initiated before being seen for 87% of patients with definite glaucoma and 28% of glaucoma suspects. Of all patients seen through the remote teleglaucoma program, most did not require an in-person consultation with an ophthalmologist and could be managed through distance collaboration. For the approximately one third who were diagnosed with glaucoma based on virtual assessment, medication was started in the majority of cases and in-person consultation was arranged. Further studies to validate and consider cost-effectiveness of this system are under way. © 2013 Canadian Ophthalmological Society Published by Canadian Ophthalmological Society All rights reserved.

  3. Lumbar Disc Replacement for Junctional Decompensation After Fusion Surgery: Clinical and Radiological Outcome at an Average Follow-Up of 33 Months

    PubMed Central

    Sliwa, Karen; Weinberg, Ian R.; Sweet, Barry MBE; de Villiers, Malan; Candy, Geoffrey P.

    2007-01-01

    Background Failed fusion surgery remains difficult to treat. Few published data on disc replacement surgery after failed fusion procedures exist. Our objective was to evaluate outcomes of junctional lumbar disc replacement after previous fusion surgery and to correlate outcome with radiological changes to parameters of sagittal balance. Methods Out of a single-center prospective registry of 290 patients with 404 lumbar disc replacements, 27 patients had had a previous lumbar fusion operation on 1 to 4 lumbar segments and had completed a mean follow- up of 33 months (range: 18–56). We correlated the clinical outcome measures (patient satisfaction, 10-point pain score, and Oswestry Disability Index [ODI] score) to parameters of spinal sagittal alignment (sacral tilt, pelvic tilt, pelvic incidence, and lumbar lordosis). Results Postoperative hospital stay averaged 3.3 days (range: 2–8). Previously-employed patients went back to their jobs with a mean of 32 days (range: 21–42) after the procedure. At the latest follow-up, 1 of the patients considered the outcome to be poor, 3 fair, 8 good, and 15 excellent. Twenty-four patients “would undergo the operation again.” Average pain score decreased from 9.1 ± 1.0 (SD) to 3.2 ± 2.1 (P < .01). Average ODI decreased from 50.2 ± 9.9 preoperatively to 21.7 ± 14.2 (P ≤ .01). We found the change in pelvic tilt to be an independent predictor of better clinical outcome by multivariate analysis (P < .05). Conclusions In patients with junctional failure adjacent to a previous posterolateral fusion, disc replacement at the junctional level(s), compared with osteotomy and fusion surgery, offers the advantage of maintaining segmental mobility and correcting the flat-back deformity through a single approach with less operative time and blood loss. Early- to intermediate-term results are promising. The influence of changes in spinal sagittal alignment on clinical outcome needs to be addressed in future research. Clinical

  4. Predicting outcome of acute non-variceal upper gastrointestinal haemorrhage without endoscopy using the clinical Rockall Score.

    PubMed

    Tham, T C K; James, C; Kelly, M

    2006-11-01

    The Rockall risk scoring system uses clinical criteria and endoscopy to identify patients at risk of adverse outcomes after acute upper gastrointestinal haemorrhage. A clinical Rockall score obtained using only the clinical criteria may be able to predict outcome without endoscopy. To validate the clinical Rockall Score in predicting outcome after acute non-variceal upper gastrointestinal haemorrhage. A retrospective observational study of consecutive patients who were admitted with non-variceal acute upper gastrointestinal haemorrhage was undertaken. Medical records were abstracted using a standardised form. 102 cases were identified (51 men and 51 women; mean age 59 years). 38 (37%) patients considered to be at low risk of adverse outcomes (clinical Rockall Score 0) had no adverse outcomes and did not require transfusion. Patients with a clinical Rockall Score of 1-3 had no adverse outcomes, although 13 of 45 (29%) patients required blood transfusions. Clinical Rockall Scores >3 (n = 19) were associated with adverse outcomes (rebleeding in 4 (21%), surgery in 1 (5%) and death in 2 (10%)). The clinical Rockall Score without endoscopy may be a useful prognostic indicator in this cohort of patients with acute non-variceal upper gastrointestinal haemorrhage. This score may reduce the need for urgent endoscopy in low-risk patients, which can instead be carried out on a more elective outpatient basis.

  5. Stakeholder Perceptions, Learning Opportunities, and Student Outcomes in Three Clinical Learning Models.

    PubMed

    Hendricks, Susan; DeMeester, Deborah; Stephenson, Evelyn; Welch, Janet

    2016-05-01

    Understanding the strengths and challenges of various clinical models is important for nursing education. Three long-standing clinical models (preceptored, hybrid, and traditional) were compared on several outcome measures related to satisfaction, learning opportunities, and student outcomes. Students, faculty, and preceptors participated in this study. Although no differences were noted in satisfaction or standardized examination scores, students in the preceptored clinical model were able to practice more psychomotor skills. Although participants in the preceptored model reported spending more time communicating with staff nurses than did those in the other models, students in the traditional model spent more time with faculty. No differences were noted among groups in student clinical observation time. All clinical learning models were focused on how clinical time was structured, without an emphasis on how faculty and preceptors work with students to develop nursing clinical reasoning skills. Identifying methodology to impact thinking in the clinical environment is a key next step. [J Nurs Educ. 2016;55(5):271-277.]. Copyright 2016, SLACK Incorporated.

  6. Septic Arthritis After Anterior Cruciate Ligament Reconstruction: Clinical and Functional Outcomes Based on Graft Retention or Removal.

    PubMed

    Waterman, Brian R; Arroyo, William; Cotter, Eric J; Zacchilli, Michael A; Garcia, E'Stephan J; Owens, Brett D

    2018-03-01

    There remains a debate over whether to retain the index anterior cruciate ligament (ACL) graft in the setting of septic arthritis. To evaluate and compare clinical outcomes for the treatment of septic arthritis after ACL reconstruction (ACLR) in those with and without early graft retention. Case series; Level of evidence, 4. The Military Health System was queried for all ACLR procedures performed between 2007 and 2013. Inclusion criteria required active military status, primary ACLR with secondary septic arthritis, and minimum 24-month surveillance. Demographic, clinical, and surgical variables were evaluated using descriptive statistics and regression analysis for factors influencing selected outcomes. Of 9511 ACLR procedures, 31 (0.32%) were identified as having secondary septic arthritis requiring urgent arthroscopic irrigation and debridement and intravenous antibiotics (mean, 6.3 weeks). The majority (62%) were treated in the subacute (2 weeks to 2 months) setting. Index ACLR was performed with a hamstring autograft (n = 17, 55%), soft tissue allograft (n = 11, 35%), and patellar tendon autograft (n = 3, 10%). The graft was retained in 71% (n = 22) of patients, while 29% (n = 9) underwent early graft debridement. At a mean 26.9-month follow-up, 48% of patients (n = 15) had returned to the military. Graft removal was not predictive of return to active duty ( P = .29). The presence of postoperative complications, including symptomatic postinfection arthritis (22.6%) and arthrofibrosis (9.7%), was the only variable predictive of inability to return to duty (odds ratio, 27.5 [95% CI, 3.24-233.47]; P = .002). Seven of 9 patients who underwent graft debridement underwent revision ACLR, and all 7 had stable knees at final follow-up compared with 68% (15/22) in the graft retention group. Arthroscopic debridement with early graft removal and staged revision ACLR remains a viable option for restoring knee stability (100%), although the rate of return to active duty was

  7. Septic Arthritis After Anterior Cruciate Ligament Reconstruction: Clinical and Functional Outcomes Based on Graft Retention or Removal

    PubMed Central

    Waterman, Brian R.; Arroyo, William; Cotter, Eric J.; Zacchilli, Michael A.; Garcia, E’Stephan J.; Owens, Brett D.

    2018-01-01

    Background: There remains a debate over whether to retain the index anterior cruciate ligament (ACL) graft in the setting of septic arthritis. Purpose: To evaluate and compare clinical outcomes for the treatment of septic arthritis after ACL reconstruction (ACLR) in those with and without early graft retention. Study Design: Case series; Level of evidence, 4. Methods: The Military Health System was queried for all ACLR procedures performed between 2007 and 2013. Inclusion criteria required active military status, primary ACLR with secondary septic arthritis, and minimum 24-month surveillance. Demographic, clinical, and surgical variables were evaluated using descriptive statistics and regression analysis for factors influencing selected outcomes. Results: Of 9511 ACLR procedures, 31 (0.32%) were identified as having secondary septic arthritis requiring urgent arthroscopic irrigation and debridement and intravenous antibiotics (mean, 6.3 weeks). The majority (62%) were treated in the subacute (2 weeks to 2 months) setting. Index ACLR was performed with a hamstring autograft (n = 17, 55%), soft tissue allograft (n = 11, 35%), and patellar tendon autograft (n = 3, 10%). The graft was retained in 71% (n = 22) of patients, while 29% (n = 9) underwent early graft debridement. At a mean 26.9-month follow-up, 48% of patients (n = 15) had returned to the military. Graft removal was not predictive of return to active duty (P = .29). The presence of postoperative complications, including symptomatic postinfection arthritis (22.6%) and arthrofibrosis (9.7%), was the only variable predictive of inability to return to duty (odds ratio, 27.5 [95% CI, 3.24-233.47]; P = .002). Seven of 9 patients who underwent graft debridement underwent revision ACLR, and all 7 had stable knees at final follow-up compared with 68% (15/22) in the graft retention group. Conclusion: Arthroscopic debridement with early graft removal and staged revision ACLR remains a viable option for restoring knee

  8. Management bundles for candidaemia: the impact of compliance on clinical outcomes

    PubMed Central

    Takesue, Yoshio; Ueda, Takashi; Mikamo, Hiroshige; Oda, Shigeto; Takakura, Shunji; Kitagawa, Yuko; Kohno, Shigeru; Masuda, A.; Yoshida, C.; Yasunaga, C.; Yamashita, C.; Nakataki, E.; Ohyagi, H.; Yagi, H.; Johnai, H.; Murai, H.; Hanamoto, H.; Nakamura, I.; Sanada, I.; Tandai, I.; Kuroki, J.; Ogawa, J.; Kawahara, K.; Amino, K.; Nakajima, K.; Yoshimoto, K.; Takeda, K.; Nakamura, K.; Suzuki, K.; Yamada, K.; Aizawa, M.; Hashimoto, M.; Ogata, M.; Shirano, M.; Kawada, M.; Kaneda, M.; Yoshioka, M.; Okuda, N.; Sugita, N.; Kikuchi, N.; Fuke, S.; Tsuchihashi, S.; Sugitani, S.; Ikuta, S.; Honda, S.; Nei, T.; Iwamura, T.; Yagi, T.; Kaji, T.; Ichimiya, Y.; Kobayashi, Y.; Minamishima, Y.; Goto, Y.; Hatano, Y.; Nagao, Y.; Yamagishi, Y.; Sashihara, J.; Tsukamoto, A.; Kawaoka, T.; Kobayashi, M.

    2015-01-01

    Objectives The Mycoses Forum in Japan has developed management bundles for candidaemia to incorporate into bedside practice. The aim of this study was to investigate nationwide compliance with the bundles and their impact on clinical outcomes. Methods Non-neutropenic patients treated with antifungals for candidaemia were surveyed. Bundles consist of nine items to complete. Data were sent to the central office between July 2011 and April 2012. Results Six hundred and eight patients were analysed. The compliance rate for achieving all elements was 6.9%, and it increased to 21.4% when compliance was analysed by the bundle except for oral switch. There was a significant difference in clinical success between patients with and without compliance [92.9% versus 75.8% (P = 0.011)]. Compliance with the bundles, however, failed to be an independent factor associated with favourable outcomes. When step-down oral therapy was excluded from the elements of compliance, compliance with the bundles was revealed to be an independent predictor of clinical success (OR 4.42, 95% CI 2.05–9.52) and mortality (OR 0.27, 95% CI 0.13–0.57). Independent individual elements contributing to clinical success were removal of central venous catheters within 24 h, assessment of clinical efficacy on the third to the fifth day and at least 2 weeks of therapy after clearance of candidaemia. Conclusions Compliance with the bundles for candidaemia had a beneficial effect on clinical outcomes. Promotion of the bundles approach may have the potential to narrow the gap between clinical evidence and bedside practice. PMID:25326087

  9. Ultrasound-guided Interdigital Neuroma Injections: Short-term Clinical Outcomes after a Single Percutaneous Injection—Preliminary Results

    PubMed Central

    Adler, Ronald S.; Ciavarra, Gina A.; Pavlov, Helene

    2006-01-01

    Purpose To describe the procedure of ultrasound-guided Morton’s neuroma and recurrent stump neuroma injections and early clinical outcomes after a single injection. Materials and Methods Retrospective review of 44 percutaneous ultrasound-guided neuroma injections in 24 patients who had completed clinical outcomes questionnaires. A 10-point pain scale [scale of 1 (no pain) to 10 (severe pain)] in a 7-day pain log format was distributed to patients at the time percutaneous neuroma injection was performed. Results Neuromas were clearly visualized with sonography as hypoechoic nodules and were distinguishable from other causes of forefoot pain, such as metatarsophalangeal joint synovitis and intermetatarsal bursae. The sizes of the neuromas injected ranged between 4 and 19 mm. Postinjection, all neuromas displayed increased echogenicity and/or the appearance of fluid surrounding it, confirming localization of the therapeutic mixture. We arbitrarily subdivided the pain ratings into symptomatic (greater than 4) and asymptomatic (less than or equal to 4) for statistical analysis. Average pain level pre injection was 5.2 and average pain level was 3.7 at 7 days post single injection, with 62% of the initially symptomatic patients asymptomatic on day 7 (p < 0.000001). Overall, 76% of the total number of neuromas injected once were asymptomatic on day 7. Conclusion Ultrasound can be used to accurately target Morton’s neuromas and, therefore, appropriately direct therapeutic interventions, with good short-term clinical results. PMID:18751769

  10. Patient and clinician reported outcomes for patients with new presentation of inflammatory arthritis: observations from the National Clinical Audit for Rheumatoid and Early Inflammatory Arthritis

    PubMed Central

    Ledingham, JM; Snowden, N; Rivett, A; Galloway, J; Firth, J; Ide, Z; MacPhie, E; Kandala, N; Dennison, EM; Rowe, I

    2017-01-01

    Objectives Our aim was to conduct a national audit assessing the impact and experience of early management of inflammatory arthritis by English and Welsh rheumatology units. The audit enables rheumatology services to measure for the first time their performance, patient outcomes and experience, benchmarked to regional and national comparators. Methods All individuals >16 years of age presenting to English and Welsh rheumatology services with suspected new-onset inflammatory arthritis were included in the audit. Clinician- and patient-derived outcome and patient-reported experience measures were collected. Results Data are presented for the 6354 patients recruited from 1 February 2014 to 31 January 2015. Ninety-seven per cent of English and Welsh trusts participated. At the first specialist assessment, the 28-joint DAS (DAS28) was calculated for 2659 (91%) RA patients [mean DAS28 was 5.0 and mean Rheumatoid Arthritis Impact of Disease (RAID) score was 5.6]. After 3 months of specialist care, the mean DAS28 was 3.5 and slightly >60% achieved a meaningful DAS28 reduction. The average RAID score and reduction in RAID score were 3.6 and 2.4, respectively. Of the working patients ages 16–65 years providing data, 7, 5, 16 and 37% reported that they were unable to work, needed frequent time off work, occasionally and rarely needed time off work due to their arthritis, respectively; only 42% reported being asked about their work. Seventy-eight per cent of RA patients providing data agreed with the statement ‘Overall in the last 3 months I have had a good experience of care for my arthritis’; <2% disagreed. Conclusion This audit demonstrates that most RA patients have severe disease at the time of presentation to rheumatology services and that a significant number continue to have high disease activity after 3 months of specialist care. There is a clear need for the National Health Service to develop better systems for capturing, coding and integrating information from

  11. Clinical finding and outcome in suicidal attempt due to intravenous injection of kerosene.

    PubMed

    Amiri, Aref Hosseinian; Tarrahi, Mohammad Javad; Rafiei, Alireza

    2009-03-01

    The aim of this study was to describe the clinical findings and outcome in suicidal attempted due to intravenous injection of kerosene. This case series study was conducted in the Department of Internal Medicine, Shohada Ashayer Hospital, Khorramabad, Iran during 8 years. Ten IV drug addicts who intravenously injected themselves with Kerosene were collected. All patients admitted in ICU, completely monitored for cardiopulmonary status and consulted with pulmonologist, cardiologist, neurologist, anesthesiologist and dermatologist. Therapeutic decision including intubation, antibiotics therapy, and oxygen, correction of water and electrolyte disturbances was applied according patients condition. The data were analyzed with fisher-exact test. Nine (90%) patients were male, 1(10%) was female. All cases were attempted suicides and IV drug abusers. Mean age was 20.3 +/- 2 years. The patients' mean arrival time to the hospital after poisoning was 1.1 h. Death of 5(50%) patients was related to the higher doses (>5 mL) of intravenous injection of kerosene, the most clinical findings were related to pulmonary involvement with pulmonary edema and subsequent cardiac and neurological complications and phlebitis due to IV injection. Intravenous kerosene injection causes major injury to the lungs, the organ bearing the first capillary bed encountered. Other complications including cardiac and neurological seems to be related to severe hypoxia and other metabolic disturbances due to lung injury. The amounts of kerosene were major determinants of lethality. Early and aggressive supportive care might be conducive to a favorable outcome with minimal residual pulmonary squeal at least in patients with injection of less than 5 mL of kerosene.

  12. Pregnancy and Neonatal Diabetes Outcomes in Remote Australia (PANDORA) study

    PubMed Central

    2013-01-01

    Background Diabetes in pregnancy carries an increased risk of adverse pregnancy outcomes for both the mother and foetus, but it also provides an excellent early opportunity for intervention in the life course for both mother and baby. In the context of the escalating epidemic of chronic diseases among Indigenous Australians, it is vital that this risk is reduced as early as possible in the life course of the individual. The aims of the PANDORA Study are to: (i) accurately assess rates of diabetes in pregnancy in the Northern Territory (NT) of Australia, where 38% of babies are born to Indigenous mothers; (ii) assess demographic, clinical, biochemical, anthropometric, socioeconomic and early life development factors that may contribute to key maternal and neonatal birth outcomes associated with diabetes in pregnancy; and (iii) monitor relevant post-partum clinical outcomes for both the mothers and their babies. Methods/Design Eligible participants are all NT women with diabetes in pregnancy aged 16 years and over. Information collected includes: standard antenatal clinical information, diagnosis and management of diabetes in pregnancy, socio-economic status, standard clinical birth information (delivery, gestational age, birth weight, adverse antenatal and birth outcomes). Cord blood is collected at the time of delivery and detailed neonatal anthropometric measurements performed within 72 hours of birth. Information will also be collected regarding maternal post-partum glucose tolerance and cardio-metabolic risk factor status, breastfeeding and growth of the baby up to 2 years post-partum in the first instance. Discussion This study will accurately document rates and outcomes of diabetes in pregnancy in the NT of Australia, including the high-risk Indigenous Australian population. The results of this study should contribute to policy and clinical guidelines with the goal of reducing the future risk of obesity and diabetes in both mothers and their offspring. PMID

  13. Pregnancy And Neonatal Diabetes Outcomes in Remote Australia (PANDORA) Study.

    PubMed

    Maple-Brown, Louise J; Brown, Alex; Lee, I-Lynn; Connors, Christine; Oats, Jeremy; McIntyre, Harold D; Whitbread, Cherie; Moore, Elizabeth; Longmore, Danielle; Dent, Glynis; Corpus, Sumaria; Kirkwood, Marie; Svenson, Stacey; van Dokkum, Paula; Chitturi, Sridhar; Thomas, Sujatha; Eades, Sandra; Stone, Monique; Harris, Mark; Inglis, Chrissie; Dempsey, Karen; Dowden, Michelle; Lynch, Michael; Boyle, Jacqueline; Sayers, Sue; Shaw, Jonathan; Zimmet, Paul; O'Dea, Kerin

    2013-12-01

    Diabetes in pregnancy carries an increased risk of adverse pregnancy outcomes for both the mother and foetus, but it also provides an excellent early opportunity for intervention in the life course for both mother and baby. In the context of the escalating epidemic of chronic diseases among Indigenous Australians, it is vital that this risk is reduced as early as possible in the life course of the individual. The aims of the PANDORA Study are to: (i) accurately assess rates of diabetes in pregnancy in the Northern Territory (NT) of Australia, where 38% of babies are born to Indigenous mothers; (ii) assess demographic, clinical, biochemical, anthropometric, socioeconomic and early life development factors that may contribute to key maternal and neonatal birth outcomes associated with diabetes in pregnancy; and (iii) monitor relevant post-partum clinical outcomes for both the mothers and their babies. Eligible participants are all NT women with diabetes in pregnancy aged 16 years and over. Information collected includes: standard antenatal clinical information, diagnosis and management of diabetes in pregnancy, socio-economic status, standard clinical birth information (delivery, gestational age, birth weight, adverse antenatal and birth outcomes). Cord blood is collected at the time of delivery and detailed neonatal anthropometric measurements performed within 72 hours of birth. Information will also be collected regarding maternal post-partum glucose tolerance and cardio-metabolic risk factor status, breastfeeding and growth of the baby up to 2 years post-partum in the first instance. This study will accurately document rates and outcomes of diabetes in pregnancy in the NT of Australia, including the high-risk Indigenous Australian population. The results of this study should contribute to policy and clinical guidelines with the goal of reducing the future risk of obesity and diabetes in both mothers and their offspring.

  14. Impact of Pre-Dialysis Care on Clinical Outcomes in Peritoneal Dialysis Patients.

    PubMed

    Spigolon, Dandara N; de Moraes, Thyago P; Figueiredo, Ana E; Modesto, Ana Paula; Barretti, Pasqual; Bastos, Marcus Gomes; Barreto, Daniela V; Pecoits-Filho, Roberto

    2016-01-01

    Structured pre-dialysis care is associated with an increase in peritoneal dialysis (PD) utilization, but not with peritonitis risk, technical and patient survival. This study aimed at analyzing the impact of pre-dialysis care on these outcomes. All incident patients starting PD between 2004 and 2011 in a Brazilian prospective cohort were included in this analysis. Patients were divided into 2 groups: early pre-dialysis care (90 days of follow-up by a nephrology team); and late pre-dialysis care (absent or less than 90 days follow-up). The socio-demographic, clinical and biochemical characteristics between the 2 groups were compared. Risk factors for the time to the first peritonitis episode, technique failure and mortality based on Cox proportional hazards models. Four thousand one hundred seven patients were included. Patients with early pre-dialysis care presented differences in gender (female - 47.0 vs. 51.1%, p = 0.01); race (white - 63.8 vs. 71.7%, p < 0.01); education (<4 years - 61.9 vs. 71.0%, p < 0.01), respectively, compared to late care. Patients with early pre-dialysis care presented a higher prevalence of comorbidities, lower levels of creatinine, phosphorus, and glucose with a significantly better control of hemoglobin and potassium serum levels. There was no impact of pre-dialysis care on peritonitis rates (hazard ratio (HR) 0.88; 95% CI 0.77-1.01) and technique survival (HR 1.12; 95% CI 0.92-1.36). Patient survival (HR 1.20; 95% CI 1.03-1.41) was better in the early pre-dialysis care group. Earlier pre-dialysis care was associated with improved patient survival, but did not influence time to the first peritonitis nor technique survival in this national PD cohort. © 2016 S. Karger AG, Basel.

  15. Diabetes mellitus in patients with pulmonary tuberculosis in an aging population in Shanghai, China: Prevalence, clinical characteristics and outcomes.

    PubMed

    Wu, Zheyuan; Guo, Juntao; Huang, Ying; Cai, Enmao; Zhang, Xia; Pan, Qichao; Yuan, Zheng'an; Shen, Xin

    2016-03-01

    To determine the prevalence of diabetes mellitus among pulmonary tuberculosis patients and the difference of clinical characteristics and outcomes between pulmonary tuberculosis patients with and without diabetes mellitus in an aging population in Shanghai, China. This is a retrospective population-based study. 201 newly diagnosed pulmonary tuberculosis patients in Changning District, Shanghai during 2007-2008 were included. Clinical characteristics and outcomes were collected. Determination of diabetes mellitus was based on the medical records before pulmonary tuberculosis was diagnosed. The prevalence of diabetes mellitus among pulmonary tuberculosis patients was 19.9% (40/201). Pulmonary tuberculosis patients with diabetes mellitus were more likely to be old (≥50, OR=5.23, 95% CI=2.07-13.25), to have pulmonary cavities (OR=3.02, 95% CI=1.31-6.98), to be sputum smear positive (OR=2.90, 95% CI=1.12-7.51), and to have extension of anti-tuberculosis treatment duration (OR=2.68, 95% CI 1.17-6.14). Besides, they had a higher 2nd month sputum smear positive proportion (OR=2.97, 95% CI 1.22-7.22) and a higher 5-year recurrence rate (OR=5.87, 95% CI 1.26-27.40). High prevalence, severe clinical characteristics and poor outcomes of pulmonary tuberculosis patients with diabetes mellitus highlight the necessity of early bi-directional screening and co-management of these two diseases in Shanghai, China. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Evaluation of hypothesized adverse outcome pathway linking thyroid peroxidase inhibition to fish early life stage toxicity

    EPA Science Inventory

    There is an interest in developing alternatives to the fish early-life stage (FELS) test (OECD test guideline 210), for predicting adverse outcomes (e.g., impacts on growth and survival) using less resource-intensive methods. Development and characterization of adverse outcome pa...

  17. The Effects of Centralised and Specialised Intervention in the Early Course of Severe Unipolar Depressive Disorder: A Randomised Clinical Trial

    PubMed Central

    Hansen, Hanne Vibe; Christensen, Ellen Margrethe; Dam, Henrik; Gluud, Christian; Wetterslev, Jørn; Kessing, Lars Vedel

    2012-01-01

    Background Little is known on whether centralised and specialised combined pharmacological and psychological intervention in the early phase of severe unipolar depression improve prognosis. The aim of the present study was to assess the benefits and harms of centralised and specialised secondary care intervention in the early course of severe unipolar depression. Methods A randomised multicentre trial with central randomisation and blinding in relation to the primary outcome comparing a centralised and specialised outpatient intervention program with standard decentralised psychiatric treatment. The interventions were offered at discharge from first, second, or third hospitalisation due to a single depressive episode or recurrent depressive disorder. The primary outcome was time to readmission to psychiatric hospital. The data on re-hospitalisation was obtained from the Danish Psychiatric Central Register. The secondary and tertiary outcomes were severity of depressive symptoms according to the Major Depression Inventory, adherence to medical treatment, and satisfaction with treatment according to the total score on the Verona Service Satisfaction Scale-Affective Disorder (VSSS-A). These outcomes were assessed using questionnaires one year after discharge from hospital. Results A total of 268 patients with unipolar depression were included. There was no significant difference in the time to readmission (unadjusted hazard ratio 0.89, 95% confidence interval 0.60 to 1.32; log rank: χ2 = 0.3, d.f. = 1, p = 0.6); severity of depressive symptoms (mood disorder clinic: median 21.6, quartiles 9.7–31.2 versus standard treatment: median 20.2, quartiles 10.0–29.8; p = 0.7); or the prevalence of patients in antidepressant treatment (73.9% versus 80.0%, p = 0.2). Centralised and specialised secondary care intervention resulted in significantly higher satisfaction with treatment (131 (SD 31.8) versus 107 (SD 25.6); p<0.001). Conclusions Centralised and

  18. The effect of exposure to hypergravity on pregnant rat dams, pregnancy outcome and early neonatal development

    NASA Astrophysics Data System (ADS)

    Ladd, B.; Nguon, K.; Sajdel-Sulkowska, E. M.

    2006-01-01

    We previously reported that hypergravity exposure affects food intake and mass gain during pregnancy. In the present study, we explored the hypothesis that changes in maternal body mass in hypergravity-exposed pregnant rat dams affect pregnancy outcome and early offspring development. Furthermore, we hypothesized that the changes observed at 1.5G will be magnified at higher gravity and by exposure during critical developmental periods. To test this hypothesis, we compared maternal body mass gain, food consumption, birth outcome and early offspring development between Sprague Dawley rat dams exposed to graded (1.5 1.75G) chronic hypergravity (HG) or rotation (rotational control, RC) on a 24-ft centrifuge for 22.5 h starting on gestational day (G) 10 with dams housed under identical conditions but not exposed to hypergravity (SC). We also compared maternal body mass, food consumption, birth outcome and early offspring development between rat dams exposed to 1.65G during different stages of pregnancy and nursing. Exposure to hypergravity resulted in transient loss in body mass and prolonged decrease in food consumption in HG dams, but the changes observed at 1.5G were not magnified at 1.65G or 1.75G. On the other hand RC dams gained more mass and consumed more food than SC dams. Exposure to hypergravity also affected pregnancy outcome as evidenced by decreased litter size, lowered neonatal mass at birth, and higher neonatal mortality; pregnancy outcome was not affected in RC dams. Neonatal changes evidenced by impaired righting response observed at 1.5G was magnified at higher gravity and was dependent on the period of hypergravity exposure. On the other hand, righting response was improved in RC neonates. Hypergravity exposure during early postpartum affected the food consumption of nursing mothers and affected early survival of their offspring. The changes observed in dams and neonates appear to be due to hypergravity exposure since animals exposed to the rotation

  19. Age at onset in patients with medically refractory temporal lobe epilepsy and mesial temporal sclerosis: impact on clinical manifestations and postsurgical outcome.

    PubMed

    Asadi-Pooya, Ali A; Sperling, Michael R

    2015-08-01

    To evaluate the demographic and clinical manifestations and postsurgical outcome of childhood-onset mesial temporal sclerosis and temporal lobe epilepsy (MTS-TLE) and establishing the potential differences as compared to the patients with adult-onset MTS-TLE. In this retrospective study all patients with a clinical diagnosis of medically refractory TLE due to mesial temporal sclerosis, who underwent epilepsy surgery at Jefferson comprehensive epilepsy center, were recruited. Patients were prospectively registered in a database from 1986 through 2014. Postsurgical outcome was classified into two groups; seizure-free or relapsed. Clinical manifestations and outcome were compared between patients with childhood-onset MTS-TLE (i.e., age at onset of the first afebrile habitual seizure below 10 years) and those with adult-onset MTS-TLE (i.e., age at onset of the first afebrile habitual seizure 20 years or above). One hundred and twelve patients had childhood-onset MTS-TLE and 76 had adult-onset MTS-TLE. Demographic, clinical, EEG and MRI characteristics of these two groups were similar. Postoperative outcome was not statistically different between these two groups of patients (P=0.9). Temporal lobe epilepsy due to mesial temporal sclerosis is a common cause of epilepsy that can start from early childhood to late adulthood. The etiology of MTS-TLE may be different in various age groups, but it seems that when mesial temporal sclerosis is the pathological substrate of TLE, clinical manifestations and response to surgical treatment of patients are very similar in patients with childhood-onset MTS-TLE compared to those with adult-onset disease. Copyright © 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  20. Integrating partner professionals. The Early Explorers project: Peers Early Education Partnership and the health visiting service.

    PubMed

    Barlow, J; Coe, C

    2013-01-01

      A range of voluntary sector organizations are involved in the delivery of services to children, particularly within the Early Year's sector and children's centres. Peers Early Education Partnership (PEEP) Early Explorers project is one example of the way in which explicit partnerships are being forged across statutory and voluntary sectors with the aim of improving outcomes for children and families. This paper reports an exploration of stakeholder views and experiences of two Early Explorer clinics located in areas of high deprivation.   Semi-structured interviews were conducted with a purposive sample of stakeholders (n= 25) from children's centres, PEEP, the health visiting service and service users. Data were fully transcribed and analysed using a thematic approach.   The data suggest that the two key groups of stakeholders providing Early Explorer clinics (i.e. health visitors and PEEP practitioners) had quite different objectives in terms of their early goals for the clinic, but that despite these differences good progress was achieved in terms of working together effectively. All stakeholders including service users referred to the presence of PEEP as having improved the quality of the clinic environment, and participating mothers identified a wide range of benefits from the enhanced service. However, somewhat restricted views about the role of practitioners within the clinics were identified by users, and the findings suggest that although the early goals for the clinic had been exceeded, these may have been limited in terms of true 'partnership' working.   Early Explorer clinics appeared to have enhanced the service provided within traditional child health clinics and to have provided practitioners with access to hard-to-reach families and parents with access to services that are consistent with the broader policy aims of improving parent-infant interaction. However, questions remain as to whether the benefit of 'partnership' working was fully

  1. Sepsis in Obstetrics: Clinical Features and Early Warning Tools.

    PubMed

    Parfitt, Sheryl E; Bogat, Mary L; Hering, Sandra L; Ottley, Charlotte; Roth, Cheryl

    Morbidity and mortality associated with sepsis has gained widespread attention on a local, state, and national level, yet, it remains a complicated disorder that can be difficult to identify in a timely manner. Sepsis in obstetric patients further complicates the diagnosis as alterations in physiology related to pregnancy can mask sepsis indicators normally seen in the general population. If early signs of sepsis go unrecognized, septic shock can develop, leading to organ dysfunction and potential death. Maternal early warning tools have been designed to assist clinicians in recognizing early indications of illness. Through use of clinical pathway-specific tools, disease processes may be detected early, subsequently benefitting patients with aggressive treatment management and intervention.This article is the second in a series of three that discuss the importance of sepsis and septic shock in pregnancy. Risk factors, causes of sepsis, signs and symptoms, and maternal early warning tools are discussed.

  2. Implementation of an institutional program to improve clinical and financial outcomes of mechanically ventilated patients: one-year outcomes and lessons learned.

    PubMed

    Burns, Suzanne M; Earven, Sidenia; Fisher, Charles; Lewis, Rose; Merrell, Paul; Schubart, Jane R; Truwit, Jonathon D; Bleck, Thomas P

    2003-12-01

    To determine the effect of an institutional approach to the care of patients requiring mechanical ventilation for longer than three consecutive days in five adult intensive care units (ICU) on clinical and financial outcomes. A multidisciplinary team was selected from five adult ICUs to design the approach. Planning occurred from August 1999 to September 2000. The process was called outcomes management (OM) and included an evidence-based clinical pathway, protocols for weaning and sedation use, and the selection of four advanced practice nurses (called outcomes managers) to manage and monitor the program. The project was completed in a 550-bed mid-Atlantic academic medical center. The ICUs included the following: coronary care, medical ICU, neuroscience ICU, surgical trauma ICU, and thoracic cardiovascular ICU. The sample included 595 pre-OM patients and 510 post-OM patients mechanically ventilated for greater than three consecutive days. Full implementation of the OM approach occurred in March 2001. Retrospective baseline (18 months pre-OM) and prospective (12 months OM) clinical and financial data were compared. Statistically significant differences in clinical outcomes were demonstrated in the managed patients compared with those managed before the institutional approach. Outcomes include ventilator duration (median days declined from ten to nine; p =.0001), ICU length of stay (median days declined from 15 to 12; p =.0008), hospital length of stay (median days declined from 22 to 20; p =.0001), and mortality rate (declined from 38% to 31%, p =.02). More than 3,000,000 US dollars cost savings were realized in the OM group. This institutional approach to the care of patients ventilated >3 days improved all clinical and financial outcomes of interest. To date, few similar initiatives have demonstrated similar results. The approach and lessons learned in this process improvement project may be helpful to other institutions attempting to improve outcomes in this

  3. Anatomical Features and Early Outcomes of Endovascular Repair of Abdominal Aortic Aneurysm from a Korean Multicenter Registry.

    PubMed

    Kwon, Hyunwook; Lee, Do Yun; Choi, Soo Jin Na; Park, Ki Hyuk; Min, Seung-Kee; Chang, Jeong-Hwan; Huh, Seung; Jeon, Yong Sun; Won, Jehwan; Byun, Seung Jae; Park, Sang Jun; Jang, Lee Chan; Kwon, Tae-Won

    2015-09-01

    To introduce a nation-based endovascular aneurysm repair (EVAR) registry in South Korea and to analyze the anatomical features and early clinical outcomes of abdominal aortic aneurysms (AAA) in patients who underwent EVAR. The Korean EVAR registry (KER) was a template-based online registry developed and established in 2009. The KER recruited 389 patients who underwent EVAR from 13 medical centers in South Korea from January 2010 to June 2010. We retrospectively reviewed the anatomic features and 30-day clinical outcomes. Initial deployment without open conversion was achieved in all cases and procedure-related 30-day mortality rate was 1.9%. Anatomic features showed the following variables: proximal aortic neck angle 48.8±25.7° (mean±standard deviation), vertical neck length 35.0±17.2 mm, aneurysmal sac diameter 57.2±14.2 mm, common iliac artery (CIA) involvement in 218 (56.3%) patients, and median right CIA length 34.9 mm. Two hundred and nineteen (56.3%) patients showed neck calcification, 98 patients (25.2%) had neck thrombus, and the inferior mesenteric arteries of 91 patients (23.4%) were occluded. Anatomical features of AAA in patients from the KER were characterized as having angulated proximal neck, tortuous iliac artery, and a higher rate of CIA involvement. Long-term follow-up and ongoing studies are required.

  4. Risk-adjusted clinical outcomes in patients enrolled in a bloodless program

    PubMed Central

    Frank, Steven M.; Wick, Elizabeth C.; Dezern, Amy E.; Ness, Paul M.; Wasey, Jack O.; Pippa, Andrew C.; Dackiw, Elizabeth; Resar, Linda M.S.

    2014-01-01

    BACKGROUND Although clinical outcomes have been reported for patients who do not accept allogeneic blood transfusion (ABT), many previous studies lack a control group, fail to use risk adjustment, and focus exclusively on cardiac surgery. STUDY DESIGN AND METHODS We report a risk-adjusted, propensity score–matched, retrospective case-control study of clinical outcomes for inpatients who did not accept ABT (bloodless, n = 294) and those who did accept ABT (control, n = 1157). Multidisciplinary specialized care was rendered to the bloodless patients to conserve blood and optimize clinical outcomes. Differences in hemoglobin (Hb), mortality, five morbid outcomes, and hospital charges and costs were compared. Subgroups of medical and surgical patients were analyzed, and independent predictors of outcome were determined by multivariate analysis. RESULTS Overall, mortality was lower in the bloodless group (0.7%) than in the control group (2.7%; p = 0.046), primarily attributed to the surgical subgroup. After risk adjustment, bloodless care was not an independent predictor of the composite adverse outcome (death or any morbid event; p = 0.91; odds ratio, 1.02; 95% confidence interval, 0.68–1.53). Discharge Hb concentrations were similar in the bloodless (10.8 ± 2.7 g/dL) and control (10.9 ± 2.3 g/dL) groups (p = 0.42). Total and direct hospital costs were 12% (p = 0.02) and 18% (p = 0.02) less, respectively, in the bloodless patients, a difference attributed to the surgical subgroup. CONCLUSIONS Using appropriate blood conservation measures for patients who do not accept ABT results in similar or better outcomes and is associated with equivalent or lower costs. This specialized care may be beneficial even for those patients who accept ABT. PMID:24942198

  5. Early dyadic patterns of mother-infant interactions and outcomes of prematurity at 18 months.

    PubMed

    Forcada-Guex, Margarita; Pierrehumbert, Blaise; Borghini, Ayala; Moessinger, Adrien; Muller-Nix, Carole

    2006-07-01

    outcome, independent of perinatal risk factors and of the family's socioeconomic background. The controlling pattern is much more prevalent among preterm than term dyads and is related to a less favorable infant outcome. However, the cooperative pattern still represents almost 30% of the preterm dyads, with infants' outcome comparable to the ones of term infants. These results point out the impact of the quality of mother-infant relationship on the infant's outcome. The most important clinical implication should be to support a healthy parent-infant relationship already in the NICU but also in the first months of the infant's life. Early individualized family-based interventions during neonatal hospitalization and transition to home have been shown to reduce maternal stress and depression and increase maternal self-esteem and to improve positive early parent-preterm infant interactions.

  6. Acute graft-versus-host disease biomarkers measured during therapy can predict treatment outcomes: a Blood and Marrow Transplant Clinical Trials Network study

    PubMed Central

    Logan, Brent R.; Wu, Juan; Alousi, Amin M.; Bolaños-Meade, Javier; Ferrara, James L. M.; Ho, Vincent T.; Weisdorf, Daniel J.

    2012-01-01

    Acute graft-versus-host disease (GVHD) is the primary limitation of allogeneic hematopoietic cell transplantation, and once it develops, there are no reliable diagnostic tests to predict treatment outcomes. We hypothesized that 6 previously validated diagnostic biomarkers of GVHD (IL-2 receptor-α; tumor necrosis factor receptor-1; hepatocyte growth factor; IL-8; elafin, a skin-specific marker; and regenerating islet–derived 3-α, a gastrointestinal tract–specific marker) could discriminate between therapy responsive and nonresponsive patients and predict survival in patients receiving GVHD therapy. We measured GVHD biomarker concentrations from samples prospectively obtained at the initiation of treatment, day 14, and day 28, on a multicenter, randomized, 4-arm phase 2 clinical trial for newly diagnosed acute GVHD. We found that at each of 3 time points, GVHD onset, 2 weeks into treatment, and 4 weeks into treatment, a 6-protein biomarker panel predicted for the important clinical outcomes of day 28 posttherapy nonresponse and mortality at day 180 from onset. GVHD biomarker panels can be used for early identification of patients at high or low risk for treatment nonresponsiveness or death, and they may provide opportunities for early intervention and improved survival after hematopoietic cell transplantation. The study was registered in clinicaltrials.gov as NCT00224874. PMID:22383800

  7. Satisfaction of care in a tertiary level diabetes clinic: correlations with diabetes knowledge, clinical outcome and health-related quality of life.

    PubMed

    Koves, Ildiko H; Boucher, Andrew; Ismail, Dunia; Donath, Susan; Cameron, Fergus J

    2008-01-01

    Patient satisfaction is regarded as an integral component of the quality of medical care. Therefore, as part of an ongoing process of outcome assessment, we analysed levels of satisfaction of care among patients and parents in our diabetes clinic and its relationship to short-term metabolic control outcome, diabetes knowledge and health-related quality of life (HRQOL). In 2004, parents and their children aged 5-18 years attending the Royal Children's Hospital (RCH) diabetes clinic completed questionnaires reporting their satisfaction with care provided, HRQOL and diabetes knowledge. Concurrent HbA(1c) levels were also recorded. The reporting profile was 83 patients, 24 fathers and 110 mothers. Generally, both patients and parents were satisfied with diabetes care provided at our tertiary centre. Satisfaction of care was not associated with the clinical outcome of metabolic control (measured by HbA(1c) levels), diabetes knowledge or HRQOL measures. Most patients and their parents in the RCH diabetes clinic appear generally satisfied with their diabetes care. The degree of satisfaction of care cannot be presumed according to clinical outcome, diabetes knowledge or HRQOL measures.

  8. [Influence of the DNA integrity of optimized sperm on the embryonic development and clinical outcomes of in vitro fertilization and embryo transfer].

    PubMed

    Jiang, Wei-jie; Jin, Fan; Zhou, Li-ming

    2016-05-01

    To investigate the influence of the DNA integrity of optimized sperm on the embryonic development and clinical outcomes of in vitro fertilization and embryo transfer (IVF-ET). This study included 605 cycles of conventional IVF-ET for pure oviductal infertility performed from January 1, 2013 to December 31, 2014. On the day of retrieval, we examined the DNA integrity of the sperm using the sperm chromatin dispersion method. According to the ROC curve and Youden index, we grouped the cycles based on the sperm DNA fragmentation index (DFI) threshold value for predicting implantation failure, early miscarriage, and fertilization failure, followed by analysis of the correlation between DFI and the outcomes of IVF-ET. According to the DFI threshold values obtained, the 605 cycles fell into four groups (DFI value < 5%, 5-10%, 10-15%, and ≥ 15%). Statistically significant differences were observed among the four groups in the rates of fertilization, cleavage, high-quality embryo, implantation, clinical pregnancy, early miscarriage, and live birth (P < 0.05), but not in the rates of multiple pregnancy, premature birth, and low birth weight (P > 0.05). DFI was found to be correlated negatively with the rates of fertilization (r = -0.32, P < 0.01), cleavage (r = -0.19, P < 0.01), high-quality embryo (r = -0.40, P < 0.01), clinical pregnancy (r = -0.20, P < 0.01), and live birth (r = -0.09 P = 0.04), positively with the rate of early miscarriage (r = 0.23, P < 0.01), but not with the rates of multiple pregnancy (r = -0.01, P = 0.83), premature birth (r = 0.04, P = 0.54), and low birth weight (r = 0.03, P = 0.62). The DNA integrity of optimized sperm influences fertilization, embryonic development, early miscarriage, and live birth of IVF-ET, but its correlation with premature birth and low birth weight has to be further studied.

  9. Clinical outcomes of temporary shunting for infants with cerebral pseudomeningocele.

    PubMed

    Mattei, Tobias A; Sambhara, Deepak; Bond, Brandon J; Lin, Julian

    2014-02-01

    Although in the case of subdural collections temporary shunting has been suggested as a viable alternative for definitive drainage of the accumulated fluid until restoration of the normal CSF dynamics, there is no agreement on the best management strategy for pseudomeningocele. The authors performed a retrospective chart review in order to evaluate the clinical outcomes of infants temporarily shunted for pseudomeningocele without encephalocele at our institution (The University of Illinois at Peoria/Illinois Neurological Institute) in the period from 2004 to 2012. The epidemiological characteristics, clinical management, and final outcomes of such subpopulation were compared with a control group which received temporary shunting for subdural hematomas (SDH) during the same period. Four patients (100% male) ranging in age from 8.9 to 27.1 months (mean = 13.88) with pseudomeningocele and 17 patients (64.7% male) ranging in age from 1.9 to 11.8 months (mean = 4.15) with SDH were identified. Although the initial management included sequential percutaneous subdural tapping in 82% of the patients, all children ultimately failed such strategy, requiring either subdural-peritoneal (81% of the cases) or subgaleal-peritoneal (19% of the cases) shunting. The mean implant duration was 201 days for the pseudomeningocele group and 384 days for the SDH one. Mean post-shunt hospitalization was 2 days for patients with pseudomeningocele and 4 days for patients with SDH. There was no statistical difference in terms of complications, length of hospitalization post-shunting, or clinical outcomes between the patients with pseudomeningocele and those with SDH. Temporary shunting of infants with pseudo-meningocele constitutes a viable therapeutic alternative with favorable clinical outcomes and a low risk of shunt dependency similar to those of children with SDH.

  10. Outcomes of an early intervention program for children with disruptive behaviour.

    PubMed

    Hayes, Louise; Giallo, Rebecca; Richardson, Kate

    2010-12-01

    Outcomes are presented from a public mental health early intervention program for children aged 5-9 years with disruptive behaviours. This was a school-based intervention initiative, delivered within a psychiatric child and adolescent mental health service and includes child, parent and teacher components. Participants were 235 children selected via school-based population assessments. A baseline period was used as a form of control that would demonstrate the stability of problem behaviours. Results showed that during a 26-week baseline period, teachers reported increasing levels of problem behaviour, and that the behaviour was creating increased difficulty in the classroom. The shorter 7-week baseline also showed the difficult behaviours were ongoing. Following the intervention, significant improvements in children's behaviour were seen on the Strengths and Difficulties Questionnaire reported by parents (η(2) = 0.30) and teachers (η(2) = 0.23), and on the parent Eyberg Child Behaviour Inventory (η(2) = 0.35), and teacher Sutter-Eyberg Student Behaviour Inventory (η(2) = 0.22). The outcomes show promising results from an early intervention program delivered in schools by a public mental health service and are discussed within the context of dissemination of evidence-based programs though mental health services.

  11. Clinical and Procedural Predictors of Outcomes From the Endovascular Treatment of Posterior Circulation Strokes.

    PubMed

    Mokin, Maxim; Sonig, Ashish; Sivakanthan, Sananthan; Ren, Zeguang; Elijovich, Lucas; Arthur, Adam; Goyal, Nitin; Kan, Peter; Duckworth, Edward; Veznedaroglu, Erol; Binning, Mandy J; Liebman, Kenneth M; Rao, Vikas; Turner, Raymond D; Turk, Aquilla S; Baxter, Blaise W; Dabus, Guilherme; Linfante, Italo; Snyder, Kenneth V; Levy, Elad I; Siddiqui, Adnan H

    2016-03-01

    Patients with posterior circulation strokes have been excluded from recent randomized endovascular stroke trials. We reviewed the recent multicenter experience with endovascular treatment of posterior circulation strokes to identify the clinical, radiographic, and procedural predictors of successful recanalization and good neurological outcomes. We performed a multicenter retrospective analysis of consecutive patients with posterior circulation strokes, who underwent thrombectomy with stent retrievers or primary aspiration thrombectomy (including A Direct Aspiration First Pass Technique [ADAPT] approach). We correlated clinical and radiographic outcomes with demographic, clinical, and technical characteristics. A total of 100 patients were included in the final analysis (mean age, 63.5±14.2 years; mean admission National Institutes of Health Stroke Scale score, 19.2±8.2). Favorable clinical outcome at 3 months (modified Rankin Scale score ≤2) was achieved in 35% of patients. Successful recanalization and shorter time from stroke onset to the start of the procedure were significant predictors of favorable clinical outcome at 90 days. Stent retriever and aspiration thrombectomy as primary treatment approaches showed comparable procedural and clinical outcomes. None of the baseline advanced imaging modalities (magnetic resonance imaging, computed tomographic perfusion, or computed tomography angiography assessment of collaterals) showed superiority in selecting patients for thrombectomy. Time to the start of the procedure is an important predictor of clinical success after thrombectomy in patients with posterior circulation strokes. Both stent retriever and aspiration thrombectomy as primary treatment approaches are effective in achieving successful recanalization. © 2016 American Heart Association, Inc.

  12. Moxifloxacin susceptibility mediates the relationship between causative organism and clinical outcome in bacterial keratitis.

    PubMed

    Oldenburg, Catherine E; Lalitha, Prajna; Srinivasan, Muthiah; Manikandan, Palanisamy; Bharathi, M Jayahar; Rajaraman, Revathi; Ravindran, Meenakshi; Mascarenhas, Jeena; Nardone, Natalie; Ray, Kathryn J; Glidden, David V; Acharya, Nisha R; Lietman, Thomas M

    2013-02-28

    Bacterial keratitis is a sight-threatening infection of the cornea that is one of the leading causes of blindness globally. In this report, we analyze the role of moxifloxacin susceptibility in the relationship between causative organisms and clinical outcome in bacteria keratitis. A mediation analysis is used to assess the role of moxifloxacin susceptibility in the relationship between causative organisms and clinical outcome in bacterial keratitis using data collected in a randomized, controlled trial. In the Steroids for Corneal Ulcers Trial (SCUT), 500 corneal infections were treated with topical moxifloxacin. The outcome of 3-week best spectacle-corrected visual acuity was significantly associated with an organism (Streptococcus pneumoniae, Pseudomonas aeruginosa, etc., P = 0.008). An indirect effects mediation model suggests that MIC accounted for approximately 13% (95% confidence interval, 3%-24%, P = 0.015) of the effect of the organism on 3-week visual acuity. Moxifloxacin mediates the relationship between causative organisms and clinical outcome in bacterial keratitis, and is likely on the causal pathway between the organism and outcome. (ClinicalTrials.gov number, NCT00324168.).

  13. Moxifloxacin Susceptibility Mediates the Relationship between Causative Organism and Clinical Outcome in Bacterial Keratitis

    PubMed Central

    Oldenburg, Catherine E.; Lalitha, Prajna; Srinivasan, Muthiah; Manikandan, Palanisamy; Bharathi, M. Jayahar; Rajaraman, Revathi; Ravindran, Meenakshi; Mascarenhas, Jeena; Nardone, Natalie; Ray, Kathryn J.; Glidden, David V.; Acharya, Nisha R.; Lietman, Thomas M.

    2013-01-01

    Purpose. Bacterial keratitis is a sight-threatening infection of the cornea that is one of the leading causes of blindness globally. In this report, we analyze the role of moxifloxacin susceptibility in the relationship between causative organisms and clinical outcome in bacteria keratitis. Methods. A mediation analysis is used to assess the role of moxifloxacin susceptibility in the relationship between causative organisms and clinical outcome in bacterial keratitis using data collected in a randomized, controlled trial. Results. In the Steroids for Corneal Ulcers Trial (SCUT), 500 corneal infections were treated with topical moxifloxacin. The outcome of 3-week best spectacle-corrected visual acuity was significantly associated with an organism (Streptococcus pneumoniae, Pseudomonas aeruginosa, etc., P = 0.008). An indirect effects mediation model suggests that MIC accounted for approximately 13% (95% confidence interval, 3%–24%, P = 0.015) of the effect of the organism on 3-week visual acuity. Conclusions. Moxifloxacin mediates the relationship between causative organisms and clinical outcome in bacterial keratitis, and is likely on the causal pathway between the organism and outcome. (ClinicalTrials.gov number, NCT00324168.) PMID:23385795

  14. Early School Engagement and Late Elementary Outcomes for Maltreated Children in Foster Care

    PubMed Central

    Pears, Katherine C.; Kim, Hyoun K.; Fisher, Philip A.; Yoerger, Karen

    2013-01-01

    Children with a history of maltreatment and placement into foster care face elevated risks of poor psychosocial outcomes including school failure, substance use, externalizing and deviant peer association. For children in the general population, school engagement appears to be a promotive factor in preventing negative outcomes. In this study, differences in behavioral, affective, and cognitive dimensions of school engagement in early elementary school were explored in maltreated children in foster care (n = 93) and a community comparison group of low SES, non-maltreated children (n = 54). It was also hypothesized that the three dimensions of school engagement would mediate the association between being maltreated and in foster care and several outcomes in late elementary school (Grades 3 to 5): academic competence, endorsement of substance use, externalizing behaviors, and deviant peer association. Measures were multi-method and multi-informant. Results showed that the children in foster care had lower affective and cognitive school engagement than children in the community comparison group. Structural equation modeling revealed that both affective and cognitive school engagement mediated the association between group status and academic competence in late elementary school. Cognitive engagement also mediated the association between group status and engagement in risk behaviors. The identification of dimensions of early school engagement that predict later outcomes suggests potential points of intervention to change trajectories of academic and behavioral adjustment for maltreated children in foster care. PMID:23477532

  15. Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

    PubMed Central

    Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.

    2016-01-01

    Purpose: Arthroscopic transosseous (TO) rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless) rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless) rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM) was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student's t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001). Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES) score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%), good in 8 (7.3%), fair in 3 (2.8%), and poor in 3 (2.8%). There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy) compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of injury preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique leads to

  16. Final visual acuity results in the early treatment for retinopathy of prematurity study.

    PubMed

    Good, William V; Hardy, Robert J; Dobson, Velma; Palmer, Earl A; Phelps, Dale L; Tung, Betty; Redford, Maryann

    2010-06-01

    To compare visual acuity at 6 years of age in eyes that received early treatment for high-risk prethreshold retinopathy of prematurity (ROP) with conventionally managed eyes. Infants with symmetrical, high-risk prethreshold ROP (n = 317) had one eye randomized to earlier treatment at high-risk prethreshold disease and the other eye managed conventionally, treated if ROP progressed to threshold severity. For asymmetric cases (n = 84), the high-risk prethreshold eye was randomized to either early treatment or conventional management. The main outcome measure was ETDRS visual acuity measured at 6 years of age by masked testers. Retinal structure was assessed as a secondary outcome. Analysis of all subjects with high-risk prethreshold ROP showed no statistically significant benefit for early treatment (24.3% vs 28.6% [corrected] unfavorable outcome; P = .15). Analysis of 6-year visual acuity results according to the Type 1 and 2 clinical algorithm showed a benefit for Type 1 eyes (25.1% vs 32.8%; P = .02) treated early but not Type 2 eyes (23.6% vs 19.4%; P = .37). Early-treated eyes showed a significantly better structural outcome compared with conventionally managed eyes (8.9% vs 15.2% unfavorable outcome; P < .001), with no greater risk of ocular complications. Early treatment for Type 1 high-risk prethreshold eyes improved visual acuity outcomes at 6 years of age. Early treatment for Type 2 high-risk prethreshold eyes did not. Application to Clinical Practice Type 1 eyes, not Type 2 eyes, should be treated early. These results are particularly important considering that 52% of Type 2 high-risk prethreshold eyes underwent regression of ROP without requiring treatment. Trial Registration clinicaltrials.gov Identifier: NCT00027222.

  17. Individual-level outcomes from a national clinical leadership development programme.

    PubMed

    Patton, Declan; Fealy, Gerard; McNamara, Martin; Casey, Mary; Connor, Tom O; Doyle, Louise; Quinlan, Christina

    2013-08-01

    A national clinical leadership development programme was instituted for Irish nurses and midwives in 2010. Incorporating a development framework and leadership pathway and a range of bespoke interventions for leadership development, including workshops, action-learning sets, mentoring and coaching, the programme was introduced at seven pilot sites in the second half of 2011. The programme pilot was evaluated with reference to structure, process and outcomes elements, including individual-level programme outcomes. Evaluation data were generated through focus groups and group interviews, individual interviews and written submissions. The data provided evidence of nurses' and midwives' clinical leadership development through self and observer-reported behaviours and dispositions including accounts of how the programme participants developed and displayed particular clinical leadership competencies. A key strength of the new programme was that it involved interventions that focussed on specific leadership competencies to be developed within the practice context.

  18. Effects of early exposure to phthalates and bisphenols on cardiometabolic outcomes in pregnancy and childhood.

    PubMed

    Philips, Elise M; Jaddoe, Vincent W V; Trasande, Leonardo

    2017-03-01

    Pregnant women are exposed to various chemicals, including endocrine-disrupting chemicals (EDCs) such as phthalates and bisphenols. Increasing evidence suggests that early life exposures to phthalates and bisphenols may contribute to cardiometabolic risks. The aim of this narrative review was to summarize current knowledge of the effects of fetal and childhood exposure to phthalates and bisphenols on child growth and child cardiometabolic outcomes and the effects on maternal outcomes. In total, 54 studies were identified and included. The majority of studies found effects of phthalates and bisphenols on maternal, child growth, and cardiometabolic outcomes. Currently results suggest that early life exposure to phthalates and bisphenols may have a substantial influence on perinatal and postnatal cardiometabolic programming. In a large part of the investigated outcomes studies show contradictory results. However, the majority of the existing evidence is based on non-cohort studies with single samples neglecting time-variant effects and complicating conclusions regarding causal inference. More studies are needed investigating the mechanisms and its potential interactions. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Effects of asymptomatic rotator cuff pathology on in vivo shoulder motion and clinical outcomes.

    PubMed

    Baumer, Timothy G; Dischler, Jack; Mende, Veronica; Zauel, Roger; van Holsbeeck, Marnix; Siegal, Daniel S; Divine, George; Moutzouros, Vasilios; Bey, Michael J

    2017-06-01

    The incidence of asymptomatic rotator cuff tears has been reported to range from 15% to 39%, but the influence of asymptomatic rotator cuff pathology on shoulder function is not well understood. This study assessed the effects of asymptomatic rotator cuff pathology on shoulder kinematics, strength, and patient-reported outcomes. A clinical ultrasound examination was performed in 46 asymptomatic volunteers (age: 60.3 ± 7.5 years) with normal shoulder function to document the condition of their rotator cuff. The ultrasound imaging identified the participants as healthy (n = 14) or pathologic (n = 32). Shoulder motion was measured with a biplane x-ray imaging system, strength was assessed with a Biodex (Biodex Medical Systems, Inc., Shirley, NY, USA), and patient-reported outcomes were assessed using the Western Ontario Rotator Cuff Index and visual analog scale pain scores. Compared with healthy volunteers, those with rotator cuff pathology had significantly less abduction (P = .050) and elevation (P = .041) strength, their humerus was positioned more inferiorly on the glenoid (P = .018), and the glenohumeral contact path length was longer (P = .007). No significant differences were detected in the Western Ontario Rotator Cuff Index, visual analog scale, range of motion, or acromiohumeral distance. The differences observed between the healthy volunteers and those with asymptomatic rotator cuff pathology lend insight into the changes in joint mechanics, shoulder strength, and conventional clinical outcomes associated with the early stages of rotator cuff pathology. Furthermore, these findings suggest a plausible mechanical progression of kinematic and strength changes associated with the development of rotator cuff pathology. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  20. The early evolution of Jean Piaget's clinical method.

    PubMed

    Mayer, Susan Jean

    2005-11-01

    This article analyzes the early evolution of Jean Piaget's renowned "clinical method" in order to investigate the method's strikingly original and generative character. Throughout his 1st decade in the field, Piaget frequently discussed and justified the many different approaches to data collection he used. Analysis of his methodological progression during this period reveals that Piaget's determination to access the genuine convictions of children eventually led him to combine 3 distinct traditions in which he had been trained-naturalistic observation, psychometrics, and the psychiatric clinical examination. It was in this amalgam, first evident in his 4th text, that Piaget discovered the clinical dynamic that would drive the classic experiments for which he is most well known.