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Sample records for cardiac outcomes trial

  1. Effects of music therapy on health-related outcomes in cardiac rehabilitation: a randomized controlled trial.

    Science.gov (United States)

    Mandel, Susan E; Hanser, Suzanne B; Secic, Michelle; Davis, Beth A

    2007-01-01

    This study tested effectiveness of music therapy in improving health-related outcomes of cardiac rehabilitation patients. Using a randomized, controlled trial with follow-up, the study was conducted in an outpatient cardiac rehabilitation program in Ohio. Sixty-eight of 103 recruited patients, 30 to 80 years of age, completed the protocol through posttreatment. Physiological and psychological outcomes were measured. Cardiac rehabilitation patients were randomly assigned to cardiac rehabilitation only or to music therapy plus cardiac rehabilitation. Music therapy included musical experiences, counseling, and Music-Assisted Relaxation and Imagery. The null hypothesis of no differences in health-related outcomes between cardiac rehabilitation patients who experienced cardiac rehabilitation with and without music therapy was rejected due to changes in systolic blood pressure pre to post-treatment. Interpretation of changes at 4 months posttreatment in anxiety, general health, and social functioning are limited, due to small sample sizes at follow-up. Pre to post-music therapy session improvements were also reported. Findings suggest that some health-related outcomes may be affected positively by participation in music therapy in addition to cardiac rehabilitation. Attrition contributed to limitations in statistical power. PMID:17645384

  2. Potential synergy between lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial

    DEFF Research Database (Denmark)

    Sever, Peter; Dahlöf, Björn; Poulter, Neil; Wedel, Hans; Beevers, Gareth; Caulfield, Mark; Collins, Rory; Kjeldsen, Sverre; Kristinsson, Arni; McInnes, Gordon; Mehlsen, Jesper; Nieminem, Markku; O'Brien, Eoin; Ostergren, Jan

    2006-01-01

    A prespecified objective of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was to assess whether any synergistic effects were apparent between the lipid-lowering and blood-pressure-lowering regimens in preventing cardiovascular events.......A prespecified objective of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was to assess whether any synergistic effects were apparent between the lipid-lowering and blood-pressure-lowering regimens in preventing cardiovascular events....

  3. The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn;

    2008-01-01

    -BPLA) compared two different antihypertensive treatment strategies on cardiovascular outcomes. ASCOT-LLA was a double-blind placebo-controlled trial of atorvastatin in those enrolled into ASCOT-BPLA with total cholesterol concentrations at baseline of <= 6.5 mmol/L. A total of 19 342 hypertensive patients were...... enrolled in ASCOT-BPLA and 10 305 were further assigned either atorvastatin, 10 mg, or placebo. ASCOT-LLA was stopped prematurely after a median 3.3 years follow-up because of substantial cardiovascular benefits in those assigned atorvastatin. Trial physicians were invited to offer atorvastatin to all...

  4. Cardiac surgery outcomes.

    Science.gov (United States)

    Halpin, Linda S; Barnett, Scott D; Beachy, Jim

    2003-01-01

    Accrediting organizations and payers are demanding valid and reliable data that demonstrate the value of services. Federal agencies, healthcare industry groups, and healthcare watchdog groups are increasing the demand for public access to outcomes data. A new and growing outcomes dynamic is the information requested by prospective patients in an increasingly consumer-oriented business. Patients demand outcomes, and resources are developing to meet these demands. Physicians are increasingly confronted with requests for information about their mortality and morbidity rates, malpractice suits, and disciplinary actions received. For example, in Virginia, prospective patients have access to data provided by the nonprofit group Virginia Health Information. After numerous resolutions by the Virginia Senate since 1999, the prospective Virginia medical consumer now has access to several annual publications: Virginia Hospitals: A Consumer's Guide, 1999 Annual Report and Strategic Plan Update, and the 1999 Industry Report: Virginia Hospitals and Nursing Facilities. Consumers have access to cardiac outcomes data stratified by hospital, gender, and cardiac service line (cardiac surgery, noninvasive cardiology, and invasive cardiology). This is particularly relevant to IHI because Virginia Health Information specifically targets cardiac care. IHI has a sizable investment in cardiovascular outcomes and has found outcomes measurement and research are key to providing quality care. IHI's goal is to move from an outcomes management model to a disease management model. The hope is to incorporate all aspects of the patient's continuum of care, from preoperative and diagnostic services through cardiac interventions to postoperative rehabilitation. Furthermore, every step along the way will be supported with functional status and quality of life assessments. Although these goals are ambitious and expensive, the return on investment is high. PMID:14618772

  5. Hypothermia improves outcome from cardiac arrest.

    Science.gov (United States)

    Bernard, S A

    2005-12-01

    Out-of-hospital cardiac arrest is common and patients who are initially resuscitated by ambulance officers and transported to hospital are usually admitted to the intensive care unit (ICU). In the past, the treatment in the ICU consisted of supportive care only, and most patients remained unconscious due to the severe anoxic neurological injury. It was this neurological injury rather than cardiac complications that caused the high rate of morbidity and mortality. However, in the early 1990's, a series of animal experiments demonstrated convincingly that mild hypothermia induced after return of spontaneous circulation and maintained for several hours dramatically reduced the severity of the anoxic neurological injury. In the mid-1990's, preliminary human studies suggested that mild hypothermia could be induced and maintained in post-cardiac arrest patients without an increase in the rate of cardiac or other complications. In the late 1990's, two prospective, randomised, controlled trials were conducted and the results confirmed the animal data that mild hypothermia induced after resuscitation and maintained for 12 - 24 hours dramatically improved neurological and overall outcomes. On the basis of these studies, mild hypothermia was endorsed in 2003 by the International Liaison Committee on Resuscitation as a recommended treatment for comatose patients with an initial cardiac rhythm of ventricular fibrillation. However, the application of this therapy into routine clinical critical care practice has been slow. The reasons for this are uncertain, but may relate to the relative complexity of the treatment, unfamiliarity with the pathophysiology of hypothermia, lack of clear protocols and/or uncertainty of benefit in particular patients. Therefore, recent research in this area has focused on the development of feasible, inexpensive techniques for the early, rapid induction of mild hypothermia after cardiac arrest. Currently, the most promising strategy is a rapid

  6. Childhood cancer survivors: cardiac disease & social outcomes

    NARCIS (Netherlands)

    E.A.M. Feijen

    2015-01-01

    The thesis is divided in two parts; Cardiac health problems and healthcare consumption & social outcomes in CCS. The general aims of part 1 creates optimal conditions for the evaluation of cardiac events in 5-year childhood cancer survivors, evaluation of the long term risk of cardiac events, and to

  7. Surface electrocardiogram to predict outcome in candidates for cardiac resynchronization therapy: a sub-analysis of the CARE-HF trial

    DEFF Research Database (Denmark)

    Gervais, Renaud; Leclercq, Christophe; Shankar, Aparna;

    2009-01-01

    AIMS: In CARE-HF, cardiac resynchronization therapy (CRT) lowered morbidity and mortality in patients with moderate to severe heart failure. We examined whether baseline and follow-up electrocardiographic characteristics might predict long-term outcome. METHODS AND RESULTS: CARE-HF randomly......, urgent transplantation, or cardiovascular hospitalization. Among patients assigned to CRT, 39% had unfavourable outcomes including 55 deaths. By single variable analysis, (i) prolonged PR interval, left QRS axis (but not QRS duration), and left bundle branch block (BBB) at baseline, and (ii) heart rate...

  8. Predictors for outcome among cardiac arrest patients

    DEFF Research Database (Denmark)

    Wibrandt, Ida; Norsted, Kristine; Schmidt, Henrik; Schierbeck, Jens

    for outcome among CA patients, we can improve the management of CA, in order to strengthen the leads in the chain of survival.MethodsA retrospective cohort study including 172 CA patients admitted to the intensive care unit (ICU) in Odense University Hospital (OUH) in a three-year period was conducted...... spontaneous circulation (ROSC).ResultsThe overall mortality was 44% and a favorable neurological outcome was seen among 52%. Strong predictors for survival and favorable neurological outcome were ventricular tachycardia/ventricular fibrillation (VT/VF) as initial rhythm, cardiac etiology and time to ROSC¿<¿20...

  9. Neurodevelopmental Outcomes After Cardiac Surgery in Infancy

    Science.gov (United States)

    Stopp, Christian; Wypij, David; Andropoulos, Dean B.; Atallah, Joseph; Atz, Andrew M.; Beca, John; Donofrio, Mary T.; Duncan, Kim; Ghanayem, Nancy S.; Goldberg, Caren S.; Hövels-Gürich, Hedwig; Ichida, Fukiko; Jacobs, Jeffrey P.; Justo, Robert; Latal, Beatrice; Li, Jennifer S.; Mahle, William T.; McQuillen, Patrick S.; Menon, Shaji C.; Pemberton, Victoria L.; Pike, Nancy A.; Pizarro, Christian; Shekerdemian, Lara S.; Synnes, Anne; Williams, Ismee; Bellinger, David C.; Newburger, Jane W.

    2015-01-01

    BACKGROUND: Neurodevelopmental disability is the most common complication for survivors of surgery for congenital heart disease (CHD). METHODS: We analyzed individual participant data from studies of children evaluated with the Bayley Scales of Infant Development, second edition, after cardiac surgery between 1996 and 2009. The primary outcome was Psychomotor Development Index (PDI), and the secondary outcome was Mental Development Index (MDI). RESULTS: Among 1770 subjects from 22 institutions, assessed at age 14.5 ± 3.7 months, PDIs and MDIs (77.6 ± 18.8 and 88.2 ± 16.7, respectively) were lower than normative means (each P < .001). Later calendar year of birth was associated with an increased proportion of high-risk infants (complexity of CHD and prevalence of genetic/extracardiac anomalies). After adjustment for center and type of CHD, later year of birth was not significantly associated with better PDI or MDI. Risk factors for lower PDI were lower birth weight, white race, and presence of a genetic/extracardiac anomaly (all P ≤ .01). After adjustment for these factors, PDIs improved over time (0.39 points/year, 95% confidence interval 0.01 to 0.78; P = .045). Risk factors for lower MDI were lower birth weight, male gender, less maternal education, and presence of a genetic/extracardiac anomaly (all P < .001). After adjustment for these factors, MDIs improved over time (0.38 points/year, 95% confidence interval 0.05 to 0.71; P = .02). CONCLUSIONS: Early neurodevelopmental outcomes for survivors of cardiac surgery in infancy have improved modestly over time, but only after adjustment for innate patient risk factors. As more high-risk CHD infants undergo cardiac surgery and survive, a growing population will require significant societal resources. PMID:25917996

  10. Effect of guideline based computerised decision support on decision making of multidisciplinary teams: cluster randomised trial in cardiac rehabilitation

    OpenAIRE

    Goud, R.; de Keizer, N F; ter Riet, G; Wyatt, J C; Hasman, A.; Hellemans, I.M.; Peek, N.

    2009-01-01

    OBJECTIVE: To determine the extent to which computerised decision support can improve concordance of multidisciplinary teams with therapeutic decisions recommended by guidelines. DESIGN: Multicentre cluster randomised trial. PARTICIPANTS: Multidisciplinary cardiac rehabilitation teams in Dutch centres and their cardiac rehabilitation patients. INTERVENTIONS: Teams received an electronic patient record system with or without additional guideline based decision support. MAIN OUTCOME MEASURES: C...

  11. The psychosocial outcome of anoxic brain injury following cardiac arrest

    OpenAIRE

    Wilson, Michelle

    2012-01-01

    Aim of the study The psychosocial outcome of anoxic brain injury following cardiac arrest is a relatively under researched, but clinically important area. The aim of the current study was to add to the limited existing literature exploring the psychosocial outcome for cardiac arrest survivors, but specifically explore if there is a greater impact on psychosocial outcome in individuals experiencing anoxic brain injury as a result. Methods A range of self report measures were used to c...

  12. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial

    DEFF Research Database (Denmark)

    Lilja, Gisela; Nielsen, Niklas; Friberg, Hans;

    2013-01-01

    Mild to moderate cognitive impairment is common amongst long-term survivors of cardiac arrest. In the Target Temperature Management trial (TTM-trial) comatose survivors were randomized to 33°C or 36°C temperature control for 24 hours after cardiac arrest and the effects on survival and neurological...... outcome assessed. This protocol describes a sub-study of the TTM-trial investigating cognitive dysfunction and its consequences for patients' and relatives' daily life....

  13. Gene Therapy in Cardiac Surgery: Clinical Trials, Challenges, and Perspectives.

    Science.gov (United States)

    Katz, Michael G; Fargnoli, Anthony S; Kendle, Andrew P; Hajjar, Roger J; Bridges, Charles R

    2016-06-01

    The concept of gene therapy was introduced in the 1970s after the development of recombinant DNA technology. Despite the initial great expectations, this field experienced early setbacks. Recent years have seen a revival of clinical programs of gene therapy in different fields of medicine. There are many promising targets for genetic therapy as an adjunct to cardiac surgery. The first positive long-term results were published for adenoviral administration of vascular endothelial growth factor with coronary artery bypass grafting. In this review we analyze the past, present, and future of gene therapy in cardiac surgery. The articles discussed were collected through PubMed and from author experience. The clinical trials referenced were found through the Wiley clinical trial database (http://www.wiley.com/legacy/wileychi/genmed/clinical/) as well as the National Institutes of Health clinical trial database (Clinicaltrials.gov). PMID:26801060

  14. The utility of cardiac sonography and capnography in predicting outcome in cardiac arrest

    OpenAIRE

    Nelson, Bret P; Patel, Vaishali R.; Norris, Marlaina M.; Richardson, Barbara K.

    2008-01-01

    Emergency physicians and intensivists are increasingly utilizing capnography and bedside echocardiography during medical resuscitations. These techniques have shown promise in predicting outcomes in cardiac arrest, and no cases of return of spontaneous circulation in the setting of sonographic cardiac standstill and low end-tidal carbon dioxide have been reported. This case report illustrates an example of such an occurrence. Our aims are to report a case of return of spontaneous circulation ...

  15. Cardiac asthma in elderly patients: incidence, clinical presentation and outcome

    Directory of Open Access Journals (Sweden)

    Ray Patrick

    2007-05-01

    Full Text Available Abstract Background Cardiac asthma is common, but has been poorly investigated. The objective was to compare the characteristics and outcome of cardiac asthma with that of classical congestive heart failure (CHF in elderly patients. Methods Prospective study in an 1,800-bed teaching hospital. Results Two hundred and twelve consecutive patients aged ≥ 65 years presenting with dyspnea due to CHF (mean age of 82 ± 8 years were included. Findings of cardiac echocardiography and natriuretic peptides levels were used to confirm CHF. Cardiac asthma patients were defined as a patient with CHF and wheezing reported by attending physician upon admission to the emergency department. The CHF group (n = 137 and the cardiac asthma group (n = 75, differed for tobacco use (34% vs. 59%, p 2 (47 ± 15 vs. 41 ± 11 mmHg, p Conclusion Patients with cardiac asthma represented one third of CHF in elderly patients. They were more hypercapnic and experienced more distal airway obstruction. However, outcomes were similar.

  16. Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC trial protocol

    Directory of Open Access Journals (Sweden)

    McCabe Chris

    2010-11-01

    Full Text Available Abstract Background Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during prehospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Prehospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest. Methods/design The primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. Methods: Ambulance service vehicles will be randomised to either manual compression (control or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase. Conclusion The trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942.

  17. Outcome of major cardiac injuries at a Canadian trauma center

    Directory of Open Access Journals (Sweden)

    Lamy Andre

    2002-06-01

    Full Text Available Abstract Background Canadian trauma units have relatively little experience with major cardiac trauma (disruption of a cardiac chamber so injury outcome may not be comparable to that reported from other countries. We compared our outcomes to those of other centers. Methods Records of patients suffering major cardiac trauma over a nine-year period were reviewed. Factors predictive of outcome were analyzed. Results Twenty-seven patients (11 blunt and 16 penetrating with major cardiac trauma were evaluated. Injury severity scores (ISS were similar for blunt (49.6 ± 16.6 and penetrating (39.5 ± 21.6, p = 0.20 injuries. Five of 11 blunt trauma patients, and 9 of 16 penetrating trauma patients, had detectable vital signs on hospital arrival (p = 0.43. Ten patients underwent emergency department thoracotomy and 11 patients had cardiac repair in the operating theatre. Eleven patients survived and 16 died. Survivors had a lower ISS (33.7 ± 15.4 than non-survivors (50.4 ± 20.4; p = 0.03. Two of 11 blunt trauma patients and 9 of 16 penetrating trauma patients survived (p = 0.06. Eleven of 14 patients with detectable vital signs survived; all 13 without detectable vital signs died (p = 0.00003. Ten of eleven patients treated in the operating theatre survived, while only one of the other 16 patients survived (p = 0.00002. Conclusions Patients with major cardiac injuries and detectable vital signs on hospital arrival can be salvaged by prompt surgical intervention in the operating theatre. Major cardiac injuries are infrequently encountered at our center but patient survival is comparable to that reported from trauma units in other countries.

  18. Age of transfused blood is not associated with increased postoperative adverse outcome after cardiac surgery.

    LENUS (Irish Health Repository)

    McKenny, M

    2011-05-01

    This study investigated the hypothesis that storage age of transfused red blood cells (RBCs) is associated with adverse outcome after cardiac surgery, and examined association between volume of RBC transfusions and outcome after cardiac surgery.

  19. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida; Tendal, Britta; Hilden, Jørgen; Boutron, Isabelle; Ravaud, Philippe; Brorson, Stig

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  20. Design and implementation of the Resuscitation Outcomes Consortium Pragmatic Airway Resuscitation Trial (PART).

    Science.gov (United States)

    Wang, Henry E; Prince, David K; Stephens, Shannon W; Herren, Heather; Daya, Mohamud; Richmond, Neal; Carlson, Jestin; Warden, Craig; Colella, M Riccardo; Brienza, Ashley; Aufderheide, Tom P; Idris, Ahamed H; Schmicker, Robert; May, Susanne; Nichol, Graham

    2016-04-01

    Airway management is an important component of resuscitation from out-of-hospital cardiac arrest (OHCA). The optimal approach to advanced airway management is unknown. The Pragmatic Airway Resuscitation Trial (PART) will compare the effectiveness of endotracheal intubation (ETI) and Laryngeal Tube (LT) insertion upon 72-h survival in adult OHCA. Encompassing United States Emergency Medical Services agencies affiliated with the Resuscitation Outcomes Consortium (ROC), PART will use a cluster-crossover randomized design. Participating subjects will include adult, non-traumatic OHCA requiring bag-valve-mask ventilation. Trial interventions will include (1) initial airway management with ETI and (2) initial airway management with LT. The primary and secondary trial outcomes are 72-h survival and return of spontaneous circulation. Additional clinical outcomes will include airway management process and adverse events. The trial will enroll a total of 3000 subjects. Results of PART may guide the selection of advanced airway management strategies in OHCA. PMID:26851059

  1. Role of Biological Sex in Normal Cardiac Function and in its Disease Outcome – A Review

    OpenAIRE

    Prabhavathi, K.; Selvi, K.Tamarai; Poornima, K.N.; Sarvanan, A.

    2014-01-01

    Biological sex plays an important role in normal cardiac physiology as well as in the heart‘s response to cardiac disease. Women generally have better cardiac function and survival than do men in the face of cardiac disease; however, this is progressively lost when comparing postmenopausal women with age matched men. Animal model of cardiac disease mirror what is seen in humans. Sex hormones contribute significantly to sex based difference in cardiac functioning and in its disease outcome. Es...

  2. Cardiac safety of citalopram: prospective trials and retrospective analyses

    DEFF Research Database (Denmark)

    Rasmussen, Søren Poul Lind; Overø, K F; Tanghøj, P

    1999-01-01

    The selective serotonin reuptake inhibitors (SSRIs) are believed to have a more benign cardiovascular safety profile than do the tricyclic antidepressants. The effects of the SSRI citalopram on cardiac conduction and repolarization have been extensively evaluated, both in prospective studies in...... variability of the QTc interval, as well as possible changes during treatment with placebo or citalopram, and its correlation to plasma drug levels. To document any dose-related changes, ECGs were performed at baseline and at the end of study in three randomized, double-blind, placebo- or active......-controlled, fixed-dose trials in adult and elderly patients (N = 1,460) with major depression and/or dementia. Finally, more than 6,000 ECGs (N = 1,789 citalopram-treated patients) collected from all clinical trials conducted from 1978 through 1996 were reassessed in a standardized manner to identify any effects of...

  3. Trial Outcome and Associative Learning Signals in the Monkey Hippocampus

    OpenAIRE

    Wirth, Sylvia; Avsar, Emin; Chiu, Cindy C.; Sharma, Varun; Smith, Anne C.; Emery N Brown; Suzuki, Wendy A.

    2009-01-01

    In tasks of associative learning, animals establish new links between unrelated items by using information about trial outcome to strengthen correct/rewarded associations and modify incorrect/unrewarded ones. To study how hippocampal neurons convey information about reward and trial outcome during new associative learning, we recorded hippocampal neurons as monkeys learned novel object-place associations. A large population of hippocampal neurons (50%) signaled trial outcome by differentiatin...

  4. Pediatric defibrillation after cardiac arrest: initial response and outcome

    Science.gov (United States)

    Rodríguez-Núñez, Antonio; López-Herce, Jesús; García, Cristina; Domínguez, Pedro; Carrillo, Angel; Bellón, Jose María

    2006-01-01

    Introduction Shockable rhythms are rare in pediatric cardiac arrest and the results of defibrillation are uncertain. The objective of this study was to analyze the results of cardiopulmonary resuscitation that included defibrillation in children. Methods Forty-four out of 241 children (18.2%) who were resuscitated from inhospital or out-of-hospital cardiac arrest had been treated with manual defibrillation. Data were recorded according to the Utstein style. Outcome variables were a sustained return of spontaneous circulation (ROSC) and one-year survival. Characteristics of patients and of resuscitation were evaluated. Results Cardiac disease was the major cause of arrest in this group. Ventricular fibrillation (VF) or pulseless ventricular tachycardia (PVT) was the first documented electrocardiogram rhythm in 19 patients (43.2%). A shockable rhythm developed during resuscitation in 25 patients (56.8%). The first shock (dose, 2 J/kg) terminated VF or PVT in eight patients (18.1%). Seventeen children (38.6%) needed more than three shocks to solve VF or PVT. ROSC was achieved in 28 cases (63.6%) and it was sustained in 19 patients (43.2%). Only three patients (6.8%), however, survived at 1-year follow-up. Children with VF or PVT as the first documented rhythm had better ROSC, better initial survival and better final survival than children with subsequent VF or PVT. Children who survived were older than the finally dead patients. No significant differences in response rate were observed when first and second shocks were compared. The survival rate was higher in patients treated with a second shock dose of 2 J/kg than in those who received higher doses. Outcome was not related to the cause or the location of arrest. The survival rate was inversely related to the duration of cardiopulmonary resuscitation. Conclusion Defibrillation is necessary in 18% of children who suffer cardiac arrest. Termination of VF or PVT after the first defibrillation dose is achieved in a low

  5. Neurodevelopmental outcome after cardiac surgery utilizing cardiopulmonary bypass in children

    Directory of Open Access Journals (Sweden)

    Aymen N Naguib

    2015-01-01

    Full Text Available Introduction: Modulating the stress response and perioperative factors can have a paramount impact on the neurodevelopmental outcome of infants who undergo cardiac surgery utilizing cardiopulmonary bypass. Materials and Methods: In this single center prospective follow-up study, we evaluated the impact of three different anesthetic techniques on the neurodevelopmental outcomes of 19 children who previously underwent congenital cardiac surgery within their 1 st year of life. Cases were done from May 2011 to December 2013. Children were assessed using the Stanford-Binet Intelligence Scales (5 th edition. Multiple regression analysis was used to test different parental and perioperative factors that could significantly predict the different neurodevelopmental outcomes in the entire cohort of patients. Results: When comparing the three groups regarding the major cognitive scores, a high-dose fentanyl (HDF patients scored significantly higher than the low-dose fentanyl (LDF + dexmedetomidine (DEX (LDF + DEX group in the quantitative reasoning scores (106 ± 22 vs. 82 ± 15 P = 0.046. The bispectral index (BIS value at the end of surgery for the -LDF group was significantly higher than that in LDF + DEX group (P = 0.011. For the entire cohort, a strong correlation was seen between the standard verbal intelligence quotient (IQ score and the baseline adrenocorticotropic hormone level, the interleukin-6 level at the end of surgery and the BIS value at the end of the procedure with an R 2 value of 0.67 and P < 0.04. There was an inverse correlation between the cardiac Intensive Care Unit length of stay and the full-scale IQ score (R = 0.4675 and P 0.027. Conclusions: Patients in the HDF group demonstrated overall higher neurodevelopmental scores, although it did not reach statistical significance except in fluid reasoning scores. Our results may point to a possible correlation between blunting the stress response and improvement of the neurodevelopmental

  6. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...... investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more...

  7. Effect of antioxidant vitamin supplementation on cardiovascular outcomes: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yizhou Ye

    Full Text Available BACKGROUND: Antioxidant vitamin (vitamin E, beta-carotene, and vitamin C are widely used for preventing major cardiovascular outcomes. However, the effect of antioxidant vitamin on cardiovascular events remains unclear. METHODOLOGY AND PRINCIPAL FINDINGS: We searched PubMed, EmBase, the Cochrane Central Register of Controlled Trials, and the proceedings of major conferences for relevant literature. Eligible studies were randomized controlled trials that reported on the effects of antioxidant vitamin on cardiovascular outcomes as compared to placebo. Outcomes analyzed were major cardiovascular events, myocardial infarction, stroke, cardiac death, total death, and any possible adverse events. We used the I(2 statistic to measure heterogeneity between trials and calculated risk estimates for cardiovascular outcomes with random-effect meta-analysis. Independent extraction was performed by two reviewers and consensus was reached. Of 293 identified studies, we included 15 trials reporting data on 188209 participants. These studies reported 12749 major cardiovascular events, 6699 myocardial infarction, 3749 strokes, 14122 total death, and 5980 cardiac deaths. Overall, antioxidant vitamin supplementation as compared to placebo had no effect on major cardiovascular events (RR, 1.00; 95%CI, 0.96-1.03, myocardial infarction (RR, 0.98; 95%CI, 0.92-1.04, stroke (RR, 0.99; 95%CI, 0.93-1.05, total death (RR, 1.03; 95%CI, 0.98-1.07, cardiac death (RR, 1.02; 95%CI, 0.97-1.07, revascularization (RR, 1.00; 95%CI, 0.95-1.05, total CHD (RR, 0.96; 95%CI, 0.87-1.05, angina (RR, 0.98; 95%CI, 0.90-1.07, and congestive heart failure (RR, 1.07; 95%CI, 0.96 to 1.19. CONCLUSION/SIGNIFICANCE: Antioxidant vitamin supplementation has no effect on the incidence of major cardiovascular events, myocardial infarction, stroke, total death, and cardiac death.

  8. 1. Predictors of cardio pulmonary resuscitation outcome in post-operative cardiac children

    OpenAIRE

    Nasser, B.

    2016-01-01

    Outcome of cardiopulmonary resuscitation (CPR) in children with congenital heart disease has improved and many children survived after in hospital cardiac arrestthe purpose of this study is to determine predictor of poor outcome after CPR in critical children undergoing cardiac surgerywe conducted a retrospective chart review and data analysis of all CPR records and charts of all postoperative cardiac children who had cardiac arrest and required resuscitation from 2012 till 2015. Demographic,...

  9. Cardiac rehabilitation adapted to transient ischaemic attack and stroke (CRAFTS: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Blake Catherine

    2009-02-01

    Full Text Available Abstract Background Coronary Heart Disease and Cerebrovascular Disease share many predisposing, modifiable risk factors (hypertension, abnormal blood lipids and lipoproteins, cigarette smoking, physical inactivity, obesity and diabetes mellitus. Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention. Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population. A Cochrane review highlighted as priority, the need to establish feasibility and efficacy of exercise based interventions for Cerebrovascular Disease. Methods A single blind randomised controlled trial is proposed to examine a primary care cardiac rehabilitation programme for adults post transient ischemic attack (TIA and stroke in effecting a positive change in the primary outcome measures of cardiac risk scores derived from Blood Pressure, lipid profile, smoking and diabetic status and lifestyle factors of habitual smoking, exercise and healthy eating participation. Secondary outcomes of interest include health related quality of life as measured by the Hospital Anxiety and Depression Scale, the Stroke Specific Quality of Life scale and WONCA COOP Functional Health Status charts and cardiovascular fitness as measured by a sub-maximal fitness test. A total of 144 patients, over 18 years of age with confirmed diagnosis of ischaemic stroke or TIA, will be recruited from Dublin community stroke services and two tertiary T.I.A clinics. Exclusion criteria will include oxygen dependence, unstable cardiac conditions, uncontrolled diabetes, major medical conditions, claudication, febrile illness, pregnancy or cognitive impairment. Participants will be block-statified, randomly allocated to one of two groups using a pre-prepared computer generated randomisation schedule. Both groups will receive a two hour education class on risk reduction post stroke. The

  10. Insulin resistance, adiponectin and adverse outcomes following elective cardiac surgery: a prospective follow-up study

    Directory of Open Access Journals (Sweden)

    Hjortdal Vibeke E

    2010-12-01

    Full Text Available Abstract Background Insulin resistance and adiponectin are markers of cardio-metabolic disease and associated with adverse cardiovascular outcomes. The present study examined whether preoperative insulin resistance or adiponectin were associated with short- and long-term adverse outcomes in non-diabetic patients undergoing elective cardiac surgery. Methods In a prospective study, we assessed insulin resistance and adiponectin levels from preoperative fasting blood samples in 836 patients undergoing cardiac surgery. Population-based medical registries were used for postoperative follow-up. Outcomes included all-cause death, myocardial infarction or percutaneous coronary intervention, stroke, re-exploration, renal failure, and infections. The ability of insulin resistance and adiponectin to predict clinical adverse outcomes was examined using receiver operating characteristics. Results Neither insulin resistance nor adiponectin were statistically significantly associated with 30-day mortality, but adiponectin was associated with an increased 31-365-day mortality (adjusted odds ratio 2.9 [95% confidence interval 1.3-6.4] comparing the upper quartile with the three lower quartiles. Insulin resistance was a poor predictor of adverse outcomes. In contrast, the predictive accuracy of adiponectin (area under curve 0.75 [95% confidence interval 0.65-0.85] was similar to that of the EuroSCORE (area under curve 0.75 [95% confidence interval 0.67-0.83] and a model including adiponectin and the EuroSCORE had an area under curve of 0.78 [95% confidence interval 0.68-0.88] concerning 31-365-day mortality. Conclusions Elevated adiponectin levels, but not insulin resistance, were associated with increased mortality and appear to be a strong predictor of long-term mortality. Additional studies are warranted to further clarify the possible clinical role of adiponectin assessment in cardiac surgery. Trial Registration The Danish Data Protection Agency; reference no

  11. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G;

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial...

  12. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...... optimistic estimates of effect. We pooled the differences in effect size using inverse variance random-effects meta-analysis and used metaregression to identify potential reasons for variation. RESULTS: We included 24 trials in our review. The main meta-analysis included 16 trials (involving 2854 patients...

  13. Outcome of children with Pentalogy of Cantrell following cardiac surgery.

    LENUS (Irish Health Repository)

    O'Gorman, Clodagh S

    2012-02-01

    Although single individual reports have documented outcomes in children with pentalogy of are few data available for postoperative outcome of this cohort of patients after cardiac surgery. The aim of this study was to retrospectively review the clinical details of patients with pentalogy of Cantrell managed at two centers. Two cardiac surgical institutions retrospectively studied all patients with pentalogy of Cantrell and significant congenital heart disease who underwent surgical intervention, excluding PDA ligation, between 1992 and 2004. Seven children with pentalogy of Cantrell underwent surgical intervention at a median age of 60 days (range, 1-11 months). Three patients had tetralogy of Fallot, two double outlet right ventricle, one patient had tricuspid atresia, and one patient a perimembranous ventricular septal defect. The mean duration of postoperative ventilation was 112.8 days (range, 4-335 days) but three patients required ventilation for more than 100 days. Patients who had a preoperative diaphragmatic plication required a longer duration of ventilation (mean = 186.5 days [range, 100-273 days] compared with mean = 132 days [range, 4-335 days]). Four patients survived, with three patients weaned from ventilation. Three patients had withdrawal of care following failure to wean from ventilation, following multisystem organ failure, and at the request of their parents. In conclusion, the postoperative care of children with pentalogy of Cantrell after cardiac surgery is often complicated by prolonged need for ventilatory support and multiple postoperative complications. Earlier surgical intervention does not necessarily reduce morbidity and mortality. These data may help in the counseling of parents prior to surgical intervention.

  14. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  15. Age‐Dependent Sex Effects on Outcomes After Pediatric Cardiac Surgery

    OpenAIRE

    Kochilas, Lazaros K.; Vinocur, Jeffrey M.; Menk, Jeremiah S.

    2014-01-01

    Background Sex has been linked to differential outcomes for cardiovascular disease in adults. We examined potential sex differences in outcomes after pediatric cardiac surgery. Methods and Results We retrospectively analyzed data from the Pediatric Cardiac Care Consortium (1982–2007) by using logistic regression to evaluate the effects of sex on 30‐day within‐hospital mortality after pediatric (

  16. Design and Rationale of the PRAGUE-12 Trial: A Large, Prospective, Randomized, Multicenter Trial That Compares Cardiac Surgery With Left Atrial Surgical Ablation With Cardiac Surgery Without Ablation in Patients With Coronary and/or Valvular Heart Disease Plus Atrial Fibrillation

    OpenAIRE

    Straka, Zbyněk; Budera, Petr; Osmančík, Pavel; Vaněk, Tomáš; Hulman, Michal; Šmíd, Michal; Malý, Marek; Widimský, Petr

    2013-01-01

    Surgical ablation procedure can restore sinus rhythm (SR) in patients with atrial fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has any impact on clinical outcomes. There is a need for a randomized trial with long-term follow-up to study the outcome of surgical ablation in patients with coronary and/or valve disease and AF. Patients are prospectively enrolled and randomized either to group A (cardiac surgery with left atrial ablation) or group B (cardiac su...

  17. Fish Oil and Atrial Fibrillation after Cardiac Surgery: A Meta-Analysis of Randomized Controlled Trials

    OpenAIRE

    Xin, Wei; Wei, Wei; Lin, Zhiqin; Zhang, Xiaoxia; Yang, Hongxia; Zhang, Tao; Li, Bin; Mi, Shuhua

    2013-01-01

    Background Influence of fish oil supplementation on postoperative atrial fibrillation (POAF) was inconsistent according to published clinical trials. The aim of the meta-analysis was to evaluate the effects of perioperative fish oil supplementation on the incidence of POAF after cardiac surgery. Methods Pubmed, Embase and the Cochrane Library databases were searched. Randomized controlled trials (RCTs) assessing perioperative fish oil supplementation for patients undergoing cardiac surgery we...

  18. Sternal Wound Infection after Cardiac Surgery: Management and Outcome.

    Directory of Open Access Journals (Sweden)

    Marie Dubert

    Full Text Available Sternal Wound Infection (SWI is a severe complication after cardiac surgery. Debridement associated with primary closure using Redon drains (RD is an effective treatment, but data on RD management and antibiotic treatment are scarce.We performed a single-center analysis of consecutive patients who were re-operated for SWI between 01/2009 and 12/2012. All patients underwent a closed drainage with RD (CDRD. Patients with endocarditis or those who died within the first 45 days were excluded from management analysis. RD fluid was cultured twice weekly. Variables recorded were clinical and biological data at SWI diagnosis, severity of SWI based on criteria for mediastinitis as defined by the Centers for Disease Control (CDC, antibiotic therapy, RD management and patient's outcome.160 patients developed SWI, 102 (64% fulfilled CDC criteria (CDC+ and 58 (36% did not (CDC- SWI. Initial antibiotic treatment and surgical management were similar in CDC+ and CDC- SWI. Patients with CDC+ SWI had a longer duration of antibiotic therapy and a mortality rate of 17% as compared to 3% in patients with CDC- SWI (p = 0.025. Rates of superinfection (10% and 9% and need for second reoperation (12% and 17% were similar. Failure (death or need for another reoperation was associated with female gender, higher EuroScore for prediction of operative mortality, and stay in the ICU.In patients with SWI, initial one-stage surgical debridement with CDRD is associated with favorable outcomes. CDC+ and CDC- SWI received essentially the same management, but CDC+ SWI has a more severe outcome.

  19. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton; Lundgren, Jens Dilling

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  20. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled

    DEFF Research Database (Denmark)

    Dahlöf, Björn; Sever, Peter S; Poulter, Neil R;

    2005-01-01

    The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics an...... and beta blockers. Our aim, therefore, was to compare the effect on non-fatal myocardial infarction and fatal CHD of combinations of atenolol with a thiazide versus amlodipine with perindopril....

  1. 从预防心肌梗死的降压、降脂治疗和英-斯堪的纳维亚心脏病后果研究的临床试验中获得的启示%Perspectives from the antihypertensive and lipid-lowering treatment to prevent heart attack trial-lipid lowering trial and the Anglo-Scandinavian cardiac outcomes trial-lipid lowering arm

    Institute of Scientific and Technical Information of China (English)

    李莹莹; 杨杰孚

    2004-01-01

    综述目的:在确诊为高血压的患者中应用他汀类药物降LDL胆固醇的两项大型临床试验中,比较其试验设计、过程及结果.将这次结果纳入先前进行的关于降低胆固醇的临床试验,并对高血压患者亚组进行分析. 最新发现:预防心肌梗死的降压和降脂治疗临床试验(the AntihypertensiVe andLipid-Lowering Treatment to Prevent Heart Attack Trial,ALLHAT-LLT)中尚未发现引起总死亡率(主要终点),心血管死亡率及心血管事件的发生率明显的下降.该结果与英-斯堪的纳维亚心脏病后果研究的临床试验(theAnglo-Scandinavian Cardiac Outcomes Trial,ASCOT-LLA)的研究结果大相径庭.后者曾因冠心病死亡率及心梗发生率(主要终点)显著下降(36%)而提前终止试验.ASCOT-LLA还表明卒中的发生率明显下降(27%),同时使各种主要的血管事件发生率下降.这两次的试验条件相似,均包括10000人以上确诊为高血压并需药物治疗的患者;二者的治疗均选用单一固定剂量他汀类药物,前者为普伐他汀(40mg/d),后者为阿伐他汀(10mg/d).两次试验的主要差别在于ASCOT-LLA的对照组使用的是安慰剂,双盲设计,而ALLHAT-LLT的对照组则仍为常规治疗.总结:ASCOT-LLA试验结果的确表明在高血压患者中服用降脂药物能使LDL胆固醇明显降低并维持其在较低水平.而ALLHAT-LLT则因为未使用更为有效的药物,对照组中常规应用他汀类药物(剂量逐渐加大),缺乏对比效果而无法获得与ASCOT-LLA相同的结果.

  2. Teamwork, Communication, Formula-One Racing and the Outcomes of Cardiac Surgery

    OpenAIRE

    Merry, Alan F.; Weller, Jennifer; Mitchell, Simon J.

    2014-01-01

    Most cardiac units achieve excellent results today, but the risk of cardiac surgery is still relatively high, and avoidable harm is common. The story of the Green Lane Cardiothoracic Unit provides an exemplar of excellence, but also illustrates the challenges associated with changes over time and with increases in the size of a unit and the complexity of practice today. The ultimate aim of cardiac surgery should be the best outcomes for (often very sick) patients rather than an undue focus on...

  3. Fish oil and atrial fibrillation after cardiac surgery: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Wei Xin

    Full Text Available BACKGROUND: Influence of fish oil supplementation on postoperative atrial fibrillation (POAF was inconsistent according to published clinical trials. The aim of the meta-analysis was to evaluate the effects of perioperative fish oil supplementation on the incidence of POAF after cardiac surgery. METHODS: Pubmed, Embase and the Cochrane Library databases were searched. Randomized controlled trials (RCTs assessing perioperative fish oil supplementation for patients undergoing cardiac surgery were identified. Data concerning study design, patient characteristics, and outcomes were extracted. Risk ratio (RR and weighted mean differences (WMD were calculated using fixed or random effects models. RESULTS: Eight RCTs involving 2687 patients were included. Perioperative supplementation of fish oil did not significantly reduce the incidence of POAF (RR = 0.86, 95%CI 0.71 to 1.03, p = 0.11 or length of hospitalization after surgery (WMD = 0.10 days, 95% CI: 0.48 to 0.67 days, p = 0.75. Fish oil supplementation also did not affect the perioperative mortality, incidence of major bleeding or the length of stay in the intensive care unit. Meta-regression and subgroup analyses indicated mean DHA dose in the supplements may be a potential modifier for the effects of fish oil for POAF. For supplements with DHA >1 g/d, fish oil significantly reduced the incidence of POAF; while it did not for the supplements with a lower dose of DHA. CONCLUSIONS: Current evidence did not support a preventative role of fish oil for POAF. However, relative amounts of DHA and EPA in fish oil may be important for the prevention of POAF.

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

    Directory of Open Access Journals (Sweden)

    Williamson Paula R

    2012-08-01

    Full Text Available Abstract 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.

  5. Outcomes in Registered, Ongoing Randomized Controlled Trials of Patient Education

    OpenAIRE

    Pino, Cécile; Boutron, Isabelle; Ravaud, Philippe

    2012-01-01

    Background With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs) evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life). Methods On May 6, 2009, we searched for all ongoing RCTs registered in the ...

  6. Effect of Rosa aromatherapy on anxiety before cardiac catheterization: A randomized controlled trial

    OpenAIRE

    Atye Babaii; Mohammad Abbasinia; Seyed Fakhreddin Hejazi; Seyyed Reza Seyyed Tabaei; Fariba Dehghani

    2015-01-01

    Background and Objectives: Most patients experience moderate to severe anxiety before cardiac catheterization. This study aimed to investigate the effect of Rosa aromatherapy on anxiety before cardiac catheterization. Methods: In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received rou...

  7. Continued efforts to translate diabetes cardiovascular outcome trials into clinical practice.

    Science.gov (United States)

    Avogaro, Angelo; Fadini, Gian Paolo; Sesti, Giorgio; Bonora, Enzo; Del Prato, Stefano

    2016-01-01

    Diabetic patients suffer from a high rate of cardiovascular events and such risk increases with HbA1c. However, lowering HbA1c does not appear to yield the same benefit on macrovascular endpoints, as observed for microvascular endpoints. As the number of glucose-lowering medications increases, clinicians have to consider several open questions in the management of type 2 diabetes, one of which is the cardiovascular risk profile of each regimen. Recent placebo-controlled cardiovascular outcome trials (CVOTs) have responded to some of these questions, but careful interpretation is needed. After general disappointment around CVOTs assessing safety of DPP-4 inhibitors (SAVOR, TECOS, EXAMINE) and the GLP-1 receptor agonist lixisenatide (ELIXA), the EMPA-REG Outcome trial and the LEADER trial have shown superiority of the SGLT2-I empagliflozin and the GLP-1RA liraglutide, respectively, on the 3-point MACE outcome (cardiovascular death, non-fatal myocardial infarction or stroke) and cardiovascular, as well as all-cause mortality. While available mechanistic studies largely support a cardioprotective effect of GLP-1, the ability of SGLT2 inhibitor(s) to prevent cardiovascular death was unexpected and deserves future investigation. We herein review the results of completed CVOTs of glucose-lowering medications and suggest a possible treatment algorithm based on cardiac and renal co-morbidities to translate CVOT findings into clinical practice. PMID:27514514

  8. Redundancy and variability in quality and outcome reporting for cardiac and thoracic surgery

    OpenAIRE

    Dixon, Jennifer L.; Papaconstantinou, Harry T.; Hodges, Bonnie; Korsmo, Robyn S.; Jupiter, Dan; Shake, Jay; Sareyyupoglu, Basar; Rascoe, Philip A.; Reznik, Scott I.

    2015-01-01

    Health care is evolving into a value-based reimbursement system focused on quality and outcomes. Reported outcomes from national databases are used for quality improvement projects and public reporting. This study compared reported outcomes in cardiac and thoracic surgery from two validated reporting databases—the Society of Thoracic Surgeons (STS) database and the National Surgical Quality Improvement Program (NSQIP)—from January 2011 to June 2012. Quality metrics and outcomes included morta...

  9. Making the Best Match: Selecting Outcome Measures for Clinical Trials and Outcome Studies

    OpenAIRE

    Coster, Wendy J.

    2013-01-01

    Selecting an appropriate outcome measure is a critical step in designing valid and useful clinical trials and outcome studies. This selection process needs to extend beyond examining basic psychometric properties to consider additional features of instruments that may affect their validity and utility for the study’s purpose. This article discusses these additional factors and their potential impact on outcome measurement. Guidelines are proposed to help clinical researchers and consumers of ...

  10. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and k...

  11. Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian;

    2006-01-01

    Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...... anaesthesia and surgical centres and one coordinating centre. Participants 921 patients aged > 39 scheduled for major non-cardiac surgery. Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. Main outcome...... was 4.6 days in the metoprolol group and 4.9 days in the placebo group. Metoprolol significantly reduced the mean heart rate by 11% (95% confidence interval 9% to 13%) and mean blood pressure by 3% (1% to 5%). The primary outcome occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of...

  12. Hypothermic cardiac arrest: an 11 year review of ED management and outcome.

    Science.gov (United States)

    Brunette, D D; McVaney, K

    2000-07-01

    The purpose of this study was to examine the emergency department (ED) management of hypothermic cardiac arrest and its outcome. The medical records of all patients with hypothermic cardiac arrest treated in the ED from January 1, 1988 to January 31, 1999 were retrospectively reviewed. Data collected included initial body temperature, serum potassium, methods of rewarming, return of perfusing rhythm, and morbidity and mortality. Data were analyzed by descriptive methods. Eleven patients were treated in the ED resuscitation room for hypothermic cardiac arrest. Six patients were found in cardiac arrest in the field, one patient arrested during transport, and four patients arrested after ED arrival. The average initial temperature was 79.1 degrees F (range 69.0 degrees F to 86.7 degrees F). Seven patients received an ED thoracotomy with internal cardiac massage and warm mediastinal irrigation. Four patients had airway management in the ED and then direct transport to the operating room for cardiac bypass rewarming. Three of the seven patients who received an ED thoracotomy subsequently went to intraoperative cardiac bypass rewarming. Five of the seven (71.4%) patients who received an ED thoracotomy survived, versus none of the four patients (0%) who went directly to intraoperative cardiac bypass. A direct comparison of immediate ED thoracotomy versus intraoperative cardiac bypass without ED thoracotomy is cautiously made as this was an unmatched and nonrandomized study. Three of the surviving patients underwent intraoperative cardiac bypass rewarming after receiving an ED thoracotomy. In two of these patients a perfusing rhythm had been established after thoracotomy in the ED and before transport to the operating room for cardiac bypass. Only one of seven (14.3%) patients who arrested prehospital survived versus four of four (100%) who arrested in the ED. ED thoracotomy with internal cardiac massage and mediastinal irrigation rewarming is effective in the management

  13. Effect of hormone replacement therapy on cardiovascular outcomes: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Dicheng Yang

    Full Text Available BACKGROUND: Hormone replacement therapy (HRT is widely used to controlling menopausal symptoms and prevent adverse cardiovascular events. However, the benefit and risk of HRT on cardiovascular outcomes remains controversial. METHODOLOGY AND PRINCIPAL FINDINGS: We systematically searched the PubMed, EmBase, and Cochrane Central Register of Controlled Trials databases for obtaining relevant literature. All eligible trials reported on the effects of HRT on cardiovascular outcomes. We did a random effects meta-analysis to obtain summary effect estimates for the clinical outcomes with use of relative risks calculated from the raw data of included trials. Of 1903 identified studies, we included 10 trials reporting data on 38908 postmenopausal women. Overall, we noted that estrogen combined with medroxyprogesterone acetate therapy as compared to placebo had no effect on coronary events (RR, 1.07; 95%CI: 0.91-1.26; P = 0.41, myocardial infarction (RR, 1.09; 95%CI: 0.85-1.41; P = 0.48, stroke (RR, 1.21; 95%CI: 1.00-1.46; P = 0.06, cardiac death (RR, 1.19; 95%CI: 0.91-1.56; P = 0.21, total death (RR, 1.06; 95%CI: 0.81-1.39; P = 0.66, and revascularization (RR, 0.95; 95%CI: 0.83-1.08; P = 0.43. In addition, estrogen therapy alone had no effect on coronary events (RR, 0.93; 95%CI: 0.80-1.08; P = 0.33, myocardial infarction (RR, 0.95; 95%CI: 0.78-1.15; P = 0.57, cardiac death (RR, 0.86; 95%CI: 0.65-1.13; P = 0.27, total mortality (RR, 1.02; 95%CI: 0.89-1.18; P = 0.73, and revascularization (RR, 0.77; 95%CI: 0.45-1.31; P = 0.34, but associated with a 27% increased risk for incident stroke (RR, 1.27; 95%CI: 1.06-1.53; P = 0.01. CONCLUSION/SIGNIFICANCE: Hormone replacement therapy does not effect on the incidence of coronary events, myocardial infarction, cardiac death, total mortality or revascularization. However, it might contributed an important role on the risk of incident stroke.

  14. Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Junker, Anders; Maeng, Michael; Tilsted, Hans-Henrik; Kaltoft, Anne; Hansen, Knud Nørregaard; Christiansen, Evald Høj; Kristensen, Steen Dalby; Ravkilde, Jan; Madsen, Morten; Sørensen, Henrik Toft; Thuesen, Leif; Lassen, Jens Flensted

    2012-01-01

    Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents...

  15. INTRAMYOCARDIAL STEM CELL TRANSPLANTATION IN CARDIAC SURGERY: FROM PRECLINICAL BACKGROUNDS TO THE PERFECT TRIAL

    Directory of Open Access Journals (Sweden)

    Peter Donndorf MD

    2011-01-01

    Full Text Available Cardiac cell therapy for regenerative purposes has been clinically applied in the fields of cardiac surgery and interventional cardiology for almost one decade. With preclinical studies showing promising regenerative concepts and results, the clinical efficacy of stem cell application reported until today in the setting of ischemic heart disease has been rather modest. However, clinical studies performed so far have been heterogenous. Hence, for final evaluation of the possible clinical benefits completion of ongoing phase III trials are mandatory. The following article repeats preclinical and clinical prerequisites for cardiac stem cell application and introduces the German Phase III PERindopril Function of the Endothelium in Coronary artery disease Trial (PERFECT for intramyocardial stem cell injection in combination with CABG surgery.

  16. Management and outcome of cardiac and endovascular cystic echinococcosis.

    Directory of Open Access Journals (Sweden)

    Marta Díaz-Menéndez

    2012-01-01

    Full Text Available BACKGROUND: Cystic echinococcosis (CE can affect the heart and the vena cava but few cases are reported. METHODS: A retrospective case series of 11 patients with cardiac and/or endovascular CE, followed-up over a period of 15 years (1995-2009 is reported. RESULTS: Main clinical manifestations included thoracic pain or dyspnea, although 2 patients were asymptomatic. Cysts were located mostly in the right atrium and inferior vena cava. Nine patients were previously diagnosed with disseminated CE. Echocardiography was the diagnostic method of choice, although serology, electrocardiogram, chest X-ray, computed tomography/magnetic resonance imaging and histology aided with diagnosis and follow-up. Nine patients underwent cardiac surgery and nine received long-term antiparasitic treatment for a median duration of 25 months (range 4-93 months. One patient died intra-operatively due to cyst rupture and endovascular dissemination. Two patients died 10 and 14 years after diagnosis, due to pulmonary embolism (PE and cardiac failure, respectively. One patient was lost to follow-up. Patients who had cardiac involvement exclusively did not have complications after surgery and were considered cured. There was only one recurrence requiring a second operation. Patients with vena cava involvement developed PEs and presented multiple complications. CONCLUSIONS: Cardiovascular CE is associated with a high risk of potentially lethal complications. Clinical manifestations and complications vary according to cyst location. Isolated cardiac CE may be cured after surgery, while endovascular extracardiac involvement is associated with severe chronic complications. CE should be included in the differential diagnosis of cardiovascular disease in patients from endemic areas.

  17. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

    Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H;

    2012-01-01

    Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we......, and measurement of biomarkers, show promise as adjuncts to the current disability measures, but are insufficiently validated to serve as substitutes. A collaborative approach that involves academic experts, regulators, industry representitives, and funding agencies is needed to most effectively develop disability...

  18. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  19. Patient-reported outcomes in lupus clinical trials with biologics.

    Science.gov (United States)

    Annapureddy, N; Devilliers, H; Jolly, M

    2016-09-01

    Therapeutic advances in systemic lupus erythematosus (SLE) are greatly needed. Despite advances in our knowledge of pathogenesis of the disease and targets, treatment remains a significant challenge. Finding effective and relatively safe medications remains one of the top priorities. SLE significantly impairs quality of life (QoL), and patient-reported outcomes (PROs) measure a unique aspect of the disease not captured by disease activity. Inclusion of PRO measurements is encouraged in SLE clinical trials, as they allow capturing benefits of a proposed intervention in language patients can relate to and in areas deemed pertinent and important to and by patients. Availability of patient-reported and patient-centric clinical trials data may facilitate patients in informed and shared decision making, and allow for comparative cost-effectiveness evaluation for future resource allocation and reimbursements. Herein we review clinical trials with biologic therapies wherein PRO tools were included in the study design. PMID:27497256

  20. Optimal Design of Cluster Randomized Trials with Binary Outcomes

    OpenAIRE

    Wu, Sheng

    2015-01-01

    Cluster randomized trials (CRTs) are increasingly used in many fields including public health and medicine. We consider two-arm CRTs with binary outcomes with possibly unequal intraclass correlations coefficients (ICCs) in the two arms. The efficacy of the intervention may be measured in terms of the risk difference (RD), relative risk (RR) or odds ratio (OR). We define cost efficiency (CE) as the ratio of the precision of the efficacy measure to the study cost and develop optimal allocations...

  1. Comprehensive cardiac rehabilitation improves outcome for patients with implantable cardioverter defibrillator

    DEFF Research Database (Denmark)

    Berg, Selina Kikkenborg; Pedersen, Preben Ulrich; Zwisler, Ann-Dorthe;

    2015-01-01

    Aims:The aim of this randomised clinical trial was to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education vs 'treatment as usual' in patients treated with an implantable cardioverter defibrillator (ICD).Methods:In this study 196 patients with...

  2. Teamwork, communication, formula-one racing and the outcomes of cardiac surgery.

    Science.gov (United States)

    Merry, Alan F; Weller, Jennifer; Mitchell, Simon J

    2014-03-01

    Most cardiac units achieve excellent results today, but the risk of cardiac surgery is still relatively high, and avoidable harm is common. The story of the Green Lane Cardiothoracic Unit provides an exemplar of excellence, but also illustrates the challenges associated with changes over time and with increases in the size of a unit and the complexity of practice today. The ultimate aim of cardiac surgery should be the best outcomes for (often very sick) patients rather than an undue focus on the prevention of error or adverse events. Measurement is fundamental to improving quality in health care, and the framework of structure, process, and outcome is helpful in considering how best to achieve this. A combination of outcomes (including some indicators of important morbidity) with key measures of process is advocated. There is substantial evidence that failures in teamwork and communication contribute to inefficiency and avoidable harm in cardiac surgery. Minor events are as important as major ones. Six approaches to improving teamwork (and hence outcomes) in cardiac surgery are suggested. These are: 1) subspecialize and replace tribes with teams; 2) sort out the leadership while flattening the gradients of authority; 3) introduce explicit training in effective communication; 4) use checklists, briefings, and debriefings and engage in the process; 5) promote a culture of respect alongside a commitment to excellence and a focus on patients; 6) focus on the performance of the team, not on individuals. PMID:24779113

  3. Effect of high or low protamine dosing on postoperative bleeding following heparin anticoagulation in cardiac surgery. A randomised clinical trial.

    Science.gov (United States)

    Meesters, Michael I; Veerhoek, Dennis; de Lange, Fellery; de Vries, Jacob-Willem; de Jong, Jan R; Romijn, Johannes W A; Kelchtermans, Hilde; Huskens, Dana; van der Steeg, Robin; Thomas, Pepijn W A; Burtman, David T M; van Barneveld, Laurentius J M; Vonk, Alexander B A; Boer, Christa

    2016-08-01

    While experimental data state that protamine exerts intrinsic anticoagulation effects, protamine is still frequently overdosed for heparin neutralisation during cardiac surgery with cardiopulmonary bypass (CPB). Since comparative studies are lacking, we assessed the influence of two protamine-to-heparin dosing ratios on perioperative haemostasis and bleeding, and hypothesised that protamine overdosing impairs the coagulation status following cardiac surgery. In this open-label, multicentre, single-blinded, randomised controlled trial, patients undergoing on-pump coronary artery bypass graft surgery were assigned to a low (0.8; n=49) or high (1.3; n=47) protamine-to-heparin dosing group. The primary outcome was 24-hour blood loss. Patient haemostasis was monitored using rotational thromboelastometry and a thrombin generation assay. The low protamine-to-heparin dosing ratio group received less protamine (329 ± 95 vs 539 ± 117 mg; pblood loss was increased in the high dosing ratio group (615 ml; 95 % CI 500-830 ml vs 470 ml; 95 % CI 420-530 ml; p=0.021) when compared to the low dosing group, respectively. More patients in the high dosing group received fresh frozen plasma (11 % vs 0 %; p=0.02) and platelet concentrate (21 % vs 6 %; p=0.04) compared to the low dosing group. Our study confirms in vitro data that abundant protamine dosing is associated with increased postoperative blood loss and higher transfusion rates in cardiac surgery. PMID:27277211

  4. Cardiac rehabilitation referral and enrolment across an academic health sciences centre with eReferral and peer navigation: a randomised controlled pilot trial

    Science.gov (United States)

    Ali-Faisal, Sobia F; Benz Scott, Lisa; Johnston, Lauren; Grace, Sherry L

    2016-01-01

    Objectives To describe (1) cardiac rehabilitation (CR) referral across cardiac units in a tertiary centre with eReferral; (2) characteristics associated with CR referral and enrolment and (3) the effects of peer navigation (PN) on referral and enrolment. This pilot was a 2 parallel-arm, randomised, single-blind trial with allocation concealment. Setting 3 cardiac units (ie, interventional, general cardiology, and cardiac surgery) in 1 of 2 hospitals of a tertiary centre. Participants CR-eligible adult cardiac inpatients were randomised to PN or usual care. 94 (54.7%) patients consented, of which 46 (48.9%) were randomised to PN. Outcomes were ascertained in 76 (80.9%) participants. Intervention The PN (1) visited participant at the bedside, (2) mailed a card to participant's home reminding about CR and (3) called participant 2 weeks postdischarge to discuss CR barriers. Outcome measures The primary outcome of enrolment was defined as participant attendance at a scheduled CR intake appointment (yes/no). The secondary outcome was referral. Blinded outcome assessment was conducted 12 weeks postdischarge, via CR chart extraction. Results Those who received care on the cardiac surgery unit (77.9%) were more likely to be referred than those treated on the general cardiology (61.1%) or interventional unit (33.3%; p=0.04). Patients who had cardiac surgery, hypertension and hyperlipidaemia were significantly more likely, and those with congenital heart disease, cancer and a previous cardiac diagnosis were less likely to be referred. Participants referred to a site closer to home (76.2% of those referred) were more likely to enrol than those not (23.7%, p<0.05). PN had no effect on referral (77.6%, p=0.45) or enrolment (46.0%, p=0.24). Conclusions There is wide variability in CR referral, even within academic centres, and despite eReferral. Referral was quite high, and thus, PN did not improve CR utilisation. Results support triaging patients to the CR programme closest

  5. Voiding trial outcome following pelvic floor repair without incontinence procedures

    Science.gov (United States)

    Wang, Rui; Won, Sara; Haviland, Miriam J.; Bargen, Emily Von; Hacker, Michele R.; Li, Janet

    2016-01-01

    Introduction and hypothesis Our aim was to identify predictors of postoperative voiding trial failure among patients who had a pelvic floor repair without a concurrent incontinence procedure in order to identify low-risk patients in whom postoperative voiding trials may be modified. Methods We conducted a retrospective cohort study of women who underwent pelvic floor repair without concurrent incontinence procedures at two institutions from 1 November 2011 through 13 October 2013 after abstracting demographic and clinical data from medical records. The primary outcome was postoperative retrograde voiding trial failure. We used modified Poisson regression to calculate the risk ratio (RR) and 95 % confidence interval (CI). Results Of the 371 women who met eligibility criteria, 294 (79.2 %) had complete data on the variables of interest. Forty nine (16.7%) failed the trial, and those women were less likely to be white (p = 0.04), more likely to have had an anterior colporrhaphy (p = 0.001), and more likely to have had a preoperative postvoid residual (PVR) ≥150 ml (p = 0.001). After adjusting for race, women were more likely to fail their voiding trial if they had a preoperative PVR of ≥150 ml (RR: 1.9; 95 % CI: 1.1–3.2); institution also was associated with voiding trial failure (RR: 3.0; 95 % CI: 1.6–5.4). Conclusions Among our cohort, postoperative voiding trial failure was associated with a PVR of ≥150 ml and institution at which the surgery was performed. PMID:26886553

  6. A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial

    Directory of Open Access Journals (Sweden)

    Wax Randy

    2011-01-01

    Full Text Available Abstract Background Advances in resuscitation science have dramatically improved survival rates following cardiac arrest. However, about 60% of adults that regain spontaneous circulation die before leaving the hospital. Recently it has been shown that inducing hypothermia in cardiac arrest survivors immediately following their arrival in hospital can dramatically improve both overall survival and neurological outcomes. Despite the strong evidence for its efficacy and the apparent simplicity of this intervention, recent surveys show that therapeutic hypothermia is delivered inconsistently, incompletely, and often with delay. Methods and design This study will evaluate a multi-faceted knowledge translation strategy designed to increase the utilization rate of induced hypothermia in survivors of cardiac arrest across a network of 37 hospitals in Southwestern Ontario, Canada. The study is designed as a stepped wedge randomized trial lasting two years. Individual hospitals will be randomly assigned to four different wedges that will receive the active knowledge translation strategy according to a sequential rollout over a number of time periods. By the end of the study, all hospitals will have received the intervention. The primary aim is to measure the effectiveness of a multifaceted knowledge translation plan involving education, reminders, and audit-feedback for improving the use of induced hypothermia in survivors of cardiac arrest presenting to the emergency department. The primary outcome is the proportion of eligible OHCA patients that are cooled to a body temperature of 32 to 34°C within six hours of arrival in the hospital. Secondary outcomes will include process of care measures and clinical outcomes. Discussion Inducing hypothermia in cardiac arrest survivors immediately following their arrival to hospital has been shown to dramatically improve both overall survival and neurological outcomes. However, this lifesaving treatment is

  7. Outcome of kidney transplantation between controlled cardiac death and brain death donors: a meta-analysis

    Institute of Scientific and Technical Information of China (English)

    Ming Yingzi; Shao Mingjie; Tian Tingting; She Xingguo; Liu Hong; Ye Shaojun; Ye Qifa

    2014-01-01

    Background Our goal was to evaluate the outcomes of kidney transplants from controlled cardiac death donors compared with brain death donors by conducting a meta-analysis of cohort studies.Methods The PubMed database and EMBASE were searched from January 1980 to July 2013 to identify studies that met pre-stated inclusion criteria.Reference lists of retrieved articles were also reviewed.Two authors independently extracted information on the designs of the studies,the characteristics of the study participants,and outcome assessments.Results Nine cohort studies involving 84 398 participants were included in this meta-analysis; 3 014 received kidneys from controlled cardiac death donors and 80 684 from brain death donors.Warm ischemia time was significantly longer for the controlled cardiac death donor group.The incidence of delayed graft function was 2.74 times (P <0.001) greater in the controlled cardiac death donor group.The results are in favor of the brain death donor group on short-term patient and graft survival while this difference became nonsignificant at mid-term and long term.Sensitivity analysis yielded similar results.No evidence of publication bias was observed.Conclusion This meta-analysis of retrospective cohort studies suggests that the outcome after controlled cardiac death donors is comparable with that obtained using kidneys from brain death donors.

  8. Developing Tools to Measure Quality in Congenital Catheterization and Interventions: The Congenital Cardiac Catheterization Project on Outcomes (C3PO)

    OpenAIRE

    Chaudhry-Waterman, Nadia; Coombs, Sandra; Porras, Diego; Holzer, Ralf; Bergersen, Lisa

    2014-01-01

    The broad range of relatively rare procedures performed in pediatric cardiac catheterization laboratories has made the standardization of care and risk assessment in the field statistically quite problematic. However, with the growing number of patients who undergo cardiac catheterization, it has become imperative that the cardiology community overcomes these challenges to study patient outcomes. The Congenital Cardiac Catheterization Project on Outcomes was able to develop benchmarks, tools ...

  9. The Aliskiren Trial to Minimize OutcomeS in Patients with HEart failure trial (ATMOSPHERE)

    DEFF Research Database (Denmark)

    Krum, Henry; McMurray, John J V; Abraham, William T; Dickstein, Kenneth; Køber, Lars; Desai, Akshay S; Solomon, Scott D; Chiang, Yanntong; Gimpelewicz, Claudio; Reimund, Bernard; Ali, M Atif; Tarnesby, Georgia; Massie, Barry M

    2015-01-01

    ATMOSPHERE with those in the Prospective comparison of Angiotensin Receptor neprilysin inhibitors with Angiotensin converting enzyme inhibitors to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF); and (iii) compare the characteristics of patients with and without...... dysfunction, and were treated with a mineralocorticoid receptor antagonist. In ATMOSPHERE, patients with diabetes differed in numerous ways from those without. Patients with diabetes were older and had worse heart failure status but a similar left ventricular ejection fraction (mean 28%); they had a higher...

  10. Multiple imputation methods for bivariate outcomes in cluster randomised trials.

    Science.gov (United States)

    DiazOrdaz, K; Kenward, M G; Gomes, M; Grieve, R

    2016-09-10

    Missing observations are common in cluster randomised trials. The problem is exacerbated when modelling bivariate outcomes jointly, as the proportion of complete cases is often considerably smaller than the proportion having either of the outcomes fully observed. Approaches taken to handling such missing data include the following: complete case analysis, single-level multiple imputation that ignores the clustering, multiple imputation with a fixed effect for each cluster and multilevel multiple imputation. We contrasted the alternative approaches to handling missing data in a cost-effectiveness analysis that uses data from a cluster randomised trial to evaluate an exercise intervention for care home residents. We then conducted a simulation study to assess the performance of these approaches on bivariate continuous outcomes, in terms of confidence interval coverage and empirical bias in the estimated treatment effects. Missing-at-random clustered data scenarios were simulated following a full-factorial design. Across all the missing data mechanisms considered, the multiple imputation methods provided estimators with negligible bias, while complete case analysis resulted in biased treatment effect estimates in scenarios where the randomised treatment arm was associated with missingness. Confidence interval coverage was generally in excess of nominal levels (up to 99.8%) following fixed-effects multiple imputation and too low following single-level multiple imputation. Multilevel multiple imputation led to coverage levels of approximately 95% throughout. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. PMID:26990655

  11. Factors associated with the clinical outcomes of paediatric out-of-hospital cardiac arrest in Japan

    OpenAIRE

    Nagata, Takashi; Abe, Takeru; Noda, Eiichiro; Hasegawa, Manabu; Hashizume, Makoto; Hagihara, Akihito

    2014-01-01

    Objectives To better understand and predict clinical outcomes of paediatric out-of-hospital cardiac arrest (OHCA). Design A population-based, observational study. Setting The National Japan Utstein Registry. Participants 2900 children aged 5–17 years who experienced OHCA and received resuscitation by emergency responders. Signal detection analysis using 17 variables was applied to identify factors associated with OHCA outcomes; the primary endpoint was cerebral performance category (CPC) 1 or...

  12. Work-related outcome after acute coronary syndrome: Implications of complex cardiac rehabilitation in occupational medicine

    OpenAIRE

    Monica Lamberti; Gennaro Ratti; Donato Gerardi; Cristina Capogrosso; Gianfranco Ricciardi; Cosimo Fulgione; Salvatore Latte; Paolo Tammaro; Gregorio Covino; Albert Nienhaus; Elpidio Maria Grazillo; Mario Mallardo; Paolo Capogrosso

    2016-01-01

    Objectives: Coronary heart disease is frequent in the working-age population. Traditional outcomes, such as mortality and hospital readmission, are useful for evaluating prognosis. Fit-for-work is an emerging outcome with clinical as well as socioeconomic significance. We describe the possible benefit of a cardiac rehabilitation (CR) program for return to work (RTW) after acute coronary syndrome (ACS). Material and Methods: We evaluated 204 patients with recent ACS. They were divided into 4 g...

  13. Insulin resistance, adiponectin and adverse outcomes following elective cardiac surgery: a prospective follow-up study

    OpenAIRE

    Hjortdal Vibeke E; Christensen Thomas D; Andersen Niels H; Gjedsted Jakob; Hansen Troels K; Mikkelsen Martin M; Johnsen Søren P

    2010-01-01

    Abstract Background Insulin resistance and adiponectin are markers of cardio-metabolic disease and associated with adverse cardiovascular outcomes. The present study examined whether preoperative insulin resistance or adiponectin were associated with short- and long-term adverse outcomes in non-diabetic patients undergoing elective cardiac surgery. Methods In a prospective study, we assessed insulin resistance and adiponectin levels from preoperative fasting blood samples in 836 patients unde...

  14. Creating clinical trial designs that incorporate clinical outcome assessments.

    Science.gov (United States)

    Gilbert, Mark R; Rubinstein, Lawrence; Lesser, Glenn

    2016-03-01

    Clinical outcome assessments (COAs) are increasingly being used in determining the efficacy of new treatment regimens. This was typified in the recent use of a symptom-based instrument combined with an organ-based measure of response for the approval of ruxolitinib in myelofibrosis. There are challenges in incorporating these COAs into clinical trials, including designating the level of priority, incorporating these measures into a combined or composite endpoint, and dealing with issues related to compliance and interpretation of results accounting for missing data. This article describes the results of a recent panel discussion that attempted to address these issues and provide guidance to the incorporation of COAs into clinical trials, including novel statistical designs, so that the testing of new treatments in patients with cancers of the central nervous system can incorporate these important clinical endpoints. PMID:26989129

  15. Reporting outcomes of back pain trials: A modified Delphi study

    DEFF Research Database (Denmark)

    Froud, Robert; Eldridge, Sandra; Kovacs, Francisco;

    2011-01-01

    trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi......BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain...... process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement. RESULTS: A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes...

  16. Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes.

    Science.gov (United States)

    Miller, Justin B; Banks, Sarah J; Léger, Gabriel C; Cummings, Jeffrey L

    2014-01-01

    Progress has been made in understanding the genetics and molecular biology of frontotemporal dementia (FTD). Targets for intervention have been identified, therapies are being developed, and clinical trials are advancing. A major challenge for FTD research is that multiple underlying pathologies can be associated with heterogeneous phenotypes. The neuropsychological profiles associated with FTD spectrum disorders often include executive dysfunction, language impairments and behavioral disturbance. Behavioral variant FTD is characterized by an initial presentation of changes in personality, behavior and/or emotion, which are often difficult to objectively capture using traditional neuropsychological measures. The two principal language variants of FTD are Progressive Nonfluent Aphasia (PNFA) with predominant agrammatic/non-fluent impairments and Semantic Dementia (SD) with semantic impairments and visual agnosia. Selection of appropriate endpoints for clinical trials is critical to ensure that the measures are adequately sensitive to detect change, yet specific enough to isolate signal from noise, and acceptable to regulatory agencies. Given the anticipated potential for small effect sizes, measures must be able to identify small incremental changes over time. It is also imperative that the measures provide adequate coverage of the constructs or behaviors of interest. Selected outcome measures should be suitable for repeat administration, yet relatively robust to practice effects to ensure that observed changes reflect true signal variance and not residual effects due to repeated measurement or poor reliability. To facilitate widespread adoption as an endpoint, measures should be readily accessible. We provide several examples of potential global, composite, and individual cognitive measures, as well as behavioral measures promising for FTD trials. Development and application of appropriate trial outcomes is critically important to success in advancing new

  17. Cardiac tumors in a tertiary care cancer hospital: clinical features, echocardiographic findings, treatment and outcomes

    Directory of Open Access Journals (Sweden)

    Joseph Swafford

    2012-02-01

    Full Text Available Cardiac tumors are a rare entity, comprised of tumors with diverse histology and natural history. We report the clinical characteristics, echocardiograhic findings, therapy and outcome of 59 patients with primary and metastatic cardiac tumors. Our institutional echocardiogram data base from 1993 through 2005 was reviewed to identify patients diagnosed with intra-cardiac tumor. A total of 59 patients with cardiac tumors were identified and included in the study. The patient’s characteristics, presenting symptoms, diagnostic tests, location, histology of the tumor, treatment and one year survival rate of this population was collected from the medical records. Of the 59 cardiac tumor cases, 16 (27% were primary cardiac tumors and 43 (73% were secondary cardiac tumors. The most common primary tumor was sarcoma affecting 13 (81% of the 16 cases. Of these, 5 patients were angiosarcoma, 5 unclassified sarcoma, one myxoid sarcoma and 2 maignant fibrous histiocytoma. The mean age at presentation was 41.1 years, and the most common location was right atrium affecting 6 cases (37.5%. The most common symptom of dyspnea was present in 10 (62.5% cases. Eleven (25.6% of the 43 secondary cardiac tumors were metastasis from renal cell carcinoma. The mean age at presentation was 55.4 years. Right atrium was the most frequent location affecting 18 (42% of the 43 patients. The most common presenting symptom was dyspnea in 15 (35% cases. For both primary and secondary tumors, dyspnea was the most common symptom and right atrium was most frequently involved. Sarcoma was the most common primary cardiac tumor while metastasis from renal cell carcinoma was the most common secondary tumor.

  18. Cardiac magnetic resonance imaging parameters as surrogate endpoints in clinical trials of acute myocardial infarction

    Directory of Open Access Journals (Sweden)

    Gutberlet Matthias

    2011-09-01

    Full Text Available Abstract Cardiac magnetic resonance (CMR offers a variety of parameters potentially suited as surrogate endpoints in clinical trials of acute myocardial infarction such as infarct size, myocardial salvage, microvascular obstruction or left ventricular volumes and ejection fraction. The present article reviews each of these parameters with regard to the pathophysiological basis, practical aspects, validity, reliability and its relative value (strengths and limitations as compared to competitive modalities. Randomized controlled trials of acute myocardial infarction which have used CMR parameters as a primary endpoint are presented.

  19. Cardiac magnetic resonance imaging parameters as surrogate endpoints in clinical trials of acute myocardial infarction

    OpenAIRE

    Gutberlet Matthias; Lurz Philipp; Fuernau Georg; de Waha Suzanne; Eitel Ingo; Desch Steffen; Schuler Gerhard; Thiele Holger

    2011-01-01

    Abstract Cardiac magnetic resonance (CMR) offers a variety of parameters potentially suited as surrogate endpoints in clinical trials of acute myocardial infarction such as infarct size, myocardial salvage, microvascular obstruction or left ventricular volumes and ejection fraction. The present article reviews each of these parameters with regard to the pathophysiological basis, practical aspects, validity, reliability and its relative value (strengths and limitations) as compared to competit...

  20. Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial

    Directory of Open Access Journals (Sweden)

    Russell Stuart J

    2012-02-01

    Full Text Available Abstract Background Heart failure patients with stable angina, acute coronary syndromes and valvular heart disease may benefit from revascularisation and/or valve surgery. However, the mortality rate is increased- 5-30%. Biventricular pacing using temporary epicardial wires after surgery is a potential mechanism to improve cardiac function and clinical endpoints. Method/design A multi-centred, prospective, randomised, single-blinded, intervention-control trial of temporary biventricular pacing versus standard pacing. Patients with ischaemic cardiomyopathy, valvular heart disease or both, an ejection fraction ≤ 35% and a conventional indication for cardiac surgery will be recruited from 2 cardiac centres. Baseline investigations will include: an electrocardiogram to confirm sinus rhythm and measure QRS duration; echocardiogram to evaluate left ventricular function and markers of mechanical dyssynchrony; dobutamine echocardiogram for viability and blood tests for renal function and biomarkers of myocardial injury- troponin T and brain naturetic peptide. Blood tests will be repeated at 18, 48 and 72 hours. The principal exclusions will be subjects with permanent atrial arrhythmias, permanent pacemakers, infective endocarditis or end-stage renal disease. After surgery, temporary pacing wires will be attached to the postero-lateral wall of the left ventricle, the right atrium and right ventricle and connected to a triple chamber temporary pacemaker. Subjects will be randomised to receive either temporary biventricular pacing or standard pacing (atrial inhibited pacing or atrial-synchronous right ventricular pacing for 48 hours. The primary endpoint will be the duration of level 3 care. In brief, this is the requirement for invasive ventilation, multi-organ support or more than one inotrope/vasoconstrictor. Haemodynamic studies will be performed at baseline, 6, 18 and 24 hours after surgery using a pulmonary arterial catheter. Measurements will be

  1. Maternal and fetal outcome in pregnant and parturient women with cardiac disease

    International Nuclear Information System (INIS)

    Objective: To study the maternal and fetal outcome in pregnant and parturient women with cardiac disease admitted in Armed Forces Institute of Cardiology Rawalpindi. Type of Study: Cross sectional descriptive study. Place and Duration: Armed Forces Institute of Cardiology Rawalpindi Jan 2008 to June 2008. Patients and Methods: All pregnant patients beyond 28 weeks gestation with cardiac disease diagnosed before pregnancy or during the index pregnancy admitted for delivery or with cardiac complications were included in the study. All neonates less than 2.5 kg were taken as low birth weight and deliveries between 28 and 37 weeks were considered preterm. Cardiac patients with pregnancy less than 28 weeks were excluded from the study. Results: Maternal mortality was 5% with 31% mortality in NYHA Class III and IV. Perinatal mortality was 9% and low birth weight babies were 17%.Perinatal mortality was 0% in NYHA Class I and II and 60% in NYHA class III and IV. There was no maternal mortality in booked patients. All patients who expired were unbooked. Conclusion: Functional cardiac status is the most important factor affecting maternal and perinatal outcome. Antenatal booking status of the patient is the next important factor. (author)

  2. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Dahlöf, Björn; Sever, Peter S; Poulter, Neil R;

    2005-01-01

    The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics an...

  3. Pregnancy outcome in women with cardiac valve prosthesis.

    Science.gov (United States)

    Caruso, A; de Carolis, S; Ferrazzani, S; Paradisi, G; Pomini, F; Pompei, A

    1994-03-31

    Twenty-one pregnancies in 16 women who conceived after cardiac valve replacement were reviewed. Oral anticoagulants were discontinued before conception or as soon as possible for subcutaneous heparin treatment (8000-14,000 IU every 8-12 h) and resumed in the second trimester until the last period of pregnancy when oral anticoagulants were replaced again by heparin. No therapeutic abortion was performed. The spontaneous abortion rate was found to be 14.3% (3/21). Preterm delivery (< or = 37 weeks) and low birth weight babies (< 2500 g) were 29.4% (5/17) and 35.3% (6/17), respectively, significantly more frequent than those of the control group (P < 0.02 and P < 0.0005). No significant statistical difference was found when the rate of spontaneous abortion [14.3% (3/21)] and the rate of fetal growth retardation [11.8% (2/17)] were compared with the control group. The majority of thromboembolic events (6/7) occurred during heparin regimen in three mothers; one of them subsequently died. No coumarin embryopathy was observed and the physical and mental development in the 16 surviving children was good. This study confirms: (1) the increased rate of preterm delivery and infants weighing < 2500 g; (2) the increased risk of maternal thrombosis related to heparin use; and (3) the good follow-up in the surviving children. PMID:8045335

  4. Outcome Measures for Clinical Trials in Interstitial Lung Diseases

    Science.gov (United States)

    Lammi, Matthew R.; Baughman, Robert P.; Birring, Surinder S.; Russell, Anne-Marie; Ryu, Jay H.; Scholand, Marybeth; Distler, Oliver; LeSage, Daphne; Sarver, Catherine; Antoniou, Katerina; Highland, Kristin B.; Kowal-Bielecka, Otylia; Lasky, Joseph A.; Wells, Athol U.; Saketkoo, Lesley Ann

    2015-01-01

    The chronic fibrosing idiopathic interstitial pneumonias (IIPs) are a group of heterogeneous pulmonary parenchymal disorders described by radiologic and histological patterns termed usual interstitial pneumonia (UIP) and non-specific interstitial pneumonia (NSIP). These include idiopathic pulmonary fibrosis (IPF) and those related to connective tissue disease (CTD) and are associated with substantial morbidity and mortality. Beyond the importance of establishing an appropriate diagnosis, designing optimal clinical trials for IIPs has been fraught with difficulties in consistency of clinical endpoints making power analyses, and the establishment of efficacy and interpretation of results across trials challenging. Preliminary recommendations, developed by rigorous consensus methods, proposed a minimum set of outcome measures, a ‘core set’, to be incorporated into future clinical trials (Saketkoo et al, THORAX. 2014.). This paper sets out to examine the candidate instruments for each domain (Dyspnea, Cough, Health Related Quality of Life, Imaging, Lung Physiology and Function, Mortality). Candidate measures that were not selected as well as measures that were not available for examination at the time of the consensus process will also be discussed. PMID:27019654

  5. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’

    OpenAIRE

    Prinsen, Cecilia A C; Vohra, Sunita; Rose, Michael R.; King-Jones, Susanne; Ishaque, Sana; Bhaloo, Zafira; Adams, Denise; Terwee, Caroline B

    2014-01-01

    Background The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of ‘core outcome sets’ (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS...

  6. Temporal Influence of Heart Failure Hospitalizations Prior to Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy With Defibrillator on Subsequent Outcome in Mild Heart Failure Patients (from MADIT-CRT)

    DEFF Research Database (Denmark)

    Lee, Andy Y; Moss, Arthur J; Ruwald, Martin H;

    2015-01-01

    effects on subsequent outcomes and benefit from cardiac resynchronization therapy with a defibrillator (CRT-D). Multivariate Cox models were used to determine the temporal influence of previous HF hospitalization on the end point of HF or death within all left bundle branch block implantable cardioverter-defibrillator...... (ICD) and CRT-D patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT) trial (n = 1,250) and to evaluate the clinical benefit of CRT-D implantation, comparing CRT-D patients with ICD patients within each previous HF hospitalization...

  7. Congestive Cardiac Failure among Nigerian Children; Pattern and Outcome

    Directory of Open Access Journals (Sweden)

    Adeola Animasahun

    2015-09-01

    Full Text Available Background: Congestive Cardiac Failure (CCF is an important cause of morbidity and mortality among children. It results from various causes, but there are only very few reports from the African sub-region. Objectives: This study aimed to define the current trends in the prevalence and causes of CCF among children admitted to the Pediatrics Department of the Lagos State University Teaching Hospital (LASUTH. Patients and Methods;: This prospective study was conducted on all the consecutive patients admitted with diagnosis of CCF between January 2011 and December 2012. The data were analyzed using Microsoft Excel. Mean, median, and standard deviation were calculated as necessary. Continuous and discrete data were analyzed using student t-test and chi-square test, respectively. P < 0.05 was considered as statistically significant. Results: Out of the 5705 children admitted to the Department of Pediatrics of LASUTH, 156 ones (2.73% had CCF. The subjects’ age ranged from 48 hours to 144 months, with the mean age of 37.1 ± 31.94 months. The common causes of CCF were Acute Lower Respiratory Tract Infections (ALRTI (32.0%, Congenital Heart Diseases (CHD (31.4%, and severe anemia (28.8%. Other less common causes were septicaemia (3.84%, acquired heart diseases (3.2%, and renal disorders (0.6%. The rate of mortality was 17.3%, and more than 90% of the deaths occurred within 48 hours of admission. Conclusions: CCF remains a major cause of morbidity and mortality in Pediatric practice in Nigeria, with ALRTI, CHD, and severe anemia being the common causes.

  8. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Sever, Peter S; Dahlöf, Björn; Poulter, Neil R; Wedel, Hans; Beevers, Gareth; Caulfield, Mark; Collins, Rory; Kjeldsen, Sverre E; Kristinsson, Arni; McInnes, Gordon T; Mehlsen, Jesper; Nieminen, Markku; O'Brien, Eoin; Ostergren, Jan

    2003-01-01

    The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study, however, has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (CHD) in hypertensive patients who are not conventionally deemed ...

  9. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Sever, Peter S; Dahlöf, Björn; Poulter, Neil R; Wedel, Hans; Beevers, Gareth; Caulfield, Mark; Collins, Rory; Kjeldsen, Sverre E; Kristinsson, Arni; McInnes, Gordon T; Mehlsen, Jesper; Nieminen, Markku; O'Brien, Eoin; Ostergren, Jan

    The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study, however, has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (CHD) in hypertensive patients who are not conventionally deemed ...

  10. A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomised controlled trial

    OpenAIRE

    Guo, Ping

    2012-01-01

    Background: Patients awaiting cardiac surgery typically experience physical and psychological stress. Although there is evidence that preoperative education can improve postoperative outcomes among general surgical patients, less is known about preoperative education for patients undergoing cardiac surgery, particularly in the context of healthcare delivered in China. Aim: The aim of this study was to evaluate whether a preoperative education intervention designed for Chinese cardiac pat...

  11. Cardiac Risk Assessment, Morbidity Prediction, and Outcome in the Vascular Intensive Care Unit.

    LENUS (Irish Health Repository)

    Dover, Mary

    2013-09-17

    Objectives: The aim of this study is to examine the predictive value of the Lee revised cardiac risk index (RCRI) for a standard vascular intensive care unit (ICU) population as well as assessing the utility of transthoracic echocardiography and the impact of prior coronary artery disease (CAD) and coronary revascularization on patient outcome. Design: This is a retrospective review of prospectively maintained Vascubase and prospectively collected ICU data. Materials and Methods: Data from 363 consecutive vascular ICU admissions were collected. Findings were used to calculate the RCRI, which was then correlated with patient outcomes. All patients were on optimal medical therapy (OMT) in the form of cardioselective β-blocker, aspirin, statin, and folic acid. Results: There was no relationship found between a reduced ejection fraction and patient outcome. Mortality was significantly increased for patients with left ventricular hypertrophy (LVH) as identified on echo (14.9% vs 6.5%, P = .028). The overall complication rates were significantly elevated for patients with valvular dysfunction. Discrimination for the RCRI on receiver-operating characteristic analysis was poor, with an area under the receiver-operating characteristic curve of .621. Model calibration was reasonable with an Hosmer-Lemeshow Ĉ statistic of 2.726 (P = .256). Of those with known CAD, 41.22% of the patients receiving best medical treatment developed acute myocardial infarction (AMI) compared to 35.3% of those who previously underwent percutaneous cardiac intervention and 23.5% of those who had undergone coronary artery bypass grafting. There was 3-fold increase in major adverse clinical events in patients with troponin rise and LVH. Conclusions: The RCRI\\'s discriminatory capacity is low, and this raises difficulties in assessing cardiac risk in patients undergoing vascular intervention. The AMI is highest in the OMT group without prior cardiac intervention, which mandates protocols to

  12. Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery

    DEFF Research Database (Denmark)

    Vedel, Anne G; Holmgaard, Frederik; Rasmussen, Lars Simon;

    2016-01-01

    coronary vessel and/or valve disease and who are undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients are stratified by age and surgical procedure and are randomised 1:1 to either an increased mean arterial pressure (70-80 mmHg) or 'usual practice' (40-50 mmHg) during cardiopulmonary...... caused by emboli, but inadequate blood flow caused by other mechanisms may increase ischaemia in the penumbra or cause watershed infarcts. During cardiopulmonary bypass, blood pressure can be below the lower limit of cerebral autoregulation. Although much debated, the constant blood flow provided by the...... cardiopulmonary bypass system is still considered by many as appropriate to avoid cerebral ischaemia despite the low blood pressure. METHODS/DESIGN: The Perfusion Pressure Cerebral Infarct trial is a single-centre superiority trial with a blinded outcome assessment. The trial is randomising 210 patients with...

  13. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review

    DEFF Research Database (Denmark)

    Cordoba Currea, Gloria Cristina; Schwartz, Lisa; Woloshin, Steven; Bae, Harold; Gøtzsche, Peter

    admission. Other major problems were change in the definition of the composite outcome between the abstract, methods, and results sections (13 trials); missing, ambiguous, or uninterpretable data (9 trials); and post hoc construction of composite outcomes (4 trials). Only 24 trials (60%) provided reliable...... also to the most important component. CONCLUSIONS: The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well...

  14. Impact of treatment with rosuvastatin and atorvastatin on cardiovascular outcomes: evidence from the Archimedes-simulated clinical trials

    Directory of Open Access Journals (Sweden)

    Colivicchi F

    2015-11-01

    Full Text Available Furio Colivicchi,1 Catarina Sternhufvud,2 Sanjay K Gandhi3 1Cardiology Division, Emergency Department, San Filippo Neri Hospital, ASL Roma E, Rome, Italy; 2Global Payer Evidence and Pricing, AstraZeneca R&D, Mölndal, Sweden; 3Global Health Economics and Outcomes Research, TEVA Pharmaceuticals, Frazer, PA, United States Objective: No clinical trials have been conducted to directly compare the effect of the two high-intensity statins, rosuvastatin and atorvastatin, on cardiovascular outcomes. However, three such trials have been computer-simulated using the Archimedes model, an individual-based simulation of human physiology and behaviors, treatment interventions, and health care systems. The results are reviewed here.Methods: The first simulated trial assessed clinical outcomes in patients receiving available doses of the two drugs. The second assessed the impact of initial treatment decisions, while the third assessed the effect of switching from rosuvastatin to atorvastatin.Results: In the first simulated trial, treatment with rosuvastatin was estimated to result in greater reductions than treatment with atorvastatin in major adverse cardiac event (MACE rates at 5 years and 20 years at all doses examined (relative risk [RR]: 0.897, 0.888, and 0.930 at 5 years for rosuvastatin 20 mg vs atorvastatin 40 mg, rosuvastatin 40 mg vs atorvastatin 80 mg, and rosuvastatin 20 mg vs atorvastatin 80 mg, respectively; all P<0.05. In the second simulated trial, outcomes were significantly better in patients initially prescribed rosuvastatin than in those initially prescribed atorvastatin (RR of MACE at 5 years: 0.918; P<0.001. In the third simulated trial, risk of MACE was significantly greater in patients switching from rosuvastatin to atorvastatin than in those remaining on rosuvastatin (RR at 5 years: 1.109; P<0.001.Conclusion: The results of these simulated clinical trials suggest improved outcomes among patients receiving rosuvastatin relative to

  15. Three-Year Outcomes After Revascularization With Everolimus- and Sirolimus-Eluting Stents From the SORT OUT IV Trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Maeng, Michael;

    2014-01-01

    OBJECTIVES: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. BACKGROUND: In the SORT OUT IV (SORT OUT IV Trial), comparing the EES...... with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES. METHODS: We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years...... was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis). RESULTS: At 3 years, the composite endpoint MACE...

  16. A Randomized Controlled Trial of Patient-Reported Outcomes With Tai Chi Exercise in Parkinson's Disease

    OpenAIRE

    Li, Fuzhong; Harmer, Peter; Liu, Yu; Eckstrom, Elizabeth; Fitzgerald, Kathleen; Stock, Ronald; Chou, Li-Shan

    2013-01-01

    A previous randomized, controlled trial of tai chi showed improvements in objectively measured balance and other motor-related outcomes in patients with Parkinson's disease. This study evaluated whether patient-reported outcomes could be improved through exercise interventions and whether improvements were associated with clinical outcomes and exercise adherence. In a secondary analysis of the tai chi trial, patient-reported and clinical outcomes and exercise adherence measures were compared ...

  17. Outcome after resuscitation beyond 30 minutes in drowned children with cardiac arrest and hypothermia : Dutch nationwide retrospective cohort study

    NARCIS (Netherlands)

    Kieboom, J. K.; Verkade, H. J.; Burgerhof, J. G.; Bierens, J. J.; van Rheenen, P. F.; Kneyber, M. C.; Albers, M. J.

    2015-01-01

    OBJECTIVES To evaluate the outcome of drowned children with cardiac arrest and hypothermia, and to determine distinct criteria for termination of cardiopulmonary resuscitation in drowned children with hypothermia and absence of spontaneous circulation. DESIGN Nationwide retrospective cohort study. S

  18. Intermittent claudication as a predictor of outcome in patients with ischaemic systolic heart failure : analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure trial (CORONA)

    NARCIS (Netherlands)

    Inglis, Sally C.; McMurray, John J. V.; Boehm, Michael; Schaufelberger, Maria; van Veldhuisen, Dirk J.; Lindberg, Magnus; Dunselman, Peter; Hjalmarson, Ake; Kjekshus, John; Waagstein, Finn; Wedel, Hans; Wikstrand, John

    2010-01-01

    To examine the relationship between baseline intermittent claudication and outcomes in patients enrolled in the Controlled Rosuvastatin Multinational Trial in Heart Failure trial (CORONA). Intermittent claudication is an independent predictor of worse outcome in coronary heart disease, but its progn

  19. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis

    DEFF Research Database (Denmark)

    Heiligenhaus, Arnd; Foeldvari, Ivan; Edelsten, Clive;

    2012-01-01

    To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis.......To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis....

  20. Sources of Bias in Outcome Assessment in Randomised Controlled Trials: A Case Study

    Science.gov (United States)

    Ainsworth, Hannah; Hewitt, Catherine E.; Higgins, Steve; Wiggins, Andy; Torgerson, David J.; Torgerson, Carole J.

    2015-01-01

    Randomised controlled trials (RCTs) can be at risk of bias. Using data from a RCT, we considered the impact of post-randomisation bias. We compared the trial primary outcome, which was administered blindly, with the secondary outcome, which was not administered blindly. From 44 schools, 522 children were randomised to receive a one-to-one maths…

  1. Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study

    DEFF Research Database (Denmark)

    La Cour, Jeppe Lerche; Brok, Jesper; Gøtzsche, Peter C

    2010-01-01

    To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity.......To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity....

  2. Non-invasive cardiac assessment in high risk patients (The GROUND study: rationale, objectives and design of a multi-center randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Moll Frans L

    2008-08-01

    calculations about 1200 patients are needed to detect a 24% reduction in primary outcome. Implications The GROUND study will provide insight into the question whether non-invasive cardiac imaging reduces the risk of cardiovascular events in patients with peripheral arterial disease, but without symptoms of coronary artery disease. Trial registration Clinicaltrials.gov NCT00189111

  3. Cardiac phantom measurement validating the methodology for a cardiac multi-centre trial with positron emission tomography

    Energy Technology Data Exchange (ETDEWEB)

    Nuyts, Johan; Mortelmans, Luc; Maes, Alex [Nuclear Medicine, UZ Gasthuisberg, K.U. Leuven, Herestraat 49, 3000 Leuven (Belgium); Van de Werf, Frans [Cardiology, UZ Gasthuisberg, K.U. Leuven, Leuven (Belgium); Djian, Jacques [Wyeth Research, Paris la Defense Cedex (France); Sambuceti, Gianmario [Instituto di Fisiologia Clinica CNR, Pisa (Italy); Schwaiger, Marcus [Nuklearmedizinische Klinik und Poliklinik, TU Muenchen, Muenchen (Germany); Touboul, Paul [Hopital Cardio-Vasculaire et Pneumologique, Lyon (France)

    2002-12-01

    In an ongoing international multi-centre trial, positron emission tomography (PET) is being used to evaluate the effect of a new P-selectin antagonist on the infarct size in patients with acute myocardial infarction, treated with thrombolysis. Although it is possible to correct for site-dependent factors, it is desirable to reduce these factors to a minimum. Therefore, acquisition and reconstruction protocols have been defined that can be closely followed by all participating centres. The resulting reconstructed images are transferred to the core centre for central processing with semi-automatic software. This paper reports on the multi-centre phantom experiment that was carried out to assess the inter-centre reproducibility of defect size determination with this protocol. Also, the spatial resolution of the short axis slices was examined. In addition, the analysis procedure was applied to normal PET studies to evaluate the specificity of perfusion defect detection. The transmural cold defect in the phantom occupied 14.8% of the left ventricular area. The automated analysis was applied to the phantom measurements from the 14 participating PET cameras. It yielded an accurate estimate of 15.1% with a standard deviation of 0.6%, indicating excellent reproducibility. The spatial resolution in the short axis slices was similar for all PET systems: 9.6{+-}0.8 mm. The same procedure produced a defect size of zero in the studies of normal volunteers. This study indicates that cardiac studies from multiple PET systems can be pooled for statistical analysis. (orig.)

  4. Perioperative Landiolol Administration reduces Atrial Fibrillation after Cardiac Surgery: A Meta-analysis of Randomized Controlled Trials

    OpenAIRE

    Sakamoto, Atsuhiro; Hamasaki, Toshimitsu; Kitakaze, Masafumi

    2014-01-01

    Introduction Postoperative atrial fibrillation (POAF) is one of the most common complications after cardiac surgery. Patients who develop POAF have a prolonged stay in the intensive care unit and hospital and an increased risk of postoperative stroke. Many guidelines for the management of cardiac surgery patients, therefore, recommend perioperative administration of beta-blockers to prevent and treat POAF. Landiolol is an ultra-short acting beta-blocker, and some randomized controlled trials ...

  5. Effect of Rosa aromatherapy on anxiety before cardiac catheterization: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Atye Babaii

    2015-09-01

    Full Text Available Background and Objectives: Most patients experience moderate to severe anxiety before cardiac catheterization. This study aimed to investigate the effect of Rosa aromatherapy on anxiety before cardiac catheterization. Methods: In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa aromatherapy for eighteen minutes. The level of anxiety was measured immediately before, and after the treatment. Results: In the stages before and after the study, there were no significant differences between the two groups in the terms of the mean scores of state and total anxiety. However, the mean score of trait anxiety in the experimental group was significantly lower than the control group. Furthermore, there was no significant difference between pre- and post-treatment in both groups. Conclusion: Most of the patients experience moderate to severe anxiety before cardiac catheterization. The findings of this study demonstrate that aromatherapy, as administered in this study, is not beneficial.

  6. Predicting the outcomes for out-of-hospital cardiac arrest patients using multiple biomarkers and suspension microarray assays

    Science.gov (United States)

    Huang, Chien-Hua; Tsai, Min-Shan; Chien, Kuo-Liong; Chang, Wei-Tien; Wang, Tzung-Dau; Chen, Shyr-Chyr; Ma, Matthew Huei-Ming; Hsu, Hsin-Yun; Chen, Wen-Jone

    2016-01-01

    Predicting the prognosis for cardiac arrest is still challenging. Combining biomarkers from diverse pathophysiological pathways may provide reliable indicators for the severity of injury and predictors of long-term outcomes. We investigated the feasibility of using a multimarker strategy with key independent biomarkers to improve the prediction of outcomes in cardiac arrest. Adult out-of-hospital cardiac arrest patients with sustained return of spontaneous circulation were prospectively enrolled in this study. Blood samples were taken at 2 and 24 hours after cardiac arrest. Suspension microarray assays were used to test 21 different biomarkers. A total of 99 patients were enrolled, 45 of whom survived to hospital discharge. We identified 11 biomarkers that, when combined with clinical variables and factors of APACHE II score and history of arrhythmia, were independent determinants for outcome of in-hospital mortality (concordance = 0.9249, standard error = 0.0779). Three biomarkers combined with APACHE II and age were independent determinants for favorable neurological outcome at hospital discharge (area under the receiver-operator characteristic curve, 0.938; 95% confidence interval, 0.854 ~ 1.0). In conclusion, a systemic multiple biomarker approach using suspension microarray assays can identify independent predictors and model the outcomes of cardiac arrest patients during the post-cardiac arrest period. PMID:27256246

  7. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    Science.gov (United States)

    Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Methods and analysis 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. Trial registration number ChiCTR-IOR-15006971. PMID:27334883

  8. The utility of magnetic resonance imaging in cardiac tissue regeneration trials.

    Science.gov (United States)

    Fuster, Valentin; Sanz, Javier; Viles-Gonzalez, Juan F; Rajagopalan, Sanjay

    2006-03-01

    The past decade has seen the emergence of paradigm shifts in concepts involving cardiovascular tissue regeneration, including the idea that adult stem cells originate in hematopoietic or bone marrow cells, the belief that even adult organs, such as the heart and nervous system, are capable of post-mitotic regeneration, and the concept of inherent plasticity in cells that have undergone limited lineage differentiation. There has consequently been a flurry of proposed regenerative strategies, and safety and limited efficacy data from both animal and limited human trials have been presented. The drive to push these advances from the bench to the bedside has created a unique environment where the therapeutic agents, delivery approaches, and methods of measuring efficacy (often imaging technology) are evolving practically in parallel. The encouraging results of recent cell-therapy trials should therefore be assessed cautiously and in consonance with an understanding of the advantages and limitations of delivery strategies and end points. Arguably, the use of imaging technologies to evaluate surrogate end points might help overcome the difficulty posed by large sample sizes required for hard end point trials in cardiovascular therapeutics. Cardiac magnetic resonance imaging is one of the most sensitive techniques available to assess spatial and temporal changes following local or systemic therapies, and the availability of a bevy of complementary techniques enables interrogation of physiology, morphology, and metabolism in one setting. We contend that cardiac magnetic resonance imaging is ideally suited to assess response to myocardial regeneration therapy and can be exploited to yield valuable insights into the mechanism of action of myocardial regeneration therapies. PMID:16501625

  9. Cardiac troponin I elevation and overall survival among cancer patients receiving investigational compounds during phase I trials

    OpenAIRE

    Hollebecque, Antoine; Lanoy, Emilie; Troallen, Frederic; Soulat-Dufour, Laurie; Massard, Christophe; Bahleda, Rastislav; VARGA, Andrea; Gazzah, Anas; Postel-Vinay, Sophie; Ribrag, Vincent; Deutsch, Eric; Angevin, Eric; Boccara, Franck; Cohen, Ariel; Soria, Jean-Charles

    2016-01-01

    Objective : To identify factors associated with troponin elevation and to measure the effect of elevated troponin on survival in cancer patients participating in phase I trials.Methods : Clinical characteristics, cardiovascular risk factors, and biological data from consecutive patients treated in phase I trials (January 2010–November 2012) were reviewed. Troponin value was measured for each patient before study-drug administration and then weekly. Cardiac troponin I was considered elevated i...

  10. Variation in outcomes in trials reporting effects of diet and lifestyle based intervention on pregnancy outcomes: a systematic review.

    Science.gov (United States)

    Rogozinska, E; Fen, Y; Molyneaux, E; Khan, K S; Thangaratinam, S

    2014-07-01

    Obesity is a growing threat to women of childbearing age. Increased maternal weight or excessive weight gain in pregnancy is associated with adverse pregnancy outcomes. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on a number of clinical outcomes. There is no consensus amongst the trialists on the core outcomes that need to be reported to inform the clinical care of pregnant women. The aim of this systematic review is to evaluate variation in the type and quality of outcomes reported in systematic reviews and randomised controlled trials on diet and lifestyle interventions on maternal and fetal outcomes. We will assess the correlation between the type of outcome, the quality of the studies and journal impact factor. We searched the major databases from the inception to October 2013 without language restrictions. We used current recommendations for quality of outcome reporting using a 6-point scale. The quality assessment of systematic reviews and RCTs was performed using the AMSTAR and Jadad scoring systems. Additionally we obtained journals' impact factor in the year of publication. We calculated Spearman rank coefficient to assess the correlation between the type of outcome, and study quality. An overview of outcome reporting will show the current attitude of the researchers towards outcomes of importance when conducting trials on diet and lifestyle management in pregnancy. If our abstract is accepted, we will provide the details of the results. PMID:26104628

  11. A Systematic Review of Studies That Aim to Determine Which Outcomes to Measure in Clinical Trials in Children

    OpenAIRE

    Sinha, Ian; Jones, Leanne; Smyth, Rosalind L; Williamson, Paula R

    2008-01-01

    Background In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children. Methods and Findings We searche...

  12. Diffuse myocardial fibrosis evaluation using cardiac magnetic resonance T1 mapping: sample size considerations for clinical trials

    Directory of Open Access Journals (Sweden)

    Liu Songtao

    2012-12-01

    Full Text Available Abstract Background Cardiac magnetic resonance (CMR T1 mapping has been used to characterize myocardial diffuse fibrosis. The aim of this study is to determine the reproducibility and sample size of CMR fibrosis measurements that would be applicable in clinical trials. Methods A modified Look-Locker with inversion recovery (MOLLI sequence was used to determine myocardial T1 values pre-, and 12 and 25min post-administration of a gadolinium-based contrast agent at 3 Tesla. For 24 healthy subjects (8 men; 29 ± 6 years, two separate scans were obtained a with a bolus of 0.15mmol/kg of gadopentate dimeglumine and b 0.1mmol/kg of gadobenate dimeglumine, respectively, with averaged of 51 ± 34 days between two scans. Separately, 25 heart failure subjects (12 men; 63 ± 14 years, were evaluated after a bolus of 0.15mmol/kg of gadopentate dimeglumine. Myocardial partition coefficient (λ was calculated according to (ΔR1myocardium/ΔR1blood, and ECV was derived from λ by adjusting (1-hematocrit. Results Mean ECV and λ were both significantly higher in HF subjects than healthy (ECV: 0.287 ± 0.034 vs. 0.267 ± 0.028, p=0.002; λ: 0.481 ± 0.052 vs. 442 ± 0.037, p Conclusion ECV and λ quantification have a low variability across scans, and could be a viable tool for evaluating clinical trial outcome.

  13. Physical conditioning and mental stress reduction - a randomised trial in patients undergoing cardiac surgery

    Directory of Open Access Journals (Sweden)

    van der Merwe Juliana

    2011-03-01

    Full Text Available Abstract Background Preoperative anxiety and physical unfitness have been shown to have adverse effects on recovery from cardiac surgery. This study involving cardiac surgery patients was primarily aimed at assessing the feasibility of delivering physical conditioning and stress reduction programs within the public hospital setting. Secondary aims were to evaluate the effect of these programs on quality of life (QOL, rates of postoperative atrial fibrillation (AF and length of stay (LOS in hospital. Methods Elective patients scheduled for coronary artery bypass graft and/or valve surgery at a public hospital in Melbourne, Australia were enrolled. Patients were randomized to receive either holistic therapy (HT or usual care (UC. HT consisted of a series of light physical exercise sessions together with a mental stress reduction program administered in an outpatient setting for the first two weeks after placement on the waiting list for surgery. A self-administered SF-36 questionnaire was used to measure QOL and hospital records to collect data on LOS and rate of postoperative AF. Results The study population comprised 117 patients of whom 60 received HT and 57 received UC. Both programs were able to be delivered within the hospital setting but ongoing therapy beyond the two week duration of the program was not carried out due to long waiting periods and insufficient resources. HT, as delivered in this study, compared to UC did not result in significant changes in QOL, LOS or AF incidence. Conclusions Preoperative holistic therapy can be delivered in the hospital setting, although two weeks is insufficient to provide benefits beyond usual care on QOL, LOS or postoperative AF. Further research is now required to determine whether a similar program of longer duration, or targeted to high risk patients can provide measurable benefits. Trial registration This trial was conducted as part of a larger study and according to the principles contained in

  14. The effect of real-time CPR feedback and post event debriefing on patient and processes focused outcomes: A cohort study: trial protocol

    Directory of Open Access Journals (Sweden)

    Gao Fang

    2011-10-01

    Full Text Available Abstract Background Cardiac arrest affects 30-35, 000 hospitalised patients in the UK every year. For these patients to be given the best chance of survival, high quality cardiopulmonary resuscitation (CPR must be delivered, however the quality of CPR in real-life is often suboptimal. CPR feedback devices have been shown to improve CPR quality in the pre-hospital setting and post-event debriefing can improve adherence to guidelines and CPR quality. However, the evidence for use of these improvement methods in hospital remains unclear. The CPR quality improvement initiative is a prospective cohort study of the Q-CPR real-time feedback device combined with post-event debriefing in hospitalised adult patients who sustain a cardiac arrest. Methods/design The primary objective of this trial is to assess whether a CPR quality improvement initiative will improve rate of return of sustained spontaneous circulation in in-hospital-cardiac-arrest patients. The study is set in one NHS trust operating three hospital sites. Secondary objectives will evaluate: any return of spontaneous circulation; survival to hospital discharge and patient cerebral performance category at discharge; quality of CPR variables and cardiac arrest team factors. Methods: All three sites will have an initial control phase before any improvements are implemented; site 1 will implement audiovisual feedback combined with post event debriefing, site 2 will implement audiovisual feedback only and site 3 will remain as a control site to measure any changes in outcome due to any other trust-wide changes in resuscitation practice. All adult patients sustaining a cardiac arrest and receiving resuscitation from the hospital cardiac arrest team will be included. Patients will be excluded if; they have a Do-not-attempt resuscitation order written and documented in their medical records, the cardiac arrest is not attended by a resuscitation team, the arrest occurs out-of-hospital or the patient

  15. Observer bias in randomized clinical trials with time-to-event outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2014-01-01

    of trials and outcomes. We compared hazard ratios based on nonblinded and blinded assessments. A ratio of hazard ratios (RHR).... Eleven trials (1969 patients) with subjective outcomes provided hazard ratios, RHR 0.88 (0.69 to 1.12), (I2=44%, P=0.06), but unconditional pooling was problematic because of qualitative heterogeneity. Four atypical cytomegalovirus retinitis trials compared experimental oral administration with control......-treatment or active control, resulting in bias favouring the experimental intervention, RHR 0.73 (0.57 to 0.93), indicating an average exaggeration of nonblinded hazard ratios by 27% (7% to 43%). CONCLUSIONS: Lack of blinded outcome assessors in randomized trials with subjective time-to-event outcomes causes high...

  16. Clinical Outcomes and Quality of Life in Recipients of Livers Donated after Cardiac Death

    Directory of Open Access Journals (Sweden)

    Neehar D. Parikh

    2015-01-01

    Full Text Available Donation after cardiac death (DCD has expanded in the last decade in the US; however, DCD liver utilization has flattened in recent years due to poor outcomes. We examined clinical and quality of life (QOL outcomes of DCD recipients by conducting a retrospective and cross-sectional review of patients from 2003 to 2010. We compared clinical outcomes of DCD recipients (n=60 to those of donation after brain death (DBD liver recipients (n=669 during the same time period. DCD recipients had significantly lower rates of 5-year graft survival (P<0.001 and a trend toward lower rates of 5-year patient survival (P=0.064 when compared to the DBD cohort. In order to examine QOL outcomes in our cohorts, we administered the Short Form Liver Disease Quality of Life questionnaire to 30 DCD and 60 DBD recipients. The DCD recipients reported lower generic and liver-specific QOL. We further stratified the DCD cohort by the presence of ischemic cholangiopathy (IC. Patients with IC reported lower QOL when compared to DBD recipients and those DCD recipients without IC (P<0.05. While the results are consistent with clinical experience, this is the first report of QOL in DCD recipients using standardized measures. These data can be used to guide future comparative effectiveness studies.

  17. 60. Mid-term outcome of cardiac resynchronization therapy in pediatrics: single institution experience

    Directory of Open Access Journals (Sweden)

    T. Jawadi

    2016-07-01

    Full Text Available Cardiac resynchronization therapy (CRT has become an increasingly important therapeutic option for patients (pts to treat dyssynchrony associated moderate and severe heart failure. Few reports however, determined the beneficial effects of CRT in pediatrics and midterm outcome following this therapy. Our aim is to assess the mid-term outcomes of CRT in children with evidence of dyssynchrony associated heart failure. Cardiac resynchronization therapy is beneficial in treating congenital heart disease patients who have evidence of dyssynchrony associated heart failure. Retrospective review of 18 consecutive pediatric patients who underwent CRT at our institution between January 2002 and August 2011 Cardiac resynchronization pacemaker was implanted in 18 pts the majority of pts (14 with congenital heart disease. Fourteen pts had preexisting complete heart block and chronic right ventricular pacing. Epicardial left ventricular leads were implanted in all pts while the atrial and right ventricular leads approach varied according to the pt size and anatomy. Indication for CRT was symptomatic dilated cardiomyopathy with evidence of electrical and/or mechanical dyssynchrony demonstrated by M-mode, 3-D echo, or tissue Doppler. The median age of this cohort was 14 years (range 6 months–16 years, the median follow-up time was 7.2 years (range 1–10 years. Subjectively, 16 out of 18 pts reported symptomatic improvement with decreased hospitalizations. The left ventricular ejection fraction improved from mean of 27% (SD 13% to mean of 50% (SD 13% (P value <0.001. Additionally, cardiomegaly improved significantly in during follow up (P value <0.001. The QRS duration with CRT was less but the change is not significant (P value = 0.1 suggesting that electrical resynchronization is not a prerequisite for clinical improvement in this cohort. Children including those with congenital heart disease patients who have evidence of dyssynchrony associated heart

  18. Practical aspects of conducting a pragmatic randomised trial in primary care: patient recruitment and outcome assessment.

    OpenAIRE

    2000-01-01

    BACKGROUND: Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. AIM: To address the difficulties involved in patient recruitment and to present measures to minimise bias during outcome assessment. METHOD: A recently conducted trial comparing the effects of corticosteroid injections and physiotherapy for painful stiff shoulder was used to i...

  19. MicroRNA-21 and Risk of Severe Acute Kidney Injury and Poor Outcomes after Adult Cardiac Surgery

    OpenAIRE

    Juan DU; Cao, Xiaoqing; Zou, Liang; Chen, Yi; Guo, Jin; Chen, Zujun; Hu, Shengshou; Zheng, Zhe

    2013-01-01

    Background Severe acute kidney injury (AKI) after cardiac surgery is associated with poor clinical outcomes. This study evaluated the potential use of miR-21 as a risk marker for postoperative AKI progression and other poor outcomes. Methodology/Principal Findings The study included 120 adult patients undergoing cardiac surgery: 40 non-AKI controls, 39 patients with progressive AKI, and 41 with non-progressive AKI. Urine and plasma levels of miR-21 were assessed by quantitative real-time PCR ...

  20. Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM: a randomised controlled trial [ISRCTN72884263

    Directory of Open Access Journals (Sweden)

    Lane Deirdre

    2003-09-01

    Full Text Available Abstract Background Cardiac rehabilitation following myocardial infarction reduces subsequent mortality, but uptake and adherence to rehabilitation programmes remains poor, particularly among women, the elderly and ethnic minority groups. Evidence of the effectiveness of home-based cardiac rehabilitation remains limited. This trial evaluates the effectiveness and cost-effectiveness of home-based compared to hospital-based cardiac rehabilitation. Methods/design A pragmatic randomised controlled trial of home-based compared with hospital-based cardiac rehabilitation in four hospitals serving a multi-ethnic inner city population in the United Kingdom was designed. The home programme is nurse-facilitated, manual-based using the Heart Manual. The hospital programmes offer comprehensive cardiac rehabilitation in an out-patient setting. Patients We will randomise 650 adult, English or Punjabi-speaking patients of low-medium risk following myocardial infarction, coronary angioplasty or coronary artery bypass graft who have been referred for cardiac rehabilitation. Main outcome measures Serum cholesterol, smoking cessation, blood pressure, Hospital Anxiety and Depression Score, distance walked on Shuttle walk-test measured at 6, 12 and 24 months. Adherence to the programmes will be estimated using patient self-reports of activity. In-depth interviews with non-attendees and non-adherers will ascertain patient views and the acceptability of the programmes and provide insights about non-attendance and aims to generate a theory of attendance at cardiac rehabilitation. The economic analysis will measure National Health Service costs using resource inputs. Patient costs will be established from the qualitative research, in particular how they affect adherence. Discussion More data are needed on the role of home-based versus hospital-based cardiac rehabilitation for patients following myocardial infarction and revascularisation, which would be provided by the

  1. Impact of etiology on the outcomes in heart failure patients treated with cardiac resynchronization therapy: a meta-analysis.

    Directory of Open Access Journals (Sweden)

    Yanmei Chen

    Full Text Available BACKGROUND: Cardiac resynchronization therapy (CRT has been extensively demonstrated to benefit heart failure patients, but the role of underlying heart failure etiology in the outcomes was not consistently proven. This meta-analysis aimed to determine whether efficacy and effectiveness of CRT is affected by underlying heart failure etiology. METHODS AND RESULTS: Searches of MEDLINE, EMBASE and Cochrane databases were conducted to identify RCTs and observational studies that reported clinical and functional outcomes of CRT in ischemic cardiomyopathy (ICM and non-ischemic cardiomyopathy (NICM patients. Efficacy of CRT was assessed in 7 randomized controlled trials (RCTs with 7072 patients and effectiveness of CRT was evaluated in 14 observational studies with 3463 patients In the pooled analysis of RCTs, we found that CRT decreased mortality or heart failure hospitalization by 29% in ICM patients (95% confidence interval [CI], 21% to 35%, and by 28% (95% CI, 18% to 37% in NICM patients. No significant difference was observed between the 2 etiology groups (P = 0.55. In the pooled analysis of observational studies, however, we found that ICM patients had a 54% greater risk for mortality or HF hospitalization than NICM patients (relative risk: 1.54; 95% CI: 1.30-1.83; P<0.001. Both RCTs and observational studies demonstrated that NICM patients had greater echocardiographic improvements in the left ventricular ejection fraction and end-systolic volume, as compared with ICM patients (both P<0.001. CONCLUSION: CRT might reduce mortality or heart failure hospitalization in both ICM and NICM patients similarly. The improvement of the left ventricular function and remodeling is greater in NICM patients.

  2. Results and outcome reporting In ClinicalTrials.gov, what makes it happen?

    Directory of Open Access Journals (Sweden)

    Olga Kirillova

    Full Text Available BACKGROUND: At the end of the past century there were multiple concerns regarding lack of transparency in the conduct of clinical trials as well as some ethical and scientific issues affecting the trials' design and reporting. In 2000 ClinicalTrials.gov data repository was developed and deployed to serve public and scientific communities with valid data on clinical trials. Later in order to increase deposited data completeness and transparency of medical research a set of restrains had been imposed making the results deposition compulsory for multiple cases. METHODS: We investigated efficiency of the results deposition and outcome reporting as well as what factors make positive impact on providing information of interest and what makes it more difficult, whether efficiency depends on what kind of institution was a trial sponsor. Data from the ClinicalTrials.gov repository has been classified based on what kind of institution a trial sponsor was. The odds ratio was calculated for results and outcome reporting by different sponsors' class. RESULTS: As of 01/01/2012 118,602 clinical trials data deposits were made to the depository. They came from 9068 different sources. 35344 (29.8% of them are assigned as FDA regulated and 25151 (21.2% as Section 801 controlled substances. Despite multiple regulatory requirements, only about 35% of trials had clinical study results deposited, the maximum 55.56% of trials with the results, was observed for trials completed in 2008. CONCLUSIONS: The most positive impact on depositing results, the imposed restrains made for hospitals and clinics. Health care companies showed much higher efficiency than other investigated classes both in higher fraction of trials with results and in providing at least one outcome for their trials. They also more often than others deposit results when it is not strictly required, particularly, in the case of non-interventional studies.

  3. Donor Hemodynamics as a Predictor of Outcomes After Kidney Transplantation From Donors After Cardiac Death.

    Science.gov (United States)

    Allen, M B; Billig, E; Reese, P P; Shults, J; Hasz, R; West, S; Abt, P L

    2016-01-01

    Donation after cardiac death is an important source of transplantable organs, but evidence suggests donor warm ischemia contributes to inferior outcomes. Attempts to predict recipient outcome using donor hemodynamic measurements have not yielded statistically significant results. We evaluated novel measures of donor hemodynamics as predictors of delayed graft function and graft failure in a cohort of 1050 kidneys from 566 donors. Hemodynamics were described using regression line slopes, areas under the curve, and time beyond thresholds for systolic blood pressure, oxygen saturation, and shock index (heart rate divided by systolic blood pressure). A logistic generalized estimation equation model showed that area under the curve for systolic blood pressure was predictive of delayed graft function (above median: odds ratio 1.42, 95% confidence interval [CI] 1.06-1.90). Multivariable Cox regression demonstrated that slope of oxygen saturation during the first 10 minutes after extubation was associated with graft failure (below median: hazard ratio 1.30, 95% CI 1.03-1.64), with 5-year graft survival of 70.0% (95%CI 64.5%-74.8%) for donors above the median versus 61.4% (95%CI 55.5%-66.7%) for those below the median. Among older donors, increased shock index slope was associated with increased hazard of graft failure. Validation of these findings is necessary to determine the utility of characterizing donor warm ischemia to predict recipient outcome. PMID:26361242

  4. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    Science.gov (United States)

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  5. Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

    DEFF Research Database (Denmark)

    Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael;

    2013-01-01

    Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels of...

  6. Risk-taking attitudes and their association with process and outcomes of cardiac care: a cohort study

    Directory of Open Access Journals (Sweden)

    Knudtson Merril L

    2009-08-01

    Full Text Available Abstract Background Prior research reveals that processes and outcomes of cardiac care differ across sociodemographic strata. One potential contributing factor to such differences is the personality traits of individuals within these strata. We examined the association between risk-taking attitudes and cardiac patients' clinical and demographic characteristics, the likelihood of undergoing invasive cardiac procedures and survival. Methods We studied a large inception cohort of patients who underwent cardiac catheterization between July 1998 and December 2001. Detailed clinical and demographic data were collected at time of cardiac catheterization and through a mailed survey one year post-catheterization. The survey included three general risk attitude items from the Jackson Personality Inventory. Patients' (n = 6294 attitudes toward risk were categorized as risk-prone versus non-risk-prone and were assessed for associations with baseline clinical and demographic characteristics, treatment received (i.e., medical therapy, coronary artery bypass graft (CABG surgery, percutaneous coronary intervention (PCI, and survival (to December 2005. Results 2827 patients (45% were categorized as risk-prone. Having risk-prone attitudes was associated with younger age (p Conclusion These exploratory findings suggest that patient attitudes toward risk taking may contribute to some of the documented differences in use of invasive cardiac procedures. An awareness of these associations could help healthcare providers as they counsel patients regarding cardiac care decisions.

  7. The cardiac troponins: uses in routine clinical practice. Experiences from GUSTO and other clinical trials.

    Science.gov (United States)

    Stubbs, P

    1998-11-01

    Recent advances in pharmacological and mechanical approaches to acute coronary syndromes have led to rapid changes in the management of patients admitted with acute coronary syndromes. These changes have been mirrored by the appearance of newer highly specific biochemical markers of myocardial damage particularly the cardiac troponins. When new biochemical markers become available it is the responsibility of the clinical chemist to evaluate them critically in terms of sensitivity, specificity, efficiency and analyzer precision, in the rigid setting of quality control that laboratories practise, and to compare them with other markers. When the data are shown to Clinical Cardiologists with supporting statements such as 'useful management tool' and 'can be used for early diagnosis of Myocardial Infarction', a different set of questions may need to be answered. The 'So what?' response is most frequent and is the most important hurdle that these newer biochemical markers have to overcome to convince physicians to change their current practice. This presentation will review the results of studies that have examined the potential clinical usefulness of the cardiac troponins with respect to diagnosis and risk stratification of patients admitted with suspected acute coronary syndromes. Any troponin variable that survives the 'so what' question has one further major hurdle to overcome. This is the requirement to inform physicians what different therapeutic strategies they should follow if the variable is present. Available clinical trial evidence about differing management options for patients according to their troponin status will be reviewed and outline management algorithms will be presented. Many questions remain unanswered and these will be included at the time points where they may be relevant. PMID:9857942

  8. Testing for heterogeneity among the components of a binary composite outcome in a clinical trial

    OpenAIRE

    Devereaux PJ; Thabane Lehana; Pogue Janice; Yusuf Salim

    2010-01-01

    Abstract Background Investigators designing clinical trials often use composite outcomes to overcome many statistical issues. Trialists want to maximize power to show a statistically significant treatment effect and avoid inflation of Type I error rate due to evaluation of multiple individual clinical outcomes. However, if the treatment effect is not similar among the components of this composite outcome, we are left not knowing how to interpret the treatment effect on the composite itself. G...

  9. Contaminated heparin and outcomes after cardiac surgery: a retrospective propensity-matched cohort study.

    Directory of Open Access Journals (Sweden)

    Heiko A Kaiser

    Full Text Available During 2007 and 2008 it is likely that millions of patients in the US received heparin contaminated (CH with oversulfated chondroitin sulfate, which was associated with anaphylactoid reactions. We tested the hypothesis that CH was associated with serious morbidity, mortality, intensive care unit (ICU stay and heparin-induced thrombocytopenia following adult cardiac surgery.We conducted a single center, retrospective, propensity-matched cohort study during the period of CH and the equivalent time frame in the three preceding or the two following years. Perioperative data were obtained from the institutional record of the Society of Thoracic Surgeons National Database, for which the data collection is prospective, standardized and performed by independent investigators. After matching, logistic regression was performed to evaluate the independent effect of CH on the composite adverse outcome (myocardial infarction, stroke, pneumonia, dialysis, cardiac arrest and on mortality. Cox regression was used to determine the association between CH and ICU length of stay. The 1∶5 matched groups included 220 patients potentially exposed to CH and 918 controls. There were more adverse outcomes in the exposed cohort (20.9% versus 12.0%; difference  =  8.9%; 95% CI 3.6% to 15.1%, P < 0.001 with an odds ratio for CH of 2.0 (95% CI, 1.4 to 3.0, P < 0.001. In the exposed group there was a non-significant increase in mortality (5.9% versus 3.5%, difference = 2.4%; 95% CI, -0.4 to 3.5%, P  =  0.1, the median ICU stay was longer by 14.1 hours (interquartile range -26.6 to 79.8, S = 3299, P = 0.0004 with an estimated hazard ratio for CH of 1.2 (95% CI, 1.0 to 1.4, P = 0.04. There was no difference in nadir platelet counts between cohorts.The results from this single center study suggest the possibility that contaminated heparin might have contributed to serious morbidity following cardiac surgery.

  10. Improved Outcome of Cardiac Extracorporeal Membrane Oxygenation in Infants and Children Using Magnetic Levitation Centrifugal Pumps.

    Science.gov (United States)

    Luciani, Giovanni Battista; Hoxha, Stiljan; Torre, Salvatore; Rungatscher, Alessio; Menon, Tiziano; Barozzi, Luca; Faggian, Giuseppe

    2016-01-01

    Extracorporeal membrane oxygenation (ECMO) has traditionally been and, for the most part, still is being performed using roller pumps. Use of first-generation centrifugal pumps has yielded controversial outcomes, perhaps due to mechanical properties of the same and the ensuing risk of hemolysis and renal morbidity. Latest-generation centrifugal pumps, using magnetic levitation (ML), exhibit mechanical properties which may have overcome limitations of first-generation devices. This retrospective study aimed to assess the safety and efficacy of veno-arterial (V-A) ECMO for cardiac indications in neonates, infants, and children, using standard (SP) and latest-generation ML centrifugal pumps. Between 2002 and 2014, 33 consecutive neonates, infants, and young children were supported using V-A ECMO for cardiac indications. There were 21 males and 12 females, with median age of 29 days (4 days-5 years) and a median body weight of 3.2 kg (1.9-18 kg). Indication for V-A ECMO were acute circulatory collapse in ICU or ward after cardiac repair in 16 (49%) patients, failure to wean after repair of complex congenital heart disease in 9 (27%), fulminant myocarditis in 4 (12%), preoperative sepsis in 2 (6%), and refractory tachy-arrhythmias in 2 (6%). Central cannulation was used in 27 (81%) patients and peripheral in 6. Seven (21%) patients were supported with SP and 26 (79%) with ML centrifugal pumps. Median duration of support was 82 h (range 24-672 h), with 26 (79%) patients weaned from support. Three patients required a second ECMO run but died on support. Seventeen (51%) patients required peritoneal dialysis for acute renal failure. Overall survival to discharge was 39% (13/33 patients). All patients with fulminant myocarditis and with refractory arrhythmias were weaned, and five (83%) survived, whereas no patient supported for sepsis survived. Risk factors for hospital mortality included lower (<2.5 kg) body weight (P = 0.02) and rescue ECMO after cardiac

  11. A prospective study of paediatric cardiac surgical microsystems: assessing the relationships between non-routine events, teamwork and patient outcomes

    NARCIS (Netherlands)

    Schraagen, J.M.C.; Schouten, T.; Smit, M.; Haas, F.; Beek, D. van der; Ven, J. van der; Barach, P.

    2011-01-01

    Objective: Paediatric cardiac surgery has a low error tolerance and demands high levels of cognitive and technical performance. Growing evidence suggests that further improvements in patient outcomes depend on system factors, in particular, effective team skills. The hypotheses that small intraopera

  12. Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes

    OpenAIRE

    Miller, Justin B; Banks, Sarah J; Léger, Gabriel C; Cummings, Jeffrey L.

    2014-01-01

    Progress has been made in understanding the genetics and molecular biology of frontotemporal dementia (FTD). Targets for intervention have been identified, therapies are being developed, and clinical trials are advancing. A major challenge for FTD research is that multiple underlying pathologies can be associated with heterogeneous phenotypes. The neuropsychological profiles associated with FTD spectrum disorders often include executive dysfunction, language impairments and behavioral disturb...

  13. Outcomes in a Randomised Controlled Trial of Mathematics Tutoring

    Science.gov (United States)

    Topping, K. J.; Miller, D.; Murray, P.; Henderson, S.; Fortuna, C.; Conlin, N.

    2011-01-01

    Background: Large-scale randomised controlled trials (RCT) are relatively rare in education. The present study was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers. Purpose: A two-year RCT of peer tutoring in mathematics was undertaken in one local…

  14. The use of cytosolic enzyme increase in cerebrospinal fluid of patients resuscitated after cardiac arrest. Brain Resuscitation Clinical Trial I Study Group.

    Science.gov (United States)

    Vaagenes, P; Mullie, A; Fodstad, D T; Abramson, N; Safar, P

    1994-11-01

    Levels of brain creatine phosphokinase (CPK), glutamic oxalic transaminase, lactate dehydrogenase, and lactate in lumbar cerebrospinal fluid (CSF) were analyzed as an adjunctive study in a randomized clinical trial evaluating the effects of thiopental loading intravenously in comatose survivors of cardiac arrest. Three hospitals participated and a total of 62 cases of enzyme changes were studied. Enzyme levels but not lactate were higher at 48 hours than at 24 hours after restoration of spontaneous circulation. All enzymes were highly correlated with one another at 24 and 48 hours (P < .001). There was a significant negative correlation between cerebral recovery and increased CPK levels at 24 hours (P < .05), and a highly significant correlation with all three enzyme levels at 48 hours (P < .0001). The increase of cytosolic enzyme activity in lumbar CSF reflects permanent brain damage, and there is a relationship between activity levels and cerebral outcome. PMID:7945601

  15. Efficacy and safety of landiolol for prevention of atrial fibrillation after cardiac surgery: a meta-analysis of randomized controlled trials

    OpenAIRE

    Liang LI; Ai, Qing; Lin, Ling; Ge, Pu; Yang, Changming; Zhang, Li

    2015-01-01

    Atrial fibrillation (AF) is a quite common complication during the postoperative period after cardiac surgery. Increasing studies have reported that landiolol may be effective in prevention of AF after cardiac surgery. Its efficacy and safety are seldom explored; hence we conducted a meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of landiolol in prevention of AF after cardiac surgery. Databases of PubMed, Embase and Cochrane Central Register of Contro...

  16. Telerehab III: a multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program. Rationale and study design.

    OpenAIRE

    Frederix, Ines; Hansen, Dominique; Coninx, Karin; Vandervoort, Pieter; Van Craenenbroeck, Emeline; Vrints, Christiaan; Dendale, Paul

    2015-01-01

    Background Telerehabilitation has been proposed as an adjunct/alternative to standard center-based cardiac rehabilitation. Two recent systematic reviews showed non-inferiority and/or superiority of this remote approach for cardiac rehabilitation. However, these trials focused only on one core component of cardiac rehabilitation and telemonitoring, rather than implementing a more comprehensive approach. The aim of Telerehab III is to investigate the long-term effectiveness of the addition of a...

  17. High intensity intermittent exercise improves cardiac structure and function and reduces liver fat in patients with type 2 diabetes: a randomised controlled trial

    OpenAIRE

    Cassidy, Sophie; Thoma, Christian; Hallsworth, Kate; Parikh, Jehill; Hollingsworth, Kieren G.; Taylor, Roy; Jakovljevic, Djordje G.; Trenell, Michael I

    2015-01-01

    Aims/hypothesis Cardiac disease remains the leading cause of mortality in type 2 diabetes, yet few strategies to target cardiac dysfunction have been developed. This randomised controlled trial aimed to investigate high intensity intermittent training (HIIT) as a potential therapy to improve cardiac structure and function in type 2 diabetes. The impact of HIIT on liver fat and metabolic control was also investigated. Methods Using an online random allocation sequence, 28 patients with type 2 ...

  18. Periodontal Treatment for Preventing Adverse Pregnancy Outcomes: A Meta- and Trial Sequential Analysis

    Science.gov (United States)

    Schwendicke, Falk; Karimbux, Nadeem; Allareddy, Veerasathpurush; Gluud, Christian

    2015-01-01

    Objectives Periodontal treatment might reduce adverse pregnancy outcomes. The efficacy of periodontal treatment to prevent preterm birth, low birth weight, and perinatal mortality was evaluated using meta-analysis and trial sequential analysis. Methods An existing systematic review was updated and meta-analyses performed. Risk of bias, heterogeneity, and publication bias were evaluated, and meta-regression performed. Subgroup analysis was used to compare different studies with low and high risk of bias and different populations, i.e., risk groups. Trial sequential analysis was used to assess risk of random errors. Results Thirteen randomized clinical trials evaluating 6283 pregnant women were meta-analyzed. Four and nine trials had low and high risk of bias, respectively. Overall, periodontal treatment had no significant effect on preterm birth (odds ratio [95% confidence interval] 0.79 [0.57-1.10]) or low birth weight (0.69 [0.43-1.13]). Trial sequential analysis demonstrated that futility was not reached for any of the outcomes. For populations with moderate occurrence (<20%) of preterm birth or low birth weight, periodontal treatment was not efficacious for any of the outcomes, and trial sequential analyses indicated that further trials might be futile. For populations with high occurrence (≥20%) of preterm birth and low birth weight, periodontal treatment seemed to reduce the risk of preterm birth (0.42 [0.24-0.73]) and low birth weight (0.32 [0.15-0.67]), but trial sequential analyses showed that firm evidence was not reached. Periodontal treatment did not significantly affect perinatal mortality, and firm evidence was not reached. Risk of bias, but not publication bias or patients’ age modified the effect estimates. Conclusions Providing periodontal treatment to pregnant women could potentially reduce the risks of perinatal outcomes, especially in mothers with high risks. Conclusive evidence could not be reached due to risks of bias, risks of random

  19. Protein kinase G signaling in cardiac pathophysiology: Impact of proteomics on clinical trials.

    Science.gov (United States)

    Kirk, Jonathan A; Holewinski, Ronald J; Crowgey, Erin L; Van Eyk, Jennifer E

    2016-03-01

    The protective role of cyclic guanosine monophosphate (cGMP)-stimulated protein kinase G (PKG) in the heart makes it an attractive target for therapeutic drug development to treat a variety of cardiac diseases. Phosphodiesterases degrade cGMP, thus phosphodiesterase inhibitors that can increase PKG are of translational interest and the subject of ongoing human trials. PKG signaling is complex, however, and understanding its downstream phosphorylation targets and upstream regulation are necessary steps toward safe and efficacious drug development. Proteomic technologies have paved the way for assays that allow us to peer broadly into signaling minutia, including protein quantity changes and phosphorylation events. However, there are persistent challenges to the proteomic study of PKG, such as the impact of the expression of different PKG isoforms, changes in its localization within the cell, and alterations caused by oxidative stress. PKG signaling is also dependent upon sex and potentially the genetic and epigenetic background of the individual. Thus, the rigorous application of proteomics to the field will be necessary to address how these effectors can alter PKG signaling and interfere with pharmacological interventions. This review will summarize PKG signaling, how it is being targeted clinically, and the proteomic challenges and techniques that are being used to study it. PMID:26670943

  20. Improved Exercise Tolerance and Quality of Life With Cardiac Rehabilitation of Older Patients After Myocardial Infarction: Results of a Randomized, Controlled Trial

    OpenAIRE

    Niccolo Marchionni; Francesco Fattirolli; Stefano Fumagalli; Neil Oldridge; Francesco Del Lungo; Linda Morosi; Costanza Burgisser; Giulio Masotti

    2003-01-01

    Background - Whether cardiac rehabilitation (CR) is effective in patients older than 75 years, who have been excluded from most trials, remains unclear. We enrolled patients 46 to 86 years old in a randomized trial and assessed the effects of 2 months of post-myocardial infarction (MI) CR on total work capacity (TWC, in kilograms per meter) and health-related quality of life (HRQL). Methods and Results - Of 773 screened patients, 270 without cardiac failure, dementia, disability, or contraind...

  1. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2012-01-01

    Full Text Available Aims and Objectives: To assess the effect of Comprehensive Yogic Breathing Program on glycemic control, quality of life, and cardiac autonomic functions in diabetes. Material and Methods: This is a prospective randomized controlled intervention trial. Cardiac autonomic functions were assessed in 120 diabetics. Patients were randomized into two groups, one group receiving standard therapy for diabetes (n = 56 and the other group receiving standard therapy for diabetes and comprehensive yogic breathing program (n = 64. Standard therapy included advice on diet, walk, and oral antidiabetic drugs. Comprehensive yogic breathing program was an interactive session in which Sudarshan kriya yoga, a rhythmic cyclical breathing, preceded by Pranayam was taught under guidance of a certified teacher. Change in fasting, post prandial blood sugars, glycated hemoglobin, and quality of life were assessed. Cardiac autonomic function tests were done before and six months after intervention. Results: There was significant improvement in psychological (P = 0.006 and social domains (P = 0.04 and total quality of life (P = 0.02 in the group practicing comprehensive yogic breathing program as compared to the group following standard therapy alone. In the group following breathing program, the improvement in sympathetic cardiac autonomic functions was statistically significant (P = 0.01, while the change in the standard group was not significant (P = 0.17. When both parasympathetic and sympathetic cardiac autonomic functions were considered, there was a trend toward improvement in patients following comprehensive yogic breathing program (P = 0.07. In the standard therapy group, no change in cardiac autonomic functions was noted (P = 0.76. The parameters of glycemic control were comparable in both groups. Conclusion: There was significant improvement in quality of life and cardiac autonomic functions in the diabetes patients practicing comprehensive yogic breathing

  2. Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

    Directory of Open Access Journals (Sweden)

    Norman Jane E

    2012-08-01

    Full Text Available Abstract Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth. Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks, improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial

  3. Randomized trials, generalizability, and meta-analysis: Graphical insights for binary outcomes

    Directory of Open Access Journals (Sweden)

    Kramer Barnett S

    2003-06-01

    Full Text Available Abstract Background Randomized trials stochastically answer the question. "What would be the effect of treatment on outcome if one turned back the clock and switched treatments in the given population?" Generalizations to other subjects are reliable only if the particular trial is performed on a random sample of the target population. By considering an unobserved binary variable, we graphically investigate how randomized trials can also stochastically answer the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?" Method For three different outcome measures, absolute difference (DIF, relative risk (RR, and odds ratio (OR, we constructed a modified BK-Plot under the assumption that treatment has the same effect on outcome if either all or no subjects had a given level of the unobserved binary variable. (A BK-Plot shows the effect of an unobserved binary covariate on a binary outcome in two treatment groups; it was originally developed to explain Simpsons's paradox. Results For DIF and RR, but not OR, the BK-Plot shows that the estimated treatment effect is invariant to the fraction of subjects with an unobserved binary variable at a given level. Conclusion The BK-Plot provides a simple method to understand generalizability in randomized trials. Meta-analyses of randomized trials with a binary outcome that are based on DIF or RR, but not OR, will avoid bias from an unobserved covariate that does not interact with treatment in its effect on outcome.

  4. New perspectives in long-term outcomes in clinical trials of pulmonary arterial hypertension

    Directory of Open Access Journals (Sweden)

    Ioana R. Preston

    2013-12-01

    Full Text Available The past two decades have seen significant improvements in the management of patients with pulmonary arterial hypertension (PAH. Although outcome has improved, long-term prognosis remains unsatisfactory. The development of new treatment options is clearly important. Equally important is testing new agents in trials designed to provide robust evidence for sustained clinical benefits enabling clinicians to determine the optimal treatment strategy for individual patients. End-points such as the change in 6-min walk distance (6MWD have been pivotal in the registration trials of currently available PAH-specific therapies. However, as current clinical trials enrol patients with milder disease, many already on background therapy, there is growing evidence that change from baseline in 6MWD is a weak surrogate of outcome in PAH. In addition, while short-term trials allowed for the rapid approval of PAH therapies in the past, there is increasing recognition that clinical trials for new agents must provide evidence of long-term benefits. Clinical trials need to evolve to provide the long-term, clinically relevant data required to appropriately assess new therapies. Event-driven long-term morbidity and mortality trials are currently underway, and will provide robust data on the frequency and timing of events, and are likely to reflect the future of clinical trial design in PAH.

  5. A comparison of imputation strategies in cluster randomized trials with missing binary outcomes.

    Science.gov (United States)

    Caille, Agnès; Leyrat, Clémence; Giraudeau, Bruno

    2014-04-01

    In cluster randomized trials, clusters of subjects are randomized rather than subjects themselves, and missing outcomes are a concern as in individual randomized trials. We assessed strategies for handling missing data when analysing cluster randomized trials with a binary outcome; strategies included complete case, adjusted complete case, and simple and multiple imputation approaches. We performed a simulation study to assess bias and coverage rate of the population-averaged intervention-effect estimate. Both multiple imputation with a random-effects logistic regression model or classical logistic regression provided unbiased estimates of the intervention effect. Both strategies also showed good coverage properties, even slightly better for multiple imputation with a random-effects logistic regression approach. Finally, this latter approach led to a slightly negatively biased intracluster correlation coefficient estimate but less than that with a classical logistic regression model strategy. We applied these strategies to a real trial randomizing households and comparing ivermectin and malathion to treat head lice. PMID:24713160

  6. Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) – lessons learned

    OpenAIRE

    Cockayne, Sarah; Hewitt, Catherine; Hashmi, Farina; Hicks, Kate; Concannon, Michael; McIntosh, Caroline; Thomas, Kim; Hall, Jill; Watson, Judith; Torgerson, David; Watt, Ian

    2016-01-01

    Background Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. Meth...

  7. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  8. Prostate Cancer: Prognostic factors, markers of outcome and design of clinical trials

    OpenAIRE

    Collette, Lau

    2006-01-01

    textabstractPhase III clinical trials to assess the clinical benefit of new treatment options often require large patient numbers and long follow-up, in particular in diseases with a long natural history, such as prostate cancer. In this thesis, we argue that in order to improve the efficiency of phase III prostate cancer clinical trials, a thorough understanding of prognostic factors of outcome is needed, as well as an exploration of potential predictive factors that might affect treatment b...

  9. Behavioural, educational and respiratory outcomes of antenatal betamethasone for term caesarean section (ASTECS trial)

    OpenAIRE

    Stutchfield, Peter Roy; Whitaker, Rhiannon; Gliddon, Angela E; Hobson, Lucie; Kotecha, Sailesh; Doull, Iolo J M

    2013-01-01

    Objectives To determine whether antenatal betamethasone prior to elective term caesarean section (CS) affects long term behavioural, cognitive or developmental outcome, and whether the risk of asthma or atopic disease is reduced. Design A questionnaire based follow-up of a multicentre randomised controlled trial (Antenatal Steroids for Term Elective Caesarean Section, BMJ 2005). Setting Four UK study centres from the original trial. Participants 862 participants from the four largest recruiti...

  10. Clinical Outcomes with β-blockers for Myocardial Infarction A Meta-Analysis of Randomized Trials

    DEFF Research Database (Denmark)

    Bangalore, Sripal; Makani, Harikrishna; Radford, Martha; Thakur, Kamia; Toklu, Bora; Katz, Stuart D; DiNicolantonio, James J; Devereaux, P J; Alexander, Karen P; Wetterslev, Jorn; Messerli, Franz H

    2014-01-01

    patients. The primary outcome was all-cause mortality. Analysis was performed stratifying trials into reperfusion era (>50% undergoing reperfusion and/or receiving aspirin/statin) or pre-reperfusion era trials. RESULTS: Sixty trials with 102003 patients satisfied the inclusion criteria. In the acute......BACKGROUND: Debate exists regarding the efficacy of â-blockers in myocardial infarction and their required duration of usage in contemporary practice. METHODS: We conducted a MEDLINE/EMBASE/CENTRAL search for randomized trials evaluating â-blockers in myocardial infarction enrolling at least 100...... myocardial infarction trials, a significant interaction (Pinteraction=0.02) was noted such that â-blockers reduced mortality in the pre-reperfusion[Incident Rate Ratio (IRR)=0.86, 95% CI 0.79-0.94] but not in the reperfusion era(IRR=0.98, 95% CI 0.92-1.05). In the pre-reperfusion era, â-blockers reduced...

  11. Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review

    Directory of Open Access Journals (Sweden)

    Hart Anna

    2005-03-01

    Full Text Available Abstract Good quality clinical trials are essential to inform the best cystic fibrosis (CF management and care, by determining and comparing the effectiveness of new and existing therapies and drug delivery systems. The formal inclusion of quality of life (QoL as an outcome measure in CF clinical trials is becoming more common. Both an appropriate QoL measure and sound methodology are required in order to draw valid inferences about treatments and QoL. A review was undertaken of randomised controlled trials in cystic fibrosis where QoL was measured. EMBASE, MEDLINE and ISI Web of Science were searched to locate all full papers in the English language reporting randomised controlled trials in cystic fibrosis, published between January 1991 and December 2004. All Cochrane reviews published before December 2004 were hand searched. Papers were included if the authors had reported that they had measured QoL or well being in the trial. 16 trials were identified. The interventions investigated were: antibiotics (4; home versus hospital administration of antibiotics (1; steroids (1; mucolytic therapies (6; exercise (3 and pancreatic enzymes (1. Not one trial evaluated in this review provided conclusive results concerning QoL. This review highlights many of the pitfalls of QoL measurement in CF clinical trials and provides constructive information concerning the design and reporting of trials measuring QoL.

  12. Distribution of guidance models for cardiac resynchronization therapy in the setting of multi-center clinical trials

    Science.gov (United States)

    Rajchl, Martin; Abhari, Kamyar; Stirrat, John; Ukwatta, Eranga; Cantor, Diego; Li, Feng P.; Peters, Terry M.; White, James A.

    2014-03-01

    Multi-center trials provide the unique ability to investigate novel techniques across a range of geographical sites with sufficient statistical power, the inclusion of multiple operators determining feasibility under a wider array of clinical environments and work-flows. For this purpose, we introduce a new means of distributing pre-procedural cardiac models for image-guided interventions across a large scale multi-center trial. In this method, a single core facility is responsible for image processing, employing a novel web-based interface for model visualization and distribution. The requirements for such an interface, being WebGL-based, are minimal and well within the realms of accessibility for participating centers. We then demonstrate the accuracy of our approach using a single-center pacemaker lead implantation trial with generic planning models.

  13. Sex, Socioeconomic Status, Access to Cardiac Catheterization and Outcomes for Acute Coronary Syndromes in the Context of Universal Healthcare Coverage

    Science.gov (United States)

    Fabreau, Gabriel E.; Leung, Alexander A.; Southern, Danielle A.; Knudtson, Merrill L.; McWilliams, J. Michael; Ayanian, John Z.; Ghali, William A.

    2015-01-01

    Background Sex and neighborhood socioeconomic status (nSES) may independently affect the care and outcomes of acute coronary syndromes (ACS), partly through barriers in timely access to cardiac catheterization. We sought to determine whether sex modifies the association between nSES, and the receipt of cardiac catheterization and mortality following an ACS in a universal healthcare system. Methods and Results We studied 14,012 ACS patients admitted to cardiology services between April 18, 2004 and December 31, 2011 in Southern Alberta, Canada. We used multivariable logistic regression to compare the odds of cardiac catheterization within 2 and 30 days of admission and the odds of 30-day and 1-year mortality for men and women by quintile of neighborhood median household income. Significant relationships between nSES and the receipt of cardiac catheterization and mortality after ACS were detected for women but not men. When examined by nSES, each incremental decrease in neighborhood income quintile for women was associated with a 6% lower odds of receiving cardiac catheterization within 30 days (p=0.01) and a 14% higher odds of 30-day mortality (p=0.03). For men, each decrease in neighborhood income quintile was associated with a 2% lower odds of receiving catheterization within 30 days (p=0.10), and a 5% higher odds of 30-day mortality (p=0.36). Conclusions Associations between nSES and receipt of cardiac catheterization and 30-day mortality were noted for women but not men in a universal healthcare system. Care protocols designed to improve equity of access to care and outcomes are required, especially for low-income women. PMID:24895450

  14. Survival with good neurological outcome in a patient with prolonged ischemic cardiac arrest--utility of automated chest compression systems in the cardiac catheterization laboratory.

    Science.gov (United States)

    Psaltis, Peter J; Meredith, Ian T; Ahmar, Walid

    2014-11-15

    The management of refractory cardiac arrest during invasive coronary procedures has substantial logistical challenges and is typically associated with disappointing outcomes. We describe the case of a young woman with recalcitrant ventricular fibrillation due to acute anterior ST-elevation myocardial infarction caused by occlusion of her proximal left anterior descending artery. Survival without neurological deficit or organ failure was achieved following primary percutaneous reperfusion and a total of 52 min of intra-procedural chest compression support, made possible by the use of an automated chest compression device. PMID:24403102

  15. Lessons learned from cardiovascular outcome clinical trials with dipeptidyl peptidase 4 (DPP-4) inhibitors.

    Science.gov (United States)

    Fiorentino, Teresa Vanessa; Sesti, Giorgio

    2016-08-01

    Previous trials of glucose-lowering strategies in subjects with type 2 diabetes have demonstrated a beneficial effect of intensive glycemic control on microvascular complications but failed to show a clear benefit on cardiovascular complications. The findings of meta-analyses of rosiglitazone trials suggesting that rosiglitazone might increase the risk of myocardial infarction have cast doubt on the cardiovascular safety of glucose-lowering drugs. In 2008, the US Food and Drug Administration has implemented rigorous criteria to approve new glucose-lowering drugs, requiring proof of cardiovascular safety. These regulatory requirements have led to a considerable increase in the number of cardiovascular outcome trials in type 2 diabetes to ensure that newer glucose-lowering drugs are not associated with increased cardiovascular risk. Incretin-based therapies including dipeptidyl peptidase 4 (DPP-4) inhibitors, and injectable glucagon-like peptide 1 (GLP-1) receptor agonists are novel treatment options for patients with inadequate glucose control. Although DPP-4 inhibitors have shown neutral effects on risk factors for cardiovascular diseases, it remains unclear whether treatment with these new glucose-lowering agents might be associated with a reduction in cardiovascular events. The results of the three cardiovascular outcome trials comparing DPP-4 inhibitors treatment to placebo in addition to other glucose-lowering drugs have been published. All the three DPP-4 inhibitor cardiovascular outcome trials have shown non-inferiority with regard to cardiovascular safety, compared with placebo, when added to usual care. In this review, we summarize cardiovascular outcome trials of DPP-4 inhibitors, and provide an overview of these trials and their limitations. PMID:26611248

  16. Relationship Between Exercise Workload During Cardiac Rehabilitation and Outcomes in Patients With Coronary Heart Disease.

    Science.gov (United States)

    Brawner, Clinton A; Abdul-Nour, Khaled; Lewis, Barry; Schairer, John R; Modi, Shalini S; Kerrigan, Dennis J; Ehrman, Jonathan K; Keteyian, Steven J

    2016-04-15

    The purpose of this retrospective, observational study was to describe the relation between exercise workload during cardiac rehabilitation (CR), expressed as metabolic equivalents of task (METs), and prognosis among patients with coronary heart disease. We included patients with coronary heart disease who participated in CR between January 1998 and June 2007. METs were calculated from treadmill workload. Cox regression analysis was used to describe the relationship between METs and time to a composite outcome of all-cause mortality, nonfatal myocardial infarction, or heart failure hospitalization. Among 1,726 patients (36% women; median age 59 years [interquartile range, 52 to 66]), there were 467 events (27%) during a median follow-up of 5.8 years (interquartile range, 2.6 to 8.7). In analyses adjusted for age, sex, Charlson co-morbidity index, hypertension, diabetes, and CR referral diagnosis, METs were independently related to the composite outcome at CR start (Wald chi-square 43, hazard ratio 0.59 [95% confidence interval 0.51 to 0.70]) and CR end (Wald chi-square 47, hazard ratio 0.68 [95% confidence interval 0.61 to 0.76]). Patients exercising below 3.5 METs on exit from CR represent a high-risk group with 1- and 3-year event rates ≥7% and ≥18%, respectively. In conclusion, METs during CR is available at no additional cost and can be used to identify patients at increased risk for an event who may benefit from closer follow-up, extended length of stay in CR, and/or participation in other strategies aimed at maximizing adherence to secondary preventive behaviors and improving exercise capacity. PMID:26897640

  17. Trends in Outcomes for Out-of-Hospital Cardiac Arrest by Age in Japan: An Observational Study.

    Science.gov (United States)

    Fukuda, Tatsuma; Ohashi-Fukuda, Naoko; Matsubara, Takehiro; Doi, Kent; Kitsuta, Yoichi; Nakajima, Susumu; Yahagi, Naoki

    2015-12-01

    Population aging has rapidly advanced throughout the world and the elderly accounting for out-of-hospital cardiac arrest (OHCA) has increased yearly.We identified all adults who experienced an out-of-hospital cardiac arrest in the All-Japan Utstein Registry of the Fire and Disaster Management Agency, a prospective, population-based clinical registry, between 2005 and 2010. Using multivariable regression, we examined temporal trends in outcomes for OHCA patients by age, as well as the influence of advanced age on outcomes. The primary outcome was a favorable neurological outcome at 1 month after OHCA.Among 605,505 patients, 454,755 (75.1%) were the elderly (≥65 years), and 154,785 (25.6%) were the oldest old (≥85 years). Although neurological outcomes were worse as the age group was older (P < 0.0001 for trend), there was a significant trend toward improved neurological outcomes during the study period by any age group (P < 0.005 for trend). After adjustment for temporal trends in various confounding variables, neurological outcomes improved yearly in all age groups (18-64 years: adjusted OR per year 1.15 [95% CI 1.13-1.18]; 65-84 years: adjusted OR per year 1.12 [95% CI 1.10-1.15]; and ≥85 years: adjusted OR per year 1.08 [95% CI 1.04-1.13]). Similar trends were found in the secondary outcomes.Although neurological outcomes from OHCA ware worse as the age group was older, the rates of favorable neurological outcomes have substantially improved since 2005 even in the elderly, including the oldest old. Careful consideration may be necessary in limiting treatment on OHCA solely for the reason of advanced age. PMID:26656330

  18. The effect of an educational intervention on coronary artery bypass graft surgery patients' participation rate in cardiac rehabilitation programs: a controlled health care trial

    Directory of Open Access Journals (Sweden)

    Novikov Ilia

    2011-10-01

    Full Text Available Abstract Background Cardiac rehabilitation has a beneficial effect on the prognosis and quality of life of cardiac patients, and has been found to be cost-effective. This report describes a comprehensive and low cost educational intervention designed to increase the attendance at cardiac rehabilitation programs of patients who have undergone coronary artery bypass graft surgery. Methods/Design A controlled prospective intervention trial. The control arm comprised 520 patients who underwent coronary artery bypass graft surgery between January 2004 and May 2005 in five medical centers across Israel. This group received no additional treatment beyond usual care. The intervention arm comprised 504 patients recruited from the same cardiothoracic departments between June 2005 and November 2006. This group received oral and written explanations about the advantages of participating in cardiac rehabilitation programs and a telephone call two weeks after hospital discharge intended to further encourage their enrollment. The medical staff attended a one-hour seminar on cardiac rehabilitation. In addition, it was recommended that referral to cardiac rehabilitation be added to the letter of discharge from the hospital. Both study groups were interviewed before surgery and one-year post surgery. A one-year post-operative interview assessed factors affecting patient attendance at cardiac rehabilitation programs, as well as the structure and content of the cardiac rehabilitation programs attended. Anthropometric parameters were measured at pre- and post-operative interviews;- and medical information was obtained from patient medical records. The effect of cardiac rehabilitation on one- and three-year mortality was assessed. Discussion We report a low cost yet comprehensive intervention designed to increase cardiac rehabilitation participation by raising both patient and medical staff awareness to the potential benefits of cardiac rehabilitation. Trial

  19. Sibling Outcomes from a Randomized Trial of Evidence-Based Treatments with Substance Abusing Juvenile Offenders

    Science.gov (United States)

    Rowland, Melisa D.; Chapman, Jason E.; Henggeler, Scott W.

    2008-01-01

    This study examined the substance use and delinquency outcomes for the nearest age siblings of substance abusing and delinquent adolescents that participated in a randomized clinical trial evaluating the effectiveness of integrating evidence-based practices into juvenile drug court. The sample of 70 siblings averaged 14.4 years of age, 50% were…

  20. THE INTERIM EXPERTS’ COUNCIL RESOLUTION ON THE EMPA-REG OUTCOME TRIAL ISSUES

    Directory of Open Access Journals (Sweden)

    M. V. Shestakova

    2016-05-01

    Full Text Available The interdisciplinary interim experts’ council on March 3, 2016 in Moscow have considered the EMPA-REG OUTCOME trial results and suggested a number of propositions and recommendations on further empagliflozin’s cardiovascular effects investigation and its clinical application in patients with type 2 diabetes at high cardiovascular risk.

  1. THE INTERIM EXPERTS’ COUNCIL RESOLUTION ON THE EMPA-REG OUTCOME TRIAL ISSUES

    OpenAIRE

    M V Shestakova; S. A. Boytsov; O. M. Drapkina; T Yu Demidova; Drexel, H.; M B Antsiferov; N A Petunina; I. A. Chernikova; V. Yu. Kalashnikov; T P Bardymova; V. K. Protasov; A. Yu. Babenko; L. A. Ruyatkina; V V Klimontov; V. V. Salukhov

    2016-01-01

    The interdisciplinary interim experts’ council on March 3, 2016 in Moscow have considered the EMPA-REG OUTCOME trial results and suggested a number of propositions and recommendations on further empagliflozin’s cardiovascular effects investigation and its clinical application in patients with type 2 diabetes at high cardiovascular risk.

  2. Is More Better? Outcome and Dose of a Universal Drug Prevention Effectiveness Trial

    Science.gov (United States)

    Ferrer-Wreder, Laura; Cadely, Hans Saint-Eloi; Domitrovich, Celene E.; Small, Meg L.; Caldwell, Linda L.; Cleveland, Michael J.

    2010-01-01

    Two evidence-based interventions, Life Skills Training and TimeWise, were combined in an effectiveness trial. Participants were predominately African American youth (N = 715; M[subscript age] = 12). The study authors provide an empirical demonstration of the implications of incorporating dosage information in intervention outcome analyses. Study…

  3. Predicting physical fitness outcomes of exercise rehabilitation: An retrospective examination of program admission data from patient records in a hospital-based early outpatient cardiac rehabilitation program

    OpenAIRE

    Fabiato, Francois Stephane

    1998-01-01

    PREDICTING PHYSICAL FITNESS OUTCOMES IN CARDIAC REHABILITATION PATIENTS by Francois S. Fabiato (ABSTRACT) Economic justification for rehabilitative services has resulted in the need for outcome based research which could quantify success or failure in individual patients and formulate baseline variables which could predict outcomes. The purpose of this study is to investigate the utilization of baseline clinical, exercise test, and psychosocial variables to pre...

  4. Choice of design and outcomes in trials among children with moderate acute malnutrition

    DEFF Research Database (Denmark)

    Friis, Henrik; Michaelsen, Kim F.; Wells, Jonathan C

    2015-01-01

    There is a need for trials on the effects of food aid products for children with moderate acute malnutrition, to identify how best to restore body tissues and function. The choice of control intervention is a major challenge, with both ethical and scientific implications. While randomized trials...... understand what components of health might be impacted by public health programs, or the underlying mechanisms whereby improved nutritional status might benefit short- and long-term health. Measurement of body composition, specific growth markers and functional outcomes may provide greater insight into the...... are needed, special designs, such as cluster-randomized, stepped-wedged or factorial designs may offer advantages. Anthropometry is widely used as the primary outcome in such trials, but anthropometric traits do not refer directly to specific organs, tissues, or functions. Thus, it is difficult to...

  5. Out-of hospital cardiac arrest in Okayama city (Japan: outcome report according to the "Utsutein Style".

    Directory of Open Access Journals (Sweden)

    Hayashi,Hoei

    2005-04-01

    Full Text Available

    The purpose of this study was to evaluate the outcomes for out-of-hospital cardiac arrest (OHCA and cardiopulmonary resuscitation (CPR in the city of Okayama, Japan, during a 1-year period after the reorganization of defibrillation by Emergency Life-Saving Technicians (ELSTs with standing orders of CPR. The data were collected prospectively according to an Utstein style between June 1, 2003 and May 31, 2004; OHCA was confirmed in 363 patients. Cardiac arrest of presumed cardiac etiology (179 was witnessed by a bystander in 62 (34.6% cases. Of this group, ventricular fibrillation (VF was documented in 20 cases (32.3%, and 1 patient (5% was discharged alive without severe neurological disability. This outcome is average in Japan, but it is quite low level compared with Western countries because there is less VF in Japan. The Utstein style revealed that we must try to detect VF before the rhythm changes and to provide defibrillation as soon as possible in order to improve outcomes. Further research will be required to accurately evaluate OHCA in Okayama city.

  6. Out-of-hospital cardiac arrests in an urban/rural area during 1991 and 1996 : have emergency medical service changes improved outcome?

    NARCIS (Netherlands)

    Absalom, AR; Bradley, P; Soar, J

    1999-01-01

    Survival after out-of-hospital cardiac arrest is influenced by pre-hospital emergency medical care. This study compares outcome of cardiac arrest victims presenting to an emergency department serving a mixed urban/rural area (Norfolk, UK) in 1991 with 1996. Between these years the regional emergency

  7. Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial

    DEFF Research Database (Denmark)

    Kjøller, Erik; Hilden, Jørgen; Winkel, Per;

    2014-01-01

    UNLABELLED: The objective of this study is to describe the agreement between randomized trial outcome assessment by committee and outcomes entirely identified through public registers. METHODS: In the CLARICOR trial, 4,372 patients with stable coronary heart disease received a short course...... of clarithromycin versus placebo and were followed up for 2.6 years. The pertinent hospital records and death certificates had originally been evaluated by the adjudication committee using common definitions of outcomes mapped into a 6-category list. We now mechanically converted the International Classification...... of Diseases-coded diagnoses of the public registries into the same categories. After cross-tabulation of the committee diagnoses with National Patient Register diagnoses and Register of Causes of Death, we calculate agreement and compare the estimated intervention effects of the 2 data sets. RESULTS...

  8. Digoxin therapy and associated clinical outcomes in the MADIT-CRT trial

    DEFF Research Database (Denmark)

    Lee, Andy Y; Kutyifa, Valentina; Ruwald, Martin H; McNitt, Scott; Polonsky, Bronislava; Zareba, Wojciech; Moss, Arthur J; Ruwald, Anne-Christine

    2015-01-01

    ventricular fibrillation (VT/VF) in 1820 patients with mild HF (New York Heart Association class I and II), prolonged QRS duration (≥130 ms), and reduced left ventricular ejection fraction (≤30%) enrolled in the Multicenter Automatic Defibrillator Implantation Trial - Cardiac Resynchronization Therapy trial....... Multivariate Cox proportional hazards regression models were used to determine the effect of time-dependent digoxinusage on the end points. RESULTS: Digoxin therapy was not associated with an increased or decreased risk of HF/death (hazard ratio [HR] 1.07; 95% confidence interval [CI] 0.86-1.33; P = .0.56), HF...... > .5). CONCLUSION: The use of digoxin in patients with mild HF implanted with an ICD or CRT-D device was not associated with reductions in HF/death events. However, digoxin therapy was associated with an increasedrisk of high-rate VT/VF (≥200 beats/min)....

  9. Cardiovascular outcome trials for anti-diabetes medication: A holy grail of drug development?

    Science.gov (United States)

    John, Mathew; Gopalakrishnan Unnikrishnan, Ambika; Kalra, Sanjay; Nair, Tiny

    2016-01-01

    Since the time questions arose on cardiovascular safety of Rosiglitazone, FDA has suggested guidelines on conduct of studies on anti-diabetic drugs so as to prove that the cardiovascular risk is acceptable. Based on the cardiovascular risks of pre-approval clinical trials, guidelines have been made to conduct cardiovascular safety outcome trials (CVSOTs) prior to the drug approval or after the drug has been approved. Unlike the trials comparing the efficacy of antidiabetic agents, the CVSOTs examine the cardiovascular safety of a drug in comparison to standard of care. These trials are expensive aspects of drug development and are associated with various technical and operational challenges. More cost effective models of assessing cardiovascular safety like use of biomarkers, electronic medical records, pragmatic and factorial designs can be adopted. This article critically looks at the antidiabetic drug approval from a cardiovascular perspective by asking a few questions and arriving at answers. PMID:27543483

  10. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte;

    2015-01-01

    cost-benefit will be assessed. A mixed-method design will be used to evaluate qualitative and quantitative findings, encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. CONCLUSION: This randomized clinical trial will contribute with evidence of whether...... cardiac rehabilitation should be provided after heart valve surgery. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: Trial registered 16 March 2012; ClinicalTrials.gov ( NCT01558765 )....

  11. The Effect of Threshold Values and Weighting Factors on the Association between Entropy Measures and Mortality after Myocardial Infarction in the Cardiac Arrhythmia Suppression Trial (CAST

    Directory of Open Access Journals (Sweden)

    Christopher Mayer

    2016-04-01

    Full Text Available Heart rate variability (HRV is a non-invasive measurement based on the intervals between normal heart beats that characterize cardiac autonomic function. Decreased HRV is associated with increased risk of cardiovascular events. Characterizing HRV using only moment statistics fails to capture abnormalities in regulatory function that are important aspects of disease risk. Thus, entropy measures are a promising approach to quantify HRV for risk stratification. The purpose of this study was to investigate this potential for approximate, corrected approximate, sample, fuzzy, and fuzzy measure entropy and its dependency on the parameter selection. Recently, published parameter sets and further parameter combinations were investigated. Heart rate data were obtained from the "Cardiac Arrhythmia Suppression Trial (CAST RR Interval Sub-Study Database" (Physionet. Corresponding outcomes and clinical data were provided by one of the investigators. The use of previously-reported parameter sets on the pre-treatment data did not significantly add to the identification of patients at risk for cardiovascular death on follow-up. After arrhythmia suppression treatment, several parameter sets predicted outcomes for all patients and patients without coronary artery bypass grafting (CABG. The strongest results were seen using the threshold parameter as a multiple of the data’s standard deviation ( r = 0 . 2 · σ . Approximate and sample entropy provided significant hazard ratios for patients without CABG and without diabetes for an entropy maximizing threshold approximation. Additional parameter combinations did not improve the results for pre-treatment data. The results of this study illustrate the influence of parameter selection on entropy measures’ potential for cardiovascular risk stratification and support the potential use of entropy measures in future studies.

  12. High Thoracic Epidural Analgesia as an Adjunct to General Anesthesia is Associated with Better Outcome in Low-to-Moderate Risk Cardiac Surgery Patients

    DEFF Research Database (Denmark)

    Stenger, Michael; Fabrin, Anja; Schmidt, Henrik; Greisen, Jacob; Erik Mortensen, Poul; Jakobsen, Carl-Johan

    2013-01-01

    The purpose of this study was to evaluate the addition of high thoracic epidural analgesia (HTEA) to general anesthesia in cardiac surgery patients to enhance the fast-track and improvement in outcome.......The purpose of this study was to evaluate the addition of high thoracic epidural analgesia (HTEA) to general anesthesia in cardiac surgery patients to enhance the fast-track and improvement in outcome....

  13. Determination of the threshold of cardiac troponin I associated with an adverse postoperative outcome after cardiac surgery: a comparative study between coronary artery bypass graft, valve surgery, and combined cardiac surgery

    Science.gov (United States)

    Fellahi, Jean-Luc; Hedoire, François; Le Manach, Yannick; Monier, Emmanuel; Guillou, Louis; Riou, Bruno

    2007-01-01

    Introduction The objective of the present study was to compare postoperative cardiac troponin I (cTnI) release and the thresholds of cTnI that predict adverse outcome after elective coronary artery bypass graft (CABG), after valve surgery, and after combined cardiac surgery. Methods Six hundred and seventy-five adult patients undergoing conventional cardiac surgery with cardiopulmonary bypass were retrospectively analyzed. Patients in the CABG (n = 225) and valve surgery groups (n = 225) were selected after matching (age, sex) with those in the combined surgery group (n = 225). cTnI was measured preoperatively and 24 hours after the end of surgery. The main endpoint was a severe postoperative cardiac event (sustained ventricular arrhythmias requiring treatment, need for inotropic support or intraaortic balloon pump for at least 24 hours, postoperative myocardial infarction) and/or death. Data are presented as the median and the odds ratio (95% confidence interval). Results Postoperative cTnI levels were significantly different among the three groups (combined surgery, 11.0 (9.5–13.1) ng/ml versus CABG, 5.2 (4.7–5.7) ng/ml and valve surgery, 7.8 (7.6–8.0) ng/ml; P < 0.05). The thresholds of cTnI predicting severe cardiac event and/or death were also significantly different among the three groups (combined surgery, 11.8 (11.5–14.8) ng/ml versus CABG, 7.8 (6.7–8.8) ng/ml and valve surgery, 9.3 (8.0–14.0) ng/ml; P < 0.05). An elevated cTnI above the threshold in each group was significantly associated with a severe cardiac event and/or death (odds ratio, 4.33 (2.82–6.64)). Conclusion The magnitude of postoperative cTnI release is related to the type of cardiac surgical procedure. Different thresholds of cTnI must be considered according to the procedure type to predict early an adverse postoperative outcome. PMID:17888156

  14. Dextrose containing intravenous fluid impairs outcome and increases death after eight minutes of cardiac arrest and resuscitation in dogs.

    Science.gov (United States)

    D'Alecy, L G; Lundy, E F; Barton, K J; Zelenock, G B

    1986-09-01

    Use of dextrose in intravenous resuscitation fluids is common practice; however, this study indicates that 5% dextrose solutions, even if administered in physiologic quantities, greatly worsens the outcome of survivable cardiac arrest. Twelve adult male mongrel dogs were premedicated with morphine, anesthetized with halothane, instrumented, intubated, and ventilated. Each dog was first given 500 ml of either lactated Ringer's (LR) (n = 6) or 5% dextrose in LR (D5LR) (n = 6). Halothane was stopped and fibrillation was induced (60 Hz). Blood glucose just before cardiac arrest was 129 mg/dl in the LR dogs and was increased to 335 mg/dl in the D5LR dogs. After eight minutes of arrest, resuscitation, including internal cardiac massage and standard advanced cardiac life support drug protocols (modified for dogs), was begun. When stable cardiac rhythm was obtained, the chest was closed, and LR or D5LR continued until a total of 1L was given. A neurologic score (0 = normal to 100 = dead) was assigned at 1, 2, 6, and 24 hours. The LR group did not differ statistically from the D5LR group in operative time, number of defibrillatory shocks, time to spontaneous ventilation, time to extubation, or drugs required. Resuscitation was successful in all six LR and five of six D5LR group; however, by 2 hours after resuscitation and thereafter, D5LR group had a significantly greater neurologic deficit (p less than 0.05) than did the LR group. By 9 hours, four of six D5LR dogs displayed convulsive activity and died. At 24 hours the D5LR group had a greater (p less than 0.008) neurologic deficit (82 +/- 11) than did the LR group (21 +/- 7), which walked and ate. We conclude that the addition of 5% dextrose to standard intravenous fluids greatly increases the morbidity and mortality associated with cardiac resuscitation. PMID:3738770

  15. Usefulness of the Sum Absolute QRST Integral to Predict Outcomes in Patients Receiving Cardiac Resynchronization Therapy.

    Science.gov (United States)

    Jacobsson, Jonatan; Borgquist, Rasmus; Reitan, Christian; Ghafoori, Elyar; Chatterjee, Neal A; Kabir, Muammar; Platonov, Pyotr G; Carlson, Jonas; Singh, Jagmeet P; Tereshchenko, Larisa G

    2016-08-01

    Cardiac resynchronization therapy (CRT) reduces mortality and morbidity in selected patients with heart failure (HF), but up to 1/3 of patients are nonresponders. Sum absolute QRST integral (SAI QRST) recently showed association with mechanical response on CRT. However, it is unknown whether SAI QRST is associated with all-cause mortality and HF hospitalizations in patients undergoing CRT. The study population included 496 patients undergoing CRT (mean age 69 ± 10 years, 84% men, 65% left bundle branch block [LBBB], left ventricular ejection fraction 23 ± 6%, 63% ischemic cardiomyopathy). Preimplant digital 12-lead electrocardiogram was transformed into orthogonal XYZ electrocardiogram. SAI QRST was measured as an arithmetic sum of areas under the QRST curve on XYZ leads and was dichotomized based on the median value (302 mV ms). All-cause mortality served as the primary end point. A composite of 2-year all-cause mortality, heart transplant, and HF hospitalization was a secondary end point. Cox regression models were adjusted for known predictors of CRT response. Patients with preimplant low mean SAI QRST had an increased risk of both the primary (hazard ratio [HR] 1.8, 95% CI 1.01 to 3.2) and secondary (HR 1.6, 95% CI 1.1 to 2.2) end points after multivariate adjustment. SAI QRST was associated with secondary outcome in subgroups of patients with LBBB (HR 2.1, 95% CI 1.5 to 3.0) and with non-LBBB (HR 1.7, 95% CI 1.0 to 2.6). In patients undergoing CRT, preimplant SAI QRST validation in another prospective cohort, SAI QRST may help to refine selection of CRT recipients. PMID:27265674

  16. Dichotomizing a continuous outcome in cluster randomized trials: impact on power.

    Science.gov (United States)

    Caille, Agnès; Leyrat, Clémence; Giraudeau, Bruno

    2012-10-30

    In cluster randomized trials (CRTs), clusters of individuals are randomized rather than the individuals themselves. For such trials, power depends in part on the degree of similarity among responses within a cluster, which is quantified by the intaclass correlation coefficient (ICC). Thus, for a fixed sample size, power decreases with increasing ICC. In reliability studies with two observers, dichotomizing a continuous outcome variable has been shown to reduce the ICC. We checked (by a simulation study) that this property still applies to CRTs, in which cluster sizes are variable and usually greater than in reliability studies and observations (within clusters) are exchangeable. Then, in a CRT, dichotomizing a continuous outcome actually induces two antagonistic effects: decreased power because of loss of information and increased power induced by attenuation of the ICC. Therefore, we aimed to assess the impact of dichotomizing a continuous outcome on power in a CRT. We derived an analytical formula for power based on a generalized estimating equation approach after dichotomizing a continuous outcome. This theoretical result was obtained by considering equal cluster sizes, and we then assessed its accuracy (by a simulation study) in the more realistic situation of varying cluster sizes. We showed that dichotomization is associated with decreased power: attenuation of the ICC does not compensate for the loss of power induced by loss of information. Loss of power is reduced with increased initial continuous-outcome ICC and/or prevalence of success for the dichotomized outcome approaching 50%. PMID:22733454

  17. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    International Nuclear Information System (INIS)

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question

  18. Physical conditioning and mental stress reduction - a randomised trial in patients undergoing cardiac surgery

    OpenAIRE

    van der Merwe Juliana; Bailey Michael; Shepherd Judy; Bradley Scott; Spitzer Ondine; Braun Lesley; Rosenfeldt Franklin; Leong Jee; Esmore Donald

    2011-01-01

    Abstract Background Preoperative anxiety and physical unfitness have been shown to have adverse effects on recovery from cardiac surgery. This study involving cardiac surgery patients was primarily aimed at assessing the feasibility of delivering physical conditioning and stress reduction programs within the public hospital setting. Secondary aims were to evaluate the effect of these programs on quality of life (QOL), rates of postoperative atrial fibrillation (AF) and length of stay (LOS) in...

  19. Patient-reported outcomes (PRO) in ovarian cancer clinical trials-lost opportunities and lessons learned.

    Science.gov (United States)

    Friedlander, M; Mercieca-Bebber, R L; King, M T

    2016-04-01

    Despite increased recognition of the value of including patient-reported outcomes (PROs) as important end points in phase III clinical trials, there has been a lack of pre-specified PRO hypotheses and shortcomings with the analyses and interpretation of PROs in many ovarian cancer trials. This paper discusses and provides examples of the so-called lost opportunities in ovarian cancer trials. These include: (i) no clear pre-specified PRO hypotheses; (ii) PRO end points not included; (iii) insensitive PRO end point selection; (iv) collection of poor-quality PRO data not suitable for analysis; (v) differences in PROs between treatment arms ignored; and (vi) poor reporting quality. We can learn from the past and with relatively little additional effort, improve the collection and interpretation of PRO data in future ovarian cancer trials. The importance of doing so is underpinned by recent initiatives to improve the standard and usefulness of PRO data in clinical trials. These include the Food and Drug Administration (FDA) Guidance for PROs to support labelling claims, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO MCBS), the International Society for Quality-of-Life Research PRO reporting guidance and the Consolidated Standards of Reporting Clinical Trials (CONSORT)-PRO-extension statement which includes a checklist of recommended items to include in PRO sections of trial protocols. Promoting the importance of hypothesis-driven PROs in ovarian cancer clinical trials will lead to improvements in the design of these trials and the interpretation of their results. PMID:27141076

  20. Mortality and neurological outcome in the elderly after target temperature management for out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Winther-Jensen, Matilde; Pellis, Tommaso; Kuiper, Michael;

    2015-01-01

    AIM: To assess older age as a prognostic factor in patients resuscitated from out-of-hospital-cardiac arrest (OHCA) and the interaction between age and level of target temperature management. METHODS AND RESULTS: 950 patients included in the target temperature management (TTM) trial were randomly...... age groups, p = 0.001, the same was true for ST segment elevation on ECG at admission, p < 0.01. Increasing age was associated with a higher mortality rate (HR = 1.04 per year, 95% CI = 1.03-1.06, p < 0.001) after adjusting for confounders. Octogenarians had an increased mortality (HR = 3.5, CI: 2...

  1. Even Four Minutes of Poor Quality of CPR Compromises Outcome in a Porcine Model of Prolonged Cardiac Arrest

    Directory of Open Access Journals (Sweden)

    Heng Li

    2013-01-01

    Full Text Available Objective. Untrained bystanders usually delivered suboptimal chest compression to victims who suffered from cardiac arrest in out-of-hospital settings. We therefore investigated the hemodynamics and resuscitation outcome of initial suboptimal quality of chest compressions compared to the optimal ones in a porcine model of cardiac arrest. Methods. Fourteen Yorkshire pigs weighted 30 ± 2 kg were randomized into good and poor cardiopulmonary resuscitation (CPR groups. Ventricular fibrillation was electrically induced and untreated for 6 mins. In good CPR group, animals received high quality manual chest compressions according to the Guidelines (25% of animal’s anterior-posterior thoracic diameter during first two minutes of CPR compared with poor (70% of the optimal depth compressions. After that, a 120-J biphasic shock was delivered. If the animal did not acquire return of spontaneous circulation, another 2 mins of CPR and shock followed. Four minutes later, both groups received optimal CPR until total 10 mins of CPR has been finished. Results. All seven animals in good CPR group were resuscitated compared with only two in poor CPR group (P<0.05. The delayed optimal compressions which followed 4 mins of suboptimal compressions failed to increase the lower coronary perfusion pressure of five non-survival animals in poor CPR group. Conclusions. In a porcine model of prolonged cardiac arrest, even four minutes of initial poor quality of CPR compromises the hemodynamics and survival outcome.

  2. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    Science.gov (United States)

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred. PMID:21179614

  3. Impact of advanced cardiac life support training program on the outcome of cardiopulmonary resuscitation in a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Kanwalpreet Sodhi

    2011-01-01

    Full Text Available Background: Guidelines on performing cardiopulmonary resuscitation (CPR have been published from time to time, and formal training programs are conducted based on these guidelines. Very few data are available in world literature highlighting the impact of these trainings on CPR outcome. Aim: The aim of our study was to evaluate the impact of the American Heart Association (AHA-certified basic life support (BLS and advanced cardiac life support (ACLS provider course on the outcomes of CPR in our hospital. Materials and Methods : An AHA-certified BLS and ACLS provider training programme was conducted in our hospital in the first week of October 2009, in which all doctors in the code blue team and intensive care units were given training. The retrospective study was performed over an 18-month period. All in-hospital adult cardiac arrest victims in the pre-BLS/ACLS training period (January 2009 to September 2009 and the post-BLS/ACLS training period (October 2009 to June 2010 were included in the study. We compared the outcomes of CPR between these two study periods. Results: There were a total of 627 in-hospital cardiac arrests, 284 during the pre-BLS/ACLS training period and 343 during the post-BLS/ACLS training period. In the pre-BLS/ACLS training period, 52 patients (18.3% had return of spontaneous circulation, compared with 97 patients (28.3% in the post-BLS/ACLS training period (P < 0.005. Survival to hospital discharge was also significantly higher in the post-BLS/ACLS training period (67 patients, 69.1% than in the pre-BLS/ACLS training period (12 patients, 23.1% (P < 0.0001. Conclusion : Formal certified BLS and ACLS training of healthcare professionals leads to definitive improvement in the outcome of CPR.

  4. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure

    Science.gov (United States)

    Cleland, John G.; Abraham, William T.; Linde, Cecilia; Gold, Michael R.; Young, James B.; Claude Daubert, J.; Sherfesee, Lou; Wells, George A.; Tang, Anthony S.L.

    2013-01-01

    Aims Cardiac resynchronization therapy (CRT) with or without a defibrillator reduces morbidity and mortality in selected patients with heart failure (HF) but response can be variable. We sought to identify pre-implantation variables that predict the response to CRT in a meta-analysis using individual patient-data. Methods and results An individual patient meta-analysis of five randomized trials, funded by Medtronic, comparing CRT either with no active device or with a defibrillator was conducted, including the following baseline variables: age, sex, New York Heart Association class, aetiology, QRS morphology, QRS duration, left ventricular ejection fraction (LVEF), and systolic blood pressure. Outcomes were all-cause mortality and first hospitalization for HF or death. Of 3782 patients in sinus rhythm, median (inter-quartile range) age was 66 (58–73) years, QRS duration was 160 (146–176) ms, LVEF was 24 (20–28)%, and 78% had left bundle branch block. A multivariable model suggested that only QRS duration predicted the magnitude of the effect of CRT on outcomes. Further analysis produced estimated hazard ratios for the effect of CRT on all-cause mortality and on the composite of first hospitalization for HF or death that suggested increasing benefit with increasing QRS duration, the 95% confidence bounds excluding 1.0 at ∼140 ms for each endpoint, suggesting a high probability of substantial benefit from CRT when QRS duration exceeds this value. Conclusion QRS duration is a powerful predictor of the effects of CRT on morbidity and mortality in patients with symptomatic HF and left ventricular systolic dysfunction who are in sinus rhythm. QRS morphology did not provide additional information about clinical response. ClinicalTrials.gov numbers NCT00170300, NCT00271154, NCT00251251. PMID:23900696

  5. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

    DEFF Research Database (Denmark)

    Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.;

    2008-01-01

    IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory...... and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome...

  6. A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten Bogh; Lund, Hans; Guyatt, GH;

    2010-01-01

    Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta-analyses in...... during activity (VAS); 3. Pain during walking (VAS); 4. General knee pain (VAS); 5. Pain at rest (VAS); 6. Other composite pain scales; 7. Other single item measures. Disability: 1. WOMAC (subscale ‘function’); 2. SF-36 (subscale ‘physical function’); 3. Physical composite score – (SF-36); 4. Other...... composite disability scores. Conclusions As choosing the most favorable PROs from individual trials can overestimate the effect compared to a systematic approach, using a prioritized list as presented in this study is recommended to reduce reviewer's likelihood of biased selection of PROs in meta-analyses....

  7. A multicentre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates, morbidity and health-care resource use following cardiac surgery (TITRe2).

    Science.gov (United States)

    Reeves, Barnaby C; Pike, Katie; Rogers, Chris A; Brierley, Rachel Cm; Stokes, Elizabeth A; Wordsworth, Sarah; Nash, Rachel L; Miles, Alice; Mumford, Andrew D; Cohen, Alan; Angelini, Gianni D; Murphy, Gavin J

    2016-01-01

    BACKGROUND Uncertainty about optimal red blood cell transfusion thresholds in cardiac surgery is reflected in widely varying transfusion rates between surgeons and cardiac centres. OBJECTIVE To test the hypothesis that a restrictive compared with a liberal threshold for red blood cell transfusion after cardiac surgery reduces post-operative morbidity and health-care costs. DESIGN Multicentre, parallel randomised controlled trial and within-trial cost-utility analysis from a UK NHS and Personal Social Services perspective. We could not blind health-care staff but tried to blind participants. Random allocations were generated by computer and minimised by centre and operation. SETTING Seventeen specialist cardiac surgery centres in UK NHS hospitals. PARTICIPANTS Patients aged > 16 years undergoing non-emergency cardiac surgery with post-operative haemoglobin research steps to address the new hypothesis about the possible harm of red blood cell transfusion. TRIAL REGISTRATION Current Controlled Trials ISRCTN70923932. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 60. See the NIHR Journals Library website for further project information. PMID:27527344

  8. Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial

    Directory of Open Access Journals (Sweden)

    Scherjon Sicco A

    2009-09-01

    Full Text Available Abstract Background Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. Methods/Design The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention or placebo (control for twelve days or until delivery, whatever comes first. Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, β 0.2 at alpha 0.05. Discussion This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. Trial Registration Clinical trial registration: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.

  9. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John;

    2013-01-01

    on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post......INTRODUCTION: Drug-induced cancer risk is of increasing interest. Both observational studies and data from clinical trials have linked several widely used treatments to cancer. When a signal for a potential drug-cancer association is generated, substantiation is required to assess the impact...... challenges must be addressed to enhance the likelihood of reliable conclusions. Advantages of post-hoc analyses of RCTs include quality of data collected and sometimes randomisation to exposure of interest. Limitations include confounding and sample size, which is fixed to suit the purposes of the trial...

  10. Micro-dosimetric study for interpretation of outcomes from boron neutron capture therapy clinical trials

    International Nuclear Information System (INIS)

    Boron neutron capture therapy is a brachy-radiotherapy utilizing the 10B(n,α)7Li reaction that has been used to treat glioblastoma multiforme (GBM), melanoma and colon carcinoma liver metastases. GBM clinical trials resulted in modestly improved life expectancies compared with conventional therapies. Early results trials focused on malignant melanoma and colon carcinoma provide dramatically better results. Macro-dosimetry cannot explain these apparent differences. The dichotomy can only be understood using Micro-dosimetry techniques. A computer program has been created to provide an improved tissue model. This model permits the dose in each cell's cytoplasm, nucleus, and the interstitium to be calculated for ellipsoidal cells placed in either random or ordered locations. The nuclei can be centered or eccentric. The new model provides insight into the micro level for differences in the trials. The differences arise from the tissue's cellular geometry and the effects of neighboring cells. These results help to explain the observed clinical outcomes. (authors)

  11. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    OpenAIRE

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minu...

  12. Is More Better? Outcome and Dose of a Universal Drug Prevention Effectiveness Trial

    OpenAIRE

    Ferrer-Wreder, Laura; Cadely, Hans Saint-Eloi; Domitrovich, Celene E.; Small, Meg L.; Caldwell, Linda L.; Cleveland, Michael J.

    2010-01-01

    Two evidence-based interventions, Life Skills Training and TimeWise, were combined in an effectiveness trial. Participants were predominately African American youth (N = 715; Mage = 12). The study authors provide an empirical demonstration of the implications of incorporating dosage information in intervention outcome analyses. Study results showed no program-related benefits for drug use. Results indicated intervention-related benefits for assertiveness and anxiety management skills and drug...

  13. The effects of endometrial injury on intrauterine insemination outcome: A randomized clinical trial

    OpenAIRE

    Afsoon Zarei; Saeed Alborzi; Nasrin Dadras; Ghazal Azadi

    2014-01-01

    Background: Implantation is considered as the rate-limiting step in success of assisted reproduction techniques, and intrauterine insemination cycles. It might be affected by ovarian superovulation and endometrial local scratching. Objective: This study aims to investigate the effect of local endometrial injury on the outcome of IUI cycles. Materials and Methods: In this randomized clinical trial 144 women with unexplained infertility, mild male factor, and mild endometriosis randomly d...

  14. OSTEOPAThic Health outcomes In Chronic low back pain: The OSTEOPATHIC Trial

    OpenAIRE

    Licciardone, John C; King, Hollis H.; Hensel, Kendi L.; Williams, Daniel G.

    2008-01-01

    Background Osteopathic manipulative treatment (OMT) and ultrasound physical therapy (UPT) are commonly used for chronic low back pain. Although there is evidence from a systematic review and meta-analysis that OMT generally reduces low back pain, there are no large clinical trials that specifically assess OMT efficacy in chronic low back pain. Similarly, there is a lack of evidence involving UPT for chronic low back pain. Methods The OSTEOPAThic Health outcomes In Chronic low back pain (OSTEO...

  15. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Wetterslev, Jørn; al-Subaie, Nawaf;

    2012-01-01

    Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32°C to 34°C for 12 to 24 hours after resuscitation...... from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia in the...... control groups. The optimal target temperature management strategy is not known....

  16. Chronic vagal stimulation for the treatment of low ejection fraction heart failure : results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial

    NARCIS (Netherlands)

    Zannad, Faiez; De Ferrari, Gaetano M; Tuinenburg, Anton E; Wright, David; Brugada, Josep; Butter, Christian; Klein, Helmut; Stolen, Craig; Meyer, Scott; Stein, Kenneth M; Ramuzat, Agnes; Schubert, Bernd; Daum, Doug; Neuzil, Petr; Botman, Cornelis; Castel, Maria Angeles; D'Onofrio, Antonio; Solomon, Scott D; Wold, Nicholas; Ruble, Stephen B

    2015-01-01

    AIM: The neural cardiac therapy for heart failure (NECTAR-HF) was a randomized sham-controlled trial designed to evaluate whether a single dose of vagal nerve stimulation (VNS) would attenuate cardiac remodelling, improve cardiac function and increase exercise capacity in symptomatic heart failure p

  17. Clinical Implications of Cardiovascular Outcome Trials in Type 2 Diabetes: From DCCT to EMPA-REG.

    Science.gov (United States)

    Rydén, Lars; Shahim, Bahira; Mellbin, Linda

    2016-06-01

    Cardiovascular disease is a major threat to people with diabetes. Attempts have long been made to lower cardiovascular risk by means of glucose-lowering treatment. Initially, it seemed that was an option, but subsequent trials could not verify the original observations and there was concern that some glucose-lowering drugs can actually cause cardiovascular harm. This led medical product agencies in the United States and Europe to require major outcomes trials before accepting new glucose-lowering drugs. The least requirement was noninferiority compared with existing treatment modalities. A large number of such trials have been performed or are ongoing, including >100,000 patients. The drug classes investigated are basal insulin, glucagon-like peptide-1 agonists, dipeptidyl peptidase 4 inhibitors, and sodium-glucose cotransporter-2 (SGLT2) inhibitors. This commentary discusses these trials and their outcomes, the reasons why several of them ended with neutral results (noninferiority), and that the likelihood for showing cardiovascular benefit was minor or even nonexistent. The surprising and highly rewarding impact of the SGLT2 inhibitor empagliflozin is described and potential mechanisms for cardiovascular benefits are discussed. PMID:27107734

  18. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials.

    Science.gov (United States)

    Inzucchi, Silvio E; Zinman, Bernard; Wanner, Christoph; Ferrari, Roberto; Fitchett, David; Hantel, Stefan; Espadero, Rosa-Maria; Woerle, Hans-Jürgen; Broedl, Uli C; Johansen, Odd Erik

    2015-03-01

    Given the multi-faceted pathogenesis of atherosclerosis in type 2 diabetes mellitus (T2DM), it is likely that interventions to mitigate this risk must address cardiovascular (CV) risk factors beyond glucose itself. Sodium glucose cotransporter-2 (SGLT-2) inhibitors are newer antihyperglycaemic agents with apparent multiple effects. Inherent in their mode of action to decrease glucose reabsorption by the kidneys by increasing urinary glucose excretion, these agents improve glycaemic control independent of insulin secretion with a low risk of hypoglycaemia. In this review, we outline those CV risk factors that this class appears to influence and provide the design features and trial characteristics of six ongoing outcome trials involving more than 41,000 individuals with T2DM. Those risk factors beyond glucose that can potentially be modulated positively with SGLT-2 inhibitors include blood pressure, weight, visceral adiposity, hyperinsulinaemia, arterial stiffness, albuminuria, circulating uric acid levels and oxidative stress. On the other hand, small increases in low-density lipoprotein (LDL)-cholesterol levels have also been observed for the class, which theoretically might offset some of these benefits. The potential translational impact of these effects is being tested with outcome trials, also reviewed in this article, powered to assess both macrovascular as well as certain microvascular outcomes in T2DM. These are expected to begin to report in late 2015. PMID:25589482

  19. Impact of Dispatcher‐Assisted Bystander Cardiopulmonary Resuscitation on Neurological Outcomes in Children With Out‐of‐Hospital Cardiac Arrests: A Prospective, Nationwide, Population‐Based Cohort Study

    OpenAIRE

    Goto, Yoshikazu; Maeda, Tetsuo; GOTO, YUMIKO

    2014-01-01

    Background The impact of dispatcher‐assisted bystander cardiopulmonary resuscitation (CPR) on neurological outcomes in children is unclear. We investigated whether dispatcher‐assisted bystander CPR shows favorable neurological outcomes (Cerebral Performance Category scale 1 or 2) in children with out‐of‐hospital cardiac arrest (OHCA). Methods and Results Children (n=5009, age

  20. Outcomes after emergency department thoracotomy for penetrating cardiac injuries: a new perspective.

    Science.gov (United States)

    Molina, Ezequiel J; Gaughan, John P; Kulp, Heather; McClurken, James B; Goldberg, Amy J; Seamon, Mark J

    2008-10-01

    Previous reports have described penetrating cardiac injuries as the anatomic injury with the greatest opportunity for emergency department thoracotomy (EDT) survival. We hypothesize that actual survival rates are lower than that initially reported. A retrospective review of our EDT experience was performed. Data collected included injury mechanism and location, presence of measurable ED vital signs, initial ED cardiac rhythm, GCS, method of transportation, and survival. Logistic regression analysis identified predictors of survival. Ninety-four of 237 patients presented penetrating cardiac injuries after EDT. Eighty-nine patients (95%) were males. Measurable ED vital signs were present in 15 patients (16%). Cardiac injuries were caused by GSW in 82 patients (87%) and SW in 12 patients (13%). Fifteen patients (16%) survived EDT and were taken to the operating room, while eight patients (8%) survived their entire hospitalization. All survivors were neurologically intact. Survival rates were 5% for GSW and 33% for SW. Mechanism of injury (SW), prehospital transportation by police, higher GCS, sinus tachycardia, and measurable ED vital signs were associated with improved survival. In urban trauma centers where firearm injuries are much more common than stabbings, the presence of a penetrating cardiac injury may no longer be considered a predictor of survival after EDT. PMID:18653499

  1. Prevention of cardiac dysfunction during adjuvant breast cancer therapy (PRADA): a 2 × 2 factorial, randomized, placebo-controlled, double-blind clinical trial of candesartan and metoprolol

    Science.gov (United States)

    Gulati, Geeta; Heck, Siri Lagethon; Ree, Anne Hansen; Hoffmann, Pavel; Schulz-Menger, Jeanette; Fagerland, Morten W.; Gravdehaug, Berit; von Knobelsdorff-Brenkenhoff, Florian; Bratland, Åse; Storås, Tryggve H.; Hagve, Tor-Arne; Røsjø, Helge; Steine, Kjetil; Geisler, Jürgen; Omland, Torbjørn

    2016-01-01

    Aims Contemporary adjuvant treatment for early breast cancer is associated with improved survival but at the cost of increased risk of cardiotoxicity and cardiac dysfunction. We tested the hypothesis that concomitant therapy with the angiotensin receptor blocker candesartan or the β-blocker metoprolol will alleviate the decline in left ventricular ejection fraction (LVEF) associated with adjuvant, anthracycline-containing regimens with or without trastuzumab and radiation. Methods and results In a 2 × 2 factorial, randomized, placebo-controlled, double-blind trial, we assigned 130 adult women with early breast cancer and no serious co-morbidity to the angiotensin receptor blocker candesartan cilexetil, the β-blocker metoprolol succinate, or matching placebos in parallel with adjuvant anticancer therapy. The primary outcome measure was change in LVEF by cardiac magnetic resonance imaging. A priori, a change of 5 percentage points was considered clinically important. There was no interaction between candesartan and metoprolol treatments (P = 0.530). The overall decline in LVEF was 2.6 (95% CI 1.5, 3.8) percentage points in the placebo group and 0.8 (95% CI −0.4, 1.9) in the candesartan group in the intention-to-treat analysis (P-value for between-group difference: 0.026). No effect of metoprolol on the overall decline in LVEF was observed. Conclusion In patients treated for early breast cancer with adjuvant anthracycline-containing regimens with or without trastuzumab and radiation, concomitant treatment with candesartan provides protection against early decline in global left ventricular function. PMID:26903532

  2. Long-Term Outcomes of Cardiac Rehabilitation in Diabetic and Non-diabetic Patients With Myocardial Infarction

    OpenAIRE

    Kim, Hyun Jun; Joo, Min Cheol; Noh, Se Eung; Kim, Ji Hee

    2015-01-01

    Objective To investigate the long-term outcomes of cardiac rehabilitation (CR) on exercise capacity in diabetic (DM) and non-diabetic (non-DM) patients with myocardial infarction (MI). Methods Of the MI patients who received hospital-based CR from February 2012 to January 2014, we retrospectively reviewed the medical records of the patients who continued follow-up through the outpatient clinic and community-based self-exercise after CR. A total of 37 patients (12 with DM and 25 without DM) we...

  3. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial

    DEFF Research Database (Denmark)

    Rafiq, Sulman; Steinbrüchel, Daniel Andreas; Wanscher, Michael Jaeger;

    2014-01-01

    BACKGROUND: To evaluate if an opiate sparing multimodal regimen of dexamethasone, gabapentin, ibuprofen and paracetamol had better analgesic effect, less side effects and was safe compared to a traditional morphine and paracetamol regimen after cardiac surgery. METHODS: Open-label, prospective...

  4. Cardiac rehabilitation adapted to transient ischaemic attack and stroke (CRAFTS): a randomised controlled trial

    OpenAIRE

    Blake Catherine; Lennon Olive

    2009-01-01

    Abstract Background Coronary Heart Disease and Cerebrovascular Disease share many predisposing, modifiable risk factors (hypertension, abnormal blood lipids and lipoproteins, cigarette smoking, physical inactivity, obesity and diabetes mellitus). Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention. Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population. ...

  5. A simple method for analyzing data from a randomized trial with a missing binary outcome

    Directory of Open Access Journals (Sweden)

    Freedman Laurence S

    2003-05-01

    Full Text Available Abstract Background Many randomized trials involve missing binary outcomes. Although many previous adjustments for missing binary outcomes have been proposed, none of these makes explicit use of randomization to bound the bias when the data are not missing at random. Methods We propose a novel approach that uses the randomization distribution to compute the anticipated maximum bias when missing at random does not hold due to an unobserved binary covariate (implying that missingness depends on outcome and treatment group. The anticipated maximum bias equals the product of two factors: (a the anticipated maximum bias if there were complete confounding of the unobserved covariate with treatment group among subjects with an observed outcome and (b an upper bound factor that depends only on the fraction missing in each randomization group. If less than 15% of subjects are missing in each group, the upper bound factor is less than .18. Results We illustrated the methodology using data from the Polyp Prevention Trial. We anticipated a maximum bias under complete confounding of .25. With only 7% and 9% missing in each arm, the upper bound factor, after adjusting for age and sex, was .10. The anticipated maximum bias of .25 × .10 =.025 would not have affected the conclusion of no treatment effect. Conclusion This approach is easy to implement and is particularly informative when less than 15% of subjects are missing in each arm.

  6. Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

    Science.gov (United States)

    Krohe, Meaghan; Hao, Yanni; Lamoureux, Roger E.; Galipeau, Nina; Globe, Denise; Foley, Catherine; Mazar, Iyar; Solomon, Jeffrey; Shields, Alan L.

    2016-01-01

    INTRODUCTION Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials. METHODS A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized. RESULTS Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy—Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain. CONCLUSION This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials. PMID:27441001

  7. Testing for heterogeneity among the components of a binary composite outcome in a clinical trial

    Directory of Open Access Journals (Sweden)

    Devereaux PJ

    2010-06-01

    Full Text Available Abstract Background Investigators designing clinical trials often use composite outcomes to overcome many statistical issues. Trialists want to maximize power to show a statistically significant treatment effect and avoid inflation of Type I error rate due to evaluation of multiple individual clinical outcomes. However, if the treatment effect is not similar among the components of this composite outcome, we are left not knowing how to interpret the treatment effect on the composite itself. Given significant heterogeneity among these components, a composite outcome may be judged as being invalid or un-interpretable for estimation of the treatment effect. This paper compares the power of different tests to detect heterogeneity of treatment effect across components of a composite binary outcome. Methods Simulations were done comparing four different models commonly used to analyze correlated binary data. These models included: logistic regression for ignoring correlation, logistic regression weighted by the intra cluster correlation coefficient, population average logistic regression using generalized estimating equations (GEE, and random effects logistic regression. Results We found that the population average model based on generalized estimating equations (GEE had the greatest power across most scenarios. Adequate power to detect possible composite heterogeneity or variation between treatment effects of individual components of a composite outcome was seen when the power for detecting the main study treatment effect for the composite outcome was also reasonably high. Conclusions It is recommended that authors report tests of composite heterogeneity for composite outcomes and that this accompany the publication of the statistically significant results of the main effect on the composite along with individual components of composite outcomes.

  8. The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

    Directory of Open Access Journals (Sweden)

    Ji Yun Lee

    Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

  9. Initial outcome following invasive cardiac electrophysiologic studies and radiofrequency ablation of atrial fibrillation

    Science.gov (United States)

    Uwanuruochi, Kelechukwu; Saravanan, Sabari; Ganasekar, Anita; Solomon, Benjamin S; Murugesan, Ravikumar; Shah, Ruchit A; Krishnamoorthy, Jaishankar; Pandurangi, Ulhas M

    2016-01-01

    Background: Cardiac electrophysiologic study and radiofrequency ablation (RFA) have become an established mode of treatment for patients with refractory arrhythmias. These procedures are carried out regularly at the cardiac catheterization laboratory of Madras Medical Mission India. Objective: The purpose of this study was to evaluate our experience with cardiac electrophysiologic studies (EPS) and RFA catheter of atrial fibrillation (AF). Materials and Methods: This was a retrospective study carried out in the Cardiac Electrophysiology Department of the Institute of Cardiovascular Diseases, Madras Medical Mission, India. All cases diagnosed to have AF following cardiac EPS between January 2010 and April 2014 was selected for the study. The records, which were obtained from the Cardiac Electrophysiology Clinical Research Office of Madras Medical Mission, were reviewed. Forty-nine cases were chosen for analysis, using SPSS statistical software version 15. Results: There were 49 patients, 23 males and 26 females. The mean age was 57.53 years. Commonly associated diseases were diabetes mellitus 8 (16.3%), hypertension 18 (36.7%), and coronary heart disease 14 (28.5%). The ventricular rate was rapid most cases (91.2%). AF was diagnosed as being paroxysmal in 40 (81.6%), persistent in 5 (10.2%), chronic in 3 (6.1%), and lone in 1 (2.0%). Ablation was carried out in 28 (57.1%), the success rate being 90% for pulmonary vein isolation, and 90.9% for atrioventricular node ablation. Complication rate was 2.04%. Conclusions: Treatment of AF by RFA is highly effective and safe.

  10. Understanding the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) Trial Implications for current and future clinical practice

    OpenAIRE

    Farooq, Vasim

    2014-01-01

    markdownabstract__Abstract__ The landmark Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) Trial1-4 has aided in reducing the area of uncertainty in decision making between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery in patients with complex coronary artery disease.5-8 As part of the SYNTAX Trial, quantification of the coronary artery disease burden was undertaken with the anatomical SYNTAX Score (www.synta...

  11. A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial

    OpenAIRE

    Wax Randy; Rubenfeld Gordon; Ferguson Niall; Dorian Paul; Needham Dale M; Brooks Steve C; Scales Damon C; Dainty Katie N; Zwarenstein Merrick; Thorpe Kevin; Morrison Laurie J

    2011-01-01

    Abstract Background Advances in resuscitation science have dramatically improved survival rates following cardiac arrest. However, about 60% of adults that regain spontaneous circulation die before leaving the hospital. Recently it has been shown that inducing hypothermia in cardiac arrest survivors immediately following their arrival in hospital can dramatically improve both overall survival and neurological outcomes. Despite the strong evidence for its efficacy and the apparent simplicity o...

  12. Urinary tract infection in children after cardiac surgery: Incidence, causes, risk factors and outcomes in a single-center study.

    Science.gov (United States)

    Kabbani, Mohamed S; Ismail, Sameh R; Fatima, Anis; Shafi, Rehana; Idris, Julinar A; Mehmood, Akhter; Singh, Reetam K; Elbarabry, Mahmoud; Hijazi, Omar; Hussein, Mohamed A

    2016-01-01

    Nosocomial urinary tract infection (UTI) increases hospitalization, cost and morbidity. In this cohort study, we aimed to determine the incidence, risk factors, etiology and outcomes of UTIs in post-operative cardiac children. To this end, we studied all post-operative patients admitted to the Pediatric Cardiac Intensive Care Unit (PCICU) in 2012, and we divided the patients into two groups: the UTI (UTI group) and the non-UTI (control group). We compared both groups for multiple peri-operative risk factors. We included 413 children in this study. Of these, 29 (7%) had UTIs after cardiac surgery (UTI group), and 384 (93%) were free from UTIs (control group). All UTI cases were catheter-associated UTIs (CAUTIs). A total of 1578 urinary catheter days were assessed in this study, with a CAUTI density rate of 18 per 1000 catheter days. Multivariate logistic regression analysis demonstrated the following risk factors for CAUTI development: duration of urinary catheter placement (pcongenital abnormalities of kidney and urinary tract (CAKUT) (purinary catheter, the presence of CAKUT, and the presence of syndromes comprised the main risk factors for CAUTI. Gram-negative organisms were the main causes for CAUTI, and one-third of them found to be resistant in this single-center study. PMID:26829892

  13. The New York State cardiac registries: history, contributions, limitations, and lessons for future efforts to assess and publicly report healthcare outcomes.

    Science.gov (United States)

    Hannan, Edward L; Cozzens, Kimberly; King, Spencer B; Walford, Gary; Shah, Nirav R

    2012-06-19

    In 1988, the New York State Health Commissioner was confronted with hospital-level data demonstrating very large, multiple-year, interhospital variations in short-term mortality and complications for cardiac surgery. The concern with the extent to which these differences were due to variations in patients' pre-surgical severity of illness versus hospitals' quality of care led to the development of clinical registries for cardiac surgery in 1989 and for percutaneous coronary interventions in 1992 in New York. In 1990, the Department of Health released hospitals' risk-adjusted cardiac surgery mortality rates for the first time, and shortly thereafter, similar data were released for hospitals and physicians for percutaneous coronary interventions, cardiac valve surgery, and pediatric cardiac surgery (only hospital data). This practice is still ongoing. The purpose of this communication is to relate the history of this initiative, including changes or purported changes that have occurred since the public release of cardiac data. These changes include decreases in risk-adjusted mortality, cessation of cardiac surgery in New York by low-volume and high-mortality surgeons, out-of-state referral or avoidance of cardiac surgery/angioplasty for high-risk patients, alteration of contracting choices by insurance companies, and modifications in market share of cardiac hospitals. Evidence related to these impacts is reviewed and critiqued. This communication also includes a summary of numerous studies that used New York's cardiac registries to examine a variety of policy issues regarding the choice and use of cardiac procedures, the comparative effectiveness of competing treatment options, and the examination of the relationship among processes, structures, and outcomes of cardiac care. PMID:22698487

  14. The InterHerz project - a web-based psychological treatment for cardiac patients with depression: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Messerli-Bürgy Nadine

    2012-12-01

    Full Text Available Abstract Background Patients with heart disease often suffer from difficulties in psychological adaptation during cardiac rehabilitation. Mood disorders such as depression are known to be highly prevalent in cardiac patients and to have a negative impact on the progression of coronary heart disease. However, cardiac patients have difficulties to get psychological treatments due to low availability and motivational difficulties. Web-based interventions have been proven to be effective in treating depressive symptoms. Deprexis is a promising web-based psychological treatment which was devised for depressed patients. The aim of the study InterHerz is to examine if Deprexis is an effective psychological treatment to reduce stress and depression in cardiac patients. Methods/Design The sample will consist of 80 depressed patients randomized to an intervention group or a waitlist (10 weeks. Patients are recruited via cardiologists, cardiac rehabilitation units and the website of the Swiss Heart Foundation. Patients have access to a guided self-help program in which they work themselves through several modules and receive feedback from a clinical psychologist. Pre- and post-assessments, and a six-month follow-up, are conducted using online questionnaires and diagnostic interviews. Discussion Deprexis is a new web-based treatment which has the potential to help depressed cardiac patients with limited access to psychological treatment to increase their mental health. Trial registration Current Controlled Trials ISRCTN45945396

  15. Process and Outcome in Cardiac Rehabilitation: An Examination of Cross-Lagged Effects.

    Science.gov (United States)

    Evon, Donna M.; Burns, John W.

    2004-01-01

    Cardiac rehabilitation patients improve cardiorespiratory fitness and quality of life, yet therapeutic processes that produce these changes remain unknown. A cross-lagged panel design was used to determine whether early-treatment enhancement of self-efficacy regarding abilities to change diet and exercise habits and the quality of the…

  16. Are antifibrinolytic drugs equivalent in reducing blood loss and transfusion in cardiac surgery? A meta-analysis of randomized head-to-head trials

    Directory of Open Access Journals (Sweden)

    Stokes Barrie J

    2005-07-01

    Full Text Available Abstract Background Aprotinin has been shown to be effective in reducing peri-operative blood loss and the need for re-operation due to continued bleeding in cardiac surgery. The lysine analogues tranexamic acid (TXA and epsilon aminocaproic acid (EACA are cheaper, but it is not known if they are as effective as aprotinin. Methods Studies were identified by searching electronic databases and bibliographies of published articles. Data from head-to-head trials were pooled using a conventional (Cochrane meta-analytic approach and a Bayesian approach which estimated the posterior probability of TXA and EACA being equivalent to aprotinin; we used as a non-inferiority boundary a 20% increase in the rates of transfusion or re-operation because of bleeding. Results Peri-operative blood loss was significantly greater with TXA and EACA than with aprotinin: weighted mean differences were 106 mls (95% CI 37 to 227 mls and 185 mls (95% CI 134 to 235 mls respectively. The pooled relative risks (RR of receiving an allogeneic red blood cell (RBC transfusion with TXA and EACA, compared with aprotinin, were 1.08 (95% CI 0.88 to 1.32 and 1.14 (95% CI 0.84 to 1.55 respectively. The equivalent Bayesian posterior mean relative risks were 1.15 (95% Bayesian Credible Interval [BCI] 0.90 to 1.68 and 1.21 (95% BCI 0.79 to 1.82 respectively. For transfusion, using a 20% non-inferiority boundary, the posterior probabilities of TXA and EACA being non-inferior to aprotinin were 0.82 and 0.76 respectively. For re-operation the Cochrane RR for TXA vs. aprotinin was 0.98 (95% CI 0.51 to 1.88, compared with a posterior mean Bayesian RR of 0.63 (95% BCI 0.16 to 1.46. The posterior probability of TXA being non-inferior to aprotinin was 0.92, but this was sensitive to the inclusion of one small trial. Conclusion The available data are conflicting regarding the equivalence of lysine analogues and aprotinin in reducing peri-operative bleeding, transfusion and the need for re

  17. Effect of Gender on Outcomes After Cardiac Resynchronization Therapy in Patients With a Narrow QRS Complex

    DEFF Research Database (Denmark)

    Steffel, Jan; Varma, Niraj; Robertson, Michele;

    2016-01-01

    because of the premature termination of the trial and the limited data. These results suggest that male sex may be a risk factor for harm by CRT in patients with narrow QRS width, an observation which deserves further investigation. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique...

  18. CKD classification based on estimated GFR over three years and subsequent cardiac and mortality outcomes: a cohort study

    Directory of Open Access Journals (Sweden)

    Salem Deeb N

    2009-09-01

    Full Text Available Abstract Background It is unknown whether defining chronic kidney disease (CKD based on one versus two estimated glomerular filtration rate (eGFR assessments changes the prognostic importance of reduced eGFR in a community-based population. Methods Participants in the Atherosclerosis Risk in Communities Study and the Cardiovascular Health Study were classified into 4 groups based on two eGFR assessments separated by 35.3 ± 2.5 months: sustained eGFR 2 (1 mL/sec per 1.73 m2; eGFR increase (change from below to above 60; eGFR decline (change from above to below 60; and eGFR persistently ≥60. Outcomes assessed in stratified multivariable Cox models included cardiac events and a composite of cardiac events, stroke, and mortality. Results There were 891 (4.9% participants with sustained eGFR 60. Participants with eGFR sustained Conclusion Individuals with persistently reduced eGFR are at highest risk of cardiovascular outcomes and mortality, while individuals with an eGFR 2 at any time are at intermediate risk. Use of even a single measurement of eGFR to classify CKD in a community population appears to have prognostic value.

  19. Costs and Outcomes in the Care of Bi-ventricular Support as a Bridge to Cardiac Transplant.

    Science.gov (United States)

    Swartz, Michael F; Angona, Ron; Smith, Karen; Kraenzlin, Franca; Stypula, Christine M; Joshi, Devang; Tchantchaleishvili, Vakhtang; Hicks, George L; Massey, H Todd

    2016-01-01

    Bi-ventricular (Bi-V) mechanical circulatory support is commonly used as a bridge to cardiac transplant. However, the optimal strategy is unknown. We examined the outcomes, as well as the costs in the use of Bi-V support as a bridge to cardiac transplant. From 2001 to 2014, three different Bi-V support strategies were utilized: 1) Para-corporeal ventricular assist device (PVAD-2001-2006), 2) Heartmate II left ventricular assist device in conjunction with a temporary CentriMag right ventricular assist device (HMII + CMAG-2006-2012), and the total artificial heart (TAH-2012-2014). Total costs were derived from the hospitalization at implant, and postimplant costs defined as equipment and re-hospitalizations before transplantation. Sixty-five (34 PVADs, 20 HMII + CMAG, and 11 TAHs) devices were used as a bridge for transplant. There were no differences in implant variables including age, INTERMACS score, or implant length of stay. Although the wait list mortality was not different between groups (PVAD-32%, HMII + CMAG-45%, TAH-54%; p = 0.3), the percentage of patients transplanted were highest in the PVAD group: (PVAD-55.8%, HMII + CMAG-30.0%, TAH-18.2%; p = 0.01). Total costs were not significantly different between groups (PVAD-$306,166 ± 247,839, HMII + CMAG-$278,958 ± 135,324, TAH-$321,387 ± 21,2477; p = 0.5). Despite variations in therapy, outcomes and costs for patients requiring Bi-V support as a bridge to cardiac transplant have remained constant. PMID:27258229

  20. Symbolic Dynamic Analysis of Relations Between Cardiac and Breathing Cycles in Patients on Weaning Trials

    OpenAIRE

    Caminal Magrans, Pere; Giraldo Giraldo, Beatriz; Vallverdú Ferrer, Montserrat; Benito Vales, Salvador; Schroeder, Rico; Voss, Andreas

    2010-01-01

    Traditional time-domain techniques of data analysis are often not sufficient to characterize the complex dynamics of the cardiorespiratory interdependencies during the weaning trials. In this paper, the interactions between the heart rate (HR) and the breathing rate (BR) were studied using joint symbolic dynamic analysis. A total of 133 patients on weaning trials from mechanical ventilation were analyzed: 94 patients with successful weaning (group S) and 39 patients that failed to ma...

  1. A trial to reduce cardiac motion artifact on HR-CT images of the lung with the use of subsecond scan and special cine reconstruction algorithm

    International Nuclear Information System (INIS)

    We describe our trial to reduce cardiac motion artifacts on HR-CT images caused by cardiac pulsation by combining use of subsecond CT (scan time 0.8 s) and a special cine reconstruction algorithm (cine reconstruction algorithm with 180-degree helical interpolation). Eleven to 51 HR-CT images were reconstructed with the special cine reconstruction algorithm at the pitch of 0.1 (0.08 s) from the data obtained by two to six contigious rotation scans at the same level. Images with the fewest cardiac motion artifacts were selected for evaluation. These images were compared with those reconstructed with a conventional cine reconstruction algorithm and step-by-step scan. In spite of its increased radiation exposure, technical complexity and slight degradation of spatial resolution, our method was useful in reducing cardiac motion artifacts on HR-CT images in regions adjacent to the heart. (author)

  2. Prediction of responders for outcome measures of Locomotor Experience Applied Post Stroke trial

    Directory of Open Access Journals (Sweden)

    Bruce H. K. Dobkin, MD

    2014-03-01

    Full Text Available The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-related outcomes and measures that captured disability, physical impairment, and quality of life. The most robust predictor was being closer at baseline to the primary outcome measure, which was the functional walking speed thresholds of 0.4 m/s (household walking and 0.8 m/s (community walking. Regardless of baseline walking speed, a younger age and higher Berg Balance Scale score were relative predictors of responding, whether operationally defined by transitioning beyond each speed boundary or by a continuous change or a greater than median increase in walking speed. Of note, the cutoff values of 0.4 and 0.8 m/s had no particular significance compared with other walking speed changes despite their general use as descriptors of functional levels of walking. No evidence was found for any difference in predictors based on treatment group.

  3. Measures of between-cluster variability in cluster randomized trials with binary outcomes.

    Science.gov (United States)

    Thomson, Andrew; Hayes, Richard; Cousens, Simon

    2009-05-30

    Cluster randomized trials (CRTs) are increasingly used to evaluate the effectiveness of health-care interventions. A key feature of CRTs is that the observations on individuals within clusters are correlated as a result of between-cluster variability. Sample size formulae exist which account for such correlations, but they make different assumptions regarding the between-cluster variability in the intervention arm of a trial, resulting in different sample size estimates. We explore the relationship for binary outcome data between two common measures of between-cluster variability: k, the coefficient of variation and rho, the intracluster correlation coefficient. We then assess how the assumptions of constant k or rho across treatment arms correspond to different assumptions about intervention effects. We assess implications for sample size estimation and present a simple solution to the problems outlined. PMID:19378266

  4. Larger Centers Produce Better Outcomes in Pediatric Cardiac Surgery: Regionalization is a Superior Model - The Con Prospective.

    Science.gov (United States)

    Danton, Mark H D

    2016-01-01

    Regionalization, in the context of congenital heart surgery, describes a process where smaller units close and patients are redistributed to larger centers. Proponents argue this will produce superior patient outcome based primarily on a volume-outcome effect. The potential disadvantage is that, as distance to center increases, access to service is compromised. In this article the volume-outcome effect is appraised and the effect of risk-stratification and threshold volumes explored. Access to service, and how certain congenital lesions and demographics might be disadvantaged, is reviewed. Alternative models are considered including collaborative programing and a standardizing approach of agreed parameters in personnel and infrastructure. Finally the influence of newer developments and quality metrics, including outcome databases, digital technologies and team-cognitive performance, needs to be factored in as the future unfolds. Ultimately, the design of a national congenital cardiac program should aspire to deliver care that is optimal, equitable and economic for the whole population. The solution lies in the distillation of competing variables cognizant of regional demographics and geography. PMID:27060038

  5. Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

    International Nuclear Information System (INIS)

    Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. A significant atrophy occurred over 6 months (PBVC = -0.33%, SE = 0.061, p < 0.0001). The number of baseline T2 lesions (p = 0.024), the on-study Gd-enhancing lesion volume (p = 0.044), and the number of on-study PBHs (p = 0.003) were associated with an increased rate of atrophy. For a 50% decrease in rate of atrophy, the sample size calculations showed that approximately 283 patients per arm are required in an unselected sampled population and 185 patients per arm are required in a selected population. Within a 6-month period, significant atrophy can be detected and on-study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism. Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power. (orig.)

  6. Technology-Enabled Remote Monitoring and Self-Management — Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol

    Science.gov (United States)

    Yost, Jennifer; Turner, Andrew; Bender, Duane; Scott, Ted; Carroll, Sandra; Ritvo, Paul; Peter, Elizabeth; Lamy, Andre; Furze, Gill; Krull, Kirsten; Dunlop, Valerie; Good, Amber; Dvirnik, Nazari; Bedini, Debbie; Naus, Frank; Pettit, Shirley; Henry, Shaunattonie; Probst, Christine; Mills, Joseph; Gossage, Elaine; Travale, Irene; Duquette, Janine; Taberner, Christy; Bhavnani, Sanjeev; Khan, James S; Cowan, David; Romeril, Eric; Lee, John; Colella, Tracey; Choinière, Manon; Busse, Jason; Katz, Joel; Victor, J Charles; Hoch, Jeffrey; Isaranuwatchai, Wanrudee; Kaasalainen, Sharon; Ladak, Salima; O'Keefe-McCarthy, Sheila; Parry, Monica; Sessler, Daniel I; Stacey, Michael; Stevens, Bonnie; Stremler, Robyn; Thabane, Lehana; Watt-Watson, Judy; Whitlock, Richard; MacDermid, Joy C; Leegaard, Marit; McKelvie, Robert; Hillmer, Michael; Cooper, Lynn; Arthur, Gavin; Sider, Krista; Oliver, Susan; Boyajian, Karen; Farrow, Mark; Lawton, Chris; Gamble, Darryl; Walsh, Jake; Field, Mark; LeFort, Sandra; Clyne, Wendy; Ricupero, Maria; Poole, Laurie; Russell-Wood, Karsten; Weber, Michael; McNeil, Jolene; Alpert, Robyn; Sharpe, Sarah; Bhella, Sue; Mohajer, David; Ponnambalam, Sem; Lakhani, Naeem; Khan, Rabia; Liu, Peter

    2016-01-01

    Background Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT—VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom. Objective Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT). Methods CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a

  7. Analyses of Results From Cardiovascular Safety Trials With DPP-4 Inhibitors: Cardiovascular Outcomes, Predefined Safety Outcomes, and Pooled Analysis and Meta-analysis.

    Science.gov (United States)

    Mannucci, Edoardo; Mosenzon, Ofri; Avogaro, Angelo

    2016-08-01

    The U.S. Food and Drug Administration requires that the cardiovascular (CV) safety of all new drugs for diabetes be demonstrated through pooled analyses of phase III studies or specifically designed trials. This requirement prompted several placebo-controlled, noninferiority CV safety trials in high-risk patients; to date, all completed trials showed that dipeptidyl peptidase (DPP)-4 inhibitors do not increase or reduce the risk of major CV events. These results apparently contrast with those of pooled analyses and meta-analyses of previous, smaller trials with metabolic end points, which had suggested a reduction of risk. However, the design of CV trials, which were required to demonstrate safety, is not adequate (for duration, management of concurrent therapies, etc.) for the assessment of potential therapeutic benefits. In addition, CV safety trials enroll patients at high risk of CV events, who are different from those included in earlier trials with metabolic end points. Differences in characteristics of patients enrolled probably account for most of the discrepancy in CV outcomes between CV safety studies and earlier trials. The availability of several large-scale trials with longer duration provides the unique opportunity for assessment of the safety of DPP-4 inhibitors not only with respect to major CV events but also with reference to other safety issues. For example, CV safety trials can be a source of information for pancreatitis, cancer, or hypoglycemia. PMID:27440833

  8. Protocol for: Sheffield Obesity Trial (SHOT): A randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents [ISRCNT83888112

    OpenAIRE

    Wright Neil P; Copeland Robert J; Daley Amanda J; Wales Jerry KH

    2005-01-01

    Abstract Background While obesity is known to have many physiological consequences, the psychopathology of this condition has not featured prominently in the literature. Cross-sectional studies have indicated that obese children have increased odds of experiencing poor quality of life and mental health. However, very limited trial evidence has examined the efficacy of exercise therapy for enhancing mental health outcomes in obese children, and the Sheffield Obesity Trial (SHOT) will provide e...

  9. Socioeconomic inequalities in quality of life and psychological outcomes among cardiac patients

    OpenAIRE

    Skodova, Zuzana; Nagyova, Iveta; van Dijk, Jitse P.; Sudzinova, Adriana; Vargova, Helena; Rosenberger, Jaroslav; Middel, Berrie; Studencan, Martin; Reijneveld, Sijmen A.

    2009-01-01

    The aim of this article is to explore socioeconomic inequalities in the psychological characteristics (psychological well-being, perceived mental health status) and perceived quality of life among cardiac patients. A structured interview was conducted with 362 patients (32% women, mean age 56 +/- 7.3 years) referred for coronary angiography. The GHQ-28 was used to measure psychological well-being, the SF-36 for perceived mental health status. Income and education indicated socioeconomic posit...

  10. Association of cardiac troponin I with disease severity and outcomes in patients with pulmonary hypertension.

    Science.gov (United States)

    Vélez-Martínez, Mariella; Ayers, Colby; Mishkin, Joseph D; Bartolome, Sonja B; García, Christine K; Torres, Fernando; Drazner, Mark H; de Lemos, James A; Turer, Aslan T; Chin, Kelly M

    2013-06-15

    Previous studies have identified cardiac troponin I (cTnI) as an important marker in pulmonary hypertension (PH) prognosis. However, traditional assays are limited by poor sensitivity, even among patients at high risk. cTnI was measured in 255 PH patients using a new highly sensitive (hs) assay. Other measures included demographics, creatinine, 6-minute walk distance, hemodynamics, cardiac magnetic resonance imaging, and B-type natriuretic peptide level. The association between cTnI and survival was assessed using Kaplan-Meier analysis and Cox regression. cTnI was detectable with the hs assay in 95% of the patients with a median level of 6.9 pg/ml (IQR 2.7-12.6 pg/ml). Higher cTnI levels associated with higher levels of B-type natriuretic peptide, shorter 6-minute walk distance, and more severe hemodynamic and cardiac magnetic resonance imaging abnormalities. During a median follow-up of 3.5 years, 60 individuals died. Unadjusted event rates increased across higher cTnI quartiles (3, 5, 13, 17 events/100 person-years, respectively, p trend = 0.002). cTnI in the fourth (vs first) quartile remained associated with death in a final stepwise multivariable model that included clinical variables and hemodynamics (adjusted hazard ratio 5.3, 95% confidence interval 1.8-15.6). In conclusion, cTnI levels, detectable with a novel hs assay, identify patients with PH who have more severe hemodynamic and cardiac structural abnormalities and provide novel and independent prognostic information. This hs assay has the potential to detect more at-risk patients and improve current risk-stratification algorithms. PMID:23540547

  11. Contaminated heparin and outcomes after cardiac surgery: a retrospective propensity-matched cohort study.

    OpenAIRE

    Kaiser, Heiko Andreas; Ben Abdallah, Arbi; Lin, Nan; Tellor, Bethany R.; Helwani, Mohammad; Smith, Jennifer R.; Moon, Marc R.; Avidan, Michael S

    2014-01-01

    BACKGROUND During 2007 and 2008 it is likely that millions of patients in the US received heparin contaminated (CH) with oversulfated chondroitin sulfate, which was associated with anaphylactoid reactions. We tested the hypothesis that CH was associated with serious morbidity, mortality, intensive care unit (ICU) stay and heparin-induced thrombocytopenia following adult cardiac surgery. METHODS AND FINDINGS We conducted a single center, retrospective, propensity-matched cohort stu...

  12. Contaminated Heparin and Outcomes after Cardiac Surgery: A Retrospective Propensity-Matched Cohort Study

    OpenAIRE

    Kaiser, Heiko A.; Arbi Ben Abdallah; Nan Lin; Tellor, Bethany R.; Mohammad Helwani; Smith, Jennifer R.; Moon, Marc R.; Avidan, Michael S

    2014-01-01

    Background During 2007 and 2008 it is likely that millions of patients in the US received heparin contaminated (CH) with oversulfated chondroitin sulfate, which was associated with anaphylactoid reactions. We tested the hypothesis that CH was associated with serious morbidity, mortality, intensive care unit (ICU) stay and heparin-induced thrombocytopenia following adult cardiac surgery. Methods and Findings We conducted a single center, retrospective, propensity-matched cohort study during th...

  13. Early and long-term outcomes of pericardiotomy in the treatment of primary cardiac tamponade

    Science.gov (United States)

    Tomaszewska, Iga; Stefaniak, Sebastian; Bartczak, Agnieszka; Jemielity, Marek

    2015-01-01

    Introduction Cardiac tamponade is a life-threatening clinical entity that requires emergent treatment. A variety of therapeutic methods have been applied. The purpose of this retrospective analysis was to study the efficacy of emergent surgical pericardiotomy in both the relief of cardiac tamponade and in the prevention of recurrence of pericardial effusion. Material and methods This study involved 90 consecutive patients (58 males and 32 females) with a mean age of 57.4 ± 14.1 years, who underwent emergent pericardiotomy in the years 2006 to 2011 due to symptomatic primary cardiac tamponade. At the end of the follow-up period all living subjects had control echocardiographic examination. Survival analysis was performed with the use of the Kaplan-Meier method. Results The mean duration time of surgery was 14.2 ± 4.5 minutes. All patients survived surgery but one died during in-hospital stay. During the post-discharge follow-up period (median 49 months) 32 patients died for any reason. One-year and four-year probability of survival was 0.68 ± 0.05 and 0.64 ± 0.05, respectively. Malignancy diagnosis was associated with significant negative impact on survival. One-year and four-year probability of survival was 0.56 ± 0.06 and 0.53 ± 0.06 for cancer patients while it was 0.93 ± 0.05 and 0.89 ± 0.06 for the others, respectively. In two cases, only cancer patients, re-intervention due to effusion recurrence was necessary. Conclusions Pericardiotomy, although invasive, is a safe method to relieve cardiac tamponade. It is also very efficient in the prevention of recurrence of pericardial effusion, even in cancer patients. PMID:26702272

  14. High incidence and variable clinical outcome of cardiac hypertrophy due to ACAD9 mutations in childhood.

    Science.gov (United States)

    Collet, Marie; Assouline, Zahra; Bonnet, Damien; Rio, Marlène; Iserin, Franck; Sidi, Daniel; Goldenberg, Alice; Lardennois, Caroline; Metodiev, Metodi Dimitrov; Haberberger, Birgit; Haack, Tobias; Munnich, Arnold; Prokisch, Holger; Rötig, Agnès

    2016-08-01

    Acyl-CoA dehydrogenase family, member 9 (ACAD9) mutation is a frequent, usually fatal cause of early-onset cardiac hypertrophy and mitochondrial respiratory chain complex I deficiency in early childhood. We retrospectively studied a series of 20 unrelated children with cardiac hypertrophy and isolated complex I deficiency and identified compound heterozygosity for missense, splice site or frame shift ACAD9 variants in 8/20 patients (40%). Age at onset ranged from neonatal period to 9 years and 5/8 died in infancy. Heart transplantation was possible in 3/8. Two of them survived and one additional patient improved spontaneously. Importantly, the surviving patients later developed delayed-onset neurologic or muscular symptoms, namely cognitive impairment, seizures, muscle weakness and exercise intolerance. Other organ involvement included proximal tubulopathy, renal failure, secondary ovarian failure and optic atrophy. We conclude that ACAD9 mutation is the most frequent cause of cardiac hypertrophy and isolated complex I deficiency. Heart transplantation in children surviving neonatal period should be considered with caution, as delayed-onset muscle and brain involvement of various severity may occur, even if absent prior to transplantation. PMID:26669660

  15. Maternal and neonatal outcomes in pregnant patients with cardiac diseases referred for labour in northwest Iran

    International Nuclear Information System (INIS)

    Objective: To evaluate maternal and neonatal mortality and morbidity rates in women with different types of significant heart diseases. Methods: The cross-sectional study was conducted at a tertiary heart care centre in Tabriz, Iran, and comprised 200 pregnant women between March 2007 and March 2012 who had different cardiac diseases and were admitted in labour wards first and then transferred to the heart center for child-bearing (vaginal delivery or caesarean section). They were categorised based on the underlying etiology into valvular heart disease, dilated cardiomyopathy, congenital heart disease and other etiologies. SPSS 18 was used for statistical analysis. Results: The mean age of the 200 subjects was 29.4+-4.28 years. Caesarean section was performed on 152 (76%) cases, while 48 (24%) underwent vaginal delivery. There were 216 neonates as 16 (8%) women had twins. Overall, 164 (75.9%) were female, and 52 (24.1%) male. Maternal and neonatal mortality rates were 4.0% (n=8) and 10% (n=22) respectively. Pregnant women with Congenital heart disease experienced more maternal (p<0.022) and neonatal (p<0.031) mortality rates than other cardiac diseases. Conclusion: Pregnant women with cardiac diseases are prone to higher maternal and neonatal mortality rates in northwest Iran. (author)

  16. Effect of preoperative abstinence on poor postoperative outcome in alcohol misusers: randomised controlled trial

    DEFF Research Database (Denmark)

    Tonnesen, H; Rosenberg, J; Nielsen, Hans Jørgen;

    1999-01-01

    OBJECTIVE: To evaluate the influence of preoperative abstinence on postoperative outcome in alcohol misusers with no symptoms who were drinking the equivalent of at least 60 g ethanol/day. DESIGN: Randomised controlled trial. Setting: Copenhagen, Denmark. SUBJECTS: 42 alcoholic patients without...... liver disease admitted for elective colorectal surgery. INTERVENTIONS: Withdrawal from alcohol consumption for 1 month before operation (disulfiram controlled) compared with continuous drinking. MAIN OUTCOME MEASURES: Postoperative complications requiring treatment within the first month after surgery...... often in the intervention group. Surgical stress responses were lower in the intervention group (P LT / =0.05). CONCLUSIONS: One month of preoperative abstinence reduces postoperative morbidity in alcohol abusers. The mechanism is probably reduced preclinical organ dysfunction and reduction...

  17. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    International Nuclear Information System (INIS)

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board–approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13–45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  18. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    Energy Technology Data Exchange (ETDEWEB)

    Schwartz, David L., E-mail: dschwartz3@nshs.edu [Department of Radiation Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, New Hyde Park, NY (United States); Feinstein Institute for Medical Research, Manhasset, NY (United States); Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Garden, Adam S.; Thomas, Jimmy [Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Chen Yipei; Zhang Yongbin [Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Lewin, Jan; Chambers, Mark S. [Department of Head and Neck Surgery, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Dong, Lei [Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  19. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  20. Evaluating the effects of increasing physical activity to optimize rehabilitation outcomes in hospitalized older adults (MOVE Trial): study protocol for a randomized controlled trial

    OpenAIRE

    Said, Catherine M.; Morris, Meg E; McGinley, Jennifer L.; Szoeke, Cassandra; Workman, Barbara; Liew, Danny; Hill, Keith; Woodward, Michael; Wittwer, Joanne E; Churilov, Leonid; Ventura, Cameron; Bernhardt, Julie

    2015-01-01

    Background Older adults who have received inpatient rehabilitation often have significant mobility disability at discharge. Physical activity levels in rehabilitation are also low. It is hypothesized that providing increased physical activity to older people receiving hospital-based rehabilitation will lead to better mobility outcomes at discharge. Methods/Design A single blind, parallel-group, multisite randomized controlled trial with blinded assessment of outcome and intention-to-treat ana...

  1. Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article)

    OpenAIRE

    Kayambu Geetha; Boots Robert J; Paratz Jennifer D

    2011-01-01

    Abstract Background Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU) patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis synd...

  2. Five-year Outcome after Coronary Artery Bypass Surgery in Survivors of Out-of-Hospital Cardiac Arrest

    Directory of Open Access Journals (Sweden)

    Matti-Aleski eMosorin

    2015-01-01

    Full Text Available Objective: The aim of this study is to evaluate the role of coronary artery bypass grafting (CABG in patients with out-of-hospital cardiac arrest (OHCA.Methods: The immediate and 5-year outcome after CABG of a consecutive series of 48 patients who survived OHCA were compared with those of control patients having had a recent myocardial infarction without ventricular arrhythmias.Results: All OHCA patients were found to have suffered myocardial infarction-related cardiac arrest. The mean delay from OHCA to CABG was 10.3±13.0 days. Despite not statistically significant, the risk of 30-day postoperative mortality was higher among OHCA patients than control patients (6.3% vs. 0%, p=0.24, propensity score adjusted analysis: p=1.00. Cardioverter defibrillator was implanted in two patients who were alive 3.8 and 4.4 years after CABG, respectively. At 5-year the overall survival rate was 80.7% in OHCA patients and 84.5% in control patients (p=0.98, propensity score adjusted analysis: p=0.87, and survival freedom from fatal cardiac event was 86.1% in OHCA patients and 86.5% in control patients (p=0.61; propensity score adjusted analysis: p=0.90. Conclusions: Early and 5-year survival rates after CABG in OHCA patients are excellent even when cardioverter defibrillator is very selectively implanted. Such good early and intermediate results observed after CABG suggest a confident approach toward surgical revascularization also in this critically ill patient population.

  3. Assessment of cardiac outcome in pancreas kidney transplant recipients using 99mTc-MIBI myocardial perfusion scintigraphy

    International Nuclear Information System (INIS)

    Full text: Simultaneous pancreas-kidney transplantation (SPK) in diabetic patients (patients) 99mTc-MIBI myocardial perfusion scintigraphy (MPI) in predicting cardiac outcome post SPK. One hundred and forty patients underwent SPK at our institution over a 15-year period. Sixty-six subjects were excluded because of incomplete follow-up (n=54) or death from non-cardiac causes (n=12). Seventy-four patients (44 men, 30 women) with age 44.3+/-7.4 yrs (range: 31-62yrs) were followed for up to 14 yrs post SPK. The mean interval between SPK and MPI was 48.1+/-37.1 months (median: 37.5, range: 6-132 months). MPI was performed using a standard two-day protocol with Adenosine or Dipyridamole and a dual-head gamma camera using 900 configuration, attenuation and scatter correction and resolution recovery. Images were reported by at least one experienced observer using standard software. MPI were classified as normal (n=33), infarct (n=4), small (n=32) or large (n=2) areas of impaired coronary flow reserve (CFR) or a combination of infarct and impaired CFR (n=3). Cardiac events were considered if infarct, angina, death or coronary revascularisation occurred. Two patients underwent coronary artery bypass surgery five yrs post SPK (both two yrs post MPI) and one patient developed angina six yrs post SPK (three yrs post MPI). In these patients, MPI showed only small areas of impaired CFR. The negative and positive predictive values for MPI were 100 and 9%, respectively. In summary, MPI has excellent NPV post SPK. The PPV is poor, suggesting that myocardial perfusion defects correlate only weakly with overall atherosclerotic risk profile post SPK. Copyright (2002) The Australian and New Zealand Society of Nuclear Medicine Inc

  4. Prospective clinical trial comparing outcome measures between Furlow and von Langenbeck Palatoplasties for UCLP.

    Science.gov (United States)

    Williams, William N; Seagle, M Brent; Pegoraro-Krook, Maria Ines; Souza, Telma V; Garla, Luis; Silva, Marcos L; Machado Neto, José S; Dutka, Jeniffer C R; Nackashi, John; Boggs, Steve; Shuster, Jonathan; Moorhead, Jacquelyn; Wharton, William; Graciano, Maria I G; Pimentel, Maria C; Feniman, Mariza; Piazentin-Penna, Silvia H A; Kemker, Joseph; Zimmermann, Maria C; Bento-Gonçalvez, Cristina; Borgo, Hilton; Marques, Ilza L; Martinelli, Angela P M C; Jorge, José C; Antonelli, Patrick; Neves, Josiane F A; Whitaker, Melina E

    2011-02-01

    The goal of this prospective randomized clinical trial was to compare 2 cohorts of standardized cleft patients with regard to functional speech outcome and the presence or absence of palatal fistulae. The 2 cohorts are randomized to undergo either a conventional von Langenbeck repair with intravelar velarplasty or the double-opposing Z-plasty Furlow procedure. A prospective 2 × 2 × 2 factorial clinical trial was used in which each subject was randomly assigned to 1 of 8 different groups: 1 of 2 different lip repairs (Spina vs. Millard), 1 of 2 different palatal repair (von Langenbeck vs. Furlow), and 1 of 2 different ages at time of palatal surgery (9-12 months vs. 15-18 months). All surgeries were performed by the same 4 surgeons. A cul-de-sac test of hypernasality and a mirror test of nasal air emission were selected as primary outcome measures for velopharyngeal function. Both a surgeon and speech pathologist examined patients for the presence of palatal fistulae. In this study, the Furlow double-opposing Z-palatoplasty resulted in significantly better velopharyngeal function for speech than the von Langenbeck procedure as determined by the perceptual cul-de-sac test of hypernasality. Fistula occurrence was significantly higher for the Furlow procedure than for the von Langenbeck. Fistulas were more likely to occur in patients with wider clefts and when relaxing incisions were not used. PMID:21042188

  5. Reducing Postpartum Weight Retention and Improving Breastfeeding Outcomes in Overweight Women: A Pilot Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Julia Martin

    2015-02-01

    Full Text Available Overweight and obesity is prevalent among women of reproductive age (42% BMI > 25 kg/m2 and parity is associated with risk of weight gain. Weight gain greater than that recommended by the Institute of Medicine (IOM is also associated with lower rates of breastfeeding initiation and duration in women. The aim of this pilot randomised controlled trial is to examine the feasibility of recruiting and maintaining a cohort of pregnant women with the view of reducing postpartum weight retention and improving breastfeeding outcomes. Women (BMI of 25–35 kg/m2 (n = 36 were recruited from the John Hunter Hospital antenatal clinic in New South Wales, Australia. Participants were stratified by BMI and randomised to one of three groups with follow-up to six months postpartum. Women received a dietary intervention with or without breastfeeding support from a lactation consultant, or were assigned to a wait-list control group where the dietary intervention was issued at three months postpartum. Feasibility and acceptability was assessed by participation rates and questionnaire. Analysis of variance and covariance was conducted to determine any differences between groups. Sixty-nine per cent of the participants were still enrolled at six months postpartum. This pilot demonstrated some difficulties in recruiting women from antenatal clinics and retaining them in the trial. Although underpowered; the results on weight; biomarkers and breastfeeding outcomes indicated improved metabolic health.

  6. Alzheimer's disease biomarkers as outcome measures for clinical trials in MCI

    Science.gov (United States)

    Caroli, Anna; Prestia, Annapaola; Wade, Sara; Chen, Kewei; Ayutyanont, Napatkamon; Landau, Susan M.; Madison, Cindee M.; Haense, Cathleen; Herholz, Karl; Reiman, Eric M.; Jagust, William J.; Frisoni, Giovanni B.

    2014-01-01

    Background Aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI). Methods MRI, FDG-PET markers, and ADAS-COG were compared in terms of effect size and statistical power over different followup periods in two MCI groups, selected from ADNI dataset based on CSF (abnormal CSF Aβ1-42 concentration - ABETA+) or MRI evidence of Alzheimer's Disease (AD) (positivity to hippocampal atrophy - HIPPO+). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms. Results Seventy-four ABETA+ and 51 HIPPO+ MCI patients were included in the study. Imaging biomarkers of neurodegeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency. Conclusions These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials. PMID:25437302

  7. Predictors of Adverse Cosmetic Outcome in the RAPID Trial: An Exploratory Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Peterson, David; Truong, Pauline T. [Vancouver Island Centre, British Columbia Cancer Agency, Victoria, British Columbia (Canada); Parpia, Sameer [Ontario Clinical Oncology Group, McMaster University, Hamilton, Ontario (Canada); Olivotto, Ivo A. [Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta (Canada); Berrang, Tanya [Vancouver Island Centre, British Columbia Cancer Agency, Victoria, British Columbia (Canada); Kim, Do-Hoon; Kong, Iwa [Juravinski Cancer Centre at Hamilton Health Sciences, McMaster University, Hamilton, Ontario (Canada); Germain, Isabelle [Centre Hospitalier Universitaire de Québec, Pavillon Hôtel-Dieu de Quebec, Quebec City, Québec (Canada); Nichol, Alan [Vancouver Centre, British Columbia Cancer Agency, Vancouver, British Columbia (Canada); Akra, Mohamed [CancerCare Manitoba, Winnipeg, Manitoba (Canada); Roy, Isabelle [Centre intégré de cancérologie de Laval, Laval, Québec (Canada); Reed, Melanie [Center for the Southern Interior, British Columbia Cancer Agency, Kelowna, British Columbia (Canada); Fyles, Anthony [University Health Network, Princess Margaret Hospital, Toronto, Ontario (Canada); Trotter, Theresa [Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta (Canada); Perera, Francisco [London Regional Cancer Centre, London, Ontario (Canada); Balkwill, Susan [Fraser Valley Centre, British Columbia Cancer Agency, Surrey, British Columbia (Canada); Lavertu, Sophie [Centre Hospitalier de l' Université de Montréal, Hôpital Notre-Dame, Montreal, Québec (Canada); Elliott, Elizabeth [Juravinski Cancer Centre at Hamilton Health Sciences, McMaster University, Hamilton, Ontario (Canada); and others

    2015-04-01

    Purpose: To evaluate factors associated with adverse cosmesis outcome in breast cancer patients randomized to accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy or whole-breast irradiation in the RAPID (Randomized Trial of Accelerated Partial Breast Irradiation) trial. Methods and Materials: Subjects were trial participants with nurse-assessed global cosmetic scores at baseline and at 3 years. Adverse cosmesis was defined as a score of fair or poor. Cosmetic deterioration was defined as any adverse change in score from baseline to 3 years. The analysis is based on data from the previously reported interim analysis. Logistic regression models were used to assess the association of risk factors for these outcomes among all patients and those treated with APBI only. Results: Clinicopathologic characteristics were similar between subjects randomized to APBI (n=569) or whole-breast irradiation (n=539). For all subjects, factors associated with adverse cosmesis at 3 years were older age, central/inner tumor location, breast infection, smoking, seroma volume, breast volume, and use of APBI; factors associated with cosmetic deterioration were smoking, seroma volume, and use of APBI (P<.05). For APBI subjects, tumor location, smoking, age, and seroma volume were associated with adverse cosmesis (P<.05), and smoking was associated with cosmetic deterioration (P=.02). An independent association between the V95/whole-breast volume ratio and adverse cosmesis (P=.28) or cosmetic deterioration (P=.07) was not detected. On further exploration a V95/whole-breast volume ratio <0.15 was associated with a lower risk of cosmetic deterioration (p=.04), but this accounted for only 11% of patients. Conclusion: In the RAPID trial, a number of patient tumor and treatment-related factors, including the use of APBI, were associated with adverse cosmesis and cosmetic deterioration. For patients treated with APBI alone, the high-dose treatment

  8. Predictors of Adverse Cosmetic Outcome in the RAPID Trial: An Exploratory Analysis

    International Nuclear Information System (INIS)

    Purpose: To evaluate factors associated with adverse cosmesis outcome in breast cancer patients randomized to accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy or whole-breast irradiation in the RAPID (Randomized Trial of Accelerated Partial Breast Irradiation) trial. Methods and Materials: Subjects were trial participants with nurse-assessed global cosmetic scores at baseline and at 3 years. Adverse cosmesis was defined as a score of fair or poor. Cosmetic deterioration was defined as any adverse change in score from baseline to 3 years. The analysis is based on data from the previously reported interim analysis. Logistic regression models were used to assess the association of risk factors for these outcomes among all patients and those treated with APBI only. Results: Clinicopathologic characteristics were similar between subjects randomized to APBI (n=569) or whole-breast irradiation (n=539). For all subjects, factors associated with adverse cosmesis at 3 years were older age, central/inner tumor location, breast infection, smoking, seroma volume, breast volume, and use of APBI; factors associated with cosmetic deterioration were smoking, seroma volume, and use of APBI (P<.05). For APBI subjects, tumor location, smoking, age, and seroma volume were associated with adverse cosmesis (P<.05), and smoking was associated with cosmetic deterioration (P=.02). An independent association between the V95/whole-breast volume ratio and adverse cosmesis (P=.28) or cosmetic deterioration (P=.07) was not detected. On further exploration a V95/whole-breast volume ratio <0.15 was associated with a lower risk of cosmetic deterioration (p=.04), but this accounted for only 11% of patients. Conclusion: In the RAPID trial, a number of patient tumor and treatment-related factors, including the use of APBI, were associated with adverse cosmesis and cosmetic deterioration. For patients treated with APBI alone, the high-dose treatment

  9. Trial of quantitative analysis of cardiac function by 3D reconstruction of multislice cine MR images

    Energy Technology Data Exchange (ETDEWEB)

    Yamamoto, Hideki (Okayama Univ. (Japan). Faculty of Education); Sei, Tetsurou; Nakagawa, Tomio; Hiraki, Yoshio

    1994-09-01

    Non-invasive techniques for measuring the dynamic behavior of the left ventricle (LV) can be invaluable tool in the diagnosis of the heart disease. In this paper we present methods for quantitative analysis of cardiac function using a compact magnetic resonance image processing system. A 256 x 256 magnetic resonance transaxial image of the left ventricle in a normal case is obtained. After gray level thresholding and region segmentation, the boundary of the left ventricular chamber is extracted. Then, the boundaries of the left ventricular chamber are displayed three-dimensionally by using the Z-buffer algorithm. Thus, LV volume and ejection fraction are calculated. Here, the value of LV ejection fraction is 60%. These results agree reasonably well with the corresponding data obtained by the echocardiography. (author).

  10. A win ratio approach to comparing continuous non-normal outcomes in clinical trials.

    Science.gov (United States)

    Wang, Duolao; Pocock, Stuart

    2016-05-01

    Clinical trials are often designed to compare continuous non-normal outcomes. The conventional statistical method for such a comparison is a non-parametric Mann-Whitney test, which provides a P-value for testing the hypothesis that the distributions of both treatment groups are identical, but does not provide a simple and straightforward estimate of treatment effect. For that, Hodges and Lehmann proposed estimating the shift parameter between two populations and its confidence interval (CI). However, such a shift parameter does not have a straightforward interpretation, and its CI contains zero in some cases when Mann-Whitney test produces a significant result. To overcome the aforementioned problems, we introduce the use of the win ratio for analysing such data. Patients in the new and control treatment are formed into all possible pairs. For each pair, the new treatment patient is labelled a 'winner' or a 'loser' if it is known who had the more favourable outcome. The win ratio is the total number of winners divided by the total numbers of losers. A 95% CI for the win ratio can be obtained using the bootstrap method. Statistical properties of the win ratio statistic are investigated using two real trial data sets and six simulation studies. Results show that the win ratio method has about the same power as the Mann-Whitney method. We recommend the use of the win ratio method for estimating the treatment effect (and CI) and the Mann-Whitney method for calculating the P-value for comparing continuous non-Normal outcomes when the amount of tied pairs is small. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26970432

  11. Community mobilization in Mumbai slums to improve perinatal care and outcomes: a cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Neena Shah More

    Full Text Available INTRODUCTION: Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health. METHODS AND FINDINGS: A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60-1.22, and the neonatal mortality rate higher (1.48, 1.06-2.08. The extended perinatal mortality rate did not differ between arms (1.19, 0.90-1.57. We have no evidence that these differences could be explained by the intervention. CONCLUSIONS: Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors. TRIAL

  12. Better management of out-of-hospital cardiac arrest increases survival rate and improves neurological outcome in the Swiss Canton Ticino

    OpenAIRE

    Mauri, Romano; Burkart, Roman; Benvenuti, Claudio; Caputo, Maria Luce; Moccetti, Tiziano; Del Bufalo, Alessandro; Gallino, Augusto; Casso, Carlo; Anselmi, Luciano; Cassina, Tiziano; Klersy, Catherine; Auricchio, Angelo

    2015-01-01

    Aim To determine the incidence of out-of-hospital cardiac arrest (OHCA) fulfilling Utstein criteria in the Canton Ticino, Switzerland, the survival rate of OHCA patients and their neurological outcome. Methods and results All OHCAs treated in Canton Ticino between 1 January 2005 and 31 December 2014 were followed until either death or hospital discharge. The survival and neurological outcome of those OHCA fulfilling Utstein criteria are reported. A total of 3367 OHCAs occurred in the Canton T...

  13. Proton Therapy for Breast Cancer After Mastectomy: Early Outcomes of a Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Purpose: Dosimetric planning studies have described potential benefits for the use of proton radiation therapy (RT) for locally advanced breast cancer. We report acute toxicities and feasibility of proton delivery for 12 women treated with postmastectomy proton radiation with or without reconstruction. Methods and Materials: Twelve patients were enrolled in an institutional review board-approved prospective clinical trial. The patients were assessed for skin toxicity, fatigue, and radiation pneumonitis during treatment and at 4 and 8 weeks after the completion of therapy. All patients consented to have photographs taken for documentation of skin toxicity. Results: Eleven of 12 patients had left-sided breast cancer. One patient was treated for right-sided breast cancer with bilateral implants. Five women had permanent implants at the time of RT, and 7 did not have immediate reconstruction. All patients completed proton RT to a dose of 50.4 Gy (relative biological effectiveness [RBE]) to the chest wall and 45 to 50.4 Gy (RBE) to the regional lymphatics. No photon or electron component was used. The maximum skin toxicity during radiation was grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE). The maximum CTCAE fatigue was grade 3. There have been no cases of RT pneumonitis to date. Conclusions: Proton RT for postmastectomy RT is feasible and well tolerated. This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods

  14. Comparing Outcomes of Donation After Cardiac Death Versus Donation After Brain Death in Liver Transplant Recipients with Hepatitis C: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Malcolm Wells

    2014-01-01

    Full Text Available BACKGROUND: Liver transplantation (LT using organs donated after cardiac death (DCD is increasing due, in large part, to a shortage of organs. The outcome of using DCD organs in recipients with hepatits C virus (HCV infection remains unclear due to the limited experience and number of publications addressing this issue.

  15. Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial

    DEFF Research Database (Denmark)

    Winkel, Per; Hilden, J; Hansen, Jørgen Fischer;

    2011-01-01

    -hospital (nonsudden) death. Result: In 100 of 189 (53%) cardiovascular (CV) deaths in which it was possible to examine the question, there was a strong association between place of death and the classification of CV death as sudden or not-sudden. The excess mortality in the clarithromycin group was confined to sudden......Objectives: To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease. Methods: Cox analyses using out-of-hospital death as a proxy for sudden death compared to in...... coronary heart disease patients not using statins....

  16. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children.

    Directory of Open Access Journals (Sweden)

    Ian Sinha

    2008-04-01

    Full Text Available BACKGROUND: In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children. METHODS AND FINDINGS: We searched Cochrane databases (no date restrictions in December 2006; and MEDLINE (1950 to 2006, CINAHL (1982 to 2006, and SCOPUS (1966 to 2006 in January 2007 for studies of the selection of outcomes for use in clinical trials in children. We also asked a group of experts in paediatric clinical research to refer us to any other relevant studies. From these articles we extracted data on the clinical condition of interest, description of the method used to select outcomes, the people involved in the selection process, the outcomes selected, and limitations of the method as defined by the authors. The literature search identified 8,889 potentially relevant abstracts. Of these, 70 were retrieved, and 25 were included in the review. These studies described the work of 13 collaborations representing various paediatric specialties including critical care, gastroenterology, haematology, psychiatry, neurology, respiratory paediatrics, rheumatology, neonatal medicine, and dentistry. Two groups utilised the Delphi technique, one used the nominal group technique, and one used both methods to reach a consensus about which outcomes should be measured in clinical trials. Other groups used semistructured discussion, and one group used a questionnaire-based survey. The collaborations involved clinical experts, research experts, and industry representatives. Three groups involved parents of children affected by the particular condition. CONCLUSIONS: Very few studies address the

  17. Statin treatment and stroke outcome in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Goldstein, L.B.; Amarenco, P.; Zivin, J.; Messig, M.; Altafullah, I.; Callahan, A.; Hennerici, M.; MacLeod, M.J.; Sillesen, H.; Zweifler, R.; Michael, K.; Welch, A.

    2009-01-01

    BACKGROUND AND PURPOSE: Laboratory experiments suggest statins reduce stroke severity and improve outcomes. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial was a placebo-controlled, randomized trial designed to determine whether treatment with atorvastatin reduces...... strokes in subjects with recent stroke or transient ischemic attack (n=4731). We analyzed SPARCL trial data to determine whether treatment favorably shifts the distribution of severities of ischemic cerebrovascular outcomes. METHODS: Severity was assessed with the National Institutes of Health Stroke...... or no event), there was only a trend toward lesser severity with treatment based on the modified Rankin Scale score (P=0.0647) with no difference based on the National Institutes of Health Stroke Scale or Barthel Index. CONCLUSIONS: The present exploratory analysis suggests that the outcome of...

  18. Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

    OpenAIRE

    Tanai, C; Nokihara, H; Yamamoto, S.; Kunitoh, H; Yamamoto, N.; Sekine, I.; Ohe, Y; Tamura, T.

    2009-01-01

    There are inadequate data on the outcomes of patients who declined to participate in randomised clinical trials as compared with those of participants. We retrospectively reviewed the patient characteristics and treatment outcomes of both participants and non-participants in the two randomised trials for chemotherapy-naive advanced non-small-cell lung cancer. Trial 1 compared four platinum-based combination regimens. Trial 2 compared two sequences of carboplatin plus paclitaxel and gefitinib ...

  19. The HEART mobile phone trial: The partial mediating effects of self-efficacy on physical activity among cardiac patients

    Directory of Open Access Journals (Sweden)

    Ralph eMaddison

    2014-05-01

    Full Text Available Background: The ubiquitous use of mobile phones provides an ideal opportunity to deliver interventions to increase physical activity levels. Understanding potential mediators of such interventions is needed to increase their effectiveness. A recent randomized controlled trial of a mobile phone and Internet (mHealth intervention was conducted in New Zealand to determine the effectiveness on exercise capacity and physical activity levels in addition to current cardiac rehabilitation (CR services for people (n=171 with ischaemic heart disease (IHD. Significant intervention effect was observed for self-reported leisure time physical activity and walking, but not peak oxygen uptake (PVO2 at 24 weeks. There was also significant improvement in self-efficacy.Objective: To evaluate the mediating effect of self-efficacy on physical activity levels in an mHealth delivered exercise CR programme. Methods: Treatment evaluations were performed on the principle of intention to treat (ITT. Adjusted regression analyses were conducted to evaluate the main treatment effect on leisure time physical activity and walking at 24 weeks, with and without change in self-efficacy as the mediator of interest. Results: Change in self-efficacy at 24 weeks significantly mediated the treatment effect on leisure time physical activity by 13%, but only partially mediated the effect on walking by 4% at 24 weeks. Conclusion: An mHealth intervention involving text messaging and Internet support had a positive treatment effect on leisure time physical activity and walking at 24 weeks, and this effect was likely mediated through changes in self-efficacy. Future trials should examine other potential mediators related to this type of intervention.

  20. Positive Outcomes Influence the Rate and Time to Publication, but Not the Impact Factor of Publications of Clinical Trial Results

    OpenAIRE

    Suñé, Pilar; Suñé, Josep Maria; Montoro, J. Bruno

    2013-01-01

    Objectives: Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. Methods and Findings: All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication....

  1. RARtool : A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes

    OpenAIRE

    Yevgen Ryeznik; Oleksandr Sverdlov; Weng Kee Wong

    2015-01-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool, a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simu...

  2. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial

    OpenAIRE

    Zannad, Faiez; De Ferrari, Gaetano M.; Tuinenburg, Anton E.; Wright, David; Brugada, Josep; Butter, Christian; Klein, Helmut; Stolen, Craig; Meyer, Scott; Stein, Kenneth M.; Ramuzat, Agnes; Schubert, Bernd; Daum, Doug; Neuzil, Petr; Botman, Cornelis

    2014-01-01

    Aim The neural cardiac therapy for heart failure (NECTAR-HF) was a randomized sham-controlled trial designed to evaluate whether a single dose of vagal nerve stimulation (VNS) would attenuate cardiac remodelling, improve cardiac function and increase exercise capacity in symptomatic heart failure patients with severe left ventricular (LV) systolic dysfunction despite guideline recommended medical therapy. Methods: Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or contro...

  3. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Kowey, Peter R; Dorian, Paul; Mitchell, L Brent;

    2009-01-01

    was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft, valvular surgery, or both. Patients were randomly assigned 2:1 to receive a 10-minute infusion of 3 mg/kg vernakalant or placebo. If AF or AFL was...... complete atrioventricular block). There were no cases of torsades de pointes, sustained ventricular tachycardia, or ventricular fibrillation. There were no deaths. CONCLUSIONS: Vernakalant was safe and effective in the rapid conversion of AF to sinus rhythm in patients who had AF after cardiac surgery....... CLINICAL TRIAL REGISTRATION: clinicaltrials.gov. Identifier: NCT00125320....

  4. Effects of nimodipine on cerebral blood flow and cerebrospinal fluid pressure after cardiac arrest: correlation with neurologic outcome.

    Science.gov (United States)

    Forsman, M; Aarseth, H P; Nordby, H K; Skulberg, A; Steen, P A

    1989-04-01

    Fifty-one patients were included in a blind randomized study to evaluate whether the Ca-blocker nimodipine could influence cerebral blood flow (CBF) or cerebrospinal fluid pressure (CSFP) during the cerebral hypoperfusion period that follows resuscitation from cardiac arrest and to determine whether changes in CBF correlate with neurologic outcome. CBF measured 1 to 4 hours after arrest with the use of 133Xe intravenous was significantly greater with nimodipine than with placebo (27 +/- 3 versus 13 +/- 1 ml.100 g-1.min-1 at 3 hours), but with no significant difference at 24 hours. There was no clinical evidence of seriously increased CSFP in any patient in either group the first 48 hours. Mean arterial pressure was significantly lower (86 +/- 4 versus 101 +/- 4 mm Hg at 3 hours), and antiarrhythmic drugs were used significantly less frequently in the nimodipine group than in the placebo group. Twelve patients in each group eventually regained consciousness. There was no significant difference in neurologic status between the two groups at any point, and no positive correlation between CBF in the hypoperfusion period and neurologic outcome. PMID:2929976

  5. Can cardiac rehabilitation programs improve functional capacity and left ventricular diastolic function in patients with mechanical reperfusion after ST elevation myocardial infarction?: A double-blind clinical trial

    OpenAIRE

    Golabchi, Allahyar; Basati, Fatemeh; Kargarfard, Mehdi; Sadeghi, Masoumeh

    2012-01-01

    BACKGROUND Current guidelines recommend cardiac rehabilitation programs (CRP) as a means to improve functional status of patients after coronary revascularization. However, research supporting this recommendation has been limited and positive effects of CRP on diastolic function are controversial. The aim of this study was to examine the effects of an 8-week CRP on left ventricular diastolic function. METHODS This randomized, clinical trial included 29 men with ST elevation myocardial infarct...

  6. A hierarchy of patient-reported outcomes for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten; Lund, Hans; Roos, Ewa M;

    2012-01-01

    Objectives. To develop a prioritised list based on responsiveness for extracting patient-reported outcomes (PROs) measuring pain and disability for performing meta-analyses in knee osteoarthritis (OA). Methods. A systematic search was conducted in 20 highest impact factor general and rheumatology......) other composite pain scales, and (7) other single item measures. Disability: (1) WOMAC "function" subscale, (2) SF-36 "physical function" subscale, (3) SF-36 (Physical composite score), and (4) Other composite disability scores. Conclusions. As choosing the PRO most favourable for the intervention from...... individual trials can lead to biased estimates, using a prioritised list as developed in this study is recommended to reduce risk of biased selection of PROs in meta-analyses....

  7. Propensity score methods for estimating relative risks in cluster randomized trials with low-incidence binary outcomes and selection bias.

    Science.gov (United States)

    Leyrat, Clémence; Caille, Agnès; Donner, Allan; Giraudeau, Bruno

    2014-09-10

    Despite randomization, selection bias may occur in cluster randomized trials. Classical multivariable regression usually allows for adjusting treatment effect estimates with unbalanced covariates. However, for binary outcomes with low incidence, such a method may fail because of separation problems. This simulation study focused on the performance of propensity score (PS)-based methods to estimate relative risks from cluster randomized trials with binary outcomes with low incidence. The results suggested that among the different approaches used (multivariable regression, direct adjustment on PS, inverse weighting on PS, and stratification on PS), only direct adjustment on the PS fully corrected the bias and moreover had the best statistical properties. PMID:24771662

  8. Sympathoadrenal activation and endothelial damage are inter correlated and predict increased mortality in patients resuscitated after out-of-hospital cardiac arrest. a post Hoc sub-study of patients from the TTM-trial.

    Directory of Open Access Journals (Sweden)

    Pär I Johansson

    Full Text Available Sympathoadrenal activation and endothelial damage are hallmarks of acute critical illness. This study investigated their association and predictive value in patients resuscitated from out-of-hospital cardiac arrest (OHCA.Post-hoc analysis of patients included at a single site in The Targeted Temperature Management at 33 degrees versus 36 degrees after Cardiac Arrest (TTM trial. The main study reported similar outcomes with targeting 33 versus 36 degrees. TTM main study ClinicalTrials.gov: NCT01020916. One hundred sixty three patients resuscitated from OHCA were included at a single site ICU. Blood was sampled a median 135 min (Inter Quartile Range (IQR 103-169 after OHCA. Plasma catecholamines (adrenaline, noradrenaline and serum endothelial biomarkers (syndecan-1, thrombomodulin, sE-selectin, sVE-cadherin were measured at admission (immediately after randomization. We had access to data on demography, medical history, characteristics of the OHCA, patients and 180-day outcome.Adrenaline and noradrenaline correlated positively with syndecan-1 and thrombomodulin i.e., biomarkers reflecting endothelial damage (both p<0.05. Overall 180-day mortality was 35%. By Cox analyses, plasma adrenaline, serum sE-selectin, reflecting endothelial cell activation, and thrombomodulin levels predicted mortality. However, thrombomodulin was the only biomarker independently associated with mortality after adjusting for gender, age, rhythm (shockable vs. non-shockable, OHCA to return of spontaneous circulation (ROSC time, shock at admission and ST elevation myocardial infarction (30-day Hazards Ratio 1.71 (IQR 1.05-2.77, p=0.031 and 180-day Hazards Ratio 1.65 (IQR 1.03-2.65, p=0.037 for 2-fold higher thrombomodulin levels.Circulating catecholamines and endothelial damage were intercorrelated and predicted increased mortality. Interventions aiming at protecting and/or restoring the endothelium may be beneficial in OHCA patients.

  9. Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life : Rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT)

    NARCIS (Netherlands)

    van den Brink, RHS; van Melle, JP; Honig, A; Schene, AH; Crijns, HJGM; Lambert, FPG; Ormel, J

    2002-01-01

    Background Patients with a depressive disorder after myocardial infarction (MI) have a significantly increased risk of major cardiac events. The Myocardial INfarction and Depression-Intervention Trial (MIND-IT) investigates whether antidepressive treatment can improve the cardiac prognosis for these

  10. Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Raquel Pei Chen Chan

    2009-01-01

    Full Text Available BACKGROUND: The objective of this study was to investigate the relationship between different target levels of glucose and the clinical outcomes of patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: We designed a prospective study in a university hospital where 109 consecutive patients were enrolled during a six-month period. All patients were scheduled for open-heart surgery requiring cardiopulmonary bypass. Patients were randomly allocated into two groups. One group consisted of 55 patients and had a target glucose level of 80-130 mg/dl, while the other contained 54 patients and had a target glucose level of 160-200 mg/dl. These parameters were controlled during surgery and for 36 hours after surgery in the intensive care unit. Primary outcomes were clinical outcomes, including time of mechanical ventilation, length of stay in the intensive care unit, infection, hypoglycemia, renal or neurological dysfunction, blood transfusion and length of stay in the hospital. The secondary outcome was a combined end-point (mortality at 30 days, infection or length of stay in the intensive care unit of more than 3 days. A p-value of 0.05. CONCLUSIONS: In 109 patients undergoing cardiac surgery with cardiopulmonary bypass, both protocols of glycemic control in an intraoperative setting and in the intensive care unit were found to be safe, easily achieved and not to differentially affect clinical outcomes.

  11. Treatment outcome of advanced pancreatic cancer patients who are ineligible for a clinical trial

    Directory of Open Access Journals (Sweden)

    Ueda A

    2013-05-01

    Full Text Available Akira Ueda, Ayumu Hosokawa, Kohei Ogawa, Hiroki Yoshita, Takayuki Ando, Shinya Kajiura, Haruka Fujinami, Kengo Kawai, Jun Nishikawa, Kazuto Tajiri, Masami Minemura, Toshiro SugiyamaDepartment of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, JapanObjective: The aim of this study was to evaluate the outcome of patients with advanced pancreatic cancer in clinical practice, and assess whether chemotherapy provided a clinical benefit for patients who did not meet the eligibility criteria of the clinical trial.Methods: We retrospectively analyzed the medical records of 75 patients who received first-line chemotherapy for pancreatic cancer between April 2006 and September 2011. Patients were treated with gemcitabine (GEM alone, S-1 (tegafur, gimeracil, and oteracil potassium alone, or GEM plus S-1. Patients were divided into the clinical trial eligible group (arm eligible or the ineligible group (arm ineligible. We evaluated the efficacy and the safety of the chemotherapy.Results: A total of 23 patients out of 75 (31% belonged to the ineligible group, for the following reasons: 20 patients had poor performance status, eight had massive ascites, one had synchronous malignancy, and one had icterus. The median progression-free survival (PFS was 3.5 months, and the median overall survival (OS was 6.7 months in all patients. In arm eligible, median PFS was 4.5 months, and median OS was 10.5 months. In arm ineligible, median PFS was 1.1 months, and median OS was 2.9 months.Conclusion: The outcome of the patients who did not meet the eligibility criteria was very poor. It is important to select the patients that could benefit from either chemotherapy or optimal supportive care.Keywords: gemcitabine, S-1, clinical practice

  12. Non-self-sufficiency as a primary outcome measure in ALS trials.

    Science.gov (United States)

    Marin, Benoît; Bianchi, Elisa; Pupillo, Elisabetta; Lunetta, Christian; Tremolizzo, Lucio; Logroscino, Giancarlo; Chiò, Adriano; Preux, Pierre Marie; Beghi, Ettore

    2015-01-01

    Our objective was to assess non-self-sufficiency (NSS) in ALS as an outcome measure in therapeutic trials. Using data from the control arm of two randomized trials and an observational study, associations between NSS (score ≤2 in the ALSFRS-R items for swallowing, cutting food and handling utensils, or walking) and the total ALSFRS-R score, forced vital capacity (FVC), and survival at selected time-points until death or 48 weeks, were assessed. These measures were used as surrogates of relevant functional impairment. Of 82 self-sufficient (SS) patients at baseline, 32 (39.0%) became NSS at four weeks and increased to 72 (87.8%) at the end of follow-up. A significant association was found between NSS, ALSFRS-R score and FVC at 24, 36 and 48 weeks. Thirty-four subjects died (41.5%). Compared to SS patients (median survival, 27.9 months), individuals becoming NSS at four weeks were at increased risk to die (median survival, 23.6 months, p = 0.02). NSS status at four weeks predicted survival even after adjustment for ALSFRS-R total score, age, gender, site of onset, disease duration, BMI, and FVC. 'Walking' was the only predictor of survival when adjusting for all covariates. In conclusion, NSS status is a possible endpoint to investigate short-term efficacy of treatments of ALS. PMID:26470831

  13. Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia.

    LENUS (Irish Health Repository)

    Niemeyer, Charlotte M

    2015-01-01

    Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.

  14. Incidence of the Bertillon and Gompertz effects on the outcome of clinical trials

    CERN Document Server

    Roehner, Bertrand M

    2013-01-01

    The accounts of medical trials provide very detailed information about the patients' health conditions. In contrast, only minimal data are usually given about demographic factors. Yet, some of these factors can have a notable impact on the overall death rate, thereby changing the outcome and conclusions of the trial. This paper focuses on two of these variables. The first is marital status; this effect, which will be referred to as the Bertillon effect, may change death rates by over 100%. The second is the age of the oldest patients; because of the exponential nature of Gompertz's law, changes in the distribution of ages in the oldest age group can have dramatic consequences on the overall number of deaths. It will be seen that randomization alone can hardly take care of these problems. Appropriate remedies are easy to formulate however. First, the marital status of patients as well as the age distribution of those over 65 should be documented for both study groups. Then, thanks to these data and based on th...

  15. Fifteen-Year Radiotherapy Outcomes of the Randomized PORTEC-1 Trial for Endometrial Carcinoma

    International Nuclear Information System (INIS)

    Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second cancers. Patients and Methods: The PORTEC trial (1990–1997) included 714 patients with Stage IC Grade 1–2 or Stage IB Grade 2–3 EC. After surgery, patients were randomly allocated to external-beam pelvic radiotherapy (EBRT) or no additional treatment (NAT). Analysis was by intention to treat. Results: 426 patients were alive at the date of analysis. The median follow-up time was 13.3 years. The 15-year actuarial locoregional recurrence (LRR) rates were 6% for EBRT vs. 15.5% for NAT (p 60 (HR 3.9, p = 0.002 for LRR and 2.7, p = 0.01 for EC death) and myometrial invasion >50% (HR 1.9, p = 0.03 and HR 1.9, p = 0.02). Conclusions: The 15-year outcomes of PORTEC-1 confirm the relevance of HIR criteria for treatment selection, and a trend for long-term risk of second cancers. EBRT should be avoided in patients with low- and intermediate-risk EC.

  16. Design and analysis of phase III trials with ordered outcome scales: the concept of the sliding dichotomy.

    Science.gov (United States)

    Murray, Gordon D; Barer, David; Choi, Sung; Fernandes, Helen; Gregson, Barbara; Lees, Kennedy R; Maas, Andrew I R; Marmarou, Anthony; Mendelow, A David; Steyerberg, Ewout W; Taylor, Gillian S; Teasdale, Graham M; Weir, Christopher J

    2005-05-01

    The conventional approach to the analysis of a Phase III trial in head injury or stroke takes an ordered scale measuring functional outcome and collapses the scale to a binary outcome of favorable versus unfavorable. This discards potentially relevant information which limits statistical power and moreover is not in accord with clinical practice. We propose an alternative approach where a favorable outcome is defined as better than would be expected, taking account of each individual patient's baseline prognosis. This is illustrated through a worked example based on data from a Phase III trial in head injury. The approach is also compared with the proportional odds model, which is another statistical approach that can exploit an ordered outcome scale. The approach raises issues of clinical, statistical, and regulatory importance, and we initiate what we believe needs to become a widespread debate amongst the community involved in clinical research in head injury and stroke. PMID:15892597

  17. Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article

    Directory of Open Access Journals (Sweden)

    Kayambu Geetha

    2011-10-01

    Full Text Available Abstract Background Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis syndromes admitted to ICU. Methods/Design A single-centred blinded randomized controlled trial will be conducted in Brisbane, Australia. Participants (n = 252 will include those ≥ 18 years, mechanically ventilated for ≥ 48 hours and diagnosed with a sepsis syndrome. Participants will be randomised to an intervention arm which will undergo an early targeted rehabilitation program according to the level of arousal, strength and cardiovascular stability and a control group which will receive normal care. The primary outcome measures will be physical function tests on discharge from ICU (The Acute Care Index of Function and The Physical Function ICU Test. Health-related quality of life will be measured using the Short Form-36 and the psychological component will be tested using The Hospital Anxiety and Depression Scale. Secondary measures will include inflammatory biomarkers; Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-α, peripheral blood mitochondrial DNA content and lactate, fat free muscle mass, tissue oxygenation and microcirculatory flow. Discussion The 'i-PERFORM Trial' will determine whether early rehabilitation for patients with sepsis is effective at improving patient outcomes with functional and physiological parameters reflecting long and short-term effects of early exercise and the safety in its application in critical illness. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000808044

  18. Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    2016-01-01

    Background Interventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs. Objective This randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program. Methods Participants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant’s experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed. Results In the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More

  19. Advanced Cardiac Resuscitation Evaluation (ACRE: A randomised single-blind controlled trial of peer-led vs. expert-led advanced resuscitation training

    Directory of Open Access Journals (Sweden)

    Hughes Thomas C

    2010-01-01

    Full Text Available Abstract Background Advanced resuscitation skills training is an important and enjoyable part of medical training, but requires small group instruction to ensure active participation of all students. Increases in student numbers have made this increasingly difficult to achieve. Methods A single-blind randomised controlled trial of peer-led vs. expert-led resuscitation training was performed using a group of sixth-year medical students as peer instructors. The expert instructors were a senior and a middle grade doctor, and a nurse who is an Advanced Life Support (ALS Instructor. A power calculation showed that the trial would have a greater than 90% chance of rejecting the null hypothesis (that expert-led groups performed 20% better than peer-led groups if that were the true situation. Secondary outcome measures were the proportion of High Pass grades in each groups and safety incidents. The peer instructors designed and delivered their own course material. To ensure safety, the peer-led groups used modified defibrillators that could deliver only low-energy shocks. Blinded assessment was conducted using an Objective Structured Clinical Examination (OSCE. The checklist items were based on International Liaison Committee on Resuscitation (ILCOR guidelines using Ebel standard-setting methods that emphasised patient and staff safety and clinical effectiveness. The results were analysed using Exact methods, chi-squared and t-test. Results A total of 132 students were randomised: 58 into the expert-led group, 74 into the peer-led group. 57/58 (98% of students from the expert-led group achieved a Pass compared to 72/74 (97% from the peer-led group: Exact statistics confirmed that it was very unlikely (p = 0.0001 that the expert-led group was 20% better than the peer-led group. There were no safety incidents, and High Pass grades were achieved by 64 (49% of students: 33/58 (57% from the expert-led group, 31/74 (42% from the peer-led group. Exact

  20. N-acetylcysteine and/or ascorbic acid versus placebo to prevent contrast-induced nephropathy in patients undergoing elective cardiac catheterization: The NAPCIN trial; A single-center, prospective, randomized trial

    OpenAIRE

    Mohammed Habib; Alaa Hillis; Amen Hammad

    2016-01-01

    Several protective measures have been described to prevent contrast-induced nephropathy (CIN). This study is aimed to evaluate the effect of a high dose of N-acetylcysteine (NAC) plus hydration, a low dose of NAC plus ascorbic acid and hydration or hydration alone on the prevention of CIN in high-risk patients undergoing elective coronary artery intervention. We conducted a randomized, prospective, placebo-controlled trial of 105 high-risk patients undergoing elective cardiac catheterization....

  1. Acute bronchodilator responsiveness and health outcomes in COPD patients in the UPLIFT trial

    Directory of Open Access Journals (Sweden)

    Decramer Marc

    2011-01-01

    Full Text Available Abstract Background Debate continues as to whether acute bronchodilator responsiveness (BDR predicts long-term outcomes in COPD. Furthermore, there is no consensus on a threshold for BDR. Methods At baseline and during the 4-year Understanding Potential Long-term Improvements in Function with Tiotropium (UPLIFT® trial, patients had spirometry performed before and after administration of ipratropium bromide 80 mcg and albuterol 400 mcg. Patients were split according to three BDR thresholds: ≥12% + ≥200 mL above baseline (criterion A, ≥15% above baseline (criterion B; and ≥10% absolute increase in percent predicted FEV1 values (criterion C. Several outcomes (pre-dose spirometry, exacerbations, St. George's Respiratory Questionnaire [SGRQ] total score were assessed according to presence or absence of BDR in the treatment groups. Results 5783 of 5993 randomized patients had evaluable pre- and post-bronchodilator spirometry at baseline. Mean age (SD was 64 (8 years, with 75% men, mean post-bronchodilator FEV1 1.33 ± 0.44 L (47.6 ± 12.7% predicted and 30% current smokers. At baseline, 52%, 66%, and 39% of patients had acute BDR using criterion A, B, and C, respectively. The presence of BDR was variable at follow-up visits. Statistically significant improvements in spirometry and health outcomes occurred with tiotropium regardless of the baseline BDR or criterion used. Conclusions A large proportion of COPD patients demonstrate significant acute BDR. BDR in these patients is variable over time and differs according to the criterion used. BDR status at baseline does not predict long-term response to tiotropium. Assessment of acute BDR should not be used as a decision-making tool when prescribing tiotropium to patients with COPD.

  2. The effects of vitamin D supplementation on maternal and neonatal outcome: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahdieh Mojibian

    2015-11-01

    Full Text Available Background: Vitamin D supplementation during pregnancy has been supposed to defend against adverse gestational outcomes. Objective: This randomized clinical trial study was conducted to assess the effects of 50,000 IU of vitamin D every two weeks supplementation on the incidence of gestational diabetes (GDM, gestational hypertension, preeclampsia and preterm labor, vitamin D status at term and neonatal outcomes contrasted with pregnant women that received 400 IU vitamin D daily. Materials and Methods: 500 women with gestational age 12-16 weeks and serum 25 hydroxy vitamin D (25 (OH D less than 30 ng/ml randomly categorized in two groups. Group A received 400 IU vitamin D daily and group B 50,000 IU vitamin D every 2 weeks orally until delivery. Maternal and Neonatal outcomes were assessed in two groups. Results: The incidence of GDM in group B was significantly lower than group A (6.7% versus 13.4% and odds ratio (95% Confidence interval was 0.46 (0.24-0.87 (P=0.01. The mean ± SD level of 25 (OH D at the time of delivery in mothers in group B was significantly higher than A (37.9 ± 19.8 versus 27.2 ± 18.8 ng/ml, respectively (P=0.001. There were no differences in the incidence of preeclampsia, gestational hypertension, preterm labor, and low birth weight between two groups. The mean level of 25 (OH D in cord blood of group B was significantly higher than group A (37.9 ± 18 versus 29.7 ± 19ng/ml, respectively. Anthropometric measures between neonates were not significantly different. Conclusion: Our study showed 50,000 IU vitamin D every 2 weeks decreased the incidence of GDM.

  3. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review

    Institute of Scientific and Technical Information of China (English)

    Phillip J Tully; Robert A Baker

    2012-01-01

    Research to date indicates that the number of coronary artery bypass graft (CABG) surgery patients affected by depression (i.e., major, minor, dysthymia) approximates between 30% and 40% of all cases. A longstanding empirical interest on psychosocial factors in CABG surgery patients highlights an association with increased risk of morbidity in the short and longer term. Recent evidence suggests that both depression and anxiety increase the risk for mortality and morbidity after CABG surgery independent of medical factors, although the behavioral and biological mechanisms are poorly understood. Though neither depression nor anxiety seem to markedly affect neuropsychological dysfunction, depression confers a risk for incident delirium. Following a comprehensive overview of recent literature, practical advice is described for clinicians taking into consideration possible screening aids to improve recognition of anxiety and depression among CABG surgery patients. An overview of contemporary interventions and randomized, controlled trials are described, along with suggestions for future CABG surgery research.

  4. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

    OpenAIRE

    Amelia Scott; Rucklidge, Julia J.; Roger T Mulder

    2015-01-01

    Objective To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which...

  5. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    Science.gov (United States)

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  6. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois;

    2014-01-01

    OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects...

  7. Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit

    Directory of Open Access Journals (Sweden)

    Choodari-Oskooei Babak

    2011-03-01

    Full Text Available Abstract background The pace of novel medical treatments and approaches to therapy has accelerated in recent years. Unfortunately, many potential therapeutic advances do not fulfil their promise when subjected to randomized controlled trials. It is therefore highly desirable to speed up the process of evaluating new treatment options, particularly in phase II and phase III trials. To help realize such an aim, in 2003, Royston and colleagues proposed a class of multi-arm, two-stage trial designs intended to eliminate poorly performing contenders at a first stage (point in time. Only treatments showing a predefined degree of advantage against a control treatment were allowed through to a second stage. Arms that survived the first-stage comparison on an intermediate outcome measure entered a second stage of patient accrual, culminating in comparisons against control on the definitive outcome measure. The intermediate outcome is typically on the causal pathway to the definitive outcome (i.e. the features that cause an intermediate event also tend to cause a definitive event, an example in cancer being progression-free and overall survival. Although the 2003 paper alluded to multi-arm trials, most of the essential design features concerned only two-arm trials. Here, we extend the two-arm designs to allow an arbitrary number of stages, thereby increasing flexibility by building in several 'looks' at the accumulating data. Such trials can terminate at any of the intermediate stages or the final stage. Methods We describe the trial design and the mathematics required to obtain the timing of the 'looks' and the overall significance level and power of the design. We support our results by extensive simulation studies. As an example, we discuss the design of the STAMPEDE trial in prostate cancer. Results The mathematical results on significance level and power are confirmed by the computer simulations. Our approach compares favourably with methodology

  8. 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 [v2; ref status: indexed, http://f1000r.es/5bj

    Directory of Open Access Journals (Sweden)

    Sreeram V Ramagopalan

    2015-04-01

    Full Text Available Background: 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. Methods: 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. Findings: 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. Conclusions: Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

  9. Improving Treatment Trial Outcomes for Rett Syndrome: The Development of Rett-specific Anchors for the Clinical Global Impression Scale.

    Science.gov (United States)

    Neul, Jeffrey L; Glaze, Daniel G; Percy, Alan K; Feyma, Tim; Beisang, Arthur; Dinh, Thuy; Suter, Bernhard; Anagnostou, Evdokia; Snape, Mike; Horrigan, Joseph; Jones, Nancy E

    2015-11-01

    Rett syndrome is a genetically based neurodevelopmental disorder. Although the clinical consequences of Rett syndrome are profound and lifelong, currently no approved drug treatments are available specifically targeted to Rett symptoms. High quality outcome measures, specific to the core symptoms of a disorder are a critical component of well-designed clinical trials for individuals with neurodevelopmental disorders. The Clinical Global Impression Scale is a measure of global clinical change with strong face validity that has been widely used as an outcome measure in clinical trials of central nervous system disorders. Despite its favorable assay sensitivity in clinical trials, as a global measure, the Clinical Global Impression Scale is not specific to the signs and symptoms of the disorder under study. Development of key anchors for the scale, specific to the disorder being assessed, holds promise for enhancing the validity and reliability of the measure for disorders such as Rett syndrome. PMID:25895911

  10. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

  11. Anxiety Disorder-Specific Predictors of Treatment Outcome in the Coordinated Anxiety Learning and Management (CALM) Trial.

    Science.gov (United States)

    Jakubovski, Ewgeni; Bloch, Michael H

    2016-09-01

    Identifying baseline characteristics associated with treatment outcome in generalized anxiety disorder, panic disorder, social anxiety disorder (SAD) or post-traumatic stress disorder. We performed two secondary analyses of the Coordinated Anxiety Learning and Management trial. Baseline characteristics and their interactions with treatment assignment were analyzed via stepwise logistic regression models and receiver-operating criterion analyses by disorder predicting remission and response for each disorder. Predictors for poor outcome across diagnoses were comorbid depression and low socioeconomic status. Good outcome was associated with positive treatment expectancy and high self-efficacy expectancy. SAD had the lowest rate of remission and response compared to the other anxiety disorders, and differed in respect to its predictors of treatment outcome. Perceived social support predicted treatment outcome in SAD. The special role of SAD among the other anxiety disorders requires further study both because of its worse prognosis and its more specific treatment needs. PMID:26563229

  12. Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Saywell Nicola

    2012-12-01

    Full Text Available Abstract Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community, participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their

  13. Blue cone monochromacy: visual function and efficacy outcome measures for clinical trials.

    Directory of Open Access Journals (Sweden)

    Xunda Luo

    Full Text Available Blue Cone Monochromacy (BCM is an X-linked retinopathy caused by mutations in the OPN1LW / OPN1MW gene cluster, encoding long (L- and middle (M-wavelength sensitive cone opsins. Recent evidence shows sufficient structural integrity of cone photoreceptors in BCM to warrant consideration of a gene therapy approach to the disease. In the present study, the vision in BCM is examined, specifically seeking clinically-feasible outcomes for a future clinical trial.BCM patients (n = 25, ages 5-72 were studied with kinetic and static chromatic perimetry, full-field sensitivity testing, and eye movement recordings. Vision at the fovea and parafovea was probed with chromatic microperimetry.Kinetic fields with a Goldmann size V target were generally full. Short-wavelength (S- sensitive cone function was normal or near normal in most patients. Light-adapted perimetry results on conventional background lights were abnormally reduced; 600-nm stimuli were seen by rods whereas white stimuli were seen by both rods and S-cones. Under dark-adapted conditions, 500-nm stimuli were seen by rods in both BCM and normals. Spectral sensitivity functions in the superior retina showed retained rod and S-cone functions in BCM under dark-adapted and light-adapted conditions. In the fovea, normal subjects showed L/M-cone mediation using a 650-nm stimulus under dark-adapted conditions, whereas BCM patients had reduced sensitivity driven by rod vision. Full-field red stimuli on bright blue backgrounds were seen by L/M-cones in normal subjects whereas BCM patients had abnormally reduced and rod-mediated sensitivities. Fixation location could vary from fovea to parafovea. Chromatic microperimetry demonstrated a large loss of sensitivity to red stimuli presented on a cyan adapting background at the anatomical fovea and surrounding parafovea.BCM rods continue to signal vision under conditions normally associated with daylight vision. Localized and retina-wide outcome measures were

  14. Prolonged cardiopulmonary resuscitation and outcomes after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Rajan, Shahzleen; Folke, Fredrik; Kragholm, Kristian;

    2016-01-01

    of spontaneous circulation (ROSC). METHODS: We included 1316 adult OHCA individuals with pre-hospital ROSC (2005-2011) handled by the largest nationwide ambulance provider in Denmark. Patients were stratified into 0-5, 6-10, 11-15, 16-20, 21-25 and >25min of cardiopulmonary resuscitation (CPR) by...... emergency medical services until ROSC was achieved. Nursing home admission and diagnosis of anoxic brain damage were measured as proxies of poor neurological/functional outcomes. FINDINGS: Median time from CPR initiation to ROSC was 12min (IQR: 7-18) while 20.4% achieved ROSC after >25min. Overall, 37.......5% (494) of the study population achieved 30-day survival. Thirty-day survival was inversely related to minutes of CPR to ROSC: ranging from 59.6% (127/213) for ≤5min to 13.8% (19/138) for >25min. If bystander initiated CPR before ambulance arrival, corresponding values ranged from 70.4% (107/152) to 21...

  15. Effect of a randomized controlled exercise trial on bone outcomes: influence of adjuvant endocrine therapy.

    Science.gov (United States)

    Knobf, M Tish; Jeon, Sangchoon; Smith, Barbara; Harris, Lyndsay; Kerstetter, Jane; Thompson, A Siobhan; Insogna, Karl

    2016-02-01

    Bone loss is a significant clinical problem for female cancer survivors (FCS) and increases fracture risk. The aim of the Yale Fitness Intervention Trial (Yale FIT) was to determine the effects of a 12-month aerobic-resistance exercise intervention compared to a home-based physical activity group on bone outcomes [bone mineral density (BMD)] and biomarkers bone turnover). Early postmenopausal FCS (N = 154) were randomized to the exercise intervention (3 times/week) or to a home-based physical activity group. Calcium (1200 mg) and Vitamin D (400 IU) supplements were provided to both groups. BMD was measured at baseline and 12 months. No significant difference in BMD was observed for the exercise vs home-based group. However, subjects on Tamoxifen or no endocrine therapy did not significantly lose BMD, with the exception of the femoral neck (FN). In contrast subjects on aromatase inhibitors (AIs) had significant BMD loss at all sites. The majority of subjects had sufficient serum levels of Vitamin D (>20 ng/mL) but there was significantly less bone loss in subjects in the 20-29 ng/mL range at the LS (p = 0.01), hip (p = 0.03), and GT (p = 0.008) compared to lower or higher levels. Exercise stimulates bone remodeling but the intervention was not superior for BMD outcomes at one year. The dose of the osteogenic stimulus in the intervention has been effective in preserving BMD in healthy postmenopausal women but it may be inadequate for survivors with chemotherapy-induced menopause and for those on adjuvant AI therapy. PMID:26850265

  16. Early Outcomes From Three Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Purpose: To report early outcomes with image-guided proton therapy for prostate cancer. Methods and Materials: We accrued 211 prostate cancer patients on prospective Institutional Review Board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low–risk disease, dose escalation from 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel followed by androgen deprivation for high-risk disease. Minimum follow-up was 2 years. Results: One intermediate-risk patient and 2 high-risk patients had disease progression. Pretreatment genitourinary (GU) symptom management was required in 38% of patients. A cumulative 88 (42%) patients required posttreatment GU symptom management. Four transient Grade 3 GU toxicities occurred, all among patients requiring pretreatment GU symptom management. Multivariate analysis showed correlation between posttreatment GU 2+ symptoms and pretreatment GU symptom management (p < 0.0001) and age (p = 0.0048). Only 1 Grade 3+ gastrointestinal (GI) symptom occurred. The prevalence of Grade 2+ GI symptoms was 0 (0%), 10 (5%), 12 (6%), and 8 (4%) at 6, 12, 18, and 24 months, with a cumulative incidence of 20 (10%) patients at 2 years after proton therapy. Univariate and multivariate analyses showed significant correlation between Grade 2+ rectal bleeding and proctitis and the percentage of rectal wall (rectum) receiving doses ranging from 40 CGE (10 CGE) to 80 CGE. Conclusions: Early outcomes with image-guided proton therapy suggest high efficacy and minimal toxicity with only 1.9% Grade 3 GU symptoms and <0.5% Grade 3 GI toxicities.

  17. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Georgopoulou Stavroula

    2010-02-01

    Full Text Available Abstract Background Cardiac surgery is a major consumer of blood products, and hemodilution increases transfusion requirements during cardiac surgery under CPB. As intraoperative parenteral fluids contribute to hemodilution, we evaluated the hypothesis that intraoperative fluid restriction reduces packed red-cell (PRC use, especially in transfusion-prone adults undergoing elective cardiac surgery. Methods 192 patients were randomly assigned to restrictive (group A, 100 pts, or liberal (group B, 92 pts intraoperative intravenous fluid administration. All operations were conducted by the same team (same surgeon and perfusionist. After anesthesia induction, intravenous fluids were turned off in Group A (fluid restriction patients, who only received fluids if directed by protocol. In contrast, intravenous fluid administration was unrestricted in group B. Transfusion decisions were made by the attending anesthesiologist, based on identical transfusion guidelines for both groups. Results 137 of 192 patients received 289 PRC units in total. Age, sex, weight, height, BMI, BSA, LVEF, CPB duration and surgery duration did not differ between groups. Fluid balance was less positive in Group A. Fewer group A patients (62/100 required transfusion compared to group B (75/92, p Conclusions Our data suggest that fluid restriction reduces intraoperative PRC transfusions without significantly increasing postoperative transfusions in cardiac surgery; this effect is more pronounced in transfusion-prone patients. Trial registration NCT00600704, at the United States National Institutes of Health.

  18. Adverse events associated with poor neurological outcome during targeted temperature management and advanced critical care after out-of-hospital cardiac arrest

    OpenAIRE

    Kim, Young-Min; Youn, Chun Song; Kim, Soo Hyun; Lee, Byung Kook; Cho, In Soo; Cho, Gyu Chong; Jeung, Kyung Woon; Oh, Sang Hoon; Choi, Seung Pill; Shin, Jong Hwan; Cha, Kyoung-Chul; Oh, Joo Suk; Yim, Hyeon Woo; Park, Kyu Nam; ,

    2015-01-01

    Introduction The aim of this study was to investigate the association of adverse events (AEs) during targeted temperature management (TTM) and other AEs and concomitant treatments during the advanced critical care period with poor neurological outcome at hospital discharge in adult out-of-hospital cardiac arrest (OHCA) patients. Methods This was a retrospective study using Korean Hypothermia Network registry data of adult OHCA patients treated with TTM in 24 teaching hospitals throughout Sout...

  19. Resistance in gram-negative bacilli in a cardiac intensive care unit in India: Risk factors and outcome

    Directory of Open Access Journals (Sweden)

    Pawar Mandakini

    2008-01-01

    Full Text Available The objective of this study was to compare the risk factors and outcome of patients with preexisting resistant gram-negative bacilli (GNB with those who develop sensitive GNB in the cardiac intensive care unit (ICU. Of the 3161 patients ( n = 3,161 admitted to the ICU during the study period, 130 (4.11% developed health care-associated infections (HAIs with GNB and were included in the cohort study. Pseudomonas aeruginosa (37.8% was the most common organism isolated followed by Klebsiella species (24.2%, E. coli (22.0%, Enterobacter species (6.1%, Stenotrophomonas maltophilia (5.7%, Acinetobacter species (1.3%, Serratia marcescens (0.8%, Weeksella virosa (0.4% and Burkholderia cepacia (0.4%. Univariate analysis revealed that the following variables were significantly associated with the antibiotic-resistant GNB: females ( P = 0.018, re-exploration ( P = 0.004, valve surgery ( P = 0.003, duration of central venous catheter ( P < 0.001, duration of mechanical ventilation ( P < 0.001, duration of intra-aortic balloon counter-pulsation ( P = 0.018, duration of urinary catheter ( P < 0.001, total number of antibiotic exposures prior to the development of resistance ( P < 0.001, duration of antibiotic use prior to the development of resistance ( P = 0.014, acute physiology and age chronic health evaluation score (APACHE II, receipt of anti-pseudomonal penicillins (piperacillin-tazobactam ( P = 0.002 and carbapenems ( P < 0.001. On multivariate analysis, valve surgery (adjusted OR = 2.033; 95% CI = 1.052-3.928; P = 0.035, duration of mechanical ventilation (adjusted OR = 1.265; 95% CI = 1.055-1.517; P = 0.011 and total number of antibiotic exposure prior to the development of resistance (adjusted OR = 1.381; 95% CI = 1.030-1.853; P = 0.031 were identified as independent risk factors for HAIs in resistant GNB. The mortality rate in patients with resistant GNB was significantly higher than those with sensitive GNB (13.9% vs. 1.8%; P = 0.03. HAI with

  20. Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun

    2016-01-01

    Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes. PMID:26389858

  1. Addressing Younger Workers' Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes.

    Science.gov (United States)

    Rohlman, Diane S; Parish, Megan; Elliot, Diane L; Hanson, Ginger; Perrin, Nancy

    2016-01-01

    Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health). All younger workers (14-24 years old) hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years) completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior. PMID:27517968

  2. Addressing Younger Workers’ Needs: The Promoting U through Safety and Health (PUSH Trial Outcomes

    Directory of Open Access Journals (Sweden)

    Diane S. Rohlman

    2016-08-01

    Full Text Available Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health. All younger workers (14–24 years old hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen’s d 0.4. However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior.

  3. Protocol for: Sheffield Obesity Trial (SHOT: A randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents [ISRCNT83888112

    Directory of Open Access Journals (Sweden)

    Wright Neil P

    2005-10-01

    Full Text Available Abstract Background While obesity is known to have many physiological consequences, the psychopathology of this condition has not featured prominently in the literature. Cross-sectional studies have indicated that obese children have increased odds of experiencing poor quality of life and mental health. However, very limited trial evidence has examined the efficacy of exercise therapy for enhancing mental health outcomes in obese children, and the Sheffield Obesity Trial (SHOT will provide evidence of the efficacy of supervised exercise therapy in obese young people aged 11–16 years versus usual care and an attention-control intervention. Method/design SHOT is a randomised controlled trial where obese young people are randomised to receive; (1 exercise therapy, (2 attention-control intervention (involving body-conditioning exercises and games that do not involve aerobic activity, or (3 usual care. The exercise therapy and attention-control sessions will take place three times per week for eight weeks and a six-week home programme will follow this. Ninety adolescents aged between 11–16 years referred from a children's hospital for evaluation of obesity or via community advertisements will need to complete the study. Participants will be recruited according to the following criteria: (1 clinically obese and aged 11–16 years (Body Mass Index Centile > 98th UK standard (2 no medical condition that would restrict ability to be active three times per week for eight weeks and (3 not diagnosed with insulin dependent diabetes or receiving oral steroids. Assessments of outcomes will take place at baseline, as well as four (intervention midpoint and eight weeks (end of intervention from baseline. Participants will be reassessed on outcome measures five and seven months from baseline. The primary endpoint is physical self-perceptions. Secondary outcomes include physical activity, self-perceptions, depression, affect, aerobic fitness and BMI.

  4. Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Crowther Caroline A

    2011-10-01

    Full Text Available Abstract Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/m2 approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between 10+0-20+0 weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m2, at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10+0 and 20+0 weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for

  5. SPECT Analysis of Cardiac Perfusion Changes After Whole-Breast/Chest Wall Radiation Therapy With or Without Active Breathing Coordinator: Results of a Randomized Phase 3 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Zellars, Richard, E-mail: zellari@jhmi.edu [Johns Hopkins Medical Institution, Baltimore, Maryland (United States); Bravo, Paco E. [University of Washington Medical Center, Seattle, Washington (United States); Tryggestad, Erik [Mayo Clinic, Rochester, Minnesota (United States); Hopfer, Kari [Hahnemann University, Philadelphia, Pennsylvania (United States); Myers, Lee; Tahari, Abdel; Asrari, Fariba; Ziessman, Harvey [Johns Hopkins Medical Institution, Baltimore, Maryland (United States); Garrett-Mayer, Elizabeth [Medical University of South Carolina, Charleston, South Carolina (United States)

    2014-03-15

    Purpose: Cardiac muscle perfusion, as determined by single-photon emission computed tomography (SPECT), decreases after breast and/or chest wall (BCW) irradiation. The active breathing coordinator (ABC) enables radiation delivery when the BCW is farther from the heart, thereby decreasing cardiac exposure. We hypothesized that ABC would prevent radiation-induced cardiac toxicity and conducted a randomized controlled trial evaluating myocardial perfusion changes after radiation for left-sided breast cancer with or without ABC. Methods and Materials: Stages I to III left breast cancer patients requiring adjuvant radiation therapy (XRT) were randomized to ABC or No-ABC. Myocardial perfusion was evaluated by SPECT scans (before and 6 months after BCW radiation) using 2 methods: (1) fully automated quantitative polar mapping; and (2) semiquantitative visual assessment. The left ventricle was divided into 20 segments for the polar map and 17 segments for the visual method. Segments were grouped by anatomical rings (apical, mid, basal) or by coronary artery distribution. For the visual method, 2 nuclear medicine physicians, blinded to treatment groups, scored each segment's perfusion. Scores were analyzed with nonparametric tests and linear regression. Results: Between 2006 and 2010, 57 patients were enrolled and 43 were available for analysis. The cohorts were well matched. The apical and left anterior descending coronary artery segments had significant decreases in perfusion on SPECT scans in both ABC and No-ABC cohorts. In unadjusted and adjusted analyses, controlling for pretreatment perfusion score, age, and chemotherapy, ABC was not significantly associated with prevention of perfusion deficits. Conclusions: In this randomized controlled trial, ABC does not appear to prevent radiation-induced cardiac perfusion deficits.

  6. SPECT Analysis of Cardiac Perfusion Changes After Whole-Breast/Chest Wall Radiation Therapy With or Without Active Breathing Coordinator: Results of a Randomized Phase 3 Trial

    International Nuclear Information System (INIS)

    Purpose: Cardiac muscle perfusion, as determined by single-photon emission computed tomography (SPECT), decreases after breast and/or chest wall (BCW) irradiation. The active breathing coordinator (ABC) enables radiation delivery when the BCW is farther from the heart, thereby decreasing cardiac exposure. We hypothesized that ABC would prevent radiation-induced cardiac toxicity and conducted a randomized controlled trial evaluating myocardial perfusion changes after radiation for left-sided breast cancer with or without ABC. Methods and Materials: Stages I to III left breast cancer patients requiring adjuvant radiation therapy (XRT) were randomized to ABC or No-ABC. Myocardial perfusion was evaluated by SPECT scans (before and 6 months after BCW radiation) using 2 methods: (1) fully automated quantitative polar mapping; and (2) semiquantitative visual assessment. The left ventricle was divided into 20 segments for the polar map and 17 segments for the visual method. Segments were grouped by anatomical rings (apical, mid, basal) or by coronary artery distribution. For the visual method, 2 nuclear medicine physicians, blinded to treatment groups, scored each segment's perfusion. Scores were analyzed with nonparametric tests and linear regression. Results: Between 2006 and 2010, 57 patients were enrolled and 43 were available for analysis. The cohorts were well matched. The apical and left anterior descending coronary artery segments had significant decreases in perfusion on SPECT scans in both ABC and No-ABC cohorts. In unadjusted and adjusted analyses, controlling for pretreatment perfusion score, age, and chemotherapy, ABC was not significantly associated with prevention of perfusion deficits. Conclusions: In this randomized controlled trial, ABC does not appear to prevent radiation-induced cardiac perfusion deficits

  7. The journal impact factor as a predictor of trial quality and outcomes

    DEFF Research Database (Denmark)

    Gluud, Lise L; Sørensen, Thorkild I A; Gøtzsche, Peter C; Gluud, Christian

    2005-01-01

    To examine the association between the impact factor and characteristics of hepatobiliary randomized clinical trials.......To examine the association between the impact factor and characteristics of hepatobiliary randomized clinical trials....

  8. A randomized clinical trial of hospital-based, comprehensive cardiac rehabilitation versus usual care for patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease (the DANREHAB trial) - design, intervention, and population

    DEFF Research Database (Denmark)

    Zwisler, A.D.O.; Schou, O.; Soja, A.M.B.;

    2005-01-01

    randomized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure, ischemic heart disease, or high risk for ischemic heart disease. A combined primary outcome measure included total mortality, myocardial infarction, or...... management, and clinical assessment. Study Population Of 5060 discharged patients, 1614 (32%) were eligible for the trial and 770 patients were randomized (47% of those eligible). Participants were younger (P < .001) and had less comorbidity than nonparticipants (P < .03). Conclusion Our trial shows that a...

  9. A randomized clinical trial of hospital-based, comprehensive cardiac rehabilitation versus usual care for patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease (the DANREHAB trial)--design, intervention, and population

    DEFF Research Database (Denmark)

    Zwisler, Ann-Dorthe Olsen; Soja, Anne Merete Boas; Brønnum-Hansen, Henrik;

    2005-01-01

    randomized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure, ischemic heart disease, or high risk for ischemic heart disease. A combined primary outcome measure included total mortality, myocardial infarction, or...... management, and clinical assessment. STUDY POPULATION: Of 5060 discharged patients, 1614 (32%) were eligible for the trial and 770 patients were randomized (47% of those eligible). Participants were younger (P < .001) and had less comorbidity than nonparticipants (P < .03). CONCLUSION: Our trial shows that a...

  10. Effects of Obstructive Sleep Apnea on Cardiac Function and Clinical Outcomes in Chinese Patients with ST-Elevation Myocardial Infarction

    Directory of Open Access Journals (Sweden)

    Baoxin Liu

    2014-01-01

    Full Text Available Aim. The objective of this study was to investigate the influence of OSA on cardiac function in Chinese patients with ST-elevation myocardial infarction (STEMI and determine the prognostic impact of OSA among these patients. Methods. In this retrospective study, 198 STEMI patients were enrolled. Doppler echocardiography was performed to detect the effect of OSA on cardiac function. Major adverse cardiac events (MACE and cardiac mortality were analyzed to determine whether OSA was a clinical prognostic factor; its prognostic impact was then assessed adjusting for other covariates. Results. The echocardiographic results showed that the myocardium of STEMI patients with OSA appeared to be more hypertrophic and with a poorer cardiac function compared with non-OSA STEMI patients. A Kaplan-Meier survival analysis revealed significantly higher cumulative incidence of MACE and cardiac mortality in the OSA group compared with that in the non-OSA group during a mean follow-up of 24 months. Multivariate Cox regression analysis revealed that OSA was an independent risk factor for MACE and cardiac mortality. Conclusion. These results indicate that the OSA is a powerful predictor of decreased survival and exerts negative prognostic impact on cardiac function in STEMI patients.

  11. Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine L; Berg, Selina K; Rasmussen, Trine B;

    2016-01-01

    OBJECTIVE: The evidence for cardiac rehabilitation after valve surgery remains sparse. Current recommendations are therefore based on patients with ischaemic heart disease. The aim of this randomised clinical trial was to assess the effects of cardiac rehabilitation versus usual care after heart.......40) or the exploratory physical and mental outcomes. Cardiac rehabilitation increased the occurrence of self-reported non-serious adverse events (11/72 vs 3/75, p=0.02). CONCLUSIONS: Cardiac rehabilitation after heart valve surgery significantly improves VO2 peak at 4 months but has no effect on mental health and other...

  12. Prolonged cardiac arrest and resuscitation by extracorporeal life support: favourable outcome without preceding anticoagulation in an experimental setting.

    Science.gov (United States)

    Foerster, K; D'Inka, M; Beyersdorf, F; Benk, C; Nguyen-Thanh, T; Mader, I; Fritsch, B; Ihling, C; Mueller, K; Heilmann, C; Trummer, G

    2013-11-01

    State-of-the-art cardiopulmonary resuscitation (CPR) restores circulation with inconsistent blood-flow and pressure. Extracorporeal life support (ECLS) following CPR opens the opportunity for "controlled reperfusion". In animal experiments investigating CPR with ECLS, systemic anticoagulation before induced cardiac arrest is normal, but a major point of dispute, since preliminary heparinization in patients undergoing unwitnessed cardiac arrest is impossible. In this study, we investigated options for ECLS after an experimental 15 minutes normothermic cardiac arrest, without preceding anticoagulation, in pigs. Neurological recovery was assessed by a scoring system, electroencephalography and brain magnetic resonance imaging. Additionally, brain histology was performed on day seven after cardiac arrest. We demonstrated that preliminary heparin administration was not necessary for survival or neurological recovery in this setting. Heparin flushing of the cannulae seemed sufficient to avoid thrombus formation. These findings may ease the way to using ECLS in patients with sudden cardiac arrest. PMID:23827862

  13. Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer - a prospective trial

    International Nuclear Information System (INIS)

    The aim of this trial was to investigate neurological outcome after emergency RT in MSCC of NSCLC patients with acute neurological deficit. This pilot trial was prospective, non-randomized, and monocentre, ten patients were treated from July 2012 until June 2013. After onset of neurological symptoms RT was started within 12 hours. The neurological outcome was assessed at baseline, and six weeks after RT using the ASIA Impairment Scale (AIS). The results showed an improved neurological outcome in one patient (10%), one patient (10%) had a decreased, and five patients (50%) a constant outcome after six weeks. Three patients (30%) died within the first six weeks following RT, additional 4 patients (40%) died within 4 month due to tumor progression. In this group of NSCLC patients we were able to show that emergency RT in MSCC with acute neurological deficit had no considerable benefit in neurological outcome. Therefore, short-course regime or best supportive care due to poor survival should be considered for these patients with additional distant metastases. Patients with favorable prognosis may be candidates for long-course RT

  14. Optimizing cutoff scores for the Barthel Index and the modified Rankin Scale for defining outcome in acute stroke trials

    OpenAIRE

    Uyttenboogaart, Maarten; Stewart, Roy E.; Vroomen, Patrick C A J; Keyser, Jacques De; Luijckx, Gert-Jan

    2005-01-01

    Background and Purpose - There is little agreement on how to assess outcome in acute stroke trials. Cutoff scores for the Barthel Index (BI) and modified Rankin Scale (mRS) are frequently arbitrarily chosen to dichotomize favorable and unfavorable outcome. We investigated sensitivity and specificity of BI cutoff scores in relation to the mRS to obtain the optimal corresponding BI and mRS scores. Methods - BI and mRS scores were collected from 1034 ischemic stroke patients. Sensitivity and spe...

  15. Those who have the gold make the evidence: how the pharmaceutical industry biases the outcomes of clinical trials of medications.

    Science.gov (United States)

    Lexchin, Joel

    2012-06-01

    Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of "seeding" trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it's not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials. PMID:21327723

  16. Peak Oxygen Uptake after Cardiac Rehabilitation: A Randomized Controlled Trial of a 12-Month Maintenance Program versus Usual Care

    OpenAIRE

    Madssen, Erik; Arbo, Ingerid; Granøien, Ingrid; Walderhaug, Liv; Moholdt, Trine

    2014-01-01

    Background Exercise capacity is a strong predictor of survival in patients with coronary artery disease (CAD). Exercise capacity improves after cardiac rehabilitation exercise training, but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program. There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients. We therefore assessed if a 12-month maintenance program following cardiac rehabilitation would l...

  17. Peak oxygen uptake after cardiac rehabilitation: A randomized controlled trial of a 12-month maintenance program versus usual care

    OpenAIRE

    Madssen, Erik; Arbo, Ingerid Brænne; Granøien, Ingrid; Walderhaug, Liv; Moholdt, Trine Tegdan

    2014-01-01

    Background: Exercise capacity is a strong predictor of survival in patients with coronary artery disease (CAD). Exercise capacity improves after cardiac rehabilitation exercise training, but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program. There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients. We therefore assessed if a 12-month maintenance program following cardiac rehabilitation wo...

  18. Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

    Directory of Open Access Journals (Sweden)

    Orton Jane

    2009-12-01

    Full Text Available Abstract Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm ( Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651

  19. Gel versus capillary electrophoresis genotyping for categorizing treatment outcomes in two anti-malarial trials in Uganda

    OpenAIRE

    Hubbard Alan E; Dorsey Grant; Gupta Vinay; Rosenthal Philip J; Greenhouse Bryan

    2010-01-01

    Abstract Background Molecular genotyping is performed in anti-malarial trials to determine whether recurrent parasitaemia after therapy represents a recrudescence (treatment failure) or new infection. The use of capillary instead of agarose gel electrophoresis for genotyping offers technical advantages, but it is unclear whether capillary electrophoresis will result in improved classification of anti-malarial treatment outcomes. Methods Samples were genotyped using both gel and capillary elec...

  20. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    OpenAIRE

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.

    2012-01-01

    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick searches of PubMed. METHODS: Twenty-two residents and specialists working at the Radboud University Nijmegen Medical Centre were trained in formulating PICO queries and then presented with a randomi...

  1. Permanency Outcomes for Toddlers in Child Welfare Two Years After a Randomized Trial of a Parenting Intervention

    OpenAIRE

    Spieker, Susan J.; Oxford, Monica L.; Fleming, Charles B.

    2014-01-01

    This study reports on child welfare outcomes of a community based, randomized control trial of Promoting First Relationships® (PFR; Kelly, Sandoval, Zuckerman, & Buehlman, 2008), a 10-week relationship-based home visiting program, on stability of children’s placements and permanency status two years after enrollment into the study. Toddlers 10 – 24 months (N = 210) with a recent placement disruption were randomized, along with their birth or foster/kin parents, to PFR (n = 105) or a compariso...

  2. Psychosocial outcomes of three triage methods for the management of borderline abnormal cervical smears: an open randomised trial

    OpenAIRE

    McCaffery, Kirsten J.; Irwig, Les; Turner, Robin; Chan, Siew Foong; Macaskill, Petra; Lewicka, Mary; Clarke, Judith; Weisberg, Edith; Barratt, Alex

    2010-01-01

    Objective To assess which of three triage strategies for women with borderline abnormal cervical smear results in the best psychosocial outcomes. Design Pragmatic, non-blinded, multicentre, randomised controlled trial. Setting 18 family planning clinics across Australia, covering both urban and rural areas, between January 2004 and October 2006. Participants Women aged 16-70 years (n=314) who attended routine cervical screening and received a borderline cervical smear. Interventions Patients ...

  3. First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings

    OpenAIRE

    McClure, Elizabeth M.; Nathan, Robert O; Saleem, Sarah; Esamai, Fabian; Garces, Ana; Chomba, Elwyn; Tshefu, Antoinette; Swanson, David; Mabeya, Hillary; Figuero, Lester; Mirza, Waseem; Muyodi, David; Franklin, Holly; Lokangaka, Adrien; Bidashimwa, Dieudonne

    2014-01-01

    Background In high-resource settings, obstetric ultrasound is a standard component of prenatal care used to identify pregnancy complications and to establish an accurate gestational age in order to improve obstetric care. Whether or not ultrasound use will improve care and ultimately pregnancy outcomes in low-resource settings is unknown. Methods/Design This multi-country cluster randomized trial will assess the impact of antenatal ultrasound screening performed by health care staff on a comp...

  4. Outcomes of a Pilot Hand Hygiene Randomized Cluster Trial to Reduce Communicable Infections Among US Office-Based Employees

    OpenAIRE

    Stedman-Smith, Maggie; DuBois, Cathy L.Z.; Grey, Scott F.; Kingsbury, Diana M.; Shakya, Sunita; Scofield, Jennifer; Slenkovich, Ken

    2015-01-01

    Objective: To determine the effectiveness of an office-based multimodal hand hygiene improvement intervention in reducing self-reported communicable infections and work-related absence. Methods: A randomized cluster trial including an electronic training video, hand sanitizer, and educational posters (n = 131, intervention; n = 193, control). Primary outcomes include (1) self-reported acute respiratory infections (ARIs)/influenza-like illness (ILI) and/or gastrointestinal (GI) infections duri...

  5. Impact of treatment with rosuvastatin and atorvastatin on cardiovascular outcomes: evidence from the Archimedes-simulated clinical trials

    OpenAIRE

    Colivicchi F.; Sternhufvud C; Gandhi SK

    2015-01-01

    Furio Colivicchi,1 Catarina Sternhufvud,2 Sanjay K Gandhi3 1Cardiology Division, Emergency Department, San Filippo Neri Hospital, ASL Roma E, Rome, Italy; 2Global Payer Evidence and Pricing, AstraZeneca R&D, Mölndal, Sweden; 3Global Health Economics and Outcomes Research, TEVA Pharmaceuticals, Frazer, PA, United States Objective: No clinical trials have been conducted to directly compare the effect of the two high-intensity statins, rosuvastatin and atorvastatin, on cardiovascular ou...

  6. Outcomes of a randomised controlled trial of a complex genetic counselling intervention to improve family communication.

    Science.gov (United States)

    Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane

    2016-03-01

    When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information. PMID:26130486

  7. Recent advances in the diagnosis and management of cardiac amyloidosis.

    Science.gov (United States)

    Sher, Taimur; Gertz, Morie A

    2014-01-01

    The heart is commonly involved in various forms of amyloidosis and cardiomyopathy is a major cause of morbidity and mortality in these patients. Diagnosis of cardiac amyloidosis is often delayed due to nonspecific presenting symptoms and failure to recognize early signs of amyloid heart disease on routine cardiac imaging. Treatment of cardiac amyloidosis depends upon the type of amyloid protein. Systemic chemotherapy with or without stem cell transplantation is used to treat immunoglobulin-related amyloidosis and liver transplantation is used for familial transthyretin amyloidosis in select patients. Clinical trials with siRNA for the treatment of transthyretin amyloid cardiomyopathies and amyloid protein stabilizers are ongoing. Prognosis depends on the type of amyloid protein with poorer outcomes noted in immunoglobulin light-chain amyloidosis. Supportive care forms the cornerstone of management and advancements in cardiac imaging and proteomics are expected to positively impact our ability to diagnose, prognosticate and treat cardiac amyloidosis. PMID:24344669

  8. Comparable three months' outcome of total arterial revascularization versus conventional coronary surgery: Copenhagen Arterial Revascularization Randomized Patency and Outcome trial

    DEFF Research Database (Denmark)

    Damgaard, S.; Lund, J.T.; Lilleor, N.B.; Perko, M.J.; Sander, K.; Dimo, B.; Jensen, Maiken Brit; Madsen, Jan Kyst; Kelbaek, H.; Steinbruchel, D.A.

    2008-01-01

    single-center trial, 331 patients underwent total arterial revascularization using single or bilateral internal thoracic and radial arteries versus conventional revascularization using the left internal thoracic artery and saphenous vein grafts. We report the results from 3 months' follow-up. RESULTS......OBJECTIVE: The in-hospital safety of total arterial revascularization for coronary artery bypass surgery seems to be comparable to conventional revascularization, but randomized trials evaluating this are few and data on complications in the postoperative months are sparse. METHODS: In a randomized......: The mean age of patients was 59 +/- 8 years, and 39 were women (12%). The median EuroSCORE was 2 (interquartile range 1-4). The arterial group comprised 161 patients, and the conventional group comprised 170 patients. The mean number of bypasses in the arterial group was 2.9 +/- 0.9 versus 3.2 +/- 0...

  9. Prevention of Prostate Cancer: Outcomes of Clinical Trials and Future Opportunities

    OpenAIRE

    Thompson, Ian; Kristal, Alan; Platz, Elizabeth A.

    2014-01-01

    Prostate cancer is an excellent target for prevention, to reduce both mortality and the burden of overdetection of potential inconsequential disease whose diagnosis increases cost, morbidity, and anxiety. The Prostate Cancer Prevention Trial has demonstrated that finasteride significantly reduces the risk of prostate cancer but only low-grade disease; overall survival is unaffected. In the Selenium and Vitamin E Cancer Prevention Trial (SELECT) clinical trial, selenium had no effect on prosta...

  10. Prediction of extubation outcome: a randomised, controlled trial with automatic tube compensation vs. pressure support ventilation

    OpenAIRE

    Cohen, Jonathan; Shapiro, Maury; Grozovski, Elad; Fox, Ben; Lev, Shaul; Singer, Pierre

    2009-01-01

    Introduction Tolerance of a spontaneous breathing trial is an evidence-based strategy to predict successful weaning from mechanical ventilation. Some patients may not tolerate the trial because of the respiratory load imposed by the endotracheal tube, so varying levels of respiratory support are widely used during the trial. Automatic tube compensation (ATC), specifically developed to overcome the imposed work of breathing because of artificial airways, appears ideally suited for the weaning ...

  11. Small bowel capsule endoscopy in patients with cardiac pacemakers and implantable cardioverter defibrillators: Outcome analysis using telemetry review

    OpenAIRE

    2012-01-01

    AIM: To determine if there were any interactions between cardiac devices and small bowel capsules secondary to electromagnetic interference (EMI) in patients who have undergone small bowel capsule endoscopy (SBCE).

  12. Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wake Melissa

    2012-07-01

    Full Text Available Abstract Background Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1 if it improves language and associated outcomes at ages 5 and 6 years and (2 its cost-effectiveness for families and the health care system. Methods/Design A large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or ‘usual care’ control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a ‘step up-step down’ therapeutic approach depending on the child’s language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills. Discussion A key strength of this robust study is the implementation of a therapeutic framework that provides a standardised

  13. Predictors of cardiac morbidity in diabetic, new-onset diabetic and non-diabetic high-risk hypertensive patients: The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial.

    Science.gov (United States)

    Aksnes, Tonje A; Kjeldsen, Sverre E; Rostrup, Morten; Holzhauer, Björn; Hua, Tsushung A; Julius, Stevo

    2016-08-01

    Diabetic and new-onset diabetic patients with hypertension have higher cardiac morbidity than patients without diabetes. We aimed to investigate whether baseline predictors of cardiac morbidity, the major constituent of the primary endpoint in the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial, were different in patients with diabetes and new-onset diabetes compared to patients without diabetes. In total, 15,245 high-risk hypertensive patients in the VALUE trial were followed for an average of 4.2 years. At baseline, 5250 patients were diabetic by the 1999 World Health Organization criteria, 1298 patients developed new-onset diabetes and 8697 patients stayed non-diabetic during follow-up. Cardiac morbidity was defined as a composite of myocardial infarction and heart failure requiring hospitalization, and baseline predictors were identified by univariate and multivariate stepwise Cox regression analyses. History of coronary heart disease (CHD) and age were the most important predictors of cardiac morbidity in both diabetic and non-diabetic patients. History of CHD, history of stroke and age were the only significant predictors of cardiac morbidity in patients with new-onset diabetes. Predictors of cardiac morbidity, in particular history of CHD and age, were essentially the same in high-risk hypertensive patients with diabetes, new-onset diabetes and without diabetes who participated in the VALUE trial. PMID:26808585

  14. Use of 3D printed models in medical education: A randomized control trial comparing 3D prints versus cadaveric materials for learning external cardiac anatomy.

    Science.gov (United States)

    Lim, Kah Heng Alexander; Loo, Zhou Yaw; Goldie, Stephen J; Adams, Justin W; McMenamin, Paul G

    2016-05-01

    Three-dimensional (3D) printing is an emerging technology capable of readily producing accurate anatomical models, however, evidence for the use of 3D prints in medical education remains limited. A study was performed to assess their effectiveness against cadaveric materials for learning external cardiac anatomy. A double blind randomized controlled trial was undertaken on undergraduate medical students without prior formal cardiac anatomy teaching. Following a pre-test examining baseline external cardiac anatomy knowledge, participants were randomly assigned to three groups who underwent self-directed learning sessions using either cadaveric materials, 3D prints, or a combination of cadaveric materials/3D prints (combined materials). Participants were then subjected to a post-test written by a third party. Fifty-two participants completed the trial; 18 using cadaveric materials, 16 using 3D models, and 18 using combined materials. Age and time since completion of high school were equally distributed between groups. Pre-test scores were not significantly different (P = 0.231), however, post-test scores were significantly higher for 3D prints group compared to the cadaveric materials or combined materials groups (mean of 60.83% vs. 44.81% and 44.62%, P = 0.010, adjusted P = 0.012). A significant improvement in test scores was detected for the 3D prints group (P = 0.003) but not for the other two groups. The finding of this pilot study suggests that use of 3D prints do not disadvantage students relative to cadaveric materials; maximally, results suggest that 3D may confer certain benefits to anatomy learning and supports their use and ongoing evaluation as supplements to cadaver-based curriculums. Anat Sci Educ 9: 213-221. © 2015 American Association of Anatomists. PMID:26468636

  15. Remote ischemic preconditioning reduces perioperative cardiac and renal events in patients undergoing elective coronary intervention: a meta-analysis of 11 randomized trials.

    Directory of Open Access Journals (Sweden)

    Hanjun Pei

    Full Text Available BACKGROUND: Results from randomized controlled trials (RCT concerning cardiac and renal effect of remote ischemic preconditioning(RIPC in patients with stable coronary artery disease(CAD are inconsistent. The aim of this study was to explore whether RIPC reduce cardiac and renal events after elective percutaneous coronary intervention (PCI. METHODS AND RESULTS: RCTs with data on cardiac or renal effect of RIPC in PCI were searched from Pubmed, EMBase, and Cochrane library (up to July 2014. Meta-regression and subgroup analysis were performed to identify the potential sources of significant heterogeneity(I(2 ≥ 40%. Eleven RCTs enrolling a total of 1713 study subjects with stable CAD were selected. Compared with controls, RIPC significantly reduced perioperative incidence of myocardial infarction (MI [odds ratio(OR = 0.68; 95% CI, 0.51 to 0.91; P = 0.01; I(2 = 41.0%] and contrast-induced acute kidney injury(AKI (OR = 0.61; 95% CI, 0.38 to 0.98; P = 0.04; I(2 = 39.0%. Meta-regression and subgroup analyses confirmed that the major source of heterogeneity for the incidence of MI was male proportion (coefficient  = -0.049; P = 0.047; adjusted R(2 = 0.988; P = 0.02 for subgroup difference. CONCLUSIONS: The present meta-analysis of RCTs suggests that RIPC may offer cardiorenal protection by reducing the incidence of MI and AKI in patients undergoing elective PCI. Moreover, this effect on MI is more pronounced in male subjects. Future high-quality, large-scale clinical trials should focus on the long-term clinical effect of RIPC.

  16. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial

    DEFF Research Database (Denmark)

    Meredith, Ian T; Verheye, Stefan; Weissman, Neil J;

    2013-01-01

    The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical...... results through two years from the EVOLVE FHU trial....

  17. Gel versus capillary electrophoresis genotyping for categorizing treatment outcomes in two anti-malarial trials in Uganda

    Directory of Open Access Journals (Sweden)

    Hubbard Alan E

    2010-01-01

    Full Text Available Abstract Background Molecular genotyping is performed in anti-malarial trials to determine whether recurrent parasitaemia after therapy represents a recrudescence (treatment failure or new infection. The use of capillary instead of agarose gel electrophoresis for genotyping offers technical advantages, but it is unclear whether capillary electrophoresis will result in improved classification of anti-malarial treatment outcomes. Methods Samples were genotyped using both gel and capillary electrophoresis from randomized trials of artemether-lumefantrine (AL vs. dihydroartemisinin-piperaquine (DP performed in two areas of Uganda: Kanungu, where transmission is moderate, and Apac, where transmission is very high. Both gel and capillary methods evaluated polymorphic regions of the merozoite surface protein 1 and 2 and glutamine rich protein genes. Results Capillary electrophoresis detected more alleles and provided higher discriminatory power than agarose gel electrophoresis at both study sites. There was only moderate agreement between classification of outcomes with the two methods in Kanungu (kappa = 0.66 and poor agreement in Apac (kappa = 0.24. Overall efficacy results were similar when using gel vs. capillary methods in Kanungu (42-day risk of treatment failure for AL: 6.9% vs. 5.5%, p = 0.4; DP 2.4% vs. 2.9%, p = 0.5. However, the measured risk of recrudescence was significantly higher when using gel vs. capillary electrophoresis in Apac (risk of treatment failure for AL: 17.0% vs. 10.7%, p = 0.02; DP: 8.5% vs. 3.4%, p = 0.03. Risk differences between AL and DP were not significantly different whether gel or capillary methods were used. Conclusions Genotyping with gel electrophoresis overestimates the risk of recrudescence in anti-malarial trials performed in areas of high transmission intensity. Capillary electrophoresis provides more accurate outcomes for such trials and should be performed when possible. In areas of moderate transmission

  18. The Breathing for Life Trial: a randomised controlled trial of fractional exhaled nitric oxide (FENO)-based management of asthma during pregnancy and its impact on perinatal outcomes and infant and childhood respiratory health

    OpenAIRE

    Vanessa E. Murphy; Jensen, Megan E.; Mattes, Joerg; Hensley, Michael J.; Giles, Warwick B; Peek, Michael J.; Bisits, Andrew; Callaway, Leonie K.; McCaffery, Kirsten; Barrett, Helen L.; Colditz, Paul B.; Seeho, Sean K.; Attia, John; Searles, Andrew; Doran, Christopher

    2016-01-01

    Background Asthma exacerbations are common during pregnancy and associated with an increased risk of adverse perinatal outcomes. Adjusting asthma treatment based on airway inflammation rather than symptoms reduces the exacerbation rate by 50 %. The Breathing for Life Trial (BLT) will test whether this approach also improves perinatal outcomes. Methods/design BLT is a multicentre, parallel group, randomised controlled trial of asthma management guided by fractional exhaled nitric oxide (FENO, ...

  19. Voice and swallowing outcomes of an organ-preservation trial for advanced laryngeal cancer

    International Nuclear Information System (INIS)

    Introduction: Organ-preservation treatment approaches for advanced laryngeal cancer patients that use combination chemoradiotherapy result in cure rates similar to primary laryngectomy with postoperative radiotherapy. In the national VA Larynx Cancer Trial, successful organ preservation was associated with an overall improvement in quality of life but not in subjective speech compared with long-term laryngectomy survivors. As part of a Phase II clinical trial, a prospective study of speech and swallowing results was conducted to determine if larynx preservation is associated with improved voice and swallowing compared with results in patients who require salvage laryngectomy. Subjects: A total of 97 patients with advanced laryngeal cancer (46 Stage III, 51 Stage IV) were given a single course of induction chemotherapy (cisplatin 100 mg/m2 on Day 1 and 5-FU 1,000 mg/m2/day x 5 days), followed by assessment of response. Patients with less than 50% response underwent early salvage laryngectomy, and patients with 50% or better response underwent concurrent chemoradiation (72 Gy and cisplatin 100 mg/m2 on Days 1, 22, and 43), followed by two cycles of adjuvant chemotherapy (DDP/5-FU). Direct laryngoscopy and biopsy were performed 8 weeks after radiation therapy to determine final tumor response. Late salvage surgery was performed on patients with persistent or recurrent disease. Methods: Completed survey data on voice and swallowing utilizing the Voice-Related Quality of Life Measure (V-RQOL) and the List Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) were obtained from 56 patients who were alive and free of disease at the time of survey, with a minimum follow-up of 8 months. Comparisons were made between patients with an intact larynx (n = 37) vs. laryngectomy (n = 19), as well as early (n = 12) vs. late salvage laryngectomy (n = 7). Multivariate analysis was performed to determine factors predictive of voice and swallowing outcomes. Overall 3-year

  20. Analysis of an ordinal outcome in a multicentric randomized controlled trial: application to a 3- arm anti- malarial drug trial in Cameroon

    Directory of Open Access Journals (Sweden)

    Gwét Henri

    2010-06-01

    Full Text Available Abstract Background Malaria remains a burden in Sub-Saharan Countries. The strategy proposed by the World Health Organization (WHO is to systematically compare the therapeutic efficacy of antimalarial drugs using as primary outcome for efficacy, a four-category ordered criterion. The objective of the present work was to analyze the treatment effects on this primary outcome taking into account both a center-effect and individual covariates. A three-arm, three-centre trial of Amodiaquine (AQ, sulfadoxine-pyrimethamine (SP and their combination (AQ + SP, conducted by OCEAC-IRD in 2003, in 538 children with uncomplicated Plasmodium falciparum malaria, is used as an illustration. Methods Analyses were based on ordinal regression methods, assuming an underlying continuous latent variable, using either the proportional odds (PO or the proportional hazards (PH models. Different algorithms, corresponding to both frequentist- and bayesian-approaches, were implemented using the freely available softwares R and Winbugs, respectively. The performances of the different methods were evaluated on a simulated data set, and then they were applied on the trial data set. Results Good coverage probability and type-1 error for the treatment effect were achieved. When the methods were applied on the trial data set, results highlighted a significance decrease of SP efficacy when compared to AQ (PO, odds ratio [OR] 0.14, 95% confidence interval [CI] 0.04-0.57; hazard ratio [HR] 0.605, 95% CI 0.42-0.82, and an equal effectiveness between AQ + SP and AQ (PO, odds ratio [OR] 1.70, 95% confidence interval [CI] 0.25-11.44; hazard ratio [HR] 1.40, 95% CI 0.88-2.18. The body temperature was significantly related to the responses. The patient weights were marginally associated to the clinical response. Conclusion The proposed analyses, based on usual statistical packages, appeared adapted to take into account the full information contained in the four categorical outcome in

  1. Statin Therapy and Outcome After Ischemic Stroke: Systematic Review and Meta-Analysis of Observational Studies and Randomized Trials.

    LENUS (Irish Health Repository)

    2013-01-03

    Background-Although experimental data suggest that statin therapy may improve neurological outcome after acute cerebral ischemia, the results from clinical studies are conflicting. We performed a systematic review and meta-analysis investigating the relationship between statin therapy and outcome after ischemic stroke. METHODS: The primary analysis investigated statin therapy at stroke onset (prestroke statin use) and good functional outcome (modified Rankin score 0 to 2) and death. Secondary analyses included the following: (1) acute poststroke statin therapy (≤72 hours after stroke), and (2) thrombolysis-treated patients. RESULTS: The primary analysis included 113 148 subjects (27 studies). Among observational studies, statin treatment at stroke onset was associated with good functional outcome at 90 days (pooled odds ratio [OR], 1.41; 95% confidence interval [CI], 1.29-1.56; P<0.001), but not 1 year (OR, 1.12; 95% CI, 0.9-1.4; P=0.31), and with reduced fatality at 90 days (pooled OR, 0.71; 95% CI, 0.62-0.82; P<0.001) and 1 year (OR, 0.80; 95% CI, 0.67-0.95; P=0.01). In the single randomized controlled trial reporting 90-day functional outcome, statin treatment was associated with good outcome (OR, 1.5; 95% CI, 1.0-2.24; P=0.05). No reduction in fatality was observed on meta-analysis of data from 3 randomized controlled trials (P=0.9). In studies of thrombolysis-treated patients, an association between statins and increased fatality at 90 days was observed (pooled OR, 1.25; 95% CI, 1.02-1.52; P=0.03, 3 studies, 4339 patients). However, this association was no longer present after adjusting for age and stroke severity in the largest study (adjusted OR, 1.14; 95% CI, 0.90-1.44; 4012 patients). CONCLUSIONS: In the largest meta-analysis to date, statin therapy at stroke onset was associated with improved outcome, a finding not observed in studies restricted to thrombolysis-treated patients. Randomized trials of statin therapy in acute ischemic stroke are needed.

  2. Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE (ARTFORCE); a randomized controlled phase II trial for individualized treatment of head and neck cancer

    International Nuclear Information System (INIS)

    Failure of locoregional control is the main cause of recurrence in advanced head and neck cancer. This multi-center trial aims to improve outcome in two ways. Firstly, by redistribution of the radiation dose to the metabolically most FDG-PET avid part of the tumour. Hereby, a biologically more effective dose distribution might be achieved while simultaneously sparing normal tissues. Secondly, by improving patient selection. Both cisplatin and Epidermal Growth Factor Receptor (EGFR) antibodies like Cetuximab in combination with Radiotherapy (RT) are effective in enhancing tumour response. However, it is unknown which patients will benefit from either agent in combination with irradiation. We will analyze the predictive value of biological markers and 89Zr-Cetuximab uptake for treatment outcome of chemoradiation with Cetuximab or cisplatin to improve patient selection. ARTFORCE is a randomized phase II trial for 268 patients with a factorial 2 by 2 design: cisplatin versus Cetuximab and standard RT versus redistributed RT. Cisplatin is dosed weekly 40 mg/m2 for 6 weeks. Cetuximab is dosed 250mg/m2 weekly (loading dose 400 mg/m2) for 6 weeks. The standard RT regimen consists of elective RT up to 54.25 Gy with a simultaneous integrated boost (SIB) to 70 Gy in 35 fractions in 6 weeks. Redistributed adaptive RT consists of elective RT up to 54.25 Gy with a SIB between 64-80 Gy in 35 fractions in 6 weeks with redistributed dose to the gross tumour volume (GTV) and clinical target volume (CTV), and adaptation of treatment for anatomical changes in the third week of treatment. Patients with locally advanced, biopsy confirmed squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx are eligible. Primary endpoints are: locoregional recurrence free survival at 2 years, correlation of the median 89Zr-cetuximab uptake and biological markers with treatment specific outcome, and toxicity. Secondary endpoints are quality of life, swallowing function preservation

  3. Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Evelyn Korkor Ansah

    2009-01-01

    Full Text Available BACKGROUND: Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly. METHODS AND FINDINGS: 2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used

  4. Impact of biodegradable versus durable polymer drug-eluting stents on clinical outcomes in patients with coronary artery disease: a meta-analysis of 15 randomized trials

    Institute of Scientific and Technical Information of China (English)

    Zhang Yaojun; Tian Nailiang; Dong Shengjie; Ye Fei; Li Minghui; Christos V.Bourantas; Javaid Iqbal

    2014-01-01

    Background Drug eluting stents (DESs) made with biodegradable polymer have been developed in an attempt to improve clinical outcomes.However,the impact of biodegradable polymers on clinical events and stent thrombosis (ST) remains controversial.Methods We searched Medline,the Cochrane Library and other internet sources,without language or date restrictions for articles comparing clinical outcomes between biodegradable polymer DES and durable polymer DES.Safety endpoints were ST (definite,definite/probable),mortality,and myocardial infarction (MI).Efficacy endpoints were major adverse cardiac event (MACE) and target lesion revascularization (TLR).Results We identified 15 randomized controlled trials (n=17 068) with a weighted mean follow-up of 20.6 months.There was no statistical difference in the incidence of definite/probable ST between durable polymer-and biodegradable polymerDES; relative risk (RR) 0.83; 95% confidence interval (CI) 0.62-1.11; P=0.22.Biodegradable polymer DES had similar rates of definite ST (RR 0.94,95% CI 0.66-1.33,P=0.72),mortality (RR 0.94,95% C/0.82-1.09,P=0.43),MI (RR 1.08,95% CI 0.92-1.26.P=0.35),MACE (RR 0.99,95% CI 0.91-1.09,P=0.85),and TLR (RR,0.94,95% CI 0.83-1.06,P=0.30) compared with durable polymer DES.Based on the stratified analysis of the included trials,the treatment effect on definite ST was different at different follow-up times:≤1 year favoring durable polymer DES and >1 year favoring biodegradable polymer DES.Conclusions Biodegradable polymer DES has similar safety and efficacy for treating patients with coronary artery disease compared with durable polymer DES.Further data with longer term follow-up are warranted to confirm the potential benefits of biodegradable polymer DES.

  5. Identification of Typical Left Bundle Branch Block Contraction by Strain Echocardiography Is Additive to Electrocardiography in Prediction of Long-Term Outcome After Cardiac Resynchronization Therapy

    DEFF Research Database (Denmark)

    Risum, Niels; Tayal, Bhupendar; Hansen, Thomas F;

    2015-01-01

    BACKGROUND: Current guidelines suggest that patients with left bundle branch block (LBBB) be treated with cardiac resynchronization therapy (CRT); however, one-third do not have a significant activation delay, which can result in nonresponse. By identifying characteristic opposing wall contraction...... whether typical LBBB contraction was present. The pre-defined outcome was freedom from death, left ventricular assist device, or heart transplantation over 4 years. RESULTS: Two-thirds of patients (63%) had a typical LBBB contraction pattern. During 4 years, 48 patients (23%) reached the primary endpoint...

  6. Baseline diabetes as a way to predict CV outcomes in a lipid-modifying trial: A meta-analysis of 330,376 patients from 47 landmark studies

    OpenAIRE

    Hermans, Michel; Bouenizabila, Evariste; Amoussou-guenou, Daniel K.; Ahn, Sylvie A; Rousseau, Michel

    2015-01-01

    Background: Diabetes is a major cardiovascular risk factor. However, its influence on the rate of occurrence of cardiovascular (CV) events during a clinical trial that included a diabetes subgroup has not yet been quantified. Aims: To establish equations relating baseline diabetes prevalence and incident CV events, based on comparator arms data of major lipid-modifying trials. Methods: Meta-analysis of primary outcomes (PO) rates of key prospective trials, for which the baseline proportion of...

  7. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    OpenAIRE

    Eisenstein, Eric L.; Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2010-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators ...

  8. Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT): protocol for a randomized clinical trial

    OpenAIRE

    Davidsen, Annika Helgadóttir; Poulsen, Stig; Waaddegaard, Mette; Lindschou, Jane; Lau, Marianne

    2014-01-01

    Background Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome. There are, however, only three published randomized trials on the effect of feedback on the treatment of eating disorders, showing inconclusive results, and there are no randomized trials on the effect of feedback in group therapy. Accordingly the current randomized clinical trial, initiated in September 2012 at the outpatient clinic for eating dis...

  9. Early and late rehabilitation and physical training in elderly patients after cardiac surgery

    OpenAIRE

    C. Macchi; Fattirolli, F; RM.Lova; AA Conti.; ML.Luisi; R.Intini; R.Zipoli; C.Burgisser; L. Guarducci; G. Masotti; Gensini GF

    2007-01-01

    OBJECTIVE: Few randomized trials have enrolled patients who have undergone cardiac surgery, and even fewer have included patients aged 75 yrs or more. Furthermore, the optimal timing of cardiac rehabilitation for postsurgical patients has not yet been codified. The aim of this study was to verify whether rehabilitation outcomes are also favorable in postsurgical patients aged 75 yrs or more and whether an early rehabilitation program is as effective and safe as a late one. DESIGN: Th...

  10. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.;

    2008-01-01

    , and HRQoL, and has a favorable safety profile. DESIGN/MEASUREMENTS: This is a prospective, double-blind, multicenter, randomized clinical trial involving 2500 MHD patients, up to 50% with diabetes mellitus, from 22 countries. Patients are randomized in a 1:1 ratio to receive daily injections of GH (20......, uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy. CONCLUSIONS: The OPPORTUNITY Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers......-related quality of life (HRQoL), which are significantly and positively associated with survival in MHD patients. The OPPORTUNITY Trial will examine whether GH reduces mortality and morbidity and improves overall health in hypoalbuminemic MHD patients. HYPOTHESIS: The primary hypothesis is that daily recombinant...

  11. PRECLINICAL DRUG TRIALS IN THE mdx MOUSE: ASSESSMENT OF RELIABLE AND SENSITIVE OUTCOME MEASURES

    OpenAIRE

    SPURNEY, CHRISTOPHER F.; Gordish-Dressman, Heather; Alfredo D Guerron; Sali, Arpana; Gouri S Pandey; Rawat, Rashmi; van der Meulen, Jack H; Cha, Hee-Jae; Pistilli, Emidio E.; Partridge, Terence A.; Hoffman, Eric P; Nagaraju, Kanneboyina

    2009-01-01

    The availability of animal models for Duchenne muscular dystrophy has led to extensive preclinical research on potential therapeutics. Few studies have focused on reliability and sensitivity of endpoints for mdx mouse drug trials. Therefore, we sought to compare a wide variety of reported and novel endpoint measures in exercised mdx and normal control mice at 10, 20, and 40 weeks of age. Statistical analysis as well as power calculations for expected effect sizes in mdx preclinical drug trial...

  12. Percutaneous coronary intervention in the Occluded Artery Trial: Procedural success, hazard, and outcomes over 5 years

    OpenAIRE

    Buller, C; Rankin, J.; Carere, R; P. Buszman; Pfisterer, M.; Dzavik, V; Thomas, B.; Forman, S.; Ruzyllo, W; Mancini, G.; Michalis, L; de Abreu, G.; Lamas, G.; Hochman, J

    2009-01-01

    BACKGROUND: The Occluded Artery Trial (OAT) was a 2,201-patient randomized clinical trial comparing routine stent-based percutaneous coronary intervention (PCI) versus optimal medical therapy alone in stable myocardial infarction (MI) survivors with persistent infarct-related artery occlusion identified day 3 to 28 post MI. Intent-to-treat analysis showed no difference between strategies with respect to the incidence of new class IV congestive heart failure, MI, or death. The influence of PCI...

  13. Safety in cardiac surgery

    OpenAIRE

    Siregar, S.

    2013-01-01

    The monitoring of safety in cardiac surgery is a complex process, which involves many clinical, practical, methodological and statistical issues. The objective of this thesis was to measure and to compare safety in cardiac surgery in The Netherlands using the Netherlands Association for Cardio-Thoracic Surgery (NVT) database. The safety of care is usually measured using patient outcomes. If outcomes are not available, the process and structure of care may be used. Outcomes should be adjusted ...

  14. Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from The TERVA randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Patja Kristiina

    2012-06-01

    Full Text Available Abstract Background The aim was to evaluate the effect of a 12-month individualized health coaching intervention by telephony on clinical outcomes. Methods An open-label cluster-randomized parallel groups trial. Pre- and post-intervention anthropometric and blood pressure measurements by trained nurses, laboratory measures from electronic medical records (EMR. A total of 2594 patients filling inclusion criteria (age 45 years or older, with type 2 diabetes, coronary artery disease or congestive heart failure, and unmet treatment goals were identified from EMRs, and 1535 patients (59% gave consent and were randomized into intervention or control arm. Final analysis included 1221 (80% participants with data on primary end-points both at entry and at end. Primary outcomes were systolic and diastolic blood pressure, serum total and LDL cholesterol concentration, waist circumference for all patients, glycated hemoglobin (HbA1c for diabetics and NYHA class in patients with congestive heart failure. The target effect was defined as a 10-percentage point increase in the proportion of patients reaching the treatment goal in the intervention arm. Results The proportion of patients with diastolic blood pressure initially above the target level decreasing to 85 mmHg or lower was 48% in the intervention arm and 37% in the control arm (difference 10.8%, 95% confidence interval 1.5–19.7%. No significant differences emerged between the arms in the other primary end-points. However, the target levels of systolic blood pressure and waist circumference were reached non-significantly more frequently in the intervention arm. Conclusions Individualized health coaching by telephony, as implemented in the trial was unable to achieve majority of the disease management clinical measures. To provide substantial benefits, interventions may need to be more intensive, target specific sub-groups, and/or to be fully integrated into local health care. Trial registration

  15. Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial

    Directory of Open Access Journals (Sweden)

    Wouters Patrick

    2011-05-01

    Full Text Available Abstract Background Pre- and postconditioning describe mechanisms whereby short ischemic periods protect an organ against a longer period of ischemia. Interestingly, short ischemic periods of a limb, in itself harmless, may increase the ischemia tolerance of remote organs, e.g. the heart (remote conditioning, RC. Although several studies have shown reduced biomarker release by RC, a reduction of complications and improvement of patient outcome still has to be demonstrated. Atrial fibrillation (AF is one of the most common complications after coronary artery bypass graft surgery (CABG, affecting 27-46% of patients. It is associated with increased mortality, adverse cardiovascular events, and prolonged in-hospital stay. We hypothesize that remote ischemic pre- and/or post-conditioning reduce the incidence of AF following CABG, and improve patient outcome. Methods/design This study is a randomized, controlled, patient and investigator blinded multicenter trial. Elective CABG patients are randomized to one of the following four groups: 1 control, 2 remote ischemic preconditioning, 3 remote ischemic postconditioning, or 4 remote ischemic pre- and postconditioning. Remote conditioning is applied at the arm by 3 cycles of 5 minutes of ischemia and reperfusion. Primary endpoint is the incidence AF in the first 72 hours after surgery, detected using a Holter-monitor. Secondary endpoints include length-of-stay on the intensive care unit and in-hospital, and the occurrence of major adverse cardiovascular events at 30 days, 3 months and 1 year. Based on an expected incidence in the control group of 27%, 195 patients per group are needed to detect with 80% power a reduction by 45% following either pre- or postconditioning, while allowing for a 10% dropout and at an alpha of 0.05. With the combined intervention expected to be stronger, we need 75 patients in this group to detect a reduction in incidence of AF of 60%. Discussion The RICO-trial (the effect of

  16. Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sung Valerie

    2012-08-01

    Full Text Available Abstract Background Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old ( Methods/Design Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i number of episodes of infant crying/fussing per 24 hours and ii infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months; iii maternal mental health scores, iv family functioning scores, v parent quality adjusted life years scores, and vi intervention cost-effectiveness (at one and six months; and vii infant faecal microbiota diversity, viii infant faecal calprotectin levels and ix Eschericia coli load (at one month only. Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied. Discussion An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If

  17. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent : 4-year results of the PROTECT randomized trial

    NARCIS (Netherlands)

    Wijns, William; Steg, Ph. Gabriel; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P.; Lipsic, Erik; Alamgir, Farqad; Rademaker-Havinga, Tessa; Boersma, Eric; Radke, Peter; van Leeuwen, Frank; Camenzind, Edoardo

    2014-01-01

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable

  18. The role of surgery for treatment of low back pain: insights from the randomized controlled Spine Patient Outcomes Research Trials

    Directory of Open Access Journals (Sweden)

    Peter Abraham

    2016-01-01

    Full Text Available Low back pain (LBP is a common medical problem with high morbidity and healthcare costs. The optimal management strategy, including the role of surgical intervention, remains controversial. The Spine Patient Outcomes Research Trials were randomized controlled studies conducted to assess the effectiveness of surgery for three of the most common conditions implicated in LBP: Intervertebral disc herniation, degenerative spondylolisthesis, and spinal stenosis. Despite challenges in data interpretation related to patient cross over, these studies support the efficacy of surgery as treatment for these three common conditions.

  19. Outcomes on the pharmacopsychometric triangle in bupropion-SR vs. buspirone augmentation of citalopram in the STAR*D trial

    DEFF Research Database (Denmark)

    Bech, P; Fava, Maurizio; Trivedi, M H;

    2012-01-01

    Bech P, Fava M, Trivedi MH, Wisniewski SR, Rush AJ. Outcomes on the pharmacopsychometric triangle in bupropion-SR vs. buspirone augmentation of citalopram in the STAR*D trial. Objective: To compare within the framework of a novel pharmacopsychometric triangle, augmentation treatment with bupropion...... intention to treat sample was used. Results: Within the pharmacopsychometric triangle, bupropion-SR (sustained release) was superior to buspirone when augmented to the current citalopram treatment. Thus, in the domain of pure antidepressive effect, bupropion-SR was superior (P = 0.05) on the HAM-D(6) , IDS...... depressed outpatients not responding to citalopram....

  20. A controlled trial of the effect of aromatherapy on birth outcomes using "Rose essential oil" inhalation and foot bath

    OpenAIRE

    Masoomeh Kheirkhah; Nassimeh Setayesh Valipour; Leila Neisani; Hamid Haghani

    2013-01-01

    Background and aim: Aromatherapy is the art and science of using essential oils extracted from aromatic plants, and is concerned with natural balance, coordination and promotion of health. This study was designed to determine the effect of "rose (Rosa damascena) essential oil" inhalation and foot bath on the improvement of maternal and neonatal health outcomes. Material and methods: This study was a randomized clinical trial, conducted on 80 primiparous women in Shahid Akbar Abadi Maternity H...

  1. The effect of preoperative renal dysfunction with or without dialysis on early postoperative outcome following cardiac surgery.

    LENUS (Irish Health Repository)

    Al-Sarraf, Nael

    2011-01-01

    Although previous studies have shown increased mortality in renal dysfunction patients undergoing cardiac surgery, there is lack of data on the pattern of postoperative complications that occur in such patients and their distribution among dialysis and non-dialysis dependent renal dysfunction.

  2. Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-03-01

    Full Text Available Abstract Background A growing body of research suggests that regular consumption of dairy foods may counteract obesity and other components of the metabolic syndrome. However, human intervention trials are lacking. We aimed to determine the cardiometabolic health effects of increasing the consumption of reduced fat dairy foods in adults with habitually low dairy intakes in the absence of energy restriction. Methods An intervention trial was undertaken in 61 overweight or obese adults who were randomly assigned to a high dairy diet (HD, 4 serves of reduced fat dairy/day or a low dairy control diet (LD, ≤1 serve/day for 6 months then crossed over to the alternate diet for a further 6 months. A range of anthropometric and cardiometabolic parameters including body composition, metabolic rate, blood lipids, blood pressure and arterial compliance were assessed at the end of each diet phase. Results Total energy intake was 1120 kJ/day higher during the HD phase, resulting in slight weight gain during this period. However, there were no significant differences between HD and LD in absolute measures of waist circumference, body weight, fat mass or any other cardiometabolic parameter. Conclusion Recommended intakes of reduced fat dairy products may be incorporated into the diet of overweight adults without adversely affecting markers of cardiometabolic health. Trial Registration The trial was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12608000538347 on 24th October, 2008.

  3. The ADOPT trial (Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D for Heart Failure Patients in China: rationale, design, and end-points

    Directory of Open Access Journals (Sweden)

    Liu B

    2011-06-01

    Full Text Available Bing Liu1*, Fu Yi1*, Hongwei Cai2, Wenyi Guo1, Weijie Li1, Min Shen1, Jielai Xia3, Liwen Liu4, Haichang Wang1, on behalf of The ADOPT Study Steering Committee and Investigators1Department of Cardiology, Xijing Hospital, FMMU, Xi’an, China; 2Department of Information, School of Stomatology, FMMU, Xi’an, China; 3Department of Statistics, FMMU, Xi’an, China; 4Department of Ultrasound, Xijing Hospital, FMMU, Xi’an, ChinaClinicalTrials.gov number, NCT01018667*Both authors contributed equally to this workBackground: Cardiac resynchronization therapy (CRT is a novel nonpharmacological treatment for patients with chronic heart failure (CHF. Some clinical trials conducted in Western countries have demonstrated that CRT could improve CHF patients’ symptoms and reduce mortality. However, due to the differences in economic and social conditions as well as inconsistencies in CHF etiologies between China and Western countries, there is an urgent need to conduct a large-scale CRT clinical study in Chinese patients with CHF. The ADOPT Trial (Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D for Heart Failure Patients in China is designed to observe whether CRT can further improve syptoms and reduce mortality in Chinese patients in addition to optimal pharmalogical therapy.Methods: The ADOPT study is a prospective, nested, case-controlled, open-label clinical trial. About 40 centers across China participate in this study with a planned 800 Chinese cases to be enrolled. All patients will receive optimal medical treatment. Patients who have successful CRT-P/D implant will be assigned to the CRT group. According to the baseline evaluation, matched cases will be selected from the enrolled optimal pharmaceutical therapy alone group (Group for Selection. After successful match, the cases in Group for Selection enter into follow-up and become the control group. The unmatched cases in the Group for Selection will be removed. If patients

  4. Urine Injury Biomarkers and Risk of Adverse Outcomes in Recipients of Prevalent Kidney Transplants: The Folic Acid for Vascular Outcome Reduction in Transplantation Trial.

    Science.gov (United States)

    Bansal, Nisha; Carpenter, Myra A; Weiner, Daniel E; Levey, Andrew S; Pfeffer, Marc; Kusek, John W; Cai, Jianwen; Hunsicker, Lawrence G; Park, Meyeon; Bennett, Michael; Liu, Kathleen D; Hsu, Chi-Yuan

    2016-07-01

    Recipients of kidney transplants (KTR) are at increased risk for cardiovascular events, graft failure, and death. It is unknown whether urine kidney injury biomarkers are associated with poor outcomes among KTRs. We conducted a post hoc analysis of the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial using a case-cohort study design, selecting participants with adjudicated cardiovascular events, graft failure, or death. Urine neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), IL-18, and liver-type fatty acid binding protein (L-FABP) were measured in spot urine samples and standardized to urine creatinine concentration. We adjusted for demographics, cardiovascular risk factors, eGFR, and urine albumin-to-creatinine ratio. Patients had 291 cardiovascular events, 257 graft failure events, and 359 deaths. Each log increase in urine NGAL/creatinine independently associated with a 24% greater risk of cardiovascular events (adjusted hazard ratio [aHR], 1.24; 95% confidence interval [95% CI], 1.06 to 1.45), a 40% greater risk of graft failure (aHR, 1.40; 95% CI, 1.16 to 1.68), and a 44% greater risk of death (aHR, 1.44; 95% CI, 1.26 to 1.65). Urine KIM-1/creatinine and IL-18/creatinine independently associated with greater risk of death (aHR, 1.29; 95% CI, 1.03 to 1.61 and aHR, 1.25; 95% CI, 1.04 to 1.49 per log increase, respectively) but not with risk of cardiovascular events or graft failure. Urine L-FABP did not associate with any study outcomes. In conclusion, among prevalent KTRs, higher urine NGAL, KIM-1, and IL-18 levels independently and differentially associated with greater risk of adverse outcomes. PMID:26538631

  5. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida (United States); Henderson, Randal H. [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

    2014-03-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

  6. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes

  7. Five-Year Outcomes after Oxandrolone Administration in Severely Burned Children: A Randomized Clinical Trial of Safety and Efficacy

    Science.gov (United States)

    Porro, Laura J; Herndon, David N; Rodriguez, Noe A; Jennings, Kristofer; Klein, Gordon L; Mlcak, Ronald P; Meyer, Walter; Lee, Jong; Suman, Oscar E; Finnerty, Celeste C

    2012-01-01

    Background Oxandrolone, an anabolic agent, has been administered for 1 year post burn with beneficial effects in pediatric patients. However, the long-lasting effects of this treatment have not been studied. This single-center prospective trial determined the long-term effects of 1 year of oxandrolone administration in severely burned children; assessments were continued for up to 4 years post-therapy. Study Design Patients 0–18 years old with burns covering >30% of the total body surface area were randomized to receive placebo (n=152) or oxandrolone, 0.1 mg/kg twice daily for 12 months (n=70). At hospital discharge, patients were randomized to a 12 week exercise program or to standard of care. Resting energy expenditure (REE), standing height, weight, lean body mass, muscle strength, bone mineral content (BMC), cardiac work, rate pressure product (RPP), sexual maturation, and concentrations of serum inflammatory cytokines, hormones, and liver enzymes were monitored. Results Oxandrolone significantly decreased REE, RPP, and increased IGF-1 secretion during the first year after burn injury, and in combination with exercise significantly increased lean body mass and muscle strength. Oxandrolone-treated children exhibited improved height percentile and BMC content compared to controls. The maximal effect of oxandrolone was found in children aged 7–18 years. No deleterious side effects were attributed to long-term administration. Conclusions Administration of oxandrolone improves the long-term recovery of severely burned children in height, BMC, cardiac work and muscle strength; the increase in BMC is likely to occur by means of IGF 1. These benefits persist for up to 5 years post burn. PMID:22463890

  8. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes

    DEFF Research Database (Denmark)

    Wood, Lesley; Egger, Matthias; Gluud, Lise Lotte;

    2008-01-01

    To examine whether the association of inadequate or unclear allocation concealment and lack of blinding with biased estimates of intervention effects varies with the nature of the intervention or outcome....

  9. ST-elevation acute coronary syndromes in the Platelet Inhibition and Patient Outcomes (PLATO) trial

    DEFF Research Database (Denmark)

    Armstrong, Paul W; Siha, Hany; Fu, Yuling;

    2012-01-01

    ) trial. This prespecified ECG substudy explored whether ticagrelor's association with vascular death and myocardial infarction within 1 year would be amplified by (1) the extent of baseline ST shift and (2) subsequently associated with fewer residual ST changes at hospital discharge....

  10. Breast Cancer Clinical Trials: Past Half Century Moving Forward Advancing Patient Outcomes.

    Science.gov (United States)

    Kuerer, Henry M; van la Parra, Raquel F D

    2016-10-01

    Clinical trials in breast cancer have contributed immensely to the advancements of modern multimodal breast cancer treatment. Due to improved screening methods and more effective biologic-based tailored systemic therapies, the extent of surgery necessary for local and systemic control of disease is decreasing. Sequential trials for ductal carcinoma in situ (DCIS) have changed the management of this disease and are culminating in randomized active surveillance studies in an effort potentially to prevent overtreatment of low- and intermediate-grade disease. For patients with initial node-positive disease, clipping and marking of the biopsy-proven nodal metastases before the start of neoadjuvant chemotherapy can allow for selective node dissection based on the axillary response. With the current advances in primary systemic therapy, feasibility trials are beginning to investigate the potential of nonoperative therapy for invasive cancers with percutaneously documented pathologic complete response. This article presents a review and update on landmark clinical trials related to DCIS, the extent of axillary surgery in node-positive disease, and the integration of systemic therapy with local therapy. PMID:27364503

  11. Ventilation strategies and outcome in randomised trials of high frequency ventilation

    OpenAIRE

    Thome, U; Carlo, W; Pohlandt, F

    2005-01-01

    Objective: Randomised controlled trials comparing elective use of high frequency ventilation (HFV) with conventional mechanical ventilation (CMV) in preterm infants have yielded conflicting results. We hypothesised that the variability of results may be explained by differences in study design, ventilation strategies, delay in initiation of HFV, and use of permissive hypercapnia.

  12. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    Science.gov (United States)

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  13. A systematic review of randomized controlled trials examining the effectiveness of saffron (Crocus sativus L.) on psychological and behavioral outcomes

    Institute of Scientific and Technical Information of China (English)

    Heather Ann Hausenblas; Kacey Heekin; Heather Lee Mutchie; Stephen Anton

    2015-01-01

    BACKGROUND: Throughout the past three decades, increased scientiifc attention has been given to examining saffron’s (Crocus sativusL.) use as a potential therapeutic or preventive agent for a number of health conditions, including cancer, cardiovascular disease, and depression. OBJECTIVE: The purpose of this systematic review is to examine and categorize the current state of scientiifc evidence from randomized controled trials (RCTs) regarding the efifcacy of saffron on psychological/behavioral outcomes. SEARCH STRATEGY: Electronic and non-electronic systematic searches were conducted to identify al relevant human clinical research on saffron. The search strategy was extensive and was designed according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).” Reference lists of articles that met the inclusion criteria were searched. Only English language studies were reviewed. INCLUSION CRITERIA:Saffron trials in combination with other substances and saffron safety studies were considered, in accordance with the PRISMA statement. Included studies must have a control group. Included studies must measure a physiological and/or a behavioral outcome. DATA EXTRACTION AND ANALYSIS:The methodological quality of al included studies was independently evaluated by two reviewers using the Jadad score. Mean scores andP-values of measures were compared both inter- and intra-study for each parameter (i.e., depression). RESULTS:Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes of: major depressive disorder (n = 6), premenstrual syndrome (n = 1), sexual dysfunction and infertility (n = 4), and weight loss/snacking behaviors (n = 1). The data from these studies support the efifcacy of saffron as compared to placebo in improving the folowing conditions:depressive symptoms (compared to anti-depressants and placebo), premenstrual symptoms, and sexual dysfunction. In addition

  14. Background rates of adverse pregnancy outcomes for assessing the safety of maternal vaccine trials in sub-Saharan Africa.

    Directory of Open Access Journals (Sweden)

    Lauren A V Orenstein

    Full Text Available BACKGROUND: Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa. METHODS: We developed a mathematical model that calculates a clinical trial's expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM, low birth weight (LBW, prematurity, and major congenital malformations (MCM in Sub-Saharan African countries were also performed. FINDINGS: Accounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6-73.3 per 1,000 total births, and the most common causes were hemorrhage (34%, dystocia (22%, and severe hypertensive disorders of pregnancy (22%. Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9-16.4 or premature (median 15.4%, IQR: 10.6-19.1 were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5-17.6, with the musculoskeletal system comprising 30%. INTERPRETATION: Some clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies

  15. Virtual histology assessment of cardiac allograft vasculopathy following introduction of everolimus--results of a multicenter trial

    DEFF Research Database (Denmark)

    Arora, Stina Jørgensen; Erikstad, I; Ueland, T;

    2012-01-01

    In this 12-month multicenter Scandinavian study, 78 maintenance heart transplant (HTx) recipients randomized to everolimus with reduced calcineurin inhibitor (CNI) exposure or continued standard CNI-therapy underwent matched virtual histology (VH) examination to evaluate morphological progression...... of cardiac allograft vasculopathy (CAV). Parallel measurement of a range of inflammatory markers was also performed. A similar rate of quantitative CAV progression was observed in the everolimus (n = 30) and standard CNI group (n = 48) (plaque index 1.9 ± 3.8% and 1.6 ± 3.9%, respectively; p = 0...

  16. Stimulating endogenous cardiac regeneration

    Directory of Open Access Journals (Sweden)

    Amanda eFinan

    2015-09-01

    Full Text Available The healthy adult heart has a low turnover of cardiac myocytes. The renewal capacity, however, is augmented after cardiac injury. Participants in cardiac regeneration include cardiac myocytes themselves, cardiac progenitor cells, and peripheral stem cells, particularly from the bone marrow compartment. Cardiac progenitor cells and bone marrow stem cells are augmented after cardiac injury, migrate to the myocardium, and support regeneration. Depletion studies of these populations have demonstrated their necessary role in cardiac repair. However, the potential of these cells to completely regenerate the heart is limited. Efforts are now being focused on ways to augment these natural pathways to improve cardiac healing, primarily after ischemic injury but in other cardiac pathologies as well. Cell and gene therapy or pharmacological interventions are proposed mechanisms. Cell therapy has demonstrated modest results and has passed into clinical trials. However, the beneficial effects of cell therapy have primarily been their ability to produce paracrine effects on the cardiac tissue and recruit endogenous stem cell populations as opposed to direct cardiac regeneration. Gene therapy efforts have focused on prolonging or reactivating natural signaling pathways. Positive results have been demonstrated to activate the endogenous stem cell populations and are currently being tested in clinical trials. A potential new avenue may be to refine pharmacological treatments that are currently in place in the clinic. Evidence is mounting that drugs such as statins or beta blockers may alter endogenous stem cell activity. Understanding the effects of these drugs on stem cell repair while keeping in mind their primary function may strike a balance in myocardial healing. To maximize endogenous cardiac regeneration,a combination of these approaches couldameliorate the overall repair process to incorporate the participation ofmultiple cell players.

  17. Effect of Behavior Modification on Outcome in Early- to Moderate-Stage Chronic Kidney Disease: A Cluster-Randomized Trial

    Science.gov (United States)

    Yamagata, Kunihiro; Makino, Hirofumi; Iseki, Kunitoshi; Ito, Sadayoshi; Kimura, Kenjiro; Kusano, Eiji; Shibata, Takanori; Tomita, Kimio; Narita, Ichiei; Nishino, Tomoya; Fujigaki, Yoshihide; Mitarai, Tetsuya; Watanabe, Tsuyoshi; Wada, Takashi; Nakamura, Teiji; Matsuo, Seiichi

    2016-01-01

    Objectives Owing to recent changes in our understanding of the underlying cause of chronic kidney disease (CKD), the importance of lifestyle modification for preventing the progression of kidney dysfunction and complications has become obvious. In addition, effective cooperation between general physicians (GPs) and nephrologists is essential to ensure a better care system for CKD treatment. In this cluster-randomized study, we studied the effect of behavior modification on the outcome of early- to moderate-stage CKD. Design Stratified open cluster-randomized trial. Setting A total of 489 GPs belonging to 49 local medical associations (clusters) in Japan. Participants A total of 2,379 patients (1,195 in group A (standard intervention) and 1,184 in group B (advanced intervention)) aged between 40 and 74 years, who had CKD and were under consultation with GPs. Intervention All patients were managed in accordance with the current CKD guidelines. The group B clusters received three additional interventions: patients received both educational intervention for lifestyle modification and a CKD status letter, attempting to prevent their withdrawal from treatment, and the group B GPs received data sheets to facilitate reducing the gap between target and practice. Main outcome measure The primary outcome measures were 1) the non-adherence rate of accepting continuous medical follow-up of the patients, 2) the collaboration rate between GPs and nephrologists, and 3) the progression of CKD. Results The rate of discontinuous clinical visits was significantly lower in group B (16.2% in group A vs. 11.5% in group B, p = 0.01). Significantly higher referral and co-treatment rates were observed in group B (pUniversity Hospital Medical Information Network clinical trials registry UMIN000001159 PMID:26999730

  18. Analysis of time to event outcomes in randomized controlled trials by generalized additive models.

    Directory of Open Access Journals (Sweden)

    Christos Argyropoulos

    Full Text Available Randomized Controlled Trials almost invariably utilize the hazard ratio calculated with a Cox proportional hazard model as a treatment efficacy measure. Despite the widespread adoption of HRs, these provide a limited understanding of the treatment effect and may even provide a biased estimate when the assumption of proportional hazards in the Cox model is not verified by the trial data. Additional treatment effect measures on the survival probability or the time scale may be used to supplement HRs but a framework for the simultaneous generation of these measures is lacking.By splitting follow-up time at the nodes of a Gauss Lobatto numerical quadrature rule, techniques for Poisson Generalized Additive Models (PGAM can be adopted for flexible hazard modeling. Straightforward simulation post-estimation transforms PGAM estimates for the log hazard into estimates of the survival function. These in turn were used to calculate relative and absolute risks or even differences in restricted mean survival time between treatment arms. We illustrate our approach with extensive simulations and in two trials: IPASS (in which the proportionality of hazards was violated and HEMO a long duration study conducted under evolving standards of care on a heterogeneous patient population.PGAM can generate estimates of the survival function and the hazard ratio that are essentially identical to those obtained by Kaplan Meier curve analysis and the Cox model. PGAMs can simultaneously provide multiple measures of treatment efficacy after a single data pass. Furthermore, supported unadjusted (overall treatment effect but also subgroup and adjusted analyses, while incorporating multiple time scales and accounting for non-proportional hazards in survival data.By augmenting the HR conventionally reported, PGAMs have the potential to support the inferential goals of multiple stakeholders involved in the evaluation and appraisal of clinical trial results under proportional and

  19. Limits of teacher delivered sex education: interim behavioural outcomes from randomised trial

    OpenAIRE

    Wight, Daniel; Raab, Gillian M.; Henderson, Marion; Abraham, Charles; Buston, Katie; Hart, Graham; Scott, Sue

    2002-01-01

    OBJECTIVE: To determine whether a theoretically based sex education programme for adolescents (SHARE) delivered by teachers reduced unsafe sexual intercourse compared with current practice. DESIGN: Cluster randomised trial with follow up two years after baseline (six months after intervention). A process evaluation investigated the delivery of sex education and broader features of each school. SETTING: Twenty five secondary schools in east Scotland. PARTICIPANTS: 8430 pupils aged 13-15 years;...

  20. PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    de Jonge Peter

    2011-06-01

    Full Text Available Abstract Background There is ample evidence from observational prospective studies that maternal depression or anxiety during pregnancy is a risk factor for adverse psychosocial outcomes in the offspring. However, to date no previous study has demonstrated that treatment of depressive or anxious symptoms in pregnancy actually could prevent psychosocial problems in children. Preventing psychosocial problems in children will eventually bring down the huge public health burden of mental disease. The main objective of this study is to assess the effects of cognitive behavioural therapy in pregnant women with symptoms of anxiety or depression on the child's development as well as behavioural and emotional problems. In addition, we aim to study its effects on the child's development, maternal mental health, and neonatal outcomes, as well as the cost-effectiveness of cognitive behavioural therapy relative to usual care. Methods/design We will include 300 women with at least moderate levels of anxiety or depression at the end of the first trimester of pregnancy. By including 300 women we will be able to demonstrate effect sizes of 0.35 or over on the total problems scale of the child behavioural checklist 1.5-5 with alpha 5% and power (1-beta 80%. Women in the intervention arm are offered 10-14 individual cognitive behavioural therapy sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week. Women in the control group receive care as usual. Primary outcome is behavioural/emotional problems at 1.5 years of age as assessed by the total problems scale of the child behaviour checklist 1.5 - 5 years. Secondary outcomes will be mental, psychomotor and behavioural development of the child at age 18 months according to the Bayley scales, maternal anxiety and depression during pregnancy and postpartum, and neonatal outcomes such as birth weight, gestational age and Apgar score, health care consumption and general health status

  1. Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT investigators

    DEFF Research Database (Denmark)

    Sever, P S; Dahlöf, B; Poulter, N R; Wedel, H; Beevers, G; Caulfield, M; Collins, R; Kjeldsen, S E; McInnes, G T; Mehlsen, J; Nieminen, M; O'Brien, E; Ostergren, J

    2001-01-01

    To test the primary hypothesis that a newer antihypertensive treatment regimen (calcium channel blocker +/- an angiotensin converting enzyme inhibitor) is more effective than an older regimen (beta-blocker +/- a diuretic) in the primary prevention of coronary heart disease (CHD). To test a second...... primary hypothesis that a statin compared with placebo will further protect against CHD endpoints in hypertensive subjects with a total cholesterol

  2. The Anglo-Scandinavian Cardiac Outcomes Trial: blood pressure-lowering limb: effects in patients with type II diabetes

    DEFF Research Database (Denmark)

    Ostergren, Jan; Poulter, Neil R; Sever, Peter S;

    2008-01-01

    . METHODS: Patients had either untreated hypertension or treated hypertension. For those with type II diabetes mellitus, inclusion criteria required at least two additional risk factors. Patients were randomized to amlodipine with addition of perindopril as required (amlodipine-based) or atenolol...

  3. Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT investigators

    DEFF Research Database (Denmark)

    Sever, P S; Dahlöf, B; Poulter, N R; Wedel, H; Beevers, G; Caulfield, M; Collins, R; Kjeldsen, S E; McInnes, G T; Mehlsen, J; Nieminen, M; O'Brien, E; Ostergren, J

    2001-01-01

    To test the primary hypothesis that a newer antihypertensive treatment regimen (calcium channel blocker +/- an angiotensin converting enzyme inhibitor) is more effective than an older regimen (beta-blocker +/- a diuretic) in the primary prevention of coronary heart disease (CHD). To test a second...

  4. Clinical effects and implications of cardiac rehabilitation for implantable cardioverter defibrillator patients

    DEFF Research Database (Denmark)

    Berg, Selina Kikkenborg; Moons, Philip; Christensen, Anne Vingaard;

    2015-01-01

    BACKGROUND:: The Copenhagen Outpatient ProgrammE-Implantable Cardioverter Defibrillator trial was a randomized clinical trial that compared a complex rehabilitation intervention including exercise training and psychoeducational interventions with usual care. A significant difference between......-time implantable cardioverter defibrillator implantation were randomized (1:1) to comprehensive cardiac rehabilitation (12 weeks of exercise training and 1 year of psychoeducational follow-up) versus treatment as usual. Two primary outcomes, perceived health (Short Form-36) and peak oxygen uptake, were used. Cohen...

  5. Pregnancy Outcomes After a Maternity Intervention for Stressful Emotions (PROMISES) : A Randomised Controlled Trial

    NARCIS (Netherlands)

    Burger, Huibert; Bockting, Claudi L H; Beijers, Chantal; Verbeek, Tjitte; Stant, A Dennis; Ormel, Johan; Stolk, Ronald P; de Jonge, Peter; van Pampus, Mariëlle G; Meijer, Judith

    2015-01-01

    There is ample evidence from observational prospective studies that maternal depression or anxiety during pregnancy is a risk factor for adverse psychosocial outcomes in the offspring. However, to date no previous study has demonstrated that treatment of depressive or anxious symptoms in pregnancy a

  6. Feedback versus no feedback to improve patient outcome in group psychotherapy for eating disorders (F-EAT): A randomized clinical trial

    DEFF Research Database (Denmark)

    Davidsen, Annika Helgadóttir; Waaddegaard, Mette; Poulsen, Stig Bernt;

    Background: A high rate of dropout in the treatment of eating disorders calls for ways to improve treatment attendance. Research indicates that continuous feedback on patient improvement and the therapeutic alliance reduces the number of dropouts and increases patient outcome. There are, however......, only three published randomized trials on the effect of feedback on the treatment of eating disorders showing inconclusive results, and there are no randomized trials on the effect of feedback in group therapy. Objective: The current randomized clinical trial aims to investigate the impact...... of continuous feedback on adherence and outcome in group psychotherapy. Methods/design: The trial is set up in a randomized design for outpatients diagnosed with bulimia nervosa, binge eating disorder, or eating disorder not otherwise specified (DSM-IV). They are allocated 1:1 to the experimental group...

  7. Impact of sirolimus-eluting stent fractures without early cardiac events on long-term clinical outcomes: A multislice computed tomography study

    Energy Technology Data Exchange (ETDEWEB)

    Ito, Tsuyoshi [Toyohashi Heart Center, Oyama-cho, Toyohashi (Japan); Nagoya City University Graduate School of Medical Sciences, Department of Cardio-Renal Medicine and Hypertension, Nagoya (Japan); Kimura, Masashi; Ehara, Mariko; Terashima, Mitsuyasu; Nasu, Kenya; Kinoshita, Yoshihisa; Habara, Maoto; Tsuchikane, Etsuo; Suzuki, Takahiko [Toyohashi Heart Center, Oyama-cho, Toyohashi (Japan)

    2014-05-15

    This study sought to evaluate the impact of sirolimus-eluting stent (SES) fractures on long-term clinical outcomes using multislice computed tomography (MSCT). In this study, 528 patients undergoing 6- to 18-month follow-up 64-slice MSCT after SES implantation without early clinical events were followed clinically (the median follow-up interval was 4.6 years). A CT-detected stent fracture was defined as a complete gap with Hounsfield units (HU) <300 at the site of separation. The major adverse cardiac events (MACEs), including cardiac death, stent thrombosis, and target lesion revascularisation, were compared according to the presence of stent fracture. Stent fractures were observed in 39 patients (7.4 %). MACEs were more common in patients with CT-detected stent fractures than in those without (46 % vs. 7 %, p < 0.01). Univariate Cox regression analysis indicated a significant relationship between MACE and stent fracture [hazard ratio (HR) 7.65; p < 0.01], age (HR 1.03; p = 0.04), stent length (HR 1.03; p < 0.01), diabetes mellitus (HR 1.77; p = 0.04), and chronic total occlusion (HR 2.54; p = 0.01). In the multivariate model, stent fracture (HR 5.36; p < 0.01) and age (HR 1.03; p = 0.04) remained significant predictors of MACE. An SES fracture detected by MSCT without early clinical events was associated with long-term clinical adverse events. (orig.)

  8. Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: a 10-year review

    OpenAIRE

    Simpson, Kit N.; Hanson, Kristin A; Harding, Gale; Haider, Seema; Tawadrous, Margaret; Khachatryan, Alexandra; Pashos, Chris L; Wu, Albert W

    2013-01-01

    Background Patient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy. Objective To identify and classify PRO instruments used to measure treatment effects in clinical trials evaluating NNRTIs. Methods We conducted a structured literature review using PubMed to identify NNRTI trials published from March 2003 to February 2013. Studies identified--based on disease, instrument, PRO, and NNRTI medication terms were rev...

  9. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

    OpenAIRE

    Thorsen, Lene; Nilsen, Tormod S; Raastad, Truls; Courneya, Kerry S.; Skovlund, Eva; Fosså, Sophie D

    2012-01-01

    Background Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC) trial is design...

  10. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

    OpenAIRE

    Thorsen Lene; Nilsen Tormod S; Raastad Truls; Courneya Kerry S; Skovlund Eva; Fosså Sophie D

    2012-01-01

    Abstract Background Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC) trial is designed to dete...

  11. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

    OpenAIRE

    Thorsen, Lene; Nilsen, Tormod Skogstad; Raastad, Truls; Courneya, Kerry S.; Skovlund, Eva; Fosså, Sophie Dorothea

    2012-01-01

    Background Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC) trial is designed to determine...

  12. Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT)

    OpenAIRE

    Haloua, Max H; Volders, José H.; Krekel, Nicole M. A.; Lopes Cardozo, Alexander M. F.; de Roos, Wifred K.; de Widt-Levert, Louise M.; van der Veen, Henk; Rijna, Herman; Bergers, Elisabeth; Jóźwiak, Katarzyna; Meijer, Sybren; van den Tol, M. Petrousjka

    2015-01-01

    Background Ultrasound-guided breast-conserving surgery (USS) results in a significant reduction in both margin involvement and excision volumes (COBALT trial). Objective The aim of the present study was to determine whether USS also leads to improvements in cosmetic outcome and patient satisfaction when compared with standard palpation-guided surgery (PGS). Methods A total of 134 patients with T1–T2 invasive breast cancer were included in the COBALT trial (NTR2579) and randomized to either US...

  13. Microdialysis Assessment of Cerebral Perfusion during Cardiac Arrest, Extracorporeal Life Support and Cardiopulmonary Resuscitation in Rats – A Pilot Trial

    Science.gov (United States)

    Schober, Andreas; Warenits, Alexandra M.; Testori, Christoph; Weihs, Wolfgang; Hosmann, Arthur; Högler, Sandra; Sterz, Fritz; Janata, Andreas; Scherer, Thomas; Magnet, Ingrid A. M.; Ettl, Florian; Laggner, Anton N.; Herkner, Harald; Zeitlinger, Markus

    2016-01-01

    Cerebral metabolic alterations during cardiac arrest, cardiopulmonary resuscitation (CPR) and extracorporeal cardiopulmonary life support (ECLS) are poorly explored. Markers are needed for a more personalized resuscitation and post—resuscitation care. Aim of this study was to investigate early metabolic changes in the hippocampal CA1 region during ventricular fibrillation cardiac arrest (VF-CA) and ECLS versus conventional CPR. Male Sprague-Dawley rats (350g) underwent 8min untreated VF-CA followed by ECLS (n = 8; bloodflow 100ml/kg), mechanical CPR (n = 18; 200/min) until return of spontaneous circulation (ROSC). Shams (n = 2) were included. Glucose, glutamate and lactate/pyruvate ratio were compared between treatment groups and animals with and without ROSC. Ten animals (39%) achieved ROSC (ECLS 5/8 vs. CPR 5/18; OR 4,3;CI:0.7–25;p = 0.189). During VF-CA central nervous glucose decreased (0.32±0.1mmol/l to 0.04±0.01mmol/l; p<0.001) and showed a significant rise (0.53±0.1;p<0.001) after resuscitation. Lactate/pyruvate (L/P) ratio showed a 5fold increase (31 to 164; p<0.001; maximum 8min post ROSC). Glutamate showed a 3.5-fold increase to (2.06±1.5 to 7.12±5.1μmol/L; p<0.001) after CA. All parameters normalized after ROSC with no significant differences between ECLS and CPR. Metabolic changes during ischemia and resuscitation can be displayed by cerebral microdialysis in our VF-CA CPR and ECLS rat model. We found similar microdialysate concentrations and patterns of normalization in both resuscitation methods used. Institutional Protocol Number: GZ0064.11/3b/2011 PMID:27175905

  14. A controlled trial of Partners in Dementia Care: veteran outcomes after six and twelve months

    OpenAIRE

    Bass, David M.; Judge, Katherine S; Snow, A. Lynn; Wilson, Nancy L.; Morgan, Robert O; Maslow, Katie; Randazzo, Ronda; Moye, Jennifer A; Odenheimer, Germaine L; Archambault, Elizabeth; Elbein, Richard; Pirraglia, Paul; Teasdale, Thomas A.; McCarthy, Catherine A; Looman, Wendy J

    2014-01-01

    Introduction: “Partners in Dementia Care” (PDC) tested the effectiveness of a care-coordination program integrating healthcare and community services and supporting veterans with dementia and their caregivers. Delivered via partnerships between Veterans Affairs medical centers and Alzheimer’s Association chapters, PDC targeted both patients and caregivers, distinguishing it from many non-pharmacological interventions. Hypotheses posited PDC would improve five veteran self-reported outcomes: 1...

  15. Detailed dosimetry and clinical outcome analysis for the argentine BNCT trials of cutaneous nodular melanomas

    International Nuclear Information System (INIS)

    Three female patients with biopsy-proven nodular melanoma were treated to six separate sites as part of the Phase I/II BNCT clinical trial conducted at the Comision Nacional de Energia Atomica (CNEA) and the Instituto A. Roffo, Argentina. This work reports on the detailed dosimetry for the clinical trials, and presents a preliminary analysis to investigate the possible influence of tumor size and total equivalent dose on the observed local tumor response. Also, the appropriateness of applying 3.5 tumor-to-blood 10B concentration ratio for the BPA compound in nodular melanoma cases is discussed. The statistical analysis showed that tumor response depends not only on the dose but also, and highly, on the tumor size. For these three patients, there was no significant difference between minimum and mean equivalent doses as explicative for tumor response. The collection of sixteen experimental-based tumor-to-blood ratios determined by CNEA in nodular melanoma patients derived an average value and standard deviation of 2.5 ± 0.6. This result suggests that a lower ratio could be more suitable for estimating the clinical dosimetry. It is also consistent with the worse tumor control rate in nodular melanomas observed by other researchers. (author)

  16. Interaction of MIF Family Proteins in Myocardial Ischemia/Reperfusion Damage and Their Influence on Clinical Outcome of Cardiac Surgery Patients

    Science.gov (United States)

    Rex, Steffen; Goetzenich, Andreas; Kraemer, Sandra; Emontzpohl, Christoph; Soppert, Josefin; Averdunk, Luisa; Sun, Yu; Rossaint, Rolf; Lue, Hongqi; Huang, Caleb; Song, Yan; Pantouris, Georgios; Lolis, Elias; Leng, Lin; Schulte, Wibke; Bucala, Richard; Weber, Christian

    2015-01-01

    Abstract Aims: Cardiac surgery involves myocardial ischemia/reperfusion (I/R) with potentially deleterious consequences. Macrophage migration inhibitory factor (MIF) is a stress-regulating chemokine-like cytokine that protects against I/R damage, but functional links with its homolog, d-dopachrome tautomerase (MIF-2), and the circulating soluble receptor CD74 (sCD74) are unknown. In this study, we investigate the role of MIF, MIF-2, sCD74, and MIF genotypes in patients scheduled for elective single or complex surgical procedures such as coronary artery bypass grafting or valve replacement. Results: MIF and MIF-2 levels significantly increased intraoperatively, whereas measured sCD74 decreased correspondingly. Circulating sCD74/MIF complexes were detectable in 50% of patients and enhanced MIF antioxidant activity. Intraoperative MIF levels were independently associated with a reduced risk for the development of atrial fibrillation (AF) (odds ratio 0.99 [0.98–1.00]; p=0.007). Circulating levels of MIF-2, but not MIF, were associated with an increased frequency of organ dysfunction and predicted the occurrence of AF (area under the curve [AUC]=0.663; p=0.041) and pneumonia (AUC=0.708; p=0.040). Patients with a high-expression MIF genotype exhibited a reduced incidence of organ dysfunction compared with patients with low-expression MIF genotypes (3 vs. 25; p=0.042). Innovation: The current study comprehensively highlights the kinetics and clinical relevance of MIF family proteins and the MIF genotype in cardiac surgery patients. Conclusion: Our findings suggest that increased MIF levels during cardiac surgery feature organ-protective properties during myocardial I/R, while the soluble MIF receptor, sCD74, may enhance MIF antioxidant activity. In contrast, high MIF-2 levels are predictive of the development of organ dysfunction. Importantly, we provide first evidence for a gene–phenotype relationship between variant MIF alleles and clinical outcome in cardiac

  17. Cardiac Outcomes in Adult Survivors of Childhood Cancer Exposed to Cardiotoxic Therapy: A Cross-Sectional Study from the St. Jude Lifetime Cohort

    Science.gov (United States)

    Mulrooney, Daniel A.; Armstrong, Gregory T.; Huang, Sujuan; Ness, Kirsten K.; Ehrhardt, Matthew J.; Joshi, Vijaya M.; Plana, Juan Carlos; Soliman, Elsayed Z.; Green, Daniel M.; Srivastava, Deokumar; Santucci, Aimee; Krasin, Matthew J.; Robison, Leslie L.; Hudson, Melissa M.

    2016-01-01

    Background Studies of cardiac disease among adult survivors of childhood cancer have generally relied upon self-reported or registry-based data. Objective Systematically assess cardiac outcomes among childhood cancer survivors Design Cross-sectional Setting St. Jude Children's Research Hospital Patients 1,853 adult survivors of childhood cancer, ≥18 years old, and ≥10 years from treatment with cardiotoxic therapy for childhood cancer. Measurements History/physical examination, fasting metabolic and lipid panels, echocardiogram, electrocardiogram (ECG), 6-minute walk test (6MWT) all collected at baseline evaluation. Results Half (52.3%) of the survivors were male, median age 8.0 years (range: 0-24) at cancer diagnosis, 31.0 years (18-60) at evaluation. Cardiomyopathy was present in 7.4% (newly identified at the time of evaluation in 4.7%), coronary artery disease (CAD) in 3.8% (newly identified in 2.2%), valvular regurgitation/stenosis in 28.0% (newly identified in 24.8%), and conduction/rhythm abnormalities in 4.6% (newly identified in 1.4%). Nearly all (99.7%) were asymptomatic. The prevalences of cardiac conditions increased with age at evaluation, ranging from 3-24% among those 30-39 years to 10-37% among those ≥40 years. On multivariable analysis, anthracycline exposure ≥250 mg/m2 increased the odds of cardiomyopathy (odds ratio [OR] 2.7, 95% CI 1.1-6.9) compared to anthracycline unexposed survivors. Radiation to the heart increased the odds of cardiomyopathy (OR 1.9 95% CI 1.1-3.7) compared to radiation unexposed survivors. Radiation >1500 cGy with any anthracycline exposure conferred the greatest odds for valve findings. Limitations 61% participation rate of survivors exposed to cardiotoxic therapies, which were limited to anthracyclines and cardiac-directed radiation. A comparison group and longitudinal assessments are not available. Conclusions Cardiovascular screening identified considerable subclinical disease among adult survivors of childhood

  18. Are There Benefits to a Fresh Whole Blood vs. Packed Red Blood Cell Cardiopulmonary Bypass Prime on Outcomes in Neonatal and Pediatric Cardiac Surgery?

    Science.gov (United States)

    Valleley, Melinda S.; Buckley, Klayton W.; Hayes, Kylie M.; Fortuna, Randall R.; Geiss, Dale M.; Holt, David W.

    2007-01-01

    Abstract: Techniques for pediatric cardiac surgery requiring cardiopulmonary bypass (CPB) have significantly improved over the years. The use of fresh whole blood (FWB) and pre-bypass ultrafiltration (PBUF) has been suggested as means for improving perioperative and postoperative outcomes. It is the intent of this study to show that fresh whole blood along with PBUF will result in balanced CPB prime that can offer a reduction in blood product exposures and blood loss along with improving several measured postoperative outcomes. After institutional review board approval, a retrospective review was conducted on 100 patients to analyze the benefits of FWB and PBUF on outcomes in neonatal and pediatric cardiac surgery. Data analysis included preoperative and CPB data, perioperative inotrope and blood product exposure, and postoperative blood loss and blood product exposure measured for up to a 12-hour period in the intensive care unit (ICU). The three groups compared were FWB prime vs. packed red blood cell (PRBC) prime, <5 kg FWB prime vs. <5 kg PRBC prime, and 5+ kg FWB prime and 5+ kg PRBC prime. Cumulative blood product exposures for the FWB prime group found 62% received one blood exposure for the operative and postoperative period (p < .0001). The majority of patients who received a PRBC prime (64%) received three or more cumulative exposures (p < .0003). The <5 kg FWB group also received significantly less cumulative blood exposure, with 64% receiving just one exposure. Comparatively, 85% of the <5 kg PRBC patients received three or more blood product exposures perioperatively and postoperatively (p < .0001). Perioperative inotrope and postoperative blood loss did not differ among the groups. Outcomes for intraoperative death, intraoperative extubation, delayed sternal closure, and mediastinal reexploration were also not statistically different. The results of this study found that FWB leads to significantly less blood exposure, specifically in the <5-kg

  19. Increased physical activity improves sleep and mood outcomes in inactive people with insomnia: a randomized controlled trial.

    Science.gov (United States)

    Hartescu, Iuliana; Morgan, Kevin; Stevinson, Clare D

    2015-10-01

    While high levels of activity and exercise training have been associated with improvements in sleep quality, minimum levels of activity likely to improve sleep outcomes have not been explored. A two-armed parallel randomized controlled trial (N=41; 30 females) was designed to assess whether increasing physical activity to the level recommended in public health guidelines can improve sleep quality among inactive adults meeting research diagnostic criteria for insomnia. The intervention consisted of a monitored program of ≥150 min of moderate- to vigorous-intensity physical activity per week, for 6 months. The principal end-point was the Insomnia Severity Index at 6 months post-baseline. Secondary outcomes included measures of mood, fatigue and daytime sleepiness. Activity and light exposure were monitored throughout the trial using accelerometry and actigraphy. At 6 months post-baseline, the physical activity group showed significantly reduced insomnia symptom severity (F(8,26) = 5.16, P = 0.03), with an average reduction of four points on the Insomnia Severity Index; and significantly reduced depression and anxiety scores (F(6,28) = 5.61, P = 0.02; and F(6,28) = 4.41, P = 0.05, respectively). All of the changes were independent of daily light exposure. Daytime fatigue showed no significant effect of the intervention (F(8,26) = 1.84, P = 0.18). Adherence and retention were high. Internationally recommended minimum levels of physical activity improve daytime and night-time symptoms of chronic insomnia independent of daily light exposure levels. PMID:25903450

  20. Outcome measures in intervention trials for adults with autism spectrum disorders; a systematic review of assessments of core autism features and associated emotional and behavioural problems.

    Science.gov (United States)

    Brugha, Traolach S; Doos, Lucy; Tempier, Althea; Einfeld, Stewart; Howlin, Patricia

    2015-06-01

    A systematic review was conducted of outcome measures used in treatment trials for older adolescents and adults with autism spectrum disorders (ASDs). Of 818 titles only 30 articles (19 of which involved pharmacological treatments) were identified that met inclusion criteria (sample size > 5; mean age of group > 15 years; mean IQ > 30; ASD diagnosis confirmed; use of objective ASD outcome measures; focus on symptoms core to or typically associated with ASDs). Selected studies included randomized and placebo-controlled trials, retrospective assessment studies, case series and open label or case-control trials. Use of outcome measures varied with frequent use of non-standardized assessments, very little use of measures designed specifically for individuals with ASD or of instruments focusing on core ASD deficits, such as communication or social functioning. Most commonly used were the Clinical Global Impression (CGI) rating scale and the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The strengths or deficiencies of the outcome measures used were not systematically evaluated. Although there are now many well controlled treatment trials for children with ASDs, adult intervention research is very limited. The lack of valid and reliable outcome measures for adults with ASDs compromises attempts at treatment evaluation. PMID:26077193

  1. Modified high-intensity interval training reduces liver fat and improves cardiac function in non-alcoholic fatty liver disease: a randomized controlled trial.

    Science.gov (United States)

    Hallsworth, Kate; Thoma, Christian; Hollingsworth, Kieren G; Cassidy, Sophie; Anstee, Quentin M; Day, Christopher P; Trenell, Michael I

    2015-12-01

    Although lifestyle changes encompassing weight loss and exercise remain the cornerstone of non-alcoholic fatty liver disease (NAFLD) management, the effect of different types of exercise on NAFLD is unknown. This study defines the effect of modified high-intensity interval training (HIIT) on liver fat, cardiac function and metabolic control in adults with NAFLD. Twenty-three patients with NAFLD [age 54±10 years, body mass index (BMI) 31±4 kg/m(2), intra-hepatic lipid >5%) were assigned to either 12 weeks HIIT or standard care (controls). HIIT involved thrice weekly cycle ergometry for 30-40 min. MRI and spectroscopy were used to assess liver fat, abdominal fat and cardiac structure/function/energetics. Glucose control was assessed by oral glucose tolerance test and body composition by air displacement plethysmography. Relative to control, HIIT decreased liver fat (11±5% to 8±2% compared with 10±4% to 10±4% P=0.019), whole-body fat mass (35±7 kg to 33±8 kg compared with 31±9 kg to 32±9 kg, P=0.013), alanine (52±29 units/l to 42±20 units/l compared with 47±22 units/l to 51±24 units/l, P=0.016) and aspartate aminotransferase (AST; 36±18 units/l to 33±15 units/l compared with 31±8 units/l to 35±8 units/l, P=0.017) and increased early diastolic filling rate (244±84 ml/s to 302±107 ml/s compared with 255±82 ml/s to 251±82 ml/s, P=0.018). There were no between groups differences in glucose control. Modified HIIT reduces liver fat and improves body composition alongside benefits to cardiac function in patients with NAFLD and should be considered as part of the broader treatment regimen by clinical care teams. ISRCTN trial ID: ISRCTN78698481. PMID:26265792

  2. Neuron-Specific Enolase as a Predictor of Death or Poor Neurological Outcome After Out-of-Hospital Cardiac Arrest and Targeted Temperature Management at 33°C and 36°C

    DEFF Research Database (Denmark)

    Stammet, Pascal; Collignon, Olivier; Hassager, Christian; Wise, Matthew P; Hovdenes, Jan; Åneman, Anders; Horn, Janneke; Devaux, Yvan; Erlinge, David; Kjaergaard, Jesper; Gasche, Yvan; Wanscher, Michael; Cronberg, Tobias; Friberg, Hans; Wetterslev, Jørn; Pellis, Tommaso; Kuiper, Michael; Gilson, Georges; Nielsen, Niklas

    2015-01-01

    BACKGROUND: Neuron-specific enolase (NSE) is a widely-used biomarker for prognostication of neurological outcome after cardiac arrest, but the relevance of recommended cutoff values has been questioned due to the lack of a standardized methodology and uncertainties over the influence of temperatu...

  3. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    Science.gov (United States)

    Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2013-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

  4. Rationale and design of the Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research Trial (MANTICORE 101 - Breast: a randomized, placebo-controlled trial to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer using cardiac MRI

    Directory of Open Access Journals (Sweden)

    Ezekowitz Justin

    2011-07-01

    Full Text Available Abstract Background MANTICORE 101 - Breast (Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research is a randomized trial to determine if conventional heart failure pharmacotherapy (angiotensin converting enzyme inhibitor or beta-blocker can prevent trastuzumab-mediated left ventricular remodeling, measured with cardiac MRI, among patients with HER2+ early breast cancer. Methods/Design One hundred and fifty-nine patients with histologically confirmed HER2+ breast cancer will be enrolled in a parallel 3-arm, randomized, placebo controlled, double-blind design. After baseline assessments, participants will be randomized in a 1:1:1 ratio to an angiotensin-converting enzyme inhibitor (perindopril, beta-blocker (bisoprolol, or placebo. Participants will receive drug or placebo for 1 year beginning 7 days before trastuzumab therapy. Dosages for all groups will be systematically up-titrated, as tolerated, at 1 week intervals for a total of 3 weeks. The primary objective of this randomized clinical trial is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer, as measured by 12 month change in left ventricular end-diastolic volume using cardiac MRI. Secondary objectives include 1 determine the evolution of left ventricular remodeling on cardiac MRI in patients with HER2+ early breast cancer, 2 understand the mechanism of trastuzumab mediated cardiac toxicity by assessing for the presence of myocardial injury and apoptosis on serum biomarkers and cardiac MRI, and 3 correlate cardiac biomarkers of myocyte injury and extra-cellular matrix remodeling with left ventricular remodeling on cardiac MRI in patients with HER2+ early breast cancer. Discussion Cardiac toxicity as a result of cancer therapies is now recognized as a significant health problem of increasing prevalence. To our knowledge, MANTICORE will be the first

  5. An Efficacy Trial of Carescapes: Home-Based Child-Care Practices and Children's Social Outcomes.

    Science.gov (United States)

    Rusby, Julie C; Jones, Laura B; Crowley, Ryann; Smolkowski, Keith

    2016-07-01

    This study reported findings from a longitudinal randomized controlled trial of Carescapes, a professional development program for home-based child-care providers in promoting children's social competence. Participants included 134 child-care providers and 310 children, ages 3-5 years, in Oregon. The Carescapes intervention group made significant improvements in observed caregiver responsiveness and monitoring, and showed decreased caregiver-reported child problem behavior and improved parent-reported peer relationships compared to the control group. Increased caregiver-reported cooperation skills were found for the intervention group at follow-up. No differences in condition were found for kindergarten teacher-reported social-behavioral, classroom, and academic skills. Moderation effects on children's behavior and peer relations were found for child age and exposure to the intervention child care. PMID:27174665

  6. Use of mouth rinse during pregnancy to improve birth and neonatal outcomes: a randomized controlled trial

    OpenAIRE

    Jiang, Hong; Xiong, Xu; BUEKENS, PIERRE; Su, Yi; Qian, Xu

    2015-01-01

    Background Poor oral health, such as periodontal (gum) disease, has been found to be associated with an increased risk of adverse pregnancy outcomes including preterm birth, low birth weight, and neonatal and infant mortality, especially in low-and middle-income countries. However, there is little or no access to preventive dental care in most low-and middle-income countries. We propose to develop and test a “Mouth Rinse Intervention” among pregnant women to prevent the progression of periodo...

  7. Short, Intermediate and long term outcomes of CABG vs. PCI with DES in Patients With Multivessel Coronary Artery Disease. Meta-Analysis of Six Randomized Controlled Trials.

    OpenAIRE

    Zaher Fanari; Weiss, Sandra A; Wei Zhang; Sonnad, Seema S.; Weintraub, William S.

    2014-01-01

    Objective: Comparing outcomes of percutaneous coronary intervention (PCI) with drug eluting stent (DES) and Coronary Artery Bypass Grafting (CABG) in patients with multivessel Coronary Artery Disease (CAD) using data from randomised controlled trials (RCT). Background: PCI and CABG are established strategies for coronary revascularization in the setting of ischemic heart disease. Multiple RCT have compared outcomes of the two modalities in patients with multivessel CAD. Methods: We did...

  8. The effect of iodine supplementation in pregnancy on early childhood neurodevelopment and clinical outcomes: results of an aborted randomised placebo-controlled trial

    OpenAIRE

    Zhou, Shao J.; Sheila A. Skeaff; Ryan, Philip; Doyle, Lex W; Anderson, Peter J.; Kornman, Louise; McPhee, Andrew J; Yelland, Lisa N; Makrides, Maria

    2015-01-01

    Background Concern that mild iodine deficiency in pregnancy may adversely affect neurodevelopment of offspring has led to recommendations for iodine supplementation in the absence of evidence from randomised controlled trials. The primary objective of the study was to investigate the effect of iodine supplementation during pregnancy on childhood neurodevelopment. Secondary outcomes included pregnancy outcomes, maternal thyroid function and general health. Methods Women with a singleton pregna...

  9. A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes

    OpenAIRE

    Yang, Xilin; Tian, Huiguang; Zhang, Fuxia; Zhang, Cuiping; Li, Yi; Leng, Junhong; Wang, Leishen; Liu, Gongsu; Dong, Ling; Yu, Zhijie; Hu, Gang; Chan, Juliana CN

    2014-01-01

    Background There are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group’s (IADPSG) criteria. We tested the effectiveness of lifestyle modifications implemented in a 3-tier’s shared care (SC) on pregnancy outcomes of GDM. Methods Between December 2010 and October 2012, we randomly assigned 700 women with IADPSG-define...

  10. A randomized controlled trial of pre-conception treatment for periodontal disease to improve periodontal status during pregnancy and birth outcomes

    OpenAIRE

    Jiang, Hong; Xiong, Xu; Su, Yi; Zhang, Yiming; Wu, Hongqiao; Jiang, Zhijun; Qian, Xu

    2013-01-01

    Background Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes. However, several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes. It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy. To date, no randomized cont...

  11. Targeted Temperature Management at 33°C versus 36°C after Cardiac Arrest

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Wetterslev, Jørn; Cronberg, Tobias;

    2013-01-01

    unknown. Our objective was to compare two target temperatures, both intended to prevent fever. Methods In an international trial, we randomly assigned 950 unconscious adults after out-of-hospital cardiac arrest of presumed cardiac cause to targeted temperature management at either 33°C or 36°C. The......Background Unconscious survivors of out-of-hospital cardiac arrest have a high risk of death or poor neurologic function. Therapeutic hypothermia is recommended by international guidelines, but the supporting evidence is limited, and the target temperature associated with the best outcome is...... (risk ratio, 1.01; 95% CI, 0.89 to 1.14; P=0.87). The results of analyses adjusted for known prognostic factors were similar. Conclusions In unconscious survivors of out-of-hospital cardiac arrest of presumed cardiac cause, hypothermia at a targeted temperature of 33°C did not confer a benefit as...

  12. Cardiac tumours in children

    Directory of Open Access Journals (Sweden)

    Parsons Jonathan M

    2007-03-01

    Full Text Available Abstract Cardiac tumours are benign or malignant neoplasms arising primarily in the inner lining, muscle layer, or the surrounding pericardium of the heart. They can be primary or metastatic. Primary cardiac tumours are rare in paediatric practice with a prevalence of 0.0017 to 0.28 in autopsy series. In contrast, the incidence of cardiac tumours during foetal life has been reported to be approximately 0.14%. The vast majority of primary cardiac tumours in children are benign, whilst approximately 10% are malignant. Secondary malignant tumours are 10–20 times more prevalent than primary malignant tumours. Rhabdomyoma is the most common cardiac tumour during foetal life and childhood. It accounts for more than 60% of all primary cardiac tumours. The frequency and type of cardiac tumours in adults differ from those in children with 75% being benign and 25% being malignant. Myxomas are the most common primary tumours in adults constituting 40% of benign tumours. Sarcomas make up 75% of malignant cardiac masses. Echocardiography, Computing Tomography (CT and Magnetic Resonance Imaging (MRI of the heart are the main non-invasive diagnostic tools. Cardiac catheterisation is seldom necessary. Tumour biopsy with histological assessment remains the gold standard for confirmation of the diagnosis. Surgical resection of primary cardiac tumours should be considered to relieve symptoms and mechanical obstruction to blood flow. The outcome of surgical resection in symptomatic, non-myxomatous benign cardiac tumours is favourable. Patients with primary cardiac malignancies may benefit from palliative surgery but this approach should not be recommended for patients with metastatic cardiac tumours. Surgery, chemotherapy and radiotherapy may prolong survival. The prognosis for malignant primary cardiac tumours is generally extremely poor.

  13. Association of Complement C3 Gene Variants with Renal Transplant Outcome of Deceased Cardiac Dead Donor Kidneys

    NARCIS (Netherlands)

    Damman, J.; Daha, M. R.; Leuvenink, H. G.; van Goor, H.; Hillebrands, J. L.; van Dijk, M. C.; Hepkema, B. G.; Snieder, H.; van den Born, J.; de Borst, M. H.; Bakker, S. J.; Navis, G. J.; Ploeg, R. J.; Seelen, M. A.

    2012-01-01

    Local renal complement activation by the donor kidney plays an important role in the pathogenesis of renal injury inherent to kidney transplantation. Contradictory results were reported about the protective effects of the donor C3F allotype on renal allograft outcome. We investigated the influence o

  14. Physical activity counseling in overweight and obese primary care patients: Outcomes of the VA-STRIDE randomized controlled trial.

    Science.gov (United States)

    Gao, Shasha; Stone, Roslyn A; Hough, Linda J; Haibach, Jeffrey P; Marcus, Bess H; Ciccolo, Joseph T; Kriska, Andrea M; Burkitt, Kelly H; Steenkiste, Ann R; Berger, Marie A; Sevick, Mary A

    2016-06-01

    The purpose of this 2-arm randomized clinical trial was to evaluate the effectiveness of a 12-month, expert system-based, print-delivered physical activity intervention in a primary care Veteran population in Pittsburgh, Pennsylvania. Participants were not excluded for many health conditions that typically are exclusionary criteria in physical activity trials. The primary outcome measures were physical activity reported using the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire and an accelerometer-based activity assessment at baseline, 6, and 12 months. Of the 232 Veterans enrolled in the study, 208 (89.7%) were retained at the 6-month follow-up and 203 (87.5%) were retained at 12 months. Compared to the attention control, intervention participants had significantly increased odds of meeting the U.S. recommended guideline of ≥ 150 min/week of at least moderate-intensity physical activity at 12 months for the modified CHAMPS (odds ratio [OR] = 2.86; 95% CI: 1.03-7.96; p = 0.04) but not at 6 months (OR = 1.54; 95% CI: 0.56-4.23; p = 0.40). Based on accelerometer data, intervention participants had significantly increased odds of meeting ≥ 150 min/week of moderate-equivalent physical activity at 6 months (OR = 6.26; 95% CI: 1.26-31.22; p = 0.03) and borderline significantly increased odds at 12 months (OR = 4.73; 95% CI: 0.98-22.76; p = 0.053). An expert system physical activity counseling intervention can increase or sustain the proportion of Veterans in primary care meeting current recommendations for moderate-intensity physical activity. Trial Registration Clinical trials.gov identifier: NCT00731094 URL: http://www.clinicaltrials.gov/ct2/show/NCT00731094. PMID:26844197

  15. Drug therapy in cardiac arrest: a review of the literature.

    Science.gov (United States)

    Lundin, Andreas; Djärv, Therese; Engdahl, Johan; Hollenberg, Jacob; Nordberg, Per; Ravn-Fischer, Annika; Ringh, Mattias; Rysz, Susanne; Svensson, Leif; Herlitz, Johan; Lundgren, Peter

    2016-01-01

    The aim of this study was to review the literature on human studies of drug therapy in cardiac arrest during the last 25 years. In May 2015, a systematic literature search was performed in PubMed, Embase, the Cochrane Library, and CRD databases. Prospective interventional and observational studies evaluating a specified drug therapy in human cardiac arrest reporting a clinical endpoint [i.e. return of spontaneous circulation (ROSC) or survival] and published in English 1990 or later were included, whereas animal studies, case series and reports, studies of drug administration, drug pharmacology, non-specified drug therapies, preventive drug therapy, drug administration after ROSC, studies with primarily physiological endpoints, and studies of traumatic cardiac arrest were excluded. The literature search identified a total of 8936 articles. Eighty-eight articles met our inclusion criteria and were included in the review. We identified no human study in which drug therapy, compared with placebo, improved long-term survival. Regarding adrenaline and amiodarone, the drugs currently recommended in cardiac arrest, two prospective randomized placebo-controlled trials, were identified for adrenaline, and one for amiodarone, but they were all underpowered to detect differences in survival to hospital discharge. Of all reviewed studies, only one recent prospective study demonstrated improved neurological outcome with one therapy over another using a combination of vasopressin, steroids, and adrenaline as the intervention compared with standard adrenaline administration. The evidence base for drug therapy in cardiac arrest is scarce. However, many human studies on drug therapy in cardiac arrest have not been powered to identify differences in important clinical outcomes such as survival to hospital discharge and favourable neurological outcome. Efforts are needed to initiate large multicentre prospective randomized clinical trials to evaluate both currently recommended and

  16. Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P Study, a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rejeski W Jack

    2011-05-01

    Full Text Available Abstract Background The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. Methods SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA and/or cognitive training intervention (CT in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Results Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004, the interventions produced marked changes in cognitive and physical performance measures (p≤0.05, and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01. Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome or 2,000 participants (categorical outcome. Conclusions Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Trial Registration Clinicaltrials.gov Identifier: NCT00688155

  17. Rationale and design of the Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research Trial (MANTICORE 101 - Breast): a randomized, placebo-controlled trial to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer using cardiac MRI

    International Nuclear Information System (INIS)

    MANTICORE 101 - Breast (Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research) is a randomized trial to determine if conventional heart failure pharmacotherapy (angiotensin converting enzyme inhibitor or beta-blocker) can prevent trastuzumab-mediated left ventricular remodeling, measured with cardiac MRI, among patients with HER2+ early breast cancer. One hundred and fifty-nine patients with histologically confirmed HER2+ breast cancer will be enrolled in a parallel 3-arm, randomized, placebo controlled, double-blind design. After baseline assessments, participants will be randomized in a 1:1:1 ratio to an angiotensin-converting enzyme inhibitor (perindopril), beta-blocker (bisoprolol), or placebo. Participants will receive drug or placebo for 1 year beginning 7 days before trastuzumab therapy. Dosages for all groups will be systematically up-titrated, as tolerated, at 1 week intervals for a total of 3 weeks. The primary objective of this randomized clinical trial is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer, as measured by 12 month change in left ventricular end-diastolic volume using cardiac MRI. Secondary objectives include 1) determine the evolution of left ventricular remodeling on cardiac MRI in patients with HER2+ early breast cancer, 2) understand the mechanism of trastuzumab mediated cardiac toxicity by assessing for the presence of myocardial injury and apoptosis on serum biomarkers and cardiac MRI, and 3) correlate cardiac biomarkers of myocyte injury and extra-cellular matrix remodeling with left ventricular remodeling on cardiac MRI in patients with HER2+ early breast cancer. Cardiac toxicity as a result of cancer therapies is now recognized as a significant health problem of increasing prevalence. To our knowledge, MANTICORE will be the first randomized trial testing proven heart failure pharmacotherapy in

  18. Cognitive function in ambulatory patients with systolic heart failure: insights from the warfarin versus aspirin in reduced cardiac ejection fraction (WARCEF trial.

    Directory of Open Access Journals (Sweden)

    Susan Graham

    Full Text Available We sought to determine whether cognitive function in stable outpatients with heart failure (HF is affected by HF severity. A retrospective, cross-sectional analysis was performed using data from 2, 043 outpatients with systolic HF and without prior stroke enrolled in the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF Trial. Multivariable regression analysis was used to assess the relationship between cognitive function measured using the Mini-Mental Status Exam (MMSE and markers of HF severity (left ventricular ejection fraction [LVEF], New York Heart Association [NYHA] functional class, and 6-minute walk distance. The mean (SD for the MMSE was 28.6 (2.0, with 64 (3.1% of the 2,043 patients meeting the cut-off of MMSE <24 that indicates need for further evaluation of cognitive impairment. After adjustment for demographic and clinical covariates, 6-minute walk distance (β-coefficient 0.002, p<0.0001, but not LVEF or NYHA functional class, was independently associated with the MMSE as a continuous measure. Age, education, smoking status, body mass index, and hemoglobin level were also independently associated with the MMSE. In conclusion, six-minute walk distance, but not LVEF or NYHA functional class, was an important predictor of cognitive function in ambulatory patients with systolic heart failure.

  19. Electrocardiographic changes associated with smoking and smoking cessation: outcomes from a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Adam D Gepner

    Full Text Available INTRODUCTION: Cardiovascular disease (CVD can be detected and quantified by analysis of the electrocardiogram (ECG; however the effects of smoking and smoking cessation on the ECG have not been characterized. METHODS: Standard 12-lead ECGs were performed at baseline and 3 years after subjects enrolled in a prospective, randomized, placebo-controlled clinical trial of smoking cessation pharmacotherapies. ECGs were interpreted using the Minnesota Code ECG Classification. The effects of (i smoking burden on the prevalence of ECG findings at baseline, and (ii smoking and smoking cessation on ECG changes after 3 years were investigated by multivariable and multinomial regression analyses. RESULTS: At baseline, 532 smokers were (mean [SD] 43.3 (11.5 years old, smoked 20.6 (7.9 cigarettes/day, with a smoking burden of 26.7 (18.6 pack-years. Major and minor ECG criteria were identified in 87 (16.4% and 131 (24.6% of subjects, respectively. After adjusting for demographic data and known CVD risk factors, higher pack-years was associated with major ECG abnormalities (p = 0.02, but current cigarettes/day (p = 0.23 was not. After 3 years, 42.9% of subjects were abstinent from smoking. New major and minor ECG criteria were observed in 7.2% and 15.6% of subjects respectively, but in similar numbers of abstinent subjects and continuing smokers (p>0.2 for both. Continuing smokers showed significant reduction in current smoking (-8.4 [8.8] cigarettes/day, p<0.001 compared to baseline. CONCLUSIONS: In conclusion, major ECG abnormalities are independently associated with lifetime smoking burden. After 3 years, smoking cessation was not associated with a decrease in ECG abnormalities, although cigarettes smoked/day decreased among continuing smokers.

  20. Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health.

    Science.gov (United States)

    Talbot, George H; Powers, John H; Hoffmann, Steven C

    2016-03-01

    One important component in determining the benefits and harms of medical interventions is the use of well-defined and reliable outcome assessments as endpoints in clinical trials. Improving endpoints can better define patient benefits, allowing more accurate assessment of drug efficacy and more informed benefit-vs-risk decisions; another potential plus is facilitating efficient trial design. Since our first report in 2012, 2 Foundation for the National Institutes of Health Biomarkers Consortium Project Teams have continued to develop outcome assessments for potential uses as endpoints in registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. In addition, the teams have initiated similar work in the indications of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. This report provides an update on progress to date in these 4 diseases. PMID:26668337

  1. A randomised trial of a 5 week, manual based, self-management programme for hypertension delivered in a cardiac patient club in Shanghai

    Directory of Open Access Journals (Sweden)

    Lewin Robert J

    2008-05-01

    Full Text Available Abstract Background In Shanghai there are 1.2 million people with hypertension, many of whom have difficulty in affording medical treatment. Community based, anti-hypertensive clubs have been created to provide health education but education alone is often ineffective. Lifestyle change programmes have shown some potential for reducing blood pressure but in previous trials have required specialist staff and extensive contact. We have previously demonstrated that self-management programmes delivered by health professionals, such as a nurse who has had short training in self-management techniques can change health behaviour and reduce symptoms. This study was designed to evaluate the benefits of a simple, cognitive-behavioural, self-management programme for hypertension based around a hypertension manual and delivered in the setting of a community anti-hypertensive club in Shanghai. Method The method was a pragmatic randomised controlled trial with an intention-to-treat analysis. Adult patients with mild-to-moderate primary hypertension, waiting to join a neighbourhood anti-hypertension club, were randomised to the self-management programme or to an information only control procedure. They attended the group treatment sessions on 4 occasions over 5 weeks for education combined with goal setting for lifestyle change and an introduction to exercise. The main outcome measures were: changes in blood pressure; blood total cholesterol; diet; activity level and health related quality of life 1 month and 4 months after the end of treatment. Results A total of 140 adults with mild-to-moderate primary hypertension took part. All of the main outcomes showed beneficial changes. Four months after the end of treatment the mean blood pressure differences between groups were systolic 10.15 mm Hg (P Conclusion Patients with mild-to-moderate primary hypertension attending a 5 week, group and manual based, cognitive-behavioural self-management programme, delivered

  2. The incidence, risk factors, and outcome of transfusion-related acute lung injury in a cohort of cardiac surgery patients: a prospective nested case-control study.

    Science.gov (United States)

    Vlaar, Alexander P J; Hofstra, Jorrit J; Determann, Rogier M; Veelo, Denise P; Paulus, Frederique; Kulik, Wim; Korevaar, Johanna; de Mol, Bas A; Koopman, Marianne M W; Porcelijn, Leendert; Binnekade, Jan M; Vroom, Margreeth B; Schultz, Marcus J; Juffermans, Nicole P

    2011-04-21

    Transfusion-related acute lung injury (TRALI) is the leading cause of transfusion-related morbidity and mortality. Both antibodies and bioactive lipids that have accumulated during storage of blood have been implicated in TRALI pathogenesis. In a single-center, nested, case-control study, patients were prospectively observed for onset of TRALI according to the consensus definition. Of 668 patients, 16 patients (2.4%) developed TRALI. Patient-related risk factors for onset of TRALI were age and time on the cardiopulmonary bypass. Transfusion-related risk factors were total amount of blood products (odds ratio [OR] = 1.2; 95% confidence interval [CI], 1.03-1.44), number of red blood cells stored more than 14 days (OR = 1.6; 95% CI, 1.04-2.37), total amount of plasma (OR = 1.2; 95% CI, 1.03-1.44), presence of antibodies in donor plasma (OR = 8.8; 95% CI, 1.8-44), and total amount of transfused bioactive lipids (OR = 1.0; 95% CI, 1.00-1.07). When adjusted for patient risk factors, only the presence of antibodies in the associated blood products remained a risk factor for TRALI (OR = 14.2; 95% CI, 1.5-132). In-hospital mortality of TRALI was 13% compared with 0% and 3% in transfused and nontransfused patients, respectively (P < .05). In conclusion, the incidence of TRALI is high in cardiac surgery patients and associated with adverse outcome. Our results suggest that cardiac surgery patients may benefit from exclusion of blood products containing HLA/HNA antibodies. PMID:21325598

  3. Weight and blood pressure response to weight management and sibutramine in diabetic and non-diabetic high-risk patients: an analysis from the 6-week lead-in period of the sibutramine cardiovascular outcomes (SCOUT) trial

    DEFF Research Database (Denmark)

    Van Gaal, L F; Caterson, I D; Coutinho, W;

    2010-01-01

    To assess treatment responses to sibutramine and weight management in diabetic patients during the lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.......To assess treatment responses to sibutramine and weight management in diabetic patients during the lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT) trial....

  4. Uterine Artery Embolization Versus Laparoscopic Uterine Artery Occlusion: The Outcomes of a Prospective, Nonrandomized Clinical Trial

    International Nuclear Information System (INIS)

    Purpose: To compare outcomes of two different types of occlusive therapy of uterine fibroids. Methods: Women with fibroid(s) unsuitable for laparoscopic myomectomy (LM) were treated with uterine artery embolization (UAE) or laparoscopic uterine artery occlusion (LUAO). Results: Before the procedure, patients treated with UAE (n = 100) had a dominant fibroid greater in size (68 vs. 48 mm) and a mean age lower (33.1 vs. 34.9 years) than surgically treated patients (n = 100). After 6 months, mean shrinkage of fibroid volume was 53 % after UAE and 39 % after LUAO (p = 0.063); 82 % of women after UAE, but only 23 % after LUAO, had complete myoma infarction (p = 0.001). Women treated with UAE had more complications (31 vs. 11 cases, p = 0.006) and greater incidence of hysteroscopically verified intrauterine necrosis (31 vs. 3 %, p = 0.001). Both groups were comparable in markers of ovarian functions and number of nonelective reinterventions. The groups did not differ in pregnancy (69 % after UAE vs. 67 % after LUAO), delivery (50 vs. 46 %), or abortion (34 vs. 33 %) rates. The mean birth weight of neonates was greater (3270 vs. 2768 g, p = 0.013) and the incidence of intrauterine growth restriction lower (13 vs. 38 %, p = 0.046) in post-UAE patients. Conclusion: Both methods are effective in the treatment of women with future reproductive plans and fibroids not suitable for LM. UAE is more effective in causing complete ischemia of fibroids, but it is associated with greater risk of intrauterine necrosis. Both methods have low rate of serious complications (except for a high abortion rate).

  5. Uterine Artery Embolization Versus Laparoscopic Uterine Artery Occlusion: The Outcomes of a Prospective, Nonrandomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Mara, Michal; Kubinova, Kristyna, E-mail: kristyna.kubinova@gmail.com [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic); Maskova, Jana [Aberdeen Royal Infirmary, Department of Radiology (United Kingdom); Horak, Petr [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic); Belsan, Tomas [Central Military Hospital, Department of Radiology (Czech Republic); Kuzel, David [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic)

    2012-10-15

    Purpose: To compare outcomes of two different types of occlusive therapy of uterine fibroids. Methods: Women with fibroid(s) unsuitable for laparoscopic myomectomy (LM) were treated with uterine artery embolization (UAE) or laparoscopic uterine artery occlusion (LUAO). Results: Before the procedure, patients treated with UAE (n = 100) had a dominant fibroid greater in size (68 vs. 48 mm) and a mean age lower (33.1 vs. 34.9 years) than surgically treated patients (n = 100). After 6 months, mean shrinkage of fibroid volume was 53 % after UAE and 39 % after LUAO (p = 0.063); 82 % of women after UAE, but only 23 % after LUAO, had complete myoma infarction (p = 0.001). Women treated with UAE had more complications (31 vs. 11 cases, p = 0.006) and greater incidence of hysteroscopically verified intrauterine necrosis (31 vs. 3 %, p = 0.001). Both groups were comparable in markers of ovarian functions and number of nonelective reinterventions. The groups did not differ in pregnancy (69 % after UAE vs. 67 % after LUAO), delivery (50 vs. 46 %), or abortion (34 vs. 33 %) rates. The mean birth weight of neonates was greater (3270 vs. 2768 g, p = 0.013) and the incidence of intrauterine growth restriction lower (13 vs. 38 %, p = 0.046) in post-UAE patients. Conclusion: Both methods are effective in the treatment of women with future reproductive plans and fibroids not suitable for LM. UAE is more effective in causing complete ischemia of fibroids, but it is associated with greater risk of intrauterine necrosis. Both methods have low rate of serious complications (except for a high abortion rate).

  6. Predictors and long-term clinical outcomes of newly developed atrial fibrillation in patients with cardiac implantable electronic devices

    Science.gov (United States)

    Kim, Bum Sung; Chun, Kwang Jin; Hwang, Jin kyung; Park, Seung-Jung; Park, Kyoung-Min; Kim, June Soo; On, Young Keun

    2016-01-01

    Abstract Objective: To evaluate predictors and long-term prognosis of atrial fibrillation (AF) following cardiac implantable electronic device (CIED) implantation in patients without history of AF. Methods: From May 1994 to April 2014, 1825 patients with CIED were enrolled in a retrospective, single-center registry. A total of 880 patients from the registry without prior documented AF history were included in the final analysis and were placed into either non-detected AF (NDAF) group or CIED-detected AF group according to development of AF over a follow-up period of 7 years. AF development was defined as any paroxysmal atrial tachyarrhythmia (atrial rate ≥ 180 beats/min) lasting at least 5 minutes according to CIED records. Results: Overall, 122 (13.8%) of the 880 patients experienced new development of AF during follow-up period. According to multivariate analysis, the independent predictors for development of AF were prior heart failure (hazard ratio [HR], 2.40; 95% confidence interval [CI], 1.50–3.85; P HR, 2.33; 95% CI, 1.62–3.55; P HR, 2.01; 95% CI, 1.23–3.30; P = 0.005). In CDAF group, the risk of heart failure readmission (adjusted HR, 3.79; 95% CI, 1.99–7.22; P HR, 5.33; 95% CI, 1.58–17.97; P = 0.007) was higher than in nondetected AF group. Conclusion: In patients with CIED, prior history of heart failure, sinus node dysfunction, and LA volume index ≥38.5 mL/m2 were independent predictors of new AF cases. Newly developed AF was significantly associated with increased risk of HF and stroke readmission, according to long-term follow up. PMID:27428213

  7. Multicenter Orthopaedic Outcome Network Early Anti-inflammatory Treatment in Patients with Acute ACL Tear” (MOON-AAA) Clinical Trial

    Science.gov (United States)

    Lattermann, Christian; Proffitt, Mary; Huston, Laura J.; Gammon, Lee; Johnson, Darren L.; Kraus, Virginia B.; Spindler, Kurt P.

    2016-01-01

    Objectives: We present the early results from the “Multicenter Orthopaedic Outcome Network Early Anti-inflammatory Treatment in Patients with Acute ACL Tear and Painful Effusions” (MOON-AAA) clinical trial (figure 1). This trial allows for a well controlled prospective cohort of patients with isolated ACL injury at risk for OA. We compared the effect of a single versus a repeated dosage of Kenalog within the first two weeks after ACL injury and its effect on chondral degradation in the first 4 weeks prior to surgical reconstruction of the ACL. Methods: 49 patients with isolated ACL tears were enrolled. Knee joints were aspirated and patients received an injection with 40 mg Kenalog either within 4 days, 10 days, both time points or not at all (saline injection control). Serum, synovial fluid and urine were collected at 3 time points. Permutated block randomization, triple blinding, independent monitoring and standardized x-ray was performed to comply with GCP standards. Patient reported outcomes were collected at 6 time points up to 6 months post-ACL reconstruction(IKDC, KOOS and Marx activity level). A standardized synovial fluid biomarker panel was analyzed according to OARSI guidelines. Statistical analysis were performed using SAS mixed models analysis. Results: Serum analysis shows significant change after injury. Chondrodegradatory markers such as CTX-II, MMP-1 and MMP-3 as well as COMP indicate a progressive destruction of chondral matrix and collagen breakdown . There is a dramatic (250%) increase of CTX-II in the first 4 weeks. Matrix proteins such as MMP-1 and 3 as well as COMP show an initial increase and then a steep decline (see figure 1). Inflammatory markers (IL-1 alpha, IL-1beta, IRAP) show a decline from the time of injury. IL-1 alpha, however shows a dramatic uptake after week 2. This longitudinal data confirms a dramatic onset of early osteoarthritic biomarker profiles immediately after ACL injury as measured in synovial fluid

  8. Serum MMP-8: a novel indicator of left ventricular remodeling and cardiac outcome in patients after acute myocardial infarction.

    Directory of Open Access Journals (Sweden)

    Marie Fertin

    Full Text Available OBJECTIVE: Left ventricular (LV remodeling following myocardial infarction (MI is characterized by progressive alterations of structure and function, named LV remodeling. Although several risk factors such as infarct size have been identified, LV remodeling remains difficult to predict in clinical practice. Changes within the extracellular matrix, involving matrix metalloproteinases (MMPs and tissue inhibitors of metalloproteinases (TIMPs, are an integral part of left ventricular (LV remodeling after myocardial infarction (MI. We investigated the temporal profile of circulating MMPs and TIMPs and their relations with LV remodeling at 1 year and clinical outcome at 3 years in post-MI patients. METHODS: This prospective multicentre study included 246 patients with a first anterior MI. Serial echocardiographic studies were performed at hospital discharge, 3 months, and 1 year after MI, and analysed at a core laboratory. LV remodeling was defined as the percent change in LV end-diastolic volume (EDV from baseline to 1 year. Serum samples were obtained at hospital discharge, 1, 3, and 12 months. Multiplex technology was used for analysis of MMP-1, -2, -3, -8, -9, -13, and TIMP-1, -2, -3, -4 serum levels. RESULTS: Baseline levels of MMP-8 and MMP-9 were positively associated with changes in LVEDV (P = 0.01 and 0.02, respectively. When adjusted for major baseline characteristics, MMP-8 levels remained an independent predictor LV remodeling (P = 0.025. By univariate analysis, there were positive relations between cardiovascular death or hospitalization for heart failure during the 3-year follow-up and the baseline levels of MMP-2 (P = 0.03, MMP-8 (P = 0.002, and MMP-9 (P = 0.03. By multivariate analysis, MMP-8 was the only MMP remaining significantly associated with clinical outcome (P = 0.02. CONCLUSION: Baseline serum MMP-8 is a significant predictor of LV remodeling and cardiovascular outcome after MI and may help to improve

  9. Effects of Continuous Use of Entonox in Comparison with Intermittent Method on Obstetric Outcomes: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Jila Agah

    2014-01-01

    Full Text Available Background. Entonox (N2O2 which is an inhalational gas for relieving labor pain is commonly used intermittently; however some women are interested in continuous breathing in face mask. So we decided to compare the complications induced by two methods to find out whether it is safe to permit the mothers to use Entonox continuously or not. Patients and Methods. This randomized clinical trial was performed in Mobini Hospital, Sabzevar, Iran. 50 parturients used Entonox intermittently and 50 cases used it continuously during labor. Then obstetrical outcomes were analyzed in two groups by spss 17 software, t-test, and Chi2 while P<0.05 was considered significant. Results. This study showed the mean duration of second stage of labor had no significant difference (P=0.3. Perineal laceration was less in continuous group significantly (P=0.04. Assisted vaginal birth was not different significantly (P=0.4. Uterine atony had no significant difference in two groups (P=0.2. Maternal collaboration in pushing and satisfaction were higher in continuous group significantly (P=0.03, (P<0.0001. Apgar score of neonates at first and fifth minute was acceptable and not different significantly in two groups (P=0.3. Conclusions. Our study demonstrated continuous method is also safe. So, it seems reasonable to set mothers free to choose the desired method of Entonox usage.

  10. Results of a Randomized Trial Testing Messages Tailored to Participant-Selected Topics Among Female College Students: Physical Activity Outcomes

    Science.gov (United States)

    Quintiliani, Lisa M.; Campbell, Marci K.; Bowling, J. Michael; Steck, Susan; Haines, Pamela S.; DeVellis, Brenda M.

    2016-01-01

    Background A better understanding of identifying tailoring variables would improve message design. Tailoring to a behavior that a participant selects as one they would like to work on may increase message relevance, and thus effectiveness. This trial compared 3 groups: message tailored to physical activity as a participant-selected topic (choice), message tailored to physical activity as an expert-determined topic (expert), or nontailored message (comparison). Methods 408 female college students received web-delivered computer-tailored messages on physical activity. Outcomes were immediate and 1-month follow-up changes in psychosocial, goal-related, and behavioral variables related to physical activity. Results Participants were predominately non-Hispanic White (73.8%). Change in self-efficacy and goal commitment at immediate follow-up and vigorous physical activity at 1-month follow-up was greater in the expert versus comparison group. Change in goal commitment at immediate follow-up was lower in the choice versus expert group. In the expert group, those choosing physical activity as their selected topic perceived the goal to be easier at immediate follow-up compared with those receiving unmatched messages. Conclusions Findings supported tailoring to an expert-determined topic. However, based on the beneficial change in perceived goal difficulty when topics matched, future research should encourage synchrony between participant-selected topics and expert recommendations. PMID:20683094

  11. Effect of assisted hatching on pregnancy outcomes: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Da; Yang, Da-Lei; An, Jing; Jiao, Jiao; Zhou, Yi-Ming; Wu, Qi-Jun; Wang, Xiu-Xia

    2016-01-01

    Emerging evidence suggests that assisted hatching (AH) techniques may improve clinical pregnancy rates, particularly in poor prognosis patients; however, there still remains considerable uncertainty. We conducted a meta-analysis to verify the effect of AH on pregnancy outcomes. We searched for related studies published in PubMed, Web of Science, and Cochrane library databases from start dates to October 10, 2015. Totally, 36 randomized controlled trials with 6459 participants were included. Summary odds ratios (ORs) with 95% confidence intervals (CIs) for whether by AH or not were estimated. We found a significant increase in clinical pregnancy (OR = 1.16, 95% CI = 1.00-1.36, I(2) = 48.3%) and multiple pregnancy rates (OR = 1.50, 95% CI = 1.11-2.01, I(2) = 44.0%) with AH when compared to the control. Numerous subgroup analyses stratified by hatching method, conception mode, extent of AH, embryos transfer status, and previous failure history were also carried out. Interestingly, significant results of clinical pregnancy as well as multiple pregnancy rates were observed among women who received intracytoplasmic sperm injection, and who received AH which the zona were completely removed. In summary, this meta-analysis supports that AH was associated with an increased chance of achieving clinical pregnancy and multiple pregnancy. Whether AH significantly changes live birth and miscarriage rates needs further investigations. PMID:27503701

  12. Effect of assisted hatching on pregnancy outcomes: a systematic review and meta-analysis of randomized controlled trials

    Science.gov (United States)

    Li, Da; Yang, Da-Lei; An, Jing; Jiao, Jiao; Zhou, Yi-Ming; Wu, Qi-Jun; Wang, Xiu-Xia

    2016-01-01

    Emerging evidence suggests that assisted hatching (AH) techniques may improve clinical pregnancy rates, particularly in poor prognosis patients; however, there still remains considerable uncertainty. We conducted a meta-analysis to verify the effect of AH on pregnancy outcomes. We searched for related studies published in PubMed, Web of Science, and Cochrane library databases from start dates to October 10, 2015. Totally, 36 randomized controlled trials with 6459 participants were included. Summary odds ratios (ORs) with 95% confidence intervals (CIs) for whether by AH or not were estimated. We found a significant increase in clinical pregnancy (OR = 1.16, 95% CI = 1.00–1.36, I2 = 48.3%) and multiple pregnancy rates (OR = 1.50, 95% CI = 1.11–2.01, I2 = 44.0%) with AH when compared to the control. Numerous subgroup analyses stratified by hatching method, conception mode, extent of AH, embryos transfer status, and previous failure history were also carried out. Interestingly, significant results of clinical pregnancy as well as multiple pregnancy rates were observed among women who received intracytoplasmic sperm injection, and who received AH which the zona were completely removed. In summary, this meta-analysis supports that AH was associated with an increased chance of achieving clinical pregnancy and multiple pregnancy. Whether AH significantly changes live birth and miscarriage rates needs further investigations. PMID:27503701

  13. Left ventricular ejection fraction normalization in cardiac resynchronization therapy and risk of ventricular arrhythmias and clinical outcomes

    DEFF Research Database (Denmark)

    Ruwald, Martin H; Solomon, Scott D; Foster, Elyse;

    2014-01-01

    %-50%, and >50%) on outcomes of ventricular tachyarrhythmias (VTAs), VTA ≥200 bpm, ICD shock, heart failure or death, and inappropriate ICD therapy by multivariable Cox models. A total of 7.3% achieved LVEF normalization (>50%). The average follow-up was 2.2±0.8 years. The risk of VTA was reduced in patients...... with LVEF >50% (hazard ratio [HR], 0.24; 95% confidence interval [CI], 0.07-0.82; P=0.023) and LVEF of 36% to 50% (HR, 0.44; 95% CI, 0.28-0.68; P50%, only 1 patient had VTA ≥200 bpm (HR, 0.16; 95% CI, 0.02-1.51), none were shocked by the ICD, and 2 died of nonarrhythmic...

  14. Standardized EEG interpretation accurately predicts prognosis after cardiac arrest

    DEFF Research Database (Denmark)

    Westhall, Erik; Rossetti, Andrea O; van Rootselaar, Anne-Fleur; Wesenberg Kjaer, Troels; Horn, Janneke; Ullén, Susann; Friberg, Hans; Nielsen, Niklas; Rosén, Ingmar; Åneman, Anders; Erlinge, David; Gasche, Yvan; Hassager, Christian; Hovdenes, Jan; Kjaergaard, Jesper; Kuiper, Michael; Pellis, Tommaso; Stammet, Pascal; Wanscher, Michael; Wetterslev, Jørn; Wise, Matt P; Cronberg, Tobias

    2016-01-01

    OBJECTIVE: To identify reliable predictors of outcome in comatose patients after cardiac arrest using a single routine EEG and standardized interpretation according to the terminology proposed by the American Clinical Neurophysiology Society. METHODS: In this cohort study, 4 EEG specialists......, blinded to outcome, evaluated prospectively recorded EEGs in the Target Temperature Management trial (TTM trial) that randomized patients to 33°C vs 36°C. Routine EEG was performed in patients still comatose after rewarming. EEGs were classified into highly malignant (suppression, suppression with...... periodic discharges, burst-suppression), malignant (periodic or rhythmic patterns, pathological or nonreactive background), and benign EEG (absence of malignant features). Poor outcome was defined as best Cerebral Performance Category score 3-5 until 180 days. RESULTS: Eight TTM sites randomized 202...

  15. Cardiac sarcoidosis—state of the art review

    Science.gov (United States)

    Hulten, Edward; Aslam, Saira; Osborne, Michael; Abbasi, Siddique; Bittencourt, Marcio Sommer

    2016-01-01

    Sarcoidosis is a multi-system inflammatory disorder of unknown etiology resulting in formation of non-caseating granulomas. Cardiac involvement—which is associated with worse prognosis—has been detected in approximately 25% of individuals based on autopsy or cardiac imaging studies. Nevertheless, the diagnosis of cardiac sarcoidosis is challenging due to the low yield of endomyocardial biopsy, and the limited accuracy of various clinical criteria. Thus, no gold standard diagnostic criterion exists. This review will summarize the pathophysiology, diagnosis, and treatment of cardiac sarcoidosis with a focus on advanced cardiovascular imaging, We review the evidence to support a role for cardiac magnetic resonance (CMR) imaging in the initial evaluation of selected patients with suspected cardiac sarcoidosis, with cardiac positron emission tomography (PET) as an alternative or complementary initial diagnostic test in a subgroup of patients in whom CMR may be contra-indicated or when CMR is negative with continued clinical concern for myocardial inflammation. In addition to the diagnostic value of these tests, CMR and PET are also useful in identifying patients who have higher risk of adverse events such as ventricular tachycardia or death, in whom preventive therapies such as defibrillators should be more strongly considered. Although no randomized controlled trials for treatment of cardiac sarcoidosis exist, immunosuppressive therapy is often used. We review emerging evidence regarding the use of cardiac PET to identify and quantity the amount of myocardial inflammation as well as to guide the use of immunotherapy. Future studies are needed to determine the benefit of imaging guided therapies aimed at improving patient outcomes. PMID:26885492

  16. Xenotransplantation of Human Cardiomyocyte Progenitor Cells Does Not Improve Cardiac Function in a Porcine Model of Chronic Ischemic Heart Failure. Results from a Randomized, Blinded, Placebo Controlled Trial

    Science.gov (United States)

    Jansen of Lorkeers, Sanne J.; Gho, Johannes M. I. H.; Koudstaal, Stefan; van Hout, Gerardus P. J.; Zwetsloot, Peter Paul M.; van Oorschot, Joep W. M.; van Eeuwijk, Esther C. M.; Leiner, Tim; Hoefer, Imo E.; Goumans, Marie-José; Doevendans, Pieter A.; Sluijter, Joost P. G.; Chamuleau, Steven A. J.

    2015-01-01

    Background Recently cardiomyocyte progenitor cells (CMPCs) were successfully isolated from fetal and adult human hearts. Direct intramyocardial injection of human CMPCs (hCMPCs) in experimental mouse models of acute myocardial infarction significantly improved cardiac function compared to controls. Aim Here, our aim was to investigate whether xenotransplantation via intracoronary infusion of fetal hCMPCs in a pig model of chronic myocardial infarction is safe and efficacious, in view of translation purposes. Methods & Results We performed a randomized, blinded, placebo controlled trial. Four weeks after ischemia/reperfusion injury by 90 minutes of percutaneous left anterior descending artery occlusion, pigs (n = 16, 68.5 ± 5.4 kg) received intracoronary infusion of 10 million fetal hCMPCs or placebo. All animals were immunosuppressed by cyclosporin (CsA). Four weeks after infusion, endpoint analysis by MRI displayed no difference in left ventricular ejection fraction, left ventricular end diastolic and left ventricular end systolic volumes between both groups. Serial pressure volume (PV-)loop and echocardiography showed no differences in functional parameters between groups at any timepoint. Infarct size at follow-up, measured by late gadolinium enhancement MRI showed no difference between groups. Intracoronary pressure and flow measurements showed no signs of coronary obstruction 30 minutes after cell infusion. No premature death occurred in cell treated animals. Conclusion Xenotransplantation via intracoronary infusion of hCMPCs is feasible and safe, but not associated with improved left ventricular performance and infarct size compared to placebo in a porcine model of chronic myocardial infarction. PMID:26678993

  17. Xenotransplantation of Human Cardiomyocyte Progenitor Cells Does Not Improve Cardiac Function in a Porcine Model of Chronic Ischemic Heart Failure. Results from a Randomized, Blinded, Placebo Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sanne J Jansen of Lorkeers

    Full Text Available Recently cardiomyocyte progenitor cells (CMPCs were successfully isolated from fetal and adult human hearts. Direct intramyocardial injection of human CMPCs (hCMPCs in experimental mouse models of acute myocardial infarction significantly improved cardiac function compared to controls.Here, our aim was to investigate whether xenotransplantation via intracoronary infusion of fetal hCMPCs in a pig model of chronic myocardial infarction is safe and efficacious, in view of translation purposes.We performed a randomized, blinded, placebo controlled trial. Four weeks after ischemia/reperfusion injury by 90 minutes of percutaneous left anterior descending artery occlusion, pigs (n = 16, 68.5 ± 5.4 kg received intracoronary infusion of 10 million fetal hCMPCs or placebo. All animals were immunosuppressed by cyclosporin (CsA. Four weeks after infusion, endpoint analysis by MRI displayed no difference in left ventricular ejection fraction, left ventricular end diastolic and left ventricular end systolic volumes between both groups. Serial pressure volume (PV-loop and echocardiography showed no differences in functional parameters between groups at any timepoint. Infarct size at follow-up, measured by late gadolinium enhancement MRI showed no difference between groups. Intracoronary pressure and flow measurements showed no signs of coronary obstruction 30 minutes after cell infusion. No premature death occurred in cell treated animals.Xenotransplantation via intracoronary infusion of hCMPCs is feasible and safe, but not associated with improved left ventricular performance and infarct size compared to placebo in a porcine model of chronic myocardial infarction.

  18. Comprehensive analysis of published phase I/II clinical trials between 1990-2010 in osteosarcoma and Ewing sarcoma confirms limited outcomes and need for translational investment

    Directory of Open Access Journals (Sweden)

    van Maldegem Annemiek M

    2012-01-01

    Full Text Available Abstract Background High grade primary bone sarcomas are rare cancers that affect mostly children and young adults. Osteosarcoma and Ewing sarcoma are the most common histological subtypes in this age group, with current multimodality treatment strategies achieving 55-70% overall survival. As there remains an urgent need to develop new therapeutic interventions, we have reviewed published phase I/II trials that have been reported for osteosarcoma and Ewing sarcoma in the last twenty years. Results We conducted a literature search for clinical trials between 1990 and 2010, either for trials enrolling bone sarcoma patients as part of a general sarcoma indication or trials specifically in osteosarcoma and Ewing sarcoma. We identified 42 clinical trials that fulfilled our search criteria for general sarcoma that enrolled these patient groups, and eight and twenty specific trials for Ewing and osteosarcoma patients, respectively. For the phase I trials which enrolled different tumour types our results were incomplete, because the sarcoma patients were not mentioned in the PubMed abstract. A total of 3,736 sarcoma patients were included in these trials over this period, 1,114 for osteosarcoma and 1,263 for Ewing sarcoma. As a proportion of the worldwide disease burden over this period, these numbers reflect a very small percentage of the potential patient recruitment, approximately 0.6% for Ewing sarcoma and 0.2% for osteosarcoma. However, these data show an increase in recent activity overall and suggest there is still much room for improvement in the current trial development structures. Conclusion Lack of resources and commercial investment will inevitably limit opportunity to develop sufficiently rapid improvements in clinical outcomes. International collaboration exists in many well founded co-operative groups for phase III trials, but progress may be more effective if there were also more investment of molecular and translational research into

  19. Cardiac fusion and complex congenital cardiac defects in thoracopagus twins: diagnostic value of cardiac CT

    Energy Technology Data Exchange (ETDEWEB)

    Goo, Hyun Woo [University of Ulsan College of Medicine, Asan Medical Center, Department of Radiology and Research Institute of Radiology, Seoul (Korea, Republic of); Park, Jeong-Jun [University of Ulsan College of Medicine, Asan Medical Center, Department of Pediatric Cardiac Surgery, Seoul (Korea, Republic of); Kim, Ellen Ai-Rhan [University of Ulsan College of Medicine, Asan Medical Center, Division of Neonatology, Department of Pediatrics, Seoul (Korea, Republic of); Won, Hye-Sung [University of Ulsan College of Medicine, Asan Medical Center, Department of Obstetrics and Gynecology, Seoul (Korea, Republic of)

    2014-09-15

    Most thoracopagus twins present with cardiac fusion and associated congenital cardiac defects, and assessment of this anatomy is of critical importance in determining patient care and outcome. Cardiac CT with electrocardiographic triggering provides an accurate and quick morphological assessment of both intracardiac and extracardiac structures in newborns, making it the best imaging modality to assess thoracopagus twins during the neonatal period. In this case report, we highlight the diagnostic value of cardiac CT in thoracopagus twins with an interatrial channel and complex congenital cardiac defects. (orig.)

  20. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

    Directory of Open Access Journals (Sweden)

    Thorsen Lene

    2012-03-01

    Full Text Available Abstract Background Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC trial is designed to determine the effectiveness of strength training on clinical and muscle cellular outcomes in non-metastatic prostate cancer patients after high-dose radiotherapy and during ongoing androgen deprivation therapy. Methods/design Patients receiving androgen deprivation therapy for 9-36 months combined with external high-dose radiotherapy for locally advanced prostate cancer are randomized to an exercise intervention group that receives a 16 week high-load strength training program or a control group that is encouraged to maintain their habitual activity level. In both arms, androgen deprivation therapy is continued until the end of the intervention period. Clinical outcomes are body composition (lean body mass, bone mineral density and fat mass measured by Dual-energy X-ray Absorptiometry, serological outcomes, physical functioning (muscle strength and cardio-respiratory fitness assessed with physical tests and psycho-social functioning (mental health, fatigue and health-related quality of life assessed by questionnaires. Muscle cellular outcomes are a muscle fiber size b regulators of muscle fiber size (number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors and proteins involved in muscle protein degradation and muscle hypertrophy and c regulators of muscle fiber function such as proteins involved in cellular stress and mitochondrial function. Muscle cellular outcomes

  1. Effect of indacaterol on lung deflation improves cardiac performance in hyperinflated COPD patients: an interventional, randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Santus P

    2015-09-01

    Full Text Available Pierachille Santus,1,2 Dejan Radovanovic,1,2 Silvia Di Marco,3 Vincenzo Valenti,4,5 Rita Raccanelli,1,2 Francesco Blasi,6,7 Stefano Centanni,8,9 Maurizio Bussotti31Department of Health Sciences, University of Milan, 2Pulmonary Rehabilitation Unit, Fondazione Salvatore Maugeri Scientific Institute of Milan-IRCCS, 3Cardiological Rehabilitation Unit, Fondazione Salvatore Maugeri Rehabilitation Institute of Milan-IRCCS, 4Department of Biomedical Sciences for Health, University of Milan, 5Respiratory Unit, Policlinico San Donato-IRCCS, San Donato Milanese, 6Department of Pathophysiology and Transplantation, University of Milan, 7IRCCS Fondazione Ospedale Maggiore Policlinico Cà Granda Milan, 8Department of Health Sciences, University of Milan, 9Respiratory Unit, Ospedale San Paolo, Milan, ItalyBackground: COPD is often associated with cardiovascular comorbidity. Treatment guidelines recommend therapy with bronchodilators as first choice. We investigated the acute effect of single-dose indacaterol on lung hyperinflation in COPD subjects, for the first time evaluating the potential effects on right heart performance.Methods: In this Phase IV, randomized, interventional, double-blind, crossover clinical study, we recruited 40 patients (50–85 years of age with stable COPD. Patients were treated with 150 µg indacaterol or placebo and after 60 minutes (T60 and 180 minutes (T180 the following tests were performed: trans-thoracic echocardiography (TTE, plethysmography, diffusing capacity of the lung for carbon monoxide, saturation of peripheral oxygen, and visual analog scale dyspnea score. Patients underwent a crossover re-challenge after a further 72 hours of pharmacological washout. All TTE measurements were conducted blindly by the same operator and further interpreted by two different blinded operators. Consensus decisions were taken on every value and parameter. The primary outcome was the effect of the reduction of residual volume and functional

  2. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes.

    Directory of Open Access Journals (Sweden)

    Brian Suffoletto

    Full Text Available Binge drinking is associated with numerous negative consequences. The prevalence and intensity of binge drinking is highest among young adults. This randomized trial tested the efficacy of a 12-week interactive text message intervention to reduce binge drinking up to 6 months after intervention completion among young adults.Young adult participants (18-25 y; n = 765 drinking above the low-risk limits (AUDIT-C score >3/4 women/men, but not seeking alcohol treatment, were enrolled from 4 Emergency Departments (EDs in Pittsburgh, PA. Participants were randomized to one of three conditions in a 2:1:1 allocation ratio: SMS Assessments + Feedback (SA+F, SMS Assessments (SA, or control. For 12 weeks, SA+F participants received texts each Thursday querying weekend drinking plans and prompting drinking limit goal commitment and each Sunday querying weekend drinking quantity. SA+F participants received tailored feedback based on their text responses. To contrast the effects of SA+F with self-monitoring, SA participants received texts on Sundays querying drinking quantity, but did not receive alcohol-specific feedback. The control arm received standard care. Follow-up outcome data collected through web-based surveys were provided by 78% of participants at 3- months, 63% at 6-months and 55% at 9-months. Multiple imputation-derived, intent-to-treat models were used for primary analysis. At 9-months, participants in the SA+F group reported greater reductions in the number of binge drinking days than participants in the control group (incident rate ratio [IRR] 0.69; 95% CI .59 to.79, lower binge drinking prevalence (odds ratio [OR] 0.52; 95% CI 0.26 to 0.98], less drinks per drinking day (beta -.62; 95% CI -1.10 to -0.15 and lower alcohol-related injury prevalence (OR 0.42; 95% CI 0.21 to 0.88. Participants in the SA group did not reduce drinking or alcohol-related injury relative to controls. Findings were similar using complete case analyses.An interactive

  3. Bisoprolol in the treatment of chronic heart failure: from pathophysiology to clinical pharmacology and trial results

    OpenAIRE

    Metra, Marco; NODARI, SAVINA; Bordonali, Tania; Milani, Patrizia; Lombardi, Carlo; Bugatti, Silvia; Fontanella, Benedetta; VERZURA, GIULIA; Danesi, Rossella; DEI CAS, LIVIO

    2007-01-01

    Clinical trials have consistently shown the benefits of beta-blocker treatment in patients with chronic heart failure (HF). As a result, bisoprolol, carvedilol, and metoprolol succinate are now indicated for the treatment of all patients with chronic HF who do not have major contraindications. Bisoprolol is the first beta-blocker shown to improve survival in an outcome trial. In the Cardiac Insufficiency Bisoprolol Study II (CIBIS-II), all-cause mortality and sudden death were reduced in pati...

  4. N-acetylcysteine and/or ascorbic acid versus placebo to prevent contrast-induced nephropathy in patients undergoing elective cardiac catheterization: The NAPCIN trial; A single-center, prospective, randomized trial

    Directory of Open Access Journals (Sweden)

    Mohammed Habib

    2016-01-01

    Full Text Available Several protective measures have been described to prevent contrast-induced nephropathy (CIN. This study is aimed to evaluate the effect of a high dose of N-acetylcysteine (NAC plus hydration, a low dose of NAC plus ascorbic acid and hydration or hydration alone on the prevention of CIN in high-risk patients undergoing elective coronary artery intervention. We conducted a randomized, prospective, placebo-controlled trial of 105 high-risk patients undergoing elective cardiac catheterization. The patients were divided into three different groups: Group A (n = 30, NAC 1200 mg orally before angiography and 1200 mg orally twice daily for three doses along with good hydration; Group B (n = 30, NAC 600 mg before angiography and 600 mg orally twice daily for three doses plus ascorbic acid (3000 mg one dose before angiography and 2000 mg two doses after angiography and good hydration; and Group C (n = 45, hydration with 0.9% saline started just before contrast media injection and continued for 12 h at a rate 1.0 mL/kg/min after angiography or 0.5 mL/kg/h in cases with overt heart failure for 12 h. CIN was defined as an increase in serum creatinine of >25% of baseline or an absolute increase of 0.5 mg/dL above baseline after 48 h. The incidence of CIN was significantly lower in Group A (6.66% compared with Group B (16.66% or Group C (17.77%. The difference between Groups A and B and between Groups A and C was also highly significant (P = 0.001. In contrast, the difference between Groups B and C was not statistically significant (P = 0.37. Our study indicates that high doses of NAC plus hydration provide better protection against CIN than combination therapy of NAC and ascorbic acid plus hydration, or hydration alone.

  5. N-acetylcysteine and/or ascorbic acid versus placebo to prevent contrast-induced nephropathy in patients undergoing elective cardiac catheterization: The NAPCIN trial; A single-center, prospective, randomized trial.

    Science.gov (United States)

    Habib, Mohammed; Hillis, Alaa; Hammad, Amen

    2016-01-01

    Several protective measures have been described to prevent contrast-induced nephropathy (CIN). This study is aimed to evaluate the effect of a high dose of N-acetylcysteine (NAC) plus hydration, a low dose of NAC plus ascorbic acid and hydration or hydration alone on the prevention of CIN in high-risk patients undergoing elective coronary artery intervention. We conducted a randomized, prospective, placebo-controlled trial of 105 high-risk patients undergoing elective cardiac catheterization. The patients were divided into three different groups: Group A (n=30), NAC 1200 mg orally before angiography and 1200 mg orally twice daily for three doses along with good hydration; Group B (n=30), NAC 600 mg before angiography and 600 mg orally twice daily for three doses plus ascorbic acid (3000 mg one dose) before angiography and 2000 mg two doses after angiography and good hydration; and Group C (n=45), hydration with 0.9% saline started just before contrast media injection and continued for 12 h at a rate 1.0 mL/kg//min after angiography or 0.5 mL/kg/h in cases with overt heart failure for 12 h. CIN was defined as an increase in serum creatinine of >25% of baseline or an absolute increase of 0.5 mg/dL above baseline after 48 h. The incidence of CIN was significantly lower in Group A (6.66%) compared with Group B (16.66%) or Group C (17.77%). The difference between Groups A and B and between Groups A and C was also highly significant (P=0.001). In contrast, the difference between Groups B and C was not statistically significant (P=0.37). Our study indicates that high doses of NAC plus hydration provide better protection against CIN than combination therapy of NAC and ascorbic acid plus hydration, or hydration alone. PMID:26787567

  6. Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials

    OpenAIRE

    Coons, Stephen Joel; Eremenco, Sonya; Lundy, J. Jason; O’Donohoe, Paul; O’Gorman, Hannah; Malizia, William

    2014-01-01

    Patient-reported outcomes (PROs) are an important means of evaluating the treatment benefit of new medical products. It is recognized that PRO measures should be used when assessing concepts best known by the patient or best measured from the patient’s perspective. As a result, there is growing emphasis on well defined and reliable PRO measures. In addition, advances in technology have significantly increased electronic PRO (ePRO) data collection capabilities and options in clinical trials. T...

  7. [Cardiovascular outcome clinical trials in type 2 diabetes mellitus: what are the epidemiological and methodological evidence and the first evaluations to date?].

    Science.gov (United States)

    Fiorentino, Teresa Vanessa; Sesti, Giorgio

    2016-03-01

    Clinical trials of glucose-lowering strategies in patients with type 2 diabetes mellitus (T2DM) have shown a favorable effect of intensive glycemic control on microvascular complications but failed to show a clear benefit on cardiovascular events. In 2008, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have required stringent criteria to approve new glucose-lowering drugs, demanding proof of cardiovascular safety. As a result of these regulatory requirements, a number of cardiovascular outcome trials in T2DM have been conducted examining the cardiovascular safety of novel glucose-lowering drugs. Dipeptidyl peptidase 4 (DPP4) inhibitors, analogs of glucagon-like peptide 1 (GLP-1), and inhibitors of the renal sodium-glucose linked transporter-2 (SGLT2) are new classes of glucose-lowering drugs for subjects with T2DM. The results of the cardiovascular outcome trials comparing the DPP4 inhibitors saxagliptin, alogliptin, and sitagliptin or the GLP-1 analog lixisenatide to placebo have demonstrated that these drugs are safe. The results of a cardiovascular outcome trial comparing the SGLT2 inhibitor empagliflozin to placebo have been published. Notably, empagliflozin treatment has been associated with a significant reduction in the primary composite cardiovascular outcome. Although the question regarding the positive effect of glycemic control on cardiovascular risk is still unanswered, current evidence suggests that a multifactorial approach aimed at treating not only hyperglycemia but also classical cardiovascular risk factors is necessary in order to reduce the risk of cardiovascular events in patients with T2DM. PMID:27030121

  8. Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial

    OpenAIRE

    Fitchett, David; Zinman, Bernard; Wanner, Christoph; Lachin, John M.; Hantel, Stefan; Salsali, Afshin; Johansen, Odd Erik; Woerle, Hans J.; Broedl, Uli C.; Inzucchi, Silvio E.

    2016-01-01

    Aims We previously reported that in the EMPA-REG OUTCOME® trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure outcomes in all patients and in subgroups, including patients with or without baseline heart failure. Methods and results Patients were randomi...

  9. Implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT: protocol of a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Trudy Rebbeck

    2016-04-01

    Discussion: This research is significant as it will be the first study to address the heterogeneity of whiplash by implementing a clinical pathway of care that matches evidence-based interventions to projected risk of poor recovery. The results of this trial have the potential to change clinical practice for WAD, thereby maximising treatment effects, improving patient outcomes, reducing costs and maintaining the compulsory third party system.

  10. Pleural subxyphoid drain confers better pulmonary function and clinical outcomes in chronic obstructive pulmonary disease after off-pump coronary artery bypass grafting: a randomized controlled trial

    OpenAIRE

    Solange Guizilini; Marcela Viceconte; Esperança, Gabriel Tavares da M.; Douglas W. Bolzan; Milena Vidotto; Rita Simone L Moreira; Andréia Azevedo Câncio; Gomes, Walter J.

    2014-01-01

    Objective: To evaluate the lung function and clinical outcome in severe chronic obstructive pulmonary disease in patients undergoing off-pump coronary artery bypass grafting with left internal thoracic artery graft, comparing the pleural drain insertion in the intercostal versus subxyphoid region. Methods: A randomized controlled trial. Chronic obstructive pulmonary disease patients were randomized into two groups according pleural drain site: II group (n=27) - pleural drain in intercostal sp...

  11. A Cluster Randomized-Controlled Trial of a Classroom-Based Drama Workshop Program to Improve Mental Health Outcomes among Immigrant and Refugee Youth in Special Classes

    OpenAIRE

    Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D.; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

    2014-01-01

    Objectives The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Methods Special classrooms in five multiethnic high schools were rand...

  12. Impact of the Positive Action program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomized, controlled trial

    OpenAIRE

    Snyder, Frank; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit

    2010-01-01

    This paper reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster randomized, controlled design. The Positive Action Hawai‘i trial included 20 racially/ethnically diverse schools (mean enrollment = 544) and was conducted from the 2002-03 through the 2005-06 academic years. Using school-level archival data, analyses comparing change from...

  13. Outcomes and moderators of a preventive school-based mental health intervention for children affected by war in Sri Lanka: a cluster randomized trial

    OpenAIRE

    TOL, WIETSE A.; KOMPROE, IVAN H.; Jordans, Mark J. D.; Vallipuram, Anavarathan; Sipsma, Heather; SIVAYOKAN, SAMBASIVAMOORTHY; Macy, Robert D; de Jong, Joop T.

    2012-01-01

    We aimed to examine outcomes, moderators and mediators of a preventive school-based mental health intervention implemented by paraprofessionals in a war-affected setting in northern Sri Lanka. A cluster randomized trial was employed. Subsequent to screening 1,370 children in randomly selected schools, 399 children were assigned to an intervention (n=199) or waitlist control condition (n=200). The intervention consisted of 15 manualized sessions over 5 weeks of cognitive behavioral techniques ...

  14. Selection of Sperm Based on Hypo-Osmotic Swelling May Improve ICSI Outcome: A Preliminary Prospective Clinical Trial

    Directory of Open Access Journals (Sweden)

    Nasim Charehjooy

    2014-03-01

    Full Text Available Background: The intra-cytoplasmic sperm injection (ICSI technique selects sperm according to morphology and motility. However, these parameters cannot predict the chromatin integrity of sperm. Considering the detrimental effects of DNA-damaged sperm on reproductive outcomes, novel sperm selection procedures have been proposed to circumvent the possibility of inseminating DNA-damaged sperm. It has been shown that different potential hypo-osmotic swelling test (HOST patterns possess the potential to differentiate between sperm that have intact or damaged chromatin. Therefore, for the first time, this preliminary study evaluates the role of HOST as a sperm selection procedure in a clinical setting. Materials and Methods: In this preliminary prospective clinical trial study, we divided infertile couples diagnosed with male infertility into two groups. In the treatment group (n=39, half of the oocytes were inseminated by sperm selected following density gradient centrifugation (DGC group. The remaining oocytes from the treatment group were inseminated by sperm chosen according to HOST pattern (c, d or e following DGC processing (HOST group. In the control group (n=63, all oocytes were inseminated by sperm chosen after DGC. Results: There was a significantly higher percentage of embryos that had good quality, implantation, and chemical pregnancy rates in the HOST group compared to the DGC group (p≤0.05. Conclusion: This study has shown that selecting sperm according to membrane functionality (HOST pattern rather morphology and viability may open a new window in our approach for determining the appropriate sperm for ICSI, particularly in individuals with severe male infertility (Registration Number: IRCT201307087223N2.

  15. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

    International Nuclear Information System (INIS)

    Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC) trial is designed to determine the effectiveness of strength training on clinical and muscle cellular outcomes in non-metastatic prostate cancer patients after high-dose radiotherapy and during ongoing androgen deprivation therapy. Patients receiving androgen deprivation therapy for 9-36 months combined with external high-dose radiotherapy for locally advanced prostate cancer are randomized to an exercise intervention group that receives a 16 week high-load strength training program or a control group that is encouraged to maintain their habitual activity level. In both arms, androgen deprivation therapy is continued until the end of the intervention period. Clinical outcomes are body composition (lean body mass, bone mineral density and fat mass) measured by Dual-energy X-ray Absorptiometry, serological outcomes, physical functioning (muscle strength and cardio-respiratory fitness) assessed with physical tests and psycho-social functioning (mental health, fatigue and health-related quality of life) assessed by questionnaires. Muscle cellular outcomes are a) muscle fiber size b) regulators of muscle fiber size (number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors and proteins involved in muscle protein degradation and muscle hypertrophy) and c) regulators of muscle fiber function such as proteins involved in cellular stress and mitochondrial function. Muscle cellular outcomes are measured on muscle cross sections and

  16. Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

    OpenAIRE

    Hodkinson, Alex; Gamble, Carrol; Smith, Catrin Tudur

    2016-01-01

    Background The quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials. Methods Publications related to clinical trials of orlistat w...

  17. Earliest Bedside Assessment of Hemodynamic Parameters and Cardiac Biomarkers: Their Role as Predictors of Adverse Outcome in Patients with Septic Shock

    Science.gov (United States)

    Sasko, Benjamin; Butz, Thomas; Prull, Magnus Wilhelm; Liebeton, Jeanette; Christ, Martin; Trappe, Hans-Joachim

    2015-01-01

    Background: Early assessment and aggressive hemodynamic treatment have been shown to increase the survival of patients in septic shock. Current and past sepsis guidelines recommend a resuscitation protocol including central venous pressure (CVP), mean arterial blood pressure (MAP), urine output and central venous oxygen saturation (ScvO2) for resuscitation within the first six hours. Currently, the established severity score systems like APACHE II score, SOFA score or SAPS II score predict the outcome of critically ill patients on the bases of variables obtained only after the first 24 hours. The present study aims to evaluate the risk of short-term mortality for patients with septic shock by the earliest possible assessment of hemodynamic parameters and cardiac biomarkers as well as their role for the prediction of the adverse outcome. Methods: 52 consecutive patients treated for septic shock in the intensive care unit of one centre (Marien Hospital Herne, Ruhr University Bochum, Germany) were prospectively enrolled in this study. Hemodynamic parameters (MAP, CVP, ScvO2, left ventricular ejection fraction, Hematocrit) and cardiac biomarkers (Troponin I) at the ICU admission were evaluated in regard to their influence on mortality. The primary endpoint was all-cause mortality within 28 days after the admission. Results: A total of 52 patients (31 male, 21 female) with a mean age of 71.4±8.5 years and a mean APACHE II score of 37.0±7.6 were enrolled in the study. 28 patients reached the primary endpoint (mortality 54%). Patients presenting with hypotension (MAP <65 mmHg) at ICU admission had significantly higher rates of 28-day mortality as compared with the group of patients without hypotension (28-day mortality rate 74 % vs. 32 %, p<0.01). Furthermore, the patients in the hypotension present group had significantly higher lactate concentration (p=0.002), higher serum creatinin (p=0.04), higher NTproBNP (p=0.03) and after the first 24 hours higher APACHE II

  18. Combining Amplitude Spectrum Area with Previous Shock Information Using Neural Networks Improves Prediction Performance of Defibrillation Outcome for Subsequent Shocks in Out-Of-Hospital Cardiac Arrest Patients.

    Directory of Open Access Journals (Sweden)

    Mi He

    Full Text Available Quantitative ventricular fibrillation (VF waveform analysis is a potentially powerful tool to optimize defibrillation. However, whether combining VF features with additional attributes that related to the previous shock could enhance the prediction performance for subsequent shocks is still uncertain.A total of 528 defibrillation shocks from 199 patients experienced out-of-hospital cardiac arrest were analyzed in this study. VF waveform was quantified using amplitude spectrum area (AMSA from defibrillator's ECG recordings prior to each shock. Combinations of AMSA with previous shock index (PSI or/and change of AMSA (ΔAMSA between successive shocks were exercised through a training dataset including 255shocks from 99patientswith neural networks. Performance of the combination methods were compared with AMSA based single feature prediction by area under receiver operating characteristic curve(AUC, sensitivity, positive predictive value (PPV, negative predictive value (NPV and prediction accuracy (PA through a validation dataset that was consisted of 273 shocks from 100patients.A total of61 (61.0% patients required subsequent shocks (N = 173 in the validation dataset. Combining AMSA with PSI and ΔAMSA obtained highest AUC (0.904 vs. 0.819, p<0.001 among different combination approaches for subsequent shocks. Sensitivity (76.5% vs. 35.3%, p<0.001, NPV (90.2% vs. 76.9%, p = 0.007 and PA (86.1% vs. 74.0%, p = 0.005were greatly improved compared with AMSA based single feature prediction with a threshold of 90% specificity.In this retrospective study, combining AMSA with previous shock information using neural networks greatly improves prediction performance of defibrillation outcome for subsequent shocks.

  19. Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    Burciul Barry

    2010-12-01

    Full Text Available Abstract Background In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions. This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS, on staff retention and satisfaction, and quality of patient care. Methods/Design A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours, intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation. Discussion The PALM PLUS trial

  20. Prevention of nosocomial infection in cardiac surgery by decontamination of the nasopharynx and oropharynx with chlorhexidine gluconate - A randomized controlled trial

    NARCIS (Netherlands)

    P. Segers; R.G.H. Speekenbrink; D.T. Ubbink; M.L. van Ogtrop; B.A. de Mol

    2006-01-01

    Context Nosocomial infections are an important cause of morbidity and mortality after cardiac surgery. Decolonization of endogenous potential pathogenic microorganisms is important in the prevention of nosocomial infections. Objective To determine the efficacy of perioperative decontamination of the

  1. A trial to reduce cardiac motion artifacts on HR-CT images of lung with combined use of subsecond scan and a high temporal resolution reconstruction algorithm

    International Nuclear Information System (INIS)

    To reduce cardiac motion artifacts with combined use of subsecond CT scanning and a high temporal resolution algorithm. Scan data were obtained with step-by-step scanning (scan time, 0.8 seconds). Two sets of images were reconstructed, with and without high temporal resolution reconstruction algorithm (HTRR), from the same set of scan data. HTRR, derived from modification of 180-degree linear helical interpolation, reduces full width at half maximum (FWHM) to half of the scan time. Motion artifacts of two sets of images were compared. The use of HTRR seemed to be useful in reducing cardiac motion artifacts owing to the improvement of effective time resolution. However, there were some images without significant reduction of cardiac motion artifacts. Our technique is useful in reducing cardiac motion artifacts without an increase in radiation exposure. (author)

  2. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial.

    NARCIS (Netherlands)

    Farkouh, M.E.; Kirshner, H.; Harrington, R.A.; Ruland, S.; Verheugt, F.W.A.; Schnitzer, T.J.; Burmester, G.R.; Mysler, E.; Hochberg, M.C.; Doherty, M.; Ehrsam, E.; Gitton, X.; Krammer, G.; Mellein, B.; Gimona, A.; Matchaba, P.; Hawkey, C.J.; Chesebro, J.H.

    2004-01-01

    BACKGROUND: The potential for cyclo-oxygenase 2 (COX2)-selective inhibitors to increase the risk for myocardial infarction is controversial. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor l

  3. Biomarkers of acute kidney injury and associations with short- and long-term outcomes

    OpenAIRE

    Schaub, Jennifer A.; Parikh, Chirag R.

    2016-01-01

    Acute kidney injury is strongly associated with increased mortality and other adverse outcomes. Medical researchers have intensively investigated novel biomarkers to predict short- and long-term outcomes of acute kidney injury in many patient care settings, such as cardiac surgery, intensive care units, heart failure, and transplant. Future research should focus on leveraging this relationship to improve enrollment for clinical trials of acute kidney injury.

  4. Relaxation therapy in cardiac rehabilitation : a randomized controlled clinical trial of breathing awareness as a relaxation method in the rehabilitation after myocardial infarction

    OpenAIRE

    Dixhoorn, J.J.

    1991-01-01

    textabstractCardiac rehabilitation is often a necessary supplement to medica! treatment of patients with acute ischaemie heart disease. Rehabilitation is directed to the functional recovery of the patient, physically as well as socially and mentally. Exercise training is at present the most common component of cardiac rehabilitation. However, most investigators have failed to show that exercise in itself would imprave the patient's functional state satisfactorily. Therefore, there is a need t...

  5. Randomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients

    OpenAIRE

    Yeung, Alan; Kiat, Hosen; Denniss, A Robert; Cheema, Birinder S.; Bensoussan, Alan; Machliss, Bianca; Colagiuri, Ben; Chang, Dennis

    2014-01-01

    Background Negative affective states such as anxiety, depression and stress are significant risk factors for cardiovascular disease, particularly in cardiac and post-cardiac rehabilitation populations. Yoga is a balanced practice of physical exercise, breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function. It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardi...

  6. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes.

    Directory of Open Access Journals (Sweden)

    Michael H Chung

    2011-03-01

    Full Text Available BACKGROUND: Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting. METHODS AND FINDINGS: A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine were randomized to one of four arms: counseling (three counseling sessions around HAART initiation, alarm (pocket electronic pill reminder carried for 6 months, counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055 and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml (HR 0.41; 95% CI 0.21-0.81; p = 0.01 compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7 or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0 compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution. CONCLUSIONS: Intensive early adherence counseling at HAART initiation resulted

  7. Exercise tolerance testing in a cardiac rehabilitation setting: an exploratory study of its safety and practicality for exercise prescription and outcome data collection

    OpenAIRE

    Simms, Kay; Myers, Chris; Adams, Jenny; Hartman, Julie; Lindsey, Christopher; Doler, Mike; Suhr, Janet

    2007-01-01

    An exercise test is a valuable tool that should be a part of every patient's assessment before beginning cardiac rehabilitation. We analyzed data from one exercise tolerance test used in a cardiac rehabilitation program among 103 subjects: 65 men with a mean age of 60.5 years and 38 women with a mean age of 62.4 years. Resultsindicated that, after cardiac rehabilitation, subjects had significantimprovementin maximum metabolic equivalents (an increase of 0.9, P < 0.0001), which indicates funct...

  8. Standardized EEG interpretation accurately predicts prognosis after cardiac arrest

    Science.gov (United States)

    Rossetti, Andrea O.; van Rootselaar, Anne-Fleur; Wesenberg Kjaer, Troels; Horn, Janneke; Ullén, Susann; Friberg, Hans; Nielsen, Niklas; Rosén, Ingmar; Åneman, Anders; Erlinge, David; Gasche, Yvan; Hassager, Christian; Hovdenes, Jan; Kjaergaard, Jesper; Kuiper, Michael; Pellis, Tommaso; Stammet, Pascal; Wanscher, Michael; Wetterslev, Jørn; Wise, Matt P.; Cronberg, Tobias

    2016-01-01

    Objective: To identify reliable predictors of outcome in comatose patients after cardiac arrest using a single routine EEG and standardized interpretation according to the terminology proposed by the American Clinical Neurophysiology Society. Methods: In this cohort study, 4 EEG specialists, blinded to outcome, evaluated prospectively recorded EEGs in the Target Temperature Management trial (TTM trial) that randomized patients to 33°C vs 36°C. Routine EEG was performed in patients still comatose after rewarming. EEGs were classified into highly malignant (suppression, suppression with periodic discharges, burst-suppression), malignant (periodic or rhythmic patterns, pathological or nonreactive background), and benign EEG (absence of malignant features). Poor outcome was defined as best Cerebral Performance Category score 3–5 until 180 days. Results: Eight TTM sites randomized 202 patients. EEGs were recorded in 103 patients at a median 77 hours after cardiac arrest; 37% had a highly malignant EEG and all had a poor outcome (specificity 100%, sensitivity 50%). Any malignant EEG feature had a low specificity to predict poor prognosis (48%) but if 2 malignant EEG features were present specificity increased to 96% (p < 0.001). Specificity and sensitivity were not significantly affected by targeted temperature or sedation. A benign EEG was found in 1% of the patients with a poor outcome. Conclusions: Highly malignant EEG after rewarming reliably predicted poor outcome in half of patients without false predictions. An isolated finding of a single malignant feature did not predict poor outcome whereas a benign EEG was highly predictive of a good outcome. PMID:26865516

  9. Improving the outcomes of primary care attenders with common mental disorders in developing countries: a cluster randomized controlled trial of a collaborative stepped care intervention in Goa, India

    Directory of Open Access Journals (Sweden)

    Chisholm Daniel

    2008-01-01

    Full Text Available Abstract Background and Objective Common mental disorders (CMD are a leading global burden of disease. Up to 30% of primary care attenders suffer from these disorders but most do not receive evidence-based drug or psychological treatments. There are no trials of interventions which attempt to integrate these treatments into routine primary care in developing countries. The aims of this trial (the MANAS Project are to evaluate the clinical and cost-effectiveness of a collaborative stepped-care intervention for the treatment of CMD in India. Study Design A cluster randomized controlled trial will be implemented in the state of Goa, on the west coast of India. Twenty-four primary care facilities, 12 from the government sector and 12 from the private sector, will be enrolled in two consecutive phases. For each sector, facilities will be randomly allocated within strata defined by urban/rural location, population size and presence of a visiting psychiatrist. Facilities will be randomly allocated to receive the collaborative stepped care intervention or the enhanced usual care control intervention. Both arms share two components of the intervention, viz., routine screening, and in the government clinics provision of antidepressants. In addition, the collaborative stepped care arm also provides a range of psychosocial treatments delivered by a specially trained Health Counselor, and supervision by a visiting Psychiatrist. A total of 3600 primary care attenders who are detected to suffer from a CMD based on a validated screening questionnaire will be recruited. The primary outcome is the proportion of subjects who recover from an ICD10 defined CMD at baseline by 6 months. Additional endpoints at 2 and 12 months will assess the speed and sustainability of achieving the primary outcomes. Other outcomes will include recovery from ICD10 defined depression and incidence of ICD-10 among individuals who were sub-threshold cases at baseline. Economic and

  10. Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    Science.gov (United States)

    2016-01-01

    Background The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). Objective The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Methods Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. Results After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the

  11. Early detection and intervention using neutrophil gelatinase-associated lipocalin (NGAL may improve renal outcome of acute contrast media induced nephropathy: A randomized controlled trial in patients undergoing intra-arterial angiography (ANTI-CIN Study

    Directory of Open Access Journals (Sweden)

    Stiegler Philipp

    2011-08-01

    Full Text Available Abstract Background Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN. Neutrophil gelatinase-associated lipocalin (NGAL, a new biomarker predictive for acute kidney injury (AKI, has been shown to be useful for earlier diagnosis of CIN; however, urinary NGAL values may be markedly increased in chronic renal failure at baseline. Results from those studies suggested that urinary NGAL values may not be helpful for the clinician. An intravenous volume load is a widely accepted prophylactic measure and possibly a reasonable intervention to prevent deterioration of renal function. The aim of our study is to evaluate NGAL as an early predictor of CIN and to investigate the clinical benefit of early post-procedural i.v. hydration. Methods/Design The study will follow a prospective, open-label, randomized controlled design. Patients requiring intra-arterial contrast media (CM application will be included and receive standardized, weight-based, intravenous hydration before investigation. Subjects with markedly increased urinary NGAL values after CM application will be randomized into one of two study groups. Group A will receive 3-4 ml/kg BW/h 0.9% saline intravenously for 6 hours. Group B will undergo only standard treatment consisting of unrestricted oral fluid intake. The primary outcome measure will be CIN defined by an increase greater than 25% of baseline serum creatinine. Secondary outcomes will include urinary NGAL values, cystatin C values, contrast media associated changes in cardiac parameters such as NT-pro-BNP/troponin T, changes in urinary cytology, need for renal replacement treatment, length of stay in hospital and death. We assume that 20% of the included patients will show a definite rise in urinary NGAL. Prospective statistical power calculations indicate that the study will have 80% statistical power to detect a clinically significant decrease of CIN of 40% in the

  12. Water aerobics in pregnancy: cardiovascular response, labor and neonatal outcomes

    OpenAIRE

    Braga Angelica F; Cecatti Jose G; Pereira Rosa I; Baciuk Erica P; Cavalcante Sergio R

    2008-01-01

    Abstract Background To evaluate the association between water aerobics, maternal cardiovascular capacity during pregnancy, labor and neonatal outcomes. Methods A randomized, controlled clinical trial was carried out in which 34 pregnant women were allocated to a water aerobics group and 37 to a control group. All women were submitted to submaximal ergometric tests on a treadmill at 19, 25 and 35 weeks of pregnancy and were followed up until delivery. Oxygen consumption (VO2 max), cardiac outp...

  13. 80岁以上患者心脏手术临床结果分析%Clinical Outcome of Cardiac Surgery In Octogenarians

    Institute of Scientific and Technical Information of China (English)

    刘兴荣; 张超纪; 马国涛; 苗齐; 刘剑州; 李晓凤; 曹丽华

    2014-01-01

    目的总结≥80岁心脏手术患者的临床资料,评价手术效果。方法回顾性分析2004年6月至2013年1月接受心脏手术年龄≥80岁的29例患者,男23例,女6例;平均年龄(81.6±1.94)岁。单纯冠心病21例,主动脉瓣狭窄5例,冠心病合并主动脉瓣关闭不全1例,升主动脉瘤1例,感染性心内膜炎1例。结果术后死亡1例,病死率为3.4%。术后出血行手术止血1例,急性呼吸功能不全6例,急性肾功能损伤8例,监护时间(4.2±2.1)d。平均随访(37.3±19.1)个月,随访期死亡9例。结论≥80岁患者仍然可以安全有效地接受心脏手术。谨慎的患者选择、详细的术前评估和密切的多学科协作是手术成功的关键。%Objective To evaluate the clinical outcome of cardiac surgery in octogenarians. Methods Clinical da-ta of 29 patients older than 80 years who underwent cardiovascular operations between 2004 and 2013 in our institution were retrospectively analyzed. There were 23 males and 6 females, with the mean age of 81.6 ±1.94. The diagnosis was iso-lated coronary artery disease in 21 patients, isolated aortic stenosis in 5 patients, combined coronary artery disease and aortic insufficiency in 1 patient, aneurysm of ascending aorta in 1 patient, and infective endocarditis in 1 patient (s). Re-sults One postoperative death occurred, the mortality rate was 3.4%. One patient underwent re-exploratory operation due to bleeding, 6 patients experienced acute respiratory distress and 8 patients suffered acute kidney injury. Mean intensive care unit stay time was 4.2±2.1 days. The mean follow-up period was 37.3±19.1 months, and 9 late deaths were observed. Conclusion Cardiac surgery procedures can be safely and effectively performed in octogenarians. Prudent selection of pa-tients, based on the evaluation of systemic co-morbidities, and close multi-disciplinary coordination are key elements for successful operation.

  14. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for children at 18 months

    OpenAIRE

    ,

    2006-01-01

    Objective To assess the long-term effects of in utero exposure to magnesium sulphate for children whose mothers had pre-eclampsia. Design Assessment at 18 months of age for children whose mothers were recruited to the Magpie Trial (recruitment 1998–2001 ISRCTN 86938761), which compared magnesium sulphate with placebo. Setting Follow-up of children born at 125 centres in 19 countries across five continents. Population A total of 6922 children were born to women randomised before delivery at fo...

  15. Long-Term Treatment Outcome in Adult Male Prisoners With Attention-Deficit/Hyperactivity Disorder: Three-Year Naturalistic Follow-Up of a 52-Week Methylphenidate Trial.

    Science.gov (United States)

    Ginsberg, Ylva; Långström, Niklas; Larsson, Henrik; Lindefors, Nils

    2015-10-01

    Despite high rates of attention-deficit/hyperactivity disorder (ADHD) among adult lawbreakers, particularly the long-term effects of ADHD pharmacotherapy remain unclear, not the least because of ethical challenges with preventing control subjects in randomized controlled trials from receiving medication over prolonged time. We followed up adult male prisoners with ADHD who completed a 5-week randomized, double-blind, placebo-controlled trial followed by a 47-week open-label extension of osmotic-release oral system methylphenidate in a Swedish high-security prison from 2007 to 2010 (ClinicalTrials.gov: NCT00482313). Twenty-five trial completers were prospectively followed up clinically 1 year (24/25, 96% participated fully or in part) and 3 years (20/25, 80% participation) after trial regarding ADHD symptoms (observer and self-reports), psychosocial functioning, substance misuse, and criminal reoffending. Methylphenidate-related improvements in ADHD symptoms and psychosocial functioning obtained during the 52-week trial were maintained at 1- and 3-year follow-ups. Specifically, after 3 years, 75% (15/20) of the respondents had been released from prison, and 67% of these (10/15) had employment, usually full time. In contrast, nonmedicated respondents at the 3-year follow-up (5/20) reported more ADHD symptoms, functional impairment, and substance misuse compared with currently medicated respondents (15/20). Further, 40% of the respondents self-reported reoffending, indicating a substantially lower relapse rate than expected (70%-80%).In summary, although these observations need validation from new and larger samples, positive effects were maintained after 4 years of methylphenidate treatment. Most study completers were employed and had no relapse in substance misuse or criminality. These results suggest that motivational support and continued medication are important for improved outcome in adult criminal offenders with ADHD. PMID:26284932

  16. Effectiveness of the palliative care ‘Availability, Current issues and Anticipation’ (ACA) communication training programme for general practitioners on patient outcomes: A controlled trial

    Science.gov (United States)

    Blankenstein, Annette H; Schweitzer, Bart PM; Knol, Dirk L; van der Horst, Henriëtte E; Aaronson, Neil K; Deliens, Luc

    2014-01-01

    Background: Although communicating effectively with patients receiving palliative care can be difficult, it may contribute to maintaining or enhancing patients’ quality of life. Little is known about the effect of training general practitioners in palliative care–specific communication. We hypothesized that palliative care patients of general practitioners exposed to the ‘Availability, Current issues and Anticipation’ communication training programme would report better outcomes than patients of control general practitioners. Aim: To evaluate the effectiveness of the Availability, Current issues and Anticipation training programme for general practitioners on patient-reported outcomes. Design: In a controlled trial, general practitioners followed the Availability, Current issues and Anticipation programme or were part of the control group. Patients receiving palliative care of participating general practitioners completed the Palliative Care Outcome Scale, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative, the Rest & Peace Scale, the Patient Satisfaction Questionnaire–III and the Availability, Current issues and Anticipation Scale, at baseline and 12 months follow-up. We analysed differences between groups using linear mixed models. Trial registration: ISRCTN56722368. Setting/participants: General practitioners who attended a 2-year Palliative Care Training Course in the Netherlands. Results: Questionnaire data were available for 145 patients (89 in intervention and 56 in control group). We found no significant differences over time between the intervention and control groups in any of the five outcome measures. Ceiling effects were observed for the Rest & Peace Scale, Patient Satisfaction Questionnaire–III and Availability, Current issues and Anticipation Scale. Conclusion: General practitioner participation in the Availability, Current issues and Anticipation training programme did not have

  17. Legacy for ChildrenTM: a pair of randomized controlled trials of a public health model to improve developmental outcomes among children in poverty

    Directory of Open Access Journals (Sweden)

    Perou Ruth

    2012-08-01

    Full Text Available Abstract Background One in five Americans under age 18 lives in a family below the Federal poverty threshold. These more than 15 million children are at increased risk of a wide variety of adverse long-term health and developmental outcomes. The early years of life are critical to short- and long-term health and well-being. The Legacy for ChildrenTM model was developed in response to this need and marries the perspectives of epidemiology and public health to developmental psychology theory in order to better address the needs of children at environmental risk for poor developmental outcomes. Methods/design The Legacy for ChildrenTM group-based parenting intervention model was evaluated as a pair of randomized controlled trials among low-income families in Miami and Los Angeles. The study was designed to allow for site-stratified analysis in order to evaluate each model implementation separately. Evaluation domains include comprehensive assessments of family, maternal, and child characteristics, process outcomes, and prospective programmatic cost. Data collection began prenatally or at birth and continues into school-age. Discussion The societal costs of poor developmental outcomes are substantial. A concerted effort from multiple sectors and disciplines, including public health, is necessary to address these societal concerns. Legacy uses a public health model to engage parents and promote overall child well-being in families in poverty through rigorous evaluation methodologies and evidence-based intervention strategies. This study collects rich and modular information on maternal and child outcomes, process, and cost that will enable a detailed understanding of how Legacy works, how it can be refined and improved, and how it can be translated and disseminated. Taken together, these results will inform public policy and help to address issues of health disparities among at-risk populations. Trial registration NCT00164697

  18. Satisfaction With the Outcome of Physical Therapist-Prescribed Exercise in Chronic Whiplash-Associated Disorders: Secondary Analysis of a Randomized Clinical Trial.

    Science.gov (United States)

    Ardern, Clare L; Peterson, Gunnel; Ludvigsson, Maria Landén; Peolsson, Anneli

    2016-08-01

    Study Design Secondary analysis of a randomized clinical trial. Background Patient perception of the benefits gained from treatment is important, yet satisfaction with the outcome of treatment for chronic whiplash-associated disorders (WADs) has not been investigated. Objectives To investigate whether satisfaction with the outcome of treatment for chronic WAD changed over time, and whether there were group differences. Methods Two hundred sixteen people with chronic WAD (66% women; mean age, 40.4 years) participated in a 3-month program of physical therapist-led neck-specific exercises with or without a behavioral approach, or received a prescription of general physical activity. The main outcome was satisfaction with the outcome of treatment, assessed at baseline and 3, 6, and 12 months later. Additional outcomes were enablement and expectation fulfillment. Results Satisfaction improved over time in the 3 groups (odds ratio = 1.15; 95% confidence interval: 1.10, 1.20; P<.001). There was a significant group-by-time interaction (P<.001), with increased odds of being satisfied in the groups receiving neck-specific exercises compared to general physical activity. Enablement increased after completion of the intervention in all groups (P<.001). People who received neck-specific exercises reported greater enablement and expectation fulfillment than people prescribed general physical activity (P<.01). Conclusion Exercise interventions for chronic WAD led to increased satisfaction for 12 months following treatment that was unrelated to the type of exercise intervention received. Level of Evidence Therapy, level 1b. Registered January 22, 2012 at www.ClinicalTrials.gov (NCT01528579). J Orthop Sports Phys Ther 2016;46(8):640-649. Epub 3 Jul 2016. doi:10.2519/jospt.2016.6136. PMID:27374016

  19. Clinical trials of homoeopathy.

    OpenAIRE

    Kleijnen, J.; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURE...

  20. Outcome of central nervous system relapses in childhood acute lymphoblastic leukaemia--prospective open cohort analyses of the ALLR3 trial.

    Directory of Open Access Journals (Sweden)

    Ashish Narayan Masurekar

    Full Text Available The outcomes of Central Nervous System (CNS relapses in children with acute lymphoblastic leukaemia (ALL treated in the ALL R3 trial, between January 2003 and March 2011 were analysed. Patients were risk stratified, to receive a matched donor allogeneic transplant or fractionated cranial irradiation with continued treatment for two years. A randomisation of Idarubicin with Mitoxantrone closed in December 2007 in favour of Mitoxantrone. The estimated 3-year progression free survival for combined and isolated CNS disease were 40.6% (25·1, 55·6 and 38.0% (26.2, 49.7 respectively. Univariate analysis showed a significantly better survival for age <10 years, progenitor-B cell disease, good-risk cytogenetics and those receiving Mitoxantrone. Adjusting for these variables (age, time to relapse, cytogenetics, treatment drug and gender a multivariate analysis, showed a poorer outcome for those with combined CNS relapse (HR 2·64, 95% CI 1·32, 5·31, p = 0·006 for OS. ALL R3 showed an improvement in outcome for CNS relapses treated with Mitoxantrone compared to Idarubicin; a potential benefit for matched donor transplant for those with very early and early isolated-CNS relapses.Controlled-Trials.com ISRCTN45724312.

  1. Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naïve patients with rheumatoid arthritis

    Science.gov (United States)

    Fleischmann, Roy; Strand, Vibeke; Wilkinson, Bethanie; Kwok, Kenneth; Bananis, Eustratios

    2016-01-01

    Objective To compare the relationship between clinical measures and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) treated with tofacitinib or methotrexate (MTX). Methods In a phase 3 randomised controlled trial, patients (N=956) who were MTX-naïve or had received ≤3 doses were randomised and received tofacitinib 5 or 10 mg twice daily or MTX titrated to 20 mg/week. Outcomes included: per cent of patients achieving American College of Rheumatology 70% responses (ACR70), ACR50, low disease activity (LDA) by Simplified Disease Activity Index (SDAI ≤11) and Clinical Disease Activity Index (CDAI ≤10), remission by SDAI (≤3.3) and CDAI (≤2.8), patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI scores <0.5), pain and global assessment of disease activity. Results At month 6, most patients who achieved LDA/remission by one definition achieved LDA/remission with others; however, discordance between measures was greater with MTX than with tofacitinib. As expected, concordance between CDAI and SDAI responses was high. Overall, patients achieving LDA or ACR50 responses reported less improvement in PROs (HAQ-DI, pain and patient global assessment) compared with clinical measures (tender and swollen joint counts). Conclusions Variability in levels of responses between clinical outcomes and PROs should be considered when setting treat-to-target goals in patients with RA. Trial registration number NCT01039688; Post-results. PMID:27175296

  2. The Magpie Trial follow up study: outcome after discharge from hospital for women and children recruited to a trial comparing magnesium sulphate with placebo for pre-eclampsia [ISRCTN86938761

    Directory of Open Access Journals (Sweden)

    2004-03-01

    Full Text Available Abstract Background The Magpie Trial compared magnesium sulphate with placebo for women with pre-eclampsia. 10,141 women were recruited, 8804 before delivery. Overall, 9024 children were included in the analysis of outcome at discharge from hospital. Magnesium sulphate more than halved the risk of eclampsia, and probably reduced the risk of maternal death. There did not appear to be any substantive harmful effects on the baby, in the short term. It is now important to assess whether these benefits persist, and to provide adequate reassurance about longer term safety. The main objective of the Magpie Trial Follow Up Study is to assess whether in utero exposure to magnesium sulphate has a clinically important effect on the child's chance of surviving without major neurosensory disability. Other objectives are to assess long term outcome for the mother, and to develop and assess appropriate strategies for following up large numbers of children in perinatal trials. Study design Follow up is only feasible in selected centres. We therefore anticipate contacting 2800–3350 families, for 2435–2915 of whom the woman was randomised before delivery. A further 280–335 children would have been eligible for follow up if they had survived. The total sample size for the children is therefore 3080–3685, 2680–3210 of whom will have been born to women randomised before delivery. Families eligible for the follow up will be contacted, and surviving children screened using the Ages and Stages Questionnaires. Children who screen positive, and a sample of those who screen negative, will whenever possible have a paediatric and neurodevelopmental assessment. When women are contacted to ask how their child is, they will also be asked about their own health. The primary outcome is a composite measure of death or neurosensory disability for the child at 18 months. Discussion The Follow Up Study began in 2002, and now involves collaborators in 19 countries. Data

  3. A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis

    OpenAIRE

    Bratton, D. J.; Phillips, P. P.; Parmar, M. K.

    2013-01-01

    Background Randomised controlled trials are becoming increasingly costly and time-consuming. In 2011, Royston and colleagues proposed a particular class of multi-arm multi-stage (MAMS) designs intended to speed up the evaluation of new treatments in phase II and III clinical trials. Their design, which controls the type I error rate and power for each pairwise comparison, discontinues randomisation to poorly performing arms at interim analyses if they fail to show a pre-specified level of ben...

  4. Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital.

    OpenAIRE

    Dahan, R.; Caulin, C; Figea, L; Kanis, J. A.; Caulin, F; Segrestaa, J M

    1986-01-01

    To examine whether written informed consent might influence the results of clinical trials the effect of placebo when given with or without informed consent to patients suffering from insomnia was studied. The study was a single blind observer blinded trial, and patients were paired according to sex, age, and hospital environment. Randomisation assigned the first patient of each pair to the control group (without informed consent) or the group to give informed consent. Of the 56 patients, 26 ...

  5. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial

    OpenAIRE

    Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; OKAMOTO, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

    2014-01-01

    Background Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of ...

  6. The secular trends in the incidence rate and outcomes of out-of-hospital cardiac arrest in Taiwan--a nationwide population-based study.

    Directory of Open Access Journals (Sweden)

    Cheng-Yi Wang

    Full Text Available This study investigated the trends in incidence and mortality of out-of-hospital cardiac arrest (OHCA, as well as factors associated with OHCA outcomes in Taiwan.Our study included OHCA patients requiring cardiopulmonary resuscitation (CPR upon arrival at the hospital. We used national time-series data on annual OHCA incidence rates and mortality rates from 2000 to 2012, and individual demographic and clinical data for all OHCA patients requiring mechanical ventilation (MV care from March of 2010 to September of 2011. Analytic techniques included the time-series regression and the logistic regression.There were 117,787 OHCAs in total. The overall incidence rate during the 13 years was 51.1 per 100,000 persons, and the secular trend indicates a sharp increase in the early 2000s and a decrease afterwards. The trend in mortality was also curvilinear, revealing a substantial increase in the early 2000s, a subsequent steep decline and finally a modest increase. Both the 30-day and 180-day mortality rates had a long-term decreasing trend over the period (p<0.01. For both incidence and mortality rates, a significant second-order autoregressive effect emerged. Among OHCA patients with MV, 1-day, 30-day and 180-day mortality rates were 31.3%, 75.8%, and 86.0%, respectively. In this cohort, older age, the female gender, and a Charlson comorbidity index score ≥ 2 were associated with higher 180-day mortality; patients delivered to regional hospitals and those residing in non-metropolitan areas had higher death risk.Overall, both the 30-day and the 180-day mortality rates after OHCA had a long-term decreasing trend, while the 1-day mortality had no long-term decline. Among OHCA patients requiring MV, those delivered to regional hospitals and those residing in non-metropolitan areas tended to have higher mortality, suggesting a need for effort to further standardize and improve in-hospital care across hospitals and to advance pre-hospital care in non

  7. Maintained intentional weight loss reduces cardiovascular outcomes

    DEFF Research Database (Denmark)

    Caterson, I D; Finer, N; Coutinho, W;

    2012-01-01

    Aim: The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Methods: Overweight...... randomization to first occurrence of a primary outcome event (non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death). Results: For the total population, mean weight change during Lead-in Period (sibutramine) was -2.54 kg. Post-randomization, mean total weight...... change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although...

  8. 2-year patient-related versus stent-related outcomes

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Christiansen, Evald Høj;

    2012-01-01

    , comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. METHODS: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2......, and 1,384 patients were assigned to receive the SES. RESULTS: At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15......OBJECTIVES: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES). BACKGROUND: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial...

  9. A cluster randomized-controlled trial of a classroom-based drama workshop program to improve mental health outcomes among immigrant and refugee youth in special classes.

    Directory of Open Access Journals (Sweden)

    Cécile Rousseau

    Full Text Available The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups.Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10, tutoring (n = 10 or control status (n = 9, for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports, impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom.The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents.The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences in the observed impact of

  10. Will Mobile Diabetes Education Teams (MDETs in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gucciardi Enza

    2012-09-01

    Full Text Available Abstract Background There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs in primary care settings in Canada. Methods/design This study will use a non-blinded, cluster-randomized controlled trial stepped wedge design to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged ≥18, who have type 2 diabetes and a hemoglobin A1c (HbA1c of ≥8%. Clusters (that is, primary care sites will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months. Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of ≤7% between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators’ field notes and debriefing sessions will be undertaken to assess the implementation process and effectiveness of the MDET intervention. Trial registration ClinicalTrials.gov NCT01553266

  11. Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation: A meta-analysis and systematic review of randomized controlled trials.

    Science.gov (United States)

    Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A; Arima, Hisatomi; Wang, Dao Wen

    2016-06-01

    Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin-angiotensin-aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin-angiotensin-aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive.A pooled study of 6 randomized controlled trials assessing the efficacy of renin-angiotensin-aldosterone blockers on subjects with atrial fibrillation was performed.A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76- 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70-0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2-2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0-6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0-0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: -0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction.This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation. PMID:27368043

  12. Can Rational Prescribing Be Improved by an Outcome-Based Educational Approach? A Randomized Trial Completed in Iran

    Science.gov (United States)

    Esmaily, Hamideh M.; Silver, Ivan; Shiva, Shadi; Gargani, Alireza; Maleki-Dizaji, Nasrin; Al-Maniri, Abdullah; Wahlstrom, Rolf

    2010-01-01

    Introduction: An outcome-based education approach has been proposed to develop more effective continuing medical education (CME) programs. We have used this approach in developing an outcome-based educational intervention for general physicians working in primary care (GPs) and evaluated its effectiveness compared with a concurrent CME program in…

  13. A Multicenter, Randomized, Open-Labeled, Parallel Group Trial of Sildenafil in Alcohol-Associated Erectile Dysfunction: The Impact on Psychosocial Outcomes

    Directory of Open Access Journals (Sweden)

    Alexander Grinshpoon

    2009-09-01

    Full Text Available To examine the effect of sildenafil on erectile dysfunction (ED and psychosocial outcomes in alcohol-dependent (AD men, 108 men with these diagnoses were randomly assigned to either take sildenafil (50 mg as add-on to standard treatment for AD, or the same treatment without sildenafil, for 12 weeks. Only 50 patients in sildenafil group and 51 in control group twice completed the International Index of Erectile Function (IIEF and a battery of self-report questionnaires. IIEF scores and psychosocial functioning, self-esteem and support from friends improved only for sildenafil-treated patients (P < 0.001. The high effect sizes suggest that the observed benefits are unlikely to be a placebo effect, although their unspecific nature could not be ruled out. In men with ED associated with AD, sildenafil improves both ED and psychosocial outcomes. Further placebo-controlled clinical trial is warranted.

  14. The implementation of a community-based aerobic walking program for mild to moderate knee osteoarthritis: A knowledge translation randomized controlled trial: Part II: Clinical outcomes

    Directory of Open Access Journals (Sweden)

    Brosseau Lucie

    2012-12-01

    Full Text Available Abstract Background Osteoarthritis (OA is the most common joint disorder in the world, as it is appears to be prevalent among 80% of individuals over the age of 75. Although physical activities such as walking have been scientifically proven to improve physical function and arthritic symptoms, individuals with OA tend to adopt a sedentary lifestyle. There is therefore a need to improve knowledge translation in order to influence individuals to adopt effective self-management interventions, such as an adapted walking program. Methods A single-blind, randomized control trial was conducted. Subjects (n = 222 were randomized to one of three knowledge translation groups: 1 Walking and Behavioural intervention (WB (18 males, 57 females which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking; 2 Walking intervention (W (24 males, 57 females wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet; 3 Self-directed control (C (32 males, 52 females wherein participants only received the educational pamphlet. One-way analyses of variance were used to test for differences in quality of life, adherence, confidence, and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period. Results The clinical and quality of life outcomes improved among participants in each of the three comparative groups. However, there were few statistically significant differences observed for quality of life and clinical outcomes at long-term measurements at 12-months end of intervention and at 6- months post intervention (18-month follow-up. Outcome results varied among the three groups. Conclusion The three groups were equivalent when determining the effectiveness of knowledge uptake and improvements in quality of life

  15. A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement

    Directory of Open Access Journals (Sweden)

    Zheng Hua

    2011-10-01

    Full Text Available Abstract Background Total knee replacement (TKR is a common and effective surgical procedure to relieve advanced knee arthritis that persists despite comprehensive medical treatment. Although TKR has excellent technical outcomes, significant variation in patient-reported functional improvement post-TKR exists. Evidence suggests that consistent post-TKR exercise and physical activity is associated with functional gain, and that this relationship is influenced by emotional health. The increasing use of TKR in the aging US population makes it critical to find strategies that maximize functional outcomes. Methods/Design This randomized clinical trial (RCT will test the efficacy of a theory-based telephone-delivered Patient Self-Management Support intervention that seeks to enhance adherence to independent exercise and activity among post- TKR patients. The intervention consists of 12 sessions, which begin prior to surgery and continue for approximately 9 weeks post-TKR. The intervention condition will be compared to a usual care control condition using a randomized design and a probabilistic sample of men and women. Assessments are conducted at baseline, eight weeks, and six- and twelve- months. The project is being conducted at a large healthcare system in Massachusetts. The study was designed to provide greater than 80% power for detecting a difference of 4 points in physical function (SF36/Physical Component Score between conditions (standard deviation of 10 at six months with secondary outcomes collected at one year, assuming a loss to follow up rate of no more than 15%. Discussion As TKR use expands, it is important to develop methods to identify patients at risk for sub-optimal functional outcome and to effectively intervene with the goal of optimizing functional outcomes. If shown efficacious, this peri-TKR intervention has the potential to change the paradigm for successful post-TKR care. We hypothesize that Patient Self-Management Support

  16. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME (TM))

    OpenAIRE

    Zinman, Bernard; Inzucchi, Silvio E.; Lachin, John M.; Wanner, Christoph; Ferrari, Roberto; Fitchett, David; Bluhmki, Erich; Hantel, Stefan; Kempthorne-Rawson, Joan; Newman, Jennifer; Johansen, Odd Erik; Woerle, Hans-Juergen; Broedl, Uli C.

    2015-01-01

    Background: Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with t...

  17. Use of 3D Printed Models in Medical Education: A Randomized Control Trial Comparing 3D Prints versus Cadaveric Materials for Learning External Cardiac Anatomy

    Science.gov (United States)

    Lim, Kah Heng Alexander; Loo, Zhou Yaw; Goldie, Stephen J.; Adams, Justin W.; McMenamin, Paul G.

    2016-01-01

    Three-dimensional (3D) printing is an emerging technology capable of readily producing accurate anatomical models, however, evidence for the use of 3D prints in medical education remains limited. A study was performed to assess their effectiveness against cadaveric materials for learning external cardiac anatomy. A double blind randomized…

  18. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery

    DEFF Research Database (Denmark)

    Gill, Ravi; Herbertson, Mike; Vuylsteke, Alain;

    2009-01-01

    BACKGROUND: Blood loss is a common complication of cardiac surgery. Evidence suggests that recombinant activated factor VII (rFVIIa) can decrease intractable bleeding in patients after cardiac surgery. Our objective was to investigate the safety and possible benefits of rFVIIa in patients who bleed...... after cardiac surgery. METHODS AND RESULTS: In this phase II dose-escalation study, patients who had undergone cardiac surgery and were bleeding were randomized to receive placebo (n=68), 40 microg/kg rFVIIa (n=35), or 80 microg/kg rFVIIa (n=69). The primary end points were the number of patients....../kg, 14%; P=0.25; 80 microg/kg, 12%; P=0.43). After randomization, significantly fewer patients in the rFVIIa group underwent a reoperation as a result of bleeding (P=0.03) or required allogeneic transfusions (P=0.01). CONCLUSIONS: On the basis of this preliminary evidence, rFVIIa may be beneficial for...

  19. Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference

    OpenAIRE

    Klaber Moffett, Jennifer A; Jackson, David A.; Richmond, Stewart; Hahn, Seokyung; Coulton, Simon; Farrin, Amanda; Manca, Andrea; Torgerson, David J

    2005-01-01

    Objectives Firstly, to compare the effectiveness of a brief physiotherapy intervention with “usual” physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome.

  20. Cardiac rehabilitation in Germany.

    Science.gov (United States)

    Karoff, Marthin; Held, Klaus; Bjarnason-Wehrens, Birna

    2007-02-01

    The purpose of this review is to give an overview of the rehabilitation measures provided for cardiac patients in Germany and to outline its legal basis and outcomes. In Germany the cardiac rehabilitation system is different from rehabilitation measures in other European countries. Cardiac rehabilitation in Germany since 1885 is based on specific laws and the regulations of insurance providers. Cardiac rehabilitation has predominantly been offered as an inpatient service, but has recently been complemented by outpatient services. A general agreement on the different indications for offering these two services has yet to be reached. Cardiac rehabilitation is mainly offered after an acute cardiac event and bypass surgery. It is also indicated in severe heart failure and special cases of percutaneous coronary intervention. Most patients are men (>65%) and the age at which events occur is increasing. The benefits obtained during the 3-4 weeks after an acute event, and confirmed in numerous studies, are often later lost under 'usual care' conditions. Many attempts have been made by rehabilitation institutions to improve this deficit by providing intensive aftercare. One instrument set up to achieve this is the nationwide institution currently comprising more than 6000 heart groups with approximately 120000 outpatients. After coronary artery bypass grafting or acute coronary syndrome cardiac rehabilitation can usually be started within 10 days. The multidisciplinary rehabilitation team consists of cardiologists, psychologists, exercise therapists, social workers, nutritionists and nurses. The positive effects of cardiac rehabilitation are also important economically, for example, for the improvement of secondary prevention and vocational integration. PMID:17301623